Women's Representation in Interventional Cardiology.

This study discusses women's representation in interventional cardiology.

Midcareer Satisfaction and Likelihood of Leaving Current Position of Former Career Development Awardees.

This study assesses career satisfaction, discrepancies between ideal and expected careers, and likelihood of leaving current positions among former K awardees.

Leadership Experiences and Perceptions of Mid-Career to Senior Clinician-Scientists: A Qualitative Exploration.

PURPOSE: This study aimed to elucidate the experiences and perceptions of mid-career to senior clinician-scientists in academic medicine regarding pursuing, attaining, or rejecting leadership roles as well as their conceptualization of the influence of leadership in their broader career trajectories. METHOD: The authors conducted a qualitative analysis of in-depth, semistructured interviews conducted in 2022 with a diverse sample of clinician-scientists who received new National Institutes of Health K08 or K23 Career Development Awards between 2006 and 2009. A total of 859 of the 915 survey respondents (94%) were eligible to be recruited for the qualitative study. Qualitative analysis was informed by thematic analysis and used a social constructionist approach to understanding participants' conceptualizations of their experiences. Interview transcripts were coded using an iterative, inductive coding process. Themes were generated by reviewing coded data and identifying common patterns in participant narratives, affording particular attention to participants' discussion of the effect of race and/or gender on their leadership experiences. RESULTS: Sixty clinician-scientists participated in individual interviews. Five themes were generated surrounding participants' conceptualizations of their leadership experiences. Themes were (1) feeling unprepared for leadership roles, (2) reluctance and lack of intention in attaining leadership positions, (3) influence of networks on leadership access and decision-making, (4) impact-related benefits and downsides of leadership, and (5) confining ideas of who leaders are. CONCLUSIONS: The study highlighted the need for formal leadership training in academic medicine and the importance of mentorship and sponsorship in attaining and succeeding in leadership positions. Individuals from communities underrepresented in leadership positions faced additional challenges internalizing a leadership identity. Efforts to encourage current leaders to engage in intentional succession planning and development of faculty towards leadership roles, including expansion of institutional leadership development programs, are needed to promote equitable distribution of leadership opportunities.

Burnout Among Mid-Career Academic Medical Faculty.

Importance: Studies reveal that most physicians report symptoms of burnout. Less is known about burnout in mid-career medical faculty specifically. Objective: To characterize burnout and its risk factors, particularly differences by gender, among mid-career medical faculty. Design, Setting, and Participants: Between August 2021 and August 2022, a survey was sent to 1430 individuals who received new National Institutes of Health K08 and K23 career development awards from 2006 to 2009. Data were analyzed between June and October 2023. Main Outcomes and Measures: Personal and work-related burnout as evaluated using the Copenhagen Burnout Inventory (CBI). The CBI score ranges from 0 to 100, with a score of 50 or higher indicating a high degree of burnout. Multivariable models were used to investigate associations between burnout and participant characteristics, including race and ethnicity, sexual orientation and gender identity, academic rank, work climate, experiences of workplace sexual harassment, sleep hours, work and domestic caregiving time, and time allocation changes in work and domestic work hours compared with before the COVID-19 pandemic. Work climate was evaluated by a general climate elements scale assessing elements such as friendliness, respect, and collegiality, and a diversity, equity, and inclusion climate elements scale assessing elements such as homogeneity, sexism, and homophobia; higher scores indicated a more favorable view of the climate. Results: In all, 1430 surveys were sent, 926 candidates responded (65% response rate), and the analytic cohort was limited to the 841 respondents who were still in academic medicine (50.7% men). Burnout was significantly more common for women than men (mean [SD] CBI personal scores, 46.6 [19.4] vs 37.5 [17.2]; P < .001; mean [SD] CBI work-related scores, 43.7 [20.4] vs 34.6 [19.7]; P < .001). In multivariable models, personal burnout was significantly more likely for women (adjusted odds ratio [AOR], 2.29 [95% CI, 1.54-3.41]; P < .001) and with more weekly hours of patient care (AOR, 1.07 [95% CI, 1.00-1.15] for each 5-hour increase; P = .04). Personal burnout was less likely with more nightly sleep hours (AOR, 0.68 [95% CI, 0.56-0.81] for each 1-hour increase; P < .001) and with an improved general work climate rating (AOR, 0.64 [95% CI, 0.48-0.85] for each 1-point increase in general work climate scale score; P = .002). Work-related burnout was also significantly more likely for women than men (AOR, 1.77 [95% CI, 1.17-2.69]; P = .007). Greater work-related burnout was associated with an increase of 8 or more work hours per week compared with before the COVID-19 pandemic (AOR, 1.87 [95% CI, 1.13-3.08]; P = .01), more weekly hours of patient care (AOR, 1.11 [95% CI, 1.03-1.19] for each 5-hour increase; P = .007), and a workplace sexual harassment experience in the past 2 years (AOR, 1.71 [95% CI, 1.11-2.62]; P = .01). Work-related burnout was significantly less likely with more nightly sleep hours (AOR, 0.80 [95% CI, 0.66-0.96] for each 1-hour increase; P = .02) and with an improved general work climate rating (AOR, 0.49; [95% CI, 0.36-0.65] for each 1-point increase in general work climate scale score; P < .001). Conclusions and Relevance: This survey study of K grant awardees revealed substantial rates of burnout among mid-career medical faculty, and burnout rates differed by gender. Evidence-based interventions are needed to realize the benefits of workforce diversity and vitality.

Projected environmental and public health benefits of extended-interval dosing: an analysis of pembrolizumab use in a US national health system.

BACKGROUND: Health care is a major source of greenhouse gas emissions, leading to climate change and public health harms. Changes are needed to improve the environmental sustainability of health-care practices, but such changes should not sacrifice patient outcomes or financial sustainability. Alternative dosing strategies that reduce the frequency with which specialty drugs are administered, without sacrificing patient outcomes, are an attractive possibility for improving environmental sustainability. We sought to inform environmentally sustainable cancer care by estimating and comparing the environmental and financial effects of alternative, clinically equivalent strategies for pembrolizumab administration. METHODS: We conducted a retrospective analysis using a cohort of patients from the Veterans Health Administration (VHA) in the USA who received one or more pembrolizumab doses between May 1, 2020, and Sept 30, 2022. Using baseline, real-world administration of pembrolizumab, we generated simulated pembrolizumab use data under three near-equivalent counterfactual pembrolizumab administration strategies defined by combinations of weight-based dosing, pharmacy-level vial sharing and dose rounding, and extended-interval dosing (ie, every 6 weeks). For each counterfactual dosing strategy, we estimated greenhouse gas emissions related to pembrolizumab use across the VHA cohort using a deterministic environmental impact model that estimated greenhouse gas emissions due to patient travel, drug manufacture, and medical waste as the primary outcome measure. FINDINGS: We identified 7813 veterans who received at least one dose of pembrolizumab-containing therapy in the VHA during the study period. 59 140 pembrolizumab administrations occurred in the study period, of which 46 255 (78·2%) were dosed at 200 mg every 3 weeks, 12 885 (21·8%) at 400 mg every 6 weeks, and 14 955 (25·3%) were coadministered with infusional chemotherapies. Adoption of weight-based, extended-interval pembrolizumab dosing (4 mg/kg every 6 weeks) and pharmacy-level stewardship strategies (ie, dose rounding and vial sharing) for all pembrolizumab infusions would have resulted in 24·7% fewer administration events than baseline dosing (44 533 events vs 59 140 events) and an estimated 200 metric tons less CO2 emitted per year as a result of pembrolizumab use within the VHA (650 tons vs 850 tons of CO2, a relative reduction of 24%), largely due to reductions in distance travelled by patients to receive treatment. Similar results were observed when weight-based and extended-interval dosing were applied only to pembrolizumab monotherapy and pembrolizumab in combination with oral therapies. INTERPRETATION: Alternative pembrolizumab administration strategies might have environmental advantages over the current dosing and compounding paradigms. Specialty medication dosing can be optimised for health-care spending and environmental sustainability without sacrificing clinical outcomes. FUNDING: None.

The Disproportionate Effects of the COVID-19 Pandemic on the Time Allocation of Recipients of NIH Career Development Awards Who Are Women or Caregivers of Dependents.

PURPOSE: To understand time allocation of a national medical faculty cohort 1.5-2 years after the COVID-19 pandemic began, compared to before. METHOD: From August 2021-April 2022, the authors conducted a retrospective survey of 1,430 clinician-researchers who received National Institutes of Health career-development awards between 2006-2009 asking about domestic and professional time allocation pre-pandemic and at the time of surveys (TOS). Of 915 respondents (64%), the 830 who remained in academic positions constituted the analytic sample. Multivariable regression models identified demographic factors associated with each time outcome and change in time between pre-pandemic and TOS, and having experienced ≥8-hour increase of total self-reported weekly professional work hours and domestic labor hours. RESULTS: Median self-reported weekly professional work hours were 55 hours/week pre- pandemic and 60 at TOS. On multivariable analysis, significant predictors of self-reported weekly professional work hours at TOS were having a non-child other dependent (+2.6 hours, P = .03), academic rank (associate -3.1 hours, assistant -9.0 hours; P < .001), and specialty (P < .001). Average self-reported TOS weekly domestic-labor hours were 23.1 among men and 30.2 among women (P < .001). Predictors of total self-reported TOS weekly domestic hours were being a woman (+5.6 hours; P < .001) and having children requiring supervision (+10.2 hours; P < .001). Overall, 9.3% of men (42/450) and 21.6% of women (88/407) experienced a ≥ 8 hour increase in domestic labor (P < .001). On multivariable analysis, women had higher odds of substantial domestic-labor increase (OR = 2.33, 95% CI: 1.47, 3.68), as did those with children requiring supervision (OR = 1.93, 95% CI: 1.25, 2.98) or other dependents (OR = 1.83, 95% CI: 1.13, 2.98). CONCLUSIONS: This study illuminates demands on women and faculty with dependents during the COVID-19 pandemic and suggests increased flexibility and resources are of heightened importance.

Gender Differences in Faculty Perceptions of Mentorship and Sponsorship.

This survey study examines gender differences in mid- to senior-career faculty experiences of receiving and providing mentorship and sponsorship during early career development.

Using Behavioral Economics to Reduce Low-Value Care Among Older Adults: A Cluster Randomized Clinical Trial.

Importance: Use of low-value care is common among older adults. It is unclear how to best engage clinicians and older patients to decrease use of low-value services. Objective: To test whether the Committing to Choose Wisely behavioral economic intervention could engage primary care clinicians and older patients to reduce low-value care. Design, Setting, and Participants: Stepped-wedge cluster randomized clinical trial conducted at 8 primary care clinics of an academic health system and a private group practice between December 12, 2017, and September 4, 2019. Participants were primary care clinicians and older adult patients who had diabetes, insomnia, or anxiety or were eligible for prostate cancer screening. Data analysis was performed from October 2019 to November 2023. Intervention: Clinicians were invited to commit in writing to Choosing Wisely recommendations for older patients to avoid use of hypoglycemic medications to achieve tight glycemic control, sedative-hypnotic medications for insomnia or anxiety, and prostate-specific antigen tests to screen for prostate cancer. Committed clinicians had their photographs displayed on clinic posters and received weekly emails with alternatives to these low-value services. Educational handouts were mailed to applicable patients before scheduled visits and available at the point of care. Main Outcomes and Measures: Patient-months with a low-value service across conditions (primary outcome) and separately for each condition (secondary outcomes). For patients with diabetes, or insomnia or anxiety, secondary outcomes were patient-months in which targeted medications were decreased or stopped (ie, deintensified). Results: The study included 81 primary care clinicians and 8030 older adult patients (mean [SD] age, 75.1 [7.2] years; 4076 men [50.8%] and 3954 women [49.2%]). Across conditions, a low-value service was used in 7627 of the 37 116 control patient-months (20.5%) and 7416 of the 46 381 intervention patient-months (16.0%) (adjusted odds ratio, 0.79; 95% CI, 0.65-0.97). For each individual condition, there were no significant differences between the control and intervention periods in the odds of patient-months with a low-value service. The intervention increased the odds of deintensification of hypoglycemic medications for diabetes (adjusted odds ratio, 1.85; 95% CI, 1.06-3.24) but not sedative-hypnotic medications for insomnia or anxiety. Conclusions and Relevance: In this stepped-wedge cluster randomized clinical trial, the Committing to Choose Wisely behavioral economic intervention reduced low-value care across 3 common clinical situations and increased deintensification of hypoglycemic medications for diabetes. Use of scalable interventions that nudge patients and clinicians to achieve greater value while preserving autonomy in decision-making should be explored more broadly. Trial Registration: ClinicalTrials.gov Identifier: NCT03411525.

Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults: A Cluster Randomized Clinical Trial.

Importance: Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults. Objective: To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening. Design, Setting, and Participants: Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023. Intervention: The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening. Main Outcomes and Measures: The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months. Results: A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp). Conclusions and Relevance: In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening. Trial Registration: ClinicalTrials.gov Identifier: NCT02027545.

Adopting Weight-Based Dosing With Pharmacy-Level Stewardship Strategies Could Reduce Cancer Drug Spending By Millions.

Immune checkpoint inhibitors, a class of drugs used in approximately forty unique cancer indications, are a sizable component of the economic burden of cancer care in the US. Instead of personalized weight-based dosing, immune checkpoint inhibitors are most commonly administered at "one-size-fits-all" flat doses that are higher than necessary for the vast majority of patients. We hypothesized that personalized weight-based dosing along with common stewardship efforts at the pharmacy level, such as dose rounding and vial sharing, would lead to reductions in immune checkpoint inhibitor use and lower spending. Using data from the Veterans Health Administration (VHA) and Medicare drug prices, we estimated reductions in immune checkpoint inhibitor use and spending that would be associated with pharmacy-level stewardship strategies, in a case-control simulation study of individual patient-level immune checkpoint inhibitor administration events. We identified baseline annual VHA spending for these drugs of approximately $537 million. Combining weight-based dosing, dose rounding, and pharmacy-level vial sharing would generate expected annual VHA health system savings of $74 million (13.7 percent). We conclude that adoption of pharmacologically justified immune checkpoint inhibitor stewardship measures would generate sizable reductions in spending for these drugs. Combining these operational innovations with value-based drug price negotiation enabled by recent policy changes may improve the long-term financial viability of cancer care in the US.

Impacts of COVID-19 on Appropriate Use of Screening Colonoscopy in a Large Integrated Healthcare Delivery System.

BACKGROUND: Decreasing low-value colonoscopy is critical to optimizing access for high-need patients, particularly in resource-constrained environments such as those created by the COVID-19 pandemic. We hypothesized that rates of screening colonoscopy overuse would decline during COVID compared to pre-COVID due to enhanced procedural scrutiny and prioritization in the setting of constrained access. OBJECTIVE: To characterize impacts of COVID-19 on screening colonoscopy overuse DESIGN: Retrospective national cohort study using Veterans Health Administration administrative data PARTICIPANTS: Veterans undergoing screening colonoscopy in Q4 2019 (pre-COVID) and Q4 2020 (COVID) at 109 endoscopy facilities MAIN MEASURES: Rates of screening colonoscopy overuse KEY RESULTS: 18,376 screening colonoscopies were performed pre-COVID, 19% (3,641) of which met overuse criteria. While only 9,360 screening colonoscopies were performed in Q4 2020, 25% met overuse criteria. Overall change in median facility-level overuse during COVID compared to pre-COVID was 6% (95%CI 5%-7%), with significant variability across facilities (IQR: 2%-11%). Of colonoscopies meeting overuse criteria, the top reason for overuse in both periods was screening colonoscopy performed <9 years after previous screening procedure (55% pre-COVID, 49% during COVID). The largest shifts in overuse category were in screening procedures performed <9 years after prior screening colonoscopy (-6% decline COVID vs. pre-COVID) and screening procedures performed in patients below average-risk screening age (i.e., age <40 (5% increase COVID compared to pre-COVID), age 40-44 (4% increase COVID vs. pre-COVID)). Within facility performance was stable over time; 83/109 facilities changed their performance by <=1 quartile during COVID compared to pre-COVID. CONCLUSIONS: Despite pandemic-related resource constraints and enhanced procedural scrutiny and prioritization in the setting of COVID-related backlogs, screening colonoscopy overuse rates remained roughly stable during COVID compared to pre-COVID, with continued variability across facilities. These data highlight the need for systematic and concerted efforts to address overuse, even in the face of strong external motivating factors.

Carpal Tunnel Syndrome as a Test Case for Value Assessment During the Presurgical Period: The Impact of Structure and Processes of Care.

BACKGROUND: Few performance measures assess presurgical value (quality and utilization). OBJECTIVES: Using carpal tunnel syndrome (CTS) as a case study: (1) develop a model to evaluate presurgical quality and utilization and (2) identify opportunities for value improvement. RESEARCH DESIGN: A retrospective cohort study utilizing Veterans Affairs (VA) national administrative data. SUBJECTS: Patients who were evaluated in a VA primary care clinic on at least 1 occasion for CTS and received carpal tunnel release over a 7-year period. MEASURES: We modeled facility-level performance on 2 outcomes: surgical delay (marker of quality) and number of presurgical encounters (utilization) for CTS, and examined association between patient, facility, and care process variables and performance. RESULTS: Among 41,912 Veterans undergoing carpal tunnel release at 127 VA medical centers, the median facility-level predicted probability of surgical delay was 48%, with 16 (13%) facilities having significantly less delay than the median and 13 (10%) facilities having greater delay. The median facility-level predicted number of presurgical encounters was 8.8 visits, with 22 (17%) facilities having significantly fewer encounters and 22 (17%) facilities having more. Care processes had a stronger association with both outcomes than structural variables included in the models. Processes associated with the greatest deviations in predicted delay and utilization included receipt of repeat electrodiagnostic testing, use of 2 or more nonoperative treatments, and community referral outside of VA. CONCLUSIONS: Using CTS as a test case, this study demonstrates the potential to assess presurgical value and identify modifiable care processes associated with presurgical delay and utilization performance.

Development and validation of a new ICD-10-based screening colonoscopy overuse measure in a large integrated healthcare system: a retrospective observational study.

BACKGROUND: Low-value use of screening colonoscopy is wasteful and potentially harmful to patients. Decreasing low-value colonoscopy prevents procedural complications, saves patient time and reduces patient discomfort, and can improve access by reducing procedural demand. The objective of this study was to develop and validate an electronic measure of screening colonoscopy overuse using International Classification of Diseases, Tenth Edition codes and then apply this measure to estimate facility-level overuse to target quality improvement initiatives to reduce overuse in a large integrated healthcare system. METHODS: Retrospective national observational study of US Veterans undergoing screening colonoscopy at 119 Veterans Health Administration (VHA) endoscopy facilities in 2017. A measure of screening colonoscopy overuse was specified by an expert workgroup, and electronic approximation of the measure numerator and denominator was performed ('electronic measure'). The electronic measure was then validated via manual record review (n=511). Reliability statistics (n=100) were calculated along with diagnostic test characteristics of the electronic measure. The measure was then applied to estimate overall rates of overuse and facility-level variation in overuse among all eligible patients. RESULTS: The electronic measure had high specificity (99%) and moderate sensitivity (46%). Adjusted positive predictive value and negative predictive value were 33% and 95%, respectively. Inter-rater reliability testing revealed near perfect agreement between raters (k=0.81). 269 572 colonoscopies were performed in VHA in 2017 (88 143 classified as screening procedures). Applying the measure to these 88 143 screening colonoscopies, 24.5% were identified as potential overuse. Median facility-level overuse was 22.5%, with substantial variability across facilities (IQR 19.1%-27.0%). CONCLUSIONS: An International Classification of Diseases, Tenth Edition based electronic measure of screening colonoscopy overuse has high specificity and improved sensitivity compared with a previous International Classification of Diseases, Ninth Edition based measure. Despite increased focus on reducing low-value care and improving access, a quarter of VHA screening colonoscopies in 2017 were identified as potential low-value procedures, with substantial facility-level variability.

Enhancing the Value of Clinical Work-Choosing Wisely to Preserve the Clinician Workforce.

This Viewpoint discusses how to extend Choosing Wisely principles to identify clinical management practices that lead to unnecessary burdens, approaches to identify and prioritize those low-value practices, the partnerships needed to reduce burdens, and a research agenda for evaluating the consequences of change.

Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial.

Importance: More than 75% of US adults with diabetes do not meet treatment goals. More effective support from family and friends ("supporters") may improve diabetes management and outcomes. Objective: To determine if the Caring Others Increasing Engagement in Patient Aligned Care Teams (CO-IMPACT) intervention improves patient activation, diabetes management, and outcomes compared with standard care. Design, Setting, and Participants: This randomized clinical trial was conducted from November 2016 to August 2019 among participants recruited from 2 Veterans Health Administration primary care sites. All patient participants were adults aged 30 to 70 years with diabetes who had hemoglobin A1c (HbA1c) levels greater than 8% of total hemoglobin (to convert to proportion of total hemoglobin, multiply by 0.01) or systolic blood pressure (SBP) higher than 150 mm Hg; each participating patient had an adult supporter. Of 1119 recruited, 239 patient-supporter dyads were enrolled between November 2016 and May 2018, randomized 1:1 to receive the CO-IMPACT intervention or standard care, and followed up for 12 to 15 months. Investigators and analysts were blinded to group assignment. Interventions: Patient-supporter dyads received a health coaching session focused on dyadic information sharing and positive support techniques, then 12 months of biweekly automated monitoring telephone calls to prompt dyadic actions to meet diabetes goals, coaching calls to help dyads prepare for primary care visits, and after-visit summaries. Standard-care dyads received general diabetes education materials only. Main Outcomes and Measures: Intent-to-treat analyses were conducted according to baseline dyad assignment. Primary prespecified outcomes were 12-month changes in Patient Activation Measure-13 (PAM-13) and UK Prospective Diabetes Study (UKPDS) 5-year diabetes-specific cardiac event risk scores. Secondary outcomes included 12-month changes in HbA1c levels, SBP, diabetes self-management behaviors, diabetes distress, diabetes management self-efficacy, and satisfaction with health system support for the involvement of family supporters. Changes in outcome measures between baseline and 12 months were analyzed using linear regression models. Results: A total of 239 dyads enrolled; among patient participants, the mean (SD) age was 60 (8.9) years, and 231 (96.7%) were male. The mean (SD) baseline HbA1c level was 8.5% (1.6%) and SBP was 140.2 mm Hg (18.4 mm Hg). A total of 168 patients (70.3%) lived with their enrolled supporter; 229 patients (95.8%) had complete 12-month outcome data. In intention-to-treat analyses vs standard care, CO-IMPACT patients had greater 12-month improvements in PAM-13 scores (intervention effect, 2.60 points; 95% CI, 0.02-5.18 points; P = .048) but nonsignificant differences in UKPDS 5-year cardiac risk (intervention effect, 1.01 points; 95% CI, -0.74 to 2.77 points; P = .26). Patients in the CO-IMPACT arm also had greater 12-month improvements in healthy eating (intervention effect, 0.71 d/wk; 95% CI, 0.20-1.22 d/wk; P = .007), diabetes self-efficacy (intervention effect, 0.40 points; 95% CI, 0.09-0.71 points; P = .01), and satisfaction with health system support for the family supporter participants' involvement (intervention effect, 0.28 points; 95% CI, 0.07-0.49 points; P = .009); however, the 2 arms had similar improvements in HbA1c levels and in other measures. Conclusions and Relevance: In this randomized clinical trial, the CO-IMPACT intervention successfully engaged patient-supporter dyads and led to improved patient activation and self-efficacy. Physiological outcomes improved similarly in both arms. More intensive direct coaching of supporters, or targeting patients with less preexisting support or fewer diabetes management resources, may have greater impact. Trial Registration: ClinicalTrials.gov Identifier: NCT02328326.

Adoption of Extended-Interval Dosing of Single-Agent Pembrolizumab and Comparative Effectiveness vs Standard Dosing in Time-to-Treatment Discontinuation.

Importance: Extended-interval dosing of pembrolizumab (400 mg every 6 weeks) was approved by US Food and Drug Administration (FDA) in April 2020 as an alternative to standard-interval dosing (200 mg every 3 weeks). Extended-interval dosing may enhance access, alleviate patient and health system financial toxicity, and improve patient quality of life, particularly during the COVID-19 pandemic. Neither adoption nor effectiveness of extended interval in the US has been adequately described. Objective: To describe adoption of extended-interval dosing of pembrolizumab since its FDA approval and to measure its preliminary real-world effectiveness compared with standard-interval dosing. Design, Setting, and Participants: This was a retrospective cohort study that used data from the Veterans Health Administration (VHA), a US-based, nationwide single-payer health system. Participants were veterans who were prescribed single-agent pembrolizumab within the VHA between April 1, 2020, and July 1, 2021. Patients receiving combinations of pembrolizumab and cytotoxic chemotherapy or tyrosine kinase inhibitors were excluded. A subcohort of veterans with non-small cell lung cancer (NSCLC) was also identified using claims-based codes. Exposures: Single-agent pembrolizumab at extended or standard intervals. Main Outcomes and Measures: The number and proportion of single-agent pembrolizumab prescriptions that were extended compared with standard interval. Effectiveness was described in terms of time-to-treatment discontinuation (TTD) and extended- to standard-interval pembrolizumab prescriptions were compared using Cox proportional hazards regression. Results: A total of 835 veterans (mean age [SD], 70.9 [8.7] years; 809 [96.9%] men) began single-agent pembrolizumab during the study period (all-diseases cohort), and of these, 234 (mean [SD] age, 71.6 [7.3] years; 225 [96.2%] men) had NSCLC (NSCLC cohort). Extended-interval adoption reached its steady state plateau of approximately 35% by January 2021; 65% of participants who began standard-interval single-agent pembrolizumab received only standard-interval dosing during the treatment course. In analysis consistent with the intention-to-treat principle, no differences in TTD were observed between standard- and extended-interval dosing in either the all-diseases cohort (HR, 1.00; 95% CI, 1.00-1.00) or the NSCLC cohort (HR, 1.00; 95% CI, 1.00-1.00). Conclusions and Relevance: This retrospective cohort study found that extended-interval dosing comprised a minority of single-agent pembrolizumab prescriptions despite the FDA approval and its potential health system and public health benefits. The findings support the TTD equivalence of standard- and extended-interval pembrolizumab across indications, complementing clinical pharmacology and single-arm clinical trial data in melanoma. This study provides further support for extended-interval pembrolizumab dosing.

Planning and Reporting Effective Web-Based RAND/UCLA Appropriateness Method Panels: Literature Review and Preliminary Recommendations.

BACKGROUND: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research; yet we know comparatively less about how researchers implement web-based expert panels. OBJECTIVE: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. METHODS: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were abstracted. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. RESULTS: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). CONCLUSIONS: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

Type 2 Diabetes Management, Control and Outcomes During the COVID-19 Pandemic in Older US Veterans: an Observational Study.

BACKGROUND: The COVID-19 pandemic required a change in outpatient care delivery models, including shifting from in-person to virtual visits, which may have impacted care of vulnerable patients. OBJECTIVE: To describe the changes in management, control, and outcomes in older people with type 2 diabetes (T2D) associated with the shift from in-person to virtual visits. DESIGN AND PARTICIPANTS: In veterans aged ≥ 65 years with T2D, we assessed the rates of visits (in person, virtual), A1c measurements, antidiabetic deintensification/intensification, ER visits and hospitalizations (for hypoglycemia, hyperglycemia, other causes), and A1c level, in March 2020 and April-November 2020 (pandemic period). We used negative binomial regression to assess change over time (reference: pre-pandemic period, July 2018 to February 2020), by baseline Charlson Comorbidity Index (CCI; > 2 vs. <= 2) and A1c level. KEY RESULTS: Among 740,602 veterans (mean age 74.2 [SD 6.6] years), there were 55% (95% CI 52-58%) fewer in-person visits, 821% (95% CI 793-856%) more virtual visits, 6% (95% CI 1-11%) fewer A1c measurements, and 14% (95% CI 10-17%) more treatment intensification during the pandemic, relative to baseline. Patients with CCI > 2 had a 14% (95% CI 12-16%) smaller relative increase in virtual visits than those with CCI <= 2. We observed a seasonality of A1c level and treatment modification, but no association of either with the pandemic. After a decrease at the beginning of the pandemic, there was a rebound in other-cause (but not hypo- and hyperglycemia-related) ER visits and hospitalizations from June to November 2020. CONCLUSION: Despite a shift to virtual visits and a decrease in A1c measurement during the pandemic, we observed no association with A1c level or short-term T2D-related outcomes, providing some reassurance about the adequacy of virtual visits. Further studies should assess the longer-term effects of shifting to virtual visits in different populations to help individualize care, improve efficiency, and maintain appropriate care while reducing overuse.

Applying User-Centered Design to Develop Practical Strategies that Address Overuse in Primary Care.

INTRODUCTION: Engaging patients and frontline clinicians in re-designing clinical care is essential for improving care delivery in a complex clinical environment. This study sought to assess an innovative user-centered design approach to improving clinical care quality, focusing on the use cases of de-intensifying non-beneficial care within the following areas: (1) de-intensifying diabetes treatment in high-risk patients; (2) stopping screening for carotid artery stenosis in asymptomatic patients; and (3) stopping colorectal cancer screening in average-risk, older adults. METHODS: The user-centered design approach, consisting of patient and patient-clinician charrettes (defined as intensive workshops where key stakeholders collaborate to develop creative solutions to a specific problem) and participant surveys, has been described previously. Following the charrettes, we used inductive coding to identify and categorize themes emerging from the de-intensification ideas prioritized by participants as well as facilitator notes and audio recordings from the charrettes. RESULTS: Thirty-five patients participated in the patient design charrettes, generating 134 unique de-intensification ideas and prioritizing 32, which were then distilled into six patient-generated principles of de-intensification by the study team. These principles provided a starting point for a subsequent patient-clinician charrette. In this follow-up charrette, 9 patients who had participated in an earlier patient design charrette collaborated with 7 clinicians to generate 63 potential de-intensification solutions. Six of these potential solutions were developed into multi-faceted, fully operationalized de-intensification strategies. DISCUSSION: The de-intensification strategies that patients and clinicians prioritized and operationalized during the co-design charrette process were detailed and multi-faceted. Each component of a strategy had a rationale based on feasibility, practical considerations, and ways of overcoming barriers. The charrette-based process may be a useful way to engage clinicians and patients in developing the complex and multi-faceted strategies needed to improve care delivery.