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BackgroundInformation about the effectiveness of oral antivirals in preventing short- and long-term COVID-19-related outcomes in the setting of Omicron variant transmission and COVID-19 vaccination is limited.ObjectiveTo measure the effectiveness of nirmatrelvir-ritonavir and molnupiravir for outpatient treatment of COVID-19.DesignThree retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir.SettingVeterans Health Administration (VHA).ParticipantsNonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022.InterventionNirmatrelvir-ritonavir or molnupiravir pharmacotherapy.MeasurementsIncidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days.ResultsEighty-seven percent of participants were male; the median age was 66 years, and 18% were unvaccinated. Compared with matched untreated control participants, those treated with nirmatrelvir-ritonavir (n = 9607) had lower 30-day risk for hospitalization (22.07 vs. 30.32 per 1000 participants; risk difference [RD], -8.25 [95% CI, -12.27 to -4.23] per 1000 participants) and death (1.25 vs. 5.47 per 1000 participants; RD, -4.22 [CI, -5.45 to -3.00] per 1000 participants). Among persons alive at day 31, reductions were seen in 31- to 180-day incidence of death (hazard ratio, 0.66 [CI, 0.49 to 0.89]) but not hospitalization (subhazard ratio, 0.90 [CI, 0.79 to 1.02]). Molnupiravir-treated participants (n = 3504) had lower 30-day and 31- to 180-day risks for death (3.14 vs. 13.56 per 1000 participants at 30 days; RD, -10.42 [CI, -13.49 to -7.35] per 1000 participants; hazard ratio at 31 to 180 days, 0.67 [CI, 0.48 to 0.95]) but not hospitalization. A difference in 30-day or 31- to 180-day risk for hospitalization or death was not observed between matched nirmatrelvir- or molnupiravir-treated participants.LimitationThe date of COVID-19 symptom onset for most veterans was unknown.ConclusionNirmatrelvir-ritonavir was effective in reducing 30-day hospitalization and death. Molnupiravir was associated with a benefit for 30-day mortality but not hospitalization. Further reductions in mortality from 31 to 180 days were observed with both antivirals.Primary funding sourceU.S. Department of Veterans Affairs.

BackgroundOpioid analgesics are often prescribed to manage pain after bariatric surgery, which may develop into chronic prescription opioid use (CPOU) in opioid-naïve patients. Bariatric surgery may affect opioid use in those with or without presurgical CPOU.ObjectiveTo compare CPOU persistence and incidence in a large multisite cohort of veterans undergoing bariatric surgery (open Roux-en-Y gastric bypass, laparoscopic RYGB, or laparoscopic sleeve gastrectomy) and matched nonsurgical controls.SettingVeterans Administration hospitals.MethodsIn a retrospective cohort study, we matched 1117 surgical patients with baseline CPOU to 9531 nonsurgical controls, and 2822 surgical patients without CPOU at baseline to 26,392 nonsurgical controls using sequential stratification. CPOU persistence in veterans with baseline CPOU was estimated using generalized estimating equations by procedure type. CPOU incidence in veterans without baseline CPOU was estimated in Cox regression models by procedure type because postoperative pain, complications, and absorption may differ by procedure.ResultsIn veterans with baseline CPOU, postsurgical CPOU declined over time for each surgical procedure; these trends did not differ between surgical patients and nonsurgical controls. In veterans without baseline CPOU, compared with nonsurgical controls, bariatric patients had higher CPOU incidence within 5 years after open Roux-en-Y gastric bypass (hazard ratio = 1.19; 95% confidence interval: 1.06-1.34) or laparoscopic open Roux-en-Y gastric bypass (hazard ratio = 1.22, 95% confidence interval: 1.06-1.41). Veterans undergoing laparoscopic sleeve gastrectomy had higher CPOU incidence 1 to 5 years after surgery (hazard ratio = 1.28; 95% confidence interval: 1.05-1.56) than nonsurgical controls.ConclusionsBariatric surgery was associated with greater risk of CPOU incidence in patients without baseline CPOU but was not associated with greater CPOU persistence.

IntroductionOnline Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions.Study designA large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!).Setting/participantsObese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial.InterventionOnline DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions.Main outcomes measuresWeight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017.ResultsFrom 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p

Background: Extracorporeal membrane oxygenation (ECMO) represents an important but limited treatment for patients with severe COVID-19. We assessed the effects of an educational intervention on a person's ECMO care preference and examined whether patients and providers had similar ECMO preferences. Methods: In the Video+Survey group, patients watched an educational video about ECMO's purpose, benefits, and risks followed by an assessment of ECMO knowledge and care preferences in seven scenarios varying by hypothetical patient age, function, and comorbidities. Patients in the Survey Only group and providers didn't watch the video. Logistic regression was used to estimate the probability of agreement for each ECMO scenario between the two patient groups and then between all patients and providers. Results: Video+Survey patients were more likely (64% vs. 17%; p = 0.02) to correctly answer all ECMO knowledge questions than Survey Only patients. Patients in both groups agreed that ECMO should be considered across all hypothetical scenarios, with predicted agreement above 65%. In adjusted analyses, patients and providers had similar predicted agreement for ECMO consideration across six of the seven scenarios, but patients showed greater preference (84% vs. 41%, p = 0.003) for the scenario of a functionally dependent 65-year-old with comorbidities than providers. Discussion and conclusions: An educational video increased a person's ECMO knowledge but did not change their ECMO preferences. Clinicians were less likely than patients to recommend ECMO for older adults, so advanced care planning discussion between patients and providers about treatment options in critically ill patients with COVID-19 is critical. [ABSTRACT FROM AUTHOR]

Background: The use of potentially inappropriate medications (PIMs) is associated with increased risk of hospitalizations and emergency room visits and varies by racial and ethnic subgroups. Medicare's nationwide medication therapy management (MTM) program requires that Part D plans offer an annual comprehensive medication review (CMR) to all beneficiaries who qualify, and provides a platform to reduce PIM use. The objective of this study was to assess the impact of CMR on PIM discontinuation in Medicare beneficiaries and whether this differed by race or ethnicity. Methods: Retrospective cohort study of community‐dwelling Medicare Part D beneficiaries ≥66 years of age who were eligible for MTM from 2013 to 2019 based on 5% Medicare fee‐for‐service claims data linked to the 100% MTM data file. Among those using a PIM, MTM‐eligible CMR recipients were matched to non‐recipients via sequential stratification. The probability of PIM discontinuation was estimated using regression models that pooled yearly subcohorts accounting for within‐beneficiary correlations. The most common PIMs that were discontinued after CMR were reported. Results: We matched 24,368 CMR recipients to 24,368 CMR non‐recipients during the observation period. Median age was 74–75, 35% were males, most were White beneficiaries (86%–87%), and the median number of PIMs was 1. In adjusted analyses, CMR receipt was positively associated with PIM discontinuation (adjusted relative risk [aRR]: 1.26, 95% CI: 1.20–1.32). There was no evidence of differential impact of CMR by race or ethnicity. The PIMs most commonly discontinued after CMR were glimepiride, zolpidem, digoxin, amitriptyline, and nitrofurantoin. Conclusions: Among Medicare beneficiaries who are using a PIM, CMR receipt was associated with PIM discontinuation, suggesting that greater CMR use could facilitate PIM reduction for all racial and ethnic groups. [ABSTRACT FROM AUTHOR]

BackgroundThe Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA).MethodsA 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m2 (or BMI ≥ 25 kg/m2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed.ResultsSeveral barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session.ConclusionsMulti-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.

IntroductionThis clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system.DesignProspective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions.Setting/participantsObese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014.InterventionVA-DPP included 22 group-based intensive lifestyle change sessions.Main outcome measuresWeight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016.ResultsA total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p

In 2016, the Veterans Health Administration (VHA) held a Weight Management State of the Art conference to identify evidence gaps and develop a research agenda for population-based weight management for veterans. Included were behavioral, pharmacologic, and bariatric surgery workgroups. This article summarizes the bariatric surgery workgroup (BSWG) findings and recommendations for future research. The BSWG agreed that there is evidence from randomized trials and large observational studies suggesting that bariatric surgery is superior to medical therapy for short- and intermediate-term remission of type 2 diabetes, long-term weight loss, and long-term survival. Priority evidence gaps include long-term comorbidity remission, mental health, substance abuse, and health care costs. Evidence of the role of endoscopic weight loss options is also lacking. The BSWG also noted the limited evidence regarding optimal timing for bariatric surgery referral, barriers to bariatric surgery itself, and management of high-risk bariatric surgery patients. Clinical trials of pre- and post-surgery interventions may help to optimize patient outcomes. A registry of overweight and obese veterans and a workforce assessment to determine the VHA's capacity to increase bariatric surgery access were recommended. These will help inform policy modifications and focus the research agenda to improve the ability of the VHA to deliver population-based weight management.

Providers have intended and unintended responses to payment reforms, such as China's new case-based payment system, i.e. Diagnosis-Intervention Packet (DIP) under global budget, that classified patients based on the combination of principal diagnosis and procedures. Our study explores the impact of DIP payment reform on hospital selection of patients undergoing total hip/knee arthroplasty (THA/TKA) or with arteriosclerotic heart disease (AHD) from July 2017 to June 2021 in a large city. We used a difference-in-differences approach to compare the changes in patient age, severity reflected by the Charlson Comorbidity Index (CCI), and a measure of treatment intensity [relative weight (RW)] in hospitals that were and were not subject to DIP incentives before and after the DIP payment reform in July 2019. Compared with non-DIP pilot hospitals, trends in patient age after the DIP reform were similar for DIP and non-DIP hospitals for both conditions, while differences in patient severity grew because severity in DIP hospitals increased more for THA/TKA (P  = 0.036) or dropped in non-DIP hospitals for AHD (P  = 0.011) following DIP reform. Treatment intensity (measured via RWs) for AHD patients in DIP hospitals increased 5.5% (P  = 0.015) more than in non-DIP hospitals after payment reform, but treatment intensity trends were similar for THA/TKA patients in DIP and non-DIP hospitals. When the DIP payment reform in China was introduced just prior to the pandemic, hospitals subject to this reform responded by admitting sicker patients and providing more treatment intensity to their AHD patients. Policymakers need to balance between cost containment and the unintended consequences of prospective payment systems, and the DIP payment could also be a new alternative payment system for other countries. [ABSTRACT FROM AUTHOR]