Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.
Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.
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DOI：
10.12688/wellcomeopenres.16486.1
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发表时间：
2021
影响因子：
--
通讯作者：
Umrani Z
中科院分区：
文献类型：
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作者：
Aryal D;Beane A;Dondorp AM;Green C;Haniffa R;Hashmi M;Jayakumar D;Marshall JC;McArthur CJ;Murthy S;Webb SA;Acharya SP;Ishani PGP;Jawad I;Khanal S;Koirala K;Luitel S;Pabasara U;Paneru HR;Kumar A;Patel SS;Ramakrishnan N;Salahuddin N;Shaikh M;Tolppa T;Udayanga I;Umrani Z
适用于COVID-19的随机嵌入式多因素自适应平台（REMAP-CAP）试验是一项针对COVID-19住院患者的全球自适应平台试验。我们描述了在惠康支持的低收入和中等收入国家（LMIC）重症监护网络：亚洲研究，实施和培训合作（CCA）的保护伞下，在三个国家的实施。该合作旨在克服在资源有限的环境中进行多中心临床试验的已知障碍。所描述的方法侧重于实施的六个方面：i，加强现有的实践社区; ii，远程研究中心招募、培训和支持; iii，将REMAP CAP-COVID试验与现有的护理流程相协调; iv，将REMAP CAP-COVID病例报告表嵌入现有的CCA登记平台; v，特定环境的适应和数据管理;与CCA中现有的流行病和重症监护研究保持一致。本文所述的方法可能使其他LMIC研究中心能够作为平等合作伙伴参与具有紧急公共卫生重要性的国际重症监护试验，无论是在此次大流行期间还是之后。
The Randomized Embedded Multifactorial Adaptive Platform (REMAP-CAP) adapted for COVID-19) trial is a global adaptive platform trial of hospitalised patients with COVID-19. We describe implementation in three countries under the umbrella of the Wellcome supported Low and Middle Income Country (LMIC) critical care network: Collaboration for Research, Implementation and Training in Asia (CCA). The collaboration sought to overcome known barriers to multi centre-clinical trials in resource-limited settings. Methods described focused on six aspects of implementation: i, Strengthening an existing community of practice; ii, Remote study site recruitment, training and support; iii, Harmonising the REMAP CAP- COVID trial with existing care processes; iv, Embedding REMAP CAP- COVID case report form into the existing CCA registry platform, v, Context specific adaptation and data management; vi, Alignment with existing pandemic and critical care research in the CCA. Methods described here may enable other LMIC sites to participate as equal partners in international critical care trials of urgent public health importance, both during this pandemic and beyond.