Device-based interventions that seek to restore bilateral and binaural hearing in adults with single-sided deafness: a conceptual analysis

Single-sided deafness (SSD) is defined by severe-to-profound sensorineural hearing loss in one ear only. This article outlines the etiologies and associated functional, psychological, social, and other consequences of SSD in adulthood. The available hearing aids and auditory implants for SSD are described, alongside an overview of the methods adopted by clinicians and researchers to define and measure their benefits and harms. Current concepts and issues to consider in the field of rerouting and restoring device-based interventions are explored. A contemporary overview of the current challenges in outcome measurement of all available interventions in the field is also provided, and cost effectiveness of SSD interventions is discussed briefly. This article therefore proves a comprehensive summary of the current knowledge on interventions and outcome measurement for SSD for those interested or actively working in the field, and recommendations for future trials. These include recommendations on the timescale of measurements, long-term benefits (or harms), cost utility, and the use of the internationally agreed core outcome domain set for all future clinical trials of device-based interventions for SSD

The psychological and social consequences of single-sided deafness in adulthood

Objectives: This study examined the subjective psychological and social effects of highly asymmetric hearing loss (single-sided deafness) in adults. Design: Three group interviews were conducted using the critical incidence technique and analysed using an inductive thematic analysis. Study sample: Eight adults with a clinical diagnosis of a moderately-severe hearing loss or greater in one ear and normal or near-normal hearing in the other ear. Results: A range of functional hearing difficulties associated with single-sided deafness including impaired speech in background noise and reduced spatial awareness were reported to affect social and psychological well-being. Social consequences of single-sided deafness resulted from activity limitations and participation restrictions including withdrawal from and within situations. Participants reported psychological effects including worrying about losing the hearing in their other ear, embarrassment related to the social stigma attached to hearing loss, and reduced confidence and belief in their abilities to participate. Conclusions: Single-sided deafness can be associated with many negative consequences. Counselling may help overcome the psychological consequences of hearing loss regardless of whether technological support such as a hearing aid is prescribed. The audiological management of these individuals should support the development of listening strategies and set appropriate expectations for participation in everyday listening situations

Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials: Formative Feedback Study

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 makes 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: An observational study evaluated the modifications taken 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 healthcare users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experience of the 22 participating members. Feedback covered (i) pre-meeting preparation, (ii) process of facilitated discussions and voting, (iii) ability to contribute, and (iv) perceived fairness of the outcome. Results: Overall, 53 out of 54 feedback responses agreed or strongly agreed with the statements given, indicating the web-based meeting achieved its original goals of open discussion, debate, and voting to agree 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 managing the unpredictability of tasks on the day. Conclusion: 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 maximise inclusiveness, enhance geographical access, as well as to reduce research costs

The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness

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

The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness

Abstract 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

Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care

A consensus on outcome measures for device-based interventions that seek to restore bilateral and binaural hearing in adults with single-sided deafness

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

A consensus on outcome measures for device-based interventions that seek to restore bilateral and binaural hearing in adults with single-sided deafness

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

Systematic review of outcome domains and instruments used in designs of clinical trials for interventions that seek to restore bilateral and binaural hearing in adults with unilateral severe to profound sensorineural hearing loss (‘single-sided deafness’)

Background: This systematic review aimed to identify, compare and contrast outcome domains and outcome instruments reported in studies investigating interventions that seek to restore bilateral (two-sided) and/or binaural (both ears) hearing in adults with Single Sided Deafness (SSD). Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.Methods: Records were identified by searching MEDLINE, EMBASE, PubMed, CINAHL, ClinicalTrials.gov, ISRCTN, CENTRAL, WHO ICTRP and the NIHR UK clinical trials gateway. The search included records published from 1946 to March 2020. Included studies were those: a) recruiting adults aged 18 years or older diagnosed with SSD of average threshold severity worse than 70 dB HL in the worse-hearing ear and normal (or near-normal) hearing in the better-hearing ear, b) evaluating interventions to restore bilateral and/or binaural hearing, and c) enrolling those adults in a controlled trial, before-and-after study, or cross-over study. Studies that fell just short of the participant eligibility criteria were included in a separate sensitivity analysis. Results: Ninety-six studies were included (72 full inclusion, 24 sensitivity analysis). For fully-included studies, 37 exclusively evaluated interventions to re-establish bilateral hearing and 29 exclusively evaluated interventions to restore binaural hearing. Overall, 520 outcome domains were identified (350 primary and 170 secondary). Speech-related outcome domains were the most common (74% of studies), followed by spatial-related domains (60% of studies). A total of 344 unique outcome instruments were reported. Speech-related outcome domains were measured by 73 different instruments and spatial-related domains by 43 different instruments. There was considerable variability in duration of follow-up, ranging from acute (baseline) testing to 10 years after the intervention. The sensitivity analysis identified no additional outcome domains.Conclusions: This review identified large variability in the reporting of outcome domains and instruments in studies evaluating the therapeutic benefits and harms of SSD interventions. Reports frequently omitted information on what domains the study intended to assess, and on what instruments were used to measure which domains.PROSPERO Registration: The systematic review protocol is registered on PROSPERO (International ProspectiveRegister of Systematic Reviews): Registration Number CRD42018084274. Registered on 13th of March 2018, last revised on 7th of May 2019