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    • "Criteria used to quote levels and grades of evidence are according to the GRADE system (Guyatt et al, 2006). Strong recommendations (grade 1, 'recommended') are made when there is confidence that the benefits either do or do not outweigh the harm and burden and costs of treatment. "
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    ABSTRACT: Although acute non-haemolytic febrile or allergic reactions (ATRs) are a common complication of transfusion and often result in little or no morbidity, prompt recognition and management are essential. The serious hazards of transfusion haemovigilance organisation (SHOT) receives 30–40 reports of anaphylactic reactions each year. Other serious complications of transfusion, such as acute haemolysis, bacterial contamination, transfusion-related acute lung injury (TRALI) or transfusion-associated circulatory overload (TACO) may present with similar clinical features to ATR. This guideline describes the approach to a patient developing adverse symptoms and signs related to transfusion, including initial recognition, establishing a likely cause, treatment, investigations, planning future transfusion and reporting within the hospital and to haemovigilance organisations. Key recommendations are that adrenaline should be used as first line treatment of anaphylaxis, and that transfusions should only be carried out where patients can be directly observed and where staff are trained in manging complications of transfusion, particularly anaphylaxis. Management of ATRs is not dependent on classification but should be guided by symptoms and signs. Patients who have experienced an anaphylactic reaction should be discussed with an allergist or immunologist, in keeping with UK resuscitation council guidelines.
    Preview · Article · Aug 2012 · British Journal of Haematology
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    • "The process used for this pilot project was adapted from that described by the GRADE working group and is more fully described elsewhere [19,24,50-53]. The approach represents an explicit assessment of the quality of evidence, the balance between benefits and risks and the strength of recommendations. "
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    ABSTRACT: Decision-making in child and youth mental health (CYMH) care requires recommendations that are developed through an efficient and effective method and are based on credible knowledge. Credible knowledge is informed by two sources: scientific evidence, and practice-based evidence, that reflects the "real world" experience of service providers. Current approaches to developing these recommendations in relation to CYMH will typically include evidence from one source or the other but do not have an objective method to combine the two. To this end, a modified version of the Grading Recommendations Assessment, Development and Evaluation (GRADE) approach was pilot-tested, a novel method for the CYMH field. GRADE has an explicit methodology that relies on input from scientific evidence as well as a panel of experts. The panel established the quality of evidence and derived detailed recommendations regarding the organization and delivery of mental health care for children and youth or their caregivers. In this study a modified GRADE method was used to provide precise recommendations based on a specific CYMH question (i.e. What is the current credible knowledge concerning the effects of parent-implemented, early intervention with their autistic children?). Overall, it appeared that early, parent-implemented interventions for autism result in positive effects that outweigh any undesirable effects. However, as opposed to overall recommendations, the heterogeneity of the evidence required that recommendations be specific to particular interventions, based on the questions of whether the benefits of a particular intervention outweighs its harms. This pilot project provided evidence that a modified GRADE method may be an effective and practical approach to making recommendations in CYMH, based on credible knowledge. Key strengths of the process included separating the assessments of the quality of the evidence and the strength of recommendations, transparency in decision-making, and the objectivity of the methods. Most importantly, this method combined the evidence and clinical experience in a more timely, explicit and simple process as compared to previous approaches. The strengths, limitations and modifications of the approach as they pertain to CYMH, are discussed.
    Full-text · Article · Mar 2011 · BMC Health Services Research
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    • "In an ideal world, guidelines developers would employ a unified system to rate the quality of evidence and strengths of recommendations[11]. Doing so would dispel the "Babylonian confusion" among users trying to make sense of the varying terminology and definitions used by various guidelines developers, ultimately helping to enhance guidelines implementation[12]. "
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    ABSTRACT: Clinical practice guidelines have been defined as systematically developed statements to assist practitioner and patient decision-making about appropriate health care for specific clinical circumstances. They play an important role in guiding evidence based clinical practice. The Australian National Health and Medical Research Council has developed and pilot-tested a new framework for guideline development, the FORM approach, the role of which has yet to be further defined. We critically review the elements of the FORM approach and compare it to other, more established methods for rating the quality of evidence and strength of recommendations. FORM recognizes five factors that impact the strength of a recommendation which are the evidence base, consistency, clinical impact, generalizability and applicability. Consideration of these elements leads to a four-tiered rating system represented by the letters A ("body of evidence can be trusted to guide practice") to D ("body of evidence is weak and recommendation must be applied with caution"). It builds on other existing guideline methodologies such as those developed by the Scottish Intercollegiate Guidelines Network (SIGN), the Strength of Recommendation Taxonomy (SORT) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) groups. FORM distinguishes itself from other systems by its strong emphasis on applicability, which is separated out as its own category and relates the relevance of the body of evidence to the Australian healthcare system. The FORM approach offers a methodologically rigorous alternative approach to guideline development that places particular emphasis on aspects of applicability. This feature is unique and may prompt future adoption by other guidelines systems.
    Full-text · Article · Feb 2011 · BMC Medical Research Methodology
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