Search

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 Objective: Evidence-based guidelines on platelet transfusion therapy assist clinicians to optimize patient care, but currently do not take into account costs associated with different methods used during the preparation, storage, selection and dosing of platelets for transfusion. This systematic review aimed to summarize the available literature regarding the cost effectiveness (CE) of these methods. Methods: Eight databases and registries, as well as 58 grey literature sources, were searched up to 29 October 2021 for full economic evaluations comparing the CE of methods for preparation, storage, selection and dosing of allogeneic platelets intended for transfusion in adults. Incremental CE ratios, expressed as standardized cost (in 2022 EUR) per quality-adjusted life-year (QALY) or per health outcome, were synthesized narratively. Studies were critically appraised using the Philips checklist. Results: Fifteen full economic evaluations were identified. Eight investigated the costs and health consequences (transfusion-related events, bacterial and viral infections or illnesses) of pathogen reduction. The estimated incremental cost per QALY varied widely from EUR 259,614 to EUR 36,688,323. For other methods, such as pathogen testing/culturing, use of apheresis instead of whole blood-derived platelets, and storage in platelet additive solution, evidence was sparse. Overall, the quality and applicability of the included studies was limited. Conclusions: Our findings are of interest to decision makers who consider implementing pathogen reduction. For other preparation, storage, selection and dosing methods in platelet transfusion, CE remains unclear due to insufficient and outdated evaluations. Future high-quality research is needed to expand the evidence base and increase our confidence in the findings. [ABSTRACT FROM AUTHOR]

Objectives: Thrombopoietin (TPO) mimetics are a potential alternative to platelet transfusion to minimize blood loss in patients with thrombocytopenia. This systematic review aimed to evaluate the cost-effectiveness of TPO mimetics, compared with not using TPO mimetics, in adult patients with thrombocytopenia. Methods: Eight databases and registries were searched for full economic evaluations (EEs) and randomized controlled trials (RCTs). Incremental cost-effectiveness ratios (ICERs) were synthesized as cost per quality-adjusted life year gained (QALY) or as cost per health outcome (e.g. bleeding event avoided). Included studies were critically appraised using the Philips reporting checklist. Results: Eighteen evaluations from nine different countries were included, evaluating the cost-effectiveness of TPO mimetics compared with no TPO, watch-and-rescue therapy, the standard of care, rituximab, splenectomy or platelet transfusion. ICERs varied from a dominant strategy (i.e. cost-saving and more effective), to an incremental cost per QALY/health outcome of EUR 25,000–50,000, EUR 75,000–750,000 and EUR > 1 million, to a dominated strategy (cost-increasing and less effective). Few evaluations (n = 2, 10%) addressed the four principal types of uncertainty (methodological, structural, heterogeneity and parameter). Parameter uncertainty was most frequently reported (80%), followed by heterogeneity (45%), structural uncertainty (43%) and methodological uncertainty (28%). Conclusions: Cost-effectiveness of TPO mimetics in adult patients with thrombocytopenia ranged from a dominant strategy to a significant incremental cost per QALY/health outcome or a strategy that is clinically inferior and has increased costs. Future validation and tackling the uncertainty of these models with country-specific cost data and up-to-date efficacy and safety data are needed to increase the generalizability. [ABSTRACT FROM AUTHOR]

Copyright of International Journal of First Aid Education is the property of International Journal of First Aid Education and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

Introduction: HIV prevalence and sexual risk have been estimated very high for transgender people. However, the limited sampling and data collection methods used in current research on transgender people potentially led to overrepresentation and generalisation of people at risk for HIV. Current HIV prevalence estimates in transgender populations are generalised from studies mainly focusing on transgender women engaging in sex work. Moreover, studies focusing on non-binary people, who identify with a broad range of identities beyond the traditional male and female gender identities, are scarce. Objectives: To estimate the HIV prevalence rate in the Flemish and Brussels (Belgium) transgender population, including transgender women, transgender men and non-binary people, and to identify the associated risk factors. Methods: In this community-based cross-sectional study, self-identified transgender and non-binary (TGNB) people will be recruited through a two-stage time-location sampling approach. First, community settings in which TGNB people gather will be mapped to develop an accurate sampling frame. Secondly, a multistage sampling design is applied involving a stratification based on setting type (healthcare facilities vs outreach events), a selection of clusters by systematic sampling and a simple random selection of TGNB people within each cluster. Participants will complete an electronic self-reported survey to measure sociological, sexual and drug-using behaviors (risk factors) and oral fluid aliquots will be collected and tested for HIV antibodies. Logistic regression models will be used to evaluate risk factors independently associated with HIV infection. The presented study is registered at ClinicalTrials.gov (NCT04930614). Discussion: This study will be the first to investigate the HIV prevalence rates and associated risk behaviors in an accurate representation of the TGNB population in a Western European country. The findings will globally serve as a knowledge base for identifying subgroups at risk for becoming infected with HIV within TGNB people and to set up targeted prevention programs. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

Objective: The aim of this project was to validate search filters for systematic reviews, intervention studies, and observational studies translated from Ovid MEDLINE and Embase syntax and used for searches in PubMed and Embase.com during the development of evidence summaries supporting first aid guidelines. We aimed to achieve a balance among recall, specificity, precision, and number needed to read (NNR). Methods: Reference gold standards were constructed per study type derived from existing evidence summaries. Search filter performance was assessed through retrospective searches and measurement of relative recall, specificity, precision, and NNR when using the translated search filters. Where necessary, search filters were optimized. Adapted filters were validated in separate validation gold standards. Results: Search filters for systematic reviews and observational studies reached recall of ≥85% in both PubMed and Embase. Corresponding specificities for systematic review filters were ≥96% in both databases, with a precision of 9.7% (NNR 10) in PubMed and 5.4% (NNR 19) in Embase. For observational study filters, specificity, precision, and NNR were 68%, 2%, and 51 in PubMed and 47%, 0.8%, and 123 in Embase, respectively. These filters were considered sufficiently effective. Search filters for intervention studies reached a recall of 85% and 83% in PubMed and Embase, respectively. Optimization led to recall of ≥95% with specificity, precision, and NNR of 49%, 1.3%, and 79 in PubMed and 56%, 0.74%, and 136 in Embase, respectively. Conclusions: We report validated filters to search for systematic reviews, observational studies, and intervention studies in guideline projects in PubMed and Embase.com. [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]

• IV Iron monotherapy may not reduce the number of patients transfused. • Iron monotherapy may not reduce the number of red blood cell (RBC) units transfused. • It is unclear if IV and oral iron monotherapy differentially impact RBC utilization. • Oral iron + ESAs probably reduce the number of patients and RBC units transfused. • IV Iron + ESAs may reduce the number of patients transfused. 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 FROM AUTHOR]

Abstract Rationale Pulmonary rehabilitation is an important treatment for patients with Chronic Obstructive Pulmonary Disease, who are often vitamin D deficient. As vitamin D status is linked to skeletal muscle function, we aimed to explore if high dose vitamin D supplementation can improve the outcomes of rehabilitation in Chronic Obstructive Pulmonary Disease. Material and methods This study is a post-hoc subgroup analysis of a larger randomized trial comparing a monthly dose of 100.000 IU of vitamin D with placebo to reduce exacerbations. 50 Subjects who followed a rehabilitation program during the trial are included in this analysis. We report changes from baseline in muscle strength and exercise performance between both study arms after 3 months of rehabilitation. Results Vitamin D intervention resulted in significantly higher median vitamin D levels compared to placebo (51 [44-62] ng/ml vs 15 [13-30] ng/ml; p < 0.001). Patients receiving vitamin D had significantly larger improvements in inspiratory muscle strength (-11±12 cmH2O vs 0±14 cmH2O; p = 0.004) and maximal oxygen uptake (110±211 ml/min vs -20±187 ml/min; p = 0.029). Improvements in quadriceps strength (15±16 Nm) or six minutes walking distance (40±55 meter) were not significantly different from the effects in the placebo group (7±19 Nm and 11±74 meter; p>0.050). Conclusion High dose vitamin D supplementation during rehabilitation may have mild additional benefits to training.

Abstract The assessment of physical activity in healthy populations and in those with chronic diseases is challenging. The aim of this systematic review was to identify whether available activity monitors (AM) have been appropriately validated for use in assessing physical activity in these groups. Following a systematic literature search we found 134 papers meeting the inclusion criteria; 40 conducted in a field setting (validation against doubly labelled water), 86 in a laboratory setting (validation against a metabolic cart, metabolic chamber) and 8 in a field and laboratory setting. Correlation coefficients between AM outcomes and energy expenditure (EE) by the criterion method (doubly labelled water and metabolic cart/chamber) and percentage mean differences between EE estimation from the monitor and EE measurement by the criterion method were extracted. Random-effects meta-analyses were performed to pool the results across studies where possible. Types of devices were compared using meta-regression analyses. Most validation studies had been performed in healthy adults (n = 118), with few carried out in patients with chronic diseases (n = 16). For total EE, correlation coefficients were statistically significantly lower in uniaxial compared to multisensor devices. For active EE, correlations were slightly but not significantly lower in uniaxial compared to triaxial and multisensor devices. Uniaxial devices tended to underestimate TEE (−12.07 (95%CI; -18.28 to −5.85) %) compared to triaxial (−6.85 (95%CI; -18.20 to 4.49) %, p = 0.37) and were statistically significantly less accurate than multisensor devices (−3.64 (95%CI; -8.97 to 1.70) %, p

Background: Mass gathering manifestations attended by large crowds are an increasingly common feature of society. In parallel, an increased number of studies have been conducted that developed and/or validated a model to predict medical usage rates at these manifestations. Aims: To conduct a systematic review to screen, analyse and critically appraise those studies that developed or validated a multivariable statistical model to predict medical usage rates at mass gatherings. To identify those biomedical, psychosocial and environmental predictors that are associated with increased medical usage rates and to summarise the predictive performance of the models. Method: We searched for relevant prediction modelling studies in six databases. The predictors from multivariable regression models were listed for each medical usage rate outcome (i.e. patient presentation rate (PPR), transfer to hospital rate (TTHR) and the incidence of new injuries). The GRADE methodology (Grades of Recommendation, Assessment, Development and Evaluation) was used to assess the certainty of evidence. Results: We identified 7,036 references and finally included 16 prediction models which were developed (n = 13) or validated (n = 3) in the USA (n = 8), Australia (n = 4), Japan (n = 1), Singapore (n = 1), South Africa (n = 1) and The Netherlands (n = 1), with a combined audience of >48 million people in >1700 mass gatherings. Variables to predict medical usage rates were biomedical (i.e. age, gender, level of competition, training characteristics and type of injury) and environmental predictors (i.e. crowd size, accommodation, weather, free water availability, time of the manifestation and type of the manifestation) (low-certainty evidence). Evidence from 3 studies indicated that using Arbon's or Zeitz' model in other contexts significantly over- or underestimated medical usage rates (from 22% overestimation to 81% underestimation). Conclusions: This systematic review identified multivariable models with biomedical and environmental predictors for medical usage rates at mass gatherings. Since the overall certainty of the evidence is low and the predictive performance is generally poor, proper development and validation of a context-specific model is recommended. [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]

Importance: Blood transfusion is one of the most frequently used therapies worldwide and is associated with benefits, risks, and costs.Objective: To develop a set of evidence-based recommendations for patient blood management (PBM) and for research.Evidence Review: The scientific committee developed 17 Population/Intervention/Comparison/Outcome (PICO) questions for red blood cell (RBC) transfusion in adult patients in 3 areas: preoperative anemia (3 questions), RBC transfusion thresholds (11 questions), and implementation of PBM programs (3 questions). These questions guided the literature search in 4 biomedical databases (MEDLINE, EMBASE, Cochrane Library, Transfusion Evidence Library), searched from inception to January 2018. Meta-analyses were conducted with the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology and the Evidence-to-Decision framework by 3 panels including clinical and scientific experts, nurses, patient representatives, and methodologists, to develop clinical recommendations during a consensus conference in Frankfurt/Main, Germany, in April 2018.Findings: From 17 607 literature citations associated with the 17 PICO questions, 145 studies, including 63 randomized clinical trials with 23 143 patients and 82 observational studies with more than 4 million patients, were analyzed. For preoperative anemia, 4 clinical and 3 research recommendations were developed, including the strong recommendation to detect and manage anemia sufficiently early before major elective surgery. For RBC transfusion thresholds, 4 clinical and 6 research recommendations were developed, including 2 strong clinical recommendations for critically ill but clinically stable intensive care patients with or without septic shock (recommended threshold for RBC transfusion, hemoglobin concentration <7 g/dL) as well as for patients undergoing cardiac surgery (recommended threshold for RBC transfusion, hemoglobin concentration <7.5 g/dL). For implementation of PBM programs, 2 clinical and 3 research recommendations were developed, including recommendations to implement comprehensive PBM programs and to use electronic decision support systems (both conditional recommendations) to improve appropriate RBC utilization.Conclusions and Relevance: The 2018 PBM International Consensus Conference defined the current status of the PBM evidence base for practice and research purposes and established 10 clinical recommendations and 12 research recommendations for preoperative anemia, RBC transfusion thresholds for adults, and implementation of PBM programs. The relative paucity of strong evidence to answer many of the PICO questions supports the need for additional research and an international consensus for accepted definitions and hemoglobin thresholds, as well as clinically meaningful end points for multicenter trials. [ABSTRACT FROM AUTHOR]

Background: Exercise capacity is an important feature in patients with COPD. Its impairment drives disability and dependency for daily activities performance. This study evaluated the six years change in exercise capacity in subjects with airflow obstruction and compared this to subjects without airflow obstruction, with and without a smoking history. Methods: Cardiopulmonary exercise tests (CPET) were repeatedly performed during a six years follow up period. Peak oxygen uptake (VO2peak), work rate (WRpeak), heart rate (HRpeak), minute ventilation (VEpeak), respiratory exchange ratio (RERpeak) and ventilatory reserve (VE/MVV) were collected as effort dependent outcomes. The slopes of oxygen uptake, ventilatory and mechanical efficiency (OUES, ΔVE/ΔVCO2 and ΔVO2/ΔWR) were collected as effort independent outcomes. Results: One hundred and thirty-eight subjects were included. Thirty-eight presented airflow obstruction (63±6 years, 74% men, FEV1 90±15%pred), 44 had a smoking history but no airflow obstruction (61±5 years, 61% men, FEV1 105±15%pred) and 56 had never smoked (61±7 years, 57% men, FEV1 117±18%pred). At baseline, the airflow obstruction group had slightly worse exercise capacity in comparison to the never smoking control group, in absolute terms and expressed as percentage of the predicted value (VO2peak = 27±5 versus 32±8 ml/min/kg, p<0.01; 112±29 versus 130±33%pred, p = 0.04). Most exercise variables showed a statistically significant yearly deterioration, with exception of VE/MVV, ΔVE/ΔVCO2 and ΔVO2/ΔWR. The yearly decline in VO2peak and OUES was not faster in subjects with airflow obstruction than in smoking and never smoking controls (VO2peak -67 (9) versus -76 (9) ml/min, p = 0.44 and versus -58 (9), p = 0.47; OUES -32 (11) versus -68 (10), p = 0.03 and versus -68 (13), p = 0.03). Conclusions: With exception of VO2peak, effort dependent variables deteriorated faster in subjects with airflow obstruction compared to never smoking controls. The deterioration of effort independent variables, however, was not accelerated in the airflow obstruction group compared to controls. [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]

A Theory of Change (ToC) is an approach to map programmes aimed at inducing change in a specific context, with the goal of increasing their impact. We applied this approach to the specific case of handwashing and sanitation practices in low- and middle-income countries and developed a ToC as part of a systematic review exercise. Different existing sources of information were used to inform the initial draft of the ToC. In addition, stakeholder involvement occurred and peer review took place. Our stakeholders included methodological (ToC/quantitative and qualitative research) and content experts (WASH (Water, Sanitation, Hygiene)/behaviour change), as well as end-users/practitioners, policy-makers and donors. In conclusion, the development of a ToC, and the involvement of stakeholders in its development, was critical in terms of understanding the context in which the promotional programmes are being implemented. We recommend ToC developers to work with stakeholders to create a ToC relevant for practice. [ABSTRACT FROM PUBLISHER]

Background: Changes in physical activity (PA) are difficult to interpret because no framework of minimal important difference (MID) exists. We aimed to determine the minimal important difference (MID) in physical activity (PA) in patients with Chronic Obstructive Pulmonary Disease and to clinically validate this MID by evaluating its impact on time to first COPD-related hospitalization. Methods: PA was objectively measured for one week in 74 patients before and after three months of rehabilitation (rehabilitation sample). In addition the intraclass correlation coefficient was measured in 30 patients (test-retest sample), by measuring PA for two consecutive weeks. Daily number of steps was chosen as outcome measurement. Different distribution and anchor based methods were chosen to calculate the MID. Time to first hospitalization due to an exacerbation was compared between patients exceeding the MID and those who did not. Results: Calculation of the MID resulted in 599 (Standard Error of Measurement), 1029 (empirical rule effect size), 1072 (Cohen's effect size) and 1131 (0.5SD) steps.day-1. An anchor based estimation could not be obtained because of the lack of a sufficiently related anchor. The time to the first hospital admission was significantly different between patients exceeding the MID and patients who did not, using the Standard Error of Measurement as cutoff. Conclusions: The MID after pulmonary rehabilitation lies between 600 and 1100 steps.day-1. The clinical importance of this change is supported by a reduced risk for hospital admission in those patients with more than 600 steps improvement. [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]

Background: Pulmonary rehabilitation programs only modestly enhance daily physical activity levels in patients with chronic obstructive pulmonary disease (COPD). This randomised controlled trial investigates the additional effect of an individual activity counselling program during pulmonary rehabilitation on physical activity levels in patients with moderate to very severe COPD. Methods: Eighty patients (66±7 years, 81% male, forced expiratory volume in 1 second 45±16% of predicted) referred for a six‐month multidisciplinary pulmonary rehabilitation program were randomised. The intervention group was offered an additional eight-session activity counselling program. The primary outcomes were daily walking time and time spent in at least moderate intense activities. Results: Baseline daily walking time was similar in the intervention and control group (median 33 [interquartile range 16–47] vs 29 [17–44]) whereas daily time spent in at least moderate intensity was somewhat higher in the intervention group (17[4–50] vs 12[2–26] min). No significant intervention*time interaction effects were observed in daily physical activity levels. In the whole group, daily walking time and time spent in at least moderate intense activities did not significantly change over time. Conclusions: The present study identified no additional effect of eight individual activity counselling sessions during pulmonary rehabilitation to enhance physical activity levels in patients with COPD. Trial Registration: clinicaltrials.gov [ABSTRACT FROM AUTHOR]

Skeletal muscle quadriceps low-frequency fatigue (LFF) during exercise promotes improvements in exercise capacity with exercise training. In healthy subjects, eccentric muscle work induced by downhill walking (DW) generates higher muscular stress, whilst metabolic cost is lower compared to level walking (LW). We investigated quadriceps LFF and metabolic cost of DW in patients with chronic obstructive pulmonary disease. Ten participants (67 ± 7 years, FEV1 51 ± 15% predicted) performed DW, DW carrying a load (DWL) of 10% body weight via vest and LW, in random order. Quadriceps potentiated twitch force (TWqpot) was assessed before and after each walk, and muscle damage was assessed before and 24 hours after each walk via serum creatine kinase (CK) levels. Ventilation (VE) and oxygen consumption (VO2) were measured via breath-by-breath analysis during each walk. DW and DWL resulted in a greater decrease in TWqpot (−30 ± 14 N in DW, p < 0.05; and −22 ± 16 N in DWL, p < 0.05) compared to LW (−3 ± 21 N, p > 0.05). CK levels only increased 24 hours following DW and DWL (p < 0.05). DW and DWL showed lower VE and VO2 than LW (p < 0.05). DW is associated with enhanced quadriceps LFF and lower cardiorespiratory costs than LW. The addition of a chest load to DW does not seem to enhance these effects. [ABSTRACT FROM PUBLISHER]

Background: Training first medical responders is considered an extremely cost-effective intervention for frequently occurring diseases and injuries in low and middle-income countries. Aims & Objectives: The Belgian Red Cross-Flanders together with the Indian Red Cross Society, aimed to develop evidence-based guidelines to train lay people on how to manage and prevent emergency situations in India. Methods: Evidence-based guidelines were developed adhering to the principles of AGREE II. The reporting of the systematic literature reviews was done according to the PRISMA statements. We identified evidence on the effectiveness of various first aid and preventive procedures from Indian studies and on alternative interventions that have been used by Indian laypeople. The quality of the scientific evidence was determined using the GRADE methodology. Values and preferences from the target group were collected and inputs from a multidisciplinary panel of 12 Indian experts were taken. Result: After developing 77 specific search strategies in PubMed, 10055 references were screened and 90 relevant studies were included as a basis for the recommendations in the guidelines. Examples of effective interventions include rice water for diarrhoea, and gargling to prevent respiratory infections. Conclusion: Evidence-based first aid and prevention guidelines for Indian laypeople were developed. These guidelines will increase the capacity of the Indian Red Cross Society in providing appropriate first aid training and first aid information to the public, and in delivering first aid assistance in case of disasters, disease outbreaks, emergencies, and road accidents in India. [ABSTRACT FROM AUTHOR]

Background: The modified version of the Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ-M) is used in patients with COPD to obtain information about their functional status. It consists of 3 components (change in activities, dyspnea and fatigue) ranging from 0 to 100 and has been shown to be responsive following pulmonary rehabilitation (PR). The interpretation of changes in PFSDQ-M score after an intervention is difficult in the absence of the minimal important difference (MID) of the PFSDQ-M. This study aims at investigating the MID of the PFSDQ-M. Methods: We enrolled 301 patients with COPD (FEV1 42 ± 15%pred) that completed the PFSDQ-M before and after a 3-month PR program (ΔChronic Respiratory Disease Questionnaire (CRDQ) +16 ± 12 points, ΔSix-minute walking distance (6MWD) +47 ± 89 m, both p < 0.001). An anchor-based approach consisted of calculating the correlation between the ΔPFSDQ-M and anchors with an established MID (ΔCRDQ and Δ6MWD). Linear regression analyses were performed to predict the MID from these anchors. Secondly several distribution-based approaches (Cohen's effect size, empirical rule effect size and standard error of measurement method) were used. Results: Anchor-based estimates for the different PFSDQ-M-components were between -3 and -5 points based on CRDQ score and -6 (only calculated for change in activities) based on 6MWD. Using the distribution-based methods, the estimates of MID ranged from -3 to -5 points for the different components. Conclusions: We concluded that the estimate of MID of the PFSDQ-M after pulmonary rehabilitation corresponds to a change of 5 points (range - 3 to -6) in each component in patients with severe COPD. [ABSTRACT FROM AUTHOR]

Background: Adult patients with cystic fibrosis have peripheral muscle weakness, which is related to exercise intolerance and poor prognosis. The influence of acute exacerbations on muscle strength has been poorly studied. This study aimed to investigate whether quadriceps force (QF), as assessed with an involuntary technique, changes during intravenous antibiotics therapy (IVAT) for an exacerbation. Methods: QF was measured in 20 patients using twitch stimulation of the femoral nerve at the day of hospitalization (day 1) and at termination (day 14) of the IVAT. Physical activity was monitored during IVAT using a SenseWear armband. Ten stable patients served as control subjects. Results: QF did not change during exacerbation (potentiated twitch force at day 1: 140 ± 42 N, at day 14: 140 ± 47 N), but a decrease was observed in individual patients. Changes in twitch force during exacerbation were correlated with time spent in activities of at least moderate intensity (r = 0.61, p = 0.007). Conclusions: QF does not systematically decrease during exacerbations of cystic fibrosis. Individual changes in QF are well correlated with daily time spent in activities of at least moderate intensity. [ABSTRACT FROM AUTHOR]

Introduction. Chronic obstructive pulmonary disease (COPD) is associated with comorbidities such as cardiovascular disease, metabolic disease, osteoporosis, and anxiety and/or depression. Although pulmonary rehabilitation programs are proven to be beneficial in patients with COPD, it is unclear whether comorbidities influence pulmonary rehabilitation outcomes. The aim of the present review was to investigate to what extent the presence of comorbidities can affect pulmonary rehabilitation outcomes. Methods. The systematic literature search (Pubmed, EMBASE, and PEDro) resulted in 4 articles meeting the inclusion criteria. The odds ratios (95% confidence intervals) of the logistic regression analyses, with comorbidities as independent variables and pulmonary rehabilitation outcomes (dyspnea, functional exercise capacity, and quality of life) as dependent variables, were used for data extraction. Results. Patients with anxiety and/or depression less likely improve in dyspnea. Osteoporosis is associated with less improvements in functional exercise capacity, while cardiovascular disease does not seem to negatively impact on this outcome. Patients with cardiovascular comorbidity will experience less positive changes in quality of life. Conclusion. Evidence from literature suggests that comorbidities can have a negative influence on pulmonary rehabilitation outcomes. Screening for comorbidities in pulmonary rehabilitation settings seems useful to readdress the right patients for individually tailored pulmonary rehabilitation. [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]

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]