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Table 3 Concerns and recommendations for informing the design and delivery of a definitive RCT

From: Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial

Concerns Recommendations
Motivation for taking part Recruiting staff to recognise that not all people are motivated by altruism
Endorsement by stakeholders (clinicians and funders) Required for identifying potential participants and starting the recruitment process; training for Participant Identification Centre (PIC) clinicians to be aware of their “gate-keeping” role
Desperation for improvement PIC clinicians and recruiting researchers to ensure potential participants are informed and understand the need for equipoise through careful reiteration of the current state of knowledge and potential risks as well as benefits of participation with the aim to facilitate appropriate decision-making
Abandoned to the control group Consider more active forms of comparator, or waiting list control. Careful inclusion of interviews to ascertain group preference
Negative effects on mental health (if allocated to the control) PIC clinicians and recruiting researchers to be aware of the vulnerability of potential participants; more active monitoring of adverse events in the control group, ensure mental health deterioration included in monitoring and reporting of adverse events
Compensatory behaviour change (control group participants seek their own version of the intervention) Consider more active comparator or waiting list control; better monitoring of control group activity. Consider alternative trial designs such as rigorous pragmatic or observational cohort studies.
Recommend process evaluations always include control group participants and update reporting check lists to this effect