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Background and Objectives: Most research studies on the effects of repeated plasma donation are observational with different study limitations, resulting in high uncertainty on the link between repeated plasma donation and health consequences. Here, we prospectively investigated the safety of intensive or less intensive plasma donation protocols. Materials and Methods: Sixty‐three male subjects participated in this randomized controlled trial and were divided into low‐frequency (LF, once/month, n = 16), high‐frequency (HF, three times/month, n = 16), very high‐frequency (VHF, two times/week, n = 16) and a placebo (P, once/month, n = 15) groups. Biochemical, haematological, clinical, physiological and exercise‐related data were collected before (D0), after 1½ months (D42) and after 3 months (D84) of donation. Results: In VHF, red blood cells, haemoglobin and haematocrit levels decreased while reticulocyte levels increased from D0 to D84. In both HF and VHF, plasma ferritin levels were lower at D42 and D84 compared to D0. In VHF, plasma levels of albumin, immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) dropped from D0 to D42 and remained lower at D84 than at D0. In HF, plasma IgG, IgA and IgM were lower at D42, and IgG and IgM were lower at D84, compared to D0. Few adverse events were reported in HF and VHF. Repeated plasma donation had no effect on blood pressure, body composition or exercise performance. Conclusion: VHF plasmapheresis may result in a large reduction in ferritin and IgG levels. HF and VHF plasmapheresis may result in little to no difference in other biochemical, haematological, clinical, physiological and exercise‐related parameters. [ABSTRACT FROM AUTHOR]

Background and Objectives: As part of a large‐scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects. Materials and Methods: We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow‐up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM). Results: Ninety‐four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9). Conclusion: The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long‐term donor follow‐up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency. [ABSTRACT FROM AUTHOR]

The article discusses the growing utilization of Plasma-Derived Medicinal Products (PDMPs) and the importance of ensuring the safety of plasma donors. It critiques two studies that concluded that repeated plasmapheresis (plasma donation) is safe for donors, pointing out methodological shortcomings and selection biases in the studies. The authors argue that more robust evidence, such as randomized controlled trials (RCTs) and real-world data analysis, is needed to determine the long-term impact of repeated plasmapheresis on donor health. They emphasize the need for trustworthy evidence syntheses and transparent criteria for evaluating the quality of evidence. Until more conclusive evidence is available, blood establishments will continue to prioritize donor safety. [Extracted from the article]

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 FROM AUTHOR]

An International Consensus Conference (ICC) on PBM was held in 2018 to develop evidence‐based clinical and research recommendations for preoperative anaemia, red blood cell (RBC) transfusion thresholds for adults and implementation of PBM programmes. An international scientific committee (SC) defined 17 Population‐Intervention‐Comparison‐Outcome (PICO) questions for the three topics preoperative anaemia, red blood cell (RBC) transfusion thresholds for adults and PBM implementation. Based on these questions, an extensive literature search was conducted in four biomedical databases. The GRADE framework (= grading of recommendations, assessment, development and evaluation) was used to develop a systematic approach to the presentation of evidence summaries and for making clinical recommendations. Three expert panels (EP) consisting of clinicians, scientists, nurses, patient representatives and methodologists were established and used these methods to develop recommendations driven by published evidence. Out of more than 17 500 literature citations, data from 145 studies were incorporated. The expert panel for preoperative anaemia developed 4 clinical and 3 research recommendations. A strong recommendation advices early detection and management of preoperative anaemia before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations have been formulated. Two strong clinical recommendations for RBC transfusion thresholds comprise a haemoglobin concentration of <7 g/dl for critically ill, but clinical stable adult intensive care patients independent of septic shock and <7·5 g/dl for adults undergoing cardiac surgery. For the implementation of PBM programmes, 2 clinical and 3 research recommendations were developed. Research recommendations were formulated as encouragement of new studies to answer open questions. Due to the relative paucity of strong evidence‐based answers in current publications to the 17 PICO questions, additional research, an international consensus for accepted definitions and Hb thresholds as well as clinically meaningful end‐points for clinical studies are necessary. The 2018 PBM ICC defined the current status of PBM evidence and established 10 clinical and 12 research recommendations for preoperative anaemia, RBC transfusion thresholds for adults and implementation of PBM programmes. [ABSTRACT FROM AUTHOR]

Background: Transfusion‐transmissible infections such as hepatitis B virus (HBV) remain a major concern for the safety of blood transfusion. This cross‐sectional study aimed to assess the trend of HBV prevalence and associated risk factors among a first‐time donor population in a low endemic country. Study Design and Methods: Between 2010 and 2018, blood samples were collected from first‐time donors presented at donor collection sites of Belgian Red Cross‐Flanders. They were tested for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti‐HBc), and HBV DNA, HIV and hepatitis virus C (HCV) antibodies and RNA, and syphilis antibodies. Results: A total of 211,331 first‐time blood donors (43.7% males, median age 25 years) were analyzed. HBsAg prevalence decreased from 0.06% in 2010 to 0.05% in 2018 (p =.004) and this declining trend was accompanied by an increased number of donors in the HBV vaccinated birth cohort (p <.001). HBsAg prevalence was 0.33% in foreign‐born donors and 0.02% in Belgian natives (p <.001). Multivariate risk profiling showed that anti‐HBc positivity was significantly associated with mainly foreign‐born donors (odds ratio [OR] = 9.24) but also with older age (OR = 1.06), male gender (OR = 1.32), year of blood donation (OR = 0.94), and co‐infections with HCV (OR = 4.31) or syphilis (OR = 4.91). Discussion: The decreasing trend in HBV prevalence could mainly be explained by the introduction of the universal HBV vaccination. Being born in endemic areas was the most important predictor for HBV infection while the co‐infections with syphilis suggest unreported sexual risk contacts. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

Background: The purpose of a donor medical questionnaire is to identify the blood donor's history relative to the current known blood-safety risks. A temporary deferral from blood donation after an endoscopic examination is enforced because of the reusable nature of the endoscope and close contact with the inner body. The objective of this systematic review was to find the best available evidence on the association between an endoscopic examination and the risk of transfusion-transmissible infections.Methods: Studies from five databases investigating the link between an endoscopic examination and transfusion-transmissible infections (hepatitis B virus, hepatitis C virus, human immunodeficiency virus infection, Treponema pallidum) were retained and assessed independently by two reviewers. The association between endoscopy and transfusion-transmissible infections was identified by conducting meta-analyses and calculating pooled effect measures (odds ratios and 95% confidence intervals). The Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to assess the quality of evidence.Results: We identified 7571 references and finally included 29 observational studies. A significant association between an endoscopic examination and hepatitis B virus infection (pooled odds ratio [OR], 2.21; 95% confidence interval [CI], 1.26-3.86; p = 0.005) or hepatitis C virus infection (pooled OR 1.76, 95% CI, 1.45-2.14; p < 0.00001) was found. The level of evidence was considered as "very low" due to the type of study design (i.e., observational) and indirect study populations (i.e., no blood donor populations).Conclusion: An endoscopic examination is associated with an increased hepatitis B virus or hepatitis C virus infection risk. Further high-quality trials are required to formulate stronger evidence-based recommendations on endoscopic examination as a blood donor deferral criterion. [ABSTRACT FROM AUTHOR]

BACKGROUND Blood is a life-saving product for many people worldwide. Voluntary blood donation serves the demand for blood but there are concerns among potential donors about the impact of blood loss on exercise performance. This systematic review aimed to collect the best available evidence of the effect of a standard whole blood donation on aerobic exercise performance. STUDY DESIGN AND METHODS Studies from six databases dealing with a standard whole blood donation (400-500 mL) followed by (sub)maximal exercise were retained. The outcomes included exercise-related blood variables (hemoglobin [Hb] concentration, hematocrit, and red blood cell count) and endurance exercise variables ((sub)maximal oxygen uptake, peak work rate, and time to exhaustion). Overall effects at different time points postdonation were investigated by performing meta-analyses and calculating mean differences (and 95% confidence intervals). The GRADE methodology (Grades of Recommendation, Assessment, Development, and Evaluation) was used to assess the quality of evidence. RESULTS We identified 6237 references and finally included 18 before-after studies of low quality. Twenty-four to 48 hours after a blood donation, 1) Hb concentration was reduced (7% decrease) until 14 days after the blood donation (4% decrease), 2) maximal oxygen uptake (VO2max) was lower (7% decrease), and 3) a reduction in maximal exercise capacity (10% decrease) was present. CONCLUSION The best available evidence indicates that a standard whole blood donation (400-500 mL) leads to small but potentially physiologically important reductions in Hb levels, VO2max, and maximal exercise capacity in the first 2 days after the blood donation. [ABSTRACT FROM AUTHOR]

Background: Recent literature suggests that more restrictive red blood cell (RBC) transfusion practices are equivalent or better than more liberal transfusion practices. The methodologic quality of guidelines recommending more restrictive transfusion thresholds and their underlying scientific evidence is unclear. Therefore, we aimed to evaluate the quality of the development process of RBC transfusion guidelines and to investigate the underlying evidence of guidelines recommending a more restrictive hemoglobin (Hb) threshold.Study Design and Methods: Via systematic literature screening of relevant databases (NGC, GIN, Medline, and Embase), RBC transfusion guidelines recommending a more restrictive Hb level (<6, <7, or <8 g/dL) were included. Four assessors independently evaluated the methodologic quality by scoring the rigor of development domain (AGREE II checklist). The level of evidence served as a reference for the quality of the underlying evidence.Results: The methodologic quality of 13 RBC transfusion guidelines was variable (18%-72%) but highest for those developed by Advancing Transfusion and Cellular Therapies Worldwide (72%), the Task Force of Advanced Bleeding Care in Trauma (70%), and the Dutch Institute for Healthcare Improvement (61%). A Hb level of less than 7 g/dL (intensive care unit patients) or less than 8 g/dL (postoperative patients) were the only thresholds based on high-quality evidence. Only four of 32 recommendations had a high-quality evidence base.Conclusion: Methodologic quality should be guaranteed in future RBC transfusion guideline development to ensure that the best available evidence is captured when recommending restrictive transfusion strategies. More high-quality trials are needed to provide a stronger scientific basis for RBC transfusion guidelines that recommend more restrictive transfusion thresholds. [ABSTRACT FROM AUTHOR]

OBJECTIVES India is the most malaria-endemic country in South-East Asia, resulting in a high socioeconomic burden. Insecticide-treated or untreated nets are effective interventions to prevent malaria. As part of an Indian first-aid guideline project, we aimed to investigate the magnitude of this effect in India. METHODS We searched MEDLINE, Embase and Central to systematically review Indian studies on the effectiveness of treated or untreated vs. no nets. Parasite prevalence and annual parasite incidence served as malaria outcomes. The overall effect was investigated by performing meta-analyses and calculating the pooled risk ratios (RR) and incidence rate ratios. RESULTS Of 479 articles, we finally retained 16 Indian studies. Untreated nets decreased the risk of parasite prevalence compared to no nets [RR 0.69 (95% CI; 0.55, 0.87) in high-endemic areas, RR 0.49 (95% CI; 0.28, 0.84) in low-endemic areas], as was the case but more pronounced for treated nets [RR 0.35 (95% CI; 0.26, 0.47) in high-endemic areas, risk ratio 0.16 (95% CI; 0.06, 0.44) in low-endemic areas]. Incidence rate ratios showed a similar observation: a significantly reduced rate of parasites in the blood for untreated nets vs. no nets, which was more pronounced in low-endemic areas and for those who used treated nets. The average effect of treated nets (vs. no nets) on parasite prevalence was higher in Indian studies (RR 0.16-0.35) than in non-Indian studies (data derived from a Cochrane systematic review; RR 0.58-0.87). CONCLUSIONS Both treated and untreated nets have a clear protective effect against malaria in the Indian context. This effect is more pronounced there than in other countries. [ABSTRACT FROM AUTHOR]

GLO:2FQ/01aug19:vox12798-fig-0001.jpg PHOTO (COLOR): Study-specific risk differences (RDs) representing the association between acupuncture and HCV infections in blood donors. 4 Orton SL, Stramer SL, Dodd RY, et al.: Risk factors for HCV infection among blood donors confirmed to be positive for the presence of HCV RNA and not reactive for the presence of anti-HCV. 5 Delage G, Infante-Rivard C, Chiavetta JA, et al.: Risk factors for acquisition of hepatitis C virus infection in blood donors: results of a case-control study. [Extracted from the article]