JAMA

Most pilot #trials are intended to focus on #feasibility, not #efficacy. Yet investigators still face important questions: When is a feasibility trial needed? How should feasibility be measured? And how much confidence should be placed in findings from small studies?

This month's @JAMAplusTrials Theme of the Month explores these challenges through an editorial examining how tools developed for confirmatory efficacy research are being adapted to an inherently exploratory endeavor.

➡️ Explore the theme and more clinical trial resources at JAMA+ Trials: ja.ma/4BKF9XL

What do extension studies add to randomized clinical trials?

In a recent @JAMAplusTrials poll, nearly half of respondents (46.4%) said extension studies provide valuable insight into longer-term safety and treatment durability. Another 36.9% felt they should be considered cohort studies rather than trials in themselves.

Explore more conversations shaping the future of clinical research at JAMA+ Trials: ja.ma/48JWcvq

#ClinicalTrials #ClinicalResearch

Presented at #ScientificSessions26: Among veterans with stable #CoronaryArteryDisease in extended follow-up of the COURAGE randomized trial, an initial strategy of #PercutaneousCoronaryIntervention plus optimal medical therapy did not reduce long-term risk of death or myocardial infarction vs optimal medical therapy alone.

These findings do not support a routine strategy of elective upfront percutaneous coronary intervention to reduce long-term ischemic outcomes in this population.

ja.ma/4BPPEsK

@AHAMeetings @AHAScience

Presented at #ScientificSessions26 from @JAMACardio:

Among patients with established #AtheroscleroticCardiovascularDisease and above-goal low-density lipoprotein cholesterol, a large language model identified that documented low-density lipoprotein cholesterol targets were absent in most relevant notes and lipid-lowering therapy was usually not escalated.

Common documented reasons for nonescalation included patient-reported adverse effects, patient preference, preference for lifestyle changes, deferral to repeat laboratory testing, and low-density lipoprotein cholesterol values close to goal.

ja.ma/4j38kh4

🧵 Presented at #ScientificSessions26: Among patients with stable #CoronaryDisease and moderate or severe ischemia, an initial invasive strategy with guideline-directed medical therapy plus coronary angiography and revascularization did not improve long-term all-cause mortality vs an initial conservative strategy with guideline-directed medical therapy alone.

These findings support shared decision-making by indicating no significant survival difference between the 2 initial management approaches over approximately a decade.

ja.ma/4Ah7BP8

@AHAMeetings @AHAScience