GP Participation and Recruitment of Patients to RCTs: Lessons from Trials of Acupuncture and Exercise for Low Back Pain in Primary Care

Sally E M Bell-Syer,Hugh Macpherson,Lucy N Thorpe,Kate Thomas

doi:10.1093/ecam/nen044

Abstract

The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested individual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment.

Highlights

Well-conducted randomized controlled trials (RCTs) provide good evidence for the effectiveness of different methods of managing specific conditions. This evidence is an invaluable tool for general practitioner (GPs) in primary care when making clinical decisions with respect to appropriate management
From the literature and from the experience of two similar trials we have identified factors that are associated with GPs willingness and/or reluctance to participate in, and to refer patients into clinical trials
According to the findings of a recent OPCS survey quoted in the report of the Clinical Standards Advisory Group (CSAG) on Back Pain [21], the annual cost of back pain to the NHS is estimated at approximately £480 million with the annual cost to a GP practice with a list of 10 000 patients estimated at £88K [15]

Summary

Introduction

Well-conducted randomized controlled trials (RCTs) provide good evidence for the effectiveness of different methods of managing specific conditions. This evidence is an invaluable tool for general practitioner (GPs) in primary care when making clinical decisions with respect to appropriate management. A key aspect to successful completion of a trial is the recruitment of patients and there are important issues around planning a trial and its subsequent conduct. The process of obtaining informed consent can be an important barrier to GP participation [4, 5], as is the worry that taking part in research could disrupt the “normal” doctor-patient relationship [6]. Lack of financial incentives may deter GP involvement [3]

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Methods

Discussion

Conclusion