Comparing the effectiveness of home visiting paraprofessionals and mental health professionals delivering a postpartum depression preventive intervention: a cluster-randomized non-inferiority clinical trial

To determine whether pregnant women receiving the Mothers and Babies group–based intervention exhibited greater depressive symptom reductions and fewer new cases of major depression than women receiving usual community-based services, and to examine whether groups run by paraprofessional home visitors and mental health professionals yielded similar depressive symptom reductions and prevention of major depression. Using a cluster-randomized design, 37 home visiting programs were randomized to usual home visiting, Mothers and Babies delivered via home visiting paraprofessionals, or Mothers and Babies delivered via mental health professionals. Baseline assessments were conducted prenatally with follow-up extending to 24 weeks postpartum. Eligibility criteria were ≥ 16 years old, ≤ 33 gestation upon referral, and Spanish/English speaking. Depressive symptoms at 24 weeks postpartum was the primary outcome. Eight hundred seventy-four women were enrolled. Neither intervention arm was superior to usual care in decreasing depressive symptoms across the sample (p = 0.401 home visiting paraprofessional vs. control; p = 0.430 mental health professional vs. control). Post hoc analyses suggest a positive intervention effect for women exhibiting mild depressive symptoms at baseline. We have evidence of non-inferiority, as the model-estimated mean difference in depressive symptoms between intervention arms (0.01 points, 95% CI: −0.79, 0.78) did not surpass our pre-specified margin of non-inferiority of two points. Although we did not find statistically significant differences between intervention and control arms, non-inferiority analyses found paraprofessional home visitors generated similar reductions in depressive symptoms as mental health professionals. Additionally, Mothers and Babies appears to reduce depressive symptoms among women with mild depressive symptoms when delivered by mental health professionals. This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444).

     

Heparin stimulates proteoglycan synthesis by vascular smooth muscle cells while suppressing cellular proliferation.

We studied the effect of heparin on proteoglycan synthesis by bovine aortic smooth muscle cells in culture. Confluent, growth-arrested cells were incubated with [35S]sulfate, [3H]glucosamine or [3]serine in the presence of 0-600 micrograms/ml heparin. Metabolically labeled proteoglycans secreted into the culture medium and associated with the cell layer were analyzed. In cultures treated with heparin there was a dose-dependent increase in [35S]sulfate incorporation into secreted proteoglycans which reached a maximum (35% above controls) at 100 micrograms/ml heparin. At higher concentrations of heparin, the stimulatory activity declined and finally disappeared. Radioactivity in cell-associated proteoglycans increased significantly (16% above controls) only in cultures treated with 100 micrograms/ml heparin. Heparin also produced similar increases in the incorporation of [3H]glucosamine and [3H]serine into secreted and cell-associated proteoglycans. While chondroitin sulfate, dermatan sulfate and heparan sulfate were elevated in the media, only chondroitin sulfate and heparan sulfate were increased in the cell layer. Heparin did not alter the degradation of proteoglycans. Heparin, while inhibiting the proliferation of subconfluent smooth muscle cells, also stimulated to a greater extent the incorporation of [35S]sulfate into proteoglycans. Other glycosaminoglycans, such as heparan sulfate, dermatan sulfate, heparin hexasaccharide and Sulodexide caused a significant but lesser stimulation of proteoglycan synthesis, while chondroitin sulfates and hyaluronic acid had no effect. Gel filtration chromatography of proteoglycans and their constituent glycosaminoglycans from heparin-treated and untreated cultures showed no differences in their molecular size. The results indicate that heparin can stimulate proteoglycan synthesis by vascular smooth muscle cells irrespective of their state of proliferation. This might have implications in vessel wall repair and arterial wall lipid deposition.     

The relative buffering capacities of saliva and moist snuff: implications for nicotine absorption

Commercial moist snuff products are used by placing a portion of tobacco inside the mouth between the inner cheek or lip and gum. Nicotine is absorbed into the blood stream via transfer across various oral membranes including the buccal mucosa (cheek lining). The resulting salivary pH when a given moist snuff product is placed in the mouth is an important factor for nicotine absorption because it will affect the proportion of free base nicotine that is readily available for absorption. The resulting salivary pH for a given moist snuff product will be determined in part by the relative acid-base buffering capacities of the saliva and moist snuff, as well as the pHs of the saliva and moist snuff prior to coming in contact with one another. In the current study, the acid-base buffering capacities (mu eq/g) of a series of commercial moist snuff products were determined and compared to the acid-base buffering capacity for unstimulated, whole human saliva. The buffering capacities of the moist snuff products were determined to be 10-20 times higher than the buffering capacity of human saliva. The resulting salivary pH ranges after contact between an artifical saliva and the various moist snuff products were also determined; the results were used to predict the proportion of free base nicotine that can be expected to occur in the mouth during the first few minutes of product use. These studies provide a basis for examining and understanding the effects that moist snuff product pHs and buffering capacities may be expected to have on nicotine absorption.     

Seminal vesicle cysts with unilateral renal agenesis and contralateral ureteral stenosis in a beta-thalassemic patient: an unknown association by incomplete development of the mesonephric duct

We report the case of a 13-year-old male patient with beta-thalassemic trait who presented for a colic pain. An ultrasound of the abdomen revealed absence of the right kidney with a complex hypoechogenic pelvic mass causing mild pressure on the posterior bladder wall. Urography showed hypertrophy of the left kidney with moderate ureteral enlargement of the distal third due to an insertion defect in the bladder suggestive of a primary segmental nonobstructing megaureter. MR studies showed right multilocular seminal vesicle cysts. One year later an MR examination of the pelvis showed an increase in size of seminal vesicle cysts and open surgery was performed to remove the cystic retrovesical mass. Our case represents a very rare association of seminal vesicle cysts, unilateral renal agenesis and alteration in contralateral ureteral insertion in a patient with beta-thalassemic trait.     

Changes in the posterior cornea after laser in situ keratomileusis and photorefractive keratectomy

PURPOSE: To study the changes in posterior corneal elevation after laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) using Scheimpflug topography with the Pentacam anterior segment imaging system (Oculus, Inc.). SETTING: Department of Ophthalmology, Albany Medical Center, and a private clinical practice, Albany, New York, USA. METHODS: In this prospective study, 121 consecutive myopic eyes (103 LASIK and 18 PRK) were evaluated preoperatively and postoperatively with the Pentacam to determine elevation changes in the posterior corneal surface. Changes in posterior elevation were calculated by comparing the best-fit sphere preoperatively and postoperatively to a fixed reference sphere using the central 9.0 mm preoperative cornea. Statistical and graphic analyses were performed. RESULTS: The 103 LASIK eyes had a mean correction of -3.76 diopters (D) and a mean ablation depth of 62.1 microm. The mean estimated residual bed thickness (RBT) (329 microm) demonstrated a mean posterior displacement of 2.64 +/- 4.95 microm. The 18 PRK eyes had a mean correction of -2.69 D and a mean ablation depth of 53.2 microm. The mean estimated RBT (464 microm) had a mean posterior displacement of -0.88 +/- 4.64 microm. The difference in the mean posterior corneal displacement between the LASIK and the PRK eyes was not statistically significant (P>.05, Student t test). CONCLUSIONS: There was no statistically significant difference in posterior corneal displacement between the LASIK and PRK patients. The changes in PRK and LASIK eyes appeared to be within acceptable measurement variation. Contrary to previous reports, ectatic changes to the posterior corneal surface did not routinely occur after LASIK surgery.     

Quantifying the cost in power of ignoring continuous covariate imbalances in clinical trial randomization

Motivated by potentially serious imbalances of continuous baseline covariates in clinical trials, we investigated the cost in statistical power of ignoring the balance of these covariates in treatment allocation design for a logistic regression model. Based on data from a clinical trial of acute ischemic stroke treatment, computer simulations were used to create scenarios varying from the best possible baseline covariate balance to the worst possible imbalance, with multiple balance levels between the two extremes. The likelihood of each scenario occurring under simple randomization was evaluated. The power of the main effect test for treatment was examined. Our simulation results show that the worst possible imbalance is highly unlikely, but it can still occur under simple random allocation. Also, power loss could be nontrivial if balancing distributions of important continuous covariates were ignored even if adjustment is made in the analysis for important covariates. This situation, although unlikely, is more serious for trials with a small sample size and for covariates with large influence on primary outcome. These results suggest that attempts should be made to balance known prognostic continuous covariates at the design phase of a clinical trial even when adjustment is planned for these covariates at the analysis.