Appendix D Process report
D1 Development process
A review by the NBA of the 2001 Clinical Practice Guidelines on the Use of Blood Components1 led to a decision by the NHMRC, ANZSBT and NBA to develop a series of six guidelines on patient blood management, of which this document is the third. The guidelines development process was initiated by a Steering Committee chaired by the NBA. In 2008, an EWG was formed to oversee development of the series of guidelines.
A CRG, with membership including a patient blood management advocate and representation from relevant colleges and societies, was established to develop the medical module. The CRG received assistance from systematic reviewers and a technical writer, and advice and mentoring from a systematic review expert. Further details of the governance framework are provided in Section 1.2 and Appendix A.
D2 Research phase
Relevant clinical research questions were developed, prioritised, combined and refined by the EWG and the CRG for this guideline, and further refined through consultation among the systematic reviewers, CRG, NBA and the systematic review expert.
D3 Methodology
Methods are outlined in Chapter 2, with greater detail given in the technical reports. Briefly, the clinical research questions for systematic review were structured according to three criteria: PICO (‘population, intervention, comparator and outcome’) for intervention questions, PPO (‘population, predictor and outcome’) for prognostic questions, or PRO (‘population, risk factor and outcome’) for aetiology questions. Three main strategies were used to identify potentially relevant literature: electronic database searching, manual searching and use of literature recommended by expert members of the CRG. The primary databases searched were EMBASE, Medline, the Cochrane Library Database and PreMedline. Additional searches were conducted of Cumulative Index to Nursing and Allied Health Literature and Australasian Medical Index. The electronic searches included articles published between 1966 and July 2010.
Inclusion criteria were determined from the PICO, PPO or PRO criteria that formed the basis of the systematically reviewed research questions. Non-English publications were excluded. Studies that were eligible for inclusion were evaluated according to NHMRC levels of evidence hierarchy, dimensions of evidence, and quality assessment criteria.14 178 An NHMRC evidence statement form was completed for each systematically reviewed research question. Where there was sufficient evidence to formulate a recommendation, NHMRC grading criteria were applied to indicate the strength of the body of evidence underpinning the recommendation.14 Where it was not possible to develop evidence-based recommendations because no evidence was identified, or where additional information was required to supplement recommendations and guide clinical practice, the CRG developed practice points through a consensus-based process.
D4 Public consultation
Public consultation was conducted from 23 January to 16 March 2012, during which time the draft module was available on the NBA website.d Notification was posted in The Australian national newspaper, and the NBA invited a range of stakeholders, committees, working groups and interested people to provide submissions.
Eleven submissions were received. The CRG met in April 2012 to consider all the public consultation submissions and, where necessary, revise this module in accordance with the submissions. Changes were made to the module to address comments and concerns raised in submissions, and to improve clarity.
D5 Finalising the guidelines
The final drafts of the module and technical reports were reviewed by a guidelines development expert (formerly a Guidelines Assessment Register consultant) to assess compliance with NHMRC requirements for externally developed guidelines. The module was then reviewed by an AGREE II expert to assess it against international quality standards. The module and accompanying documents were then sent to the NHMRC for methodological and independent peer review on 20 April 2012.
Approval from the NHMRC was received on 18 July 2012.