Development of a Core Domain Set for Ankle Osteoarthritis

Ankle osteoarthritis (OA) is a debilitating health condition that is increasing in prevalence. Currently, there are no evidence-based guidelines for managing ankle OA. One of the possible reasons for this is the lack of an agreed set of outcome measures that are reported in all clinical trial research papers. Using a consistent set of outcome measures will enable meta-analysis of many trials - an essential component of evidence based practice. In order to develop this set of outcome measures, we will first develop a set of health-related core domains for ankle OA.

A Core Domain Set is an agreed-upon set of health-related domains for a specific condition that should be measured and reported in clinical trials. This represents the minimum set of outcomes that should be measured and reported in clinical trials and does not restrict researchers from using other constructs of interest.

A Core Domain Set would guide researchers as to which outcomes should be measured in clinical trials. We will involve relevant stakeholders (e.g. patients and clinicians) in the development process to capture the most relevant and meaningful outcomes of these key stakeholders. The overarching aim of this project is to endorse an evidence-based Core Domain Set for ankle OA research.


Mr Alanazi, Sultan 1,2 (Principal investigator)
Professor Hunter, David 3,4
Professor Menz, Hylton 5
Dr Smith, Michelle 1
Dr Van Bergen, Christiaan 6
Professor Vicenzino, Bill 1
Associate Professor Wikstrom, Erik 7
Professor Yvonne Golightly 8,9

1 Physical Therapy Division, School of health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia
2 Department of Physical Therapy, College of Applied Medical Sciences, Majmaah University, Al- Majmaah, 11952, Saudi Arabia
3 Institute of Bone and Joint Research, the Kolling Institute, The University of Sydney
4 Rheumatology Department, Royal North Shore Hospital, Sydney, Australia
5 Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, Australia
6 Department of Orthopedic Surgery, Amphia Hospital, Breda 4818 CK, the Netherlands.
7 MOTION Science Institute Department of Exercise & Sport Science University of North Carolina at Chapel Hill, North Carolina, USA
8 College of Allied Health Professionals, University of Nebraska Medical Center, Omaha, NE, USA
9 Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA

Further Study Information

Current Stage: Ongoing
Date: March 2021 - February 2023
Funding source(s): None

Health Area

Disease Category: Rheumatology

Disease Name: Osteoarthritis

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers

Study Type

- 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.