How pre-trial qualitative research can change proposed RCT design: a case study and implications for future research

Findings Qualitative findings informed changes to fundamental aspects of trial design and proposed outcome measures. Clinicians’ interpretations of the original interventions were variable, and descriptions of current practice/ terminology consistently differed with assumptions made in the grant proposal and commissioned call for research. New outcomes were recognised, prompted by clinicians’/patients’ priorities. Measuring and reporting these outcomes was deemed crucial for a full trial’s potential to impact future practice. Interviews with clinicians also prompted new ‘in trial’ data collection requirements, as clinicians anticipated potential changes to their clinical practice to accommodate the trial interventions. These changes had potential to impact the primary outcomes, prompting recommendations to measure/record these practices during trial conduct.