Improving the patient-reported outcome sections of clinical trial protocols: a mixed methods evaluation of educational workshops.

ABSTRACT:

Introduction

Failure 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.

Method

Annual workshops were conducted 2011-2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descr

SUBMITTER: King MT 

PROVIDER: S-EPMC9470723 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature