Copenhagen Trial Unit (CTU), Centre for Clinical Intervention Research, Capital Region of Denmark, Denmark; Centre for Research in Intensive Care (CRIC), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Department of Critical Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
J Clin Epidemiol. 2021 Jul;135:29-41. doi: 10.1016/j.jclinepi.2021.01.023. Epub 2021 Feb 6.
To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions.
The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups.
CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters.
CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.
开发并验证临床多样性在荟萃分析中的应用(CDIM),这是一种用于评估干预措施荟萃分析中试验间临床多样性的新工具。
CDIM 的开发基于共识工作,这些工作得到了实证文献和专业知识的支持。我们起草了 CDIM 工具,对其进行了改进,并在三组中验证了 CDIM 的评分者间量表可靠性和一致性。
CDIM 通过包含四个领域的 11 个项目的量表来衡量临床多样性:环境(进行的时间/国家发展状况/单位类型);人群(年龄、性别、患者纳入标准/基线疾病严重程度、合并症);干预措施(干预强度/力度/干预持续时间、时间、对照干预、共干预);结局(结局定义、结局评估时间)。CDIM 分两步完成:首先,两位作者独立评估四个领域的临床多样性。其次,在就各个项目的评分达成一致后,得出共识评分。评分者间量表可靠性和一致性因评分者类型而异,从中度到几乎完美不等。
CDIM 是为评估干预措施荟萃分析中的临床多样性而开发的第一个工具。我们发现 CDIM 是评估荟萃分析中试验间临床多样性的可靠工具。