Development and Evaluation of a Clinical Guideline for a Pediatric Telemedicine and Medication Delivery Service: A Prospective Cohort Study in Haiti

ABSTRACT

Objective Despite the emergence of telemedicine as an important model for healthcare delivery, there is a lack of evidence-based telemedicine guidelines, especially for resource-limited settings. We sought to develop and evaluate a guideline for a pediatric telemedicine and medication delivery service (TMDS).

Methods A prospective cohort study was conducted at a TMDS in Haiti; children ≤10 years were enrolled. Among non-severe cases, paired virtual and in-person exams were conducted at the call center and household; severe cases were referred to the hospital. The primary outcome was the performance of the virtual exam compared to the in-person exam (reference standard).

Findings A total of 391 cases were enrolled. Among 320 cases with paired exams, no general World Health Organization (WHO) danger signs were identified at the household; problem-specific danger signs were identified in 6 cases (2%). Cohen’s kappa for the designation of mild cases was 0.78 (95%CI 0.69-0.87). Among components of the virtual exam, the sensitivity and specificity of a reported fever were 91% (87%-96%) and 69% (62%-74%), respectively; the sensitivity and specificity of ‘fast breathing’ were 47% (21%-72%) and 89% (85%-94%), respectively. Kappa for dehydration assessments indicated moderate congruence (0.69; 95%CI 0.41-0.98). At 10 days, 95% (273) of the 287 cases reached were better/recovered.

Conclusion This study, and resulting guideline, represents a formative step towards an evidence-based pediatric telemedicine guideline built on WHO clinical principles. In-person exams for select cases were important to address limitations with virtual exams and identify cases for escalation.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT03943654

Funding Statement

This research was supported by a National Institutes of Health grant to EJN [DP5OD019893] as well as internal support from the Emerging Pathogens Institute (EJN), the Departments of Pediatrics (EJN), the Department of Environmental and Global Health (EJN), the Department of Emergency Medicine (KEF/TKB) at the University of Florida, and the Children’s Miracle Network. These funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the 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:

The University of Florida Institutional Review Board gave ethical approval for this work (IRB201802920). Additionally the Comite National de Bioethique in Port-au-Prince Haiti gave ethical approval for this work (1819-51).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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).

Yes

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 study are available upon reasonable request to the authors.

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