After considering additional studies for questions where adequate RCTs were not available, another iteration of evidence statements and recommendations was developed. The full panel met again to consider this iteration, which was considered by small groups assigned to focus on either a specific treatment modality or outcome measure. The small groups brought their recommendations back to the full panel for their final consideration. The panel weighed the evidence based on a thorough examination of the threshold or magnitude of the treatment effect. The consensus process used for drawing conclusions and writing the recommendations was a group process that took into account all opinions.
Conclusions reflect the widest possible agreement of the panel.
Category A therefore requires substantial numbers of studies involving substantial numbers of participants. Evidence is from endpoints of intervention studies that include only a limited number of RCTs, post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In general, Category B pertains when few randomized trials exist, they are small in size, and the trial results are somewhat inconsistent, or the trials were undertaken in a population that differs from the target population of the recommendation. Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies.