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乳腺癌指南透明化时代的推荐意见

  欧洲各国的乳腺癌预防和早期检测计划及其结局均不统一。2003年12月,欧洲理事会将最佳实践作为确保制定高质量癌症筛查计划的关键。为了支持各国癌症控制政策,欧盟行政机构对各种癌症制定了若干倡议。欧盟委员会乳腺癌倡议是其中最新的倡议,也是实施最有效的倡议。该倡议正在制定欧洲乳腺癌筛查和诊断指南

  2019年7月23日,美国内科医师学会《内科学报》在线发表加拿大麦克马斯特大学、欧盟委员会联合研究中心、意大利米兰大学、雷焦艾米利亚省医疗中心、都灵大学医疗中心、西班牙拉丁美洲循证中心、巴塞罗那地中海医院、德国癌症学会、帕特伯恩放射中心、汉堡大学埃彭多夫医疗中心、吕贝克病理学协作组、爱尔兰全国筛查中心、都柏林大学圣文森特医院、英国卡迪夫大学、伦敦大学玛丽王后学院、瑞典于默奥大学、荷兰奈梅亨大学医疗中心、希腊雅典大学医学院、瑞士日内瓦大学全球卫生研究所、挪威癌症登记中心代表欧盟委员会乳腺癌倡议协作组起草的欧盟委员会乳腺癌倡议指南制定方法:指南透明化时代的推荐意见。

  本文介绍了欧盟委员会乳腺癌倡议筛查和诊断指南的依据、方法和流程。为了与医学研究所以及其他机构制定的标准保持一致,欧盟委员会遵循以下6项一般原则:

  • 首先,欧盟委员会通过公开方式选出一个广泛代表各个专业领域的专家组。

  • 其次,欧盟委员会确保所有推荐意见都由文献系统回顾提供支持证据。

  • 第三,欧盟委员会分别审议了重要的女性亚组,将患者代言人加入指南制定小组,并且注重良好的沟通,为女性的决策提供信息。

  • 第四,欧盟委员会遵循利益冲突的规则,并且采用推荐意见评定、制定与评价的分级(G.R.A.D.E.)决策证据原则建立流程,并且尽可能减少竞争利益的影响。

  • 第五,欧盟委员会推荐意见重点关注对女性至关重要的结局,并且对各项证据的确定性进行评级。

  • 第六,欧盟委员会要求利益相关方提供反馈,以确保推荐意见及时新,并且与实践相关。

  本文阐述了上述原则的具体实施方法,并且重点阐述了利用创新信息技术工具传播并适应欧洲内外推荐意见的方法。

Ann Intern Med. 2019 Jul 23. [Epub ahead of print]

Methods for Development of the European Commission Initiative on Breast Cancer Guidelines: Recommendations in the Era of Guideline Transparency.

Schünemann HJ, Lerda D, Dimitrova N, Alonso-Coello P, Grawingholt A, Quinn C, Follmann M, Mansel R, Sardanelli F, Rossi PG, Lebeau A, Nystrom L, Broeders M, Ioannidou-Mouzaka L, Duffy SW, Borisch B, Fitzpatrick P, Hofvind S, Castells X, Giordano L, Warman S, Saz-Parkinson Z; European Commission Initiative on Breast Cancer Contributor Group.

McMaster University Health Sciences Centre, Hamilton, Ontario, Canada; European Commission, Joint Research Centre, Ispra, Italy; Iberoamerican Cochrane Centre, Barcelona, Spain; Radiologie am Theater, Paderborn, Germany; St. Vincent's University Hospital, Dublin, Ireland; German Cancer Society, Berlin, Germany; Cardiff University, Cardiff, United Kingdom; Università degli Studi di Milano, Milan, Italy; Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy; University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Private Group Practice for Pathology, Lübeck, Germany; Umea University, Umea, Sweden; Radboud University Medical Centre, Nijmegen, Netherlands; University of Athens Medical School, Athens, Greece; Queen Mary University of London, London, United Kingdom; Institute of Global Health. University of Geneva, Geneva, Switzerland; National Screening Service, Dublin, Ireland; Cancer Registry of Norway, Oslo, Norway; Hospital del Mar Medical Research Institute, Barcelona, Spain; CPO-Piedmont - AOU Città della Salute e della Scienza, Torino, Italy; Langford, North Somerset, United Kingdom.

Neither breast cancer prevention and early-detection programs, nor their outcomes, are uniform across Europe. This article describes the rationale, methods, and process for development of the European Commission (EC) Initiative on Breast Cancer Screening and Diagnosis Guidelines. To be consistent with standards set by the Institute of Medicine and others, the EC followed 6 general principles. First, the EC selected, via an open call, a panel with broad representation of areas of expertise. Second, it ensured that all recommendations were supported by systematic reviews. Third, the EC separately considered important subgroups of women, included patient advocates in the guidelines development group, and focused on good communication to inform women's decisions. Fourth, EC rules on conflicts of interest were followed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests. Fifth, it focused its recommendations on outcomes that matter to women, and certainty of the evidence is rated for each. Sixth, the EC elicited stakeholder feedback to ensure that the recommendations remain up to date and relevant to practice. This article describes the approach and highlights ways of disseminating and adapting the recommendations both within and outside Europe, using innovative information technology tools.

PMID: 31330534

DOI: 10.7326/M18-3445

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