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Doctor and patient
Researchers have recommended changes to international guidelines used in the development of clinical trials.
The group’s goal is to improve the use of 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 labeling claims, clinical guidelines, and health policy,” said Melanie Calvert, PhD, of the University of Birmingham in Edgbaston, Birmingham, England.
“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-centered care.”
Dr Calvert and her colleagues published the guidance in JAMA.
The guidance is known as the SPIRIT-PRO Extension. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement, which was published in 2013, was intended to improve trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed.
To add a PRO component to SPIRIT, Dr Calvert and her colleagues conducted a systematic review of existing PRO-specific protocol guidance. A taskforce used this data to compile a list of potential PRO-specific protocol items.
The review revealed 162 PRO-specific protocol recommendations, and the task force reduced this to 56. After 138 international stakeholders and 99 Delphi panelists weighed in, the final recommendations were agreed upon by 29 participants at a consensus meeting.
The final recommendations include 11 extensions and 5 elaborations to the SPIRIT checklist. The recommendations focus on PRO-specific issues relating to objectives, eligibility criteria, data collection, monitoring, and other aspects of trials.
“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,” Dr Calvert said.
“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.”
