Division of Rheumatology, Department of Pediatrics, University Hospital Tuebingen, Tübingen, Germany.
Paediatric Rheumatology, Wilhelmina Children's Hospital, University Medical Center, Utrecht, The Netherlands.
Ann Rheum Dis. 2018 Mar;77(3):319-327. doi: 10.1136/annrheumdis-2017-211904. Epub 2017 Oct 11.
Innovative research in childhood rheumatic diseases mandates international collaborations. However, researchers struggle with significant regulatory heterogeneity; an enabling European Union (EU)-wide framework is missing. The aims of the study were to systematically review the evidence for best practice and to establish recommendations for collaborative research. The Paediatric Rheumatology European Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) project enabled a scoping review and expert discussion, which then informed the systematic literature review. Published evidence was synthesised; recommendations were drafted. An iterative review process and consultations with Ethics Committees and European experts for ethical and legal aspects of paediatric research refined the recommendations. SHARE experts and patient representatives vetted the proposed recommendations at a consensus meeting using Nominal Group Technique. Agreement of 80% was mandatory for inclusion. The systematic literature review returned 1319 records. A total of 223 full-text publications plus 22 international normative documents were reviewed; 85 publications and 16 normative documents were included. A total of 21 recommendations were established including general principles (1-3), ethics (4-7), paediatric principles (8 and 9), consent to paediatric research (10-14), paediatric databank and biobank (15 and 16), sharing of data and samples (17-19), and commercialisation and third parties (20 and 21). The refined recommendations resulted in an agreement of >80% for all recommendations. The SHARE initiative established the first recommendations for Paediatric Rheumatology collaborative research across borders in Europe. These provide strong support for an urgently needed European framework and evidence-based guidance for its implementation. Such changes will promote research in children with rheumatic diseases.
创新性的儿童风湿病研究需要国际合作。然而，研究人员面临着重大的监管差异；缺少一个支持性的欧盟（EU）范围内的框架。该研究的目的是系统地回顾最佳实践的证据，并为合作研究建立建议。儿科风湿病欧洲单一中心和欧洲儿科风湿病接入点（SHARE）项目使范围审查和专家讨论成为可能，这为系统文献综述提供了信息。对已发表的证据进行了综合分析；起草了建议。一个迭代审查过程以及与伦理委员会和欧洲专家就儿科研究的伦理和法律方面进行的磋商，完善了建议。SHARE 专家和患者代表在共识会议上使用名义群体技术对拟议建议进行了审查。必须达成 80%的共识才能纳入建议。系统文献综述返回了 1319 条记录。共审查了 223 篇全文出版物和 22 份国际规范性文件；纳入了 85 篇出版物和 16 份规范性文件。共制定了 21 项建议，包括一般原则（1-3）、伦理（4-7）、儿科原则（8 和 9）、儿童研究同意（10-14）、儿科数据库和生物库（15 和 16）、数据和样本共享（17-19）以及商业化和第三方（20 和 21）。经过精炼的建议在所有建议上都达成了>80%的共识。SHARE 倡议为欧洲跨边界儿科风湿病合作研究制定了第一批建议。这些建议为急需的欧洲框架提供了强有力的支持，并为其实施提供了循证指导。这些变化将促进儿童风湿病的研究。
