EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.
EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.
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DOI：
10.1136/annrheumdis-2020-219523
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发表时间：
2021-09
影响因子：
27.4
通讯作者：
Ramiro S
中科院分区：
文献类型：
--
作者：
Boonen A;Putrik P;Marques ML;Alunno A;Abasolo L;Beaton D;Betteridge N;Bjørk M;Boers M;Boteva B;Fautrel B;Guillemin F;Mateus EF;Nikiphorou E;Péntek M;Pimentel Santos F;Severens JL;Verstappen SMM;Walker-Bone K;Wallman JK;Ter Wee MM;Westhovens R;Ramiro S
以工作参与（WP）作为结果域的临床研究提出了特殊的方法学挑战，阻碍了研究和荟萃分析之间的解释，比较。制定考虑要点（PtC），用于设计、分析和报告包括WP作为主要或次要结局领域的炎性关节炎患者研究。遵循EULAR标准化操作程序。一个由来自10个EULAR国家和加拿大的22名专家（包括风湿性疾病患者）组成的多学科工作组确定了关注的方法学领域。两篇系统性文献综述（SLR）评估了这些领域的方法。与此同时，在工作队以外的专业协会和专家中进行了两次调查，以寻求更多的方法领域或现有的开展/报告建议。工作队在介绍了SLR和调查结果并进行了讨论之后，制定了PtC。协商一致意见是通过非正式投票获得的，同意的程度是匿名获得的。制定了两项总体原则和九项具体目标。专责小组建议将与工作有关的研究目的与研究的设计、持续时间及结果范畴/测量工具保持一致（PtC：1-3）;预先确定环境因素并在分析中说明这些因素（PtC：4）;说明不同工作成果领域的相互依赖性和工作状态随时间的变化（PtC：5-7）;将结果显示为达到预定义有意义类别的患者的平均值和比例（PtC：8），并在成本为结局时明确报告生产力损失量（PtC：9）。遵守这些EULAR PtC将提高评价WP的研究的方法学质量。
Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses. To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain. The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously. Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1–3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5–7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9). Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.
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影响因子：
27.4
作者：
Manica, Santiago Rodrigues;Sepriano, Alexandre;Boonen, Annelies
通讯作者：
Boonen, Annelies
DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
4.4
作者：
REILLY, MC;ZBROZEK, AS;DUKES, EM
通讯作者：
DUKES, EM
影响因子：
4.9
作者：
van der Zee-Neuen A;Putrik P;Ramiro S;Keszei AP;Hmamouchi I;Dougados M;Boonen A
通讯作者：
Boonen A
影响因子：
3.9
作者：
Strand, Vibeke;Wright, Grace C.;Taylor, Peter C.
通讯作者：
Taylor, Peter C.