Background: The World Health Organization (WHO) has a central role in preparing for, responding to, and supporting the recovery from public-health emergencies. Guidelines are fundamental to accomplish this mandate, however, emergency situations challenge traditional guideline-development processes and tools because of condensed timelines, paucity of structured data and shifting needs in the field.
Objectives: To describe production processes and to present development tools for health emergency interim guidelines (HEIG) when there are no existing suitable guidelines and guidance is needed in less than 4 weeks.
Methods: These tools were developed at WHO using an iterative, consensus-based approach by experts in guideline development and response to public-health emergencies (all types of hazards). The basis for these tools is standard guideline methods and existing adaptations for rapid reviews and rapid advice guidelines. We applied these approaches to guidelines developed by WHO in the context of Zika virus disease to refine and improve the tools.
Results: Steps for developing HEIGS include: 1) determine knowledge needs and gaps in the field; 2) prepare a brief work plan (basis for the guideline); 3) constitute an expert panel, examine and manage their declarations of interest; 4) identify and synthesise evidence; 5) prepare evidence-to-decision frameworks; and, 6) formulate recommendations (by the expert panel). We provide explicit, pragmatic guidance on each of these steps, including templates, algorithms and checklists to facilitate the work. We present a case study of a Zika virus-related guideline that followed these steps and was produced in 3 weeks.
Conclusions: Guidelines produced in public-health emergencies must respect the same development principles and quality standards for guidelines in other contexts: they must be transparent, contain explicit methods, minimise the risk of bias, and reflect all relevant perspectives. The HEIG processes and tools designed by WHO outline an approach that adheres to these principles while meeting specific challenges brought by public-health emergencies.