Lange T, Kottner J, Weberschock T, Hahnel E, Apfelbacher C, Brandstetter S, Dreher A, Datzmann T, Burden-Teh E, Rogers N K, Spuls P, Grainge M J, Jacobi L, Williams H C, Schmitt J
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus Dresden, TU Dresden, Dresden, Germany.
Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
J Eur Acad Dermatol Venereol. 2021 Feb;35(2):523-535. doi: 10.1111/jdv.16854. Epub 2020 Sep 11.
Standardized outcome reporting is crucial for trial evidence synthesis and translation of findings into clinical decision-making. The OMERACT 2.0 Filter and COMET outcome domain taxonomy propose frameworks for consistent reporting of outcomes. There is an absence of a uniform dermatology-specific reporting strategy that uses precise and consistent outcome definitions.
Our aim was to map efficacy/effectiveness outcomes assessed in dermatological trials to the OMERACT 2.0 Filter as a starting point for developing an outcome taxonomy in dermatology.
We critically appraised 10 Cochrane Skin Reviews randomly selected from all 69 Cochrane Skin Reviews published until 01/2015 and the 220 trials included covering a broad spectrum of dermatological conditions and interventions. Efficacy/effectiveness outcomes were mapped to core areas and domains according to the OMERACT 2.0 Filter. The extracted trial outcomes were used for critical appraisal of outcome reporting in dermatology trials and for the preliminary development of a dermatology-specific outcome taxonomy.
The allocation of 1086 extracted efficacy/effectiveness outcomes to the OMERACT 2.0 Filter resulted in a hierarchically structured dermatology-specific outcome classification. In 506 outcomes (47%), the outcome concept to be measured was insufficiently described, hindering meaningful evidence synthesis. Although the core areas assessed in different dermatology trials of the same condition overlap considerably, quantitative evidence synthesis usually failed due to imprecise outcome definitions, non-comparable outcome measurement instruments, metrics and reporting.
We present an efficacy/effectiveness outcome classification as a starting point for a dermatology-specific taxonomy to provide trialists and reviewers with the opportunity to better synthesize and compare evidence.
标准化的结果报告对于试验证据的综合以及将研究结果转化为临床决策至关重要。OMERACT 2.0筛选标准和COMET结果领域分类法提出了结果一致报告的框架。目前缺乏一种使用精确且一致的结果定义的统一的皮肤病学特定报告策略。
我们的目的是将皮肤病学试验中评估的疗效/有效性结果映射到OMERACT 2.0筛选标准，以此作为制定皮肤病学结果分类法的起点。
我们严格评估了从截至2015年1月发表的所有69篇Cochrane皮肤系统评价中随机选取的10篇，以及其中包含的220项试验，这些试验涵盖了广泛的皮肤病状况和干预措施。根据OMERACT 2.0筛选标准，将疗效/有效性结果映射到核心领域和范畴。提取的试验结果用于对皮肤病学试验中的结果报告进行严格评估，并初步制定皮肤病学特定的结果分类法。
将1086个提取的疗效/有效性结果按照OMERACT 2.0筛选标准进行分类，得到了一个层次结构分明的皮肤病学特定结果分类。在506个结果（47%）中，待测量的结果概念描述不充分，阻碍了有意义的证据综合。尽管在相同疾病的不同皮肤病学试验中评估的核心领域有相当大的重叠，但由于结果定义不精确、结果测量工具、指标和报告不可比，定量证据综合通常无法进行。
我们提出了一种疗效/有效性结果分类法，作为皮肤病学特定分类法的起点，为试验者和综述者提供更好地综合和比较证据的机会。
