Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate. Reviewed full papers against pre-specified inclusion and exclusion criteria to identify relevant studies (see below for details). When this was done informally, the GDG took into account the clinical benefits and harms when one intervention was compared with another. The questions, the study types applied, the databases searched and the years covered can be found in Appendix G in the full guideline appendices. Stratified analyses were predefined for some review questions at the protocol stage when the GDG identified that these strata are different in terms of biological and clinical characteristics and the interventions were expected to have a different effect on subpopulations. 24). A network meta-analysis (NMA) was conducted for two review questions which evaluated interventions which are alternatives to blood transfusion in surgical patients. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. All evidence tables are in Appendices H and I in the full guideline appendices (see the "Availability of Companion Documents" field). Generated summaries of the evidence in NICE economic evidence profiles (included in the relevant chapter for each review question). Affiliations 1 German Red Cross Blood Transfusion Service and Goethe University Clinics, Frankfurt/Main, Germany. 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. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Patients with Thrombocytopenia Who Are Bleeding. Available from the, Blood transfusion. However, facilities should develop local procedures and protocols using relevant produ ct information and other jurisdictional resources (e.g. When the only evidence was based on studies that summarised results by presenting medians (and interquartile ranges), or only p values were given, this information was assessed in terms of the study's sample size and was included in the GRADE tables without calculating the relative or absolute effects. The general principles of these guidelines apply to the administration of all blood products. Qualitative studies: each study was summarised in a table where possible, otherwise presented in a narrative. <> For example, all RCTs started as High and the overall quality became Moderate, Low or Very low if 1, 2 or 3 points were deducted respectively. Where possible, searches were restricted to articles published in English. Where p values were reported as 'less than', a conservative approach was undertaken. 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. 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. For the networks set up in our NMA, both fixed- and random-effect models were performed. Studies that only reported cost per hospital (not per patient), or only reported average cost-effectiveness without disaggregated costs and effects, were excluded. 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 full versions of all NICE guidance can be found at www.nice.org.uk. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the strength of the recommendation). ; 4 European Blood Alliance (EBA), … Methods, evidence and recommendations. 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. Searching for unpublished literature was not undertaken. In type A cats given type B blood, the transfusion reaction is unlikely to be fatal, but Services of Headquarters Donor Centre is suspended from February 2019 2018-12-01. Evidence statements are summary statements that are presented after the GRADE profiles, summarising the key features of the clinical effectiveness evidence presented. This is generally the case if the benefits clearly outweigh the harms for most people and the intervention is likely to be cost-effective. When Prophylactic Platelet Transfusions Are Not Indicated. Interventions That Must (or Must Not) Be Used. The group met approximately every 5 to 6 weeks during the development of the guideline. See Table 1 in the full version of the guideline for a list of all review questions considered in the guideline. The means and standard deviations of continuous outcomes were required for meta-analysis. 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. As part of our continued efforts towards protecting your privacy and personal information, we’ve made recent updates to our privacy policy. Effectiveness Patient-centeredness Safety Timeliness. Blood transfusion. The GDG were asked to assess if the absolute risk difference for each outcome was indicative of a clinically important benefit or harm and this was noted accordingly. 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, if a high quality, directly applicable UK analysis was available, then other less relevant studies may not have been included. The evidence statements are presented by outcome and encompass the following key features of the evidence: The NICE economic evidence profile has been used to summarise cost and cost-effectiveness estimates. The following recommendations have been identified as priorities for implementation. London (UK): National Institute for Health and Care Excellence; 2015 Nov. (NICE guideline; no. RCTs start as High, observational studies as Low, and uncontrolled case series as Low or Very low. See Appendices F and I in the full guideline appendices for economic article selection and economic evidence tables. Reassess the patient's clinical condition and repeat the coagulation tests after fresh frozen plasma transfusion to ensure that they are getting an adequate dose, and give further doses if needed. These assessments were made by the health economist using the economic evaluation checklist from The guidelines manual. No difference was observed between groups with respect to side effects of transfusion and serious adverse events, including sepsis and respiratory deterioration, but there was considerable uncertainty. 4 0 obj Please visit our privacy policy page for more information. from the Blood Service, transfusion.com.au and the New Zealand <> The titles and abstracts of records retrieved by the searches were sifted for relevance, with potentially significant publications obtained in full text. 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. Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. 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. Guideline Transfusion. The number of studies and the number of participants for a particular outcome, An indication of the direction of effect (if one treatment is beneficial or harmful compared to the other, or whether there is no difference between the 2 tested treatments), A description of the overall quality of evidence (GRADE overall quality). NICE funds the NCGC and thus supported the development of this guideline. FDA Alerts CHEST: Blood Transfusion Practices Should Be Revisited THURSDAY, Oct. 24, 2019 -- Restricting blood transfusion guidelines may save both lives and money, according to a study presented at CHEST 2019, the annual meeting of the American College of Chest Physicians, held from Oct. 19 to 23 in New Orleans. To facilitate this, binary outcomes were converted into absolute risk differences (ARDs) using GRADEpro software: the median control group risk across studies was used to calculate the ARD and its 95% CI from the pooled risk ratio. 2 0 obj Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Systematic literature searches were also undertaken to identify health economic evidence within published literature relevant to the review questions. London (UK): National Institute for Health and Care Excellence; 2015 Nov. 351 p. (NICE guideline; no. 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 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. Assessments of potential differences in effect between subgroups were based on the chi-squared tests for heterogeneity statistics between subgroups. All searches were updated on January 29, 2015. 1 0 obj London (UK): National Institute for Health and Care Excellence (NICE); 2012 Nov. 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). The importance of the outcomes was directly related to the focus of the guideline which is to optimise the use of blood and blood components and products without compromising on patient safety and clinical effectiveness. The clinical evidence suggested that using electronic decision support systems for blood ordering may reduce the number of patients transfused, the number of units transfused, the proportion of inappropriate transfusions and the length of stay in hospital. Diagnosis and initial management of acute stroke and transient ischaemic attack (TIA). 8 0 obj On behalf of the working group for revision of the Blood Transfusion Guideline René de Vries and Fred Haas, Chairmen . Literature reviews, posters, letters, editorials, comment articles, unpublished studies and studies not in English were excluded. endobj r � Q Q !�Q !� z&. All NICE clinical guidelines are prepared in relation to the National Health Service in England and Wales. All comments received from registered stakeholders are responded to in turn and posted on the National Institute for Health and Care Excellence (NICE) website. Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate. Appraising the Quality of Evidence by Outcomes. Developing the Review Questions and Outcomes. These models were then compared based on residual deviance and deviance information criteria (DIC). NICE's report 'Social value judgements: principles for the development of NICE guidance' sets out the principles that GDGs should consider when judging whether an intervention offers good value for money. stream Good Practice Papers. 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. The GDG uses 'consider' to reflect a recommendation for which the evidence of benefit is less certain. %���� 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. Absolute risk differences were presented in the GRADE profiles and in clinical summary of findings tables, for discussion with the GDG. Literature reviews, abstracts, posters, letters, editorials, comment articles, unpublished studies and studies not in English were excluded. ; 2 Centre for Evidence-Based Practice (CEBaP), Belgian Red Cross, Mechelen, Belgium. Blood transfusions carry risks, are costly, and the supply of blood is limited. Advances in preservation solutions, anticoagulants, and storage conditions have increased storage time for red-blood-cell units up to 42 days at 2–6°C. Further details. Position Papers. 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. The reasons or criteria used for downgrading were specified in the footnotes. 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). Excluded studies by review question (with the reasons for their exclusion) are listed in Appendix P in the full guideline appendices. Published: 09/10/2020. Consider single-unit red blood cell transfusions for adults (or equivalent volumes calculated based on body weight for children or adults with low body weight) who do not have active bleeding. ��C�F�]����]���CRJ�Xt���2M���7�1�o�͛����+o����%�=�\�R�r)�h�z:������za`s�N6��BXz`�~5�|�N���%�vH�[ o�Si/5HD�[��r J��9�I�őȑ�$J^H@\-&����v�ng_Y�bIg{� s^�kB� mYJ�e)������������v�a+�f�-3S��k�l��ӡٵ�f� By ECRI Institute on January 29, 2015 team and refined and validated by the Institute... 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