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 second. 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 perioperative 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.24
Methods are outlined in Chapter 2, with greater detail given in the technical reports.24 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 after 1966. Literature retrievals were limited by the holdings of the databases accessed. Publication cut-off points varied from 29 April 2009 to 30 June 2009, as shown in Table D.1, below. Any future searches undertaken to revise, reuse or update these searches should take 1 April 2009 as the start date, to ensure complete coverage of the date range.
Following a review of the search results by the CRG in November 2009, the terms for some searches (specific question 2 and generic question 6) were revised to ensure inclusion of patients undergoing invasive procedures and minimally invasive surgical procedures (see Table D.2, below, and Section 2.1.2 and Appendix 1 of Volume 1a of the technical report for specific patient populations and subgroups). Table D.1 shows the dates on which the revised searches were conducted. The cut-off date for these searches was 30 June 2009, to better align with previous cut-off dates.
Table D.1 Search dates and cut-off points
|CONDUCTED||WITH CUT-OFF||UPDATED||WITH CUT-OFF|
|Specific question 1|
|Cochrane Library Database||12/06/2009||12/06/2009||-||-|
|BMJ Clinical Evidence||18/06/2009||18/06/2009||-||-|
|Specific question 2|
|Cochrane Library Database||18/06/2009||18/06/2009||27/01/2010||30/06/2009|
|Specific question 3|
|Searches by IMS Ltd.|
|Cochrane Library Database||22/06/2009||22/06/2009||-||-|
|Searches by HTA Ltd.|
|Intervention 1 (acute normovolemic haemodilution)|
|Interventions 2–4 (cell salvage)|
|Intervention 2 (intraoperative cell salvage)|
|Intervention 3 (ANH and intraoperative cell salvage)|
|EMBASE lower level evidence||11/02/2010||30/06/2009||-||-|
|Intervention 4 (postoperative cell salvage)|
|Intervention 5 (induced hypotension)|
|Intervention 6 (prevention of hypothermia)|
|Intervention 7 (point-of-care testing)|
|EMBASE lower level evidence||8/04/2010||30/06/2009||-||-|
|Intervention 8 (antifibrinolytics)|
|EMBASE RCT (desmopressin)||16/02/2010||30/06/2009||-||-|
|EMBASE RCT (aminocaproic and tranexamic acid)||24/02/2010||30/06/2009||-||-|
|Intervention 9 (patient positioning)|
|Intervention 10 (autologous transfusion)|
|Quality of life search (all interventions)|
|EMBASE lower level evidence||14/02/2010||30/06/2009||-||-|
|Generic question 1|
|Cochrane Library Database||14/05/2009||14/05/2009||-||-|
|Generic question 2|
|Cochrane Library Database||13/05/2009||13/05/2009||-||-|
|Generic question 3|
|Cochrane Library Database||21/05/2009||21/05/2009||-||-|
|Generic question 4|
|Cochrane Library Database||24/06/2009||24/06/2009||-||-|
|Generic question 5|
|Cochrane Library Database||25/06/2009||25/06/2009||-||-|
|Generic question 6|
|Cochrane Library Database||28/06/2009||28/06/2009||4/01/2010||30/06/2009|
AMI, Australasian Medical Index; CINAHL, Cumulative Index to Nursing and Allied Health Literature; EMBASE, Excerpta Medica Database; RCT, randomised controlled trial; SR, systematic review
Table D.2 Populations,subgroups and stratification criteria
|1||All patients scheduled for surgery – elective and emergency patients||
|2||All surgical and invasive procedures||
|3||All surgical patients (elective, emergency, obstetrics and paediatric/neonates)||
|5||All patients, with or without defined anaemia (however defined)||
|6||All patients with anaemia||
|7||All patients, with and without anaemia||
|8||All patients, with and without anaemia||
|9||All adult (medical, surgical or obstetric), neonatal and paediatric patients eligible for transfusion, with and without anaemia||
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.297,298 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.297 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 for eight weeks, from 7 February 2011, 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-five submissions were received. The CRG met on 9–10 May and 12–13 July to consider all responses to the public consultation submissions and, where necessary, revise this module in accordance with the submissions. Many 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 GAR 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 4 August 2011.
The module was further refined in response to the reviewer’s recommendations.
Approval from the NHMRC was received on 15 November 2011.