Article
Developing a Core Outcome Set for the Research and Treatment of Thumb Carpometacarpal Osteoarthritis: A Delphi Study
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Authors
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Amy Ladd
- Stanford University, Department of Orthopedic Surgery, Stanford, United States
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Joseph Crisco
- Brown University, Warren Alpert Medical School, Richmond, United States
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Deborah Kenney
- Stanford University, Department of Orthopedic Surgery, Stanford, United States
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Miriam Marks
- Schulthess Clinic, Zurich, Switzerland
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Douglas Moore
- Brown University, Warren Alpert Medical School, Richmond, United States
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Arnold Peter C. Weiss
- Brown University, Warren Alpert Medical School, Richmond, United States
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Jennifer Wolf
- University of Chicago Hospitals, Chicago, United States
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Amy Milena Hoang-Kim
- University of Toronto, Toronto, Canada
| Published: | February 6, 2020 |
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Outline
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Objectives/Interrogation: We aim to establish a multidisciplinary consensus in developing a minimum core set of outcomes (COS) with research and clinical relevance for thumb carpometacarpal (CMC) osteoarthritis (OA). Comparative studies of treatment and clinical tools are lacking, since uniform outcome measures specific to CMC OA do not exist. A meaningful outcome measurements will minimize bias in both study design and interpretation of results. Agreed-upon outcomes similarly impact the robust design of clinical trials.
Methods: 32 experts in CMC OA treatment & research participated in the 2nd round of the CMC OA COS Delphi survey. Participants included hand surgeons, therapists, and scientists. The areas were: clinical record keeping (N=17); observational studies (N=29); clinical trials investigating symptom modification (N= 23); and clinical trials investigating structure modification (N=20). Outcomes were derived from the first Delphi round and a thorough review of the CMC OA literature. All outcomes were listed and categorized according to the OMERACT framework. The survey contained a list of 59 individual outcome measures, and an open text field to add missing outcomes perceived by participants. Using an anonymous online survey, participants scored each outcome on a 7-point Likert scale. A score of 1-3 represented an outcome of limited importance; 4-6, an important but not critical outcome, and a score of 7-9, a critically important outcome. Consensus was reached if at least 70% of total respondents rated the outcome critical (7-9) and less than 15% of respondent rated the outcome not-important.
Results and Conclusions: 32 of 46 stakeholders responded to this online survey. After the 2nd round consensus was reached for 5 outcomes in Clinical Record Keeping, 8 outcomes for Observational Studies, 6 outcomes for Clinical Trials -Symptom Modification, and 9 outcomes for Clinical Trials - Structure Modification. No consensus was reached for the 16 outcomes representing the economic impact of health condition for the individual, society, in the presence of a health impairment, and the resource use incurred by treatment of this condition.
In this second round of the CMC OA COS Delphi, participants reached consensus for outcomes in each of the clinical/study domains. Patient derived surveys are in process, and we will incorporate these findings in the final round of consensus of primary stakeholders. We will report on the final round, being held in November 2018 (Palo Alto, CA).
