Call to better record patient-reported outcomes in clinical trials
Researchers have recommended changes to the international guidelines used in the development of clinical trials, in an effort to gain information about the impact on the quality of life of participating patients.
Protocols describe how a clinical trial will be conducted — including its objectives, design, methodology, statistical considerations and organisation — and ensure the safety of participating patients as well as the integrity of the data collected. However, research recently published in the BMJ has found that sometimes there can be a lack of emphasis on patient-reported outcomes (PROs) — feedback from patients about how the clinical trial has affected their overall health and quality of life.
“Patient-reported outcome data from clinical trials can provide valuable evidence to inform shared decision-making, pharmaceutical labelling claims, clinical guidelines and health policy,” said Professor Melanie Calvert, director of the Centre for Patient-Reported Outcomes Research (CPROR) at the University of Birmingham. “However, clinical trial protocols often lack important information regarding the collection of quality of life and symptom data.
“Working in collaboration with international stakeholders we have developed consensus-based, PRO-specific protocol guidance to help ensure high-quality data to inform patient-centred care.”
The recommended changes follow research funded by Macmillan Cancer Support and conducted by researchers at the Universities of Birmingham, Toronto and Sydney. The results have been published in JAMA: The Journal of the American Medical Association.
“As more new cancer treatments are tested as part of clinical trials, it is vital that we know about the impact they have on patients’ lives,” said Professor Jane Maher, joint chief medical officer at Macmillan Cancer Support.
“New cancer treatments can add months or even years to life, but they can also have side effects which can really have an impact on quality of life, in some cases long after treatment finishes. Such outcomes have often not been reported.
“These recommended changes to international guidelines will help ensure that people’s experiences of new treatments are properly recorded and published, and I would urge researchers to adopt them.”
Eleven extensions and five elaborations to the SPIRIT 2013 checklist are recommended for inclusion in clinical trial protocols where PROs are a primary or key secondary outcome. However, Professor Calvert noted that the study authors are “actively encouraging protocol writers to consider use of this guidance in all trials or clinical research studies where PROs are collected”.
“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.”
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