ePOCT+ and the medAL-suite: Development of an electronic clinical decision support algorithm and digital platform for pediatric outpatients in low- and middle-income countries

Abstract

Electronic clinical decision support algorithms (CDSAs) have been developed to address high childhood mortality and inappropriate antibiotic prescription by helping clinicians adhere to guidelines. Previously identified challenges of CDSAs include its limited scope, usability, and outdated clinical algorithms. To address these challenges we developed ePOCT+, a CDSA for the care of pediatric outpatients in low- and middle-income settings, and the medical algorithm suite (medAL-suite), a software for the creation and execution of CDSAs. Following the principles of digital development, we aim to describe the process and lessons learnt from the development of ePOCT+ and the medAL-suite. In particular, this work outlines the systematic integrative development process in the design and implementation of these tools required to meet the needs of clinicians to improve uptake and quality of care. We considered the feasibility, acceptability and reliability of clinical signs and symptoms, as well as the diagnostic and prognostic performance of predictors. To assure clinical validity, and appropriateness for the country of implementation the algorithm underwent numerous reviews by clinical experts and health authorities from the implementing countries. The digitalization process involved the creation of medAL-creator, a digital platform which allows clinicians without IT skills to easily create the algorithms, and medAL-reader the mobile health (mHealth) app used by clinicians during the consultation. Extensive feasibility tests were done with feedback from end-users of multiple countries to improve the clinical algorithm and medAL-reader software. We hope that the development framework used for developing ePOCT+ will help support the development of other CDSAs, and that the open-source medAL-suite will enable others to easily and independently implement them.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This work took place within the framework of the DYNAMIC project that is funded by the Fondation Botnar, Switzerland (grant n 6278) as well as the Swiss Development Cooperation (grant n 7F-10361.01.01) received by VDA. The TIMCI project funded by UNITAID (grant n 2019-35-TIMCI) received by VDA allowed for adapting of ePOCT+ or the medAL-suite software to Senegal, Kenya and India. The funders had no role in the development of ePOCT+ or the medAL-suite software, data collection, analysis, nor did they have a role in the decision to publish, or preparation of this manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee/IRB of Ifakara Health Institute in Tanzania, the National Institute for Medical Research in Tanzania, the National Ethics Committee of Rwanda, the Comite National d Ethique pour la Recherche en Sante of Senegal, the University of Nairobi Ethics and Research Committee in Kenya, the King George s Medical College Institutional Ethics Committee in India, the Indian Council of Medical Research, the cantonal ethics review board of Vaud, Switzerland, and the WHO Ethics Review Committee, the Ethikkommission Beider Basel in Switzerland, and the Boston Children s Hospital, all gave ethical approval for this work

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present work are available upon reasonable request to the authors.

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