One size does not fit all: developing common standards for outcomes in early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions for chronic subjective tinnitus in adults

Hall, Deborah Ann; Hibbert, Alice; Smith, Harriet; Haider, Haula Faruk; Londero, Alain; Mazurek, Birgit; Fackerell, Kathryn; Core Outcome Measures in Tinnitus (COMiT)

Abstract

Good practice in clinical trials advocates common standards for assessing and reporting condition-specific complaints (‘outcome domains’). For tinnitus there is no common standard. The COMiT’ID study created recommendations that are relevant to the most common intervention approaches for chronic subjective tinnitus in adults using consensus methods. Here, the objectives were to examine why it is important to tailor outcome domain selection to the tinnitus intervention which is being evaluated in the clinical trial, and to demonstrate that the COMiT’ID recommendations are robust. The COMiT’ID study used an online three-round Delphi method with three separate surveys for sound-, psychology- and pharmacology-based interventions. Survey data were analysed to assess quality and confidence in the consensus achieved across surveys and stakeholder groups, and between survey rounds. Results found participants were highly discriminatory in their decision-making. Of the 34 outcome domains reaching the prespecified consensus definition in the final round, 17 (50%) were unique to one intervention, while only 12 (35%) were common to all three. Robustness was demonstrated by an acceptable level of agreement across and within stakeholder groups, across survey rounds, across medical specialties (for the healthcare practitioners), and across healthcare users with varying tinnitus duration. There were few dissenting voices and results showed no attrition bias. In conclusion, there is compelling evidence that one set of outcomes does not fit all therapeutic aims. Our analyses evidence robust decisions by the e-Delphi process, leading to recommendations for three unique interventionspecific outcome domain sets. This provides an important starting point for standardisation.

Citation

Hall, D. A., Hibbert, A., Smith, H., Haider, H. F., Londero, A., Mazurek, B., …Core Outcome Measures in Tinnitus (COMiT). (2019). One size does not fit all: developing common standards for outcomes in early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions for chronic subjective tinnitus in adults. Trends in Hearing, 23, 1-16. https://doi.org/10.1177/2331216518824827

• Journal Article Type: Article
• Acceptance Date: Dec 21, 2018
• Online Publication Date: Jan 29, 2019
• Publication Date: Jan 31, 2019
• Deposit Date: Jan 14, 2019
• Publicly Available Date: Jan 15, 2019
• Journal: Trends in Hearing
• Electronic ISSN: 2331-2165
• Publisher: SAGE Publications
• Peer Reviewed: Peer Reviewed
• Volume: 23
• Pages: 1-16
• DOI: https://doi.org/10.1177/2331216518824827
• Keywords: Assessment; Patient reported outcome measures; Treatment Effectiveness; Stakeholder Agreement
• Public URL: https://nottingham-repository.worktribe.com/output/1442963
• Publisher URL: https://journals.sagepub.com/doi/10.1177/2331216518824827