Intravenous immune globulin and thromboembolic adverse events: A systematic review and meta-analysis of RCTs.

Prior case reports and observational studies indicate that intravenous immune globulin (IVIg) products may cause thromboembolic events (TEEs), leading the FDA to require a boxed warning in 2013. The effect of IVIg treatment on the risk of serious TEEs (acute myocardial infarction, ischemic stroke, or venous thromboembolism) was assessed using adverse event data reported in randomized controlled trials (RCTs) of IVIg. RCTs of IVIg in adult patients from 1995 to 2015 were identified from Pubmed, Embase, ClinicalTrials.Gov, and two large prior reviews of IVIg's therapeutic applications. Trials at high risk of detection or reporting bias for serious adverse events were excluded. 31 RCTs with a total of 4,129 participants (2,318 IVIg-treated, 1,811 control) were eligible for quantitative synthesis. No evidence was found of increased TEE risk among IVIg-treated patients compared with control patients (odds ratio = 1.10, 95% CI: 0.44, 2.88; risk difference = 0.0%, 95% CI: -0.7%, 0.7%, I(2) = 0%). No significant increase in risk was found when arterial and venous TEEs were analyzed as separate endpoints. Trial publications provided little specific information concerning the methods used to ascertain potential adverse events. Care should be taken in extrapolating the results to patients with higher baseline risks of TEE. Am. J. Hematol. 91:594-605, 2016. © 2016 Wiley Periodicals, Inc.

The effectiveness of an implementation intentions intervention for fruit and vegetable consumption as moderated by self-schema status.

Two experiments were conducted to determine whether self-schema status moderates the effectiveness of an implementation intentions intervention on nutrition behavior among university students not meeting relevant dietary guidelines. In Experiment 1, students were asked to eat at least 2 servings of fruit and 3 of vegetables daily for a week. Implementation intention condition participants listed what fruits and vegetables they would eat and when and where they would eat them; control condition participants did not. Among those who did not initially meet vegetable targets (n = 108), implementation intentions increased the vegetable consumption of healthy eater schematics, but not of nonschematics. There were no significant effects for fruit consumption among those initially not meeting fruit targets (n = 83). Experiment 2 replicated the moderating effect of healthy eater self-schema status in regard to the effectiveness of an implementation intentions intervention for vegetable consumption among undergraduates who were not initially eating at least 3 servings of vegetables daily (n = 62). Findings are discussed in regard to promoting healthy eating among university students, as well as the implementation intention, self-schema, and self-concordance literatures.