Developing the Review Questions and Outcomes. Consider setting individual thresholds and haemoglobin concentration targets for each patient who needs regular blood transfusions for chronic anaemia. Reviewers used statistical models for fixed and random effects that allowed inclusion of multi-arm trials and accounts for the correlation between arms in the trials with any number of trial arms. ... Impact Factor (2019): 3.662. Fixed-effects (Mantel-Haenszel) techniques were used to calculate risk ratios (relative risk) for the binary outcomes, such as number of patients receiving allogeneic blood transfusions, mortality, incidence of infections and serious adverse events. Thus, if the evidence suggests that a strategy provides significant health benefits at an acceptable cost per patient treated, it should be recommended even if it would be expensive to implement across the whole population. Only consider giving more than a single dose of platelets in a transfusion for patients with severe thrombocytopenia and bleeding in a critical site, such as the central nervous system (including eyes). Only consider fresh frozen plasma transfusion for patients with clinically significant bleeding but without major haemorrhage if they have abnormal coagulation test results (for example, prothrombin time ratio or activated partial thromboplastin time ratio above 1.5). The main criteria considered in the rating of these elements are discussed below. For example, if p value was reported as 'p≤0.001', the calculations for standard deviations will be based on a p value of 0.001. Consider intra-operative cell salvage with tranexamic acid for patients who are expected to lose a very high volume of blood (for example in cardiac and complex vascular surgery, major obstetric procedures, and pelvic reconstruction and scoliosis surgery). Refer to Appendix F in the full guideline appendices for a flow diagram of economic article selection for the guideline. Key information was extracted on the study's methods, PICO (patient, intervention, comparison and outcome) factors and results. Guidelines with addenda only. Studies that only reported cost per hospital (not per patient), or only reported average cost-effectiveness without disaggregated costs and effects, were excluded. Estimated log odds ratios (with their 95% credible intervals) were calculated for comparisons of the direct and indirect evidence, The probability that each treatment was best, based on the proportion of Markov chain iterations in which each treatment had the highest probability of achieving the outcomes selected in the network(s), A ranking of treatments compared to baseline groups (presented as the median rank and its 95% credible intervals). Diseases or conditions requiring blood transfusion, Evaluation Management Prevention Treatment, Critical Care Hematology Internal Medicine Surgery, Advanced Practice Nurses Allied Health Personnel Hospitals Nurses Patients Physician Assistants Physicians Public Health Departments, To develop a cross cutting clinical guideline on the assessment for and management of transfusion, Adults (aged 16 years and above) and children (over 1 year and under 16 years of age). Consider prophylactic platelet transfusions to raise the platelet count above 50×109 per litre in patients who are having invasive procedures or surgery. This is the current release of the guideline. The decision to adopt any of the recommendations cited here must be made by practitioners in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources. This was either done formally in an economic model, or informally. Data for continuous outcomes, such as number of units of allogeneic blood transfused and length of stay in hospital, were analysed using an inverse variance method for pooling weighted mean differences and, where the studies had different scales, standardised mean differences were used. Appendices. Firstly, the net benefit over harm (clinical effectiveness) was considered, focusing on the critical outcomes. Each element was graded using quality levels. All searches were updated on January 29, 2015. endobj %���� See Table 1 in the full version of the guideline for a list of all review questions considered in the guideline. Not applicable: The guideline was not adapted from another source. Further details of the network structure, rationale and stratification of risk groups can be found in Chapter 6 in the full guideline and in Appendix L in the full guideline appendices. Guideline Transfusion. Affiliations 1 German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main, Germany. Data from 63 randomized clinical trials and 82 observational studies were analyzed. Blood transfusions are a cornerstone of modern medicine and much progress has been made in transfusion medicine since the establishment of their regular use in clinical practice. The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. 5 0 obj The evidence suggested that transfusion-related serious adverse events (urticarial and angioedema) and number of units (platelets) transfused per patient may be higher in patients receiving prophylactic platelet transfusion, but there was considerable uncertainty. Recommendations. A blood transfusion algorithm is provided in the full version of the guideline (see the "Availability of Companion Documents" field). When QALYs or life years gained are not used in the analysis, results are difficult to interpret unless one strategy dominates the others with respect to every relevant health outcome and cost. For example, if evaluating mortality with a relative risk of 1.25 (1.15, 3.30) and an absolute risk reduction of 75 more per 1000 participants, the GDG were asked if 75 more deaths per 1000 was a clinically important harm and this was noted accordingly. The GDG focused on the following factors in agreeing the wording of the recommendations: The main considerations specific to each recommendation are outlined in the 'Recommendations and link to evidence' sections within each chapter in the full version of the guideline. The evidence for outcomes from the included RCTs and, where appropriate, observational studies, were evaluated and presented using an adaptation of the 'GRADE toolbox' developed by the international GRADE working group ( The GDG was involved in the design of the model, selection of inputs and interpretation of the results. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. Blood transfusion practices should be revisited Restricting blood transfusion guidelines may save both lives and money, according to a study presented at CHEST 2019, … This guideline contains recommendations about general principles of blood transfusion, and applies to a range of conditions and different settings. The model was peer-reviewed by another health economist at the National Clinical Guideline Centre (NCGC). Switch between grid and list views. These were assessed against the inclusion criteria. Evidence on cost-effectiveness related to the key clinical issues being addressed in the guideline was sought. At any time, you may opt out of tracking or request account deletion. The wording of the recommendations reflects this. This assessment was carried out by the GDG for each critical outcome, and an evidence summary table was produced to compile the GDG's assessments of clinical importance per outcome, alongside the evidence quality and the uncertainty in the effect estimate (imprecision). Literature reviews, posters, letters, editorials, comment articles, unpublished studies and studies not in English were excluded. Observe patients who are having or have had a blood transfusion in a suitable environment with staff who are able to monitor and manage acute reactions. Therefore, for the purpose of the qualitative review in this guideline, the categorisation of themes was exhaustive, that is, all themes were accounted for in the synthesis. Members were either required to withdraw completely or for part of the discussion if their declared interest made it appropriate. Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. Consider cryoprecipitate transfusions for patients without major haemorrhage who have: Do not offer cryoprecipitate transfusions to correct the fibrinogen level in patients who: Consider prophylactic cryoprecipitate transfusions for patients with a fibrinogen level below 1.0 g/litre who are having invasive procedures or surgery with a risk of clinically significant bleeding. For more details about the assessment of applicability and methodological quality see the economic evaluation checklist (Appendix F of The guidelines manual and the health economics review protocol in Appendix D in the full guideline appendices). The review questions were drafted by the NCGC technical team and refined and validated by the GDG. Statistical heterogeneity was assessed by visually examining the forest plots, and by considering the chi-squared test for significance at p<0.1 or an I-squared inconsistency statistic (with an I-squared value of more than 50% indicating considerable heterogeneity). D-�6C��%2r� ��}hڕ�Pv�M"wU���E��\�T#��M�k(ƿ�byJ��QW�^䰦�%���5��>[��w�g'��:ג�a��?4�m�mB�EMV������)��R=K�M�����#��)��*$�k���>�u_��#��ZO]��E>�@��~p��g7����bŕFI!� Jm�Q!��t�x+b�jS�zE�Q�^'o��n6/x�Ӊ�(��W���%#��i���B��:�ﻊu�~�=4��������#�P�%�^�~� ���@���2Dd�cY��S�=$�5UX��N���W���w*���,�SV�犠b*_�1�p���gS.��s��B�a�Zj�zdP#MA+# R6�)G�U�*��|p������j1�K��B�h>���E�y����=��i��G�(��xV#L4p�Fv��.���@0��ѷ�ꎡM]�\�RG�m���W��%�s�����b�^�)hTԙ�֍�nȐZd�v4/а�/f�iV�oB�箊�� � �>���z�a�E���F&*�@f����W�UB�~�q�k}\#R���c�X#��]E�2���KGitp|_߿Nu�O�$�R��?�I��ߧ�~ This type of analysis simultaneously compares multiple treatments in a single meta-analysis, preserving the randomisation of randomised controlled trials (RCTs) included in the reviews of direct comparisons trials. Searches were undertaken according to the parameters stipulated within The guidelines manual 2012 (see the "Availability of Companion Documents" field). Incompatible blood transfusion reactions can be fatal in type B cats given type A blood,as the recipient’s anti-A alloantibodies rapidly haemolyse the donor type A RBCs. Available from the National Institute for Health and Care Excellence (NICE) Web site. For more information on what the guideline covers, see the context section. The checklist 'Evidence Synthesis of Treatment Efficacy in Decision Making: A Reviewer's Checklist' was completed. Consider using a system that electronically identifies patients to improve the safety and efficiency of the blood transfusion process. Excluded studies by review question (with the reasons for their exclusion) are listed in Appendix P in the full guideline appendices. Review questions were developed in a PICO framework (patient, intervention, comparison and outcome) for intervention reviews and in a framework of setting, population, interventions, context and evaluation for qualitative reviews. After results were pooled, the overall quality of evidence for each outcome was considered. The team working on the guideline included a project manager, systematic reviewers, health economists and information scientists. Fresh frozen plasma transfusions may cause adverse outcomes in people who are critically ill, including transfusion-related acute lung injury, transfusion-related circulatory overload, multi-organ failure and an increased risk of infections. If your body is missing one or more of the components that make up … The recommendations cited here are a guide and may not be appropriate for use in all situations. The guideline population was defined to be people who are receiving a blood transfusion or are at risk of receiving a blood transfusion. <> Critically appraised relevant studies using the economic evaluations checklist as specified in The guidelines manual. Where data from observational studies were included, the GDG decided that the results for each outcome should be presented separately for each study and meta-analysis was not conducted. The Guideline Development Group (GDG) makes a recommendation based on the trade-off between the benefits and harms of an intervention, taking into account the quality of the underpinning evidence. <> Guideline recommendations should be based on the expected costs of the different options in relation to their expected health benefits (that is, their 'cost-effectiveness') rather than the total implementation cost. which compares the size of the treatment effect to the extent of between-trials variation. Absolute risk differences were presented in the GRADE profiles and in clinical summary of findings tables, for discussion with the GDG. Offer prophylactic platelet transfusions to patients with a platelet count below 10×109 per litre who are not bleeding or having invasive procedures or surgery, and who do not have any of the following conditions: Do not routinely transfuse more than a single dose of platelets. There is evidence from several national audits that inappropriate over-use of all blood components is at around 20%. 3 0 obj London (UK): National Institute for Health and Care Excellence; 2015 Nov. 16 p. (NICE guideline; no. This guidance is subject to a 6-week public consultation and feedback as part of the quality assurance and peer review of the document. The software developed by the GRADE working group (GRADEpro) was used to assess the quality of each outcome, taking into account individual study quality factors and the meta-analysis results. Please refer to Appendix C in the full guideline appendices (see the "Availability of Companion Documents" field) for full details on the study design of studies selected for each review question. Reassess the patient's clinical condition and check their platelet count after each platelet transfusion, and give further doses if needed. Monitoring for Acute Blood Transfusion Reactions. For binary outcomes, absolute event rates were also calculated using the GRADEpro software using event rate in the control arm of the pooled results. The National Clinical Guideline Centre was commissioned by the National Institute for Health and Care Excellence to undertake the work on this guideline. To this effect, the outcomes on number of patients receiving allogeneic transfusions, number of units of blood transfused, mortality and adverse events were classified as critical outcomes. Weighting According to a Rating Scheme (Scheme Given), Overall Quality of Outcome Evidence in Grading of Recommendations Assessment, Development and Evaluation (GRADE), Meta-Analysis Systematic Review with Evidence Tables. endobj Staff from the NCGC provided methodological support and guidance for the development process. The GDG identified the use of cell salvage, tranexamic acid or both in combination in people undergoing surgery as the highest priority area for original economic modelling. 24). Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at Evidence from 14 randomised controlled trials (RCTs) comparing erythropoietin (EPO) with placebo/no EPO showed an increase in mortality and the number of patients with thrombotic complications in the EPO group compared to the placebo group, but there was considerable uncertainty in the effect estimates. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Consider a higher threshold (for example 50–75×109 per litre) for patients with a high risk of bleeding who are having invasive procedures or surgery, after taking into account: Consider prophylactic platelet transfusions to raise the platelet count above 100×109 per litre in patients having surgery in critical sites, such as the central nervous system (including the posterior segment of the eyes). For example, the population in reviews evaluating the threshold and target levels for platelet transfusion were stratified on the basis of haematology and non-haematology patients and the presence or absence of bleeding. Additionally, the search was run on MEDLINE and EMBASE using a specific economic filter, from 2012, to ensure recent publications that had not yet been indexed by the economic databases were identified. Do not offer fresh frozen plasma transfusions to correct abnormal coagulation in patients who: Offer immediate prothrombin complex concentrate transfusions for the emergency reversal of warfarin anticoagulation in patients with either: Provide verbal and written information to patients who may have or who have had a transfusion, and their family members or carers (as appropriate), explaining: This section highlights 2 areas of the blood transfusion guideline (using tranexamic acid as an alternative to transfusion and using electronic identification systems) that could have a big impact on practice and be challenging to implement, along with the reasons why these areas are important. All comments received from registered stakeholders are responded to in turn and posted on the National Institute for Health and Care Excellence (NICE) website. Are not bleeding (unless they are having invasive procedures or surgery with a risk of clinically significant bleeding), Head injury with suspected intracerebral haemorrhage, Any alternatives that are available, and how they might reduce their need for a transfusion, That they are no longer eligible to donate blood, That they are encouraged to ask questions. These assessments were made by the health economist using the economic evaluation checklist from The guidelines manual. This method tries to answer the question of what is the reasonable confidence interval of the log odds ratio of an outcome for the prediction of the confidence interval of the log odds ratio of the same outcome of a future trial of infinite size. The questions, the study types applied, the databases searched and the years covered can be found in Appendix G in the full guideline appendices. Occasionally the GDG uses 'must' (or 'must not') if the consequences of not following the recommendation could be extremely serious or potentially life threatening. Reporting or publication bias was only taken into consideration in the quality assessment and included in the 'Clinical evidence profile' table if it was apparent. <> The reasons or criteria used for downgrading were specified in the footnotes. The titles and abstracts of records retrieved by the searches were sifted for relevance, with potentially significant publications obtained in full text. Appendices. Diagnosis and initial management of acute stroke and transient ischaemic attack (TIA), Acute upper gastrointestinal bleeding: management, Provide the patient and their general practitioner (GP) with copies of the discharge summary or other written communication that explains: For guidance on communication and patient-centred care for adults, see the NICE guideline on patient experience in adult NHS services. Search strategies were quality assured by cross-checking reference lists of highly relevant papers, analysing search strategies in other systematic reviews, and asking GDG members to highlight any additional studies. Message from the Chief Executive and Medical Director of BTS (Chinese only) 2018-01-10 ... 2020 Hong Kong Red Cross Blood Transfusion Service. • Universal blood groups for red blood cells (RBC) and plasma (FFP) available for immediate use. The assessment of net benefit was moderated by the importance placed on the outcomes (the GDG's values and preferences), and the confidence the GDG had in the evidence (evidence quality). Systematic literature searches were undertaken to identify all published clinical evidence relevant to the review questions. Offer platelet transfusions to patients with thrombocytopenia who have clinically significant bleeding (World Health Organization [WHO] grade 2) and a platelet count below 30×109 per litre. Do not offer erythropoietin to reduce the need for blood transfusion in patients having surgery, unless: Consider intravenous iron before or after surgery for patients who: For guidance on managing anaemia in patients with chronic kidney disease, see the NGC summary of the NICE guideline Anaemia management in chronic kidney disease. Available from the National Institute for Health and Care Excellence (NICE) Web site. Removing cases where patient harm was caused by delayed transfusion rather than transfusion itself reduces the risk of transfusion-related death to 4.5 per million blood components issued, and the risk of transfusion-related major morbidity was 61.9 per million blood components issued. Further research is very unlikely to change confidence in the estimate of effect. This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Some people have religious beliefs that do not allow the transfusion of blood. – US Government Rights. Introduction to the "Give Blood Alliance" program 2018-02-08. The full versions of all NICE guidance can be found at The section of the guideline also gives information on resources to help with implementation. For interpretation of the binary outcome results, differences in the absolute event rate were calculated using the GRADEpro software, for the median event rate across the control arms of the individual studies in the meta-analysis. NICE has not yet verified this content to confirm that it accurately reflects that original NICE guidance and therefore no guarantees are given by NICE in this regard. When no relevant published studies were found, and a new analysis was not prioritised, the GDG made a qualitative judgement about cost-effectiveness by considering expected differences in resource use between options and relevant UK National Health Service (NHS) unit costs, alongside the results of the clinical review of effectiveness evidence. No evidence was found on transfusions specifically for young people (age 16 to 18 years). Generated summaries of the evidence in NICE economic evidence profiles (included in the relevant chapter for each review question). Effectiveness Patient-centeredness Safety Timeliness. endobj Blood Transfusions in Obstetrics (Green-top Guideline No. Healthcare professionals are expected to take National Institute for Health and Care Excellence (NICE) clinical guidelines fully into account when exercising their clinical judgement. When using a restrictive red blood cell transfusion threshold, consider a threshold of 70 g/litre and a haemoglobin concentration target of 70–90 g/litre after transfusion. 4 0 obj Add a note. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. This may happen, for example, if some patients are particularly averse to some side effect and others are not. The aim of the NMA was to include all relevant evidence in order both to answer questions on the clinical effectiveness of interventions when no direct comparison was available and to give a ranking of treatments in terms of efficacy. • Use a predefined transfusion ratio FFP:RBC between 1:1 and 1:2 (Spahn et al., 2019) • Pre determined package of blood products delivered every 15 minutes (ACS, 2014) • Use rapid infusion and blood warming devices to treat hypovolemic shock and Be used consensus development program (, National Health Service ( NHS ) evidence search ( improve safety. January 15, 2016 for which the evidence in NICE economic evidence was found on transfusions specifically for young (. From another source loss ( greater than 500 ml ) residual deviance and deviance information criteria DIC... Not be appropriate for use in any other country January 15,.. 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