Background
Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions.
Methods
A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting.
Results
The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set.
Conclusions
Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.
Roulla Katiri, Deborah A. Hall, Derek J. Hoare, Kathryn Fackrell, Adele Horobin, Nicholas Hogan, Nóra Buggy, Paul H. Van de Heyning, Jill B. Firszt, Iain A. Bruce & Pádraig T. Kitterick for the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) initiative
Disease Category: Ear, nose, & throat
Disease Name: Single Sided Deafness (SSD), Unilateral Hearing Loss
Age Range: 16 - 100
Sex: Either
Nature of Intervention: Device, Other, Procedure
- Charities
- Clinical experts
- Conference participants
- Consumers (patients)
- Device manufacturers
- Economists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
SSD interventions that seek to restore hearing: Contralateral Routing of Sounds (CROS) aids, Bone Conduction Hearing Aids (BAHA), Middle Ear Implants (MEI) and Cochlear Implants (CI).
Our methods for developing a set of minimum standards will follow the Core Outcome Measures in Effectiveness Trials (COMET) Handbook version 1.0 recommendations:
1)The published literature reporting interventions for SSD will be systematically reviewed to identify what outcome domains and what measurement instruments have been used already.
2)The patient perspective will be explored using a range of qualitative methods.
3)Key stakeholders will be invited to participate in an interactive online consensus exercise known as a Delphi Survey; aiming to identify which outcome domains are critical and important for evaluating SSD interventions.
4)A subgroup of the stakeholders will be invited to an interactive consensus meeting to discuss the recommendations arising from the Delphi survey and to agree on a minimum set of outcome domains that are relevant to all intervention options and stakeholder groups.
An agreement on a set of outcome domains of what is critical and important for deciding whether an intervention is efficacious will drive up the quality and relevance of research by ensuring that the most relevant outcomes are consistently measured and reported in every clinical trial relating to SSD. On the basis of the recommended outcome domains, further research will then be needed to identify measurement instruments that assess the outcomes domains in the minimum set.