Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Exposure-response analysis predicted 15 mg upadacitinib daily would achieve robust efficacy in patients with psoriatic arthritis (PsA) with a limited decrease in hemoglobin or occurrence of serious infections.

Major finding: The potential benefits of increasing upadacitinib plasma exposure beyond 15 mg daily were not consistent, with 8% and 7% higher percentage of patients predicted to achieve 50% and 70% improvement in American College of Rheumatology response levels, respectively, with 30 mg upadacitinib compared to 15 mg at week 12 but not at week 24. At week 24, the percentage of patients with serious infection was 2% for both upadacitinib doses, and the percentage of patients with hemoglobin decrease >2 g/dL was 3% and 4% for 15 mg and 30 mg upadacitinib, respectively.

Study details: Findings are from an analysis of two phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, including 1,916 patients with PsA with an inadequate response to biologic or nonbiologic disease-modifying antirheumatic drugs.

Disclosures: This work was funded by AbbVie. The authors declared being current/former employees of AbbVie and may hold stocks/stock options.

Source: Muensterman E et al. Clin Transl Sci. 2021 Aug 31. doi: 10.1111/cts.13146.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: Golimumab was effective for both musculoskeletal and cutaneous manifestations along with good drug persistence in patients with moderate-to-severe psoriatic arthritis (PsA) and concomitant psoriasis in a long-term real-life clinical setting.

Major finding: Disease activity in PsA score (P < .0001) and psoriasis activity and severity index score (P < .01) improved significantly after 6, 12, 24, 36, and 48 months of treatment. The retention rate of golimumab was 82.8%, 73.4%, 62.0%, and 54.4% at 6, 12, 24, and 48 months, respectively. The major reasons for drug discontinuation were primary/secondary inefficacy.

Study details: Findings are from a retrospective observational study including 105 patients with moderate-to-severe PsA and concomitant psoriasis with high disease activity and elevated prevalence of comorbidities and who started treatment with golimumab.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Chimenti MS et al. Clin Rheumatol. 2021 Aug 19. doi: 10.1007/s10067-021-05874-6.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: The chances of counseling or education for modifiable lifestyle risk factors were rare during psoriatic arthritis (PsA) or psoriasis outpatient visits, with rates being even lower among dermatologists compared to nondermatologists.

Major finding: Overall, low rates of counseling were observed for any modifiable lifestyle risk factor (11.1%; 95% CI 7.9%-15.3%), tobacco (4.8%; 95% CI 2.8%-8.0%), and obesity (2.8%; 95% CI 1.7%-4.5%). Moreover, counseling rates for any modifiable risk factor were lower for dermatologists compared to nondermatologists visits (0.9% vs. 22.6%; P < .001).

Study details: This study used the National Ambulatory Medical Care Survey (2002-2016) and the National Hospital Ambulatory Medical Care Survey (2002-2011) conducted in the United States to assess the frequency of education/counseling for modifiable risk factors in an estimated 41.8 million psoriasis or PsA outpatient visits.

Disclosures: Dr. Barbieri is supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health and receives partial support from Pfizer. The authors declared no conflicts of interest.

Source: Taylor MT et al. J Am Acad Dermatol. 2021 Aug 24. doi: 10.1016/j.jaad.2021.08.034.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Patients with psoriasis with higher vs. lower affected body surface area (BSA) were at an increased risk of developing psoriatic arthritis (PsA).

Major finding: During a mean follow-up of 4.2 years, the incidence of PsA was 5.4 cases per 1,000 person years. Compared with BSA < 3%, BSA > 10% (hazard ratio [HR] 2.01; 95% CI 1.29-3.13) and BSA = 3%-10% (HR 1.44; 95% CI 1.02-2.03) were associated with incident PsA.

Study details: Findings are from a prospective, population-based cohort study including 9,056 patients with at least 1 code for psoriasis (mild to severe) and 90,547 matched general population controls.

Disclosures: This study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Heart, Lung, and Blood Institute of the National Institutes of Health. Some authors declared serving as consultant or co-patent holder or receiving grants, honoraria, or payments for medical education from several sources.

Source: Ogdie A et al. Rheumatology. 2021 Sep 11. doi: 10.1093/rheumatology/keab622.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

Key clinical point: Treating skin manifestations with biologics significantly reduced the risk of developing psoriatic arthritis (PsA) in patients with psoriasis.

Major finding: The risk of developing PsA was significantly higher in patients who did not receive treatment with biologics vs. the biological treatment group (adjusted hazard ratio 1.39; 95% CI 1.03-1.87).

Study details: Findings are from a retrospective cohort including 1,326 patients with psoriasis without PsA, of which 663 patients received biological treatment and 663 patients did not receive biological treatment.

Disclosures: This study did not report any external funding. Dr. Pavlovsky declared serving as investigator, advisor, consultant, and invited lecturer for various sources.

Source: Rosenthal YS et al. Arthritis Rheumatol. 2021 Aug 23. doi: 10.1002/art.41946.

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

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

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]

Federal efforts to improve the quality, safety, and efficacy of over-the-counter sunscreens took a step forward today with the release of two orders aimed at updating regulatory requirements for most sunscreen products in the United States.

“We see it as a key public health priority and our regulatory obligation to make sure that marketed sunscreen products offer protection from the sun’s effects and that they deliver on those promises to consumers,” Theresa Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said during a media briefing.

When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in 2020, the FDA was in the middle of amending a sunscreen monograph through the previous rule-making process, and the agency had issued a proposed rule for sunscreens in February of 2019. The CARES Act provided the FDA with new authority related to OTC drugs including sunscreens.

It also established a deemed final order for sunscreens, which set the current requirements for OTC sunscreen products marketed without an application. The deemed final order, released on Sept. 24, “essentially preserves the pre-CARES Act status quo marketing conditions for these sunscreens,” Dr. Michele explained. “Before the CARES Act was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the agency believes that most sunscreens on the market today are already in compliance with this order.”

The CARES Act also required the FDA to issue a proposed order by Sept. 27 to amend and revise the deemed final order. Dr. Michele described the proposed order, which was released on Sept. 24, as “a vehicle to effectively transition our ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rule-making process to this new order process. The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens. With this proposed order, we’re proposing new requirements to improve the quality, safety, and efficacy of sunscreens that Americans use every day.”

The order proposes to update the generally recognized as safe (GRASE) status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments, and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.

Adam Friedman, MD, FAAD, professor and chair of dermatology at George Washington University, Washington, emphasized that photoprotection “is important for everyone, regardless of skin tone,” in an interview. “Broad-spectrum sunscreens with an SPF of 15 and higher play an important role in this. This should not be lost amidst the proposed order.”

Changes between the deemed and proposed order that he highlighted include a maximum SPF of 60+ (though up to 80 might be allowed) and that zinc oxide and titanium dioxide are GRASE. “The FDA did not say that nanoparticle formulations of these, which are easier to use, are not GRASE; they are asking for community input,” he said.

Other changes between the deemed and proposed order are that PABA and trolamine salicylate are not GRASE and that broad-spectrum testing will be mandatory. In addition, Dr. Friedman said, “sprays will be considered for GRASE so long as properly tested, labeling should be clearer (and a warning will be applied to those sunscreens not shown to prevent all the bad stuff with UVR [ultraviolet radiation]), and bug spray–sunscreen combos are a no-go.”

The FDA will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order. “As part of this process, we’ll consider all timely comments submitted both in response to the February 2019 proposed rule and to the current proposed order,” Dr. Michele said.

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is also a speaker for Regeneron, Sanofi Genzyme, Abbvie, LRP, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

[email protected]

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

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

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

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

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

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

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

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

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

The American College of Obstetricians and Gynecologists (ACOG), took a prominent stand in the battle over abortion legislation by filing an amicus brief to the United States Supreme Court in the case of Dobbs v. Jackson Women’s Health Organization, according to a statement from ACOG issued on Sept. 21.

The case, filed by Thomas E. Dobbs, MD, state health officer of the Mississippi Department of Health, and others, appeals the decision by the U.S. Court of Appeals for the Fifth Circuit to throw out Mississippi’s law banning abortion after 15 weeks of pregnancy.*

ACOG’s amicus brief, which was signed by 24 additional medical organizations, including the American Medical Association, “represents an unprecedented level of support from a diverse group of physicians, nurses, and other health care professionals, which demonstrates the concrete medical consensus of opposition to abortion restriction legislation such as the law at the heart of Dobbs v. Jackson,” according to the ACOG statement.

The brief explains how the ban goes against not only the ability of health professionals to provide safe and essential care, but also goes against scientific evidence and medical ethics. “By preventing clinicians from providing patients with necessary medical care, the ban represents gross interference in the patient-clinician relationship,” according to the ACOG brief. 

Potential implications if the ban is upheld include health risks to pregnant women at or near 15 weeks’ gestation, who might be forced to travel out of state, attempt self-induced abortion, or carry a pregnancy to term, according to the brief.

“Each of these outcomes increases the likelihood of negative consequences to a woman’s physical and psychological health that could be avoided if care were available,” according to the brief.

The brief also emphasizes that the ban will have a disproportionate effect on women who are already at risk for being medically underserved and who make up a majority of women seeking abortion: women of color, women in rural areas, and women with limited financial resources.

“This law is an example of harmful legislative interference into the practice of medicine,” said ACOG President J. Martin Tucker, MD, FACOG, on behalf of ACOG, in the statement.

“The outcome of this case could overturn decades of legal precedent that safeguards safe, legal abortion before viability, and the consequences of this case have national implications,” said Maureen G. Phipps, MD, MPH, CEO of ACOG, in an interview, as reported by ACOG press person Kate Connors.

“If the court does not strike down this law, clinicians in states across the country may face similar restrictions in their ability to provide necessary, evidence-based medical care,” Dr. Phipps explained. “If states are allowed to create new laws that further restrict abortion access, patients and families across the country will suffer,” she said.

“We hope that the Supreme Court will respond to the arguments of our brief and to the remarkable medical consensus represented by 25 organization signing the brief,” Dr. Phipps said. “We will continue educating and working through the judicial system in support of our patients’ access to evidence-based care and in opposition to legislative interference in the practice of medicine,” she emphasized.

Other medical organizations that signed the brief in support of the case against the Mississippi abortion ban included the American Academy of Pediatrics, the American Association of Family Physicians, the American College of Nurse Midwives, the American College of Physicians, the American Psychological Association, the American Society for Reproductive Medicine, the Association of Women’s Health, Obstetric and Neonatal Nurses, the American Medical Women’s Association, the Council of University Chairs of Obstetrics and Gynecology, the National Association of Nurse Practitioners in Women’s Health, the North American Society for Pediatric and Adolescent Gynecology, the Society of OB/GYN Hospitalists, and the Society of Family Planning.

*This story was updated on 10/7/2021.

The American College of Obstetricians and Gynecologists (ACOG), took a prominent stand in the battle over abortion legislation by filing an amicus brief to the United States Supreme Court in the case of Dobbs v. Jackson Women’s Health Organization, according to a statement from ACOG issued on Sept. 21.

The case, filed by Thomas E. Dobbs, MD, state health officer of the Mississippi Department of Health, and others, appeals the decision by the U.S. Court of Appeals for the Fifth Circuit to throw out Mississippi’s law banning abortion after 15 weeks of pregnancy.*

ACOG’s amicus brief, which was signed by 24 additional medical organizations, including the American Medical Association, “represents an unprecedented level of support from a diverse group of physicians, nurses, and other health care professionals, which demonstrates the concrete medical consensus of opposition to abortion restriction legislation such as the law at the heart of Dobbs v. Jackson,” according to the ACOG statement.

The brief explains how the ban goes against not only the ability of health professionals to provide safe and essential care, but also goes against scientific evidence and medical ethics. “By preventing clinicians from providing patients with necessary medical care, the ban represents gross interference in the patient-clinician relationship,” according to the ACOG brief. 

Potential implications if the ban is upheld include health risks to pregnant women at or near 15 weeks’ gestation, who might be forced to travel out of state, attempt self-induced abortion, or carry a pregnancy to term, according to the brief.

“Each of these outcomes increases the likelihood of negative consequences to a woman’s physical and psychological health that could be avoided if care were available,” according to the brief.

The brief also emphasizes that the ban will have a disproportionate effect on women who are already at risk for being medically underserved and who make up a majority of women seeking abortion: women of color, women in rural areas, and women with limited financial resources.

“This law is an example of harmful legislative interference into the practice of medicine,” said ACOG President J. Martin Tucker, MD, FACOG, on behalf of ACOG, in the statement.

“The outcome of this case could overturn decades of legal precedent that safeguards safe, legal abortion before viability, and the consequences of this case have national implications,” said Maureen G. Phipps, MD, MPH, CEO of ACOG, in an interview, as reported by ACOG press person Kate Connors.

“If the court does not strike down this law, clinicians in states across the country may face similar restrictions in their ability to provide necessary, evidence-based medical care,” Dr. Phipps explained. “If states are allowed to create new laws that further restrict abortion access, patients and families across the country will suffer,” she said.

“We hope that the Supreme Court will respond to the arguments of our brief and to the remarkable medical consensus represented by 25 organization signing the brief,” Dr. Phipps said. “We will continue educating and working through the judicial system in support of our patients’ access to evidence-based care and in opposition to legislative interference in the practice of medicine,” she emphasized.

Other medical organizations that signed the brief in support of the case against the Mississippi abortion ban included the American Academy of Pediatrics, the American Association of Family Physicians, the American College of Nurse Midwives, the American College of Physicians, the American Psychological Association, the American Society for Reproductive Medicine, the Association of Women’s Health, Obstetric and Neonatal Nurses, the American Medical Women’s Association, the Council of University Chairs of Obstetrics and Gynecology, the National Association of Nurse Practitioners in Women’s Health, the North American Society for Pediatric and Adolescent Gynecology, the Society of OB/GYN Hospitalists, and the Society of Family Planning.

*This story was updated on 10/7/2021.

The American College of Obstetricians and Gynecologists (ACOG), took a prominent stand in the battle over abortion legislation by filing an amicus brief to the United States Supreme Court in the case of Dobbs v. Jackson Women’s Health Organization, according to a statement from ACOG issued on Sept. 21.

The case, filed by Thomas E. Dobbs, MD, state health officer of the Mississippi Department of Health, and others, appeals the decision by the U.S. Court of Appeals for the Fifth Circuit to throw out Mississippi’s law banning abortion after 15 weeks of pregnancy.*

ACOG’s amicus brief, which was signed by 24 additional medical organizations, including the American Medical Association, “represents an unprecedented level of support from a diverse group of physicians, nurses, and other health care professionals, which demonstrates the concrete medical consensus of opposition to abortion restriction legislation such as the law at the heart of Dobbs v. Jackson,” according to the ACOG statement.

The brief explains how the ban goes against not only the ability of health professionals to provide safe and essential care, but also goes against scientific evidence and medical ethics. “By preventing clinicians from providing patients with necessary medical care, the ban represents gross interference in the patient-clinician relationship,” according to the ACOG brief. 

Potential implications if the ban is upheld include health risks to pregnant women at or near 15 weeks’ gestation, who might be forced to travel out of state, attempt self-induced abortion, or carry a pregnancy to term, according to the brief.

“Each of these outcomes increases the likelihood of negative consequences to a woman’s physical and psychological health that could be avoided if care were available,” according to the brief.

The brief also emphasizes that the ban will have a disproportionate effect on women who are already at risk for being medically underserved and who make up a majority of women seeking abortion: women of color, women in rural areas, and women with limited financial resources.

“This law is an example of harmful legislative interference into the practice of medicine,” said ACOG President J. Martin Tucker, MD, FACOG, on behalf of ACOG, in the statement.

“The outcome of this case could overturn decades of legal precedent that safeguards safe, legal abortion before viability, and the consequences of this case have national implications,” said Maureen G. Phipps, MD, MPH, CEO of ACOG, in an interview, as reported by ACOG press person Kate Connors.

“If the court does not strike down this law, clinicians in states across the country may face similar restrictions in their ability to provide necessary, evidence-based medical care,” Dr. Phipps explained. “If states are allowed to create new laws that further restrict abortion access, patients and families across the country will suffer,” she said.

“We hope that the Supreme Court will respond to the arguments of our brief and to the remarkable medical consensus represented by 25 organization signing the brief,” Dr. Phipps said. “We will continue educating and working through the judicial system in support of our patients’ access to evidence-based care and in opposition to legislative interference in the practice of medicine,” she emphasized.

Other medical organizations that signed the brief in support of the case against the Mississippi abortion ban included the American Academy of Pediatrics, the American Association of Family Physicians, the American College of Nurse Midwives, the American College of Physicians, the American Psychological Association, the American Society for Reproductive Medicine, the Association of Women’s Health, Obstetric and Neonatal Nurses, the American Medical Women’s Association, the Council of University Chairs of Obstetrics and Gynecology, the National Association of Nurse Practitioners in Women’s Health, the North American Society for Pediatric and Adolescent Gynecology, the Society of OB/GYN Hospitalists, and the Society of Family Planning.

*This story was updated on 10/7/2021.

Growth mindset is a well-established phenomenon in childhood education that is now starting to appear in health care education literature.¹ This concept emphasizes the capacity of individuals to change and grow through experience and that an individual’s basic qualities can be cultivated through hard work, open-mindedness, and help from others.²

Growth mindset opposes the concept of fixed mindset, which implies intelligence or other personal traits are set in stone, unable to be fundamentally changed.² Individuals with fixed mindsets are less adept at coping with perceived failures and critical feedback because they view these as attacks on their own abilities.² This oftentimes leads these individuals to avoid potential challenges and feedback because of fear of being exposed as incompetent or feeling inadequate. Conversely, individuals with a growth mindset embrace challenges and failures as learning opportunities and identify feedback as a critical element of growth.² These individuals maintain a sense of resilience in the face of adversity and strive to become lifelong learners.

As the field of pediatric hospital medicine (PHM) continues to rapidly evolve, so too does the landscape of PHM fellowships. New programs are opening at a torrid pace to accommodate the increasing demand of residents looking to enter the field with new subspecialty accreditation. Most first-year PHM fellows in established programs enter with a clear precedent to follow, set forth by fellows who have come before them. For PHM fellows in new programs, however, there is often no beaten path to follow.

Entering fellowship as a first-year PHM fellow in a new program and blazing one’s own trail can be intriguing and exhilarating given the unique opportunities available. However, the potential challenges for both fellows and program directors during this transition cannot be understated. The role of new PHM fellows within the institutional framework may initially be unclear to others, which can lead to ambiguous expectations and disruptions to normal workflows. Furthermore, assessing and evaluating new fellows may prove difficult as a result of these unclear expectations and general uncertainties. Using the growth mindset can help both PHM fellows and program directors take a deliberate approach to the challenges and uncertainty that may accompany the creation of a new fellowship program.

One of the challenges new PHM fellows may encounter lies within the structure of the care team. Resident and medical student learners may express consternation that the new fellow role may limit their own autonomy. In addition, finding the right balance of autonomy and supervision between the attending-fellow dyad may prove to be difficult. However, using the growth mindset may allow fellows to see the inherent benefits of this new role.

Fellows should seize the opportunity to discuss the nuances and differing approaches to difficult clinical questions, managing a team and interpersonal dynamics, and balancing clinical and nonclinical responsibilities with an experienced supervising clinician; issues that are often less pressing as a resident. The fellow role also affords the opportunity to more carefully observe different clinical styles of practice to subsequently shape one’s own preferred style.

Finally, fellows should employ a growth mindset to optimize clinical time by discussing expectations with involved stakeholders prior to rotations and explicitly identifying goals for feedback and improvement. Program directors can also help stakeholders including faculty, residency programs, medical schools, and other health care professionals on the clinical teams prepare for this transition by providing expectations for the fellow role and by soliciting questions and feedback before and after fellows begin.

One of the key tenets of the growth mindset is actively seeking out constructive feedback and learning from failures to grow and improve. This can be a particularly useful practice for fellows during the course of their scholarly pursuits in clinical research, quality improvement, and medical education. From initial stages of idea development through the final steps of manuscript submission and peer review, fellows will undoubtedly navigate a plethora of challenges and setbacks along the way. Program directors and other core faculty members can promote a growth mindset culture by honestly discussing their own challenges and failures in career endeavors in addition to giving thoughtful constructive feedback.

Fellows should routinely practice explicitly identifying knowledge and skills gaps that represent areas for potential improvement. But perhaps most importantly, fellows must strive to see all feedback and perceived failures not as personal affronts or as commentaries on personal abilities, but rather as opportunities to strengthen their scholarly products and gain valuable experience for future endeavors.

Not all learners will come equipped with a growth mindset. So, what can fellows and program directors in new programs do to develop this practice and mitigate some of the inevitable uncertainty? To begin, program directors should think about how to create cultures of growth and development as the fixed and growth mindsets are not just limited to individuals.³ Program directors can strive to augment this process by committing to solicit feedback for themselves and acknowledging their own vulnerabilities and perceived weaknesses.

Fellows must have early, honest discussions with program directors and other stakeholders about expectations and goals. Program directors should consider creating lists of “must meet” individuals within the institution that can help fellows begin to carve out their roles in the clinical, educational, and research realms. Deliberately crafting a mentorship team that will encourage a commitment to growth and improvement is critical. Seeking out growth feedback, particularly in areas that prove challenging, should become common practice for fellows from the onset.

Most importantly, fellows should reframe uncertainty as opportunity for growth and progression. Seeing oneself as a work in progress provides a new perspective that prioritizes learning and emphasizes improvement potential.

Embodying this approach requires patience and practice. Being part of a newly created fellowship represents an opportunity to learn from personal challenges rather than leaning on the precedent set by previous fellows. And although fellows will often face uncertainty as a part of the novelty within a new program, they can ultimately succeed by practicing the principles of Dweck’s Growth Mindset: embracing challenges and failure as learning experiences, seeking out feedback, and pursuing the opportunities among ambiguity.
 

Dr. Herchline is a pediatric hospitalist at Cincinnati Children’s Hospital Medical Center and recent fellow graduate of the Children’s Hospital of Philadelphia. During fellowship, he completed a master’s degree in medical education at the University of Pennsylvania. His academic interests include graduate medical education, interprofessional collaboration and teamwork, and quality improvement.

References

1. Klein J et al. A growth mindset approach to preparing trainees for medical error. BMJ Qual Saf. 2017 Sep;26(9):771-4. doi: 10.1136/bmjqs-2016-006416.

2. Dweck C. Mindset: The new psychology of success. New York: Ballantine Books; 2006.

3. Murphy MC, Dweck CS. A culture of genius: How an organization’s lay theory shapes people’s cognition, affect, and behavior. Pers Soc Psychol Bull. 2010 Mar;36(3):283-96. doi: 10.1177/0146167209347380.

Growth mindset is a well-established phenomenon in childhood education that is now starting to appear in health care education literature.¹ This concept emphasizes the capacity of individuals to change and grow through experience and that an individual’s basic qualities can be cultivated through hard work, open-mindedness, and help from others.²

Growth mindset opposes the concept of fixed mindset, which implies intelligence or other personal traits are set in stone, unable to be fundamentally changed.² Individuals with fixed mindsets are less adept at coping with perceived failures and critical feedback because they view these as attacks on their own abilities.² This oftentimes leads these individuals to avoid potential challenges and feedback because of fear of being exposed as incompetent or feeling inadequate. Conversely, individuals with a growth mindset embrace challenges and failures as learning opportunities and identify feedback as a critical element of growth.² These individuals maintain a sense of resilience in the face of adversity and strive to become lifelong learners.

As the field of pediatric hospital medicine (PHM) continues to rapidly evolve, so too does the landscape of PHM fellowships. New programs are opening at a torrid pace to accommodate the increasing demand of residents looking to enter the field with new subspecialty accreditation. Most first-year PHM fellows in established programs enter with a clear precedent to follow, set forth by fellows who have come before them. For PHM fellows in new programs, however, there is often no beaten path to follow.

Entering fellowship as a first-year PHM fellow in a new program and blazing one’s own trail can be intriguing and exhilarating given the unique opportunities available. However, the potential challenges for both fellows and program directors during this transition cannot be understated. The role of new PHM fellows within the institutional framework may initially be unclear to others, which can lead to ambiguous expectations and disruptions to normal workflows. Furthermore, assessing and evaluating new fellows may prove difficult as a result of these unclear expectations and general uncertainties. Using the growth mindset can help both PHM fellows and program directors take a deliberate approach to the challenges and uncertainty that may accompany the creation of a new fellowship program.

One of the challenges new PHM fellows may encounter lies within the structure of the care team. Resident and medical student learners may express consternation that the new fellow role may limit their own autonomy. In addition, finding the right balance of autonomy and supervision between the attending-fellow dyad may prove to be difficult. However, using the growth mindset may allow fellows to see the inherent benefits of this new role.

Fellows should seize the opportunity to discuss the nuances and differing approaches to difficult clinical questions, managing a team and interpersonal dynamics, and balancing clinical and nonclinical responsibilities with an experienced supervising clinician; issues that are often less pressing as a resident. The fellow role also affords the opportunity to more carefully observe different clinical styles of practice to subsequently shape one’s own preferred style.

Finally, fellows should employ a growth mindset to optimize clinical time by discussing expectations with involved stakeholders prior to rotations and explicitly identifying goals for feedback and improvement. Program directors can also help stakeholders including faculty, residency programs, medical schools, and other health care professionals on the clinical teams prepare for this transition by providing expectations for the fellow role and by soliciting questions and feedback before and after fellows begin.

One of the key tenets of the growth mindset is actively seeking out constructive feedback and learning from failures to grow and improve. This can be a particularly useful practice for fellows during the course of their scholarly pursuits in clinical research, quality improvement, and medical education. From initial stages of idea development through the final steps of manuscript submission and peer review, fellows will undoubtedly navigate a plethora of challenges and setbacks along the way. Program directors and other core faculty members can promote a growth mindset culture by honestly discussing their own challenges and failures in career endeavors in addition to giving thoughtful constructive feedback.

Fellows should routinely practice explicitly identifying knowledge and skills gaps that represent areas for potential improvement. But perhaps most importantly, fellows must strive to see all feedback and perceived failures not as personal affronts or as commentaries on personal abilities, but rather as opportunities to strengthen their scholarly products and gain valuable experience for future endeavors.

Not all learners will come equipped with a growth mindset. So, what can fellows and program directors in new programs do to develop this practice and mitigate some of the inevitable uncertainty? To begin, program directors should think about how to create cultures of growth and development as the fixed and growth mindsets are not just limited to individuals.³ Program directors can strive to augment this process by committing to solicit feedback for themselves and acknowledging their own vulnerabilities and perceived weaknesses.

Fellows must have early, honest discussions with program directors and other stakeholders about expectations and goals. Program directors should consider creating lists of “must meet” individuals within the institution that can help fellows begin to carve out their roles in the clinical, educational, and research realms. Deliberately crafting a mentorship team that will encourage a commitment to growth and improvement is critical. Seeking out growth feedback, particularly in areas that prove challenging, should become common practice for fellows from the onset.

Most importantly, fellows should reframe uncertainty as opportunity for growth and progression. Seeing oneself as a work in progress provides a new perspective that prioritizes learning and emphasizes improvement potential.

Embodying this approach requires patience and practice. Being part of a newly created fellowship represents an opportunity to learn from personal challenges rather than leaning on the precedent set by previous fellows. And although fellows will often face uncertainty as a part of the novelty within a new program, they can ultimately succeed by practicing the principles of Dweck’s Growth Mindset: embracing challenges and failure as learning experiences, seeking out feedback, and pursuing the opportunities among ambiguity.
 

Dr. Herchline is a pediatric hospitalist at Cincinnati Children’s Hospital Medical Center and recent fellow graduate of the Children’s Hospital of Philadelphia. During fellowship, he completed a master’s degree in medical education at the University of Pennsylvania. His academic interests include graduate medical education, interprofessional collaboration and teamwork, and quality improvement.

References

1. Klein J et al. A growth mindset approach to preparing trainees for medical error. BMJ Qual Saf. 2017 Sep;26(9):771-4. doi: 10.1136/bmjqs-2016-006416.

2. Dweck C. Mindset: The new psychology of success. New York: Ballantine Books; 2006.

3. Murphy MC, Dweck CS. A culture of genius: How an organization’s lay theory shapes people’s cognition, affect, and behavior. Pers Soc Psychol Bull. 2010 Mar;36(3):283-96. doi: 10.1177/0146167209347380.

Growth mindset is a well-established phenomenon in childhood education that is now starting to appear in health care education literature.¹ This concept emphasizes the capacity of individuals to change and grow through experience and that an individual’s basic qualities can be cultivated through hard work, open-mindedness, and help from others.²

Growth mindset opposes the concept of fixed mindset, which implies intelligence or other personal traits are set in stone, unable to be fundamentally changed.² Individuals with fixed mindsets are less adept at coping with perceived failures and critical feedback because they view these as attacks on their own abilities.² This oftentimes leads these individuals to avoid potential challenges and feedback because of fear of being exposed as incompetent or feeling inadequate. Conversely, individuals with a growth mindset embrace challenges and failures as learning opportunities and identify feedback as a critical element of growth.² These individuals maintain a sense of resilience in the face of adversity and strive to become lifelong learners.

As the field of pediatric hospital medicine (PHM) continues to rapidly evolve, so too does the landscape of PHM fellowships. New programs are opening at a torrid pace to accommodate the increasing demand of residents looking to enter the field with new subspecialty accreditation. Most first-year PHM fellows in established programs enter with a clear precedent to follow, set forth by fellows who have come before them. For PHM fellows in new programs, however, there is often no beaten path to follow.

Entering fellowship as a first-year PHM fellow in a new program and blazing one’s own trail can be intriguing and exhilarating given the unique opportunities available. However, the potential challenges for both fellows and program directors during this transition cannot be understated. The role of new PHM fellows within the institutional framework may initially be unclear to others, which can lead to ambiguous expectations and disruptions to normal workflows. Furthermore, assessing and evaluating new fellows may prove difficult as a result of these unclear expectations and general uncertainties. Using the growth mindset can help both PHM fellows and program directors take a deliberate approach to the challenges and uncertainty that may accompany the creation of a new fellowship program.

One of the challenges new PHM fellows may encounter lies within the structure of the care team. Resident and medical student learners may express consternation that the new fellow role may limit their own autonomy. In addition, finding the right balance of autonomy and supervision between the attending-fellow dyad may prove to be difficult. However, using the growth mindset may allow fellows to see the inherent benefits of this new role.

Fellows should seize the opportunity to discuss the nuances and differing approaches to difficult clinical questions, managing a team and interpersonal dynamics, and balancing clinical and nonclinical responsibilities with an experienced supervising clinician; issues that are often less pressing as a resident. The fellow role also affords the opportunity to more carefully observe different clinical styles of practice to subsequently shape one’s own preferred style.

Finally, fellows should employ a growth mindset to optimize clinical time by discussing expectations with involved stakeholders prior to rotations and explicitly identifying goals for feedback and improvement. Program directors can also help stakeholders including faculty, residency programs, medical schools, and other health care professionals on the clinical teams prepare for this transition by providing expectations for the fellow role and by soliciting questions and feedback before and after fellows begin.

One of the key tenets of the growth mindset is actively seeking out constructive feedback and learning from failures to grow and improve. This can be a particularly useful practice for fellows during the course of their scholarly pursuits in clinical research, quality improvement, and medical education. From initial stages of idea development through the final steps of manuscript submission and peer review, fellows will undoubtedly navigate a plethora of challenges and setbacks along the way. Program directors and other core faculty members can promote a growth mindset culture by honestly discussing their own challenges and failures in career endeavors in addition to giving thoughtful constructive feedback.

Fellows should routinely practice explicitly identifying knowledge and skills gaps that represent areas for potential improvement. But perhaps most importantly, fellows must strive to see all feedback and perceived failures not as personal affronts or as commentaries on personal abilities, but rather as opportunities to strengthen their scholarly products and gain valuable experience for future endeavors.

Not all learners will come equipped with a growth mindset. So, what can fellows and program directors in new programs do to develop this practice and mitigate some of the inevitable uncertainty? To begin, program directors should think about how to create cultures of growth and development as the fixed and growth mindsets are not just limited to individuals.³ Program directors can strive to augment this process by committing to solicit feedback for themselves and acknowledging their own vulnerabilities and perceived weaknesses.

Fellows must have early, honest discussions with program directors and other stakeholders about expectations and goals. Program directors should consider creating lists of “must meet” individuals within the institution that can help fellows begin to carve out their roles in the clinical, educational, and research realms. Deliberately crafting a mentorship team that will encourage a commitment to growth and improvement is critical. Seeking out growth feedback, particularly in areas that prove challenging, should become common practice for fellows from the onset.

Most importantly, fellows should reframe uncertainty as opportunity for growth and progression. Seeing oneself as a work in progress provides a new perspective that prioritizes learning and emphasizes improvement potential.

Embodying this approach requires patience and practice. Being part of a newly created fellowship represents an opportunity to learn from personal challenges rather than leaning on the precedent set by previous fellows. And although fellows will often face uncertainty as a part of the novelty within a new program, they can ultimately succeed by practicing the principles of Dweck’s Growth Mindset: embracing challenges and failure as learning experiences, seeking out feedback, and pursuing the opportunities among ambiguity.
 

Dr. Herchline is a pediatric hospitalist at Cincinnati Children’s Hospital Medical Center and recent fellow graduate of the Children’s Hospital of Philadelphia. During fellowship, he completed a master’s degree in medical education at the University of Pennsylvania. His academic interests include graduate medical education, interprofessional collaboration and teamwork, and quality improvement.

References

1. Klein J et al. A growth mindset approach to preparing trainees for medical error. BMJ Qual Saf. 2017 Sep;26(9):771-4. doi: 10.1136/bmjqs-2016-006416.

2. Dweck C. Mindset: The new psychology of success. New York: Ballantine Books; 2006.

3. Murphy MC, Dweck CS. A culture of genius: How an organization’s lay theory shapes people’s cognition, affect, and behavior. Pers Soc Psychol Bull. 2010 Mar;36(3):283-96. doi: 10.1177/0146167209347380.