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’)

Katiri, Roulla; Hall, Deborah A.; Killan, Catherine F.; Smith, Sandra; Prayuenyong, Pattarawadee; Kitterick, P�draig T.

Abstract

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 Prospective
Register of Systematic Reviews): Registration Number CRD42018084274. Registered on 13th of March 2018, last revised on 7th of May 2019.

Citation

Katiri, R., Hall, D. A., Killan, C. F., Smith, S., Prayuenyong, P., & Kitterick, P. T. (2021). 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’). Trials, 22, Article 220. https://doi.org/10.1186/s13063-021-05160-5

• Journal Article Type: Review
• Acceptance Date: Feb 27, 2021
• Online Publication Date: Mar 20, 2021
• Publication Date: Mar 20, 2021
• Deposit Date: Mar 4, 2021
• Publicly Available Date: Mar 20, 2021
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 22
• Article Number: 220
• DOI: https://doi.org/10.1186/s13063-021-05160-5
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://nottingham-repository.worktribe.com/output/5366875
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05160-5