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
{"title":"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","authors":"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","doi":"10.1093/nop/npae042","DOIUrl":null,"url":null,"abstract":"\n \n \n 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.\n \n \n \n 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.\n \n \n \n 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.\n \n \n \n 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.\n","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":null,"pages":null},"PeriodicalIF":2.4000,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts and trials:Adherence to the SPIRIT and CONSORT statements\",\"authors\":\"Mr Joshua S Suppree, Miss Sophia Hart, Sumirat M. 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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.\\n \\n \\n \\n 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.\\n \\n \\n \\n The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. 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Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts and trials:Adherence to the SPIRIT and CONSORT statements
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.
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