African critical care registry network for pandemic surveillance, clinical management and research.
Lead Research Organisation:
University of Oxford
Department Name: Tropical Medicine
Abstract
Patients from Africa are not represented in clinical research for unwell patients, COVID-19 related or otherwise, thus disenfranchising entire populations and stymying pandemic response. The underlying reasons are related to infrastructure, data availability, knowhow and opportunity. Our group and project partners with pandemic response expertise will address both this knowledge gap and the underlying operational (and opportunity) gap by three activities.
1.Implementing a setting-adapted registry for unwell patients with and without COVID-19, compliant with the ISARIC protocol in 35 critical care units in seven countries adopting methods used in a parallel Wellcome-supported nine country network. Registry output will include patient characteristics, quality of care processes and outcomes. We will also do a national critical care service evaluation.
2.Identifying stakeholder (clinician and community) research priorities to improve critical care processes and outcomes leveraging activity 1 output, especially for pregnant women and surgical patients. We will determine stakeholder priorities for improvement, pandemic response and further research by using the data to facilitate workshops for all, including the public.
3.We will recruit network sites to participate in all types of clinical research that will benefit population health and wellbeing, supported by the registry infrastructure, our group and project partners. The network will directly assist doctors and nurses participate in research through mentorship, registry enabled patient recruitment and study monitoring.
1.Implementing a setting-adapted registry for unwell patients with and without COVID-19, compliant with the ISARIC protocol in 35 critical care units in seven countries adopting methods used in a parallel Wellcome-supported nine country network. Registry output will include patient characteristics, quality of care processes and outcomes. We will also do a national critical care service evaluation.
2.Identifying stakeholder (clinician and community) research priorities to improve critical care processes and outcomes leveraging activity 1 output, especially for pregnant women and surgical patients. We will determine stakeholder priorities for improvement, pandemic response and further research by using the data to facilitate workshops for all, including the public.
3.We will recruit network sites to participate in all types of clinical research that will benefit population health and wellbeing, supported by the registry infrastructure, our group and project partners. The network will directly assist doctors and nurses participate in research through mentorship, registry enabled patient recruitment and study monitoring.
Technical Summary
Our group of LMIC based co-investigators and project partners from established critical care and pandemic networks aims to address the knowledge gaps that exist regarding the natural history and clinical course of COVID-19 related critical illness in seven African countries. In achieving this aim, we will address operational gaps in pandemic responsiveness by establishing a network with the infrastructure to identify optimal strategies for supportive care and interventions for the same patients.
The aim will be achieved by 3 activities.
1. Implementing a setting-adapted (International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Clinical Characterisation Protocol (CCP) compliant critical care registry.
The near-real time registry with integrated ISARIC tier 0-2 CCP and capacity for clinical research will be implemented in 35 critical care sites in seven countries building on the methods used in the Wellcome-supported nine country Critical Care Asia (CCA) network. Registry data output will include epidemiology, quality of care processes, risk stratification and outcomes. A comprehensive national service evaluation of critical care services and an EARL evaluation will also be conducted.
2. Identifying stakeholder research priorities to optimise critical care processes and outcomes leveraging activity 1 data.
We will facilitate Audit & Feedback workshops and research prioritisation exercises for site stakeholders (inc. public) using Activity 1 output to determine priorities for optimising COVID-19 clinical management and pandemic responsiveness, especially for the critically ill, obstetric and surgical populations.
3. Recruiting sites to registry enabled clinical trials.
We will facilitate sites to participate in registry-enabled clinical trials mentored by our group and project partners. The registry infrastructure and specific data will optimise sampling strategies, patient recruitment and study monitoring.
The aim will be achieved by 3 activities.
1. Implementing a setting-adapted (International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Clinical Characterisation Protocol (CCP) compliant critical care registry.
The near-real time registry with integrated ISARIC tier 0-2 CCP and capacity for clinical research will be implemented in 35 critical care sites in seven countries building on the methods used in the Wellcome-supported nine country Critical Care Asia (CCA) network. Registry data output will include epidemiology, quality of care processes, risk stratification and outcomes. A comprehensive national service evaluation of critical care services and an EARL evaluation will also be conducted.
2. Identifying stakeholder research priorities to optimise critical care processes and outcomes leveraging activity 1 data.
We will facilitate Audit & Feedback workshops and research prioritisation exercises for site stakeholders (inc. public) using Activity 1 output to determine priorities for optimising COVID-19 clinical management and pandemic responsiveness, especially for the critically ill, obstetric and surgical populations.
3. Recruiting sites to registry enabled clinical trials.
We will facilitate sites to participate in registry-enabled clinical trials mentored by our group and project partners. The registry infrastructure and specific data will optimise sampling strategies, patient recruitment and study monitoring.
Organisations
- University of Oxford (Lead Research Organisation)
- National Institute for Health Research (Co-funder)
- World Health Organization (WHO) (Collaboration)
- Wellcome Trust (Collaboration)
- Beth Israel Deaconess Hospital (Collaboration)
- The Global Health Network (Collaboration)
- UNIVERSITY OF EDINBURGH (Collaboration)
- Kumasi Centre for Collaborative Research (Project Partner)
- Remap (Project Partner)
- World Health Organization (Project Partner)
- ISARIC (Project Partner)
- Ziauddin University (Project Partner)
- University of British Columbia (Project Partner)
- University of Edinburgh (Project Partner)
- University of Toronto (Project Partner)
- Makerere University (Project Partner)
Publications
Aryal D
(2023)
Epidemiology of critically ill patients in intensive care units in Nepal: a retrospective observational study
in Wellcome Open Research
Beane A
(2021)
What intensive care registries can teach us about outcomes.
in Current opinion in critical care
Jawad I
(2021)
A scoping review of registry captured indicators for evaluating quality of critical care in ICU.
in Journal of intensive care
Kifle F
(2022)
Intensive Care in Sub-Saharan Africa: A National Review of the Service Status in Ethiopia.
in Anesthesia and analgesia
Laytin A
(2021)
465: UTILIZING AN ETHIOPIAN ICU REGISTRY TO IDENTIFY OPPORTUNITIES FOR QUALITY IMPROVEMENT
in Critical Care Medicine
Marotta C
(2020)
Epidemiology, Outcomes, and Risk Factors for Mortality in Critically Ill Women Admitted to an Obstetric High-Dependency Unit in Sierra Leone.
in The American journal of tropical medicine and hygiene
Mwangi W
(2023)
Organisation, staffing and resources of critical care units in Kenya
in PLOS ONE
Network For Peri-Operative Critical Care (N4PCc)*
(2021)
Addressing priorities for surgical research in Africa: implementation of a multicentre cloud-based peri-operative registry in Ethiopia.
in Anaesthesia
Pari V
(2022)
Development of a quality indicator set to measure and improve quality of ICU care in low- and middle-income countries.
in Intensive care medicine
| Description | There are two significant achievements from this award. First the successful implementation of setting-adapted (International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Clinical Characterisation Protocol (CCP) compliant critical care registries in 7 countries. It has to date provided data on the case mix and clinical outcomes for more than 26000 patients. It has contributed data to ISARIC CCP, and to the WHO respiratory infections database, including, via the adaptation of the registry for paediatric and neonatal populations, data on underrepresented patient groups. Each country has established a registry coordinating centre, with the expertise and resources to implement the registry platform, coordinate day to day financial and operational oversight of their registry, curation and management of data. In doing so, collaborators have overcome known ethical regulatory and administrative barriers. Secondly, collaborators within the newly established registry networks have successfully leveraged the newly established registry infrastructure to begin recruiting patients to pandemic and critical care platform clinical trials; REMAP CAP, and ARISE; the latter designed and led by emerging LMIC researchers in response to critical care priorities of the regional population. |
| Exploitation Route | The data collected through the registry platforms is being used by clinical and hospital management teams to assess service and forcast resource utilisation. The casemix and clinical outcomes data has contributed to published international analysis for COVID 19, respiratory management in critical illness. The same data is now being used to identify and prioritise investment in critical care services; including establishment of neonatal services, appraisal of the need for ECMO services, and obstetric triage services. The data and quality indicator metric pertaining to care processes associated with respiratory management and antimicrobial stewardship are being used by PhD candidates in the network to identify and develop context specific improvement interventions. The co-investigators of this award, have been awarded funding by Wellcome Trust Innovations, from 2023-2025 to achieve sustainability of the national registry networks, to undertake academic training programmes (PhD and MScs) which will leverage the data to drive clinical trials and quality improvement, and to participate in further international data driven research. |
| Sectors | Digital/Communication/Information Technologies (including Software),Healthcare,Government, Democracy and Justice |
| Description | Research capacity: Emerging senior clinical researchers within the network are (in addition to undertaking formal academic training), actively facilitating population specific research through participation in funder programme management groups, trial steering committees, DSMBs, ethical review boards and WHO advisory boards. Junior and early career research team members have completed technical skills training in quality improvement, qualitative data collection, data science, software development and data management and grants management, allied specialties essential for building independent research teams. South to south collaboration: The project has enabled critical care clinicians and project co-investigators the opportunity to network with peers in other countries both within the African continent and internationally; ISARIC, LOGIC, Wellcome-CCAA, WHO. This networking has resulted in successful collaboration on academic publications, registration of PhDs, mixed methods research to identify gaps in existing care pathways, consensus research to identify priorities for care quality evaluation and improvement and working groups focused on designing interventions for population specific disease management and clinical trials. These same co-investigators have been successful in securing funding awards for their national registries, and clinical trials. Institutional impact: The project has provided resources and mentorship to collaborating institutions to establish mechanisms for data driven audit and feedback within their hospitals. These mechanisms, in addition to providing data pertaining to COVID-19 and respiratory management, are facilitating service data regarding critically ill trauma, obstetric, neonatal and surgical patient care delivery. Collaboration with NGOs and third party sectors: Academic impact: Two Phd tracks started (and more planned) which constitute the backbone of research leadership and sustainable development of research capacity. The availability and ownership of real-time data, united to the growing presence of local research champions will tackle the pervasive deficiencies in operational infrastructure which prevents these realities from engaging in clinical research opportunities. |
| First Year Of Impact | 2021 |
| Sector | Digital/Communication/Information Technologies (including Software),Healthcare,Government, Democracy and Justice |
| Impact Types | Cultural,Societal,Policy & public services |
| Description | Implementation of quality indicators for ICU evaluation of care |
| Geographic Reach | Africa |
| Policy Influence Type | Contribution to new or improved professional practice |
| Description | Collaboration for Research Implementation and Training in Asia and Africa |
| Amount | £8,300,000 (GBP) |
| Organisation | Wellcome Trust |
| Sector | Charity/Non Profit |
| Country | United Kingdom |
| Start | 01/2023 |
| End | 12/2025 |
| Title | Adaptataion of the PROTECT multicountry registry platform for neonatal intensive care use |
| Description | The registry platform was adapted to be used with a core dataset in African NICUs. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2022 |
| Provided To Others? | No |
| Impact | The platform refinement and backend improvements now allow for the use in a 15-country wide registry across Asia and African countries. |
| Title | E-CRF integration in PROTECT platform |
| Description | Development and operationalization of CCAA registry e-CRF for adult, pediatric and neonatal intensive care core data collection. |
| Type Of Material | Improvements to research infrastructure |
| Year Produced | 2021 |
| Provided To Others? | No |
| Impact | The PROTECT platforms e-CRFS were setting-adapted (International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) Clinical Characterisation Protocol (CCP) compliant critical care registries in 7 countries. |
| Title | Critical Care Africa registry database |
| Description | Core registry data for 26.000+ patient episodes from 40 different sites |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | No |
| Impact | A core dataset was captured on all patients admitted with critical illness. The deliberately small core dataset includes case mix, severity of illness, treatments and clinical outcomes. An optional module of critical care process measures of quality is available to evaluate existing processes of care. |
| Title | Organisation, staffing and resources of critical care units in Kenya |
| Description | The csv file contains data on organisational, staffing, resources and service-evaluation features regarding 60 critical care units in Kenya. Organisational variables included number of beds in the unit compared to the hospital beds, unit type (ICU or HDU), ICU status (medical, surgical, COVID unit, etc.), model of care and use of quality related interventions. Staffing variables included nurse to bed ratio during daytime and night time, the availability of ICU physicians, specialities available for consultation, training status of critical care nurses. Resources variables included number of functioning ventilators and high flow nasal cannula machines, type of oxygen supply, availability of imaging and monitoring equipment, availability of point of care laboratory equipment; availability of infusion and syringe pumps, difficult airway trolley, defibrillator apparatus; availability of electronic medical record; visiting hours policy before and after COVID-19 pandemic. The survey also sought to capture existing service evaluation activities in the units, as morbidity and mortality meetings, quality improvement programs, root cause analysis meetings and continuous medical education events. The willingness to participate in a National ICU registry was also assessed. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| URL | https://figshare.com/articles/dataset/Organisation_staffing_and_resources_of_critical_care_units_in_... |
| Title | Organisation, staffing and resources of critical care units in Kenya |
| Description | The csv file contains data on organisational, staffing, resources and service-evaluation features regarding 60 critical care units in Kenya. Organisational variables included number of beds in the unit compared to the hospital beds, unit type (ICU or HDU), ICU status (medical, surgical, COVID unit, etc.), model of care and use of quality related interventions. Staffing variables included nurse to bed ratio during daytime and night time, the availability of ICU physicians, specialities available for consultation, training status of critical care nurses. Resources variables included number of functioning ventilators and high flow nasal cannula machines, type of oxygen supply, availability of imaging and monitoring equipment, availability of point of care laboratory equipment; availability of infusion and syringe pumps, difficult airway trolley, defibrillator apparatus; availability of electronic medical record; visiting hours policy before and after COVID-19 pandemic. The survey also sought to capture existing service evaluation activities in the units, as morbidity and mortality meetings, quality improvement programs, root cause analysis meetings and continuous medical education events. The willingness to participate in a National ICU registry was also assessed. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2022 |
| Provided To Others? | Yes |
| URL | https://figshare.com/articles/dataset/Organisation_staffing_and_resources_of_critical_care_units_in_... |
| Description | ARISE |
| Organisation | Wellcome Trust |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | ARISE "Adult respiratory failure intervention study Africa" Is a Wellcome awarded trial for 15 hospitals in Uganda. The trial is using the registry platform to embed the trial E-CRF and provide near real time data for study screening, recruitment and monitoring. NCT04693403 |
| Collaborator Contribution | Clinical trial design, site training. |
| Impact | trial ongoing |
| Start Year | 2021 |
| Description | BREATHE |
| Organisation | Beth Israel Deaconess Hospital |
| Country | United States |
| Sector | Hospitals |
| PI Contribution | study design, registry embedding for E CRF, support with trial monitoring, data management, data pipeline and statistical analysis. |
| Collaborator Contribution | trial concept, design, study partners, IRB processes, statistical analysis, procurement, logistics and trial oversight. |
| Impact | trial in early phase of development. |
| Start Year | 2022 |
| Description | Genomicc |
| Organisation | University of Edinburgh |
| Department | MRC Centre for Inflammation Research |
| Country | United Kingdom |
| Sector | Academic/University |
| PI Contribution | Collaboration on genome sequencing in critically ill outcomes - establishing infrastructure for research and sampling, embedding CRF in registry. |
| Collaborator Contribution | genome sequencing and patient recruitment. Establishing research and ethical partnerships. Funding for sequencing. |
| Impact | new collaboration multi disciplinary. |
| Start Year | 2022 |
| Description | ISARIC |
| Organisation | The Global Health Network |
| Department | International Severe Acute Respiratory Infection Consortium (ISARIC) |
| Country | United Kingdom |
| Sector | Charity/Non Profit |
| PI Contribution | Our team has mentored the three fellows from Ghana to implement and utilise the registry. |
| Collaborator Contribution | ISARIC has supported three fellows from Ghana to aid in the implementation of the critical care registry, pandemic surveillance and to develop capacity in partnership with our project. |
| Impact | NA |
| Start Year | 2020 |
| Description | World Health Organisation |
| Organisation | World Health Organization (WHO) |
| Country | Global |
| Sector | Public |
| PI Contribution | Our team is working closely with the WHO, as part of the Respiratory Support Group, to develop and conduct observational and interventional research for Covid-19/SARI patients in a registry-embedded manner in LMIC. |
| Collaborator Contribution | The WHO is proposing to conduct observational and interventional research for Covid-19 patients using our registry platform. |
| Impact | NA |
| Start Year | 2020 |
| Title | A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) |
| Description | This study will use a study design known as a REMAP, a Randomised, Embedded, Multifactorial, Adaptive Platform trial. The broad objective of this REMAP is, over time, to determine and continuously update the optimal set of treatments for community-acquired pneumonia including Covid-19. This project is enabling the participation of African critical care units to participate in REMAP-CAP in a registry-embedded manner. |
| Type | Management of Diseases and Conditions |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2021 |
| Development Status | Under active development/distribution |
| Impact | REMAP-CAP has reported domain conclusions changing standard of care for Covid-19 patients in several domains- anti-viral, steroids, IL-6 inhibitor and anticoagulation. |
| URL | https://www.remapcap.org |
| Title | Adult Respiratory Failure Intervention Study Africa (ARISE-AFRICA) |
| Description | The aim of this prospective, multicenter, randomized, controlled, trial (PI Kwizera who is a co-I on this grant) is to determine whether High-flow oxygen through a nasal cannula (HFNC) or Continuous positive airway pressure (CPAP) system can reduce mortality among patients with acute hypoxemic respiratory failure (AHRF) in a limited resource setting as compared with standard low flow oxygen therapy? Our project will enable the implementation, monitoring and conduct of this locally-led trial via our platform. |
| Type | Management of Diseases and Conditions |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2021 |
| Development Status | Under active development/distribution |
| Impact | Frugal CPAP or HFNC , as compared with standard oxygen therapy, could reduce the mortality among adults presenting with AHRF in a resource-limited setting. |
| URL | https://clinicaltrials.gov/ct2/show/NCT04693403 |
| Title | BREATHE - Building Respiratory support in East Africa Through High flow versus low flow oxygen Evaluation |
| Description | Randomized, controlled, open-label, multi-center trial. Type 1 implementation-effectiveness hybrid clinical trial design, with: 1) primary aim of determining the effectiveness of clinical interventions and 2) secondary aim of determining the contextual factors influencing feasibility Primary Objective To determine whether: A. High flow oxygen (HFO) will decrease in-hospital mortality compared with standard flow oxygen (SFO); |
| Type | Management of Diseases and Conditions |
| Current Stage Of Development | Wide-scale adoption |
| Year Development Stage Completed | 2023 |
| Development Status | Under active development/distribution |
| Impact | The CCAA team operationalized the pre-trial observational cohort study for BREATHE (eCRF development, multisite implementation in 3 African countries, data management) including Nakuru Level V Hospital, one of the registry projects sites active in Kenya. |
| URL | https://app.dimensions.ai/details/grant/grant.10030319 |
| Title | Platform adaptation for the Neonatal Intensive Care Unit registries |
| Description | The platform adaptation to host a registry for critically ill neonates in three neonatal ICUs in collaborating centres in three different countries was completed, and >400 neonates were registered so far from Mozambique, Ethiopia and Tanzania. |
| Type Of Technology | Webtool/Application |
| Year Produced | 2022 |
| Impact | The platform will allow for the evaluation of care and computation of quality indicators across the NICUs joining the CCAA registry. |
| Description | A research priority setting exercise in partnership with the James Lind Alliance. |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | The workshop was conducted at the September co-investigators meeting in Bangkok (Sep 16 and 17, 2022). The workshop aimed to identify areas of research to be prioritized across the Critical Care Africa Asia network in the years 2023 to 2025. Collaborators from 15 different African and Asian countries participated in the working group. |
| Year(s) Of Engagement Activity | 2022 |
| Description | APORG-N4PCc |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Building African acute care research capacity as a priority in global health. Convened with critical care and surgical practitioners in Africa seeking to use data riven research to improve care. Focus on training, research priorities, research outputs and collaborations to date and quality improvement interventions underway in the regions. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Abstract presentation at European Society of Intensive Care Medicine annual congress, Paris 2022 |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | In Kenya an abstract with the preliminary analysis of 2223 patients was accepted to the European Society of Intensive Care Medicine (ESICM) annual congress and presented in Paris on the 25 Oct 22. |
| Year(s) Of Engagement Activity | 2022 |
| Description | COVID -CIRCLE |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | An online Researchers Show and Tell, where selected researchers presented their research to date, provide insights and shared their solutions to data sharing barriers/challenges in low and middle-income country settings. The aim was that this event would accelerate mutual learning amongst two communities of researchers; facilitate sharing of solutions, knowledge and experiences; and maximise the impact of research on COVID-19 in low-resource settings through broad engagement. Dr Luigi Pisani and Dr Caolryn Njoki presented on 'African critical care registry network for pandemic surveillance, clinical management and research (CRIT Care Africa)'. describing the progress of registry implementation in 7 countries, and ongoing research and how we have overcome barriers and found solutions to setting up the registries and sharing/compiling data across a number of collaborating countries. |
| Year(s) Of Engagement Activity | 2021 |
| URL | https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fcommunity.covidcircle.org%2F&data=... |
| Description | International Critical Care Africa Asia Co-investigators Meeting |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | A co-investigators meeting was held in Bangkok in September 14 to 16th 2022, bringing together the GECO CCA Africa investigators and the Wellcome Asia investigators to discuss progress. Representation from the countries supported by the current UKRI grant included Kenya (1 delegate), Ghana (2 delegates), Uganda (1 delegate), South Africa (1 delegate), Ethiopia (1 delegate) and Sierra Leone (1 delegate). Presentations with an update on the national registries work was given by the Uganda and Kenya team in two dedicated sessions. |
| Year(s) Of Engagement Activity | 2022 |
| Description | Presentation of the African Critical Care registry network at the Annual GIVITI meeting (Italian National Registry Network) |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Professional Practitioners |
| Results and Impact | A 30 minutes presentation was allocated in the annual meeting with title "Implementation of Critical Care registries in low resource settings - the experience of the Critical Care Africa Asia network". |
| Year(s) Of Engagement Activity | 2022 |
| URL | https://giviti.marionegri.it/attachments/Meeting/Meeting2022/Programma/Programma2022.pdf |