Background:
The burden of critically ill patients is growing in low and middle income countries (LMICs),
but the resources available to assist these patients are limited.1 Critical care is an
established and rapidly evolving service in Kenya.2 Yet, patient epidemiological
characteristics, patterns of ICU management and patient outcomes in Kenyan ICUs remain
scarcely investigated.3,6,7
The ICU registry:
The Kenyan Critical Care Registry was started in December 2020 after receiving ethical
approval in November 2020, and currently involves 10 units in 6 Hospitals. The registry was
launched in collaboration with the Network for Intensive Care Systems and Training (NICST)
and the Mahidol Oxford Research Unit (MORU). As in other countries, the Kenyan Critical Care
registry aims to play an increasingly pivotal role in evaluating treatment outcomes,
benchmarking services and providing opportunities for service forecasting. Dedicated data
collectors in each registry site perform real-time data collection. All registry data is
housed and stored securely on a national server located on Kenyan soil. Once entered
electronically on password-protected computers at participating facilities, it is
automatically encrypted before it leaves the institution for the visualization loop within a
ring-fenced server at NICST, where it is unencrypted and aggregated for automated
visualization. NICST follows healthcare standard GDP and HIPAA standards. The processed data
is then re-encrypted before it is transferred back to the national server, where it is
automatically unencrypted and available for review by authorized personnel, through a secure
two step log in - a process that is navigated with the help of Kenyan IT teams. An audit
trail is created any time the registry is accessed, to see who has logged into it, when, and
what data was retrieved or modified.
Study aims:
In this study we aim to describe patient epidemiological characteristics, basic management
and outcomes of critically ill patients in Kenya during and after the COVID-19 pandemic,
leveraging on the newly-implemented Kenya Critical Care Registry housed under the Critical
Care Society of Kenya (CCSK). Study outcomes include clinico-demographic characteristics of
patients admitted to critical care units within the Kenya Critical Care Registry network,
primary management process measures and short-term critical care outcomes.
Patients:
All patients admitted to participating critical care units from the day of registry onset to
the day of database analysis will be included. A secure, non-proprietary, real-time,
cloud-based platform designed by NICST, adapted for use at participating facilities when the
registry began, is used for data entry and management. A critical care minimum dataset
(CCMDS) of variables was employed by the investigators, in consultation with the critical
care team at participating facilities.
Ethical Considerations:
Ethical clearance from the Aga Khan University Institutional Ethics Review Committee (IERC)
to begin registry creation was obtained in November 2020 (Ref:2019/IERC-89) and a NACOSTI
licence secured. Site approvals from NACOSTI-accredited ethical committees and/or
administrative clearance were obtained from participating institutions prior to commencement.
Ethical/administrative and national regulatory approvals for this present study will be
sought in the same manner, prior to study commencement.
Benefits:
There will not be any direct benefit to patients at the outset. The expected improvement in
critical care processes and outcomes enabled by the registry data analysis will have the
potential to directly benefit future critically ill patients in Kenya. In addition the
information gathered on admission, patient flow, occupancy and acuity will be essential to
helping Kenyan administrative and management team plan future critical care resource
provision, optimising critical care resource utilisation and cost effectiveness. The study
may also provide important context specific COVID-19 case-mix and outcome data that may be of
value to clinicians, administrators and policy makers during the ongoing pandemic.
Confidentiality:
Access to the electronic registry will be restricted to personnel authorized by the
leadership at participating facilities, each of whom have been provided with a unique login
and password for this purpose. Each person with such access to the registry has signed a data
protection agreement, indicating that they will not share their login details with anyone
else, and that they will not share the contents of the registry with unauthorized personnel.
As in other ICU registries, identifiable patient data is restricted to hospital staff
authorized to access the critical care registry by the administration of individual
facilities.The data extraction for analysis will concern only de-identified data.