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Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review
Samaneh Khanpour Ardestani1, Mohammad Karkhaneh1, Hai Chuan Yu1
1CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Insights
Reporting of primary outcomes and adverse events in pediatric type 1 diabetes mellitus (T1DM) randomized clinical trials (RCTs) needs improvement. Many RCTs fail to clearly state primary outcomes or report adverse events, hindering evidence synthesis.
Area of Science:
- Pediatric Endocrinology
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Type 1 diabetes mellitus (T1DM) is a chronic condition affecting children and adolescents.
- Randomized clinical trials (RCTs) are crucial for evaluating interventions in pediatric T1DM.
- Standardized and transparent reporting of trial outcomes is essential for clinical decision-making.
Purpose of the Study:
- To systematically review RCTs in pediatric T1DM.
- To assess the reporting quality of primary outcomes, outcome measurement properties, and adverse events.
- To identify areas for improvement in trial reporting.
Main Methods:
- Systematic review of English-language RCTs on pediatric T1DM (children < 21 years).
- Searches conducted in major databases (MEDLINE, EMBASE, CINAHL, Cochrane) from 2001-2017.
- Exclusion of studies on diagnostic tools, multiple phase studies, protocols, and secondary analyses.
Main Results:
- 231 RCTs were included; 50.6% failed to report primary outcomes.
- Of those reporting primary outcomes, 77.2% reported one, and 22.8% reported multiple.
- Adverse events were reported in 45.5% of trials, not identified in 16.9%, and unreported in 37.7%.
Conclusions:
- Significant deficiencies exist in reporting primary outcomes in pediatric T1DM RCTs.
- Reporting of adverse events in pediatric T1DM interventions is often inadequate.
- Improved transparency in reporting primary outcomes, measurement properties, and adverse events is necessary for pediatric T1DM trials.
Objective:
Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events.
Methods:
Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data.
Results:
Of 11 816 unique references, 231 T1DM RCTs 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.
Conclusion:
Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. 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.
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