Trial and error: challenges conducting pragmatic trials in general practice

Katharine Ann Wallis; Carolyn Raina Elley

doi:10.3399/bjgp22X718289

INTRODUCTION

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.

Challenges	Potential solutions
Noise in the real-world	Robust intervention, with strong theoretical underpinnings, capable of impact despite contextual changes Established practice network that rigorously tests quality improvement initiatives via randomised controlled trials
Difficulty recruiting practices	Topic that is interesting and important to GPs Participation remunerated and not too onerous Established practice network that supports long-term engagement
Between group differences	Software to stratify practices by important variables Availability of accurate intraclass correlation coefficients to assess likely differences between practices in key outcome variables
Poor intervention uptake	Piloting to determine feasibility, acceptability, and utility Support practice engagement
Loss to follow up	Sufficiently powered trials Established practice network that supports long-term engagement
Randomisation error	Automated software systems to randomly allocate practices, avoiding human handling

Box 1.

Lessons from SPACE:¹ challenges conducting pragmatic trials in general practice and potential solutions

NOISE IN THE REAL-WORLD

SPACE 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 …

View Full Text