Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.

Aryal, Diptesh; Beane, Abi; Dondorp, Arjen M.; Green, Cameron; Jayakumar, Devachandran; Marshall, John C.; McArthur, Colin; Murthy, Srinivas; Webb, Steven A R; Acharya, Subhash Prasad; Ishani, Pramodya; Jawad, Issrah; Khanal, Sushil; Koirala, Kanchan; Luitel, Subekshya; Pabasara, Upulee; Paneru, Hem Raj; Kumar, Ashok; Patel, Shoaib Siddiq; Ramakrishnan, Nagarajan; Salahuddin, Nawal; Shaikh, Mohiuddin; Tolppa, Timo; Udayanga, Ishara; Umrani, Zulfiqar

doi:10.12688/wellcomeopenres.16486.1

Cited by 24 publications

(25 citation statements)

References 13 publications

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“…6 Potential limitations of registry-based trials concern the controlling for confounding and bias. 29 The CCA network is already supporting several of the REMAP-CAP arms trials, 6,30,31 , while also enabling observational and outcome research 22 .…”

Section: Discussionmentioning

confidence: 99%

“…Regarding trial recruitment, adapted registry platforms promote rapid onboarding, inform site selection and improve patient recruitment, and can facilitate study monitoring through inbuilt data quality and validation processes. 6 Potential limitations of registry-based trials concern the controlling for confounding and bias. 29 The CCA network is already supporting several of the REMAP-CAP arms trials, 6,30,31 , while also enabling observational and outcome research 22 .…”

Section: Discussionmentioning

confidence: 99%

“…All encounters of care reported through the seven registries during a prespecified period of six months (June-December 2020) were included. The selection of this time period enabled evaluation of established collaborating registries (Indian Registry of IntenSive care [IRIS], 18 Pakistan registry of intensive care [PRICE] 19 and Nepal Intensive Care Registry Foundation [NICRF]), 6 and the inclusion of newly implemented registries (Afghanistan, Bangladesh, Malaysia and Vietnam). Basic information on these registries is detailed in Table 2 .…”

Section: Methodsmentioning

confidence: 99%

“…The global coronavirus disease 2019 (COVID-19) pandemic has accelerated the role of registries in driving global research. For example, registries in Brazil, Australia, Europe, and in Asia have been instrumental as part of collaborations for pre-COVID-19 large scale multicentre studies, 4,5 observational research on COVID-19 6 and more recently interventional research, as exemplified by the randomized, embedded, multi factorial adaptive platform for community acquired pneumonia (REMAP-CAP) operational through registries in the USA and in South Asia. 6 Whilst registries are increasingly being promoted for their role in enabling greater accountability of healthcare quality, and for their ability to facilitate multi centre clinical trials, the quality of data such systems provide requires rigorous evaluation.…”

Section: Introductionmentioning

confidence: 99%

“…For example, registries in Brazil, Australia, Europe, and in Asia have been instrumental as part of collaborations for pre-COVID-19 large scale multicentre studies, 4,5 observational research on COVID-19 6 and more recently interventional research, as exemplified by the randomized, embedded, multi factorial adaptive platform for community acquired pneumonia (REMAP-CAP) operational through registries in the USA and in South Asia. 6 Whilst registries are increasingly being promoted for their role in enabling greater accountability of healthcare quality, and for their ability to facilitate multi centre clinical trials, the quality of data such systems provide requires rigorous evaluation. 7,8 To date, evaluation of existing vertical programme assessments for digital clinical and research registries, and for the WHO endorsed district health information system platform, 9 have focused predominantly on the ongoing challenges of missingness and inaccuracies in reporting.…”

Section: Introductionmentioning

confidence: 99%

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Performance evaluation of a multinational data platform for critical care in Asia

Pisani¹,

Rashan

Shamal

et al. 2021

Preprint

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Objective We aimed to evaluate the quality of a multinational intensive care unit (ICU) network of registries of critically ill patients established in seven Asian low and middle income countries (LMICs). Methods The Critical Care Asia federated registry platform enables ICUs to collect clinical, outcome and process data for aggregate and unit-level analysis. The evaluation used the standardised criteria of the Directory of Clinical Databases (DoCDat) and a framework for data quality assurance in medical registries. Six reviewers assessed structure, coverage, reliability and validity of the ICU registry data. Case mix and process measures on patient episodes from June to December 2020 were analysed. Results Data on 20,507 consecutive patient episodes from 97 ICUs in Afghanistan, Bangladesh, India, Malaysia, Nepal, Pakistan and Vietnam were included. The quality level achieved according to the ten prespecified DoCDat criteria was high (average score 3.4 out of 4) as was the structural and organizational performance -- comparable to ICU registries in high-income countries. Identified strengths were types of variables included, reliability of coding, data completeness and validation. Potential improvements include extension of national coverage. Conclusion The Critical Care Asia platform evaluates well using standardised frameworks for data quality and equally to registries in resource-rich settings. Funding This work was undertaken as part of the existing Wellcome Innovations Flagship award, Collaboration for Research, Improvement and Training in Critical CARE in ASIA (ref. 215522/Z/19/Z). The funder had no role in the decision to publish or in the preparation of this manuscript.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Performance evaluation of a multinational data platform for critical care in Asia

Pisani¹,

Rashan

Shamal

et al. 2021

Preprint

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A health systems approach to critical care delivery in low-resource settings: a narrative review

et al. 2023

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There is a high burden of critical illness in low-income countries (LICs), adding pressure to already strained health systems. Over the next decade, the need for critical care is expected to grow due to ageing populations with increasing medical complexity; limited access to primary care; climate change; natural disasters; and conflict. In 2019, the 72nd World Health Assembly emphasised that an essential part of universal health coverage is improved access to effective emergency and critical care and to “ensure the timely and effective delivery of life-saving health care services to those in need”. In this narrative review, we examine critical care capacity building in LICs from a health systems perspective. We conducted a systematic literature search, using the World Heath Organisation (WHO) health systems framework to structure findings within six core components or “building blocks”: (1) service delivery; (2) health workforce; (3) health information systems; (4) access to essential medicines and equipment; (5) financing; and (6) leadership and governance. We provide recommendations using this framework, derived from the literature identified in our review. These recommendations are useful for policy makers, health service researchers and healthcare workers to inform critical care capacity building in low-resource settings. Supplementary Information The online version contains supplementary material available at 10.1007/s00134-023-07136-2.

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Designing and Implementing “Living and Breathing” Clinical Trials

Horvat¹,

King²,

Huang³

2023

Critical Care Clinics

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Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.

Cited by 24 publications

References 13 publications

Performance evaluation of a multinational data platform for critical care in Asia

Performance evaluation of a multinational data platform for critical care in Asia

A health systems approach to critical care delivery in low-resource settings: a narrative review

Designing and Implementing “Living and Breathing” Clinical Trials

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