Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol.
Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol.
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DOI：
10.1136/bmjopen-2021-051810
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发表时间：
2022-02-16
期刊：
影响因子：
2.9
通讯作者：
Siddiqi N
中科院分区：
文献类型：
--
作者：
Boehnke JR;Rana RZ;Kirkham JJ;Rose L;Agarwal G;Barbui C;Chase-Vilchez A;Churchill R;Flores-Flores O;Hurst JR;Levitt N;van Olmen J;Purgato M;Siddiqi K;Uphoff E;Vedanthan R;Wright J;Wright K;Zavala GA;Siddiqi N
“多发病”描述了两种或两种以上长期疾病的存在，包括传染性、非传染性疾病和精神障碍。多发性硬化症造成的全球负担不断增加是有据可查的，但在低收入/中等收入国家（LMIC）进行有效干预的试验证据有限。选择适当的结果是试验设计的基础，以确保交叉研究的可比性，但目前还没有达成一致的核心结果集（COS），包括在试验中，特别是在LMIC的多药耐药。我们的目标是在两个COS上达成国际共识，用于在LMIC环境中预防和治疗多发性骨髓瘤的干预试验。根据有效性试验核心结局指标倡议推荐的方法，这两个COS的制定将分三个阶段并行进行：（1）生成一长串潜在结局供纳入;（2）两轮在线德尔菲调查和（3）共识会议。首先，为了产生一个初步的结果列表，我们将对多发病干预和预防试验进行系统性回顾，并对LMIC中的多发病患者及其护理人员进行访谈。将使用结果分类法对结果进行分类。两轮德尔菲调查将用于从LMIC的多Morphine患者、护理人员、医疗保健专业人员、政策制定者和研究人员中获得这些结果的重要性评分。最后，将举行包括所有这些利益攸关方在内的共识会议，以商定纳入两个COS的成果。该研究已获得英国约克大学健康科学系研究管理委员会的批准（HSRGC/2020/409/D：COSMOS）。每个参与国家/研究小组将获得当地伦理委员会的批准。将获得所有参与者的知情同意。我们将通过同行评审的开放获取出版物传播研究结果，并在全球会议上进行演讲，以达到广泛的LMIC利益相关者。CRD42020197293。
‘Multimorbidity’ describes the presence of two or more long-term conditions, which can include communicable, non-communicable diseases, and mental disorders. The rising global burden from multimorbidity is well documented, but trial evidence for effective interventions in low-/middle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental to trial design to ensure cross-study comparability, but there is currently no agreement on a core outcome set (COS) to include in trials investigating multimorbidity specifically in LMICs. Our aim is to develop international consensus on two COSs for trials of interventions to prevent and treat multimorbidity in LMIC settings. Following methods recommended by the Core Outcome Measures in Effectiveness Trials initiative, the development of these two COSs will occur in parallel in three stages: (1) generation of a long list of potential outcomes for inclusion; (2) two-round online Delphi surveys and (3) consensus meetings. First, to generate an initial list of outcomes, we will conduct a systematic review of multimorbidity intervention and prevention trials and interviews with people living with multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcome taxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomes from people living with multimorbidity, caregivers, healthcare professionals, policy makers and researchers in LMICs. Finally, consensus meetings including all of these stakeholders will be held to agree outcomes for inclusion in the two COSs. The study has been approved by the Research Governance Committee of the Department of Health Sciences, University of York, UK (HSRGC/2020/409/D:COSMOS). Each participating country/research group will obtain local ethics board approval. Informed consent will be obtained from all participants. We will disseminate findings through peer-reviewed open access publications, and presentations at global conferences selected to reach a wide range of LMIC stakeholders. CRD42020197293.
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