Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set for conservative and surgical interventions for elbow disorders (COSed)

General Information

Summary:
There is a growing number of published clinical trials investigating conservative or surgical interventions for elbow disorders, but an agreed standardized set of outcomes that should be measured and reported, as a minimum, is lacking.
Therefore, the aim of this study is to develop a COS for clinical trials of interventions for elbow disorders. This COS is intended to cover all conservative and surgical interventions for elbow disorders and patient populations and can be used in all settings, in which clinical trials evaluating elbow disorders are being conducted.

Contributors:
Prof. Dr. Christian Kopkow (University of Applied Sciences, Bochum, Germany)
Prof. Dr. Philip Kasten (Orthop├Ądisch Chirurgisches Centrum, T├╝bingen, Germany)

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - 2022
Funding source(s):
None

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Elbow disorders

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Systematic review

The COS for clinical trials of interventions for elbow disorders will be developed by a multinational, multidisciplinary working group representing scientific societies or associations and including patient representatives to ensure involvement of relevant stakeholders
The development of the COS for clinical trials of interventions for elbow disorders will include several steps in line with the Outcome measures in Rheumatology (OMERACT) recommendations for developing Core Outcome Measurement Sets for clinical trials, the recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the recommendations from the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) in cooperation with the COMET initiative.
The development will include the following five steps:
Step 1: Systematic Review on outcome domains reported in clinical trials of interventions for elbow disorders
The aim of this systematic review is to identify outcome domains used in clinical trials of interventions for elbow disorders. The outcome domains identified by this systematic review will be used as the domains to be scored in the Delphi survey (step 2).
Step 2: Delphi survey on outcome domains in clinical trials of interventions for elbow disorders
The outcome domains identified during the systematic review on outcome domains reported in randomized trials of interventions for elbow disorders (step 1) will be rated regarding their importance during a multinational Delphi survey. An international panel consisting of clinicians, patients and researchers will be recruited for this purpose.
Step 3: Systematic review on measurement instruments in clinical trials of interventions for elbow disorders for outcome domains defined during the Delphi survey
The aim of this systematic review is to identify measurement instruments which can be used to measure the outcome domains as consented during the Delphi survey on outcome domains in randomized trials of interventions for elbow disorders (Step 2). For this systematic review we will follow the consensus-based guideline proposed by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) in cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The result of this review will be a list of candidate measurement instruments of potential use for measurement of the outcome domains as consented during step 2.
Step 4: Delphi survey on measurement instruments in clinical trials of interventions for elbow disorders
The measurement instruments identified during the systematic review on measurement instruments in randomized trials of interventions for elbow disorders (step 3) will be rated regarding their importance during a multinational Delphi survey. All participants from the Delphi survey on outcome domains (step 2) will be invited to participate. For each outcome domain as consented during step 2, at least one measurement instrument needs to be proposed. In case one of the consented outcome domains is not covered by at least one measurement instrument, a new measurement instrument needs to be developed and validated in a prospective study as recommend. In such a case, a preliminary Core Outcome Measurement Set will be consented during step 4.
Step 5: Core Outcome Measurement Sets for clinical trials of interventions for elbow disorders
Depending from funding a face-to-face meeting of all COSed group members, but at least with representatives from key stakeholder groups, will be arranged for discussion of the results of the previous steps to agree a final core set and undertake additional voting if needed. When all domains have at least one applicable instrument (agreement on how to measure), the COS for clinical trials of interventions for elbow disorders is finalized.


Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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