Standardized clinical decision-support algorithms to improve patient outcomes

Linking diagnostics and appropriate treatment to improve patient outcome in the context of universal health care

Electronic clinical decision-support algorithms (eCDAs) are important tools with the potential to improve patient outcomes in the context of universal health coverage. On 27 November 2018, FIND and the World Health Organization (WHO)* convened a workshop to define the role of eCDAs in translating diagnostic results into therapeutic decisions. The meeting involved 39 experts from academic institutions, industry, private and public sectors from 11 countries, and included researchers, software developers, implementers, government officials and representatives from international organizations and funding agencies.

Participants evaluated the current landscape, use and development of eCDAs in low- and middle-income countries (LMICs), as well as their integration with diagnostics and other essential healthcare products. Focus was given to the development and implementation of eCDAs at the point of care in resource- and connectivity-challenged settings, and their impact.

Requirements were discussed for eCDAs that integrate point-of-care tests into a toolkit for stakeholders such as ministries of health, health programme implementers and software developers; and these formed the basis of a draft target product profile (TPP) currently in development. Implementation guidance supporting linkage of algorithms to diagnostics was also considered.

Participants agreed that:

  • eCDAs should be contextualized, and their development should be based on established or new evidence
  • Validation must include clinical validation studies, ideally based on user experience in situ
  • Implementation should tie into existing infrastructure and requires local buy-in
  • Systems should support clinical workflows appropriate to the user and the settings, inclusive of workflow adaptations for diagnostics.

The group expressed concern about the market readiness for eCDAs, and recognized that market shaping and potential donor backing will be needed to increase access and support country adoption of these tools, either individually or as a toolkit with diagnostics.

Future follow-up workshops will focus on validation methods and data standards as they apply to eCDAs.

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*WHO groups/departments involved: Essential Medicines and Health Products; Digital Health Innovations; Reproductive Health and Research.