Monday, April 6, 2020

Rapid Guidelines in GRADE Pt. I: Needed Advice when Time is of the Essence

While most clinical practice guidelines take 2-3 years to develop and publish, the emergence of a public health crisis or urgent humanitarian need requires the dissemination of evidence-based guidance in a more rapid manner. To this effect, several national- and international-level guideline-producing organizations, such as the Centers for Disease Control (CDC) and the World Health Organization (WHO), have developed processes for the development of evidence-based guidance for these more urgent situations.

WHO’s 2006 recommendations for the pharmacological management of avian influenza in humans is one example of a rapidly developed guideline. Of current relevance, WHO has recently published interim guidance on the management of severe acute respiratory infection when novel coronavirus is suspected, and the UK’s National Institute for Health and Care Excellence (NICE) has also developed interim guidelines for the treatment of COVID-19 in patients receiving critical care, kidney dialysis, and systemic anticancer therapy. Because this matter is rapidly evolving and advice is needed immediately, the protocols used by NICE, WHO and other organizations are different than it would be for less urgent topics.

Can rapid guidelines use GRADE?

In short, yes. Recommendations can be made based on the transparent grading and reporting of the certainty of evidence that lie at the heart of GRADE, whether this is over the timeframe of hours, days, weeks, or months. The key word here is transparent: no matter the speed of development, recommendations should always be couched within the terms of the certainty of evidence behind them, and judgments of the evidence should be clearly presented. In a 2016 paper on the use of GRADE to respond to health questions with different levels of urgency, Thayer and Schünemann provide terms for the various speeds of response, and considerations for recommendations therein:
  • Ultra-short emergency response: 1 or more hours
  • Urgent response: 1-3 weeks
  • Rapid response: 1-3 months
  • Routine response: More than three months

Recommendations can still be formed based on the certainty of the evidence that's available, whatever that evidence may be. While systematic reviews of all available evidence are a foundational aspect of non-urgent guidelines, evidence in the form of narrative syntheses, modeling, or late-breaking data from the field can be used when time is short and systematically compiled data are sparse. Regardless of the source, the domains of GRADE still allow for evidence to be appraised and to guide the resulting direction and strength of recommendations.

Stay tuned for Pt. II coming soon, where we'll take a closer look at organizations that have developed rapid recommendations in response to time-sensitive public health issues.

For a checklist to guide the development of rapid recommendations, see the G-I-N/McMaster checklist.

For more information about appraising the certainty of evidence in the lack of meta-analyzed data, see this paper.

Thayer KA & Schünemann H. Using GRADE to Respond to Health Question With Different Levels of Urgency. Environment international. 2016 July-August: 585-589.

Manuscript available at the publisher's website here.