Hospital Medicine

Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.¹ Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.² Promotion is often used as a proxy measure for academic success.

Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.^3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).^3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).^3,4

Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.

Study Design, Setting, and Participants

We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.⁵ Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.

Data Collection

The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.

Sample Size Determination

Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.⁶

Data Analysis

By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.

Thematic Mapping to Organizing Themes of the Conceptual Model (Table)

The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.

Intrinsic—Job Satisfaction

With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.

“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”

This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.

“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”

This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.

“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”

The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.

“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”

Intrinsic—Career Satisfaction

Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.

“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”

Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.

“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”

Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.

Extrinsic—Advancement

Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.

Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.

“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”

Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.

Extrinsic—Compensation

Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.

Unexpected Findings

While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.

“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”

The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.

“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”

Conflict Among Organizing Themes

At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.

“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”

Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.

Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”^4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.

The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.

Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.

While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.⁹ Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.⁹

The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.

Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.

Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.

Disclosure: The authors have nothing to disclose.

Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.¹ Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.² Promotion is often used as a proxy measure for academic success.

Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.^3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).^3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).^3,4

Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.

Study Design, Setting, and Participants

We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.⁵ Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.

Data Collection

The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.

Sample Size Determination

Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.⁶

Data Analysis

By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.

Thematic Mapping to Organizing Themes of the Conceptual Model (Table)

The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.

Intrinsic—Job Satisfaction

With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.

“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”

This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.

“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”

This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.

“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”

The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.

“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”

Intrinsic—Career Satisfaction

Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.

“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”

Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.

“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”

Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.

Extrinsic—Advancement

Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.

Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.

“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”

Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.

Extrinsic—Compensation

Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.

Unexpected Findings

While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.

“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”

The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.

“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”

Conflict Among Organizing Themes

At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.

“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”

Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.

Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”^4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.

The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.

Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.

While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.⁹ Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.⁹

The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.

Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.

Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.

Disclosure: The authors have nothing to disclose.

Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.¹ Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.² Promotion is often used as a proxy measure for academic success.

Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.^3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).^3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).^3,4

Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.

Study Design, Setting, and Participants

We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.⁵ Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.

Interview Guide Development and Content

The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.

Data Collection

The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.

Sample Size Determination

Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.⁶

Data Analysis

By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.

Thematic Mapping to Organizing Themes of the Conceptual Model (Table)

The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.

Intrinsic—Job Satisfaction

With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.

“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”

This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.

“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”

This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.

“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”

The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.

“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”

Intrinsic—Career Satisfaction

Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.

“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”

Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.

“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”

Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.

Extrinsic—Advancement

Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.

Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.

“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”

Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.

Extrinsic—Compensation

Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.

Unexpected Findings

While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.

“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”

The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.

“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”

Conflict Among Organizing Themes

At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.

“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”

Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.

Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”^4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.

The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.

Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.

While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.⁹ Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.⁹

The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.

Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.

Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.

Disclosure: The authors have nothing to disclose.

The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.^1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.^3,4

However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.^5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.⁸

There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.^9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”¹¹ In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.¹² The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.

Study Design

This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.

Selection and Grading of Progress Notes

Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).¹²

Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.¹³

Statistical Analysis

Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).

The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.

A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.¹¹ We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.

Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.^6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.

The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.^14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.¹⁷ Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.¹⁹ Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.

We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.^20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.

Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.

Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.²¹ However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.²³ The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.

Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.^15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.

Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”¹⁹ Institutions should consider developing internal best practices for clinical documentation and building structured note templates.¹⁹ Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.

The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.

Disclosure: The authors declare no conflicts of interest.

The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.^1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.^3,4

However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.^5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.⁸

There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.^9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”¹¹ In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.¹² The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.

Study Design

This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.

Selection and Grading of Progress Notes

Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).¹²

Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.¹³

Statistical Analysis

Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).

The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.

A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.¹¹ We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.

Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.^6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.

The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.^14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.¹⁷ Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.¹⁹ Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.

We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.^20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.

Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.

Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.²¹ However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.²³ The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.

Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.^15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.

Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”¹⁹ Institutions should consider developing internal best practices for clinical documentation and building structured note templates.¹⁹ Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.

The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.

Disclosure: The authors declare no conflicts of interest.

The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.^1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.^3,4

However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.^5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.⁸

There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.^9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”¹¹ In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.¹² The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.

Study Design

This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.

Selection and Grading of Progress Notes

Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).¹²

Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.¹³

Statistical Analysis

Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).

The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.

A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.¹¹ We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.

Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.^6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.

The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.^14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.¹⁷ Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.¹⁹ Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.

We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.^20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.

Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.

Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.²¹ However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.²³ The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.

Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.^15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.

Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”¹⁹ Institutions should consider developing internal best practices for clinical documentation and building structured note templates.¹⁹ Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.

The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.

Disclosure: The authors declare no conflicts of interest.

The American Board of Internal Medicine (ABIM) changed its certification policy for bedside procedures over a decade ago.¹ Acquiring manual competence in abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis is no longer an expectation of residency training. ABIM diplomates should “know” these procedures but not necessarily “do” them. Hospitalists, most of whom are themselves ABIM diplomates, are still, however, expected to do them as core competencies,²perhaps because hospitalists are often available off-hours, when roughly half of bedside procedures are performed.³

Hospitalists increasingly perform bedside procedures with ultrasound guidance.⁴ Yet training in ultrasound guidance is significantly varied as well,⁵ simply because point-of-care ultrasound (POCUS) has only recently become widespread.⁶ And though some skills are transferrable from landmark-guided to ultrasound -guided procedures, many are not.^7-10 Furthermore, ultrasound guidance is often not explicitly delineated on the privileging forms used by hospitals,¹¹ even where ultrasound guidance has become standard.¹²

Working Group Formation

In January 2015, the SHM Board of Directors asked the SHM Education Committee to convene the POCUS Task Force. The purpose of the task force was to develop recommendations on ultrasound guidance for bedside procedures. The SHM Education Committee appointed 3 chairs of the task force: 1 senior member of the SHM Education Committee and 2 POCUS experts. The chairs assembled a task force of 31 members that included 5 working groups, a multispecialty peer review group, and a guideline methodologist (supplemental Appendix 1). Invitation was based on members’ past contributions to SHM POCUS-related activities, up-front commitment, and declared conflicts of interest. Working group members self-identified as “hospitalists,” whereas peer reviewers were nonhospitalists but nationally recognized POCUS physician-leaders specializing in emergency medicine, cardiology, critical care medicine, and anesthesiology. Task force membership was vetted by a chair of the SHM POCUS Task Force and the Director of Education before work began. This position statement was authored by the Credentialing Working Group together with the chairs of the other 4 working groups and a guideline methodologist.

Disclosures

Signed disclosure statements of all task force members were reviewed prior to inclusion on the task force (supplemental Appendix 2); no members received honoraria for participation. Industry representatives did not contribute to the development of the guidelines nor to any conference calls or meetings.

Literature Search Strategy

A literature search was conducted by a biomedical librarian. Records from 1979 to January of 2017 were searched in Medline, Embase, CINAHL, Cochrane, and Google Scholar (supplemental Appendix 3). Search limiters were English language and adults. Articles were manually screened to exclude nonhuman or endoscopic ultrasound applications. Final article selection was based on working group consensus.

Draft Pathways

The Credentialing Working Group drafted initial and ongoing certification pathways (Figure 1 and Figure 2). The other 4 working groups from the task force were surveyed about the elements and overall appropriateness of these draft pathways. This survey and its results have already been published.¹² The Credentialing Working Group then revised the certification pathways by using these survey results and codified individual aspects of these pathways into recommendations.

Development of Position Statement

Based on the Grading of Recommendation Assessment Development and Evaluation methodology, all final article selections were initially rated as either low-quality (observational studies) or unclassifiable (expert opinion).¹⁶ These initial ratings were downgraded further because of indirectness, because none of the articles involved the intervention of interest (a credentialing pathway) in a population of interest (hospitalists) measuring the outcomes of interest (patient-level outcomes).¹⁷ Given the universal low-quality evidence ratings, we altered the task force strategy of developing guidelines, which the other 4 working groups are writing, and instead developed a position statement by using consensus gathering in 3 steps.

First, the Credentialing Working Group drafted an initial position statement composed of recommendations for credentialing pathways and other general aspects of credentialing. All final article selections were incorporated as references in a draft of the position statement and compiled in a full-text compendium. Second, feedback was provided by the other 4 task force working groups, the task force peer reviewers, and the SHM Education Committee. Feedback was incorporated by the authors of this statement who were the Credentialing Working Group, the chairs of the other 4 working groups, and a guideline methodologist. Third, final suggestions from all members of the SHM POCUS Task Force and SHM Education Committee were incorporated before final approval by the SHM Board of Directors in September 2017.

A total of 1438 references were identified in the original search. Manual selection led to 101 articles, which were incorporated into the following 4 domains with 16 recommendations.

General Credentialing Process

Basic Cognitive Competence Can Be Certified with Written or Oral Examinations

The ABIM defines cognitive competence as having 3 abilities: “(1) to explain indications, contraindications, patient preparation methods, sterile techniques, pain management, proper techniques for handling specimens and fluids obtained, and test results; (2) to recognize and manage complications; and, (3) to clearly explain to a patient all facets of the procedure necessary to obtain informed consent.”¹ These abilities can be assessed with written or oral examinations that may be integrated into simulation- or patient-based assessments.^18-21

Minimum Thresholds of Experience to Trigger the Timing of a Patient-Based Assessment Should Be Determined by Empirical Methods

Learning curves are highly variable^22-25 and even plateaus may not herald basic competence.²⁶ Expert opinions²⁷ can be used to establish minimum thresholds of experience, but such opinions may paradoxically exceed the current thresholds of experts’ own hospitals.¹² Thus, empirical methods, such as those based on cumulative sum analysis^28-30 or local learning curves,^31,32 are preferred. If such methods are not available, a recent survey of hospitalist experts may provide guidance.¹² Regardless, once established, minimum thresholds are necessary but not sufficient to determine competency (see “Basic manual competence must be certified through patient-based assessments” section).

Hospitalists Should Formally Log All of Their Attempted Procedures, Ideally in an Electronic Medical Record

Simple self-reported numbers of procedures performed often misrepresent actual experience^33,34 and do not include periprocedural complications.^35,36 Thus, hospitalists should report their experience with logs of all attempted procedures, both successful and unsuccessful. Such logs must include information about supervising providers (if applicable) and patient outcomes, including periprocedural adverse events,³⁷ but they must also remain compliant with the Health Insurance Portability and Accountability Act.

Health Information Technology Service Should Routinely Pull Collations of All Attempted Procedures from Comprehensive Electronic Medical Records

Active surveillance may reduce complications by identifying hospitalists who may benefit from further training.³⁸ In order to facilitate active surveillance systems, documentation (such as a procedure note) should be both integrated into an electronic medical record and protocol driven,³⁹ including procedure technique, ultrasound findings, and any safety events (both near misses and adverse events).

Basic Manual Competence Must Be Certified Through Patient-Based Assessments

Multiple interacting factors, including environment, patients, baseline skills, training, experience, and skills decay, affect manual competence. Certifications that are based solely on reaching minimum thresholds of experience, even when accurate, are not valid reflections of manual competence,^15,40-43 and neither are those based on self-perception.⁴⁴ Patient-based assessments are, thus, necessary to ensure manual competence.^45-48

Certification Assessments of Manual Competence Should Combine 2 Types of Structured Instruments: Checklists and Overall Scores

Assessments based on direct observation are more reliable when formally structured.^49,50 Though checklists used in observed structured clinical examinations capture many important manual skills,^51-56 they do not completely reflect a hospitalist’s manual competence;⁵⁷ situations may occur in which a hospitalist meets all the individual items on a checklist but cannot perform an entire procedure with basic competence. Therefore, checklists should be paired with overall scores.^58-61 Both checklists and overall scores ought to be obtained from reliable and valid instruments.

Certification Assessments Should Include Feedback

Assessments without feedback are missed learning opportunities.⁶² Both simulation-⁶³ and patient-based assessments should provide feedback in real time to reinforce effective behaviors and remedy faulty ones.

If Remedial Training is Needed, Simulator-Based Training Can Supplement but Not Replace Patient-Based Training

Supervised simulator-based training allows hospitalists to master basic components of a procedure⁶⁴ (including orientation to equipment, sequence of operations, dexterity, ultrasound anatomy, and real-time guidance technique) while improving both cognitive and manual skills.^42,43,65-71 In addition to their role in basic training (which is outside the scope of this position statement), simulators can be useful for remedial training. To be sufficient for hospitalists who do not pass their patient-based assessments, however, remedial training that begins with simulation must also include patient-based training and assessment.^72-75

Initial Credentialing Process

A Minimum Threshold of Experience Should Be Reached before Patient-Based Assessments are Conducted (Figure 1)

Initial Certification Assessments Should Ideally Begin on Simulators

Simulators allow the assurance of safe manual skills, including proper needle insertion techniques and disposal of sharp objects.^3,79 If simulators are not available, however, then patient-based training and assessments can still be performed under direct observation. Safe performance of ultrasound-guided procedures during patient-based assessments (without preceding simulator-based assessments) is sufficient to certify manual competence.

Ongoing Credentialing

Certification to Perform Ultrasound-Guided Procedures Should Be Routinely Re-Evaluated During Ongoing Credentialing (Figure 2)

Observed Patient-Based Assessments Should Occur When a Periprocedural Safety Event Occurs that is Potentially Caused by “Provider Error”

Safety events include both near misses and adverse events. Information about both is ideally “flagged” and “pushed” to hospitalist group leaders by active surveillance and reporting systems. Once reviewed, if a safety event is considered to potentially have been caused by provider error (including knowledge- and skill-based errors),⁸³ then the provider who performed the procedure should undergo an observed patient-based assessment.

Simulation-Based Practice Can Supplement Patient-Based Experience for Ongoing Credentialing

When hospitalists do not achieve a minimum threshold of patient-based experience since the antecedent certification, simulation-based training can supplement their patient-based experience.⁸⁴ In these cases, however, an observed patient-based assessment must occur. Another consideration is whether or not the privilege should be relinquished because of an infrequent need.

Credentialing Infrastructure

Hospitalists Themselves Should Not Bear the Financial Costs of Developing and Maintaining Training and Certification Programs for Ultrasound-Guided Procedures

Equipment and personnel costs^85,86 commonly impede ultrasound-guided procedure programs.^4,87,88 Hospitalists whose job descriptions include the performance of ultrasound-guided procedures should not be expected to bear the costs of ultrasound machines, image archival software, equipment maintenance, and initial and ongoing training and certification.

Assessors Should Be Unbiased Expert Providers Who Have Demonstrated Mastery in Performance of the Procedure Being Assessed and Regularly Perform It in a Similar Practice Environment

Assessors should be expert providers who regularly perform the ultrasound-guided procedure in a similar practice environment.^9,89-94 For example, providers who are not hospitalists but who are experts in an ultrasound-guided procedure and commonly perform it on the hospital wards would be acceptable assessors. However, a radiologist who only performs that procedure in a fully-staffed interventional radiology suite with fluoroscopy or computed tomography guidance would not be an acceptable assessor. More than 1 assessor may balance idiosyncratic assessments;⁹⁵ but when assessments are well structured, additional assessors are generally not needed.¹⁸Candidate assessors should be vetted by the hospitalist group leader and the hospital privileging committee.

If Intramural Assessors Are Not Available, Extramural Assessors May Be Considered

Intramural assessors are generally preferred because of familiarity with the local practice environment, including the available procedure kits and typical patient characteristics. Nevertheless, extramural assessors^27,77,85,96 may theoretically provide even more valid assessments than intramural ones because extramural assessors are neither influenced by relationships with local hospitalists nor biased by local hospitalists’ skills.^97,98 Remote performance assessment through video recordings⁹⁹ or live-video streaming is another option¹⁰⁰ but is not sufficient unless a room camera is available to simultaneously view probe movement and the ultrasound screen.¹⁰¹ In addition, remote assessment does not allow the assessor to physically assume control of the procedure to either salvage it or perhaps, in some cases, prevent a complication.

There are no high-quality randomized trials in support of a single credentialing pathway over any other.^94,102 The credentialing pathways at the center of this position statement are based on expert opinion. Our methods can be criticized straightaway, therefore, for reliance on the experience and expertise of our working group and task force. Any position statement written without high-quality supportive evidence would be appropriately subject to the same criticism. Without evidence in support of an overall pathway, we codified specific aspects of the pathways into 16 individual recommendations.

Patient-level outcomes do not back these recommendations. Consider, for example, our recommendation that certification assessments be made from structured instruments and not simply from an assessor’s gestalt. Here, the basis is not improved patient-level outcomes from a trial (such as reduced complications or increased procedural success) but improved psychometric performance from reliability studies. The body of evidence for our recommendations is similarly indirect, mostly because the outcomes studied are more proximate and, thus, less meaningful than patient-level outcomes, which are the outcomes of greatest interest but are woefully understudied for clinical competence.^17,97,103

The need for high-quality evidence is most pronounced in distinguishing how recommendations should be modified for various settings. Wide variations in resources and patient-mix will make some recommendations impracticable, meaning that they could not be carried out with available resources. For example, our recommendation that credentialing decisions should ultimately rely on certifications made by assessors during patient-based assessments may not be practicable at small, rural hospitals. Such hospitals may not have access to local assessors, and they may not admit enough patients who need the types of ultrasound-guided procedures for which hospitalists seek certification (especially given the need to coordinate the schedules of patients, procedure-performing hospitalists, and assessors). Collaborative efforts between hospitals for regional certification may be a potential solution to consider. But if recommendations are truly impracticable, the task force recognizes they may need to be modified. Given the low quality of evidence supporting our recommendations, such modifications would be readily defendable, especially if they emerged from collaborative discussions between privileging committees, hospitalist directors, and local experts.

One way for hospitals to implement our recommendations may be to follow a recommendation proposed by the authors of the original hospitalist core competencies over a decade ago: “The presence of a procedural skill in the Core Competencies does not necessarily indicate that every hospitalist will perform or be proficient in that procedure.”¹⁰⁴ In other words, bedside procedures may be delegated to some but not all hospitalists. Such “proceduralists” would have some proportion of their clinical responsibility dedicated to performing procedures. Delineation of this job description must be made locally because it balances 2 hospital-specific characteristics: patients’ needs for procedures against the availability of providers with basic competence to perform them, which includes hospitalists but also emergency medicine physicians, specialists, and interventional radiologists. A salutary benefit for hospitals is that hospitalists who are not proceduralists would not need to undergo certification in basic competence for the bedside procedures they will not be performing.

Regardless of whether some or all hospitalists at a particular hospital are expected to perform bedside procedures, technology may help to improve the practicability of our recommendations. For example, simulators may evolve to replace actual patient-level experience in achieving minimum thresholds. Certification assessments of manual skills may even someday occur entirely on simulators. Real-time high-definition video streaming enhanced with multiple cameras may allow for remote assessments. Until such advances mature, high-quality patient-level data should be sought through additional research to refine our current recommendations.

We hope that these recommendations will improve how basic competence in ultrasound-guided bedside procedures is assessed. Our ultimate goal is to improve how hospitalists perform these procedures. Patient safety is, therefore, considered paramount to cost. Nevertheless, the hospital administrative leaders and privileging committee members on our Task Force concluded that many hospitals have been seeking guidance on credentialing for bedside procedures, and the likely difficulties of implementing our recommendations (including cost) would not be prohibitive at most hospitals, especially given recognition that these recommendations can be tailored to each setting.

Collaborators from SHM POCUS Task Force are Saaid Abdel-Ghani, Michael Blaivas, Dan Brotman, Carolina Candotti, Jagriti Chadha, Joel Cho, Ria Dancel, Ricardo Franco, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Benji Mathews, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, Jeff Bates, Anjali Bhagra, Kreegan Reierson, Robert Arntfield, Paul Mayo, Loretta Grikis.

Disclosure

Brian P. Lucas received funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086). Nilam Soni received funding from the Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (HX002263-01A1). The contents of this publication do not represent the views of the United States Department of Veterans Affairs or the United States Government.

The American Board of Internal Medicine (ABIM) changed its certification policy for bedside procedures over a decade ago.¹ Acquiring manual competence in abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis is no longer an expectation of residency training. ABIM diplomates should “know” these procedures but not necessarily “do” them. Hospitalists, most of whom are themselves ABIM diplomates, are still, however, expected to do them as core competencies,²perhaps because hospitalists are often available off-hours, when roughly half of bedside procedures are performed.³

Hospitalists increasingly perform bedside procedures with ultrasound guidance.⁴ Yet training in ultrasound guidance is significantly varied as well,⁵ simply because point-of-care ultrasound (POCUS) has only recently become widespread.⁶ And though some skills are transferrable from landmark-guided to ultrasound -guided procedures, many are not.^7-10 Furthermore, ultrasound guidance is often not explicitly delineated on the privileging forms used by hospitals,¹¹ even where ultrasound guidance has become standard.¹²

Working Group Formation

In January 2015, the SHM Board of Directors asked the SHM Education Committee to convene the POCUS Task Force. The purpose of the task force was to develop recommendations on ultrasound guidance for bedside procedures. The SHM Education Committee appointed 3 chairs of the task force: 1 senior member of the SHM Education Committee and 2 POCUS experts. The chairs assembled a task force of 31 members that included 5 working groups, a multispecialty peer review group, and a guideline methodologist (supplemental Appendix 1). Invitation was based on members’ past contributions to SHM POCUS-related activities, up-front commitment, and declared conflicts of interest. Working group members self-identified as “hospitalists,” whereas peer reviewers were nonhospitalists but nationally recognized POCUS physician-leaders specializing in emergency medicine, cardiology, critical care medicine, and anesthesiology. Task force membership was vetted by a chair of the SHM POCUS Task Force and the Director of Education before work began. This position statement was authored by the Credentialing Working Group together with the chairs of the other 4 working groups and a guideline methodologist.

Disclosures

Signed disclosure statements of all task force members were reviewed prior to inclusion on the task force (supplemental Appendix 2); no members received honoraria for participation. Industry representatives did not contribute to the development of the guidelines nor to any conference calls or meetings.

Literature Search Strategy

A literature search was conducted by a biomedical librarian. Records from 1979 to January of 2017 were searched in Medline, Embase, CINAHL, Cochrane, and Google Scholar (supplemental Appendix 3). Search limiters were English language and adults. Articles were manually screened to exclude nonhuman or endoscopic ultrasound applications. Final article selection was based on working group consensus.

Draft Pathways

The Credentialing Working Group drafted initial and ongoing certification pathways (Figure 1 and Figure 2). The other 4 working groups from the task force were surveyed about the elements and overall appropriateness of these draft pathways. This survey and its results have already been published.¹² The Credentialing Working Group then revised the certification pathways by using these survey results and codified individual aspects of these pathways into recommendations.

Development of Position Statement

Based on the Grading of Recommendation Assessment Development and Evaluation methodology, all final article selections were initially rated as either low-quality (observational studies) or unclassifiable (expert opinion).¹⁶ These initial ratings were downgraded further because of indirectness, because none of the articles involved the intervention of interest (a credentialing pathway) in a population of interest (hospitalists) measuring the outcomes of interest (patient-level outcomes).¹⁷ Given the universal low-quality evidence ratings, we altered the task force strategy of developing guidelines, which the other 4 working groups are writing, and instead developed a position statement by using consensus gathering in 3 steps.

First, the Credentialing Working Group drafted an initial position statement composed of recommendations for credentialing pathways and other general aspects of credentialing. All final article selections were incorporated as references in a draft of the position statement and compiled in a full-text compendium. Second, feedback was provided by the other 4 task force working groups, the task force peer reviewers, and the SHM Education Committee. Feedback was incorporated by the authors of this statement who were the Credentialing Working Group, the chairs of the other 4 working groups, and a guideline methodologist. Third, final suggestions from all members of the SHM POCUS Task Force and SHM Education Committee were incorporated before final approval by the SHM Board of Directors in September 2017.

A total of 1438 references were identified in the original search. Manual selection led to 101 articles, which were incorporated into the following 4 domains with 16 recommendations.

General Credentialing Process

Basic Cognitive Competence Can Be Certified with Written or Oral Examinations

The ABIM defines cognitive competence as having 3 abilities: “(1) to explain indications, contraindications, patient preparation methods, sterile techniques, pain management, proper techniques for handling specimens and fluids obtained, and test results; (2) to recognize and manage complications; and, (3) to clearly explain to a patient all facets of the procedure necessary to obtain informed consent.”¹ These abilities can be assessed with written or oral examinations that may be integrated into simulation- or patient-based assessments.^18-21

Minimum Thresholds of Experience to Trigger the Timing of a Patient-Based Assessment Should Be Determined by Empirical Methods

Learning curves are highly variable^22-25 and even plateaus may not herald basic competence.²⁶ Expert opinions²⁷ can be used to establish minimum thresholds of experience, but such opinions may paradoxically exceed the current thresholds of experts’ own hospitals.¹² Thus, empirical methods, such as those based on cumulative sum analysis^28-30 or local learning curves,^31,32 are preferred. If such methods are not available, a recent survey of hospitalist experts may provide guidance.¹² Regardless, once established, minimum thresholds are necessary but not sufficient to determine competency (see “Basic manual competence must be certified through patient-based assessments” section).

Hospitalists Should Formally Log All of Their Attempted Procedures, Ideally in an Electronic Medical Record

Simple self-reported numbers of procedures performed often misrepresent actual experience^33,34 and do not include periprocedural complications.^35,36 Thus, hospitalists should report their experience with logs of all attempted procedures, both successful and unsuccessful. Such logs must include information about supervising providers (if applicable) and patient outcomes, including periprocedural adverse events,³⁷ but they must also remain compliant with the Health Insurance Portability and Accountability Act.

Health Information Technology Service Should Routinely Pull Collations of All Attempted Procedures from Comprehensive Electronic Medical Records

Active surveillance may reduce complications by identifying hospitalists who may benefit from further training.³⁸ In order to facilitate active surveillance systems, documentation (such as a procedure note) should be both integrated into an electronic medical record and protocol driven,³⁹ including procedure technique, ultrasound findings, and any safety events (both near misses and adverse events).

Basic Manual Competence Must Be Certified Through Patient-Based Assessments

Multiple interacting factors, including environment, patients, baseline skills, training, experience, and skills decay, affect manual competence. Certifications that are based solely on reaching minimum thresholds of experience, even when accurate, are not valid reflections of manual competence,^15,40-43 and neither are those based on self-perception.⁴⁴ Patient-based assessments are, thus, necessary to ensure manual competence.^45-48

Certification Assessments of Manual Competence Should Combine 2 Types of Structured Instruments: Checklists and Overall Scores

Assessments based on direct observation are more reliable when formally structured.^49,50 Though checklists used in observed structured clinical examinations capture many important manual skills,^51-56 they do not completely reflect a hospitalist’s manual competence;⁵⁷ situations may occur in which a hospitalist meets all the individual items on a checklist but cannot perform an entire procedure with basic competence. Therefore, checklists should be paired with overall scores.^58-61 Both checklists and overall scores ought to be obtained from reliable and valid instruments.

Certification Assessments Should Include Feedback

Assessments without feedback are missed learning opportunities.⁶² Both simulation-⁶³ and patient-based assessments should provide feedback in real time to reinforce effective behaviors and remedy faulty ones.

If Remedial Training is Needed, Simulator-Based Training Can Supplement but Not Replace Patient-Based Training

Supervised simulator-based training allows hospitalists to master basic components of a procedure⁶⁴ (including orientation to equipment, sequence of operations, dexterity, ultrasound anatomy, and real-time guidance technique) while improving both cognitive and manual skills.^42,43,65-71 In addition to their role in basic training (which is outside the scope of this position statement), simulators can be useful for remedial training. To be sufficient for hospitalists who do not pass their patient-based assessments, however, remedial training that begins with simulation must also include patient-based training and assessment.^72-75

Initial Credentialing Process

A Minimum Threshold of Experience Should Be Reached before Patient-Based Assessments are Conducted (Figure 1)

Initial Certification Assessments Should Ideally Begin on Simulators

Simulators allow the assurance of safe manual skills, including proper needle insertion techniques and disposal of sharp objects.^3,79 If simulators are not available, however, then patient-based training and assessments can still be performed under direct observation. Safe performance of ultrasound-guided procedures during patient-based assessments (without preceding simulator-based assessments) is sufficient to certify manual competence.

Ongoing Credentialing

Certification to Perform Ultrasound-Guided Procedures Should Be Routinely Re-Evaluated During Ongoing Credentialing (Figure 2)

Observed Patient-Based Assessments Should Occur When a Periprocedural Safety Event Occurs that is Potentially Caused by “Provider Error”

Safety events include both near misses and adverse events. Information about both is ideally “flagged” and “pushed” to hospitalist group leaders by active surveillance and reporting systems. Once reviewed, if a safety event is considered to potentially have been caused by provider error (including knowledge- and skill-based errors),⁸³ then the provider who performed the procedure should undergo an observed patient-based assessment.

Simulation-Based Practice Can Supplement Patient-Based Experience for Ongoing Credentialing

When hospitalists do not achieve a minimum threshold of patient-based experience since the antecedent certification, simulation-based training can supplement their patient-based experience.⁸⁴ In these cases, however, an observed patient-based assessment must occur. Another consideration is whether or not the privilege should be relinquished because of an infrequent need.

Credentialing Infrastructure

Hospitalists Themselves Should Not Bear the Financial Costs of Developing and Maintaining Training and Certification Programs for Ultrasound-Guided Procedures

Equipment and personnel costs^85,86 commonly impede ultrasound-guided procedure programs.^4,87,88 Hospitalists whose job descriptions include the performance of ultrasound-guided procedures should not be expected to bear the costs of ultrasound machines, image archival software, equipment maintenance, and initial and ongoing training and certification.

Assessors Should Be Unbiased Expert Providers Who Have Demonstrated Mastery in Performance of the Procedure Being Assessed and Regularly Perform It in a Similar Practice Environment

Assessors should be expert providers who regularly perform the ultrasound-guided procedure in a similar practice environment.^9,89-94 For example, providers who are not hospitalists but who are experts in an ultrasound-guided procedure and commonly perform it on the hospital wards would be acceptable assessors. However, a radiologist who only performs that procedure in a fully-staffed interventional radiology suite with fluoroscopy or computed tomography guidance would not be an acceptable assessor. More than 1 assessor may balance idiosyncratic assessments;⁹⁵ but when assessments are well structured, additional assessors are generally not needed.¹⁸Candidate assessors should be vetted by the hospitalist group leader and the hospital privileging committee.

If Intramural Assessors Are Not Available, Extramural Assessors May Be Considered

Intramural assessors are generally preferred because of familiarity with the local practice environment, including the available procedure kits and typical patient characteristics. Nevertheless, extramural assessors^27,77,85,96 may theoretically provide even more valid assessments than intramural ones because extramural assessors are neither influenced by relationships with local hospitalists nor biased by local hospitalists’ skills.^97,98 Remote performance assessment through video recordings⁹⁹ or live-video streaming is another option¹⁰⁰ but is not sufficient unless a room camera is available to simultaneously view probe movement and the ultrasound screen.¹⁰¹ In addition, remote assessment does not allow the assessor to physically assume control of the procedure to either salvage it or perhaps, in some cases, prevent a complication.

There are no high-quality randomized trials in support of a single credentialing pathway over any other.^94,102 The credentialing pathways at the center of this position statement are based on expert opinion. Our methods can be criticized straightaway, therefore, for reliance on the experience and expertise of our working group and task force. Any position statement written without high-quality supportive evidence would be appropriately subject to the same criticism. Without evidence in support of an overall pathway, we codified specific aspects of the pathways into 16 individual recommendations.

Patient-level outcomes do not back these recommendations. Consider, for example, our recommendation that certification assessments be made from structured instruments and not simply from an assessor’s gestalt. Here, the basis is not improved patient-level outcomes from a trial (such as reduced complications or increased procedural success) but improved psychometric performance from reliability studies. The body of evidence for our recommendations is similarly indirect, mostly because the outcomes studied are more proximate and, thus, less meaningful than patient-level outcomes, which are the outcomes of greatest interest but are woefully understudied for clinical competence.^17,97,103

The need for high-quality evidence is most pronounced in distinguishing how recommendations should be modified for various settings. Wide variations in resources and patient-mix will make some recommendations impracticable, meaning that they could not be carried out with available resources. For example, our recommendation that credentialing decisions should ultimately rely on certifications made by assessors during patient-based assessments may not be practicable at small, rural hospitals. Such hospitals may not have access to local assessors, and they may not admit enough patients who need the types of ultrasound-guided procedures for which hospitalists seek certification (especially given the need to coordinate the schedules of patients, procedure-performing hospitalists, and assessors). Collaborative efforts between hospitals for regional certification may be a potential solution to consider. But if recommendations are truly impracticable, the task force recognizes they may need to be modified. Given the low quality of evidence supporting our recommendations, such modifications would be readily defendable, especially if they emerged from collaborative discussions between privileging committees, hospitalist directors, and local experts.

One way for hospitals to implement our recommendations may be to follow a recommendation proposed by the authors of the original hospitalist core competencies over a decade ago: “The presence of a procedural skill in the Core Competencies does not necessarily indicate that every hospitalist will perform or be proficient in that procedure.”¹⁰⁴ In other words, bedside procedures may be delegated to some but not all hospitalists. Such “proceduralists” would have some proportion of their clinical responsibility dedicated to performing procedures. Delineation of this job description must be made locally because it balances 2 hospital-specific characteristics: patients’ needs for procedures against the availability of providers with basic competence to perform them, which includes hospitalists but also emergency medicine physicians, specialists, and interventional radiologists. A salutary benefit for hospitals is that hospitalists who are not proceduralists would not need to undergo certification in basic competence for the bedside procedures they will not be performing.

Regardless of whether some or all hospitalists at a particular hospital are expected to perform bedside procedures, technology may help to improve the practicability of our recommendations. For example, simulators may evolve to replace actual patient-level experience in achieving minimum thresholds. Certification assessments of manual skills may even someday occur entirely on simulators. Real-time high-definition video streaming enhanced with multiple cameras may allow for remote assessments. Until such advances mature, high-quality patient-level data should be sought through additional research to refine our current recommendations.

We hope that these recommendations will improve how basic competence in ultrasound-guided bedside procedures is assessed. Our ultimate goal is to improve how hospitalists perform these procedures. Patient safety is, therefore, considered paramount to cost. Nevertheless, the hospital administrative leaders and privileging committee members on our Task Force concluded that many hospitals have been seeking guidance on credentialing for bedside procedures, and the likely difficulties of implementing our recommendations (including cost) would not be prohibitive at most hospitals, especially given recognition that these recommendations can be tailored to each setting.

Collaborators from SHM POCUS Task Force are Saaid Abdel-Ghani, Michael Blaivas, Dan Brotman, Carolina Candotti, Jagriti Chadha, Joel Cho, Ria Dancel, Ricardo Franco, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Benji Mathews, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, Jeff Bates, Anjali Bhagra, Kreegan Reierson, Robert Arntfield, Paul Mayo, Loretta Grikis.

Disclosure

Brian P. Lucas received funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086). Nilam Soni received funding from the Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (HX002263-01A1). The contents of this publication do not represent the views of the United States Department of Veterans Affairs or the United States Government.

The American Board of Internal Medicine (ABIM) changed its certification policy for bedside procedures over a decade ago.¹ Acquiring manual competence in abdominal paracentesis, arterial catheter placement, arthrocentesis, central venous catheter placement, lumbar puncture, and thoracentesis is no longer an expectation of residency training. ABIM diplomates should “know” these procedures but not necessarily “do” them. Hospitalists, most of whom are themselves ABIM diplomates, are still, however, expected to do them as core competencies,²perhaps because hospitalists are often available off-hours, when roughly half of bedside procedures are performed.³

Hospitalists increasingly perform bedside procedures with ultrasound guidance.⁴ Yet training in ultrasound guidance is significantly varied as well,⁵ simply because point-of-care ultrasound (POCUS) has only recently become widespread.⁶ And though some skills are transferrable from landmark-guided to ultrasound -guided procedures, many are not.^7-10 Furthermore, ultrasound guidance is often not explicitly delineated on the privileging forms used by hospitals,¹¹ even where ultrasound guidance has become standard.¹²

Working Group Formation

In January 2015, the SHM Board of Directors asked the SHM Education Committee to convene the POCUS Task Force. The purpose of the task force was to develop recommendations on ultrasound guidance for bedside procedures. The SHM Education Committee appointed 3 chairs of the task force: 1 senior member of the SHM Education Committee and 2 POCUS experts. The chairs assembled a task force of 31 members that included 5 working groups, a multispecialty peer review group, and a guideline methodologist (supplemental Appendix 1). Invitation was based on members’ past contributions to SHM POCUS-related activities, up-front commitment, and declared conflicts of interest. Working group members self-identified as “hospitalists,” whereas peer reviewers were nonhospitalists but nationally recognized POCUS physician-leaders specializing in emergency medicine, cardiology, critical care medicine, and anesthesiology. Task force membership was vetted by a chair of the SHM POCUS Task Force and the Director of Education before work began. This position statement was authored by the Credentialing Working Group together with the chairs of the other 4 working groups and a guideline methodologist.

Disclosures

Signed disclosure statements of all task force members were reviewed prior to inclusion on the task force (supplemental Appendix 2); no members received honoraria for participation. Industry representatives did not contribute to the development of the guidelines nor to any conference calls or meetings.

Literature Search Strategy

A literature search was conducted by a biomedical librarian. Records from 1979 to January of 2017 were searched in Medline, Embase, CINAHL, Cochrane, and Google Scholar (supplemental Appendix 3). Search limiters were English language and adults. Articles were manually screened to exclude nonhuman or endoscopic ultrasound applications. Final article selection was based on working group consensus.

Draft Pathways

The Credentialing Working Group drafted initial and ongoing certification pathways (Figure 1 and Figure 2). The other 4 working groups from the task force were surveyed about the elements and overall appropriateness of these draft pathways. This survey and its results have already been published.¹² The Credentialing Working Group then revised the certification pathways by using these survey results and codified individual aspects of these pathways into recommendations.

Development of Position Statement

Based on the Grading of Recommendation Assessment Development and Evaluation methodology, all final article selections were initially rated as either low-quality (observational studies) or unclassifiable (expert opinion).¹⁶ These initial ratings were downgraded further because of indirectness, because none of the articles involved the intervention of interest (a credentialing pathway) in a population of interest (hospitalists) measuring the outcomes of interest (patient-level outcomes).¹⁷ Given the universal low-quality evidence ratings, we altered the task force strategy of developing guidelines, which the other 4 working groups are writing, and instead developed a position statement by using consensus gathering in 3 steps.

First, the Credentialing Working Group drafted an initial position statement composed of recommendations for credentialing pathways and other general aspects of credentialing. All final article selections were incorporated as references in a draft of the position statement and compiled in a full-text compendium. Second, feedback was provided by the other 4 task force working groups, the task force peer reviewers, and the SHM Education Committee. Feedback was incorporated by the authors of this statement who were the Credentialing Working Group, the chairs of the other 4 working groups, and a guideline methodologist. Third, final suggestions from all members of the SHM POCUS Task Force and SHM Education Committee were incorporated before final approval by the SHM Board of Directors in September 2017.

A total of 1438 references were identified in the original search. Manual selection led to 101 articles, which were incorporated into the following 4 domains with 16 recommendations.

General Credentialing Process

Basic Cognitive Competence Can Be Certified with Written or Oral Examinations

The ABIM defines cognitive competence as having 3 abilities: “(1) to explain indications, contraindications, patient preparation methods, sterile techniques, pain management, proper techniques for handling specimens and fluids obtained, and test results; (2) to recognize and manage complications; and, (3) to clearly explain to a patient all facets of the procedure necessary to obtain informed consent.”¹ These abilities can be assessed with written or oral examinations that may be integrated into simulation- or patient-based assessments.^18-21

Minimum Thresholds of Experience to Trigger the Timing of a Patient-Based Assessment Should Be Determined by Empirical Methods

Learning curves are highly variable^22-25 and even plateaus may not herald basic competence.²⁶ Expert opinions²⁷ can be used to establish minimum thresholds of experience, but such opinions may paradoxically exceed the current thresholds of experts’ own hospitals.¹² Thus, empirical methods, such as those based on cumulative sum analysis^28-30 or local learning curves,^31,32 are preferred. If such methods are not available, a recent survey of hospitalist experts may provide guidance.¹² Regardless, once established, minimum thresholds are necessary but not sufficient to determine competency (see “Basic manual competence must be certified through patient-based assessments” section).

Hospitalists Should Formally Log All of Their Attempted Procedures, Ideally in an Electronic Medical Record

Simple self-reported numbers of procedures performed often misrepresent actual experience^33,34 and do not include periprocedural complications.^35,36 Thus, hospitalists should report their experience with logs of all attempted procedures, both successful and unsuccessful. Such logs must include information about supervising providers (if applicable) and patient outcomes, including periprocedural adverse events,³⁷ but they must also remain compliant with the Health Insurance Portability and Accountability Act.

Health Information Technology Service Should Routinely Pull Collations of All Attempted Procedures from Comprehensive Electronic Medical Records

Active surveillance may reduce complications by identifying hospitalists who may benefit from further training.³⁸ In order to facilitate active surveillance systems, documentation (such as a procedure note) should be both integrated into an electronic medical record and protocol driven,³⁹ including procedure technique, ultrasound findings, and any safety events (both near misses and adverse events).

Basic Manual Competence Must Be Certified Through Patient-Based Assessments

Multiple interacting factors, including environment, patients, baseline skills, training, experience, and skills decay, affect manual competence. Certifications that are based solely on reaching minimum thresholds of experience, even when accurate, are not valid reflections of manual competence,^15,40-43 and neither are those based on self-perception.⁴⁴ Patient-based assessments are, thus, necessary to ensure manual competence.^45-48

Certification Assessments of Manual Competence Should Combine 2 Types of Structured Instruments: Checklists and Overall Scores

Assessments based on direct observation are more reliable when formally structured.^49,50 Though checklists used in observed structured clinical examinations capture many important manual skills,^51-56 they do not completely reflect a hospitalist’s manual competence;⁵⁷ situations may occur in which a hospitalist meets all the individual items on a checklist but cannot perform an entire procedure with basic competence. Therefore, checklists should be paired with overall scores.^58-61 Both checklists and overall scores ought to be obtained from reliable and valid instruments.

Certification Assessments Should Include Feedback

Assessments without feedback are missed learning opportunities.⁶² Both simulation-⁶³ and patient-based assessments should provide feedback in real time to reinforce effective behaviors and remedy faulty ones.

If Remedial Training is Needed, Simulator-Based Training Can Supplement but Not Replace Patient-Based Training

Supervised simulator-based training allows hospitalists to master basic components of a procedure⁶⁴ (including orientation to equipment, sequence of operations, dexterity, ultrasound anatomy, and real-time guidance technique) while improving both cognitive and manual skills.^42,43,65-71 In addition to their role in basic training (which is outside the scope of this position statement), simulators can be useful for remedial training. To be sufficient for hospitalists who do not pass their patient-based assessments, however, remedial training that begins with simulation must also include patient-based training and assessment.^72-75

Initial Credentialing Process

A Minimum Threshold of Experience Should Be Reached before Patient-Based Assessments are Conducted (Figure 1)

Initial Certification Assessments Should Ideally Begin on Simulators

Simulators allow the assurance of safe manual skills, including proper needle insertion techniques and disposal of sharp objects.^3,79 If simulators are not available, however, then patient-based training and assessments can still be performed under direct observation. Safe performance of ultrasound-guided procedures during patient-based assessments (without preceding simulator-based assessments) is sufficient to certify manual competence.

Ongoing Credentialing

Certification to Perform Ultrasound-Guided Procedures Should Be Routinely Re-Evaluated During Ongoing Credentialing (Figure 2)

Observed Patient-Based Assessments Should Occur When a Periprocedural Safety Event Occurs that is Potentially Caused by “Provider Error”

Safety events include both near misses and adverse events. Information about both is ideally “flagged” and “pushed” to hospitalist group leaders by active surveillance and reporting systems. Once reviewed, if a safety event is considered to potentially have been caused by provider error (including knowledge- and skill-based errors),⁸³ then the provider who performed the procedure should undergo an observed patient-based assessment.

Simulation-Based Practice Can Supplement Patient-Based Experience for Ongoing Credentialing

When hospitalists do not achieve a minimum threshold of patient-based experience since the antecedent certification, simulation-based training can supplement their patient-based experience.⁸⁴ In these cases, however, an observed patient-based assessment must occur. Another consideration is whether or not the privilege should be relinquished because of an infrequent need.

Credentialing Infrastructure

Hospitalists Themselves Should Not Bear the Financial Costs of Developing and Maintaining Training and Certification Programs for Ultrasound-Guided Procedures

Equipment and personnel costs^85,86 commonly impede ultrasound-guided procedure programs.^4,87,88 Hospitalists whose job descriptions include the performance of ultrasound-guided procedures should not be expected to bear the costs of ultrasound machines, image archival software, equipment maintenance, and initial and ongoing training and certification.

Assessors Should Be Unbiased Expert Providers Who Have Demonstrated Mastery in Performance of the Procedure Being Assessed and Regularly Perform It in a Similar Practice Environment

Assessors should be expert providers who regularly perform the ultrasound-guided procedure in a similar practice environment.^9,89-94 For example, providers who are not hospitalists but who are experts in an ultrasound-guided procedure and commonly perform it on the hospital wards would be acceptable assessors. However, a radiologist who only performs that procedure in a fully-staffed interventional radiology suite with fluoroscopy or computed tomography guidance would not be an acceptable assessor. More than 1 assessor may balance idiosyncratic assessments;⁹⁵ but when assessments are well structured, additional assessors are generally not needed.¹⁸Candidate assessors should be vetted by the hospitalist group leader and the hospital privileging committee.

If Intramural Assessors Are Not Available, Extramural Assessors May Be Considered

Intramural assessors are generally preferred because of familiarity with the local practice environment, including the available procedure kits and typical patient characteristics. Nevertheless, extramural assessors^27,77,85,96 may theoretically provide even more valid assessments than intramural ones because extramural assessors are neither influenced by relationships with local hospitalists nor biased by local hospitalists’ skills.^97,98 Remote performance assessment through video recordings⁹⁹ or live-video streaming is another option¹⁰⁰ but is not sufficient unless a room camera is available to simultaneously view probe movement and the ultrasound screen.¹⁰¹ In addition, remote assessment does not allow the assessor to physically assume control of the procedure to either salvage it or perhaps, in some cases, prevent a complication.

There are no high-quality randomized trials in support of a single credentialing pathway over any other.^94,102 The credentialing pathways at the center of this position statement are based on expert opinion. Our methods can be criticized straightaway, therefore, for reliance on the experience and expertise of our working group and task force. Any position statement written without high-quality supportive evidence would be appropriately subject to the same criticism. Without evidence in support of an overall pathway, we codified specific aspects of the pathways into 16 individual recommendations.

Patient-level outcomes do not back these recommendations. Consider, for example, our recommendation that certification assessments be made from structured instruments and not simply from an assessor’s gestalt. Here, the basis is not improved patient-level outcomes from a trial (such as reduced complications or increased procedural success) but improved psychometric performance from reliability studies. The body of evidence for our recommendations is similarly indirect, mostly because the outcomes studied are more proximate and, thus, less meaningful than patient-level outcomes, which are the outcomes of greatest interest but are woefully understudied for clinical competence.^17,97,103

The need for high-quality evidence is most pronounced in distinguishing how recommendations should be modified for various settings. Wide variations in resources and patient-mix will make some recommendations impracticable, meaning that they could not be carried out with available resources. For example, our recommendation that credentialing decisions should ultimately rely on certifications made by assessors during patient-based assessments may not be practicable at small, rural hospitals. Such hospitals may not have access to local assessors, and they may not admit enough patients who need the types of ultrasound-guided procedures for which hospitalists seek certification (especially given the need to coordinate the schedules of patients, procedure-performing hospitalists, and assessors). Collaborative efforts between hospitals for regional certification may be a potential solution to consider. But if recommendations are truly impracticable, the task force recognizes they may need to be modified. Given the low quality of evidence supporting our recommendations, such modifications would be readily defendable, especially if they emerged from collaborative discussions between privileging committees, hospitalist directors, and local experts.

One way for hospitals to implement our recommendations may be to follow a recommendation proposed by the authors of the original hospitalist core competencies over a decade ago: “The presence of a procedural skill in the Core Competencies does not necessarily indicate that every hospitalist will perform or be proficient in that procedure.”¹⁰⁴ In other words, bedside procedures may be delegated to some but not all hospitalists. Such “proceduralists” would have some proportion of their clinical responsibility dedicated to performing procedures. Delineation of this job description must be made locally because it balances 2 hospital-specific characteristics: patients’ needs for procedures against the availability of providers with basic competence to perform them, which includes hospitalists but also emergency medicine physicians, specialists, and interventional radiologists. A salutary benefit for hospitals is that hospitalists who are not proceduralists would not need to undergo certification in basic competence for the bedside procedures they will not be performing.

Regardless of whether some or all hospitalists at a particular hospital are expected to perform bedside procedures, technology may help to improve the practicability of our recommendations. For example, simulators may evolve to replace actual patient-level experience in achieving minimum thresholds. Certification assessments of manual skills may even someday occur entirely on simulators. Real-time high-definition video streaming enhanced with multiple cameras may allow for remote assessments. Until such advances mature, high-quality patient-level data should be sought through additional research to refine our current recommendations.

We hope that these recommendations will improve how basic competence in ultrasound-guided bedside procedures is assessed. Our ultimate goal is to improve how hospitalists perform these procedures. Patient safety is, therefore, considered paramount to cost. Nevertheless, the hospital administrative leaders and privileging committee members on our Task Force concluded that many hospitals have been seeking guidance on credentialing for bedside procedures, and the likely difficulties of implementing our recommendations (including cost) would not be prohibitive at most hospitals, especially given recognition that these recommendations can be tailored to each setting.

Collaborators from SHM POCUS Task Force are Saaid Abdel-Ghani, Michael Blaivas, Dan Brotman, Carolina Candotti, Jagriti Chadha, Joel Cho, Ria Dancel, Ricardo Franco, Richard Hoppmann, Susan Hunt, Venkat Kalidindi, Ketino Kobaidze, Josh Lenchus, Benji Mathews, Satyen Nichani, Vicki Noble, Martin Perez, Nitin Puri, Aliaksei Pustavoitau, Sophia Rodgers, Gerard Salame, Daniel Schnobrich, Kirk Spencer, Vivek Tayal, Jeff Bates, Anjali Bhagra, Kreegan Reierson, Robert Arntfield, Paul Mayo, Loretta Grikis.

Disclosure

Brian P. Lucas received funding from the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, and National Center for Translational Science (UL1TR001086). Nilam Soni received funding from the Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (HX002263-01A1). The contents of this publication do not represent the views of the United States Department of Veterans Affairs or the United States Government.

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Communication failures are a leading cause of sentinel events, the most serious adverse events that occur in hospitals.¹ Interventions to improve patient safety have focused on communication between healthcare providers.^2-4 Interventions focusing on communication between providers and families or other patient caregivers are under-studied.^5,6 Given their availability, proximity, historical knowledge, and motivation for a good outcome,⁷ families can play a vital role as “vigilant partners”⁸ in promoting hospital communication and safety.

In this month’s Journal of Hospital Medicine, Solan et al. conducted focus groups and interviews of 61 caregivers of hospitalized pediatric patients at 30 days after discharge to assess their perceptions of communication during hospitalization and discharge home.⁹ They identified several caregiver themes pertaining to communication between the inpatient medical team and families, communication challenges due to the teaching hospital environment, and communication between providers. Caregiver concerns included feeling out of the loop, excessive provider use of medical jargon, confusing messages on rounds, and inadequate communication between inpatient and outpatient providers.

The manuscript serves both to uncover family concerns that may be underappreciated by clinicians and suggest some potential solutions. For instance, caregivers can be apprehensive about whom to call for postdischarge advice because they are sometimes uncertain whether their outpatient providers have sufficient information about the hospitalization to properly advise them. The authors propose using photo “face sheets” to improve caregiver identification of healthcare provider roles, including families in hospital committees, improving transition communication between inpatient and outpatient healthcare providers through timely faxed discharge summaries and telephone calls, and informing families about such communications with their outpatient providers.

These are important suggestions. However, in order to move from promoting communication alone to promoting true partnership in care, there are additional steps that providers can take to fully engage families in hospital and discharge communications.

Meaningful family engagement in hospital communications—eg, during family-centered rounds (FCRs)—has been associated with improved patient safety and experience.^10-12 To further enhance family partnership in care, we would make the following 3 suggestions for hospitals and healthcare providers: (1) focus on health literacy in all communications with families, (2) work towards shared decision making (SDM), and (3) make discharges family-centered.

In order to partner with one another, families and healthcare providers need to speak a common language. A key way to ensure that families and providers speak a common language is for providers to espouse good health literacy principles. Health literacy is the “capacity to obtain, process, and understand basic health information and services to make appropriate health decisions.”¹³ Health literacy is dynamic, varying based on medical problem, provider, and healthcare system.¹⁴ Overall, only 12% of United States adults possess the health literacy skills required to navigate our complex healthcare system.^15,16 Stress, illness, and other factors can compromise the ability of even these individuals to process and utilize health information. Yet health literacy is routinely overestimated by providers.^17-19

To optimize communication with families, providers should use “universal health literacy precautions”¹⁶ with all patients, not just those believed to need extra assistance, in both verbal (eg, FCRs) and written communications (eg, discharge instructions).¹⁶ Providers should speak in plain, nonmedical language, be specific and concrete, and have families engage in “teach-back” (ie, state in their own words their understanding of the plan). They should focus on what families “need to know” rather than what is “good to know.” They should use simpler sentence structure and “chunk and check”²⁰ (ie, provide small, “bite-sized” pieces of information and check for understanding by using teach-back).²¹ In writing, they should use simpler sentence structure, bullet points, active statements, and be cognizant of reading level, medical jargon, and word choice (eg, “has a fever” instead of “febrile”). It is worth recognizing that even highly educated, highly literate families—not least of all those who are physicians and nurses themselves—can benefit from universal health literacy precautions because the ability to process and grasp information is dynamic and can be markedly lower than usual when faced with the illness of a loved one.

At a systematic level, medical schools, nursing schools, residency training programs, and continuing education should include health literacy training in their curricula. While learning to speak the language of medicine is an important part of medical education, the next step is learning to “unspeak” it, a challenging but important charge to promote partnership.

SDM is the process by which providers and patients make decisions together by balancing clinical evidence with patient preferences and values.²² However, despite providers believing they are engaging in SDM,^23,24 families report they are often not as involved in SDM as they would like.^24-26 Indeed, most hospital communications with families, including FCRs and discharge instructions, typically emphasize information sharing, not SDM. SDM tends to be more commonly applied in outpatient settings.²⁷ To encourage SDM in the hospital setting, patients and families should not only understand communication during FCRs and at discharge but should be encouraged to be active participants in developing care plans,²⁶ no matter how minor the decisions involved.²⁸ SDM can be applied to a variety of discussions, both during hospitalization (eg, initiation of antibiotics, transition from intravenous to oral medications, pursuing imaging) and at discharge (eg, assessing discharge readiness, deciding duration of therapy, formulating follow-up recommendations). Providers will benefit from incorporating information from personal and medical histories that only families possess, resulting in more informed and potentially safer care plans that may be more likely to fit into the family’s life at home. SDM can also ensure patient and family “buy-in” and increase the likelihood of compliance with the shared plan.

Discharge processes often involve multiple redundancies and parallel processes that fail to actively involve families or promote transparency.²⁹ Discharge summaries are typically written in medical jargon and intended for the outpatient provider (who may not receive them in a timely fashion), not the family.^30-32 Separate discharge instructions are often provided to families without sufficient attention to health literacy, contingency planning, or individualization (eg, a generic asthma fact sheet).³⁰ Outpatient providers are not always contacted directly about the hospitalization, nor are families always informed when providers are contacted, as Solan et al. describe.

Providers can apply lessons from FCRs to discharge processes, pursuing a similar family-centered, interprofessional approach promoting partnership and transparency. Just as providers engage families during discussions on FCRs, they can engage families in discharge conversations with outpatient providers and nursing colleagues. Indeed, Berry et al. propose a discharge framework that emphasizes involvement of and dialogue between patients, families, and providers as they systematically develop and assess plans for discharge and postdischarge care.³³ To accomplish this, inpatient providers can copy families on discharge summaries and other correspondence with outpatient providers (eg, through secure emails or open-source notes such as OpenNotes^34-36). Moreover, particularly for complex discharges, inpatient providers can call outpatient providers in the family’s presence or invite outpatient providers to join—via telephone or videoconference—day-of-discharge FCRs or discharge huddles. Such efforts require logistical and pragmatic considerations, as well as culture change, but are not insurmountable and may help address many family concerns around peridischarge communication and care. Such efforts may also promote accountability on the part of families and providers alike, thereby ensuring that families are truly engaged as vigilant partners in care.

As one of us (SC) reflected once when considering her experience navigating healthcare as a parent of 2 children with cystic fibrosis, “We have to make it easier for families to be a true part of their children’s care. When patients and families are true members of the medical team, care is more informed, more targeted, and more safe for everyone.”

Disclosure: Dr. Landrigan has consulted with and holds equity in the I-PASS Patient Safety Institute, a company that seeks to train institutions in best handoff practices and aid in their implementation. Dr. Landrigan is supported in part by the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Landrigan has also served as a paid consultant to Virgin Pulse to help develop a Sleep and Health Program. In addition, Dr. Landrigan has received monetary awards, honoraria, and travel reimbursement from multiple academic and professional organizations for teaching and consulting on sleep deprivation, physician performance, handoffs, and safety and has served as an expert witness in cases regarding patient safety and sleep deprivation.

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Provision of high-quality, high-value medical care hinges upon effective communication. During a hospitalization, critical information is communicated between patients, caregivers, and providers multiple times each day. This can cause inconsistent and misinterpreted messages, leaving ample room for error.¹ The Joint Commission notes that communication failures occurring between medical providers account for ~60% of all sentinel or serious adverse events that result in death or harm to a patient.² Communication that occurs between patients and/or their caregivers and medical providers is also critically important. The content and consistency of this communication is highly valued by patients and providers and can affect patient outcomes during hospitalizations and during transitions to home.^3,4 Still, the multifactorial, complex nature of communication in the pediatric inpatient setting is not well understood.^5,6

During hospitalization, communication happens continuously during both daytime and nighttime hours. It also precedes the particularly fragile period of transition from hospital to home. Studies have shown that nighttime communication between caregivers and medical providers (ie, nurses and physicians), as well as caregivers’ perceptions of interactions that occur between nurses and physicians, may be closely linked to that caregiver’s satisfaction and perceived quality of care.^6,7 Communication that occurs between inpatient and outpatient providers is also subject to barriers (eg, limited availability for direct communication)^8-12; studies have shown that patient and/or caregiver satisfaction has also been tied to perceptions of this communication.^13,14 Moreover, a caregiver’s ability to understand diagnoses and adhere to postdischarge care plans is intimately tied to communication during the hospitalization and at discharge. Although many improvement efforts have aimed to enhance communication during these vulnerable time periods,^3,15,16 there remains much work to be done.^1,10,12

The many facets and routes of communication, and the multiple stakeholders involved, make improvement efforts challenging. We believe that more effective communication strategies could result from a deeper understanding of how caregivers view communication successes and challenges during a hospitalization. We see this as key to developing meaningful interventions that are directed towards improving communication and, by extension, patient satisfaction and safety. Here, we sought to extend findings from a broader qualitative study¹⁷ by developing an in-depth understanding of communication issues experienced by families during their child’s hospitalization and during the transition to home.

Setting

The analyses presented here emerged from the Hospital to Home Outcomes Study (H2O). The first objective of H2O was to explore the caregiver perspective on hospital-to-home transitions. Here, we present the results related to caregiver perspectives of communication, while broader results of our qualitative investigation have been published elsewhere.¹⁷ This objective informed the latter 2 aims of the H2O study, which were to modify an existing nurse-led transitional home visit (THV) program and to study the effectiveness of the modified THV on reutilization and patient-specific outcomes via a randomized control trial. The specifics of the H2O protocol and design have been presented elsewhere.¹⁸

H2O was approved by the Institutional Review Board at Cincinnati Children’s Hospital Medical Center (CCHMC), a free-standing, academic children’s hospital with ~600 inpatient beds. This teaching hospital has >800 total medical students, residents, and fellows. Approximately 8000 children are hospitalized annually at CCHMC for general pediatric conditions, with ~85% of such admissions staffed by hospitalists from the Division of Hospital Medicine. The division is composed of >40 providers who devote the majority of their clinical time to the hospital medicine service; 15 additional providers work on the hospital medicine service but have primary clinical responsibilities in another division.

Family-centered rounds (FCR) are the standard of care at CCHMC, involving family members at the bedside to discuss patient care plans and diagnoses with the medical team.¹⁹ On a typical day, a team conducting FCR is composed of 1 attending, 1 fellow, 2 to 3 pediatric residents, 2 to 3 medical students, a charge nurse or bedside nurse, and a pharmacist. Other ancillary staff, such as social workers, care coordinators, nurse practitioners, or dieticians, may also participate on rounds, particularly for children with greater medical complexity.

Population

Caregivers of children discharged with acute medical conditions were eligible for recruitment if they were English-speaking (we did not have access to interpreter services during focus groups/interviews), had a child admitted to 1 of 3 services (hospital medicine, neurology, or neurosurgery), and could attend a focus group within 30 days of the child’s discharge. The majority of participants had a child admitted to hospital medicine; however, caregivers with a generally healthy child admitted to either neurology or neurosurgery were eligible to participate in the study.

Study Design

As presented elsewhere,^17,20 we used focus groups and individual in-depth interviews to generate consensus themes about patient and caregiver experiences during the transition from hospital to home. Because there is evidence suggesting that focus group participants are more willing to talk openly when among others of similar backgrounds, we stratified the sample by the family’s estimated socioeconomic status.^21,22 Socioeconomic status was estimated by identifying the poverty rate in the census tract in which each participant lived. Census tracts, relatively homogeneous areas of ~4000 individuals, have been previously shown to effectively detect socioeconomic gradients.^23-26 Here, we separated participants into 2 socioeconomically distinct groupings (those in census tracts where <15% or ≥15% of the population lived below the federal poverty level).²⁶ This cut point ensured an equivalent number of eligible participants within each stratum and diversity within our sample.

Data Collection

Caregivers were recruited on the inpatient unit during their child’s hospitalization. Participants then returned to CCHMC facilities for the focus group within 30 days of discharge. Though efforts were made to enhance participation by scheduling sessions at multiple sites and during various days and times of the week, 4 sessions yielded just 1 participant; thus, the format for those became an individual interview. Childcare was provided, and participants received a gift card for their participation.

An open-ended, semistructured question guide,¹⁷ developed de novo by the research team, directed the discussion for focus groups and interviews. As data collection progressed, the question guide was adapted to incorporate new issues raised by participants. Questions broadly focused on aspects of the inpatient experience, discharge processes, and healthcare system and family factors thought to be most relevant to patient- and family-centered outcomes. Communication-related questions addressed information shared with families from the medical team about discharge, diagnoses, instructions, and care plans. An experienced moderator and qualitative research methodologist (SNS) used probes to further elucidate responses and expand discussion by participants. Sessions were held in private conference rooms, lasted ~90 minutes, were audiotaped, and were transcribed verbatim. Identifiers were stripped and transcripts were reviewed for accuracy. After conducting 11 focus groups (generally composed of 5-10 participants) and 4 individual interviews, the research team determined that theoretical saturation²⁷ was achieved, and recruitment was suspended.

Data Analysis

An inductive, thematic approach was used for analysis.²⁷ Transcripts were independently reviewed by a multidisciplinary team of 4 researchers, including 2 pediatricians (LGS and AFB), a clinical research coordinator (SAS), and a qualitative research methodologist (SNS). The study team identified emerging concepts and themes related to the transition from hospital to home; themes related to communication during hospitalization are presented here.

During the first phase of analysis, investigators independently read transcripts and later convened to identify and define initial concepts and themes. A preliminary codebook was then designed. Investigators continued to review and code transcripts independently, meeting regularly to discuss coding decisions collaboratively, resolving differences through consensus.²⁸ As patterns in the data became apparent, the codebook was modified iteratively, adding, subtracting, and refining codes as needed and grouping related codes. Results were reviewed with key stakeholders, including parents, inpatient and outpatient pediatricians, and home health nurses, throughout the analytic process.^27,28 Coded data were maintained in an electronic database accessible only to study personnel.

Participants

Resulting Themes

Analyses revealed the following 3 major communication-related themes with associated subthemes: (1) experiences that affect caregiver perceptions of communication between the inpatient medical team and families, (2) communication challenges for caregivers related to a teaching hospital environment, and (3) caregiver perceptions of communication between medical providers. Each theme (and subtheme) is explored below with accompanying verbatim quotes in the narrative and the tables.

Major Theme 1: Experiences that Affect Caregiver Perceptions of Communication Between the Inpatient Medical Team and Families

In contrast, some of the negative experiences shared by participants related to feeling excluded from discussions about their child’s care. One participant said, “They tell you…as much as they want to tell you. They don’t fully inform you on things.” Additionally, concerns were voiced about insufficient time for face-to-face discussions with physicians: “I forget what I have to say and it’s something really, really important…But now, my doctor is going, you can’t get the doctor back.” Finally, participants discussed how the use of medical jargon often made it more difficult to understand things, especially for those not in the medical field.

Major Theme 2: Communication Challenges for Caregivers Related to a Teaching Hospital Environment

Major Theme 3: Caregiver Perceptions of Communication Between Medical Providers

Perceptions were not isolated to the inpatient setting. Based on their experiences, caregivers similarly described their sense of how inpatient and outpatient providers were communicating with each other. In some cases, it was clear that good communication, as perceived by the participant, had occurred in situations in which the primary care physician knew “everything” about the hospitalization when they saw the patient in follow-up. One participant described, “We didn’t even realize at the time, [the medical team] had actually called our doctor and filled them in on our situation, and we got [to the follow up visit]…He already knew the entire situation.” There were others, however, who shared their uncertainty about whether the information exchange about their child’s hospitalization had actually occurred. They, therefore, voiced apprehension around who to call for advice after discharge; would their outpatient provider have their child’s hospitalization history and be able to properly advise them?

Communication during a hospitalization and at transition from hospital to home happens in both formal and informal ways; it is a vital component of appropriate, effective patient care. When done poorly, it has the potential to negatively affect a patient’s safety, care, and key outcomes.² During a hospitalization, the multifaceted nature of communication and multidisciplinary approach to care provision can create communication challenges and make fixing challenges difficult. In order to more comprehensively move toward mitigation, it is important to gather perspectives of key stakeholders, such as caregivers. Caregivers are an integral part of their child’s care during the hospitalization and particularly at home during their child’s recovery. They are also a valued member of the team, particularly in this era of family-centered care.^19,29 The perspectives of the caregivers presented here identified both successes and challenges of their communication experiences with the medical team during their child’s hospitalization. These perspectives included experiences affecting perceptions of communication between the inpatient medical team and families; communication related to the teaching hospital environment, including confusing messages associated with large multidisciplinary teams, aspects of FCR, and confusion about medical team member roles; and caregivers’ perceptions of communication between providers in and out of the hospital, including types of communication caregivers observed or believed occurred between medical providers. We believe that these qualitative results are crucial to developing better, more targeted interventions to improve communication.

Maintaining a healthy and productive relationship with patients and their caregivers is critical to providing comprehensive and safe patient care. As supported in the literature, we found that when caregivers were included in conversations, they felt appreciated and valued; in addition, when answers were not directly shared by providers or there were lingering questions, nurses often served as “interpreters.”^29,30 Indeed, nurses were seen as a critical touchpoint for many participants, individuals that could not only answer questions but also be a trusted source of information. Supporting such a relationship, and helping enhance the relationship between the family and other team members, may be particularly important considering the degree to which a hospitalization can stress a patient, caregiver, and family.^31-34 Developing rapport with families and facilitating relationships with the inclusion of nursing during FCR can be particularly helpful. Though this can be challenging with the many competing priorities of medical providers and the fast-paced, acute nature of inpatient care, making an effort to include nursing staff on rounds can cut down on confusion and assist the family in understanding care plans. This, in turn, can minimize the stress associated with hospitalization and improve the patient and family experience.

While academic institutions’ resources and access to subspecialties are often thought to be advantageous, there are other challenges inherent to providing care in such complex environments. Some caregivers cited confusion related to large teams of providers with, to them, indistinguishable roles asking redundant questions. These experiences affected their perceptions of FCR, generally leading to a fixation on its overwhelming aspects. Certain caregivers highlighted that FCR caused them, and their child, to feel overwhelmed and more confused about the plan for the day. It is important to find ways to mitigate these feelings while simultaneously continuing to support the inclusion of caregivers during their child’s hospitalization and understanding of care plans. Some initiatives (in addition to including nursing on FCR as discussed above) focus on improving the ways in which providers communicate with families during rounds and throughout the day, seeking to decrease miscommunications and medical errors while also striving for better quality of care and patient/family satisfaction.³⁵ Other initiatives seek to clarify identities and roles of the often large and confusing medical team. One such example of this is the development of a face sheet tool, which provides families with medical team members’ photos and role descriptions. Unaka et al.³⁶ found that the use of the face sheet tool improved the ability of caregivers to correctly identify providers and their roles. Thinking beyond interventions at the bedside, it is also important to include caregivers on higher level committees within the institution, such as on family advisory boards and/or peer support groups, to inform systems-wide interventions that support the tenants of family-centered care.²⁹ Efforts such as these are worth trialing in order to improve the patient and family experience and quality of communication.

Multiple studies have evaluated the challenges with ensuring consistent and useful handoffs across the inpatient-to-outpatient transition,^8-10,12 but few have looked at it from the perspective of the caregiver.¹³ After leaving the hospital to care for their recovering child, caregivers often feel overwhelmed; they may want, or need, to rely on the support of others in the outpatient environment. This support can be enhanced when outpatient providers are intimately aware of what occurred during the hospitalization; trust erodes if this is not the case. Given the value caregivers place on this communication occurring and occurring well, interventions supporting this communication are critical. Furthermore, as providers, we should also inform families that communication with outpatient providers is happening. Examples of efforts that have worked to improve the quality and consistency of communication with outpatient providers include improving discharge summary documentation, ensuring timely faxing of documentation to outpatient providers, and reliably making phone calls to outpatient providers.^37-39 These types of interventions seek to bridge the gap between inpatient and outpatient care and facilitate a smooth transfer of information in order to provide optimal quality of care and avoid undesired outcomes (eg, emergency department revisits, readmissions, medication errors, etc) and can be adopted by institutions to address the issue of communication between inpatient and outpatient providers.

We acknowledge limitations to our study. This was done at a single academic institution with only English-speaking participants. Thus, our results may not be reflective of caregivers of children cared for in different, more ethnically or linguistically diverse settings. The patient population at CCHMC, however, is diverse both demographically and clinically, which was reflected in the composition of our focus groups and interviews. Additionally, the inclusion of participants who received a nurse home visit after discharge may limit generalizability. However, only 4 participants had a nurse home visit; thus, the overwhelming majority of participants did not receive such an intervention. We also acknowledge that those willing to participate may have differed from nonparticipants, specifically sharing more positive experiences. We believe that our sampling strategy and use of an unbiased, nonhospital affiliated moderator minimized this possibility. Recall bias is possible, as participants were asked to reflect back on a discharge experience occurring in their past. We attempted to minimize this by holding sessions no more than 30 days from the day of discharge. Finally, we present data on caregivers’ perception of communication and not directly observed communication occurrences. Still, we expect that perception is powerful in and of itself, relevant to both outcomes and to interventions.

Communication during hospitalization influences how caregivers understand diagnoses and care plans. Communication perceived as effective fosters mutual understandings and positive relationships with the potential to result in better care and improved outcomes. Communication perceived as ineffective negatively affects experiences of patients and their caregivers and can adversely affect patient outcomes. Learning from caregivers’ experiences with communication during their child’s hospitalization can help identify modifiable factors and inform strategies to improve communication, support families through hospitalization, and facilitate a smooth reentry home.

This manuscript is submitted on behalf of the H2O study group: Katherine A. Auger, MD, MSc, JoAnne Bachus, BSN, Monica L. Borell, BSN, Lenisa V. Chang, MA, PhD, Jennifer M. Gold, BSN, Judy A. Heilman, RN, Joseph A. Jabour, BS, Jane C. Khoury, PhD, Margo J. Moore, BSN, CCRP, Rita H. Pickler, PNP, PhD, Anita N. Shah, DO, Angela M. Statile, MD, MEd, Heidi J. Sucharew, PhD, Karen P. Sullivan, BSN, Heather L. Tubbs-Cooley, RN, PhD, Susan Wade-Murphy, MSN, and Christine M. White, MD, MAT.

Disclaimer

All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or Methodology Committee.

Disclosure

 This work was (partially) supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (HIS-1306-0081). The authors have no financial relationships relevant to this article to disclose. The authors have no conflicts of interest to disclose.

Drug product shortages threaten health care quality and public health by creating barriers to optimal care. The frequency of drug shortages has risen dramatically since 2005 and now influences broad areas of health care practice. More than 400 generic drug products have been affected, forcing institutions to purchase costly brand-name products, substitute alternative therapies, or procure from gray market vendors at increased institutional costs.¹ Scarcity and cost have potential to negatively impact patient outcomes and the ability of health care organizations to respond to the needs of their patients.

Background

Although constantly fluctuating, the number of active shortages reached a height of 320 products at the end the third quarter of 2014.² A 2011 analysis from Premier Healthcare Alliance estimated the added cost of purchasing brand, generic, or alternative drugs due to shortage may have inflated hospital costs by $200 million annually.¹ In 2016, the number of active shortages dropped to 176, suggesting a downward trend. However, the drug supply chain remains a concern for pharmacies in the U.S.

Despite creative approaches to shortage management, the variable characteristics of shortages make planning difficult. For example, the drug product in short supply may or may not have an alternative for use in similar clinical scenarios. The impact of shortages of medications lacking an equivalent alternative product has been documented, such as the past shortage of succinylcholine for anesthesia, resulting in surgery cancellations when an alternative paralytic agent was not appropriate.³ In 2016, the Cleveland Clinic reported undertaking “military-style triage” in determining patients who required use of aminocaproic acid during open heart surgery due to its limited supply.⁴ Decisions to reserve drug supply for emergency use and prefilling syringes under pharmacy supervision to extend stability and shelf life are short-term solutions to larger, systemic issues. Unfortunately, these scenarios have the potential to disrupt patient care and diminish health outcomes.

Shortages of products that have an available therapeutic substitution may seem easily manageable, but additional considerations may be present. Bacillus Calmette-Guérin (BCG) is considered the drug of choice for bladder cancer. In 2011, there was a shortage of the BCG vaccine after mold was discovered in the formulation.⁵ Providers were forced to choose between reducing or reallocating the dose of BCG, turning away patient, or substituting mitomycin C, which is less effective and costlier. When tamsulosin capsules became difficult to obtain in 2014, some institutions began switching patients to alfuzosin.⁶ Although alfuzosin is similar in mechanism to tamsulosin, it may prolong the QTc interval. Not only did this substitution present a contraindication for patients with elevated QTc intervals or who were already receiving concomitant medications that prolonged the QTc interval, but also it required additional cost and resources needed to update electrocardiograms.

VA Consolidated Mail Outpatient Pharmacies

The VHA serves nearly 9 million patients at more than 1,200 facilities across the U.S.⁷ This large patient population results in an estimated 149 million outpatient prescriptions annually.⁸ About 80% of these are distributed by mail through 7 VA consolidated mail outpatient pharmacies (CMOPs). When drug scarcity impedes the ability of the CMOP to respond to medication demand, the local facility must fill these prescriptions. These rejections sent back to the facility impact workload, patient wait times, and access to medication therapy. Barriers to medication procurement in the VA also stem from regulations based on legislation, including the Trade Agreements Act, Drug Supply Chain Security Act, and the Federal Acquisition Regulation (FAR) (Table).

The impact of drug shortages has been described previously in the private sector, particularly for emergency medicine and chemotherapy.^9,10 However, the impact of drug shortages on health care provision to veteran populations within the VA has not previously been analyzed. Due to the unique procurement regulations that influence the VA and the importance of continuing to provide optimal health care services to veterans, assessing the impact of drug shortages on patient safety and health care costs is necessary in informing policy decisions and guiding recommendations for mitigation strategies. The purpose of this study was to assess the influence of drug shortages on institutional costs and patient care within VA facilities and formulate recommendations for enhanced mitigation of this issue.

Methods

The primary outcome of this study was to characterize the impact of drug shortages on institutional cost and patient safety events among VHA facilities. Secondary outcomes included subgroup evaluation in reported drug shortage impact among 1a, 1b, and 1c complexity VA facility survey respondents and assessment of drug shortage impact on CMOP prescription order fulfillment and operation cost.

Definitions

The complexity ranking system is a facility grouping method used within the VA to characterize the level of service provision, teaching and research opportunities, patient volume, intensive care unit level, and other factors offered by a VA site. Rankings start from 1 (highest level of services offered) to 3 (lowest level of services offered), with level 1 facilities further divided into a, b, and c subdivisions. A level 1a facility will be larger with more services offered than a 1b, which is larger and offers more services than a 1c facility. The VA facilities are further characterized by regional distribution. Sites are grouped under VISNs of which there are currently 21.

The CMOP program was responsible for dispensing about 119 million outpatient prescriptions in 2016 and includes designated sites for the dispensing of controlled substances and supply items. The VA Pharmacy Benefits Management Service (PBM) oversees formulary management, plans national drug policy, promotes safe and appropriate drug therapy, and delivers high-quality and sustainable pharmacy benefits for veterans.

Study Design

A descriptive study was initiated to characterize the impact of drug shortages among VA facilities. An analysis of administrative medication safety event reporting and institutional costs data at the Denver VAMC in Colorado was done, focusing on predetermined drug products involved in a recent shortage. The analysis was accomplished through a review of the VA adverse drug events reporting system (VA ADERS) reports and a local medication errors quality improvement database and paper procurement records, respectively. Concurrently, a survey was disseminated among qualifying VA facilities across the country that sought to characterize the impact of drug shortages nationally.

Sample Selection

Denver VAMC. The Denver VAMC, where the authors were located, was selected as the local sample site. The intention was to compare the strategies used locally with strategies used among similar (level 1a, 1b, and 1c) facilities. Preselected “cost-impacting” drug products were identified through a review of historic shortages with a significant local impact. These drugs were defined as low cost/high utilization (eg, tamsulosin 0.4-mg capsules and ketorolac solution), medium cost/utilization (eg, piperacillin/tazobactam IV solutions and aminocaproic acid solution), and high cost/low utilization (eg, nitroprusside IV solution and BCG vaccine solution). Additionally, patient safety event data reported internally for quality improvement and locally via VA ADERS were reviewed for preselected “safety impact” drug products and included BCG vaccine, tamsulosin capsules, IV fluid products, calcium gluconate and chloride injections, and aminocaproic acid injection.

National Survey. The authors identified 84 level 1 complexity facilities and used the PBM pharmacy directory to contact the administrative personnel representing each facility. These representatives identified a point of contact to aid in survey completion. A separate survey also was sent to the CMOP facilities (survey outlines available at www.fedprac.com).

Data Collection

Denver VAMC. Financial data were sampled through a manual review of paper procurement records stored by date in the inpatient pharmacy of the Denver VAMC. Variables included units of product used over the period of drug shortage, cost per unit during shortage, and cost per unit before shortage. This information also was supplemented with data from the prescription processing software’s drug file. Patient safety data were gathered through query of the identified event reporting databases for the prespecified drug on shortage. These variables included the type of error and the effect the error had on the patient.

National Survey. Data collection focused on notable drug shortages and patient safety reporting between January 1, 2013 and December 31, 2016. The survey was maintained in a facility-specific spreadsheet. Editing capabilities were disabled for all actions other than responding to questions. Recipients were followed up with a courtesy e-mail after 2 weeks and another 2 times unless a survey was received. Data were de-identified and aggregated for analyses.

Statistical Analyses

Excel 2010 (Microsoft, Redmond, WA) descriptive statistics were used to relay information from this assessment. Extrapolations from procurement cost data and drug product utilization were used to estimate the enhanced direct cost associated with identified drug shortages. Similar extrapolations were used to estimate the cost associated with shortages leading to CMOP rejection and local fill.

Results

Survey completion totaled 20% of invited facilities (n = 17). Good geographic and VISN distribution was noted with representatives from VISNs 2, 4, 8, 9, 10, 12, 15, 16, 21, and 22. VISNs 10 and 12 provided the most representation with 3 participants, each. Level 1a facilities participated most (n = 9), followed by 1b (n = 6) and 1c (n = 2). Participating facilities reported a mean (SD) of 54 (21.5) pharmacists and 34 (15.3) pharmacy technician staff members employed. The most common reason for not participating was lack of personnel resources and competing demands. The CMOP participation was 100% (n = 7) and completed through a coordinated response.

Results of the budgetary increase and staff member time allocation survey assessments are provided (Figures 1 and 2). Five facilities provided an annual estimate of increased cost due to acquisition of drugs on shortage through open market purchases that ranged from about $150,000 to $750,000. Nearly half of the surveyed facilities endorsed having a drug shortage task force (n = 8) to respond to drug shortages and mitigate their impact.

Regarding drug product allocation, only 2 facilities did not have current restrictions for use due to a shortage. Many had between 1 and 10 of these restrictions implemented to conserve supply (n = 11, 64%), 2 facilities reported 11 to 20 restrictions, and 2 facilities noted more than 30 restrictions. Similarly, 3 facilities had not needed to revise any current treatment protocols due to drug shortages. The majority of facilities had revised 1 to 5 current protocols (n = 12, 70%), 1 revised 6 to 10 protocols, and 1 facility revised more than 10 protocols.

In assessing patient safety concerns, 1 facility identified a history of transferring patients to alternative medical sites for the patients to obtain necessary medication impacted by a local shortage. Additionally, during the BCG vaccine shortage, 6 facilities (35.3%) substituted mitomycin C for the treatment of urinary bladder cancer.

Most participants either agreed (n = 8, 47.0%) or strongly agreed (n = 4, 23.5%) that modifications to FAR to increase purchasing opportunities from foreign distributors during drug shortage would help mitigate the impact of such shortages. Similarly, most participants agreed (n = 10, 58.8%) or strongly agreed (n = 3, 17.6%) that PBM guidance on drug shortage management would help efficiently and effectively respond to issues that might arise. The consensus of participants also agreed (n = 13, 76.5%) that organized collaborations or working groups within each VISN might help assist in drug shortage management.

The CMOP facility data revealed that 2 sites did not require dedicated staffing to respond to shortages, and 3 sites had not experienced cost increases because of shortages. Pharmacist use varied between sites, with 2 facilities using 1 to 10 pharmacist h/wk, and 1 facility using 11 to 20 pharmacist h/wk, and 1 facility using 21 to 30 pharmacist h/wk. Technician utilization was more pronounced, with 2 facilities using more than 30 technician h/wk, and 2 facilities using 1 to 10 technician h/wk. Workload and costs may have been influenced in other ways as 3 sites endorsed using overtime pay, shifting product responsibility between CMOPs, prolonging patient wait times, and close monitoring for each. In fiscal year 2015, some sites experienced a 1% to 5% (n = 2) and 6% to 10% (n = 1) increase in operation cost attributable to shortage. Results from fiscal year 2016 showed that some sites continued to see a 1% to 5% (n = 1) and 6% to 10% (n = 2) increase in operation cost attributable to shortage.

Through aggregation of CMOP responses on the number of prescriptions sent back to local facility for fill due to back order, a downward trend in the total number of rejections was seen over the 2.5 fiscal years assessed. This amounted to more than 1 million rejections in fiscal year 2015, about 788,000 rejections in 2016, and about 318,000 rejections through the first 2 quarters of 2017.

A consistent rise in the medication procurement budget requirement was characterized within the single VA facility review. The quarterly median increase was 2.7% over 2.5 years (min: -1.4%; max: 6.6%) for total outpatient medication costs, excluding hepatitis C antiviral therapies. Procurement cost records were insufficient to characterize historic expenditures for 4 of the prespecified drug products. The data collected on tamsulosin capsule and nitroprusside vial procurement during shortage is provided (Figures 3 and 4). Over the time frame of procurement records found on review, the added costs of nitroprusside vials and tamsulosin capsules were $22,766.09 (+167.9% of base cost) and $17,433.70 (+657.3% of base cost), respectively. No patient safety data were found on review.

Discussion

Drug product shortages represent a barrier to quality and efficiency across health care institutions. A survey of health system pharmacies in the southeastern U.S. found that the majority of respondents tracking shortage data reported a 300% to 500% markup by alternative or gray market suppliers for hard-to-find medications.¹¹ These reports are similar to the authors’ analyses of the trends in increased procurement expenditures documented during the tamsulosin capsule and nitroprusside vial shortages and indirectly correlate with the survey results indicating that most facilities endorsed a trend in operation cost increase attributable to drugs product shortage. The estimated annual costs for open market purchases further informs the financial burden aggregated by this issue.

Indirect costs from drug shortage further complicated quantifying the impact of shortages. Many facilities acknowledged the indirect influence drug shortages have on staffing and workload due to the implementation of mitigation strategies. Most participants found it necessary to establish restrictions for use in addition to altering protocols. These required the time investment of essential personnel from development through execution and education. Situations also can arise for mass therapeutic substitution. In this example, pharmacy staff may be required to oversee medication transition from the product on shortage to an appropriate alternative. When substitution involves hundreds or thousands of outpatient prescriptions, such as the tamsulosin shortage, the process may be tedious and time consuming, depending on the level of clinical decision making needed to determine patient candidacy for transitioning products.

Improving institutional cost efficiency becomes a significant challenge with persistent drug shortages. Professional advocacy groups, such as the American Society of Health-System Pharmacists (ASHP), help provide guidance to organizations constrained by specific drug shortages.¹² Staff knowledgeable in allocation, supply considerations, and product repackaging and stability data also are essential. Other mitigation strategies include automatic substitutions, restrictions for use or inventory control strategies, and open market procurement, or borrowing from other institutions.

Data gathered from the survey of CMOP facilities also helped elucidate strategies used to mitigate drug shortage impacts for those respondents impacted by shortage. Likely, the 2 CMOP facilities without dedicated staff focused on shortages are those whose outpatient prescription fulfillment responsibility were focused on supply items or controlled substances. The impacted CMOP respondents cited overtime pay, shifting product responsibility, and prolonging patient wait times as the most frequently employed mitigation strategies. When these and other strategies fail to manage a shortage, prescriptions are often sent back to the local facility to be filled. Unfortunately for these facilities, the same mitigation strategies used by CMOP are not always feasible. Overtime pay may not be possible given staffing and budgetary resources, sending prescriptions back to facilities in itself prolongs patient wait times, and local medical centers do not have the option of shifting product responsibility between sites or sending the prescription to another facility. Herein lies 1 rationale for the CMOP effort to reduce the volume of prescriptions sent back to local medical centers.

Multiple offices within the FDA have roles in the mitigation of national drug shortages within their regulatory purview. Much of the recent focus stems from provisions enacted under Title X of the FDA Safety and Innovation Act of 2012, which addresses problems in the drug-supply chain.¹² Rectifying a shortage involves short- and long-term strategic planning to address supply, distribution, and market reaction to need. Collaboration between the FDA and manufacturers is one method by which demand can be satisfied through the coordination of resources, expedition of inspections, and root cause analysis of the shortage.

Similar collaborations within the VA were viewed favorably by respondents and might yield productive relationships if regional or VISN working groups were to be established. Alternative long-term strategies are executed through regulation, particularly concerning the importation of foreign manufactured drugs and regulatory discretion on supplier vetting. Despite a strong respondent consensus that regulatory modifications of foreign product importation in the setting of a drug shortage may be beneficial, such a change would require a congressional action and is not likely to be timely. Unfortunately, gray market pharmaceutical distribution, driven by wholesaler stockpiling to raise prices, is separate from manufacturer driven shortages and falls outside the FDA’s regulatory purview and institutional mitigation strategies.

Although based on this limited survey, general agreement existed on the importance of greater national collaboration and communication regarding drug shortage management strategies. This could include PBM guidance on specific shortage management opportunities or establishing collaborations by region or VISN. These possibilities may be more realistically attainable in comparison to modifying federal regulations on drug product procurement during active shortages, which requires an act of Congress. Many of the survey participants endorsed a drug shortage task force within their facility. Coordinating interaction between preexisting or newly established task forces or working groups on a monthly or quarterly basis may provide fruitful interactions and the exchange of strategies to reduce shortage impact on institutional cost, efficiency, and patient care.

Limitations

Quantifying the extent of drug shortage impact on patient safety and institutional costs is a difficult task. The procurement records data used for the analysis of a single VAMC were gathered through manual review of stored paper invoices, opening the possibility for missing data. It is also difficult to extrapolate the sum of indirect costs such as process changes, alternative product utilization, and pharmacy staffing resources as additional financial burdens to the affected institution. Any quantifiable cost assessment also is biased by contract terms between the VA and wholesalers in which unavailable products that must be purchased off-contract are subsequently reimbursed through credit or alternative means.

Patient safety events are frequently underreported, leading to underestimation of true safety event incidence. Given that these events are documented by multiple disciplines and that many of these documenters may not be aware consistently of the drug products and volume impacted by shortage, elucidating safety events unfolding in relation to shortage also is difficult to quantify.

The response rate for the survey was low but near the expected rate for this methodology. Feedback from several facilities was received, citing competing demands and workforce shortage as barriers to participation. The survey also was limited by reporting bias and recall bias. As assessment of prespecified past drug shortages may require intimate knowledge of pharmacy department processes and mitigation strategies, the accuracy of question answering may have been limited to the length of time the points of contact had been in their current position.

Conclusion

Drug shortages are a pervasive barrier to patient care within larger facilities of the VA health care system, similar to what has been characterized in the private sector. As a result of these shortages and the mitigation strategies to reduce their burden, many facilities endorsed trends in increasing workload for staff, institutional operation costs, and risk for patient safety and care quality concerns. Due to the demands of shortages, some facilities have implemented drug shortage task forces or equivalent groups to specifically manage these issues. Moving forward, the VA health care system may benefit from similar task forces or working groups at the VISN level, to aid in collaborative efforts to respond to shortage. Support for revising federal regulations on procurement in times of shortage and enhanced PBM drug shortage management guidance also was endorsed.

Drug product shortages threaten health care quality and public health by creating barriers to optimal care. The frequency of drug shortages has risen dramatically since 2005 and now influences broad areas of health care practice. More than 400 generic drug products have been affected, forcing institutions to purchase costly brand-name products, substitute alternative therapies, or procure from gray market vendors at increased institutional costs.¹ Scarcity and cost have potential to negatively impact patient outcomes and the ability of health care organizations to respond to the needs of their patients.

Background

Although constantly fluctuating, the number of active shortages reached a height of 320 products at the end the third quarter of 2014.² A 2011 analysis from Premier Healthcare Alliance estimated the added cost of purchasing brand, generic, or alternative drugs due to shortage may have inflated hospital costs by $200 million annually.¹ In 2016, the number of active shortages dropped to 176, suggesting a downward trend. However, the drug supply chain remains a concern for pharmacies in the U.S.

Despite creative approaches to shortage management, the variable characteristics of shortages make planning difficult. For example, the drug product in short supply may or may not have an alternative for use in similar clinical scenarios. The impact of shortages of medications lacking an equivalent alternative product has been documented, such as the past shortage of succinylcholine for anesthesia, resulting in surgery cancellations when an alternative paralytic agent was not appropriate.³ In 2016, the Cleveland Clinic reported undertaking “military-style triage” in determining patients who required use of aminocaproic acid during open heart surgery due to its limited supply.⁴ Decisions to reserve drug supply for emergency use and prefilling syringes under pharmacy supervision to extend stability and shelf life are short-term solutions to larger, systemic issues. Unfortunately, these scenarios have the potential to disrupt patient care and diminish health outcomes.

Shortages of products that have an available therapeutic substitution may seem easily manageable, but additional considerations may be present. Bacillus Calmette-Guérin (BCG) is considered the drug of choice for bladder cancer. In 2011, there was a shortage of the BCG vaccine after mold was discovered in the formulation.⁵ Providers were forced to choose between reducing or reallocating the dose of BCG, turning away patient, or substituting mitomycin C, which is less effective and costlier. When tamsulosin capsules became difficult to obtain in 2014, some institutions began switching patients to alfuzosin.⁶ Although alfuzosin is similar in mechanism to tamsulosin, it may prolong the QTc interval. Not only did this substitution present a contraindication for patients with elevated QTc intervals or who were already receiving concomitant medications that prolonged the QTc interval, but also it required additional cost and resources needed to update electrocardiograms.

VA Consolidated Mail Outpatient Pharmacies

The VHA serves nearly 9 million patients at more than 1,200 facilities across the U.S.⁷ This large patient population results in an estimated 149 million outpatient prescriptions annually.⁸ About 80% of these are distributed by mail through 7 VA consolidated mail outpatient pharmacies (CMOPs). When drug scarcity impedes the ability of the CMOP to respond to medication demand, the local facility must fill these prescriptions. These rejections sent back to the facility impact workload, patient wait times, and access to medication therapy. Barriers to medication procurement in the VA also stem from regulations based on legislation, including the Trade Agreements Act, Drug Supply Chain Security Act, and the Federal Acquisition Regulation (FAR) (Table).

The impact of drug shortages has been described previously in the private sector, particularly for emergency medicine and chemotherapy.^9,10 However, the impact of drug shortages on health care provision to veteran populations within the VA has not previously been analyzed. Due to the unique procurement regulations that influence the VA and the importance of continuing to provide optimal health care services to veterans, assessing the impact of drug shortages on patient safety and health care costs is necessary in informing policy decisions and guiding recommendations for mitigation strategies. The purpose of this study was to assess the influence of drug shortages on institutional costs and patient care within VA facilities and formulate recommendations for enhanced mitigation of this issue.

Methods

The primary outcome of this study was to characterize the impact of drug shortages on institutional cost and patient safety events among VHA facilities. Secondary outcomes included subgroup evaluation in reported drug shortage impact among 1a, 1b, and 1c complexity VA facility survey respondents and assessment of drug shortage impact on CMOP prescription order fulfillment and operation cost.

Definitions

The complexity ranking system is a facility grouping method used within the VA to characterize the level of service provision, teaching and research opportunities, patient volume, intensive care unit level, and other factors offered by a VA site. Rankings start from 1 (highest level of services offered) to 3 (lowest level of services offered), with level 1 facilities further divided into a, b, and c subdivisions. A level 1a facility will be larger with more services offered than a 1b, which is larger and offers more services than a 1c facility. The VA facilities are further characterized by regional distribution. Sites are grouped under VISNs of which there are currently 21.

The CMOP program was responsible for dispensing about 119 million outpatient prescriptions in 2016 and includes designated sites for the dispensing of controlled substances and supply items. The VA Pharmacy Benefits Management Service (PBM) oversees formulary management, plans national drug policy, promotes safe and appropriate drug therapy, and delivers high-quality and sustainable pharmacy benefits for veterans.

Study Design

A descriptive study was initiated to characterize the impact of drug shortages among VA facilities. An analysis of administrative medication safety event reporting and institutional costs data at the Denver VAMC in Colorado was done, focusing on predetermined drug products involved in a recent shortage. The analysis was accomplished through a review of the VA adverse drug events reporting system (VA ADERS) reports and a local medication errors quality improvement database and paper procurement records, respectively. Concurrently, a survey was disseminated among qualifying VA facilities across the country that sought to characterize the impact of drug shortages nationally.

Sample Selection

Denver VAMC. The Denver VAMC, where the authors were located, was selected as the local sample site. The intention was to compare the strategies used locally with strategies used among similar (level 1a, 1b, and 1c) facilities. Preselected “cost-impacting” drug products were identified through a review of historic shortages with a significant local impact. These drugs were defined as low cost/high utilization (eg, tamsulosin 0.4-mg capsules and ketorolac solution), medium cost/utilization (eg, piperacillin/tazobactam IV solutions and aminocaproic acid solution), and high cost/low utilization (eg, nitroprusside IV solution and BCG vaccine solution). Additionally, patient safety event data reported internally for quality improvement and locally via VA ADERS were reviewed for preselected “safety impact” drug products and included BCG vaccine, tamsulosin capsules, IV fluid products, calcium gluconate and chloride injections, and aminocaproic acid injection.

National Survey. The authors identified 84 level 1 complexity facilities and used the PBM pharmacy directory to contact the administrative personnel representing each facility. These representatives identified a point of contact to aid in survey completion. A separate survey also was sent to the CMOP facilities (survey outlines available at www.fedprac.com).

Data Collection

Denver VAMC. Financial data were sampled through a manual review of paper procurement records stored by date in the inpatient pharmacy of the Denver VAMC. Variables included units of product used over the period of drug shortage, cost per unit during shortage, and cost per unit before shortage. This information also was supplemented with data from the prescription processing software’s drug file. Patient safety data were gathered through query of the identified event reporting databases for the prespecified drug on shortage. These variables included the type of error and the effect the error had on the patient.

National Survey. Data collection focused on notable drug shortages and patient safety reporting between January 1, 2013 and December 31, 2016. The survey was maintained in a facility-specific spreadsheet. Editing capabilities were disabled for all actions other than responding to questions. Recipients were followed up with a courtesy e-mail after 2 weeks and another 2 times unless a survey was received. Data were de-identified and aggregated for analyses.

Statistical Analyses

Excel 2010 (Microsoft, Redmond, WA) descriptive statistics were used to relay information from this assessment. Extrapolations from procurement cost data and drug product utilization were used to estimate the enhanced direct cost associated with identified drug shortages. Similar extrapolations were used to estimate the cost associated with shortages leading to CMOP rejection and local fill.

Results

Survey completion totaled 20% of invited facilities (n = 17). Good geographic and VISN distribution was noted with representatives from VISNs 2, 4, 8, 9, 10, 12, 15, 16, 21, and 22. VISNs 10 and 12 provided the most representation with 3 participants, each. Level 1a facilities participated most (n = 9), followed by 1b (n = 6) and 1c (n = 2). Participating facilities reported a mean (SD) of 54 (21.5) pharmacists and 34 (15.3) pharmacy technician staff members employed. The most common reason for not participating was lack of personnel resources and competing demands. The CMOP participation was 100% (n = 7) and completed through a coordinated response.

Results of the budgetary increase and staff member time allocation survey assessments are provided (Figures 1 and 2). Five facilities provided an annual estimate of increased cost due to acquisition of drugs on shortage through open market purchases that ranged from about $150,000 to $750,000. Nearly half of the surveyed facilities endorsed having a drug shortage task force (n = 8) to respond to drug shortages and mitigate their impact.

Regarding drug product allocation, only 2 facilities did not have current restrictions for use due to a shortage. Many had between 1 and 10 of these restrictions implemented to conserve supply (n = 11, 64%), 2 facilities reported 11 to 20 restrictions, and 2 facilities noted more than 30 restrictions. Similarly, 3 facilities had not needed to revise any current treatment protocols due to drug shortages. The majority of facilities had revised 1 to 5 current protocols (n = 12, 70%), 1 revised 6 to 10 protocols, and 1 facility revised more than 10 protocols.

In assessing patient safety concerns, 1 facility identified a history of transferring patients to alternative medical sites for the patients to obtain necessary medication impacted by a local shortage. Additionally, during the BCG vaccine shortage, 6 facilities (35.3%) substituted mitomycin C for the treatment of urinary bladder cancer.

Most participants either agreed (n = 8, 47.0%) or strongly agreed (n = 4, 23.5%) that modifications to FAR to increase purchasing opportunities from foreign distributors during drug shortage would help mitigate the impact of such shortages. Similarly, most participants agreed (n = 10, 58.8%) or strongly agreed (n = 3, 17.6%) that PBM guidance on drug shortage management would help efficiently and effectively respond to issues that might arise. The consensus of participants also agreed (n = 13, 76.5%) that organized collaborations or working groups within each VISN might help assist in drug shortage management.

The CMOP facility data revealed that 2 sites did not require dedicated staffing to respond to shortages, and 3 sites had not experienced cost increases because of shortages. Pharmacist use varied between sites, with 2 facilities using 1 to 10 pharmacist h/wk, and 1 facility using 11 to 20 pharmacist h/wk, and 1 facility using 21 to 30 pharmacist h/wk. Technician utilization was more pronounced, with 2 facilities using more than 30 technician h/wk, and 2 facilities using 1 to 10 technician h/wk. Workload and costs may have been influenced in other ways as 3 sites endorsed using overtime pay, shifting product responsibility between CMOPs, prolonging patient wait times, and close monitoring for each. In fiscal year 2015, some sites experienced a 1% to 5% (n = 2) and 6% to 10% (n = 1) increase in operation cost attributable to shortage. Results from fiscal year 2016 showed that some sites continued to see a 1% to 5% (n = 1) and 6% to 10% (n = 2) increase in operation cost attributable to shortage.

Through aggregation of CMOP responses on the number of prescriptions sent back to local facility for fill due to back order, a downward trend in the total number of rejections was seen over the 2.5 fiscal years assessed. This amounted to more than 1 million rejections in fiscal year 2015, about 788,000 rejections in 2016, and about 318,000 rejections through the first 2 quarters of 2017.

A consistent rise in the medication procurement budget requirement was characterized within the single VA facility review. The quarterly median increase was 2.7% over 2.5 years (min: -1.4%; max: 6.6%) for total outpatient medication costs, excluding hepatitis C antiviral therapies. Procurement cost records were insufficient to characterize historic expenditures for 4 of the prespecified drug products. The data collected on tamsulosin capsule and nitroprusside vial procurement during shortage is provided (Figures 3 and 4). Over the time frame of procurement records found on review, the added costs of nitroprusside vials and tamsulosin capsules were $22,766.09 (+167.9% of base cost) and $17,433.70 (+657.3% of base cost), respectively. No patient safety data were found on review.

Discussion

Drug product shortages represent a barrier to quality and efficiency across health care institutions. A survey of health system pharmacies in the southeastern U.S. found that the majority of respondents tracking shortage data reported a 300% to 500% markup by alternative or gray market suppliers for hard-to-find medications.¹¹ These reports are similar to the authors’ analyses of the trends in increased procurement expenditures documented during the tamsulosin capsule and nitroprusside vial shortages and indirectly correlate with the survey results indicating that most facilities endorsed a trend in operation cost increase attributable to drugs product shortage. The estimated annual costs for open market purchases further informs the financial burden aggregated by this issue.

Indirect costs from drug shortage further complicated quantifying the impact of shortages. Many facilities acknowledged the indirect influence drug shortages have on staffing and workload due to the implementation of mitigation strategies. Most participants found it necessary to establish restrictions for use in addition to altering protocols. These required the time investment of essential personnel from development through execution and education. Situations also can arise for mass therapeutic substitution. In this example, pharmacy staff may be required to oversee medication transition from the product on shortage to an appropriate alternative. When substitution involves hundreds or thousands of outpatient prescriptions, such as the tamsulosin shortage, the process may be tedious and time consuming, depending on the level of clinical decision making needed to determine patient candidacy for transitioning products.

Improving institutional cost efficiency becomes a significant challenge with persistent drug shortages. Professional advocacy groups, such as the American Society of Health-System Pharmacists (ASHP), help provide guidance to organizations constrained by specific drug shortages.¹² Staff knowledgeable in allocation, supply considerations, and product repackaging and stability data also are essential. Other mitigation strategies include automatic substitutions, restrictions for use or inventory control strategies, and open market procurement, or borrowing from other institutions.

Data gathered from the survey of CMOP facilities also helped elucidate strategies used to mitigate drug shortage impacts for those respondents impacted by shortage. Likely, the 2 CMOP facilities without dedicated staff focused on shortages are those whose outpatient prescription fulfillment responsibility were focused on supply items or controlled substances. The impacted CMOP respondents cited overtime pay, shifting product responsibility, and prolonging patient wait times as the most frequently employed mitigation strategies. When these and other strategies fail to manage a shortage, prescriptions are often sent back to the local facility to be filled. Unfortunately for these facilities, the same mitigation strategies used by CMOP are not always feasible. Overtime pay may not be possible given staffing and budgetary resources, sending prescriptions back to facilities in itself prolongs patient wait times, and local medical centers do not have the option of shifting product responsibility between sites or sending the prescription to another facility. Herein lies 1 rationale for the CMOP effort to reduce the volume of prescriptions sent back to local medical centers.

Multiple offices within the FDA have roles in the mitigation of national drug shortages within their regulatory purview. Much of the recent focus stems from provisions enacted under Title X of the FDA Safety and Innovation Act of 2012, which addresses problems in the drug-supply chain.¹² Rectifying a shortage involves short- and long-term strategic planning to address supply, distribution, and market reaction to need. Collaboration between the FDA and manufacturers is one method by which demand can be satisfied through the coordination of resources, expedition of inspections, and root cause analysis of the shortage.

Similar collaborations within the VA were viewed favorably by respondents and might yield productive relationships if regional or VISN working groups were to be established. Alternative long-term strategies are executed through regulation, particularly concerning the importation of foreign manufactured drugs and regulatory discretion on supplier vetting. Despite a strong respondent consensus that regulatory modifications of foreign product importation in the setting of a drug shortage may be beneficial, such a change would require a congressional action and is not likely to be timely. Unfortunately, gray market pharmaceutical distribution, driven by wholesaler stockpiling to raise prices, is separate from manufacturer driven shortages and falls outside the FDA’s regulatory purview and institutional mitigation strategies.

Although based on this limited survey, general agreement existed on the importance of greater national collaboration and communication regarding drug shortage management strategies. This could include PBM guidance on specific shortage management opportunities or establishing collaborations by region or VISN. These possibilities may be more realistically attainable in comparison to modifying federal regulations on drug product procurement during active shortages, which requires an act of Congress. Many of the survey participants endorsed a drug shortage task force within their facility. Coordinating interaction between preexisting or newly established task forces or working groups on a monthly or quarterly basis may provide fruitful interactions and the exchange of strategies to reduce shortage impact on institutional cost, efficiency, and patient care.

Limitations

Quantifying the extent of drug shortage impact on patient safety and institutional costs is a difficult task. The procurement records data used for the analysis of a single VAMC were gathered through manual review of stored paper invoices, opening the possibility for missing data. It is also difficult to extrapolate the sum of indirect costs such as process changes, alternative product utilization, and pharmacy staffing resources as additional financial burdens to the affected institution. Any quantifiable cost assessment also is biased by contract terms between the VA and wholesalers in which unavailable products that must be purchased off-contract are subsequently reimbursed through credit or alternative means.

Patient safety events are frequently underreported, leading to underestimation of true safety event incidence. Given that these events are documented by multiple disciplines and that many of these documenters may not be aware consistently of the drug products and volume impacted by shortage, elucidating safety events unfolding in relation to shortage also is difficult to quantify.

The response rate for the survey was low but near the expected rate for this methodology. Feedback from several facilities was received, citing competing demands and workforce shortage as barriers to participation. The survey also was limited by reporting bias and recall bias. As assessment of prespecified past drug shortages may require intimate knowledge of pharmacy department processes and mitigation strategies, the accuracy of question answering may have been limited to the length of time the points of contact had been in their current position.

Conclusion

Drug shortages are a pervasive barrier to patient care within larger facilities of the VA health care system, similar to what has been characterized in the private sector. As a result of these shortages and the mitigation strategies to reduce their burden, many facilities endorsed trends in increasing workload for staff, institutional operation costs, and risk for patient safety and care quality concerns. Due to the demands of shortages, some facilities have implemented drug shortage task forces or equivalent groups to specifically manage these issues. Moving forward, the VA health care system may benefit from similar task forces or working groups at the VISN level, to aid in collaborative efforts to respond to shortage. Support for revising federal regulations on procurement in times of shortage and enhanced PBM drug shortage management guidance also was endorsed.

Drug product shortages threaten health care quality and public health by creating barriers to optimal care. The frequency of drug shortages has risen dramatically since 2005 and now influences broad areas of health care practice. More than 400 generic drug products have been affected, forcing institutions to purchase costly brand-name products, substitute alternative therapies, or procure from gray market vendors at increased institutional costs.¹ Scarcity and cost have potential to negatively impact patient outcomes and the ability of health care organizations to respond to the needs of their patients.

Background

Although constantly fluctuating, the number of active shortages reached a height of 320 products at the end the third quarter of 2014.² A 2011 analysis from Premier Healthcare Alliance estimated the added cost of purchasing brand, generic, or alternative drugs due to shortage may have inflated hospital costs by $200 million annually.¹ In 2016, the number of active shortages dropped to 176, suggesting a downward trend. However, the drug supply chain remains a concern for pharmacies in the U.S.

Despite creative approaches to shortage management, the variable characteristics of shortages make planning difficult. For example, the drug product in short supply may or may not have an alternative for use in similar clinical scenarios. The impact of shortages of medications lacking an equivalent alternative product has been documented, such as the past shortage of succinylcholine for anesthesia, resulting in surgery cancellations when an alternative paralytic agent was not appropriate.³ In 2016, the Cleveland Clinic reported undertaking “military-style triage” in determining patients who required use of aminocaproic acid during open heart surgery due to its limited supply.⁴ Decisions to reserve drug supply for emergency use and prefilling syringes under pharmacy supervision to extend stability and shelf life are short-term solutions to larger, systemic issues. Unfortunately, these scenarios have the potential to disrupt patient care and diminish health outcomes.

Shortages of products that have an available therapeutic substitution may seem easily manageable, but additional considerations may be present. Bacillus Calmette-Guérin (BCG) is considered the drug of choice for bladder cancer. In 2011, there was a shortage of the BCG vaccine after mold was discovered in the formulation.⁵ Providers were forced to choose between reducing or reallocating the dose of BCG, turning away patient, or substituting mitomycin C, which is less effective and costlier. When tamsulosin capsules became difficult to obtain in 2014, some institutions began switching patients to alfuzosin.⁶ Although alfuzosin is similar in mechanism to tamsulosin, it may prolong the QTc interval. Not only did this substitution present a contraindication for patients with elevated QTc intervals or who were already receiving concomitant medications that prolonged the QTc interval, but also it required additional cost and resources needed to update electrocardiograms.

VA Consolidated Mail Outpatient Pharmacies

The VHA serves nearly 9 million patients at more than 1,200 facilities across the U.S.⁷ This large patient population results in an estimated 149 million outpatient prescriptions annually.⁸ About 80% of these are distributed by mail through 7 VA consolidated mail outpatient pharmacies (CMOPs). When drug scarcity impedes the ability of the CMOP to respond to medication demand, the local facility must fill these prescriptions. These rejections sent back to the facility impact workload, patient wait times, and access to medication therapy. Barriers to medication procurement in the VA also stem from regulations based on legislation, including the Trade Agreements Act, Drug Supply Chain Security Act, and the Federal Acquisition Regulation (FAR) (Table).

The impact of drug shortages has been described previously in the private sector, particularly for emergency medicine and chemotherapy.^9,10 However, the impact of drug shortages on health care provision to veteran populations within the VA has not previously been analyzed. Due to the unique procurement regulations that influence the VA and the importance of continuing to provide optimal health care services to veterans, assessing the impact of drug shortages on patient safety and health care costs is necessary in informing policy decisions and guiding recommendations for mitigation strategies. The purpose of this study was to assess the influence of drug shortages on institutional costs and patient care within VA facilities and formulate recommendations for enhanced mitigation of this issue.

Methods

The primary outcome of this study was to characterize the impact of drug shortages on institutional cost and patient safety events among VHA facilities. Secondary outcomes included subgroup evaluation in reported drug shortage impact among 1a, 1b, and 1c complexity VA facility survey respondents and assessment of drug shortage impact on CMOP prescription order fulfillment and operation cost.

Definitions

The complexity ranking system is a facility grouping method used within the VA to characterize the level of service provision, teaching and research opportunities, patient volume, intensive care unit level, and other factors offered by a VA site. Rankings start from 1 (highest level of services offered) to 3 (lowest level of services offered), with level 1 facilities further divided into a, b, and c subdivisions. A level 1a facility will be larger with more services offered than a 1b, which is larger and offers more services than a 1c facility. The VA facilities are further characterized by regional distribution. Sites are grouped under VISNs of which there are currently 21.

The CMOP program was responsible for dispensing about 119 million outpatient prescriptions in 2016 and includes designated sites for the dispensing of controlled substances and supply items. The VA Pharmacy Benefits Management Service (PBM) oversees formulary management, plans national drug policy, promotes safe and appropriate drug therapy, and delivers high-quality and sustainable pharmacy benefits for veterans.

Study Design

A descriptive study was initiated to characterize the impact of drug shortages among VA facilities. An analysis of administrative medication safety event reporting and institutional costs data at the Denver VAMC in Colorado was done, focusing on predetermined drug products involved in a recent shortage. The analysis was accomplished through a review of the VA adverse drug events reporting system (VA ADERS) reports and a local medication errors quality improvement database and paper procurement records, respectively. Concurrently, a survey was disseminated among qualifying VA facilities across the country that sought to characterize the impact of drug shortages nationally.

Sample Selection

Denver VAMC. The Denver VAMC, where the authors were located, was selected as the local sample site. The intention was to compare the strategies used locally with strategies used among similar (level 1a, 1b, and 1c) facilities. Preselected “cost-impacting” drug products were identified through a review of historic shortages with a significant local impact. These drugs were defined as low cost/high utilization (eg, tamsulosin 0.4-mg capsules and ketorolac solution), medium cost/utilization (eg, piperacillin/tazobactam IV solutions and aminocaproic acid solution), and high cost/low utilization (eg, nitroprusside IV solution and BCG vaccine solution). Additionally, patient safety event data reported internally for quality improvement and locally via VA ADERS were reviewed for preselected “safety impact” drug products and included BCG vaccine, tamsulosin capsules, IV fluid products, calcium gluconate and chloride injections, and aminocaproic acid injection.

National Survey. The authors identified 84 level 1 complexity facilities and used the PBM pharmacy directory to contact the administrative personnel representing each facility. These representatives identified a point of contact to aid in survey completion. A separate survey also was sent to the CMOP facilities (survey outlines available at www.fedprac.com).

Data Collection

Denver VAMC. Financial data were sampled through a manual review of paper procurement records stored by date in the inpatient pharmacy of the Denver VAMC. Variables included units of product used over the period of drug shortage, cost per unit during shortage, and cost per unit before shortage. This information also was supplemented with data from the prescription processing software’s drug file. Patient safety data were gathered through query of the identified event reporting databases for the prespecified drug on shortage. These variables included the type of error and the effect the error had on the patient.

National Survey. Data collection focused on notable drug shortages and patient safety reporting between January 1, 2013 and December 31, 2016. The survey was maintained in a facility-specific spreadsheet. Editing capabilities were disabled for all actions other than responding to questions. Recipients were followed up with a courtesy e-mail after 2 weeks and another 2 times unless a survey was received. Data were de-identified and aggregated for analyses.

Statistical Analyses

Excel 2010 (Microsoft, Redmond, WA) descriptive statistics were used to relay information from this assessment. Extrapolations from procurement cost data and drug product utilization were used to estimate the enhanced direct cost associated with identified drug shortages. Similar extrapolations were used to estimate the cost associated with shortages leading to CMOP rejection and local fill.

Results

Survey completion totaled 20% of invited facilities (n = 17). Good geographic and VISN distribution was noted with representatives from VISNs 2, 4, 8, 9, 10, 12, 15, 16, 21, and 22. VISNs 10 and 12 provided the most representation with 3 participants, each. Level 1a facilities participated most (n = 9), followed by 1b (n = 6) and 1c (n = 2). Participating facilities reported a mean (SD) of 54 (21.5) pharmacists and 34 (15.3) pharmacy technician staff members employed. The most common reason for not participating was lack of personnel resources and competing demands. The CMOP participation was 100% (n = 7) and completed through a coordinated response.

Results of the budgetary increase and staff member time allocation survey assessments are provided (Figures 1 and 2). Five facilities provided an annual estimate of increased cost due to acquisition of drugs on shortage through open market purchases that ranged from about $150,000 to $750,000. Nearly half of the surveyed facilities endorsed having a drug shortage task force (n = 8) to respond to drug shortages and mitigate their impact.

Regarding drug product allocation, only 2 facilities did not have current restrictions for use due to a shortage. Many had between 1 and 10 of these restrictions implemented to conserve supply (n = 11, 64%), 2 facilities reported 11 to 20 restrictions, and 2 facilities noted more than 30 restrictions. Similarly, 3 facilities had not needed to revise any current treatment protocols due to drug shortages. The majority of facilities had revised 1 to 5 current protocols (n = 12, 70%), 1 revised 6 to 10 protocols, and 1 facility revised more than 10 protocols.

In assessing patient safety concerns, 1 facility identified a history of transferring patients to alternative medical sites for the patients to obtain necessary medication impacted by a local shortage. Additionally, during the BCG vaccine shortage, 6 facilities (35.3%) substituted mitomycin C for the treatment of urinary bladder cancer.

Most participants either agreed (n = 8, 47.0%) or strongly agreed (n = 4, 23.5%) that modifications to FAR to increase purchasing opportunities from foreign distributors during drug shortage would help mitigate the impact of such shortages. Similarly, most participants agreed (n = 10, 58.8%) or strongly agreed (n = 3, 17.6%) that PBM guidance on drug shortage management would help efficiently and effectively respond to issues that might arise. The consensus of participants also agreed (n = 13, 76.5%) that organized collaborations or working groups within each VISN might help assist in drug shortage management.

The CMOP facility data revealed that 2 sites did not require dedicated staffing to respond to shortages, and 3 sites had not experienced cost increases because of shortages. Pharmacist use varied between sites, with 2 facilities using 1 to 10 pharmacist h/wk, and 1 facility using 11 to 20 pharmacist h/wk, and 1 facility using 21 to 30 pharmacist h/wk. Technician utilization was more pronounced, with 2 facilities using more than 30 technician h/wk, and 2 facilities using 1 to 10 technician h/wk. Workload and costs may have been influenced in other ways as 3 sites endorsed using overtime pay, shifting product responsibility between CMOPs, prolonging patient wait times, and close monitoring for each. In fiscal year 2015, some sites experienced a 1% to 5% (n = 2) and 6% to 10% (n = 1) increase in operation cost attributable to shortage. Results from fiscal year 2016 showed that some sites continued to see a 1% to 5% (n = 1) and 6% to 10% (n = 2) increase in operation cost attributable to shortage.

Through aggregation of CMOP responses on the number of prescriptions sent back to local facility for fill due to back order, a downward trend in the total number of rejections was seen over the 2.5 fiscal years assessed. This amounted to more than 1 million rejections in fiscal year 2015, about 788,000 rejections in 2016, and about 318,000 rejections through the first 2 quarters of 2017.

A consistent rise in the medication procurement budget requirement was characterized within the single VA facility review. The quarterly median increase was 2.7% over 2.5 years (min: -1.4%; max: 6.6%) for total outpatient medication costs, excluding hepatitis C antiviral therapies. Procurement cost records were insufficient to characterize historic expenditures for 4 of the prespecified drug products. The data collected on tamsulosin capsule and nitroprusside vial procurement during shortage is provided (Figures 3 and 4). Over the time frame of procurement records found on review, the added costs of nitroprusside vials and tamsulosin capsules were $22,766.09 (+167.9% of base cost) and $17,433.70 (+657.3% of base cost), respectively. No patient safety data were found on review.

Discussion

Drug product shortages represent a barrier to quality and efficiency across health care institutions. A survey of health system pharmacies in the southeastern U.S. found that the majority of respondents tracking shortage data reported a 300% to 500% markup by alternative or gray market suppliers for hard-to-find medications.¹¹ These reports are similar to the authors’ analyses of the trends in increased procurement expenditures documented during the tamsulosin capsule and nitroprusside vial shortages and indirectly correlate with the survey results indicating that most facilities endorsed a trend in operation cost increase attributable to drugs product shortage. The estimated annual costs for open market purchases further informs the financial burden aggregated by this issue.

Indirect costs from drug shortage further complicated quantifying the impact of shortages. Many facilities acknowledged the indirect influence drug shortages have on staffing and workload due to the implementation of mitigation strategies. Most participants found it necessary to establish restrictions for use in addition to altering protocols. These required the time investment of essential personnel from development through execution and education. Situations also can arise for mass therapeutic substitution. In this example, pharmacy staff may be required to oversee medication transition from the product on shortage to an appropriate alternative. When substitution involves hundreds or thousands of outpatient prescriptions, such as the tamsulosin shortage, the process may be tedious and time consuming, depending on the level of clinical decision making needed to determine patient candidacy for transitioning products.

Improving institutional cost efficiency becomes a significant challenge with persistent drug shortages. Professional advocacy groups, such as the American Society of Health-System Pharmacists (ASHP), help provide guidance to organizations constrained by specific drug shortages.¹² Staff knowledgeable in allocation, supply considerations, and product repackaging and stability data also are essential. Other mitigation strategies include automatic substitutions, restrictions for use or inventory control strategies, and open market procurement, or borrowing from other institutions.

Data gathered from the survey of CMOP facilities also helped elucidate strategies used to mitigate drug shortage impacts for those respondents impacted by shortage. Likely, the 2 CMOP facilities without dedicated staff focused on shortages are those whose outpatient prescription fulfillment responsibility were focused on supply items or controlled substances. The impacted CMOP respondents cited overtime pay, shifting product responsibility, and prolonging patient wait times as the most frequently employed mitigation strategies. When these and other strategies fail to manage a shortage, prescriptions are often sent back to the local facility to be filled. Unfortunately for these facilities, the same mitigation strategies used by CMOP are not always feasible. Overtime pay may not be possible given staffing and budgetary resources, sending prescriptions back to facilities in itself prolongs patient wait times, and local medical centers do not have the option of shifting product responsibility between sites or sending the prescription to another facility. Herein lies 1 rationale for the CMOP effort to reduce the volume of prescriptions sent back to local medical centers.

Multiple offices within the FDA have roles in the mitigation of national drug shortages within their regulatory purview. Much of the recent focus stems from provisions enacted under Title X of the FDA Safety and Innovation Act of 2012, which addresses problems in the drug-supply chain.¹² Rectifying a shortage involves short- and long-term strategic planning to address supply, distribution, and market reaction to need. Collaboration between the FDA and manufacturers is one method by which demand can be satisfied through the coordination of resources, expedition of inspections, and root cause analysis of the shortage.

Similar collaborations within the VA were viewed favorably by respondents and might yield productive relationships if regional or VISN working groups were to be established. Alternative long-term strategies are executed through regulation, particularly concerning the importation of foreign manufactured drugs and regulatory discretion on supplier vetting. Despite a strong respondent consensus that regulatory modifications of foreign product importation in the setting of a drug shortage may be beneficial, such a change would require a congressional action and is not likely to be timely. Unfortunately, gray market pharmaceutical distribution, driven by wholesaler stockpiling to raise prices, is separate from manufacturer driven shortages and falls outside the FDA’s regulatory purview and institutional mitigation strategies.

Although based on this limited survey, general agreement existed on the importance of greater national collaboration and communication regarding drug shortage management strategies. This could include PBM guidance on specific shortage management opportunities or establishing collaborations by region or VISN. These possibilities may be more realistically attainable in comparison to modifying federal regulations on drug product procurement during active shortages, which requires an act of Congress. Many of the survey participants endorsed a drug shortage task force within their facility. Coordinating interaction between preexisting or newly established task forces or working groups on a monthly or quarterly basis may provide fruitful interactions and the exchange of strategies to reduce shortage impact on institutional cost, efficiency, and patient care.

Limitations

Quantifying the extent of drug shortage impact on patient safety and institutional costs is a difficult task. The procurement records data used for the analysis of a single VAMC were gathered through manual review of stored paper invoices, opening the possibility for missing data. It is also difficult to extrapolate the sum of indirect costs such as process changes, alternative product utilization, and pharmacy staffing resources as additional financial burdens to the affected institution. Any quantifiable cost assessment also is biased by contract terms between the VA and wholesalers in which unavailable products that must be purchased off-contract are subsequently reimbursed through credit or alternative means.

Patient safety events are frequently underreported, leading to underestimation of true safety event incidence. Given that these events are documented by multiple disciplines and that many of these documenters may not be aware consistently of the drug products and volume impacted by shortage, elucidating safety events unfolding in relation to shortage also is difficult to quantify.

The response rate for the survey was low but near the expected rate for this methodology. Feedback from several facilities was received, citing competing demands and workforce shortage as barriers to participation. The survey also was limited by reporting bias and recall bias. As assessment of prespecified past drug shortages may require intimate knowledge of pharmacy department processes and mitigation strategies, the accuracy of question answering may have been limited to the length of time the points of contact had been in their current position.

Conclusion

Drug shortages are a pervasive barrier to patient care within larger facilities of the VA health care system, similar to what has been characterized in the private sector. As a result of these shortages and the mitigation strategies to reduce their burden, many facilities endorsed trends in increasing workload for staff, institutional operation costs, and risk for patient safety and care quality concerns. Due to the demands of shortages, some facilities have implemented drug shortage task forces or equivalent groups to specifically manage these issues. Moving forward, the VA health care system may benefit from similar task forces or working groups at the VISN level, to aid in collaborative efforts to respond to shortage. Support for revising federal regulations on procurement in times of shortage and enhanced PBM drug shortage management guidance also was endorsed.

Three-dimensional printing has revolutionized the drug and device market and already has changed the lives of millions of patients. The FDA has reviewed more than 100 devices now on the market that were manufactured on 3-D printers, including knee replacements and implants “designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction,” says FDA Commissioner Scott Gottlieb, MD. The FDA also has approved the first drug produced on a 3-D printer. It has a more porous matrix than that of the drug manufactured in the traditional way, which allows it to dissolve more rapidly. But the technology advances have been moving so fast that they have threatened to outpace safeguards.

Now the FDA is preparing for a “significant wave” of new technologies, Gottlieb says, such as 3-D-printer skin cells for burn victims and is working to provide a regulatory pathway that keeps pace with those advances, helping to keep them safe and effective. To that end, the FDA has issued new guidance to help advise manufacturers on technical aspects of 3-D printing. And as more hospitals and academic centers use their 3-D printers for innovations to use in clinical studies, the FDA also is establishing a regulatory framework for applying existing laws to nontraditional manufacturers.

The Center for Drug Evaluation and Research state-of-the-art 3-D printing facility allows FDA scientists to conduct research to determine how 3-D printing of drugs, for instance, affects drug components. The Center for Devices and Radiological Health also has a 3-D printing facility to investigate the effect of design changes on safety and performance.

Gottlieb calls the technical guidance leapfrog guidance because it helps bridge current policy with innovation. It is only intended, he says, to provide “initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

Three-dimensional printing has revolutionized the drug and device market and already has changed the lives of millions of patients. The FDA has reviewed more than 100 devices now on the market that were manufactured on 3-D printers, including knee replacements and implants “designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction,” says FDA Commissioner Scott Gottlieb, MD. The FDA also has approved the first drug produced on a 3-D printer. It has a more porous matrix than that of the drug manufactured in the traditional way, which allows it to dissolve more rapidly. But the technology advances have been moving so fast that they have threatened to outpace safeguards.

Now the FDA is preparing for a “significant wave” of new technologies, Gottlieb says, such as 3-D-printer skin cells for burn victims and is working to provide a regulatory pathway that keeps pace with those advances, helping to keep them safe and effective. To that end, the FDA has issued new guidance to help advise manufacturers on technical aspects of 3-D printing. And as more hospitals and academic centers use their 3-D printers for innovations to use in clinical studies, the FDA also is establishing a regulatory framework for applying existing laws to nontraditional manufacturers.

The Center for Drug Evaluation and Research state-of-the-art 3-D printing facility allows FDA scientists to conduct research to determine how 3-D printing of drugs, for instance, affects drug components. The Center for Devices and Radiological Health also has a 3-D printing facility to investigate the effect of design changes on safety and performance.

Gottlieb calls the technical guidance leapfrog guidance because it helps bridge current policy with innovation. It is only intended, he says, to provide “initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

Three-dimensional printing has revolutionized the drug and device market and already has changed the lives of millions of patients. The FDA has reviewed more than 100 devices now on the market that were manufactured on 3-D printers, including knee replacements and implants “designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction,” says FDA Commissioner Scott Gottlieb, MD. The FDA also has approved the first drug produced on a 3-D printer. It has a more porous matrix than that of the drug manufactured in the traditional way, which allows it to dissolve more rapidly. But the technology advances have been moving so fast that they have threatened to outpace safeguards.

Now the FDA is preparing for a “significant wave” of new technologies, Gottlieb says, such as 3-D-printer skin cells for burn victims and is working to provide a regulatory pathway that keeps pace with those advances, helping to keep them safe and effective. To that end, the FDA has issued new guidance to help advise manufacturers on technical aspects of 3-D printing. And as more hospitals and academic centers use their 3-D printers for innovations to use in clinical studies, the FDA also is establishing a regulatory framework for applying existing laws to nontraditional manufacturers.

The Center for Drug Evaluation and Research state-of-the-art 3-D printing facility allows FDA scientists to conduct research to determine how 3-D printing of drugs, for instance, affects drug components. The Center for Devices and Radiological Health also has a 3-D printing facility to investigate the effect of design changes on safety and performance.

Gottlieb calls the technical guidance leapfrog guidance because it helps bridge current policy with innovation. It is only intended, he says, to provide “initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.”

Neither of the two cardiac risk assessment indexes most commonly used (Table 1)^1,2 is completely accurate, nor is one superior to the other. To provide the most accurate assessment of cardiac risk, practitioners need to select the index most applicable to the circumstances of the individual patient.

CARDIAC COMPLICATIONS ARE INCREASING

CARDIAC RISK ASSESSMENT INDEXES

The 2 risk assessment indexes most often used are:

• The Revised Cardiac Risk Index (RCRI)¹
• The National Surgical Quality Improvement Program (NSQIP) risk index, also known as the Gupta index.²

Both are endorsed by the American College of Cardiology (ACC) and the American Heart Association (AHA).⁵ The RCRI, introduced in 1999, is more commonly used, but the NSQIP, introduced in 2011, is based on a larger sample size.

Both indexes consider various factors in estimating the risk, with some overlap. The main outcome assessed in both indexes is the risk of a major cardiac event, ie, myocardial infarction or cardiac arrest. The RCRI outcome also includes ventricular fibrillation, complete heart block, and pulmonary edema, which may be sequelae to cardiac arrest and myocardial infarction. This difference in defined outcomes between the indexes is not likely to account for a significant variation in the prediction of risk; however, this is difficult to prove.

Each index defines myocardial infarction differently. The current clinical definition⁶ includes detection of a rise or fall of cardiac biomarker values (preferably cardiac troponins) with at least 1 value above the 99th percentile upper reference limit and at least 1 of the following:

• Symptoms of ischemia
• New ST-T wave changes or new left bundle branch block
• New pathologic Q waves
• Imaging evidence of new loss of viable myocardium tissue or new regional wall- motion abnormality
• Finding of an intracoronary thrombus.

As seen in Table 1, the definition of myocardial infarction in NSQIP was one of the following: ST-segment elevation, new left bundle branch block, Q waves, or a troponin level greater than 3 times normal. Patients may have mild troponin leak of unknown significance without chest pain after surgery. This suggests that NSQIP may have overdiagnosed myocardial infarction.

USE IN CLINICAL PRACTICE

In clinical practice, which risk index is more accurate? Should clinicians become familiar with one index and keep using it? The 2014 ACC/AHA guidelines⁵ do not recommend one over the other, nor do they define the clinical situations that could lead to significant underestimation of risk.

The following are cases in which the indexes provide contradictory risk assessments.

Case 1. A 60-year-old man scheduled for surgery has diabetes mellitus, for which he takes insulin, and stable heart failure (left ventricular ejection fraction 40%). His RCRI score is 2, indicating an elevated 7% risk of cardiac complications; however, his NSQIP index is 0.31%. In this case, the NSQIP index probably underestimates the risk, as insulin-dependent diabetes and heart failure are not variables in the NSQIP index.

Case 2. A 60-year-old man who is partially functionally dependent and is on oxygen for severe chronic obstructive pulmonary disease is scheduled for craniotomy. His RCRI score is 0 (low risk), but his NSQIP index score (4.87%) indicates an elevated risk of cardiac complications based on his functional status, symptomatic chronic obstructive pulmonary disease, and high-risk surgery. In this case, the RCRI probably underestimates the risk.

These cases show that practitioners should not rely on just one index, but should rather decide which index to apply case by case. This avoids underestimating the risk. In patients with poor functional status and higher American Society of Anesthesiology class, the NSQIP index may provide a more accurate risk estimation than the RCRI. Patients with cardiomyopathy as well as those with insulin-dependent diabetes may be well assessed by the RCRI.

The following situations require additional caution when using these indexes, to avoid over- and underestimating cardiac risk.

Neither index lists severe aortic stenosis as a risk factor. The RCRI derivation and validation studies had only 5 patients with severe aortic stenosis, and the NSQIP validation study did not include any patients with aortic stenosis. Nevertheless, severe aortic stenosis increases the risk of cardiac complications in the perioperative period,⁷ making it important to consider in these patients.

Although patients with severe symptomatic aortic stenosis need valvular intervention before the surgery, patients who have asymptomatic severe aortic stenosis without associated cardiac dysfunction do not. Close hemodynamic monitoring during surgery is reasonable in the latter group.^5,7

PATIENTS WITH RECENT STROKE

What would be the cardiac risk for a patient scheduled for elective hip surgery who has had a stroke within the last 3 months? If one applies both indexes, the cardiac risk comes to less than 1% (low risk) in both cases. However, this could be deceiving. A large study⁸ published in 2014 showed an elevated risk of cardiac complications in patients undergoing noncardiac surgery who had had an ischemic stroke within the previous 6 months; in the first 3 months, the odds ratio of developing a major adverse cardiovascular event was 14.23.This clearly overrides the traditional expert opinion-based evidence, which is that a time lapse of only 1 month after an ischemic stroke is safe for surgery.

PATIENTS WITH DIASTOLIC DYSFUNCTION

A 2016 meta-analysis and systematic review found that preoperative diastolic dysfunction was associated with higher rates of postoperative mortality and major adverse cardiac events, regardless of the left ventricular ejection fraction.⁹ However, the studies investigated included mostly patients undergoing cardiovascular surgeries. This raises the question of whether asymptomatic patients need echocardiography before surgery.

In a patient who has diastolic dysfunction, one should maintain adequate blood pressure control and euvolemia before the surgery and avoid hypertensive spikes in the immediate perioperative period, as hypertension is the worst enemy of those with diastolic dysfunction. Patients with atrial fibrillation may need more stringent heart rate control.

In a prospective study involving 1,005 consecutive vascular surgery patients, the 30-day cardiovascular event rate was highest in patients with symptomatic heart failure (49%), followed by those with asymptomatic systolic left ventricular dysfunction (23%), asymptomatic diastolic left ventricular dysfunction (18%), and normal left ventricular function (10%).¹⁰

Further studies are needed to determine whether the data obtained from the assessment of ventricular function in patients without signs or symptoms are significant enough to require updates to the criteria.

WHAT ABOUT THE ROLE OF BNP?

In a meta-analysis of 15 noncardiac surgery studies in 850 patients, preoperative B-type natriuretic peptide (BNP) levels independently predicted major adverse cardiac events, with levels greater than 372 pg/mL having a 36.7% incidence of major adverse cardiac events.¹¹

A recent publication by the Canadian Cardiovascular Society¹² strongly recommended measuring N-terminal-proBNP or BNP before noncardiac surgery to enhance perioperative cardiac risk estimation in patients who are age 65 or older, patients who are age 45 to 64 with significant cardiovascular disease, or patients who have an RCRI score of 1 or higher.

Further prospective randomized studies are needed to assess the utility of measuring BNP for preoperative cardiac risk evaluation.

PATIENTS WITH OBSTRUCTIVE SLEEP APNEA

Patients with obstructive sleep apnea scheduled for surgery under anesthesia have a higher risk of perioperative complications than patients without the disease, including higher rates of cardiac complications and atrial fibrillation. However, the evidence is insufficient to support canceling or delaying surgery in patients with suspected obstructive sleep apnea.

After comorbid conditions are optimally treated, patients with obstructive sleep apnea can proceed to surgery, provided strategies for mitigating complications are implemented.¹³

A common question is whether to perform a stress test before surgery. Based on the ACC/AHA guidelines,⁵ preoperative stress testing is not indicated solely to assess surgical risk if there is no other indication for it.

Stress testing can be used to determine whether the patient needs coronary revascularization. However, routine coronary revascularization is not recommended before noncardiac surgery exclusively to reduce perioperative cardiac events.

This conclusion is based on a landmark trial in which revascularization had no significant effect on outcomes.¹⁴ That trial included high-risk patients undergoing major vascular surgery who had greater than 70% stenosis of 1 or more major coronary arteries on angiography, randomized to either revascularization or no revascularization. It excluded patients with severe left main artery disease, ejection fraction less than 20%, and severe aortic stenosis. Results showed no differences in the rates of postoperative death, myocardial infarction, and stroke between the 2 groups. Furthermore, there was no postoperative survival difference during 5 years of follow-up.

Stress testing may be considered for patients with elevated risk and whose functional capacity is poor (< 4 metabolic equivalents) or unknown if it will change the management strategy. Another consideration affecting whether to perform stress testing is whether the surgery can be deferred for a month if the stress test is positive and a bare-metal coronary stent is placed, to allow for completion of dual antiplatelet therapy.

SHOULD WE ROUTINELY MONITOR TROPONIN AFTER SURGERY IN ASYMPTOMATIC PATIENTS?

Currently, the role of routine monitoring of troponin postoperatively in asymptomatic patients is unclear. The Canadian Cardiovascular Society¹² recommends monitoring troponin in selected group of patients, eg, those with an RCRI score of 1 or higher, age 65 or older, a significant cardiac history, or elevated BNP preoperatively. However, at this point we do not have strong evidence regarding the implications of mild asymptomatic troponin elevation postoperatively and how to manage it. Two currently ongoing randomized controlled trials will answer those questions:

• The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial, comparing the use of dabigatran and omeprazole vs placebo in myocardial injury postoperatively
• The Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery (INTREPID).

Neither of the two cardiac risk assessment indexes most commonly used (Table 1)^1,2 is completely accurate, nor is one superior to the other. To provide the most accurate assessment of cardiac risk, practitioners need to select the index most applicable to the circumstances of the individual patient.

CARDIAC COMPLICATIONS ARE INCREASING

CARDIAC RISK ASSESSMENT INDEXES

The 2 risk assessment indexes most often used are:

• The Revised Cardiac Risk Index (RCRI)¹
• The National Surgical Quality Improvement Program (NSQIP) risk index, also known as the Gupta index.²

Both are endorsed by the American College of Cardiology (ACC) and the American Heart Association (AHA).⁵ The RCRI, introduced in 1999, is more commonly used, but the NSQIP, introduced in 2011, is based on a larger sample size.

Both indexes consider various factors in estimating the risk, with some overlap. The main outcome assessed in both indexes is the risk of a major cardiac event, ie, myocardial infarction or cardiac arrest. The RCRI outcome also includes ventricular fibrillation, complete heart block, and pulmonary edema, which may be sequelae to cardiac arrest and myocardial infarction. This difference in defined outcomes between the indexes is not likely to account for a significant variation in the prediction of risk; however, this is difficult to prove.

Each index defines myocardial infarction differently. The current clinical definition⁶ includes detection of a rise or fall of cardiac biomarker values (preferably cardiac troponins) with at least 1 value above the 99th percentile upper reference limit and at least 1 of the following:

• Symptoms of ischemia
• New ST-T wave changes or new left bundle branch block
• New pathologic Q waves
• Imaging evidence of new loss of viable myocardium tissue or new regional wall- motion abnormality
• Finding of an intracoronary thrombus.

As seen in Table 1, the definition of myocardial infarction in NSQIP was one of the following: ST-segment elevation, new left bundle branch block, Q waves, or a troponin level greater than 3 times normal. Patients may have mild troponin leak of unknown significance without chest pain after surgery. This suggests that NSQIP may have overdiagnosed myocardial infarction.

USE IN CLINICAL PRACTICE

In clinical practice, which risk index is more accurate? Should clinicians become familiar with one index and keep using it? The 2014 ACC/AHA guidelines⁵ do not recommend one over the other, nor do they define the clinical situations that could lead to significant underestimation of risk.

The following are cases in which the indexes provide contradictory risk assessments.

Case 1. A 60-year-old man scheduled for surgery has diabetes mellitus, for which he takes insulin, and stable heart failure (left ventricular ejection fraction 40%). His RCRI score is 2, indicating an elevated 7% risk of cardiac complications; however, his NSQIP index is 0.31%. In this case, the NSQIP index probably underestimates the risk, as insulin-dependent diabetes and heart failure are not variables in the NSQIP index.

Case 2. A 60-year-old man who is partially functionally dependent and is on oxygen for severe chronic obstructive pulmonary disease is scheduled for craniotomy. His RCRI score is 0 (low risk), but his NSQIP index score (4.87%) indicates an elevated risk of cardiac complications based on his functional status, symptomatic chronic obstructive pulmonary disease, and high-risk surgery. In this case, the RCRI probably underestimates the risk.

These cases show that practitioners should not rely on just one index, but should rather decide which index to apply case by case. This avoids underestimating the risk. In patients with poor functional status and higher American Society of Anesthesiology class, the NSQIP index may provide a more accurate risk estimation than the RCRI. Patients with cardiomyopathy as well as those with insulin-dependent diabetes may be well assessed by the RCRI.

The following situations require additional caution when using these indexes, to avoid over- and underestimating cardiac risk.

Neither index lists severe aortic stenosis as a risk factor. The RCRI derivation and validation studies had only 5 patients with severe aortic stenosis, and the NSQIP validation study did not include any patients with aortic stenosis. Nevertheless, severe aortic stenosis increases the risk of cardiac complications in the perioperative period,⁷ making it important to consider in these patients.

Although patients with severe symptomatic aortic stenosis need valvular intervention before the surgery, patients who have asymptomatic severe aortic stenosis without associated cardiac dysfunction do not. Close hemodynamic monitoring during surgery is reasonable in the latter group.^5,7

PATIENTS WITH RECENT STROKE

What would be the cardiac risk for a patient scheduled for elective hip surgery who has had a stroke within the last 3 months? If one applies both indexes, the cardiac risk comes to less than 1% (low risk) in both cases. However, this could be deceiving. A large study⁸ published in 2014 showed an elevated risk of cardiac complications in patients undergoing noncardiac surgery who had had an ischemic stroke within the previous 6 months; in the first 3 months, the odds ratio of developing a major adverse cardiovascular event was 14.23.This clearly overrides the traditional expert opinion-based evidence, which is that a time lapse of only 1 month after an ischemic stroke is safe for surgery.

PATIENTS WITH DIASTOLIC DYSFUNCTION

A 2016 meta-analysis and systematic review found that preoperative diastolic dysfunction was associated with higher rates of postoperative mortality and major adverse cardiac events, regardless of the left ventricular ejection fraction.⁹ However, the studies investigated included mostly patients undergoing cardiovascular surgeries. This raises the question of whether asymptomatic patients need echocardiography before surgery.

In a patient who has diastolic dysfunction, one should maintain adequate blood pressure control and euvolemia before the surgery and avoid hypertensive spikes in the immediate perioperative period, as hypertension is the worst enemy of those with diastolic dysfunction. Patients with atrial fibrillation may need more stringent heart rate control.

In a prospective study involving 1,005 consecutive vascular surgery patients, the 30-day cardiovascular event rate was highest in patients with symptomatic heart failure (49%), followed by those with asymptomatic systolic left ventricular dysfunction (23%), asymptomatic diastolic left ventricular dysfunction (18%), and normal left ventricular function (10%).¹⁰

Further studies are needed to determine whether the data obtained from the assessment of ventricular function in patients without signs or symptoms are significant enough to require updates to the criteria.

WHAT ABOUT THE ROLE OF BNP?

In a meta-analysis of 15 noncardiac surgery studies in 850 patients, preoperative B-type natriuretic peptide (BNP) levels independently predicted major adverse cardiac events, with levels greater than 372 pg/mL having a 36.7% incidence of major adverse cardiac events.¹¹

A recent publication by the Canadian Cardiovascular Society¹² strongly recommended measuring N-terminal-proBNP or BNP before noncardiac surgery to enhance perioperative cardiac risk estimation in patients who are age 65 or older, patients who are age 45 to 64 with significant cardiovascular disease, or patients who have an RCRI score of 1 or higher.

Further prospective randomized studies are needed to assess the utility of measuring BNP for preoperative cardiac risk evaluation.

PATIENTS WITH OBSTRUCTIVE SLEEP APNEA

Patients with obstructive sleep apnea scheduled for surgery under anesthesia have a higher risk of perioperative complications than patients without the disease, including higher rates of cardiac complications and atrial fibrillation. However, the evidence is insufficient to support canceling or delaying surgery in patients with suspected obstructive sleep apnea.

After comorbid conditions are optimally treated, patients with obstructive sleep apnea can proceed to surgery, provided strategies for mitigating complications are implemented.¹³

A common question is whether to perform a stress test before surgery. Based on the ACC/AHA guidelines,⁵ preoperative stress testing is not indicated solely to assess surgical risk if there is no other indication for it.

Stress testing can be used to determine whether the patient needs coronary revascularization. However, routine coronary revascularization is not recommended before noncardiac surgery exclusively to reduce perioperative cardiac events.

This conclusion is based on a landmark trial in which revascularization had no significant effect on outcomes.¹⁴ That trial included high-risk patients undergoing major vascular surgery who had greater than 70% stenosis of 1 or more major coronary arteries on angiography, randomized to either revascularization or no revascularization. It excluded patients with severe left main artery disease, ejection fraction less than 20%, and severe aortic stenosis. Results showed no differences in the rates of postoperative death, myocardial infarction, and stroke between the 2 groups. Furthermore, there was no postoperative survival difference during 5 years of follow-up.

Stress testing may be considered for patients with elevated risk and whose functional capacity is poor (< 4 metabolic equivalents) or unknown if it will change the management strategy. Another consideration affecting whether to perform stress testing is whether the surgery can be deferred for a month if the stress test is positive and a bare-metal coronary stent is placed, to allow for completion of dual antiplatelet therapy.

SHOULD WE ROUTINELY MONITOR TROPONIN AFTER SURGERY IN ASYMPTOMATIC PATIENTS?

Currently, the role of routine monitoring of troponin postoperatively in asymptomatic patients is unclear. The Canadian Cardiovascular Society¹² recommends monitoring troponin in selected group of patients, eg, those with an RCRI score of 1 or higher, age 65 or older, a significant cardiac history, or elevated BNP preoperatively. However, at this point we do not have strong evidence regarding the implications of mild asymptomatic troponin elevation postoperatively and how to manage it. Two currently ongoing randomized controlled trials will answer those questions:

• The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial, comparing the use of dabigatran and omeprazole vs placebo in myocardial injury postoperatively
• The Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery (INTREPID).

Neither of the two cardiac risk assessment indexes most commonly used (Table 1)^1,2 is completely accurate, nor is one superior to the other. To provide the most accurate assessment of cardiac risk, practitioners need to select the index most applicable to the circumstances of the individual patient.

CARDIAC COMPLICATIONS ARE INCREASING

CARDIAC RISK ASSESSMENT INDEXES

The 2 risk assessment indexes most often used are:

• The Revised Cardiac Risk Index (RCRI)¹
• The National Surgical Quality Improvement Program (NSQIP) risk index, also known as the Gupta index.²

Both are endorsed by the American College of Cardiology (ACC) and the American Heart Association (AHA).⁵ The RCRI, introduced in 1999, is more commonly used, but the NSQIP, introduced in 2011, is based on a larger sample size.

Both indexes consider various factors in estimating the risk, with some overlap. The main outcome assessed in both indexes is the risk of a major cardiac event, ie, myocardial infarction or cardiac arrest. The RCRI outcome also includes ventricular fibrillation, complete heart block, and pulmonary edema, which may be sequelae to cardiac arrest and myocardial infarction. This difference in defined outcomes between the indexes is not likely to account for a significant variation in the prediction of risk; however, this is difficult to prove.

Each index defines myocardial infarction differently. The current clinical definition⁶ includes detection of a rise or fall of cardiac biomarker values (preferably cardiac troponins) with at least 1 value above the 99th percentile upper reference limit and at least 1 of the following:

• Symptoms of ischemia
• New ST-T wave changes or new left bundle branch block
• New pathologic Q waves
• Imaging evidence of new loss of viable myocardium tissue or new regional wall- motion abnormality
• Finding of an intracoronary thrombus.

As seen in Table 1, the definition of myocardial infarction in NSQIP was one of the following: ST-segment elevation, new left bundle branch block, Q waves, or a troponin level greater than 3 times normal. Patients may have mild troponin leak of unknown significance without chest pain after surgery. This suggests that NSQIP may have overdiagnosed myocardial infarction.

USE IN CLINICAL PRACTICE

In clinical practice, which risk index is more accurate? Should clinicians become familiar with one index and keep using it? The 2014 ACC/AHA guidelines⁵ do not recommend one over the other, nor do they define the clinical situations that could lead to significant underestimation of risk.

The following are cases in which the indexes provide contradictory risk assessments.

Case 1. A 60-year-old man scheduled for surgery has diabetes mellitus, for which he takes insulin, and stable heart failure (left ventricular ejection fraction 40%). His RCRI score is 2, indicating an elevated 7% risk of cardiac complications; however, his NSQIP index is 0.31%. In this case, the NSQIP index probably underestimates the risk, as insulin-dependent diabetes and heart failure are not variables in the NSQIP index.

Case 2. A 60-year-old man who is partially functionally dependent and is on oxygen for severe chronic obstructive pulmonary disease is scheduled for craniotomy. His RCRI score is 0 (low risk), but his NSQIP index score (4.87%) indicates an elevated risk of cardiac complications based on his functional status, symptomatic chronic obstructive pulmonary disease, and high-risk surgery. In this case, the RCRI probably underestimates the risk.

These cases show that practitioners should not rely on just one index, but should rather decide which index to apply case by case. This avoids underestimating the risk. In patients with poor functional status and higher American Society of Anesthesiology class, the NSQIP index may provide a more accurate risk estimation than the RCRI. Patients with cardiomyopathy as well as those with insulin-dependent diabetes may be well assessed by the RCRI.

The following situations require additional caution when using these indexes, to avoid over- and underestimating cardiac risk.

Neither index lists severe aortic stenosis as a risk factor. The RCRI derivation and validation studies had only 5 patients with severe aortic stenosis, and the NSQIP validation study did not include any patients with aortic stenosis. Nevertheless, severe aortic stenosis increases the risk of cardiac complications in the perioperative period,⁷ making it important to consider in these patients.

Although patients with severe symptomatic aortic stenosis need valvular intervention before the surgery, patients who have asymptomatic severe aortic stenosis without associated cardiac dysfunction do not. Close hemodynamic monitoring during surgery is reasonable in the latter group.^5,7

PATIENTS WITH RECENT STROKE

What would be the cardiac risk for a patient scheduled for elective hip surgery who has had a stroke within the last 3 months? If one applies both indexes, the cardiac risk comes to less than 1% (low risk) in both cases. However, this could be deceiving. A large study⁸ published in 2014 showed an elevated risk of cardiac complications in patients undergoing noncardiac surgery who had had an ischemic stroke within the previous 6 months; in the first 3 months, the odds ratio of developing a major adverse cardiovascular event was 14.23.This clearly overrides the traditional expert opinion-based evidence, which is that a time lapse of only 1 month after an ischemic stroke is safe for surgery.

PATIENTS WITH DIASTOLIC DYSFUNCTION

A 2016 meta-analysis and systematic review found that preoperative diastolic dysfunction was associated with higher rates of postoperative mortality and major adverse cardiac events, regardless of the left ventricular ejection fraction.⁹ However, the studies investigated included mostly patients undergoing cardiovascular surgeries. This raises the question of whether asymptomatic patients need echocardiography before surgery.

In a patient who has diastolic dysfunction, one should maintain adequate blood pressure control and euvolemia before the surgery and avoid hypertensive spikes in the immediate perioperative period, as hypertension is the worst enemy of those with diastolic dysfunction. Patients with atrial fibrillation may need more stringent heart rate control.

In a prospective study involving 1,005 consecutive vascular surgery patients, the 30-day cardiovascular event rate was highest in patients with symptomatic heart failure (49%), followed by those with asymptomatic systolic left ventricular dysfunction (23%), asymptomatic diastolic left ventricular dysfunction (18%), and normal left ventricular function (10%).¹⁰

Further studies are needed to determine whether the data obtained from the assessment of ventricular function in patients without signs or symptoms are significant enough to require updates to the criteria.

WHAT ABOUT THE ROLE OF BNP?

In a meta-analysis of 15 noncardiac surgery studies in 850 patients, preoperative B-type natriuretic peptide (BNP) levels independently predicted major adverse cardiac events, with levels greater than 372 pg/mL having a 36.7% incidence of major adverse cardiac events.¹¹

A recent publication by the Canadian Cardiovascular Society¹² strongly recommended measuring N-terminal-proBNP or BNP before noncardiac surgery to enhance perioperative cardiac risk estimation in patients who are age 65 or older, patients who are age 45 to 64 with significant cardiovascular disease, or patients who have an RCRI score of 1 or higher.

Further prospective randomized studies are needed to assess the utility of measuring BNP for preoperative cardiac risk evaluation.

PATIENTS WITH OBSTRUCTIVE SLEEP APNEA

Patients with obstructive sleep apnea scheduled for surgery under anesthesia have a higher risk of perioperative complications than patients without the disease, including higher rates of cardiac complications and atrial fibrillation. However, the evidence is insufficient to support canceling or delaying surgery in patients with suspected obstructive sleep apnea.

After comorbid conditions are optimally treated, patients with obstructive sleep apnea can proceed to surgery, provided strategies for mitigating complications are implemented.¹³

A common question is whether to perform a stress test before surgery. Based on the ACC/AHA guidelines,⁵ preoperative stress testing is not indicated solely to assess surgical risk if there is no other indication for it.

Stress testing can be used to determine whether the patient needs coronary revascularization. However, routine coronary revascularization is not recommended before noncardiac surgery exclusively to reduce perioperative cardiac events.

This conclusion is based on a landmark trial in which revascularization had no significant effect on outcomes.¹⁴ That trial included high-risk patients undergoing major vascular surgery who had greater than 70% stenosis of 1 or more major coronary arteries on angiography, randomized to either revascularization or no revascularization. It excluded patients with severe left main artery disease, ejection fraction less than 20%, and severe aortic stenosis. Results showed no differences in the rates of postoperative death, myocardial infarction, and stroke between the 2 groups. Furthermore, there was no postoperative survival difference during 5 years of follow-up.

Stress testing may be considered for patients with elevated risk and whose functional capacity is poor (< 4 metabolic equivalents) or unknown if it will change the management strategy. Another consideration affecting whether to perform stress testing is whether the surgery can be deferred for a month if the stress test is positive and a bare-metal coronary stent is placed, to allow for completion of dual antiplatelet therapy.

SHOULD WE ROUTINELY MONITOR TROPONIN AFTER SURGERY IN ASYMPTOMATIC PATIENTS?

Currently, the role of routine monitoring of troponin postoperatively in asymptomatic patients is unclear. The Canadian Cardiovascular Society¹² recommends monitoring troponin in selected group of patients, eg, those with an RCRI score of 1 or higher, age 65 or older, a significant cardiac history, or elevated BNP preoperatively. However, at this point we do not have strong evidence regarding the implications of mild asymptomatic troponin elevation postoperatively and how to manage it. Two currently ongoing randomized controlled trials will answer those questions:

• The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial, comparing the use of dabigatran and omeprazole vs placebo in myocardial injury postoperatively
• The Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery (INTREPID).

The transition of care from pediatric to adult providers has drawn increased national attention to the survival of patients with chronic childhood conditions into adulthood.ttps://www.ncbi.nlm.nih.gov/books/NBK11432/ While survival outcomes have improved due to advances in care, many of these patients experience gaps in medical care when they move from pediatric to adult healthcare systems, resulting in age-inappropriate and fragmented care in adulthood.⁴ Many youth with chronic childhood conditions are not prepared to move into adult healthcare, and this lack of transition preparation is associated with poorer health outcomes, including elevated glycosylated hemoglobin and loss of transplanted organs.^5-7 National transition efforts have largely focused on the outpatient setting and there remains a paucity of literature on inpatient transitions of care.^8,9 Although transition-age patients represent a small percentage of patients at children’s hospitals, they accumulate more hospital days and have higher resource utilization compared to their pediatric cohorts.¹⁰ In this issue, Coller et al.¹¹ characterize the current state of pediatric to adult inpatient transitions of care among general pediatric services at US children’s hospitals. Over 50% of children’s hospitals did not have a specific adult-oriented hospital identified to receive transitioning patients. Fewer than half of hospitals (38%) had an explicit inpatient transition policy. Notably only 2% of hospitals could track patient outcomes through transitions; however, 41% had systems in place to address insurance issues. Institutions with combined internal medicine-pediatric (Med-Peds) providers more frequently had inpatient transition initiatives (P = .04). It is clear from Coller et al.¹¹ that the adoption of transition initiatives has been delayed since its introduction at the US Surgeon’s conference in 1989, and much work is needed to bridge this gap.¹²

Coller et al.¹¹ spearhead establishing standardized transition programs using the multidisciplinary Six Core Elements framework and highlight effective techniques from existing inpatient transition processes.¹³ While we encourage providers to utilize existing partnerships in the outpatient community to bridge the gap for this at-risk population, shifting to adult care continues to be disorganized in the face of some key barriers including challenges in addressing psychosocial needs, gaps in insurance, and poor care coordination between pediatric and adult healthcare systems.⁴

We propose several inpatient activities to improve transitions. First, we suggest the development of an inpatient transition or Med-Peds consult service across all hospitals. The Med-Peds consult service would implement the Six Core Elements, including transition readiness, transition planning, and providing insurance and referral resources. A Med-Peds consult service has been well received at our institution as it identifies clear leaders with expertise in transition. Coller et al.11 report only 11% of children’s hospitals surveyed had transition policies that referenced inpatient transitions of care. For those institutions without Med-Peds providers, we recommend establishing a hospital-wide transition policy, and identifying hospitalists trained in transitions, with multidisciplinary approaches to staff their transition consult service.

Tracking and monitoring youth in the inpatient transition process occurred in only 2% of hospitals surveyed. We urge for automatic consults to the transition service for adult aged patients admitted to children’s hospitals. With current electronic health records (EHRs), admission order sets with built-in transition consults for adolescents and young adults would improve the identification and tracking of youths. Assuming care of a pediatric patient with multiple comorbidities can be overwhelming for providers.¹⁴ The transition consult service could alleviate some of this anxiety with clear and concise documentation using standardized, readily available transition templates. These templates would summarize the patient’s past medical history and outline current medical problems, necessary subspecialty referrals, insurance status, limitations in activities of daily living, ancillary services (including physical therapy, occupational therapy, speech therapy, transportation services), and current level of readiness and independence.

In summary, the transition of care from pediatric to adult providers is a particularly vulnerable time for young adults with chronic medical conditions, and efforts focused on inpatient transitions of medical care have overall been limited. Crucial barriers include addressing psychosocial needs, gaps in insurance, and poor communication between pediatric and adult providers.⁴ Coller et al.¹¹ have identified several gaps in inpatient transitions of care as well as multiple areas of focus to improve the patient experience. Based on the findings of this study, we urge children’s hospitals caring for adult patients to identify transition leaders, partner with an adult hospital to foster effective transitions, and to protocolize inpatient and outpatient models of transition. Perhaps the most concerning finding of this study was the widespread inability to track transition outcomes. Our group’s experience has led us to believe that coupling an inpatient transition consult team with EHR-based interventions to identify patients and follow outcomes has the most potential to improve inpatient transitions of care from pediatric to adult providers.

Disclosure

The authors have no conflicts of interests or financial disclosures.

The transition of care from pediatric to adult providers has drawn increased national attention to the survival of patients with chronic childhood conditions into adulthood.ttps://www.ncbi.nlm.nih.gov/books/NBK11432/ While survival outcomes have improved due to advances in care, many of these patients experience gaps in medical care when they move from pediatric to adult healthcare systems, resulting in age-inappropriate and fragmented care in adulthood.⁴ Many youth with chronic childhood conditions are not prepared to move into adult healthcare, and this lack of transition preparation is associated with poorer health outcomes, including elevated glycosylated hemoglobin and loss of transplanted organs.^5-7 National transition efforts have largely focused on the outpatient setting and there remains a paucity of literature on inpatient transitions of care.^8,9 Although transition-age patients represent a small percentage of patients at children’s hospitals, they accumulate more hospital days and have higher resource utilization compared to their pediatric cohorts.¹⁰ In this issue, Coller et al.¹¹ characterize the current state of pediatric to adult inpatient transitions of care among general pediatric services at US children’s hospitals. Over 50% of children’s hospitals did not have a specific adult-oriented hospital identified to receive transitioning patients. Fewer than half of hospitals (38%) had an explicit inpatient transition policy. Notably only 2% of hospitals could track patient outcomes through transitions; however, 41% had systems in place to address insurance issues. Institutions with combined internal medicine-pediatric (Med-Peds) providers more frequently had inpatient transition initiatives (P = .04). It is clear from Coller et al.¹¹ that the adoption of transition initiatives has been delayed since its introduction at the US Surgeon’s conference in 1989, and much work is needed to bridge this gap.¹²

Coller et al.¹¹ spearhead establishing standardized transition programs using the multidisciplinary Six Core Elements framework and highlight effective techniques from existing inpatient transition processes.¹³ While we encourage providers to utilize existing partnerships in the outpatient community to bridge the gap for this at-risk population, shifting to adult care continues to be disorganized in the face of some key barriers including challenges in addressing psychosocial needs, gaps in insurance, and poor care coordination between pediatric and adult healthcare systems.⁴

We propose several inpatient activities to improve transitions. First, we suggest the development of an inpatient transition or Med-Peds consult service across all hospitals. The Med-Peds consult service would implement the Six Core Elements, including transition readiness, transition planning, and providing insurance and referral resources. A Med-Peds consult service has been well received at our institution as it identifies clear leaders with expertise in transition. Coller et al.11 report only 11% of children’s hospitals surveyed had transition policies that referenced inpatient transitions of care. For those institutions without Med-Peds providers, we recommend establishing a hospital-wide transition policy, and identifying hospitalists trained in transitions, with multidisciplinary approaches to staff their transition consult service.

Tracking and monitoring youth in the inpatient transition process occurred in only 2% of hospitals surveyed. We urge for automatic consults to the transition service for adult aged patients admitted to children’s hospitals. With current electronic health records (EHRs), admission order sets with built-in transition consults for adolescents and young adults would improve the identification and tracking of youths. Assuming care of a pediatric patient with multiple comorbidities can be overwhelming for providers.¹⁴ The transition consult service could alleviate some of this anxiety with clear and concise documentation using standardized, readily available transition templates. These templates would summarize the patient’s past medical history and outline current medical problems, necessary subspecialty referrals, insurance status, limitations in activities of daily living, ancillary services (including physical therapy, occupational therapy, speech therapy, transportation services), and current level of readiness and independence.

In summary, the transition of care from pediatric to adult providers is a particularly vulnerable time for young adults with chronic medical conditions, and efforts focused on inpatient transitions of medical care have overall been limited. Crucial barriers include addressing psychosocial needs, gaps in insurance, and poor communication between pediatric and adult providers.⁴ Coller et al.¹¹ have identified several gaps in inpatient transitions of care as well as multiple areas of focus to improve the patient experience. Based on the findings of this study, we urge children’s hospitals caring for adult patients to identify transition leaders, partner with an adult hospital to foster effective transitions, and to protocolize inpatient and outpatient models of transition. Perhaps the most concerning finding of this study was the widespread inability to track transition outcomes. Our group’s experience has led us to believe that coupling an inpatient transition consult team with EHR-based interventions to identify patients and follow outcomes has the most potential to improve inpatient transitions of care from pediatric to adult providers.

Disclosure

The authors have no conflicts of interests or financial disclosures.

The transition of care from pediatric to adult providers has drawn increased national attention to the survival of patients with chronic childhood conditions into adulthood.ttps://www.ncbi.nlm.nih.gov/books/NBK11432/ While survival outcomes have improved due to advances in care, many of these patients experience gaps in medical care when they move from pediatric to adult healthcare systems, resulting in age-inappropriate and fragmented care in adulthood.⁴ Many youth with chronic childhood conditions are not prepared to move into adult healthcare, and this lack of transition preparation is associated with poorer health outcomes, including elevated glycosylated hemoglobin and loss of transplanted organs.^5-7 National transition efforts have largely focused on the outpatient setting and there remains a paucity of literature on inpatient transitions of care.^8,9 Although transition-age patients represent a small percentage of patients at children’s hospitals, they accumulate more hospital days and have higher resource utilization compared to their pediatric cohorts.¹⁰ In this issue, Coller et al.¹¹ characterize the current state of pediatric to adult inpatient transitions of care among general pediatric services at US children’s hospitals. Over 50% of children’s hospitals did not have a specific adult-oriented hospital identified to receive transitioning patients. Fewer than half of hospitals (38%) had an explicit inpatient transition policy. Notably only 2% of hospitals could track patient outcomes through transitions; however, 41% had systems in place to address insurance issues. Institutions with combined internal medicine-pediatric (Med-Peds) providers more frequently had inpatient transition initiatives (P = .04). It is clear from Coller et al.¹¹ that the adoption of transition initiatives has been delayed since its introduction at the US Surgeon’s conference in 1989, and much work is needed to bridge this gap.¹²

Coller et al.¹¹ spearhead establishing standardized transition programs using the multidisciplinary Six Core Elements framework and highlight effective techniques from existing inpatient transition processes.¹³ While we encourage providers to utilize existing partnerships in the outpatient community to bridge the gap for this at-risk population, shifting to adult care continues to be disorganized in the face of some key barriers including challenges in addressing psychosocial needs, gaps in insurance, and poor care coordination between pediatric and adult healthcare systems.⁴

We propose several inpatient activities to improve transitions. First, we suggest the development of an inpatient transition or Med-Peds consult service across all hospitals. The Med-Peds consult service would implement the Six Core Elements, including transition readiness, transition planning, and providing insurance and referral resources. A Med-Peds consult service has been well received at our institution as it identifies clear leaders with expertise in transition. Coller et al.11 report only 11% of children’s hospitals surveyed had transition policies that referenced inpatient transitions of care. For those institutions without Med-Peds providers, we recommend establishing a hospital-wide transition policy, and identifying hospitalists trained in transitions, with multidisciplinary approaches to staff their transition consult service.

Tracking and monitoring youth in the inpatient transition process occurred in only 2% of hospitals surveyed. We urge for automatic consults to the transition service for adult aged patients admitted to children’s hospitals. With current electronic health records (EHRs), admission order sets with built-in transition consults for adolescents and young adults would improve the identification and tracking of youths. Assuming care of a pediatric patient with multiple comorbidities can be overwhelming for providers.¹⁴ The transition consult service could alleviate some of this anxiety with clear and concise documentation using standardized, readily available transition templates. These templates would summarize the patient’s past medical history and outline current medical problems, necessary subspecialty referrals, insurance status, limitations in activities of daily living, ancillary services (including physical therapy, occupational therapy, speech therapy, transportation services), and current level of readiness and independence.

In summary, the transition of care from pediatric to adult providers is a particularly vulnerable time for young adults with chronic medical conditions, and efforts focused on inpatient transitions of medical care have overall been limited. Crucial barriers include addressing psychosocial needs, gaps in insurance, and poor communication between pediatric and adult providers.⁴ Coller et al.¹¹ have identified several gaps in inpatient transitions of care as well as multiple areas of focus to improve the patient experience. Based on the findings of this study, we urge children’s hospitals caring for adult patients to identify transition leaders, partner with an adult hospital to foster effective transitions, and to protocolize inpatient and outpatient models of transition. Perhaps the most concerning finding of this study was the widespread inability to track transition outcomes. Our group’s experience has led us to believe that coupling an inpatient transition consult team with EHR-based interventions to identify patients and follow outcomes has the most potential to improve inpatient transitions of care from pediatric to adult providers.

Disclosure

The authors have no conflicts of interests or financial disclosures.

There is abundant evidence that the use of computed tomography pulmonary angiography (CTPA) is increasing in emergency departments and more patients are being diagnosed with pulmonary embolism (PE).^1,2 The increasing availability and resolution of CTPA technology since the late 1990s has led some to suggest that PE is now being overdiagnosed, which is supported by decreasing PE case–fatality rates and the detection of small, subsegmental clots that do not result in any meaningful right-ventricular dysfunction.^3,4 Indeed, recent guidelines allow that not all small PEs require anticoagulation therapy.⁵ Beyond overdiagnosis, there are potential patient-level harms associated with the liberal use of CTPA imaging, including the consequences of radiation and intravenous contrast exposure.^4,6 At the societal level, excess CTPA use contributes to the growing costs of healthcare.^2,7

Despite the above concerns, CTPA remains the diagnostic test of choice for PE. There are multiple approaches that are suggested to appropriately use CTPA in the workup of suspected PE, the most common of which is endorsed by best practice publications and combines a clinical score (eg, Well’s score) with D-dimer testing, reserving CTPA for those patients with high clinical risk and/or positive D-dimer.^8,9 Despite the professional recommendation, studies have shown that the use of PE diagnostic algorithms in clinical practice is suboptimal, resulting in much practice variation and contributing to the overuse of CTPA.^10,11 In this issue, as a means of clarifying what measures improve adherence with recommended best practices, Deblois and colleagues¹² perform a systematic review of the published interventions that have attempted to reduce CTPA imaging in the diagnosis of PE.

Deblois and colleagues are to be commended for summarizing what is unfortunately a very heterogeneous literature, the limitations of which precluded a formal meta-analysis. The authors report that most of the 17 reviewed studies incorporated either electronic clinical decision support (CDS; usually imbedded into a computerized physician order entry) tools or educational interventions in a retrospective, before-and-after design; only 3 studies were experimental and included a control group. Most of the studies included efficacy, with a few evaluating safety. There was little available evidence regarding cost-effectiveness or barriers to implementation. The most studied approach, CDS, was associated with a decrease in the use of CTPA of between 8.3% and 25.4% along with an increase in PE diagnostic yield of between 3.3% and 4.4%. Likewise, the appropriate use of CTPA (consistent with best practice recommendations) increased with CDS intervention from 18% to 19%. The addition of individual performance feedback seemed to enhance the impact of CDS, although this finding was limited to one investigation. Conversely, educational interventions to improve physician adherence to best practice approaches were less effective than CDS, with only 1 study describing a significant decrease in CTPA use or increase in diagnostic yield. Although safety data were limited, in aggregate, the reported studies did not suggest any increase in mortality with interventions to reduce CTPA use.

As discussed by the authors, CDS was the most studied and most effective intervention to improve appropriate CTPA use, albeit modest in its impact. The lack of contextual details about what factors made CDS effective or not effective makes it difficult to make general recommendations. One cited study did include physician reasons for not embracing CDS, which are not surprising in nature and reflect concerns about impaired efficiency and preference for native clinical judgement over that of electronic tools.

Moving forward, CDS, perhaps coupled with performance feedback, seems to offer the best hope of reducing inappropriate CTPA use. The growing use of electronic medical records, which is accelerated in the United States by the meaningful use provisions of the Health Information Technology for Economic and Clinical Health Act of 2009, implies that CDS tools are going to be implemented across the spectrum of diagnoses, including that of PE.¹³ The goals of CDS interventions, namely improved patient safety, quality, and cost-effectiveness, are more likely to be achieved if those studying and designing these electronic tools understand the day-to-day practice of clinical medicine. As summarized by Bates and colleagues¹⁴ in the “Ten Commandments for Effective Clinical Decision Support,” CDS interventions will be successful in changing physician behavior and promoting the right test or treatment only if they seamlessly fit into the clinical workflow, have no impact on (or improve upon) physician efficiency, and minimize the need for additional information from the user. As suggested by Deblois et al.,¹² future studies of CDS interventions that aim to align CTPA use with recommended best practices should incorporate more rigorous methodological quality, include safety and cost-effectiveness outcomes, and, perhaps most importantly, attempt to understand the environmental and organizational factors that contribute to CDS tool effectiveness.

Disclosure

The authors have declared no conflicts of interest.

There is abundant evidence that the use of computed tomography pulmonary angiography (CTPA) is increasing in emergency departments and more patients are being diagnosed with pulmonary embolism (PE).^1,2 The increasing availability and resolution of CTPA technology since the late 1990s has led some to suggest that PE is now being overdiagnosed, which is supported by decreasing PE case–fatality rates and the detection of small, subsegmental clots that do not result in any meaningful right-ventricular dysfunction.^3,4 Indeed, recent guidelines allow that not all small PEs require anticoagulation therapy.⁵ Beyond overdiagnosis, there are potential patient-level harms associated with the liberal use of CTPA imaging, including the consequences of radiation and intravenous contrast exposure.^4,6 At the societal level, excess CTPA use contributes to the growing costs of healthcare.^2,7

Despite the above concerns, CTPA remains the diagnostic test of choice for PE. There are multiple approaches that are suggested to appropriately use CTPA in the workup of suspected PE, the most common of which is endorsed by best practice publications and combines a clinical score (eg, Well’s score) with D-dimer testing, reserving CTPA for those patients with high clinical risk and/or positive D-dimer.^8,9 Despite the professional recommendation, studies have shown that the use of PE diagnostic algorithms in clinical practice is suboptimal, resulting in much practice variation and contributing to the overuse of CTPA.^10,11 In this issue, as a means of clarifying what measures improve adherence with recommended best practices, Deblois and colleagues¹² perform a systematic review of the published interventions that have attempted to reduce CTPA imaging in the diagnosis of PE.

Deblois and colleagues are to be commended for summarizing what is unfortunately a very heterogeneous literature, the limitations of which precluded a formal meta-analysis. The authors report that most of the 17 reviewed studies incorporated either electronic clinical decision support (CDS; usually imbedded into a computerized physician order entry) tools or educational interventions in a retrospective, before-and-after design; only 3 studies were experimental and included a control group. Most of the studies included efficacy, with a few evaluating safety. There was little available evidence regarding cost-effectiveness or barriers to implementation. The most studied approach, CDS, was associated with a decrease in the use of CTPA of between 8.3% and 25.4% along with an increase in PE diagnostic yield of between 3.3% and 4.4%. Likewise, the appropriate use of CTPA (consistent with best practice recommendations) increased with CDS intervention from 18% to 19%. The addition of individual performance feedback seemed to enhance the impact of CDS, although this finding was limited to one investigation. Conversely, educational interventions to improve physician adherence to best practice approaches were less effective than CDS, with only 1 study describing a significant decrease in CTPA use or increase in diagnostic yield. Although safety data were limited, in aggregate, the reported studies did not suggest any increase in mortality with interventions to reduce CTPA use.

As discussed by the authors, CDS was the most studied and most effective intervention to improve appropriate CTPA use, albeit modest in its impact. The lack of contextual details about what factors made CDS effective or not effective makes it difficult to make general recommendations. One cited study did include physician reasons for not embracing CDS, which are not surprising in nature and reflect concerns about impaired efficiency and preference for native clinical judgement over that of electronic tools.

Moving forward, CDS, perhaps coupled with performance feedback, seems to offer the best hope of reducing inappropriate CTPA use. The growing use of electronic medical records, which is accelerated in the United States by the meaningful use provisions of the Health Information Technology for Economic and Clinical Health Act of 2009, implies that CDS tools are going to be implemented across the spectrum of diagnoses, including that of PE.¹³ The goals of CDS interventions, namely improved patient safety, quality, and cost-effectiveness, are more likely to be achieved if those studying and designing these electronic tools understand the day-to-day practice of clinical medicine. As summarized by Bates and colleagues¹⁴ in the “Ten Commandments for Effective Clinical Decision Support,” CDS interventions will be successful in changing physician behavior and promoting the right test or treatment only if they seamlessly fit into the clinical workflow, have no impact on (or improve upon) physician efficiency, and minimize the need for additional information from the user. As suggested by Deblois et al.,¹² future studies of CDS interventions that aim to align CTPA use with recommended best practices should incorporate more rigorous methodological quality, include safety and cost-effectiveness outcomes, and, perhaps most importantly, attempt to understand the environmental and organizational factors that contribute to CDS tool effectiveness.

Disclosure

The authors have declared no conflicts of interest.

There is abundant evidence that the use of computed tomography pulmonary angiography (CTPA) is increasing in emergency departments and more patients are being diagnosed with pulmonary embolism (PE).^1,2 The increasing availability and resolution of CTPA technology since the late 1990s has led some to suggest that PE is now being overdiagnosed, which is supported by decreasing PE case–fatality rates and the detection of small, subsegmental clots that do not result in any meaningful right-ventricular dysfunction.^3,4 Indeed, recent guidelines allow that not all small PEs require anticoagulation therapy.⁵ Beyond overdiagnosis, there are potential patient-level harms associated with the liberal use of CTPA imaging, including the consequences of radiation and intravenous contrast exposure.^4,6 At the societal level, excess CTPA use contributes to the growing costs of healthcare.^2,7

Despite the above concerns, CTPA remains the diagnostic test of choice for PE. There are multiple approaches that are suggested to appropriately use CTPA in the workup of suspected PE, the most common of which is endorsed by best practice publications and combines a clinical score (eg, Well’s score) with D-dimer testing, reserving CTPA for those patients with high clinical risk and/or positive D-dimer.^8,9 Despite the professional recommendation, studies have shown that the use of PE diagnostic algorithms in clinical practice is suboptimal, resulting in much practice variation and contributing to the overuse of CTPA.^10,11 In this issue, as a means of clarifying what measures improve adherence with recommended best practices, Deblois and colleagues¹² perform a systematic review of the published interventions that have attempted to reduce CTPA imaging in the diagnosis of PE.

Deblois and colleagues are to be commended for summarizing what is unfortunately a very heterogeneous literature, the limitations of which precluded a formal meta-analysis. The authors report that most of the 17 reviewed studies incorporated either electronic clinical decision support (CDS; usually imbedded into a computerized physician order entry) tools or educational interventions in a retrospective, before-and-after design; only 3 studies were experimental and included a control group. Most of the studies included efficacy, with a few evaluating safety. There was little available evidence regarding cost-effectiveness or barriers to implementation. The most studied approach, CDS, was associated with a decrease in the use of CTPA of between 8.3% and 25.4% along with an increase in PE diagnostic yield of between 3.3% and 4.4%. Likewise, the appropriate use of CTPA (consistent with best practice recommendations) increased with CDS intervention from 18% to 19%. The addition of individual performance feedback seemed to enhance the impact of CDS, although this finding was limited to one investigation. Conversely, educational interventions to improve physician adherence to best practice approaches were less effective than CDS, with only 1 study describing a significant decrease in CTPA use or increase in diagnostic yield. Although safety data were limited, in aggregate, the reported studies did not suggest any increase in mortality with interventions to reduce CTPA use.

As discussed by the authors, CDS was the most studied and most effective intervention to improve appropriate CTPA use, albeit modest in its impact. The lack of contextual details about what factors made CDS effective or not effective makes it difficult to make general recommendations. One cited study did include physician reasons for not embracing CDS, which are not surprising in nature and reflect concerns about impaired efficiency and preference for native clinical judgement over that of electronic tools.

Moving forward, CDS, perhaps coupled with performance feedback, seems to offer the best hope of reducing inappropriate CTPA use. The growing use of electronic medical records, which is accelerated in the United States by the meaningful use provisions of the Health Information Technology for Economic and Clinical Health Act of 2009, implies that CDS tools are going to be implemented across the spectrum of diagnoses, including that of PE.¹³ The goals of CDS interventions, namely improved patient safety, quality, and cost-effectiveness, are more likely to be achieved if those studying and designing these electronic tools understand the day-to-day practice of clinical medicine. As summarized by Bates and colleagues¹⁴ in the “Ten Commandments for Effective Clinical Decision Support,” CDS interventions will be successful in changing physician behavior and promoting the right test or treatment only if they seamlessly fit into the clinical workflow, have no impact on (or improve upon) physician efficiency, and minimize the need for additional information from the user. As suggested by Deblois et al.,¹² future studies of CDS interventions that aim to align CTPA use with recommended best practices should incorporate more rigorous methodological quality, include safety and cost-effectiveness outcomes, and, perhaps most importantly, attempt to understand the environmental and organizational factors that contribute to CDS tool effectiveness.

Disclosure

The authors have declared no conflicts of interest.