What is it about?
Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken was between 2001 and 2017. English-language RCTs on children younger than 21 years with Type 1 DM were selected excluding studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Out of 11 816 unique references, 231 studies were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events.
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Why is it important?
Systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) have been observed to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM has been shown to be lacking in our systemic review. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials.
Perspectives
The results of this systematic review underscore the potential opportunities for improving the quality of reporting in paediatric clinical trials relating to diabetes. It is important for journals that endorse CONSORT to ensure that authors and reviewers use the checklist to confirm reporting of main components of RCTs is complete and transparent. To be of most use to clinicians and policy-makers, trials in this field would benefit from improved reporting of primary outcomes and adverse events. In addition, development of a core outcome set (to reduce heterogeneity in primary outcome measurements) and using outcome measurement instruments that are valid and reliable and reported as such are of great importance to support quality meta-analysis leading to more precise and unbiased findings.
Dr Muhammad Zafar Iqbal Hydrie
Baqai Medical University
Read the Original
This page is a summary of: Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review, BMJ Open, December 2017, BMJ,
DOI: 10.1136/bmjopen-2016-014610.
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