Abstract

BACKGROUND AND OBJECTIVES Timely and adequate access to safe blood forms an integral part of universal health coverage, but it may be compromised by natural or man-made disasters. This systematic review provides MATERIALS AND METHODS Five databases (The Cochrane Library, MEDLINE, Embase, Web of Science and CINAHL) were searched until 27 March 2020 for (un)controlled studies investigating the impact of disasters on blood donation rates and/or safety. Risk of bias and overall certainty of the evidence were assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS Eighteen observational studies were identified, providing very low certainty of evidence (due to high risk of bias, inconsistency and/or imprecision) on the impact of natural (12 studies) and man-made/technological (6 studies) disasters. The available evidence did not enable us to form any generalizable conclusions on the impact on blood donation rates. Meta-analyses could not detect any statistically significant changes in transfusion-transmissible infection (TTI) rates [hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2, human T-lymphotropic virus I and II (HTLV-I/II) and syphilis] in donated blood after a disaster, either in first-time or repeat donors, although the evidence is very uncertain. CONCLUSION The very low certainty of evidence synthetized in this systematic review indicates that it is very uncertain whether there is an association between disaster occurrence and changes in TTI rates in donated blood. The currently available evidence did not allow us to draw generalizable conclusions on the impact of disasters on blood donation rates.

Abstract

BACKGROUND AND OBJECTIVES Platelet transfusions are used across multiple patient populations to prevent and correct bleeding. This scoping review aimed to map the currently available systematic reviews (SRs) and evidence-based guidelines in the field of platelet transfusion. MATERIALS AND METHODS A systematic literature search was conducted in seven databases for SRs on effectiveness (including dose and timing, transfusion trigger and ratio to other blood products), production modalities and decision support related to platelet transfusion. The following data were charted: methodological features of the SR, population, concept and context features, outcomes reported, study design and number of studies included. Results were synthesized in interactive evidence maps. RESULTS We identified 110 SRs. The majority focused on clinical effectiveness, including prophylactic or therapeutic transfusions compared to no platelet transfusion (34 SRs), prophylactic compared to therapeutic-only transfusion (8 SRs), dose, timing (11 SRs) and threshold for platelet transfusion (15 SRs) and the ratio of platelet transfusion to other blood products in massive transfusion (14 SRs). Furthermore, we included 34 SRs on decision support, of which 26 evaluated viscoelastic testing. Finally, we identified 22 SRs on platelet production modalities, including derivation (4 SRs), pathogen inactivation (6 SRs), leucodepletion (4 SRs) and ABO/human leucocyte antigen matching (5 SRs). The SRs were mapped according to concept and clinical context. CONCLUSION An interactive evidence map of SRs and evidence-based guidelines in the field of platelet transfusion has been developed and identified multiple reviews. This work serves as a tool for researchers looking for evidence gaps, thereby both supporting research and avoiding unnecessary duplication.

Abstract

Patient Blood Management (PBM) is an evidence-based, multidisciplinary, patient-centred approach to optimizing the care of patients who might need a blood transfusion. This systematic review aimed to collect the best available evidence on the effectiveness of preoperative iron supplementation with or without erythropoiesis-stimulating agents (ESAs) on red blood cell (RBC) utilization in all-cause anaemic patients scheduled for elective surgery. Five databases and two trial registries were screened. Primary outcomes were the number of patients and the number of RBC units transfused. Effect estimates were synthesized by conducting meta-analyses. GRADE (Grades of Recommendation, Assessment, Development and Evaluation) was used to assess the certainty of evidence. We identified 29 randomized controlled trials (RCTs) and 2 non-RCTs comparing the effectiveness of preoperative iron monotherapy, or iron + ESAs, to control (no treatment, usual care, placebo). We found that: (1) IV and/or oral iron monotherapy may not result in a reduced number of units transfused and IV iron may not reduce the number of patients transfused (low-certainty evidence); (2) uncertainty exists whether the administration route of iron therapy (IV vs oral) differentially affects RBC utilization (very low-certainty evidence); (3) IV ferric carboxymaltose monotherapy may not result in a different number of patients transfused compared to IV iron sucrose monotherapy (low-certainty evidence); (4) oral iron + ESAs probably results in a reduced number of patients transfused and number of units transfused (moderate-certainty evidence); (5) IV iron + ESAs may result in a reduced number of patients transfused (low-certainty evidence); (6) oral and/or IV iron + ESAs probably results in a reduced number of RBC units transfused in transfused patients (moderate-certainty evidence); (7) uncertainty exists about the effect of oral and/or IV iron + ESAs on the number of patients requiring transfusion of multiple units (very low-certainty evidence). Effect estimates of different haematological parameters and length of stay were synthesized as secondary outcomes. In conclusion, in patients with anaemia of any cause scheduled for elective surgery, the preoperative administration of iron monotherapy may not result in a reduced number of patients or units transfused (low-certainty evidence). Iron supplementation in addition to ESAs probably results in a reduced RBC utilization (moderate-certainty evidence).

Abstract

OBJECTIVES For anaemic elective surgery patients, current clinical practice guidelines weakly recommend the routine use of iron, but not erythrocyte-stimulating agents (ESAs), except for short-acting ESAs in major orthopaedic surgery. This recommendation is, however, not based on any cost-effectiveness studies. The aim of this research was to (1) systematically review the literature regarding cost effectiveness of preoperative iron and/or ESAs in anaemic, elective surgery patients and (2) update existing economic evaluations (EEs) with recent data. METHODS Eight databases and registries were searched for EEs and randomized controlled trials (RCTs) reporting cost-effectiveness data on November 11, 2020. Data were extracted, narratively synthesized and critically appraised using the Philips reporting checklist. Pre-existing full EEs were updated with effectiveness data from a recent systematic review and current cost data. Incremental cost-effectiveness ratios were expressed as cost per (quality-adjusted) life-year [(QA)LY] gained. RESULTS Only five studies (4 EEs and 1 RCT) were included, one on intravenous iron and four on ESAs + oral iron. The EE on intravenous iron only had an in-hospital time horizon. Therefore, cost effectiveness of preoperative iron remains uncertain. The three EEs on ESAs had a lifetime time horizon, but reported cost per (QA)LY gained of 20-65 million (GBP or CAD). Updating these analyses with current data confirmed ESAs to have a cost per (QA)LY gained of 3.5-120 million (GBP or CAD). CONCLUSIONS Cost effectiveness of preoperative iron is unproven, whereas routine preoperative ESA therapy cannot be considered cost effective in elective surgery, based on the limited available data. Future guidelines should reflect these findings.

Abstract

BACKGROUND Every day, blood banks worldwide face the challenge of ensuring an adequate blood supply. Iron deficiency is by far the most common cause of deferral of blood donors. The aim of the present study was to determine the effect of iron supplementation after repeated blood donation on iron status and physiological performance. MATERIALS AND METHODS Forty-four moderately trained and iron-replete subjects were randomly divided into a whole blood donation (n=36) and a placebo donation (n=8) group. One third of the donation group received no iron supplementation, whereas one third received 20 mg iron and one third received 80 mg iron daily for 28 days. The subjects were intended to make three donations 3 months apart, and recovery of endurance capacity, assessed by an incremental maximal cycling test, and haematological parameters was monitored up to 28 days after each donation. RESULTS Negative effects of repeated blood donation were found for markers of iron storage, markers of functional iron and/or iron metabolism regulation, and physiological markers. Iron supplementation did not affect iron storage but did limit, at the highest dose of 80 mg, the effect of blood donations on functional iron and/or iron metabolism regulation, and at both 20 and 80 mg the negative effects on maximal power output and peak oxygen consumption. DISCUSSION Iron supplementation limited the deleterious effects of repeated blood donation on endurance sport performance but not on decline in iron status in iron-replete young men. These results underline the importance of iron supplementation to minimise the deleterious effects of blood donation on physiological functions, and the necessity to optimise the supplementation strategy to preserve iron status.

Abstract

BACKGROUND AND OBJECTIVES The deferral policy for blood donation after dental care is based on the precautionary principle. The aim of this systematic review is to give an overview of the scientific evidence concerning the risk of transfusion transmissible infections (TTIs) after dental care. MATERIALS AND METHODS Four databases were searched: Medline, the Cochrane Library, Embase and Web of Science. Screening was independently performed by two reviewers. The quality of evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation principle. A meta-analysis was performed to assess the association between dental treatment and TTI markers. RESULTS A total of 22 studies were included. Meta-analysis of 16 studies showed an increased association of TTIs with dental treatment, however with large heterogeneity. Subgroup analysis revealed a significant increased association of hepatitis B virus (HBV) with dental treatment [odds ratio 1.79, 95% confidence interval (1.48; 2.18)]. There was conflicting evidence concerning the risk of hepatitis C virus (HCV). One study could not demonstrate a statistically significant increased association of human T-lymphotropic virus type I with dental treatment. Three studies showed a significant increased association of HCV with tooth extraction [odds ratio 1.48, 95% confidence interval (1.11; 1.97)]. Finally, there is conflicting evidence concerning the risk of HBV or HCV after dental cleaning. One study could not demonstrate an association between HIV and dental cleaning. All evidence is of very low certainty and results cannot be considered precise. CONCLUSION Studies of high quality concerning the risk of TTI after dental care in blood donors are scarce. An association of HBV after dental treatment and HCV after tooth extraction was demonstrated but evidence is of very low certainty. The currently identified studies are of too low certainty to make any suggestions regarding the value of deferral or deferral times.

Abstract

BACKGROUND AND OBJECTIVES Patient Blood Management (PBM) aims to optimize the care of patients who might need a blood transfusion. The International Consensus Conference on PBM (ICC-PBM) aimed to develop evidence-based recommendations on three topics: preoperative anaemia, red blood cell transfusion thresholds and implementation of PBM programmes. This paper reports how evidence-based methodologies and technologies were used to enhance shared decision-making in formulating recommendations during the ICC-PBM. MATERIALS & METHODS Systematic reviews on 17 PICO (Population, Intervention, Comparison, Outcomes) questions were conducted by a Scientific Committee (22 international topic experts and one methodologist) according to GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methodology. Evidence-based recommendations were formulated using Consensus Development Conference methodology. RESULTS We screened 17 607 references and included 145 studies. The overall certainty in the evidence of effect estimates was generally low or very low. During the ICC, plenary sessions (100-200 stakeholders from a range of clinical disciplines and community representatives) were followed by closed sessions where multidisciplinary decision-making panels (>50 experts and patient organizations) formulated recommendations. Two chairs (content-expert and methodologist) moderated each session and two rapporteurs documented the discussions. The Evidence-to-Decision template (GRADEpro software) was used as the central basis in the process of formulating recommendations. CONCLUSION This ICC-PBM resulted in 10 clinical and 12 research recommendations supported by an international stakeholder group of experts in blood transfusion. Systematic, rigorous and transparent evidence-based methodology in a formal consensus format should be the new standard to evaluate (cost-) effectiveness of medical treatments, such as blood transfusion.

Abstract

BACKGROUND AND OBJECTIVES The donor medical questionnaire identifies a blood donor's history of known blood safety risks. Current Australian, Canadian, European and USA legislation temporarily defers blood donors who received different percutaneous needle treatments (i.e. tattooing, acupuncture and piercing) from blood donation. This systematic review aimed to scientifically underpin these deferrals by identifying the best available evidence on the association between percutaneous needle treatments and the risk of transfusion-transmissible infections (TTIs). MATERIALS AND METHODS Studies from three databases investigating the link between percutaneous needle treatments and TTIs (HBV, HCV and HIV infection) in blood donors were retained and assessed on eligibility by two reviewers independently. The association between percutaneous needle treatments and TTIs was expressed by conducting meta-analyses and calculating pooled effect measures (odds ratios (ORs) and 95% CIs). The GRADE methodology (Grades of Recommendation, Assessment, Development and Evaluation) was used to assess the quality of evidence. RESULTS We identified 1242 references and finally included 21 observational studies. Twenty studies assessed the link between percutaneous needle treatments and HCV infection and found that blood donors receiving these treatments had an increased risk of HCV infection (tattooing: pooled OR 5.28, 95% CI [4.33, 6.44], P < 0.00001 (low-quality evidence); acupuncture: pooled OR 1.56, 95% CI [1.17, 2.08], P = 0.03 (very low-quality evidence); and piercing: pooled OR 3.25, 95% CI [1.68, 6.30], P = 0.0005 (low-quality evidence)). CONCLUSION Percutaneous needle treatments may be associated with an increased HCV infection risk. Further high-quality studies are required to formulate stronger evidence-based recommendations on percutaneous needle treatments as a blood donor deferral criterion.

Abstract

BACKGROUND AND OBJECTIVES The donor medical questionnaire is designed to aid blood establishments in supporting a safe blood supply. According to blood donor deferral policies, sexual risk behaviour (SRB) leads to a (temporary) deferral from blood donation. This systematic review aimed to scientifically underpin these policies by identifying the best available evidence on the association between SRB and the risk of transfusion transmissible infections (TTIs). MATERIALS & METHODS Studies from three databases investigating the link between SRB (excluding men who have sex with men (MSM)) and TTIs (HBV, HCV, HIV, Treponema pallidum) in donors from Western and Pacific countries were obtained and assessed on eligibility by two reviewers independently. The association between SRB and TTIs was expressed by calculating pooled effect measures via meta-analyses. The GRADE methodology (Grades of Recommendation, Assessment, Development and Evaluation) was used to assess the quality of evidence. RESULTS We identified 3750 references and finally included 15 observational studies. Meta-analyses showed that there is a significant (P < 0.05) positive association between the following SRB and HBV and/or HCV infection: having sex with an intravenous drug user (high-certainty evidence), receiving money or goods for sex (moderate-high certainty evidence), having a sex partner with hepatitis/HIV (moderate-certainty evidence) and paid for sex or anal sex (low-certainty evidence). CONCLUSION Sexual risk behaviour (including having sex with an intravenous drug user, receiving money or goods for sex or having a sex partner with hepatitis/HIV) is probably associated with an increased risk of HBV/HCV infection in blood donors from Western and Pacific countries.

Abstract

OBJECTIVE In many countries people with epilepsy are temporarily or permanently excluded from blood donation. This exclusion is based on the assumption that they are more likely to experience adverse donor reactions such as epileptic seizures, and not on scientific evidence. A systematic review was therefore performed to critically examine the evidence with regard to adverse effects of blood donation on epilepsy patients. METHODS Five databases (MEDLINE, Embase, The Cochrane Library, Web of Science and CINAHL) were searched for studies from the date of inception until December 2014. Two of the authors screened the articles and extracted the data independently and used the GRADE approach to assess the quality of evidence. RESULTS The literature search yielded 7283 references. Following title and abstract screening in the first phase, and full text screening in the second phase, only three observational studies were finally withheld: one cohort study and two case series. None of the three studies could demonstrate that a blood donation resulted in adverse events in epilepsy patients. However, the studies were of poor methodological quality and lacked a solid statistical analysis. CONCLUSIONS Limited low quality studies could not demonstrate that blood donors with epilepsy are at an increased risk of adverse events. Further research is necessary to determine whether and how long epilepsy patients have to be excluded from blood donation.