Literature DB >> 33604455

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

Diptesh Aryal1, Abi Beane2,3, Arjen M Dondorp2,3, Cameron Green4, Rashan Haniffa2,3, Madiha Hashmi5, Devachandran Jayakumar6,7, John C Marshall8, Colin J McArthur9,10, Srinivas Murthy11, Steven A Webb4,12,13, Subhash P Acharya14, Pramodya G P Ishani15, Issrah Jawad15, Sushil Khanal16, Kanchan Koirala1, Subekshya Luitel17, Upulee Pabasara15, Hem Raj Paneru18, Ashok Kumar19, Shoaib Siddiq Patel20, Nagarajan Ramakrishnan7, Nawal Salahuddin21, Mohiuddin Shaikh20, Timo Tolppa15, Ishara Udayanga15, Zulfiqar Umrani22.   

Abstract

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. Copyright:
© 2021 Aryal D et al.

Entities:  

Keywords:  LMICS; Pandemic; capacity building.; clinical trials; registry platform; research network

Year:  2021        PMID: 33604455      PMCID: PMC7883321          DOI: 10.12688/wellcomeopenres.16486.1

Source DB:  PubMed          Journal:  Wellcome Open Res        ISSN: 2398-502X


  14 in total

1.  Observational Health Data Sciences and Informatics (OHDSI): Opportunities for Observational Researchers.

Authors:  George Hripcsak; Jon D Duke; Nigam H Shah; Christian G Reich; Vojtech Huser; Martijn J Schuemie; Marc A Suchard; Rae Woong Park; Ian Chi Kei Wong; Peter R Rijnbeek; Johan van der Lei; Nicole Pratt; G Niklas Norén; Yu-Chuan Li; Paul E Stang; David Madigan; Patrick B Ryan
Journal:  Stud Health Technol Inform       Date:  2015

2.  Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

Authors: 
Journal:  Lancet       Date:  2018-11-10       Impact factor: 79.321

Review 3.  Barriers for conducting clinical trials in developing countries- a systematic review.

Authors:  Chalachew Alemayehu; Geoffrey Mitchell; Jane Nikles
Journal:  Int J Equity Health       Date:  2018-03-22

4.  Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study.

Authors:  Neema Toto; Elaine Douglas; Markus Gmeiner; Lynn K Barrett; Robert Lindblad; Lumbani Makhaza; Wilfred Nedi; Jacob Phulusa; Gerald V Quinnan; Leigh A Sawyer; Herbert Thole; Wesley C Van Voorhis; Pui-Ying Iroh Tam
Journal:  Trials       Date:  2020-07-25       Impact factor: 2.279

5.  Addressing the information deficit in global health: lessons from a digital acute care platform in Sri Lanka.

Authors:  Abi Beane; Ambepitiyawaduge Pubudu De Silva; Priyantha Lakmini Athapattu; Saroj Jayasinghe; Anuja Unnathie Abayadeera; Mandika Wijerathne; Ishara Udayanga; Shriyananda Rathnayake; Arjen M Dondorp; Rashan Haniffa
Journal:  BMJ Glob Health       Date:  2019-01-29

6.  Pakistan Registry of Intensive CarE (PRICE): Expanding a lower middle-income, clinician-designed critical care registry in South Asia.

Authors:  M Hashmi; A Beane; A Taqi; M I Memon; P Athapattu; Z Khan; A M Dondorp; R Haniffa
Journal:  J Intensive Care Soc       Date:  2018-11-14

7.  The FAIR Guiding Principles for scientific data management and stewardship.

Authors:  Mark D Wilkinson; Michel Dumontier; I Jsbrand Jan Aalbersberg; Gabrielle Appleton; Myles Axton; Arie Baak; Niklas Blomberg; Jan-Willem Boiten; Luiz Bonino da Silva Santos; Philip E Bourne; Jildau Bouwman; Anthony J Brookes; Tim Clark; Mercè Crosas; Ingrid Dillo; Olivier Dumon; Scott Edmunds; Chris T Evelo; Richard Finkers; Alejandra Gonzalez-Beltran; Alasdair J G Gray; Paul Groth; Carole Goble; Jeffrey S Grethe; Jaap Heringa; Peter A C 't Hoen; Rob Hooft; Tobias Kuhn; Ruben Kok; Joost Kok; Scott J Lusher; Maryann E Martone; Albert Mons; Abel L Packer; Bengt Persson; Philippe Rocca-Serra; Marco Roos; Rene van Schaik; Susanna-Assunta Sansone; Erik Schultes; Thierry Sengstag; Ted Slater; George Strawn; Morris A Swertz; Mark Thompson; Johan van der Lei; Erik van Mulligen; Jan Velterop; Andra Waagmeester; Peter Wittenburg; Katherine Wolstencroft; Jun Zhao; Barend Mons
Journal:  Sci Data       Date:  2016-03-15       Impact factor: 6.444

8.  Implementing an intensive care registry in India: preliminary results of the case-mix program and an opportunity for quality improvement and research.

Authors:  Neill K J Adhikari; Rajeshwari Arali; Udara Attanayake; Sampath Balasundaram; Abi Beane; Vijay Chakravarthy; Niyaz Channanath Ashraf; Sri Darshana; Dedeepiya Devaprasad; Arjen M Dondorp; Robert Fowler; Rashan Haniffa; Pramodya Ishani; Augustian James; Issrah Jawad; Devachandran Jayakumar; Chamira Kodipilly; Rakesh Laxmappa; Kishore Mangal; Ashwin Mani; Meghena Mathew; Sristi Patodia; Rajyabardhan Pattnaik; Dilanthi Priyadarshini; Mathew Pulicken; Ebenezer Rabindrarajan; Pratheema Ramachandran; Kavita Ramesh; Usha Rani; Suchitra Ranjit; Ananth Ramaiyan; Nagarajan Ramakrishnan; Lakshmi Ranganathan; Thalha Rashan; Raymond Dominic Savio; Jaganathan Selva; Bharath Kumar Tirupakuzhi Vijayaraghavan; Swagata Tripathy; Timo Tolppa; Ishara Udayanga; Ramesh Venkataraman; Deepak Vijayan
Journal:  Wellcome Open Res       Date:  2020-07-30

9.  Establishing a critical care network in Asia to improve care for critically ill patients in low- and middle-income countries.

Authors: 
Journal:  Crit Care       Date:  2020-10-15       Impact factor: 9.097

10.  Leveraging a Cloud-Based Critical Care Registry for COVID-19 Pandemic Surveillance and Research in Low- and Middle-Income Countries.

Authors:  Madiha Hashmi; Abi Beane; Srinivas Murthy; Arjen M Dondorp; Rashan Haniffa
Journal:  JMIR Public Health Surveill       Date:  2020-11-23
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  5 in total

1.  Worldwide clinical intensive care registries response to the pandemic: An international survey.

Authors:  Dave A Dongelmans; Amanda Quintairos; Eirik Alnes Buanes; Diptesh Aryal; Sean Bagshaw; Stepani Bendel; Joe Bonney; Gaston Burghi; Eddy Fan; Bertrand Guidet; Rashan Haniffa; Madiha Hashimi; Satoru Hashimoto; Nao Ichihara; Bharath Kumar Tirupakuzhi Vijayaraghavan; Nazir Lone; Maria Del Pilar Arias Lopez; Mohd Zulfakar Mazlam; Hiroshi Okamoto; Andreas Perren; Kathy Rowan; Martin Sigurdsson; Wangari Silka; Marcio Soares; Grazielle Viana; David Pilcher; Abigail Beane; Jorge I F Salluh
Journal:  J Crit Care       Date:  2022-07-08       Impact factor: 4.298

Review 2.  Barriers and facilitators to the conduct of critical care research in low and lower-middle income countries: A scoping review.

Authors:  Bharath Kumar Tirupakuzhi Vijayaraghavan; Ena Gupta; Nagarajan Ramakrishnan; Abi Beane; Rashan Haniffa; Nazir Lone; Nicolette de Keizer; Neill K J Adhikari
Journal:  PLoS One       Date:  2022-05-05       Impact factor: 3.240

Review 3.  Promises and challenges of personalized medicine to guide ARDS therapy.

Authors:  Katherine D Wick; Daniel F McAuley; Joseph E Levitt; Jeremy R Beitler; Djillali Annane; Elisabeth D Riviello; Carolyn S Calfee; Michael A Matthay
Journal:  Crit Care       Date:  2021-11-23       Impact factor: 19.334

4.  The research environment of critical care in three Asian countries: A cross-sectional questionnaire survey.

Authors:  Yuki Kotani; Sungwon Na; Jason Phua; Nobuaki Shime; Tatsuya Kawasaki; Hideto Yasuda; Jong Hun Jun; Atsushi Kawaguchi
Journal:  Front Med (Lausanne)       Date:  2022-09-20

5.  A scoping review of registry captured indicators for evaluating quality of critical care in ICU.

Authors:  Issrah Jawad; Sumayyah Rashan; Chathurani Sigera; Jorge Salluh; Arjen M Dondorp; Rashan Haniffa; Abi Beane
Journal:  J Intensive Care       Date:  2021-08-05
  5 in total

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