Roulla Katiri1,2,3, Deborah A Hall1,3,4, Catherine F Killan1,3,5, Sandra Smith1,3, Pattarawadee Prayuenyong1,3,6, Pádraig T Kitterick7,8,9. 1. National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU, UK. 2. Department of Audiology, Mater Misericordiae University Hospital, Dublin, D07 R2WY, Ireland. 3. Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK. 4. University of Nottingham Malaysia, Jalan Broga, 43500, Semenyih, Selangor Darul Ehsan, Malaysia. 5. Yorkshire Auditory Implant Service, Bradford Teaching Hospitals Foundation NHS Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. 6. Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. 7. National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU, UK. padraig.kitterick@nottingham.ac.uk. 8. Hearing Sciences, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK. padraig.kitterick@nottingham.ac.uk. 9. Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH, UK. padraig.kitterick@nottingham.ac.uk.
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 as follows: (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. TRIAL REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): Registration Number CRD42018084274 . Registered on 13 March 2018, last revised on 7th of May 2019.
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 as follows: (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. TRIAL REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): Registration Number CRD42018084274 . Registered on 13 March 2018, last revised on 7th of May 2019.
Authors: Wilhelm Wimmer; Nicolas Gerber; Jérémie Guignard; Patrick Dubach; Martin Kompis; Stefan Weber; Marco Caversaccio Journal: Eur Arch Otorhinolaryngol Date: 2014-03-14 Impact factor: 2.503
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Authors: 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 Journal: Trials Date: 2022-09-08 Impact factor: 2.728