Katiri, Roulla
(2023)
A consensus on outcome measures for device-based interventions that seek to restore bilateral and binaural hearing in adults with single-sided deafness.
PhD thesis, University of Nottingham.
Abstract
Objectives: Unilateral severe-to-profound sensorineural hearing loss (single-sided deafness, SSD) often has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms of these interventions (outcome domains) are until now reported inconsistently in clinical trials involving adults with SSD. Inconsistency in reporting of 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 product is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions. An assessment of the available measurement instruments for relevance and comprehensiveness has implications on how the outcome domains should be measured in clinical trials assessing the benefits and harms of SSD interventions.
Methods: A long list of candidate outcome domains was compiled from a systematic review of outcome domains and measurement instruments used in designs of clinical trials for SSD interventions, and published qualitative data on the psychological and social consequences of SSD in adulthood; to inform 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: 1-3 = not important in deciding whether an SSD intervention is effective, 4-6 = important but not critical, and 7-9 = critically important to measure in all trials. A domain was considered for inclusion if ≥70% of participants in all stakeholder groups (healthcare users, healthcare professionals, and clinical researchers) scored 7-9 and <15% in any stakeholder group scored 1-3. 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. Subsequent focus groups were conducted to help with domain conceptualisation, to identify themes or conceptual elements, to inform an assessment of the relevance of available measurement instruments for the core outcome domains.
Results: The first round of the survey listed 44 potential outcome domains, organised thematically in ten categories: factors related to the treatment being tested, health-related quality of life, hearing disability, other effects, physical effects, psychological effects, self, sound quality, spatial hearing, and tinnitus. 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 (knowing where you are in relation to the position of a sound source), Group conversations in noisy social situations (listening and following a conversation between a group of people, when others are talking in the background), and Impact on social situations (your hearing loss or device limiting your ability to fully participate in the social world). Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set. Three conceptual elements were identified for each outcome domain that were used to assess 76 available patient reported outcome measurement instruments. The relevance and comprehensiveness to the conceptual elements and detailed operational definitions of the outcome domains were assessed independently by three coders. The Speech, Spatial and Qualities (SSQ) scale, the Nijmegen Cochlear Implant Questionnaire (NCIQ), the Spatial Hearing Questionnaire (SHQ), the Hearing Implant Sound Quality Index (HISQUI-NL), and the Monaural auditory capacity assessment scale (MACAS) match several operational definitions in the Spatial orientation and Group conversations in noisy social situations outcome domains. The Communication profile for hearing impaired (CPHI) questionnaire was the only identified patient reported outcome measure (PROM) suitable for assessing the Impact on social situations outcome domain.
Conclusions: Adoption of the core outcome domain set will promote consistent assessment and reporting of outcomes that are meaningful and important to all stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste in clinical trials of SSD interventions. Further prospective validation of measurement instruments will provide validation data and help finalise the core outcome set for clinical trials of SSD interventions in adults.
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