Which outcome measures are reported by clinical trials investigating OME treatment? A case for standardised reporting.
BACKGROUND
Many different OME treatment trials have been published using different outcomes measures to evaluate the success of particular interventions. We set out to identify the variation in reporting of outcome measures in OME trials that exists at present. This has been achieved by reviewing published trials to determine which outcome measures have been reported.


METHODS
The literature review was carried out using PUBMED database (1980 to 2013). Data were collected on the treatment outcomes reported, with particular focus on the methods of assessment and the number of treatment outcomes used in each study.


RESULTS
The 171 studies identified used 12 broad treatment outcome measures. The most common outcome measure was OME resolution (48%) followed by hearing level (36%). Only 95 studies used a single outcome measure, with 76 studies using between 2 and 4 outcome measures. The method of assessment varied between studies that used the same treatment outcome measures.


CONCLUSIONS
OME treatment trials report a wide range of measures and comparison across studies is thus difficult. Establishing a core set of outcome measures to be reported by all trials in the future could be useful, and would allow comprehensive comparison of different studies and minimise potential for reporting bias.
Nottingham University Hospitals, UK. Electronic address: robert.chessman@nhs.net.
Robert
R
Chessman
Nottingham University Hospitals, UK.
Tawakir
T
Kamani
Nottingham University Hospitals, UK; Otology and Hearing Group, The University of Nottingham, UK.
John P
JP
Birchall
Nottingham University Hospitals, UK; MRC Institute of Hearing Research Clinical Section, The University of Nottingham, UK.
Johanna G
JG
Barry
Nottingham University Hospitals, UK; Otology and Hearing Group, The University of Nottingham, UK.
Matija
M
Daniel
D002986:Clinical Trials as Topic; D006801:Humans; D010034:Otitis Media with Effusion / Q000628:therapy*; D017063:Outcome Assessment, Health Care
Clinical trial; Otitis media; Outcomes