چکیده (انگلیسی):

Background: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. 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.
Methods:We 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.
Results:We 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
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* Correspondence:cliodna.mcnulty@phe.gov.uk
1
Public Health England Primary Care Unit, Microbiology Department,
Gloucestershire Royal Hospital, Great Western Road, Gloucester GL1 3NN, UK
2
Cardiff University, Cardiff, Wales, UK
Full list of author information is available at the end of the article
© 2015 McNulty et al.Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
McNultyet al. BMC Family Practice (2015) 16:169
DOI 10.1186/s12875-015-0356-0
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information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the
consent procedure.
Discussion:Our 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.
Implications: The McNulty-Zelen design should be considered for theevaluation of educational interventions, but these
designs should have clear consent protocols and proportionate ethical review.
Trial registration:The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722.