TY - JOUR
T1 - 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’)
AU - Katiri, Roulla
AU - Hall, Deborah A.
AU - Killan, Catherine F.
AU - Smith, Sandra
AU - Prayuenyong, Pattarawadee
AU - Kitterick, Pádraig T.
N1 - Funding Information:
We would like to acknowledge contributions from Nicholas Hogan and Nora Buggy, collaborators with lived experience of SSD and Adele Horobin, Patient and Public Involvement manager whose viewpoints during workshop discussions have guided outcome domains categorisation. Many thanks to Henryk Faas, Assistant Professor in Neuroimaging, Sir Peter Mansfield Imaging Centre, School of Medicine, University of Nottingham who has assisted with the systematic review qualitative synthesis of publications in German. The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.
Funding Information:
The main body of work for this project is funded by the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), funding reference number BRC-1215-20003. Additional grants obtained: Graham Fraser Foundation Travel Grant to attend the 15th International Conference on Cochlear Implants and other Implantable Auditory Technology (Ci2018.org), where the study was first launched. Oticon Medical™ provided funding to purchase the DelphiManager software from the COMET Initiative, University of Liverpool. DAH is an NIHR Senior Investigator. The funding bodies have no role in the study design and implementation, writing the report, or decision to submit the report for publication.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/3/20
Y1 - 2021/3/20
N2 - 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.
AB - 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.
KW - Clinical trial design
KW - Hearing interventions
KW - Measurement instruments
KW - Outcome domains
KW - Single-sided deafness
UR - http://www.scopus.com/inward/record.url?scp=85103219308&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05160-5
DO - 10.1186/s13063-021-05160-5
M3 - Review article
C2 - 33743802
AN - SCOPUS:85103219308
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
M1 - 220
ER -