Guidelines for red blood cell and plasma transfusion for adults and children
Methods
These guidelines were developed according to the CMA's Guidelines for Canadian Clinical Practice Guidelines.1 They cover red blood cell and plasma transfusions in adults and in children over 4 months of age. For infants under 4 months, the Canadian Paediatric Society has developed guidelines for transfusion of red blood cells.6 Informed consent and the infectious risks related to the transfusion of these components are also addressed.
Broad guidelines and principles have been developed; specific clinical conditions or indications for specialized blood components, such as leuko-reduced or irradiated components or components at low risk of transmitting cytomegalovirus, are not addressed. The specific development process comprised 4 steps:
1. Background research
In this initial phase, consultants with the required expertise were commissioned to provide:
- a review of the scientific evidence supporting clinical indications for transfusion. For all sections, excluding that relating to autologous transfusion, a search of MEDLINE from January 1966 to July 1996 for all languages was constructed using the following medical subject headings: blood transfusion, erythrocyte transfusion and blood component transfusion. Manual searches of bibliographies of relevant reviews, guidelines and textbooks were also undertaken. During the search 1287 articles relevant to plasma or red blood cell transfusions for human adults or children over 4 months of age were found. For autologous transfusion, a recent meta-analysis was used as the evidence base (Andreas Laupacis, Phillip Wells, Dean Fergusson, Melissa Forgie, Ottawa Civic Hospital, Ottawa, Ont. 1997. A meta-analysis of the efficacy of preoperative autologous donation of blood [unpublished data]).
- a review of relevant ethical and legal issues
- an evaluation of physicians' current needs related to transfusion and counselling practices as expressed in 9 focus groups convened in Toronto, Vancouver, Ottawa, Montreal and Cornwall.
2. Guideline development
- Expert Working Group: Organizations representing various stakeholders (Appendix 1) were asked to suggest members for the EWG. All sponsors reviewed the curricula vitae of potential members. Criteria for selection included: credentials, practical experience, authorship of relevant works, fair representation of various specialties involved in transfusion medicine and the various regions of Canada. All short-listed candidates were asked to complete a conflict-of-interest evaluation form. By this process, 8 candidates were selected and appointed to the EWG by the CMA's Board of Directors.
- Advisory Panel: A larger group was convened to reflect the concerns of patients and practising providers and to provide feedback to the EWG. The 26 members of the Advisory Panel were appointed by their organizations (Appendix 1), to represent their stakeholder group on the panel.
- Levels of evidence: The definition of the levels of evidence used to grade the recommendations in these guidelines is a modified version of that used by the Canadian Task Force on the Periodic Health Examination:7
Level I: Evidence obtained from at least one properly randomized controlled trial.
Level II: Evidence obtained from well-designed controlled trials without randomization, cohort or casecontrol analytic studies, preferably from more than one centre, or research or evidence obtained from comparisons between times or places with or without the intervention.
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.
Not applicable (N/A): opinions of the EWG about issues that cannot be evaluated using accepted study designs.
- Consensus: The EWG reviewed both the background research identified above and additional articles retrieved by its members. The evidence was synthesized and draft positions were written, reviewed and revised during both face-to-face and teleconference meetings. A composite document was then constructed and presented at an assembly of the EWG and Advisory Panel. This document was further revised by the EWG, then circulated to the Advisory Panel, the participating organizations and the consultants for written commentary. This commentary was reviewed by the EWG in a series of teleconferences and the final document was prepared and submitted to the Canadian Medical Association Journal for peer review.
3. External review
Members of the EWG and the Advisory Panel suggested external reviewers who were members of medical organizations and other health professional associations, experts in the field and other interested parties. The comments of the external reviewers were considered by the EWG for incorporation into the final draft of the guidelines.
4. Endorsement
All organizations who appointed representatives to the Advisory Panel were contacted to obtain an official endorsement of the final draft of the guidelines.
| CMAJ June 1, 1997 (vol 156, no 11)
/ JAMC le 1er juin 1997 (vol 156, no 11) |
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