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- Title
Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts, and trials: Adherence to the SPIRIT and CONSORT statements.
- Authors
Suppree, Joshua S; Hart, Sophia; Keshwara, Sumirat M; Krishna, Sandhya Trichinopoly; Gillespie, Conor S; Richardson, George E; Mustafa, Mohammad A; Mallucci, Conor L; Pizer, Barry; Hayden, James; Islim, Abdurrahman I; Jenkinson, Michael D; Millward, Christopher P
- Abstract
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.
- Publication
Neuro-Oncology Practice, 2024, Vol 11, Issue 5, p617
- ISSN
2054-2577
- Publication type
Article
- DOI
10.1093/nop/npae042