Position Paper Transfusion. The evidence for each outcome was examined separately for the quality elements. A blood transfusion is a routine medical procedure in which donated blood is provided to you through a narrow tube placed within a vein in your arm.This potentially life-saving procedure can help replace blood lost due to surgery or injury. Data from 63 randomized clinical trials and 82 observational studies were analyzed. Guideline Transfusion. London (UK): National Institute for Health and Care Excellence; 2015 Nov. 8 p. (NICE guideline; no. The consensus recommendations were agreed through discussions in the GDG. This was either done formally in an economic model, or informally. RCTs start as High, observational studies as Low, and uncontrolled case series as Low or Very low. Methods, evidence and recommendations. Costing statement. The considerations for making consensus-based recommendations include the balance between potential harms and benefits, the economic costs compared to the economic benefits, current practices, recommendations made in other relevant guidelines, patient preferences and equality issues. Interventions That Must (or Must Not) Be Used. In these circumstances the recommendation is generally weaker, although it may be possible to make stronger recommendations about specific groups of patients. For example, the Guideline Development Group (GDG) uses 'offer' to reflect a strong recommendation, usually where there is clear evidence of benefit. The choice of intervention, and whether or not to have the intervention at all, is more likely to depend on the patient's values and preferences than for a strong recommendation, and so the healthcare professional should spend more time considering and discussing the options with the patient. NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Add a note. For some interventions, the GDG is confident that, given the information it has looked at, most patients would choose the intervention. Accurate patient identification is a crucial step. The National Clinical Guideline Centre (NCGC) disclaims any responsibility for damages arising out of the use or non-use of this guideline and the literature used in support of this guideline. Available from the, The guidelines manual 2012. 6 0 obj 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. Refer to Appendix F in the full guideline appendices for a flow diagram of economic article selection for the guideline. Where possible, searches were restricted to articles published in English. 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. This guideline covers the assessment for and management of blood transfusions in adults, young people and children over 1 year old. The GDG could then draw conclusions on the relative merits of each of the themes and how they may help in forming recommendations. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the strength of the recommendation). 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 (http://www.gradeworkinggroup.org/). These were presented in summary tables (in each review chapter) and evidence tables (in Appendix H in the full guideline appendices [see the "Availability of Companion Documents" field]). Available from the National Institute for Health and Care Excellence (NICE) Web site. 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. Monitor the international normalised ratio (INR) to confirm that warfarin anticoagulation has been adequately reversed, and consider further prothrombin complex concentrate. Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Clinical Guideline Centre (NCGC) on behalf of the National Institute for Health and Care Excellence (NICE). The Guideline Development Group (GDG) noted the potential for side effects of oral iron, for example, nausea and gastric discomfort, and the risk of accidental overdose in children. Reassess the patient's clinical condition and check their platelet count after each platelet transfusion, and give further doses if needed. Readers with questions regarding guideline content are directed to contact the guideline developer. 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. Some people have religious beliefs that do not allow the transfusion of blood. Additional subject specific databases were used for some questions: Cumulative Index to Nursing and Allied Health Literature (CINAHL) for monitoring and patient information; Health Management Information Consortium (HMIC) for decision support and patient identification; PsycINFO for patient information. See the original guideline document for terms used in this guideline. 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 http://www.guideline.gov/about/inclusion-criteria.aspx. Developing the Review Questions and Outcomes. Conference abstracts were not automatically excluded from the review but were initially assessed against the inclusion criteria and then further processed only if no other full publication was available for that review question. Staff from the NCGC provided methodological support and guidance for the development process. There are no notes to display. The GDG considered the 'strength' of recommendations. Absolute risk differences were presented in the GRADE profiles and in clinical summary of findings tables, for discussion with the GDG. which compares the size of the treatment effect to the extent of between-trials variation. Guidelines International Network database (, National Institutes of Health Consensus Development Program (, National Health Service (NHS) Evidence Search (. %���� 24). In this table, the columns for intervention and control indicate summary measures and measures of dispersion (such as mean and standard deviation or median and range) for continuous outcomes and frequency of events (n/N: the sum across studies of the number of patients with events divided by sum of the number of completers) for binary outcomes. For some review questions (alternatives to blood transfusion), the review population was limited to surgical patients who are receiving blood transfusions. A network meta-analysis (NMA) was conducted for two review questions which evaluated interventions which are alternatives to blood transfusion in surgical patients. A quality rating was assigned, based on the study design. Thank you for being a user of Guideline Central! Sensitivity analysis based on the quality of studies was also carried out, eliminating studies at overall high risk of bias (randomisation, allocation concealment and blinding, missing outcome data). When no relevant economic studies were found from the economic literature review, relevant UK NHS unit costs related to the compared interventions were presented to the GDG to inform the possible economic implications of the recommendations. Literature reviews, posters, letters, editorials, comment articles, unpublished studies and studies not in English were excluded. 7 0 obj 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). information technology to influence transfusion practices, and details blood management in the perioperative period. The health economic search strategies are included in Appendix G of the full guideline appendices. Databases were searched using relevant medical subject headings, free-text terms and study-type filters where appropriate. 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. If these statistical measures were not available then the methods described in Section 16.1.3 of the Cochrane Handbook (March 2011) 'Missing standard deviations' were applied as the last resort. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content. 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. Also available for download in ePub and eBook formats from the NICE Web site. Searches were undertaken according to the parameters stipulated within The guidelines manual 2012 (see the "Availability of Companion Documents" field). Some recommendations are made with more certainty than others. Full papers were then obtained. The output was expressed as the probability of each treatment being the best for an outcome and as effect estimates for how much each treatment is better than the other treatments included in the network. The GDG uses 'offer' (and similar words such as 'refer' or 'advise') when confident that, for the vast majority of patients, an intervention will do more good than harm, and be cost effective. Undertook a systematic review of the published economic literature, Undertook new cost-effectiveness analysis in priority areas. Some recommendations are 'strong' in that the GDG believes that the vast majority of healthcare and other professionals and patients would choose a particular intervention if they considered the evidence in the same way that the GDG has. 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. 23: Specification for the uniform labelling of blood, blood components and blood donor samples 24: Specification for the uniform labelling of human tissue products using ISBT 128 25: Standards for electronic data interchange within the UK Blood Transfusion Services Available from the, Blood transfusion. 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. Alternatives to Blood Transfusion for Patients Having Surgery. Register 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. However, if the difference in DIC between a fixed and random effect model was smaller than 5 points and the models made very similar inferences, then reviewers reported the fixed-effects model results as that makes fewer assumptions than the random-effect model, contains fewer parameters and is easier to interpret clinically. It covers the general principles of blood transfusion, but does not make recommendations relating to specific conditions. Where considerable heterogeneity was present, reviewers carried out predefined subgroup analyses as was defined in the individual review protocols. Electronic Patient Identification Systems. 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). Recommendations. Blood Transfusion welcomes international submissions of Original Articles, Review Articles and Letters on all the fields related to Transfusion Medicine. However, uncertainty remained regarding whether one may be more cost-effective than the other (head-to-head comparison) or whether they are more cost-effective when given in combination. After results were pooled, the overall quality of evidence for each outcome was considered. However, in cases where standard deviations were not reported, the standard error was calculated if the p values or 95% CIs were reported and meta-analysis was undertaken with the mean and standard error using the generic inverse variance method in RevMan5. <> – US Government Rights. Remaining studies were prioritised for inclusion based on their relative applicability to the development of this guideline and the study limitations. transfusion, and neonatal isoerythrolysis. To get started, log in or create your free account Create Account, © Guideline Central 2020 | All Rights Reserved – Privacy, Terms, and Rights, CPT© copyright 2019 American Medical Association. *By signing up I agree to the privacy terms listed here, Type of Evidence Supporting the Recommendations, Methods Used to Collect/Select the Evidence, Description of Methods Used to Collect/Select the Evidence, Methods Used to Assess the Quality and Strength of the Evidence, Rating Scheme for the Strength of the Evidence, Description of the Methods Used to Analyze the Evidence, Methods Used to Formulate the Recommendations, Description of Methods Used to Formulate the Recommendations, Description of Method of Guideline Validation, Composition of Group That Authored the Guideline, Financial Disclosures/Conflicts of Interest, *By signing up I agree to the privacy terms listed, Benefits/harms Of Implementing The Guideline Recommendations, Rating Scheme For The Strength Of The Recommendations, Institute Of Medicine (iom) National Healthcare Quality Report Categories, National Institute for Health and Care Excellence (NICE) Web site, Anaemia management in chronic kidney disease, Stroke. Guidelines for National External Quality Assessment Scheme in Blood Group Serelogy (NEQAS-BGS) Evidence tables of the clinical and economic evidence reviewed from the literature. Refer to the original guideline document for details. Interventions That Should (or Should Not) Be Used – a 'Strong' Recommendation. 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). A blood transfusion algorithm is provided in the full version of the guideline (see the "Availability of Companion Documents" field). Not applicable: The guideline was not adapted from another source. This guidance is subject to a 6-week public consultation and feedback as part of the quality assurance and peer review of the document. In type A cats given type B blood, the transfusion reaction is unlikely to be fatal, but Available from the, Blood transfusion. The questions, the study types applied, the databases searched and the years covered can be found in Appendix G in the full guideline appendices. %PDF-1.5 Firstly, the net benefit over harm (clinical effectiveness) was considered, focusing on the critical outcomes. When we collect your data through site visits and account creation, we agree to never sell that information to third-parties. The GDG considered the side effects of intravenous (IV) iron, as all preparations carry a small risk of adverse reactions which can be life threatening if not treated promptly. A total of 21 review questions were considered in this guideline. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. All searches were conducted in MEDLINE, EMBASE, and The Cochrane Library. 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). For guidance on reversing anticoagulation treatment in people who have a stroke and a primary intracerebral haemorrhage, see the recommendations in the NGC summary of the NICE guideline Stroke. Where possible, meta-analyses were conducted to combine the results of studies for each review question using Cochrane Review Manager (RevMan5) software. See Table 1 in the full version of the guideline for a list of all review questions considered in the guideline. Full guideline. Affiliations 1 German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main, Germany. Heterogeneity was assessed in the results of the random-effects model by using the method described by Dias et al. Searching for unpublished literature was not undertaken. Evidence from observational studies (which had not previously been downgraded) was upgraded if there was: a large magnitude of effect, a dose–response gradient, and if all plausible confounding would reduce a demonstrated effect or suggest a spurious effect when results showed no effect. London (UK): National Institute for Health and Care Excellence; 2015 Nov. 351 p. (NICE guideline; no. No evidence was found on transfusions specifically for young people (age 16 to 18 years). The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. This personal information is used solely to provide you a more personalized experience when using the Guideline Central website and app. 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. The wording of the recommendations reflects this. The evidence was identified by conducting a broad search relating to transfusion in the NHS Economic Evaluation Database (NHS EED), the Health Technology Assessment database (HTA) and the Health Economic Evaluations Database (HEED) with no date restrictions. The GDG uses 'consider' when confident that an intervention will do more good than harm for most patients, and be cost effective, but other options may be similarly cost effective. A generic inverse variance option in RevMan5 was used if any studies reported solely the summary statistics and 95% confidence interval (95% CI) or standard error; this included any hazard ratios reported. 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). Study type and population in qualitative research can differ widely, meaning that themes that may only be identified by one or a few studies can provide important new information. 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. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The same point estimate but in the opposite direction would apply if the outcome was negative. All searches were updated on January 29, 2015. Refer to Appendix E in the full guideline appendices (see the "Availability of Companion Documents" field) for flow diagrams of clinical selection, which detail the total number of studies included for each guideline topic. 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. Studies that only reported cost per hospital (not per patient), or only reported average cost-effectiveness without disaggregated costs and effects, were excluded. 24). Search. Two RCTs compared prophylactic platelet transfusion with no prophylactic platelet transfusion in adult haematology patients. 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. The titles and abstracts of records retrieved by the searches were sifted for relevance, with potentially significant publications obtained in full text. When all themes were extracted from studies, common concepts were categorised and tabulated. 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