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Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts, and trials: Adherence to the SPIRIT
Joshua S Suppree1,2, Sophia Hart2, Sumirat M Keshwara2
1School of Medicine, University of Liverpool, Liverpool, UK.
Insights
Reporting quality for pediatric neuro-oncology clinical trial protocols and results needs improvement, especially in randomization and blinding. This study assessed adherence to SPIRIT and CONSORT guidelines.
Area of Science:
- Oncology
- Clinical Trials
- Methodology
Background:
- Comprehensive reporting of clinical trial activity is crucial.
- SPIRIT 2013 and CONSORT 2010 statements guide reporting for protocols and results, respectively.
- Assessing reporting quality in pediatric neuro-oncology is essential.
Purpose of the Study:
- To evaluate the reporting quality of pediatric neuro-oncology trial protocols.
- To assess the reporting quality of pediatric neuro-oncology trial result articles.
- To identify areas for improvement in trial reporting.
Main Methods:
- Methodological review of published pediatric brain tumor trial protocols and phase II/III result articles.
- Searches conducted across 4 electronic bibliographic databases.
- Assessment using SPIRIT 2013, CONSORT 2010, and CONSORT-A checklists.
Main Results:
- Nine trial protocols, 68 phase II, and 8 phase III result articles were analyzed.
- Mean adherence to SPIRIT for protocols was 76.8%.
- Adherence to CONSORT for phase II and III results was 71.3% and 70.3%, respectively. Abstract adherence to CONSORT-A was lower (67.4% for phase II, 47.5% for phase III).
Conclusions:
- Pediatric neuro-oncology trial reporting quality requires enhancement.
- Areas needing improvement include randomization and blinding.
- Findings align with previous assessments of adult neuro-oncology trial reporting.
Background:
It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles.
Methods:
Published trial protocols and phase II/III trial result articles relating to pediatric brain tumors (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article.
Results:
Nine trial protocols, 68 phase II trials, and 8 phase III trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials.
Conclusions:
The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.
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