Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) [added]. (ClinicalTrials.gov number, NCT00032487.)

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Background Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Methods In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. Results A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P = 0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P = 0.03). Conclusions Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)

OBJECTIVE: Patients' self‐management practices have substantial consequences on morbidity and mortality in diabetes. While the quality of patient‐physician relations has been associated with improved health outcomes and functional status, little is known about the impact of different patient‐physician interaction styles on patients' diabetes self‐management. This study assessed the influence of patients' evaluation of their physicians' participatory decision‐making style, rating of physician communication, and reported understanding of diabetes self‐care on their self‐reported diabetes management. DESIGN: We surveyed 2,000 patients receiving diabetes care across 25 Veterans' Affairs facilities. We measured patients' evaluation of provider participatory decision making with a 4‐item scale (Provider Participatory Decision‐making Style [PDMstyle]; α = 0.96), rating of providers' communication with a 5‐item scale (Provider Communication [PCOM]; α = 0.93), understanding of diabetes self‐care with an 8‐item scale (α = 0.90), and patients' completion of diabetes self‐care activities (self‐management) in 5 domains (α = 0.68). Using multivariable linear regression, we examined self‐management with the independent associations of PDMstyle, PCOM, and Understanding. RESULTS: Sixty‐six percent of the sample completed the surveys (N = 1,314). Higher ratings in PDMstyle and PCOM were each associated with higher self‐management assessments (P < .01 in all models). When modeled together, PCOM remained a significant independent predictor of self‐management (standardized β: 0.18; P < .001), but PDMstyle became nonsignificant. Adding Understanding to the model diminished the unique effect of PCOM in predicting self‐management (standardized β: 0.10; P = .004). Understanding was strongly and independently associated with self‐management (standardized β: 0.25; P < .001). CONCLUSION: For these patients, ratings of providers' communication effectiveness were more important than a participatory decision‐making style in predicting diabetes self‐management. Reported understanding of self‐care behaviors was highly predictive of and attenuated the effect of both PDMstyle and PCOM on self‐management, raising the possibility that both provider styles enhance self‐management through increased patient understanding or self‐confidence.

Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE) across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm) across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results) or secondary (exploratory) subgroup analyses (performed to inform future research). A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

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After nearly 10 years of follow-up, patients with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to standard therapy, but no improvement was seen in the rate of overall survival. (Funded by the VA Cooperative Studies Program and others; VADT ClinicalTrials.gov number, NCT00032487.).

Patients from the VHA received higher-quality care according to a broad measure. Differences were greatest in areas where the VHA has established performance measures and actively monitors performance.