Archive | 2021
Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops
Abstract
\n IntroductionFailure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018.MethodAnnual workshops were conducted 2011–2017. Participants were investigators/ trialists from cancer clinical trials groups. Although developed pre-2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0\u2009=\u2009not addressed, 10\u2009=\u2009fully addressed). Mann-Whitney U-tests assessed whether workshop protocols scored higher than controls by item and overall.ResultsParticipants (n\u2009=\u2009107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n\u2009=\u200916, mean\u2009=\u20093.84 (standard deviation\u2009=\u20091.86)) and control protocols (n\u2009=\u20096, 2.46 (1.35)), (p\u2009=\u20090.09). Workshop protocols scored higher than controls on two items: ‘specify PRO concepts/domains’ (p\u2009=\u20090.035); ‘specify analysis methods’ (p\u2009=\u20090.011).ConclusionAlthough participants were highly satisfied with these workshops, the completeness of PRO protocol content improved only slightly. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content.