“Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal,” according to researchers.
The new international guidelines – the SPIRIT-PRO protocol checklist – were developed by a team of researchers from the University of Birmingham and the University of Sydney, in collaboration with various international stakeholders, including patients, and were recently published in the Journal of the American Medical Association.
The protocol checklist expands on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement published in 2013.
“The guidelines provide information that should be included in a clinical trial protocol when a patient-reported outcome (PRO) is a primary or key secondary outcome,” Professor Melanie Calvert, Director of the Center for Patient-Reported Outcomes Research (CPROR) at the University of Birmingham told us.
Sixteen PRO-specific items are included in the updated guidelines and focus on issues relating to trial rationale, objectives, eligibility criteria, time points for assessment, PRO instrument selection and measurement properties, data collection plans, translation, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care, among others, Calvert explained.
“We are currently working to implement the new guidance through collaboration with our international partners, including funders, regulatory agencies, ethics committees, patient groups, journal editors, international trial groups and clinical societies,” she said.
“We hope that endorsement and international implementation of the guidance will make a real difference to patients, providing high quality evidence on which to base decisions regarding their care.”
Authors: Calvert et al
Title: Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension
Source: Journal of the American Medical Association