Designing randomised trials in primary care that are relevant to practice – the views of those that will use the results towards a trial design tool, PRECIS-2

Problem

Randomised trials are difficult and costly. Like most things that are hard, the effort expended is only worth it because we hope to make a difference. Sadly, the benefit to potential users such as patients, healthcare professionals and policy makers is often smaller than it should be because trial design decisions reduce the relevance of the trial to users. To maximize the relevance of trial results to users it is recommended that researchers design pragmatic trials, testing their intervention under conditions similar to those found in the real world. PRECIS-2 is a trial design tool which encourages trialists to consider how pragmatic their trial is across nine different domains covering the population in the trial, how the intervention is delivered and the outcomes measured. The tool aims to help ensure researchers match their design decisions to the information needs of those they hope will use the trial results.This research explores the views of those using the results of randomsied trials to find out their attitudes towards the different PRECIS-2 domains, pragmatic approaches to clinical trial design and what makes research relevant to primary care. The aim of the study is to improve the design of randomised trials in primary care so they produce results are more relevant to practice.

Approach

We carried out semi structured interviews with individuals or small groups of people involved in implementing research in primary care. We interviewed people involved with journals, guideline development, research charities, research funders, primary care educators, clinical commissioning groups, GPs and clinical effectiveness research. A thematic analysis of the data from the interviews was carried out using the framework approach.

Findings

We conducted 12 interviews across the target groups. We found differences between the way participants used evidence from trials with those involved in synthesizing evidence for guidelines or reviews encountering different challenges from clinicians applying evidence in practice. Important aspects of trial design identified included that the populations in trials matched those seen in practice and that trials aiming to inform primary care practice are carried out in primary care settings. PRECIS-2 covers many the design issues raises by our participants as being important to ensure trial results are relevant to primary care. There were differing views on whether a more or less pragmatic approach is required for some PRECIS-2 domains particularly whether trials should restrict the flexibility of how an intervention is delivered beyond what would occur in practice.

Consequences

This work provides insights into how to design randomised trials in primary care so that their results are relevant to practice. The findings are relevant to those designing trials as well as those involved in funding decisions or using the results of randomised trials.