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Clinician attitudes regarding ICD deactivation in DNR/DNI patients
Implantable cardioverter-defibrillators (ICDs) offer lifesaving therapies to many patients and have been implanted in hundreds of thousands of patients.1 The population of patients with ICDs is growing rapidly, and the national ICD Registry reports over 12,000 devices are implanted monthly.2 This population includes patients with congenital heart disease, ischemic cardiomyopathy, and idiopathic arrhythmias. If these patients experience ventricular tachycardia or fibrillation, an ICD attempts to restore sinus rhythm and prevent death. While a shock from an ICD may be lifesaving, it can be a traumatic and startling experience for the patient and perhaps distressful for families to witness.3,4
Although ICDs are intended to save lives, they do not slow the progress of the patient’s underlying cardiac and noncardiac comorbidities. All these patients will eventually die, whether from their cardiac disease or another condition. The literature includes many anecdotes about patients shocked multiple times by their defibrillator while actively dying.4 These situations could be prevented with preemptive ICD deactivation. (ICDs can function not only as cardioverters and defibrillators, as implied by their name, but also as pacemakers. “Deactivation” as used in this paper refers only to disabling the tachycardia therapies. No distinction was made between defibrillation with a shock and anti-tachycardia pacing.) Therefore, research on ICD deactivation has emphasized patients who are acutely terminally ill, while less emphasis has been placed on patients who are not actively dying.4–8
Patients may, for a variety of reasons, request a do-not-resuscitate/do-not-intubate (DNR/DNI) order as their code status. However, it is not necessarily clear what a DNR/DNI order implies for ICD management. One survey of attending physicians found that 19% of respondents felt a DNR/DNI order was equivalent to requesting ICD deactivation.9 On the other hand, patients are split on whether they would want their device deactivated while in hospice or even at the very end of life.6 Heart Rhythm Society (HRS) guidelines favor a nuanced approach to ICD deactivation in DNR/DNI patients that emphasizes the individual patient’s comorbidities and goals.10 A patient’s individual circumstances might justify a choice to be DNR/DNI without deactivating the ICD. Decision-making in these circumstances requires a careful conversation between the patient and clinician. It is important to identify barriers that might prevent optimal shared decision-making.
Clinicians have been surveyed on ICD management at the end of life, but these studies have generally focused on attending physicians.5,9,11 However, physician trainees (ie, residents and fellows) as well as advanced practice providers (ie, physician assistants and nurse practitioners) are responsible for much of the clinical care provided to hospitalized patients. In particular, they are often the clinicians to discuss code status with patients. Different specialties (eg, cardiology, general medicine, and geriatrics) manage different sets of patients, which might affect clinicians’ opinions on ICD management. We therefore designed a survey to assess clinician attitudes and beliefs regarding ICD deactivation, including in non-terminally ill patients, and to evaluate for differences according to training level and specialty.
METHODS
Case-based and Likert-scale questions were considered for this survey, with the latter being chosen for ease of completion by respondents. An online survey tool (SurveyMonkey; San Mateo, CA) was used for data collection; no identifying data were collected. E-mail invitations to participate were sent to a combination of mailing lists and individual addresses for residents, fellows, advanced practice providers, and attending physicians in general internal medicine, cardiology, electrophysiology, and geriatrics. The survey remained open for 2.5 weeks. It was conducted 5 months into the academic year, thus trainees were well-established in their current roles. Two $25 gift cards were offered to respondents who entered their e-mail into a drawing; responses were not tied to e-mail addresses. Approval for the study was obtained from the University of Michigan Institutional Review Board.
The survey posed 12 questions assessing general attitudes about ICDs as well as individual beliefs and behaviors relating to ICD deactivation. Answers were on a Likert scale of 1 to 5 with 1 representing “strongly disagree” and 5 representing “strongly agree.” A score of 3 indicated “unsure or neutral.” The first 3 questions appeared together on the first page and were prefaced with “Please respond to the following statements about ICD shocks.” The next 9 were likewise grouped on the next page and were prefaced with “Please respond to the following statements about ICD deactivation.” All 12 questions are shown in Figures 1 and 2. Respondents could easily return to previous questions and change their answers. The survey ended with a third page showing 3 multiple choice demographic questions. The demographic questions were about clinical role (first-, second-, third-, or fourth-year resident, fellow, advanced practice provider, and attending), specialty, and number of ICD deactivations the respondent had been directly involved in (0, 1 to 5, 5 to 10, and more than 10). Specialty options were internal medicine resident, inpatient general medicine, outpatient general medicine, cardiology, electrophysiology, and geriatrics.
Likert scale answers of “agree” or “strongly agree” were grouped together as an affirmative response, while all other answers were grouped together as a nonaffirmative response. For analysis, residents were grouped together and their responses compared with attending physicians as a group. Additional analysis was done comparing attending physicians stratified by clinical specialty. Given the small number of responses from attending electrophysiologists, they were grouped with attending cardiologists for analysis. Due to the limited number of fellows and advanced practice providers who responded, further evaluation of these groups was not performed. Finally, the number of ICD deactivations respondents had been involved in was stratified by training level. All comparisons were performed using the two-tailed Pearson’s chi-squared test.
RESULTS
A total of 170 responses were collected from 508 individuals on the e-mail lists. Two responses were from registered nurses who were not part of the intended study sample and 7 responses were incomplete, having only answered the first 3 questions. These 9 responses were excluded from further analysis, yielding an overall response rate of 32%. The demographics of the remaining 161 respondents are shown in Table 1. Figure 1 shows overall responses to each question.
When comparing residents to attending physicians, there were no statistically significant between-differences except on questions 5 and 6. Specifically, residents were less comfortable than attending physicians discussing ICD deactivation and did so with less regularity (P < .001 and P = .018, respectively; Figure 2). Comfort levels improved markedly with experience: 29.2% of interns expressed comfort asking about ICD deactivation as compared with 60.7% of third- and-fourth year residents and 78.8% of attending physicians. Furthermore, comfort level seemed to parallel the regularity with which respondents asked about ICD deactivation: 4.2% of interns routinely asked about ICD deactivation as compared with 21.4% of third- and fourth-year residents and 34.8% of attending physicians.
The only statistically significant difference when comparing attending physicians by specialty was on question 6 of the survey with the groups being unequal in their reliability at asking about ICD deactivation during code status discussions (P < .001; Figure 2). Of cardiologists and electrophysiologists, 73.3% said they routinely ask about ICD deactivation, as well as 83.3% of geriatricians. By contrast, only 19.2% of outpatient general internists and 10.5% of inpatient general internists (ie, hospitalists) said they routinely ask about ICD deactivation.
There were no differences between groups when asked whether ICD deactivation was part of a DNR/DNI order (question 8), or if an ICD should be deactivated in DNR/DNI patients (questions 9 and 10). As shown in Figure 1, 21.1% of respondents felt that a DNR/DNI order is equivalent to requesting ICD deactivation, 60.2% felt that terminally ill DNR/DNI patients should have their device deactivated, and 28% felt that non-terminally ill DNR/DNI patients should have their device deactivated.
Groups were unequal with respect to the number of ICD deactivations in which they had been directly involved (Figure 3; P < .001). Over half of interns had not been involved in any ICD deactivations as compared with only 10.7% of third- or fourth-year residents. Of the 20 geriatricians, cardiologists, and electrophysiologists, 45% had been involved in at least 5 ICD deactivations. Of note, although 77.8% of fellows reported being involved in more than 10 ICD deactivations, these 9 respondents were all in cardiology or electrophysiology.
DISCUSSION
Overall, our major findings were (1) residents, who provide much of the clinical care in a teaching hospital, are remarkably uncomfortable discussing ICD deactivation, (2) general internists and residents ask about ICD deactivation infrequently compared to geriatricians and cardiologists, and (3) about one fifth of our respondents believe ICD deactivation is automatically part of a DNR/DNI order.
Although the majority of respondents did not routinely address ICD deactivation in conjunction with code status, there was significant variability among subgroups. For example, 83.3% of geriatricians routinely discussed ICD deactivation as part of code status compared with only 4% of first-year residents and 10.5% of inpatient general internists. This finding is interesting because 90.7% of all respondents believed that discussions of code status should address preferences on ICD deactivation. This apparent discrepancy could be explained by the relatively small number of patients admitted to the hospital who have both an ICD and a request to be DNR/DNI. Residents and inpatient general internists see a very broad spectrum of patients; ICD deactivation is frequently irrelevant in the cases these physicians manage. The subset of patients seen in consultation by cardiologists and geriatricians, by contrast, is expected to include a larger proportion of patients with ICDs. Therefore, discussing ICD deactivation will be more relevant to their daily practice. Fear of alienating patients was not a reason for our findings, as our respondents did not express concern that recommending ICD deactivation would harm the patient-clinician relationship.
There are several possible reasons that residents, particularly interns, are uncomfortable discussing ICD deactivation. A lack of exposure to ICD deactivation is probably a key contributor. Over half of interns had never been involved in any ICD deactivations. Residents and hospitalists may also feel as if they are overstepping their boundaries to discuss deactivating ICD therapies. Their feelings may not be misplaced, as one survey of ICD patients found that over 75% thought responsibility for discussing ICD deactivation, at least at the end of life, rests with cardiologists or electrophysiologists.6
The HRS guidelines call for individualized decisions regarding ICD deactivation, even if a patient is DNR/DNI. However, our respondents frequently felt a standardized approach was indicated, with 21% believing that a DNR/DNI order included ICD deactivation. Additionally, 28% agreed that even non-terminally ill DNR/DNI patients should have their device deactivated. This is relevant because it is the role of clinicians to engage in shared decision-making with their patients. If the clinician holds the fixed belief that a DNR/DNI order, regardless of the precise clinical scenario, should include ICD deactivation, they may pressure a patient to have their device deactivated even if it could still benefit them.
In 2009, Kelley et al published results of a survey on ICD deactivation at the end of life.9 They contacted 4,876 attending physicians in cardiology, electrophysiology, geriatrics, and general medicine, receiving 558 responses. The survey included Likert-scale questions assessing attitudes and knowledge about ICD functionality. Demographic information was also collected, including how many patients in their practice had ICDs and how often they had previously discussed ICD deactivation.
There are some interesting comparisons between Kelley et al’s findings and ours, although we included trainees and the precise wording of questions was different. The specific questions used by Kelley et al to ask whether ICD shocks were painful or distressing and to ask if ICD deactivation is part of a DNR order were: “The shock from an ICD is very painful for most patients.” “The shock of an ICD at the end of life is distressing to a patient and their loved ones.” “A DNR order is equivalent to deactivation of an ICD.”
Only 47% of general internists in the Kelley et al survey thought that ICD shocks were painful, compared with 83% of electrophysiologists. In addition, 65% of general internists and 85% of electrophysiologists viewed shocks at the end of life to be distressing to patients and families. By contrast, our respondents were nearly unanimous in believing shocks to be painful and distressing. This discrepancy may be due to the growing prevalence of ICDs over the past several years as well as the growing body of literature on unnecessary shocks at the end of life. In line with our study, 19% of their respondents believed a DNR order was equivalent to ICD deactivation.9 
Taken together, our findings indicate that additional education for clinicians of all levels could be helpful. Didactic lessons cannot replace experience, and it is important for residents to be exposed to discussions of ICD deactivation. However, lessons about ICD therapies and practical examples of how to broach the topic of deactivation could be beneficial, especially for interns whose responsibility includes discussions of code status. Within the context of an internal medicine residency, the fundamentals of ICD functionality could be covered during rotations on cardiology or palliative care services. Additionally, the recommendations of the HRS for device management can be covered in didactic sessions. Similar opportunities could be built into continuing medical education for practicing physicians and the training of advanced practice providers.
There are limitations to this survey, most notably the fact that it was restricted to a single academic medical center, the patient population and practices of which may not be generalizable to medical practice at large. Selection bias is also a distinct possibility given the 32% overall response rate; those who responded may feel more strongly about the survey topic. Our study subgroups may have interpreted questions differently because of their particular area of clinical practice. The small sample size also precluded an effective analysis of fellows and advanced practice practitioners due to lack of power. A major strength of this survey was the inclusion of a large number of residents upon whom the majority of inpatient contact rests. Future work could include expanding the survey to multiple medical centers, which would enhance generalizability and improve the ability to recruit sufficient fellows and advanced practice providers.
CONCLUSION
In summary, we conducted a single-center survey of residents, fellows, advanced practice providers, and attending physicians on their attitudes and beliefs about ICD deactivation in DNR/DNI patients. Residents are particularly uncomfortable discussing ICD deactivation with patients, which is an important finding because of their crucial role in providing patient care. Additionally, residents and hospitalists do not broach the topic of deactivation regularly, especially when compared to geriatricians and cardiologists. Despite HRS guidelines to the contrary, a fifth of our respondents believed that DNR/DNI orders include ICD deactivation. Overall, ICD deactivation in DNR/DNI patients is a topic that needs further attention in clinical education so that patients receive care that respects their individual wishes.
Disclosure
Nothing to report.
1. Freeman JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky MA. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012;125(1):57-64. doi:10.1161/CIRCULATIONAHA.111.046995. PubMed
2. Kremers MS, Hammill SC, Berul CI, et al. The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011. Hear Rhythm. 2013;10(4):e59-e65. doi:10.1016/j.hrthm.2013.01.035. PubMed
3. Goldstein NE, Mehta D, Siddiqui S, et al. “That’s like an act of suicide” patients’ attitudes toward deactivation of implantable defibrillators. J Gen Intern Med. 2008;23 Suppl 1:7-12. PubMed
4. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med. 2004;141(11):835-838. http://annals.org/article.aspx?articleid=717985&issueno=11. Accessed October 23, 2013.
5. Sherazi S, Daubert JP, Block RC, et al. Physicians’ preferences and attitudes about end-of-life care in patients with an implantable cardioverter-defibrillator. Mayo Clin Proc. 2008;83(10):1139-1141. doi:10.4065/83.10.1139. PubMed
6. Kirkpatrick JN, Gottlieb M, Sehgal P, Patel R, Verdino RJ. Deactivation of implantable cardioverter defibrillators in terminal illness and end of life care. Am J Cardiol. 2012;109(1):91-94. doi:10.1016/j.amjcard.2011.08.011. PubMed
7. Marinskis G, van Erven L. Deactivation of implanted cardioverter-defibrillators at the end of life: results of the EHRA survey. Europace. 2010;12(8):1176-1177. doi:10.1093/europace/euq272. PubMed
8. Mueller PS, Jenkins SM, Bramstedt KA, Hayes DL. Deactivating implanted cardiac devices in terminally ill patients: practices and attitudes. Pacing Clin Electrophysiol. 2008;31(5):560-568. doi:10.1111/j.1540-8159.2008.01041.x. PubMed
9. Kelley AS, Reid MC, Miller DH, Fins JJ, Lachs MS. Implantable cardioverter-defibrillator deactivation at the end of life: a physician survey. Am Heart J. 2009;157(4):702-8.e1. doi:10.1016/j.ahj.2008.12.011. PubMed
10. Lampert R, Hayes DL, Annas GJ, et al. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Hear Rhythm. 2010;7(7):1008-1026. doi:10.1016/j.hrthm.2010.04.033.PubMed
11. Kelley AS, Mehta SS, Reid MC. Management of patients with ICDs at the end of life (EOL): a qualitative study. Am J Hosp Palliat Care. 2008;25(6):440-446. doi:10.1177/1049909108320885. PubMed
Implantable cardioverter-defibrillators (ICDs) offer lifesaving therapies to many patients and have been implanted in hundreds of thousands of patients.1 The population of patients with ICDs is growing rapidly, and the national ICD Registry reports over 12,000 devices are implanted monthly.2 This population includes patients with congenital heart disease, ischemic cardiomyopathy, and idiopathic arrhythmias. If these patients experience ventricular tachycardia or fibrillation, an ICD attempts to restore sinus rhythm and prevent death. While a shock from an ICD may be lifesaving, it can be a traumatic and startling experience for the patient and perhaps distressful for families to witness.3,4
Although ICDs are intended to save lives, they do not slow the progress of the patient’s underlying cardiac and noncardiac comorbidities. All these patients will eventually die, whether from their cardiac disease or another condition. The literature includes many anecdotes about patients shocked multiple times by their defibrillator while actively dying.4 These situations could be prevented with preemptive ICD deactivation. (ICDs can function not only as cardioverters and defibrillators, as implied by their name, but also as pacemakers. “Deactivation” as used in this paper refers only to disabling the tachycardia therapies. No distinction was made between defibrillation with a shock and anti-tachycardia pacing.) Therefore, research on ICD deactivation has emphasized patients who are acutely terminally ill, while less emphasis has been placed on patients who are not actively dying.4–8
Patients may, for a variety of reasons, request a do-not-resuscitate/do-not-intubate (DNR/DNI) order as their code status. However, it is not necessarily clear what a DNR/DNI order implies for ICD management. One survey of attending physicians found that 19% of respondents felt a DNR/DNI order was equivalent to requesting ICD deactivation.9 On the other hand, patients are split on whether they would want their device deactivated while in hospice or even at the very end of life.6 Heart Rhythm Society (HRS) guidelines favor a nuanced approach to ICD deactivation in DNR/DNI patients that emphasizes the individual patient’s comorbidities and goals.10 A patient’s individual circumstances might justify a choice to be DNR/DNI without deactivating the ICD. Decision-making in these circumstances requires a careful conversation between the patient and clinician. It is important to identify barriers that might prevent optimal shared decision-making.
Clinicians have been surveyed on ICD management at the end of life, but these studies have generally focused on attending physicians.5,9,11 However, physician trainees (ie, residents and fellows) as well as advanced practice providers (ie, physician assistants and nurse practitioners) are responsible for much of the clinical care provided to hospitalized patients. In particular, they are often the clinicians to discuss code status with patients. Different specialties (eg, cardiology, general medicine, and geriatrics) manage different sets of patients, which might affect clinicians’ opinions on ICD management. We therefore designed a survey to assess clinician attitudes and beliefs regarding ICD deactivation, including in non-terminally ill patients, and to evaluate for differences according to training level and specialty.
METHODS
Case-based and Likert-scale questions were considered for this survey, with the latter being chosen for ease of completion by respondents. An online survey tool (SurveyMonkey; San Mateo, CA) was used for data collection; no identifying data were collected. E-mail invitations to participate were sent to a combination of mailing lists and individual addresses for residents, fellows, advanced practice providers, and attending physicians in general internal medicine, cardiology, electrophysiology, and geriatrics. The survey remained open for 2.5 weeks. It was conducted 5 months into the academic year, thus trainees were well-established in their current roles. Two $25 gift cards were offered to respondents who entered their e-mail into a drawing; responses were not tied to e-mail addresses. Approval for the study was obtained from the University of Michigan Institutional Review Board.
The survey posed 12 questions assessing general attitudes about ICDs as well as individual beliefs and behaviors relating to ICD deactivation. Answers were on a Likert scale of 1 to 5 with 1 representing “strongly disagree” and 5 representing “strongly agree.” A score of 3 indicated “unsure or neutral.” The first 3 questions appeared together on the first page and were prefaced with “Please respond to the following statements about ICD shocks.” The next 9 were likewise grouped on the next page and were prefaced with “Please respond to the following statements about ICD deactivation.” All 12 questions are shown in Figures 1 and 2. Respondents could easily return to previous questions and change their answers. The survey ended with a third page showing 3 multiple choice demographic questions. The demographic questions were about clinical role (first-, second-, third-, or fourth-year resident, fellow, advanced practice provider, and attending), specialty, and number of ICD deactivations the respondent had been directly involved in (0, 1 to 5, 5 to 10, and more than 10). Specialty options were internal medicine resident, inpatient general medicine, outpatient general medicine, cardiology, electrophysiology, and geriatrics.
Likert scale answers of “agree” or “strongly agree” were grouped together as an affirmative response, while all other answers were grouped together as a nonaffirmative response. For analysis, residents were grouped together and their responses compared with attending physicians as a group. Additional analysis was done comparing attending physicians stratified by clinical specialty. Given the small number of responses from attending electrophysiologists, they were grouped with attending cardiologists for analysis. Due to the limited number of fellows and advanced practice providers who responded, further evaluation of these groups was not performed. Finally, the number of ICD deactivations respondents had been involved in was stratified by training level. All comparisons were performed using the two-tailed Pearson’s chi-squared test.
RESULTS
A total of 170 responses were collected from 508 individuals on the e-mail lists. Two responses were from registered nurses who were not part of the intended study sample and 7 responses were incomplete, having only answered the first 3 questions. These 9 responses were excluded from further analysis, yielding an overall response rate of 32%. The demographics of the remaining 161 respondents are shown in Table 1. Figure 1 shows overall responses to each question.
When comparing residents to attending physicians, there were no statistically significant between-differences except on questions 5 and 6. Specifically, residents were less comfortable than attending physicians discussing ICD deactivation and did so with less regularity (P < .001 and P = .018, respectively; Figure 2). Comfort levels improved markedly with experience: 29.2% of interns expressed comfort asking about ICD deactivation as compared with 60.7% of third- and-fourth year residents and 78.8% of attending physicians. Furthermore, comfort level seemed to parallel the regularity with which respondents asked about ICD deactivation: 4.2% of interns routinely asked about ICD deactivation as compared with 21.4% of third- and fourth-year residents and 34.8% of attending physicians.
The only statistically significant difference when comparing attending physicians by specialty was on question 6 of the survey with the groups being unequal in their reliability at asking about ICD deactivation during code status discussions (P < .001; Figure 2). Of cardiologists and electrophysiologists, 73.3% said they routinely ask about ICD deactivation, as well as 83.3% of geriatricians. By contrast, only 19.2% of outpatient general internists and 10.5% of inpatient general internists (ie, hospitalists) said they routinely ask about ICD deactivation.
There were no differences between groups when asked whether ICD deactivation was part of a DNR/DNI order (question 8), or if an ICD should be deactivated in DNR/DNI patients (questions 9 and 10). As shown in Figure 1, 21.1% of respondents felt that a DNR/DNI order is equivalent to requesting ICD deactivation, 60.2% felt that terminally ill DNR/DNI patients should have their device deactivated, and 28% felt that non-terminally ill DNR/DNI patients should have their device deactivated.
Groups were unequal with respect to the number of ICD deactivations in which they had been directly involved (Figure 3; P < .001). Over half of interns had not been involved in any ICD deactivations as compared with only 10.7% of third- or fourth-year residents. Of the 20 geriatricians, cardiologists, and electrophysiologists, 45% had been involved in at least 5 ICD deactivations. Of note, although 77.8% of fellows reported being involved in more than 10 ICD deactivations, these 9 respondents were all in cardiology or electrophysiology.
DISCUSSION
Overall, our major findings were (1) residents, who provide much of the clinical care in a teaching hospital, are remarkably uncomfortable discussing ICD deactivation, (2) general internists and residents ask about ICD deactivation infrequently compared to geriatricians and cardiologists, and (3) about one fifth of our respondents believe ICD deactivation is automatically part of a DNR/DNI order.
Although the majority of respondents did not routinely address ICD deactivation in conjunction with code status, there was significant variability among subgroups. For example, 83.3% of geriatricians routinely discussed ICD deactivation as part of code status compared with only 4% of first-year residents and 10.5% of inpatient general internists. This finding is interesting because 90.7% of all respondents believed that discussions of code status should address preferences on ICD deactivation. This apparent discrepancy could be explained by the relatively small number of patients admitted to the hospital who have both an ICD and a request to be DNR/DNI. Residents and inpatient general internists see a very broad spectrum of patients; ICD deactivation is frequently irrelevant in the cases these physicians manage. The subset of patients seen in consultation by cardiologists and geriatricians, by contrast, is expected to include a larger proportion of patients with ICDs. Therefore, discussing ICD deactivation will be more relevant to their daily practice. Fear of alienating patients was not a reason for our findings, as our respondents did not express concern that recommending ICD deactivation would harm the patient-clinician relationship.
There are several possible reasons that residents, particularly interns, are uncomfortable discussing ICD deactivation. A lack of exposure to ICD deactivation is probably a key contributor. Over half of interns had never been involved in any ICD deactivations. Residents and hospitalists may also feel as if they are overstepping their boundaries to discuss deactivating ICD therapies. Their feelings may not be misplaced, as one survey of ICD patients found that over 75% thought responsibility for discussing ICD deactivation, at least at the end of life, rests with cardiologists or electrophysiologists.6
The HRS guidelines call for individualized decisions regarding ICD deactivation, even if a patient is DNR/DNI. However, our respondents frequently felt a standardized approach was indicated, with 21% believing that a DNR/DNI order included ICD deactivation. Additionally, 28% agreed that even non-terminally ill DNR/DNI patients should have their device deactivated. This is relevant because it is the role of clinicians to engage in shared decision-making with their patients. If the clinician holds the fixed belief that a DNR/DNI order, regardless of the precise clinical scenario, should include ICD deactivation, they may pressure a patient to have their device deactivated even if it could still benefit them.
In 2009, Kelley et al published results of a survey on ICD deactivation at the end of life.9 They contacted 4,876 attending physicians in cardiology, electrophysiology, geriatrics, and general medicine, receiving 558 responses. The survey included Likert-scale questions assessing attitudes and knowledge about ICD functionality. Demographic information was also collected, including how many patients in their practice had ICDs and how often they had previously discussed ICD deactivation.
There are some interesting comparisons between Kelley et al’s findings and ours, although we included trainees and the precise wording of questions was different. The specific questions used by Kelley et al to ask whether ICD shocks were painful or distressing and to ask if ICD deactivation is part of a DNR order were: “The shock from an ICD is very painful for most patients.” “The shock of an ICD at the end of life is distressing to a patient and their loved ones.” “A DNR order is equivalent to deactivation of an ICD.”
Only 47% of general internists in the Kelley et al survey thought that ICD shocks were painful, compared with 83% of electrophysiologists. In addition, 65% of general internists and 85% of electrophysiologists viewed shocks at the end of life to be distressing to patients and families. By contrast, our respondents were nearly unanimous in believing shocks to be painful and distressing. This discrepancy may be due to the growing prevalence of ICDs over the past several years as well as the growing body of literature on unnecessary shocks at the end of life. In line with our study, 19% of their respondents believed a DNR order was equivalent to ICD deactivation.9 
Taken together, our findings indicate that additional education for clinicians of all levels could be helpful. Didactic lessons cannot replace experience, and it is important for residents to be exposed to discussions of ICD deactivation. However, lessons about ICD therapies and practical examples of how to broach the topic of deactivation could be beneficial, especially for interns whose responsibility includes discussions of code status. Within the context of an internal medicine residency, the fundamentals of ICD functionality could be covered during rotations on cardiology or palliative care services. Additionally, the recommendations of the HRS for device management can be covered in didactic sessions. Similar opportunities could be built into continuing medical education for practicing physicians and the training of advanced practice providers.
There are limitations to this survey, most notably the fact that it was restricted to a single academic medical center, the patient population and practices of which may not be generalizable to medical practice at large. Selection bias is also a distinct possibility given the 32% overall response rate; those who responded may feel more strongly about the survey topic. Our study subgroups may have interpreted questions differently because of their particular area of clinical practice. The small sample size also precluded an effective analysis of fellows and advanced practice practitioners due to lack of power. A major strength of this survey was the inclusion of a large number of residents upon whom the majority of inpatient contact rests. Future work could include expanding the survey to multiple medical centers, which would enhance generalizability and improve the ability to recruit sufficient fellows and advanced practice providers.
CONCLUSION
In summary, we conducted a single-center survey of residents, fellows, advanced practice providers, and attending physicians on their attitudes and beliefs about ICD deactivation in DNR/DNI patients. Residents are particularly uncomfortable discussing ICD deactivation with patients, which is an important finding because of their crucial role in providing patient care. Additionally, residents and hospitalists do not broach the topic of deactivation regularly, especially when compared to geriatricians and cardiologists. Despite HRS guidelines to the contrary, a fifth of our respondents believed that DNR/DNI orders include ICD deactivation. Overall, ICD deactivation in DNR/DNI patients is a topic that needs further attention in clinical education so that patients receive care that respects their individual wishes.
Disclosure
Nothing to report.
Implantable cardioverter-defibrillators (ICDs) offer lifesaving therapies to many patients and have been implanted in hundreds of thousands of patients.1 The population of patients with ICDs is growing rapidly, and the national ICD Registry reports over 12,000 devices are implanted monthly.2 This population includes patients with congenital heart disease, ischemic cardiomyopathy, and idiopathic arrhythmias. If these patients experience ventricular tachycardia or fibrillation, an ICD attempts to restore sinus rhythm and prevent death. While a shock from an ICD may be lifesaving, it can be a traumatic and startling experience for the patient and perhaps distressful for families to witness.3,4
Although ICDs are intended to save lives, they do not slow the progress of the patient’s underlying cardiac and noncardiac comorbidities. All these patients will eventually die, whether from their cardiac disease or another condition. The literature includes many anecdotes about patients shocked multiple times by their defibrillator while actively dying.4 These situations could be prevented with preemptive ICD deactivation. (ICDs can function not only as cardioverters and defibrillators, as implied by their name, but also as pacemakers. “Deactivation” as used in this paper refers only to disabling the tachycardia therapies. No distinction was made between defibrillation with a shock and anti-tachycardia pacing.) Therefore, research on ICD deactivation has emphasized patients who are acutely terminally ill, while less emphasis has been placed on patients who are not actively dying.4–8
Patients may, for a variety of reasons, request a do-not-resuscitate/do-not-intubate (DNR/DNI) order as their code status. However, it is not necessarily clear what a DNR/DNI order implies for ICD management. One survey of attending physicians found that 19% of respondents felt a DNR/DNI order was equivalent to requesting ICD deactivation.9 On the other hand, patients are split on whether they would want their device deactivated while in hospice or even at the very end of life.6 Heart Rhythm Society (HRS) guidelines favor a nuanced approach to ICD deactivation in DNR/DNI patients that emphasizes the individual patient’s comorbidities and goals.10 A patient’s individual circumstances might justify a choice to be DNR/DNI without deactivating the ICD. Decision-making in these circumstances requires a careful conversation between the patient and clinician. It is important to identify barriers that might prevent optimal shared decision-making.
Clinicians have been surveyed on ICD management at the end of life, but these studies have generally focused on attending physicians.5,9,11 However, physician trainees (ie, residents and fellows) as well as advanced practice providers (ie, physician assistants and nurse practitioners) are responsible for much of the clinical care provided to hospitalized patients. In particular, they are often the clinicians to discuss code status with patients. Different specialties (eg, cardiology, general medicine, and geriatrics) manage different sets of patients, which might affect clinicians’ opinions on ICD management. We therefore designed a survey to assess clinician attitudes and beliefs regarding ICD deactivation, including in non-terminally ill patients, and to evaluate for differences according to training level and specialty.
METHODS
Case-based and Likert-scale questions were considered for this survey, with the latter being chosen for ease of completion by respondents. An online survey tool (SurveyMonkey; San Mateo, CA) was used for data collection; no identifying data were collected. E-mail invitations to participate were sent to a combination of mailing lists and individual addresses for residents, fellows, advanced practice providers, and attending physicians in general internal medicine, cardiology, electrophysiology, and geriatrics. The survey remained open for 2.5 weeks. It was conducted 5 months into the academic year, thus trainees were well-established in their current roles. Two $25 gift cards were offered to respondents who entered their e-mail into a drawing; responses were not tied to e-mail addresses. Approval for the study was obtained from the University of Michigan Institutional Review Board.
The survey posed 12 questions assessing general attitudes about ICDs as well as individual beliefs and behaviors relating to ICD deactivation. Answers were on a Likert scale of 1 to 5 with 1 representing “strongly disagree” and 5 representing “strongly agree.” A score of 3 indicated “unsure or neutral.” The first 3 questions appeared together on the first page and were prefaced with “Please respond to the following statements about ICD shocks.” The next 9 were likewise grouped on the next page and were prefaced with “Please respond to the following statements about ICD deactivation.” All 12 questions are shown in Figures 1 and 2. Respondents could easily return to previous questions and change their answers. The survey ended with a third page showing 3 multiple choice demographic questions. The demographic questions were about clinical role (first-, second-, third-, or fourth-year resident, fellow, advanced practice provider, and attending), specialty, and number of ICD deactivations the respondent had been directly involved in (0, 1 to 5, 5 to 10, and more than 10). Specialty options were internal medicine resident, inpatient general medicine, outpatient general medicine, cardiology, electrophysiology, and geriatrics.
Likert scale answers of “agree” or “strongly agree” were grouped together as an affirmative response, while all other answers were grouped together as a nonaffirmative response. For analysis, residents were grouped together and their responses compared with attending physicians as a group. Additional analysis was done comparing attending physicians stratified by clinical specialty. Given the small number of responses from attending electrophysiologists, they were grouped with attending cardiologists for analysis. Due to the limited number of fellows and advanced practice providers who responded, further evaluation of these groups was not performed. Finally, the number of ICD deactivations respondents had been involved in was stratified by training level. All comparisons were performed using the two-tailed Pearson’s chi-squared test.
RESULTS
A total of 170 responses were collected from 508 individuals on the e-mail lists. Two responses were from registered nurses who were not part of the intended study sample and 7 responses were incomplete, having only answered the first 3 questions. These 9 responses were excluded from further analysis, yielding an overall response rate of 32%. The demographics of the remaining 161 respondents are shown in Table 1. Figure 1 shows overall responses to each question.
When comparing residents to attending physicians, there were no statistically significant between-differences except on questions 5 and 6. Specifically, residents were less comfortable than attending physicians discussing ICD deactivation and did so with less regularity (P < .001 and P = .018, respectively; Figure 2). Comfort levels improved markedly with experience: 29.2% of interns expressed comfort asking about ICD deactivation as compared with 60.7% of third- and-fourth year residents and 78.8% of attending physicians. Furthermore, comfort level seemed to parallel the regularity with which respondents asked about ICD deactivation: 4.2% of interns routinely asked about ICD deactivation as compared with 21.4% of third- and fourth-year residents and 34.8% of attending physicians.
The only statistically significant difference when comparing attending physicians by specialty was on question 6 of the survey with the groups being unequal in their reliability at asking about ICD deactivation during code status discussions (P < .001; Figure 2). Of cardiologists and electrophysiologists, 73.3% said they routinely ask about ICD deactivation, as well as 83.3% of geriatricians. By contrast, only 19.2% of outpatient general internists and 10.5% of inpatient general internists (ie, hospitalists) said they routinely ask about ICD deactivation.
There were no differences between groups when asked whether ICD deactivation was part of a DNR/DNI order (question 8), or if an ICD should be deactivated in DNR/DNI patients (questions 9 and 10). As shown in Figure 1, 21.1% of respondents felt that a DNR/DNI order is equivalent to requesting ICD deactivation, 60.2% felt that terminally ill DNR/DNI patients should have their device deactivated, and 28% felt that non-terminally ill DNR/DNI patients should have their device deactivated.
Groups were unequal with respect to the number of ICD deactivations in which they had been directly involved (Figure 3; P < .001). Over half of interns had not been involved in any ICD deactivations as compared with only 10.7% of third- or fourth-year residents. Of the 20 geriatricians, cardiologists, and electrophysiologists, 45% had been involved in at least 5 ICD deactivations. Of note, although 77.8% of fellows reported being involved in more than 10 ICD deactivations, these 9 respondents were all in cardiology or electrophysiology.
DISCUSSION
Overall, our major findings were (1) residents, who provide much of the clinical care in a teaching hospital, are remarkably uncomfortable discussing ICD deactivation, (2) general internists and residents ask about ICD deactivation infrequently compared to geriatricians and cardiologists, and (3) about one fifth of our respondents believe ICD deactivation is automatically part of a DNR/DNI order.
Although the majority of respondents did not routinely address ICD deactivation in conjunction with code status, there was significant variability among subgroups. For example, 83.3% of geriatricians routinely discussed ICD deactivation as part of code status compared with only 4% of first-year residents and 10.5% of inpatient general internists. This finding is interesting because 90.7% of all respondents believed that discussions of code status should address preferences on ICD deactivation. This apparent discrepancy could be explained by the relatively small number of patients admitted to the hospital who have both an ICD and a request to be DNR/DNI. Residents and inpatient general internists see a very broad spectrum of patients; ICD deactivation is frequently irrelevant in the cases these physicians manage. The subset of patients seen in consultation by cardiologists and geriatricians, by contrast, is expected to include a larger proportion of patients with ICDs. Therefore, discussing ICD deactivation will be more relevant to their daily practice. Fear of alienating patients was not a reason for our findings, as our respondents did not express concern that recommending ICD deactivation would harm the patient-clinician relationship.
There are several possible reasons that residents, particularly interns, are uncomfortable discussing ICD deactivation. A lack of exposure to ICD deactivation is probably a key contributor. Over half of interns had never been involved in any ICD deactivations. Residents and hospitalists may also feel as if they are overstepping their boundaries to discuss deactivating ICD therapies. Their feelings may not be misplaced, as one survey of ICD patients found that over 75% thought responsibility for discussing ICD deactivation, at least at the end of life, rests with cardiologists or electrophysiologists.6
The HRS guidelines call for individualized decisions regarding ICD deactivation, even if a patient is DNR/DNI. However, our respondents frequently felt a standardized approach was indicated, with 21% believing that a DNR/DNI order included ICD deactivation. Additionally, 28% agreed that even non-terminally ill DNR/DNI patients should have their device deactivated. This is relevant because it is the role of clinicians to engage in shared decision-making with their patients. If the clinician holds the fixed belief that a DNR/DNI order, regardless of the precise clinical scenario, should include ICD deactivation, they may pressure a patient to have their device deactivated even if it could still benefit them.
In 2009, Kelley et al published results of a survey on ICD deactivation at the end of life.9 They contacted 4,876 attending physicians in cardiology, electrophysiology, geriatrics, and general medicine, receiving 558 responses. The survey included Likert-scale questions assessing attitudes and knowledge about ICD functionality. Demographic information was also collected, including how many patients in their practice had ICDs and how often they had previously discussed ICD deactivation.
There are some interesting comparisons between Kelley et al’s findings and ours, although we included trainees and the precise wording of questions was different. The specific questions used by Kelley et al to ask whether ICD shocks were painful or distressing and to ask if ICD deactivation is part of a DNR order were: “The shock from an ICD is very painful for most patients.” “The shock of an ICD at the end of life is distressing to a patient and their loved ones.” “A DNR order is equivalent to deactivation of an ICD.”
Only 47% of general internists in the Kelley et al survey thought that ICD shocks were painful, compared with 83% of electrophysiologists. In addition, 65% of general internists and 85% of electrophysiologists viewed shocks at the end of life to be distressing to patients and families. By contrast, our respondents were nearly unanimous in believing shocks to be painful and distressing. This discrepancy may be due to the growing prevalence of ICDs over the past several years as well as the growing body of literature on unnecessary shocks at the end of life. In line with our study, 19% of their respondents believed a DNR order was equivalent to ICD deactivation.9 
Taken together, our findings indicate that additional education for clinicians of all levels could be helpful. Didactic lessons cannot replace experience, and it is important for residents to be exposed to discussions of ICD deactivation. However, lessons about ICD therapies and practical examples of how to broach the topic of deactivation could be beneficial, especially for interns whose responsibility includes discussions of code status. Within the context of an internal medicine residency, the fundamentals of ICD functionality could be covered during rotations on cardiology or palliative care services. Additionally, the recommendations of the HRS for device management can be covered in didactic sessions. Similar opportunities could be built into continuing medical education for practicing physicians and the training of advanced practice providers.
There are limitations to this survey, most notably the fact that it was restricted to a single academic medical center, the patient population and practices of which may not be generalizable to medical practice at large. Selection bias is also a distinct possibility given the 32% overall response rate; those who responded may feel more strongly about the survey topic. Our study subgroups may have interpreted questions differently because of their particular area of clinical practice. The small sample size also precluded an effective analysis of fellows and advanced practice practitioners due to lack of power. A major strength of this survey was the inclusion of a large number of residents upon whom the majority of inpatient contact rests. Future work could include expanding the survey to multiple medical centers, which would enhance generalizability and improve the ability to recruit sufficient fellows and advanced practice providers.
CONCLUSION
In summary, we conducted a single-center survey of residents, fellows, advanced practice providers, and attending physicians on their attitudes and beliefs about ICD deactivation in DNR/DNI patients. Residents are particularly uncomfortable discussing ICD deactivation with patients, which is an important finding because of their crucial role in providing patient care. Additionally, residents and hospitalists do not broach the topic of deactivation regularly, especially when compared to geriatricians and cardiologists. Despite HRS guidelines to the contrary, a fifth of our respondents believed that DNR/DNI orders include ICD deactivation. Overall, ICD deactivation in DNR/DNI patients is a topic that needs further attention in clinical education so that patients receive care that respects their individual wishes.
Disclosure
Nothing to report.
1. Freeman JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky MA. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012;125(1):57-64. doi:10.1161/CIRCULATIONAHA.111.046995. PubMed
2. Kremers MS, Hammill SC, Berul CI, et al. The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011. Hear Rhythm. 2013;10(4):e59-e65. doi:10.1016/j.hrthm.2013.01.035. PubMed
3. Goldstein NE, Mehta D, Siddiqui S, et al. “That’s like an act of suicide” patients’ attitudes toward deactivation of implantable defibrillators. J Gen Intern Med. 2008;23 Suppl 1:7-12. PubMed
4. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med. 2004;141(11):835-838. http://annals.org/article.aspx?articleid=717985&issueno=11. Accessed October 23, 2013.
5. Sherazi S, Daubert JP, Block RC, et al. Physicians’ preferences and attitudes about end-of-life care in patients with an implantable cardioverter-defibrillator. Mayo Clin Proc. 2008;83(10):1139-1141. doi:10.4065/83.10.1139. PubMed
6. Kirkpatrick JN, Gottlieb M, Sehgal P, Patel R, Verdino RJ. Deactivation of implantable cardioverter defibrillators in terminal illness and end of life care. Am J Cardiol. 2012;109(1):91-94. doi:10.1016/j.amjcard.2011.08.011. PubMed
7. Marinskis G, van Erven L. Deactivation of implanted cardioverter-defibrillators at the end of life: results of the EHRA survey. Europace. 2010;12(8):1176-1177. doi:10.1093/europace/euq272. PubMed
8. Mueller PS, Jenkins SM, Bramstedt KA, Hayes DL. Deactivating implanted cardiac devices in terminally ill patients: practices and attitudes. Pacing Clin Electrophysiol. 2008;31(5):560-568. doi:10.1111/j.1540-8159.2008.01041.x. PubMed
9. Kelley AS, Reid MC, Miller DH, Fins JJ, Lachs MS. Implantable cardioverter-defibrillator deactivation at the end of life: a physician survey. Am Heart J. 2009;157(4):702-8.e1. doi:10.1016/j.ahj.2008.12.011. PubMed
10. Lampert R, Hayes DL, Annas GJ, et al. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Hear Rhythm. 2010;7(7):1008-1026. doi:10.1016/j.hrthm.2010.04.033.PubMed
11. Kelley AS, Mehta SS, Reid MC. Management of patients with ICDs at the end of life (EOL): a qualitative study. Am J Hosp Palliat Care. 2008;25(6):440-446. doi:10.1177/1049909108320885. PubMed
1. Freeman JV, Wang Y, Curtis JP, Heidenreich PA, Hlatky MA. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012;125(1):57-64. doi:10.1161/CIRCULATIONAHA.111.046995. PubMed
2. Kremers MS, Hammill SC, Berul CI, et al. The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011. Hear Rhythm. 2013;10(4):e59-e65. doi:10.1016/j.hrthm.2013.01.035. PubMed
3. Goldstein NE, Mehta D, Siddiqui S, et al. “That’s like an act of suicide” patients’ attitudes toward deactivation of implantable defibrillators. J Gen Intern Med. 2008;23 Suppl 1:7-12. PubMed
4. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med. 2004;141(11):835-838. http://annals.org/article.aspx?articleid=717985&issueno=11. Accessed October 23, 2013.
5. Sherazi S, Daubert JP, Block RC, et al. Physicians’ preferences and attitudes about end-of-life care in patients with an implantable cardioverter-defibrillator. Mayo Clin Proc. 2008;83(10):1139-1141. doi:10.4065/83.10.1139. PubMed
6. Kirkpatrick JN, Gottlieb M, Sehgal P, Patel R, Verdino RJ. Deactivation of implantable cardioverter defibrillators in terminal illness and end of life care. Am J Cardiol. 2012;109(1):91-94. doi:10.1016/j.amjcard.2011.08.011. PubMed
7. Marinskis G, van Erven L. Deactivation of implanted cardioverter-defibrillators at the end of life: results of the EHRA survey. Europace. 2010;12(8):1176-1177. doi:10.1093/europace/euq272. PubMed
8. Mueller PS, Jenkins SM, Bramstedt KA, Hayes DL. Deactivating implanted cardiac devices in terminally ill patients: practices and attitudes. Pacing Clin Electrophysiol. 2008;31(5):560-568. doi:10.1111/j.1540-8159.2008.01041.x. PubMed
9. Kelley AS, Reid MC, Miller DH, Fins JJ, Lachs MS. Implantable cardioverter-defibrillator deactivation at the end of life: a physician survey. Am Heart J. 2009;157(4):702-8.e1. doi:10.1016/j.ahj.2008.12.011. PubMed
10. Lampert R, Hayes DL, Annas GJ, et al. HRS Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Hear Rhythm. 2010;7(7):1008-1026. doi:10.1016/j.hrthm.2010.04.033.PubMed
11. Kelley AS, Mehta SS, Reid MC. Management of patients with ICDs at the end of life (EOL): a qualitative study. Am J Hosp Palliat Care. 2008;25(6):440-446. doi:10.1177/1049909108320885. PubMed
© 2017 Society of Hospital Medicine
Imaging after bariatric surgery appears overdone
Nearly 70% of bariatric surgery patients received postoperative imaging, with more than one-third receiving CT imaging. This high level of screening resulted in symptom-related findings in only 23% of cases, and may be excessive, according to researchers who studied nearly 600 adults who underwent bariatric surgery.
As the volume of bariatric surgery has increased, so has the role of postoperative imaging, wrote Dana Haddad, MD, and her colleagues at Harlem Hospital Center, New York.
“However, there is a lack of well-defined postoperative imaging guidelines,” they said. “Detrimental aspects of postoperative imaging include the potential for false-positive findings leading to further and often unnecessary investigations, radiation exposure, and additional cost,” they added.
The primary outcomes were the numbers of initial postimaging studies and whether the findings supported subsequent studies.
The study population included 399 adults who underwent laparoscopic bypass and 144 who underwent sleeve gastrectomy. The average age of the patients was 41 years and 90% were women.
The researchers identified 907 imaging studies performed in 400 patients (69% of the study population). Of these, 38% were ultrasound, 36% were CT, 15% were x-ray, 6.6% were fluoroscopy, 3.3% were MRI, and .6% were nuclear medicine.
On review of the imaging findings, the researchers found that half (50%) were unremarkable, while 13% were either surgery related or symptom related, 6.8% were not related to surgery but might have explained patients’ symptoms, 4.3% were surgery-related but not likely to explain symptoms, and 26% were incidental. “Interestingly, no incidental findings were found to be of major clinical importance; all were benign,” according to the researchers.
However, incidental findings led to a total of 71 additional studies, and to 5 laparoscopic cholecystectomies.
A univariate analysis showed that the factors with a significant impact a patient’s odds of undergoing postoperative abdominal imaging included having a bypass procedure vs. a sleeve procedure, older age, and lower baseline body mass index. In addition, patients with a history of abdominal surgery or dyspepsia or those who had a routine postoperative upper gastrointestinal series were significantly more likely to undergo CT scans. Patients with history of ulcer or reflux were significantly less likely to undergo CT scans.
Although the study was limited by the retrospective design and lack of information about possible imaging of patients at other centers, “results suggest that nonroutine postoperative abdominal imaging in the bariatric population is common and requires streamlined protocols, with almost 70% of patients undergoing imaging and greater than 70% of findings being unrelated to symptoms or negative,” the researchers said.
A clinical algorithm for imaging of bariatric patients should be based on clinical parameters collected during a physical exam. “Once an algorithm is in place, further studies will be needed to validate its accuracy and efficiency,” the researchers stated.
Dr. Haddad and her colleagues had no financial conflicts to disclose. 
Nearly 70% of bariatric surgery patients received postoperative imaging, with more than one-third receiving CT imaging. This high level of screening resulted in symptom-related findings in only 23% of cases, and may be excessive, according to researchers who studied nearly 600 adults who underwent bariatric surgery.
As the volume of bariatric surgery has increased, so has the role of postoperative imaging, wrote Dana Haddad, MD, and her colleagues at Harlem Hospital Center, New York.
“However, there is a lack of well-defined postoperative imaging guidelines,” they said. “Detrimental aspects of postoperative imaging include the potential for false-positive findings leading to further and often unnecessary investigations, radiation exposure, and additional cost,” they added.
The primary outcomes were the numbers of initial postimaging studies and whether the findings supported subsequent studies.
The study population included 399 adults who underwent laparoscopic bypass and 144 who underwent sleeve gastrectomy. The average age of the patients was 41 years and 90% were women.
The researchers identified 907 imaging studies performed in 400 patients (69% of the study population). Of these, 38% were ultrasound, 36% were CT, 15% were x-ray, 6.6% were fluoroscopy, 3.3% were MRI, and .6% were nuclear medicine.
On review of the imaging findings, the researchers found that half (50%) were unremarkable, while 13% were either surgery related or symptom related, 6.8% were not related to surgery but might have explained patients’ symptoms, 4.3% were surgery-related but not likely to explain symptoms, and 26% were incidental. “Interestingly, no incidental findings were found to be of major clinical importance; all were benign,” according to the researchers.
However, incidental findings led to a total of 71 additional studies, and to 5 laparoscopic cholecystectomies.
A univariate analysis showed that the factors with a significant impact a patient’s odds of undergoing postoperative abdominal imaging included having a bypass procedure vs. a sleeve procedure, older age, and lower baseline body mass index. In addition, patients with a history of abdominal surgery or dyspepsia or those who had a routine postoperative upper gastrointestinal series were significantly more likely to undergo CT scans. Patients with history of ulcer or reflux were significantly less likely to undergo CT scans.
Although the study was limited by the retrospective design and lack of information about possible imaging of patients at other centers, “results suggest that nonroutine postoperative abdominal imaging in the bariatric population is common and requires streamlined protocols, with almost 70% of patients undergoing imaging and greater than 70% of findings being unrelated to symptoms or negative,” the researchers said.
A clinical algorithm for imaging of bariatric patients should be based on clinical parameters collected during a physical exam. “Once an algorithm is in place, further studies will be needed to validate its accuracy and efficiency,” the researchers stated.
Dr. Haddad and her colleagues had no financial conflicts to disclose. 
Nearly 70% of bariatric surgery patients received postoperative imaging, with more than one-third receiving CT imaging. This high level of screening resulted in symptom-related findings in only 23% of cases, and may be excessive, according to researchers who studied nearly 600 adults who underwent bariatric surgery.
As the volume of bariatric surgery has increased, so has the role of postoperative imaging, wrote Dana Haddad, MD, and her colleagues at Harlem Hospital Center, New York.
“However, there is a lack of well-defined postoperative imaging guidelines,” they said. “Detrimental aspects of postoperative imaging include the potential for false-positive findings leading to further and often unnecessary investigations, radiation exposure, and additional cost,” they added.
The primary outcomes were the numbers of initial postimaging studies and whether the findings supported subsequent studies.
The study population included 399 adults who underwent laparoscopic bypass and 144 who underwent sleeve gastrectomy. The average age of the patients was 41 years and 90% were women.
The researchers identified 907 imaging studies performed in 400 patients (69% of the study population). Of these, 38% were ultrasound, 36% were CT, 15% were x-ray, 6.6% were fluoroscopy, 3.3% were MRI, and .6% were nuclear medicine.
On review of the imaging findings, the researchers found that half (50%) were unremarkable, while 13% were either surgery related or symptom related, 6.8% were not related to surgery but might have explained patients’ symptoms, 4.3% were surgery-related but not likely to explain symptoms, and 26% were incidental. “Interestingly, no incidental findings were found to be of major clinical importance; all were benign,” according to the researchers.
However, incidental findings led to a total of 71 additional studies, and to 5 laparoscopic cholecystectomies.
A univariate analysis showed that the factors with a significant impact a patient’s odds of undergoing postoperative abdominal imaging included having a bypass procedure vs. a sleeve procedure, older age, and lower baseline body mass index. In addition, patients with a history of abdominal surgery or dyspepsia or those who had a routine postoperative upper gastrointestinal series were significantly more likely to undergo CT scans. Patients with history of ulcer or reflux were significantly less likely to undergo CT scans.
Although the study was limited by the retrospective design and lack of information about possible imaging of patients at other centers, “results suggest that nonroutine postoperative abdominal imaging in the bariatric population is common and requires streamlined protocols, with almost 70% of patients undergoing imaging and greater than 70% of findings being unrelated to symptoms or negative,” the researchers said.
A clinical algorithm for imaging of bariatric patients should be based on clinical parameters collected during a physical exam. “Once an algorithm is in place, further studies will be needed to validate its accuracy and efficiency,” the researchers stated.
Dr. Haddad and her colleagues had no financial conflicts to disclose. 
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: No well-defined guidelines exist for when to use postoperative imaging in bariatric surgery patients.
Major finding: Approximately 70% of postoperative imaging findings were not symptom related, and incidental findings led to 71 additional studies.
Data source: A review of 578 patients who underwent gastric bypass or sleeve gastrectomy.
Disclosures: The researchers had no financial conflicts to disclose.
Use of simulation to assess incoming interns’ recognition of opportunities to choose wisely
In recent years, the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely™ campaign has advanced the dialogue on cost-consciousness by identifying potential examples of overuse in clinical practice.1 Eliminating low-value care can decrease costs, improve quality, and potentially decrease patient harm.2 In fact, there is growing consensus among health leaders and educators on the need for a physician workforce that is conscious of high-value care.3,4 The Institute of Medicine has issued a call-to-action for graduate medical education (GME) to emphasize value-based care,5 and the Accreditation Council for Graduate Medical Education has outlined expectations that residents receive formal and experiential training on overuse as a part of its Clinical Learning Environment Review.6
However, recent reports highlight a lack of emphasis on value-based care in medical education.7 For example, few residency program directors believe that residents are prepared to incorporate value and cost into their medical decisions.8 In 2012, only 15% of medicine residencies reported having formal curricula addressing value, although many were developing one.8 Of the curricula reported, most were didactic in nature and did not include an assessment component.8
Experiential learning through simulation is one promising method to teach clinicians-in-training to practice value-based care. Simulation-based training promotes situational awareness (defined as being cognizant of one’s working environment), a concept that is crucial for recognizing both low-value and unsafe care.9,10 Simulated training exercises are often included in GME orientation “boot-camps,” which have typically addressed safety.11 The incorporation of value into existing GME boot-camp exercises could provide a promising model for the addition of value-based training to GME.
At the University of Chicago, we had successfully implemented the “Room of Horrors,” a simulation for entering interns to promote the detection of patient safety hazards.11 Here, we describe a modification to this simulation to embed low-value hazards in addition to traditional patient safety hazards. The aim of this study is to assess the entering interns’ recognition of low-value care and their ability to recognize unsafe care in a simulation designed to promote situational awareness.
METHODS
Setting and Participants
The simulation was conducted during GME orientation at a large, urban academic medical institution. One hundred and twenty-five entering postgraduate year one (PGY1) interns participated in the simulation, which was a required component of a multiday orientation “boot-camp” experience. All eligible interns participated in the simulation, representing 13 specialty programs and 60 medical schools. Interns entering into pathology were excluded because of infrequent patient contact. Participating interns were divided into 7 specialty groups for analysis in order to preserve the anonymity of interns in smaller residency programs (surgical subspecialties combined with general surgery, medicine-pediatrics grouped with internal medicine). The University of Chicago Institutional Review Board deemed this study exempt from review.
Program Description
A simulation of an inpatient hospital room, known as the “Room of Horrors,” was constructed in collaboration with the University of Chicago Simulation Center and adapted from a previous version of the exercise.11 The simulation consisted of a mock door chart highlighting the patient had been admitted for diarrhea (Clostridium difficile positive) following a recent hospitalization for pneumonia. A clinical scenario was constructed by using a patient mannequin and an accompanying door chart that listed information on the patient’s hospital course, allergies, and medications. In addition to the 8 patient safety hazards utilized in the prior version, our team selected 4 low-value hazards to be included in the simulation.
The 8 safety hazards have been detailed in a prior study and were previously selected from Medicare’s Hospital-Acquired Conditions (HAC) Reduction Program and Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators.11-13 Each of the hazards was represented either physically in the simulation room and/or was indicated on the patient’s chart. For example, the latex allergy hazard was represented by latex gloves at the bedside despite an allergy indicated on the patient’s chart and wristband. A complete list of the 8 safety hazards and their representations in the simulation is shown in Table 1.
The Choosing Wisely™ lists were reviewed to identify low-value hazards for addition to the simulation.14 Our team selected 3 low-value hazards from the Society of Hospital Medicine (SHM) list,15 including (1) arbitrary blood transfusion despite the patient’s stable hemoglobin level of 8.0 g/dL and absence of cardiac symptoms,16 (2) addition of a proton pump inhibitor (PPI) for stress ulcer prophylaxis in a patient without high risk for gastrointestinal (GI) complications who was not on a PPI prior to admission, and (3) placement of a urinary catheter without medical indication. We had originally selected continuous telemetry monitoring as a fourth hazard from the SHM list, but were unable to operationalize, as it was difficult to simulate continuous telemetry on a mannequin. Because many inpatients are older than 65 years, we reviewed the American Geriatrics Society list17 and selected our fourth low-value hazard: (4) unnecessary use of physical restraints to manage behavioral symptoms in a hospitalized patient with delirium. Several of these hazards were also quality and safety priorities at our institution, including the overuse of urinary catheters, physical restraints, and blood transfusions. All 4 low-value hazards were referenced in the patient’s door chart, and 3 were also physically represented in the room via presence of a hanging unit of blood, Foley catheter, and upper-arm restraints (Table 1). See Appendix for a photograph of the simulation setup.
Each intern was allowed 10 minutes inside the simulation room. During this time, they were instructed to read the 1-page door chart, inspect the simulation room, and write down as many potential low-value and safety hazards as they could identify on a free-response form (see Appendix). Upon exiting the room, they were allotted 5 additional minutes to complete their free-response answers and provide written feedback on the simulation. The simulation was conducted in 3 simulated hospital rooms over the course of 2 days, and the correct answers were provided via e-mail after all interns had completed the exercise.
To assess prior training and safety knowledge, interns were asked to complete a 3-question preassessment on a ScanTronTM (Tustin, CA) form. The preassessment asked interns whether they had received training on hospital safety during medical school (yes, no, or unsure), if they were satisfied with the hospital safety training they received during medical school (strongly disagree to strongly agree on a Likert scale), and if they were confident in their ability to identify potential hazards in a hospital setting (strongly disagree to strongly agree). Interns were also given the opportunity to provide feedback on the simulation experience on the ScanTronTM (Tustin, CA) form.
One month after participating in the simulation, interns were asked to complete an online follow-up survey on MedHubTM (Ann Arbor, MI), which included 2 Likert-scale questions (strongly disagree to strongly agree) assessing the simulation’s impact on their experience mitigating hospital hazards during the first month of internship.
Data Analysis
Interns’ free-response answers were manually coded, and descriptive statistics were used to summarize the mean percent correct for each hazard. A paired t test was used to compare intern identification of low-value vs safety hazards. T tests were used to compare hazard identification for interns entering highly procedural-intensive specialties (ie, surgical specialties, emergency medicine, anesthesia, obstetrics/gynecology) and those entering less procedural-intensive specialties (ie, internal medicine, pediatrics, psychiatry), as well as among those graduating from “Top 30” medical schools (based on US News & World Report Medical School Rankings18) and our own institution. One-way analysis of variance (ANOVA) calculations were used to test for differences in hazard identification based on interns’ prior hospital safety training, with interns who rated their satisfaction with prior training or confidence in identifying hazards as a “4” or a “5” considered “satisfied” and “confident,” respectively. Responses to the MedHubTM (Ann Arbor, MI) survey were dichotomized with “strongly agree” and “agree” considered positive responses. Statistical significance was defined at P < .05. All data analysis was conducted using Stata 14TM software (College Station, TX).
RESULTS
Intern Characteristics
One hundred twenty-five entering PGY1 interns participated in the simulation, representing 60 medical schools and 7 different specialty groups (Table 2). Thirty-five percent (44/125) were graduates from “Top 30” medical schools, and 8.8% (11/125) graduated from our own institution. Seventy-four percent (89/121) had received prior hospital safety training during medical school, and 62.9% (56/89) were satisfied with their training. A majority of interns (64.2%, 79/123) felt confident in their ability to identify potential hazards in a hospital setting, although confidence was much higher among those with prior safety training (71.9%, 64/89) compared to those without prior training or who were unsure about their training (40.6%, 13/32; P = .09, t test).
Identification of Hazards
The mean percentage of hazards correctly identified by interns during the simulation was 50.4% (standard deviation [SD] 11.8%), with a normal distribution (Figure 1). Interns identified a significantly lower percentage of low-value hazards than safety hazards in the simulation (mean 19.2% [SD 18.6%] vs 66.0% [SD 16.0%], respectively; P < .001, paired t test). Interns also identified significantly more room-based errors than chart-based errors (mean 58.6% [SD 13.4%] vs 9.6% [SD 19.8%], respectively; P < .001, paired t test). The 3 most commonly identified hazards were unavailability of hand hygiene (120/125, 96.0%), presence of latex gloves despite the patient’s allergy (111/125, 88.8%), and fall risk due to the lowered bed rail (107/125, 85.6%). More than half of interns identified the incorrect name on the patient’s wristband and IV bag (91/125, 72.8%), a lack of isolation precautions (90/125, 72.0%), administration of penicillin despite the patient’s allergy (67/125, 53.6%), and unnecessary restraints (64/125, 51.2%). Less than half of interns identified the wrong medication being administered (50/125, 40.0%), unnecessary Foley catheter (25/125, 20.0%), and absence of venous thromboembolism (VTE) prophylaxis (24/125, 19.2%). Few interns identified the unnecessary blood transfusion (7/125, 5.6%), and no one identified the unnecessary stress ulcer prophylaxis (0/125, 0.0%; Figure 2).
Predictors of Hazard Identification
Interns who self-reported as confident in their ability to identify hazards were not any more likely to correctly identify hazards than those who were not confident (50.9% overall hazard identification vs 49.6%, respectively; P = .56, t test). Interns entering into less procedural-intensive specialties identified significantly more safety hazards than those entering highly procedural-intensive specialties (mean 69.1% [SD 16.9%] vs 61.8% [SD 13.7%], respectively; P = .01, t test). However, there was no statistically significant difference in their identification of low-value hazards (mean 19.8% [SD 18.3%] for less procedural-intensive vs 18.4% [SD 19.1%] for highly procedural-intensive; P = .68, t test). There was no statistically significant difference in hazard identification among graduates of “Top 30” medical schools or graduates of our own institution. Prior hospital safety training had no significant impact on interns’ ability to identify safety or low-value hazards. Overall, interns who were satisfied with their prior training identified a mean of 51.8% of hazards present (SD 11.8%), interns who were not satisfied with their prior training identified 51.5% (SD 12.7%), interns with no prior training identified 48.7% (SD 11.7%), and interns who were unsure about their prior training identified 47.4% (SD 11.5%) [F(3,117) = .79; P = .51, ANOVA]. There was also no significant association between prior training and the identification of any one of the 12 specific hazards (chi-square tests, all P values > .1).
Intern Feedback and Follow-Up Survey
Debriefing revealed that most interns passively assumed the patient’s chart was correct and did not think they should question the patient’s current care regimen. For example, many interns commented that they did not think to consider the patient’s blood transfusion as unnecessary, even though they were aware of the recommended hemoglobin cutoffs for stable patients.
Interns also provided formal feedback on the simulation through open-ended comments on their ScanTronTM (Tustin, CA) form. For example, one intern wrote that they would “inherently approach every patient room ‘looking’ for safety issues, probably directly because of this exercise.” Another commented that the simulation was “more difficult than I expected, but very necessary to facilitate discussion and learning.” One intern wrote that “I wish I had done this earlier in my career.”
Ninety-six percent of participating interns (120/125) completed an online follow-up survey 1 month after beginning internship. In the survey, 68.9% (82/119) of interns indicated they were more aware of how to identify potential hazards facing hospitalized patients as a result of the simulation. Furthermore, 52.1% (62/119) of interns had taken action during internship to reduce a potential hazard that was present in the simulation.
DISCUSSION
While many GME orientations include simulation and safety training, this study is the first of its kind to incorporate low-value care from Choosing Wisely™ recommendations into simulated training. It is concerning that interns identified significantly fewer low-value hazards than safety hazards in the simulation. In some cases, no interns identified the low-value hazard. For example, while almost all interns identified the hand hygiene hazard, not one could identify the unnecessary stress ulcer prophylaxis. Furthermore, interns who self-reported as confident in their ability to identify hazards did not perform any better in the simulation. Interns entering less procedural-intensive specialties identified more safety hazards overall.
The simulation was well received by interns. Many commented that the experience was engaging, challenging, and effective in cultivating situational awareness towards low-value care. Our follow-up survey demonstrated the majority of interns reported taking action during their first month of internship to reduce a hazard included in the simulation. Most interns also reported a greater awareness of how to identify hospital hazards as a result of the simulation. These findings suggest that a brief simulation-based experience has the potential to create a lasting retention of situational awareness and behavior change.
It is worth exploring why interns identified significantly fewer low-value hazards than safety hazards in the simulation. One hypothesis is that interns were less attuned to low-value hazards, which may reflect a lacking emphasis on value-based care in undergraduate medical education (UME). It is especially concerning that so few interns identified the catheter-associated urinary tract infection (CAUTI) risk, as interns are primarily responsible for recognizing and removing an unnecessary catheter. Although the risks of low-value care should be apparent to most trainees, the process of recognizing and deliberately stopping or avoiding low-value care can be challenging for young clinicians.19 To promote value-based thinking among entering residents, UME programs should teach students to question the utility of the interventions their patients are receiving. One promising framework for doing so is the Subjective, Objective, Assessment, Plan- (SOAP)-V, in which a V for “Value” is added to the traditional SOAP note.20 SOAP-V notes serve as a cognitive forcing function that requires students to pause and assess the value and cost-consciousness of their patients’ care.20
The results from the “Room of Horrors” simulation can also guide health leaders and educators in identifying institutional areas of focus towards providing high-value and safe care. For example, at the University of Chicago we launched an initiative to improve the inappropriate use of urinary catheters after learning that few of our incoming interns recognized this during the simulation. Institutions could use this model to raise awareness of initiatives and redirect resources from areas that trainees perform well in (eg, hand hygiene) to areas that need improvement (eg, recognition of low-value care). Given the simulation’s low cost and minimal material requirements, it could be easily integrated into existing training programs with the support of an institution’s simulation center.
This study’s limitations include its conduction at single-institution, although the participants represented graduates of 60 different institutions. Furthermore, while the 12 hazards included in the simulation represent patient safety and value initiatives from a wide array of medical societies, they were not intended to be comprehensive and were not tailored to specific specialties. The simulation included only 4 low-value hazards, and future iterations of this exercise should aim to include an equal number of safety and low-value hazards. Furthermore, the evaluation of interns’ prior hospital safety training relied on self-reporting, and the specific context and content of each interns’ training was not examined. Finally, at this point we are unable to provide objective longitudinal data assessing the simulation’s impact on clinical practice and patient outcomes. Subsequent work will assess the sustained impact of the simulation by correlating with institutional data on measurable occurrences of low-value care.
In conclusion, interns identified significantly fewer low-value hazards than safety hazards in an inpatient simulation designed to promote situational awareness. Our results suggest that interns are on the lookout for errors of omission (eg, absence of hand hygiene, absence of isolation precautions) but are often blinded to errors of commission, such that when patients are started on therapies there is an assumption that the therapies are correct and necessary (eg, blood transfusions, stress ulcer prophylaxis). These findings suggest poor awareness of low-value care among incoming interns and highlight the need for additional training in both UME and GME to place a greater emphasis on preventing low-value care.
Disclosure
Dr. Arora is a member of the American Board of Medicine Board of Directors and has received grant funding from ABIM Foundation via Costs of Care for the Teaching Value Choosing Wisely™ Challenge. Dr. Farnan, Dr. Arora, and Ms. Hirsch receive grant funds from Accreditation Council of Graduate Medical Education as part of the Pursuing Excellence Initiative. Dr. Arora and Dr. Farnan also receive grant funds from the American Medical Association Accelerating Change in Medical Education initiative. Kathleen Wiest and Lukas Matern were funded through matching funds of the Pritzker Summer Research Program for NIA T35AG029795.
1. Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015;30(2):221-228. doi:10.1007/s11606-014-3070-z. PubMed
2. Elshaug AG, McWilliams JM, Landon BE. The value of low-value lists. JAMA. 2013;309(8):775-776. doi:10.1001/jama.2013.828. PubMed
3. Cooke M. Cost consciousness in patient care--what is medical education’s responsibility? N Engl J Med. 2010;362(14):1253-1255. doi:10.1056/NEJMp0911502. PubMed
4. Weinberger SE. Providing high-value, cost-conscious care: a critical seventh general competency for physicians. Ann Intern Med. 2011;155(6):386-388. doi:10.7326/0003-4819-155-6-201109200-00007. PubMed
5. Graduate Medical Education That Meets the Nation’s Health Needs. Institute of Medicine. http://www.nationalacademies.org/hmd/Reports/2014/Graduate-Medical-Education-That-Meets-the-Nations-Health-Needs.aspx. Accessed May 25, 2016.
6. Accreditation Council for Graduate Medical Education. CLER Pathways to Excellence. https://www.acgme.org/acgmeweb/Portals/0/PDFs/CLER/CLER_Brochure.pdf. Accessed July 15, 2015.
7. Varkey P, Murad MH, Braun C, Grall KJH, Saoji V. A review of cost-effectiveness, cost-containment and economics curricula in graduate medical education. J Eval Clin Pract. 2010;16(6):1055-1062. doi:10.1111/j.1365-2753.2009.01249.x. PubMed
8. Patel MS, Reed DA, Loertscher L, McDonald FS, Arora VM. Teaching residents to provide cost-conscious care: a national survey of residency program directors. JAMA Intern Med. 2014;174(3):470-472. doi:10.1001/jamainternmed.2013.13222. PubMed
9. Cohen NL. Using the ABCs of situational awareness for patient safety. Nursing. 2013;43(4):64-65. doi:10.1097/01.NURSE.0000428332.23978.82. PubMed
10. Varkey P, Karlapudi S, Rose S, Swensen S. A patient safety curriculum for graduate medical education: results from a needs assessment of educators and patient safety experts. Am J Med Qual. 2009;24(3):214-221. doi:10.1177/1062860609332905. PubMed
11. Farnan JM, Gaffney S, Poston JT, et al. Patient safety room of horrors: a novel method to assess medical students and entering residents’ ability to identify hazards of hospitalisation. BMJ Qual Saf. 2016;25(3):153-158. doi:10.1136/bmjqs-2015-004621. PubMed
12. Centers for Medicare and Medicaid Services Hospital-acquired condition reduction program. Medicare.gov. https://www.medicare.gov/hospitalcompare/HAC-reduction-program.html. Accessed August 1, 2015.
13. Agency for Healthcare Research and Quality. Patient Safety Indicators Overview. http://www. qualityindicators.ahrq.gov/modules/psi_overview.aspx. Accessed August 20, 2015.
14. ABIM Foundation. Choosing Wisely. http://www.choosingwisely.org. Accessed August 21, 2015.
15. ABIM Foundation. Society of Hospital Medicine – Adult Hospital Medicine List. Choosing Wisely. http://www.choosingwisely.org/societies/ society-of-hospital-medicine-adult/. Accessed August 21, 2015.
16. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: A clinical practice guideline from the AABB*. Ann Intern Med. 2012;157(1):49-58. PubMed
17. ABIM Foundation. American Geriatrics Society List. Choosing Wisely. http://www.choosingwisely.org/societies/american-geriatrics-society/. Accessed August 21, 2015.
18. The Best Medical Schools for Research, Ranked. http://grad-schools.usnews.rankingsandreviews.com/best-graduate-schools/top-medical-schools/research-rankings?int=af3309&int=b3b50a&int=b14409. Accessed June 7, 2016.
19. Roman BR, Asch DA. Faded promises: The challenge of deadopting low-value care. Ann Intern Med. 2014;161(2):149-150. doi:10.7326/M14-0212. PubMed
20. Moser EM, Huang GC, Packer CD, et al. SOAP-V: Introducing a method to empower medical students to be change agents in bending the cost curve. J Hosp Med. 2016;11(3):217-220. doi:10.1002/jhm.2489. PubMed
In recent years, the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely™ campaign has advanced the dialogue on cost-consciousness by identifying potential examples of overuse in clinical practice.1 Eliminating low-value care can decrease costs, improve quality, and potentially decrease patient harm.2 In fact, there is growing consensus among health leaders and educators on the need for a physician workforce that is conscious of high-value care.3,4 The Institute of Medicine has issued a call-to-action for graduate medical education (GME) to emphasize value-based care,5 and the Accreditation Council for Graduate Medical Education has outlined expectations that residents receive formal and experiential training on overuse as a part of its Clinical Learning Environment Review.6
However, recent reports highlight a lack of emphasis on value-based care in medical education.7 For example, few residency program directors believe that residents are prepared to incorporate value and cost into their medical decisions.8 In 2012, only 15% of medicine residencies reported having formal curricula addressing value, although many were developing one.8 Of the curricula reported, most were didactic in nature and did not include an assessment component.8
Experiential learning through simulation is one promising method to teach clinicians-in-training to practice value-based care. Simulation-based training promotes situational awareness (defined as being cognizant of one’s working environment), a concept that is crucial for recognizing both low-value and unsafe care.9,10 Simulated training exercises are often included in GME orientation “boot-camps,” which have typically addressed safety.11 The incorporation of value into existing GME boot-camp exercises could provide a promising model for the addition of value-based training to GME.
At the University of Chicago, we had successfully implemented the “Room of Horrors,” a simulation for entering interns to promote the detection of patient safety hazards.11 Here, we describe a modification to this simulation to embed low-value hazards in addition to traditional patient safety hazards. The aim of this study is to assess the entering interns’ recognition of low-value care and their ability to recognize unsafe care in a simulation designed to promote situational awareness.
METHODS
Setting and Participants
The simulation was conducted during GME orientation at a large, urban academic medical institution. One hundred and twenty-five entering postgraduate year one (PGY1) interns participated in the simulation, which was a required component of a multiday orientation “boot-camp” experience. All eligible interns participated in the simulation, representing 13 specialty programs and 60 medical schools. Interns entering into pathology were excluded because of infrequent patient contact. Participating interns were divided into 7 specialty groups for analysis in order to preserve the anonymity of interns in smaller residency programs (surgical subspecialties combined with general surgery, medicine-pediatrics grouped with internal medicine). The University of Chicago Institutional Review Board deemed this study exempt from review.
Program Description
A simulation of an inpatient hospital room, known as the “Room of Horrors,” was constructed in collaboration with the University of Chicago Simulation Center and adapted from a previous version of the exercise.11 The simulation consisted of a mock door chart highlighting the patient had been admitted for diarrhea (Clostridium difficile positive) following a recent hospitalization for pneumonia. A clinical scenario was constructed by using a patient mannequin and an accompanying door chart that listed information on the patient’s hospital course, allergies, and medications. In addition to the 8 patient safety hazards utilized in the prior version, our team selected 4 low-value hazards to be included in the simulation.
The 8 safety hazards have been detailed in a prior study and were previously selected from Medicare’s Hospital-Acquired Conditions (HAC) Reduction Program and Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators.11-13 Each of the hazards was represented either physically in the simulation room and/or was indicated on the patient’s chart. For example, the latex allergy hazard was represented by latex gloves at the bedside despite an allergy indicated on the patient’s chart and wristband. A complete list of the 8 safety hazards and their representations in the simulation is shown in Table 1.
The Choosing Wisely™ lists were reviewed to identify low-value hazards for addition to the simulation.14 Our team selected 3 low-value hazards from the Society of Hospital Medicine (SHM) list,15 including (1) arbitrary blood transfusion despite the patient’s stable hemoglobin level of 8.0 g/dL and absence of cardiac symptoms,16 (2) addition of a proton pump inhibitor (PPI) for stress ulcer prophylaxis in a patient without high risk for gastrointestinal (GI) complications who was not on a PPI prior to admission, and (3) placement of a urinary catheter without medical indication. We had originally selected continuous telemetry monitoring as a fourth hazard from the SHM list, but were unable to operationalize, as it was difficult to simulate continuous telemetry on a mannequin. Because many inpatients are older than 65 years, we reviewed the American Geriatrics Society list17 and selected our fourth low-value hazard: (4) unnecessary use of physical restraints to manage behavioral symptoms in a hospitalized patient with delirium. Several of these hazards were also quality and safety priorities at our institution, including the overuse of urinary catheters, physical restraints, and blood transfusions. All 4 low-value hazards were referenced in the patient’s door chart, and 3 were also physically represented in the room via presence of a hanging unit of blood, Foley catheter, and upper-arm restraints (Table 1). See Appendix for a photograph of the simulation setup.
Each intern was allowed 10 minutes inside the simulation room. During this time, they were instructed to read the 1-page door chart, inspect the simulation room, and write down as many potential low-value and safety hazards as they could identify on a free-response form (see Appendix). Upon exiting the room, they were allotted 5 additional minutes to complete their free-response answers and provide written feedback on the simulation. The simulation was conducted in 3 simulated hospital rooms over the course of 2 days, and the correct answers were provided via e-mail after all interns had completed the exercise.
To assess prior training and safety knowledge, interns were asked to complete a 3-question preassessment on a ScanTronTM (Tustin, CA) form. The preassessment asked interns whether they had received training on hospital safety during medical school (yes, no, or unsure), if they were satisfied with the hospital safety training they received during medical school (strongly disagree to strongly agree on a Likert scale), and if they were confident in their ability to identify potential hazards in a hospital setting (strongly disagree to strongly agree). Interns were also given the opportunity to provide feedback on the simulation experience on the ScanTronTM (Tustin, CA) form.
One month after participating in the simulation, interns were asked to complete an online follow-up survey on MedHubTM (Ann Arbor, MI), which included 2 Likert-scale questions (strongly disagree to strongly agree) assessing the simulation’s impact on their experience mitigating hospital hazards during the first month of internship.
Data Analysis
Interns’ free-response answers were manually coded, and descriptive statistics were used to summarize the mean percent correct for each hazard. A paired t test was used to compare intern identification of low-value vs safety hazards. T tests were used to compare hazard identification for interns entering highly procedural-intensive specialties (ie, surgical specialties, emergency medicine, anesthesia, obstetrics/gynecology) and those entering less procedural-intensive specialties (ie, internal medicine, pediatrics, psychiatry), as well as among those graduating from “Top 30” medical schools (based on US News & World Report Medical School Rankings18) and our own institution. One-way analysis of variance (ANOVA) calculations were used to test for differences in hazard identification based on interns’ prior hospital safety training, with interns who rated their satisfaction with prior training or confidence in identifying hazards as a “4” or a “5” considered “satisfied” and “confident,” respectively. Responses to the MedHubTM (Ann Arbor, MI) survey were dichotomized with “strongly agree” and “agree” considered positive responses. Statistical significance was defined at P < .05. All data analysis was conducted using Stata 14TM software (College Station, TX).
RESULTS
Intern Characteristics
One hundred twenty-five entering PGY1 interns participated in the simulation, representing 60 medical schools and 7 different specialty groups (Table 2). Thirty-five percent (44/125) were graduates from “Top 30” medical schools, and 8.8% (11/125) graduated from our own institution. Seventy-four percent (89/121) had received prior hospital safety training during medical school, and 62.9% (56/89) were satisfied with their training. A majority of interns (64.2%, 79/123) felt confident in their ability to identify potential hazards in a hospital setting, although confidence was much higher among those with prior safety training (71.9%, 64/89) compared to those without prior training or who were unsure about their training (40.6%, 13/32; P = .09, t test).
Identification of Hazards
The mean percentage of hazards correctly identified by interns during the simulation was 50.4% (standard deviation [SD] 11.8%), with a normal distribution (Figure 1). Interns identified a significantly lower percentage of low-value hazards than safety hazards in the simulation (mean 19.2% [SD 18.6%] vs 66.0% [SD 16.0%], respectively; P < .001, paired t test). Interns also identified significantly more room-based errors than chart-based errors (mean 58.6% [SD 13.4%] vs 9.6% [SD 19.8%], respectively; P < .001, paired t test). The 3 most commonly identified hazards were unavailability of hand hygiene (120/125, 96.0%), presence of latex gloves despite the patient’s allergy (111/125, 88.8%), and fall risk due to the lowered bed rail (107/125, 85.6%). More than half of interns identified the incorrect name on the patient’s wristband and IV bag (91/125, 72.8%), a lack of isolation precautions (90/125, 72.0%), administration of penicillin despite the patient’s allergy (67/125, 53.6%), and unnecessary restraints (64/125, 51.2%). Less than half of interns identified the wrong medication being administered (50/125, 40.0%), unnecessary Foley catheter (25/125, 20.0%), and absence of venous thromboembolism (VTE) prophylaxis (24/125, 19.2%). Few interns identified the unnecessary blood transfusion (7/125, 5.6%), and no one identified the unnecessary stress ulcer prophylaxis (0/125, 0.0%; Figure 2).
Predictors of Hazard Identification
Interns who self-reported as confident in their ability to identify hazards were not any more likely to correctly identify hazards than those who were not confident (50.9% overall hazard identification vs 49.6%, respectively; P = .56, t test). Interns entering into less procedural-intensive specialties identified significantly more safety hazards than those entering highly procedural-intensive specialties (mean 69.1% [SD 16.9%] vs 61.8% [SD 13.7%], respectively; P = .01, t test). However, there was no statistically significant difference in their identification of low-value hazards (mean 19.8% [SD 18.3%] for less procedural-intensive vs 18.4% [SD 19.1%] for highly procedural-intensive; P = .68, t test). There was no statistically significant difference in hazard identification among graduates of “Top 30” medical schools or graduates of our own institution. Prior hospital safety training had no significant impact on interns’ ability to identify safety or low-value hazards. Overall, interns who were satisfied with their prior training identified a mean of 51.8% of hazards present (SD 11.8%), interns who were not satisfied with their prior training identified 51.5% (SD 12.7%), interns with no prior training identified 48.7% (SD 11.7%), and interns who were unsure about their prior training identified 47.4% (SD 11.5%) [F(3,117) = .79; P = .51, ANOVA]. There was also no significant association between prior training and the identification of any one of the 12 specific hazards (chi-square tests, all P values > .1).
Intern Feedback and Follow-Up Survey
Debriefing revealed that most interns passively assumed the patient’s chart was correct and did not think they should question the patient’s current care regimen. For example, many interns commented that they did not think to consider the patient’s blood transfusion as unnecessary, even though they were aware of the recommended hemoglobin cutoffs for stable patients.
Interns also provided formal feedback on the simulation through open-ended comments on their ScanTronTM (Tustin, CA) form. For example, one intern wrote that they would “inherently approach every patient room ‘looking’ for safety issues, probably directly because of this exercise.” Another commented that the simulation was “more difficult than I expected, but very necessary to facilitate discussion and learning.” One intern wrote that “I wish I had done this earlier in my career.”
Ninety-six percent of participating interns (120/125) completed an online follow-up survey 1 month after beginning internship. In the survey, 68.9% (82/119) of interns indicated they were more aware of how to identify potential hazards facing hospitalized patients as a result of the simulation. Furthermore, 52.1% (62/119) of interns had taken action during internship to reduce a potential hazard that was present in the simulation.
DISCUSSION
While many GME orientations include simulation and safety training, this study is the first of its kind to incorporate low-value care from Choosing Wisely™ recommendations into simulated training. It is concerning that interns identified significantly fewer low-value hazards than safety hazards in the simulation. In some cases, no interns identified the low-value hazard. For example, while almost all interns identified the hand hygiene hazard, not one could identify the unnecessary stress ulcer prophylaxis. Furthermore, interns who self-reported as confident in their ability to identify hazards did not perform any better in the simulation. Interns entering less procedural-intensive specialties identified more safety hazards overall.
The simulation was well received by interns. Many commented that the experience was engaging, challenging, and effective in cultivating situational awareness towards low-value care. Our follow-up survey demonstrated the majority of interns reported taking action during their first month of internship to reduce a hazard included in the simulation. Most interns also reported a greater awareness of how to identify hospital hazards as a result of the simulation. These findings suggest that a brief simulation-based experience has the potential to create a lasting retention of situational awareness and behavior change.
It is worth exploring why interns identified significantly fewer low-value hazards than safety hazards in the simulation. One hypothesis is that interns were less attuned to low-value hazards, which may reflect a lacking emphasis on value-based care in undergraduate medical education (UME). It is especially concerning that so few interns identified the catheter-associated urinary tract infection (CAUTI) risk, as interns are primarily responsible for recognizing and removing an unnecessary catheter. Although the risks of low-value care should be apparent to most trainees, the process of recognizing and deliberately stopping or avoiding low-value care can be challenging for young clinicians.19 To promote value-based thinking among entering residents, UME programs should teach students to question the utility of the interventions their patients are receiving. One promising framework for doing so is the Subjective, Objective, Assessment, Plan- (SOAP)-V, in which a V for “Value” is added to the traditional SOAP note.20 SOAP-V notes serve as a cognitive forcing function that requires students to pause and assess the value and cost-consciousness of their patients’ care.20
The results from the “Room of Horrors” simulation can also guide health leaders and educators in identifying institutional areas of focus towards providing high-value and safe care. For example, at the University of Chicago we launched an initiative to improve the inappropriate use of urinary catheters after learning that few of our incoming interns recognized this during the simulation. Institutions could use this model to raise awareness of initiatives and redirect resources from areas that trainees perform well in (eg, hand hygiene) to areas that need improvement (eg, recognition of low-value care). Given the simulation’s low cost and minimal material requirements, it could be easily integrated into existing training programs with the support of an institution’s simulation center.
This study’s limitations include its conduction at single-institution, although the participants represented graduates of 60 different institutions. Furthermore, while the 12 hazards included in the simulation represent patient safety and value initiatives from a wide array of medical societies, they were not intended to be comprehensive and were not tailored to specific specialties. The simulation included only 4 low-value hazards, and future iterations of this exercise should aim to include an equal number of safety and low-value hazards. Furthermore, the evaluation of interns’ prior hospital safety training relied on self-reporting, and the specific context and content of each interns’ training was not examined. Finally, at this point we are unable to provide objective longitudinal data assessing the simulation’s impact on clinical practice and patient outcomes. Subsequent work will assess the sustained impact of the simulation by correlating with institutional data on measurable occurrences of low-value care.
In conclusion, interns identified significantly fewer low-value hazards than safety hazards in an inpatient simulation designed to promote situational awareness. Our results suggest that interns are on the lookout for errors of omission (eg, absence of hand hygiene, absence of isolation precautions) but are often blinded to errors of commission, such that when patients are started on therapies there is an assumption that the therapies are correct and necessary (eg, blood transfusions, stress ulcer prophylaxis). These findings suggest poor awareness of low-value care among incoming interns and highlight the need for additional training in both UME and GME to place a greater emphasis on preventing low-value care.
Disclosure
Dr. Arora is a member of the American Board of Medicine Board of Directors and has received grant funding from ABIM Foundation via Costs of Care for the Teaching Value Choosing Wisely™ Challenge. Dr. Farnan, Dr. Arora, and Ms. Hirsch receive grant funds from Accreditation Council of Graduate Medical Education as part of the Pursuing Excellence Initiative. Dr. Arora and Dr. Farnan also receive grant funds from the American Medical Association Accelerating Change in Medical Education initiative. Kathleen Wiest and Lukas Matern were funded through matching funds of the Pritzker Summer Research Program for NIA T35AG029795.
In recent years, the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely™ campaign has advanced the dialogue on cost-consciousness by identifying potential examples of overuse in clinical practice.1 Eliminating low-value care can decrease costs, improve quality, and potentially decrease patient harm.2 In fact, there is growing consensus among health leaders and educators on the need for a physician workforce that is conscious of high-value care.3,4 The Institute of Medicine has issued a call-to-action for graduate medical education (GME) to emphasize value-based care,5 and the Accreditation Council for Graduate Medical Education has outlined expectations that residents receive formal and experiential training on overuse as a part of its Clinical Learning Environment Review.6
However, recent reports highlight a lack of emphasis on value-based care in medical education.7 For example, few residency program directors believe that residents are prepared to incorporate value and cost into their medical decisions.8 In 2012, only 15% of medicine residencies reported having formal curricula addressing value, although many were developing one.8 Of the curricula reported, most were didactic in nature and did not include an assessment component.8
Experiential learning through simulation is one promising method to teach clinicians-in-training to practice value-based care. Simulation-based training promotes situational awareness (defined as being cognizant of one’s working environment), a concept that is crucial for recognizing both low-value and unsafe care.9,10 Simulated training exercises are often included in GME orientation “boot-camps,” which have typically addressed safety.11 The incorporation of value into existing GME boot-camp exercises could provide a promising model for the addition of value-based training to GME.
At the University of Chicago, we had successfully implemented the “Room of Horrors,” a simulation for entering interns to promote the detection of patient safety hazards.11 Here, we describe a modification to this simulation to embed low-value hazards in addition to traditional patient safety hazards. The aim of this study is to assess the entering interns’ recognition of low-value care and their ability to recognize unsafe care in a simulation designed to promote situational awareness.
METHODS
Setting and Participants
The simulation was conducted during GME orientation at a large, urban academic medical institution. One hundred and twenty-five entering postgraduate year one (PGY1) interns participated in the simulation, which was a required component of a multiday orientation “boot-camp” experience. All eligible interns participated in the simulation, representing 13 specialty programs and 60 medical schools. Interns entering into pathology were excluded because of infrequent patient contact. Participating interns were divided into 7 specialty groups for analysis in order to preserve the anonymity of interns in smaller residency programs (surgical subspecialties combined with general surgery, medicine-pediatrics grouped with internal medicine). The University of Chicago Institutional Review Board deemed this study exempt from review.
Program Description
A simulation of an inpatient hospital room, known as the “Room of Horrors,” was constructed in collaboration with the University of Chicago Simulation Center and adapted from a previous version of the exercise.11 The simulation consisted of a mock door chart highlighting the patient had been admitted for diarrhea (Clostridium difficile positive) following a recent hospitalization for pneumonia. A clinical scenario was constructed by using a patient mannequin and an accompanying door chart that listed information on the patient’s hospital course, allergies, and medications. In addition to the 8 patient safety hazards utilized in the prior version, our team selected 4 low-value hazards to be included in the simulation.
The 8 safety hazards have been detailed in a prior study and were previously selected from Medicare’s Hospital-Acquired Conditions (HAC) Reduction Program and Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators.11-13 Each of the hazards was represented either physically in the simulation room and/or was indicated on the patient’s chart. For example, the latex allergy hazard was represented by latex gloves at the bedside despite an allergy indicated on the patient’s chart and wristband. A complete list of the 8 safety hazards and their representations in the simulation is shown in Table 1.
The Choosing Wisely™ lists were reviewed to identify low-value hazards for addition to the simulation.14 Our team selected 3 low-value hazards from the Society of Hospital Medicine (SHM) list,15 including (1) arbitrary blood transfusion despite the patient’s stable hemoglobin level of 8.0 g/dL and absence of cardiac symptoms,16 (2) addition of a proton pump inhibitor (PPI) for stress ulcer prophylaxis in a patient without high risk for gastrointestinal (GI) complications who was not on a PPI prior to admission, and (3) placement of a urinary catheter without medical indication. We had originally selected continuous telemetry monitoring as a fourth hazard from the SHM list, but were unable to operationalize, as it was difficult to simulate continuous telemetry on a mannequin. Because many inpatients are older than 65 years, we reviewed the American Geriatrics Society list17 and selected our fourth low-value hazard: (4) unnecessary use of physical restraints to manage behavioral symptoms in a hospitalized patient with delirium. Several of these hazards were also quality and safety priorities at our institution, including the overuse of urinary catheters, physical restraints, and blood transfusions. All 4 low-value hazards were referenced in the patient’s door chart, and 3 were also physically represented in the room via presence of a hanging unit of blood, Foley catheter, and upper-arm restraints (Table 1). See Appendix for a photograph of the simulation setup.
Each intern was allowed 10 minutes inside the simulation room. During this time, they were instructed to read the 1-page door chart, inspect the simulation room, and write down as many potential low-value and safety hazards as they could identify on a free-response form (see Appendix). Upon exiting the room, they were allotted 5 additional minutes to complete their free-response answers and provide written feedback on the simulation. The simulation was conducted in 3 simulated hospital rooms over the course of 2 days, and the correct answers were provided via e-mail after all interns had completed the exercise.
To assess prior training and safety knowledge, interns were asked to complete a 3-question preassessment on a ScanTronTM (Tustin, CA) form. The preassessment asked interns whether they had received training on hospital safety during medical school (yes, no, or unsure), if they were satisfied with the hospital safety training they received during medical school (strongly disagree to strongly agree on a Likert scale), and if they were confident in their ability to identify potential hazards in a hospital setting (strongly disagree to strongly agree). Interns were also given the opportunity to provide feedback on the simulation experience on the ScanTronTM (Tustin, CA) form.
One month after participating in the simulation, interns were asked to complete an online follow-up survey on MedHubTM (Ann Arbor, MI), which included 2 Likert-scale questions (strongly disagree to strongly agree) assessing the simulation’s impact on their experience mitigating hospital hazards during the first month of internship.
Data Analysis
Interns’ free-response answers were manually coded, and descriptive statistics were used to summarize the mean percent correct for each hazard. A paired t test was used to compare intern identification of low-value vs safety hazards. T tests were used to compare hazard identification for interns entering highly procedural-intensive specialties (ie, surgical specialties, emergency medicine, anesthesia, obstetrics/gynecology) and those entering less procedural-intensive specialties (ie, internal medicine, pediatrics, psychiatry), as well as among those graduating from “Top 30” medical schools (based on US News & World Report Medical School Rankings18) and our own institution. One-way analysis of variance (ANOVA) calculations were used to test for differences in hazard identification based on interns’ prior hospital safety training, with interns who rated their satisfaction with prior training or confidence in identifying hazards as a “4” or a “5” considered “satisfied” and “confident,” respectively. Responses to the MedHubTM (Ann Arbor, MI) survey were dichotomized with “strongly agree” and “agree” considered positive responses. Statistical significance was defined at P < .05. All data analysis was conducted using Stata 14TM software (College Station, TX).
RESULTS
Intern Characteristics
One hundred twenty-five entering PGY1 interns participated in the simulation, representing 60 medical schools and 7 different specialty groups (Table 2). Thirty-five percent (44/125) were graduates from “Top 30” medical schools, and 8.8% (11/125) graduated from our own institution. Seventy-four percent (89/121) had received prior hospital safety training during medical school, and 62.9% (56/89) were satisfied with their training. A majority of interns (64.2%, 79/123) felt confident in their ability to identify potential hazards in a hospital setting, although confidence was much higher among those with prior safety training (71.9%, 64/89) compared to those without prior training or who were unsure about their training (40.6%, 13/32; P = .09, t test).
Identification of Hazards
The mean percentage of hazards correctly identified by interns during the simulation was 50.4% (standard deviation [SD] 11.8%), with a normal distribution (Figure 1). Interns identified a significantly lower percentage of low-value hazards than safety hazards in the simulation (mean 19.2% [SD 18.6%] vs 66.0% [SD 16.0%], respectively; P < .001, paired t test). Interns also identified significantly more room-based errors than chart-based errors (mean 58.6% [SD 13.4%] vs 9.6% [SD 19.8%], respectively; P < .001, paired t test). The 3 most commonly identified hazards were unavailability of hand hygiene (120/125, 96.0%), presence of latex gloves despite the patient’s allergy (111/125, 88.8%), and fall risk due to the lowered bed rail (107/125, 85.6%). More than half of interns identified the incorrect name on the patient’s wristband and IV bag (91/125, 72.8%), a lack of isolation precautions (90/125, 72.0%), administration of penicillin despite the patient’s allergy (67/125, 53.6%), and unnecessary restraints (64/125, 51.2%). Less than half of interns identified the wrong medication being administered (50/125, 40.0%), unnecessary Foley catheter (25/125, 20.0%), and absence of venous thromboembolism (VTE) prophylaxis (24/125, 19.2%). Few interns identified the unnecessary blood transfusion (7/125, 5.6%), and no one identified the unnecessary stress ulcer prophylaxis (0/125, 0.0%; Figure 2).
Predictors of Hazard Identification
Interns who self-reported as confident in their ability to identify hazards were not any more likely to correctly identify hazards than those who were not confident (50.9% overall hazard identification vs 49.6%, respectively; P = .56, t test). Interns entering into less procedural-intensive specialties identified significantly more safety hazards than those entering highly procedural-intensive specialties (mean 69.1% [SD 16.9%] vs 61.8% [SD 13.7%], respectively; P = .01, t test). However, there was no statistically significant difference in their identification of low-value hazards (mean 19.8% [SD 18.3%] for less procedural-intensive vs 18.4% [SD 19.1%] for highly procedural-intensive; P = .68, t test). There was no statistically significant difference in hazard identification among graduates of “Top 30” medical schools or graduates of our own institution. Prior hospital safety training had no significant impact on interns’ ability to identify safety or low-value hazards. Overall, interns who were satisfied with their prior training identified a mean of 51.8% of hazards present (SD 11.8%), interns who were not satisfied with their prior training identified 51.5% (SD 12.7%), interns with no prior training identified 48.7% (SD 11.7%), and interns who were unsure about their prior training identified 47.4% (SD 11.5%) [F(3,117) = .79; P = .51, ANOVA]. There was also no significant association between prior training and the identification of any one of the 12 specific hazards (chi-square tests, all P values > .1).
Intern Feedback and Follow-Up Survey
Debriefing revealed that most interns passively assumed the patient’s chart was correct and did not think they should question the patient’s current care regimen. For example, many interns commented that they did not think to consider the patient’s blood transfusion as unnecessary, even though they were aware of the recommended hemoglobin cutoffs for stable patients.
Interns also provided formal feedback on the simulation through open-ended comments on their ScanTronTM (Tustin, CA) form. For example, one intern wrote that they would “inherently approach every patient room ‘looking’ for safety issues, probably directly because of this exercise.” Another commented that the simulation was “more difficult than I expected, but very necessary to facilitate discussion and learning.” One intern wrote that “I wish I had done this earlier in my career.”
Ninety-six percent of participating interns (120/125) completed an online follow-up survey 1 month after beginning internship. In the survey, 68.9% (82/119) of interns indicated they were more aware of how to identify potential hazards facing hospitalized patients as a result of the simulation. Furthermore, 52.1% (62/119) of interns had taken action during internship to reduce a potential hazard that was present in the simulation.
DISCUSSION
While many GME orientations include simulation and safety training, this study is the first of its kind to incorporate low-value care from Choosing Wisely™ recommendations into simulated training. It is concerning that interns identified significantly fewer low-value hazards than safety hazards in the simulation. In some cases, no interns identified the low-value hazard. For example, while almost all interns identified the hand hygiene hazard, not one could identify the unnecessary stress ulcer prophylaxis. Furthermore, interns who self-reported as confident in their ability to identify hazards did not perform any better in the simulation. Interns entering less procedural-intensive specialties identified more safety hazards overall.
The simulation was well received by interns. Many commented that the experience was engaging, challenging, and effective in cultivating situational awareness towards low-value care. Our follow-up survey demonstrated the majority of interns reported taking action during their first month of internship to reduce a hazard included in the simulation. Most interns also reported a greater awareness of how to identify hospital hazards as a result of the simulation. These findings suggest that a brief simulation-based experience has the potential to create a lasting retention of situational awareness and behavior change.
It is worth exploring why interns identified significantly fewer low-value hazards than safety hazards in the simulation. One hypothesis is that interns were less attuned to low-value hazards, which may reflect a lacking emphasis on value-based care in undergraduate medical education (UME). It is especially concerning that so few interns identified the catheter-associated urinary tract infection (CAUTI) risk, as interns are primarily responsible for recognizing and removing an unnecessary catheter. Although the risks of low-value care should be apparent to most trainees, the process of recognizing and deliberately stopping or avoiding low-value care can be challenging for young clinicians.19 To promote value-based thinking among entering residents, UME programs should teach students to question the utility of the interventions their patients are receiving. One promising framework for doing so is the Subjective, Objective, Assessment, Plan- (SOAP)-V, in which a V for “Value” is added to the traditional SOAP note.20 SOAP-V notes serve as a cognitive forcing function that requires students to pause and assess the value and cost-consciousness of their patients’ care.20
The results from the “Room of Horrors” simulation can also guide health leaders and educators in identifying institutional areas of focus towards providing high-value and safe care. For example, at the University of Chicago we launched an initiative to improve the inappropriate use of urinary catheters after learning that few of our incoming interns recognized this during the simulation. Institutions could use this model to raise awareness of initiatives and redirect resources from areas that trainees perform well in (eg, hand hygiene) to areas that need improvement (eg, recognition of low-value care). Given the simulation’s low cost and minimal material requirements, it could be easily integrated into existing training programs with the support of an institution’s simulation center.
This study’s limitations include its conduction at single-institution, although the participants represented graduates of 60 different institutions. Furthermore, while the 12 hazards included in the simulation represent patient safety and value initiatives from a wide array of medical societies, they were not intended to be comprehensive and were not tailored to specific specialties. The simulation included only 4 low-value hazards, and future iterations of this exercise should aim to include an equal number of safety and low-value hazards. Furthermore, the evaluation of interns’ prior hospital safety training relied on self-reporting, and the specific context and content of each interns’ training was not examined. Finally, at this point we are unable to provide objective longitudinal data assessing the simulation’s impact on clinical practice and patient outcomes. Subsequent work will assess the sustained impact of the simulation by correlating with institutional data on measurable occurrences of low-value care.
In conclusion, interns identified significantly fewer low-value hazards than safety hazards in an inpatient simulation designed to promote situational awareness. Our results suggest that interns are on the lookout for errors of omission (eg, absence of hand hygiene, absence of isolation precautions) but are often blinded to errors of commission, such that when patients are started on therapies there is an assumption that the therapies are correct and necessary (eg, blood transfusions, stress ulcer prophylaxis). These findings suggest poor awareness of low-value care among incoming interns and highlight the need for additional training in both UME and GME to place a greater emphasis on preventing low-value care.
Disclosure
Dr. Arora is a member of the American Board of Medicine Board of Directors and has received grant funding from ABIM Foundation via Costs of Care for the Teaching Value Choosing Wisely™ Challenge. Dr. Farnan, Dr. Arora, and Ms. Hirsch receive grant funds from Accreditation Council of Graduate Medical Education as part of the Pursuing Excellence Initiative. Dr. Arora and Dr. Farnan also receive grant funds from the American Medical Association Accelerating Change in Medical Education initiative. Kathleen Wiest and Lukas Matern were funded through matching funds of the Pritzker Summer Research Program for NIA T35AG029795.
1. Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015;30(2):221-228. doi:10.1007/s11606-014-3070-z. PubMed
2. Elshaug AG, McWilliams JM, Landon BE. The value of low-value lists. JAMA. 2013;309(8):775-776. doi:10.1001/jama.2013.828. PubMed
3. Cooke M. Cost consciousness in patient care--what is medical education’s responsibility? N Engl J Med. 2010;362(14):1253-1255. doi:10.1056/NEJMp0911502. PubMed
4. Weinberger SE. Providing high-value, cost-conscious care: a critical seventh general competency for physicians. Ann Intern Med. 2011;155(6):386-388. doi:10.7326/0003-4819-155-6-201109200-00007. PubMed
5. Graduate Medical Education That Meets the Nation’s Health Needs. Institute of Medicine. http://www.nationalacademies.org/hmd/Reports/2014/Graduate-Medical-Education-That-Meets-the-Nations-Health-Needs.aspx. Accessed May 25, 2016.
6. Accreditation Council for Graduate Medical Education. CLER Pathways to Excellence. https://www.acgme.org/acgmeweb/Portals/0/PDFs/CLER/CLER_Brochure.pdf. Accessed July 15, 2015.
7. Varkey P, Murad MH, Braun C, Grall KJH, Saoji V. A review of cost-effectiveness, cost-containment and economics curricula in graduate medical education. J Eval Clin Pract. 2010;16(6):1055-1062. doi:10.1111/j.1365-2753.2009.01249.x. PubMed
8. Patel MS, Reed DA, Loertscher L, McDonald FS, Arora VM. Teaching residents to provide cost-conscious care: a national survey of residency program directors. JAMA Intern Med. 2014;174(3):470-472. doi:10.1001/jamainternmed.2013.13222. PubMed
9. Cohen NL. Using the ABCs of situational awareness for patient safety. Nursing. 2013;43(4):64-65. doi:10.1097/01.NURSE.0000428332.23978.82. PubMed
10. Varkey P, Karlapudi S, Rose S, Swensen S. A patient safety curriculum for graduate medical education: results from a needs assessment of educators and patient safety experts. Am J Med Qual. 2009;24(3):214-221. doi:10.1177/1062860609332905. PubMed
11. Farnan JM, Gaffney S, Poston JT, et al. Patient safety room of horrors: a novel method to assess medical students and entering residents’ ability to identify hazards of hospitalisation. BMJ Qual Saf. 2016;25(3):153-158. doi:10.1136/bmjqs-2015-004621. PubMed
12. Centers for Medicare and Medicaid Services Hospital-acquired condition reduction program. Medicare.gov. https://www.medicare.gov/hospitalcompare/HAC-reduction-program.html. Accessed August 1, 2015.
13. Agency for Healthcare Research and Quality. Patient Safety Indicators Overview. http://www. qualityindicators.ahrq.gov/modules/psi_overview.aspx. Accessed August 20, 2015.
14. ABIM Foundation. Choosing Wisely. http://www.choosingwisely.org. Accessed August 21, 2015.
15. ABIM Foundation. Society of Hospital Medicine – Adult Hospital Medicine List. Choosing Wisely. http://www.choosingwisely.org/societies/ society-of-hospital-medicine-adult/. Accessed August 21, 2015.
16. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: A clinical practice guideline from the AABB*. Ann Intern Med. 2012;157(1):49-58. PubMed
17. ABIM Foundation. American Geriatrics Society List. Choosing Wisely. http://www.choosingwisely.org/societies/american-geriatrics-society/. Accessed August 21, 2015.
18. The Best Medical Schools for Research, Ranked. http://grad-schools.usnews.rankingsandreviews.com/best-graduate-schools/top-medical-schools/research-rankings?int=af3309&int=b3b50a&int=b14409. Accessed June 7, 2016.
19. Roman BR, Asch DA. Faded promises: The challenge of deadopting low-value care. Ann Intern Med. 2014;161(2):149-150. doi:10.7326/M14-0212. PubMed
20. Moser EM, Huang GC, Packer CD, et al. SOAP-V: Introducing a method to empower medical students to be change agents in bending the cost curve. J Hosp Med. 2016;11(3):217-220. doi:10.1002/jhm.2489. PubMed
1. Colla CH, Morden NE, Sequist TD, Schpero WL, Rosenthal MB. Choosing wisely: prevalence and correlates of low-value health care services in the United States. J Gen Intern Med. 2015;30(2):221-228. doi:10.1007/s11606-014-3070-z. PubMed
2. Elshaug AG, McWilliams JM, Landon BE. The value of low-value lists. JAMA. 2013;309(8):775-776. doi:10.1001/jama.2013.828. PubMed
3. Cooke M. Cost consciousness in patient care--what is medical education’s responsibility? N Engl J Med. 2010;362(14):1253-1255. doi:10.1056/NEJMp0911502. PubMed
4. Weinberger SE. Providing high-value, cost-conscious care: a critical seventh general competency for physicians. Ann Intern Med. 2011;155(6):386-388. doi:10.7326/0003-4819-155-6-201109200-00007. PubMed
5. Graduate Medical Education That Meets the Nation’s Health Needs. Institute of Medicine. http://www.nationalacademies.org/hmd/Reports/2014/Graduate-Medical-Education-That-Meets-the-Nations-Health-Needs.aspx. Accessed May 25, 2016.
6. Accreditation Council for Graduate Medical Education. CLER Pathways to Excellence. https://www.acgme.org/acgmeweb/Portals/0/PDFs/CLER/CLER_Brochure.pdf. Accessed July 15, 2015.
7. Varkey P, Murad MH, Braun C, Grall KJH, Saoji V. A review of cost-effectiveness, cost-containment and economics curricula in graduate medical education. J Eval Clin Pract. 2010;16(6):1055-1062. doi:10.1111/j.1365-2753.2009.01249.x. PubMed
8. Patel MS, Reed DA, Loertscher L, McDonald FS, Arora VM. Teaching residents to provide cost-conscious care: a national survey of residency program directors. JAMA Intern Med. 2014;174(3):470-472. doi:10.1001/jamainternmed.2013.13222. PubMed
9. Cohen NL. Using the ABCs of situational awareness for patient safety. Nursing. 2013;43(4):64-65. doi:10.1097/01.NURSE.0000428332.23978.82. PubMed
10. Varkey P, Karlapudi S, Rose S, Swensen S. A patient safety curriculum for graduate medical education: results from a needs assessment of educators and patient safety experts. Am J Med Qual. 2009;24(3):214-221. doi:10.1177/1062860609332905. PubMed
11. Farnan JM, Gaffney S, Poston JT, et al. Patient safety room of horrors: a novel method to assess medical students and entering residents’ ability to identify hazards of hospitalisation. BMJ Qual Saf. 2016;25(3):153-158. doi:10.1136/bmjqs-2015-004621. PubMed
12. Centers for Medicare and Medicaid Services Hospital-acquired condition reduction program. Medicare.gov. https://www.medicare.gov/hospitalcompare/HAC-reduction-program.html. Accessed August 1, 2015.
13. Agency for Healthcare Research and Quality. Patient Safety Indicators Overview. http://www. qualityindicators.ahrq.gov/modules/psi_overview.aspx. Accessed August 20, 2015.
14. ABIM Foundation. Choosing Wisely. http://www.choosingwisely.org. Accessed August 21, 2015.
15. ABIM Foundation. Society of Hospital Medicine – Adult Hospital Medicine List. Choosing Wisely. http://www.choosingwisely.org/societies/ society-of-hospital-medicine-adult/. Accessed August 21, 2015.
16. Carson JL, Grossman BJ, Kleinman S, et al. Red blood cell transfusion: A clinical practice guideline from the AABB*. Ann Intern Med. 2012;157(1):49-58. PubMed
17. ABIM Foundation. American Geriatrics Society List. Choosing Wisely. http://www.choosingwisely.org/societies/american-geriatrics-society/. Accessed August 21, 2015.
18. The Best Medical Schools for Research, Ranked. http://grad-schools.usnews.rankingsandreviews.com/best-graduate-schools/top-medical-schools/research-rankings?int=af3309&int=b3b50a&int=b14409. Accessed June 7, 2016.
19. Roman BR, Asch DA. Faded promises: The challenge of deadopting low-value care. Ann Intern Med. 2014;161(2):149-150. doi:10.7326/M14-0212. PubMed
20. Moser EM, Huang GC, Packer CD, et al. SOAP-V: Introducing a method to empower medical students to be change agents in bending the cost curve. J Hosp Med. 2016;11(3):217-220. doi:10.1002/jhm.2489. PubMed
© 2017 Society of Hospital Medicine
Inherited mutations shed light on atopic dermatitis pathway
Inherited mutations in a single gene may contribute to a severe form of atopic dermatitis (AD), a study of eight patients showed.
Investigators from the National Institute of Allergy and Infectious Diseases (NIAID) and elsewhere identified eight individuals with severe AD from four unrelated families. All of the patients had a mutation in the CARD11 gene, which is part of the nuclear factor–kappa B (NF-kB) pathway.
When the mutated genes were inserted into T cells, the researchers found that the mutated copy of the gene interfered with the normal copy, preventing the activation of NF-kB and mTORC1 (mammalian target of rapamycin complex 1) – effects that may contribute to the severity of AD in these patients.
The results could have broad-ranging clinical implications, Dr. Milner said in an interview. CARD11 has been shown to be associated with AD in previous genomewide association studies. “It may not be the case that this is just found in a few rare families. This could potentially be a gene or pathway that could explain a lot of atopic dermatitis,” he noted.
The study results also point to a potential therapy for AD. The pathway can lead to a deficiency in glutamine uptake into cells, and the study suggests that glutamine supplementation could potentially restore some cells to normal functioning.
Dr. Milner also pointed out that glutamine deficiency could be an indirect consequence of the disease. “Kids with bad allergic disease are usually on a poor diet because they are avoiding foods. They may not be getting enough protein intake,” he said.
In fact, a prevention trial in premature infants sought to determine if glutamine supplementation could reduce infections. The primary endpoint failed, but researchers noted a reduction in AD, according to Dr. Milner. “That’s pretty amazing, given what we just found.”
This study is among recent studies that have highlighted potential targets for treatment of AD, including one reporting that tumor necrosis factor–like weak inducer of apoptosis, a protein, may be involved in both AD and psoriasis (Nat Commun. 2017 May 22;8:15395.).
Research identifying novel pathways involved in AD led to the development of dupilumab, which targets interleukin-4 and interleukin-13 and was recently approved by the Food and Drug Administration for moderate to severe AD. It is the first targeted biologic therapy to become available for AD. “I can’t underscore the importance of dupilumab enough,” Dr. Milner commented.
He and the other authors had no related disclosures.
Inherited mutations in a single gene may contribute to a severe form of atopic dermatitis (AD), a study of eight patients showed.
Investigators from the National Institute of Allergy and Infectious Diseases (NIAID) and elsewhere identified eight individuals with severe AD from four unrelated families. All of the patients had a mutation in the CARD11 gene, which is part of the nuclear factor–kappa B (NF-kB) pathway.
When the mutated genes were inserted into T cells, the researchers found that the mutated copy of the gene interfered with the normal copy, preventing the activation of NF-kB and mTORC1 (mammalian target of rapamycin complex 1) – effects that may contribute to the severity of AD in these patients.
The results could have broad-ranging clinical implications, Dr. Milner said in an interview. CARD11 has been shown to be associated with AD in previous genomewide association studies. “It may not be the case that this is just found in a few rare families. This could potentially be a gene or pathway that could explain a lot of atopic dermatitis,” he noted.
The study results also point to a potential therapy for AD. The pathway can lead to a deficiency in glutamine uptake into cells, and the study suggests that glutamine supplementation could potentially restore some cells to normal functioning.
Dr. Milner also pointed out that glutamine deficiency could be an indirect consequence of the disease. “Kids with bad allergic disease are usually on a poor diet because they are avoiding foods. They may not be getting enough protein intake,” he said.
In fact, a prevention trial in premature infants sought to determine if glutamine supplementation could reduce infections. The primary endpoint failed, but researchers noted a reduction in AD, according to Dr. Milner. “That’s pretty amazing, given what we just found.”
This study is among recent studies that have highlighted potential targets for treatment of AD, including one reporting that tumor necrosis factor–like weak inducer of apoptosis, a protein, may be involved in both AD and psoriasis (Nat Commun. 2017 May 22;8:15395.).
Research identifying novel pathways involved in AD led to the development of dupilumab, which targets interleukin-4 and interleukin-13 and was recently approved by the Food and Drug Administration for moderate to severe AD. It is the first targeted biologic therapy to become available for AD. “I can’t underscore the importance of dupilumab enough,” Dr. Milner commented.
He and the other authors had no related disclosures.
Inherited mutations in a single gene may contribute to a severe form of atopic dermatitis (AD), a study of eight patients showed.
Investigators from the National Institute of Allergy and Infectious Diseases (NIAID) and elsewhere identified eight individuals with severe AD from four unrelated families. All of the patients had a mutation in the CARD11 gene, which is part of the nuclear factor–kappa B (NF-kB) pathway.
When the mutated genes were inserted into T cells, the researchers found that the mutated copy of the gene interfered with the normal copy, preventing the activation of NF-kB and mTORC1 (mammalian target of rapamycin complex 1) – effects that may contribute to the severity of AD in these patients.
The results could have broad-ranging clinical implications, Dr. Milner said in an interview. CARD11 has been shown to be associated with AD in previous genomewide association studies. “It may not be the case that this is just found in a few rare families. This could potentially be a gene or pathway that could explain a lot of atopic dermatitis,” he noted.
The study results also point to a potential therapy for AD. The pathway can lead to a deficiency in glutamine uptake into cells, and the study suggests that glutamine supplementation could potentially restore some cells to normal functioning.
Dr. Milner also pointed out that glutamine deficiency could be an indirect consequence of the disease. “Kids with bad allergic disease are usually on a poor diet because they are avoiding foods. They may not be getting enough protein intake,” he said.
In fact, a prevention trial in premature infants sought to determine if glutamine supplementation could reduce infections. The primary endpoint failed, but researchers noted a reduction in AD, according to Dr. Milner. “That’s pretty amazing, given what we just found.”
This study is among recent studies that have highlighted potential targets for treatment of AD, including one reporting that tumor necrosis factor–like weak inducer of apoptosis, a protein, may be involved in both AD and psoriasis (Nat Commun. 2017 May 22;8:15395.).
Research identifying novel pathways involved in AD led to the development of dupilumab, which targets interleukin-4 and interleukin-13 and was recently approved by the Food and Drug Administration for moderate to severe AD. It is the first targeted biologic therapy to become available for AD. “I can’t underscore the importance of dupilumab enough,” Dr. Milner commented.
He and the other authors had no related disclosures.
FROM NATURE GENETICS
Key clinical point: Mutations in the CARD11 gene may play a role in severe atopic dermatitis.
Major finding: A mutation in one copy of the CARD11 gene appears to interfere with the normal functioning copy.
Data source: A case study of eight patients with severe AD, all from different families.
Disclosures: Dr. Milner reported having no relevant financial disclosures.
Colonoscopy patients prefer propofol over fentanyl/midazolam
SEATTLE – As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.
The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.
“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.
The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.
Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.
Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.
Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.
Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.
“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.
The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.
There was no external funding for the work, and the investigators had no disclosures.
SEATTLE – As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.
The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.
“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.
The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.
Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.
Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.
Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.
Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.
“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.
The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.
There was no external funding for the work, and the investigators had no disclosures.
SEATTLE – As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.
The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.
“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.
The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.
Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.
Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.
Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.
Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.
“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.
The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.
There was no external funding for the work, and the investigators had no disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point: 
Major finding: The 300 patients randomized to propofol were more likely than were the 300 randomized to standard-of-care fentanyl/midazolam to state that they were “very satisfied” with their anesthesia during the procedure (86.3% versus 74%).
Data source: Randomized, blinded trial of 600 patients at a single center.
Disclosures: There was no external funding for the work, and the investigators had no disclosures.
Docs still don’t get MACRA
Seven months into the first year of the Quality Payment Program, the new value-based payment plan set up by the Medicare Access and CHIP Reauthorization Act (MACRA), and doctors’ knowledge of the program is still light.
“Physicians, especially those in small practices, need more help in preparing” for participation in QPP either through the Merit-Based Incentive Payment System (MIPS) or advanced Alternative Payment Models (APMs), according to a new report issued by the American Medical Association and consulting firm KPMG.
That said, about 70% of those surveyed responded that they have begun preparing to meet the requirements of the QPP in 2017. The survey did not make clear whether this meant meeting the minimum requirements to avoid any penalties or doing more to become eligible for potential bonus Medicare payments.
“Even those who feel prepared still don’t fully understand the financial ramifications of the program,” the report said. “In short, they may be prepared to ‘check the box’ of reporting requirements, but may lack the long-term strategic financial vision to succeed in 2018 and beyond,” noting that only 8% of the respondents said they are “very prepared” for long-term financial success. On the other side of the that spectrum, 26% said they are not at all prepared and 58% said they were slightly prepared.
Survey respondents indicated a number of areas where they need help:
• Time required to accurately capture and report performance data (66%)
• Understanding reporting requirements (58%)
• Understanding the overall MIPS scoring process (57%)
• Cost required to accurately capture and report performance data (53%)
• Organizational infrastructure needed to report performance (49%)
The report also noted the significant differences when it comes to practice size, although the differences were “not unexpected.” For example, solo practices, compared to those groups of 50 or more physicians, were “significantly more likely (56%) to view reporting requirements as very burdensome, ... significantly more like to feel ‘not at all prepared’ for long-term financial success, ... less likely to be participating in an advanced APM, [and] less likely to have begun preparing.”
Specialists, more so than primary care physicians were “slightly more likely to be deeply knowledgeable about MACRA/QPP, [and] more likely to expect to participate in MIPS (61% versus 48%) and less likely to participate in an advanced APM (15% versus 22%),” the report adds.
“Ongoing educational assistance from CMS, as well as those in the private sector, should focus on the areas where physicians need the most help: understanding requirements and potential financial impact, selection of quality measures, and clinical practice transformation strategies,” the report states.
The survey comes on the heels of CMS releasing its proposed update to the regulations surrounding the QPP for 2018. Comments on the proposed regulatory update are due to CMS on Aug. 21, 2017.
 
Seven months into the first year of the Quality Payment Program, the new value-based payment plan set up by the Medicare Access and CHIP Reauthorization Act (MACRA), and doctors’ knowledge of the program is still light.
“Physicians, especially those in small practices, need more help in preparing” for participation in QPP either through the Merit-Based Incentive Payment System (MIPS) or advanced Alternative Payment Models (APMs), according to a new report issued by the American Medical Association and consulting firm KPMG.
That said, about 70% of those surveyed responded that they have begun preparing to meet the requirements of the QPP in 2017. The survey did not make clear whether this meant meeting the minimum requirements to avoid any penalties or doing more to become eligible for potential bonus Medicare payments.
“Even those who feel prepared still don’t fully understand the financial ramifications of the program,” the report said. “In short, they may be prepared to ‘check the box’ of reporting requirements, but may lack the long-term strategic financial vision to succeed in 2018 and beyond,” noting that only 8% of the respondents said they are “very prepared” for long-term financial success. On the other side of the that spectrum, 26% said they are not at all prepared and 58% said they were slightly prepared.
Survey respondents indicated a number of areas where they need help:
• Time required to accurately capture and report performance data (66%)
• Understanding reporting requirements (58%)
• Understanding the overall MIPS scoring process (57%)
• Cost required to accurately capture and report performance data (53%)
• Organizational infrastructure needed to report performance (49%)
The report also noted the significant differences when it comes to practice size, although the differences were “not unexpected.” For example, solo practices, compared to those groups of 50 or more physicians, were “significantly more likely (56%) to view reporting requirements as very burdensome, ... significantly more like to feel ‘not at all prepared’ for long-term financial success, ... less likely to be participating in an advanced APM, [and] less likely to have begun preparing.”
Specialists, more so than primary care physicians were “slightly more likely to be deeply knowledgeable about MACRA/QPP, [and] more likely to expect to participate in MIPS (61% versus 48%) and less likely to participate in an advanced APM (15% versus 22%),” the report adds.
“Ongoing educational assistance from CMS, as well as those in the private sector, should focus on the areas where physicians need the most help: understanding requirements and potential financial impact, selection of quality measures, and clinical practice transformation strategies,” the report states.
The survey comes on the heels of CMS releasing its proposed update to the regulations surrounding the QPP for 2018. Comments on the proposed regulatory update are due to CMS on Aug. 21, 2017.
 
Seven months into the first year of the Quality Payment Program, the new value-based payment plan set up by the Medicare Access and CHIP Reauthorization Act (MACRA), and doctors’ knowledge of the program is still light.
“Physicians, especially those in small practices, need more help in preparing” for participation in QPP either through the Merit-Based Incentive Payment System (MIPS) or advanced Alternative Payment Models (APMs), according to a new report issued by the American Medical Association and consulting firm KPMG.
That said, about 70% of those surveyed responded that they have begun preparing to meet the requirements of the QPP in 2017. The survey did not make clear whether this meant meeting the minimum requirements to avoid any penalties or doing more to become eligible for potential bonus Medicare payments.
“Even those who feel prepared still don’t fully understand the financial ramifications of the program,” the report said. “In short, they may be prepared to ‘check the box’ of reporting requirements, but may lack the long-term strategic financial vision to succeed in 2018 and beyond,” noting that only 8% of the respondents said they are “very prepared” for long-term financial success. On the other side of the that spectrum, 26% said they are not at all prepared and 58% said they were slightly prepared.
Survey respondents indicated a number of areas where they need help:
• Time required to accurately capture and report performance data (66%)
• Understanding reporting requirements (58%)
• Understanding the overall MIPS scoring process (57%)
• Cost required to accurately capture and report performance data (53%)
• Organizational infrastructure needed to report performance (49%)
The report also noted the significant differences when it comes to practice size, although the differences were “not unexpected.” For example, solo practices, compared to those groups of 50 or more physicians, were “significantly more likely (56%) to view reporting requirements as very burdensome, ... significantly more like to feel ‘not at all prepared’ for long-term financial success, ... less likely to be participating in an advanced APM, [and] less likely to have begun preparing.”
Specialists, more so than primary care physicians were “slightly more likely to be deeply knowledgeable about MACRA/QPP, [and] more likely to expect to participate in MIPS (61% versus 48%) and less likely to participate in an advanced APM (15% versus 22%),” the report adds.
“Ongoing educational assistance from CMS, as well as those in the private sector, should focus on the areas where physicians need the most help: understanding requirements and potential financial impact, selection of quality measures, and clinical practice transformation strategies,” the report states.
The survey comes on the heels of CMS releasing its proposed update to the regulations surrounding the QPP for 2018. Comments on the proposed regulatory update are due to CMS on Aug. 21, 2017.
 
New Center of Excellence to Lead Research of “Signature Wounds”
Take a brand-new research facility, then add a neighboring U.S. Army base with one of the largest veteran populations of any health care network and a world-class team of researchers—that’s a “recipe for success,” says Dr. Michael Russell, director of the VA Center of Excellence for Research on Returning War Veterans in Waco, Texas.
The 53,000-square-foot center is designed to conduct state-of-the-art research on mental health problems associated with PTSD and TBI, “signature wounds” of conflicts in Afghanistan and the Middle East. The flagship study is named Project MAVEREX. Researchers will examine whether the inability of the regions in injured brains to communicate with one another worsens behavior outcomes. Using “cutting-edge data analysis techniques,” they hope to characterize the effects of TBI on brain structure and function “with very high precision,” says Dr. Evan Gordon, a cognitive neuroscientist working on MAVEREX.
The Center of Excellence is on the campus of the historic Doris Miller VAMC. The facility has space for 75 staff members and faculty as well as 25 trainees. It features multiple examination rooms, observation rooms, electrocardiography, electroencephalography, a 3 Tesla MRI, a transcranial magnetic stimulation suite, and a custom-built laboratory wing.
Take a brand-new research facility, then add a neighboring U.S. Army base with one of the largest veteran populations of any health care network and a world-class team of researchers—that’s a “recipe for success,” says Dr. Michael Russell, director of the VA Center of Excellence for Research on Returning War Veterans in Waco, Texas.
The 53,000-square-foot center is designed to conduct state-of-the-art research on mental health problems associated with PTSD and TBI, “signature wounds” of conflicts in Afghanistan and the Middle East. The flagship study is named Project MAVEREX. Researchers will examine whether the inability of the regions in injured brains to communicate with one another worsens behavior outcomes. Using “cutting-edge data analysis techniques,” they hope to characterize the effects of TBI on brain structure and function “with very high precision,” says Dr. Evan Gordon, a cognitive neuroscientist working on MAVEREX.
The Center of Excellence is on the campus of the historic Doris Miller VAMC. The facility has space for 75 staff members and faculty as well as 25 trainees. It features multiple examination rooms, observation rooms, electrocardiography, electroencephalography, a 3 Tesla MRI, a transcranial magnetic stimulation suite, and a custom-built laboratory wing.
Take a brand-new research facility, then add a neighboring U.S. Army base with one of the largest veteran populations of any health care network and a world-class team of researchers—that’s a “recipe for success,” says Dr. Michael Russell, director of the VA Center of Excellence for Research on Returning War Veterans in Waco, Texas.
The 53,000-square-foot center is designed to conduct state-of-the-art research on mental health problems associated with PTSD and TBI, “signature wounds” of conflicts in Afghanistan and the Middle East. The flagship study is named Project MAVEREX. Researchers will examine whether the inability of the regions in injured brains to communicate with one another worsens behavior outcomes. Using “cutting-edge data analysis techniques,” they hope to characterize the effects of TBI on brain structure and function “with very high precision,” says Dr. Evan Gordon, a cognitive neuroscientist working on MAVEREX.
The Center of Excellence is on the campus of the historic Doris Miller VAMC. The facility has space for 75 staff members and faculty as well as 25 trainees. It features multiple examination rooms, observation rooms, electrocardiography, electroencephalography, a 3 Tesla MRI, a transcranial magnetic stimulation suite, and a custom-built laboratory wing.
Prehabilitation for lymphedema in head and neck cancer patients at a community cancer center
Lymphedema is the swelling of tissue caused by the accumulation of interstitial fluid in any area of the body where lymphatic flow has been compromised.1 Secondary lymphedema is an acquired abnormality in lymph drainage1,2 and is the type commonly seen in cancer patients. Secondary lymphedema can be described as external or internal. Internal lymphedema, swelling of deep structures and tissues, is very difficult to quantify.
Lymphedema in patients with head and neck cancers
Lymphedema is a complicating morbidity frequently seen in head and neck cancer patients who have undergone treatment with surgery, radiation, and chemotherapy. However, although it is one of the most prevalent side effects of treatment, it is both under-recognized and under-treated.3
In head and neck cancer patients, internal swelling may develop in the soft tissues of the upper aero-digestive tract,4 affecting articulation and swallowing. Currently, there does not seem to be an effective practical and reliable tool with which to measure internal lymphedema. In addition, it is generally accepted that there is no effective way to treat internal lymphedema. By contrast, external lymphedema is more readily observed, but both subjective and objective assessments are difficult. External swelling may occur in the face, jaw, and neck. However, the subjective scales currently available are insufficient to capture very important characteristics of external lymphedema.5 The Edge Task Force on Head and Neck Cancer in 2015 was not able to recommend any outcome measures for objectively quantifying external edema.6 Furthermore, objective measurements of head and neck lymphedema can be expensive and time consuming.
Extent and risk
A combination of both internal and external swelling is seen in more than 50% of patients.7 Risk factors include “throat” tumors, multicancer treatment approaches, higher total radiation dose, a greater number of radiation procedures, and radiation at the surgical site.5 More than 500,000 survivors of head and neck cancer in the United States are at risk of lymphedema.5 Although recent advances in treatment have reduced the incidence of other morbidities, 50% of patients who are treated for head and neck cancer may still develop lymphedema.1,8 The reported incidence in some centers may be much higher, with up to 75% of patients developing lymphedema following treatment.9
Measurement modalities for clinical evaluation
There is little current research into lymphedema of the head and neck, despite the high prevalence of the condition.8 According to Deng and colleagues, measurement of head and neck lymphedema is a challenge, which has an impact on clinical assessment, diagnosis, and treatment of this under-recognized, under-reported and under-addressed problem in head and neck cancer patients.10 In a review of the literature, Deng and colleagues identified three measurement modalities available for clinical evaluation: patient-reported outcomes, clinician-reported outcomes, and technology.10 One major factor, though, in detecting lymphedema, is physician awareness: physicians, health care professionals, and even some lymphedema therapists are not well educated about this problem.8
Treatment
The effectiveness of traditional lymphedema treatment is not well defined.8 Currently, complete decongestive therapy (CDT), is considered the standard of care for lymphedema. The National Lymphedema Network has stated that modifications of CDT, especially manual lymphatic drainage and modified compressive garments for external lymphedema, have been shown to be beneficial for the treatment of lymphedema in head and neck cancer patients.11 Most findings in lymphedema research, mainly in breast cancer patients, have shown that early intervention is the best management and yields the best outcomes. As with other chronic conditions, early identification and timely, appropriate treatment of lymphedema is critical to improve clinical outcomes, to decrease symptom burden and functional impairment, and to improve overall quality of life in head and neck cancer patients.10
Improving recognition and treatment
Head and neck oncologic treatment is increasingly offered outside the network of specialist academic hospitals, at hospitals serving more localized communities where the neediest, sickest patient groups may be receiving less than optimal care.3 This challenges community hospitals to provide optimal treatment, similar to that being offered at nationally recognized institutions. In January 2012, we implemented a prehabilitation program in our community hospital cancer center to provide early intervention for our patients based on the understanding that proper and prompt treatment for patients with early signs of lymphedema should be a priority.12 In this article, we outline how we implemented the program and the describe improvements we observed before and after the implementation of the program.
The prehabilitation program
The role of the nurse navigator
Before the introduction of the prehabilitation program, our pattern of practice was to refer patients to oncology rehabilitation for lymphedema management after they had completed their medical treatment with surgery, radiation, and chemotherapy. In 2012, that was changed to a prehabilitation model of care that was overseen by a head and neck nurse navigator. This focus on prehabilitation begins with patients being referred to oncology rehabilitation at the time of cancer diagnosis for baseline assessment of head and neck swelling. In addition, there is assessment of the many possible other side effects associated with head and neck cancer and its treatment, namely loss of range of motion of the neck, jaw (trismus), and/or shoulders, postural deficits, functional loss, pain, balance dysfunction with fall risk, weakness, and fatigue. Therapeutic interventions are initiated as needed and appropriate. This process also raises awareness of a condition that has been described as under-recognized and under-treated.3
The nurse navigator sits in on each radiation oncology consultation and aids in “navigating” patients through their treatment. The nurse ensures that each patient is referred to different ancillary services from the outset, such as seeing a dietician, social worker, physical/occupational therapist and certified lymphedema therapist, speech pathologist, and financial assistance advisor, if necessary (Table 1).
Assessment of lymphedema
Measurement of head and neck lymphedema is a challenge.10 In our program, the physical therapy assessment also includes the evaluation of several other morbidities associated with head and neck cancer and its treatment, such as range of motion, weakness, fatigue, radiation fibrosis, balance dysfunction, and risk of falling (Table 2).
Patient-reported outcomes are essential to fully capture observable and unobservable symptoms (eg, sensations) as well as the functional impacts of lymphedema.10 In addition to lymphedema, there are many other morbidities that may be assessed on the basis of patient-reported outcome tools, such as upper extremity function with QuickDASH.13 At our clinic for head and neck cancer patients we use the Neck Disability Index (NDI)14 and Care Connections (CC)15 survey for the patient-reported outcomes. The Quick DASH, NDI, and CC tools all assess standard functional outcomes that are not specific to lymphedema, but are useful in documenting changes related to lymphedema. We initially used the CC survey and later transitioned to using the NDI. Neck pain is common with lymphedema in the head and neck region, and the NDI is a valid, reliable, responsive and internally consistent clinical tool to measure self-reported disability in patients with neck pain.16 These questionnaires were completed by the patients at their initial assessment, at reassessment, and at time of discharge.
Although objective criteria for external lymphedema have not been established, simple measurements such as using a tape measure to record neck circumference, allow a useful longitudinal assessment. Digital photography may be effective in the documentation and subjective evaluation of changes of external lymphedema.10,17 However, there are some limitations with photography because although external photographs (including digital photography and three-dimensional imaging) can capture some features, such as changes in contours, symmetry, and changes in skin quality and color, they do not detect changes in skin and soft tissue texture and compliance (Table 3).10
Impact on clinical outcomes
We retrospectively reviewed the medical records of 230 head and neck cancer patients who had been treated at our center between June 2008 and June 2015. Complete clinical data were available for 190 patients. The following information was extracted from each patient’s chart: whether they developed lymphedema, tumor stage, had surgery, radiation dose, type of chemotherapy given, their smoking history, if they had had a neck dissection and the primary site of the tumor (Table 3).
Incidence in different time periods. Of the 190 patients with complete records 78 (41%) were found to have lymphedema. These were all patients undergoing treatment for head and neck cancer during June 2008-June 2015. The prehabilitation program was initiated with the hiring of a nurse navigator for head and neck cancer, starting in January 2012. It is interesting to note that the incidence of lymphedema was 27% before the program was started, but after nurse navigator joined the team, the incidence increased significantly to 48% (P = .0002), in line with published expectations. This increase in recorded incidence may be attributable to the greater awareness of lymphedema intentionally fostered by the prehabilitation program.
Smoking history. Patients’ lifetime smoking history was retrieved from their medical records, based on their verbal admission of tobacco use. Most of the patients (n = 110) self-reported a history of smoking. Of those with a history of smoking, 36 (33%) developed external lymphedema after treatment for head and neck cancer, and 74 (67%) did not. However, this difference was not statistically significant. Hence, although smoking is a risk factor for head and neck cancer, it was not associated with the development of external lymphedema in our cohort of patients.
Type of tumor
Most of the patients (n = 156, 82%) had squamous cell carcinomas (SCC). Of those, 45% developed external lymphedema and 55% did not. Therefore, having SCC did not predispose to lymphedema. The other cancers were mixed type, mainly adenocaricoma, but their numbers were too small to draw statistical conclusions.
Stage of the tumor
About two thirds of the patients (n = 121, 64%) had stage 3 or 4 cancer. However, treatment of more advanced cancers was not associated with lymphedema development.
Site of the tumor
The literature suggests that patients with a primary tumor in the throat are at increased risk for lymphedema.5 The American Cancer Society has defined cancers of the oropharynx (throat) as including the base of the tongue (back third of the tongue), the soft palate, the tonsils, and the side and back walls of the throat.18 In our head and neck cancer cohort, patients with primary tumors of the oropharnyx were, perhaps, more susceptible to lymphedema (P = .044, Table 3). By contrast, in our cohort of patients, those with nasopharyngeal, hypopharyngeal, and parotid gland tumors were significantly less likely to develop lymphedema (Ps = .017, .04, .012, respectively).
No surgery
Half of our patients (n = 95) were not treated with surgery. In the patients who did not have surgery, 25 (26%) developed lymphedema, whereas 70 (74%) did not. Hence, although the incidence of lymphedema was significantly lower in patients who did not have surgery (P = .015), lymphedema did develop in patients who did not have a surgical procedure.
Resection of primary tumor without neck dissection
Of the 64 patients who had surgery, but without neck dissection, 35 (55%) developed external lymphedema. Compared with the no-surgery patients, the doubling of the incidence (from 26% to 55%) was highly significant (P = .0004). These findings are compatible with the literature reports that surgery increases the incidence of lymphedema, which is not surprising because surgery and subsequent scarring is known to compromise the lymphatic system.
Resection of primary tumor with neck dissection
The incidence of external lymphedema was increased to 69% when patients were subjected to both surgery and neck dissection. Compared with the June 2008-June 2015 cohort, there was a significant increase in the incidence of lymphedema in the neck dissection group (P = .007). Neck dissection involves the removal of lymph nodes and disruption of the lymphatic vessels, so it is not surprising that there is a higher incidence of external lymphedema. In our practice, neck dissections increased in frequency every year from June 2008 until December 2011, when 8 patients underwent neck dissections, 6 (75%) of whom developed lymphedema. Since January 2012, when the prehabilitation program was implemented, the number of neck dissections have declined, with more patients receiving chemoradiation and surgery being reserved for surgery. Hamoir and colleagues have reported that neck dissection is no longer justified unless there is clinically residual disease in the neck.19
Radiation
Lymphedema occurred in patients regardless of the dose of radiation received. Although the incidence of lymphedema seemed to be higher in patients who received more than 60 cGy, that difference was not statistically significant (Table 3). We had expected a relationship between radiation damage and greater lymphedema, but that was not evident in our patients.
Chemotherapy
The majority of patients (n = 131, 69%) received chemotherapy. The exposure to chemotherapy was not correlated with the risk of external lymphedema in our cohort of patients, with 58 of the 131 treated patients (44%) developing lymphedema, compared with 73 (56%) of treated patients who did not (Table 3).
Complete decongestive therapy
All patients with documented lymphedema were evaluated for complete decongestive therapy (CDT). Contraindications to CDT included congestive heart failure, renal failure, acute infection, peripheral artery disease, upper-quadrant deep vein thrombosis, and carotid artery stenosis. Eligible patients were referred to a certified lymphedema therapist for CDT. As the program evolved, patients at risk for lymphedema were referred for CDT early on, usually at the time of diagnosis, to improve early identification and surveillance of lymphedema.
CDT included manual lymph drainage, 
Patients’ responses to CDT were documented with digital photographs that were taken at each visit and, more recently, use of the NDI.
Communication and education
The head and neck cancer nurse navigator attends the cancer center’s multidisciplinary head and neck tumor board, which has representation from otolaryngology, diagnostic radiology, pathology, radiation oncology, medical oncology, reconstructive surgery, oncology rehabilitation (physical/occupational therapist), dietary services, speech pathology, social services and clinical research. This regular contact allows for earlier awareness about which patients are at greater risk for developing lymphedema, thus enabling early intervention (and patient education) in a timely manner.
Education of the patient, before cancer therapy, of the risks of lymphedema is very important. Before the implementation of the prehabilitation program, some patients did not fully comprehend what a painful and debilitating consequence of cancer treatment lymphedema could be.
Discussion
We introduced a prehabilitation program to detect and treat lymphedema in head and neck cancer patients in January 2012 part way through following an observation cohort from June2008 through June2015. Central to this, in our center, was the appointment of a nurse navigator whose primary focus was on head and neck cancer patients. We placed a high priority on the early detection and treatment of lymphedema because do so has been associated with better outcomes in other centers.
One immediate consequence of the inception of our program was the identification of more patients with external lymphedema. Our detected incidence rose significantly (P = .0002), from 27% in the period June 2008-December 20112010, before the program, to 48% during the January 2012-June 2015 period, after the inception of the program. This later incidence rate is in line with published incidence rates in most centers. However, it is still somewhat short of the 75% suggested in one center,9 which suggests we are either we are underdetecting lymphedema or there are differences in definition criteria or sensitivity levels for defining lymphedema. 
There are currently no specific objective measures of lymphedema, so there is bound to be some variation in diagnosis rates. In our program, we rely heavily on the patient-reported outcome measures, the NDI instrument, and digital photography to detect and monitor lymphedema, starting with the pretreatment baseline values that are established for each patient.
The use of digital photography in our community hospital setting, which includes taking photographs before and after treatment and at each visit, motivates and encourages patients and provides a tool for clinical lymphedema therapists to visually document benefits of treatment. Patients’ motivation and compliance with their established home program for head and neck lymphedema self-management are essential. The elements of the home program may include self-manual lymph drainage, home-modified compression bandaging and garment wear, therapeutic exercises, and skin care. Patients with lymphedema who adhered closely with their therapy program were more than 8 times more likely to improve compared with noncompliant patients.17
Some groups of patients have a greater risk of developing lymphedema than others,5 so the development of an algorithm to predict lymphedema seemed possible. However, in our cohort of patients, only neck dissection, with its disruption of the lymphatic system of the neck, was strongly associated with external lymphedema (Table 3). It is important to note that some patients who did not undergo surgery developed lymphedema. In our patients, high doses of radiation alone did not seem to predispose to lymphedema. That suggests that no group of head and neck cancer patients should be ignored, which is why we did routine screening of all patients before, during, and after treatment.
Our protocol falls short in the detection of internal lymphedema. For example, information on swallowing gathered by our speech pathologists (in a different department) has not, so far, been included in our assessment. This is one opportunity to improve on our approach, especially because speech difficulties may be associated with internal lymphedema. In addition, we are not equipped for the requisite internal examinations. Unfortunately, there are no practical and successful treatments for patients suffering from internal swelling. This represents a challenge for the medical community to better meet this need. Therefore, although we are missing some assessments of internal lymphedema, this is of little therapeutic consequence at this time.
The increase in the detected incidence of external lymphedema points to a practice gap that has been resolved by the appointment of a dedicated nurse navigator who attends oncology reviews to share knowledge and information. Another educational effort has been made with the patients themselves to increase compliance and improve continuous care at home.
There is always room for improvement, however, either by feedback acquired from other institutions and hospitals or through the future introduction of more objective assessment techniques.
Conclusions
The introduction of the prehabilitation program at our center has coincided with a significantly improved detection rate for external lymphedema in head and neck cancer patients. It may be because the program emphasizes education about lymphedema that awareness of the condition has increased throughout the center. It is now widely recognized that all patients are at risk of lymphedema regardless of whether they fall into an acknowledged high-risk group. Our experience shows that there is no significant difference between treatment modalities apart from neck dissection. In our population, the use of this procedure is decreasing. External lymphedema can develop even in patients who do not have surgery. Therefore, there is no sound way to predict which patients are most likely to suffer from the accumulation of fluid in their head and neck after treatment for head and neck cancer. Thus, an assessment as described here, during and after treatment for all patients, is warranted. Patients are now being seen earlier as a part of the prehabilitation program, which facilitates access to complete decongestive treatment at an earlier stage, improves patient outcomes, and increases patient satisfaction with their treatment. Our prehabilitation program could serve as a model for other community hospital centers in achieving outcomes that are as good as those in academic centers.
Acknowledgments 
The authors thank Irene Kadota and Heather Peters, from the Department of Radiation Oncology, and Julianne Courtenay, from the Department of Physical Therapy at the Disney Family Cancer Center, Burbank, California, for providing the original clinical data for analysis.
1. The National Lymphedema Medical Advisory Committee. The diagnosis and treatment of lymphedema. National Lymphedema Network. http://www.lymphnet.org/pdfDocs/nlntreatment.pdf. Updated February 2011. Accessed April 26, 2017.
2. McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Lymphedema following treatment for head and neck cancer: impact on patients, and beliefs of health professionals. Eur J Cancer Care (Engl). 2014;23(3):317-327.
3. Bhattacharyya N, Abemayor E. Patterns of hospital utilization for head and neck cancer care: changing demographics. JAMA Otolaryngol Head Neck Surg. 2015;141(4):307-312.
4. Deng J, Ridner SH, Dietrich MS, et al. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012;43(2):244-252.
5. Deng J, Ridner SH, Dietrich MS, et al. Factors associated with external and internal lymphedema in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2012;84(3):e319-328.
6. Flores AM, Spinelli BA, Eden MM, Galantino ML. EDGE task force on head and neck cancer outcomes: a systematic review of outcomes measures for quantifying external lymphedema. Rehabil Oncol. 2015;33(2):15-23.
7. Ridner SH, Doersam J, Galford E. An update on lymphedema of the head and neck. http://www.lymphnet.org/pdfDocs/Vol_28-N2_Update_HN.pdf. Published April-June 2015. Accessed April 26, 2017.
8. Smith BG, Hutcheson KA, Little LG, et al. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015;152(2);284-291.
9. Naqvi SHS, Karni RJ, Tan IC, et al. Int J Rad Oncol Biol Phys. 2016;4:927-928.
10. Deng J, Ridner SH, Aulino JM, Murphy BA. Assessment and measurement of head and neck lymphedema: state-of-the-science and future directions. Oral Oncol. 2015; 51(5):431-437.
11. Purcell A. Head and neck lymphedema management practices. J Lymphedema. 2013;8(2):8-15.
12. Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis treatment and impact: a review. J Clinl Oncol. 2012;30(30):3726-3733.
13. Quick DASH questionnaire. http://www.dash.iwh.on.ca/about-quickdash. [Last update not stated.] Accessed May 18, 2017.
14. Neck Disability Index questionnaire. www.aaos.org/uploadedFiles/NDI.pdf Accessed May 18, 2017.
15. Care Connections questionnaire. http://www.careconnections.com/.  Accessed May 18, 2017.
16. Galantino ML, Eden MM, Spinelli BA, Flores AM. EDGE task force on head and neck cancer outcomes a systematic review of outcome measures for temporomandibular-related dysfunction. Rehabil Oncol. 2015;33(1):6-14.
17. Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011;38(1):e1-e10.
18. What are oral cavity and oropharyngeal cancers? American Cancer Society. http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/oral-cavity-and-oropharyngeal-cancer-what-is-oral-cavity-cancer. Last revised August 8, 2016. Accessed April 26, 2017.
19. Hamoir M, Schmitz S, Gregoire V. The role of neck dissection in squamous cell carcinoma of the head and neck. Curr Treat Options Oncol. 2014;15:611-624.
Lymphedema is the swelling of tissue caused by the accumulation of interstitial fluid in any area of the body where lymphatic flow has been compromised.1 Secondary lymphedema is an acquired abnormality in lymph drainage1,2 and is the type commonly seen in cancer patients. Secondary lymphedema can be described as external or internal. Internal lymphedema, swelling of deep structures and tissues, is very difficult to quantify.
Lymphedema in patients with head and neck cancers
Lymphedema is a complicating morbidity frequently seen in head and neck cancer patients who have undergone treatment with surgery, radiation, and chemotherapy. However, although it is one of the most prevalent side effects of treatment, it is both under-recognized and under-treated.3
In head and neck cancer patients, internal swelling may develop in the soft tissues of the upper aero-digestive tract,4 affecting articulation and swallowing. Currently, there does not seem to be an effective practical and reliable tool with which to measure internal lymphedema. In addition, it is generally accepted that there is no effective way to treat internal lymphedema. By contrast, external lymphedema is more readily observed, but both subjective and objective assessments are difficult. External swelling may occur in the face, jaw, and neck. However, the subjective scales currently available are insufficient to capture very important characteristics of external lymphedema.5 The Edge Task Force on Head and Neck Cancer in 2015 was not able to recommend any outcome measures for objectively quantifying external edema.6 Furthermore, objective measurements of head and neck lymphedema can be expensive and time consuming.
Extent and risk
A combination of both internal and external swelling is seen in more than 50% of patients.7 Risk factors include “throat” tumors, multicancer treatment approaches, higher total radiation dose, a greater number of radiation procedures, and radiation at the surgical site.5 More than 500,000 survivors of head and neck cancer in the United States are at risk of lymphedema.5 Although recent advances in treatment have reduced the incidence of other morbidities, 50% of patients who are treated for head and neck cancer may still develop lymphedema.1,8 The reported incidence in some centers may be much higher, with up to 75% of patients developing lymphedema following treatment.9
Measurement modalities for clinical evaluation
There is little current research into lymphedema of the head and neck, despite the high prevalence of the condition.8 According to Deng and colleagues, measurement of head and neck lymphedema is a challenge, which has an impact on clinical assessment, diagnosis, and treatment of this under-recognized, under-reported and under-addressed problem in head and neck cancer patients.10 In a review of the literature, Deng and colleagues identified three measurement modalities available for clinical evaluation: patient-reported outcomes, clinician-reported outcomes, and technology.10 One major factor, though, in detecting lymphedema, is physician awareness: physicians, health care professionals, and even some lymphedema therapists are not well educated about this problem.8
Treatment
The effectiveness of traditional lymphedema treatment is not well defined.8 Currently, complete decongestive therapy (CDT), is considered the standard of care for lymphedema. The National Lymphedema Network has stated that modifications of CDT, especially manual lymphatic drainage and modified compressive garments for external lymphedema, have been shown to be beneficial for the treatment of lymphedema in head and neck cancer patients.11 Most findings in lymphedema research, mainly in breast cancer patients, have shown that early intervention is the best management and yields the best outcomes. As with other chronic conditions, early identification and timely, appropriate treatment of lymphedema is critical to improve clinical outcomes, to decrease symptom burden and functional impairment, and to improve overall quality of life in head and neck cancer patients.10
Improving recognition and treatment
Head and neck oncologic treatment is increasingly offered outside the network of specialist academic hospitals, at hospitals serving more localized communities where the neediest, sickest patient groups may be receiving less than optimal care.3 This challenges community hospitals to provide optimal treatment, similar to that being offered at nationally recognized institutions. In January 2012, we implemented a prehabilitation program in our community hospital cancer center to provide early intervention for our patients based on the understanding that proper and prompt treatment for patients with early signs of lymphedema should be a priority.12 In this article, we outline how we implemented the program and the describe improvements we observed before and after the implementation of the program.
The prehabilitation program
The role of the nurse navigator
Before the introduction of the prehabilitation program, our pattern of practice was to refer patients to oncology rehabilitation for lymphedema management after they had completed their medical treatment with surgery, radiation, and chemotherapy. In 2012, that was changed to a prehabilitation model of care that was overseen by a head and neck nurse navigator. This focus on prehabilitation begins with patients being referred to oncology rehabilitation at the time of cancer diagnosis for baseline assessment of head and neck swelling. In addition, there is assessment of the many possible other side effects associated with head and neck cancer and its treatment, namely loss of range of motion of the neck, jaw (trismus), and/or shoulders, postural deficits, functional loss, pain, balance dysfunction with fall risk, weakness, and fatigue. Therapeutic interventions are initiated as needed and appropriate. This process also raises awareness of a condition that has been described as under-recognized and under-treated.3
The nurse navigator sits in on each radiation oncology consultation and aids in “navigating” patients through their treatment. The nurse ensures that each patient is referred to different ancillary services from the outset, such as seeing a dietician, social worker, physical/occupational therapist and certified lymphedema therapist, speech pathologist, and financial assistance advisor, if necessary (Table 1).
Assessment of lymphedema
Measurement of head and neck lymphedema is a challenge.10 In our program, the physical therapy assessment also includes the evaluation of several other morbidities associated with head and neck cancer and its treatment, such as range of motion, weakness, fatigue, radiation fibrosis, balance dysfunction, and risk of falling (Table 2).
Patient-reported outcomes are essential to fully capture observable and unobservable symptoms (eg, sensations) as well as the functional impacts of lymphedema.10 In addition to lymphedema, there are many other morbidities that may be assessed on the basis of patient-reported outcome tools, such as upper extremity function with QuickDASH.13 At our clinic for head and neck cancer patients we use the Neck Disability Index (NDI)14 and Care Connections (CC)15 survey for the patient-reported outcomes. The Quick DASH, NDI, and CC tools all assess standard functional outcomes that are not specific to lymphedema, but are useful in documenting changes related to lymphedema. We initially used the CC survey and later transitioned to using the NDI. Neck pain is common with lymphedema in the head and neck region, and the NDI is a valid, reliable, responsive and internally consistent clinical tool to measure self-reported disability in patients with neck pain.16 These questionnaires were completed by the patients at their initial assessment, at reassessment, and at time of discharge.
Although objective criteria for external lymphedema have not been established, simple measurements such as using a tape measure to record neck circumference, allow a useful longitudinal assessment. Digital photography may be effective in the documentation and subjective evaluation of changes of external lymphedema.10,17 However, there are some limitations with photography because although external photographs (including digital photography and three-dimensional imaging) can capture some features, such as changes in contours, symmetry, and changes in skin quality and color, they do not detect changes in skin and soft tissue texture and compliance (Table 3).10
Impact on clinical outcomes
We retrospectively reviewed the medical records of 230 head and neck cancer patients who had been treated at our center between June 2008 and June 2015. Complete clinical data were available for 190 patients. The following information was extracted from each patient’s chart: whether they developed lymphedema, tumor stage, had surgery, radiation dose, type of chemotherapy given, their smoking history, if they had had a neck dissection and the primary site of the tumor (Table 3).
Incidence in different time periods. Of the 190 patients with complete records 78 (41%) were found to have lymphedema. These were all patients undergoing treatment for head and neck cancer during June 2008-June 2015. The prehabilitation program was initiated with the hiring of a nurse navigator for head and neck cancer, starting in January 2012. It is interesting to note that the incidence of lymphedema was 27% before the program was started, but after nurse navigator joined the team, the incidence increased significantly to 48% (P = .0002), in line with published expectations. This increase in recorded incidence may be attributable to the greater awareness of lymphedema intentionally fostered by the prehabilitation program.
Smoking history. Patients’ lifetime smoking history was retrieved from their medical records, based on their verbal admission of tobacco use. Most of the patients (n = 110) self-reported a history of smoking. Of those with a history of smoking, 36 (33%) developed external lymphedema after treatment for head and neck cancer, and 74 (67%) did not. However, this difference was not statistically significant. Hence, although smoking is a risk factor for head and neck cancer, it was not associated with the development of external lymphedema in our cohort of patients.
Type of tumor
Most of the patients (n = 156, 82%) had squamous cell carcinomas (SCC). Of those, 45% developed external lymphedema and 55% did not. Therefore, having SCC did not predispose to lymphedema. The other cancers were mixed type, mainly adenocaricoma, but their numbers were too small to draw statistical conclusions.
Stage of the tumor
About two thirds of the patients (n = 121, 64%) had stage 3 or 4 cancer. However, treatment of more advanced cancers was not associated with lymphedema development.
Site of the tumor
The literature suggests that patients with a primary tumor in the throat are at increased risk for lymphedema.5 The American Cancer Society has defined cancers of the oropharynx (throat) as including the base of the tongue (back third of the tongue), the soft palate, the tonsils, and the side and back walls of the throat.18 In our head and neck cancer cohort, patients with primary tumors of the oropharnyx were, perhaps, more susceptible to lymphedema (P = .044, Table 3). By contrast, in our cohort of patients, those with nasopharyngeal, hypopharyngeal, and parotid gland tumors were significantly less likely to develop lymphedema (Ps = .017, .04, .012, respectively).
No surgery
Half of our patients (n = 95) were not treated with surgery. In the patients who did not have surgery, 25 (26%) developed lymphedema, whereas 70 (74%) did not. Hence, although the incidence of lymphedema was significantly lower in patients who did not have surgery (P = .015), lymphedema did develop in patients who did not have a surgical procedure.
Resection of primary tumor without neck dissection
Of the 64 patients who had surgery, but without neck dissection, 35 (55%) developed external lymphedema. Compared with the no-surgery patients, the doubling of the incidence (from 26% to 55%) was highly significant (P = .0004). These findings are compatible with the literature reports that surgery increases the incidence of lymphedema, which is not surprising because surgery and subsequent scarring is known to compromise the lymphatic system.
Resection of primary tumor with neck dissection
The incidence of external lymphedema was increased to 69% when patients were subjected to both surgery and neck dissection. Compared with the June 2008-June 2015 cohort, there was a significant increase in the incidence of lymphedema in the neck dissection group (P = .007). Neck dissection involves the removal of lymph nodes and disruption of the lymphatic vessels, so it is not surprising that there is a higher incidence of external lymphedema. In our practice, neck dissections increased in frequency every year from June 2008 until December 2011, when 8 patients underwent neck dissections, 6 (75%) of whom developed lymphedema. Since January 2012, when the prehabilitation program was implemented, the number of neck dissections have declined, with more patients receiving chemoradiation and surgery being reserved for surgery. Hamoir and colleagues have reported that neck dissection is no longer justified unless there is clinically residual disease in the neck.19
Radiation
Lymphedema occurred in patients regardless of the dose of radiation received. Although the incidence of lymphedema seemed to be higher in patients who received more than 60 cGy, that difference was not statistically significant (Table 3). We had expected a relationship between radiation damage and greater lymphedema, but that was not evident in our patients.
Chemotherapy
The majority of patients (n = 131, 69%) received chemotherapy. The exposure to chemotherapy was not correlated with the risk of external lymphedema in our cohort of patients, with 58 of the 131 treated patients (44%) developing lymphedema, compared with 73 (56%) of treated patients who did not (Table 3).
Complete decongestive therapy
All patients with documented lymphedema were evaluated for complete decongestive therapy (CDT). Contraindications to CDT included congestive heart failure, renal failure, acute infection, peripheral artery disease, upper-quadrant deep vein thrombosis, and carotid artery stenosis. Eligible patients were referred to a certified lymphedema therapist for CDT. As the program evolved, patients at risk for lymphedema were referred for CDT early on, usually at the time of diagnosis, to improve early identification and surveillance of lymphedema.
CDT included manual lymph drainage, 
Patients’ responses to CDT were documented with digital photographs that were taken at each visit and, more recently, use of the NDI.
Communication and education
The head and neck cancer nurse navigator attends the cancer center’s multidisciplinary head and neck tumor board, which has representation from otolaryngology, diagnostic radiology, pathology, radiation oncology, medical oncology, reconstructive surgery, oncology rehabilitation (physical/occupational therapist), dietary services, speech pathology, social services and clinical research. This regular contact allows for earlier awareness about which patients are at greater risk for developing lymphedema, thus enabling early intervention (and patient education) in a timely manner.
Education of the patient, before cancer therapy, of the risks of lymphedema is very important. Before the implementation of the prehabilitation program, some patients did not fully comprehend what a painful and debilitating consequence of cancer treatment lymphedema could be.
Discussion
We introduced a prehabilitation program to detect and treat lymphedema in head and neck cancer patients in January 2012 part way through following an observation cohort from June2008 through June2015. Central to this, in our center, was the appointment of a nurse navigator whose primary focus was on head and neck cancer patients. We placed a high priority on the early detection and treatment of lymphedema because do so has been associated with better outcomes in other centers.
One immediate consequence of the inception of our program was the identification of more patients with external lymphedema. Our detected incidence rose significantly (P = .0002), from 27% in the period June 2008-December 20112010, before the program, to 48% during the January 2012-June 2015 period, after the inception of the program. This later incidence rate is in line with published incidence rates in most centers. However, it is still somewhat short of the 75% suggested in one center,9 which suggests we are either we are underdetecting lymphedema or there are differences in definition criteria or sensitivity levels for defining lymphedema. 
There are currently no specific objective measures of lymphedema, so there is bound to be some variation in diagnosis rates. In our program, we rely heavily on the patient-reported outcome measures, the NDI instrument, and digital photography to detect and monitor lymphedema, starting with the pretreatment baseline values that are established for each patient.
The use of digital photography in our community hospital setting, which includes taking photographs before and after treatment and at each visit, motivates and encourages patients and provides a tool for clinical lymphedema therapists to visually document benefits of treatment. Patients’ motivation and compliance with their established home program for head and neck lymphedema self-management are essential. The elements of the home program may include self-manual lymph drainage, home-modified compression bandaging and garment wear, therapeutic exercises, and skin care. Patients with lymphedema who adhered closely with their therapy program were more than 8 times more likely to improve compared with noncompliant patients.17
Some groups of patients have a greater risk of developing lymphedema than others,5 so the development of an algorithm to predict lymphedema seemed possible. However, in our cohort of patients, only neck dissection, with its disruption of the lymphatic system of the neck, was strongly associated with external lymphedema (Table 3). It is important to note that some patients who did not undergo surgery developed lymphedema. In our patients, high doses of radiation alone did not seem to predispose to lymphedema. That suggests that no group of head and neck cancer patients should be ignored, which is why we did routine screening of all patients before, during, and after treatment.
Our protocol falls short in the detection of internal lymphedema. For example, information on swallowing gathered by our speech pathologists (in a different department) has not, so far, been included in our assessment. This is one opportunity to improve on our approach, especially because speech difficulties may be associated with internal lymphedema. In addition, we are not equipped for the requisite internal examinations. Unfortunately, there are no practical and successful treatments for patients suffering from internal swelling. This represents a challenge for the medical community to better meet this need. Therefore, although we are missing some assessments of internal lymphedema, this is of little therapeutic consequence at this time.
The increase in the detected incidence of external lymphedema points to a practice gap that has been resolved by the appointment of a dedicated nurse navigator who attends oncology reviews to share knowledge and information. Another educational effort has been made with the patients themselves to increase compliance and improve continuous care at home.
There is always room for improvement, however, either by feedback acquired from other institutions and hospitals or through the future introduction of more objective assessment techniques.
Conclusions
The introduction of the prehabilitation program at our center has coincided with a significantly improved detection rate for external lymphedema in head and neck cancer patients. It may be because the program emphasizes education about lymphedema that awareness of the condition has increased throughout the center. It is now widely recognized that all patients are at risk of lymphedema regardless of whether they fall into an acknowledged high-risk group. Our experience shows that there is no significant difference between treatment modalities apart from neck dissection. In our population, the use of this procedure is decreasing. External lymphedema can develop even in patients who do not have surgery. Therefore, there is no sound way to predict which patients are most likely to suffer from the accumulation of fluid in their head and neck after treatment for head and neck cancer. Thus, an assessment as described here, during and after treatment for all patients, is warranted. Patients are now being seen earlier as a part of the prehabilitation program, which facilitates access to complete decongestive treatment at an earlier stage, improves patient outcomes, and increases patient satisfaction with their treatment. Our prehabilitation program could serve as a model for other community hospital centers in achieving outcomes that are as good as those in academic centers.
Acknowledgments 
The authors thank Irene Kadota and Heather Peters, from the Department of Radiation Oncology, and Julianne Courtenay, from the Department of Physical Therapy at the Disney Family Cancer Center, Burbank, California, for providing the original clinical data for analysis.
Lymphedema is the swelling of tissue caused by the accumulation of interstitial fluid in any area of the body where lymphatic flow has been compromised.1 Secondary lymphedema is an acquired abnormality in lymph drainage1,2 and is the type commonly seen in cancer patients. Secondary lymphedema can be described as external or internal. Internal lymphedema, swelling of deep structures and tissues, is very difficult to quantify.
Lymphedema in patients with head and neck cancers
Lymphedema is a complicating morbidity frequently seen in head and neck cancer patients who have undergone treatment with surgery, radiation, and chemotherapy. However, although it is one of the most prevalent side effects of treatment, it is both under-recognized and under-treated.3
In head and neck cancer patients, internal swelling may develop in the soft tissues of the upper aero-digestive tract,4 affecting articulation and swallowing. Currently, there does not seem to be an effective practical and reliable tool with which to measure internal lymphedema. In addition, it is generally accepted that there is no effective way to treat internal lymphedema. By contrast, external lymphedema is more readily observed, but both subjective and objective assessments are difficult. External swelling may occur in the face, jaw, and neck. However, the subjective scales currently available are insufficient to capture very important characteristics of external lymphedema.5 The Edge Task Force on Head and Neck Cancer in 2015 was not able to recommend any outcome measures for objectively quantifying external edema.6 Furthermore, objective measurements of head and neck lymphedema can be expensive and time consuming.
Extent and risk
A combination of both internal and external swelling is seen in more than 50% of patients.7 Risk factors include “throat” tumors, multicancer treatment approaches, higher total radiation dose, a greater number of radiation procedures, and radiation at the surgical site.5 More than 500,000 survivors of head and neck cancer in the United States are at risk of lymphedema.5 Although recent advances in treatment have reduced the incidence of other morbidities, 50% of patients who are treated for head and neck cancer may still develop lymphedema.1,8 The reported incidence in some centers may be much higher, with up to 75% of patients developing lymphedema following treatment.9
Measurement modalities for clinical evaluation
There is little current research into lymphedema of the head and neck, despite the high prevalence of the condition.8 According to Deng and colleagues, measurement of head and neck lymphedema is a challenge, which has an impact on clinical assessment, diagnosis, and treatment of this under-recognized, under-reported and under-addressed problem in head and neck cancer patients.10 In a review of the literature, Deng and colleagues identified three measurement modalities available for clinical evaluation: patient-reported outcomes, clinician-reported outcomes, and technology.10 One major factor, though, in detecting lymphedema, is physician awareness: physicians, health care professionals, and even some lymphedema therapists are not well educated about this problem.8
Treatment
The effectiveness of traditional lymphedema treatment is not well defined.8 Currently, complete decongestive therapy (CDT), is considered the standard of care for lymphedema. The National Lymphedema Network has stated that modifications of CDT, especially manual lymphatic drainage and modified compressive garments for external lymphedema, have been shown to be beneficial for the treatment of lymphedema in head and neck cancer patients.11 Most findings in lymphedema research, mainly in breast cancer patients, have shown that early intervention is the best management and yields the best outcomes. As with other chronic conditions, early identification and timely, appropriate treatment of lymphedema is critical to improve clinical outcomes, to decrease symptom burden and functional impairment, and to improve overall quality of life in head and neck cancer patients.10
Improving recognition and treatment
Head and neck oncologic treatment is increasingly offered outside the network of specialist academic hospitals, at hospitals serving more localized communities where the neediest, sickest patient groups may be receiving less than optimal care.3 This challenges community hospitals to provide optimal treatment, similar to that being offered at nationally recognized institutions. In January 2012, we implemented a prehabilitation program in our community hospital cancer center to provide early intervention for our patients based on the understanding that proper and prompt treatment for patients with early signs of lymphedema should be a priority.12 In this article, we outline how we implemented the program and the describe improvements we observed before and after the implementation of the program.
The prehabilitation program
The role of the nurse navigator
Before the introduction of the prehabilitation program, our pattern of practice was to refer patients to oncology rehabilitation for lymphedema management after they had completed their medical treatment with surgery, radiation, and chemotherapy. In 2012, that was changed to a prehabilitation model of care that was overseen by a head and neck nurse navigator. This focus on prehabilitation begins with patients being referred to oncology rehabilitation at the time of cancer diagnosis for baseline assessment of head and neck swelling. In addition, there is assessment of the many possible other side effects associated with head and neck cancer and its treatment, namely loss of range of motion of the neck, jaw (trismus), and/or shoulders, postural deficits, functional loss, pain, balance dysfunction with fall risk, weakness, and fatigue. Therapeutic interventions are initiated as needed and appropriate. This process also raises awareness of a condition that has been described as under-recognized and under-treated.3
The nurse navigator sits in on each radiation oncology consultation and aids in “navigating” patients through their treatment. The nurse ensures that each patient is referred to different ancillary services from the outset, such as seeing a dietician, social worker, physical/occupational therapist and certified lymphedema therapist, speech pathologist, and financial assistance advisor, if necessary (Table 1).
Assessment of lymphedema
Measurement of head and neck lymphedema is a challenge.10 In our program, the physical therapy assessment also includes the evaluation of several other morbidities associated with head and neck cancer and its treatment, such as range of motion, weakness, fatigue, radiation fibrosis, balance dysfunction, and risk of falling (Table 2).
Patient-reported outcomes are essential to fully capture observable and unobservable symptoms (eg, sensations) as well as the functional impacts of lymphedema.10 In addition to lymphedema, there are many other morbidities that may be assessed on the basis of patient-reported outcome tools, such as upper extremity function with QuickDASH.13 At our clinic for head and neck cancer patients we use the Neck Disability Index (NDI)14 and Care Connections (CC)15 survey for the patient-reported outcomes. The Quick DASH, NDI, and CC tools all assess standard functional outcomes that are not specific to lymphedema, but are useful in documenting changes related to lymphedema. We initially used the CC survey and later transitioned to using the NDI. Neck pain is common with lymphedema in the head and neck region, and the NDI is a valid, reliable, responsive and internally consistent clinical tool to measure self-reported disability in patients with neck pain.16 These questionnaires were completed by the patients at their initial assessment, at reassessment, and at time of discharge.
Although objective criteria for external lymphedema have not been established, simple measurements such as using a tape measure to record neck circumference, allow a useful longitudinal assessment. Digital photography may be effective in the documentation and subjective evaluation of changes of external lymphedema.10,17 However, there are some limitations with photography because although external photographs (including digital photography and three-dimensional imaging) can capture some features, such as changes in contours, symmetry, and changes in skin quality and color, they do not detect changes in skin and soft tissue texture and compliance (Table 3).10
Impact on clinical outcomes
We retrospectively reviewed the medical records of 230 head and neck cancer patients who had been treated at our center between June 2008 and June 2015. Complete clinical data were available for 190 patients. The following information was extracted from each patient’s chart: whether they developed lymphedema, tumor stage, had surgery, radiation dose, type of chemotherapy given, their smoking history, if they had had a neck dissection and the primary site of the tumor (Table 3).
Incidence in different time periods. Of the 190 patients with complete records 78 (41%) were found to have lymphedema. These were all patients undergoing treatment for head and neck cancer during June 2008-June 2015. The prehabilitation program was initiated with the hiring of a nurse navigator for head and neck cancer, starting in January 2012. It is interesting to note that the incidence of lymphedema was 27% before the program was started, but after nurse navigator joined the team, the incidence increased significantly to 48% (P = .0002), in line with published expectations. This increase in recorded incidence may be attributable to the greater awareness of lymphedema intentionally fostered by the prehabilitation program.
Smoking history. Patients’ lifetime smoking history was retrieved from their medical records, based on their verbal admission of tobacco use. Most of the patients (n = 110) self-reported a history of smoking. Of those with a history of smoking, 36 (33%) developed external lymphedema after treatment for head and neck cancer, and 74 (67%) did not. However, this difference was not statistically significant. Hence, although smoking is a risk factor for head and neck cancer, it was not associated with the development of external lymphedema in our cohort of patients.
Type of tumor
Most of the patients (n = 156, 82%) had squamous cell carcinomas (SCC). Of those, 45% developed external lymphedema and 55% did not. Therefore, having SCC did not predispose to lymphedema. The other cancers were mixed type, mainly adenocaricoma, but their numbers were too small to draw statistical conclusions.
Stage of the tumor
About two thirds of the patients (n = 121, 64%) had stage 3 or 4 cancer. However, treatment of more advanced cancers was not associated with lymphedema development.
Site of the tumor
The literature suggests that patients with a primary tumor in the throat are at increased risk for lymphedema.5 The American Cancer Society has defined cancers of the oropharynx (throat) as including the base of the tongue (back third of the tongue), the soft palate, the tonsils, and the side and back walls of the throat.18 In our head and neck cancer cohort, patients with primary tumors of the oropharnyx were, perhaps, more susceptible to lymphedema (P = .044, Table 3). By contrast, in our cohort of patients, those with nasopharyngeal, hypopharyngeal, and parotid gland tumors were significantly less likely to develop lymphedema (Ps = .017, .04, .012, respectively).
No surgery
Half of our patients (n = 95) were not treated with surgery. In the patients who did not have surgery, 25 (26%) developed lymphedema, whereas 70 (74%) did not. Hence, although the incidence of lymphedema was significantly lower in patients who did not have surgery (P = .015), lymphedema did develop in patients who did not have a surgical procedure.
Resection of primary tumor without neck dissection
Of the 64 patients who had surgery, but without neck dissection, 35 (55%) developed external lymphedema. Compared with the no-surgery patients, the doubling of the incidence (from 26% to 55%) was highly significant (P = .0004). These findings are compatible with the literature reports that surgery increases the incidence of lymphedema, which is not surprising because surgery and subsequent scarring is known to compromise the lymphatic system.
Resection of primary tumor with neck dissection
The incidence of external lymphedema was increased to 69% when patients were subjected to both surgery and neck dissection. Compared with the June 2008-June 2015 cohort, there was a significant increase in the incidence of lymphedema in the neck dissection group (P = .007). Neck dissection involves the removal of lymph nodes and disruption of the lymphatic vessels, so it is not surprising that there is a higher incidence of external lymphedema. In our practice, neck dissections increased in frequency every year from June 2008 until December 2011, when 8 patients underwent neck dissections, 6 (75%) of whom developed lymphedema. Since January 2012, when the prehabilitation program was implemented, the number of neck dissections have declined, with more patients receiving chemoradiation and surgery being reserved for surgery. Hamoir and colleagues have reported that neck dissection is no longer justified unless there is clinically residual disease in the neck.19
Radiation
Lymphedema occurred in patients regardless of the dose of radiation received. Although the incidence of lymphedema seemed to be higher in patients who received more than 60 cGy, that difference was not statistically significant (Table 3). We had expected a relationship between radiation damage and greater lymphedema, but that was not evident in our patients.
Chemotherapy
The majority of patients (n = 131, 69%) received chemotherapy. The exposure to chemotherapy was not correlated with the risk of external lymphedema in our cohort of patients, with 58 of the 131 treated patients (44%) developing lymphedema, compared with 73 (56%) of treated patients who did not (Table 3).
Complete decongestive therapy
All patients with documented lymphedema were evaluated for complete decongestive therapy (CDT). Contraindications to CDT included congestive heart failure, renal failure, acute infection, peripheral artery disease, upper-quadrant deep vein thrombosis, and carotid artery stenosis. Eligible patients were referred to a certified lymphedema therapist for CDT. As the program evolved, patients at risk for lymphedema were referred for CDT early on, usually at the time of diagnosis, to improve early identification and surveillance of lymphedema.
CDT included manual lymph drainage, 
Patients’ responses to CDT were documented with digital photographs that were taken at each visit and, more recently, use of the NDI.
Communication and education
The head and neck cancer nurse navigator attends the cancer center’s multidisciplinary head and neck tumor board, which has representation from otolaryngology, diagnostic radiology, pathology, radiation oncology, medical oncology, reconstructive surgery, oncology rehabilitation (physical/occupational therapist), dietary services, speech pathology, social services and clinical research. This regular contact allows for earlier awareness about which patients are at greater risk for developing lymphedema, thus enabling early intervention (and patient education) in a timely manner.
Education of the patient, before cancer therapy, of the risks of lymphedema is very important. Before the implementation of the prehabilitation program, some patients did not fully comprehend what a painful and debilitating consequence of cancer treatment lymphedema could be.
Discussion
We introduced a prehabilitation program to detect and treat lymphedema in head and neck cancer patients in January 2012 part way through following an observation cohort from June2008 through June2015. Central to this, in our center, was the appointment of a nurse navigator whose primary focus was on head and neck cancer patients. We placed a high priority on the early detection and treatment of lymphedema because do so has been associated with better outcomes in other centers.
One immediate consequence of the inception of our program was the identification of more patients with external lymphedema. Our detected incidence rose significantly (P = .0002), from 27% in the period June 2008-December 20112010, before the program, to 48% during the January 2012-June 2015 period, after the inception of the program. This later incidence rate is in line with published incidence rates in most centers. However, it is still somewhat short of the 75% suggested in one center,9 which suggests we are either we are underdetecting lymphedema or there are differences in definition criteria or sensitivity levels for defining lymphedema. 
There are currently no specific objective measures of lymphedema, so there is bound to be some variation in diagnosis rates. In our program, we rely heavily on the patient-reported outcome measures, the NDI instrument, and digital photography to detect and monitor lymphedema, starting with the pretreatment baseline values that are established for each patient.
The use of digital photography in our community hospital setting, which includes taking photographs before and after treatment and at each visit, motivates and encourages patients and provides a tool for clinical lymphedema therapists to visually document benefits of treatment. Patients’ motivation and compliance with their established home program for head and neck lymphedema self-management are essential. The elements of the home program may include self-manual lymph drainage, home-modified compression bandaging and garment wear, therapeutic exercises, and skin care. Patients with lymphedema who adhered closely with their therapy program were more than 8 times more likely to improve compared with noncompliant patients.17
Some groups of patients have a greater risk of developing lymphedema than others,5 so the development of an algorithm to predict lymphedema seemed possible. However, in our cohort of patients, only neck dissection, with its disruption of the lymphatic system of the neck, was strongly associated with external lymphedema (Table 3). It is important to note that some patients who did not undergo surgery developed lymphedema. In our patients, high doses of radiation alone did not seem to predispose to lymphedema. That suggests that no group of head and neck cancer patients should be ignored, which is why we did routine screening of all patients before, during, and after treatment.
Our protocol falls short in the detection of internal lymphedema. For example, information on swallowing gathered by our speech pathologists (in a different department) has not, so far, been included in our assessment. This is one opportunity to improve on our approach, especially because speech difficulties may be associated with internal lymphedema. In addition, we are not equipped for the requisite internal examinations. Unfortunately, there are no practical and successful treatments for patients suffering from internal swelling. This represents a challenge for the medical community to better meet this need. Therefore, although we are missing some assessments of internal lymphedema, this is of little therapeutic consequence at this time.
The increase in the detected incidence of external lymphedema points to a practice gap that has been resolved by the appointment of a dedicated nurse navigator who attends oncology reviews to share knowledge and information. Another educational effort has been made with the patients themselves to increase compliance and improve continuous care at home.
There is always room for improvement, however, either by feedback acquired from other institutions and hospitals or through the future introduction of more objective assessment techniques.
Conclusions
The introduction of the prehabilitation program at our center has coincided with a significantly improved detection rate for external lymphedema in head and neck cancer patients. It may be because the program emphasizes education about lymphedema that awareness of the condition has increased throughout the center. It is now widely recognized that all patients are at risk of lymphedema regardless of whether they fall into an acknowledged high-risk group. Our experience shows that there is no significant difference between treatment modalities apart from neck dissection. In our population, the use of this procedure is decreasing. External lymphedema can develop even in patients who do not have surgery. Therefore, there is no sound way to predict which patients are most likely to suffer from the accumulation of fluid in their head and neck after treatment for head and neck cancer. Thus, an assessment as described here, during and after treatment for all patients, is warranted. Patients are now being seen earlier as a part of the prehabilitation program, which facilitates access to complete decongestive treatment at an earlier stage, improves patient outcomes, and increases patient satisfaction with their treatment. Our prehabilitation program could serve as a model for other community hospital centers in achieving outcomes that are as good as those in academic centers.
Acknowledgments 
The authors thank Irene Kadota and Heather Peters, from the Department of Radiation Oncology, and Julianne Courtenay, from the Department of Physical Therapy at the Disney Family Cancer Center, Burbank, California, for providing the original clinical data for analysis.
1. The National Lymphedema Medical Advisory Committee. The diagnosis and treatment of lymphedema. National Lymphedema Network. http://www.lymphnet.org/pdfDocs/nlntreatment.pdf. Updated February 2011. Accessed April 26, 2017.
2. McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Lymphedema following treatment for head and neck cancer: impact on patients, and beliefs of health professionals. Eur J Cancer Care (Engl). 2014;23(3):317-327.
3. Bhattacharyya N, Abemayor E. Patterns of hospital utilization for head and neck cancer care: changing demographics. JAMA Otolaryngol Head Neck Surg. 2015;141(4):307-312.
4. Deng J, Ridner SH, Dietrich MS, et al. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012;43(2):244-252.
5. Deng J, Ridner SH, Dietrich MS, et al. Factors associated with external and internal lymphedema in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2012;84(3):e319-328.
6. Flores AM, Spinelli BA, Eden MM, Galantino ML. EDGE task force on head and neck cancer outcomes: a systematic review of outcomes measures for quantifying external lymphedema. Rehabil Oncol. 2015;33(2):15-23.
7. Ridner SH, Doersam J, Galford E. An update on lymphedema of the head and neck. http://www.lymphnet.org/pdfDocs/Vol_28-N2_Update_HN.pdf. Published April-June 2015. Accessed April 26, 2017.
8. Smith BG, Hutcheson KA, Little LG, et al. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015;152(2);284-291.
9. Naqvi SHS, Karni RJ, Tan IC, et al. Int J Rad Oncol Biol Phys. 2016;4:927-928.
10. Deng J, Ridner SH, Aulino JM, Murphy BA. Assessment and measurement of head and neck lymphedema: state-of-the-science and future directions. Oral Oncol. 2015; 51(5):431-437.
11. Purcell A. Head and neck lymphedema management practices. J Lymphedema. 2013;8(2):8-15.
12. Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis treatment and impact: a review. J Clinl Oncol. 2012;30(30):3726-3733.
13. Quick DASH questionnaire. http://www.dash.iwh.on.ca/about-quickdash. [Last update not stated.] Accessed May 18, 2017.
14. Neck Disability Index questionnaire. www.aaos.org/uploadedFiles/NDI.pdf Accessed May 18, 2017.
15. Care Connections questionnaire. http://www.careconnections.com/.  Accessed May 18, 2017.
16. Galantino ML, Eden MM, Spinelli BA, Flores AM. EDGE task force on head and neck cancer outcomes a systematic review of outcome measures for temporomandibular-related dysfunction. Rehabil Oncol. 2015;33(1):6-14.
17. Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011;38(1):e1-e10.
18. What are oral cavity and oropharyngeal cancers? American Cancer Society. http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/oral-cavity-and-oropharyngeal-cancer-what-is-oral-cavity-cancer. Last revised August 8, 2016. Accessed April 26, 2017.
19. Hamoir M, Schmitz S, Gregoire V. The role of neck dissection in squamous cell carcinoma of the head and neck. Curr Treat Options Oncol. 2014;15:611-624.
1. The National Lymphedema Medical Advisory Committee. The diagnosis and treatment of lymphedema. National Lymphedema Network. http://www.lymphnet.org/pdfDocs/nlntreatment.pdf. Updated February 2011. Accessed April 26, 2017.
2. McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Lymphedema following treatment for head and neck cancer: impact on patients, and beliefs of health professionals. Eur J Cancer Care (Engl). 2014;23(3):317-327.
3. Bhattacharyya N, Abemayor E. Patterns of hospital utilization for head and neck cancer care: changing demographics. JAMA Otolaryngol Head Neck Surg. 2015;141(4):307-312.
4. Deng J, Ridner SH, Dietrich MS, et al. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012;43(2):244-252.
5. Deng J, Ridner SH, Dietrich MS, et al. Factors associated with external and internal lymphedema in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2012;84(3):e319-328.
6. Flores AM, Spinelli BA, Eden MM, Galantino ML. EDGE task force on head and neck cancer outcomes: a systematic review of outcomes measures for quantifying external lymphedema. Rehabil Oncol. 2015;33(2):15-23.
7. Ridner SH, Doersam J, Galford E. An update on lymphedema of the head and neck. http://www.lymphnet.org/pdfDocs/Vol_28-N2_Update_HN.pdf. Published April-June 2015. Accessed April 26, 2017.
8. Smith BG, Hutcheson KA, Little LG, et al. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015;152(2);284-291.
9. Naqvi SHS, Karni RJ, Tan IC, et al. Int J Rad Oncol Biol Phys. 2016;4:927-928.
10. Deng J, Ridner SH, Aulino JM, Murphy BA. Assessment and measurement of head and neck lymphedema: state-of-the-science and future directions. Oral Oncol. 2015; 51(5):431-437.
11. Purcell A. Head and neck lymphedema management practices. J Lymphedema. 2013;8(2):8-15.
12. Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis treatment and impact: a review. J Clinl Oncol. 2012;30(30):3726-3733.
13. Quick DASH questionnaire. http://www.dash.iwh.on.ca/about-quickdash. [Last update not stated.] Accessed May 18, 2017.
14. Neck Disability Index questionnaire. www.aaos.org/uploadedFiles/NDI.pdf Accessed May 18, 2017.
15. Care Connections questionnaire. http://www.careconnections.com/.  Accessed May 18, 2017.
16. Galantino ML, Eden MM, Spinelli BA, Flores AM. EDGE task force on head and neck cancer outcomes a systematic review of outcome measures for temporomandibular-related dysfunction. Rehabil Oncol. 2015;33(1):6-14.
17. Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011;38(1):e1-e10.
18. What are oral cavity and oropharyngeal cancers? American Cancer Society. http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/detailedguide/oral-cavity-and-oropharyngeal-cancer-what-is-oral-cavity-cancer. Last revised August 8, 2016. Accessed April 26, 2017.
19. Hamoir M, Schmitz S, Gregoire V. The role of neck dissection in squamous cell carcinoma of the head and neck. Curr Treat Options Oncol. 2014;15:611-624.
Oncology and the heart
A typical example is a patient who had Hodgkin disease in his teens and received mediastinal mantle radiation. Fifteen to 25 years later, the patient has a pacemaker for heart block, coronary artery disease that requires a stent, and most recently has two valves replaced—so aortic and mitral valve replacement because of late radiation effects. This scenario is typical for the “old” days. The 20-year cumulative incidence of radiation-induced cardiac toxicity is 15%-20% (Table, Figure).1 Sitting with a patient about to begin chest radiation, the absolute risks are unknown but presumed to be less as treatment is delivered according to the modern techniques that you described in the question.
DH They’re so much better now, so this is less common.
JC With the shielding and breath-holding techniques and position changes, doing upright radiation rather than supine, and because the technology has improved both in the delivery of radiation and the technology in understanding where all the radiation is going, in today’s world, we can calculate pretty precisely how much radiation the heart actually receives. Ultimately, with the protective mechanisms that are in place going forward, the risks that I described for that survivor are probably exponentially less than what’s reported in the literature and what we see clinically. Radiation has become much, much safer. There is still probably some small risk of development of late changes, but I don’t think we know what that risk is today because the shielding and things we do to protect the heart have not yet been studied in the long term.
DH Of course, the patient is breathing and there’ll be some movement of the target. Some of the radiation techniques can follow the target despite the breathing?
JC Yes, definitely true. Radiation delivery is much more precise today. Not only has the delivery changed, but so has what we know about the location of potential arterial disease. For example, if you read any textbook, it says that for the coronaries, that it’s ostial and proximal disease of the left main, or the left anterior descending, or the right coronary artery. Today, somebody who gets chest/mediastinal radiation, for either breast cancer, lymphoma, or for a mediastinal tumor, the location of potential disease is more likely to mimic the location of classic coronary disease in the mid-portion of the left anterior descending artery rather than at the ostium. It’s going to be a different disease going forward.2,3
DH Let’s switch from radiation to chemotherapy. Of course, all of us worry about and are very familiar with the toxicity potential of doxorubicin and trastuzumab. I remember an American Society of Clinical Oncology meeting a few years ago, one of the speakers was a cardiologist and was advising us that perhaps the ejection fraction, albeit readily available and reproducible, was probably too simple and we should watch more closely with other techniques. My final question and then I’ll let you comment – I thought I recalled 5-fluorouracil (5-FU) infusions, which we do in some of our colorectal cancers, for example, can cause a vasospasm, Prinzmetal-type angina from time to time, and is that true in capecitabine? What are your thoughts on how to follow the doxorubicin, trastuzumab analogs, and anything about 5-FU and its analogs?
JC Okay, this is a giant question. I’ll take them in order. First, doxorubicin. Cumulative dose-related cardiotoxicity was first described by Von Hoff in 1979.4 That is, the more you get, the higher likelihood of developing cardiotoxicity. Up to a total of 400 mg/m2, the risk is <1%, with a sharp rise as the dose increases beyond this level.4 That being said, there is a clear large and individual variation: I’ve seen sarcoma patients who’ve gotten close to 1,000 mg/m2 without cardiac dysfunction, and some people with minimal exposure have full-blown cardiomyopathy. One of the protective strategies that we developed over the years is to give less of the drug, and with that get the same cancer treatment efficacy. There is definitely a risk for anthracyclines. Full-blown heart failure is probably in the 4%-8% range – and that’s cumulative lifetime – it’s not as high as we once thought it was. That doesn’t mean that it isn’t there, but, relatively speaking, from the standpoint of benefit of anthracyclines, the benefit certainly clearly outweighs the cardiac risk.
With administration of the anthracyclines, we try to do whatever protective things we can do. There are some people who believe that continuous infusion is safer for the heart than bolus injection. It’s pretty controversial. Dexrazoxane, which is a chelating agent, has been shown to reduce cardiotoxicity, and using a lipophilic anthracycline preparation may also have less cardiac toxicity.
DH I have a population in which a lot of liposomal doxorubicin is used and I’ve given a lot and rarely if ever get cardiac toxicity. You see that as well?
JC Yes. There’s a significant financial difference between doxorubicin and liposomal doxorubicin; the latter is more expensive. From the standpoint of safety, and from the standpoint of if I ever needed doxorubicin, I would probably jump on that and ask for the liposomal preparation and/or dexrazoxane.
DH For trastuzumab, we are getting echo- cardiograms every 9 weeks. That seems awfully simple, but there’s a whole algorithm we follow for particular change in ejection fraction and watch the drug or stop the drug. Are we doing that correctly?
JC The first statement I would make about that is that there are too many women who need trastuzumab whose therapy has been prematurely stopped because of just looking at the ejection fractions. So, there has to be more to decision-making other than just the number of the ejection fraction. We’re pretty aggressive and tend to try to get women to get the full dose and whatever dose-effective dose they need, especially with curative intent in the adjuvant setting that we make decisions based not only on the ejection fraction.
We also have, I would say, a handful of our medical breast oncologists who do not follow the package insert. We don’t get ejection fractions every 3 cycles. We have substituted a little bit by following biomarkers so that we use N-terminal pro b-type natriuretic peptide (NT-proBNP) to monitor people, either with each cycle or every third cycle. The benefit of BNP is its negative predictive value. If it’s normal, it’s hard to have any clinically significant myocardial dysfunction.
What we’re going to see over – I would hope – the next year or two is that the recommendations about getting echocardiograms frequently will go away.
 
DH That would be welcome because in our electronic medical records, it’s 9 weeks, stop, do this, etc. How about a comment on infusional 5-FU and possibly its cousins, such as capecitabine, and any coronary issues?
JC Let me come back, just one more thing about trastuzumab. For metastatic disease, we do whatever is necessary to continue effective cancer therapy and in the absence of any cardiac symptoms or abnormal physical findings, we continue cancer treatment without any serial echocardiographic monitoring.
DH You think the NT-proBNP might be useful? I know that’s excreted by the kidneys, so that might rise in renal failure, but we can adjust for that.
JC The negative predictive value of having a normal BNP is helpful. I think what I wanted to say was that screening echocardiograms and looking at ejection fraction in low-risk populations probably is clearly not cost-effective. It probably never alters decision making. If you have a 30-year-old person with no cardiac risk factors and no past cardiac history who develops B-cell lymphoma and is going to get anthracycline-based chemotherapy, the likelihood of finding a reason not to give that therapy based on an echocardiogram is quite small. I would even go further and say close to zero. We’ve begun to look at this. There is literature that supports the concept. Also, that in low-risk people – if you can define the low-risk population in an accurate way – for lymphoma patients or women with breast cancer getting either anthracyclines, trastuzumab, or the other human epidermal growth factor receptor-2 (HER2)-directed therapies, there’s probably little yield to even getting a baseline study.
DH Very interesting. I would agree with you.
JC We’re going to talk about 5-FU, of course. The 5-FU thing has become a passion of mine. Over the last two to two-and-a- half years we have gotten very aggressive with treating coronary spasm that’s induced by the fluoropyrimidines. That’s 5-FU and capecitabine, the oral version.
There is an incidence that the literature says is less than 1%. It probably is somewhere between 3% and 5%. It’s a little bit more common than has been reported. The reason is the way that it presents has classically been described in the literature as different than what occurs in real life. It is a phenomenon. It’s the most common cardiac side effect. Sometimes it is large epicardial coronary artery spasm. Sometimes it’s small vessel spasm. You can have chest pain with no electrocardiographic changes or ECG changes without chest pain (so-called silent ischemia). The description doesn’t always sound like classic angina but symptoms are temporally related to getting the drug.
So, we’ve developed a protocol to treat documented spasm as an outpatient to be able to continue those drugs to their logical conclusion from an oncologic standpoint. In fact, we just submitted a manuscript to the 
 
DH Finally, it occurred to me that we cause problems with radiation. We cause problems with chemotherapy and other infusions. Are there particular cancers that you think of or you’re called in to see that you worry about cardiac involvement by their location? What comes to mind are cases I’ve had in which there is pericardial involvement and tamponade or restrictive pericarditis. 
JC We see metastatic disease to the pericardium with breast cancer, lung cancer, and lymphoma. Renal cell has an interesting predilection to go to the pericardium. We’ve seen in the last probably 6 months 2 cases of bladder cancer with pericardial metastases. When we reviewed the literature, we were only able to find 9 or 10 case reports. It’s rare, but it occurs.
Fluid in the pericardium with and without tamponade is increasingly common, and because we do a better job in treating complicated cancer, people successively can receive cycles of sequential chemotherapeutic regimens – they are living longer, their cancer can get more complicated and/or resistant and with it, there’s more time for metastatic disease to occur. Tamponade is a common phenomenon. We always say that at 4 o’clock on Friday we always see somebody who has tamponade. We see a lot of pericardial disease.
Then, another area of a concern is the tyrosine kinase inhibitors that can cause hypertension, which is very common. We’ve become pretty aggressive. The oncologists recognize the importance of being able to follow and treat blood pressures to allow patients to get these treatments. I guess we couldn’t end without talking about checkpoint inhibitors and the recent lay press flurry about reporting myocarditis.
 
DH I haven’t personally experienced that. How common is that, and how do we watch for it?
JC Personally, I’ve seen probably four or five people who were referred because of heart failure on checkpoint inhibitors. For each of them, there was historically something as a preexisting problem before the checkpoint inhibitor. It was coincident that with either fluid changes or blood pressure changes associated with the treatment that they had a flare-up of heart failure.
We have not seen, fortunately, the dynamics that were reported in the 
 
DH Well, certainly with the proliferation of the checkpoint inhibitors, and so many different tumors, and so much widespread use, it looks like there is a small safety signal there but still yet to be defined. How common is that, and what should we watch for?
JC Actually, it’s serendipitous that yesterday I was walking to the parking lot with one of the nurse practitioners who takes care of the melanoma population. She said to me, “Now, do you think that we should be getting BNP levels on everybody who is getting a checkpoint inhibitor?”
I don’t think that we’re there. Just the awareness to ask the right questions when you see a patient and before starting ask, is this somebody who, in the absence of a checkpoint inhibitor, could be at risk for myocardial disease? Recognize that and use the cardiology and oncology community to work together and try to make sure that you do whatever cardioprotective things you can do and to monitor them a little bit more closely. I’m not sure that everybody who is going to start a checkpoint inhibitor needs a cardiac evaluation, doesn’t need an echocardiogram, and doesn’t need baseline biomarkers to decide if there’s a potential cardiotoxicity problem.
 
DH Well certainly, you’ve raised my awareness. It was not something that I had been thinking of with checkpoint inhibitors. Now, I certainly would if the patient has some comorbid illness that involves the heart, maybe think about it, wait to see how these reports develop, and what you and the registry do. 
JC You’ve seen people who get this sort of immunologic reaction that they require steroids for fluid accumulation, rash, or other things that are in this constellation. I wouldn’t be surprised if that group might have some subclinical myocarditis that just gets better when they get treated for the other things.
We have actually been trying to get a quick look at the left ventricle when patients on checkpoint inhibitors present with systemic, noncardiac symptoms to see if there is a cardiac signal we are missing. We have a handheld portable echocardiogram device called a Vscan (General Electric Company, Fairfield, CT). It’s not much bigger than the larger cellphones that are available. We’ve been going to the bedside when people have the reaction and sticking the transducer on to get a feeling of what the ventricle looks like. There’s a lot that we don’t know. It’s a fertile ground for investigation.
DH Well, I couldn’t ask you to end on a higher note than covering the checkpoint inhibitors, which are so popular and so interesting and used everywhere. We’re still managing that whole concept. I want to thank you very much.
JC It was a great pleasure. Thank you.
 
1. Galper SL, Yu JB, Mauch PM, et al. Clinically significant cardiac disease in patients with Hodgkin lymphoma treated with mediastinal irradiation. Blood. 2011;117(2):412-418.
2. Darby SC, Ewertz M, McGale P, et al. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013;368(11):987-998.
3. Specht L, Yahalom J, Illidge T, et al. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the International Lymphoma Radiation Oncology Group (ILROG). Int J Radiat Oncol Biol Phys. 2014;89(4):854-862.
4. Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979;91(5):710-717.
5. Johnson DB, Balko JM, Compton ML, et al. Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med. 2016;375(18):1749-1755.
A typical example is a patient who had Hodgkin disease in his teens and received mediastinal mantle radiation. Fifteen to 25 years later, the patient has a pacemaker for heart block, coronary artery disease that requires a stent, and most recently has two valves replaced—so aortic and mitral valve replacement because of late radiation effects. This scenario is typical for the “old” days. The 20-year cumulative incidence of radiation-induced cardiac toxicity is 15%-20% (Table, Figure).1 Sitting with a patient about to begin chest radiation, the absolute risks are unknown but presumed to be less as treatment is delivered according to the modern techniques that you described in the question.
DH They’re so much better now, so this is less common.
JC With the shielding and breath-holding techniques and position changes, doing upright radiation rather than supine, and because the technology has improved both in the delivery of radiation and the technology in understanding where all the radiation is going, in today’s world, we can calculate pretty precisely how much radiation the heart actually receives. Ultimately, with the protective mechanisms that are in place going forward, the risks that I described for that survivor are probably exponentially less than what’s reported in the literature and what we see clinically. Radiation has become much, much safer. There is still probably some small risk of development of late changes, but I don’t think we know what that risk is today because the shielding and things we do to protect the heart have not yet been studied in the long term.
DH Of course, the patient is breathing and there’ll be some movement of the target. Some of the radiation techniques can follow the target despite the breathing?
JC Yes, definitely true. Radiation delivery is much more precise today. Not only has the delivery changed, but so has what we know about the location of potential arterial disease. For example, if you read any textbook, it says that for the coronaries, that it’s ostial and proximal disease of the left main, or the left anterior descending, or the right coronary artery. Today, somebody who gets chest/mediastinal radiation, for either breast cancer, lymphoma, or for a mediastinal tumor, the location of potential disease is more likely to mimic the location of classic coronary disease in the mid-portion of the left anterior descending artery rather than at the ostium. It’s going to be a different disease going forward.2,3
DH Let’s switch from radiation to chemotherapy. Of course, all of us worry about and are very familiar with the toxicity potential of doxorubicin and trastuzumab. I remember an American Society of Clinical Oncology meeting a few years ago, one of the speakers was a cardiologist and was advising us that perhaps the ejection fraction, albeit readily available and reproducible, was probably too simple and we should watch more closely with other techniques. My final question and then I’ll let you comment – I thought I recalled 5-fluorouracil (5-FU) infusions, which we do in some of our colorectal cancers, for example, can cause a vasospasm, Prinzmetal-type angina from time to time, and is that true in capecitabine? What are your thoughts on how to follow the doxorubicin, trastuzumab analogs, and anything about 5-FU and its analogs?
JC Okay, this is a giant question. I’ll take them in order. First, doxorubicin. Cumulative dose-related cardiotoxicity was first described by Von Hoff in 1979.4 That is, the more you get, the higher likelihood of developing cardiotoxicity. Up to a total of 400 mg/m2, the risk is <1%, with a sharp rise as the dose increases beyond this level.4 That being said, there is a clear large and individual variation: I’ve seen sarcoma patients who’ve gotten close to 1,000 mg/m2 without cardiac dysfunction, and some people with minimal exposure have full-blown cardiomyopathy. One of the protective strategies that we developed over the years is to give less of the drug, and with that get the same cancer treatment efficacy. There is definitely a risk for anthracyclines. Full-blown heart failure is probably in the 4%-8% range – and that’s cumulative lifetime – it’s not as high as we once thought it was. That doesn’t mean that it isn’t there, but, relatively speaking, from the standpoint of benefit of anthracyclines, the benefit certainly clearly outweighs the cardiac risk.
With administration of the anthracyclines, we try to do whatever protective things we can do. There are some people who believe that continuous infusion is safer for the heart than bolus injection. It’s pretty controversial. Dexrazoxane, which is a chelating agent, has been shown to reduce cardiotoxicity, and using a lipophilic anthracycline preparation may also have less cardiac toxicity.
DH I have a population in which a lot of liposomal doxorubicin is used and I’ve given a lot and rarely if ever get cardiac toxicity. You see that as well?
JC Yes. There’s a significant financial difference between doxorubicin and liposomal doxorubicin; the latter is more expensive. From the standpoint of safety, and from the standpoint of if I ever needed doxorubicin, I would probably jump on that and ask for the liposomal preparation and/or dexrazoxane.
DH For trastuzumab, we are getting echo- cardiograms every 9 weeks. That seems awfully simple, but there’s a whole algorithm we follow for particular change in ejection fraction and watch the drug or stop the drug. Are we doing that correctly?
JC The first statement I would make about that is that there are too many women who need trastuzumab whose therapy has been prematurely stopped because of just looking at the ejection fractions. So, there has to be more to decision-making other than just the number of the ejection fraction. We’re pretty aggressive and tend to try to get women to get the full dose and whatever dose-effective dose they need, especially with curative intent in the adjuvant setting that we make decisions based not only on the ejection fraction.
We also have, I would say, a handful of our medical breast oncologists who do not follow the package insert. We don’t get ejection fractions every 3 cycles. We have substituted a little bit by following biomarkers so that we use N-terminal pro b-type natriuretic peptide (NT-proBNP) to monitor people, either with each cycle or every third cycle. The benefit of BNP is its negative predictive value. If it’s normal, it’s hard to have any clinically significant myocardial dysfunction.
What we’re going to see over – I would hope – the next year or two is that the recommendations about getting echocardiograms frequently will go away.
 
DH That would be welcome because in our electronic medical records, it’s 9 weeks, stop, do this, etc. How about a comment on infusional 5-FU and possibly its cousins, such as capecitabine, and any coronary issues?
JC Let me come back, just one more thing about trastuzumab. For metastatic disease, we do whatever is necessary to continue effective cancer therapy and in the absence of any cardiac symptoms or abnormal physical findings, we continue cancer treatment without any serial echocardiographic monitoring.
DH You think the NT-proBNP might be useful? I know that’s excreted by the kidneys, so that might rise in renal failure, but we can adjust for that.
JC The negative predictive value of having a normal BNP is helpful. I think what I wanted to say was that screening echocardiograms and looking at ejection fraction in low-risk populations probably is clearly not cost-effective. It probably never alters decision making. If you have a 30-year-old person with no cardiac risk factors and no past cardiac history who develops B-cell lymphoma and is going to get anthracycline-based chemotherapy, the likelihood of finding a reason not to give that therapy based on an echocardiogram is quite small. I would even go further and say close to zero. We’ve begun to look at this. There is literature that supports the concept. Also, that in low-risk people – if you can define the low-risk population in an accurate way – for lymphoma patients or women with breast cancer getting either anthracyclines, trastuzumab, or the other human epidermal growth factor receptor-2 (HER2)-directed therapies, there’s probably little yield to even getting a baseline study.
DH Very interesting. I would agree with you.
JC We’re going to talk about 5-FU, of course. The 5-FU thing has become a passion of mine. Over the last two to two-and-a- half years we have gotten very aggressive with treating coronary spasm that’s induced by the fluoropyrimidines. That’s 5-FU and capecitabine, the oral version.
There is an incidence that the literature says is less than 1%. It probably is somewhere between 3% and 5%. It’s a little bit more common than has been reported. The reason is the way that it presents has classically been described in the literature as different than what occurs in real life. It is a phenomenon. It’s the most common cardiac side effect. Sometimes it is large epicardial coronary artery spasm. Sometimes it’s small vessel spasm. You can have chest pain with no electrocardiographic changes or ECG changes without chest pain (so-called silent ischemia). The description doesn’t always sound like classic angina but symptoms are temporally related to getting the drug.
So, we’ve developed a protocol to treat documented spasm as an outpatient to be able to continue those drugs to their logical conclusion from an oncologic standpoint. In fact, we just submitted a manuscript to the 
 
DH Finally, it occurred to me that we cause problems with radiation. We cause problems with chemotherapy and other infusions. Are there particular cancers that you think of or you’re called in to see that you worry about cardiac involvement by their location? What comes to mind are cases I’ve had in which there is pericardial involvement and tamponade or restrictive pericarditis. 
JC We see metastatic disease to the pericardium with breast cancer, lung cancer, and lymphoma. Renal cell has an interesting predilection to go to the pericardium. We’ve seen in the last probably 6 months 2 cases of bladder cancer with pericardial metastases. When we reviewed the literature, we were only able to find 9 or 10 case reports. It’s rare, but it occurs.
Fluid in the pericardium with and without tamponade is increasingly common, and because we do a better job in treating complicated cancer, people successively can receive cycles of sequential chemotherapeutic regimens – they are living longer, their cancer can get more complicated and/or resistant and with it, there’s more time for metastatic disease to occur. Tamponade is a common phenomenon. We always say that at 4 o’clock on Friday we always see somebody who has tamponade. We see a lot of pericardial disease.
Then, another area of a concern is the tyrosine kinase inhibitors that can cause hypertension, which is very common. We’ve become pretty aggressive. The oncologists recognize the importance of being able to follow and treat blood pressures to allow patients to get these treatments. I guess we couldn’t end without talking about checkpoint inhibitors and the recent lay press flurry about reporting myocarditis.
 
DH I haven’t personally experienced that. How common is that, and how do we watch for it?
JC Personally, I’ve seen probably four or five people who were referred because of heart failure on checkpoint inhibitors. For each of them, there was historically something as a preexisting problem before the checkpoint inhibitor. It was coincident that with either fluid changes or blood pressure changes associated with the treatment that they had a flare-up of heart failure.
We have not seen, fortunately, the dynamics that were reported in the 
 
DH Well, certainly with the proliferation of the checkpoint inhibitors, and so many different tumors, and so much widespread use, it looks like there is a small safety signal there but still yet to be defined. How common is that, and what should we watch for?
JC Actually, it’s serendipitous that yesterday I was walking to the parking lot with one of the nurse practitioners who takes care of the melanoma population. She said to me, “Now, do you think that we should be getting BNP levels on everybody who is getting a checkpoint inhibitor?”
I don’t think that we’re there. Just the awareness to ask the right questions when you see a patient and before starting ask, is this somebody who, in the absence of a checkpoint inhibitor, could be at risk for myocardial disease? Recognize that and use the cardiology and oncology community to work together and try to make sure that you do whatever cardioprotective things you can do and to monitor them a little bit more closely. I’m not sure that everybody who is going to start a checkpoint inhibitor needs a cardiac evaluation, doesn’t need an echocardiogram, and doesn’t need baseline biomarkers to decide if there’s a potential cardiotoxicity problem.
 
DH Well certainly, you’ve raised my awareness. It was not something that I had been thinking of with checkpoint inhibitors. Now, I certainly would if the patient has some comorbid illness that involves the heart, maybe think about it, wait to see how these reports develop, and what you and the registry do. 
JC You’ve seen people who get this sort of immunologic reaction that they require steroids for fluid accumulation, rash, or other things that are in this constellation. I wouldn’t be surprised if that group might have some subclinical myocarditis that just gets better when they get treated for the other things.
We have actually been trying to get a quick look at the left ventricle when patients on checkpoint inhibitors present with systemic, noncardiac symptoms to see if there is a cardiac signal we are missing. We have a handheld portable echocardiogram device called a Vscan (General Electric Company, Fairfield, CT). It’s not much bigger than the larger cellphones that are available. We’ve been going to the bedside when people have the reaction and sticking the transducer on to get a feeling of what the ventricle looks like. There’s a lot that we don’t know. It’s a fertile ground for investigation.
DH Well, I couldn’t ask you to end on a higher note than covering the checkpoint inhibitors, which are so popular and so interesting and used everywhere. We’re still managing that whole concept. I want to thank you very much.
JC It was a great pleasure. Thank you.
 
A typical example is a patient who had Hodgkin disease in his teens and received mediastinal mantle radiation. Fifteen to 25 years later, the patient has a pacemaker for heart block, coronary artery disease that requires a stent, and most recently has two valves replaced—so aortic and mitral valve replacement because of late radiation effects. This scenario is typical for the “old” days. The 20-year cumulative incidence of radiation-induced cardiac toxicity is 15%-20% (Table, Figure).1 Sitting with a patient about to begin chest radiation, the absolute risks are unknown but presumed to be less as treatment is delivered according to the modern techniques that you described in the question.
DH They’re so much better now, so this is less common.
JC With the shielding and breath-holding techniques and position changes, doing upright radiation rather than supine, and because the technology has improved both in the delivery of radiation and the technology in understanding where all the radiation is going, in today’s world, we can calculate pretty precisely how much radiation the heart actually receives. Ultimately, with the protective mechanisms that are in place going forward, the risks that I described for that survivor are probably exponentially less than what’s reported in the literature and what we see clinically. Radiation has become much, much safer. There is still probably some small risk of development of late changes, but I don’t think we know what that risk is today because the shielding and things we do to protect the heart have not yet been studied in the long term.
DH Of course, the patient is breathing and there’ll be some movement of the target. Some of the radiation techniques can follow the target despite the breathing?
JC Yes, definitely true. Radiation delivery is much more precise today. Not only has the delivery changed, but so has what we know about the location of potential arterial disease. For example, if you read any textbook, it says that for the coronaries, that it’s ostial and proximal disease of the left main, or the left anterior descending, or the right coronary artery. Today, somebody who gets chest/mediastinal radiation, for either breast cancer, lymphoma, or for a mediastinal tumor, the location of potential disease is more likely to mimic the location of classic coronary disease in the mid-portion of the left anterior descending artery rather than at the ostium. It’s going to be a different disease going forward.2,3
DH Let’s switch from radiation to chemotherapy. Of course, all of us worry about and are very familiar with the toxicity potential of doxorubicin and trastuzumab. I remember an American Society of Clinical Oncology meeting a few years ago, one of the speakers was a cardiologist and was advising us that perhaps the ejection fraction, albeit readily available and reproducible, was probably too simple and we should watch more closely with other techniques. My final question and then I’ll let you comment – I thought I recalled 5-fluorouracil (5-FU) infusions, which we do in some of our colorectal cancers, for example, can cause a vasospasm, Prinzmetal-type angina from time to time, and is that true in capecitabine? What are your thoughts on how to follow the doxorubicin, trastuzumab analogs, and anything about 5-FU and its analogs?
JC Okay, this is a giant question. I’ll take them in order. First, doxorubicin. Cumulative dose-related cardiotoxicity was first described by Von Hoff in 1979.4 That is, the more you get, the higher likelihood of developing cardiotoxicity. Up to a total of 400 mg/m2, the risk is <1%, with a sharp rise as the dose increases beyond this level.4 That being said, there is a clear large and individual variation: I’ve seen sarcoma patients who’ve gotten close to 1,000 mg/m2 without cardiac dysfunction, and some people with minimal exposure have full-blown cardiomyopathy. One of the protective strategies that we developed over the years is to give less of the drug, and with that get the same cancer treatment efficacy. There is definitely a risk for anthracyclines. Full-blown heart failure is probably in the 4%-8% range – and that’s cumulative lifetime – it’s not as high as we once thought it was. That doesn’t mean that it isn’t there, but, relatively speaking, from the standpoint of benefit of anthracyclines, the benefit certainly clearly outweighs the cardiac risk.
With administration of the anthracyclines, we try to do whatever protective things we can do. There are some people who believe that continuous infusion is safer for the heart than bolus injection. It’s pretty controversial. Dexrazoxane, which is a chelating agent, has been shown to reduce cardiotoxicity, and using a lipophilic anthracycline preparation may also have less cardiac toxicity.
DH I have a population in which a lot of liposomal doxorubicin is used and I’ve given a lot and rarely if ever get cardiac toxicity. You see that as well?
JC Yes. There’s a significant financial difference between doxorubicin and liposomal doxorubicin; the latter is more expensive. From the standpoint of safety, and from the standpoint of if I ever needed doxorubicin, I would probably jump on that and ask for the liposomal preparation and/or dexrazoxane.
DH For trastuzumab, we are getting echo- cardiograms every 9 weeks. That seems awfully simple, but there’s a whole algorithm we follow for particular change in ejection fraction and watch the drug or stop the drug. Are we doing that correctly?
JC The first statement I would make about that is that there are too many women who need trastuzumab whose therapy has been prematurely stopped because of just looking at the ejection fractions. So, there has to be more to decision-making other than just the number of the ejection fraction. We’re pretty aggressive and tend to try to get women to get the full dose and whatever dose-effective dose they need, especially with curative intent in the adjuvant setting that we make decisions based not only on the ejection fraction.
We also have, I would say, a handful of our medical breast oncologists who do not follow the package insert. We don’t get ejection fractions every 3 cycles. We have substituted a little bit by following biomarkers so that we use N-terminal pro b-type natriuretic peptide (NT-proBNP) to monitor people, either with each cycle or every third cycle. The benefit of BNP is its negative predictive value. If it’s normal, it’s hard to have any clinically significant myocardial dysfunction.
What we’re going to see over – I would hope – the next year or two is that the recommendations about getting echocardiograms frequently will go away.
 
DH That would be welcome because in our electronic medical records, it’s 9 weeks, stop, do this, etc. How about a comment on infusional 5-FU and possibly its cousins, such as capecitabine, and any coronary issues?
JC Let me come back, just one more thing about trastuzumab. For metastatic disease, we do whatever is necessary to continue effective cancer therapy and in the absence of any cardiac symptoms or abnormal physical findings, we continue cancer treatment without any serial echocardiographic monitoring.
DH You think the NT-proBNP might be useful? I know that’s excreted by the kidneys, so that might rise in renal failure, but we can adjust for that.
JC The negative predictive value of having a normal BNP is helpful. I think what I wanted to say was that screening echocardiograms and looking at ejection fraction in low-risk populations probably is clearly not cost-effective. It probably never alters decision making. If you have a 30-year-old person with no cardiac risk factors and no past cardiac history who develops B-cell lymphoma and is going to get anthracycline-based chemotherapy, the likelihood of finding a reason not to give that therapy based on an echocardiogram is quite small. I would even go further and say close to zero. We’ve begun to look at this. There is literature that supports the concept. Also, that in low-risk people – if you can define the low-risk population in an accurate way – for lymphoma patients or women with breast cancer getting either anthracyclines, trastuzumab, or the other human epidermal growth factor receptor-2 (HER2)-directed therapies, there’s probably little yield to even getting a baseline study.
DH Very interesting. I would agree with you.
JC We’re going to talk about 5-FU, of course. The 5-FU thing has become a passion of mine. Over the last two to two-and-a- half years we have gotten very aggressive with treating coronary spasm that’s induced by the fluoropyrimidines. That’s 5-FU and capecitabine, the oral version.
There is an incidence that the literature says is less than 1%. It probably is somewhere between 3% and 5%. It’s a little bit more common than has been reported. The reason is the way that it presents has classically been described in the literature as different than what occurs in real life. It is a phenomenon. It’s the most common cardiac side effect. Sometimes it is large epicardial coronary artery spasm. Sometimes it’s small vessel spasm. You can have chest pain with no electrocardiographic changes or ECG changes without chest pain (so-called silent ischemia). The description doesn’t always sound like classic angina but symptoms are temporally related to getting the drug.
So, we’ve developed a protocol to treat documented spasm as an outpatient to be able to continue those drugs to their logical conclusion from an oncologic standpoint. In fact, we just submitted a manuscript to the 
 
DH Finally, it occurred to me that we cause problems with radiation. We cause problems with chemotherapy and other infusions. Are there particular cancers that you think of or you’re called in to see that you worry about cardiac involvement by their location? What comes to mind are cases I’ve had in which there is pericardial involvement and tamponade or restrictive pericarditis. 
JC We see metastatic disease to the pericardium with breast cancer, lung cancer, and lymphoma. Renal cell has an interesting predilection to go to the pericardium. We’ve seen in the last probably 6 months 2 cases of bladder cancer with pericardial metastases. When we reviewed the literature, we were only able to find 9 or 10 case reports. It’s rare, but it occurs.
Fluid in the pericardium with and without tamponade is increasingly common, and because we do a better job in treating complicated cancer, people successively can receive cycles of sequential chemotherapeutic regimens – they are living longer, their cancer can get more complicated and/or resistant and with it, there’s more time for metastatic disease to occur. Tamponade is a common phenomenon. We always say that at 4 o’clock on Friday we always see somebody who has tamponade. We see a lot of pericardial disease.
Then, another area of a concern is the tyrosine kinase inhibitors that can cause hypertension, which is very common. We’ve become pretty aggressive. The oncologists recognize the importance of being able to follow and treat blood pressures to allow patients to get these treatments. I guess we couldn’t end without talking about checkpoint inhibitors and the recent lay press flurry about reporting myocarditis.
 
DH I haven’t personally experienced that. How common is that, and how do we watch for it?
JC Personally, I’ve seen probably four or five people who were referred because of heart failure on checkpoint inhibitors. For each of them, there was historically something as a preexisting problem before the checkpoint inhibitor. It was coincident that with either fluid changes or blood pressure changes associated with the treatment that they had a flare-up of heart failure.
We have not seen, fortunately, the dynamics that were reported in the 
 
DH Well, certainly with the proliferation of the checkpoint inhibitors, and so many different tumors, and so much widespread use, it looks like there is a small safety signal there but still yet to be defined. How common is that, and what should we watch for?
JC Actually, it’s serendipitous that yesterday I was walking to the parking lot with one of the nurse practitioners who takes care of the melanoma population. She said to me, “Now, do you think that we should be getting BNP levels on everybody who is getting a checkpoint inhibitor?”
I don’t think that we’re there. Just the awareness to ask the right questions when you see a patient and before starting ask, is this somebody who, in the absence of a checkpoint inhibitor, could be at risk for myocardial disease? Recognize that and use the cardiology and oncology community to work together and try to make sure that you do whatever cardioprotective things you can do and to monitor them a little bit more closely. I’m not sure that everybody who is going to start a checkpoint inhibitor needs a cardiac evaluation, doesn’t need an echocardiogram, and doesn’t need baseline biomarkers to decide if there’s a potential cardiotoxicity problem.
 
DH Well certainly, you’ve raised my awareness. It was not something that I had been thinking of with checkpoint inhibitors. Now, I certainly would if the patient has some comorbid illness that involves the heart, maybe think about it, wait to see how these reports develop, and what you and the registry do. 
JC You’ve seen people who get this sort of immunologic reaction that they require steroids for fluid accumulation, rash, or other things that are in this constellation. I wouldn’t be surprised if that group might have some subclinical myocarditis that just gets better when they get treated for the other things.
We have actually been trying to get a quick look at the left ventricle when patients on checkpoint inhibitors present with systemic, noncardiac symptoms to see if there is a cardiac signal we are missing. We have a handheld portable echocardiogram device called a Vscan (General Electric Company, Fairfield, CT). It’s not much bigger than the larger cellphones that are available. We’ve been going to the bedside when people have the reaction and sticking the transducer on to get a feeling of what the ventricle looks like. There’s a lot that we don’t know. It’s a fertile ground for investigation.
DH Well, I couldn’t ask you to end on a higher note than covering the checkpoint inhibitors, which are so popular and so interesting and used everywhere. We’re still managing that whole concept. I want to thank you very much.
JC It was a great pleasure. Thank you.
 
1. Galper SL, Yu JB, Mauch PM, et al. Clinically significant cardiac disease in patients with Hodgkin lymphoma treated with mediastinal irradiation. Blood. 2011;117(2):412-418.
2. Darby SC, Ewertz M, McGale P, et al. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013;368(11):987-998.
3. Specht L, Yahalom J, Illidge T, et al. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the International Lymphoma Radiation Oncology Group (ILROG). Int J Radiat Oncol Biol Phys. 2014;89(4):854-862.
4. Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979;91(5):710-717.
5. Johnson DB, Balko JM, Compton ML, et al. Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med. 2016;375(18):1749-1755.
1. Galper SL, Yu JB, Mauch PM, et al. Clinically significant cardiac disease in patients with Hodgkin lymphoma treated with mediastinal irradiation. Blood. 2011;117(2):412-418.
2. Darby SC, Ewertz M, McGale P, et al. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013;368(11):987-998.
3. Specht L, Yahalom J, Illidge T, et al. Modern radiation therapy for Hodgkin lymphoma: field and dose guidelines from the International Lymphoma Radiation Oncology Group (ILROG). Int J Radiat Oncol Biol Phys. 2014;89(4):854-862.
4. Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979;91(5):710-717.
5. Johnson DB, Balko JM, Compton ML, et al. Fulminant myocarditis with combination immune checkpoint blockade. N Engl J Med. 2016;375(18):1749-1755.
Case Management Improves Quality of Life for Cancer Survivors
After cancer treatment, a new challenge emerges as patients negotiate reentry into their everyday lives. These patients often need multifaceted, simultaneous, and ongoing help with physical, emotional, and psychological issues. And they’re often dealing with a multiplicity of health care providers.
Researchers from University of Zurich and Centres for Addiction Medicine in Zurich, Switzerland, saw similarities between these needs and those of patients with chronic medical conditions. They hypothesized that case management—like that for chronic diseases—could work for cancer survivors perhaps even better than usual care. Among other duties, case managers can assess individual needs, identify barriers, ensure coordination among care providers, and perhaps most important, promote empowering self-management skills and self-efficacy. All of which could help cancer survivors cope with the long-term consequences of cancer and improve health-related quality of life (QOL).
Related: Putting the Focus on Quality of Life in Cancer Care
The researchers designed an intervention study in which 5 oncology nurse case managers met with 95 patients at least once a month for 3 months, then conducted telephone follow-ups for 9 months. Questionnaires measured health-related QOL at 12 months via the Functional Assessment of Cancer Therapy-General (FACT-G), self-efficacy, and concordance of received care with the Patient Assessment of Chronic Illness Care (PACIC).
Although the researchers’ study did not show a significant absolute difference between the groups in FACT-G after 12 months, all scores improved in the case management group compared with the usual care group. Overall, case management clearly boosted QOL and self-efficacy and aligned health care with the chronic care model.
Related: Quality of Supportive Care for Patients With Advanced Lung Cancer in the VHA
According to the researchers, their study is the first, to their knowledge, to examine the effect of case management on the QOL of early cancer survivors. Several factors help explain the intervention’s success: (1) The case managers provided important information on long-term symptoms and available services and therapies; (2) They offered a continuity of care when treatment appointments ceased and medical follow-up visits were less frequent; and (3) They offered support to cope with the psychological issues of the reentry phase.
All in all, the researchers say their findings show case management is a practical approach to bridging a “fragmented oncological health care system” and addressing the heterogenic needs of cancer survivors.
Source:
Scherz N, Bachmann-Mettler I, Chmiel C. BMC Cancer. 2017;17(1):223.
doi: 10.1186/s12885-017-3213-9.
After cancer treatment, a new challenge emerges as patients negotiate reentry into their everyday lives. These patients often need multifaceted, simultaneous, and ongoing help with physical, emotional, and psychological issues. And they’re often dealing with a multiplicity of health care providers.
Researchers from University of Zurich and Centres for Addiction Medicine in Zurich, Switzerland, saw similarities between these needs and those of patients with chronic medical conditions. They hypothesized that case management—like that for chronic diseases—could work for cancer survivors perhaps even better than usual care. Among other duties, case managers can assess individual needs, identify barriers, ensure coordination among care providers, and perhaps most important, promote empowering self-management skills and self-efficacy. All of which could help cancer survivors cope with the long-term consequences of cancer and improve health-related quality of life (QOL).
Related: Putting the Focus on Quality of Life in Cancer Care
The researchers designed an intervention study in which 5 oncology nurse case managers met with 95 patients at least once a month for 3 months, then conducted telephone follow-ups for 9 months. Questionnaires measured health-related QOL at 12 months via the Functional Assessment of Cancer Therapy-General (FACT-G), self-efficacy, and concordance of received care with the Patient Assessment of Chronic Illness Care (PACIC).
Although the researchers’ study did not show a significant absolute difference between the groups in FACT-G after 12 months, all scores improved in the case management group compared with the usual care group. Overall, case management clearly boosted QOL and self-efficacy and aligned health care with the chronic care model.
Related: Quality of Supportive Care for Patients With Advanced Lung Cancer in the VHA
According to the researchers, their study is the first, to their knowledge, to examine the effect of case management on the QOL of early cancer survivors. Several factors help explain the intervention’s success: (1) The case managers provided important information on long-term symptoms and available services and therapies; (2) They offered a continuity of care when treatment appointments ceased and medical follow-up visits were less frequent; and (3) They offered support to cope with the psychological issues of the reentry phase.
All in all, the researchers say their findings show case management is a practical approach to bridging a “fragmented oncological health care system” and addressing the heterogenic needs of cancer survivors.
Source:
Scherz N, Bachmann-Mettler I, Chmiel C. BMC Cancer. 2017;17(1):223.
doi: 10.1186/s12885-017-3213-9.
After cancer treatment, a new challenge emerges as patients negotiate reentry into their everyday lives. These patients often need multifaceted, simultaneous, and ongoing help with physical, emotional, and psychological issues. And they’re often dealing with a multiplicity of health care providers.
Researchers from University of Zurich and Centres for Addiction Medicine in Zurich, Switzerland, saw similarities between these needs and those of patients with chronic medical conditions. They hypothesized that case management—like that for chronic diseases—could work for cancer survivors perhaps even better than usual care. Among other duties, case managers can assess individual needs, identify barriers, ensure coordination among care providers, and perhaps most important, promote empowering self-management skills and self-efficacy. All of which could help cancer survivors cope with the long-term consequences of cancer and improve health-related quality of life (QOL).
Related: Putting the Focus on Quality of Life in Cancer Care
The researchers designed an intervention study in which 5 oncology nurse case managers met with 95 patients at least once a month for 3 months, then conducted telephone follow-ups for 9 months. Questionnaires measured health-related QOL at 12 months via the Functional Assessment of Cancer Therapy-General (FACT-G), self-efficacy, and concordance of received care with the Patient Assessment of Chronic Illness Care (PACIC).
Although the researchers’ study did not show a significant absolute difference between the groups in FACT-G after 12 months, all scores improved in the case management group compared with the usual care group. Overall, case management clearly boosted QOL and self-efficacy and aligned health care with the chronic care model.
Related: Quality of Supportive Care for Patients With Advanced Lung Cancer in the VHA
According to the researchers, their study is the first, to their knowledge, to examine the effect of case management on the QOL of early cancer survivors. Several factors help explain the intervention’s success: (1) The case managers provided important information on long-term symptoms and available services and therapies; (2) They offered a continuity of care when treatment appointments ceased and medical follow-up visits were less frequent; and (3) They offered support to cope with the psychological issues of the reentry phase.
All in all, the researchers say their findings show case management is a practical approach to bridging a “fragmented oncological health care system” and addressing the heterogenic needs of cancer survivors.
Source:
Scherz N, Bachmann-Mettler I, Chmiel C. BMC Cancer. 2017;17(1):223.
doi: 10.1186/s12885-017-3213-9.




















