For patients with obesity who want to lose weight but for whom conventional weight-loss strategies have failed, the combination of intragastric balloon placement and lifestyle modifications may be preferable to lifestyle modifications alone, according to new clinical practice guidelines from the American Gastroenterological Association.

In randomized clinical trials of patients with obesity (body mass index >30 kg/m²), placing an intragastric balloon (IGB) significantly improved key outcomes such as weight loss, metabolic parameters (such as fasting blood glucose, hemoglobin A1c), and rates of remission of diabetes, hypertension, and dyslipidemia, compared with standard noninvasive weight loss interventions, Thiruvengadam Muniraj, MD, MRCP, of Yale University in New Haven, Conn., and associates wrote in Gastroenterology. However, concomitant lifestyle modifications of “moderate to high intensity” are strongly recommended “to maintain and augment weight loss” after IGB placement, according to the guidelines published in Gastroenterology.

Obesity (BMI >30), affects approximately 40% of U.S. adults, but only about 1.1% of eligible patients receive bariatric weight-loss surgery, and few are aware that endoscopic treatment is an option, according to the guideline. Early IGB models were associated with “a number of devastating adverse events,” spurring their removal from the U.S. market in the 1980s and 1990s. Since then, however, several new models of IGBs have become available. The guidelines noted that, in seven randomized, controlled trials of these newer IGBs, there were no deaths and only a 5.6% overall rate of serious adverse events – most commonly injury to the gastrointestinal tract at 6-8 months’ follow-up. “More recently, postmarketing surveillance of IGB has reported additional rare adverse events of hyperinflation, acute pancreatitis, and death,” but overall, “IGBs appear to be associated with both a favorable adverse event and patient tolerability profile.”

Three models of fluid-filled balloons and two models of gas-filled balloons are currently available in the United States, the guidelines noted. The authors did not recommend one specific type or model over another. They cite limited data indicating that “fluid-filled balloons may be associated with more weight loss, lower tolerability, and less favorable safety profile, than gas filled balloons. Shared decision-making is suggested for determining device choice.”

Relatively few studies have evaluated lifestyle modifications after IGB placement. In one study of 80 patients, a very-low-calorie ketogenic diet led to significantly more weight loss (on average, 7.1 kg), compared with a conventional low-calorie diet. “Although diet does augment and sustain weight loss in patients receiving IGB therapy, it is unclear whether other lifestyle modifications (e.g., exercise) would have the same impact,” the guideline authors wrote.

They strongly recommended prophylactic proton pump inhibitor (PPI) therapy after IGB placement. The procedure can erode the gastrointestinal mucosa, and studies in which patients received prophylactic PPIs reported lower rates of serious adverse events, most notably upper GI bleeding. However, the numerous short- and long-term risks of these drugs make it “imperative that the lowest dose, frequency, and duration of PPIs be used in patients undergoing IGB therapy.”

Intragastric balloons can cause nausea and vomiting, leading to their premature removal. Therefore, when placing an IGB, concomitant antiemetic therapy is recommended along with an anesthetic that is unlikely to cause nausea. “Evidence is insufficient to recommend a specific antiemetic regimen” and “choice of regimen [should be] based on institutional policy, clinical context, and availability,” according to the guidelines.

Based on low-quality evidence, they included a conditional recommendation for daily vitamin supplementation with one to two adult-dose multivitamins after IGB placement. They suggest against perioperative laboratory screening for nutritional deficiencies, based on a lack of supporting evidence. However, since nutritional deficiencies with IGB placement have been reported, decisions about screening for nutritional deficiencies should be tailored based on clinical judgment.

To create the guideline, the authors reviewed databases for studies published through January 2020 in which patients with obesity had an IGB placed for at least 6 months. In all, 79 articles were cited, including more than 10 randomized clinical trials.

An update of the clinical practice guidelines is expected in 2024. The AGA Institute provided the only funding. Dr. Muniraj and five coauthors reported having no conflicts of interest. The other two coauthors disclosed relationships with Nestle Health Sciences, the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, and the Association of American Indian Physicians.
 

For patients with obesity who want to lose weight but for whom conventional weight-loss strategies have failed, the combination of intragastric balloon placement and lifestyle modifications may be preferable to lifestyle modifications alone, according to new clinical practice guidelines from the American Gastroenterological Association.

In randomized clinical trials of patients with obesity (body mass index >30 kg/m²), placing an intragastric balloon (IGB) significantly improved key outcomes such as weight loss, metabolic parameters (such as fasting blood glucose, hemoglobin A1c), and rates of remission of diabetes, hypertension, and dyslipidemia, compared with standard noninvasive weight loss interventions, Thiruvengadam Muniraj, MD, MRCP, of Yale University in New Haven, Conn., and associates wrote in Gastroenterology. However, concomitant lifestyle modifications of “moderate to high intensity” are strongly recommended “to maintain and augment weight loss” after IGB placement, according to the guidelines published in Gastroenterology.

Obesity (BMI >30), affects approximately 40% of U.S. adults, but only about 1.1% of eligible patients receive bariatric weight-loss surgery, and few are aware that endoscopic treatment is an option, according to the guideline. Early IGB models were associated with “a number of devastating adverse events,” spurring their removal from the U.S. market in the 1980s and 1990s. Since then, however, several new models of IGBs have become available. The guidelines noted that, in seven randomized, controlled trials of these newer IGBs, there were no deaths and only a 5.6% overall rate of serious adverse events – most commonly injury to the gastrointestinal tract at 6-8 months’ follow-up. “More recently, postmarketing surveillance of IGB has reported additional rare adverse events of hyperinflation, acute pancreatitis, and death,” but overall, “IGBs appear to be associated with both a favorable adverse event and patient tolerability profile.”

Three models of fluid-filled balloons and two models of gas-filled balloons are currently available in the United States, the guidelines noted. The authors did not recommend one specific type or model over another. They cite limited data indicating that “fluid-filled balloons may be associated with more weight loss, lower tolerability, and less favorable safety profile, than gas filled balloons. Shared decision-making is suggested for determining device choice.”

Relatively few studies have evaluated lifestyle modifications after IGB placement. In one study of 80 patients, a very-low-calorie ketogenic diet led to significantly more weight loss (on average, 7.1 kg), compared with a conventional low-calorie diet. “Although diet does augment and sustain weight loss in patients receiving IGB therapy, it is unclear whether other lifestyle modifications (e.g., exercise) would have the same impact,” the guideline authors wrote.

They strongly recommended prophylactic proton pump inhibitor (PPI) therapy after IGB placement. The procedure can erode the gastrointestinal mucosa, and studies in which patients received prophylactic PPIs reported lower rates of serious adverse events, most notably upper GI bleeding. However, the numerous short- and long-term risks of these drugs make it “imperative that the lowest dose, frequency, and duration of PPIs be used in patients undergoing IGB therapy.”

Intragastric balloons can cause nausea and vomiting, leading to their premature removal. Therefore, when placing an IGB, concomitant antiemetic therapy is recommended along with an anesthetic that is unlikely to cause nausea. “Evidence is insufficient to recommend a specific antiemetic regimen” and “choice of regimen [should be] based on institutional policy, clinical context, and availability,” according to the guidelines.

Based on low-quality evidence, they included a conditional recommendation for daily vitamin supplementation with one to two adult-dose multivitamins after IGB placement. They suggest against perioperative laboratory screening for nutritional deficiencies, based on a lack of supporting evidence. However, since nutritional deficiencies with IGB placement have been reported, decisions about screening for nutritional deficiencies should be tailored based on clinical judgment.

To create the guideline, the authors reviewed databases for studies published through January 2020 in which patients with obesity had an IGB placed for at least 6 months. In all, 79 articles were cited, including more than 10 randomized clinical trials.

An update of the clinical practice guidelines is expected in 2024. The AGA Institute provided the only funding. Dr. Muniraj and five coauthors reported having no conflicts of interest. The other two coauthors disclosed relationships with Nestle Health Sciences, the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, and the Association of American Indian Physicians.
 

For patients with obesity who want to lose weight but for whom conventional weight-loss strategies have failed, the combination of intragastric balloon placement and lifestyle modifications may be preferable to lifestyle modifications alone, according to new clinical practice guidelines from the American Gastroenterological Association.

In randomized clinical trials of patients with obesity (body mass index >30 kg/m²), placing an intragastric balloon (IGB) significantly improved key outcomes such as weight loss, metabolic parameters (such as fasting blood glucose, hemoglobin A1c), and rates of remission of diabetes, hypertension, and dyslipidemia, compared with standard noninvasive weight loss interventions, Thiruvengadam Muniraj, MD, MRCP, of Yale University in New Haven, Conn., and associates wrote in Gastroenterology. However, concomitant lifestyle modifications of “moderate to high intensity” are strongly recommended “to maintain and augment weight loss” after IGB placement, according to the guidelines published in Gastroenterology.

Obesity (BMI >30), affects approximately 40% of U.S. adults, but only about 1.1% of eligible patients receive bariatric weight-loss surgery, and few are aware that endoscopic treatment is an option, according to the guideline. Early IGB models were associated with “a number of devastating adverse events,” spurring their removal from the U.S. market in the 1980s and 1990s. Since then, however, several new models of IGBs have become available. The guidelines noted that, in seven randomized, controlled trials of these newer IGBs, there were no deaths and only a 5.6% overall rate of serious adverse events – most commonly injury to the gastrointestinal tract at 6-8 months’ follow-up. “More recently, postmarketing surveillance of IGB has reported additional rare adverse events of hyperinflation, acute pancreatitis, and death,” but overall, “IGBs appear to be associated with both a favorable adverse event and patient tolerability profile.”

Three models of fluid-filled balloons and two models of gas-filled balloons are currently available in the United States, the guidelines noted. The authors did not recommend one specific type or model over another. They cite limited data indicating that “fluid-filled balloons may be associated with more weight loss, lower tolerability, and less favorable safety profile, than gas filled balloons. Shared decision-making is suggested for determining device choice.”

Relatively few studies have evaluated lifestyle modifications after IGB placement. In one study of 80 patients, a very-low-calorie ketogenic diet led to significantly more weight loss (on average, 7.1 kg), compared with a conventional low-calorie diet. “Although diet does augment and sustain weight loss in patients receiving IGB therapy, it is unclear whether other lifestyle modifications (e.g., exercise) would have the same impact,” the guideline authors wrote.

They strongly recommended prophylactic proton pump inhibitor (PPI) therapy after IGB placement. The procedure can erode the gastrointestinal mucosa, and studies in which patients received prophylactic PPIs reported lower rates of serious adverse events, most notably upper GI bleeding. However, the numerous short- and long-term risks of these drugs make it “imperative that the lowest dose, frequency, and duration of PPIs be used in patients undergoing IGB therapy.”

Intragastric balloons can cause nausea and vomiting, leading to their premature removal. Therefore, when placing an IGB, concomitant antiemetic therapy is recommended along with an anesthetic that is unlikely to cause nausea. “Evidence is insufficient to recommend a specific antiemetic regimen” and “choice of regimen [should be] based on institutional policy, clinical context, and availability,” according to the guidelines.

Based on low-quality evidence, they included a conditional recommendation for daily vitamin supplementation with one to two adult-dose multivitamins after IGB placement. They suggest against perioperative laboratory screening for nutritional deficiencies, based on a lack of supporting evidence. However, since nutritional deficiencies with IGB placement have been reported, decisions about screening for nutritional deficiencies should be tailored based on clinical judgment.

To create the guideline, the authors reviewed databases for studies published through January 2020 in which patients with obesity had an IGB placed for at least 6 months. In all, 79 articles were cited, including more than 10 randomized clinical trials.

An update of the clinical practice guidelines is expected in 2024. The AGA Institute provided the only funding. Dr. Muniraj and five coauthors reported having no conflicts of interest. The other two coauthors disclosed relationships with Nestle Health Sciences, the American Society for Gastrointestinal Endoscopy, the American College of Gastroenterology, and the Association of American Indian Physicians.
 

Across the country, residents are bound to a set of rules from the Accreditation Council for Graduate Medical Education (ACGME) designed to mini mize fatigue, maintain quality of life, and reduce fatigue-related patient safety events. Adherence to work hours regulations is required to maintain accreditation. Among other guidelines, residents are required to work fewer than 80 hours per week on average over 4 consecutive weeks.¹ When work hour violations occur, programs risk citation, penalties, and harm to the program’s reputation.

Residents self-report their adherence to program regulations in an annual survey conducted by the ACGME.² To collect more frequent data, most training programs monitor resident work hours through self-report on an electronic tracking platform.³ These data generally are used internally to identify problems and opportunities for improvement. However, self-report approaches are subject to imperfect recall and incomplete reporting, and require time and effort to complete.⁴

The widespread adoption of electronic health records (EHRs) brings new opportunity to measure and promote adherence to work hours. EHR log data capture when users log in and out of the system, along with their location and specific actions. These data offer a compelling alternative to self-report because they are already being collected and can be analyzed almost immediately. Recent studies using EHR log data to approximate resident work hours in a pediatric hospital successfully approximated scheduled hours, but the approach was customized to their hospital’s workflows and might not generalize to other settings.⁵ Furthermore, earlier studies have not captured evening out-of-hospital work, which contributes to total work hours and is associated with physician burnout.⁶

We developed a computational method that sought to accurately capture work hours, including out-of-hospital work, which could be used as a screening tool to identify at-risk residents and rotations in near real-time. We estimated work hours, including EHR and non-EHR work, from these EHR data and compared these daily estimations to self-report. We then used a heuristic to estimate the frequency of exceeding the 80-hour workweek in a large internal medicine residency program.

The population included 82 internal medicine interns (PGY-1) and 121 residents (PGY-2 = 60, PGY-3 = 61) who rotated through University of California, San Francisco Medical Center (UCSFMC) between July 1, 2018, and June 30, 2019, on inpatient rotations. In the UCSF internal medicine residency program, interns spend an average of 5 months per year and residents spend an average of 2 months per year on inpatient rotations at UCSFMC. Scheduled inpatient rotations generally are in 1-month blocks and include general medical wards, cardiology, liver transplant, night-float, and a procedures and jeopardy rotation where interns perform procedures at UCSFMC and serve as backup for their colleagues across sites. Although expected shift duration differs by rotation, types of shifts include regular length days, call days that are not overnight (but expected duration of work is into the late evening), 28-hour overnight call (PGY-2 and PGY-3), and night-float.

Data Source

This computational method was developed at UCSFMC. This study was approved by the University of California, San Francisco institutional review board. Using the UCSF Epic Clarity database, EHR access log data were obtained, including all Epic logins/logoffs, times, and access devices. Access devices identified included medical center computers, personal computers, and mobile devices.

Trainees self-report their work hours in MedHub, a widely used electronic tracking platform for self-report of resident work hours.⁷ Data were extracted from this database for interns and residents who matched the criteria above. The self-report data were considered the gold standard for comparison, because it is the best available despite its known limitations.

We used data collected from UCSF’s physician scheduling platform, AMiON, to identify interns and residents assigned to rotations at UCSF hospitals.⁸ AMiON also was used to capture half-days of off-site scheduled clinics and teaching, which count toward the workday but would not be associated with on-campus logins.

Developing a Computational Method to Measure Work Hours

We developed a heuristic to accomplish two goals: (1) infer the duration of continuous in-hospital work hours while providing clinical care and (2) measure “out-of-hospital” work. Logins from medical center computers were considered to be “on-campus” work. Logins from personal computers were considered to be “out-of-hospital.” “Out-of-hospital” login sessions were further subdivided into “out-of-hospital work” and “out-of-hospital study” based on activity during the session; if any work activities listed in Appendix Table 1 were performed, the session was attributed to work. If only chart review was performed, the session was attributed to study and did not count towards total hours worked. Logins from mobile devices also did not count towards total hours worked.

We inferred continuous in-hospital work by linking on-campus EHR sessions from the first on-campus login until the last on-campus logoff (Figure 1).

If there was overlapping time measurement between on-campus work and personal computer logins (for example, a resident was inferred to be doing on-campus work based on frequent medical center computer logins but there were also logins from personal computers), we inferred this to indicate that a personal device had been brought on-campus and the time was only attributed to on-campus work and was not double counted as out-of-hospital work. Out-of-hospital work that did not overlap with inferred on-campus work time contributed to the total hours worked in a week, consistent with ACGME guidelines.

Our internal medicine residents work at three hospitals: UCSFMC and two affiliated teaching hospitals. Although this study measured work hours while the residents were on an inpatient rotation at UCSFMC, trainees also might have occasional half-day clinics or teaching activities at other sites not captured by these EHR log data. The allocated time for that scheduled activity (extracted from AMiON) was counted as work hours. If the trainee was assigned to a morning half-day of off-site work (eg, didactics), this was counted the same as an 8 am to noon on-campus EHR session. If a trainee was assigned an afternoon half-day of off-site work (eg, a non-UCSF clinic), this was counted the same as a 1 pm to 5 pm on-campus EHR session. Counting this scheduled time as an on-campus EHR session allowed half-days of off-site work to be linked with inferred in-hospital work.

Comparison of EHR-Derived Work Hours Heuristic to Self-Report

Because resident adherence with daily self-report is imperfect, we compared EHR-derived work to self-report on days when both were available. We generated scatter plots of EHR-derived work hours compared with self-report and calculated the mean absolute error of estimation. We fit a linear mixed-effect model for each PGY, modeling self-reported hours as a linear function of estimated hours (fixed effect) with a random intercept (random effect) for each trainee to account for variations among individuals. StatsModels, version 0.11.1, was used for statistical analyses.⁹

We reviewed detailed data from outlier clusters to understand situations where the heuristic might not perform optimally. To assess whether EHR-derived work hours reasonably overlapped with expected shifts, 20 8-day blocks from separate interns and residents were randomly selected for qualitative detail review in comparison with AMiON schedule data.

Estimating Hours Worked and Work Hours Violations

After validating against self-report on a daily basis, we used our heuristic to infer the average rate at which the 80-hour workweek was exceeded across all inpatient rotations at UCSFMC. This was determined both including “out-of-hospital” work as derived from logins on personal computers and excluding it. Using the estimated daily hours worked, we built a near real-time dashboard to assist program leadership with identifying at-risk trainees and trends across the program.

Data from 82 interns (PGY-1) and 121 internal medicine residents (PGY-2 and PGY-3) who rotated at UCSFMC between July 1, 2018, and June 30, 2019, were included in the study. Table 1 shows the number of days and rotations worked at UCSFMC as well as the frequency of self-report of work hours according to program year.

Qualitative review of EHR-derived data compared with schedule data showed that, although residents often reported homogenous daily work hours, EHR-derived work hours often varied as expected on a day-to-day basis according to the schedule (Appendix Table 2).

Because out-of-hospital EHR use does not count as work if done for educational purposes, we evaluated the proportion of out-of-hospital EHR use that is considered work and found that 67% of PGY-1, 50% of PGY-2, and 53% of PGY-3 out-of-hospital sessions included at least one work activity, as denoted in Appendix Table 1. Out-of-hospital work therefore represented 85% of PGY-1, 66% of PGY-2, and 73% of PGY-3 time spent in the EHR out-of-hospital. These sessions were counted towards work hours in accordance with ACGME rules and included 29% of PGY-1 workdays and 21% of PGY-2 and PGY-3 workdays. This amounted to a median of 1.0 hours per day (95% CI, 0.1-4.6 hours) of out-of-hospital work for PGY-1, 0.9 hours per day (95% CI, 0.1-4.1 hours) for PGY-2, and 0.8 hours per day (95% CI, 0.1-4.7 hours) for PGY-3 residents. Out-of-hospital logins that did not include work activities, as denoted in Appendix Table 1, were labeled out-of-hospital study and did not count towards work hours; this amounted to a median of 0.3 hours per day (95% CI, 0.02-1.6 hours) for PGY-1, 0.5 hours per day (95% CI, 0.04-0.25 hours) for PGY-2, and 0.3 hours per day (95% CI, 0.03-1.7 hours) for PGY-3. Mobile device logins also were not counted towards total work hours, with a median of 3 minutes per day for PGY-1, 6 minutes per day for PGY-2, and 5 minutes per day for PGY-3.

The percentage of rotation months where average hours worked exceeded 80 hours weekly is shown in Table 2. Inclusion of out-of-hospital work hours substantially increased the frequency at which the 80-hour workweek was exceeded. The frequency of individual residents working more than 80 hours weekly on average is shown in Appendix Figure 3. A narrow majority of PGY-1 and PGY-2 trainees and a larger majority of PGY-3 trainees never worked in excess of 80 hours per week when averaged over the course of a rotation, but several trainees did on several occasions.

Estimations from the computational method were built into a dashboard for use as screening tool by residency program directors (Appendix Figure 4).

EHR log data can be used to automate measurement of trainee work hours, providing timely data to program directors for identifying residents at risk of exceeding work hours limits. We demonstrated this by developing a data-driven approach to link on-campus logins that can be replicated in other training programs. We further demonstrated that out-of-hospital work substantially contributed to resident work hours and the frequency with which they exceed the 80-hour workweek, making it a critical component of any work hour estimation approach. Inclusive of out-of-hospital work, our computational method found that residents exceeded the 80-hour workweek 10% to 21% of the time, depending on their year in residency, with a small majority of residents never exceeding the 80-hour workweek.

Historically, most ACGME residency programs have relied on resident self-report to determine work hours.³ The validity of this method has been extensively studied and results remain mixed; in some surveys, residents admit to underreporting their hours while other validation studies, including the use of clock-in and clock-out or time-stamped parking data, align with self-report relatively well.^10-12 Regardless of the reliability of self-report, it is a cumbersome task that residents have difficulty adhering to, as shown in our study, where only slightly more than one-half of the days worked had associated self-report. By relying on resident self-report, we are adding to the burden of clerical work, which is associated with physician burnout.¹³ Furthermore, because self-report typically does not happen in real-time, it limits a program’s ability to intervene on recent or impending work-hour violations. Our computational method enabled us to build a dashboard that is updated daily and provides critical insight into resident work hours at any time, without waiting for retrospective self-report.

Our study builds on previous work by Dziorny et al using EHR log data to algorithmically measure in-hospital work.⁵ In their study, the authors isolated shifts with a login gap of 4 hours and then combined shifts according to a set of heuristics. However, their logic integrated an extensive workflow analysis of trainee shifts, which might limit generalizability.⁵ Our approach computationally derives the temporal threshold for linking EHR sessions, which in our data was 5 hours but might differ at other sites. Automated derivation of this threshold will support generalizability to other programs and sites, although programs will still need to manually account for off-site work such as didactics. In a subsequent study evaluating the 80-hour workweek, Dziorny et al evaluated shift duration and appropriate time-off between shifts and found systematic underreporting of work.¹⁴ In our study, we prioritized evaluation of the 80-hour workweek and found general alignment between self-report and EHR-derived work-hour estimates, with a tendency to underestimate at lower reported work hours and overestimate at higher reported work hours (potentially because of underreporting as illustrated by Dziorny et al). We included the important out-of-hospital logins as discrete work events because out-of-hospital work contributes to the total hours worked and to the number of workweeks that exceed the 80-hour workweek, and might contribute to burnout.¹⁵ The incidence of exceeding the 80-hour workweek increased by 7% to 8% across all residents when out-of-hospital work was included, demonstrating that tools such as ResQ (ResQ Medical) that rely primarily on geolocation data might not sufficiently capture the ways in which residents spend their time working.¹⁶

Our approach has limitations. We determined on-campus vs out-of-hospital locations based on whether the login device belonged to the medical center or was a personal computer. Consequently, if trainees exclusively used a personal computer while on-campus and never used a medical center computer, we would have captured this work done while logged into the EHR but would not have inferred on-campus work. Although nearly all trainees in our organization use medical center computers throughout the day, this might impact generalizability for programs where trainees use personal computers exclusively in the hospital. Our approach also assumes trainees will use the EHR at the beginning and end of their workdays, which could lead to underestimation of work hours in trainees who do not employ this practice. With regards to work done on personal computers, our heuristic required that at least one work activity (as denoted in Appendix Table 1) be included in the session in order for it to count as work. Although this approach allows us to exclude sessions where trainees might be reviewing charts exclusively for educational purposes, it is difficult to infer the true intent of chart review.

There might be periods of time where residents are doing in-hospital work but more than 5 hours elapsed between EHR user sessions. As we have started adapting this computational method for other residency programs, we have added logic that allows for long periods of time in the operating room to be considered part of a continuous workday. There also are limitations to assigning blocks of time to off-site clinics; clinics that are associated with after-hours work but use a different EHR would not be captured in total out-of-hospital work.

Although correlation with self-report was good, we identified clusters of inaccuracy. This likely resulted from our residency program covering three medical centers, two of which were not included in the data set. For example, if a resident had an off-site clinic that was not accounted for in AMiON, EHR-derived work hours might have been underestimated relative to self-report. Operationally leveraging an automated system for measuring work hours in the form of dashboards and other tools could provide the impetus to ensure accurate documentation of schedule anomalies.

Implementation of our EHR-derived work-hour model will allow ACGME residency programs to understand and act upon trainee work-hour violations closer to real time, as the data extraction is daily and automated. Automation will save busy residents a cumbersome task, provide more complete data than self-report, and empower residency programs to intervene quickly to support overworked trainees.

The authors thank Drs Bradley Monash, Larissa Thomas, and Rebecca Berman for providing residency program input.

Across the country, residents are bound to a set of rules from the Accreditation Council for Graduate Medical Education (ACGME) designed to mini mize fatigue, maintain quality of life, and reduce fatigue-related patient safety events. Adherence to work hours regulations is required to maintain accreditation. Among other guidelines, residents are required to work fewer than 80 hours per week on average over 4 consecutive weeks.¹ When work hour violations occur, programs risk citation, penalties, and harm to the program’s reputation.

Residents self-report their adherence to program regulations in an annual survey conducted by the ACGME.² To collect more frequent data, most training programs monitor resident work hours through self-report on an electronic tracking platform.³ These data generally are used internally to identify problems and opportunities for improvement. However, self-report approaches are subject to imperfect recall and incomplete reporting, and require time and effort to complete.⁴

The widespread adoption of electronic health records (EHRs) brings new opportunity to measure and promote adherence to work hours. EHR log data capture when users log in and out of the system, along with their location and specific actions. These data offer a compelling alternative to self-report because they are already being collected and can be analyzed almost immediately. Recent studies using EHR log data to approximate resident work hours in a pediatric hospital successfully approximated scheduled hours, but the approach was customized to their hospital’s workflows and might not generalize to other settings.⁵ Furthermore, earlier studies have not captured evening out-of-hospital work, which contributes to total work hours and is associated with physician burnout.⁶

We developed a computational method that sought to accurately capture work hours, including out-of-hospital work, which could be used as a screening tool to identify at-risk residents and rotations in near real-time. We estimated work hours, including EHR and non-EHR work, from these EHR data and compared these daily estimations to self-report. We then used a heuristic to estimate the frequency of exceeding the 80-hour workweek in a large internal medicine residency program.

The population included 82 internal medicine interns (PGY-1) and 121 residents (PGY-2 = 60, PGY-3 = 61) who rotated through University of California, San Francisco Medical Center (UCSFMC) between July 1, 2018, and June 30, 2019, on inpatient rotations. In the UCSF internal medicine residency program, interns spend an average of 5 months per year and residents spend an average of 2 months per year on inpatient rotations at UCSFMC. Scheduled inpatient rotations generally are in 1-month blocks and include general medical wards, cardiology, liver transplant, night-float, and a procedures and jeopardy rotation where interns perform procedures at UCSFMC and serve as backup for their colleagues across sites. Although expected shift duration differs by rotation, types of shifts include regular length days, call days that are not overnight (but expected duration of work is into the late evening), 28-hour overnight call (PGY-2 and PGY-3), and night-float.

Data Source

This computational method was developed at UCSFMC. This study was approved by the University of California, San Francisco institutional review board. Using the UCSF Epic Clarity database, EHR access log data were obtained, including all Epic logins/logoffs, times, and access devices. Access devices identified included medical center computers, personal computers, and mobile devices.

Trainees self-report their work hours in MedHub, a widely used electronic tracking platform for self-report of resident work hours.⁷ Data were extracted from this database for interns and residents who matched the criteria above. The self-report data were considered the gold standard for comparison, because it is the best available despite its known limitations.

We used data collected from UCSF’s physician scheduling platform, AMiON, to identify interns and residents assigned to rotations at UCSF hospitals.⁸ AMiON also was used to capture half-days of off-site scheduled clinics and teaching, which count toward the workday but would not be associated with on-campus logins.

Developing a Computational Method to Measure Work Hours

We developed a heuristic to accomplish two goals: (1) infer the duration of continuous in-hospital work hours while providing clinical care and (2) measure “out-of-hospital” work. Logins from medical center computers were considered to be “on-campus” work. Logins from personal computers were considered to be “out-of-hospital.” “Out-of-hospital” login sessions were further subdivided into “out-of-hospital work” and “out-of-hospital study” based on activity during the session; if any work activities listed in Appendix Table 1 were performed, the session was attributed to work. If only chart review was performed, the session was attributed to study and did not count towards total hours worked. Logins from mobile devices also did not count towards total hours worked.

We inferred continuous in-hospital work by linking on-campus EHR sessions from the first on-campus login until the last on-campus logoff (Figure 1).

If there was overlapping time measurement between on-campus work and personal computer logins (for example, a resident was inferred to be doing on-campus work based on frequent medical center computer logins but there were also logins from personal computers), we inferred this to indicate that a personal device had been brought on-campus and the time was only attributed to on-campus work and was not double counted as out-of-hospital work. Out-of-hospital work that did not overlap with inferred on-campus work time contributed to the total hours worked in a week, consistent with ACGME guidelines.

Our internal medicine residents work at three hospitals: UCSFMC and two affiliated teaching hospitals. Although this study measured work hours while the residents were on an inpatient rotation at UCSFMC, trainees also might have occasional half-day clinics or teaching activities at other sites not captured by these EHR log data. The allocated time for that scheduled activity (extracted from AMiON) was counted as work hours. If the trainee was assigned to a morning half-day of off-site work (eg, didactics), this was counted the same as an 8 am to noon on-campus EHR session. If a trainee was assigned an afternoon half-day of off-site work (eg, a non-UCSF clinic), this was counted the same as a 1 pm to 5 pm on-campus EHR session. Counting this scheduled time as an on-campus EHR session allowed half-days of off-site work to be linked with inferred in-hospital work.

Comparison of EHR-Derived Work Hours Heuristic to Self-Report

Because resident adherence with daily self-report is imperfect, we compared EHR-derived work to self-report on days when both were available. We generated scatter plots of EHR-derived work hours compared with self-report and calculated the mean absolute error of estimation. We fit a linear mixed-effect model for each PGY, modeling self-reported hours as a linear function of estimated hours (fixed effect) with a random intercept (random effect) for each trainee to account for variations among individuals. StatsModels, version 0.11.1, was used for statistical analyses.⁹

We reviewed detailed data from outlier clusters to understand situations where the heuristic might not perform optimally. To assess whether EHR-derived work hours reasonably overlapped with expected shifts, 20 8-day blocks from separate interns and residents were randomly selected for qualitative detail review in comparison with AMiON schedule data.

Estimating Hours Worked and Work Hours Violations

After validating against self-report on a daily basis, we used our heuristic to infer the average rate at which the 80-hour workweek was exceeded across all inpatient rotations at UCSFMC. This was determined both including “out-of-hospital” work as derived from logins on personal computers and excluding it. Using the estimated daily hours worked, we built a near real-time dashboard to assist program leadership with identifying at-risk trainees and trends across the program.

Data from 82 interns (PGY-1) and 121 internal medicine residents (PGY-2 and PGY-3) who rotated at UCSFMC between July 1, 2018, and June 30, 2019, were included in the study. Table 1 shows the number of days and rotations worked at UCSFMC as well as the frequency of self-report of work hours according to program year.

Qualitative review of EHR-derived data compared with schedule data showed that, although residents often reported homogenous daily work hours, EHR-derived work hours often varied as expected on a day-to-day basis according to the schedule (Appendix Table 2).

Because out-of-hospital EHR use does not count as work if done for educational purposes, we evaluated the proportion of out-of-hospital EHR use that is considered work and found that 67% of PGY-1, 50% of PGY-2, and 53% of PGY-3 out-of-hospital sessions included at least one work activity, as denoted in Appendix Table 1. Out-of-hospital work therefore represented 85% of PGY-1, 66% of PGY-2, and 73% of PGY-3 time spent in the EHR out-of-hospital. These sessions were counted towards work hours in accordance with ACGME rules and included 29% of PGY-1 workdays and 21% of PGY-2 and PGY-3 workdays. This amounted to a median of 1.0 hours per day (95% CI, 0.1-4.6 hours) of out-of-hospital work for PGY-1, 0.9 hours per day (95% CI, 0.1-4.1 hours) for PGY-2, and 0.8 hours per day (95% CI, 0.1-4.7 hours) for PGY-3 residents. Out-of-hospital logins that did not include work activities, as denoted in Appendix Table 1, were labeled out-of-hospital study and did not count towards work hours; this amounted to a median of 0.3 hours per day (95% CI, 0.02-1.6 hours) for PGY-1, 0.5 hours per day (95% CI, 0.04-0.25 hours) for PGY-2, and 0.3 hours per day (95% CI, 0.03-1.7 hours) for PGY-3. Mobile device logins also were not counted towards total work hours, with a median of 3 minutes per day for PGY-1, 6 minutes per day for PGY-2, and 5 minutes per day for PGY-3.

The percentage of rotation months where average hours worked exceeded 80 hours weekly is shown in Table 2. Inclusion of out-of-hospital work hours substantially increased the frequency at which the 80-hour workweek was exceeded. The frequency of individual residents working more than 80 hours weekly on average is shown in Appendix Figure 3. A narrow majority of PGY-1 and PGY-2 trainees and a larger majority of PGY-3 trainees never worked in excess of 80 hours per week when averaged over the course of a rotation, but several trainees did on several occasions.

Estimations from the computational method were built into a dashboard for use as screening tool by residency program directors (Appendix Figure 4).

EHR log data can be used to automate measurement of trainee work hours, providing timely data to program directors for identifying residents at risk of exceeding work hours limits. We demonstrated this by developing a data-driven approach to link on-campus logins that can be replicated in other training programs. We further demonstrated that out-of-hospital work substantially contributed to resident work hours and the frequency with which they exceed the 80-hour workweek, making it a critical component of any work hour estimation approach. Inclusive of out-of-hospital work, our computational method found that residents exceeded the 80-hour workweek 10% to 21% of the time, depending on their year in residency, with a small majority of residents never exceeding the 80-hour workweek.

Historically, most ACGME residency programs have relied on resident self-report to determine work hours.³ The validity of this method has been extensively studied and results remain mixed; in some surveys, residents admit to underreporting their hours while other validation studies, including the use of clock-in and clock-out or time-stamped parking data, align with self-report relatively well.^10-12 Regardless of the reliability of self-report, it is a cumbersome task that residents have difficulty adhering to, as shown in our study, where only slightly more than one-half of the days worked had associated self-report. By relying on resident self-report, we are adding to the burden of clerical work, which is associated with physician burnout.¹³ Furthermore, because self-report typically does not happen in real-time, it limits a program’s ability to intervene on recent or impending work-hour violations. Our computational method enabled us to build a dashboard that is updated daily and provides critical insight into resident work hours at any time, without waiting for retrospective self-report.

Our study builds on previous work by Dziorny et al using EHR log data to algorithmically measure in-hospital work.⁵ In their study, the authors isolated shifts with a login gap of 4 hours and then combined shifts according to a set of heuristics. However, their logic integrated an extensive workflow analysis of trainee shifts, which might limit generalizability.⁵ Our approach computationally derives the temporal threshold for linking EHR sessions, which in our data was 5 hours but might differ at other sites. Automated derivation of this threshold will support generalizability to other programs and sites, although programs will still need to manually account for off-site work such as didactics. In a subsequent study evaluating the 80-hour workweek, Dziorny et al evaluated shift duration and appropriate time-off between shifts and found systematic underreporting of work.¹⁴ In our study, we prioritized evaluation of the 80-hour workweek and found general alignment between self-report and EHR-derived work-hour estimates, with a tendency to underestimate at lower reported work hours and overestimate at higher reported work hours (potentially because of underreporting as illustrated by Dziorny et al). We included the important out-of-hospital logins as discrete work events because out-of-hospital work contributes to the total hours worked and to the number of workweeks that exceed the 80-hour workweek, and might contribute to burnout.¹⁵ The incidence of exceeding the 80-hour workweek increased by 7% to 8% across all residents when out-of-hospital work was included, demonstrating that tools such as ResQ (ResQ Medical) that rely primarily on geolocation data might not sufficiently capture the ways in which residents spend their time working.¹⁶

Our approach has limitations. We determined on-campus vs out-of-hospital locations based on whether the login device belonged to the medical center or was a personal computer. Consequently, if trainees exclusively used a personal computer while on-campus and never used a medical center computer, we would have captured this work done while logged into the EHR but would not have inferred on-campus work. Although nearly all trainees in our organization use medical center computers throughout the day, this might impact generalizability for programs where trainees use personal computers exclusively in the hospital. Our approach also assumes trainees will use the EHR at the beginning and end of their workdays, which could lead to underestimation of work hours in trainees who do not employ this practice. With regards to work done on personal computers, our heuristic required that at least one work activity (as denoted in Appendix Table 1) be included in the session in order for it to count as work. Although this approach allows us to exclude sessions where trainees might be reviewing charts exclusively for educational purposes, it is difficult to infer the true intent of chart review.

There might be periods of time where residents are doing in-hospital work but more than 5 hours elapsed between EHR user sessions. As we have started adapting this computational method for other residency programs, we have added logic that allows for long periods of time in the operating room to be considered part of a continuous workday. There also are limitations to assigning blocks of time to off-site clinics; clinics that are associated with after-hours work but use a different EHR would not be captured in total out-of-hospital work.

Although correlation with self-report was good, we identified clusters of inaccuracy. This likely resulted from our residency program covering three medical centers, two of which were not included in the data set. For example, if a resident had an off-site clinic that was not accounted for in AMiON, EHR-derived work hours might have been underestimated relative to self-report. Operationally leveraging an automated system for measuring work hours in the form of dashboards and other tools could provide the impetus to ensure accurate documentation of schedule anomalies.

Implementation of our EHR-derived work-hour model will allow ACGME residency programs to understand and act upon trainee work-hour violations closer to real time, as the data extraction is daily and automated. Automation will save busy residents a cumbersome task, provide more complete data than self-report, and empower residency programs to intervene quickly to support overworked trainees.

The authors thank Drs Bradley Monash, Larissa Thomas, and Rebecca Berman for providing residency program input.

Across the country, residents are bound to a set of rules from the Accreditation Council for Graduate Medical Education (ACGME) designed to mini mize fatigue, maintain quality of life, and reduce fatigue-related patient safety events. Adherence to work hours regulations is required to maintain accreditation. Among other guidelines, residents are required to work fewer than 80 hours per week on average over 4 consecutive weeks.¹ When work hour violations occur, programs risk citation, penalties, and harm to the program’s reputation.

Residents self-report their adherence to program regulations in an annual survey conducted by the ACGME.² To collect more frequent data, most training programs monitor resident work hours through self-report on an electronic tracking platform.³ These data generally are used internally to identify problems and opportunities for improvement. However, self-report approaches are subject to imperfect recall and incomplete reporting, and require time and effort to complete.⁴

The widespread adoption of electronic health records (EHRs) brings new opportunity to measure and promote adherence to work hours. EHR log data capture when users log in and out of the system, along with their location and specific actions. These data offer a compelling alternative to self-report because they are already being collected and can be analyzed almost immediately. Recent studies using EHR log data to approximate resident work hours in a pediatric hospital successfully approximated scheduled hours, but the approach was customized to their hospital’s workflows and might not generalize to other settings.⁵ Furthermore, earlier studies have not captured evening out-of-hospital work, which contributes to total work hours and is associated with physician burnout.⁶

We developed a computational method that sought to accurately capture work hours, including out-of-hospital work, which could be used as a screening tool to identify at-risk residents and rotations in near real-time. We estimated work hours, including EHR and non-EHR work, from these EHR data and compared these daily estimations to self-report. We then used a heuristic to estimate the frequency of exceeding the 80-hour workweek in a large internal medicine residency program.

The population included 82 internal medicine interns (PGY-1) and 121 residents (PGY-2 = 60, PGY-3 = 61) who rotated through University of California, San Francisco Medical Center (UCSFMC) between July 1, 2018, and June 30, 2019, on inpatient rotations. In the UCSF internal medicine residency program, interns spend an average of 5 months per year and residents spend an average of 2 months per year on inpatient rotations at UCSFMC. Scheduled inpatient rotations generally are in 1-month blocks and include general medical wards, cardiology, liver transplant, night-float, and a procedures and jeopardy rotation where interns perform procedures at UCSFMC and serve as backup for their colleagues across sites. Although expected shift duration differs by rotation, types of shifts include regular length days, call days that are not overnight (but expected duration of work is into the late evening), 28-hour overnight call (PGY-2 and PGY-3), and night-float.

Data Source

This computational method was developed at UCSFMC. This study was approved by the University of California, San Francisco institutional review board. Using the UCSF Epic Clarity database, EHR access log data were obtained, including all Epic logins/logoffs, times, and access devices. Access devices identified included medical center computers, personal computers, and mobile devices.

Trainees self-report their work hours in MedHub, a widely used electronic tracking platform for self-report of resident work hours.⁷ Data were extracted from this database for interns and residents who matched the criteria above. The self-report data were considered the gold standard for comparison, because it is the best available despite its known limitations.

We used data collected from UCSF’s physician scheduling platform, AMiON, to identify interns and residents assigned to rotations at UCSF hospitals.⁸ AMiON also was used to capture half-days of off-site scheduled clinics and teaching, which count toward the workday but would not be associated with on-campus logins.

Developing a Computational Method to Measure Work Hours

We developed a heuristic to accomplish two goals: (1) infer the duration of continuous in-hospital work hours while providing clinical care and (2) measure “out-of-hospital” work. Logins from medical center computers were considered to be “on-campus” work. Logins from personal computers were considered to be “out-of-hospital.” “Out-of-hospital” login sessions were further subdivided into “out-of-hospital work” and “out-of-hospital study” based on activity during the session; if any work activities listed in Appendix Table 1 were performed, the session was attributed to work. If only chart review was performed, the session was attributed to study and did not count towards total hours worked. Logins from mobile devices also did not count towards total hours worked.

We inferred continuous in-hospital work by linking on-campus EHR sessions from the first on-campus login until the last on-campus logoff (Figure 1).

If there was overlapping time measurement between on-campus work and personal computer logins (for example, a resident was inferred to be doing on-campus work based on frequent medical center computer logins but there were also logins from personal computers), we inferred this to indicate that a personal device had been brought on-campus and the time was only attributed to on-campus work and was not double counted as out-of-hospital work. Out-of-hospital work that did not overlap with inferred on-campus work time contributed to the total hours worked in a week, consistent with ACGME guidelines.

Our internal medicine residents work at three hospitals: UCSFMC and two affiliated teaching hospitals. Although this study measured work hours while the residents were on an inpatient rotation at UCSFMC, trainees also might have occasional half-day clinics or teaching activities at other sites not captured by these EHR log data. The allocated time for that scheduled activity (extracted from AMiON) was counted as work hours. If the trainee was assigned to a morning half-day of off-site work (eg, didactics), this was counted the same as an 8 am to noon on-campus EHR session. If a trainee was assigned an afternoon half-day of off-site work (eg, a non-UCSF clinic), this was counted the same as a 1 pm to 5 pm on-campus EHR session. Counting this scheduled time as an on-campus EHR session allowed half-days of off-site work to be linked with inferred in-hospital work.

Comparison of EHR-Derived Work Hours Heuristic to Self-Report

Because resident adherence with daily self-report is imperfect, we compared EHR-derived work to self-report on days when both were available. We generated scatter plots of EHR-derived work hours compared with self-report and calculated the mean absolute error of estimation. We fit a linear mixed-effect model for each PGY, modeling self-reported hours as a linear function of estimated hours (fixed effect) with a random intercept (random effect) for each trainee to account for variations among individuals. StatsModels, version 0.11.1, was used for statistical analyses.⁹

We reviewed detailed data from outlier clusters to understand situations where the heuristic might not perform optimally. To assess whether EHR-derived work hours reasonably overlapped with expected shifts, 20 8-day blocks from separate interns and residents were randomly selected for qualitative detail review in comparison with AMiON schedule data.

Estimating Hours Worked and Work Hours Violations

After validating against self-report on a daily basis, we used our heuristic to infer the average rate at which the 80-hour workweek was exceeded across all inpatient rotations at UCSFMC. This was determined both including “out-of-hospital” work as derived from logins on personal computers and excluding it. Using the estimated daily hours worked, we built a near real-time dashboard to assist program leadership with identifying at-risk trainees and trends across the program.

Data from 82 interns (PGY-1) and 121 internal medicine residents (PGY-2 and PGY-3) who rotated at UCSFMC between July 1, 2018, and June 30, 2019, were included in the study. Table 1 shows the number of days and rotations worked at UCSFMC as well as the frequency of self-report of work hours according to program year.

Qualitative review of EHR-derived data compared with schedule data showed that, although residents often reported homogenous daily work hours, EHR-derived work hours often varied as expected on a day-to-day basis according to the schedule (Appendix Table 2).

Because out-of-hospital EHR use does not count as work if done for educational purposes, we evaluated the proportion of out-of-hospital EHR use that is considered work and found that 67% of PGY-1, 50% of PGY-2, and 53% of PGY-3 out-of-hospital sessions included at least one work activity, as denoted in Appendix Table 1. Out-of-hospital work therefore represented 85% of PGY-1, 66% of PGY-2, and 73% of PGY-3 time spent in the EHR out-of-hospital. These sessions were counted towards work hours in accordance with ACGME rules and included 29% of PGY-1 workdays and 21% of PGY-2 and PGY-3 workdays. This amounted to a median of 1.0 hours per day (95% CI, 0.1-4.6 hours) of out-of-hospital work for PGY-1, 0.9 hours per day (95% CI, 0.1-4.1 hours) for PGY-2, and 0.8 hours per day (95% CI, 0.1-4.7 hours) for PGY-3 residents. Out-of-hospital logins that did not include work activities, as denoted in Appendix Table 1, were labeled out-of-hospital study and did not count towards work hours; this amounted to a median of 0.3 hours per day (95% CI, 0.02-1.6 hours) for PGY-1, 0.5 hours per day (95% CI, 0.04-0.25 hours) for PGY-2, and 0.3 hours per day (95% CI, 0.03-1.7 hours) for PGY-3. Mobile device logins also were not counted towards total work hours, with a median of 3 minutes per day for PGY-1, 6 minutes per day for PGY-2, and 5 minutes per day for PGY-3.

The percentage of rotation months where average hours worked exceeded 80 hours weekly is shown in Table 2. Inclusion of out-of-hospital work hours substantially increased the frequency at which the 80-hour workweek was exceeded. The frequency of individual residents working more than 80 hours weekly on average is shown in Appendix Figure 3. A narrow majority of PGY-1 and PGY-2 trainees and a larger majority of PGY-3 trainees never worked in excess of 80 hours per week when averaged over the course of a rotation, but several trainees did on several occasions.

Estimations from the computational method were built into a dashboard for use as screening tool by residency program directors (Appendix Figure 4).

EHR log data can be used to automate measurement of trainee work hours, providing timely data to program directors for identifying residents at risk of exceeding work hours limits. We demonstrated this by developing a data-driven approach to link on-campus logins that can be replicated in other training programs. We further demonstrated that out-of-hospital work substantially contributed to resident work hours and the frequency with which they exceed the 80-hour workweek, making it a critical component of any work hour estimation approach. Inclusive of out-of-hospital work, our computational method found that residents exceeded the 80-hour workweek 10% to 21% of the time, depending on their year in residency, with a small majority of residents never exceeding the 80-hour workweek.

Historically, most ACGME residency programs have relied on resident self-report to determine work hours.³ The validity of this method has been extensively studied and results remain mixed; in some surveys, residents admit to underreporting their hours while other validation studies, including the use of clock-in and clock-out or time-stamped parking data, align with self-report relatively well.^10-12 Regardless of the reliability of self-report, it is a cumbersome task that residents have difficulty adhering to, as shown in our study, where only slightly more than one-half of the days worked had associated self-report. By relying on resident self-report, we are adding to the burden of clerical work, which is associated with physician burnout.¹³ Furthermore, because self-report typically does not happen in real-time, it limits a program’s ability to intervene on recent or impending work-hour violations. Our computational method enabled us to build a dashboard that is updated daily and provides critical insight into resident work hours at any time, without waiting for retrospective self-report.

Our study builds on previous work by Dziorny et al using EHR log data to algorithmically measure in-hospital work.⁵ In their study, the authors isolated shifts with a login gap of 4 hours and then combined shifts according to a set of heuristics. However, their logic integrated an extensive workflow analysis of trainee shifts, which might limit generalizability.⁵ Our approach computationally derives the temporal threshold for linking EHR sessions, which in our data was 5 hours but might differ at other sites. Automated derivation of this threshold will support generalizability to other programs and sites, although programs will still need to manually account for off-site work such as didactics. In a subsequent study evaluating the 80-hour workweek, Dziorny et al evaluated shift duration and appropriate time-off between shifts and found systematic underreporting of work.¹⁴ In our study, we prioritized evaluation of the 80-hour workweek and found general alignment between self-report and EHR-derived work-hour estimates, with a tendency to underestimate at lower reported work hours and overestimate at higher reported work hours (potentially because of underreporting as illustrated by Dziorny et al). We included the important out-of-hospital logins as discrete work events because out-of-hospital work contributes to the total hours worked and to the number of workweeks that exceed the 80-hour workweek, and might contribute to burnout.¹⁵ The incidence of exceeding the 80-hour workweek increased by 7% to 8% across all residents when out-of-hospital work was included, demonstrating that tools such as ResQ (ResQ Medical) that rely primarily on geolocation data might not sufficiently capture the ways in which residents spend their time working.¹⁶

Our approach has limitations. We determined on-campus vs out-of-hospital locations based on whether the login device belonged to the medical center or was a personal computer. Consequently, if trainees exclusively used a personal computer while on-campus and never used a medical center computer, we would have captured this work done while logged into the EHR but would not have inferred on-campus work. Although nearly all trainees in our organization use medical center computers throughout the day, this might impact generalizability for programs where trainees use personal computers exclusively in the hospital. Our approach also assumes trainees will use the EHR at the beginning and end of their workdays, which could lead to underestimation of work hours in trainees who do not employ this practice. With regards to work done on personal computers, our heuristic required that at least one work activity (as denoted in Appendix Table 1) be included in the session in order for it to count as work. Although this approach allows us to exclude sessions where trainees might be reviewing charts exclusively for educational purposes, it is difficult to infer the true intent of chart review.

There might be periods of time where residents are doing in-hospital work but more than 5 hours elapsed between EHR user sessions. As we have started adapting this computational method for other residency programs, we have added logic that allows for long periods of time in the operating room to be considered part of a continuous workday. There also are limitations to assigning blocks of time to off-site clinics; clinics that are associated with after-hours work but use a different EHR would not be captured in total out-of-hospital work.

Although correlation with self-report was good, we identified clusters of inaccuracy. This likely resulted from our residency program covering three medical centers, two of which were not included in the data set. For example, if a resident had an off-site clinic that was not accounted for in AMiON, EHR-derived work hours might have been underestimated relative to self-report. Operationally leveraging an automated system for measuring work hours in the form of dashboards and other tools could provide the impetus to ensure accurate documentation of schedule anomalies.

Implementation of our EHR-derived work-hour model will allow ACGME residency programs to understand and act upon trainee work-hour violations closer to real time, as the data extraction is daily and automated. Automation will save busy residents a cumbersome task, provide more complete data than self-report, and empower residency programs to intervene quickly to support overworked trainees.

The authors thank Drs Bradley Monash, Larissa Thomas, and Rebecca Berman for providing residency program input.

A new study on the changing rheumatology workforce found that, although there has been a notable rise in female rheumatologists, they see fewer patients and have lower earnings than their male counterparts.

BSIP/UIG/GettyImages

“In order for future health workforce policy and planning to be effective and equitable, it is essential to consider policies and other solutions to support the sustainability of rheumatology workforces in light of increasing feminization,” wrote Jessica Widdifield, PhD, of the Sunnybrook Research Institute in Toronto and her colleagues. The study was published in the Journal of Rheumatology.

To investigate potential workload and earnings disparities between male and female rheumatologists, the researchers launched a population-based study of rheumatologists practicing in Ontario, Canada, and their patient visits between April 1, 2000, and March 31, 2015. To quantify clinical activity, they calculated full-time equivalents (FTEs) using annual fee-for-service billing claims and defined rheumatologists practicing at least one clinical FTE as those at or above the 40th percentile of total billings each year. Any rheumatologists practicing less than one FTE were not included in the larger analysis.

Overall, they found that the total number of rheumatologists increased from 146 in 2000 to 194 in 2015, with 49% of the latter workforce being women. When assessing only rheumatologists practicing at greater than one FTE, the number increased from 89 in 2000 to 120 in 2015, with women making up 41.7% of the 2015 workforce. Although practice sizes decreased for both genders over the course of the study, in 2015 the median practice size was 1,948.5 patients (interquartile range, 1,433-2,562) for men, compared with 1,468.5 patients (IQR, 1,212-1,984) for women. In every year but 2001, men had larger median practice sizes than women.

Total patient visits remained relatively stable for men throughout the study period but declined for women, with the gap between genders widening over time. The peak gap in visits was 1,486 (95% confidence interval, 628-2,517) in 2008. And while median payments increased over time for all rheumatologists, median renumeration peaked in 2015 at $362,522 (IQR, $309,503-$437,127) for women, compared with $403,903 (IQR, $313,297-$544,703) for men. That said, the median difference that year – $45,556.10 (95% confidence interval, $951.60-$92,470.40; P = .04) – was the smallest for any in the study period. The largest difference was $102,176.10 (95% CI, $58,457.50-$152,821.20; P < .0001) in 2011.

An opportunity for female rheumatologists to reshape the specialty

Of course, gender gaps like these are not limited to rheumatology or even medicine, wrote Grace C. Wright, MD, PhD, president of the Association of Women in Rheumatology, in an accompanying editorial. “This issue exists across industries as well as across boundaries.”

“Particularly for women physicians, we do have additional demands on our time,” agreed April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, in an interview. “For example, we know that women who work often have additional caregiving responsibilities at home, for kids and/or elderly relatives. I do think those are real reasons why certain providers, particularly women, might have a lower clinical volume.”

Despite the significant gender gaps that still exist, Dr. Jorge – who authored a previous study on the gaps in academic rheumatology – was heartened by the data that indicated more women finding their way into the specialty.

“I think it’s good news for rheumatology to be so balanced between men and women as providers,” she said. “For young women trainees, it’s really important to see role models in their field. For patients, it’s incredibly important for them to have a doctor who can relate and who can advocate for them. So many rheumatic conditions that we treat disproportionately affect women, often women of childbearing age. So it’s really important to have women involved in leading the specialty of rheumatology, including clinical practice but also research, education, and policy.”

Dr. Wright concurred in her editorial, stating that “this feminization of rheumatology provides an opportunity to assess the needs of working women, the generational shifts in attitudes toward work-life balance, and a change in clinical practice toward value over volume.”

The study’s authors shared its possible limitations, including the lack of a standard definition of a clinical FTE rheumatologist – thus their decision to define one – and a lack of context as to why certain rheumatologists were practicing less than others. In addition, they preemptively acknowledged Dr. Jorge’s concern by noting their inability to access gender-related details like marital status, family size, and childcare roles, all of which “could contribute to the relationship between physician gender and practice-level activity.”

The study was funded by an operating grant from the Canadian Initiative for Outcomes in Rheumatology Care and supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Two of the authors reported receiving support from the Arthritis Society Stars Career Development Award.
 

A new study on the changing rheumatology workforce found that, although there has been a notable rise in female rheumatologists, they see fewer patients and have lower earnings than their male counterparts.

BSIP/UIG/GettyImages

“In order for future health workforce policy and planning to be effective and equitable, it is essential to consider policies and other solutions to support the sustainability of rheumatology workforces in light of increasing feminization,” wrote Jessica Widdifield, PhD, of the Sunnybrook Research Institute in Toronto and her colleagues. The study was published in the Journal of Rheumatology.

To investigate potential workload and earnings disparities between male and female rheumatologists, the researchers launched a population-based study of rheumatologists practicing in Ontario, Canada, and their patient visits between April 1, 2000, and March 31, 2015. To quantify clinical activity, they calculated full-time equivalents (FTEs) using annual fee-for-service billing claims and defined rheumatologists practicing at least one clinical FTE as those at or above the 40th percentile of total billings each year. Any rheumatologists practicing less than one FTE were not included in the larger analysis.

Overall, they found that the total number of rheumatologists increased from 146 in 2000 to 194 in 2015, with 49% of the latter workforce being women. When assessing only rheumatologists practicing at greater than one FTE, the number increased from 89 in 2000 to 120 in 2015, with women making up 41.7% of the 2015 workforce. Although practice sizes decreased for both genders over the course of the study, in 2015 the median practice size was 1,948.5 patients (interquartile range, 1,433-2,562) for men, compared with 1,468.5 patients (IQR, 1,212-1,984) for women. In every year but 2001, men had larger median practice sizes than women.

Total patient visits remained relatively stable for men throughout the study period but declined for women, with the gap between genders widening over time. The peak gap in visits was 1,486 (95% confidence interval, 628-2,517) in 2008. And while median payments increased over time for all rheumatologists, median renumeration peaked in 2015 at $362,522 (IQR, $309,503-$437,127) for women, compared with $403,903 (IQR, $313,297-$544,703) for men. That said, the median difference that year – $45,556.10 (95% confidence interval, $951.60-$92,470.40; P = .04) – was the smallest for any in the study period. The largest difference was $102,176.10 (95% CI, $58,457.50-$152,821.20; P < .0001) in 2011.

An opportunity for female rheumatologists to reshape the specialty

Of course, gender gaps like these are not limited to rheumatology or even medicine, wrote Grace C. Wright, MD, PhD, president of the Association of Women in Rheumatology, in an accompanying editorial. “This issue exists across industries as well as across boundaries.”

“Particularly for women physicians, we do have additional demands on our time,” agreed April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, in an interview. “For example, we know that women who work often have additional caregiving responsibilities at home, for kids and/or elderly relatives. I do think those are real reasons why certain providers, particularly women, might have a lower clinical volume.”

Despite the significant gender gaps that still exist, Dr. Jorge – who authored a previous study on the gaps in academic rheumatology – was heartened by the data that indicated more women finding their way into the specialty.

“I think it’s good news for rheumatology to be so balanced between men and women as providers,” she said. “For young women trainees, it’s really important to see role models in their field. For patients, it’s incredibly important for them to have a doctor who can relate and who can advocate for them. So many rheumatic conditions that we treat disproportionately affect women, often women of childbearing age. So it’s really important to have women involved in leading the specialty of rheumatology, including clinical practice but also research, education, and policy.”

Dr. Wright concurred in her editorial, stating that “this feminization of rheumatology provides an opportunity to assess the needs of working women, the generational shifts in attitudes toward work-life balance, and a change in clinical practice toward value over volume.”

The study’s authors shared its possible limitations, including the lack of a standard definition of a clinical FTE rheumatologist – thus their decision to define one – and a lack of context as to why certain rheumatologists were practicing less than others. In addition, they preemptively acknowledged Dr. Jorge’s concern by noting their inability to access gender-related details like marital status, family size, and childcare roles, all of which “could contribute to the relationship between physician gender and practice-level activity.”

The study was funded by an operating grant from the Canadian Initiative for Outcomes in Rheumatology Care and supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Two of the authors reported receiving support from the Arthritis Society Stars Career Development Award.
 

A new study on the changing rheumatology workforce found that, although there has been a notable rise in female rheumatologists, they see fewer patients and have lower earnings than their male counterparts.

BSIP/UIG/GettyImages

“In order for future health workforce policy and planning to be effective and equitable, it is essential to consider policies and other solutions to support the sustainability of rheumatology workforces in light of increasing feminization,” wrote Jessica Widdifield, PhD, of the Sunnybrook Research Institute in Toronto and her colleagues. The study was published in the Journal of Rheumatology.

To investigate potential workload and earnings disparities between male and female rheumatologists, the researchers launched a population-based study of rheumatologists practicing in Ontario, Canada, and their patient visits between April 1, 2000, and March 31, 2015. To quantify clinical activity, they calculated full-time equivalents (FTEs) using annual fee-for-service billing claims and defined rheumatologists practicing at least one clinical FTE as those at or above the 40th percentile of total billings each year. Any rheumatologists practicing less than one FTE were not included in the larger analysis.

Overall, they found that the total number of rheumatologists increased from 146 in 2000 to 194 in 2015, with 49% of the latter workforce being women. When assessing only rheumatologists practicing at greater than one FTE, the number increased from 89 in 2000 to 120 in 2015, with women making up 41.7% of the 2015 workforce. Although practice sizes decreased for both genders over the course of the study, in 2015 the median practice size was 1,948.5 patients (interquartile range, 1,433-2,562) for men, compared with 1,468.5 patients (IQR, 1,212-1,984) for women. In every year but 2001, men had larger median practice sizes than women.

Total patient visits remained relatively stable for men throughout the study period but declined for women, with the gap between genders widening over time. The peak gap in visits was 1,486 (95% confidence interval, 628-2,517) in 2008. And while median payments increased over time for all rheumatologists, median renumeration peaked in 2015 at $362,522 (IQR, $309,503-$437,127) for women, compared with $403,903 (IQR, $313,297-$544,703) for men. That said, the median difference that year – $45,556.10 (95% confidence interval, $951.60-$92,470.40; P = .04) – was the smallest for any in the study period. The largest difference was $102,176.10 (95% CI, $58,457.50-$152,821.20; P < .0001) in 2011.

An opportunity for female rheumatologists to reshape the specialty

Of course, gender gaps like these are not limited to rheumatology or even medicine, wrote Grace C. Wright, MD, PhD, president of the Association of Women in Rheumatology, in an accompanying editorial. “This issue exists across industries as well as across boundaries.”

“Particularly for women physicians, we do have additional demands on our time,” agreed April Jorge, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, in an interview. “For example, we know that women who work often have additional caregiving responsibilities at home, for kids and/or elderly relatives. I do think those are real reasons why certain providers, particularly women, might have a lower clinical volume.”

Despite the significant gender gaps that still exist, Dr. Jorge – who authored a previous study on the gaps in academic rheumatology – was heartened by the data that indicated more women finding their way into the specialty.

“I think it’s good news for rheumatology to be so balanced between men and women as providers,” she said. “For young women trainees, it’s really important to see role models in their field. For patients, it’s incredibly important for them to have a doctor who can relate and who can advocate for them. So many rheumatic conditions that we treat disproportionately affect women, often women of childbearing age. So it’s really important to have women involved in leading the specialty of rheumatology, including clinical practice but also research, education, and policy.”

Dr. Wright concurred in her editorial, stating that “this feminization of rheumatology provides an opportunity to assess the needs of working women, the generational shifts in attitudes toward work-life balance, and a change in clinical practice toward value over volume.”

The study’s authors shared its possible limitations, including the lack of a standard definition of a clinical FTE rheumatologist – thus their decision to define one – and a lack of context as to why certain rheumatologists were practicing less than others. In addition, they preemptively acknowledged Dr. Jorge’s concern by noting their inability to access gender-related details like marital status, family size, and childcare roles, all of which “could contribute to the relationship between physician gender and practice-level activity.”

The study was funded by an operating grant from the Canadian Initiative for Outcomes in Rheumatology Care and supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care. Two of the authors reported receiving support from the Arthritis Society Stars Career Development Award.
 

Most patients who are receiving maintenance hemodialysis develop a good antibody response after being given two doses of the Pfizer-BioNTech COVID-19 vaccine, but their responses are still significantly lower than those of health care workers who do not have kidney disease, the first study of its kind shows.

“It is well known that patients on dialysis may have a reduced response to vaccination,” Ayelet Grupper, MD, of Tel Aviv Medical Center, and colleagues observe. Their study was published online April 6 in the Clinical Journal of the American Society of Nephrology.

“I believe our findings should encourage patients with kidney failure treated with dialysis to be vaccinated as soon as vaccination becomes available for them, while we as caregivers should explore ways to enhance its efficacy in our patients,” senior author Moshe Shashar, MD, noted in a statement from the American Society of Nephrology.

Asked to comment, Peter Blake, MD, professor of medicine, University of Western Ontario, London, pointed out that COVID-19 is very common among hemodialysis patients and that the likelihood of these patients dying from it is very high. Indeed, 1.5% of approximately 12,500 patients receiving dialysis in the province of Ontario have died of COVID-19 – “a horrifying statistic and one that only long-term care home residents can compare with,” he told this news organization.

In the Israeli study, almost all dialysis patients mounted a serologic response to the Pfizer-BioNTech vaccine, which is “good news” overall, Dr. Blake said.

Also commenting on the study, Anushree Shirali, MD, of Yale University, New Haven, Conn., said she was impressed by the fact that most of the dialysis patients in the study mounted at least some IgG response to vaccination, which she said was good “in and of itself,” because that is not always the case with other vaccines.
 

Study compared dialysis patients with health care workers

The Israeli study included 56 patients who were receiving maintenance hemodialysis and 95 health care workers, who served as control persons.

“All participants had been previously vaccinated with the [Pfizer-BioNTech] vaccine, with the recommended dosing interval of 21 days between the first and second doses,” the investigators note. Immunogenicity was assessed using a dedicated immunoassay to quantify the level of IgG antibodies from participants’ plasma.

A cutoff for a positive antibody response was greater than or equal to 50 arbitrary units per milliliter (AU/mL). “All subjects in the control group developed a positive antibody response (≥50 AU/mL) as compared with 96% (54 of 56) in the dialysis group,” Dr. Shashar and colleagues report.

The median IgG level in the dialysis group was 2,900 AU/mL, which is significantly lower than the median of 7,401 AU/mL in the control group (P < .001), they report.

The investigators also observed a significant inverse correlation between older age and antibody levels in both groups.

The odds of being in the lower quartile were significantly higher for older individuals (odds ratio, 1.11 per year of age; P = .004) and for the dialysis group compared with the control group (OR, 2.7; P = .05).

Among the dialysis patients, older age and lower lymphocyte count were associated with antibody response in the lower quartile (OR, 1.22 per 1 year older; P = .03; and OR, 0.83 per 10-e3/mL-higher lymphocyte count; P = .05).

Among recipients older than 70 years, there was little difference in antibody response between the dialysis patients and the control group. Thus, age is clearly an important contributor to a robust humoral response, the authors observe.

For more than 90% of the patients receiving dialysis, the antibody response was well above 50 AU/mL, which was the cutoff for having a positive response.

Nevertheless, the authors suggest that their findings should prompt clinicians to consider either changing the dose or the schedule of COVID-19 vaccination for dialysis patients, as was done, for example, with the hepatitis B vaccine Engerix-B.

Dialysis patients now receive double doses of the hepatitis B vaccine, which is given in a four-series vaccine schedule rather than a three-series vaccine schedule, as is given to healthy individuals.

The authors also call for studies to assess the longevity of vaccine efficacy for dialysis patients and whether current vaccines are effective against variant strains among patients undergoing dialysis.
 

Some suggestion COVID-19 vaccines also elicit T-cell responses

Dr. Shirali said the news regarding the COVID-19 vaccine for dialysis patients is good, given the fact that such patients exhibit a poor response to the hepatitis B vaccine.

“There isn’t a large percentage of dialysis patients who mount a humoral response to the hepatitis B vaccine, even with the change in dosing that we use that is different than it is for the general population,” she told this news organization.

Dr. Shirali also noted that preliminary evidence suggests that COVID-19 vaccines elicit nonantibody and antibody T-cell responses and that such immunity is going to be just as important for protecting dialysis patients against COVID-19 as it is for protecting patients who are not receiving dialysis.

“Antibody responses are just one arm of vaccination,” she explained. “People can form memory T-cell responses with vaccination, and while this has not been well studied with COVID-19, there are preliminary data to suggest that T-cell responses are likely to be effective in the fight against COVID-19.” There is also the possibility that this type of response “may even be more durable than antibody responses,” she said.

The study received no funding. The authors, Dr. Blake and Dr. Shirali, have disclosed no relevant financial relationships.

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

Most patients who are receiving maintenance hemodialysis develop a good antibody response after being given two doses of the Pfizer-BioNTech COVID-19 vaccine, but their responses are still significantly lower than those of health care workers who do not have kidney disease, the first study of its kind shows.

“It is well known that patients on dialysis may have a reduced response to vaccination,” Ayelet Grupper, MD, of Tel Aviv Medical Center, and colleagues observe. Their study was published online April 6 in the Clinical Journal of the American Society of Nephrology.

“I believe our findings should encourage patients with kidney failure treated with dialysis to be vaccinated as soon as vaccination becomes available for them, while we as caregivers should explore ways to enhance its efficacy in our patients,” senior author Moshe Shashar, MD, noted in a statement from the American Society of Nephrology.

Asked to comment, Peter Blake, MD, professor of medicine, University of Western Ontario, London, pointed out that COVID-19 is very common among hemodialysis patients and that the likelihood of these patients dying from it is very high. Indeed, 1.5% of approximately 12,500 patients receiving dialysis in the province of Ontario have died of COVID-19 – “a horrifying statistic and one that only long-term care home residents can compare with,” he told this news organization.

In the Israeli study, almost all dialysis patients mounted a serologic response to the Pfizer-BioNTech vaccine, which is “good news” overall, Dr. Blake said.

Also commenting on the study, Anushree Shirali, MD, of Yale University, New Haven, Conn., said she was impressed by the fact that most of the dialysis patients in the study mounted at least some IgG response to vaccination, which she said was good “in and of itself,” because that is not always the case with other vaccines.
 

Study compared dialysis patients with health care workers

The Israeli study included 56 patients who were receiving maintenance hemodialysis and 95 health care workers, who served as control persons.

“All participants had been previously vaccinated with the [Pfizer-BioNTech] vaccine, with the recommended dosing interval of 21 days between the first and second doses,” the investigators note. Immunogenicity was assessed using a dedicated immunoassay to quantify the level of IgG antibodies from participants’ plasma.

A cutoff for a positive antibody response was greater than or equal to 50 arbitrary units per milliliter (AU/mL). “All subjects in the control group developed a positive antibody response (≥50 AU/mL) as compared with 96% (54 of 56) in the dialysis group,” Dr. Shashar and colleagues report.

The median IgG level in the dialysis group was 2,900 AU/mL, which is significantly lower than the median of 7,401 AU/mL in the control group (P < .001), they report.

The investigators also observed a significant inverse correlation between older age and antibody levels in both groups.

The odds of being in the lower quartile were significantly higher for older individuals (odds ratio, 1.11 per year of age; P = .004) and for the dialysis group compared with the control group (OR, 2.7; P = .05).

Among the dialysis patients, older age and lower lymphocyte count were associated with antibody response in the lower quartile (OR, 1.22 per 1 year older; P = .03; and OR, 0.83 per 10-e3/mL-higher lymphocyte count; P = .05).

Among recipients older than 70 years, there was little difference in antibody response between the dialysis patients and the control group. Thus, age is clearly an important contributor to a robust humoral response, the authors observe.

For more than 90% of the patients receiving dialysis, the antibody response was well above 50 AU/mL, which was the cutoff for having a positive response.

Nevertheless, the authors suggest that their findings should prompt clinicians to consider either changing the dose or the schedule of COVID-19 vaccination for dialysis patients, as was done, for example, with the hepatitis B vaccine Engerix-B.

Dialysis patients now receive double doses of the hepatitis B vaccine, which is given in a four-series vaccine schedule rather than a three-series vaccine schedule, as is given to healthy individuals.

The authors also call for studies to assess the longevity of vaccine efficacy for dialysis patients and whether current vaccines are effective against variant strains among patients undergoing dialysis.
 

Some suggestion COVID-19 vaccines also elicit T-cell responses

Dr. Shirali said the news regarding the COVID-19 vaccine for dialysis patients is good, given the fact that such patients exhibit a poor response to the hepatitis B vaccine.

“There isn’t a large percentage of dialysis patients who mount a humoral response to the hepatitis B vaccine, even with the change in dosing that we use that is different than it is for the general population,” she told this news organization.

Dr. Shirali also noted that preliminary evidence suggests that COVID-19 vaccines elicit nonantibody and antibody T-cell responses and that such immunity is going to be just as important for protecting dialysis patients against COVID-19 as it is for protecting patients who are not receiving dialysis.

“Antibody responses are just one arm of vaccination,” she explained. “People can form memory T-cell responses with vaccination, and while this has not been well studied with COVID-19, there are preliminary data to suggest that T-cell responses are likely to be effective in the fight against COVID-19.” There is also the possibility that this type of response “may even be more durable than antibody responses,” she said.

The study received no funding. The authors, Dr. Blake and Dr. Shirali, have disclosed no relevant financial relationships.

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

Most patients who are receiving maintenance hemodialysis develop a good antibody response after being given two doses of the Pfizer-BioNTech COVID-19 vaccine, but their responses are still significantly lower than those of health care workers who do not have kidney disease, the first study of its kind shows.

“It is well known that patients on dialysis may have a reduced response to vaccination,” Ayelet Grupper, MD, of Tel Aviv Medical Center, and colleagues observe. Their study was published online April 6 in the Clinical Journal of the American Society of Nephrology.

“I believe our findings should encourage patients with kidney failure treated with dialysis to be vaccinated as soon as vaccination becomes available for them, while we as caregivers should explore ways to enhance its efficacy in our patients,” senior author Moshe Shashar, MD, noted in a statement from the American Society of Nephrology.

Asked to comment, Peter Blake, MD, professor of medicine, University of Western Ontario, London, pointed out that COVID-19 is very common among hemodialysis patients and that the likelihood of these patients dying from it is very high. Indeed, 1.5% of approximately 12,500 patients receiving dialysis in the province of Ontario have died of COVID-19 – “a horrifying statistic and one that only long-term care home residents can compare with,” he told this news organization.

In the Israeli study, almost all dialysis patients mounted a serologic response to the Pfizer-BioNTech vaccine, which is “good news” overall, Dr. Blake said.

Also commenting on the study, Anushree Shirali, MD, of Yale University, New Haven, Conn., said she was impressed by the fact that most of the dialysis patients in the study mounted at least some IgG response to vaccination, which she said was good “in and of itself,” because that is not always the case with other vaccines.
 

Study compared dialysis patients with health care workers

The Israeli study included 56 patients who were receiving maintenance hemodialysis and 95 health care workers, who served as control persons.

“All participants had been previously vaccinated with the [Pfizer-BioNTech] vaccine, with the recommended dosing interval of 21 days between the first and second doses,” the investigators note. Immunogenicity was assessed using a dedicated immunoassay to quantify the level of IgG antibodies from participants’ plasma.

A cutoff for a positive antibody response was greater than or equal to 50 arbitrary units per milliliter (AU/mL). “All subjects in the control group developed a positive antibody response (≥50 AU/mL) as compared with 96% (54 of 56) in the dialysis group,” Dr. Shashar and colleagues report.

The median IgG level in the dialysis group was 2,900 AU/mL, which is significantly lower than the median of 7,401 AU/mL in the control group (P < .001), they report.

The investigators also observed a significant inverse correlation between older age and antibody levels in both groups.

The odds of being in the lower quartile were significantly higher for older individuals (odds ratio, 1.11 per year of age; P = .004) and for the dialysis group compared with the control group (OR, 2.7; P = .05).

Among the dialysis patients, older age and lower lymphocyte count were associated with antibody response in the lower quartile (OR, 1.22 per 1 year older; P = .03; and OR, 0.83 per 10-e3/mL-higher lymphocyte count; P = .05).

Among recipients older than 70 years, there was little difference in antibody response between the dialysis patients and the control group. Thus, age is clearly an important contributor to a robust humoral response, the authors observe.

For more than 90% of the patients receiving dialysis, the antibody response was well above 50 AU/mL, which was the cutoff for having a positive response.

Nevertheless, the authors suggest that their findings should prompt clinicians to consider either changing the dose or the schedule of COVID-19 vaccination for dialysis patients, as was done, for example, with the hepatitis B vaccine Engerix-B.

Dialysis patients now receive double doses of the hepatitis B vaccine, which is given in a four-series vaccine schedule rather than a three-series vaccine schedule, as is given to healthy individuals.

The authors also call for studies to assess the longevity of vaccine efficacy for dialysis patients and whether current vaccines are effective against variant strains among patients undergoing dialysis.
 

Some suggestion COVID-19 vaccines also elicit T-cell responses

Dr. Shirali said the news regarding the COVID-19 vaccine for dialysis patients is good, given the fact that such patients exhibit a poor response to the hepatitis B vaccine.

“There isn’t a large percentage of dialysis patients who mount a humoral response to the hepatitis B vaccine, even with the change in dosing that we use that is different than it is for the general population,” she told this news organization.

Dr. Shirali also noted that preliminary evidence suggests that COVID-19 vaccines elicit nonantibody and antibody T-cell responses and that such immunity is going to be just as important for protecting dialysis patients against COVID-19 as it is for protecting patients who are not receiving dialysis.

“Antibody responses are just one arm of vaccination,” she explained. “People can form memory T-cell responses with vaccination, and while this has not been well studied with COVID-19, there are preliminary data to suggest that T-cell responses are likely to be effective in the fight against COVID-19.” There is also the possibility that this type of response “may even be more durable than antibody responses,” she said.

The study received no funding. The authors, Dr. Blake and Dr. Shirali, have disclosed no relevant financial relationships.

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

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

The federal government has approved a request by Illinois to extend postpartum Medicaid coverage to a full year from the current standard of 60 days.

Health & Human Services Secretary Xavier Becerra announced the approval at a press briefing on April 12, noting that it was occurring during Black Maternal Health Week. The coverage extension is aimed at decreasing maternal morbidity and mortality, particularly among women of color.

Black women are two times more likely to die from a pregnancy-related cause than White women, according to HHS. Mr. Becerra noted that, in the United States, 52% of pregnancy-related deaths take place up to 1 year post partum, and that in Illinois the figure is 80%.

“The continuity of coverage available through this action will help new mothers manage chronic conditions like hypertension and diabetes, and it will provide access to behavioral health and other mental health care services,” he said.

Continuing Medicaid coverage for new mothers has been backed by the American Medical Association, is a priority of the American College of Obstetricians and Gynecologists, and has been promoted by Republicans and Democrats in Congress and state legislatures.

Illinois is the first state to seek and win approval to extend its Medicaid coverage from the current 60-days postbirth requirement. The program was granted through an existing section 1115 waiver program. It begins today and is authorized through Dec. 31, 2025. The state estimates that some 2,500 women with incomes up to 208% of the federal poverty level will receive the year of continuous Medicaid coverage. Illinois will evaluate whether the extension improves women’s health and if it benefits the Medicaid program overall.

However, the recently passed coronavirus rescue package creates a new process that lets states more easily expand postpartum coverage, but they must act by April 2022. Mr. Becerra said the federal government is encouraging more states to follow Illinois’ lead in extending postpartum eligibility by taking advantage of the new process.

States won’t get extra money – they will receive the regular per capita–based federal match if they extend Medicaid coverage through this pathway. Even so, Mr. Becerra said there has been much interest.

“I hope that we begin to see states not only express interest but actually submit their proposals on how they would do this,” Mr. Becerra said.

Medicaid has become one of the key providers of maternal health care in the United States, as it covers 4 in 10 births, according to the Kaiser Family Foundation. But postpartum coverage after the 60-day federal requirement is a patchwork. In 38 states (plus Washington, D.C.) that have expanded Medicaid under the Affordable Care Act, mothers who earn up to 138% of the federal poverty level can continue on Medicaid; for those who earn more than that, they can get coverage through the ACA.

In the 12 states that did not expand Medicaid, new mothers have to seek Medicaid coverage after 60 days as parents, and the income limits are strict. In Texas, for example, a married mother with a newborn loses Medicaid coverage 2 months after giving birth if she and her partner have an annual income above $3,733, reports the Kaiser Family Foundation.

Coverage disruptions are harmful to mothers, said Mr. Becerra. HHS data shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months postpartum and that disruptions in coverage often lead to delayed care and less preventive care.

Mr. Becerra also announced that the Health Resources and Services Administration will make $12 million available over 4 years for the Rural Maternity and Obstetrics Management Strategies program. Applicants for the new funds will be required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

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

Read the supplement here or by clicking on the image

Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

Read the supplement here or by clicking on the image

Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

Read the supplement here or by clicking on the image

Elevations in serum neurofilament light chain levels in people with multiple sclerosis (MS) are significantly linked to worse neurologic function, clinical disability, and lower brain volumes, according to new findings from a large, diverse population of patients with MS. “This is one of the largest studies to evaluate serum neurofilament light chain levels in people with MS,” said lead author Elias S. Sotirchos, MD, an assistant professor of neurology at Johns Hopkins University, Baltimore. “An important strength of this cohort is that it is a realworld cohort of patients followed in U.S. and European MS centers,” he said. “The study captures the diversity of the MS population, including demographics, comorbidities, lifestyle factors, and clinical characteristics that may otherwise not be captured in a clinical trial population.” The research was presented at the 2021 ACTRIMS Forum.

When Lesley Solomon’s son was 10 years old, he was standing in an unlucky spot on the playground when a schoolmate kicked over a cup of hot chocolate, sending droplets flying into the air. For the young boy with a severe milk allergy, the hot liquid splattering was less of a hazard for him than the dairy stirred into the drink.

copyright/Jupiterimages/Getty Images

Ms. Solomon’s son quickly washed the fluids off his clothes and skin, took some Benadryl, and called his parents. But on the car ride home, his throat began to close and his pulse raced. It was one of about a dozen times he has needed an epinephrine injection, which increases blood flow, reduces swelling, and reverses anaphylaxis.

“Until you see a child going through that anaphylaxis and not being able to breathe, or throwing up so much that they can’t breathe, you don’t understand” how serious food allergies can be, said Ms. Solomon, who is senior vice president and chief innovation officer of the Dana-Farber Cancer Institute in Boston and cofounder of the Food Allergy Science Initiative, an independent nonprofit that funds food allergy research.

The rate of children hospitalized for food-induced anaphylaxis rose by 25% from 2006 to 2012 – from 1.2 to 1.5 per 100,000 – according to a 2019 analysis of data from pediatric hospitals in the United States. And severe symptoms were more often linked to milk than to peanuts or tree nuts, the study showed.

Cow’s milk is the most common food allergy in children aged younger than 5 years, and accounts for about half of all food allergies in children younger than 1. Most children grow out of it, but when milk allergy persists into the teenage years and adulthood, it is more likely to cause severe reactions.
 

A dangerous allergy

“Cow’s milk allergy is the most distressing of the food allergies. Many people are unaware that it can cause anaphylaxis that is so severe,” said Carla Davis, MD, director of the food allergy program at the Texas Children’s Hospital in Houston. “People do not think about how much of this is in our food.”

And cow’s milk was shown to be the food allergy most likely to lead to death in school-aged children in the United Kingdom, according to an analysis of national data reported by this news organization.

Lack of awareness is what makes milk allergy so dangerous, said Paul Turner, BMBCh, PhD, a pediatric allergist and immunologist from Imperial College London, who was involved in the British analysis. “We need to get that information out to the public and businesses so they take the same level of care that they have with nuts, and when someone says they have milk allergy, they take it seriously.

In food allergy, the body treats certain proteins, such as the casein and whey in milk, as invaders, mounting an immune response. Antibodies known as IgE – which normally protect against bacteria, viruses, and parasites – trigger inflammation, the release of histamine, and can lead to symptoms, typically within minutes, ranging from rash and swelling to vomiting, difficulty swallowing, and difficulty breathing.

So, the very thing that makes milk a healthy choice for kids – its high protein content – can cause serious reactions in a small portion of children and adults. “You don’t need much milk to get a decent dose” of the allergen, Dr. Turner pointed out.

The mechanisms of milk allergy are complex, even compared with other food allergies. The IgE antibody can be detected with a skin-prick test or IgE blood test, but some people have positive results even though they are not allergic. To complicate things further, people can also have non–IgE-mediated milk allergy, which cannot be detected with testing and can lead to symptoms that emerge hours or even days after exposure.
 

More serious than lactose intolerance

Unfortunately, milk allergy is often confused with a milk-related digestive problem. Globally, about 70% of people lack the enzyme to break down the sugar in milk; the condition, known as lactose intolerance, can cause bloating, abdominal cramps, and diarrhea but is not life-threatening.

“Because lactose intolerance is so common, people don’t think of milk allergy as something that can be significant or severe,” said Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at the Northwestern University, Chicago.

In babies, colic, the regurgitation of milk-based formula, and rash are sometimes misinterpreted as a milk allergy, leading parents to buy expensive, specialized formula unnecessarily.

Frustrated by a lack of data about food allergies, Dr. Gupta and colleagues launched a nationally representative survey of 38,408 American parents in 2009, which was updated in 2015 and 2016.

On average, children with milk allergy had their first reaction before the age of 2, most commonly vomiting, diarrhea, hives, and eczema; this is a younger age of onset than for other food allergies. And children with milk allergy were twice as likely as children with other allergies to grow out of it.

Yet about one-third of milk-allergic children in the updated study were 11 years and older. And in a similar survey of adults who self-reported symptoms, milk allergy was as common as peanut allergy (1.9% vs 1.8%). “We don’t know why milk allergy is becoming more persistent,” Dr. Gupta said. And, she warned, only one in four children with a milk allergy had a current prescription for an epinephrine autoinjector, compared with about 70% of children with peanut allergy.

Food allergy can’t be caused by genetics alone, said Christine Olsen, MD, cofounder and CEO of the Food Allergy Science Initiative at the Broad Institute in Cambridge, Mass. “There may be a genetic predisposition, but there must be something environmental” that has influenced the development of food allergies.

One theory is that the body’s natural defense against noxious substances has been disrupted in the modern world by processed foods, chemical additives, and hygienic surroundings.

Dr. Olson’s own son vomited when he had his first small taste of hummus as a baby; he is severely allergic to sesame. The immediacy of his bodily reaction made Dr. Olsen think that the response involved neurons, not just a misguided immune system.

Researchers are currently looking for drug targets that could shut off the immune response as quickly as it starts. If you think of the fact that some kids outgrow their allergies and some adults get allergies, that suggests there’s some lever that you can turn on and off,” said Dr. Olsen, who is also a radiation oncologist.
 

Preventing allergy

The approach to food allergy prevention has already been transformed by the Learning Early About Peanut Allergy (LEAP) study conducted in the United Kingdom. LEAP investigators randomly assigned 640 infants to ingest regular amounts of peanut snacks or peanut butter or to avoid peanut products until they reached 5 years of age. The babies who had regular exposure to peanut from an early age were much less likely to develop a peanut allergy than those who avoided peanuts.

The National Institute of Allergy and Infectious Diseases revised its guidelines and now recommends that all babies be exposed to peanut-containing food at around 6 months of age; for high-risk babies, that can start as early as 4 months.

Allergy experts are planning to study that concept again with other foods, including cow’s milk. The 5-year iREACH study, launched by the Center for Food Allergy & Asthma Research at Northwestern and Lurie Children’s Hospital in Chicago, is currently enrolling 10,500 infants to test early exposure to peanuts, milk, egg, and cashew. A portion of the infants will have severe eczema, putting them at high risk for food allergies, and others will be low risk, said Dr. Gupta, who is the principal iREACH investigator.

“Hopefully in the next 5 years we will have data showing whether this prevention technique will work for other common food allergens, in addition to peanuts,” she said.

Introducing foods early “promotes tolerance rather than early sensitization,” explained Stephanie Leeds, MD, an allergist and immunologist at Yale University, New Haven, Conn. In the future, rather than just diagnosing and treating food allergies, allergists might work with pediatricians to help prevent them from ever happening.

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

When Lesley Solomon’s son was 10 years old, he was standing in an unlucky spot on the playground when a schoolmate kicked over a cup of hot chocolate, sending droplets flying into the air. For the young boy with a severe milk allergy, the hot liquid splattering was less of a hazard for him than the dairy stirred into the drink.

copyright/Jupiterimages/Getty Images

Ms. Solomon’s son quickly washed the fluids off his clothes and skin, took some Benadryl, and called his parents. But on the car ride home, his throat began to close and his pulse raced. It was one of about a dozen times he has needed an epinephrine injection, which increases blood flow, reduces swelling, and reverses anaphylaxis.

“Until you see a child going through that anaphylaxis and not being able to breathe, or throwing up so much that they can’t breathe, you don’t understand” how serious food allergies can be, said Ms. Solomon, who is senior vice president and chief innovation officer of the Dana-Farber Cancer Institute in Boston and cofounder of the Food Allergy Science Initiative, an independent nonprofit that funds food allergy research.

The rate of children hospitalized for food-induced anaphylaxis rose by 25% from 2006 to 2012 – from 1.2 to 1.5 per 100,000 – according to a 2019 analysis of data from pediatric hospitals in the United States. And severe symptoms were more often linked to milk than to peanuts or tree nuts, the study showed.

Cow’s milk is the most common food allergy in children aged younger than 5 years, and accounts for about half of all food allergies in children younger than 1. Most children grow out of it, but when milk allergy persists into the teenage years and adulthood, it is more likely to cause severe reactions.
 

A dangerous allergy

“Cow’s milk allergy is the most distressing of the food allergies. Many people are unaware that it can cause anaphylaxis that is so severe,” said Carla Davis, MD, director of the food allergy program at the Texas Children’s Hospital in Houston. “People do not think about how much of this is in our food.”

And cow’s milk was shown to be the food allergy most likely to lead to death in school-aged children in the United Kingdom, according to an analysis of national data reported by this news organization.

Lack of awareness is what makes milk allergy so dangerous, said Paul Turner, BMBCh, PhD, a pediatric allergist and immunologist from Imperial College London, who was involved in the British analysis. “We need to get that information out to the public and businesses so they take the same level of care that they have with nuts, and when someone says they have milk allergy, they take it seriously.

In food allergy, the body treats certain proteins, such as the casein and whey in milk, as invaders, mounting an immune response. Antibodies known as IgE – which normally protect against bacteria, viruses, and parasites – trigger inflammation, the release of histamine, and can lead to symptoms, typically within minutes, ranging from rash and swelling to vomiting, difficulty swallowing, and difficulty breathing.

So, the very thing that makes milk a healthy choice for kids – its high protein content – can cause serious reactions in a small portion of children and adults. “You don’t need much milk to get a decent dose” of the allergen, Dr. Turner pointed out.

The mechanisms of milk allergy are complex, even compared with other food allergies. The IgE antibody can be detected with a skin-prick test or IgE blood test, but some people have positive results even though they are not allergic. To complicate things further, people can also have non–IgE-mediated milk allergy, which cannot be detected with testing and can lead to symptoms that emerge hours or even days after exposure.
 

More serious than lactose intolerance

Unfortunately, milk allergy is often confused with a milk-related digestive problem. Globally, about 70% of people lack the enzyme to break down the sugar in milk; the condition, known as lactose intolerance, can cause bloating, abdominal cramps, and diarrhea but is not life-threatening.

“Because lactose intolerance is so common, people don’t think of milk allergy as something that can be significant or severe,” said Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at the Northwestern University, Chicago.

In babies, colic, the regurgitation of milk-based formula, and rash are sometimes misinterpreted as a milk allergy, leading parents to buy expensive, specialized formula unnecessarily.

Frustrated by a lack of data about food allergies, Dr. Gupta and colleagues launched a nationally representative survey of 38,408 American parents in 2009, which was updated in 2015 and 2016.

On average, children with milk allergy had their first reaction before the age of 2, most commonly vomiting, diarrhea, hives, and eczema; this is a younger age of onset than for other food allergies. And children with milk allergy were twice as likely as children with other allergies to grow out of it.

Yet about one-third of milk-allergic children in the updated study were 11 years and older. And in a similar survey of adults who self-reported symptoms, milk allergy was as common as peanut allergy (1.9% vs 1.8%). “We don’t know why milk allergy is becoming more persistent,” Dr. Gupta said. And, she warned, only one in four children with a milk allergy had a current prescription for an epinephrine autoinjector, compared with about 70% of children with peanut allergy.

Food allergy can’t be caused by genetics alone, said Christine Olsen, MD, cofounder and CEO of the Food Allergy Science Initiative at the Broad Institute in Cambridge, Mass. “There may be a genetic predisposition, but there must be something environmental” that has influenced the development of food allergies.

One theory is that the body’s natural defense against noxious substances has been disrupted in the modern world by processed foods, chemical additives, and hygienic surroundings.

Dr. Olson’s own son vomited when he had his first small taste of hummus as a baby; he is severely allergic to sesame. The immediacy of his bodily reaction made Dr. Olsen think that the response involved neurons, not just a misguided immune system.

Researchers are currently looking for drug targets that could shut off the immune response as quickly as it starts. If you think of the fact that some kids outgrow their allergies and some adults get allergies, that suggests there’s some lever that you can turn on and off,” said Dr. Olsen, who is also a radiation oncologist.
 

Preventing allergy

The approach to food allergy prevention has already been transformed by the Learning Early About Peanut Allergy (LEAP) study conducted in the United Kingdom. LEAP investigators randomly assigned 640 infants to ingest regular amounts of peanut snacks or peanut butter or to avoid peanut products until they reached 5 years of age. The babies who had regular exposure to peanut from an early age were much less likely to develop a peanut allergy than those who avoided peanuts.

The National Institute of Allergy and Infectious Diseases revised its guidelines and now recommends that all babies be exposed to peanut-containing food at around 6 months of age; for high-risk babies, that can start as early as 4 months.

Allergy experts are planning to study that concept again with other foods, including cow’s milk. The 5-year iREACH study, launched by the Center for Food Allergy & Asthma Research at Northwestern and Lurie Children’s Hospital in Chicago, is currently enrolling 10,500 infants to test early exposure to peanuts, milk, egg, and cashew. A portion of the infants will have severe eczema, putting them at high risk for food allergies, and others will be low risk, said Dr. Gupta, who is the principal iREACH investigator.

“Hopefully in the next 5 years we will have data showing whether this prevention technique will work for other common food allergens, in addition to peanuts,” she said.

Introducing foods early “promotes tolerance rather than early sensitization,” explained Stephanie Leeds, MD, an allergist and immunologist at Yale University, New Haven, Conn. In the future, rather than just diagnosing and treating food allergies, allergists might work with pediatricians to help prevent them from ever happening.

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

When Lesley Solomon’s son was 10 years old, he was standing in an unlucky spot on the playground when a schoolmate kicked over a cup of hot chocolate, sending droplets flying into the air. For the young boy with a severe milk allergy, the hot liquid splattering was less of a hazard for him than the dairy stirred into the drink.

copyright/Jupiterimages/Getty Images

Ms. Solomon’s son quickly washed the fluids off his clothes and skin, took some Benadryl, and called his parents. But on the car ride home, his throat began to close and his pulse raced. It was one of about a dozen times he has needed an epinephrine injection, which increases blood flow, reduces swelling, and reverses anaphylaxis.

“Until you see a child going through that anaphylaxis and not being able to breathe, or throwing up so much that they can’t breathe, you don’t understand” how serious food allergies can be, said Ms. Solomon, who is senior vice president and chief innovation officer of the Dana-Farber Cancer Institute in Boston and cofounder of the Food Allergy Science Initiative, an independent nonprofit that funds food allergy research.

The rate of children hospitalized for food-induced anaphylaxis rose by 25% from 2006 to 2012 – from 1.2 to 1.5 per 100,000 – according to a 2019 analysis of data from pediatric hospitals in the United States. And severe symptoms were more often linked to milk than to peanuts or tree nuts, the study showed.

Cow’s milk is the most common food allergy in children aged younger than 5 years, and accounts for about half of all food allergies in children younger than 1. Most children grow out of it, but when milk allergy persists into the teenage years and adulthood, it is more likely to cause severe reactions.
 

A dangerous allergy

“Cow’s milk allergy is the most distressing of the food allergies. Many people are unaware that it can cause anaphylaxis that is so severe,” said Carla Davis, MD, director of the food allergy program at the Texas Children’s Hospital in Houston. “People do not think about how much of this is in our food.”

And cow’s milk was shown to be the food allergy most likely to lead to death in school-aged children in the United Kingdom, according to an analysis of national data reported by this news organization.

Lack of awareness is what makes milk allergy so dangerous, said Paul Turner, BMBCh, PhD, a pediatric allergist and immunologist from Imperial College London, who was involved in the British analysis. “We need to get that information out to the public and businesses so they take the same level of care that they have with nuts, and when someone says they have milk allergy, they take it seriously.

In food allergy, the body treats certain proteins, such as the casein and whey in milk, as invaders, mounting an immune response. Antibodies known as IgE – which normally protect against bacteria, viruses, and parasites – trigger inflammation, the release of histamine, and can lead to symptoms, typically within minutes, ranging from rash and swelling to vomiting, difficulty swallowing, and difficulty breathing.

So, the very thing that makes milk a healthy choice for kids – its high protein content – can cause serious reactions in a small portion of children and adults. “You don’t need much milk to get a decent dose” of the allergen, Dr. Turner pointed out.

The mechanisms of milk allergy are complex, even compared with other food allergies. The IgE antibody can be detected with a skin-prick test or IgE blood test, but some people have positive results even though they are not allergic. To complicate things further, people can also have non–IgE-mediated milk allergy, which cannot be detected with testing and can lead to symptoms that emerge hours or even days after exposure.
 

More serious than lactose intolerance

Unfortunately, milk allergy is often confused with a milk-related digestive problem. Globally, about 70% of people lack the enzyme to break down the sugar in milk; the condition, known as lactose intolerance, can cause bloating, abdominal cramps, and diarrhea but is not life-threatening.

“Because lactose intolerance is so common, people don’t think of milk allergy as something that can be significant or severe,” said Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at the Northwestern University, Chicago.

In babies, colic, the regurgitation of milk-based formula, and rash are sometimes misinterpreted as a milk allergy, leading parents to buy expensive, specialized formula unnecessarily.

Frustrated by a lack of data about food allergies, Dr. Gupta and colleagues launched a nationally representative survey of 38,408 American parents in 2009, which was updated in 2015 and 2016.

On average, children with milk allergy had their first reaction before the age of 2, most commonly vomiting, diarrhea, hives, and eczema; this is a younger age of onset than for other food allergies. And children with milk allergy were twice as likely as children with other allergies to grow out of it.

Yet about one-third of milk-allergic children in the updated study were 11 years and older. And in a similar survey of adults who self-reported symptoms, milk allergy was as common as peanut allergy (1.9% vs 1.8%). “We don’t know why milk allergy is becoming more persistent,” Dr. Gupta said. And, she warned, only one in four children with a milk allergy had a current prescription for an epinephrine autoinjector, compared with about 70% of children with peanut allergy.

Food allergy can’t be caused by genetics alone, said Christine Olsen, MD, cofounder and CEO of the Food Allergy Science Initiative at the Broad Institute in Cambridge, Mass. “There may be a genetic predisposition, but there must be something environmental” that has influenced the development of food allergies.

One theory is that the body’s natural defense against noxious substances has been disrupted in the modern world by processed foods, chemical additives, and hygienic surroundings.

Dr. Olson’s own son vomited when he had his first small taste of hummus as a baby; he is severely allergic to sesame. The immediacy of his bodily reaction made Dr. Olsen think that the response involved neurons, not just a misguided immune system.

Researchers are currently looking for drug targets that could shut off the immune response as quickly as it starts. If you think of the fact that some kids outgrow their allergies and some adults get allergies, that suggests there’s some lever that you can turn on and off,” said Dr. Olsen, who is also a radiation oncologist.
 

Preventing allergy

The approach to food allergy prevention has already been transformed by the Learning Early About Peanut Allergy (LEAP) study conducted in the United Kingdom. LEAP investigators randomly assigned 640 infants to ingest regular amounts of peanut snacks or peanut butter or to avoid peanut products until they reached 5 years of age. The babies who had regular exposure to peanut from an early age were much less likely to develop a peanut allergy than those who avoided peanuts.

The National Institute of Allergy and Infectious Diseases revised its guidelines and now recommends that all babies be exposed to peanut-containing food at around 6 months of age; for high-risk babies, that can start as early as 4 months.

Allergy experts are planning to study that concept again with other foods, including cow’s milk. The 5-year iREACH study, launched by the Center for Food Allergy & Asthma Research at Northwestern and Lurie Children’s Hospital in Chicago, is currently enrolling 10,500 infants to test early exposure to peanuts, milk, egg, and cashew. A portion of the infants will have severe eczema, putting them at high risk for food allergies, and others will be low risk, said Dr. Gupta, who is the principal iREACH investigator.

“Hopefully in the next 5 years we will have data showing whether this prevention technique will work for other common food allergens, in addition to peanuts,” she said.

Introducing foods early “promotes tolerance rather than early sensitization,” explained Stephanie Leeds, MD, an allergist and immunologist at Yale University, New Haven, Conn. In the future, rather than just diagnosing and treating food allergies, allergists might work with pediatricians to help prevent them from ever happening.

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

A punch biopsy from one of the lesions on the feet showed subtle basal vacuolar interface inflammation on the epidermis and rare apoptotic keratinocytes. There was an underlying dermal lymphocytic inflammatory infiltrate around the vascular plexus. Dermal mucin appeared slightly increased. The histologic findings are consistent with pernio. He had a negative direct immunofluorescence study.

Laboratory work-up showed an elevated antinuclear antibody (ANA) of 1:620; positive anticardiolipin IgM was at 15.2. A complete blood count showed no anemia or lymphopenia, he had normal complement C3 and C4 levels, normal urinalysis, negative cryoglobulins and cold agglutinins, and a normal protein electrophoresis.

Given the chronicity of his lesions, the lack of improvement with weather changes, the histopathologic findings of a vacuolar interface dermatitis and the positive ANA titer he was diagnosed with chilblain lupus.

Chilblain lupus erythematosus (CLE) is an uncommon form of chronic cutaneous lupus erythematosus that presents with tender pink to violaceous macules, papules, and/or nodules that sometimes can ulcerate and are present on the fingers, toes, and sometimes the nose and ears. The lesions are usually triggered by cold exposure.¹ These patients also have clinical and laboratory findings consistent with lupus erythematosus.

Even though more studies are needed to clarify the clinical and histopathologic features of chilblain lupus, compared with idiopathic pernio, some authors suggest several characteristics: CLE lesions tend to persist in summer months, as occurred in our patient, and histopathologic evaluation usually shows vacuolar and interface inflammation on the basal cell layer and may also have a positive lupus band on direct immunofluorescence.² About 20% of patient with CLE may later develop systemic lupus erythematosus.³

There is also a familial form of CLE which is usually inherited as an autosomal-dominant trait. Mutations in TREX1, SAMHD1, and STING have been described in these patients.⁴ Affected children present with skin lesions at a young age and those with TREX1 mutations are at a higher risk to develop systemic lupus erythematosus.

The differential diagnosis of chilblain lupus includes idiopathic pernio or pernio secondary to other conditions. Other conditions that are thought to be associated with pernio, besides lupus erythematosus, include infectious causes (hepatitis B, COVID-19 infection),⁵ autoimmune conditions, malignancy and hematologic disorders (paraproteinemia).⁶ In histopathology, pernio lesions present with dermal edema and superficial and deep lymphocytic infiltrate.

The pathogenesis of pernio is not fully understood but is thought be related to vasospasm with secondary poor perfusion and ischemia and type I interferon (INF1) immune response. A recent review of the published studies trying to explain the causality between COVID 19 and pernio-like lesions, from January 2020 to December 2020, speculate several possible mechanisms: an increase in the vasoconstrictive, prothrombotic, and proinflammatory effects of the angiotensin II pathway through activation of the ACE2 by the virus; COVID-19 triggers a robust INF1 immune response in predisposed patients; pernio as a sign of mild disease, may be explained by genetic and hormonal differences in the patients affected.⁷

Another condition that can be confused with CLE is Raynaud phenomenon, were patients present with white to purple to red patches on the fingers and toes after exposure to cold, but in comparison with pernio, the lesions improve within minutes to hours after rewarming. Secondary Raynaud phenomenon can be seen in patients with systemic lupus erythematosus and in patients with other connective tissue disorders. The skin lesions in our patient were persistent and were not triggered by cold exposure, making Raynaud phenomenon less likely. Children with vasculitis can present with painful red, violaceous, or necrotic lesions on the extremities, which can mimic pernio. Vasculitis lesions tend to be more purpuric and angulated, compared with pernio lesions, though in severe cases of pernio with ulceration it may be difficult to distinguish between the two entities and a skin biopsy may be needed.

Sweet syndrome, also known as acute febrile neutrophilic dermatosis, is a rare skin condition in which children present with edematous tender nodules on the hands and with less frequency in other parts of the body with associated fever, malaise, conjunctivitis, or joint pain and it is usually associated with infection or malignancy. Our patient denied any systemic symptoms and had no conjunctivitis nor arthritis.

Most patients with idiopathic pernio do not require a biopsy or further laboratory evaluation unless the lesions are atypical, chronic, or there is a suspected associated condition. The workup for patients with prolonged or atypical pernio-like lesions include a skin biopsy with direct immunofluorescence, ANA, complete blood count, complement levels, antiphospholipid antibodies, cold agglutinins, and cryoglobulins.

Treatment of mild CLE is with moderate- to high-potency topical corticosteroids. In those patients not responding to topical measures and keeping the extremities warm, the use of hydroxychloroquine has been reported to be beneficial in some patients as well as the use of calcium-channel blockers.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Su WP et al. Cutis. 1994 Dec;54(6):395-9.

2. Boada A et al. Am J Dermatopathol. 2010 Feb;32(1):19-23.

3. Patel et al. SBMJ Case Rep. 2013;2013:bcr2013201165.

4. Genes Yi et al. BMC. 2020 Apr 15;18(1):32.

5. Battesti G et al. J Am Acad Dermatol. 2020;83(4):1219-22.

6. Cappel JA et al. Mayo Clin Proc. 2014 Feb;89(2):207-15.

7. Cappel MA et al. Mayo Clin Proc. 2021;96(4):989-1005.

A punch biopsy from one of the lesions on the feet showed subtle basal vacuolar interface inflammation on the epidermis and rare apoptotic keratinocytes. There was an underlying dermal lymphocytic inflammatory infiltrate around the vascular plexus. Dermal mucin appeared slightly increased. The histologic findings are consistent with pernio. He had a negative direct immunofluorescence study.

Laboratory work-up showed an elevated antinuclear antibody (ANA) of 1:620; positive anticardiolipin IgM was at 15.2. A complete blood count showed no anemia or lymphopenia, he had normal complement C3 and C4 levels, normal urinalysis, negative cryoglobulins and cold agglutinins, and a normal protein electrophoresis.

Given the chronicity of his lesions, the lack of improvement with weather changes, the histopathologic findings of a vacuolar interface dermatitis and the positive ANA titer he was diagnosed with chilblain lupus.

Chilblain lupus erythematosus (CLE) is an uncommon form of chronic cutaneous lupus erythematosus that presents with tender pink to violaceous macules, papules, and/or nodules that sometimes can ulcerate and are present on the fingers, toes, and sometimes the nose and ears. The lesions are usually triggered by cold exposure.¹ These patients also have clinical and laboratory findings consistent with lupus erythematosus.

Even though more studies are needed to clarify the clinical and histopathologic features of chilblain lupus, compared with idiopathic pernio, some authors suggest several characteristics: CLE lesions tend to persist in summer months, as occurred in our patient, and histopathologic evaluation usually shows vacuolar and interface inflammation on the basal cell layer and may also have a positive lupus band on direct immunofluorescence.² About 20% of patient with CLE may later develop systemic lupus erythematosus.³

There is also a familial form of CLE which is usually inherited as an autosomal-dominant trait. Mutations in TREX1, SAMHD1, and STING have been described in these patients.⁴ Affected children present with skin lesions at a young age and those with TREX1 mutations are at a higher risk to develop systemic lupus erythematosus.

The differential diagnosis of chilblain lupus includes idiopathic pernio or pernio secondary to other conditions. Other conditions that are thought to be associated with pernio, besides lupus erythematosus, include infectious causes (hepatitis B, COVID-19 infection),⁵ autoimmune conditions, malignancy and hematologic disorders (paraproteinemia).⁶ In histopathology, pernio lesions present with dermal edema and superficial and deep lymphocytic infiltrate.

The pathogenesis of pernio is not fully understood but is thought be related to vasospasm with secondary poor perfusion and ischemia and type I interferon (INF1) immune response. A recent review of the published studies trying to explain the causality between COVID 19 and pernio-like lesions, from January 2020 to December 2020, speculate several possible mechanisms: an increase in the vasoconstrictive, prothrombotic, and proinflammatory effects of the angiotensin II pathway through activation of the ACE2 by the virus; COVID-19 triggers a robust INF1 immune response in predisposed patients; pernio as a sign of mild disease, may be explained by genetic and hormonal differences in the patients affected.⁷

Another condition that can be confused with CLE is Raynaud phenomenon, were patients present with white to purple to red patches on the fingers and toes after exposure to cold, but in comparison with pernio, the lesions improve within minutes to hours after rewarming. Secondary Raynaud phenomenon can be seen in patients with systemic lupus erythematosus and in patients with other connective tissue disorders. The skin lesions in our patient were persistent and were not triggered by cold exposure, making Raynaud phenomenon less likely. Children with vasculitis can present with painful red, violaceous, or necrotic lesions on the extremities, which can mimic pernio. Vasculitis lesions tend to be more purpuric and angulated, compared with pernio lesions, though in severe cases of pernio with ulceration it may be difficult to distinguish between the two entities and a skin biopsy may be needed.

Sweet syndrome, also known as acute febrile neutrophilic dermatosis, is a rare skin condition in which children present with edematous tender nodules on the hands and with less frequency in other parts of the body with associated fever, malaise, conjunctivitis, or joint pain and it is usually associated with infection or malignancy. Our patient denied any systemic symptoms and had no conjunctivitis nor arthritis.

Most patients with idiopathic pernio do not require a biopsy or further laboratory evaluation unless the lesions are atypical, chronic, or there is a suspected associated condition. The workup for patients with prolonged or atypical pernio-like lesions include a skin biopsy with direct immunofluorescence, ANA, complete blood count, complement levels, antiphospholipid antibodies, cold agglutinins, and cryoglobulins.

Treatment of mild CLE is with moderate- to high-potency topical corticosteroids. In those patients not responding to topical measures and keeping the extremities warm, the use of hydroxychloroquine has been reported to be beneficial in some patients as well as the use of calcium-channel blockers.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Su WP et al. Cutis. 1994 Dec;54(6):395-9.

2. Boada A et al. Am J Dermatopathol. 2010 Feb;32(1):19-23.

3. Patel et al. SBMJ Case Rep. 2013;2013:bcr2013201165.

4. Genes Yi et al. BMC. 2020 Apr 15;18(1):32.

5. Battesti G et al. J Am Acad Dermatol. 2020;83(4):1219-22.

6. Cappel JA et al. Mayo Clin Proc. 2014 Feb;89(2):207-15.

7. Cappel MA et al. Mayo Clin Proc. 2021;96(4):989-1005.

A punch biopsy from one of the lesions on the feet showed subtle basal vacuolar interface inflammation on the epidermis and rare apoptotic keratinocytes. There was an underlying dermal lymphocytic inflammatory infiltrate around the vascular plexus. Dermal mucin appeared slightly increased. The histologic findings are consistent with pernio. He had a negative direct immunofluorescence study.

Laboratory work-up showed an elevated antinuclear antibody (ANA) of 1:620; positive anticardiolipin IgM was at 15.2. A complete blood count showed no anemia or lymphopenia, he had normal complement C3 and C4 levels, normal urinalysis, negative cryoglobulins and cold agglutinins, and a normal protein electrophoresis.

Given the chronicity of his lesions, the lack of improvement with weather changes, the histopathologic findings of a vacuolar interface dermatitis and the positive ANA titer he was diagnosed with chilblain lupus.

Chilblain lupus erythematosus (CLE) is an uncommon form of chronic cutaneous lupus erythematosus that presents with tender pink to violaceous macules, papules, and/or nodules that sometimes can ulcerate and are present on the fingers, toes, and sometimes the nose and ears. The lesions are usually triggered by cold exposure.¹ These patients also have clinical and laboratory findings consistent with lupus erythematosus.

Even though more studies are needed to clarify the clinical and histopathologic features of chilblain lupus, compared with idiopathic pernio, some authors suggest several characteristics: CLE lesions tend to persist in summer months, as occurred in our patient, and histopathologic evaluation usually shows vacuolar and interface inflammation on the basal cell layer and may also have a positive lupus band on direct immunofluorescence.² About 20% of patient with CLE may later develop systemic lupus erythematosus.³

There is also a familial form of CLE which is usually inherited as an autosomal-dominant trait. Mutations in TREX1, SAMHD1, and STING have been described in these patients.⁴ Affected children present with skin lesions at a young age and those with TREX1 mutations are at a higher risk to develop systemic lupus erythematosus.

The differential diagnosis of chilblain lupus includes idiopathic pernio or pernio secondary to other conditions. Other conditions that are thought to be associated with pernio, besides lupus erythematosus, include infectious causes (hepatitis B, COVID-19 infection),⁵ autoimmune conditions, malignancy and hematologic disorders (paraproteinemia).⁶ In histopathology, pernio lesions present with dermal edema and superficial and deep lymphocytic infiltrate.

The pathogenesis of pernio is not fully understood but is thought be related to vasospasm with secondary poor perfusion and ischemia and type I interferon (INF1) immune response. A recent review of the published studies trying to explain the causality between COVID 19 and pernio-like lesions, from January 2020 to December 2020, speculate several possible mechanisms: an increase in the vasoconstrictive, prothrombotic, and proinflammatory effects of the angiotensin II pathway through activation of the ACE2 by the virus; COVID-19 triggers a robust INF1 immune response in predisposed patients; pernio as a sign of mild disease, may be explained by genetic and hormonal differences in the patients affected.⁷

Another condition that can be confused with CLE is Raynaud phenomenon, were patients present with white to purple to red patches on the fingers and toes after exposure to cold, but in comparison with pernio, the lesions improve within minutes to hours after rewarming. Secondary Raynaud phenomenon can be seen in patients with systemic lupus erythematosus and in patients with other connective tissue disorders. The skin lesions in our patient were persistent and were not triggered by cold exposure, making Raynaud phenomenon less likely. Children with vasculitis can present with painful red, violaceous, or necrotic lesions on the extremities, which can mimic pernio. Vasculitis lesions tend to be more purpuric and angulated, compared with pernio lesions, though in severe cases of pernio with ulceration it may be difficult to distinguish between the two entities and a skin biopsy may be needed.

Sweet syndrome, also known as acute febrile neutrophilic dermatosis, is a rare skin condition in which children present with edematous tender nodules on the hands and with less frequency in other parts of the body with associated fever, malaise, conjunctivitis, or joint pain and it is usually associated with infection or malignancy. Our patient denied any systemic symptoms and had no conjunctivitis nor arthritis.

Most patients with idiopathic pernio do not require a biopsy or further laboratory evaluation unless the lesions are atypical, chronic, or there is a suspected associated condition. The workup for patients with prolonged or atypical pernio-like lesions include a skin biopsy with direct immunofluorescence, ANA, complete blood count, complement levels, antiphospholipid antibodies, cold agglutinins, and cryoglobulins.

Treatment of mild CLE is with moderate- to high-potency topical corticosteroids. In those patients not responding to topical measures and keeping the extremities warm, the use of hydroxychloroquine has been reported to be beneficial in some patients as well as the use of calcium-channel blockers.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

1. Su WP et al. Cutis. 1994 Dec;54(6):395-9.

2. Boada A et al. Am J Dermatopathol. 2010 Feb;32(1):19-23.

3. Patel et al. SBMJ Case Rep. 2013;2013:bcr2013201165.

4. Genes Yi et al. BMC. 2020 Apr 15;18(1):32.

5. Battesti G et al. J Am Acad Dermatol. 2020;83(4):1219-22.

6. Cappel JA et al. Mayo Clin Proc. 2014 Feb;89(2):207-15.

7. Cappel MA et al. Mayo Clin Proc. 2021;96(4):989-1005.

Necrobiosis lipoidica, or Necrobiosis lipoidica diabeticorum (NLD), is an uncommon dermatologic condition that presents as plaques on the skin. Women are often more affected than men. Patients often present in their 30s and 40s. The cause of NLD is unknown. Twenty percent of patients with NLD will have glucose intolerance or a family history of diabetes.¹ The percentage of patients with NLD who have diabetes varies in reports from 11% to 65%.² NLD may progress despite the diabetes treatment. Only 0.03% of patient with diabetes will have NLD.³

Lesions most commonly occur on the extremities, with shins being affected in most cases. They vary from asymptomatic to painful. Typically, lesions begin as small, firm erythematous papules that evolve into shiny, well-defined plaques. In older plaques, the center will often appear yellow, depressed, and atrophic, with telangiectasias. The periphery appears pink to violaceous to brown. Ulceration may be present, particularly after trauma, and there may be decreased sensation in the plaques. NLD is clinically distinct from diabetic dermopathy, which appear as brown macules, often in older patients with diabetes.

Ideally, biopsy should be taken at the edge of a lesion. Histologically, the epidermis appears normal or atrophic. A diffuse palisaded and interstitial granulomatous dermatitis consisting of histiocytes, multinucleated giant cells, lymphocytes, and plasma cells is seen in the dermis. Granulomas are often oriented parallel to the epidermis. There is no mucin at the center of the granulomas (as seen in granuloma annulare). Inflammation may extend into the subcutaneous fat. Asteroid bodies (as seen in sarcoid) are absent.

Unfortunately, treatment of NLD is often unsuccessful. Treatment includes potent topical corticosteroids for early lesions and intralesional triamcinolone to the leading edge of lesions. Care should be taken to avoid injecting centrally where atrophy and ulceration may result. Systemic steroids may be helpful in some cases, but can elevate glucose levels. Other reported medical treatments include pentoxifylline, cyclosporine, and niacinamide. Some lesions may spontaneously resolve. Ulcerations may require surgical excision with grafting.

This case and photo are provided by Dr. Bilu Martin, who is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. James WD et al. Andrews’ Diseases of the Skin: Clinical Dermatology. Philadelphia: Saunders Elsevier, 2006.

2. Hashemi D et al. JAMA Dermatol. 2019 Apr 1;155(4):455-9.

3. Bolognia JL et al. Dermatology. St. Louis, Mo.: Mosby Elsevier, 2008.

Necrobiosis lipoidica, or Necrobiosis lipoidica diabeticorum (NLD), is an uncommon dermatologic condition that presents as plaques on the skin. Women are often more affected than men. Patients often present in their 30s and 40s. The cause of NLD is unknown. Twenty percent of patients with NLD will have glucose intolerance or a family history of diabetes.¹ The percentage of patients with NLD who have diabetes varies in reports from 11% to 65%.² NLD may progress despite the diabetes treatment. Only 0.03% of patient with diabetes will have NLD.³

Lesions most commonly occur on the extremities, with shins being affected in most cases. They vary from asymptomatic to painful. Typically, lesions begin as small, firm erythematous papules that evolve into shiny, well-defined plaques. In older plaques, the center will often appear yellow, depressed, and atrophic, with telangiectasias. The periphery appears pink to violaceous to brown. Ulceration may be present, particularly after trauma, and there may be decreased sensation in the plaques. NLD is clinically distinct from diabetic dermopathy, which appear as brown macules, often in older patients with diabetes.

Ideally, biopsy should be taken at the edge of a lesion. Histologically, the epidermis appears normal or atrophic. A diffuse palisaded and interstitial granulomatous dermatitis consisting of histiocytes, multinucleated giant cells, lymphocytes, and plasma cells is seen in the dermis. Granulomas are often oriented parallel to the epidermis. There is no mucin at the center of the granulomas (as seen in granuloma annulare). Inflammation may extend into the subcutaneous fat. Asteroid bodies (as seen in sarcoid) are absent.

Unfortunately, treatment of NLD is often unsuccessful. Treatment includes potent topical corticosteroids for early lesions and intralesional triamcinolone to the leading edge of lesions. Care should be taken to avoid injecting centrally where atrophy and ulceration may result. Systemic steroids may be helpful in some cases, but can elevate glucose levels. Other reported medical treatments include pentoxifylline, cyclosporine, and niacinamide. Some lesions may spontaneously resolve. Ulcerations may require surgical excision with grafting.

This case and photo are provided by Dr. Bilu Martin, who is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. James WD et al. Andrews’ Diseases of the Skin: Clinical Dermatology. Philadelphia: Saunders Elsevier, 2006.

2. Hashemi D et al. JAMA Dermatol. 2019 Apr 1;155(4):455-9.

3. Bolognia JL et al. Dermatology. St. Louis, Mo.: Mosby Elsevier, 2008.

Necrobiosis lipoidica, or Necrobiosis lipoidica diabeticorum (NLD), is an uncommon dermatologic condition that presents as plaques on the skin. Women are often more affected than men. Patients often present in their 30s and 40s. The cause of NLD is unknown. Twenty percent of patients with NLD will have glucose intolerance or a family history of diabetes.¹ The percentage of patients with NLD who have diabetes varies in reports from 11% to 65%.² NLD may progress despite the diabetes treatment. Only 0.03% of patient with diabetes will have NLD.³

Lesions most commonly occur on the extremities, with shins being affected in most cases. They vary from asymptomatic to painful. Typically, lesions begin as small, firm erythematous papules that evolve into shiny, well-defined plaques. In older plaques, the center will often appear yellow, depressed, and atrophic, with telangiectasias. The periphery appears pink to violaceous to brown. Ulceration may be present, particularly after trauma, and there may be decreased sensation in the plaques. NLD is clinically distinct from diabetic dermopathy, which appear as brown macules, often in older patients with diabetes.

Ideally, biopsy should be taken at the edge of a lesion. Histologically, the epidermis appears normal or atrophic. A diffuse palisaded and interstitial granulomatous dermatitis consisting of histiocytes, multinucleated giant cells, lymphocytes, and plasma cells is seen in the dermis. Granulomas are often oriented parallel to the epidermis. There is no mucin at the center of the granulomas (as seen in granuloma annulare). Inflammation may extend into the subcutaneous fat. Asteroid bodies (as seen in sarcoid) are absent.

Unfortunately, treatment of NLD is often unsuccessful. Treatment includes potent topical corticosteroids for early lesions and intralesional triamcinolone to the leading edge of lesions. Care should be taken to avoid injecting centrally where atrophy and ulceration may result. Systemic steroids may be helpful in some cases, but can elevate glucose levels. Other reported medical treatments include pentoxifylline, cyclosporine, and niacinamide. Some lesions may spontaneously resolve. Ulcerations may require surgical excision with grafting.

This case and photo are provided by Dr. Bilu Martin, who is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1. James WD et al. Andrews’ Diseases of the Skin: Clinical Dermatology. Philadelphia: Saunders Elsevier, 2006.

2. Hashemi D et al. JAMA Dermatol. 2019 Apr 1;155(4):455-9.

3. Bolognia JL et al. Dermatology. St. Louis, Mo.: Mosby Elsevier, 2008.