What are the current reported outcome domains in studies of adults with a focus on the treatment of tinnitus?
Cochrane Central Register of Controlled Trials (CENTRAL)
Types of study to be included
Inclusion: Meta-analysis, Systematic review, Randomised controlled trials, Before and after studies, Non-randomised controlled trials/Case controlled study, Cohort study
Exclusion: Opinion articles, Practice guidelines, Expert opinions, Case series, Case reports, Book chapters, Conference papers, manufacturers’ articles and other grey literature, Animal studies, Non-English language articles.
Condition or domain being studied
Inclusion: adults with tinnitus (=18 years, male and female)
All interventions for tinnitus
The purpose of this systematic review is not to assess the quality of clinical trials of tinnitus nor is it to synthesize the findings of these studies. Instead, our systematic review seeks to produce a list of the outcome domains and outcome instruments used in clinical trials of tinnitus. A subsequent Delphi survey will seek consensus on what should be measured as a core domain set.
All outcomes related to tinnitus will be considered. We will create a comprehensive list of outcome domains and outcome instruments used in clinical trials of tinnitus in the past 10 years.
Data extraction, (selection and coding)
1. Two independent reviewers will examine the titles and abstracts of the citations obtained from the search. The full text will be retrieved from the potentially relevant citations, 2. Both reviewers will reach consensus on
relevant papers. Would this be problematic, a third reviewer will be consulted. 3. All retrieved documents will be saved in pdf version. The extracted data will include but is not limited to: Article reference - Study design - Outcome domains that were measured - Outcome instruments.
Risk of bias (quality) assessment
The data collection for consolidated records will enable summary statistics and a narrative synthesis about selective outcome reporting (reporting bias) either where original descriptions of outcomes as ‘primary’ or ‘secondary’ may have been altered retrospectively in the light of the findings, or where a subset of the original outcomes may have been selected, on the basis of the results, for inclusion in the publication of trial findings.
Strategy for data synthesis
The identified outcome measurement domains and outcome measurement instruments will be tabulated and analysed using descriptive statistics.
Analysis of subgroups or subsets
If there is sufficient extracted data, we will explore the effects of subtypes of tinnitus on the choice of outcome domains and the instruments.
The authors have published the full systematic review protocol before completing the actual review.
Hall DA, Szczepek A, Kennedy V, Haider H (2015) Current reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review. BMJ Open Nov;5:e009091. doi:10.1136/bmjopen-2015-009091
Professor Deborah Hall, University of Nottingham, UK Dr Agnieszka Szczepek, CHarite University Hospital Berlin, Germany Dr Veronica Kennedy, Bolton NHS Foundation Trust, UK Ms Shailaja Kottapalli, Bolton NHS Foundation Trust, UK Dr Haula Haider, Hospital Cuf Infante Santo, Lisbon, Portugal
, TINNET working group 5
Details of any existing review of the same topic by the same authors
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.