Objectives
To develop an internationally agreed-upon core domain set for ankle osteoarthritis (OA).
Methods
In a three-part Delphi process, a group of multidisciplinary health professionals with expertise in ankle OA and people with ankle OA responded to online questionnaires. The questionnaires proposed a list of 29 candidate domains derived from a systematic review of ankle OA research, and interviews with people with ankle OA and health professionals. Consensus was defined a priori as =70% agreement in people with ankle OA and health professionals whether a domain should or should not be included in a core domain set. An online consensus meeting was held to discuss and resolve undecided candidate domains.
Results
A total of 100 people (75 health professionals and 25 people with ankle OA) from 18 countries (4 continents) participated in this study. Five domains reached consensus for inclusion in a core domain set for ankle OA – pain severity, health-related quality of life, function, disability and ankle range of motion. Twenty-one candidate domains reached agreement not to be included in the core domain set, and three domains remained undecided (ankle instability, physical capacity, and mental health).
Conclusion
This international consensus study, which included people with ankle OA and health professionals, has established a core domain set for ankle OA with five domains that should be measured and reported in all ankle OA trials – pain severity, health-related quality of life, function, disability and ankle range of motion. This core domain set will guide the reporting of outcomes in clinical trials on ankle OA. Future research should determine which outcome measurement instruments should be used to measure each of the core domains.
Sultan Ayyadah Alanazi, Bill Vicenzino, Christiaan J A van Bergen, David J Hunter, Erik A Wikstrom, Hylton B Menz, Yvonne M Golightly, Michelle D Smith; Core Domain Set for Ankle Osteoarthritis Consensus group
Disease Category: Rheumatology
Disease Name: Osteoarthritis
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Interview
- Systematic review
We will use a consensus development process to develop a health-related core domain set for ankle OA. The participants will be health care professionals who have a track record in ankle problems and patients who live with ankle OA. The study will involve a multi-staged and iterative approach consisting of the following phases:
Phase 1: Identification of candidate domains
The initial list of candidate items (potential domains) was gleaned by a 3-stages process:
i. Systematic review of outcome measures used in ankle OA trials. This enabled us to extract and list all outcome measures used.
ii. Semi-structured interviews with patients who have ankle OA to explore their lived experience with ankle OA.
iii. Semi-structured interviews with an international group of healthcare professionals (e.g. orthopedic surgeons, athletic trainers, and podiatrists) – who were identified as experts in ankle problems – to explore their views on ankle OA.
Phase 2: Develop a list of candidate domains
Steering committee to formulate a list of candidate domains from the information derived in the first phase. This list will form the basis for the next phase.
Phase 3: Agreement on the core domain set
A number of iterative online surveys (Qulatircs softwere) will be used to reach a consensus on the most important domains for ankle OA.