Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts and trials:Adherence to the SPIRIT and CONSORT statements

IF 2.4 Q2 CLINICAL NEUROLOGY

Neuro-oncology practice Pub Date : 2024-05-11 DOI:10.1093/nop/npae042

Mr Joshua S Suppree, Miss Sophia Hart, Sumirat M. Keshwara, Miss Sandhya Trichinopoly Krishna, Conor S Gillespie, G. Richardson, M. Mustafa, Conor L Mallucci, Barry Pizer, James Hayden, A. Islim, Michael D Jenkinson, Mr Christopher P Millward

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引用次数: 0

Abstract

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. Published trial protocols and phase II/III trial result articles relating to pediatric brain tumours (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. 9 trial protocols, 68 phase II trials, and 8 phase III trial results 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. 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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评估儿科神经肿瘤学方案、摘要和试验的报告质量：遵守 SPIRIT 和 CONSORT 声明

全面、透明地报告临床试验活动至关重要。SPIRIT 2013 和 CONSORT 2010 声明分别定义了临床试验方案和随机对照试验的报告项目。本方法学综述旨在评估儿科神经肿瘤学试验方案和试验结果文章的报告质量。通过检索 4 个电子文献数据库，确定了已发表的与小儿脑肿瘤相关的试验方案和 II/III 期试验结果文章（在 SPIRIT 2013 声明发布后发表）。根据上述声明对纳入的试验方案和结果文章的报告质量进行了评估。此外，还使用 CONSORT-A 核对表评估试验结果文章的摘要。计算了每篇文章的遵守百分比。共纳入了 9 篇试验方案、68 篇 II 期试验和 8 篇 III 期试验结果文章。试验方案对 SPIRIT 声明的平均遵守率为 76.8%（SD：0.09）。II期试验摘要遵守CONSORT-A声明的平均比例为67.4%（标度：0.13），III期试验摘要遵守CONSORT-A声明的平均比例为47.5%（标度：0.09）。II期试验结果文章符合CONSORT的比例为71.3%（SD：0.10），III期试验结果文章符合CONSORT的比例为70.3%（SD：0.13）。小儿神经肿瘤学试验方案和试验结果文章的报告质量有待提高，尤其是在随机化和盲法方面。这与我们之前对成人神经肿瘤学试验方案和结果文章的报告质量进行类似评估后得出的结果一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neuro-oncology practice CLINICAL NEUROLOGY-

CiteScore

5.30

自引率

11.10%

发文量

期刊介绍： Neuro-Oncology Practice focuses on the clinical aspects of the subspecialty for practicing clinicians and healthcare specialists from a variety of disciplines including physicians, nurses, physical/occupational therapists, neuropsychologists, and palliative care specialists, who have focused their careers on clinical patient care and who want to apply the latest treatment advances to their practice. These include: Applying new trial results to improve standards of patient care Translating scientific advances such as tumor molecular profiling and advanced imaging into clinical treatment decision making and personalized brain tumor therapies Raising awareness of basic, translational and clinical research in areas of symptom management, survivorship, neurocognitive function, end of life issues and caregiving