Heidi Splete

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

The National Rosacea Society (NRS) has launched a new Seal of Acceptance program to help patients and physicians identify skin care and cosmetic products that are appropriate for sensitive and redness-prone skin in people who have rosacea, according to a press release from the NRS.

The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.

Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.

National Rosacea Society

Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.

Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.

Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.

More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.

Early treatment with ibuprofen had no significant impact on the risk of death or adverse outcomes in preterm infants with patent ductus arteriosus vs. placebo.

The study population included infants born between 23 weeks 0 days’ and 28 weeks 6 days’ gestation. The researchers randomized 326 extremely preterm infants with patent ductus arteriosus (PDA) at 72 hours or less after birth to ibuprofen at a loading dose of 10 mg/kg followed by two doses of 5 mg/kg at least 24 hours apart, and 327 to placebo.

The PDAs in the infants had a diameter of at least 1.5 mm with pulsatile flow.

Severe dysplasia outcome

The study’s primary outcome was a composite of death or moderate to severe bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. Overall, a primary outcome occurred in 69.2% of infants who received ibuprofen and 63.5% of those who received a placebo.

Risk of death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age was not reduced by early ibuprofen vs. placebo for preterm infants, the researchers concluded. Moderate or severe bronchopulmonary dysplasia occurred in 64.2% of the infants in the ibuprofen group and 59.3% of the placebo group who survived to 36 weeks’ postmenstrual age.

‘Unforeseeable’ serious adverse events

Forty-four deaths occurred in the ibuprofen group and 33 in the placebo group (adjusted risk ratio 1.09). Two “unforeseeable” serious adverse events occurred during the study that were potentially related to ibuprofen.

The lead author was Samir Gupta, MD, of Sidra Medicine, Doha, Qatar. The study was published online in the New England Journal of Medicine.

Study limitations include incomplete data for some patients.

The study was supported by the National Institute for Health Research Health Technology Assessment Programme. The researchers had no financial conflicts to disclose.

TOPLINE:

Less than half of patients with rheumatoid arthritis (RA) initiating a first-line tumor necrosis factor inhibitor (TNFi) in clinical practice had a recorded composite disease activity assessment at the start of the treatment, and many remained on that treatment for years without evidence recorded in their electronic medical record of achieving low-disease activity or remission.

METHODOLOGY:

• Researchers reviewed data from 1651 adults aged 18 years and older with moderate to severe RA at baseline or follow-up in the electronic medical record database of the American Rheumatology Network, a large community network of independent practices with > 200 rheumatologists across the United States.
• Patients received a TNFi as their first advanced therapy between January 2014 and August 2021 and were assessed for measurement of disease activity with the Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3) at baseline and follow-up visits.

TAKEAWAY:

• Among the patients with moderate to severe RA, 47.2% of patients remained on first-line TNFi therapy 1 year after initiation despite no evidence of achieving treatment targets of low disease activity or remission (defined as CDAI ≤ 10 and/or RAPID3 ≤ 2).
• Approximately one third of patients remained on TNFi therapy for 2 (38.1%) or 3 (35.4%) years after initiation despite not achieving these targets. The median times to TNFi discontinuation was 30.4 months and to subsequent therapy initiation 68.3 months.
• A total of 52% discontinued their initial TNFi during the study period; among those who started a second therapy, 15% restarted the same TNFi, 45.6% started another TNFi, 27.6% started a non-TNFi biologic, and 11.5% started a Janus kinase inhibitor.
• The most common reported reasons for discontinuation were a combination of efficacy and intolerance, efficacy only, and intolerance only (26.9%, 25.3%, and 20.3%, respectively).
• Persistent pain was the most common reason for efficacy-related discontinuation (39.0%), followed by persistent inflammation/swelling and overall general discomfort (31.8% for both).

IN PRACTICE:

“Consistent monitoring of treatment response and timely switch to effective therapy as appropriate is needed in patients with RA initiating their first advanced therapies,” the researchers wrote.

SOURCE:

First author Colin Edgerton, MD, of Articularis Healthcare Group and American Rheumatology Network, Charleston, South Carolina, reported their work on January 14, 2024, in ACR Open Rheumatology.

LIMITATIONS:

The findings were limited by several factors including the retrospective design, incomplete data from electronic medical records, and reliance on physician documentation for drivers of discontinuation.

DISCLOSURES:

The study was supported by AbbVie. Lead author Edgerton also disclosed relationships with Novartis and Boehringer Ingelheim.

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

TOPLINE:

Less than half of patients with rheumatoid arthritis (RA) initiating a first-line tumor necrosis factor inhibitor (TNFi) in clinical practice had a recorded composite disease activity assessment at the start of the treatment, and many remained on that treatment for years without evidence recorded in their electronic medical record of achieving low-disease activity or remission.

METHODOLOGY:

• Researchers reviewed data from 1651 adults aged 18 years and older with moderate to severe RA at baseline or follow-up in the electronic medical record database of the American Rheumatology Network, a large community network of independent practices with > 200 rheumatologists across the United States.
• Patients received a TNFi as their first advanced therapy between January 2014 and August 2021 and were assessed for measurement of disease activity with the Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3) at baseline and follow-up visits.

TAKEAWAY:

• Among the patients with moderate to severe RA, 47.2% of patients remained on first-line TNFi therapy 1 year after initiation despite no evidence of achieving treatment targets of low disease activity or remission (defined as CDAI ≤ 10 and/or RAPID3 ≤ 2).
• Approximately one third of patients remained on TNFi therapy for 2 (38.1%) or 3 (35.4%) years after initiation despite not achieving these targets. The median times to TNFi discontinuation was 30.4 months and to subsequent therapy initiation 68.3 months.
• A total of 52% discontinued their initial TNFi during the study period; among those who started a second therapy, 15% restarted the same TNFi, 45.6% started another TNFi, 27.6% started a non-TNFi biologic, and 11.5% started a Janus kinase inhibitor.
• The most common reported reasons for discontinuation were a combination of efficacy and intolerance, efficacy only, and intolerance only (26.9%, 25.3%, and 20.3%, respectively).
• Persistent pain was the most common reason for efficacy-related discontinuation (39.0%), followed by persistent inflammation/swelling and overall general discomfort (31.8% for both).

IN PRACTICE:

“Consistent monitoring of treatment response and timely switch to effective therapy as appropriate is needed in patients with RA initiating their first advanced therapies,” the researchers wrote.

SOURCE:

First author Colin Edgerton, MD, of Articularis Healthcare Group and American Rheumatology Network, Charleston, South Carolina, reported their work on January 14, 2024, in ACR Open Rheumatology.

LIMITATIONS:

The findings were limited by several factors including the retrospective design, incomplete data from electronic medical records, and reliance on physician documentation for drivers of discontinuation.

DISCLOSURES:

The study was supported by AbbVie. Lead author Edgerton also disclosed relationships with Novartis and Boehringer Ingelheim.

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

TOPLINE:

Less than half of patients with rheumatoid arthritis (RA) initiating a first-line tumor necrosis factor inhibitor (TNFi) in clinical practice had a recorded composite disease activity assessment at the start of the treatment, and many remained on that treatment for years without evidence recorded in their electronic medical record of achieving low-disease activity or remission.

METHODOLOGY:

• Researchers reviewed data from 1651 adults aged 18 years and older with moderate to severe RA at baseline or follow-up in the electronic medical record database of the American Rheumatology Network, a large community network of independent practices with > 200 rheumatologists across the United States.
• Patients received a TNFi as their first advanced therapy between January 2014 and August 2021 and were assessed for measurement of disease activity with the Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3) at baseline and follow-up visits.

TAKEAWAY:

• Among the patients with moderate to severe RA, 47.2% of patients remained on first-line TNFi therapy 1 year after initiation despite no evidence of achieving treatment targets of low disease activity or remission (defined as CDAI ≤ 10 and/or RAPID3 ≤ 2).
• Approximately one third of patients remained on TNFi therapy for 2 (38.1%) or 3 (35.4%) years after initiation despite not achieving these targets. The median times to TNFi discontinuation was 30.4 months and to subsequent therapy initiation 68.3 months.
• A total of 52% discontinued their initial TNFi during the study period; among those who started a second therapy, 15% restarted the same TNFi, 45.6% started another TNFi, 27.6% started a non-TNFi biologic, and 11.5% started a Janus kinase inhibitor.
• The most common reported reasons for discontinuation were a combination of efficacy and intolerance, efficacy only, and intolerance only (26.9%, 25.3%, and 20.3%, respectively).
• Persistent pain was the most common reason for efficacy-related discontinuation (39.0%), followed by persistent inflammation/swelling and overall general discomfort (31.8% for both).

IN PRACTICE:

“Consistent monitoring of treatment response and timely switch to effective therapy as appropriate is needed in patients with RA initiating their first advanced therapies,” the researchers wrote.

SOURCE:

First author Colin Edgerton, MD, of Articularis Healthcare Group and American Rheumatology Network, Charleston, South Carolina, reported their work on January 14, 2024, in ACR Open Rheumatology.

LIMITATIONS:

The findings were limited by several factors including the retrospective design, incomplete data from electronic medical records, and reliance on physician documentation for drivers of discontinuation.

DISCLOSURES:

The study was supported by AbbVie. Lead author Edgerton also disclosed relationships with Novartis and Boehringer Ingelheim.

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

TOPLINE:

Indicators of early bone loss were significantly higher in adults with severe obstructive sleep apnea (OSA) than in those with mild or moderate OSA and controls.

METHODOLOGY:

• The researchers enrolled 90 men aged 30-59 years who were patients at a single sleep and respiratory center between August 2017 and February 2019; the average age was 47.1 years, and the average body mass index was 25.7 kg/m².
• The study population included 25 individuals with mild OSA, 21 with moderate OSA, 34 with severe OSA, and 10 controls without OSA.
• Bone loss was assessed using high-resolution peripheral quantitative computed tomography and blood samples. The researchers collected information on metabolic and inflammatory bone turnover indicators, as well as bone geometric parameters, bone microstructure parameters, and measures of bone mineral density (BMD).

TAKEAWAY:

• Total volumetric bone mineral density was significantly lower in patients with OSA than in controls and significantly different among OSA groups, as were the meta trabecular volumetric BMD, trabecular thickness (Tb.Th), and cortical thickness (Ct.Th).
• Differences in bone microstructure between patients with OSA and controls were most evident in measures of Tb.Th and Ct.Th.
• No significant differences appeared in blood bone turnover indicators or inflammation indicators among the groups.

IN PRACTICE:

“A study with a larger sample is necessary to further assess the relationship and mechanisms between OSA and osteoporosis,” the researchers wrote. 

SOURCE:

The lead author on the study was Yixian Qiao, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. The study was published online in BMC Pulmonary Medicine.

LIMITATIONS:

The cross-sectional design, small sample size, and inability to control for several key confounders such as nutritional status and amount of exercise, as well as the exclusion of women and elderly individuals, limited the findings.

DISCLOSURES:

The study was supported by the National Key Research and Development Projects of China. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Indicators of early bone loss were significantly higher in adults with severe obstructive sleep apnea (OSA) than in those with mild or moderate OSA and controls.

METHODOLOGY:

• The researchers enrolled 90 men aged 30-59 years who were patients at a single sleep and respiratory center between August 2017 and February 2019; the average age was 47.1 years, and the average body mass index was 25.7 kg/m².
• The study population included 25 individuals with mild OSA, 21 with moderate OSA, 34 with severe OSA, and 10 controls without OSA.
• Bone loss was assessed using high-resolution peripheral quantitative computed tomography and blood samples. The researchers collected information on metabolic and inflammatory bone turnover indicators, as well as bone geometric parameters, bone microstructure parameters, and measures of bone mineral density (BMD).

TAKEAWAY:

• Total volumetric bone mineral density was significantly lower in patients with OSA than in controls and significantly different among OSA groups, as were the meta trabecular volumetric BMD, trabecular thickness (Tb.Th), and cortical thickness (Ct.Th).
• Differences in bone microstructure between patients with OSA and controls were most evident in measures of Tb.Th and Ct.Th.
• No significant differences appeared in blood bone turnover indicators or inflammation indicators among the groups.

IN PRACTICE:

“A study with a larger sample is necessary to further assess the relationship and mechanisms between OSA and osteoporosis,” the researchers wrote. 

SOURCE:

The lead author on the study was Yixian Qiao, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. The study was published online in BMC Pulmonary Medicine.

LIMITATIONS:

The cross-sectional design, small sample size, and inability to control for several key confounders such as nutritional status and amount of exercise, as well as the exclusion of women and elderly individuals, limited the findings.

DISCLOSURES:

The study was supported by the National Key Research and Development Projects of China. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Indicators of early bone loss were significantly higher in adults with severe obstructive sleep apnea (OSA) than in those with mild or moderate OSA and controls.

METHODOLOGY:

• The researchers enrolled 90 men aged 30-59 years who were patients at a single sleep and respiratory center between August 2017 and February 2019; the average age was 47.1 years, and the average body mass index was 25.7 kg/m².
• The study population included 25 individuals with mild OSA, 21 with moderate OSA, 34 with severe OSA, and 10 controls without OSA.
• Bone loss was assessed using high-resolution peripheral quantitative computed tomography and blood samples. The researchers collected information on metabolic and inflammatory bone turnover indicators, as well as bone geometric parameters, bone microstructure parameters, and measures of bone mineral density (BMD).

TAKEAWAY:

• Total volumetric bone mineral density was significantly lower in patients with OSA than in controls and significantly different among OSA groups, as were the meta trabecular volumetric BMD, trabecular thickness (Tb.Th), and cortical thickness (Ct.Th).
• Differences in bone microstructure between patients with OSA and controls were most evident in measures of Tb.Th and Ct.Th.
• No significant differences appeared in blood bone turnover indicators or inflammation indicators among the groups.

IN PRACTICE:

“A study with a larger sample is necessary to further assess the relationship and mechanisms between OSA and osteoporosis,” the researchers wrote. 

SOURCE:

The lead author on the study was Yixian Qiao, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. The study was published online in BMC Pulmonary Medicine.

LIMITATIONS:

The cross-sectional design, small sample size, and inability to control for several key confounders such as nutritional status and amount of exercise, as well as the exclusion of women and elderly individuals, limited the findings.

DISCLOSURES:

The study was supported by the National Key Research and Development Projects of China. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range.

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals.
• The study population was divided into quartiles based on BMI as follows: 3180 individuals with BMI of 13.2-24.9 kg/m², 3175 with BMI of 24.9-28.4 kg/m², 3180 with BMI of 28.4-32.5 kg/m², and 3184 with BMI of 32.5-82.0 kg/m².
• The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status.

TAKEAWAY:

• In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles.
• In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001).
• The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma.
• The results support previous studies showing that a BMI that is too low can be detrimental to health.

IN PRACTICE:

“These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD,” the researchers wrote. 

SOURCE:

The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China. The study was published online on January 10, 2024, in Scientific Reports. 

LIMITATIONS:

The cross-sectional NHANES database prevented conclusions of causality, and potential confounding factors that were not accounted for could have affected the results.

DISCLOSURES:

The study was supported by the Shandong Province Taishan Scholar Project. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Exercise with weight machines or elastic resistance bands yielded similar improvements in strength and function in adults with psoriatic arthritis (PsA) after 12 weeks.

METHODOLOGY:

• Researchers recruited 41 adults aged 18-65 years with PsA who were then randomized to a functional training group (FT) or a resistance exercise group (RE) for 12 weeks of twice-weekly, 55-minute sessions under the supervision of a physical trainer.
• Functional training involved the use of elastic bands to work upper body, lower body, and trunk muscles including the biceps, triceps, back quadriceps, glutes, and hips; the RE used weight machines instead of bands.
• Participants were evaluated at baseline and after 6 and 12 weeks of training sessions; the primary outcome was functional status based on the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S).
• Secondary outcomes included the Bath Ankylosing Spondylitis Functional Index (BASFI) to assess functional capacity, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Disease Activity Score in 28 joints (DAS28) to assess disease activity, and the Short Form 36 (SF-36) to measure quality of life.

TAKEAWAY:

• Participants in both groups showed significant improvement from baseline on the primary outcome measure, with no significant differences between the groups on the primary outcome of function or secondary measures of function and disease activity after 12 weeks.
• Significant intragroup changes occurred between times for both groups on the HAQ-S, BASFI, BASDAI, and DAS28 (P = .001, .007, .001, and .001, respectively).
• Improvement in quality of life was significant from baseline and similar between the FT and RE, with the exception of the “social aspects” domain, for which only the FT showed significant improvement.
• No intervention-related adverse events were reported in either group.

IN PRACTICE:

Despite the absence of consensus guidelines on the use and effectiveness of FT and RE, “we can conclude that both FT and RE have similar effectiveness in improving functional capacity, functional status, disease activity, general quality of life, and muscle strength in patients with psoriatic arthritis,” the researchers wrote.

SOURCE:

The study was led by Diego Roger Silva, MD, of the Universidade Federal de São Paulo, Brazil, and published online in Advances in Rheumatology.

LIMITATIONS:

The study population was recruited from outpatient clinics, and the mean age of 52 years was higher than in previous studies; the study also lacked long-term follow-up data.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Exercise with weight machines or elastic resistance bands yielded similar improvements in strength and function in adults with psoriatic arthritis (PsA) after 12 weeks.

METHODOLOGY:

• Researchers recruited 41 adults aged 18-65 years with PsA who were then randomized to a functional training group (FT) or a resistance exercise group (RE) for 12 weeks of twice-weekly, 55-minute sessions under the supervision of a physical trainer.
• Functional training involved the use of elastic bands to work upper body, lower body, and trunk muscles including the biceps, triceps, back quadriceps, glutes, and hips; the RE used weight machines instead of bands.
• Participants were evaluated at baseline and after 6 and 12 weeks of training sessions; the primary outcome was functional status based on the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S).
• Secondary outcomes included the Bath Ankylosing Spondylitis Functional Index (BASFI) to assess functional capacity, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Disease Activity Score in 28 joints (DAS28) to assess disease activity, and the Short Form 36 (SF-36) to measure quality of life.

TAKEAWAY:

• Participants in both groups showed significant improvement from baseline on the primary outcome measure, with no significant differences between the groups on the primary outcome of function or secondary measures of function and disease activity after 12 weeks.
• Significant intragroup changes occurred between times for both groups on the HAQ-S, BASFI, BASDAI, and DAS28 (P = .001, .007, .001, and .001, respectively).
• Improvement in quality of life was significant from baseline and similar between the FT and RE, with the exception of the “social aspects” domain, for which only the FT showed significant improvement.
• No intervention-related adverse events were reported in either group.

IN PRACTICE:

Despite the absence of consensus guidelines on the use and effectiveness of FT and RE, “we can conclude that both FT and RE have similar effectiveness in improving functional capacity, functional status, disease activity, general quality of life, and muscle strength in patients with psoriatic arthritis,” the researchers wrote.

SOURCE:

The study was led by Diego Roger Silva, MD, of the Universidade Federal de São Paulo, Brazil, and published online in Advances in Rheumatology.

LIMITATIONS:

The study population was recruited from outpatient clinics, and the mean age of 52 years was higher than in previous studies; the study also lacked long-term follow-up data.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Exercise with weight machines or elastic resistance bands yielded similar improvements in strength and function in adults with psoriatic arthritis (PsA) after 12 weeks.

METHODOLOGY:

• Researchers recruited 41 adults aged 18-65 years with PsA who were then randomized to a functional training group (FT) or a resistance exercise group (RE) for 12 weeks of twice-weekly, 55-minute sessions under the supervision of a physical trainer.
• Functional training involved the use of elastic bands to work upper body, lower body, and trunk muscles including the biceps, triceps, back quadriceps, glutes, and hips; the RE used weight machines instead of bands.
• Participants were evaluated at baseline and after 6 and 12 weeks of training sessions; the primary outcome was functional status based on the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S).
• Secondary outcomes included the Bath Ankylosing Spondylitis Functional Index (BASFI) to assess functional capacity, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Disease Activity Score in 28 joints (DAS28) to assess disease activity, and the Short Form 36 (SF-36) to measure quality of life.

TAKEAWAY:

• Participants in both groups showed significant improvement from baseline on the primary outcome measure, with no significant differences between the groups on the primary outcome of function or secondary measures of function and disease activity after 12 weeks.
• Significant intragroup changes occurred between times for both groups on the HAQ-S, BASFI, BASDAI, and DAS28 (P = .001, .007, .001, and .001, respectively).
• Improvement in quality of life was significant from baseline and similar between the FT and RE, with the exception of the “social aspects” domain, for which only the FT showed significant improvement.
• No intervention-related adverse events were reported in either group.

IN PRACTICE:

Despite the absence of consensus guidelines on the use and effectiveness of FT and RE, “we can conclude that both FT and RE have similar effectiveness in improving functional capacity, functional status, disease activity, general quality of life, and muscle strength in patients with psoriatic arthritis,” the researchers wrote.

SOURCE:

The study was led by Diego Roger Silva, MD, of the Universidade Federal de São Paulo, Brazil, and published online in Advances in Rheumatology.

LIMITATIONS:

The study population was recruited from outpatient clinics, and the mean age of 52 years was higher than in previous studies; the study also lacked long-term follow-up data.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Adults whose rheumatoid arthritis caused them severe functional limitations showed significant improvement in measures of function and quality of life following at least 1 year of a personalized, supervised exercise program than those who received usual care.

METHODOLOGY:

• Researchers randomized 217 adults with rheumatoid arthritis and severe functional limitations to an active exercise intervention delivered by a physical therapist (PT) or usual care; the mean age of the participants was approximately 59 years, and approximately 90% were female.
• The intervention consisted of individualized goal setting, active exercises adapted to functional limitations, and education about self-management of physical activity in two sessions per week for the first 12 weeks, followed by once weekly sessions with the option for additional sessions if needed. The primary care PTs in the Netherlands who treated the patients were primarily recruited through a national network of PTs with specific expertise regarding rheumatic diseases.
• In considering each participant’s three most limited activities, the study’s primary outcome at 52 weeks measured the change from the one ranked highest at baseline on the Patient-Specific Complaints Numeric Rating Scale (PSC1 NRS); secondary outcomes included changes in the NRS for participants’ second and third most difficult activities, as well as the Patient Reported Outcome Measurement Information System Physical Function-10, the Health Assessment Questionnaire-Disability Index, the Rheumatoid Arthritis Quality of Life Questionnaire, the 36-Item Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scales (PCS and MCS), and the 6-minute walk test.

TAKEAWAY:

• At 52 weeks, the change in PSC1 NRS was significantly greater in the intervention group than in the usual care group, with a mean difference of −1.7 and a between-group effect size from baseline of 0.7.
• Improvements in secondary outcome measures at 52 weeks also were significantly greater in the intervention group than in the usual care group, with the exception of the SF-36 MCS, which showed no difference between the groups.
• A total of 89 participants in the intervention group and 45 participants in the usual care group responded to questions about muscle soreness and fatigue; 70% and 60%, and 71% and 64%, of each group reported these conditions, respectively.

IN PRACTICE:

“The completion of the trial substantiates the feasibility of recruiting and training primary care [physical therapists] to deliver a complex intervention,” although more research is needed to explore long-term outcomes and cost-effectiveness, the researchers wrote.

SOURCE:

The lead author on the study was Max M.H. Teuwen, MSc, a PhD candidate at Leiden University Medical Center, Leiden, the Netherlands. The study was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The participants were not blinded to their group, and blinded assessors became aware of the allocations, which might have impacted measurements; other limitations included lack of data on medication changes and the exclusion of physical activity amount as an outcome measure.

DISCLOSURES:

The study was supported by the Netherlands Organization for Health Research and Development; the Ministry of Health, Welfare and Sport; the Royal Dutch Society for Physical Therapy; and the Dutch Arthritis Society. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Adults whose rheumatoid arthritis caused them severe functional limitations showed significant improvement in measures of function and quality of life following at least 1 year of a personalized, supervised exercise program than those who received usual care.

METHODOLOGY:

• Researchers randomized 217 adults with rheumatoid arthritis and severe functional limitations to an active exercise intervention delivered by a physical therapist (PT) or usual care; the mean age of the participants was approximately 59 years, and approximately 90% were female.
• The intervention consisted of individualized goal setting, active exercises adapted to functional limitations, and education about self-management of physical activity in two sessions per week for the first 12 weeks, followed by once weekly sessions with the option for additional sessions if needed. The primary care PTs in the Netherlands who treated the patients were primarily recruited through a national network of PTs with specific expertise regarding rheumatic diseases.
• In considering each participant’s three most limited activities, the study’s primary outcome at 52 weeks measured the change from the one ranked highest at baseline on the Patient-Specific Complaints Numeric Rating Scale (PSC1 NRS); secondary outcomes included changes in the NRS for participants’ second and third most difficult activities, as well as the Patient Reported Outcome Measurement Information System Physical Function-10, the Health Assessment Questionnaire-Disability Index, the Rheumatoid Arthritis Quality of Life Questionnaire, the 36-Item Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scales (PCS and MCS), and the 6-minute walk test.

TAKEAWAY:

• At 52 weeks, the change in PSC1 NRS was significantly greater in the intervention group than in the usual care group, with a mean difference of −1.7 and a between-group effect size from baseline of 0.7.
• Improvements in secondary outcome measures at 52 weeks also were significantly greater in the intervention group than in the usual care group, with the exception of the SF-36 MCS, which showed no difference between the groups.
• A total of 89 participants in the intervention group and 45 participants in the usual care group responded to questions about muscle soreness and fatigue; 70% and 60%, and 71% and 64%, of each group reported these conditions, respectively.

IN PRACTICE:

“The completion of the trial substantiates the feasibility of recruiting and training primary care [physical therapists] to deliver a complex intervention,” although more research is needed to explore long-term outcomes and cost-effectiveness, the researchers wrote.

SOURCE:

The lead author on the study was Max M.H. Teuwen, MSc, a PhD candidate at Leiden University Medical Center, Leiden, the Netherlands. The study was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The participants were not blinded to their group, and blinded assessors became aware of the allocations, which might have impacted measurements; other limitations included lack of data on medication changes and the exclusion of physical activity amount as an outcome measure.

DISCLOSURES:

The study was supported by the Netherlands Organization for Health Research and Development; the Ministry of Health, Welfare and Sport; the Royal Dutch Society for Physical Therapy; and the Dutch Arthritis Society. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Adults whose rheumatoid arthritis caused them severe functional limitations showed significant improvement in measures of function and quality of life following at least 1 year of a personalized, supervised exercise program than those who received usual care.

METHODOLOGY:

• Researchers randomized 217 adults with rheumatoid arthritis and severe functional limitations to an active exercise intervention delivered by a physical therapist (PT) or usual care; the mean age of the participants was approximately 59 years, and approximately 90% were female.
• The intervention consisted of individualized goal setting, active exercises adapted to functional limitations, and education about self-management of physical activity in two sessions per week for the first 12 weeks, followed by once weekly sessions with the option for additional sessions if needed. The primary care PTs in the Netherlands who treated the patients were primarily recruited through a national network of PTs with specific expertise regarding rheumatic diseases.
• In considering each participant’s three most limited activities, the study’s primary outcome at 52 weeks measured the change from the one ranked highest at baseline on the Patient-Specific Complaints Numeric Rating Scale (PSC1 NRS); secondary outcomes included changes in the NRS for participants’ second and third most difficult activities, as well as the Patient Reported Outcome Measurement Information System Physical Function-10, the Health Assessment Questionnaire-Disability Index, the Rheumatoid Arthritis Quality of Life Questionnaire, the 36-Item Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scales (PCS and MCS), and the 6-minute walk test.

TAKEAWAY:

• At 52 weeks, the change in PSC1 NRS was significantly greater in the intervention group than in the usual care group, with a mean difference of −1.7 and a between-group effect size from baseline of 0.7.
• Improvements in secondary outcome measures at 52 weeks also were significantly greater in the intervention group than in the usual care group, with the exception of the SF-36 MCS, which showed no difference between the groups.
• A total of 89 participants in the intervention group and 45 participants in the usual care group responded to questions about muscle soreness and fatigue; 70% and 60%, and 71% and 64%, of each group reported these conditions, respectively.

IN PRACTICE:

“The completion of the trial substantiates the feasibility of recruiting and training primary care [physical therapists] to deliver a complex intervention,” although more research is needed to explore long-term outcomes and cost-effectiveness, the researchers wrote.

SOURCE:

The lead author on the study was Max M.H. Teuwen, MSc, a PhD candidate at Leiden University Medical Center, Leiden, the Netherlands. The study was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

The participants were not blinded to their group, and blinded assessors became aware of the allocations, which might have impacted measurements; other limitations included lack of data on medication changes and the exclusion of physical activity amount as an outcome measure.

DISCLOSURES:

The study was supported by the Netherlands Organization for Health Research and Development; the Ministry of Health, Welfare and Sport; the Royal Dutch Society for Physical Therapy; and the Dutch Arthritis Society. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

• Anxiety about laterality
• Lack of mentoring on lateral preference
• Difficulty handling traditional instruments
• Difficulty with minimally invasive instruments
• Inconvenience while assisting a right-handed person
• Pressure to change lateral preference
• Possible disadvantages with certain procedures
• Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

• Disorienting advice from faculty or residents
• Discouraging right-handed pressures and left-handed stigmatization
• Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

• Anxiety about laterality
• Lack of mentoring on lateral preference
• Difficulty handling traditional instruments
• Difficulty with minimally invasive instruments
• Inconvenience while assisting a right-handed person
• Pressure to change lateral preference
• Possible disadvantages with certain procedures
• Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

• Disorienting advice from faculty or residents
• Discouraging right-handed pressures and left-handed stigmatization
• Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Left-handed surgical residents and fellows reported persistent disorienting advice and stigma during training, according to a new study of 31 individuals from 15 US institutions.

“Surgical education is designed for the right-handed,” wrote Timothy J. Gilbert, MD, of the University of Michigan, Ann Arbor, and colleagues. Left-handed medical students “contend with instruments designed for right-handed use, perform worse on surgical skills assessments that are biased toward the right-handed, and are assumed to be right-handed by educators,” they said.

Challenges for left-handed medical students are not new. A study published in 2010 in the Journal of Surgical Education identified eight major issues for left-handed surgeons:

• Anxiety about laterality
• Lack of mentoring on lateral preference
• Difficulty handling traditional instruments
• Difficulty with minimally invasive instruments
• Inconvenience while assisting a right-handed person
• Pressure to change lateral preference
• Possible disadvantages with certain procedures
• Possible advantage situs inversus

Previous studies have shown reports of stigmatization and a lack of training and educational resources as barriers to improving the experience and fostering the skills of left-handed students, but the current data on the subjective experiences of left-handed students are limited, the authors said.

“Some of the members of the research team are left-handed, and I think their personal experience/understanding of the topic informed their desire to do projects within this space, since handedness is so thoroughly taken for granted by the right-handed majority,” Dr. Gilbert, who is right-handed, said in an interview. “It was important for our study to have parity between handedness to reduce bias in data interpretation,” he said. “In an era where much has been done to ensure equity between different groups, there’s not as much discussion about handedness within surgery as I believe there should be.”

In a new study published in Academic Medicine, the researchers recruited 31 self-identified left-handed surgical residents and fellows in six surgical specialties (general surgery, urology, plastic surgery, obstetrics and gynecology, otolaryngology, and neurosurgery) and conducted semi-structured interviews between January 31, 2021, and June 20, 2021. The study population included 21 seniors (postgraduate year of 3 or higher), five juniors (postgraduate years 1 or 2), and five surgical fellows.

Overall, three themes surfaced from the participants’ educational experiences:

• Disorienting advice from faculty or residents
• Discouraging right-handed pressures and left-handed stigmatization
• Expression of the educational wishes of left-handed medical students

Conflicting Advice

The interviewees described feeling confused by conflicting advice about how to manage surgical procedures given their left-handedness, the researchers said. Some respondents reported being told to learn to do everything with the right hand; others were told to use their dominant hand (right or left) for fine motor skill elements but use the right hand for sewing.

Persistent Stigma and Switching

Survey respondents reported perceptions that others in the surgical setting were judgmental and inconsiderate; workshops involved demonstrations with a right-handed focus; and surgical technicians prepared needles that were loaded right-handed. “To minimize this negativity, participants often changed to their right hand,” the authors wrote. Some students who changed handedness reported an improved learning experience, in part because their handedness aligned with the instruments they used.

Educational Wish List

Study participants expressed the need for destigmatization of left-handedness in surgical through strategies including tangible mentorship, more granular and meaningful instruction, and normalization of left-handedness.

The study was limited by several factors including the focus only on surgical residents and fellows, with no left-handed medical students who pursued other specialties, the researchers noted. Other limitations included the retrospective design and potential bias from left-handed members of the research team, they said.

Notably, left-handed medical students reported negative experiences during training whether they operated with the right or left hand, the researchers wrote in their discussion. “From a strictly technical perspective, a left-handed medical student who is operatively left-handed will struggle to use hand-discordant tools in their dominant hand, whereas one who is operatively right-handed will struggle to use hand-concordant tools in their nondominant hand,” they said.

The researchers emphasized the need to consider the data in context; a nervous left-handed student who has been shown only right-handed tools and techniques and has not disclosed their left-handedness struggles when asked to close an incision may see themselves as the problem rather than the surgical education.

Takeaways to Improve Training

The current study showed the diversity of needs of left-handed surgical trainees and how more positive encouragement and support could improve their experiences, Dr. Gilbert told this news organization.

The strategies to improve training for left-handed medical students vary according to educational level, said Dr. Gilbert. “If you’re a surgical fellow or chief resident, you probably want more formal training, different tools, access to attendings who have experience performing an operation left-handed. If you’re a medical student, that is likely less important than feeling like you won’t be penalized of looked down upon for your handedness,” he said.

In the survey responses, “I at least was struck by how far a few accepting words could do when said in the right way at the right time,” he said.

“I think the most important takeaway is that educators should consider more what they say and do in the operating room to these junior students/trainees, as our data suggest even a single sentence at such a vulnerable point in time can push them into a choosing their handedness,” Dr. Gilbert said. “That’s not a small decision to make, and educators should be more thoughtful when engaging in the topic.”

Also, educators should offer left-handed resources during clerkship orientations on techniques such as knot-tying, he said. “This normalized handedness and may make students more comfortable with themselves in the operating room.”

Finally, “educators should be able to teach medical students the level-appropriate skills in either hand. If a medical student asks how to tie a knot or throw a stitch in their left hand, the educator should be able to demonstrate this to them effectively,” Dr. Gilbert added.

More research is needed to understand the needs and wants of left-handed medical students, including those who do not pursue surgery and of the skills of the residents and attendings who are tasked with educating these students, Dr. Gilbert told this news organization.

“Eventually, the goal is to implement concrete changes to improve resources for these students, but I think the most effective way to design these resources is to fully grasp the desires and concerns of all involved parties,” he said.

Residency Director Perspective

“We are increasingly sensitive to individual differences, but for some reason, left-handedness is a blind spot, although 10% of the population is left-handed,” said Stephen M. Kavic, MD, professor of surgery at the University of Maryland School of Medicine, in an interview.

“Interestingly, we do not ask handedness on residency applications, suggesting that it may be viewed as a negative trait in the selection process,” said Dr. Kavic, who also serves as program director of residency in surgery at the University of Maryland.

“While not left-handed myself, as Program Director, I have been tasked with training left-handed residents, and I appreciate the challenges,” Dr. Kavic said. “Our department is about 6% left-handed. Most left-handed surgeons are far more comfortable with their nondominant hand than right-handers are with theirs,” he noted. “We do have left-handed instruments available, but the ratio of sets is easily 100:1 right to left.”

With regard to the current study, Dr. Kavic said it was understandable that left-handed medical students feel stigmatized. A message for educators is to not presume right-handedness; instead, ask students about the hand preference on first meeting, and then training will be more inclusive, he said.

“There is a fundamental difference in mirror image training when a righty tries to teach a lefty. How do we do this better and in a standardized fashion? This article clearly shows that we still have a problem; now we must do the work to fix it,” Dr. Kavic said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Kavic had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

A combination of remote, supervised aerobic training, resistance training, and a hypocaloric diet significantly improved cardiovascular risk factors in adults with rheumatoid arthritis (RA) and overweight or obesity.

METHODOLOGY:

• The researchers recruited 24 adults aged 60-80 years with RA who met criteria for overweight or obesity; participants were randomized to a Supervised Weight Loss and Exercise Training (SWET) or Counseling Health as Treatment (CHAT) program for 16 weeks.
• The SWET intervention included remote supervision of aerobic training of 150 minutes/week moderate-to-vigorous intensity, 2 days per week of resistance training, and a hypocaloric diet based on a weight loss goal of 7% of body weight. The CHAT patients served as controls and completed two lifestyle counseling sessions followed by monthly check-ins.
• The primary outcome was change in a composite measure of cardiovascular risk based on metabolic syndrome z-score (MSSc), a continuous weighted score of five metabolic syndrome components: Waist circumference, mean arterial blood pressure, fasting glucose, triglycerides, and high-density lipoprotein cholesterol.

TAKEAWAY:

• Both groups showed improvement in the primary outcome of MSSc, with absolute changes from baseline of −1.67 for the SWET group and −1.34 for the CHAT group (P < .01 for both).
• Participants in the SWET group showed significantly more improvement in secondary outcome measures of body weight, fat mass, and disease activity score in 28 joints based on C-reactive protein (DAS28-CRP), as well as greater improvement in patient-reported physical and mental health, physical function, and fatigue, than those in the CHAT group, but the CHAT group improved significantly compared with their baseline.
• The strongest specific effects for the different components of the intervention were those of aerobic training on physical function and fatigue, resistance training on DAS28-CRP, and weight loss on MSSc.
• Neither group experienced significant changes in lean mass, absolute peak V02, unilateral isometric knee extension, or bilateral grip strength.

IN PRACTICE:

“Findings from our study indicate, at a minimum, integrating even 2 hours of healthy lifestyle counseling may improve RA management, let alone demonstrate the substantial impact that can be provided by a comprehensive, remotely supervised lifestyle intervention,” the researchers wrote.

SOURCE:

The lead author on the study was Brian J. Andonian, MD, of Duke University, Durham, North Carolina. The study was published online in ACR Open Rheumatology.

LIMITATIONS:

The small sample size was a limitation of the study findings, as was the lack of blinding and high level of motivation in the CHAT group, who had greater improvements than expected in weight loss and increased physical activity; the study also was conducted during the COVID-19 pandemic, with potential physical and mental effects on participants who tested positive during the study period.

DISCLOSURES:

The study was supported by the US National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Claude D. Pepper Older Americans Independence Center of the US National Institute on Aging.

A version of this article appeared on Medscape.com.

TOPLINE:

A combination of remote, supervised aerobic training, resistance training, and a hypocaloric diet significantly improved cardiovascular risk factors in adults with rheumatoid arthritis (RA) and overweight or obesity.

METHODOLOGY:

• The researchers recruited 24 adults aged 60-80 years with RA who met criteria for overweight or obesity; participants were randomized to a Supervised Weight Loss and Exercise Training (SWET) or Counseling Health as Treatment (CHAT) program for 16 weeks.
• The SWET intervention included remote supervision of aerobic training of 150 minutes/week moderate-to-vigorous intensity, 2 days per week of resistance training, and a hypocaloric diet based on a weight loss goal of 7% of body weight. The CHAT patients served as controls and completed two lifestyle counseling sessions followed by monthly check-ins.
• The primary outcome was change in a composite measure of cardiovascular risk based on metabolic syndrome z-score (MSSc), a continuous weighted score of five metabolic syndrome components: Waist circumference, mean arterial blood pressure, fasting glucose, triglycerides, and high-density lipoprotein cholesterol.

TAKEAWAY:

• Both groups showed improvement in the primary outcome of MSSc, with absolute changes from baseline of −1.67 for the SWET group and −1.34 for the CHAT group (P < .01 for both).
• Participants in the SWET group showed significantly more improvement in secondary outcome measures of body weight, fat mass, and disease activity score in 28 joints based on C-reactive protein (DAS28-CRP), as well as greater improvement in patient-reported physical and mental health, physical function, and fatigue, than those in the CHAT group, but the CHAT group improved significantly compared with their baseline.
• The strongest specific effects for the different components of the intervention were those of aerobic training on physical function and fatigue, resistance training on DAS28-CRP, and weight loss on MSSc.
• Neither group experienced significant changes in lean mass, absolute peak V02, unilateral isometric knee extension, or bilateral grip strength.

IN PRACTICE:

“Findings from our study indicate, at a minimum, integrating even 2 hours of healthy lifestyle counseling may improve RA management, let alone demonstrate the substantial impact that can be provided by a comprehensive, remotely supervised lifestyle intervention,” the researchers wrote.

SOURCE:

The lead author on the study was Brian J. Andonian, MD, of Duke University, Durham, North Carolina. The study was published online in ACR Open Rheumatology.

LIMITATIONS:

The small sample size was a limitation of the study findings, as was the lack of blinding and high level of motivation in the CHAT group, who had greater improvements than expected in weight loss and increased physical activity; the study also was conducted during the COVID-19 pandemic, with potential physical and mental effects on participants who tested positive during the study period.

DISCLOSURES:

The study was supported by the US National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Claude D. Pepper Older Americans Independence Center of the US National Institute on Aging.

A version of this article appeared on Medscape.com.

TOPLINE:

A combination of remote, supervised aerobic training, resistance training, and a hypocaloric diet significantly improved cardiovascular risk factors in adults with rheumatoid arthritis (RA) and overweight or obesity.

METHODOLOGY:

• The researchers recruited 24 adults aged 60-80 years with RA who met criteria for overweight or obesity; participants were randomized to a Supervised Weight Loss and Exercise Training (SWET) or Counseling Health as Treatment (CHAT) program for 16 weeks.
• The SWET intervention included remote supervision of aerobic training of 150 minutes/week moderate-to-vigorous intensity, 2 days per week of resistance training, and a hypocaloric diet based on a weight loss goal of 7% of body weight. The CHAT patients served as controls and completed two lifestyle counseling sessions followed by monthly check-ins.
• The primary outcome was change in a composite measure of cardiovascular risk based on metabolic syndrome z-score (MSSc), a continuous weighted score of five metabolic syndrome components: Waist circumference, mean arterial blood pressure, fasting glucose, triglycerides, and high-density lipoprotein cholesterol.

TAKEAWAY:

• Both groups showed improvement in the primary outcome of MSSc, with absolute changes from baseline of −1.67 for the SWET group and −1.34 for the CHAT group (P < .01 for both).
• Participants in the SWET group showed significantly more improvement in secondary outcome measures of body weight, fat mass, and disease activity score in 28 joints based on C-reactive protein (DAS28-CRP), as well as greater improvement in patient-reported physical and mental health, physical function, and fatigue, than those in the CHAT group, but the CHAT group improved significantly compared with their baseline.
• The strongest specific effects for the different components of the intervention were those of aerobic training on physical function and fatigue, resistance training on DAS28-CRP, and weight loss on MSSc.
• Neither group experienced significant changes in lean mass, absolute peak V02, unilateral isometric knee extension, or bilateral grip strength.

IN PRACTICE:

“Findings from our study indicate, at a minimum, integrating even 2 hours of healthy lifestyle counseling may improve RA management, let alone demonstrate the substantial impact that can be provided by a comprehensive, remotely supervised lifestyle intervention,” the researchers wrote.

SOURCE:

The lead author on the study was Brian J. Andonian, MD, of Duke University, Durham, North Carolina. The study was published online in ACR Open Rheumatology.

LIMITATIONS:

The small sample size was a limitation of the study findings, as was the lack of blinding and high level of motivation in the CHAT group, who had greater improvements than expected in weight loss and increased physical activity; the study also was conducted during the COVID-19 pandemic, with potential physical and mental effects on participants who tested positive during the study period.

DISCLOSURES:

The study was supported by the US National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Claude D. Pepper Older Americans Independence Center of the US National Institute on Aging.

A version of this article appeared on Medscape.com.