Core Outcome Measures in Effectiveness Trials

Creation of a core outcome set for clinical trials of people with shoulder pain

General Information

Summary:
Background

The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders.
Methods/Design

The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence.
Discussion

The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

Contributors:
Joel J. Gagnier, Matthew J. Page, Hsiaomin Huang, Arianne P. Verhagen and Rachelle Buchbinder

Further Study Information

Current Stage:
Ongoing
Date:
Funding source(s):
This project is supported by funding from a Patient Centered Outcomes Research Institute (PCORI) Eugene Washington Engagement Award #2072. MJP is supported by an Australian National Health and Medical Research Council (NHMRC) Early Career Fellowship (1088535). RB is supported by an NHMRC Senior Principal Research Fellowship.

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Shoulder disorders

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Delphi process
Focus group(s)
Systematic review

The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence.


Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers
Service providers

Study Type

COS for clinical trials or clinical research

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