中低收入国家成人多病预防和治疗干预试验的核心结果集:COSMOS 研究。

IF 7.1 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH BMJ Global Health Pub Date : 2024-08-19 DOI:10.1136/bmjgh-2024-015120
Aishwarya Lakshmi Vidyasagaran, Rubab Ayesha, Jan R Boehnke, Jamie Kirkham, Louise Rose, John R Hurst, Juan Jaime Miranda, Rusham Zahra Rana, Rajesh Vedanthan, Mehreen Riaz Faisal, Saima Afaq, Gina Agarwal, Carlos Alberto Aguilar-Salinas, Kingsley Akinroye, Rufus Olusola Akinyemi, Syed Rahmat Ali, Rabeea Aman, Cecilia Anza-Ramirez, Koralagamage Kavindu Appuhamy, Se-Sergio Baldew, Corrado Barbui, Sandro Rogerio Rodrigues Batista, María Del Carmen Caamaño, Asiful Haidar Chowdhury, Noemia Teixeira de Siqueira-Filha, Darwin Del Castillo Fernández, Laura Downey, Oscar Flores-Flores, Olga P García, Ana Cristina García-Ulloa, Richard Ig Holt, Rumana Huque, Johnblack K Kabukye, Sushama Kanan, Humaira Khalid, Kamrun Nahar Koly, Joseph Senyo Kwashie, Naomi S Levitt, Patricio Lopez-Jaramillo, Sailesh Mohan, Krishna Prasad Muliyala, Qirat Naz, Augustine Nonso Odili, Adewale L Oyeyemi, Niels Victor Pacheco-Barrios, Devarsetty Praveen, Marianna Purgato, Dolores Ronquillo, Kamran Siddiqi, Rakesh Singh, Phuong Bich Tran, Pervaiz Tufail, Eleonora P Uphoff, Josefien van Olmen, Ruth Verhey, Judy M Wright, Jessica Hanae Zafra-Tanaka, Gerardo A Zavala, Yang William Zhao, Najma Siddiqi
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引用次数: 0

摘要

导言:在低收入和中等收入国家(LMICs),人们日益认识到多病共存所带来的负担,因此非常强调需要采取有效的循证干预措施。目前还没有适合研究低收入和中等收入国家多病症的核心结果集(COS)。我们需要核心结果集来规范报告,并为政策和实践提供连贯一致的证据基础。我们介绍了为旨在预防和治疗低收入和中等收入国家成人多病症的干预试验制定两项 COS 的情况:为了编制一份相关预防和治疗结果的综合清单,我们对生活在低收入和中等收入国家的多病症患者及其护理人员进行了系统回顾和定性访谈。然后,我们采用经过修改的两轮德尔菲程序,确定了对四个利益相关者群体(多病症患者/护理者、多病症研究人员、医疗保健专业人员和政策制定者)最重要的成果,这些利益相关者来自 33 个国家。共识会议就最终的两项 COS 达成了一致意见。https://www.comet-initiative.org/Studies/Details/1580.Results:通过系统回顾和定性访谈,确定了 24 项多病预防成果和 49 项多病治疗成果。德尔菲第一轮调查的 132 位参与者中有 95 位(72.0%)完成了德尔菲第二轮调查的预防结果,133 位参与者中有 95 位(71.4%)完成了德尔菲第二轮调查的治疗结果。共识会议就预防 COS 的四项结果达成一致意见:(1) 不良事件,(2) 出现新的合并症,(3) 健康风险行为和 (4) 生活质量;就治疗 COS 的四项结果达成一致意见:(1) 坚持治疗,(2) 不良事件,(3) 自付费用和 (4) 生活质量:按照既定的指导原则,我们为针对低收入和中等收入国家成人的多病症预防和治疗干预试验制定了两个COS。我们建议在未来的试验中纳入这两项内容,以切实推进低收入和中等收入国家的多病症研究领域:CRD42020197293。
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Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

Introduction: The 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.

Methods: To 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.

Results: The 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.

Conclusion: Following 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 number: CRD42020197293.

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来源期刊
BMJ Global Health
BMJ Global Health Medicine-Health Policy
CiteScore
11.40
自引率
4.90%
发文量
429
审稿时长
18 weeks
期刊介绍: BMJ Global Health is an online Open Access journal from BMJ that focuses on publishing high-quality peer-reviewed content pertinent to individuals engaged in global health, including policy makers, funders, researchers, clinicians, and frontline healthcare workers. The journal encompasses all facets of global health, with a special emphasis on submissions addressing underfunded areas such as non-communicable diseases (NCDs). It welcomes research across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialized studies. The journal also encourages opinionated discussions on controversial topics.
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