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• W1979265498 abstract "The ability to transfer new knowledge or experience into relevant health-care practice is important in many fields of medicine, especially in transfusion medicine. The legacy of delays in implementing suitable screening measures for human immunodeficiency virus (HIV) and for hepatitis C has dramatically influenced subsequent decision making, particularly in some countries (e.g., Canada, France, Japan, Ireland). The adoption of new technologies or additional interventions aimed at enhancing blood safety is more likely to occur where the evidence to support the technology is very strong, where the cost of the intervention is not very high, or where the impact on the donor base is minimal. Only a few technologies or interventions in the past two decades readily meet these criteria. Rather, when dealing with issues such as universal prestorage leukoreduction, variant Creutzfeldt-Jakob disease, nucleic acid testing, or testing for Chagas disease, we as an industry have faced complex decision making, have not readily achieved consensus on paths of action, and have succeeded best in pitting against each other the regulators, blood service or system operators, those responsible for funding or reimbursement, commercial vendors, and the patient recipient groups. It is evident to us that a consistent and robust mechanism to evaluate available scientific information in a timely manner and develop consensus recommendations that advance understanding of the issue under consideration will be very useful to health practitioners and the public. Three main approaches to consensus development have been used in the health sector. The Delphi method, developed in the 1950s by the Rand Corporation, as a forecasting tool, was followed by the nominal group technique (NGT) in the 1960s; the consensus development conference approach was developed in the 1970s by the National Institutes of Health (NIH). The Delphi and NGT methods are focused to obtain a decision from a group of experts, while the consensus development conferences (CDs) add the ability to gain public input. The Delphi method allows for the exchange of information among individuals without face to face meetings using an iterative process. Similarly, the NGT method collects individual information privately before any face-to-face discussion and then again privately collects judgment at the end of the process. This method has been extensively used for guideline development on appropriate indications for treatment in a wide variety of diseases. In all three processes the use of cues are important to the generation of clinical guidelines. Examples would include severity of a disease, age, and comorbidity. These cues direct the group toward a particular set of factors that should be taken into account during decision making. Lack of agreement among physicians with respect to the importance of particular cues may account for variation in practice, as exemplified in the variation in decision to transfuse.1 Information obtained from the consensus exercise is aggregated in the Delphi and NGT processes by explicit methods including statistical analysis and mathematical integration. The CD information is aggregated with implicit methods that tend to be qualitative or in some cases modestly quantitative, for example, majority voting on an issue. Importantly, interaction among participants in all three methods is intentionally structured to remove the ability of single voices to dominate the formation of group opinion and the effects of similar social pressures. A discussion of the cognitive and social psychological aspects of group decision making are beyond the scope of this editorial; however, the reader is referred to the excellent review of Murphy and colleagues2 for more detailed discussion of the aspects that influence consensus development. In general, studies comparing various consensus development methods have not clearly shown a preferred method; a single collection of comparative studies normally shows all possible outcomes: better than, worse than, or equivalent.2, 3 The consensus development conference as formulated by the NIH is viewed favorably on the whole as a process by both users of the consensus statements and by the panelists who participate.4 In this issue of TRANSFUSION, Klein and colleagues5 present an eloquent summary of the deliberations by the consensus panel they formed, exploring the issue of pathogen inactivation (PI). Using a consensus development conference model similar to that of the NIH, Klein and his colleagues were asked to deliberate on a series of questions relating to the introduction of PI. Briefly, the consensus reached by this particular panel suggests that PI is a worthy goal for blood systems and would afford an opportunity to shift the paradigm from one of reactive testing to proactive protection. The panel further recommended the implementation of feasible and safe method(s) that inactivate a broad-spectrum of pathogens and that all components should be so treated. Such changes to the blood supply must only be undertaken with societal informed consent obtained through a broad consultation process. Additional considerations must be given to the possibility of removing tests from the existing menus, to the need for cost-benefit analyses to assist decision making, and to the clear need for large-scale public sector financial support for the development of integrated PI technology for all blood components that would be suitable for both developed and developing countries. This particular consensus conference is the sixth such event to have taken place in Canada since 2000, jointly hosted and funded by Canadian Blood Services and Héma-Québec, the two agencies responsible for managing the blood supply system in Canada The previous five CDs hosted by these agencies are: “Prevention of posttransfusion CMV in the era of universal leukoreduction” (January 2000). “Prescribing intravenous immune globulin: prioritizing use and optimizing practice” (October 2000). “Blood-borne HIV and hepatitis: optimizing the donor selection process” (November 2001). “Consensus conference on variant CJD screening of blood donors” (March 2003). “Towards an understanding of TRALI” (April 2004). Although each of these CDs has principally addressed issues that Canadian Blood Services and Héma-Québec felt were relevant in Canada at the time, and the consensus panel had been directed to consider their recommendations in the Canadian context, the events themselves have attracted international participation, and the recommendations have often been more universal in nature than specific to Canada. The format of these Canadian CDs, while very similar to that of the NIH, has not been exactly the same. The NIH Consensus Development Program has a prescribed format that is used to select the topic, guide the planning, establish the panel membership, and determine the processes to be followed before, during, and after the conference itself. With some minor differences in format (e.g., panel membership not necessarily exclusively Canadian; conference length typically 1.5 days, not 2.5 days), the basic principles governing the conduct of the Canadian CDs align with those established by the NIH: A broad-based, nonadvocacy, and independent panel is assembled to provide balanced, objective, and knowledgeable attention to the topic. In addition to subject matter experts and methodologists, panels include public representatives and, in the case of the Canadian CDs, have typically involved both donor and patient group representatives. Invited experts present data to the panel in public sessions. The program includes time for questions and comments from members of the audience, which may further help the panel in its deliberations. Between four and six predetermined questions define the scope and direction of the conference. A draft consensus statement is developed by the panel in executive session and is then presented in plenary session. Following further public discussion, the panel may modify the statement as they deem appropriate. Conducting CDs takes considerable resources not only in terms of the financial investment required to gather participants but also in the very significant amount of time donated by experts and panelists to the process. As a result, it is important to reflect on the value derived from the resource investment. Do CDs of this nature serve their purpose? How effective are they at influencing medical practice or health-care decision making? Do they help solve complex problems or do they expedite the introduction of novel technologies or interventions? In general, there is not an abundance of literature that directly assesses whether CDs work. There is certainly an implicit assumption that obtaining agreement among experts will facilitate practice change. It has been apparent since the start of consensus processes that the qualitative aspects of consensus development can have a very large impact on the outcome and much of the research has focused on these aspects. While studies primarily have addressed the method, cognitive psychology, and social psychological aspects of the processes of consensus and guideline development, it is clear that the effective dissemination of the outcomes is necessary to have an impact on clinical practice and ultimately on the health of patients.6 An older systematic review reports that of 59 articles evaluating clinical guidelines, 55 found that the guidelines significantly improved the quality of care provided to patients. Of 11 studies that measured defined patient outcomes, 9 found the use of guidelines produced improved outcomes.7 Other studies highlight the fact that organized dissemination of information is essential to successful practice change.8, 9 Many consensus statements provide guidance for future research directions. A recent evaluation of the ability of such statements to stimulate new research as defined by increased NIH funding showed that for six consensus development conferences held over a 3-year period the research funding increased for five specific areas.10 In addition to the six Canadian CDs, there have been eight conferences under the auspices of the NIH broadly relevant to transfusion medicine since the NIH program began in 1977 (see Table 1). Although the scope of this editorial does not allow us to objectively assess the impact of these transfusion-related NIH consensus conferences, we do make the following observations relevant to the six Canadian CDs. In general, our experience has reinforced the observation that the way in which a group goes about conducting the consensus conference may have a large impact on the outcome. In addition to carefully setting the task or questions to be addressed, consideration must be given to the selection of participants in a manner that avoids overt bias on the topic. Furthermore, as the development of consensus is based in large part on acceptance of the application of the scientific method, the choice and preparation of the scientific evidence must be done in a robust manner so the credibility of the process is not in question. Those who host consensus conferences must recognize that the resultant answers and recommendations may differ from what they hoped to see arise from the process. It is not uncommon for evidence-based processes within the consensus method to determine that the quality of the data is not adequate to support a particular position and more data are needed. The Canadian CD “Prevention of posttransfusion CMV in the era of universal leukoreduction” determined that more data are required to evaluate CMV safe components, and the practice of providing products that are both CMV-negative and leukoreduced remains the norm today in Canada. Consensus conference recommendations have at times been held hostage to political imperatives,11 perhaps the most dramatic example of which was the response of the US Congress to the NIH Consensus Conference on the appropriate age for breast cancer screening.12 It is important to recognize that the elements of consensus development may at times be in conflict with the societal processes within a democracy and the right to hold individual, and possibly dissenting, opinion. In our CD “Blood-borne HIV and hepatitis: Optimizing the donor selection process” (which focused principally on the issue of MSM donor deferral), the reality of societal issues that were capable of confounding a science-based exercise was always near. It is well recognized that consensus development methods rarely resolve disputes where there is strong disagreement.12 On balance, our least contentious CD and the one, to date, that has most influenced practice or decision making is the 2004 CD “Towards an understanding of TRALI,” perhaps because it was a fairly narrow issue, with relatively few side issues and a clear need within the industry for a CD on the topic. In fact, the outcome of this CD contributed in important ways to the development of AABB guidance on primary risk reduction for TRALI. Although it is well known that the influence of an individual on the development of a group opinion is commensurate with his or her status, the value of heterogeneity to the CD process cannot be overstated.2 The voices of all are required to build meaningful consensus. In the Canadian CDs, we have ensured participation on the consensus panel from blood donor and/or patient recipient groups. Even if the outcome of the CD cannot be directly linked to a change in policy or practice, one of the important value contributions of a public consensus building approach is to lend credibility to the process in the eyes of the stakeholders. In transfusion medicine, where the voice of the involuntary end user (the blood recipient) has been dominant since the era of HIV, we place high value on public participation in the decision-making process. By this measure alone, we deem the investment of resources in the CD process to have a high return. It is up to the scientific community to determine their value in influencing practice or facilitating the introduction of novel technologies such as PI." @default.
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• W1979265498 title "The consensus development process in transfusion medicine: does it add value?" @default.
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