NEW YORK (Reuters Health) – The SPIRIT-PRO extension substantially revises and updates the guidelines for including patient-reported outcomes (PROs) in clinical trial protocols.
“We recommend that trialists working with patient partners in the co-design of clinical trials use the new SPIRIT-PRO checklist alongside the SPIRIT 2013 guidance to help improve the quality of PRO data collected in the trial,” Dr. Melanie Calvert from the University of Birmingham, Edgbaston, in England, told Reuters Health by email. “We hope that the SPIRIT-PRO extension will help the trial team consider important issues relating to PROs at an early stage of study development so that the resulting data captures outcomes that matter to patients, is robust, and will help inform patient-centered care.”
The original SPIRIT 2013 statement provided an evidence-based list of items recommended for inclusion in trial protocols, but not specific guidance on PRO-related protocol content, such as health-related quality of life or patient-reported symptoms.
Dr. Calvert and colleagues considered 162 PRO-specific protocol recommendations from 54 sources before settling on 16 items (11 extensions and 5 elaborations to the existing SPIRIT 2013) that should be routinely addressed in all clinical trial protocols in which PROs are a primary or key secondary outcome.
The elaborations range from specifying individuals responsible for the PRO content of the trial protocol and stating PRO analysis methods to showing how missing data will be described and describing the process of PRO assessment for study participants who discontinue or deviate from the assigned protocol.
Most of the 11 extensions address PRO-related data collection, management, and analysis, with recommendations to justify which PRO assessment instruments should be used, to include data collection plans, to specify whether more than one language version will be used, and to specify strategies for minimizing avoidable missing data.
All 16 items and their relationship to SPIRIT 2013 are detailed in the February 6 online report in JAMA.
“We would recommend that all of the SPIRIT-PRO items are addressed; however, having a clear PRO-specific research question and rationale for assessment is crucial to ensure that the PRO data collected in the trial can provide meaningful evidence to inform future patient care and health policy,” Dr. Calvert said.
“To help facilitate use of the guidance, we are currently identifying a number of examples of good practice which will be provided in a future explanatory publication and on the freely accessible PROlearn (http://bit.ly/2GUGQpN) and SPIRIT Initiative websites,” she said. “Journal editors publishing trial protocols and IRBs undertaking ethical review of trial protocols can help through endorsement of the guidance.”
“Empirical assessments highlight ongoing barriers to widespread adoption of patient-centered tools at the point of care, variable effects on improving processes or quality of care, and methodological deficiencies in the collection, analysis, and reporting of such outcomes,” write Dr. Roxana Mehran and colleagues from Mount Sinai Medical Center and Icahn School of Medicine at Mount Sinai New York in a related editorial. “The explicit guidance offered by SPIRIT-PRO will enable a more valid appraisal of different tools and uniform approaches toward the collection and reporting of PRO data, thereby overcoming many of these barriers.”
“For now,” they conclude, “PROs are essential as important outcome measures that matter to patients and will need to be incorporated in a systematic and standardized way in clinical trial protocols.”
Dr. Pamela W. Duncan of Wake Forest School of Medicine, Winston-Salem, North Carolina told Reuters Health by email, “Patient-reported outcomes are now being accepted as primary outcomes of trials as well as benchmarks for quality of care. Major challenges in using PROs are well-defined methods for selecting PROs, administering, interpreting, and evaluating bias in missing data. These guidelines will be useful for research reporting; however, we need to use the same methodological rigor as we accept PROs as benchmarks of quality of care.”
“(These guidelines) are well developed and can be implemented,” she said. “In fact, I am leading a large pragmatic trial with PROs (from patient and caregivers) as the primary outcomes as well as drivers of the patient-centered individualized care plans. As we prepare to report our results this year, I will use/refer to these guidelines and recommendations for missing data.”
“Physicians, health administrators, and policy experts need to be informed and knowledgeable of these issues and translate to health system utilization of PROs,” Dr. Duncan concluded. “However, for now, these guidelines are critical for implementation and acceptability of PROs for clinical trials.”
SOURCES: http://bit.ly/2GVsCFs and http://bit.ly/2FSyM7I
JAMA 2018.
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