Updated Framework for Development of Evidence-Based Recommendations by the Advisory Committee on Immunization Practices

Carr, Wendy; Reingold, Art; Hunter, Paul; Lee, Grace; Temte, Jon; Campos‐Outcalt, Doug; Rubin, Lorry G.; O’Leary, Sean T.; Savoy, Margot; Qaseem, Amir; Sicard, Nadine; Ismail, Shainoor J.; Ramanathan, Roshan; Weber, David J.; Lavergne, Valéry; Calonge, Ned; Wiysonge, Charles Shey; Duclos, Philippe; Marti, Melanie; Harder, Thomas; Falkenhorst, Gerhard; Matanock, Almea; Pilishvili, Tamara; Dooling, Kathleen; Bridges, Carolyn B.; Lindley, Megan C.; Shimabukuro, Tom T.

doi:10.15585/mmwr.mm6745a4

Cited by 36 publications

(31 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These guidelines are regularly updated with the most up-to-date evidence. 1,2 Despite wide recognition that adherence to evidence-based guidelines improves outcomes, clinicians struggle to implement guidelines in a timely fashion. [3][4][5] Meanwhile, overscreening of breast, cervical, and prostate cancer, underscreening of lung cancer, and suboptimal vaccination rates continue to put patients at harm.…”

Section: Introductionmentioning

confidence: 99%

Factors Influencing Uptake of Changes to Clinical Preventive Guidelines

et al. 2020

View full text Add to dashboard Cite

Background: Despite widespread recognition that adherence to clinical preventive guidelines improves patient outcomes, clinicians struggle to implement guideline changes in a timely manner. Multiple factors influence guideline adoption and effective implementation. However, few studies evaluate their collective and interrelated effects. This qualitative study provides a comprehensive picture of the interplay between multiple factors on uptake of new or changed preventive guidelines. Methods: Semistructured interviews conducted in 2018 with a diverse sample of clinicians and practice leaders sought to understand patient, clinician, practice, health system, environment, and guideline factors of influence. An immersion-crystallization approach was used to identify emergent themes. Results: Interviewees expressed motivation to adhere to guidelines but also valued sharing decisions with patients. Personal biases and fears affected both clinician and patient guideline adoption. Practices facilitated implementation through workflow optimization and encouraging a culture of evidence-based practice while a key health system function was to maintain electronic health record alerts. More traditional environmental factors, such as insurance coverage or transportation, were less of a barrier to guideline adoption and implementation than the influence of media and specialists. Various specific guideline characteristics also affected ease of adoption and implementation. Different settings expressed greater health system, practice, or clinician-centric approaches to guideline implementation. Conclusions: Guideline uptake is influenced by a complex interplay of multiple levels of factors including the patient, clinician, practice, health system, environment, and guideline levels. Comprehensively understanding all levels of influence for each specific clinical setting may help to determine the optimal intervention(s) for improving uptake of evidence-based guidelines.

show abstract

Section: Introductionmentioning

confidence: 99%

Factors Influencing Uptake of Changes to Clinical Preventive Guidelines

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Vaccine Licensure by the FDA The Center for Biologics Evaluation and Research is the center within the FDA that is responsible for regulatory oversight of biologic products for human use including vaccine development as well as licensure of new vaccines in the United States. 18,19,22 The mission of this center is to protect and enhance public health through regulation of biologic and related products including vaccines, blood, allergenics, tissues, and cellular and gene therapies. To obtain a US license, the product must be shown to be safe, pure, effective, and manufactured in a consistent manner.…”

Section: Process Developmentmentioning

confidence: 99%

“…In 2010, the ACIP formally adopted a framework called Grading of Recommendations, Assessment, Development and Evaluation (GRADE) for developing evidence-based recommendations. 18 Using the GRADE framework, ACIP systematically assesses the type and quality of evidence about a vaccine's expected health impacts and the expected balance of health benefits and harms. When making a decision about a vaccine, ACIP considers other key factors such as equity, values, and preferences of people affected as well as economic issues including costeffectiveness and risk benefit.…”

Section: Grading Of Recommendations Assessment Development and Evalmentioning

confidence: 99%

“…In February 2018, substantial additions were incorporated into the GRADE methodology, particularly use of the Evidence to Recommendations (EtR) framework to move from evidence to decision and to provide transparency regarding the impact of additional factors on deliberations when considering a recommendation. 18 The EtR framework is used to summarize key factors, including balance of benefits and harms, type or quality of evidence, values and preferences of people affected, resource use, and feasibility of implementation (Table 2). This standardized and more explicit process using the EtR framework for developing ACIP recommendations enhances transparency, consistency, and communication to health care providers, partner organizations, and the public.…”

Section: Grading Of Recommendations Assessment Development and Evalmentioning

confidence: 99%

See 1 more Smart Citation

Principles of Vaccine Licensure, Approval, and Recommendations for Use

Pickering

Meissner

Orenstein

et al. 2020

Mayo Clinic Proceedings

View full text Add to dashboard Cite

The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP.

show abstract

“…7 These routine recommendations apply to people within the specified age or risk group and were previously referred to as Category A, although the Centers for Disease Control and Prevention has transitioned to new nomenclature. [8][9][10] The incidence of meningococcal disease has steadily declined in the United States over the last 2 decades, and the reduction in the incidence of meningococcal disease due to serogroups C, W, and Y among adolescents suggests an effect of the MenACWY vaccine program in this age group. 11 However, MenACWY vaccines do not protect against meningococcal serogroup B (MenB) disease, which has become the predominant serogroup causing meningococcal disease in recent years in the United States.…”

Section: Introductionmentioning

confidence: 99%

Disparities in healthcare providers’ interpretations and implementations of ACIP’s meningococcal vaccine recommendations

Huang

Goren

Lee

et al. 2019

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

Invasive meningococcal disease (IMD) caused by the bacteria Neisseria meningitidis is rare but potentially fatal. For healthy adolescents, the US Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MenACWY and recommends MenB vaccination under shared clinical decision-making (previously "Category B"). The recommendation for MenB vaccination was the first category B recommendation in adolescents, and it is unclear how healthcare providers (HCPs) implement these guidelines. This 2017 web-based survey of US HCPs explored characteristics associated with prescribing or receiving MenB and MenACWY vaccines, HCP knowledge of vaccine recommendations, and real-world practice patterns. Of 529 respondents, 436 prescribed MenB vaccines to their eligible adolescent/young adult patients and 93 prescribed MenACWY vaccines only. MenB vaccine prescribers were more likely to be pediatricians compared with MenACWY vaccine only prescribers, and patients who received MenB vaccines were more likely to be non-Hispanic whites living in shared spaces (eg, college dormitories) than those not receiving the vaccine. Seventy-seven percent of HCPs indicated that they prescribe MenACWY vaccines consistently with ACIP recommendations (to all members of an age group), whereas only 7% indicated that they prescribe MenB vaccines consistently with ACIP recommendations (individual clinical decision making). Patientrelated factors, disease-related factors, and guidelines all influenced HCP decisions to prescribe meningococcal vaccines. Providing HCPs with clear guidance on how to initiate discussion of MenB vaccines with patients and their caregivers may aid in fully protecting US adolescents against meningococcal disease caused by 5 of the disease-causing serogroups. ARTICLE HISTORY

show abstract

Updated Framework for Development of Evidence-Based Recommendations by the Advisory Committee on Immunization Practices

Cited by 36 publications

References 5 publications

Factors Influencing Uptake of Changes to Clinical Preventive Guidelines

Factors Influencing Uptake of Changes to Clinical Preventive Guidelines

Principles of Vaccine Licensure, Approval, and Recommendations for Use

Disparities in healthcare providers’ interpretations and implementations of ACIP’s meningococcal vaccine recommendations

Contact Info

Product

Resources

About