Figure A1 illustrates the management framework used to manage the development of the six modules of the guidelines.

Figure A1 Management framework for development of the guidelines

ANZSBT, Australian & New Zealand Society of Blood Transfusion; CRG, Clinical/Consumer Reference Group; EWG, Expert Working Group; GAR, Guidelines Assessment Register; JBC, Jurisdictional Blood Committee; NBA, National Blood Authority; NHMRC, National Health and Medical Research Council

A2 Terms of reference

Steering Committee

The overarching Steering Committee was established to provide coordination and direction for development of the guidelines. It was chaired by the NBA, with representation from the ANZSBT, the NHMRC (including a member from the National Institute of Clinical Studies), a state expert and an expert from the Australian Government Department of Health and Ageing. The role of the Steering Committee was to:

• develop and oversee the project plan for the revision of the guidelines
• recommend the membership of the EWG to the NBA Chief Executive Officer, who will appoint the recommended members
• endorse the scope of the project as proposed by the EWG, and the process by which it will be undertaken
• ensure that there is effective communication and consultation with all relevant stakeholders for the duration of the project, including the development of a communications and engagement strategy that meets NHMRC requirements
• provide information through the NBA to the Jurisdictional Blood Committee (JBC) on the project
• review resources that are dedicated to the project, to ensure that they are sufficient for the project to meet its deadlines
• review and approve revisions to the project plan and terms of reference
• address other matters as raised by members of the Steering Committee or EWG.

Expert Working Group

The EWG was formed to advise the Steering Committee about the scope and structure of the guidelines, and to determine the focus of the systematic review of the evidence-based literature. The group’s terms of reference were:

• to consider the scope of the project and proposed structure of the guidelines, as referred by the Steering Committee and, if necessary, to present recommendations for revisions to the Steering Committee
• under the guidance of the NHMRC GAR expert, to formulate the clinical questions to be answered by the literature review
• to provide clinical oversight for the development of the content of the guidelines, in particular, ensuring that:
  –    the research undertaken is comprehensive
  –    the quality of the revised guidelines will meet with clinical approval
• to provide recommendations on the terms of reference for the CRGs and oversee coordination of the activities of the CRGs
• to ensure appropriate engagement by consumers at all relevant points
• to assist in the development or review of tools and strategies to support the implementation and audit of the guidelines and review their uptake
• to facilitate consultation and the uptake of the guidelines
• to respond to any additional requirements to ensure compliance with the NHMRC guidelines development processes.

A2 Terms of reference

Systematic reviewers and technical writers

The NBA contracted systematic reviewers and technical writers to conduct systematic reviews of the scientific literature and provide technical writing services to produce each module and associated deliverables, including technical reports.

Clinical/Consumer Reference Groups

A CRG was formed to review the module during development and, with the assistance of technical writers, to formulate recommendations aimed at optimising patient blood management based on systematic review findings, or, in the absence of evidence, to develop practice points through a consensus-based process. The CRG also provided advice to the EWG on guideline relevance and utility for targeted service providers and recipients who will use or benefit from the guidelines. Pertinent terms of reference for guidelines development included:

• the CRGs may review and offer advice on the set of questions to be put to the systematic review for the project
• the CRGs may review the draft guidelines and consumer materials, and offer advice on the way information is presented in terms of relevance and utility to the groups they represent
• the CRGs will not have authority or decision-making power over how that advice is used.

Guidelines Assessment Register expert

Two GAR experts were appointed by the NHMRC to provide advice and mentoring to the EWG and CRG, and to ensure that the new guidelines and the development process implemented by each reference group complied with NHMRC requirements.

A3 Membership of bodies involved in governance of the guidelines

Steering Committee

Expert Working Group

Clinical/Consumer Reference Group for Critical Bleeding/Massive Transfusion

Background research

National Health and Medical Research Council appointed Guidelines
Assessment Register consultants

Project Management and Committee Secretariat – provided by the NBA

Systematic review team for critical bleeding/massive transfusion

Medical writing (Guideline only) and technical editing – Health Technology Analysts

A4 Conflict of interest

All members of the Steering Committee, CRG and EWG declared any conflicts of interest before starting work on the guidelines. Conflicts of interest were reviewed at intervals during the development of the guidelines and required to be declared at the commencement of each meeting.

A5 Acknowledgements

The CRG thanks the following facilities, whose MTPs were considered in developing the template MTP:

• Australia
  –    Northern Sydney Central Coast Area Health Service
  –    Queensland Blood Products Advisory Committee
  –    Royal Perth Hospital, Western Australia
  –    Royal Adelaide Hospital, South Australia
  –    Sydney South West Area Health Service
  –    The Alfred, Victoria
• New Zealand
  –    Auckland District Health Board
  –    Canterbury District Health Board

The CRG thanks the Haemostasis Registry, Department of Epidemiology and Preventive Medicine, Monash University for providing access to their data on rFVIIa.