key: cord-0943705-jkduta58
authors: Yao, Xiaomei; Jin, Ying-Hui; Djulbegovic, Benjamin
title: Some thoughts on conducting and implementing clinical practice guidelines in a pandemic
date: 2021-04-20
journal: Chin Med J (Engl)
DOI: 10.1097/cm9.0000000000001169
sha: 0d7f76f2c191efc46868d17b65d3c97e7faa180e
doc_id: 943705
cord_uid: jkduta58

nan

A pandemic is a disease that spreads worldwide. When disease is new such as coronavirus disease 2019 (COVID-19), evidentiary basis, by definition, to prevent, diagnose, and treat the disease is limited. Nevertheless, clinical practice guidelines are urgently required to assist policy and healthcare workers to make informed decisions. But, acting in the high-quality evidentiary vacuum, that is, basing guidelines on poor-quality research can be counterproductive and potentially harmful. [1, 2] Thus, guideline developers face a number of challenges during a pandemic like COVID-19 that we wish to address in this paper.

Should a standard guideline or a rapid advice guideline be conducted?

The World Health Organization (WHO) classifies the 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) (https:// www.who.int/). In determining if a rapid advice guideline is appropriate, the key question is how quickly the uncertainty needs to be dealt with. The WHO recommends that rapid response guidelines can be developed within hours to 3 months based on evaluation of all the information from the public health emergency or pandemic.

Who develops a rapid advice guideline?

From national to state/province agencies, professional organizations, local hospitals etc., anyone can develop a rapid advice guideline as long as they have resource (such as sufficient human capital and adequate funding) and ability (such as guideline developers with relevantly 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. [3] Therefore, rapid advice guidelines may be evidence-based guidelines or nonevidence-based guidelines. One fundamental misconception about evidence-based guidelines is that they can be only developed if well-designed controlled trials exist. On the contrary, evidence-based medicine principles apply equally well to low or high quality evidence and the situations when only low quality evidence is available may be those in which clinicians most need guidance. [4] Nonevidence-based guidelines that neglect the underlying evidence may be bound to make different and potentially erroneous advices compared with evidence-based guidelines. [1] We searched the ECRI Guideline Trust (https://guidelines. ecri.org/), the Center for Disease Control and Prevention library database, PubMed, Medline, Embase, WHO database (https://www.cdc.gov/library/researchguides/) for COVID-19 guidelines released up to May 19 2020. We found seven evidence-based guidelines that were based on a systematic review, and four non-evidence-based guidelines that were based on guideline developers' clinical experience rather than a systematic review, regarding antiviral treatment in adult patients with COVID-19 [ Table 1 ]. This shows that different organizers can make different recommendations on the same topics and questions. There are many reasons why guidelines differ: some are warranted (eg, difference between settings, accessibility, implement ability of interventions, etc.) but most are unwarranted (eg, conflict of interest, failure to perform high-quality systematic reviews, lack of familiarity with evidence-based guideline's development methods, etc.). [5] However, the most serious difference among guidelines in terms of their consequences on decisionmaking and patients' outcomes is between evidence-based and non-evidence-based guidelines. Table 1 shows a typical case: non-evidence-based guidelines rarely or ever make recommendations against use of a particular treatment. Because the development process for nonevidence-based guidelines is not transparent, the accuracy of its recommendations cannot be assessed, and, therefore, the end users should not feel confident to implement them. Hence, we recommend that rapid advice guidelines, like all other types of clinical guidelines, should always be evidence-based. It is noticed that some living evidencebased guidelines are neither registered at the ECRI Guideline Trust nor published in a medical literature databases, such as the NIH treatment guideline for COVID-19 (http://www.covid19treatmentguidelines.nih. gov/).

The guideline reporting checklist, the tool that assists guideline developers on how to report the guideline, is a key mechanism for assuring transparency. Therefore, it should be mandatory. In addition, it does not take too much time to complete. [6] It also helps the end users to assess the quality of guidelines using the guidelines appraisal tools such as AGREE II and AGREE-REX (https://www.agreetrust.org/) to facilitate decisions on whether to implement guidelines in clinical practice or not.

When should a guideline be updated due to continuously emerging evidence?

For the conditions that represent a serious public threat with new evidence emerging at fast pace that may make previous recommendations obsolete. The guidelines updating should be continuous. The "living" evidencebased guidelines that employ a combination of continuous literature surveillance, rapid updating of systematic reviews and virtual panel meeting represent the best mechanism to provide trustworthy recommendations on evolving basis (see http://metaevidence.org/COVID19. aspx for an example). However, to succeed, living guidelines require commitment and resources.

How should a rapid advice guideline be implemented?

Implementation of a rapid advice guideline should be taken into account right from the beginning of guideline development. Guideline development should include a plan of the steps and options for dissemination and implementation. Implementation tools, like decision aids or evidence tables must be easy to follow by all clinicians. Translating guidelines into clinical algorithms/pathways and decision-tree is particularly promising strategy for their implementation at the point of care. [7] Guidelines deemed impractical for use in local settings due to resource demands may be the biggest barriers for guideline implementation in a public health emergency. For example, the RT-PCR test is regarded as the reference standard to diagnose COVID-19, but 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 that are affected by the coronavirus pandemic.

According to the Institute of Medicine, a trustworthy guideline is to be developed via a transparent process, supported by a systematic review of the evidence and updated continuously. In the time of pandemic, this can only be achieved by developing "living" evidence-based rapid services. Historically, development of guidelines has not been well coordinated or funded, often resulting in their inefficient and duplicated production. Given international scope of pandemics such as COVID-19, we call for establishing an international center of "living" evidencebased guidelines. The existence of such a center with its branches in all continents would help avoid duplication of the efforts and pool resources to efficiently develop high quality systematic reviews and guidelines, which, in turn, could quickly be disseminated for local implementation across the globe.

Dr. Djulbegovic was supported by a grant from the Agency for Healthcare Research and Quality (No. R01HS024917).

The content is solely the responsibility of the author and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.

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