Date Published: May 29, 2007
Publisher: Public Library of Science
Author(s): Holger J Schünemann, Suzanne R Hill, Meetali Kakad, Gunn E Vist, Richard Bellamy, Lauren Stockman, Torbjørn Fosen Wisløff, Chris Del Mar, Frederick Hayden, Timothy M Uyeki, Jeremy Farrar, Yazdan Yazdanpanah, Howard Zucker, John Beigel, Tawee Chotpitayasunondh, Tran Tinh Hien, Bülent Özbay, Norio Sugaya, Andrew D Oxman
Abstract: Emerging health problems require rapid advice. We describe the development and pilot testing of a systematic, transparent approach used by the World Health Organization (WHO) to develop rapid advice guidelines in response to requests from member states confronted with uncertainty about the pharmacological management of avian influenza A (H5N1) virus infection. We first searched for systematic reviews of randomized trials of treatment and prevention of seasonal influenza and for non-trial evidence on H5N1 infection, including case reports and animal and in vitro studies. A panel of clinical experts, clinicians with experience in treating patients with H5N1, influenza researchers, and methodologists was convened for a two-day meeting. Panel members reviewed the evidence prior to the meeting and agreed on the process. It took one month to put together a team to prepare the evidence profiles (i.e., summaries of the evidence on important clinical and policy questions), and it took the team only five weeks to prepare and revise the evidence profiles and to prepare draft guidelines prior to the panel meeting. A draft manuscript for publication was prepared within 10 days following the panel meeting. Strengths of the process include its transparency and the short amount of time used to prepare these WHO guidelines. The process could be improved by shortening the time required to commission evidence profiles. Further development is needed to facilitate stakeholder involvement, and evaluate and ensure the guideline’s usefulness.
Partial Text: Clinical practice guidelines generally, and some WHO guidelines specifically, have been criticized for not being based on the best available evidence, for being exposed to undue influence by industry and experts who participate in guideline panels, and for not adhering to guidelines for preparing guidelines [1–7]. Guidance that is not informed by the best available evidence or by statements that the available evidence is of low quality can harm patients, waste limited resources, and hinder research to address important uncertainties .
In January 2006, the WHO decided to convene a rapid advice guidelines panel for the pharmacological management of H5N1 patients in response to requests for advice from frontline clinicians and public health professionals managing H5N1 infections. The key steps and timeline for developing the guidelines are summarized in Box 1.
It took approximately one month to put together a team to prepare the evidence profiles, but once the team was assembled it took only five weeks to prepare and revise the evidence profiles and prepare draft guidelines prior to the panel meeting (Box 1). A draft manuscript for publication was prepared within 10 days following the panel meeting. It took only two additional weeks to complete a final draft of the document (on April 21, 2006) that included all of the considered evidence and recommendations.
These guidelines were prepared in less than two months through an intense international collaboration, the use of electronic communication, and one panel meeting. However, it took one additional month initially to put together the team that prepared the evidence profiles.
In summary, we found that it is feasible to develop evidence-based guidelines systematically and transparently in as little as two months. The cost of doing this is prohibitively high for low- and middle-income countries and it would be wasteful for high-income countries to duplicate this process unnecessarily. WHO, or others developing rapid advice, can therefore provide an important service by using a robust and transparent process that simplifies adaptation to specific settings. Further work is required to develop systematic processes for WHO to give even faster or immediate guidance for emerging infectious diseases.