OUTCOME MEASURES IN CLINICAL TRIALS OF ANKLE OSTEOARTHRITIS: A SYSTEMATIC REVIEW

S. Alanazi1,2, B. Vicenzino1, J. Rhodes1, M. Smith1
1The University of Queensland, Physiotherapy Department, Brisbane, Australia, 2Majmmah University, Department of Physical Therapy and Health Rehabilitation, Majmaah, Saudi Arabia

Background: Ankle osteoarthritis (OA) is a debilitating musculoskeletal condition. Individuals with ankle OA have a poor quality of life and physical and mental disability, which is similar to that experienced by people with end-stage hip OA, radiculopathy, renal failure, and congestive heart failure. The lack of guidelines in reporting outcome measures in ankle OA research has impeded the ability to synthesise data in meta-analysis in existing ankle OA research.

Purpose: To determine which outcome measures have been used in ankle OA research and propose aligned potential domains.

Methods: Six databases (PubMed, Web of Science, CINAHL, Cochrane, Embase, and SPORTDiscus) were searched by two reviewers, from inception to January 2019 with no restrictions. All studies were screened for eligibility by two independent reviewers. Any study that reported outcome measures for ankle OA in participants older than 18-years and had >50% of participants with ankle OA were included. Non-English, animal and cadaveric studies, systematic reviews, and studies with fewer than five participants were excluded. We grouped the outcome measures into proposed health-related domains of ankle OA as per the Outcome Measures in Rheumatology (OMERACT) guidelines. These domains were then aligned with the OMERACT four core areas: (1) life impact, (2) pathophysiological manifestations, (3) resource use (economic impact), (4) death and adverse events.

Results: 11448 unique studies were identified, of which 488 met selection criteria. A total of 268 outcome measures were recorded. The top 5 reported outcome measures were: the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (n=221 studies), ankle alignment measured using plain radiographs (n=181 studies), pain measured using Numerical Rating Scale (n=145 studies), ankle range of motion (ROM) measured with a goniometer (n=129 studies), and general physical function using SF-36 Physical Component subscale (n=116 studies). The top 5 aligned domains based on the number of studies we aggregated to them were: pain (n=304 studies), general ankle assessment (n=278 studies), ankle alignment (n=229 studies), ankle specific function (n=210 studies) and ROM (n=168 studies).

Conclusion(s): A large number and a wide variety of outcome measures are used in ankle OA, which proves the challenges when designing and reporting research of ankle OA. This also makes it difficult to implement such research into clinical care. Further research is needed to ascertain consensus from key stakeholders (e.g. patients and healthcare professionals) on the core health-related domains and measures that should be included in ankle OA research.

Implications: This systematic review established the need for standardization of outcome measures for ankle OA research. In order to obtain the most benefits of the published research, clinicians should consider using outcome measures related to pain, general and specific ankle assessments (e.g., alignment, function, ROM). Researchers may consider agreeing on what health-related domains and outcome measures should be used in ankle OA research. Studies with similar and relevant outcome measures should increase the ability to synthesise data into a meta-analysis, which will progress the clinical decision making and advance clinical care.

Funding, acknowledgements: Sultan Alanazi is a sponsored student by Saudi Arabia Cultural Mission in Australia.

Keywords: Ankle osteoarthritis, Outcome measures, Core domains

Topic: Musculoskeletal: lower limb

Did this work require ethics approval? No
Institution: N/A
Committee: N/A
Reason: This study is a systematic review.


All authors, affiliations and abstracts have been published as submitted.

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