Researchers have developed a list of recommended changes to international guidelines for the development of clinical trials to gain insights on the impact of treatment on participants and their quality of life. Finding were published in the Journal of the American Medical Association.
Current research into participant feedback on the effects of clinical trials on overall health lacks reporting on patient-reported outcomes (PROs). The recommended changes from the study aim to better describe how trials are conducted including objectives, design, methodology, statistical considerations and organization.
"Patient-reported outcome data from clinical trials can provide valuable evidence to inform shared-decision making, pharmaceutical labelling claims, clinical guidelines and health policy. However, clinical trial protocols often lack important information regarding the collection of quality of life and symptom data,” said Melanie Calvert, director of the Centre for Patient-Reported Outcomes Research (CPROR) at the University of Birmingham in the U.K. "Working in collaboration with international stakeholders, we have developed consensus-based, PRO-specific protocol guidance to help ensure high-quality data to inform patient-centered care."
A total of 11 extensions and five elaborations to the APIRIT 2013 checklist were recommended for inclusions of clinical trials where PROs are the first or second measured outcome. Extensions included PRO changes to trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies in minimizing missing data and whether PRO data will be monitored during the study to inform clinical care.
"While this guidance has been developed for trials where PROs are a primary or key secondary outcome, we are actively encouraging protocol writers to consider use of this guidance in all trials or clinical research studies where PROs are collected,” added Calvert. "The guidance does not aim to be prescriptive, but instead to encourage and facilitate careful planning of PRO components of trials, and thereby improve PRO trial design, which we hope will help staff and patients understand the rationale for PRO assessment, improve PRO data completeness and quality, facilitate high quality analysis and reporting, and ultimately improve the quality of the global PRO evidence base."