Development of the Handbook

Overview

The Australian Technical Advisory Group on Immunisation (ATAGI) develops the recommendations in the Australian Immunisation Handbook. ATAGI advises the Australian Minister for Health on the Immunise Australia Program and other vaccine-related issues. ATAGI’s membership includes technical experts, immunisation nurses, a consumer representative and general practitioners.

Other contributions to the Handbook:

• The National Centre for Immunisation Research & Surveillance of Vaccine Preventable Diseases provides technical support for ATAGI.
• ATAGI consults members of each of its current disease-based working parties.
• Other peak advisory groups — in particular, the National Immunisation Committee and the Communicable Diseases Network Australia — provide valuable input.
• The National Health and Medical Research Council approves the recommendations (under s. 14A of the National Health and Medical Research Council Act 1992).

Literature search updates for the Handbook

New chapter sections or major chapter updates are based on literature searches. These searches ensure that technical writers from the National Centre for Immunisation Research & Surveillance of Vaccine Preventable Diseases and the Australian Technical Advisory Group on Immunisation have access to relevant information from the latest medical literature. Literature searches help to identify important issues for updates of Handbook chapters. In addition, selected dissemination of information searches allows writers to collect new information on key search topics.

Databases and searches

Technical writers from the National Centre for Immunisation Research & Surveillance of Vaccine Preventable Diseases and the Australian Technical Advisory Group on Immunisation identify focused clinical questions for each of the Handbook chapters, and design and conduct searches to answer these questions. Up to 23 electronic databases are used for the searches:

• MEDLINE
• EMBASE
• Cochrane Library (when required), including Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Methods Studies, Health Technology Assessment Database and NHS Economic Evaluation Database
• Cumulated Index Nursing and Allied Health Literature (when required)
• Australian-focused Informit databases (when required), including
  • Australasian Medical Index
  • Australian Public Affairs Information Service
  • Aboriginal and Torres Strait Islander Health Bibliography
  • Australian Sport Database
  • Australian Criminology Database — Health
  • Drug Database
  • Health & Society Database
  • HIV/AIDS Database
  • Health Collection
  • Indigenous Collection
  • Rural and Remote Health Database
  • Science and Geography Education

If required, additional databases and resources are consulted, such as clinical trial registries. The search scope is broad, to ensure that all relevant articles are retrieved. Previous Handbook searches are examined to determine the scope required for the new searches, and similar search strategies are used, where possible. This ensures that the information retrieved is consistent and considers new terms added to the databases.

Search strings

Thesaurus terms — the controlled vocabulary terms used in the database — are used whenever possible. This ensures relevant and accurate retrieval. All subheadings assigned to the subject headings are generally included. Boolean operators are used as appropriate. Keyword searching is used where required, especially in the absence of an appropriate thesaurus term or if the database does not have thesaurus terms. Items discussing animals only are generally removed. The corresponding evidence summary describes the specific search terms and databases used to answer each clinical question.

Process of developing Handbook recommendations

The Handbook informs clinicians about the safest and most effective vaccination strategies in Australia. The Australian Technical Advisory Group on Immunisation (ATAGI) bases its recommendations on high-quality evidence, such as well-conducted randomised controlled trials and meta-analyses. However, if high-quality studies do not exist, ATAGI refers to less rigorous studies, such as uncontrolled clinical trials, case series or other observational studies. ATAGI consults other clinical guidelines, if relevant, to help frame recommendations in the Australian setting.

ATAGI also reviews immunisation handbooks produced by comparable countries. If published sources are inadequate, recommendations are based on expert opinion.

However, developing recommendations can have limitations and challenges as a result of:

• unaddressed scientific questions
• complex medical practice issues
• continuous new information
• differences in expert opinion

Despite these limitations, ATAGI seeks to provide clear and relevant recommendations, where possible.

Since July 2020, ATAGI has been moving towards the use of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for developing Handbook recommendations. This aligns with the recommendation of the National Health and Medical Research Council (NHMRC) of Australia for the development of its guidelines.

The GRADE approach was developed by the GRADE Working Group. It offers a framework for rating the quality of the available evidence in a systematic review, and developing and grading the strength of healthcare recommendations in guidelines. The GRADE approach also offers transparency to the recommendation development by using a standard format for presenting the evidence-to-decision process.

It has since been widely recommended by international guideline development bodies such as the World Health Organization (WHO). The WHO Strategic Advisory Group of Experts (SAGE) on Immunization and the Advisory Committee on Immunization Practices (ACIP) of the USA have used GRADE for developing some of their recommendations on use of vaccines.

Levels of recommendations

ATAGI is standardising current Handbook recommendations to reflect the intended “strength” of the recommendations. This involves consistently applying standardised terminology for all recommendations within and across different chapters. The new system will consistently conceptualise recommendations on the use of a vaccine at 3 levels: Recommend, Optional and Not recommend.  This will avoid terminology that may be misunderstood as indicating different strengths of recommendations within and across different chapters, when ATAGI intended for those recommendations to be at the same level of strength. 

Cost-effectiveness of the recommendations

The Handbook recommendations do not address the cost-effectiveness of vaccines or vaccine schedules. Since January 2006, the Pharmaceutical Benefits Advisory Committee (PBAC) has assessed the cost-effectiveness of vaccines. The PBAC advises the Australian Government about vaccine funding under the National Immunisation Program (NIP) and/or the Pharmaceutical Benefits Scheme (PBS).

Most of the vaccines in the Handbook’s recommendations are funded by:

• the NIP
• the PBS
• other programs, such as special schemes and state- or territory-based programs

In 2023, a label will be introduced to identify recommendations that are associated with NIP funding of vaccines for particular population groups.