Core Outcome Measures in Effectiveness Trials

Development of a Core set of Outcome Measures for the Thumb Carpometacarpal Osteoarthritis

General Information

Summary:
Thumb carpometacarpal (CMC) osteoarthritis is a common and disabling disorder, affecting members of both sexes; however, it is most prevalent among middle-aged and post-menopausal women, affecting two-thirds of women over the age of 55. Thumb pain, weakness, and loss of dexterity lead to disabling impairment in hand and upper extremity function. Despite its prevalence and the extent to which it can limit function, there is ongoing debate about the etiology and pathophysiology of the disease. Current treatment options do not modify the normal progression of the disease, and surgery for end-stage disease is based upon limited scientific evidence and is typically of limited success for the patient. Core outcome sets have been developed for use in a wide variety of clinical specialties, including cancer, rheumatology, neurology, and cardiorespiratory research; for use with different populations, such as adults and children. Further the development of core outcome set is necessary not only for the US Food and Drug Administration, but also for funding bodies like the National Institute for Health Research (NIHR) as it optimizes trial design and proven treatment effects because of the ability to synthesize and compare results. Defining content for the core domains is essential to reach an agreed standardized core set of outcomes. Thumb CMC OA is a widespread, disabling disease and is characterized by thumb pain, weakness, and loss of dexterity, leading to disabling impairment in hand and upper extremity function. The goal of the consensus meeting to be held in Palo Alto, November 2018 will be to finalize a core set of domains for thumb CMC OA.

Contributors:
Amy Hoang-Kim (University Toronto)
Amy Ladd (Stanford University)
Douglas Moore (Brown University)
Joseph Crisco (Brown University)
Arnold-Peter Weiss (Brown University)
Miriam Marks (Schulthess Clinic)
Jennifer Wolf (Chicago University)

Further Study Information

Current Stage:
Ongoing
Date:
2013 - 2020
Funding source(s):
NIH, applied funding to ASSH

Health Area

Disease Category
Rheumatology

Disease Name
Osteoarthritis

Target Population

Age Range
45 - 100

Sex
Either


Nature / type of Intervention
Drug
Surgery

Method(s)

Delphi process
Nominal group technique (NGT)
Other

Participants individually note their ideas on most important symptoms and areas that matter most to them with the condition, or experience in the field of OA. Using a nominal group technique, the ideas were shared with the small group to discuss. Participants will be highlighting 4 most important domains within the ICF framework that are of critical importance to those with thumb CMC OA. Results from these discussions were brought to the large group for discussion. In Round 1, Delphi, participants ranked independently the results using Qualtrics Survey platform, from 1 to 9, their top domains based on the results from the large group. Patient partners will participate either remotely or in-person via webinar and a secure telephone line. Half of the patients will be administered an on-line survey and in lieu of a webinar will attend in person. The meetings with patients will include those with symptomatic thumb CMC OA, with a range of genders, ethnicities and socioeconomic statuses and from urban and suburban areas. The meetings will be held in English; efforts will be made to ensure plain language is used. A thematic analysis approach to analyze transcripts in Nvivo11. The codes generated during memoing will comprise the initial coding tree. We will then conduct a pilot coding phase where 20% of transcripts will be coded by two analysts. Kappa coefficients will be calculated and any discrepancies below 0.6 will be discussed and resolved. The remaining transcripts will be coded by a single analyst. All survey responses will be captured using unique identifiers. The goal is to itemize important domains to present and discuss further at an in-person meeting. An in-person meeting will serve the purpose of discussing what to use in order to measure the appropriate content within those core domains while being informed by psychometric properties established for each measurement tool. Prior to the final round of consensus, surveys will be administered to patients in a multi-site trial to understand the importance and clarity of the results from round 2. Feedback opportunity for the patients and working group will ensure that the COS reflects patient perspectives.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research

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