Creating recommendations on types of data to present in patient-Reported outcome measure development studies
This guidance will likely improve the completeness of reporting of these important studies. LIMITATIONS: One potential drawback is the possibility of having missed important and salient resources in our search of the literature, which may have restricted our initial items list. In addition, the indi...
| Main Authors: | , , |
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| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
Washington, DC
Patient-Centered Outcomes Research Institute
2021, [2021]
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | This guidance will likely improve the completeness of reporting of these important studies. LIMITATIONS: One potential drawback is the possibility of having missed important and salient resources in our search of the literature, which may have restricted our initial items list. In addition, the individuals who volunteered to be part of our Delphi panel could have been a selective group with specific unique characteristics that could be different in a repeated study. Consequently, their views on reporting specific MPs may have made them more likely to volunteer and respond, biasing the voting and the resultant final item list. Finally, another potential drawback is the use of the Delphi process instead of a face-to-face consensus process After 3 rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on MPs) and 36 "specific" items (exclusively relevant to 1 of the 9 MPs: (1) reliability, (2) measurement error, (3) internal consistency, (4) content validity, (5) face validity, (6) construct validity [including structural validity, hypothesis testing, and cross-cultural validity], (7) criterion validity, (8) responsiveness, and (9) interpretability). We created a manuscript for publication of the protocol, a PCORI final report, and similar to the final report, but much shorter, a manuscript also meant for publication of this work. CONCLUSIONS: Consensus was achieved on 2 nonduplicative sets of items, 71 in total, for inclusion in a reporting guideline for studies on MPs of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of MPs of PROMs. METHODS: This study included 4 phases: (1) conducting an extensive literature review of methods for performing or reporting studies testing MPs of PROMs; (2) preparing for a Delphi process to develop a consensus about reporting requirements by identifying experts to participate; (3) conducting the Delphi rounds of voting on the item lists developed in phase 1; and (4) developing recommendation and guidance documents. RESULTS: The literature review resulted in our including 92 reporting items in the Delphi survey. A total of 83 individuals (from 12 countries) agreed to participate in the Delphi survey, with 47, 30, and 25 responding in rounds 1, 2, and 3, respectively. BACKGROUND: Patient-reported outcome measures (PROMs) are key tools when performing clinical research or monitoring patient progress. One barrier to interpreting individual studies on the measurement properties (MPs) of PROMs is the frequent underreporting of important information. Although a checklist for investigating the methodological quality of studies on MPs of health status measurement instruments has been developed, guidelines for reporting these studies in the peer-reviewed literature do not exist. OBJECTIVE: To develop a set of consensus and empirically based reporting recommendations for primary studies of the MPs of PROMs. |
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| Physical Description: | 1 PDF file (400 pages) illustrations |