Background

Opioid 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.

Objective

To 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.

Setting

Veterans Administration hospitals.

Methods

In 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.

Results

In 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.

Conclusions

Bariatric surgery was associated with greater risk of CPOU incidence in patients without baseline CPOU but was not associated with greater CPOU persistence.

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.

Background

The 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).

Methods

A 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.

Results

Several 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.

Conclusions

Multi-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.

Background

Information 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.

Objective

To measure the effectiveness of nirmatrelvir-ritonavir and molnupiravir for outpatient treatment of COVID-19.

Design

Three retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir.

Setting

Veterans Health Administration (VHA).

Participants

Nonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022.

Intervention

Nirmatrelvir-ritonavir or molnupiravir pharmacotherapy.

Measurements

Incidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days.

Results

Eighty-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.

Limitation

The date of COVID-19 symptom onset for most veterans was unknown.

Conclusion

Nirmatrelvir-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 source

U.S. Department of Veterans Affairs.

Introduction

Online 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 design

A 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/participants

Obese/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.

Intervention

Online 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 measures

Weight 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.

Results

From 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 < 0.001). Online and in-person DPP participants lost significantly more weight than MOVE! participants at 6 and 12 months; there was no significant difference in weight change between online and in-person DPP.

Conclusions

An intensive, multifaceted online DPP intervention had higher participation but similar weight loss compared to in-person DPP. An intensive, multifaceted online DPP intervention may be as effective as in-person DPP and help expand reach to those at risk.

Introduction

This 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.

Design

Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions.

Setting/participants

Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014.

Intervention

VA-DPP included 22 group-based intensive lifestyle change sessions.

Main outcome measures

Weight 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.

Results

A 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<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures.

Conclusions

VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE!

Participants

Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.