Core Outcome Measures in Effectiveness Trials

The COMiT’ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology- Based Interventions for Chronic Subjective Tinnitus in Adults

General Information

Abstract:
Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews

Authors:
Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, Londero A, Mazurek B, Thacker B, Fackrell K; for the Core Outcome Measures in Tinnitus (COMiT) initiative.

Publication

Journal:
Trends in Hearing
Volume:
22
Issue:
Pages:
1 - 16
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):
This work was primarily funded through the NIHR Nottingham Biomedical Research Centre and European Cooperation in Science and Technology Action (BM1306). 14 Trends in Hearing D. A. H. is an NIHR senior investigator. Small research grants were awarded by Action on Hearing Loss to purchase relevant software licenses and to create the Introduction video described in this article, and British Tinnitus Association to support Public Research Partner Involvement. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the article. The views expressed in this article are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care.

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Tinnitus

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any
Drug
Psychological & behavioural

Method(s)

Consensus meeting
Delphi process
Systematic review

The first phase comprised three Delphi surveys to prioritize outcome domains for each family of interventions. These used three rounds of
questions and were delivered online (e-Delphi) to engage a large number of international stakeholders. The second phase involved structured face-to-face meetings with a smaller subset of stakeholders, allowing for in depth conversation to reduce the priority list to a core set. The third and final phase widened input to all consented stakeholders inviting them to vote on the intervention specific recommendations.


Stakeholders Involved

Clinical experts
Consumers (patients)
Funders
Pharmaceutical industry representatives
Researchers

Study Type

COS for clinical trials or clinical research

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