Core outcome sets for trials of interventions to prevent and to treat multimorbidity in low- and middle-income countries: the COSMOS study.
Core outcome sets for trials of interventions to prevent and to treat multimorbidity in low- and middle-income countries: the COSMOS study.
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低收入和中等收入国家预防和治疗多种疾病的干预措施试验的核心成果：COSMOS 研究。
DOI：
10.1101/2024.01.29.24301589
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发表时间：
2024
期刊：
影响因子：
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通讯作者：
COSMOSCollaboration
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作者：
Vidyasagaran,AishwaryaLakshmi;Ayesha,Rubab;Boehnke,Jan;Kirkham,Jamie;Rose,Louise;Hurst,John;Miranda,JJaime;Rana,RushamZahra;Vedanthan,Rajesh;Faisal,Mehreen;Siddiqi,Najma;COSMOSCollaboration
在低收入和中等收入国家（LMICs）中，越来越多的人认识到多重死亡的负担，因此强烈强调需要有效的循证干预措施。目前不存在适合于在中低收入国家研究多药耐药的核心结果集。这些都是必要的，以简化报告，并有助于建立一个连贯一致的证据基础，为政策和做法提供信息。我们描述了两个COS干预试验的发展，旨在预防和治疗多发性硬化症的成人在LMICs.MethodsTo生成一个全面的列表相关的预防和治疗结果，我们进行了系统的回顾和定性访谈与多发性硬化症的人和他们的照顾者生活在LMICs。然后，我们使用了一个修改后的两轮德尔菲过程，以确定最重要的结果，四个利益相关者群体（多Mortality/照顾者，多Mortality研究人员，医疗保健专业人员和政策制定者）与代表来自33个国家。协商一致会议被用来就两个最终COS达成协议。登记：https://www.comet-initiative.org/Studies/Details/1580.ResultsThe系统审查和定性访谈确定了24项预防结果和49项治疗结果。从德尔菲第1轮增加了另外12个预防和6个治疗结局。德尔菲第2轮调查由132名第1轮参与者中的95名（72.0%）完成预防，133名参与者中的95名（71.4%）完成治疗结果。共识会议就预防COS达成了四项成果：（1）不良事件，（2）新合并症的发生，（3）健康风险行为和（4）生活质量;治疗COS达成了四项成果：（1）治疗依从性，（2）不良事件，（3）自付费用和（4）生活质量。我们开发了两种COS，用于LMIC背景下成人多发病预防和治疗干预试验。我们建议将其纳入未来的试验中，以有意义地推进LMICs的多药研究领域。PROSPERO注册号CRD 42020197293。
IntroductionThe burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs.MethodsTo generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS. Registration: https://www.comet-initiative.org/Studies/Details/1580.ResultsThe systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life.ConclusionFollowing established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.PROSPERO registration numberCRD42020197293.