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Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults
BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluatin...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4888312/ https://www.ncbi.nlm.nih.gov/pubmed/27250987 http://dx.doi.org/10.1186/s13063-016-1399-9 |
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author | Hall, Deborah A. Haider, Haula Szczepek, Agnieszka J. Lau, Pia Rabau, Sarah Jones-Diette, Julie Londero, Alain Edvall, Niklas K. Cederroth, Christopher R. Mielczarek, Marzena Fuller, Thomas Batuecas-Caletrio, Angel Brueggemen, Petra Thompson, Dean M. Norena, Arnaud Cima, Rilana F. F. Mehta, Rajnikant L. Mazurek, Birgit |
author_facet | Hall, Deborah A. Haider, Haula Szczepek, Agnieszka J. Lau, Pia Rabau, Sarah Jones-Diette, Julie Londero, Alain Edvall, Niklas K. Cederroth, Christopher R. Mielczarek, Marzena Fuller, Thomas Batuecas-Caletrio, Angel Brueggemen, Petra Thompson, Dean M. Norena, Arnaud Cima, Rilana F. F. Mehta, Rajnikant L. Mazurek, Birgit |
author_sort | Hall, Deborah A. |
collection | PubMed |
description | BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Registered on 12 March 2015 revised on 15 March 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4888312 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-48883122016-06-02 Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults Hall, Deborah A. Haider, Haula Szczepek, Agnieszka J. Lau, Pia Rabau, Sarah Jones-Diette, Julie Londero, Alain Edvall, Niklas K. Cederroth, Christopher R. Mielczarek, Marzena Fuller, Thomas Batuecas-Caletrio, Angel Brueggemen, Petra Thompson, Dean M. Norena, Arnaud Cima, Rilana F. F. Mehta, Rajnikant L. Mazurek, Birgit Trials Research BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Registered on 12 March 2015 revised on 15 March 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users. BioMed Central 2016-06-01 /pmc/articles/PMC4888312/ /pubmed/27250987 http://dx.doi.org/10.1186/s13063-016-1399-9 Text en © Hall et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Hall, Deborah A. Haider, Haula Szczepek, Agnieszka J. Lau, Pia Rabau, Sarah Jones-Diette, Julie Londero, Alain Edvall, Niklas K. Cederroth, Christopher R. Mielczarek, Marzena Fuller, Thomas Batuecas-Caletrio, Angel Brueggemen, Petra Thompson, Dean M. Norena, Arnaud Cima, Rilana F. F. Mehta, Rajnikant L. Mazurek, Birgit Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title | Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title_full | Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title_fullStr | Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title_full_unstemmed | Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title_short | Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
title_sort | systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4888312/ https://www.ncbi.nlm.nih.gov/pubmed/27250987 http://dx.doi.org/10.1186/s13063-016-1399-9 |
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