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肿瘤学临床实践指南与共识声明——对其方法学质量的评估

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

作者信息

Jacobs Carmel, Graham Ian D, Makarski Julie, Chassé Michaël, Fergusson Dean, Hutton Brian, Clemons Mark

机构信息

Division of Medical Oncology, The Ottawa Hospital Cancer Centre and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada; Ottawa Hospital Research Institute and University of Ottawa, Department of Medicine, Ottawa, Ontario, Canada.

出版信息

PLoS One. 2014 Oct 17;9(10):e110469. doi: 10.1371/journal.pone.0110469. eCollection 2014.

Abstract

BACKGROUND

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.

METHODS

Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.

FINDINGS

Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases.

CONCLUSION

Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.

摘要

背景

关于改善癌症患者护理的共识声明和临床实践指南广泛可得。尽管它们在定义和目的上存在细微差异,但这些术语经常被互换使用。我们系统评估了在三本广泛阅读、地域不同的癌症专科期刊上发表的共识声明和临床实践指南的方法学质量。

方法

对2005年1月至2013年9月在《当代肿瘤学》《欧洲癌症杂志》和《临床肿瘤学杂志》上发表的共识声明和临床实践指南进行评估。使用《研究与评价指南评估II》(AGREE II)的制定严谨性和编辑独立性领域对每篇出版物进行评估。为评估文件制定的透明度,从医学研究所的实践指南标准和《临床肿瘤学杂志》的指南作者指南中选取了另外7项内容。

结果

评估了34份共识声明和67份临床实践指南。三本期刊上共识声明的制定严谨性得分比临床实践指南低32%。共识声明的编辑独立性得分比临床实践指南低15%。一本期刊在这两个领域的得分始终低于其他期刊。没有期刊遵守所有与文件制定透明度相关的项目。一本期刊的共识声明在64%的情况下认可了主办制药公司生产的产品。

结论

指导文件是肿瘤护理的重要组成部分,应经过严格且经过验证的制定过程。使用AGREE II评估,共识声明的方法学质量低于临床实践指南。至少,期刊应确保所有共识声明和临床实践指南符合AGREE II标准。期刊应考虑明确要求指南声明制药公司的赞助并识别赞助商的产品,以提高透明度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1c8/4201546/e43e47a653ac/pone.0110469.g001.jpg

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