Challenges in the design, planning and implementation of trials evaluating group interventions

Biggs, Katie; Hind, Daniel; Gossage-Worrall, Rebecca; Sprange, Kirsty; White, David; Wright, Jessica; Chatters, Robin; Berry, Katherine; Papaioannou, Diana; Bradburn, Mike; Walters, Stephen J.; Cooper, Cindy

Abstract

BACKGROUND: Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or health education. Evaluating group interventions in randomised controlled trials (RCTs) presents trialists with a set of practical problems, which are not present in RCTs of one-to-one interventions and which may not be immediately obvious.

METHODS: Case-based approach summarising Sheffield trials unit's experience in the design and implementation of five group interventions. We reviewed participant recruitment and attrition, facilitator training and attrition, attendance at the group sessions, group size and fidelity aspects across five RCTs.

RESULTS: Median recruitment across the five trials was 3.2 (range 1.7-21.0) participants per site per month. Group intervention trials involve a delay in starting the intervention for some participants, until sufficient numbers are available to start a group. There was no evidence that the timing of consent, relative to randomisation, affected post-randomisation attrition which was a matter of concern for all trial teams. Group facilitator attrition was common in studies where facilitators were employed by the health system rather than the by the grant holder and led to the early closure of one trial; research sites responded by training 'back-up' and new facilitators. Trials specified that participants had to attend a median of 62.5% (range 16.7%-80%) of sessions, in order to receive a 'therapeutic dose'; a median of 76.7% (range 42.9%-97.8%) received a therapeutic dose. Across the five trials, 75.3% of all sessions went ahead without the pre-specified ideal group size. A variety of methods were used to assess the fidelity of group interventions at a group and individual level across the five trials.

CONCLUSION: This is the first paper to provide an empirical basis for planning group intervention trials. Investigators should expect delays/difficulties in recruiting groups of the optimal size, plan for both facilitator and participant attrition, and consider how group attendance and group size affects treatment fidelity.

Citation

Biggs, K., Hind, D., Gossage-Worrall, R., Sprange, K., White, D., Wright, J., …Cooper, C. (2020). Challenges in the design, planning and implementation of trials evaluating group interventions. Trials, 21(1), Article 116. https://doi.org/10.1186/s13063-019-3807-4

• Journal Article Type: Article
• Acceptance Date: Oct 17, 2019
• Online Publication Date: Jan 29, 2020
• Publication Date: Jan 29, 2020
• Deposit Date: Feb 20, 2020
• Publicly Available Date: Feb 25, 2020
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Article Number: 116
• DOI: https://doi.org/10.1186/s13063-019-3807-4
• Keywords: Group interventions, Therapy groups, Treatment fidelity, Implementation, Intervention design, Clinical trials
• Public URL: https://nottingham-repository.worktribe.com/output/3919102
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3807-4