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.
There are at least two ways in which the time needed to prepare rapid advice could be shortened: first, by identifying or establishing collaborating centres with the competency needed to prepare evidence profiles and second, by building up in-house capacity to reduce the time needed to organize a review team.
Strengths of the process
Strengths of the applied process include its transparency and the short amount of time used to prepare the guidelines. Guideline developers are increasingly using the GRADE approach because it includes transparent judgments about each of the key factors that determine the quality of evidence for each important outcome, and overall across outcomes for each recommendation [10
]. In addition, the approach used in developing these guidelines included transparent consideration of the key factors that determine the strength of a recommendation. The rapid preparation of evidence profiles was possible because of the availability of high-quality systematic reviews of the evidence from seasonal influenza and the involvement of a review team with experience in preparing evidence profiles and relevant clinical expertise. In the absence of higher-quality direct evidence, the panel considered case reports, animal studies, and in vitro studies for H5N1, as well as the available indirect evidence from systematic reviews of clinical trials for seasonal influenza, systematically and transparently.
The broad representation of stakeholders in the guideline group allowed the inclusion of different perspectives for making informed judgments about the importance of outcomes, the quality of evidence, and the strength of recommendations. The publicly available evidence profiles facilitate adaptation of the guidelines to specific settings and updating of the guidelines, as well as contributing to transparency [13
Limitations of the process
Limitations of this process relate to its very purpose: providing rapid advice. Thus, the time available for developing these guidelines did not permit detailed consideration of all clinical questions that clinicians may face. For example, the discussions about whether to use prophylactic antibiotics and which recommendations apply to situations of human-to-human transmission were short and, therefore, did not result in specific recommendations. It is unlikely that important evidence that would have led to different recommendations was missed given the nature of the problem; i.e., an emerging disease. In areas with an ample evidentiary base, evidence could be missed by relying on systematic reviews of the indirect evidence. However, this generally should not be the case when rapid advice is needed. It is not clear whether the differences the panel identified within the category of very low-quality evidence are truly important for decision making, but panel members requested that this information should not be lost in translating the quality of evidence into the four categories based on the GRADE approach.
The total budget required for this guideline development project amounted to approximately US$150,000, for a focused guideline. This was made possible in part by limiting the number of meetings through the use of electronic communication tools. While this cost compares favourably with the cost of other guideline development processes, it remains out of reach for many countries trying to develop national rapid advice guidelines.
Involvement of stakeholders through consultation is limited by the rapid process. There are at least three ways in which stakeholder involvement could be improved. First, rapid consultations could be facilitated by establishing stakeholder groups and mechanisms for involvement such as those used by the National Centre for Health and Clinical Excellence. Second, evaluation and updating of the guidelines offer opportunities for more stakeholder involvement in revisions of the guidelines. Third, because the guidelines need to be adapted to specific settings, stakeholders could be involved in local adaptation processes.
Although research needs were identified by the guideline panel, these do not provide clear guidance for what research should be prioritized to address the most important uncertainties about pharmacological management of H5N1 infection. While this is partly due to the mandate that was given to the panel, recommendations for research should be viewed as an integral part of making recommendations.