The implementation of a translational study involving a primary care based behavioral program to improve blood pressure control: The HTN-IMPROVE study protocol (01295)

<p>Abstract</p> <p>Background</p> <p>Despite the impact of hypertension and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.</p> <p>Objectives</p> <p>We describe the design of a 'translational' study that examines the implementation, impact, sustainability, and cost of an evidence-based nurse-delivered tailored behavioral self-management intervention to improve BP control as it moves from a research context to healthcare delivery. The study addresses four specific aims: assess the implementation of an evidence-based behavioral self-management intervention to improve BP levels; evaluate the clinical impact of the intervention as it is implemented; assess organizational factors associated with the sustainability of the intervention; and assess the cost of implementing and sustaining the intervention.</p> <p>Methods</p> <p>The project involves three geographically diverse VA intervention facilities and nine control sites. We first conduct an evaluation of barriers and facilitators for implementing the intervention at intervention sites. We examine the impact of the intervention by comparing 12-month pre/post changes in BP control between patients in intervention sites versus patients in the matched control sites. Next, we examine the sustainability of the intervention and organizational factors facilitating or hindering the sustained implementation. Finally, we examine the costs of intervention implementation. Key outcomes are acceptability and costs of the program, as well as changes in BP. Outcomes will be assessed using mixed methods (<it>e.g</it>., qualitative analyses--pattern matching; quantitative methods--linear mixed models).</p> <p>Discussion</p> <p>The study results will provide information about the challenges and costs to implement and sustain the intervention, and what clinical impact can be expected.</p

RA-MAP, molecular immunological landscapes in early rheumatoid arthritis and healthy vaccine recipients

Rheumatoid arthritis (RA) is a chronic inflammatory disorder with poorly defined aetiology characterised by synovial inflammation with variable disease severity and drug responsiveness. To investigate the peripheral blood immune cell landscape of early, drug naive RA, we performed comprehensive clinical and molecular profiling of 267 RA patients and 52 healthy vaccine recipients for up to 18 months to establish a high quality sample biobank including plasma, serum, peripheral blood cells, urine, genomic DNA, RNA from whole blood, lymphocyte and monocyte subsets. We have performed extensive multi-omic immune phenotyping, including genomic, metabolomic, proteomic, transcriptomic and autoantibody profiling. We anticipate that these detailed clinical and molecular data will serve as a fundamental resource offering insights into immune-mediated disease pathogenesis, progression and therapeutic response, ultimately contributing to the development and application of targeted therapies for RA.</p

Long-term opioid use after bariatric surgery

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

Giving information strategically and transparently: A pilot trial of the Oncolo‐GIST intervention to promote patients' prognostic understanding

Abstract Purpose Most patients with cancer lack the prognostic understanding necessary to make informed decisions. We tested the feasibility and acceptability of the Oncolo‐GIST (“Giving Information Strategically and Transparently, GIST”) intervention and explored its associations with patients' improved prognostic understanding. Methods The Oncolo‐GIST intervention distills prognostic discussions into easy‐to‐understand talking points. Patients with metastatic cancers that progressed on ≥1 line of chemotherapy and not expected to survive 12 months (n = 31) were recruited from October 2020 through November 2022. We compared patients who discussed their progressive scans with an oncologist trained in the GIST technique or not (i.e., usual care). A primary outcome was prognostic understanding (e.g., patients reporting a life‐expectancy of months) assessed within a week of the scan discussion visit. Results Oncologists (n = 4) appeared receptive to the Oncolo‐GIST intervention and scored nearly perfectly on post‐training tests of material mastery after a < 2‐h tutorial. Post‐scan discussion visit, 100% of patients who met with an Oncolo‐GIST‐trained clinician understood that their cancer was considered incurable (a 31% improvement from pre‐visit) compared with 91% of patients meeting with usual care oncologists (an 18% improvement); 33% of patients who met with an Oncolo‐GIST‐trained oncologist understood that they likely had months, not years, compared to 18% in the usual care group. No statistically significant differences emerged for these changes, nor for therapeutic alliance, anxiety, or depression scores between groups. Conclusion Oncolo‐GIST appears to be an easily learned approach to improve prognostic understanding that neither undermines therapeutic alliances nor increases patients' anxiety or depressive symptoms. Efficacy testing in a larger trial is warranted

Does Long-Term Post-Bariatric Weight Change Differ Across Antidepressants?

Objectives:. We sought to evaluate whether weight change up to 5 years after bariatric surgery differed by antidepressant class taken before surgery. Background:. Bariatric surgery induces significant weight loss, but outcomes are highly variable. The specific type of antidepressant used prior to surgery may be an important factor in long-term weight loss. Methods:. This retrospective cohort study from 2000 to 2016 compared the 5-year weight loss of 556 Veterans who were taking antidepressant monotherapy (bupropion, selective serotonin reuptake inhibitors [SSRIs], or serotonin-norepinephrine reuptake inhibitors [SNRIs]) before bariatric surgery (229 sleeve gastrectomy and 327 Roux-en-Y gastric bypass) versus 556 matched nonsurgical controls. Results:. Patients taking bupropion before sleeve gastrectomy had greater differential weight loss between surgical patients and matched controls than those taking SSRIs at 1 (8.9 pounds; 95% confidence interval [CI], 1.6–16.3; P = 0.02) and 2 years (17.6 pounds; 95% CI, 5.9–29.3; P = 0.003), but there was no difference at 5 years (11.9 pounds; 95% CI, –8.9 to 32.8; P = 0.26). Findings were similar for gastric bypass patients taking bupropion compared to SSRIs at 1 (9.7 pounds; 95% CI, 2.0–17.4; P = 0.014), 2 (12.0 pounds; 95% CI, –0.5 to 24.5; P = 0.06), and 5 years (4.8 pounds; 95% CI, –16.7 to 26.3; P = 0.66). No significant differences were observed comparing patients taking SNRI versus SSRI medications. Conclusions:. Sleeve gastrectomy and gastric bypass patients taking bupropion had greater weight loss than those taking SSRIs, although these differences may wane over time. Bupropion may be the first-line antidepressant of choice among patients with severe obesity considering bariatric surgery

Design and analysis of outcomes following SARS-CoV-2 infection in veterans

Abstract Background Understanding how SARS-CoV-2 infection impacts long-term patient outcomes requires identification of comparable persons with and without infection. We report the design and implementation of a matching strategy employed by the Department of Veterans Affairs’ (VA) COVID-19 Observational Research Collaboratory (CORC) to develop comparable cohorts of SARS-CoV-2 infected and uninfected persons for the purpose of inferring potential causative long-term adverse effects of SARS-CoV-2 infection in the Veteran population. Methods In a retrospective cohort study, we identified VA health care system patients who were and were not infected with SARS-CoV-2 on a rolling monthly basis. We generated matched cohorts within each month utilizing a combination of exact and time-varying propensity score matching based on electronic health record (EHR)-derived covariates that can be confounders or risk factors across a range of outcomes. Results From an initial pool of 126,689,864 person-months of observation, we generated final matched cohorts of 208,536 Veterans infected between March 2020-April 2021 and 3,014,091 uninfected Veterans. Matched cohorts were well-balanced on all 39 covariates used in matching after excluding patients for: no VA health care utilization; implausible age, weight, or height; living outside of the 50 states or Washington, D.C.; prior SARS-CoV-2 diagnosis per Medicare claims; or lack of a suitable match. Most Veterans in the matched cohort were male (88.3%), non-Hispanic (87.1%), white (67.2%), and living in urban areas (71.5%), with a mean age of 60.6, BMI of 31.3, Gagne comorbidity score of 1.4 and a mean of 2.3 CDC high-risk conditions. The most common diagnoses were hypertension (61.4%), diabetes (34.3%), major depression (32.2%), coronary heart disease (28.5%), PTSD (25.5%), anxiety (22.5%), and chronic kidney disease (22.5%). Conclusion This successful creation of matched SARS-CoV-2 infected and uninfected patient cohorts from the largest integrated health system in the United States will support cohort studies of outcomes derived from EHRs and sample selection for qualitative interviews and patient surveys. These studies will increase our understanding of the long-term outcomes of Veterans who were infected with SARS-CoV-2