New Framework for Developing Evidence Based Recommendations by the Advisory Committee On Immunization Practices (ACIP)

Background: The ACIP voted in October 2010 to adopt an explicit evidence framework for making recommendations.  The vote represented a culmination of years of work by the ACIP’s Evidence Based Recommendations Work Group (EBRWG), which was charged with the task to develop a uniform approach to making explicit the evidence base for ACIP recommendations.

Setting: United States.

Population: Vaccination recommendations for infants, children, adolescents, and adults.

Project Description: The EBRWG’s guiding principles for developing an explicit evidence framework included focus on transparency; use of evidence of varying strengths; consideration of both individual and community health; adoption of an existing system; and a need to continually strive to improve the process. The EBRWG reviewed several evidence evaluation systems for developing guidelines and recommendations, and proposed an evidence framework based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Results/Lessons Learned: The ACIP adopted the GRADE approach for evaluating evidence and for translating evidence to recommendations. Key factors for developing recommendations include the balance of benefits and harms, type or quality of evidence, values, and health economic analyses (e.g., cost-effectiveness). Category A recommendations will be for all persons in an age group or for all persons in a risk-based group (with the exception of persons who have a contraindication). Category B recommendations will require individual clinical decision making; it will not apply to all members of an age- or risk-factor-based subgroup of the population, but in the context of a clinician-patient interaction, vaccination may be found to be appropriate for a person. Category B recommendations are similar to what was previously referred to as permissive recommendations. Evidence tables will be used to summarize the benefits and harms and the strengths and limitations of the body of evidence. The new evidence framework will make the ACIP’s decision-making process more transparent and systematic.