MyMedR

Displaying all 5 publications

Abstract:

Sort:

Fulltext Defining Symptom Concepts in Chronic Subjective Tinnitus: Web-Based Discussion Forum Study

Hibbert A, Vesala M, Kerr M, Fackrell K, Harrison S, Smith H, et al.

Interact J Med Res, 2020 Jan 07;9(1):e14446.
PMID: 31909716 DOI: 10.2196/14446

BACKGROUND: A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) that should be assessed and reported in all clinical trials as this enables comparisons to be made across studies as well as data pooling for meta-analysis.
OBJECTIVE: This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified.
METHODS: A series of 5 focus group-style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders.
RESULTS: The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case.
CONCLUSIONS: The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.
Fulltext Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study

Labree B, Hoare DJ, Fackrell K, Hall DA, Gascoyne LE, Sereda M

Trials, 2022 Dec 21;23(1):1039.
PMID: 36539777 DOI: 10.1186/s13063-022-07020-2

BACKGROUND: Tinnitus is the awareness of a sound in the ear or head in the absence of an external source. It affects around 10-15% of people and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus. This study seeks to address this by establishing a Core Domain Set: a common standard of what specific tinnitus-related complaints are critical and important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus.
METHODS: A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience.
DISCUSSION: This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.
Fulltext 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 DA, Hibbert A, Smith H, Haider HF, Londero A, Mazurek B, et al.

Trends Hear, 2019;23:2331216518824827.
PMID: 30803389 DOI: 10.1177/2331216518824827

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 Core Outcome Measures in Tinnitus International Delphi (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 that 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 analyzed 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 health-care practitioners), and across health-care 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 electronic Delphi process, leading to recommendations for three unique intervention-specific outcome domain sets. This provides an important starting point for standardization.
Fulltext Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials: Formative Feedback Study

Katiri R, Hall DA, Hoare DJ, Fackrell K, Horobin A, Buggy N, et al.

JMIR Form Res, 2021 Aug 19;5(8):e28878.
PMID: 34420915 DOI: 10.2196/28878

BACKGROUND: Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study.
OBJECTIVE: This study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol.
METHODS: The study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome.
RESULTS: Overall, 98% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day.
CONCLUSIONS: Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs.
Fulltext 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

Hall DA, Smith H, Hibbert A, Colley V, Haider HF, Horobin A, et al.

Trends Hear, 2018;22:2331216518814384.
PMID: 30488765 DOI: 10.1177/2331216518814384

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.