Which outcome measures are reported by clinical trials investigating OME treatment? A case for standardised reporting
Section snippets
Background
Otitis media with effusion (OME) is one of the commonest reasons why children visit their doctor and undergo surgery in the developed world [1]. In addition to its effects on the patients and their families, there is a large economic cost, associated both with treatment as well as lost days at school and work. In the USA alone, OME has been estimated to cost in the region of US$3–5 billion annually [2], [3]. It is therefore important that future management of the condition is informed by
Methods
A literature review was carried out using PUBMED database, including studies published between 1980 and 2013. This range was chosen so as to capture a large range of studies for comparison, and to highlight any obvious change in outcome measures over time. Although older studies might contain additional outcomes, this is deemed unlikely. All original human studies with participants of any age, written in English, which reported on either surgical or non-surgical treatments for OME were
Results
The initial search returned 17,158 titles, with 171 studies eventually determined to be relevant and included (Fig. 1). The studies originated from 31 different countries: USA (55 studies), UK (44), Netherlands (9), Denmark (8), Japan (6), 5 each from Italy and Sweden, 4 each from Canada and Turkey, 3 each from Belgium, New Zealand and Norway, 2 each from Australia, Israel and Poland, and 1 study each from Bulgaria, Brazil, China, Finland, Germany, Greece, India, Iran, Jordan, Malaysia,
Discussion
A total of 171 studies were included in this study aiming to determine what outcome measures are reported in trials of OME treatment. They varied in study design and size, however the data collected for this review were focused on the outcomes that they had used to evaluate the success of the specific treatment. A wide range of different OME treatment outcome measures were reported, with 12 broad treatment outcome categories identified. In addition to the wide range of outcome measures used,
Conclusion
OME treatment trials report a wide range of measures, with different studies choosing different outcomes. 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.
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Cited by (2)
A core outcome set for research on the management of otitis media with effusion in otherwise-healthy children
2020, International Journal of Pediatric OtorhinolaryngologyCitation Excerpt :Our long list was developed from following three sources. Our previously published systematic review [11] which extracted data on which outcomes were reported by studies investigating OME treatment. Analysis of questionnaires developed for the assessment of children with OME (OM-6 and OMQ14), extracting outcomes contained in those questionnaires.
Quality of questionnaires for the assessment of otitis media with effusion in children
2018, Clinical Otolaryngology