Abstract

BackgroundTraditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants’ behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development.MethodsWe undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT.ResultsWe reached data saturation and found five main themes;Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings.Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty–Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable.Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that these trial designs should go through at least a proportionate ethical review. GP staff were happy for the PCT leads to give consent on their behalf.GP research capacity and trial participation: GP staff considered the design increased generalisability, as staff who would not normally volunteer to participate in research due to perceived time constraints and paperwork might do so.Design ‘worth it’: All interviewees agreed that the advantages of the “more accurate” or “truer” results and information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the consent procedure.DiscussionOur RCT was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine.ImplicationsThe McNulty-Zelen design should be considered for the evaluation of educational interventions, but these designs should have clear consent protocols and proportionate ethical review.Trial registrationThe trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722.Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-015-0356-0) contains supplementary material, which is available to authorized users.

Highlights

  • Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated

  • Our Randomised Controlled Trial (RCT) was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine

  • The educational intervention took place between April 2010 and April 2011, and in December 2011, after process evaluation interviews had been completed, all randomised surgeries were sent a letter to let them know that their practice had been taking part in a RCT of an intervention aimed at increasing chlamydia screening in general practice, and providing information about their random allocation, the consent procedure, the reason for the trial design and references explaining the Zelen design

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Summary

Introduction

Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. The method used to select participants within a Randomised Controlled Trial (RCT) is a crucial aspect of trial design [1]. In a traditional RCT, individuals are the unit of analysis and are invited to participate and consent; it is at this point randomisation to an intervention occurs. In a standard cluster randomised trial groups of participants (“clusters”), rather than individuals, are invited to participate and consent to take part before randomisation.

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