Some Thoughts on Conducting and Implementing Clinical Practice Guidelines in a Pandemic
A pandemic, such as the coronavirus disease 2019 (COVID-19), presents unique challenges for the development and implementation of clinical practice guidelines. In the face of a novel disease, the evidentiary basis for prevention, diagnosis, and treatment is inherently limited. Despite this, the urgent need for guidelines to assist policymakers and healthcare workers in making informed decisions is paramount. However, acting in a high-quality evidentiary vacuum—basing guidelines on poor-quality research—can be counterproductive and potentially harmful. This paper addresses the challenges faced by guideline developers during a pandemic like COVID-19 and provides insights into the development and implementation of rapid advice guidelines.
Should a Standard Guideline or a Rapid Advice Guideline Be Conducted?
The World Health Organization (WHO) classifies guidelines into four categories: standard guidelines, comprehensive guidelines (consolidated guidelines), interim guidelines, and emergency guidelines in response to an emergency or urgent need (rapid advice guidelines). The key question in determining the appropriateness of a rapid advice guideline is how quickly the uncertainty needs to be addressed. The WHO recommends that rapid response guidelines can be developed within hours to three months based on an evaluation of all the information from the public health emergency or pandemic.
Who Develops a Rapid Advice Guideline?
Rapid advice guidelines can be developed by a range of entities, from national to state/province agencies, professional organizations, and local hospitals. The primary requirements are sufficient resources (such as human capital and adequate funding) and the ability to develop guidelines (such as having developers with relevant clinical and methodological expertise).
Is It Acceptable to Develop Non-Evidence-Based Guidelines Based on Experts’ Opinion Only?
Guidelines are classified into evidence-based guidelines and non-evidence-based guidelines. Rapid advice guidelines may fall into either category. A common misconception about evidence-based guidelines is that they can only be developed if well-designed controlled trials exist. However, evidence-based medicine principles apply equally well to low or high-quality evidence. In situations where only low-quality evidence is available, clinicians may need guidance the most. Non-evidence-based guidelines that neglect the underlying evidence may lead to different and potentially erroneous advice compared to evidence-based guidelines.
A search of the ECRI Guideline Trust, the Center for Disease Control and Prevention library database, PubMed, Medline, Embase, and the WHO database for COVID-19 guidelines released up to May 19, 2020, revealed seven evidence-based guidelines based on a systematic review and four non-evidence-based guidelines based on the clinical experience of guideline developers. This highlights that different organizers can make different recommendations on the same topics and questions. The reasons for these differences can be warranted (e.g., differences between settings, accessibility, and implementability of interventions) or unwarranted (e.g., conflict of interest, failure to perform high-quality systematic reviews, lack of familiarity with evidence-based guideline development methods).
The most serious difference among guidelines in terms of their consequences on decision-making and patient outcomes is between evidence-based and non-evidence-based guidelines. Non-evidence-based guidelines rarely or ever make recommendations against the use of a particular treatment. Because the development process for non-evidence-based guidelines is not transparent, the accuracy of their recommendations cannot be assessed, and end-users should not feel confident in implementing them. Therefore, it is recommended that rapid advice guidelines, like all other types of clinical guidelines, should always be evidence-based.
Should Rapid Advice Guideline Developers Follow the Regular Guideline Reporting Standards?
The guideline reporting checklist is a key mechanism for ensuring transparency in guideline development. It assists guideline developers in reporting the guideline and should be mandatory. Completing the checklist does not take much time and helps end-users assess the quality of guidelines using appraisal tools such as AGREE II and AGREE-REX. These tools facilitate decisions on whether to implement guidelines in clinical practice.
When Should a Guideline Be Updated Due to Continuously Emerging Evidence?
For conditions that represent a serious public threat with new evidence emerging at a fast pace, guidelines should be updated continuously. “Living” evidence-based guidelines that employ a combination of continuous literature surveillance, rapid updating of systematic reviews, and virtual panel meetings represent the best mechanism to provide trustworthy recommendations on an evolving basis. However, living guidelines require commitment and resources to succeed.
How Should a Rapid Advice Guideline Be Implemented?
The implementation of a rapid advice guideline should be considered from the beginning of guideline development. The development process should include a plan for dissemination and implementation. Implementation tools, such as decision aids or evidence tables, must be easy for all clinicians to follow. Translating guidelines into clinical algorithms/pathways and decision trees is a particularly promising strategy for their implementation at the point of care. Guidelines deemed impractical for use in local settings due to resource demands may be the biggest barriers to implementation in a public health emergency. For example, the RT-PCR test, regarded as the reference standard to diagnose COVID-19, was not available at some hospitals in Wuhan or other cities in Hubei province in China in January and February of 2020 and is still not widely implemented in other countries affected by the coronavirus pandemic.
Conclusions
According to the Institute of Medicine, a trustworthy guideline is developed via a transparent process, supported by a systematic review of the evidence, and updated continuously. In the time of a pandemic, this can only be achieved by developing “living” evidence-based rapid services. Historically, the development of guidelines has not been well coordinated or funded, often resulting in inefficient and duplicated production. Given the international scope of pandemics such as COVID-19, there is a call for establishing an international center of “living” evidence-based guidelines. The existence of such a center with branches in all continents would help avoid duplication of efforts and pool resources to efficiently develop high-quality systematic reviews and guidelines, which could then be quickly disseminated for local implementation across the globe.
doi.org/10.1097/CM9.0000000000001169
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