ARTICLE: Recommendations for including or reviewing patient reported outcome endpoints in grant applications

AUTHORS: Claire Snyder, Alexandra Gilbert, David Moher, Derek Kyte, Ellie Daniels, Madeleine King, Melanie Calvert, Ronald C Chen, Michael Brundage, PROTEUS consortium

JOURNAL: BMJ. 2021 Jun 30;373:n1367. doi: 10.1136/bmj.n1367.

Abstract

Patient reported outcomes are increasingly included in research studies to provide the patient perspective. Grant applicants and grant reviewers require guidance on the key information that should be included in funding applications to demonstrate rigorous methods for patient reported outcomes. This paper provides prioritised practical recommendations from an international consortium of experts on patient reported outcomes to inform grant applicants in preparing their research strategies and grant reviewers in evaluating applications.

Patients, clinicians, regulators, policy makers, and clinical guideline developers value information regarding the impact of disease and treatment from the perspective of patients. Thus, patient reported outcome (PRO) assessments that collect this information are a critical aspect of research studies.12345678 The PRO results from research studies can only be used if they are measured appropriately and reported clearly. However, a recent review of 160 international clinical trials with PRO endpoints found frequent suboptimal reporting, and over a third of trials failed to report PRO findings at all. 9

Several methodological tools have been developed to improve the design, analysis, reporting, and interpretation of PROs in research studies.101112131415 These tools were developed using rigorous methods, including engaging patients and other stakeholders, to provide guidance on designing the PRO aspects of research studies, collecting and analysing the data, and interpreting and reporting the results. The PROTEUS consortium (patient reported outcomes tools: engaging users and stakeholders) was formed to optimise the use of PROs in research studies and clinical practice, in part by promoting the use of these and other PRO resources.16 It builds on the work of other initiatives, such as those to develop core outcome sets17 and inform selection of PRO measures. 18 A PROTEUS consortium meeting in June 2019 (Baltimore, MD), including both grant applicants and funders, identified publication of recommendations regarding the key PRO elements that should be included in grant applications as an important strategic initiative.

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