Assessment of Risk Indicators for Targeted Cytomegalovirus Screening in Neonates.

BACKGROUND: In the absence of universal screening for congenital cytomegalovirus (cCMV) infection, the aim of this study was to assess the outcomes of a targeted screening protocol based on maternal and neonatal risk indicators. METHODS: The medical records of 2,623 neonates born in our maternal hospital between June 2016 and December 2018 and screened for cCMV infection were reviewed. Among those of the included neonates, the records of 380 CMV-negative and 19 CMV-positive neonates were randomly assigned to obtain additional comparative data. RESULTS: During the study period, a total of 63 neonates were identified as positive for cCMV, comprising 0.2% of the total birth cohort (63/28,982) and 2.4% of all neonates screened for cCMV (63/2,623). The comparative data analysis showed that suspected or confirmed CMV infection during pregnancy, maternal age, and maternal diabetes mellitus were found to be significantly associated with a positive cCMV diagnosis. Although symmetric small for gestational age and hearing screening failure contributed to the detection of some of the CMV-positive infants, these factors were not specific to this group. The results of the logistic regression model showed that the only factor that was significantly associated with an increased risk for a cCMV diagnosis was maternal serology suspected of CMV infection during pregnancy, with a regression coefficient estimate of 2.657 (adjusted p < 0.001). CONCLUSIONS: A targeted neonatal screening protocol based on multiple maternal and neonatal risk indicators is feasible but provides limited information. Our study emphasizes the importance of universal neonatal screening for the detection of neonates with cCMV.

Questioning a publication bias between industry-funded and non-industry-funded randomized controlled trials on biological and small molecule therapy for rheumatoid arthritis.

BACKGROUND: There has been a significant increase in financial support of clinical research by the pharmaceutical industry. METHODS: We performed a comprehensive systematic literature review to determine whether there is publication bias for rheumatoid arthritis (RA) studies between industry-funded and non-industry funded randomized controlled trials (RCTs), and between RCTs with positive results (PRs) and those with negative results (NRs) of FDAapproved biological and small molecule drug therapy for RA. Each RCT was classified as having either a PR or a NR, and as having received commercial funding or not. RESULTS: Most (297/349, 85.18%) of the RCTs were commercially funded. There was no significant difference in PRs or association with publication between commercially and noncommercially funded RCTs. Sample size was significantly larger in commercially funded RCTs and in those with PRs, and it was the only significant parameter that predicted publication in higher impact factor journals in the field of RA. CONCLUSION: There is no significant association between commercial funding and the publication of positive results or the publication of an RCT in higher impact factor journals.

Pre-induction cervical ripening: comparing between two vaginal preparations of dinoprostone in women with an unfavorable cervix.

OBJECTIVE: Prostaglandin E2 (PGE2-Dinoprostone) is accepted for both ripening of the cervix and induction of labor. As conflicting data exist concerning the efficiency and safety of different treatment modalities, we aimed to compare slow-release vaginal insert PGE2 with serial vaginal tablets of PGE2 for cervical ripening and induction of labor. METHODS: A retrospective cohort study comparing all pregnancies who underwent induction of labor by either a single slow-release vaginal insert of 10 mg PGE2 (study group) to a historical control group of women who were treated with serial administration of 3 mg vaginal PGE2 tablets in a 2:1 ratio, matched by parity. RESULTS: Overall, 639 women were enrolled (213 treated with PGE2 tablets and 426 with slow-release vaginal inserts). Vaginal insert was associated with shorter initiation-to-ripening interval (12.4 ± 7.7 versus 18.6 ± 15.2 h, p < 0.001) and a higher rate of delivery within 24 h (61.5 versus 51.6%, p = 0.018). Vaginal insert was associated with an increased rate of tachysystole (8.0 versus 3.1%, p < 0.01); however, the rates of cesarean section or operative delivery due to non-reassuring fetal heart rate (NRFHR) were similar. On multivariable analysis, slow-release vaginal insert was independently associated with a higher rate of delivery within 24 h (OR 1.50, 95% CI 1.04-2.18). CONCLUSION: Slow-release PGE2 vaginal insert achieves cervical ripening and subsequently delivery over a shorter time period than PGE2 tablets, without increasing uterine hyperstimulation rate.