Maternal Infection in Pregnancy and Childhood Leukemia: A Systematic Review and Meta-analysis.

OBJECTIVE: To summarize the published evidence regarding the association between maternal infection during pregnancy and childhood leukemia. STUDY DESIGN: In this systematic review and meta-analysis (PROSPERO number, CRD42018087289), we searched PubMed and Embase to identify relevant studies. We included human studies that reported associations of at least one measure of maternal infection during pregnancy with acute lymphoblastic leukemia (ALL) or all childhood leukemias in the offspring. One reviewer extracted the data first using a standardized form, and the second reviewer independently checked the data for accuracy. Two reviewers used the Newcastle-Ottawa Scale to assess the quality of included studies. We conducted random effects meta-analyses to pool the ORs of specific type of infection on ALL and childhood leukemia. RESULTS: This review included 20 studies (ALL, n = 15; childhood leukemia, n = 14) reported in 32 articles. Most (>65%) included studies reported a positive association between infection variables and ALL or childhood leukemia. Among specific types of infection, we found that influenza during pregnancy was associated with higher risk of ALL (pooled OR, 3.64; 95% CI, 1.34-9.90) and childhood leukemia (pooled OR, 1.77; 95% CI, 1.01-3.11). Varicella (pooled OR, 10.19; 95% CI, 1.98-52.39) and rubella (pooled OR, 2.79; 95% CI, 1.16-6.71) infections were also associated with higher childhood leukemia risk. CONCLUSIONS: Our findings suggest that maternal infection during pregnancy may be associated with a higher risk of childhood leukemia.

Transfusion-associated circulatory overload risk mitigation: survey on hospital policies for compliance with AABB Standard 5.9.17.

BACKGROUND: AABB Standards for Blood Banks and Transfusion Services require accredited institutions to have a policy for handling requests for blood components on patients clinically identified as being at high risk for transfusion-associated circulatory overload (TACO; Standard 5.19.7, 31st edition). This survey elucidated how AABB accredited hospital transfusion services/blood banks around the world are complying with this Standard. METHODS: A link to a Web-based survey in English was e-mailed under the auspice of the AABB to each AABB accredited hospital transfusion service/blood bank (n = 851) asking for details on how their institution is complying with this Standard and for general information on any TACO risk mitigation strategies in place. RESULTS: Of the 290 responses received (34% response rate), 282 met the criteria for analysis. There were 174 of 282 (62%) respondents who indicated that their institution has a formal policy for complying with the Standard, and 108 of 282 (38%) who indicated that their institution does not have a formal policy. A diverse range of policies and practices were in place at the institutions with and without a formal policy ranging from writing advice/recommendations in the charts of patients at increased risk of TACO, promulgating policies from the transfusion service/blood bank or institution itself that would reduce the risk, or using decision support tools to provide education about reducing the risk of TACO. CONCLUSIONS: Many but not all AABB accredited institutions have policies to comply with the TACO risk mitigation Standard. However, the vast majority conduct activities that could mitigate risk for TACO.

When novelty is not enough.

Neither orderly nor fully rational, the current healthcare environment is a mosaic of providers, products, services, and intermediaries delivering healthcare, regulatory, and other government institutions, and consumers. The information required for informed healthcare decisions for novel pharmaceutical interventions varies appreciably with the audience, the therapeutic area, and the stage of product development. In this environment, the viability of new product introductions can be heavily influenced by perceived value as well as by mechanistic novelty. Correspondingly, research and development activities can be influenced profoundly by the use of incentive-based formularies, prior authorization requirements, or systems of reimbursement that mandate a stream of evidence confirming clinical utility in the presence of therapeutic uncertainty (eg, Centers for Medicare & Medicaid Services, Coverage with Evidence Development). The economic impact of innovative technology on the healthcare system, as well as the effects on the individual patient, can become a significant variable that influences the extent of research activities from the bench to the physician-patient-payor interface.