Patient Blood Management Guidelines: Module 1

Critical Bleeding Massive Transfusion

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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 first. 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 an independent consumer advocate and representation from relevant colleges and societies, was established to develop the critical bleeding/massive transfusion module, with assistance from systematic reviewers and a technical writer, and advice and mentoring from GAR consultants initially contracted by the NHMRC. 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 reviewer, CRG, NBA and NHMRC GAR consultants. A two-volume technical report, Patient blood management in critical bleeding/massive transfusion, was circulated to the EWG in 2009.2,3

D3 Methodology

Methods are outlined in Chapter 2, with greater detail given in Volume 1 of the accompanying technical report.2 Briefly, the clinical research questions for systematic review were structured according to 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) criteria. 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 April–June 2009.

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. 10,100 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. 10 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 (Volume 1 of the technical report, Appendix 4). 2

D4 Public consultation

Public consultation was conducted from Monday 12 April to Friday 14 May 2010, during which time the draft module was available on the NBA website. 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.

Twenty-seven formal submissions were received, including one very detailed submission from an independent international reviewer from Canada. The CRG met in on 19 and 20 May 2010 to consider all responses to the public consultation submission and, where necessary, revise this module in accordance with the submissions.

One of the recurrent themes in the submissions was that access to health-care resources (products, specialist advice and equipment) varies between geographical and health-care settings, creating a need for general guidance on how to develop an MTP for a local setting, rather than a prescriptive MTP. The MTP in the public consultation draft was intended as an example; however, in response to the submissions, the template MTP has been modified, and further advice has been provided on how the template can be adapted to suit the local patient population and health-care resources.

Another recurrent theme was that ratios provided in the public consultation draft were based on data that could be subject to survivor bias, because outcomes were based on subgroup analyses. In response, the document has been modified to provide a stronger emphasis on goal directed-rather than ratio-driven protocols in the management of the critically bleeding patient requiring massive transfusion, and a clear statement that evidence was not found to support or refute specific ratios.

Many other changes to the module were made to address comments and concerns raised in submissions, and to improve clarity.

D5 Finalising the module

The final draft of the Module and technical reports were reviewed by a guidelines development expert (formerly a GAR) to assess compliance with NHMRC requirements for externally developed guidelines. The Module was then reviewed by an AGREE II expert to assess the Module against international quality standards. The Module and accompanying documents were then sent to the NHMRC for methodogical and independent peer review on 6 August 2010.

The module was further refined in response to the reviewer’s recommendations.

Approval from the NHMRC was received on 12 November, 2010.