Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

A version of this article first appeared on WebMD.com.

Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

A version of this article first appeared on WebMD.com.

Cancer dietitian Lisa Cianciotta often finds herself sitting across from a patient who suddenly fishes a bottle of antioxidant supplements from their bag and says, “My friend told me this works really well,” or “I read on the Internet that this is supposed to be really good for cancer.” 

Although taking an antioxidant pill sounds harmless, Ms. Cianciotta, a clinical dietitian who works with cancer patients at New York–Presbyterian Hospital, knows well that this popular dietary supplement can interfere with a patient’s radiation or chemotherapy.

But many patients with cancer believe these over-the-counter vitamins, minerals, or herbal remedies will help them, and most use at least one dietary supplement alongside their cancer treatment.

And that leaves Ms. Cianciotta with a delicate conversation ahead of her. 

Drug-supplement interactions are complex, often varying by supplement, cancer, and treatment type, and can do more harm than good. Popular dietary supplements may, for instance, cancel the effects of a cancer treatment, making it less effective, or increase serious side effects, such as liver toxicity. But in other cases, supplementation, such as vitamin D for patients who lack the vitamin, may be beneficial, Ms. Cianciotta said. 

These drug-supplement interactions can be hard to pinpoint, given that more than two-thirds of doctors don’t know their patients are using supplements.

Here’s what patients need to know about the potential risks of supplement use during treatment, and how oncologists can address this thorny, often poorly understood topic with patients.
 

The complex drug-supplement landscape

The list of dietary supplements and how they can interact with different treatments and cancer types is long and nuanced. 

But certain supplements appear to affect cancer treatments regardless of other things and should be avoided. Any supplement that strongly alters the body’s levels of the protein cytochromes P450 is one example. This group of enzymes plays a key role in metabolizing drugs, including chemotherapy and immunotherapy agents. 

Certain supplements – most notably St. John’s wort extract – may decrease or increase the activity of cytochrome P450, which can then  affect the concentrations of anticancer drugs in the blood, said William Figg, PharmD, an associate director of the Center for Cancer Research at the National Cancer Institute in Bethesda, Md. Studies show, for instance, that this common herbal supplement can increase the activity of cytochrome P450, resulting in lower levels of cancer drugs.

Outside of drug metabolism, patients with hormone-related cancers, such as breast and prostate cancers, should steer clear of dietary supplements that can alter levels of testosterone or estrogen, Dr. Figg said. The evergreen shrub ashwagandha, for example, is marketed to reduce stress and fatigue, but can also increase testosterone levels – a potential problem for those with prostate cancer receiving androgen deprivation therapy, which lowers testosterone levels. 

Many oncologists counsel patients against using antioxidant-based dietary supplements – particularly turmeric and green tea extract – while they have radiation therapy and certain chemotherapies. These therapies work by creating an abundance of highly reactive molecules called free radicals in tumor cells, which increase stress within these cells, ultimately killing them off. Antioxidants, in theory, can neutralize this effect, said Skyler Johnson, MD, a radiation oncologist at Huntsman Cancer Institute at the University of Utah, Salt Lake City.  Some studies suggest that antioxidant supplements may lessen the effects of radiation and chemotherapy, although the evidence is mixed.

Some dietary supplements, including high-dose green tea extract and vitamin A, can cause kidney or liver toxicity, and “many cancer patients already have compromised kidney or liver function,” said Jun J. Mao, MD, chief of integrative medicine at Memorial Sloan Kettering Cancer Center in New York. Even herbs that don’t interfere with how well a cancer drug works, such as stevia, can increase treatment-related side effects, such as nausea and vomiting. 

Another potential problem with dietary supplements: It’s nearly impossible to know exactly what’s in them. For instance, just last year, the Food and Drug Administration sent nearly 50 warning letters to companies marketing dietary supplements. The issue is that federal regulations governing production are less strict for supplements than for medications. As a result, some supplements contain ingredients not listed on the label. 

One historical example was the supplement PC-SPES, a mix of eight herbs, marketed to men with prostate cancer. The supplement was recalled in 2002 after certain batches were found to contain traces of prescription drugs, including diethylstilbestrol, ethinyl estradiol, warfarin, and alprazolam.

To further complicate matters, some dietary supplements can be helpful. Most patients with cancer “are malnourished and missing out on nutrients they could be getting from food,” said Ms. Cianciotta.

Patients are tested routinely for vitamin deficiencies and receive supplements as needed, she said. Vitamin D and folic acid are two of the most common deficiencies in this patient population. Vitamin D supplementation can improve outcomes in patients who have received a stem cell transplant by aiding engraftment and rebuilding the immune system, while folic acid supplementation can help to raise low red blood cell counts and hemoglobin levels. 

Although she rarely sees vitamin toxicity, Ms. Cianciotta stressed that more is not always better and supplement use, even when it seems safe or warranted due to a deficiency, should be taken under supervision, and monitored carefully by the patient’s care team. 
 

Bringing supplement use into the light

Too often, providers are unaware of a patient’s supplement use. 

A core reason: Dietary supplements are often touted as natural, which many patients equate with safety, said Samantha Heller, a senior clinical nutritionist at New York (N.Y.) University Langone Health. 

That means patients may not know a supplement can act like a drug and interfere with their cancer treatment, and thus may not see the importance of telling their doctors.

Still, the promise of herbs, vitamins, and minerals can be alluring, and there are many reasons patients decide to partake. One major appeal: Dietary supplements can help some patients feel empowered.

“Cancer is a disease that takes away a lot of control from the individual. Taking supplements or herbs is a way to regain some sense of control,” said Dr. Mao. 

The phenomenon can also be cultural, he said. Some people grow up taking herbs and supplements to stay healthy or combat health woes.

Pressure or advice from family or friends who may think they are helping a loved one with their dietary recommendations may play a role as well. Friends and family “cannot prescribe chemo, but they can buy herbs and supplements,” Dr. Mao said. 

Patients seeking greater control over their health or who feel high levels of anxiety may be more likely to take suggestions from friends and family or more likely to believe false or misleading claims about the efficacy or safety of supplements, explained  medical oncologist William Dahut, MD, chief scientific officer for the American Cancer Society. 

Plus, social media often amplifies and normalizes this misinformation, noted Dr. Johnson. In a 2021 study published in the Journal of the National Cancer Institute, he and colleagues found that one-third of the most popular articles on cancer treatment posted to social media in 2018 and 2019 contained false, inaccurate, or misleading information that was often harmful. 

Some of the false claims centered on unproven, potentially unsafe herbal remedies, according to Dr. Johnson. These included “lung cancer can be cured with cannabis oil” and “golden berries cure and prevent cancer.” 

Given exaggerated claims of “cures,” some patients may keep their supplement use under the radar out of fear they will be judged or criticized. 

“Clinicians should avoid making patients feel judged or telling people not to go online to do their own research,” Dr. Johnson said.

Guiding patients, instead, to accurate sources of online information may be one way to help patients feel empowered, he said. Cancer.gov and the Memorial Sloan Kettering Cancer Center’s About Herbs database provide accessible and accurate information on dietary supplements and cancer treatment for both health care professionals and patients, he noted. 

If a particular supplement is not safe during treatment, providers should be able to explain why, said  Ms. Cianciotta. In a recent study, 80% of health care providers surveyed believed that interactions between herbals and medications could be problematic, but only 15% could explain why. 

“Being able to explain why we are discouraging a particular supplement right now tends to be much better received than just telling a patient not to take something, because it is bad,” she said. 

Another key is listening closely to patients to understand why they may be taking a particular supplement. Does the patient feel out of control? Is nausea a problem? 

“Allowing patients to tell you why they are using a particular supplement will often reveal unmet needs or psychosocial challenges,” Dr. Mao said. This information can allow providers to suggest an evidence-based alternative, such as mindfulness meditation or acupuncture, to manage stress.

And if a patient has received a dietary supplement from well-meaning family and friends?

“Simply telling a patient that a given supplement is useless or harmful could create family tension,” said  Dr. Mao. 

Instead, he recommends reframing the issue. 

“We want to have a better understanding of how patients are tolerating chemo or immunotherapy before throwing other things on top of it. Let them know that now may just not be the right time to add a supplement to the mix,” Dr. Mao said. 

The bottom line: “Patients want to play an active role in their own care, and we want to help them do that in a safe way,” he said. 

A version of this article first appeared on WebMD.com.

ABSTRACT

Objective: Promoting a culture of safety is a critical component of improving health care quality. Recognizing staff who stop the line for safety can positively impact the growth of a culture of safety. The purpose of this initiative was to demonstrate to staff the importance of speaking up for safety and being acknowledged for doing so.

Methods: Following a review of the literature on safety awards programs and their role in promoting a culture of safety in health care covering the period 2017 to 2020, a formal process was developed and implemented to disseminate safety awards to employees.

Results: During the initial 18 months of the initiative, a total of 59 awards were presented. The awards were well received by the recipients and other staff members. Within this period, adjustments were made to enhance the scope and reach of the program.

Conclusion: Recognizing staff behaviors that support a culture of safety is important for improving health care quality and employee engagement. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Keywords: patient safety, culture of safety, incident reporting, near miss.

A key aspect of improving health care quality is promoting and sustaining a culture of safety in the workplace. Improving the quality of health care services and systems involves making informed choices regarding the types of strategies to implement.¹ An essential aspect of supporting a safety culture is safety-event reporting. To approach the goal of zero harm, all safety events, whether they result in actual harm or are considered near misses, need to be reported. Near-miss events are errors that occur while care is being provided but are detected and corrected before harm reaches the patient.^1-3 Near-miss reporting plays a critical role in helping to identify and correct weaknesses in health care delivery systems and processes.⁴ However, evidence shows that there are a multitude of barriers to the reporting of near-miss events, such as fear of punitive actions, additional workload, unsupportive work environments, a culture with poor psychological safety, knowledge deficit, and lack of recognition of staff who do report near misses.^4-11

According to The Joint Commission (TJC), acknowledging health care team members who recognize and report unsafe conditions that provide insight for improving patient safety is a key method for promoting the reporting of near-miss events.⁶ As a result, some health care organizations and patient safety agencies have started to institute some form of recognition for their employees in the realm of safety.^8-10 The Pennsylvania Patient Safety Authority offers exceptional guidance for creating a safety awards program to promote a culture of safety.¹² Furthermore, TJC supports recognizing individuals and health care teams who identify and report near misses, or who have suggestions for initiatives to promote patient safety, with “good catch” awards. Individuals or teams working to promote and sustain a culture of safety should be recognized for their efforts. Acknowledging “good catches” to reward the identification, communication, and resolution of safety issues is an effective strategy for improving patient safety and health care quality.^6,8

This quality improvement (QI) initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. If health care organizations want staff to be motivated to report near misses and improve safety and health care quality, the culture needs to shift from focusing on blame to incentivizing individuals and teams to speak up when they have concerns.^8-10 Although deciding which safety actions are worthy of recognition can be challenging, recognizing all safe acts, regardless of how big or small they are perceived to be, is important. This QI initiative aimed to establish a tiered approach to recognize staff members for various categories of safety acts.

METHODS

A review of the literature from January 2017 to May 2020 for peer-reviewed publications regarding how other organizations implemented safety award programs to promote a culture of safety resulted in a dearth of evidence. This prompted us at the Veterans Affairs Connecticut Healthcare System to develop and implement a formal program to disseminate safety awards to employees.

Program Launch and Promotion

In 2020, our institution embarked on a journey to high reliability with the goal of approaching zero harm. As part of efforts to promote a culture of safety, the hospital’s High Reliability Organization (HRO) team worked to develop a safety awards recognition program. Prior to the launch, the hospital’s patient safety committee recognized staff members through the medical center safety event reporting system (the Joint Patient Safety Reporting system [JPSR]) or through direct communication with staff members on safety actions they were engaged in. JPSR is the Veterans Health Administration National Center for Patient Safety incident reporting system for reporting, tracking, and trending of patient incidents in a national database. The award consisted of a certificate presented by the patient safety committee chairpersons to the employee in front of their peers in their respective work area. Hospital leadership was not involved in the safety awards recognition program at that time. No nomination process existed prior to our QI launch.

Once the QI initiative was launched and marketed heavily at staff meetings, we started to receive nominations for actions that were truly exceptional, while many others were submitted for behaviors that were within the day-to-day scope of practice of the staff member. For those early nominations that did not meet criteria for an award, we thanked staff for their submissions with a gentle statement that their nomination did not meet the criteria for an award. After following this practice for a few weeks, we became concerned that if we did not acknowledge the staff who came forward to request recognition for their routine work that supported safety, we could risk losing their engagement in a culture of safety. As such, we decided to create 3 levels of awards to recognize behaviors that went above and beyond while also acknowledging staff for actions within their scope of practice. Additionally, hospital leadership wanted to ensure that all staff recognize that their safety efforts are valued by leadership and that that sense of value will hopefully contribute to a culture of safety over time.

Initially, the single award system was called the “Good Catch Award” to acknowledge staff who go above and beyond to speak up and take action when they have safety concerns. This particular recognition includes a certificate, an encased baseball card that has been personalized by including the staff member’s picture and safety event identified, a stress-release baseball, and a stick of Bazooka gum (similar to what used to come in baseball cards packs). The award is presented to employees in their work area by the HRO and patient safety teams and includes representatives from the executive leadership team (ELT). The safety event identified is described by an ELT member, and all items are presented to the employee. Participation by the leadership team communicates how much the work being done to promote a culture of safety and advance quality health care is appreciated. This action also encourages others in the organization to identify and report safety concerns.¹³

With the rollout of the QI initiative, the volume of nominations submitted quickly increased (eg, approximately 1 every 2 months before to 3 per month following implementation). Frequently, nominations were for actions believed to be within the scope of the employee’s responsibilities. Our institution’s leadership team quickly recognized that, as an organization, not diminishing the importance of the “Good Catch Award” was important. However, the leadership team also wanted to encourage nominations from employees that involved safety issues that were part of the employee’s scope of responsibilities. As a result, 2 additional and equally notable award tiers were established, with specific criteria created for each.¹⁴ The addition of the other awards was instrumental in getting the leadership team to feel confident that all staff were being recognized for their commitment to patient safety.

The original Good Catch Award was labelled as a Level 1 award. The Level 2 safety recognition award, named the HRO Safety Champion Award, is given to employees who stop the line for a safety concern within their scope of practice and also participate as part of a team to investigate and improve processes to avoid recurring safety concerns in the future. For the Level Two award, a certificate is presented to an employee by the hospital’s HRO lead, HRO physician champion, patient safety manager, immediate supervisor, and peers. With the Level 3 award, the Culture of Safety Appreciation Award, individuals are recognized for addressing safety concerns within their assigned scope of responsibilities. Recognition is bestowed by an email of appreciation sent to the employee, acknowledging their commitment to promoting a culture of safety and quality health care. The recipient’s direct supervisor and other hospital leaders are copied on the message.¹⁴ See Table 1 for a comparison of awards.

Our institution’s HRO and patient safety teams utilized many additional venues to disseminate information regarding awardees and their actions. These included our monthly HRO newsletter, monthly safety forums, and biweekly Team Connecticut Healthcare system-wide huddles.

Nomination Process

Awards nominations are submitted via the hospital intranet homepage, where there is an “HRO Safety Award Nomination” icon. Once a staff member clicks the icon, a template opens asking for information, such as the reason for the nomination submission, and then walks them through the template using the CAR (C-context, A-actions, and R-results)¹⁵ format for describing the situation, identifying actions taken, and specifying the outcome of the action. Emails with award nominations can also be sent to the HRO lead, HRO champion, or Patient Safety Committee co-chairs. Calls for nominations are made at several venues attended by employees as well as supervisors. These include monthly safety forums, biweekly Team Connecticut Healthcare system-wide huddles, supervisory staff meetings, department and unit-based staff meetings, and many other formal and informal settings. This QI initiative has allowed us to capture potential awardees through several avenues, including self-nominations. All nominations are reviewed by a safety awards committee. Each committee member ranks the nomination as a Level 1, 2, or 3 award. For nominations where conflicting scores are obtained, the committee discusses the nomination together to resolve discrepancies.

Needed Resources

Material resources required for this QI initiative include certificate paper, plastic baseball card sleeves, stress-release baseballs, and Bazooka gum. The largest resource investment was the time needed to support the initiative. This included the time spent scheduling the Level 1 and 2 award presentations with staff and leadership. Time was also required to put the individual award packages together, which included printing the paper certificates, obtaining awardee pictures, placing them with their safety stories in a plastic baseball card sleeve, and arranging for the hospital photographer to take pictures of the awardees with their peers and leaders.

RESULTS

Prior to this QI initiative launch, 14 awards were given out over the preceding 2-year period. During the initial 18 months of the initiative (December 2020 to June 2022), 59 awards were presented (Level 1, n = 26; Level 2, n = 22; and Level 3, n = 11). Looking further into the Level 1 awards presented, 25 awardees worked in clinical roles and 1 in a nonclinical position (Table 2). The awardees represented multidisciplinary areas, including medical/surgical (med/surg) inpatient units, anesthesia, operating room, pharmacy, mental health clinics, surgical intensive care, specialty care clinics, and nutrition and food services. With the Level 2 awards, 18 clinical staff and 4 nonclinical staff received awards from the areas of med/surg inpatient, outpatient surgical suites, the medical center director’s office, radiology, pharmacy, primary care, facilities management, environmental management, infection prevention, and emergency services. All Level 3 awardees were from clinical areas, including primary care, hospital education, sterile processing, pharmacies, operating rooms, and med/surg inpatient units.

With the inception of this QI initiative, our organization has begun to see trends reflecting increased reporting of both actual and close-call events in JPSR (Figure 1).

With the inclusion of information regarding awardees and their actions in monthly safety forums, attendance at these forums has increased from an average of 64 attendees per month in 2021 to an average of 131 attendees per month in 2022 (Figure 2).

Finally, our organization’s annual All-Employee Survey results have shown incremental increases in staff reporting feeling psychologically safe and not fearing reprisal (Figure 3). It is important to note that there may be other contributing factors to these incremental changes.

Stories From the 3 Award Categories

Level 1 – Good Catch Award. M.S. was assigned as a continuous safety monitor, or “sitter,” on one of the med/surg inpatient units. M.S. arrived at the bedside and asked for a report on the patient at a change in shift. The report stated that the patient was sleeping and had not moved in a while. M.S. set about to perform the functions of a sitter and did her usual tasks in cleaning and tidying the room for the patient for breakfast and taking care of all items in the room, in general. M.S. introduced herself to the patient, who she thought might wake up because of her speaking to him. She thought the patient was in an odd position, and knowing that a patient should be a little further up in the bed, she tried with touch to awaken him to adjust his position. M.S. found that the patient was rather chilly to the touch and immediately became concerned. She continued to attempt to rouse the patient. M.S. called for the nurse and began to adjust the patient’s position. M.S. insisted that the patient was cold and “something was wrong.” A set of vitals was taken and a rapid response team code was called. The patient was immediately transferred to the intensive care unit to receive a higher level of care. If not for the diligence and caring attitude of M.S., this patient may have had a very poor outcome.

Reason for criteria being met: The scope of practice of a sitter is to be present in a patient’s room to monitor for falls and overall safety. This employee noticed that the patient was not responsive to verbal or tactile stimuli. Her immediate reporting of her concern to the nurse resulted in prompt intervention. If she had let the patient be, the patient could have died. The staff member went above and beyond by speaking up and taking action when she had a patient safety concern.

Level 2 – HRO Safety Champion Award. A patient presented to an outpatient clinic for monoclonal antibody (mAb) therapy for a COVID-19 infection; the treatment has been scheduled by the patient’s primary care provider. At that time, outpatient mAb therapy was the recommended care option for patients stable enough to receive treatment in this setting, but it is contraindicated in patients who are too unstable to receive mAb therapy in an outpatient setting, such as those with increased oxygen demands. R.L., a staff nurse, assessed the patient on arrival and found that his vital signs were stable, except for a slightly elevated respiratory rate. Upon questioning, the patient reported that he had increased his oxygen use at home from 2 to 4 L via a nasal cannula. R.L. assessed that the patient was too high-risk for outpatient mAb therapy and had the patient checked into the emergency department (ED) to receive a full diagnostic workup and evaluation by Dr. W., an ED provider. The patient required admission to the hospital for a higher level of care in an inpatient unit because of severe COVID-19 infection. Within 48 hours of admission, the patient’s condition further declined, requiring an upgrade to the medical intensive care unit with progressive interventions. Owing to the clinical assessment skills and prompt action of R.L., the patient was admitted to the hospital instead of receiving treatment in a suboptimal care setting and returning home. Had the patient gone home, his rapid decline could have had serious consequences.

Reason for criteria being met: On a cursory look, the patient may have passed as someone sufficiently stable to undergo outpatient treatment. However, the nurse stopped the line, paid close attention, and picked up on an abnormal vital sign and the projected consequences. The nurse brought the patient to a higher level of care in the ED so that he could get the attention he needed. If this patient was given mAb therapy in the outpatient setting, he would have been discharged and become sicker with the COVID-19 illness. As a result of this incident, R.L. is working with the outpatient clinic and ED staff to enahance triage and evaluation of patients referred for outpatient therapy for COVID-19 infections to prevent a similar event from recurring.

Level 3 – Culture of Safety Appreciation Award. While C.C. was reviewing the hazardous item competencies of the acute psychiatric inpatient staff, it was learned that staff were sniffing patients’ personal items to see if they were “safe” and free from alcohol. This is a potentially dangerous practice, and if fentanyl is present, it can be life-threatening. All patients admitted to acute inpatient psychiatry have all their clothing and personal items checked for hazardous items—pockets are emptied, soles of shoes are lifted, and so on. Staff wear personal protective equipment during this process to mitigate any powders or other harmful substances being inhaled or coming in contact with their skin or clothes. The gloves can be punctured if needles are found in the patient’s belongings. C.C. not only educated the staff on the dangers of sniffing for alcohol during hazardous-item checks, but also looked for further potential safety concerns. An additional identified risk was for needle sticks when such items were found in a patient’s belongings. C.C.’s recommendations included best practices to allow only unopened personal items and have available hospital-issued products as needed. C.C. remembered having a conversation with an employee from the psychiatric emergency room regarding the purchase of puncture-proof gloves to mitigate puncture sticks. C.C. recommended that the same gloves be used by staff on the acute inpatient psychiatry unit during searches for hazardous items.

Reason for criteria being met: The employee works in the hospital education department. It is within her scope of responsibilities to provide ongoing education to staff in order to address potential safety concerns.

DISCUSSION

This QI initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety and advancing quality health care, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. As part of efforts to continuously build on a safety-first culture, transparency and celebration of successes were demonstrated. This QI initiative demonstrated that a diverse and wide range of employees were reached, from clinical to nonclinical staff, and frontline to supervisory staff, as all were included in the recognition process. While many award nominations were received through the submission of safety concerns to the high-reliability team and patient safety office, several came directly from staff who wanted to recognize their peers for their work, supporting a culture of safety. This showed that staff felt that taking the time to submit a write-up to recognize a peer was an important task. Achieving zero harm for patients and staff alike is a top priority for our institution and guides all decisions, which reinforces that everyone has a responsibility to ensure that safety is always the first consideration. A culture of safety is enhanced by staff recognition. This QI initiative also showed that staff felt valued when they were acknowledged, regardless of the level of recognition they received. The theme of feeling valued came from unsolicited feedback. For example, some direct comments from awardees are presented in the Box.

In addition to endorsing the importance of safe practices to staff, safety award programs can identify gaps in existing standard procedures that can be updated quickly and shared broadly across a health care organization. The authors observed that the existence of the award program gives staff permission to use their voice to speak up when they have questions or concerns related to safety and to proactively engage in safety practices; a cultural shift of this kind informs safety practices and procedures and contributes to a more inspiring workplace. Staff at our organization who have received any of the safety awards, and those who are aware of these awards, have embraced the program readily. At the time of submission of this manuscript, there was a relative paucity of published literature on the details, performance, and impact of such programs. This initiative aims to share a road map highlighting the various dimensions of staff recognition and how the program supports our health care system in fostering a strong, sustainable culture of safety and health care quality. A next step is to formally assess the impact of the awards program on our culture of safety and quality using a psychometrically sound measurement tool, as recommended by TJC,¹⁶ such as the Hospital Survey on Patient Safety Culture.^17,18

CONCLUSION

A health care organization safety awards program is a strategy for building and sustaining a culture of safety. This QI initiative may be valuable to other organizations in the process of establishing a safety awards program of their own. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel Street, Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

ABSTRACT

Objective: Promoting a culture of safety is a critical component of improving health care quality. Recognizing staff who stop the line for safety can positively impact the growth of a culture of safety. The purpose of this initiative was to demonstrate to staff the importance of speaking up for safety and being acknowledged for doing so.

Methods: Following a review of the literature on safety awards programs and their role in promoting a culture of safety in health care covering the period 2017 to 2020, a formal process was developed and implemented to disseminate safety awards to employees.

Results: During the initial 18 months of the initiative, a total of 59 awards were presented. The awards were well received by the recipients and other staff members. Within this period, adjustments were made to enhance the scope and reach of the program.

Conclusion: Recognizing staff behaviors that support a culture of safety is important for improving health care quality and employee engagement. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Keywords: patient safety, culture of safety, incident reporting, near miss.

A key aspect of improving health care quality is promoting and sustaining a culture of safety in the workplace. Improving the quality of health care services and systems involves making informed choices regarding the types of strategies to implement.¹ An essential aspect of supporting a safety culture is safety-event reporting. To approach the goal of zero harm, all safety events, whether they result in actual harm or are considered near misses, need to be reported. Near-miss events are errors that occur while care is being provided but are detected and corrected before harm reaches the patient.^1-3 Near-miss reporting plays a critical role in helping to identify and correct weaknesses in health care delivery systems and processes.⁴ However, evidence shows that there are a multitude of barriers to the reporting of near-miss events, such as fear of punitive actions, additional workload, unsupportive work environments, a culture with poor psychological safety, knowledge deficit, and lack of recognition of staff who do report near misses.^4-11

According to The Joint Commission (TJC), acknowledging health care team members who recognize and report unsafe conditions that provide insight for improving patient safety is a key method for promoting the reporting of near-miss events.⁶ As a result, some health care organizations and patient safety agencies have started to institute some form of recognition for their employees in the realm of safety.^8-10 The Pennsylvania Patient Safety Authority offers exceptional guidance for creating a safety awards program to promote a culture of safety.¹² Furthermore, TJC supports recognizing individuals and health care teams who identify and report near misses, or who have suggestions for initiatives to promote patient safety, with “good catch” awards. Individuals or teams working to promote and sustain a culture of safety should be recognized for their efforts. Acknowledging “good catches” to reward the identification, communication, and resolution of safety issues is an effective strategy for improving patient safety and health care quality.^6,8

This quality improvement (QI) initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. If health care organizations want staff to be motivated to report near misses and improve safety and health care quality, the culture needs to shift from focusing on blame to incentivizing individuals and teams to speak up when they have concerns.^8-10 Although deciding which safety actions are worthy of recognition can be challenging, recognizing all safe acts, regardless of how big or small they are perceived to be, is important. This QI initiative aimed to establish a tiered approach to recognize staff members for various categories of safety acts.

METHODS

A review of the literature from January 2017 to May 2020 for peer-reviewed publications regarding how other organizations implemented safety award programs to promote a culture of safety resulted in a dearth of evidence. This prompted us at the Veterans Affairs Connecticut Healthcare System to develop and implement a formal program to disseminate safety awards to employees.

Program Launch and Promotion

In 2020, our institution embarked on a journey to high reliability with the goal of approaching zero harm. As part of efforts to promote a culture of safety, the hospital’s High Reliability Organization (HRO) team worked to develop a safety awards recognition program. Prior to the launch, the hospital’s patient safety committee recognized staff members through the medical center safety event reporting system (the Joint Patient Safety Reporting system [JPSR]) or through direct communication with staff members on safety actions they were engaged in. JPSR is the Veterans Health Administration National Center for Patient Safety incident reporting system for reporting, tracking, and trending of patient incidents in a national database. The award consisted of a certificate presented by the patient safety committee chairpersons to the employee in front of their peers in their respective work area. Hospital leadership was not involved in the safety awards recognition program at that time. No nomination process existed prior to our QI launch.

Once the QI initiative was launched and marketed heavily at staff meetings, we started to receive nominations for actions that were truly exceptional, while many others were submitted for behaviors that were within the day-to-day scope of practice of the staff member. For those early nominations that did not meet criteria for an award, we thanked staff for their submissions with a gentle statement that their nomination did not meet the criteria for an award. After following this practice for a few weeks, we became concerned that if we did not acknowledge the staff who came forward to request recognition for their routine work that supported safety, we could risk losing their engagement in a culture of safety. As such, we decided to create 3 levels of awards to recognize behaviors that went above and beyond while also acknowledging staff for actions within their scope of practice. Additionally, hospital leadership wanted to ensure that all staff recognize that their safety efforts are valued by leadership and that that sense of value will hopefully contribute to a culture of safety over time.

Initially, the single award system was called the “Good Catch Award” to acknowledge staff who go above and beyond to speak up and take action when they have safety concerns. This particular recognition includes a certificate, an encased baseball card that has been personalized by including the staff member’s picture and safety event identified, a stress-release baseball, and a stick of Bazooka gum (similar to what used to come in baseball cards packs). The award is presented to employees in their work area by the HRO and patient safety teams and includes representatives from the executive leadership team (ELT). The safety event identified is described by an ELT member, and all items are presented to the employee. Participation by the leadership team communicates how much the work being done to promote a culture of safety and advance quality health care is appreciated. This action also encourages others in the organization to identify and report safety concerns.¹³

With the rollout of the QI initiative, the volume of nominations submitted quickly increased (eg, approximately 1 every 2 months before to 3 per month following implementation). Frequently, nominations were for actions believed to be within the scope of the employee’s responsibilities. Our institution’s leadership team quickly recognized that, as an organization, not diminishing the importance of the “Good Catch Award” was important. However, the leadership team also wanted to encourage nominations from employees that involved safety issues that were part of the employee’s scope of responsibilities. As a result, 2 additional and equally notable award tiers were established, with specific criteria created for each.¹⁴ The addition of the other awards was instrumental in getting the leadership team to feel confident that all staff were being recognized for their commitment to patient safety.

The original Good Catch Award was labelled as a Level 1 award. The Level 2 safety recognition award, named the HRO Safety Champion Award, is given to employees who stop the line for a safety concern within their scope of practice and also participate as part of a team to investigate and improve processes to avoid recurring safety concerns in the future. For the Level Two award, a certificate is presented to an employee by the hospital’s HRO lead, HRO physician champion, patient safety manager, immediate supervisor, and peers. With the Level 3 award, the Culture of Safety Appreciation Award, individuals are recognized for addressing safety concerns within their assigned scope of responsibilities. Recognition is bestowed by an email of appreciation sent to the employee, acknowledging their commitment to promoting a culture of safety and quality health care. The recipient’s direct supervisor and other hospital leaders are copied on the message.¹⁴ See Table 1 for a comparison of awards.

Our institution’s HRO and patient safety teams utilized many additional venues to disseminate information regarding awardees and their actions. These included our monthly HRO newsletter, monthly safety forums, and biweekly Team Connecticut Healthcare system-wide huddles.

Nomination Process

Awards nominations are submitted via the hospital intranet homepage, where there is an “HRO Safety Award Nomination” icon. Once a staff member clicks the icon, a template opens asking for information, such as the reason for the nomination submission, and then walks them through the template using the CAR (C-context, A-actions, and R-results)¹⁵ format for describing the situation, identifying actions taken, and specifying the outcome of the action. Emails with award nominations can also be sent to the HRO lead, HRO champion, or Patient Safety Committee co-chairs. Calls for nominations are made at several venues attended by employees as well as supervisors. These include monthly safety forums, biweekly Team Connecticut Healthcare system-wide huddles, supervisory staff meetings, department and unit-based staff meetings, and many other formal and informal settings. This QI initiative has allowed us to capture potential awardees through several avenues, including self-nominations. All nominations are reviewed by a safety awards committee. Each committee member ranks the nomination as a Level 1, 2, or 3 award. For nominations where conflicting scores are obtained, the committee discusses the nomination together to resolve discrepancies.

Needed Resources

Material resources required for this QI initiative include certificate paper, plastic baseball card sleeves, stress-release baseballs, and Bazooka gum. The largest resource investment was the time needed to support the initiative. This included the time spent scheduling the Level 1 and 2 award presentations with staff and leadership. Time was also required to put the individual award packages together, which included printing the paper certificates, obtaining awardee pictures, placing them with their safety stories in a plastic baseball card sleeve, and arranging for the hospital photographer to take pictures of the awardees with their peers and leaders.

RESULTS

Prior to this QI initiative launch, 14 awards were given out over the preceding 2-year period. During the initial 18 months of the initiative (December 2020 to June 2022), 59 awards were presented (Level 1, n = 26; Level 2, n = 22; and Level 3, n = 11). Looking further into the Level 1 awards presented, 25 awardees worked in clinical roles and 1 in a nonclinical position (Table 2). The awardees represented multidisciplinary areas, including medical/surgical (med/surg) inpatient units, anesthesia, operating room, pharmacy, mental health clinics, surgical intensive care, specialty care clinics, and nutrition and food services. With the Level 2 awards, 18 clinical staff and 4 nonclinical staff received awards from the areas of med/surg inpatient, outpatient surgical suites, the medical center director’s office, radiology, pharmacy, primary care, facilities management, environmental management, infection prevention, and emergency services. All Level 3 awardees were from clinical areas, including primary care, hospital education, sterile processing, pharmacies, operating rooms, and med/surg inpatient units.

With the inception of this QI initiative, our organization has begun to see trends reflecting increased reporting of both actual and close-call events in JPSR (Figure 1).

With the inclusion of information regarding awardees and their actions in monthly safety forums, attendance at these forums has increased from an average of 64 attendees per month in 2021 to an average of 131 attendees per month in 2022 (Figure 2).

Finally, our organization’s annual All-Employee Survey results have shown incremental increases in staff reporting feeling psychologically safe and not fearing reprisal (Figure 3). It is important to note that there may be other contributing factors to these incremental changes.

Stories From the 3 Award Categories

Level 1 – Good Catch Award. M.S. was assigned as a continuous safety monitor, or “sitter,” on one of the med/surg inpatient units. M.S. arrived at the bedside and asked for a report on the patient at a change in shift. The report stated that the patient was sleeping and had not moved in a while. M.S. set about to perform the functions of a sitter and did her usual tasks in cleaning and tidying the room for the patient for breakfast and taking care of all items in the room, in general. M.S. introduced herself to the patient, who she thought might wake up because of her speaking to him. She thought the patient was in an odd position, and knowing that a patient should be a little further up in the bed, she tried with touch to awaken him to adjust his position. M.S. found that the patient was rather chilly to the touch and immediately became concerned. She continued to attempt to rouse the patient. M.S. called for the nurse and began to adjust the patient’s position. M.S. insisted that the patient was cold and “something was wrong.” A set of vitals was taken and a rapid response team code was called. The patient was immediately transferred to the intensive care unit to receive a higher level of care. If not for the diligence and caring attitude of M.S., this patient may have had a very poor outcome.

Reason for criteria being met: The scope of practice of a sitter is to be present in a patient’s room to monitor for falls and overall safety. This employee noticed that the patient was not responsive to verbal or tactile stimuli. Her immediate reporting of her concern to the nurse resulted in prompt intervention. If she had let the patient be, the patient could have died. The staff member went above and beyond by speaking up and taking action when she had a patient safety concern.

Level 2 – HRO Safety Champion Award. A patient presented to an outpatient clinic for monoclonal antibody (mAb) therapy for a COVID-19 infection; the treatment has been scheduled by the patient’s primary care provider. At that time, outpatient mAb therapy was the recommended care option for patients stable enough to receive treatment in this setting, but it is contraindicated in patients who are too unstable to receive mAb therapy in an outpatient setting, such as those with increased oxygen demands. R.L., a staff nurse, assessed the patient on arrival and found that his vital signs were stable, except for a slightly elevated respiratory rate. Upon questioning, the patient reported that he had increased his oxygen use at home from 2 to 4 L via a nasal cannula. R.L. assessed that the patient was too high-risk for outpatient mAb therapy and had the patient checked into the emergency department (ED) to receive a full diagnostic workup and evaluation by Dr. W., an ED provider. The patient required admission to the hospital for a higher level of care in an inpatient unit because of severe COVID-19 infection. Within 48 hours of admission, the patient’s condition further declined, requiring an upgrade to the medical intensive care unit with progressive interventions. Owing to the clinical assessment skills and prompt action of R.L., the patient was admitted to the hospital instead of receiving treatment in a suboptimal care setting and returning home. Had the patient gone home, his rapid decline could have had serious consequences.

Reason for criteria being met: On a cursory look, the patient may have passed as someone sufficiently stable to undergo outpatient treatment. However, the nurse stopped the line, paid close attention, and picked up on an abnormal vital sign and the projected consequences. The nurse brought the patient to a higher level of care in the ED so that he could get the attention he needed. If this patient was given mAb therapy in the outpatient setting, he would have been discharged and become sicker with the COVID-19 illness. As a result of this incident, R.L. is working with the outpatient clinic and ED staff to enahance triage and evaluation of patients referred for outpatient therapy for COVID-19 infections to prevent a similar event from recurring.

Level 3 – Culture of Safety Appreciation Award. While C.C. was reviewing the hazardous item competencies of the acute psychiatric inpatient staff, it was learned that staff were sniffing patients’ personal items to see if they were “safe” and free from alcohol. This is a potentially dangerous practice, and if fentanyl is present, it can be life-threatening. All patients admitted to acute inpatient psychiatry have all their clothing and personal items checked for hazardous items—pockets are emptied, soles of shoes are lifted, and so on. Staff wear personal protective equipment during this process to mitigate any powders or other harmful substances being inhaled or coming in contact with their skin or clothes. The gloves can be punctured if needles are found in the patient’s belongings. C.C. not only educated the staff on the dangers of sniffing for alcohol during hazardous-item checks, but also looked for further potential safety concerns. An additional identified risk was for needle sticks when such items were found in a patient’s belongings. C.C.’s recommendations included best practices to allow only unopened personal items and have available hospital-issued products as needed. C.C. remembered having a conversation with an employee from the psychiatric emergency room regarding the purchase of puncture-proof gloves to mitigate puncture sticks. C.C. recommended that the same gloves be used by staff on the acute inpatient psychiatry unit during searches for hazardous items.

Reason for criteria being met: The employee works in the hospital education department. It is within her scope of responsibilities to provide ongoing education to staff in order to address potential safety concerns.

DISCUSSION

This QI initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety and advancing quality health care, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. As part of efforts to continuously build on a safety-first culture, transparency and celebration of successes were demonstrated. This QI initiative demonstrated that a diverse and wide range of employees were reached, from clinical to nonclinical staff, and frontline to supervisory staff, as all were included in the recognition process. While many award nominations were received through the submission of safety concerns to the high-reliability team and patient safety office, several came directly from staff who wanted to recognize their peers for their work, supporting a culture of safety. This showed that staff felt that taking the time to submit a write-up to recognize a peer was an important task. Achieving zero harm for patients and staff alike is a top priority for our institution and guides all decisions, which reinforces that everyone has a responsibility to ensure that safety is always the first consideration. A culture of safety is enhanced by staff recognition. This QI initiative also showed that staff felt valued when they were acknowledged, regardless of the level of recognition they received. The theme of feeling valued came from unsolicited feedback. For example, some direct comments from awardees are presented in the Box.

In addition to endorsing the importance of safe practices to staff, safety award programs can identify gaps in existing standard procedures that can be updated quickly and shared broadly across a health care organization. The authors observed that the existence of the award program gives staff permission to use their voice to speak up when they have questions or concerns related to safety and to proactively engage in safety practices; a cultural shift of this kind informs safety practices and procedures and contributes to a more inspiring workplace. Staff at our organization who have received any of the safety awards, and those who are aware of these awards, have embraced the program readily. At the time of submission of this manuscript, there was a relative paucity of published literature on the details, performance, and impact of such programs. This initiative aims to share a road map highlighting the various dimensions of staff recognition and how the program supports our health care system in fostering a strong, sustainable culture of safety and health care quality. A next step is to formally assess the impact of the awards program on our culture of safety and quality using a psychometrically sound measurement tool, as recommended by TJC,¹⁶ such as the Hospital Survey on Patient Safety Culture.^17,18

CONCLUSION

A health care organization safety awards program is a strategy for building and sustaining a culture of safety. This QI initiative may be valuable to other organizations in the process of establishing a safety awards program of their own. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel Street, Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

ABSTRACT

Objective: Promoting a culture of safety is a critical component of improving health care quality. Recognizing staff who stop the line for safety can positively impact the growth of a culture of safety. The purpose of this initiative was to demonstrate to staff the importance of speaking up for safety and being acknowledged for doing so.

Methods: Following a review of the literature on safety awards programs and their role in promoting a culture of safety in health care covering the period 2017 to 2020, a formal process was developed and implemented to disseminate safety awards to employees.

Results: During the initial 18 months of the initiative, a total of 59 awards were presented. The awards were well received by the recipients and other staff members. Within this period, adjustments were made to enhance the scope and reach of the program.

Conclusion: Recognizing staff behaviors that support a culture of safety is important for improving health care quality and employee engagement. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Keywords: patient safety, culture of safety, incident reporting, near miss.

A key aspect of improving health care quality is promoting and sustaining a culture of safety in the workplace. Improving the quality of health care services and systems involves making informed choices regarding the types of strategies to implement.¹ An essential aspect of supporting a safety culture is safety-event reporting. To approach the goal of zero harm, all safety events, whether they result in actual harm or are considered near misses, need to be reported. Near-miss events are errors that occur while care is being provided but are detected and corrected before harm reaches the patient.^1-3 Near-miss reporting plays a critical role in helping to identify and correct weaknesses in health care delivery systems and processes.⁴ However, evidence shows that there are a multitude of barriers to the reporting of near-miss events, such as fear of punitive actions, additional workload, unsupportive work environments, a culture with poor psychological safety, knowledge deficit, and lack of recognition of staff who do report near misses.^4-11

According to The Joint Commission (TJC), acknowledging health care team members who recognize and report unsafe conditions that provide insight for improving patient safety is a key method for promoting the reporting of near-miss events.⁶ As a result, some health care organizations and patient safety agencies have started to institute some form of recognition for their employees in the realm of safety.^8-10 The Pennsylvania Patient Safety Authority offers exceptional guidance for creating a safety awards program to promote a culture of safety.¹² Furthermore, TJC supports recognizing individuals and health care teams who identify and report near misses, or who have suggestions for initiatives to promote patient safety, with “good catch” awards. Individuals or teams working to promote and sustain a culture of safety should be recognized for their efforts. Acknowledging “good catches” to reward the identification, communication, and resolution of safety issues is an effective strategy for improving patient safety and health care quality.^6,8

This quality improvement (QI) initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. If health care organizations want staff to be motivated to report near misses and improve safety and health care quality, the culture needs to shift from focusing on blame to incentivizing individuals and teams to speak up when they have concerns.^8-10 Although deciding which safety actions are worthy of recognition can be challenging, recognizing all safe acts, regardless of how big or small they are perceived to be, is important. This QI initiative aimed to establish a tiered approach to recognize staff members for various categories of safety acts.

METHODS

A review of the literature from January 2017 to May 2020 for peer-reviewed publications regarding how other organizations implemented safety award programs to promote a culture of safety resulted in a dearth of evidence. This prompted us at the Veterans Affairs Connecticut Healthcare System to develop and implement a formal program to disseminate safety awards to employees.

Program Launch and Promotion

In 2020, our institution embarked on a journey to high reliability with the goal of approaching zero harm. As part of efforts to promote a culture of safety, the hospital’s High Reliability Organization (HRO) team worked to develop a safety awards recognition program. Prior to the launch, the hospital’s patient safety committee recognized staff members through the medical center safety event reporting system (the Joint Patient Safety Reporting system [JPSR]) or through direct communication with staff members on safety actions they were engaged in. JPSR is the Veterans Health Administration National Center for Patient Safety incident reporting system for reporting, tracking, and trending of patient incidents in a national database. The award consisted of a certificate presented by the patient safety committee chairpersons to the employee in front of their peers in their respective work area. Hospital leadership was not involved in the safety awards recognition program at that time. No nomination process existed prior to our QI launch.

Once the QI initiative was launched and marketed heavily at staff meetings, we started to receive nominations for actions that were truly exceptional, while many others were submitted for behaviors that were within the day-to-day scope of practice of the staff member. For those early nominations that did not meet criteria for an award, we thanked staff for their submissions with a gentle statement that their nomination did not meet the criteria for an award. After following this practice for a few weeks, we became concerned that if we did not acknowledge the staff who came forward to request recognition for their routine work that supported safety, we could risk losing their engagement in a culture of safety. As such, we decided to create 3 levels of awards to recognize behaviors that went above and beyond while also acknowledging staff for actions within their scope of practice. Additionally, hospital leadership wanted to ensure that all staff recognize that their safety efforts are valued by leadership and that that sense of value will hopefully contribute to a culture of safety over time.

Initially, the single award system was called the “Good Catch Award” to acknowledge staff who go above and beyond to speak up and take action when they have safety concerns. This particular recognition includes a certificate, an encased baseball card that has been personalized by including the staff member’s picture and safety event identified, a stress-release baseball, and a stick of Bazooka gum (similar to what used to come in baseball cards packs). The award is presented to employees in their work area by the HRO and patient safety teams and includes representatives from the executive leadership team (ELT). The safety event identified is described by an ELT member, and all items are presented to the employee. Participation by the leadership team communicates how much the work being done to promote a culture of safety and advance quality health care is appreciated. This action also encourages others in the organization to identify and report safety concerns.¹³

With the rollout of the QI initiative, the volume of nominations submitted quickly increased (eg, approximately 1 every 2 months before to 3 per month following implementation). Frequently, nominations were for actions believed to be within the scope of the employee’s responsibilities. Our institution’s leadership team quickly recognized that, as an organization, not diminishing the importance of the “Good Catch Award” was important. However, the leadership team also wanted to encourage nominations from employees that involved safety issues that were part of the employee’s scope of responsibilities. As a result, 2 additional and equally notable award tiers were established, with specific criteria created for each.¹⁴ The addition of the other awards was instrumental in getting the leadership team to feel confident that all staff were being recognized for their commitment to patient safety.

The original Good Catch Award was labelled as a Level 1 award. The Level 2 safety recognition award, named the HRO Safety Champion Award, is given to employees who stop the line for a safety concern within their scope of practice and also participate as part of a team to investigate and improve processes to avoid recurring safety concerns in the future. For the Level Two award, a certificate is presented to an employee by the hospital’s HRO lead, HRO physician champion, patient safety manager, immediate supervisor, and peers. With the Level 3 award, the Culture of Safety Appreciation Award, individuals are recognized for addressing safety concerns within their assigned scope of responsibilities. Recognition is bestowed by an email of appreciation sent to the employee, acknowledging their commitment to promoting a culture of safety and quality health care. The recipient’s direct supervisor and other hospital leaders are copied on the message.¹⁴ See Table 1 for a comparison of awards.

Our institution’s HRO and patient safety teams utilized many additional venues to disseminate information regarding awardees and their actions. These included our monthly HRO newsletter, monthly safety forums, and biweekly Team Connecticut Healthcare system-wide huddles.

Nomination Process

Awards nominations are submitted via the hospital intranet homepage, where there is an “HRO Safety Award Nomination” icon. Once a staff member clicks the icon, a template opens asking for information, such as the reason for the nomination submission, and then walks them through the template using the CAR (C-context, A-actions, and R-results)¹⁵ format for describing the situation, identifying actions taken, and specifying the outcome of the action. Emails with award nominations can also be sent to the HRO lead, HRO champion, or Patient Safety Committee co-chairs. Calls for nominations are made at several venues attended by employees as well as supervisors. These include monthly safety forums, biweekly Team Connecticut Healthcare system-wide huddles, supervisory staff meetings, department and unit-based staff meetings, and many other formal and informal settings. This QI initiative has allowed us to capture potential awardees through several avenues, including self-nominations. All nominations are reviewed by a safety awards committee. Each committee member ranks the nomination as a Level 1, 2, or 3 award. For nominations where conflicting scores are obtained, the committee discusses the nomination together to resolve discrepancies.

Needed Resources

Material resources required for this QI initiative include certificate paper, plastic baseball card sleeves, stress-release baseballs, and Bazooka gum. The largest resource investment was the time needed to support the initiative. This included the time spent scheduling the Level 1 and 2 award presentations with staff and leadership. Time was also required to put the individual award packages together, which included printing the paper certificates, obtaining awardee pictures, placing them with their safety stories in a plastic baseball card sleeve, and arranging for the hospital photographer to take pictures of the awardees with their peers and leaders.

RESULTS

Prior to this QI initiative launch, 14 awards were given out over the preceding 2-year period. During the initial 18 months of the initiative (December 2020 to June 2022), 59 awards were presented (Level 1, n = 26; Level 2, n = 22; and Level 3, n = 11). Looking further into the Level 1 awards presented, 25 awardees worked in clinical roles and 1 in a nonclinical position (Table 2). The awardees represented multidisciplinary areas, including medical/surgical (med/surg) inpatient units, anesthesia, operating room, pharmacy, mental health clinics, surgical intensive care, specialty care clinics, and nutrition and food services. With the Level 2 awards, 18 clinical staff and 4 nonclinical staff received awards from the areas of med/surg inpatient, outpatient surgical suites, the medical center director’s office, radiology, pharmacy, primary care, facilities management, environmental management, infection prevention, and emergency services. All Level 3 awardees were from clinical areas, including primary care, hospital education, sterile processing, pharmacies, operating rooms, and med/surg inpatient units.

With the inception of this QI initiative, our organization has begun to see trends reflecting increased reporting of both actual and close-call events in JPSR (Figure 1).

With the inclusion of information regarding awardees and their actions in monthly safety forums, attendance at these forums has increased from an average of 64 attendees per month in 2021 to an average of 131 attendees per month in 2022 (Figure 2).

Finally, our organization’s annual All-Employee Survey results have shown incremental increases in staff reporting feeling psychologically safe and not fearing reprisal (Figure 3). It is important to note that there may be other contributing factors to these incremental changes.

Stories From the 3 Award Categories

Level 1 – Good Catch Award. M.S. was assigned as a continuous safety monitor, or “sitter,” on one of the med/surg inpatient units. M.S. arrived at the bedside and asked for a report on the patient at a change in shift. The report stated that the patient was sleeping and had not moved in a while. M.S. set about to perform the functions of a sitter and did her usual tasks in cleaning and tidying the room for the patient for breakfast and taking care of all items in the room, in general. M.S. introduced herself to the patient, who she thought might wake up because of her speaking to him. She thought the patient was in an odd position, and knowing that a patient should be a little further up in the bed, she tried with touch to awaken him to adjust his position. M.S. found that the patient was rather chilly to the touch and immediately became concerned. She continued to attempt to rouse the patient. M.S. called for the nurse and began to adjust the patient’s position. M.S. insisted that the patient was cold and “something was wrong.” A set of vitals was taken and a rapid response team code was called. The patient was immediately transferred to the intensive care unit to receive a higher level of care. If not for the diligence and caring attitude of M.S., this patient may have had a very poor outcome.

Reason for criteria being met: The scope of practice of a sitter is to be present in a patient’s room to monitor for falls and overall safety. This employee noticed that the patient was not responsive to verbal or tactile stimuli. Her immediate reporting of her concern to the nurse resulted in prompt intervention. If she had let the patient be, the patient could have died. The staff member went above and beyond by speaking up and taking action when she had a patient safety concern.

Level 2 – HRO Safety Champion Award. A patient presented to an outpatient clinic for monoclonal antibody (mAb) therapy for a COVID-19 infection; the treatment has been scheduled by the patient’s primary care provider. At that time, outpatient mAb therapy was the recommended care option for patients stable enough to receive treatment in this setting, but it is contraindicated in patients who are too unstable to receive mAb therapy in an outpatient setting, such as those with increased oxygen demands. R.L., a staff nurse, assessed the patient on arrival and found that his vital signs were stable, except for a slightly elevated respiratory rate. Upon questioning, the patient reported that he had increased his oxygen use at home from 2 to 4 L via a nasal cannula. R.L. assessed that the patient was too high-risk for outpatient mAb therapy and had the patient checked into the emergency department (ED) to receive a full diagnostic workup and evaluation by Dr. W., an ED provider. The patient required admission to the hospital for a higher level of care in an inpatient unit because of severe COVID-19 infection. Within 48 hours of admission, the patient’s condition further declined, requiring an upgrade to the medical intensive care unit with progressive interventions. Owing to the clinical assessment skills and prompt action of R.L., the patient was admitted to the hospital instead of receiving treatment in a suboptimal care setting and returning home. Had the patient gone home, his rapid decline could have had serious consequences.

Reason for criteria being met: On a cursory look, the patient may have passed as someone sufficiently stable to undergo outpatient treatment. However, the nurse stopped the line, paid close attention, and picked up on an abnormal vital sign and the projected consequences. The nurse brought the patient to a higher level of care in the ED so that he could get the attention he needed. If this patient was given mAb therapy in the outpatient setting, he would have been discharged and become sicker with the COVID-19 illness. As a result of this incident, R.L. is working with the outpatient clinic and ED staff to enahance triage and evaluation of patients referred for outpatient therapy for COVID-19 infections to prevent a similar event from recurring.

Level 3 – Culture of Safety Appreciation Award. While C.C. was reviewing the hazardous item competencies of the acute psychiatric inpatient staff, it was learned that staff were sniffing patients’ personal items to see if they were “safe” and free from alcohol. This is a potentially dangerous practice, and if fentanyl is present, it can be life-threatening. All patients admitted to acute inpatient psychiatry have all their clothing and personal items checked for hazardous items—pockets are emptied, soles of shoes are lifted, and so on. Staff wear personal protective equipment during this process to mitigate any powders or other harmful substances being inhaled or coming in contact with their skin or clothes. The gloves can be punctured if needles are found in the patient’s belongings. C.C. not only educated the staff on the dangers of sniffing for alcohol during hazardous-item checks, but also looked for further potential safety concerns. An additional identified risk was for needle sticks when such items were found in a patient’s belongings. C.C.’s recommendations included best practices to allow only unopened personal items and have available hospital-issued products as needed. C.C. remembered having a conversation with an employee from the psychiatric emergency room regarding the purchase of puncture-proof gloves to mitigate puncture sticks. C.C. recommended that the same gloves be used by staff on the acute inpatient psychiatry unit during searches for hazardous items.

Reason for criteria being met: The employee works in the hospital education department. It is within her scope of responsibilities to provide ongoing education to staff in order to address potential safety concerns.

DISCUSSION

This QI initiative was undertaken to demonstrate to staff that, in building an organizational culture of safety and advancing quality health care, it is important that staff be encouraged to speak up for safety and be acknowledged for doing so. As part of efforts to continuously build on a safety-first culture, transparency and celebration of successes were demonstrated. This QI initiative demonstrated that a diverse and wide range of employees were reached, from clinical to nonclinical staff, and frontline to supervisory staff, as all were included in the recognition process. While many award nominations were received through the submission of safety concerns to the high-reliability team and patient safety office, several came directly from staff who wanted to recognize their peers for their work, supporting a culture of safety. This showed that staff felt that taking the time to submit a write-up to recognize a peer was an important task. Achieving zero harm for patients and staff alike is a top priority for our institution and guides all decisions, which reinforces that everyone has a responsibility to ensure that safety is always the first consideration. A culture of safety is enhanced by staff recognition. This QI initiative also showed that staff felt valued when they were acknowledged, regardless of the level of recognition they received. The theme of feeling valued came from unsolicited feedback. For example, some direct comments from awardees are presented in the Box.

In addition to endorsing the importance of safe practices to staff, safety award programs can identify gaps in existing standard procedures that can be updated quickly and shared broadly across a health care organization. The authors observed that the existence of the award program gives staff permission to use their voice to speak up when they have questions or concerns related to safety and to proactively engage in safety practices; a cultural shift of this kind informs safety practices and procedures and contributes to a more inspiring workplace. Staff at our organization who have received any of the safety awards, and those who are aware of these awards, have embraced the program readily. At the time of submission of this manuscript, there was a relative paucity of published literature on the details, performance, and impact of such programs. This initiative aims to share a road map highlighting the various dimensions of staff recognition and how the program supports our health care system in fostering a strong, sustainable culture of safety and health care quality. A next step is to formally assess the impact of the awards program on our culture of safety and quality using a psychometrically sound measurement tool, as recommended by TJC,¹⁶ such as the Hospital Survey on Patient Safety Culture.^17,18

CONCLUSION

A health care organization safety awards program is a strategy for building and sustaining a culture of safety. This QI initiative may be valuable to other organizations in the process of establishing a safety awards program of their own. Future research should focus on a formal evaluation of the impact of safety awards programs on patient safety outcomes.

Corresponding author: John S. Murray, PhD, MPH, MSGH, RN, FAAN, 20 Chapel Street, Unit A502, Brookline, MA 02446; [email protected]

Disclosures: None reported.

ABSTRACT

Objective: To teach internal medicine residents quality improvement (QI) principles in an effort to improve resident knowledge and comfort with QI, as well as address quality care gaps in resident clinic primary care patient panels.

Design: A QI curriculum was implemented for all residents rotating through a primary care block over a 6-month period. Residents completed Institute for Healthcare Improvement (IHI) modules, participated in a QI workshop, and received panel data reports, ultimately completing a plan-do-study-act (PDSA) cycle to improve colorectal cancer screening and hypertension control.

Setting and participants: This project was undertaken at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. All internal medicine residents were included, with 55 (73%) of the 75 residents completing the presurvey, and 39 (52%) completing the postsurvey.

Measurements: We administered a 10-question pre- and postsurvey looking at resident attitudes toward and comfort with QI and familiarity with their panel data as well as measured rates of colorectal cancer screening and hypertension control in resident panels.

Results: There was an increase in the numbers of residents who performed a PDSA cycle (P = .002), completed outreach based on their panel data (P = .02), and felt comfortable in both creating aim statements and designing and implementing PDSA cycles (P < .0001). The residents’ knowledge of their panel data significantly increased. There was no significant improvement in hypertension control, but there was an increase in colorectal cancer screening rates (P < .0001).

Conclusion: Providing panel data and performing targeted QI interventions can improve resident comfort with QI, translating to improvement in patient outcomes.

Keywords: quality improvement, resident education, medical education, care gaps, quality metrics.

As quality improvement (QI) has become an integral part of clinical practice, residency training programs have continued to evolve in how best to teach QI. The Accreditation Council for Graduate Medical Education (ACGME) Common Program requirements mandate that core competencies in residency programs include practice-based learning and improvement and systems-based practice.¹ Residents should receive education in QI, receive data on quality metrics and benchmarks related to their patient population, and participate in QI activities. The Clinical Learning Environment Review (CLER) program was established to provide feedback to institutions on 6 focused areas, including patient safety and health care quality. In visits to institutions across the United States, the CLER committees found that many residents had limited knowledge of QI concepts and limited access to data on quality metrics and benchmarks.²

There are many barriers to implementing a QI curriculum in residency programs, and creating and maintaining successful strategies has proven challenging.³ Many QI curricula for internal medicine residents have been described in the literature, but the results of many of these studies focus on resident self-assessment of QI knowledge and numbers of projects rather than on patient outcomes.^4-13 As there is some evidence suggesting that patients treated by residents have worse outcomes on ambulatory quality measures when compared with patients treated by staff physicians,^14,15 it is important to also look at patient outcomes when evaluating a QI curriculum. Experts in education recommend the following to optimize learning: exposure to both didactic and experiential opportunities, connection to health system improvement efforts, and assessment of patient outcomes in addition to learner feedback.^16,17 A study also found that providing panel data to residents could improve quality metrics.¹⁸

In this study, we sought to investigate the effects of a resident QI intervention during an ambulatory block on both residents’ self-assessments of QI knowledge and attitudes as well as on patient quality metrics.

Methods

Curriculum

We implemented this educational initiative at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. Co-located with the 415-bed academic medical center in downtown Boston, the practice serves more than 40,000 patients, approximately 7000 of whom are cared for by resident primary care physicians (PCPs). The internal medicine residents rotate through the primary care clinic as part of continuity clinic during ambulatory or elective blocks. In addition to continuity clinic, the residents have 2 dedicated 3-week primary care rotations during the course of an academic year. Primary care rotations consist of 5 clinic sessions a week as well as structured teaching sessions. Each resident inherits a panel of patients from an outgoing senior resident, with an average panel size of 96 patients per resident.

Prior to this study intervention, we did not do any formal QI teaching to our residents as part of their primary care curriculum, and previous panel management had focused more on chart reviews of patients whom residents perceived to be higher risk. Residents from all 3 years were included in the intervention. We taught a QI curriculum to our residents from January 2018 to June 2018 during the 3-week primary care rotation, which consisted of the following components:

• Institute for Healthcare Improvement (IHI) module QI 102 completed independently online.
• A 2-hour QI workshop led by 1 of 2 primary care faculty with backgrounds in QI, during which residents were taught basic principles of QI, including how to craft aim statements and design plan-do-study-act (PDSA) cycles, and participated in a hands-on QI activity designed to model rapid cycle improvement (the Paper Airplane Factory¹⁹).
• Distribution of individualized reports of residents’ patient panel data by email at the start of the primary care block that detailed patients’ overall rates of colorectal cancer screening and hypertension (HTN) control, along with the average resident panel rates and the average attending panel rates. The reports also included a list of all residents’ patients who were overdue for colorectal cancer screening or whose last blood pressure (BP) was uncontrolled (systolic BP ≥ 140 mm Hg or diastolic BP ≥  90 mm Hg). These reports were originally designed by our practice’s QI team and run and exported in Microsoft Excel format monthly by our information technology (IT) administrator.
• Instruction on aim statements as a group, followed by the expectation that each resident create an individualized aim statement tailored to each resident’s patient panel rates, with the PDSA cycle to be implemented during the remainder of the primary care rotation, focusing on improvement of colorectal cancer screening and HTN control (see supplementary eFigure 1 online for the worksheet used for the workshop).
• Residents were held accountable for their interventions by various check-ins. At the end of the primary care block, residents were required to submit their completed worksheets showing the intervention they had undertaken and when it was performed. The 2 primary care attendings primarily responsible for QI education would review the resident’s work approximately 1 to 2 months after they submitted their worksheets describing their intervention. These attendings sent the residents personalized feedback based on whether the intervention had been completed or successful as evidenced by documentation in the chart, including direct patient outreach by phone, letter, or portal; outreach to the resident coordinator; scheduled follow-up appointment; or booking or completion of colorectal cancer screening. Along with this feedback, residents were also sent suggestions for next steps. Resident preceptors were copied on the email to facilitate reinforcement of the goals and plans. Finally, the resident preceptors also helped with accountability by going through the residents’ worksheets and patient panel metrics with the residents during biannual evaluations.

Evaluation

Residents were surveyed with a 10-item questionnaire pre and post intervention regarding their attitudes toward QI, understanding of QI principles, and familiarity with their patient panel data. Surveys were anonymous and distributed via the SurveyMonkey platform (see supplementary eFigure 2 online). Residents were asked if they had ever performed a PDSA cycle, performed patient outreach, or performed an intervention and whether they knew the rates of diabetes, HTN, and colorectal cancer screening in their patient panels. Questions rated on a 5-point Likert scale were used to assess comfort with panel management, developing an aim statement, designing and implementing a PDSA cycle, as well as interest in pursuing QI as a career. For the purposes of analysis, these questions were dichotomized into “somewhat comfortable” and “very comfortable” vs “neutral,” “somewhat uncomfortable,” and “very uncomfortable.” Similarly, we dichotomized the question about interest in QI as a career into “somewhat interested” and “very interested” vs “neutral,” “somewhat disinterested,” and “very disinterested.” As the surveys were anonymous, we were unable to pair the pre- and postintervention surveys and used a chi-square test to evaluate whether there was an association between survey assessments pre intervention vs post intervention and a positive or negative response to the question.

We also examined rates of HTN control and colorectal cancer screening in all 75 resident panels pre and post intervention. The paired t-test was used to determine whether the mean change from pre to post intervention was significant. SAS 9.4 (SAS Institute Inc.) was used for all analyses. Institutional Review Board exemption was obtained from the Tufts Medical Center IRB. There was no funding received for this study.

Respondents

Of the 75 residents, 55 (73%) completed the survey prior to the intervention, and 39 (52%) completed the survey after the intervention.

Panel Knowledge and Intervention

Prior to the intervention, 45% of residents had performed a PDSA cycle, compared with 77% post intervention, which was a significant increase (P = .002) (Table 1). Sixty-two percent of residents had performed outreach or an intervention based on their patient panel reports prior to the intervention, compared with 85% of residents post intervention, which was also a significant increase (P = .02). The increase post intervention was not 100%, as there were residents who either missed the initial workshop or who did not follow through with their planned intervention. Common interventions included the residents giving their coordinators a list of patients to call to schedule appointments, utilizing fellow team members (eg, pharmacists, social workers) for targeted patient outreach, or calling patients themselves to reestablish a connection.

In terms of knowledge of their patient panels, prior to the intervention, 55%, 62%, and 62% of residents knew the rates of patients in their panel with diabetes, HTN, and colorectal cancer screening, respectively. After the intervention, the residents’ knowledge of these rates increased significantly, to 85% for diabetes (P = .002), 97% for HTN (P < .0001), and 97% for colorectal cancer screening (P < .0001).

Comfort With QI Approaches

Prior to the intervention, 82% of residents were comfortable managing their primary care panel, which did not change significantly post intervention (Table 2). The residents’ comfort with designing an aim statement did significantly increase, from 55% to 95% (P < .0001). The residents also had a significant increase in comfort with both designing and implementing a PDSA cycle. Prior to the intervention, 22% felt comfortable designing a PDSA cycle, which increased to 79% (P < .0001) post intervention, and 24% felt comfortable implementing a PDSA cycle, which increased to 77% (P < .0001) post intervention.

Patient Outcome Measures

The rate of HTN control in the residents' patient panels did not change significantly pre and post intervention (Table 3). The rate of resident patients who were up to date with colorectal cancer screening increased by 6.5% post intervention (P < .0001).

Interest in QI as a Career

As part of the survey, residents were asked how interested they were in making QI a part of their career. Fifty percent of residents indicated an interest in QI pre intervention, and 54% indicated an interest post intervention, which was not a significant difference (P = .72).

Discussion

In this study, we found that integration of a QI curriculum into a primary care rotation improved both residents’ knowledge of their patient panels and comfort with QI approaches, which translated to improvement in patient outcomes. Several previous studies have found improvements in resident self-assessment or knowledge after implementation of a QI curriculum.^4-13 Liao et al implemented a longitudinal curriculum including both didactic and experiential components and found an improvement in both QI confidence and knowledge.³ Similarly, Duello et al⁸ found that a curriculum including both didactic lectures and QI projects improved subjective QI knowledge and comfort. Interestingly, Fok and Wong⁹ found that resident knowledge could be sustained post curriculum after completion of a QI project, suggesting that experiential learning may be helpful in maintaining knowledge.

Studies also have looked at providing performance data to residents. Hwang et al¹⁸ found that providing audit and feedback in the form of individual panel performance data to residents compared with practice targets led to statistically significant improvement in cancer screening rates and composite quality score, indicating that there is tremendous potential in providing residents with their data. While the ACGME mandates that residents should receive data on their quality metrics, on CLER visits, many residents interviewed noted limited access to data on their metrics and benchmarks.^1,2

Though previous studies have individually looked at teaching QI concepts, providing panel data, or targeting select metrics, our study was unique in that it reviewed both self-reported resident outcomes data as well as actual patient outcomes. In addition to finding increased knowledge of patient panels and comfort with QI approaches, we found a significant increase in colorectal cancer screening rates post intervention. We thought this finding was particularly important given some data that residents' patients have been found to have worse outcomes on quality metrics compared with patients cared for by staff physicians.^14,15 Given that having a resident physician as a PCP has been associated with failing to meet quality measures, it is especially important to focus targeted quality improvement initiatives in this patient population to reduce disparities in care.

We found that residents had improved knowledge on their patient panels as a result of this initiative. The residents were noted to have a higher knowledge of their HTN and colorectal cancer screening rates in comparison to their diabetes metrics. We suspect this is because residents are provided with multiple metrics related to diabetes, including process measures such as A1c testing, as well as outcome measures such as A1c control, so it may be harder for them to elucidate exactly how they are doing with their diabetes patients, whereas in HTN control and colorectal cancer screening, there is only 1 associated metric. Interestingly, even though HTN and colorectal cancer screening were the 2 measures focused on in the study, the residents had a significant improvement in knowledge of the rates of diabetes in their panel as well. This suggests that even just receiving data alone is valuable, hopefully translating to better outcomes with better baseline understanding of panels. We believe that our intervention was successful because it included both a didactic and an experiential component, as well as the use of individual panel performance data.

There were several limitations to our study. It was performed at a single institution, translating to a small sample size. Our data analysis was limited because we were unable to pair our pre- and postintervention survey responses because we used an anonymous survey. We also did not have full participation in postintervention surveys from all residents, which may have biased the study in favor of high performers. Another limitation was that our survey relied on self-reported outcomes for the questions about the residents knowing their patient panels.

This study required a 2-hour workshop every 3 weeks led by a faculty member trained in QI. Given the amount of time needed for the curriculum, this study may be difficult to replicate at other institutions, especially if faculty with an interest or training in QI are not available. Given our finding that residents had increased knowledge of their patient panels after receiving panel metrics, simply providing data with the goal of smaller, focused interventions may be easier to implement. At our institution, we discontinued the longer 2-hour QI workshops designed to teach QI approaches more broadly. We continue to provide individualized panel data to all residents during their primary care rotations and conduct half-hour, small group workshops with the interns that focus on drafting aim statements and planning interventions. All residents are required to submit worksheets to us at the end of their primary care blocks listing their current rates of each predetermined metric and laying out their aim statements and planned interventions. Residents also continue to receive feedback from our faculty with expertise in QI afterward on their plans and evidence of follow-through in the chart, with their preceptors included on the feedback emails. Even without the larger QI workshop, this approach has continued to be successful and appreciated. In fact, it does appear as though improvement in colorectal cancer screening has been sustained over several years. At the end of our study period, the resident patient colorectal cancer screening rate rose from 34% to 43%, and for the 2021-2022 academic year, the rate rose further, from 46% to 50%.

Given that the resident clinic patient population is at higher risk overall, targeted outreach and approaches to improve quality must be continued. Future areas of research include looking at which interventions, whether QI curriculum, provision of panel data, or required panel management interventions, translate to the greatest improvements in patient outcomes in this vulnerable population.

Conclusion

Our study showed that a dedicated QI curriculum for the residents and access to quality metric data improved both resident knowledge and comfort with QI approaches. Beyond resident-centered outcomes, there was also translation to improved patient outcomes, with a significant increase in colon cancer screening rates post intervention.

Corresponding author: Kinjalika Sathi, MD, 800 Washington St., Boston, MA 02111; [email protected]

Disclosures: None reported.

ABSTRACT

Objective: To teach internal medicine residents quality improvement (QI) principles in an effort to improve resident knowledge and comfort with QI, as well as address quality care gaps in resident clinic primary care patient panels.

Design: A QI curriculum was implemented for all residents rotating through a primary care block over a 6-month period. Residents completed Institute for Healthcare Improvement (IHI) modules, participated in a QI workshop, and received panel data reports, ultimately completing a plan-do-study-act (PDSA) cycle to improve colorectal cancer screening and hypertension control.

Setting and participants: This project was undertaken at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. All internal medicine residents were included, with 55 (73%) of the 75 residents completing the presurvey, and 39 (52%) completing the postsurvey.

Measurements: We administered a 10-question pre- and postsurvey looking at resident attitudes toward and comfort with QI and familiarity with their panel data as well as measured rates of colorectal cancer screening and hypertension control in resident panels.

Results: There was an increase in the numbers of residents who performed a PDSA cycle (P = .002), completed outreach based on their panel data (P = .02), and felt comfortable in both creating aim statements and designing and implementing PDSA cycles (P < .0001). The residents’ knowledge of their panel data significantly increased. There was no significant improvement in hypertension control, but there was an increase in colorectal cancer screening rates (P < .0001).

Conclusion: Providing panel data and performing targeted QI interventions can improve resident comfort with QI, translating to improvement in patient outcomes.

Keywords: quality improvement, resident education, medical education, care gaps, quality metrics.

As quality improvement (QI) has become an integral part of clinical practice, residency training programs have continued to evolve in how best to teach QI. The Accreditation Council for Graduate Medical Education (ACGME) Common Program requirements mandate that core competencies in residency programs include practice-based learning and improvement and systems-based practice.¹ Residents should receive education in QI, receive data on quality metrics and benchmarks related to their patient population, and participate in QI activities. The Clinical Learning Environment Review (CLER) program was established to provide feedback to institutions on 6 focused areas, including patient safety and health care quality. In visits to institutions across the United States, the CLER committees found that many residents had limited knowledge of QI concepts and limited access to data on quality metrics and benchmarks.²

There are many barriers to implementing a QI curriculum in residency programs, and creating and maintaining successful strategies has proven challenging.³ Many QI curricula for internal medicine residents have been described in the literature, but the results of many of these studies focus on resident self-assessment of QI knowledge and numbers of projects rather than on patient outcomes.^4-13 As there is some evidence suggesting that patients treated by residents have worse outcomes on ambulatory quality measures when compared with patients treated by staff physicians,^14,15 it is important to also look at patient outcomes when evaluating a QI curriculum. Experts in education recommend the following to optimize learning: exposure to both didactic and experiential opportunities, connection to health system improvement efforts, and assessment of patient outcomes in addition to learner feedback.^16,17 A study also found that providing panel data to residents could improve quality metrics.¹⁸

In this study, we sought to investigate the effects of a resident QI intervention during an ambulatory block on both residents’ self-assessments of QI knowledge and attitudes as well as on patient quality metrics.

Methods

Curriculum

We implemented this educational initiative at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. Co-located with the 415-bed academic medical center in downtown Boston, the practice serves more than 40,000 patients, approximately 7000 of whom are cared for by resident primary care physicians (PCPs). The internal medicine residents rotate through the primary care clinic as part of continuity clinic during ambulatory or elective blocks. In addition to continuity clinic, the residents have 2 dedicated 3-week primary care rotations during the course of an academic year. Primary care rotations consist of 5 clinic sessions a week as well as structured teaching sessions. Each resident inherits a panel of patients from an outgoing senior resident, with an average panel size of 96 patients per resident.

Prior to this study intervention, we did not do any formal QI teaching to our residents as part of their primary care curriculum, and previous panel management had focused more on chart reviews of patients whom residents perceived to be higher risk. Residents from all 3 years were included in the intervention. We taught a QI curriculum to our residents from January 2018 to June 2018 during the 3-week primary care rotation, which consisted of the following components:

• Institute for Healthcare Improvement (IHI) module QI 102 completed independently online.
• A 2-hour QI workshop led by 1 of 2 primary care faculty with backgrounds in QI, during which residents were taught basic principles of QI, including how to craft aim statements and design plan-do-study-act (PDSA) cycles, and participated in a hands-on QI activity designed to model rapid cycle improvement (the Paper Airplane Factory¹⁹).
• Distribution of individualized reports of residents’ patient panel data by email at the start of the primary care block that detailed patients’ overall rates of colorectal cancer screening and hypertension (HTN) control, along with the average resident panel rates and the average attending panel rates. The reports also included a list of all residents’ patients who were overdue for colorectal cancer screening or whose last blood pressure (BP) was uncontrolled (systolic BP ≥ 140 mm Hg or diastolic BP ≥  90 mm Hg). These reports were originally designed by our practice’s QI team and run and exported in Microsoft Excel format monthly by our information technology (IT) administrator.
• Instruction on aim statements as a group, followed by the expectation that each resident create an individualized aim statement tailored to each resident’s patient panel rates, with the PDSA cycle to be implemented during the remainder of the primary care rotation, focusing on improvement of colorectal cancer screening and HTN control (see supplementary eFigure 1 online for the worksheet used for the workshop).
• Residents were held accountable for their interventions by various check-ins. At the end of the primary care block, residents were required to submit their completed worksheets showing the intervention they had undertaken and when it was performed. The 2 primary care attendings primarily responsible for QI education would review the resident’s work approximately 1 to 2 months after they submitted their worksheets describing their intervention. These attendings sent the residents personalized feedback based on whether the intervention had been completed or successful as evidenced by documentation in the chart, including direct patient outreach by phone, letter, or portal; outreach to the resident coordinator; scheduled follow-up appointment; or booking or completion of colorectal cancer screening. Along with this feedback, residents were also sent suggestions for next steps. Resident preceptors were copied on the email to facilitate reinforcement of the goals and plans. Finally, the resident preceptors also helped with accountability by going through the residents’ worksheets and patient panel metrics with the residents during biannual evaluations.

Evaluation

Residents were surveyed with a 10-item questionnaire pre and post intervention regarding their attitudes toward QI, understanding of QI principles, and familiarity with their patient panel data. Surveys were anonymous and distributed via the SurveyMonkey platform (see supplementary eFigure 2 online). Residents were asked if they had ever performed a PDSA cycle, performed patient outreach, or performed an intervention and whether they knew the rates of diabetes, HTN, and colorectal cancer screening in their patient panels. Questions rated on a 5-point Likert scale were used to assess comfort with panel management, developing an aim statement, designing and implementing a PDSA cycle, as well as interest in pursuing QI as a career. For the purposes of analysis, these questions were dichotomized into “somewhat comfortable” and “very comfortable” vs “neutral,” “somewhat uncomfortable,” and “very uncomfortable.” Similarly, we dichotomized the question about interest in QI as a career into “somewhat interested” and “very interested” vs “neutral,” “somewhat disinterested,” and “very disinterested.” As the surveys were anonymous, we were unable to pair the pre- and postintervention surveys and used a chi-square test to evaluate whether there was an association between survey assessments pre intervention vs post intervention and a positive or negative response to the question.

We also examined rates of HTN control and colorectal cancer screening in all 75 resident panels pre and post intervention. The paired t-test was used to determine whether the mean change from pre to post intervention was significant. SAS 9.4 (SAS Institute Inc.) was used for all analyses. Institutional Review Board exemption was obtained from the Tufts Medical Center IRB. There was no funding received for this study.

Respondents

Of the 75 residents, 55 (73%) completed the survey prior to the intervention, and 39 (52%) completed the survey after the intervention.

Panel Knowledge and Intervention

Prior to the intervention, 45% of residents had performed a PDSA cycle, compared with 77% post intervention, which was a significant increase (P = .002) (Table 1). Sixty-two percent of residents had performed outreach or an intervention based on their patient panel reports prior to the intervention, compared with 85% of residents post intervention, which was also a significant increase (P = .02). The increase post intervention was not 100%, as there were residents who either missed the initial workshop or who did not follow through with their planned intervention. Common interventions included the residents giving their coordinators a list of patients to call to schedule appointments, utilizing fellow team members (eg, pharmacists, social workers) for targeted patient outreach, or calling patients themselves to reestablish a connection.

In terms of knowledge of their patient panels, prior to the intervention, 55%, 62%, and 62% of residents knew the rates of patients in their panel with diabetes, HTN, and colorectal cancer screening, respectively. After the intervention, the residents’ knowledge of these rates increased significantly, to 85% for diabetes (P = .002), 97% for HTN (P < .0001), and 97% for colorectal cancer screening (P < .0001).

Comfort With QI Approaches

Prior to the intervention, 82% of residents were comfortable managing their primary care panel, which did not change significantly post intervention (Table 2). The residents’ comfort with designing an aim statement did significantly increase, from 55% to 95% (P < .0001). The residents also had a significant increase in comfort with both designing and implementing a PDSA cycle. Prior to the intervention, 22% felt comfortable designing a PDSA cycle, which increased to 79% (P < .0001) post intervention, and 24% felt comfortable implementing a PDSA cycle, which increased to 77% (P < .0001) post intervention.

Patient Outcome Measures

The rate of HTN control in the residents' patient panels did not change significantly pre and post intervention (Table 3). The rate of resident patients who were up to date with colorectal cancer screening increased by 6.5% post intervention (P < .0001).

Interest in QI as a Career

As part of the survey, residents were asked how interested they were in making QI a part of their career. Fifty percent of residents indicated an interest in QI pre intervention, and 54% indicated an interest post intervention, which was not a significant difference (P = .72).

Discussion

In this study, we found that integration of a QI curriculum into a primary care rotation improved both residents’ knowledge of their patient panels and comfort with QI approaches, which translated to improvement in patient outcomes. Several previous studies have found improvements in resident self-assessment or knowledge after implementation of a QI curriculum.^4-13 Liao et al implemented a longitudinal curriculum including both didactic and experiential components and found an improvement in both QI confidence and knowledge.³ Similarly, Duello et al⁸ found that a curriculum including both didactic lectures and QI projects improved subjective QI knowledge and comfort. Interestingly, Fok and Wong⁹ found that resident knowledge could be sustained post curriculum after completion of a QI project, suggesting that experiential learning may be helpful in maintaining knowledge.

Studies also have looked at providing performance data to residents. Hwang et al¹⁸ found that providing audit and feedback in the form of individual panel performance data to residents compared with practice targets led to statistically significant improvement in cancer screening rates and composite quality score, indicating that there is tremendous potential in providing residents with their data. While the ACGME mandates that residents should receive data on their quality metrics, on CLER visits, many residents interviewed noted limited access to data on their metrics and benchmarks.^1,2

Though previous studies have individually looked at teaching QI concepts, providing panel data, or targeting select metrics, our study was unique in that it reviewed both self-reported resident outcomes data as well as actual patient outcomes. In addition to finding increased knowledge of patient panels and comfort with QI approaches, we found a significant increase in colorectal cancer screening rates post intervention. We thought this finding was particularly important given some data that residents' patients have been found to have worse outcomes on quality metrics compared with patients cared for by staff physicians.^14,15 Given that having a resident physician as a PCP has been associated with failing to meet quality measures, it is especially important to focus targeted quality improvement initiatives in this patient population to reduce disparities in care.

We found that residents had improved knowledge on their patient panels as a result of this initiative. The residents were noted to have a higher knowledge of their HTN and colorectal cancer screening rates in comparison to their diabetes metrics. We suspect this is because residents are provided with multiple metrics related to diabetes, including process measures such as A1c testing, as well as outcome measures such as A1c control, so it may be harder for them to elucidate exactly how they are doing with their diabetes patients, whereas in HTN control and colorectal cancer screening, there is only 1 associated metric. Interestingly, even though HTN and colorectal cancer screening were the 2 measures focused on in the study, the residents had a significant improvement in knowledge of the rates of diabetes in their panel as well. This suggests that even just receiving data alone is valuable, hopefully translating to better outcomes with better baseline understanding of panels. We believe that our intervention was successful because it included both a didactic and an experiential component, as well as the use of individual panel performance data.

There were several limitations to our study. It was performed at a single institution, translating to a small sample size. Our data analysis was limited because we were unable to pair our pre- and postintervention survey responses because we used an anonymous survey. We also did not have full participation in postintervention surveys from all residents, which may have biased the study in favor of high performers. Another limitation was that our survey relied on self-reported outcomes for the questions about the residents knowing their patient panels.

This study required a 2-hour workshop every 3 weeks led by a faculty member trained in QI. Given the amount of time needed for the curriculum, this study may be difficult to replicate at other institutions, especially if faculty with an interest or training in QI are not available. Given our finding that residents had increased knowledge of their patient panels after receiving panel metrics, simply providing data with the goal of smaller, focused interventions may be easier to implement. At our institution, we discontinued the longer 2-hour QI workshops designed to teach QI approaches more broadly. We continue to provide individualized panel data to all residents during their primary care rotations and conduct half-hour, small group workshops with the interns that focus on drafting aim statements and planning interventions. All residents are required to submit worksheets to us at the end of their primary care blocks listing their current rates of each predetermined metric and laying out their aim statements and planned interventions. Residents also continue to receive feedback from our faculty with expertise in QI afterward on their plans and evidence of follow-through in the chart, with their preceptors included on the feedback emails. Even without the larger QI workshop, this approach has continued to be successful and appreciated. In fact, it does appear as though improvement in colorectal cancer screening has been sustained over several years. At the end of our study period, the resident patient colorectal cancer screening rate rose from 34% to 43%, and for the 2021-2022 academic year, the rate rose further, from 46% to 50%.

Given that the resident clinic patient population is at higher risk overall, targeted outreach and approaches to improve quality must be continued. Future areas of research include looking at which interventions, whether QI curriculum, provision of panel data, or required panel management interventions, translate to the greatest improvements in patient outcomes in this vulnerable population.

Conclusion

Our study showed that a dedicated QI curriculum for the residents and access to quality metric data improved both resident knowledge and comfort with QI approaches. Beyond resident-centered outcomes, there was also translation to improved patient outcomes, with a significant increase in colon cancer screening rates post intervention.

Corresponding author: Kinjalika Sathi, MD, 800 Washington St., Boston, MA 02111; [email protected]

Disclosures: None reported.

ABSTRACT

Objective: To teach internal medicine residents quality improvement (QI) principles in an effort to improve resident knowledge and comfort with QI, as well as address quality care gaps in resident clinic primary care patient panels.

Design: A QI curriculum was implemented for all residents rotating through a primary care block over a 6-month period. Residents completed Institute for Healthcare Improvement (IHI) modules, participated in a QI workshop, and received panel data reports, ultimately completing a plan-do-study-act (PDSA) cycle to improve colorectal cancer screening and hypertension control.

Setting and participants: This project was undertaken at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. All internal medicine residents were included, with 55 (73%) of the 75 residents completing the presurvey, and 39 (52%) completing the postsurvey.

Measurements: We administered a 10-question pre- and postsurvey looking at resident attitudes toward and comfort with QI and familiarity with their panel data as well as measured rates of colorectal cancer screening and hypertension control in resident panels.

Results: There was an increase in the numbers of residents who performed a PDSA cycle (P = .002), completed outreach based on their panel data (P = .02), and felt comfortable in both creating aim statements and designing and implementing PDSA cycles (P < .0001). The residents’ knowledge of their panel data significantly increased. There was no significant improvement in hypertension control, but there was an increase in colorectal cancer screening rates (P < .0001).

Conclusion: Providing panel data and performing targeted QI interventions can improve resident comfort with QI, translating to improvement in patient outcomes.

Keywords: quality improvement, resident education, medical education, care gaps, quality metrics.

As quality improvement (QI) has become an integral part of clinical practice, residency training programs have continued to evolve in how best to teach QI. The Accreditation Council for Graduate Medical Education (ACGME) Common Program requirements mandate that core competencies in residency programs include practice-based learning and improvement and systems-based practice.¹ Residents should receive education in QI, receive data on quality metrics and benchmarks related to their patient population, and participate in QI activities. The Clinical Learning Environment Review (CLER) program was established to provide feedback to institutions on 6 focused areas, including patient safety and health care quality. In visits to institutions across the United States, the CLER committees found that many residents had limited knowledge of QI concepts and limited access to data on quality metrics and benchmarks.²

There are many barriers to implementing a QI curriculum in residency programs, and creating and maintaining successful strategies has proven challenging.³ Many QI curricula for internal medicine residents have been described in the literature, but the results of many of these studies focus on resident self-assessment of QI knowledge and numbers of projects rather than on patient outcomes.^4-13 As there is some evidence suggesting that patients treated by residents have worse outcomes on ambulatory quality measures when compared with patients treated by staff physicians,^14,15 it is important to also look at patient outcomes when evaluating a QI curriculum. Experts in education recommend the following to optimize learning: exposure to both didactic and experiential opportunities, connection to health system improvement efforts, and assessment of patient outcomes in addition to learner feedback.^16,17 A study also found that providing panel data to residents could improve quality metrics.¹⁸

In this study, we sought to investigate the effects of a resident QI intervention during an ambulatory block on both residents’ self-assessments of QI knowledge and attitudes as well as on patient quality metrics.

Methods

Curriculum

We implemented this educational initiative at Tufts Medical Center Primary Care, Boston, Massachusetts, the primary care teaching practice for all 75 internal medicine residents at Tufts Medical Center. Co-located with the 415-bed academic medical center in downtown Boston, the practice serves more than 40,000 patients, approximately 7000 of whom are cared for by resident primary care physicians (PCPs). The internal medicine residents rotate through the primary care clinic as part of continuity clinic during ambulatory or elective blocks. In addition to continuity clinic, the residents have 2 dedicated 3-week primary care rotations during the course of an academic year. Primary care rotations consist of 5 clinic sessions a week as well as structured teaching sessions. Each resident inherits a panel of patients from an outgoing senior resident, with an average panel size of 96 patients per resident.

Prior to this study intervention, we did not do any formal QI teaching to our residents as part of their primary care curriculum, and previous panel management had focused more on chart reviews of patients whom residents perceived to be higher risk. Residents from all 3 years were included in the intervention. We taught a QI curriculum to our residents from January 2018 to June 2018 during the 3-week primary care rotation, which consisted of the following components:

• Institute for Healthcare Improvement (IHI) module QI 102 completed independently online.
• A 2-hour QI workshop led by 1 of 2 primary care faculty with backgrounds in QI, during which residents were taught basic principles of QI, including how to craft aim statements and design plan-do-study-act (PDSA) cycles, and participated in a hands-on QI activity designed to model rapid cycle improvement (the Paper Airplane Factory¹⁹).
• Distribution of individualized reports of residents’ patient panel data by email at the start of the primary care block that detailed patients’ overall rates of colorectal cancer screening and hypertension (HTN) control, along with the average resident panel rates and the average attending panel rates. The reports also included a list of all residents’ patients who were overdue for colorectal cancer screening or whose last blood pressure (BP) was uncontrolled (systolic BP ≥ 140 mm Hg or diastolic BP ≥  90 mm Hg). These reports were originally designed by our practice’s QI team and run and exported in Microsoft Excel format monthly by our information technology (IT) administrator.
• Instruction on aim statements as a group, followed by the expectation that each resident create an individualized aim statement tailored to each resident’s patient panel rates, with the PDSA cycle to be implemented during the remainder of the primary care rotation, focusing on improvement of colorectal cancer screening and HTN control (see supplementary eFigure 1 online for the worksheet used for the workshop).
• Residents were held accountable for their interventions by various check-ins. At the end of the primary care block, residents were required to submit their completed worksheets showing the intervention they had undertaken and when it was performed. The 2 primary care attendings primarily responsible for QI education would review the resident’s work approximately 1 to 2 months after they submitted their worksheets describing their intervention. These attendings sent the residents personalized feedback based on whether the intervention had been completed or successful as evidenced by documentation in the chart, including direct patient outreach by phone, letter, or portal; outreach to the resident coordinator; scheduled follow-up appointment; or booking or completion of colorectal cancer screening. Along with this feedback, residents were also sent suggestions for next steps. Resident preceptors were copied on the email to facilitate reinforcement of the goals and plans. Finally, the resident preceptors also helped with accountability by going through the residents’ worksheets and patient panel metrics with the residents during biannual evaluations.

Evaluation

Residents were surveyed with a 10-item questionnaire pre and post intervention regarding their attitudes toward QI, understanding of QI principles, and familiarity with their patient panel data. Surveys were anonymous and distributed via the SurveyMonkey platform (see supplementary eFigure 2 online). Residents were asked if they had ever performed a PDSA cycle, performed patient outreach, or performed an intervention and whether they knew the rates of diabetes, HTN, and colorectal cancer screening in their patient panels. Questions rated on a 5-point Likert scale were used to assess comfort with panel management, developing an aim statement, designing and implementing a PDSA cycle, as well as interest in pursuing QI as a career. For the purposes of analysis, these questions were dichotomized into “somewhat comfortable” and “very comfortable” vs “neutral,” “somewhat uncomfortable,” and “very uncomfortable.” Similarly, we dichotomized the question about interest in QI as a career into “somewhat interested” and “very interested” vs “neutral,” “somewhat disinterested,” and “very disinterested.” As the surveys were anonymous, we were unable to pair the pre- and postintervention surveys and used a chi-square test to evaluate whether there was an association between survey assessments pre intervention vs post intervention and a positive or negative response to the question.

We also examined rates of HTN control and colorectal cancer screening in all 75 resident panels pre and post intervention. The paired t-test was used to determine whether the mean change from pre to post intervention was significant. SAS 9.4 (SAS Institute Inc.) was used for all analyses. Institutional Review Board exemption was obtained from the Tufts Medical Center IRB. There was no funding received for this study.

Respondents

Of the 75 residents, 55 (73%) completed the survey prior to the intervention, and 39 (52%) completed the survey after the intervention.

Panel Knowledge and Intervention

Prior to the intervention, 45% of residents had performed a PDSA cycle, compared with 77% post intervention, which was a significant increase (P = .002) (Table 1). Sixty-two percent of residents had performed outreach or an intervention based on their patient panel reports prior to the intervention, compared with 85% of residents post intervention, which was also a significant increase (P = .02). The increase post intervention was not 100%, as there were residents who either missed the initial workshop or who did not follow through with their planned intervention. Common interventions included the residents giving their coordinators a list of patients to call to schedule appointments, utilizing fellow team members (eg, pharmacists, social workers) for targeted patient outreach, or calling patients themselves to reestablish a connection.

In terms of knowledge of their patient panels, prior to the intervention, 55%, 62%, and 62% of residents knew the rates of patients in their panel with diabetes, HTN, and colorectal cancer screening, respectively. After the intervention, the residents’ knowledge of these rates increased significantly, to 85% for diabetes (P = .002), 97% for HTN (P < .0001), and 97% for colorectal cancer screening (P < .0001).

Comfort With QI Approaches

Prior to the intervention, 82% of residents were comfortable managing their primary care panel, which did not change significantly post intervention (Table 2). The residents’ comfort with designing an aim statement did significantly increase, from 55% to 95% (P < .0001). The residents also had a significant increase in comfort with both designing and implementing a PDSA cycle. Prior to the intervention, 22% felt comfortable designing a PDSA cycle, which increased to 79% (P < .0001) post intervention, and 24% felt comfortable implementing a PDSA cycle, which increased to 77% (P < .0001) post intervention.

Patient Outcome Measures

The rate of HTN control in the residents' patient panels did not change significantly pre and post intervention (Table 3). The rate of resident patients who were up to date with colorectal cancer screening increased by 6.5% post intervention (P < .0001).

Interest in QI as a Career

As part of the survey, residents were asked how interested they were in making QI a part of their career. Fifty percent of residents indicated an interest in QI pre intervention, and 54% indicated an interest post intervention, which was not a significant difference (P = .72).

Discussion

In this study, we found that integration of a QI curriculum into a primary care rotation improved both residents’ knowledge of their patient panels and comfort with QI approaches, which translated to improvement in patient outcomes. Several previous studies have found improvements in resident self-assessment or knowledge after implementation of a QI curriculum.^4-13 Liao et al implemented a longitudinal curriculum including both didactic and experiential components and found an improvement in both QI confidence and knowledge.³ Similarly, Duello et al⁸ found that a curriculum including both didactic lectures and QI projects improved subjective QI knowledge and comfort. Interestingly, Fok and Wong⁹ found that resident knowledge could be sustained post curriculum after completion of a QI project, suggesting that experiential learning may be helpful in maintaining knowledge.

Studies also have looked at providing performance data to residents. Hwang et al¹⁸ found that providing audit and feedback in the form of individual panel performance data to residents compared with practice targets led to statistically significant improvement in cancer screening rates and composite quality score, indicating that there is tremendous potential in providing residents with their data. While the ACGME mandates that residents should receive data on their quality metrics, on CLER visits, many residents interviewed noted limited access to data on their metrics and benchmarks.^1,2

Though previous studies have individually looked at teaching QI concepts, providing panel data, or targeting select metrics, our study was unique in that it reviewed both self-reported resident outcomes data as well as actual patient outcomes. In addition to finding increased knowledge of patient panels and comfort with QI approaches, we found a significant increase in colorectal cancer screening rates post intervention. We thought this finding was particularly important given some data that residents' patients have been found to have worse outcomes on quality metrics compared with patients cared for by staff physicians.^14,15 Given that having a resident physician as a PCP has been associated with failing to meet quality measures, it is especially important to focus targeted quality improvement initiatives in this patient population to reduce disparities in care.

We found that residents had improved knowledge on their patient panels as a result of this initiative. The residents were noted to have a higher knowledge of their HTN and colorectal cancer screening rates in comparison to their diabetes metrics. We suspect this is because residents are provided with multiple metrics related to diabetes, including process measures such as A1c testing, as well as outcome measures such as A1c control, so it may be harder for them to elucidate exactly how they are doing with their diabetes patients, whereas in HTN control and colorectal cancer screening, there is only 1 associated metric. Interestingly, even though HTN and colorectal cancer screening were the 2 measures focused on in the study, the residents had a significant improvement in knowledge of the rates of diabetes in their panel as well. This suggests that even just receiving data alone is valuable, hopefully translating to better outcomes with better baseline understanding of panels. We believe that our intervention was successful because it included both a didactic and an experiential component, as well as the use of individual panel performance data.

There were several limitations to our study. It was performed at a single institution, translating to a small sample size. Our data analysis was limited because we were unable to pair our pre- and postintervention survey responses because we used an anonymous survey. We also did not have full participation in postintervention surveys from all residents, which may have biased the study in favor of high performers. Another limitation was that our survey relied on self-reported outcomes for the questions about the residents knowing their patient panels.

This study required a 2-hour workshop every 3 weeks led by a faculty member trained in QI. Given the amount of time needed for the curriculum, this study may be difficult to replicate at other institutions, especially if faculty with an interest or training in QI are not available. Given our finding that residents had increased knowledge of their patient panels after receiving panel metrics, simply providing data with the goal of smaller, focused interventions may be easier to implement. At our institution, we discontinued the longer 2-hour QI workshops designed to teach QI approaches more broadly. We continue to provide individualized panel data to all residents during their primary care rotations and conduct half-hour, small group workshops with the interns that focus on drafting aim statements and planning interventions. All residents are required to submit worksheets to us at the end of their primary care blocks listing their current rates of each predetermined metric and laying out their aim statements and planned interventions. Residents also continue to receive feedback from our faculty with expertise in QI afterward on their plans and evidence of follow-through in the chart, with their preceptors included on the feedback emails. Even without the larger QI workshop, this approach has continued to be successful and appreciated. In fact, it does appear as though improvement in colorectal cancer screening has been sustained over several years. At the end of our study period, the resident patient colorectal cancer screening rate rose from 34% to 43%, and for the 2021-2022 academic year, the rate rose further, from 46% to 50%.

Given that the resident clinic patient population is at higher risk overall, targeted outreach and approaches to improve quality must be continued. Future areas of research include looking at which interventions, whether QI curriculum, provision of panel data, or required panel management interventions, translate to the greatest improvements in patient outcomes in this vulnerable population.

Conclusion

Our study showed that a dedicated QI curriculum for the residents and access to quality metric data improved both resident knowledge and comfort with QI approaches. Beyond resident-centered outcomes, there was also translation to improved patient outcomes, with a significant increase in colon cancer screening rates post intervention.

Corresponding author: Kinjalika Sathi, MD, 800 Washington St., Boston, MA 02111; [email protected]

Disclosures: None reported.

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

A version of this article originally appeared on Medscape.com.

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

A version of this article originally appeared on Medscape.com.

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

A version of this article originally appeared on Medscape.com.

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

Abstract

Diagnostic errors in hospitalized patients are a leading cause of preventable morbidity and mortality. Significant challenges in defining and measuring diagnostic errors and underlying process failure points have led to considerable variability in reported rates of diagnostic errors and adverse outcomes. In this article, we explore the diagnostic process and its discrete components, emphasizing the centrality of the patient in decision-making as well as the continuous nature of the process. We review the incidence of diagnostic errors in hospitalized patients and different methodological approaches that have been used to arrive at these estimates. We discuss different but interdependent provider- and system-related process-failure points that lead to diagnostic errors. We examine specific challenges related to measurement of diagnostic errors and describe traditional and novel approaches that are being used to obtain the most precise estimates. Finally, we examine various patient-, provider-, and organizational-level interventions that have been proposed to improve diagnostic safety in hospitalized patients.

Keywords: diagnostic error, hospital medicine, patient safety.

Diagnosis is defined as a “pre-existing set of categories agreed upon by the medical profession to designate a specific condition.”¹ The diagnostic process involves obtaining a clinical history, performing a physical examination, conducting diagnostic testing, and consulting with other clinical providers to gather data that are relevant to understanding the underlying disease processes. This exercise involves generating hypotheses and updating prior probabilities as more information and evidence become available. Throughout this process of information gathering, integration, and interpretation, there is an ongoing assessment of whether sufficient and necessary knowledge has been obtained to make an accurate diagnosis and provide appropriate treatment.²

Diagnostic error is defined as a missed opportunity to make a timely diagnosis as part of this iterative process, including the failure of communicating the diagnosis to the patient in a timely manner.³ It can be categorized as a missed, delayed, or incorrect diagnosis based on available evidence at the time. Establishing the correct diagnosis has important implications. A timely and precise diagnosis ensures the patient the highest probability of having a positive health outcome that reflects an appropriate understanding of underlying disease processes and is consistent with their overall goals of care.³ When diagnostic errors occur, they can cause patient harm. Adverse events due to medical errors, including diagnostic errors, are estimated to be the third leading cause of death in the United States.⁴ Most people will experience at least 1 diagnostic error in their lifetime. In the 2015 National Academy of Medicine report Improving Diagnosis in Healthcare, diagnostic errors were identified as a major hazard as well as an opportunity to improve patient outcomes.²

Diagnostic errors during hospitalizations are especially concerning, as they are more likely to be implicated in a wider spectrum of harm, including permanent disability and death. This has become even more relevant for hospital medicine physicians and other clinical providers as they encounter increasing cognitive and administrative workloads, rising dissatisfaction and burnout, and unique obstacles such as night-time scheduling.⁵

Incidence of Diagnostic Errors in Hospitalized Patients

Several methodological approaches have been used to estimate the incidence of diagnostic errors in hospitalized patients. These include retrospective reviews of a sample of all hospital admissions, evaluations of selected adverse outcomes including autopsy studies, patient and provider surveys, and malpractice claims. Laboratory testing audits and secondary reviews in other diagnostic subspecialities (eg, radiology, pathology, and microbiology) are also essential to improving diagnostic performance in these specialized fields, which in turn affects overall hospital diagnostic error rates.^6-8 These diverse approaches provide unique insights regarding our ability to assess the degree to which potential harms, ranging from temporary impairment to permanent disability, to death, are attributable to different failure points in the diagnostic process.

Large retrospective chart reviews of random hospital admissions remain the most accurate way to determine the overall incidence of diagnostic errors in hospitalized patients.⁹ The Harvard Medical Practice Study, published in 1991, laid the groundwork for measuring the incidence of adverse events in hospitalized patients and assessing their relation to medical error, negligence, and disability. Reviewing 30,121 randomly selected records from 51 randomly selected acute care hospitals in New York State, the study found that adverse events occurred in 3.7% of hospitalizations, diagnostic errors accounted for 13.8% of these events, and these errors were likely attributable to negligence in 74.7% of cases. The study not only outlined individual-level process failures, but also focused attention on some of the systemic causes, setting the agenda for quality improvement research in hospital-based care for years to come.^10-12 A recent systematic review and meta-analysis of 22 hospital admission studies found a pooled rate of 0.7% (95% CI, 0.5%-1.1%) for harmful diagnostic errors.⁹ It found significant variations in the rates of adverse events, diagnostic errors, and range of diagnoses that were missed. This was primarily because of variabilities in pre-test probabilities in detecting diagnostic errors in these specific cohorts, as well as due to heterogeneity in study definitions and methodologies, especially regarding how they defined and measured “diagnostic error.” The analysis, however, did not account for diagnostic errors that were not related to patient harm (missed opportunities); therefore, it likely significantly underestimated the true incidence of diagnostic errors in these study populations. Table 1 summarizes some of key studies that have examined the incidence of harmful diagnostic errors in hospitalized patients.^9-21

The chief limitation of reviewing random hospital admissions is that, since overall rates of diagnostic errors are still relatively low, a large number of case reviews are required to identify a sufficient sample of adverse outcomes to gain a meaningful understanding of the underlying process failure points and develop tools for remediation. Patient and provider surveys or data from malpractice claims can be high-yield starting points for research on process errors.^22,23 Reviews of enriched cohorts of adverse outcomes, such as rapid-response events, intensive care unit (ICU) transfers, deaths, and hospital readmissions, can be an efficient way to identify process failures that lead to greatest harm. Depending on the research approach and the types of underlying patient populations sampled, rates of diagnostic errors in these high-risk groups have been estimated to be approximately 5% to 20%, or even higher.^6,24-31 For example, a retrospective study of 391 cases of unplanned 7-day readmissions found that 5.6% of cases contained at least 1 diagnostic error during the index admission.³² In a study conducted at 6 Belgian acute-care hospitals, 56% of patients requiring an unplanned transfer to a higher level of care were determined to have had an adverse event, and of these adverse events, 12.4% of cases were associated with errors in diagnosis.²⁹ A systematic review of 16 hospital-based studies estimated that 3.1% of all inpatient deaths were likely preventable, which corresponded to 22,165 deaths annually in the United States.³⁰ Another such review of 31 autopsy studies reported that 28% of autopsied ICU patients had at least 1 misdiagnosis; of these diagnostic errors, 8% were classified as potentially lethal, and 15% were considered major but not lethal.³¹ Significant drawbacks of such enriched cohort studies, however, are their poor generalizability and inability to detect failure points that do not lead to patient harm (near-miss events).³³

Causes of Diagnostic Errors in Hospitalized Patients

All aspects of the diagnostic process are susceptible to errors. These errors stem from a variety of faulty processes, including failure of the patient to engage with the health care system (eg, due to lack of insurance or transportation, or delay in seeking care); failure in information gathering (eg, missed history or exam findings, ordering wrong tests, laboratory errors); failure in information interpretation (eg, exam finding or test result misinterpretation); inaccurate hypothesis generation (eg, due to suboptimal prioritization or weighing of supporting evidence); and failure in communication (eg, with other team members or with the patient).^2,34 Reasons for diagnostic process failures vary widely across different health care settings. While clinician assessment errors (eg, failure to consider or alternatively overweigh competing diagnoses) and errors in testing and the monitoring phase (eg, failure to order or follow up diagnostic tests) can lead to a majority of diagnostic errors in some patient populations, in other settings, social (eg, poor health literacy, punitive cultural practices) and economic factors (eg, lack of access to appropriate diagnostic tests or to specialty expertise) play a more prominent role.^34,35

The Figure describes the relationship between components of the diagnostic process and subsequent outcomes, including diagnostic process failures, diagnostic errors, and absence or presence of patient harm.^2,36,37 It reemphasizes the centrality of the patient in decision-making and the continuous nature of the process. The Figure also illustrates that only a minority of process failures result in diagnostic errors, and a smaller proportion of diagnostic errors actually lead to patient harm. Conversely, it also shows that diagnostic errors can happen without any obvious process-failure points, and, similarly, patient harm can take place in the absence of any evident diagnostic errors.^36-38 Finally, it highlights the need to incorporate feedback from process failures, diagnostic errors, and favorable and unfavorable patient outcomes in order to inform future quality improvement efforts and research.

A significant proportion of diagnostic errors are due to system-related vulnerabilities, such as limitations in availability, adoption or quality of work force training, health informatics resources, and diagnostic capabilities. Lack of institutional culture that promotes safety and transparency also predisposes to diagnostic errors.^39,40 The other major domain of process failures is related to cognitive errors in clinician decision-making. Anchoring, confirmation bias, availability bias, and base-rate neglect are some of the common cognitive biases that, along with personality traits (aversion to risk or ambiguity, overconfidence) and affective biases (influence of emotion on decision-making), often determine the degree of utilization of resources and the possibility of suboptimal diagnostic performance.^41,42 Further, implicit biases related to age, race, gender, and sexual orientation contribute to disparities in access to health care and outcomes.⁴³ In a large number of cases of preventable adverse outcomes, however, there are multiple interdependent individual and system-related failure points that lead to diagnostic error and patient harm.^6,32

Challenges in Defining and Measuring Diagnostic Errors

In order to develop effective, evidence-based interventions to reduce diagnostic errors in hospitalized patients, it is essential to be able to first operationally define, and then accurately measure, diagnostic errors and the process failures that contribute to these errors in a standardized way that is reproducible across different settings.^6,44 There are a number of obstacles in this endeavor.

A fundamental problem is that establishing a diagnosis is not a single act but a process. Patterns of symptoms and clinical presentations often differ for the same disease. Information required to make a diagnosis is usually gathered in stages, where the clinician obtains additional data, while considering many possibilities, of which 1 may be ultimately correct. Diagnoses evolve over time and in different care settings. “The most likely diagnosis” is not always the same as “the final correct diagnosis.” Moreover, the diagnostic process is influenced by patients’ individual clinical courses and preferences over time. This makes determination of missed, delayed, or incorrect diagnoses challenging.^45,46

For hospitalized patients, generally the goal is to first rule out more serious and acute conditions (eg, pulmonary embolism or stroke), even if their probability is rather low. Conversely, a diagnosis that appears less consequential if delayed (eg, chronic anemia of unclear etiology) might not be pursued on an urgent basis, and is often left to outpatient providers to examine, but still may manifest in downstream harm (eg, delayed diagnosis of gastrointestinal malignancy or recurrent admissions for heart failure due to missed iron-deficiency anemia). Therefore, coming up with disease diagnosis likelihoods in hindsight may turn out to be highly subjective and not always accurate. This can be particularly difficult when clinician and other team deliberations are not recorded in their entirety.⁴⁷

Another hurdle in the practice of diagnostic medicine is to preserve the balance between underdiagnosing versus pursuing overly aggressive diagnostic approaches. Conducting laboratory, imaging, or other diagnostic studies without a clear shared understanding of how they would affect clinical decision-making (eg, use of prostate-specific antigen to detect prostate cancer) not only leads to increased costs but can also delay appropriate care. Worse, subsequent unnecessary diagnostic tests and treatments can sometimes lead to serious harm.^48,49

Finally, retrospective reviews by clinicians are subject to multiple potential limitations that include failure to create well-defined research questions, poorly developed inclusion and exclusion criteria, and issues related to inter- and intra-rater reliability.⁵⁰ These methodological deficiencies can occur despite following "best practice" guidelines during the study planning, execution, and analysis phases. They further add to the challenge of defining and measuring diagnostic errors.⁴⁷

Strategies to Improve Measurement of Diagnostic Errors

Development of new methodologies to reliably measure diagnostic errors is an area of active research. The advancement of uniform and universally agreed-upon frameworks to define and identify process failure points and diagnostic errors would help reduce measurement error and support development and testing of interventions that could be generalizable across different health care settings. To more accurately define and measure diagnostic errors, several novel approaches have been proposed (Table 2).

The Safer Dx framework is an all-round tool developed to advance the discipline of measuring diagnostic errors. For an episode of care under review, the instrument scores various items to determine the likelihood of a diagnostic error. These items evaluate multiple dimensions affecting diagnostic performance and measurements across 3 broad domains: structure (provider and organizational characteristics—from everyone involved with patient care, to computing infrastructure, to policies and regulations), process (elements of the patient-provider encounter, diagnostic test performance and follow-up, and subspecialty- and referral-specific factors), and outcome (establishing accurate and timely diagnosis as opposed to missed, delayed, or incorrect diagnosis). This instrument has been revised and can be further modified by a variety of stakeholders, including clinicians, health care organizations, and policymakers, to identify potential diagnostic errors in a standardized way for patient safety and quality improvement research.^51,52

Use of standardized tools, such as the Diagnosis Error Evaluation and Research (DEER) taxonomy, can help to identify and classify specific failure points across different diagnostic process dimensions.³⁷ These failure points can be classified into: issues related to patient presentation or access to health care; failure to obtain or misinterpretation of history or physical exam findings; errors in use of diagnostics tests due to technical or clinician-related factors; failures in appropriate weighing of evidence and hypothesis generation; errors associated with referral or consultation process; and failure to monitor the patient or obtain timely follow-up.³⁴ The DEER taxonomy can also be modified based on specific research questions and study populations. Further, it can be recategorized to correspond to Safer Dx framework diagnostic process dimensions to provide insights into reasons for specific process failures and to develop new interventions to mitigate errors and patient harm.⁶

Since a majority of diagnostic errors do not lead to actual harm, use of “triggers” or clues (eg, procedure-related complications, patient falls, transfers to a higher level of care, readmissions within 30 days) can be a more efficient method to identify diagnostic errors and adverse events that do cause harm. The Global Trigger Tool, developed by the Institute for Healthcare Improvement, uses this strategy. This tool has been shown to identify a significantly higher number of serious adverse events than comparable methods.⁵³ This facilitates selection and development of strategies at the institutional level that are most likely to improve patient outcomes.²⁴

Encouraging and facilitating voluntary or prompted reporting from patients and clinicians can also play an important role in capturing diagnostic errors. Patients and clinicians are not only the key stakeholders but are also uniquely placed within the diagnostic process to detect and report potential errors.^25,54 Patient-safety-event reporting systems, such as RL6, play a vital role in reporting near-misses and adverse events. These systems provide a mechanism for team members at all levels within the hospital to contribute toward reporting patient adverse events, including those arising from diagnostic errors.⁵⁵ The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first standardized, nationally reported patient survey designed to measure patients’ perceptions of their hospital experience. The US Centers for Medicare and Medicaid Services (CMS) publishes HCAHPS results on its website 4 times a year, which serves as an important incentive for hospitals to improve patient safety and quality of health care delivery.⁵⁶

Another novel approach links multiple symptoms to a range of target diseases using the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) framework. Using “big data” technologies, this technique can help discover otherwise hidden symptom-disease links and improve overall diagnostic performance. This approach is proposed for both case-control (look-back) and cohort (look-forward) studies assessing diagnostic errors and misdiagnosis-related harms. For example, starting with a known diagnosis with high potential for harm (eg, stroke), the “look-back” approach can be used to identify high-risk symptoms (eg, dizziness, vertigo). In the “look-forward” approach, a single symptom or exposure risk factor known to be frequently misdiagnosed (eg, dizziness) can be analyzed to identify potential adverse disease outcomes (eg, stroke, migraine).⁵⁷

Many large ongoing studies looking at diagnostic errors among hospitalized patients, such as Utility of Predictive Systems to identify Inpatient Diagnostic Errors (UPSIDE),⁵⁸Patient Safety Learning Lab (PSLL),⁵⁹ and Achieving Diagnostic Excellence through Prevention and Teamwork (ADEPT),⁶⁰ are using structured chart review methodologies incorporating many of the above strategies in combination. Cases triggered by certain events (eg, ICU transfer, death, rapid response event, new or worsening acute kidney injury) are reviewed using validated tools, including Safer Dx framework and DEER taxonomy, to provide the most precise estimates of the burden of diagnostic errors in hospitalized patients. These estimates may be much higher than previously predicted using traditional chart review approaches.^6,24 For example, a recently published study of 2809 random admissions in 11 Massachusetts hospitals identified 978 adverse events but only 10 diagnostic errors (diagnostic error rate, 0.4%).¹⁹ This was likely because the trigger method used in the study did not specifically examine the diagnostic process as critically as done by the Safer Dx framework and DEER taxonomy tools, thereby underestimating the total number of diagnostic errors. Further, these ongoing studies (eg, UPSIDE, ADEPT) aim to employ new and upcoming advanced machine-learning methods to create models that can improve overall diagnostic performance. This would pave the way to test and build novel, efficient, and scalable interventions to reduce diagnostic errors and improve patient outcomes.

Strategies to Improve Diagnostic Safety in Hospitalized Patients

Disease-specific biomedical research, as well as advances in laboratory, imaging, and other technologies, play a critical role in improving diagnostic accuracy. However, these technical approaches do not address many of the broader clinician- and system-level failure points and opportunities for improvement. Various patient-, provider-, and organizational-level interventions that could make diagnostic processes more resilient and reduce the risk of error and patient harm have been proposed.⁶¹

Among these strategies are approaches to empower patients and their families. Fostering therapeutic relationships between patients and members of the care team is essential to reducing diagnostic errors.⁶² Facilitating timely access to health records, ensuring transparency in decision making, and tailoring communication strategies to patients’ cultural and educational backgrounds can reduce harm.⁶³ Similarly, at the system level, enhancing communication among different providers by use of tools such as structured handoffs can prevent communication breakdowns and facilitate positive outcomes.⁶⁴

Interventions targeted at individual health care providers, such as educational programs to improve content-specific knowledge, can enhance diagnostic performance. Regular feedback, strategies to enhance equity, and fostering an environment where all providers are actively encouraged to think critically and participate in the diagnostic process (training programs to use “diagnostic time-outs” and making it a “team sport”) can improve clinical reasoning.^65,66 Use of standardized patients can help identify individual-level cognitive failure points and facilitate creation of new interventions to improve clinical decision-making processes.⁶⁷

Novel health information technologies can further augment these efforts. These include effective documentation by maintaining dynamic and accurate patient histories, problem lists, and medication lists^68-70; use of electronic health record–based algorithms to identify potential diagnostic delays for serious conditions^71,72; use of telemedicine technologies to improve accessibility and coordination⁷³;application of mobile health and wearable technologies to facilitate data-gathering and care delivery^74,75; and use of computerized decision-support tools, including applications to interpret electrocardiograms, imaging studies, and other diagnostic tests.⁷⁶

Use of precision medicine, powered by new artificial intelligence (AI) tools, is becoming more widespread. Algorithms powered by AI can augment and sometimes even outperform clinician decision-making in areas such as oncology, radiology, and primary care.⁷⁷ Creation of large biobanks like the All of Us research program can be used to study thousands of environmental and genetic risk factors and health conditions simultaneously, and help identify specific treatments that work best for people of different backgrounds.⁷⁸ Active research in these areas holds great promise in terms of how and when we diagnose diseases and make appropriate preventative and treatment decisions. Significant scientific, ethical, and regulatory challenges will need to be overcome before these technologies can address some of the most complex problems in health care.⁷⁹

Finally, diagnostic performance is affected by the external environment, including the functioning of the medical liability system. Diagnostic errors that lead to patient harm are a leading cause of malpractice claims.⁸⁰ Developing a legal environment, in collaboration with patient advocacy groups and health care organizations, that promotes and facilitates timely disclosure of diagnostic errors could decrease the incentive to hide errors, advance care processes, and improve outcomes.^81,82

Conclusion

The burden of diagnostic errors in hospitalized patients is unacceptably high and remains an underemphasized cause of preventable morbidity and mortality. Diagnostic errors often result from a breakdown in multiple interdependent processes that involve patient-, provider-, and system-level factors. Significant challenges remain in defining and identifying diagnostic errors as well as underlying process-failure points. The most effective interventions to reduce diagnostic errors will require greater patient participation in the diagnostic process and a mix of evidence-based interventions that promote individual-provider excellence as well as system-level changes. Further research and collaboration among various stakeholders should help improve diagnostic safety for hospitalized patients.

Corresponding author: Abhishek Goyal, MD, MPH; [email protected]

Disclosures: Dr. Dalal disclosed receiving income ≥ $250 from MayaMD.

Abstract

Diagnostic errors in hospitalized patients are a leading cause of preventable morbidity and mortality. Significant challenges in defining and measuring diagnostic errors and underlying process failure points have led to considerable variability in reported rates of diagnostic errors and adverse outcomes. In this article, we explore the diagnostic process and its discrete components, emphasizing the centrality of the patient in decision-making as well as the continuous nature of the process. We review the incidence of diagnostic errors in hospitalized patients and different methodological approaches that have been used to arrive at these estimates. We discuss different but interdependent provider- and system-related process-failure points that lead to diagnostic errors. We examine specific challenges related to measurement of diagnostic errors and describe traditional and novel approaches that are being used to obtain the most precise estimates. Finally, we examine various patient-, provider-, and organizational-level interventions that have been proposed to improve diagnostic safety in hospitalized patients.

Keywords: diagnostic error, hospital medicine, patient safety.

Diagnosis is defined as a “pre-existing set of categories agreed upon by the medical profession to designate a specific condition.”¹ The diagnostic process involves obtaining a clinical history, performing a physical examination, conducting diagnostic testing, and consulting with other clinical providers to gather data that are relevant to understanding the underlying disease processes. This exercise involves generating hypotheses and updating prior probabilities as more information and evidence become available. Throughout this process of information gathering, integration, and interpretation, there is an ongoing assessment of whether sufficient and necessary knowledge has been obtained to make an accurate diagnosis and provide appropriate treatment.²

Diagnostic error is defined as a missed opportunity to make a timely diagnosis as part of this iterative process, including the failure of communicating the diagnosis to the patient in a timely manner.³ It can be categorized as a missed, delayed, or incorrect diagnosis based on available evidence at the time. Establishing the correct diagnosis has important implications. A timely and precise diagnosis ensures the patient the highest probability of having a positive health outcome that reflects an appropriate understanding of underlying disease processes and is consistent with their overall goals of care.³ When diagnostic errors occur, they can cause patient harm. Adverse events due to medical errors, including diagnostic errors, are estimated to be the third leading cause of death in the United States.⁴ Most people will experience at least 1 diagnostic error in their lifetime. In the 2015 National Academy of Medicine report Improving Diagnosis in Healthcare, diagnostic errors were identified as a major hazard as well as an opportunity to improve patient outcomes.²

Diagnostic errors during hospitalizations are especially concerning, as they are more likely to be implicated in a wider spectrum of harm, including permanent disability and death. This has become even more relevant for hospital medicine physicians and other clinical providers as they encounter increasing cognitive and administrative workloads, rising dissatisfaction and burnout, and unique obstacles such as night-time scheduling.⁵

Incidence of Diagnostic Errors in Hospitalized Patients

Several methodological approaches have been used to estimate the incidence of diagnostic errors in hospitalized patients. These include retrospective reviews of a sample of all hospital admissions, evaluations of selected adverse outcomes including autopsy studies, patient and provider surveys, and malpractice claims. Laboratory testing audits and secondary reviews in other diagnostic subspecialities (eg, radiology, pathology, and microbiology) are also essential to improving diagnostic performance in these specialized fields, which in turn affects overall hospital diagnostic error rates.^6-8 These diverse approaches provide unique insights regarding our ability to assess the degree to which potential harms, ranging from temporary impairment to permanent disability, to death, are attributable to different failure points in the diagnostic process.

Large retrospective chart reviews of random hospital admissions remain the most accurate way to determine the overall incidence of diagnostic errors in hospitalized patients.⁹ The Harvard Medical Practice Study, published in 1991, laid the groundwork for measuring the incidence of adverse events in hospitalized patients and assessing their relation to medical error, negligence, and disability. Reviewing 30,121 randomly selected records from 51 randomly selected acute care hospitals in New York State, the study found that adverse events occurred in 3.7% of hospitalizations, diagnostic errors accounted for 13.8% of these events, and these errors were likely attributable to negligence in 74.7% of cases. The study not only outlined individual-level process failures, but also focused attention on some of the systemic causes, setting the agenda for quality improvement research in hospital-based care for years to come.^10-12 A recent systematic review and meta-analysis of 22 hospital admission studies found a pooled rate of 0.7% (95% CI, 0.5%-1.1%) for harmful diagnostic errors.⁹ It found significant variations in the rates of adverse events, diagnostic errors, and range of diagnoses that were missed. This was primarily because of variabilities in pre-test probabilities in detecting diagnostic errors in these specific cohorts, as well as due to heterogeneity in study definitions and methodologies, especially regarding how they defined and measured “diagnostic error.” The analysis, however, did not account for diagnostic errors that were not related to patient harm (missed opportunities); therefore, it likely significantly underestimated the true incidence of diagnostic errors in these study populations. Table 1 summarizes some of key studies that have examined the incidence of harmful diagnostic errors in hospitalized patients.^9-21

The chief limitation of reviewing random hospital admissions is that, since overall rates of diagnostic errors are still relatively low, a large number of case reviews are required to identify a sufficient sample of adverse outcomes to gain a meaningful understanding of the underlying process failure points and develop tools for remediation. Patient and provider surveys or data from malpractice claims can be high-yield starting points for research on process errors.^22,23 Reviews of enriched cohorts of adverse outcomes, such as rapid-response events, intensive care unit (ICU) transfers, deaths, and hospital readmissions, can be an efficient way to identify process failures that lead to greatest harm. Depending on the research approach and the types of underlying patient populations sampled, rates of diagnostic errors in these high-risk groups have been estimated to be approximately 5% to 20%, or even higher.^6,24-31 For example, a retrospective study of 391 cases of unplanned 7-day readmissions found that 5.6% of cases contained at least 1 diagnostic error during the index admission.³² In a study conducted at 6 Belgian acute-care hospitals, 56% of patients requiring an unplanned transfer to a higher level of care were determined to have had an adverse event, and of these adverse events, 12.4% of cases were associated with errors in diagnosis.²⁹ A systematic review of 16 hospital-based studies estimated that 3.1% of all inpatient deaths were likely preventable, which corresponded to 22,165 deaths annually in the United States.³⁰ Another such review of 31 autopsy studies reported that 28% of autopsied ICU patients had at least 1 misdiagnosis; of these diagnostic errors, 8% were classified as potentially lethal, and 15% were considered major but not lethal.³¹ Significant drawbacks of such enriched cohort studies, however, are their poor generalizability and inability to detect failure points that do not lead to patient harm (near-miss events).³³

Causes of Diagnostic Errors in Hospitalized Patients

All aspects of the diagnostic process are susceptible to errors. These errors stem from a variety of faulty processes, including failure of the patient to engage with the health care system (eg, due to lack of insurance or transportation, or delay in seeking care); failure in information gathering (eg, missed history or exam findings, ordering wrong tests, laboratory errors); failure in information interpretation (eg, exam finding or test result misinterpretation); inaccurate hypothesis generation (eg, due to suboptimal prioritization or weighing of supporting evidence); and failure in communication (eg, with other team members or with the patient).^2,34 Reasons for diagnostic process failures vary widely across different health care settings. While clinician assessment errors (eg, failure to consider or alternatively overweigh competing diagnoses) and errors in testing and the monitoring phase (eg, failure to order or follow up diagnostic tests) can lead to a majority of diagnostic errors in some patient populations, in other settings, social (eg, poor health literacy, punitive cultural practices) and economic factors (eg, lack of access to appropriate diagnostic tests or to specialty expertise) play a more prominent role.^34,35

The Figure describes the relationship between components of the diagnostic process and subsequent outcomes, including diagnostic process failures, diagnostic errors, and absence or presence of patient harm.^2,36,37 It reemphasizes the centrality of the patient in decision-making and the continuous nature of the process. The Figure also illustrates that only a minority of process failures result in diagnostic errors, and a smaller proportion of diagnostic errors actually lead to patient harm. Conversely, it also shows that diagnostic errors can happen without any obvious process-failure points, and, similarly, patient harm can take place in the absence of any evident diagnostic errors.^36-38 Finally, it highlights the need to incorporate feedback from process failures, diagnostic errors, and favorable and unfavorable patient outcomes in order to inform future quality improvement efforts and research.

A significant proportion of diagnostic errors are due to system-related vulnerabilities, such as limitations in availability, adoption or quality of work force training, health informatics resources, and diagnostic capabilities. Lack of institutional culture that promotes safety and transparency also predisposes to diagnostic errors.^39,40 The other major domain of process failures is related to cognitive errors in clinician decision-making. Anchoring, confirmation bias, availability bias, and base-rate neglect are some of the common cognitive biases that, along with personality traits (aversion to risk or ambiguity, overconfidence) and affective biases (influence of emotion on decision-making), often determine the degree of utilization of resources and the possibility of suboptimal diagnostic performance.^41,42 Further, implicit biases related to age, race, gender, and sexual orientation contribute to disparities in access to health care and outcomes.⁴³ In a large number of cases of preventable adverse outcomes, however, there are multiple interdependent individual and system-related failure points that lead to diagnostic error and patient harm.^6,32

Challenges in Defining and Measuring Diagnostic Errors

In order to develop effective, evidence-based interventions to reduce diagnostic errors in hospitalized patients, it is essential to be able to first operationally define, and then accurately measure, diagnostic errors and the process failures that contribute to these errors in a standardized way that is reproducible across different settings.^6,44 There are a number of obstacles in this endeavor.

A fundamental problem is that establishing a diagnosis is not a single act but a process. Patterns of symptoms and clinical presentations often differ for the same disease. Information required to make a diagnosis is usually gathered in stages, where the clinician obtains additional data, while considering many possibilities, of which 1 may be ultimately correct. Diagnoses evolve over time and in different care settings. “The most likely diagnosis” is not always the same as “the final correct diagnosis.” Moreover, the diagnostic process is influenced by patients’ individual clinical courses and preferences over time. This makes determination of missed, delayed, or incorrect diagnoses challenging.^45,46

For hospitalized patients, generally the goal is to first rule out more serious and acute conditions (eg, pulmonary embolism or stroke), even if their probability is rather low. Conversely, a diagnosis that appears less consequential if delayed (eg, chronic anemia of unclear etiology) might not be pursued on an urgent basis, and is often left to outpatient providers to examine, but still may manifest in downstream harm (eg, delayed diagnosis of gastrointestinal malignancy or recurrent admissions for heart failure due to missed iron-deficiency anemia). Therefore, coming up with disease diagnosis likelihoods in hindsight may turn out to be highly subjective and not always accurate. This can be particularly difficult when clinician and other team deliberations are not recorded in their entirety.⁴⁷

Another hurdle in the practice of diagnostic medicine is to preserve the balance between underdiagnosing versus pursuing overly aggressive diagnostic approaches. Conducting laboratory, imaging, or other diagnostic studies without a clear shared understanding of how they would affect clinical decision-making (eg, use of prostate-specific antigen to detect prostate cancer) not only leads to increased costs but can also delay appropriate care. Worse, subsequent unnecessary diagnostic tests and treatments can sometimes lead to serious harm.^48,49

Finally, retrospective reviews by clinicians are subject to multiple potential limitations that include failure to create well-defined research questions, poorly developed inclusion and exclusion criteria, and issues related to inter- and intra-rater reliability.⁵⁰ These methodological deficiencies can occur despite following "best practice" guidelines during the study planning, execution, and analysis phases. They further add to the challenge of defining and measuring diagnostic errors.⁴⁷

Strategies to Improve Measurement of Diagnostic Errors

Development of new methodologies to reliably measure diagnostic errors is an area of active research. The advancement of uniform and universally agreed-upon frameworks to define and identify process failure points and diagnostic errors would help reduce measurement error and support development and testing of interventions that could be generalizable across different health care settings. To more accurately define and measure diagnostic errors, several novel approaches have been proposed (Table 2).

The Safer Dx framework is an all-round tool developed to advance the discipline of measuring diagnostic errors. For an episode of care under review, the instrument scores various items to determine the likelihood of a diagnostic error. These items evaluate multiple dimensions affecting diagnostic performance and measurements across 3 broad domains: structure (provider and organizational characteristics—from everyone involved with patient care, to computing infrastructure, to policies and regulations), process (elements of the patient-provider encounter, diagnostic test performance and follow-up, and subspecialty- and referral-specific factors), and outcome (establishing accurate and timely diagnosis as opposed to missed, delayed, or incorrect diagnosis). This instrument has been revised and can be further modified by a variety of stakeholders, including clinicians, health care organizations, and policymakers, to identify potential diagnostic errors in a standardized way for patient safety and quality improvement research.^51,52

Use of standardized tools, such as the Diagnosis Error Evaluation and Research (DEER) taxonomy, can help to identify and classify specific failure points across different diagnostic process dimensions.³⁷ These failure points can be classified into: issues related to patient presentation or access to health care; failure to obtain or misinterpretation of history or physical exam findings; errors in use of diagnostics tests due to technical or clinician-related factors; failures in appropriate weighing of evidence and hypothesis generation; errors associated with referral or consultation process; and failure to monitor the patient or obtain timely follow-up.³⁴ The DEER taxonomy can also be modified based on specific research questions and study populations. Further, it can be recategorized to correspond to Safer Dx framework diagnostic process dimensions to provide insights into reasons for specific process failures and to develop new interventions to mitigate errors and patient harm.⁶

Since a majority of diagnostic errors do not lead to actual harm, use of “triggers” or clues (eg, procedure-related complications, patient falls, transfers to a higher level of care, readmissions within 30 days) can be a more efficient method to identify diagnostic errors and adverse events that do cause harm. The Global Trigger Tool, developed by the Institute for Healthcare Improvement, uses this strategy. This tool has been shown to identify a significantly higher number of serious adverse events than comparable methods.⁵³ This facilitates selection and development of strategies at the institutional level that are most likely to improve patient outcomes.²⁴

Encouraging and facilitating voluntary or prompted reporting from patients and clinicians can also play an important role in capturing diagnostic errors. Patients and clinicians are not only the key stakeholders but are also uniquely placed within the diagnostic process to detect and report potential errors.^25,54 Patient-safety-event reporting systems, such as RL6, play a vital role in reporting near-misses and adverse events. These systems provide a mechanism for team members at all levels within the hospital to contribute toward reporting patient adverse events, including those arising from diagnostic errors.⁵⁵ The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first standardized, nationally reported patient survey designed to measure patients’ perceptions of their hospital experience. The US Centers for Medicare and Medicaid Services (CMS) publishes HCAHPS results on its website 4 times a year, which serves as an important incentive for hospitals to improve patient safety and quality of health care delivery.⁵⁶

Another novel approach links multiple symptoms to a range of target diseases using the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) framework. Using “big data” technologies, this technique can help discover otherwise hidden symptom-disease links and improve overall diagnostic performance. This approach is proposed for both case-control (look-back) and cohort (look-forward) studies assessing diagnostic errors and misdiagnosis-related harms. For example, starting with a known diagnosis with high potential for harm (eg, stroke), the “look-back” approach can be used to identify high-risk symptoms (eg, dizziness, vertigo). In the “look-forward” approach, a single symptom or exposure risk factor known to be frequently misdiagnosed (eg, dizziness) can be analyzed to identify potential adverse disease outcomes (eg, stroke, migraine).⁵⁷

Many large ongoing studies looking at diagnostic errors among hospitalized patients, such as Utility of Predictive Systems to identify Inpatient Diagnostic Errors (UPSIDE),⁵⁸Patient Safety Learning Lab (PSLL),⁵⁹ and Achieving Diagnostic Excellence through Prevention and Teamwork (ADEPT),⁶⁰ are using structured chart review methodologies incorporating many of the above strategies in combination. Cases triggered by certain events (eg, ICU transfer, death, rapid response event, new or worsening acute kidney injury) are reviewed using validated tools, including Safer Dx framework and DEER taxonomy, to provide the most precise estimates of the burden of diagnostic errors in hospitalized patients. These estimates may be much higher than previously predicted using traditional chart review approaches.^6,24 For example, a recently published study of 2809 random admissions in 11 Massachusetts hospitals identified 978 adverse events but only 10 diagnostic errors (diagnostic error rate, 0.4%).¹⁹ This was likely because the trigger method used in the study did not specifically examine the diagnostic process as critically as done by the Safer Dx framework and DEER taxonomy tools, thereby underestimating the total number of diagnostic errors. Further, these ongoing studies (eg, UPSIDE, ADEPT) aim to employ new and upcoming advanced machine-learning methods to create models that can improve overall diagnostic performance. This would pave the way to test and build novel, efficient, and scalable interventions to reduce diagnostic errors and improve patient outcomes.

Strategies to Improve Diagnostic Safety in Hospitalized Patients

Disease-specific biomedical research, as well as advances in laboratory, imaging, and other technologies, play a critical role in improving diagnostic accuracy. However, these technical approaches do not address many of the broader clinician- and system-level failure points and opportunities for improvement. Various patient-, provider-, and organizational-level interventions that could make diagnostic processes more resilient and reduce the risk of error and patient harm have been proposed.⁶¹

Among these strategies are approaches to empower patients and their families. Fostering therapeutic relationships between patients and members of the care team is essential to reducing diagnostic errors.⁶² Facilitating timely access to health records, ensuring transparency in decision making, and tailoring communication strategies to patients’ cultural and educational backgrounds can reduce harm.⁶³ Similarly, at the system level, enhancing communication among different providers by use of tools such as structured handoffs can prevent communication breakdowns and facilitate positive outcomes.⁶⁴

Interventions targeted at individual health care providers, such as educational programs to improve content-specific knowledge, can enhance diagnostic performance. Regular feedback, strategies to enhance equity, and fostering an environment where all providers are actively encouraged to think critically and participate in the diagnostic process (training programs to use “diagnostic time-outs” and making it a “team sport”) can improve clinical reasoning.^65,66 Use of standardized patients can help identify individual-level cognitive failure points and facilitate creation of new interventions to improve clinical decision-making processes.⁶⁷

Novel health information technologies can further augment these efforts. These include effective documentation by maintaining dynamic and accurate patient histories, problem lists, and medication lists^68-70; use of electronic health record–based algorithms to identify potential diagnostic delays for serious conditions^71,72; use of telemedicine technologies to improve accessibility and coordination⁷³;application of mobile health and wearable technologies to facilitate data-gathering and care delivery^74,75; and use of computerized decision-support tools, including applications to interpret electrocardiograms, imaging studies, and other diagnostic tests.⁷⁶

Use of precision medicine, powered by new artificial intelligence (AI) tools, is becoming more widespread. Algorithms powered by AI can augment and sometimes even outperform clinician decision-making in areas such as oncology, radiology, and primary care.⁷⁷ Creation of large biobanks like the All of Us research program can be used to study thousands of environmental and genetic risk factors and health conditions simultaneously, and help identify specific treatments that work best for people of different backgrounds.⁷⁸ Active research in these areas holds great promise in terms of how and when we diagnose diseases and make appropriate preventative and treatment decisions. Significant scientific, ethical, and regulatory challenges will need to be overcome before these technologies can address some of the most complex problems in health care.⁷⁹

Finally, diagnostic performance is affected by the external environment, including the functioning of the medical liability system. Diagnostic errors that lead to patient harm are a leading cause of malpractice claims.⁸⁰ Developing a legal environment, in collaboration with patient advocacy groups and health care organizations, that promotes and facilitates timely disclosure of diagnostic errors could decrease the incentive to hide errors, advance care processes, and improve outcomes.^81,82

Conclusion

The burden of diagnostic errors in hospitalized patients is unacceptably high and remains an underemphasized cause of preventable morbidity and mortality. Diagnostic errors often result from a breakdown in multiple interdependent processes that involve patient-, provider-, and system-level factors. Significant challenges remain in defining and identifying diagnostic errors as well as underlying process-failure points. The most effective interventions to reduce diagnostic errors will require greater patient participation in the diagnostic process and a mix of evidence-based interventions that promote individual-provider excellence as well as system-level changes. Further research and collaboration among various stakeholders should help improve diagnostic safety for hospitalized patients.

Corresponding author: Abhishek Goyal, MD, MPH; [email protected]

Disclosures: Dr. Dalal disclosed receiving income ≥ $250 from MayaMD.

Abstract

Diagnostic errors in hospitalized patients are a leading cause of preventable morbidity and mortality. Significant challenges in defining and measuring diagnostic errors and underlying process failure points have led to considerable variability in reported rates of diagnostic errors and adverse outcomes. In this article, we explore the diagnostic process and its discrete components, emphasizing the centrality of the patient in decision-making as well as the continuous nature of the process. We review the incidence of diagnostic errors in hospitalized patients and different methodological approaches that have been used to arrive at these estimates. We discuss different but interdependent provider- and system-related process-failure points that lead to diagnostic errors. We examine specific challenges related to measurement of diagnostic errors and describe traditional and novel approaches that are being used to obtain the most precise estimates. Finally, we examine various patient-, provider-, and organizational-level interventions that have been proposed to improve diagnostic safety in hospitalized patients.

Keywords: diagnostic error, hospital medicine, patient safety.

Diagnosis is defined as a “pre-existing set of categories agreed upon by the medical profession to designate a specific condition.”¹ The diagnostic process involves obtaining a clinical history, performing a physical examination, conducting diagnostic testing, and consulting with other clinical providers to gather data that are relevant to understanding the underlying disease processes. This exercise involves generating hypotheses and updating prior probabilities as more information and evidence become available. Throughout this process of information gathering, integration, and interpretation, there is an ongoing assessment of whether sufficient and necessary knowledge has been obtained to make an accurate diagnosis and provide appropriate treatment.²

Diagnostic error is defined as a missed opportunity to make a timely diagnosis as part of this iterative process, including the failure of communicating the diagnosis to the patient in a timely manner.³ It can be categorized as a missed, delayed, or incorrect diagnosis based on available evidence at the time. Establishing the correct diagnosis has important implications. A timely and precise diagnosis ensures the patient the highest probability of having a positive health outcome that reflects an appropriate understanding of underlying disease processes and is consistent with their overall goals of care.³ When diagnostic errors occur, they can cause patient harm. Adverse events due to medical errors, including diagnostic errors, are estimated to be the third leading cause of death in the United States.⁴ Most people will experience at least 1 diagnostic error in their lifetime. In the 2015 National Academy of Medicine report Improving Diagnosis in Healthcare, diagnostic errors were identified as a major hazard as well as an opportunity to improve patient outcomes.²

Diagnostic errors during hospitalizations are especially concerning, as they are more likely to be implicated in a wider spectrum of harm, including permanent disability and death. This has become even more relevant for hospital medicine physicians and other clinical providers as they encounter increasing cognitive and administrative workloads, rising dissatisfaction and burnout, and unique obstacles such as night-time scheduling.⁵

Incidence of Diagnostic Errors in Hospitalized Patients

Several methodological approaches have been used to estimate the incidence of diagnostic errors in hospitalized patients. These include retrospective reviews of a sample of all hospital admissions, evaluations of selected adverse outcomes including autopsy studies, patient and provider surveys, and malpractice claims. Laboratory testing audits and secondary reviews in other diagnostic subspecialities (eg, radiology, pathology, and microbiology) are also essential to improving diagnostic performance in these specialized fields, which in turn affects overall hospital diagnostic error rates.^6-8 These diverse approaches provide unique insights regarding our ability to assess the degree to which potential harms, ranging from temporary impairment to permanent disability, to death, are attributable to different failure points in the diagnostic process.

Large retrospective chart reviews of random hospital admissions remain the most accurate way to determine the overall incidence of diagnostic errors in hospitalized patients.⁹ The Harvard Medical Practice Study, published in 1991, laid the groundwork for measuring the incidence of adverse events in hospitalized patients and assessing their relation to medical error, negligence, and disability. Reviewing 30,121 randomly selected records from 51 randomly selected acute care hospitals in New York State, the study found that adverse events occurred in 3.7% of hospitalizations, diagnostic errors accounted for 13.8% of these events, and these errors were likely attributable to negligence in 74.7% of cases. The study not only outlined individual-level process failures, but also focused attention on some of the systemic causes, setting the agenda for quality improvement research in hospital-based care for years to come.^10-12 A recent systematic review and meta-analysis of 22 hospital admission studies found a pooled rate of 0.7% (95% CI, 0.5%-1.1%) for harmful diagnostic errors.⁹ It found significant variations in the rates of adverse events, diagnostic errors, and range of diagnoses that were missed. This was primarily because of variabilities in pre-test probabilities in detecting diagnostic errors in these specific cohorts, as well as due to heterogeneity in study definitions and methodologies, especially regarding how they defined and measured “diagnostic error.” The analysis, however, did not account for diagnostic errors that were not related to patient harm (missed opportunities); therefore, it likely significantly underestimated the true incidence of diagnostic errors in these study populations. Table 1 summarizes some of key studies that have examined the incidence of harmful diagnostic errors in hospitalized patients.^9-21

The chief limitation of reviewing random hospital admissions is that, since overall rates of diagnostic errors are still relatively low, a large number of case reviews are required to identify a sufficient sample of adverse outcomes to gain a meaningful understanding of the underlying process failure points and develop tools for remediation. Patient and provider surveys or data from malpractice claims can be high-yield starting points for research on process errors.^22,23 Reviews of enriched cohorts of adverse outcomes, such as rapid-response events, intensive care unit (ICU) transfers, deaths, and hospital readmissions, can be an efficient way to identify process failures that lead to greatest harm. Depending on the research approach and the types of underlying patient populations sampled, rates of diagnostic errors in these high-risk groups have been estimated to be approximately 5% to 20%, or even higher.^6,24-31 For example, a retrospective study of 391 cases of unplanned 7-day readmissions found that 5.6% of cases contained at least 1 diagnostic error during the index admission.³² In a study conducted at 6 Belgian acute-care hospitals, 56% of patients requiring an unplanned transfer to a higher level of care were determined to have had an adverse event, and of these adverse events, 12.4% of cases were associated with errors in diagnosis.²⁹ A systematic review of 16 hospital-based studies estimated that 3.1% of all inpatient deaths were likely preventable, which corresponded to 22,165 deaths annually in the United States.³⁰ Another such review of 31 autopsy studies reported that 28% of autopsied ICU patients had at least 1 misdiagnosis; of these diagnostic errors, 8% were classified as potentially lethal, and 15% were considered major but not lethal.³¹ Significant drawbacks of such enriched cohort studies, however, are their poor generalizability and inability to detect failure points that do not lead to patient harm (near-miss events).³³

Causes of Diagnostic Errors in Hospitalized Patients

All aspects of the diagnostic process are susceptible to errors. These errors stem from a variety of faulty processes, including failure of the patient to engage with the health care system (eg, due to lack of insurance or transportation, or delay in seeking care); failure in information gathering (eg, missed history or exam findings, ordering wrong tests, laboratory errors); failure in information interpretation (eg, exam finding or test result misinterpretation); inaccurate hypothesis generation (eg, due to suboptimal prioritization or weighing of supporting evidence); and failure in communication (eg, with other team members or with the patient).^2,34 Reasons for diagnostic process failures vary widely across different health care settings. While clinician assessment errors (eg, failure to consider or alternatively overweigh competing diagnoses) and errors in testing and the monitoring phase (eg, failure to order or follow up diagnostic tests) can lead to a majority of diagnostic errors in some patient populations, in other settings, social (eg, poor health literacy, punitive cultural practices) and economic factors (eg, lack of access to appropriate diagnostic tests or to specialty expertise) play a more prominent role.^34,35

The Figure describes the relationship between components of the diagnostic process and subsequent outcomes, including diagnostic process failures, diagnostic errors, and absence or presence of patient harm.^2,36,37 It reemphasizes the centrality of the patient in decision-making and the continuous nature of the process. The Figure also illustrates that only a minority of process failures result in diagnostic errors, and a smaller proportion of diagnostic errors actually lead to patient harm. Conversely, it also shows that diagnostic errors can happen without any obvious process-failure points, and, similarly, patient harm can take place in the absence of any evident diagnostic errors.^36-38 Finally, it highlights the need to incorporate feedback from process failures, diagnostic errors, and favorable and unfavorable patient outcomes in order to inform future quality improvement efforts and research.

A significant proportion of diagnostic errors are due to system-related vulnerabilities, such as limitations in availability, adoption or quality of work force training, health informatics resources, and diagnostic capabilities. Lack of institutional culture that promotes safety and transparency also predisposes to diagnostic errors.^39,40 The other major domain of process failures is related to cognitive errors in clinician decision-making. Anchoring, confirmation bias, availability bias, and base-rate neglect are some of the common cognitive biases that, along with personality traits (aversion to risk or ambiguity, overconfidence) and affective biases (influence of emotion on decision-making), often determine the degree of utilization of resources and the possibility of suboptimal diagnostic performance.^41,42 Further, implicit biases related to age, race, gender, and sexual orientation contribute to disparities in access to health care and outcomes.⁴³ In a large number of cases of preventable adverse outcomes, however, there are multiple interdependent individual and system-related failure points that lead to diagnostic error and patient harm.^6,32

Challenges in Defining and Measuring Diagnostic Errors

In order to develop effective, evidence-based interventions to reduce diagnostic errors in hospitalized patients, it is essential to be able to first operationally define, and then accurately measure, diagnostic errors and the process failures that contribute to these errors in a standardized way that is reproducible across different settings.^6,44 There are a number of obstacles in this endeavor.

A fundamental problem is that establishing a diagnosis is not a single act but a process. Patterns of symptoms and clinical presentations often differ for the same disease. Information required to make a diagnosis is usually gathered in stages, where the clinician obtains additional data, while considering many possibilities, of which 1 may be ultimately correct. Diagnoses evolve over time and in different care settings. “The most likely diagnosis” is not always the same as “the final correct diagnosis.” Moreover, the diagnostic process is influenced by patients’ individual clinical courses and preferences over time. This makes determination of missed, delayed, or incorrect diagnoses challenging.^45,46

For hospitalized patients, generally the goal is to first rule out more serious and acute conditions (eg, pulmonary embolism or stroke), even if their probability is rather low. Conversely, a diagnosis that appears less consequential if delayed (eg, chronic anemia of unclear etiology) might not be pursued on an urgent basis, and is often left to outpatient providers to examine, but still may manifest in downstream harm (eg, delayed diagnosis of gastrointestinal malignancy or recurrent admissions for heart failure due to missed iron-deficiency anemia). Therefore, coming up with disease diagnosis likelihoods in hindsight may turn out to be highly subjective and not always accurate. This can be particularly difficult when clinician and other team deliberations are not recorded in their entirety.⁴⁷

Another hurdle in the practice of diagnostic medicine is to preserve the balance between underdiagnosing versus pursuing overly aggressive diagnostic approaches. Conducting laboratory, imaging, or other diagnostic studies without a clear shared understanding of how they would affect clinical decision-making (eg, use of prostate-specific antigen to detect prostate cancer) not only leads to increased costs but can also delay appropriate care. Worse, subsequent unnecessary diagnostic tests and treatments can sometimes lead to serious harm.^48,49

Finally, retrospective reviews by clinicians are subject to multiple potential limitations that include failure to create well-defined research questions, poorly developed inclusion and exclusion criteria, and issues related to inter- and intra-rater reliability.⁵⁰ These methodological deficiencies can occur despite following "best practice" guidelines during the study planning, execution, and analysis phases. They further add to the challenge of defining and measuring diagnostic errors.⁴⁷

Strategies to Improve Measurement of Diagnostic Errors

Development of new methodologies to reliably measure diagnostic errors is an area of active research. The advancement of uniform and universally agreed-upon frameworks to define and identify process failure points and diagnostic errors would help reduce measurement error and support development and testing of interventions that could be generalizable across different health care settings. To more accurately define and measure diagnostic errors, several novel approaches have been proposed (Table 2).

The Safer Dx framework is an all-round tool developed to advance the discipline of measuring diagnostic errors. For an episode of care under review, the instrument scores various items to determine the likelihood of a diagnostic error. These items evaluate multiple dimensions affecting diagnostic performance and measurements across 3 broad domains: structure (provider and organizational characteristics—from everyone involved with patient care, to computing infrastructure, to policies and regulations), process (elements of the patient-provider encounter, diagnostic test performance and follow-up, and subspecialty- and referral-specific factors), and outcome (establishing accurate and timely diagnosis as opposed to missed, delayed, or incorrect diagnosis). This instrument has been revised and can be further modified by a variety of stakeholders, including clinicians, health care organizations, and policymakers, to identify potential diagnostic errors in a standardized way for patient safety and quality improvement research.^51,52

Use of standardized tools, such as the Diagnosis Error Evaluation and Research (DEER) taxonomy, can help to identify and classify specific failure points across different diagnostic process dimensions.³⁷ These failure points can be classified into: issues related to patient presentation or access to health care; failure to obtain or misinterpretation of history or physical exam findings; errors in use of diagnostics tests due to technical or clinician-related factors; failures in appropriate weighing of evidence and hypothesis generation; errors associated with referral or consultation process; and failure to monitor the patient or obtain timely follow-up.³⁴ The DEER taxonomy can also be modified based on specific research questions and study populations. Further, it can be recategorized to correspond to Safer Dx framework diagnostic process dimensions to provide insights into reasons for specific process failures and to develop new interventions to mitigate errors and patient harm.⁶

Since a majority of diagnostic errors do not lead to actual harm, use of “triggers” or clues (eg, procedure-related complications, patient falls, transfers to a higher level of care, readmissions within 30 days) can be a more efficient method to identify diagnostic errors and adverse events that do cause harm. The Global Trigger Tool, developed by the Institute for Healthcare Improvement, uses this strategy. This tool has been shown to identify a significantly higher number of serious adverse events than comparable methods.⁵³ This facilitates selection and development of strategies at the institutional level that are most likely to improve patient outcomes.²⁴

Encouraging and facilitating voluntary or prompted reporting from patients and clinicians can also play an important role in capturing diagnostic errors. Patients and clinicians are not only the key stakeholders but are also uniquely placed within the diagnostic process to detect and report potential errors.^25,54 Patient-safety-event reporting systems, such as RL6, play a vital role in reporting near-misses and adverse events. These systems provide a mechanism for team members at all levels within the hospital to contribute toward reporting patient adverse events, including those arising from diagnostic errors.⁵⁵ The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first standardized, nationally reported patient survey designed to measure patients’ perceptions of their hospital experience. The US Centers for Medicare and Medicaid Services (CMS) publishes HCAHPS results on its website 4 times a year, which serves as an important incentive for hospitals to improve patient safety and quality of health care delivery.⁵⁶

Another novel approach links multiple symptoms to a range of target diseases using the Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) framework. Using “big data” technologies, this technique can help discover otherwise hidden symptom-disease links and improve overall diagnostic performance. This approach is proposed for both case-control (look-back) and cohort (look-forward) studies assessing diagnostic errors and misdiagnosis-related harms. For example, starting with a known diagnosis with high potential for harm (eg, stroke), the “look-back” approach can be used to identify high-risk symptoms (eg, dizziness, vertigo). In the “look-forward” approach, a single symptom or exposure risk factor known to be frequently misdiagnosed (eg, dizziness) can be analyzed to identify potential adverse disease outcomes (eg, stroke, migraine).⁵⁷

Many large ongoing studies looking at diagnostic errors among hospitalized patients, such as Utility of Predictive Systems to identify Inpatient Diagnostic Errors (UPSIDE),⁵⁸Patient Safety Learning Lab (PSLL),⁵⁹ and Achieving Diagnostic Excellence through Prevention and Teamwork (ADEPT),⁶⁰ are using structured chart review methodologies incorporating many of the above strategies in combination. Cases triggered by certain events (eg, ICU transfer, death, rapid response event, new or worsening acute kidney injury) are reviewed using validated tools, including Safer Dx framework and DEER taxonomy, to provide the most precise estimates of the burden of diagnostic errors in hospitalized patients. These estimates may be much higher than previously predicted using traditional chart review approaches.^6,24 For example, a recently published study of 2809 random admissions in 11 Massachusetts hospitals identified 978 adverse events but only 10 diagnostic errors (diagnostic error rate, 0.4%).¹⁹ This was likely because the trigger method used in the study did not specifically examine the diagnostic process as critically as done by the Safer Dx framework and DEER taxonomy tools, thereby underestimating the total number of diagnostic errors. Further, these ongoing studies (eg, UPSIDE, ADEPT) aim to employ new and upcoming advanced machine-learning methods to create models that can improve overall diagnostic performance. This would pave the way to test and build novel, efficient, and scalable interventions to reduce diagnostic errors and improve patient outcomes.

Strategies to Improve Diagnostic Safety in Hospitalized Patients

Disease-specific biomedical research, as well as advances in laboratory, imaging, and other technologies, play a critical role in improving diagnostic accuracy. However, these technical approaches do not address many of the broader clinician- and system-level failure points and opportunities for improvement. Various patient-, provider-, and organizational-level interventions that could make diagnostic processes more resilient and reduce the risk of error and patient harm have been proposed.⁶¹

Among these strategies are approaches to empower patients and their families. Fostering therapeutic relationships between patients and members of the care team is essential to reducing diagnostic errors.⁶² Facilitating timely access to health records, ensuring transparency in decision making, and tailoring communication strategies to patients’ cultural and educational backgrounds can reduce harm.⁶³ Similarly, at the system level, enhancing communication among different providers by use of tools such as structured handoffs can prevent communication breakdowns and facilitate positive outcomes.⁶⁴

Interventions targeted at individual health care providers, such as educational programs to improve content-specific knowledge, can enhance diagnostic performance. Regular feedback, strategies to enhance equity, and fostering an environment where all providers are actively encouraged to think critically and participate in the diagnostic process (training programs to use “diagnostic time-outs” and making it a “team sport”) can improve clinical reasoning.^65,66 Use of standardized patients can help identify individual-level cognitive failure points and facilitate creation of new interventions to improve clinical decision-making processes.⁶⁷

Novel health information technologies can further augment these efforts. These include effective documentation by maintaining dynamic and accurate patient histories, problem lists, and medication lists^68-70; use of electronic health record–based algorithms to identify potential diagnostic delays for serious conditions^71,72; use of telemedicine technologies to improve accessibility and coordination⁷³;application of mobile health and wearable technologies to facilitate data-gathering and care delivery^74,75; and use of computerized decision-support tools, including applications to interpret electrocardiograms, imaging studies, and other diagnostic tests.⁷⁶

Use of precision medicine, powered by new artificial intelligence (AI) tools, is becoming more widespread. Algorithms powered by AI can augment and sometimes even outperform clinician decision-making in areas such as oncology, radiology, and primary care.⁷⁷ Creation of large biobanks like the All of Us research program can be used to study thousands of environmental and genetic risk factors and health conditions simultaneously, and help identify specific treatments that work best for people of different backgrounds.⁷⁸ Active research in these areas holds great promise in terms of how and when we diagnose diseases and make appropriate preventative and treatment decisions. Significant scientific, ethical, and regulatory challenges will need to be overcome before these technologies can address some of the most complex problems in health care.⁷⁹

Finally, diagnostic performance is affected by the external environment, including the functioning of the medical liability system. Diagnostic errors that lead to patient harm are a leading cause of malpractice claims.⁸⁰ Developing a legal environment, in collaboration with patient advocacy groups and health care organizations, that promotes and facilitates timely disclosure of diagnostic errors could decrease the incentive to hide errors, advance care processes, and improve outcomes.^81,82

Conclusion

The burden of diagnostic errors in hospitalized patients is unacceptably high and remains an underemphasized cause of preventable morbidity and mortality. Diagnostic errors often result from a breakdown in multiple interdependent processes that involve patient-, provider-, and system-level factors. Significant challenges remain in defining and identifying diagnostic errors as well as underlying process-failure points. The most effective interventions to reduce diagnostic errors will require greater patient participation in the diagnostic process and a mix of evidence-based interventions that promote individual-provider excellence as well as system-level changes. Further research and collaboration among various stakeholders should help improve diagnostic safety for hospitalized patients.

Corresponding author: Abhishek Goyal, MD, MPH; [email protected]

Disclosures: Dr. Dalal disclosed receiving income ≥ $250 from MayaMD.

Each year, 40,000 to 98,000 deaths occur due to medical errors.¹ The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.² The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.³

Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,⁴ with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.

Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al⁵ report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,⁶ noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.

Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Each year, 40,000 to 98,000 deaths occur due to medical errors.¹ The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.² The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.³

Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,⁴ with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.

Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al⁵ report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,⁶ noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.

Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Each year, 40,000 to 98,000 deaths occur due to medical errors.¹ The Harvard Medical Practice Study (HMPS), published in 1991, found that 3.7% of hospitalized patients were harmed by adverse events and 1% were harmed by adverse events due to negligence.² The latest HMPS showed that, despite significant improvements in patient safety over the past 3 decades, patient safety challenges persist. This study found that inpatient care leads to harm in nearly a quarter of patients, and that 1 in 4 of these adverse events are preventable.³

Since the first HMPS study was published, efforts to improve patient safety have focused on identifying causes of medical error and the design and implementation of interventions to mitigate errors. Factors contributing to medical errors have been well documented: the complexity of care delivery from inpatient to outpatient settings, with transitions of care and extensive use of medications; multiple comorbidities; and the fragmentation of care across multiple systems and specialties. Although most errors are related to process or system failure, accountability of each practitioner and clinician is essential to promoting a culture of safety. Many medical errors are preventable through multifaceted approaches employed throughout the phases of the care,⁴ with medication errors, both prescribing and administration, and diagnostic and treatment errors encompassing most risk prevention areas. Broadly, safety efforts should emphasize building a culture of safety where all safety events are reported, including near-miss events.

Two articles in this issue of JCOM address key elements of patient safety: building a safety culture and diagnostic error. Merchant et al⁵ report on an initiative designed to promote a safety culture by recognizing and rewarding staff who identify and report near misses. The tiered awards program they designed led to significantly increased staff participation in the safety awards nomination process and was associated with increased reporting of actual and close-call events and greater attendance at monthly safety forums. Goyal et al,⁶ noting that diagnostic error rates in hospitalized patients remain unacceptably high, provide a concise update on diagnostic error among inpatients, focusing on issues related to defining and measuring diagnostic errors and current strategies to improve diagnostic safety in hospitalized patients. In a third article, Sathi et al report on efforts to teach quality improvement (QI) methods to internal medicine trainees; their project increased residents’ knowledge of their patient panels and comfort with QI approaches and led to improved patient outcomes.

Major progress has been made to improve health care safety since the first HMPS was published. However, the latest HMPS shows that patient safety efforts must continue, given the persistent risk for patient harm in the current health care delivery system. Safety, along with clear accountability for identifying, reporting, and addressing errors, should be a top priority for health care systems throughout the preventive, diagnostic, and therapeutic phases of care.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.

It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.

Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.

In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.

When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.

“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”

Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.

“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”

The conversation turned a few heads in her office.

“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.

She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”

A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”

The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”

“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.

And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
 

The Twitter storm

After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.

Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”

The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.

“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.

The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.

Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.

According to health policy expert Kelly Anderson, PhD, MPP, getting patients the cancer care they need should not require an oncologist venting on social media. Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.

Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”

But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”

In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.

In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.

“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”

A version of this article first appeared on Medscape.com.

“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.

It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.

Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.

In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.

When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.

“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”

Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.

“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”

The conversation turned a few heads in her office.

“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.

She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”

A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”

The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”

“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.

And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
 

The Twitter storm

After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.

Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”

The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.

“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.

The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.

Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.

According to health policy expert Kelly Anderson, PhD, MPP, getting patients the cancer care they need should not require an oncologist venting on social media. Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.

Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”

But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”

In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.

In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.

“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”

A version of this article first appeared on Medscape.com.

“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.

It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.

Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.

In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.

When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.

“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”

Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.

“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”

The conversation turned a few heads in her office.

“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.

She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”

A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”

The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”

“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.

And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
 

The Twitter storm

After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.

Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”

The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.

“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.

The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.

Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.

According to health policy expert Kelly Anderson, PhD, MPP, getting patients the cancer care they need should not require an oncologist venting on social media. Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.

Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”

But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”

In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.

In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.

“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”

A version of this article first appeared on Medscape.com.

A combination of HER2-targeted drugs used in breast cancer is now available for use in colorectal cancer.

The U.S. Food and Drug Administration has granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for use in RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

This is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer, maker Seagen said in a Jan. 19 press release.

“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes. The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients,” John Strickler, MD, associate professor of medicine at Duke University Medical Center, Durham, N.C., said in the press release.

Dr. Strickler was the lead investigator on the approval trial, dubbed MOUNTAINEER, which involved 84 patients who met the treatment criteria and who had also been treated with an anti-VEGF antibody. Participants whose tumors were deficient in mismatch repair proteins or were microsatellite instability–high must also have received a PD-1 inhibitor. Patients who received prior anti-HER2 therapy were excluded, the FDA explained in its own press release.

Participants were treated with tucatinib 300 mg orally twice daily– the recommended dose in product labeling – with trastuzumab administered at a loading dose of 8 mg/kg intravenously on day 1 of cycle 1 followed by a maintenance dose of trastuzumab 6 mg/kg on day 1 of each subsequent 21-day cycle.

Overall response rate was 38%, and median duration of response was 12.4 months.

The most common adverse events, occurring in at least 20% of study participants, were diarrhea, fatigue, rash, nausea, abdominal pain, infusion related reactions, and pyrexia. The most common laboratory abnormalities were increased creatinine, decreased lymphocytes, increased alanine aminotransferase, and decreased hemoglobin, among others.

Serious adverse reactions occurred in 22% of patients. The most common (occurring in ≥ 2% of patients) were intestinal obstruction (7%); urinary tract infection (3.5%); and pneumonia, abdominal pain, and rectal perforation (2.3% each). Adverse reactions leading to permanent discontinuation occurred in 6% of patients, including increased alanine aminotransferase in 2.3%.

Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company said.

A global, randomized phase 3 clinical trial (MOUNTAINEER-03) is ongoing and is comparing tucatinib in combination with trastuzumab and mFOLFOX6 with standard of care and is intended to serve as a confirmatory trial, the company said.

Tucatinib is already approved in combination with trastuzumab and capecitabine for use in the treatment of advanced unresectable or metastatic HER2-positive breast cancer.

A version of this article first appeared on Medscape.com.

A combination of HER2-targeted drugs used in breast cancer is now available for use in colorectal cancer.

The U.S. Food and Drug Administration has granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for use in RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

This is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer, maker Seagen said in a Jan. 19 press release.

“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes. The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients,” John Strickler, MD, associate professor of medicine at Duke University Medical Center, Durham, N.C., said in the press release.

Dr. Strickler was the lead investigator on the approval trial, dubbed MOUNTAINEER, which involved 84 patients who met the treatment criteria and who had also been treated with an anti-VEGF antibody. Participants whose tumors were deficient in mismatch repair proteins or were microsatellite instability–high must also have received a PD-1 inhibitor. Patients who received prior anti-HER2 therapy were excluded, the FDA explained in its own press release.

Participants were treated with tucatinib 300 mg orally twice daily– the recommended dose in product labeling – with trastuzumab administered at a loading dose of 8 mg/kg intravenously on day 1 of cycle 1 followed by a maintenance dose of trastuzumab 6 mg/kg on day 1 of each subsequent 21-day cycle.

Overall response rate was 38%, and median duration of response was 12.4 months.

The most common adverse events, occurring in at least 20% of study participants, were diarrhea, fatigue, rash, nausea, abdominal pain, infusion related reactions, and pyrexia. The most common laboratory abnormalities were increased creatinine, decreased lymphocytes, increased alanine aminotransferase, and decreased hemoglobin, among others.

Serious adverse reactions occurred in 22% of patients. The most common (occurring in ≥ 2% of patients) were intestinal obstruction (7%); urinary tract infection (3.5%); and pneumonia, abdominal pain, and rectal perforation (2.3% each). Adverse reactions leading to permanent discontinuation occurred in 6% of patients, including increased alanine aminotransferase in 2.3%.

Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company said.

A global, randomized phase 3 clinical trial (MOUNTAINEER-03) is ongoing and is comparing tucatinib in combination with trastuzumab and mFOLFOX6 with standard of care and is intended to serve as a confirmatory trial, the company said.

Tucatinib is already approved in combination with trastuzumab and capecitabine for use in the treatment of advanced unresectable or metastatic HER2-positive breast cancer.

A version of this article first appeared on Medscape.com.

A combination of HER2-targeted drugs used in breast cancer is now available for use in colorectal cancer.

The U.S. Food and Drug Administration has granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for use in RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

This is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer, maker Seagen said in a Jan. 19 press release.

“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes. The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients,” John Strickler, MD, associate professor of medicine at Duke University Medical Center, Durham, N.C., said in the press release.

Dr. Strickler was the lead investigator on the approval trial, dubbed MOUNTAINEER, which involved 84 patients who met the treatment criteria and who had also been treated with an anti-VEGF antibody. Participants whose tumors were deficient in mismatch repair proteins or were microsatellite instability–high must also have received a PD-1 inhibitor. Patients who received prior anti-HER2 therapy were excluded, the FDA explained in its own press release.

Participants were treated with tucatinib 300 mg orally twice daily– the recommended dose in product labeling – with trastuzumab administered at a loading dose of 8 mg/kg intravenously on day 1 of cycle 1 followed by a maintenance dose of trastuzumab 6 mg/kg on day 1 of each subsequent 21-day cycle.

Overall response rate was 38%, and median duration of response was 12.4 months.

The most common adverse events, occurring in at least 20% of study participants, were diarrhea, fatigue, rash, nausea, abdominal pain, infusion related reactions, and pyrexia. The most common laboratory abnormalities were increased creatinine, decreased lymphocytes, increased alanine aminotransferase, and decreased hemoglobin, among others.

Serious adverse reactions occurred in 22% of patients. The most common (occurring in ≥ 2% of patients) were intestinal obstruction (7%); urinary tract infection (3.5%); and pneumonia, abdominal pain, and rectal perforation (2.3% each). Adverse reactions leading to permanent discontinuation occurred in 6% of patients, including increased alanine aminotransferase in 2.3%.

Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company said.

A global, randomized phase 3 clinical trial (MOUNTAINEER-03) is ongoing and is comparing tucatinib in combination with trastuzumab and mFOLFOX6 with standard of care and is intended to serve as a confirmatory trial, the company said.

Tucatinib is already approved in combination with trastuzumab and capecitabine for use in the treatment of advanced unresectable or metastatic HER2-positive breast cancer.

A version of this article first appeared on Medscape.com.

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

A version of this article first appeared on Medscape.com.

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

A version of this article first appeared on Medscape.com.

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

A version of this article first appeared on Medscape.com.