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南亚蛇咬伤中毒干预研究的核心结局指标集。

Core outcome set for intervention research on snakebite envenomation in South Asia.

作者信息

Bhaumik Soumyadeep, Beri Deepti, Santra Vishal, Gopalakrishnan Maya, Faiz Mohammad Abul, Williamson Paula R, Clarke Mike, Sharma Sanjib Kumar, Jagnoor Jagnoor

机构信息

The George Institute for Global Health India, New Delhi, India

Meta-research and Evidence Synthesis Unit, George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.

出版信息

Inj Prev. 2024 Sep 11. doi: 10.1136/ip-2023-045155.

DOI:10.1136/ip-2023-045155
PMID:39266207
Abstract

BACKGROUND

The 2019 WHO strategy to reduce snakebite burden emphasises the need for fostering research on snakebite treatments. A core outcome set (COS) is a consensus minimal list of outcomes that should be measured in research on a particular condition. We aimed to develop a COS for snakebite research in South Asia, the region with the highest burden.

METHODS

We used data from a systematic review of outcomes to develop a long list of outcomes which were rated in two rounds of online Delphi survey with healthcare providers, patients and the public, and potential COS users to develop a COS for intervention research on snakebite treatments in South Asia for five intervention groups. Subsequently, meetings, consultations and workshops were organised to reach further consensus. We defined the consensus criteria a priori.

RESULTS

Overall, 72 and 61 people, including patients and the public, participated in round I and round II of the Delphi, respectively. Consensus COSs (including definition and time points) were developed for interventions that prevent adverse reaction to snake antivenom (three outcomes), specifically manage neurotoxic manifestations (five outcomes), specifically manage haematological manifestations (five outcomes) and those that act against snake venom (seven) outcomes. A priori criteria for inclusion in COS were not met for COS on interventions for management of the bitten part.

CONCLUSION

The COS contributes to improving research efficiency by standardising outcome measurement in South Asia. It also provides methodological insights for future development of COS, beyond snakebite.

摘要

背景

2019年世界卫生组织减轻蛇咬伤负担的战略强调了促进蛇咬伤治疗研究的必要性。核心结局集(COS)是在针对特定疾病的研究中应测量的最低限度的共识性结局清单。我们旨在为南亚地区(蛇咬伤负担最高的地区)制定蛇咬伤研究的核心结局集。

方法

我们使用了对结局进行系统评价的数据来制定一长串结局清单,这些结局在两轮在线德尔菲调查中由医疗保健提供者、患者和公众以及潜在的核心结局集使用者进行评分,以制定针对南亚地区五个干预组的蛇咬伤治疗干预研究的核心结局集。随后,组织了会议、磋商和研讨会以达成进一步的共识。我们预先定义了共识标准。

结果

总体而言,分别有72人和61人(包括患者和公众)参与了德尔菲调查的第一轮和第二轮。针对预防抗蛇毒血清不良反应的干预措施(三个结局)、专门处理神经毒性表现的干预措施(五个结局)、专门处理血液学表现的干预措施(五个结局)以及对抗蛇毒的干预措施(七个结局)制定了共识性核心结局集(包括定义和时间点)。关于咬伤部位处理干预措施的核心结局集未达到纳入核心结局集的预先标准。

结论

该核心结局集通过规范南亚地区的结局测量,有助于提高研究效率。它还为核心结局集在蛇咬伤之外的未来发展提供了方法学见解。

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