Core Outcome Measures in Effectiveness Trials

Developing a global consensus on outcome measures for clinical trials in tinnitus: the COMiT initiative (Core Outcome Measures in Tinnitus)

General Information

Summary:
In Europe alone, over 70 million people experience tinnitus. For seven million of those, it is a debilitating condition. Despite its considerable socioeconomic relevance, progress in developing successful treatments for tinnitus has been somewhat limited. Treatment effectiveness is judged according to its effect on a primary (and secondary) outcome measures. But since tinnitus is a subjective condition the definition of outcomes is challenging and it remains unclear which distinct aspects (‘domains’) of tinnitus are most relevant for assessment. Currently, there is no accepted minimum outcome reporting standard for clinical trials in tinnitus. In 2006, a consensus meeting of the Tinnitus Research Initiative recommended using one of four standard questionnaires for tinnitus severity as an outcome. The rationale for this choice was motivated by pragmatism (e.g. availability in different language translations). Our initiative takes a new approach motivated by clinimetrics; first determining what to measure before seeking to determine how to measure it.

Deciding which outcomes should be core outcomes requires a great deal of discussion and so lends itself well to international effort. We will involve people who experience tinnitus as well as professional stakeholder groups. We have defined a programme of collaborative effort which starts with three projects to define a Core Domain Set for clinical trials of tinnitus. We will use a mixed methods approach. The first step is a systematic review which will establish which outcome domains and outcome instruments have been measured in recent registered and published clinical trials. This information will be used to inform the next step in which patients and clinicians will participate in an iterative consensus exercise known as a Delphi survey to refine the contents of the Core Domain Set.

International agreement on a core set would drive up the quality and relevance of research by ensuring that the most relevant outcomes are consistently measured and reported in trials relating to tinnitus.

Protocol: https://www.ncbi.nlm.nih.gov/pubmed/28835261

Contributors:
Principal investigator: Deborah Hall, National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit, Nottingham, UK

Contributors so far include:

• Yossi Arzouan, Beit Berl College, Israel
• Angel Batuecas-Caletrio, University Hospital of Salamanca, Spain
• Christopher Cederroth, Karolinska Institutet, Stockholm, Sweden
• Rilana Cima, Maastrict University, Netherlands
• Haúla Haider, Hospital Cuf Infante Santo, Lisbon, Portugal
• Veronica Kennedy and Shailaja Kottapalli, Bolton NHS Foundation Trust, UK
• Dimitris Kikidis, National and Kapodistrian University of Athens, Greece
• Berthold Langguth, University Hospital Regensburg, Germany
• Pia Lau, University of Münster, Germany
• Marzena Mielczarek, Medical University of Lodz, Poland
• Birgit Mazurek, Agnieszka Szczepek and Petra Brüggemann, Charité University Hospital, Germany
• Susanne Nemholt, University of Southern Denmark, Denmark
• Arnaud Norena, Université Aix-Marsaille, France
• Ozolem Sengoz Sirin, Mehmet Akif Ersoy University, Turkey
• Sarah Rabau, Antwerp University Hospital, Belgium
• Deborah Hall, Dean Thompson, Kathryn Fackrell and Julie Jones-Diette, National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit, Nottingham, UK

Further Study Information

Current Stage:
Ongoing
Date:
November 2014 - May 2018
Funding source(s):
EU COST Action BM1306: Better understanding the heterogeneity of tinnitus to improve and develop new treatments TINNET, http://tinnet.tinnitusresearch.net

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Tinnitus

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Delphi process
Literature review
Systematic review

Our methodological approach is outlined in the following publication:
Hall et al. Trends in Hearing, 2015, 19:1-7.
DOI: 10.1177/2331216515580272 (see linked paper)

(1) The aim of the first step is to contribute to the development of a Core Domain Set for controlled trials on tinnitus treatment effectiveness using quantitative data collected from ongoing registered or published trials since the 2006 consensus meeting. A systematic review will establish which outcome domains and outcome instruments have been measured. The research question is “What are the current reported outcome domains in studies of adults with a focus on the treatment of tinnitus?”
PROSPERO registration number: CRD42015017525

(2) The aim of the second step is to contribute to the development of a Core Domain Set for controlled trials on tinnitus treatment effectiveness using qualitative data collected from people who experience tinnitus. A scoping review will map out what is known about which domains of functioning and disability are reported by people who experience tinnitus. The research question is: ‘“Why is tinnitus a problem for you?”

These pieces of information will be used to inform the third step in which patients and clinicians will participate in an iterative consensus exercise known as a Delphi survey to refine the contents of the Core Domain Set by voting and agreeing about what domains are important and should be included in all relevant clinical trials.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Device manufacturers
Funders
Health insurance company representatives
Journal editors
Patient/ support group representatives
Pharmaceutical industry representatives
Regulatory agency representatives
Researchers
Service commissioners

Study Type

COS for clinical trials or clinical research

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