TY - JOUR T1 - Trial and error: challenges conducting pragmatic trials in general practice JF - British Journal of General Practice JO - Br J Gen Pract SP - 54 LP - 55 DO - 10.3399/bjgp22X718289 VL - 72 IS - 715 AU - Katharine Ann Wallis AU - Carolyn Raina Elley Y1 - 2022/02/01 UR - http://bjgp.org/content/72/715/54.abstract N2 - Conducting pragmatic trials testing complex interventions in general practice is important for determining which interventions work in the real-world. However, pragmatic trials present many methodological and logistical challenges. In this article, we share our experience and lessons from the SPACE trial (Safer Prescribing And Care for the Elderly) in the hope that others might avoid some of the pitfalls (Box 1).1 SPACE was conducted in New Zealand general practice where there is no established infrastructure supporting practice-based research.ChallengesPotential solutionsNoise in the real-world Robust intervention, with strong theoretical underpinnings, capable of impact despite contextual changesEstablished practice network that rigorously tests quality improvement initiatives via randomised controlled trialsDifficulty recruiting practices Topic that is interesting and important to GPsParticipation remunerated and not too onerousEstablished practice network that supports long-term engagementBetween group differences Software to stratify practices by important variablesAvailability of accurate intraclass correlation coefficients to assess likely differences between practices in key outcome variablesPoor intervention uptake Piloting to determine feasibility, acceptability, and utilitySupport practice engagementLoss to follow up Sufficiently powered trialsEstablished practice network that supports long-term engagementRandomisation error Automated software systems to randomly allocate practices, avoiding human handlingBox 1. Lessons from SPACE:1 challenges conducting pragmatic trials in general practice and potential solutionsSPACE was a pragmatic trial testing an intervention to support safer prescribing. Unfortunately, soon after securing funding for the trial, a non-trial quality improvement (QI) initiative was introduced in the same region, targeting the same prescribing topic. This reduced the pool of practices for recruitment (we excluded participating practices), introduced confounding by increasing awareness of the prescribing issue, and since some trial practices joined the initiative during follow up, contaminated our results. In traditional explanatory trials that test whether an intervention can work under ideal conditions, it would … ER -