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      Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

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          Abstract

          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.

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          Most cited references24

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          Development of the Tinnitus Handicap Inventory.

          To develop a self-report tinnitus handicap measure that is brief, easy to administer and interpret, broad in scope, and psychometrically robust. A standardization study of a self-report tinnitus handicap measure was conducted to determine its internal consistency reliability and convergent and construct validity. Audiology clinics in tertiary care centers in two sites. In the first investigation, 84 patients reporting tinnitus as their primary complaint or secondary to hearing loss completed the 45-item alpha version of the Tinnitus Handicap Inventory (THI). In the second investigation, 66 subjects also reporting tinnitus completed the 25-item beta version. Convergent validity was assessed using another measure of perceived tinnitus handicap (Tinnitus Handicap Questionnaire). Construct validity was assessed using the Beck Depression Inventory, Modified Somatic Perception Questionnaire, symptom rating scales (annoyance, sleep disruption, depression, and concentration), and perceived tinnitus pitch and loudness judgments. From the alpha version of the THI, we derived a 25-item beta version with the items grouped into functional, emotional, and catastrophic subscales. The total scale yielded excellent internal consistency reliability (Cronbach's alpha = .93). No significant age or gender effects were seen. Weak correlations were observed between the THI and the Beck Depression Inventory, Modified Somatic Perception Questionnaire, and pitch and loudness judgments. Significant correlations were found between the THI and the symptom rating scales. The THI is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living.
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            Consensus for tinnitus patient assessment and treatment outcome measurement: Tinnitus Research Initiative meeting, Regensburg, July 2006.

            There is widespread recognition that consistency between research centres in the ways that patients with tinnitus are assessed and outcomes following interventions are measured would facilitate more effective co-operation and more meaningful evaluations and comparisons of outcomes. At the first Tinnitus Research Initiative meeting held in Regensburg in July 2006 an attempt was made through workshops to gain a consensus both for patient assessments and for outcome measurements. It is hoped that this will contribute towards better cooperation between research centres in finding and evaluating treatments for tinnitus by allowing better comparability between studies.
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              The psychometric properties of a tinnitus handicap questionnaire.

              The psychometric properties of a tinnitus handicap questionnaire are reported. There were two phases in this study. In Phase I, 87 questions were administered to 100 tinnitus patients. From their responses, 59 items that were either redundant, insensitive, or had low item-total correlations were eliminated. In Phase II, the resulting 27-item questionnaire was administered to 319 patients. Fifty-three of these patients also completed psychological and psychophysical measures that were used to validate the questionnaire. A factor analysis of patients' responses revealed a three-factor structure. These three factors appeared to reflect the physical, emotional, and social consequences of tinnitus (Factor 1), hearing ability of the patient (Factor 2), and the patients' view of tinnitus (Factor 3). Although the 27-item questionnaire had high internal consistency reliability and validity as reflected by correlations with life satisfaction and depression scales, it is recommended that only the items on the Factor 1 and the Factor 2 subscales be scored because of the low internal consistency reliability of the Factor 3 subscale. This questionnaire can be used to compare a patient's tinnitus handicap with the norm, identify specific areas of handicaps, and to monitor a patient's progress with particular treatment programs.
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                Author and article information

                Contributors
                +44 (0) 115 8232600 , deborah.hall@nottingham.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                1 June 2016
                1 June 2016
                2016
                : 17
                : 270
                Affiliations
                [ ]National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit, Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU UK
                [ ]Otology and Hearing Group, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK
                [ ]ENT Department of Hospital Cuf Infante Santo – Nova Medical School, Travessa do Castro 3, 1350-070 Lisbon, Portugal
                [ ]Department of Otorhinolaryngology, Charite University Hospital, Chariteplatz 1, 10117 Berlin, Germany
                [ ]Institute of Biomagnetism and Biosignalanalysis, University Hospital Münster, Malmedyweg 15, 48149 Münster, Germany
                [ ]Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium
                [ ]Centre for Reviews and Dissemination, University of York, York, YO10 5DD UK
                [ ]Service ORL et CCF, Consultation Acouphène et Hyperacousie, Hôpital Européen G. Pompidou, 20, rue Leblanc, 75015 Paris, France
                [ ]Experimental Audiology, Department of Physiology and Pharmacology, Karolinska Institutet, Von Eulers väg 8, 171 77 Stockholm, Sweden
                [ ]Department of Otolaryngology, Laryngological Oncology, Audiology and Phoniatrics, |Medical University of Lodz, 90-549 Lodz, 113 Zeromskiego Street, Lodz, Poland
                [ ]Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Universiteitssingel 40, PO Box 616, 6200 MD Maastricht, The Netherlands
                [ ]Adelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 CC Hoensbroek, The Netherlands
                [ ]Department of Otorhinolaryngology, IBSAL, University Hospital of Salamanca, Paseo San Vicente 58-182, 37007 Salamanca, Spain
                [ ]Tinnitus Center, Charite University Hospital, Chariteplatz 1, 10117 Berlin, Germany
                [ ]Laboratory of Adaptive and Integrative Neuroscience, Centre National de la Recherche Scientifique, Fédération de Recherche 3C, Aix-Marseille Université, Marseille, France
                Article
                1399
                10.1186/s13063-016-1399-9
                4888312
                27250987
                4f1c88cc-43ea-415d-b4e8-5f1788dc189c
                © 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.

                History
                : 12 February 2016
                : 14 May 2016
                Funding
                Funded by: EU COST Action
                Categories
                Research
                Custom metadata
                © The Author(s) 2016

                Medicine
                adult otolaryngology,audiology,clinical trials,methods
                Medicine
                adult otolaryngology, audiology, clinical trials, methods

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