Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for clinical trials in Greater Trochanteric Pain Syndrome: A scoping review and a Delphi study of healthcare professionals and patients

General Information

Summary:
Greater Trochanteric Pain Syndrome (GTPS) is a clinical diagnosis for load-related pain and disability related to soft tissue pathology at the greater trochanter, primarily a condition of the gluteus medius and/or minimus tendons (gluteal tendinopathy) but also encompassing pathology of the adjacent bursae and fascia. This condition is prevalent in older adults, particularly in post-menopausal women, with substantial impacts on quality of life and healthcare demands. The number of studies investigating interventions targeting the population suffering with this condition is growing, and yet there is wide variation in both patient-rated and physical measures selected for evaluating outcomes. Selection of outcome measurement tools that have not been recommended, developed or validated for use in populations with GTPS may bias outcome reporting. Homogeneity in selection and reporting of outcomes is important for interpretation and comparison of outcomes of interventions. This is critical for allowing meta-analyses which form the basis for evidence-informed practice. Therefore, a need exists to define a core outcome set (COS) of validated outcome measures that evaluate established core health-related domains. A Delphi study of healthcare professionals and researchers with expertise in the field of tendinopathy, with additional consultation with patients with tendinopathy (at various locations) established a tendinopathy-specific core domain set of 9 items (patient rating of condition, participation in life activities, pain on activity/loading, function, psychological factors, physical function capacity, disability, quality of life and pain over a specified time), providing the foundation for subsequent identification of a COS for various specific tendinopathies. The aim of the present project is to develop and disseminate a COS for clinical trials specific for GTPS via a review of the available literature, assessment of quality of outcome measurement instruments available, and a 3-stage Delphi process with two online surveys and a face-to-face consensus meeting of those involved in GTPS clinical research, clinical practice and patients with GTPS.

Contributors:
Principal Investigator:Dr Alison Grimaldi, School of Health & Rehabilitation Sciences, University of Queensland, Australia.

Principal Investigator:Assistant Professor Angie Fearon, Faculty of Health, University of Canberra, Australia.

Associate Professor Jane Fitzpatrick, Faculty of Medicine, Dentistry and Health Science, University of Melbourne; Epworth Hospital,Richmond, Australia.

Dr Andreas Ladurner, Department of Orthopedics and Traumatology, Kantonsspital St. Gallen, Switzerland.

Dr Rebecca Mellor, School of Health & Rehabilitation Sciences, University of Queensland, Australia.

Supervisor:Professor Bill Vicenzino, School of Health & Rehabilitation Sciences, University of Queensland

Further Study Information

Current Stage:
Ongoing
Date:
October 2019 - October 2021
Funding source(s):
None

Health Area

Disease Category
Rehabilitation

Disease Name
Gluteal tendinopathy
Greater trochanteric pain syndrome
Trochanteric bursitis

Target Population

Age Range
18 - 120

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Literature review
Survey

The COS-GTPS development process will involve 5 major steps: 1. A scoping review to extract information on outcome measurement instruments reported in the literature for GTPS studies, performed by the study working group, 2. Delphi 1: An online survey assessment of Truth (Content and Face Validity) and Feasibility of each outcome measure and an initial consensus as to whether each measure should be included in a COS for GTPS, 3. As assessment of the Truth (Construct Validity) and Discrimination of each outcome measure, performed by the study working group, 4. Delphi 2: An online survey presenting results of Delphi 1 and the assessment of Truth and Discrimination and asking participants to deliberate again on the inclusion of the remaining outcome measures into COS-GTPS, 5. Delphi 3: A face to face consensus meeting for final voting on undecided items and a discussion regarding future research to establish high quality outcome measurement instruments in any core domains that are lacking in adequate outcome measures.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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