A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials...

Area of Science:

• Health Services Research
• Clinical Trials Methodology
• Public Health Interventions

Background:

• Traditional randomized controlled trials (RCTs) for educational interventions in general practice risk biased results due to participant awareness of evaluation.
• The McNulty-Zelen Cluster Randomised Control Trial (CRT) design aims to conceal participant involvement in an RCT.
• Consent is obtained from a third party, allowing practice staff to opt into educational activities as usual.

Purpose of the Study:

• To explore the acceptability of the McNulty-Zelen CRT design for evaluating educational interventions in general practice.
• To assess the perceptions of general practice staff and research stakeholders regarding this novel trial design.

Main Methods:

• Semi-structured telephone interviews were conducted with 16 general practice staff, 4 Primary Care Research Network officers, 5 Primary Care Trust leads, and 1 Research Ethics Committee chair in England.
• Interviews were conducted by experienced qualitative researchers from the original study team using a semi-structured schedule.
• Data analysis was performed by a researcher not involved in the original RCT to mitigate bias.

Main Results:

• Participants found the McNulty-Zelen design acceptable, believing it generates more reliable evidence for educational interventions in real-world general practice settings.
• General practice staff perceived the design as similar to routine audit and feedback, making it acceptable.
• Stakeholders emphasized the need for clear consent procedures and proportionate ethical review, with GP staff comfortable with third-party consent.

Conclusions:

• The McNulty-Zelen design is considered acceptable for evaluating educational interventions, enhancing generalizability and potentially increasing participation.
• The design's advantages, including more accurate results, were seen to outweigh disadvantages of the consent procedure.
• Clear consent protocols and proportionate ethical review are recommended for McNulty-Zelen designs evaluating educational interventions.