When the Ideal Meets the Feasible: Constructing a Protocol for Developmental Assessment at Early School-Age

Objective: To describe development of a methodology for an outcome study of children born following in-vitro fertilization or spontaneously-conceived, as a model for defining normal and below-normal development of school-age children for research purposes.Study Design: The main issues addressed were defining the major health and developmental domains to be investigated, selection of age-appropriate validated instruments, considering time constraints to maximize compliance, and budgetary limitations. The final protocol included a half-hour structured telephone interview with mothers of all 759 children and a 2-h developmental assessment of 294 of them. Each of the instruments and recruiting methods are described in terms of the abovementioned considerations.Results: Almost all of the mothers who agreed to be interviewed completed it within the half-hour allotted; however only about half of those who agreed to bring the child for the developmental assessment actually did so. The entire examination battery, assessing cognitive ability, executive functions, attention, and learning skills, was completed by almost all 294 children. There was a significant degree of agreement between the maternal report of the child's reading, writing and arithmetic skills and the in-person examination, as well as regarding the child's weight and height measurements.Conclusion: The findings lend support for a low-budget study, relying on telephone interviews. However, limitations such as the validity of maternal report and recall bias must be taken into consideration

Multicenter Cross-Sectional Study of Nontuberculous Mycobacterial Infections among Cystic Fibrosis Patients, Israel

A multicenter cross-sectional study showed prevalence appears to be increasing

Multicenter Cross-Sectional Study of Nontuberculous Mycobacterial Infections among Cystic Fibrosis Patients, Israel

A multicenter cross-sectional study showed prevalence appears to be increasing

Assessing and monitoring the impact of the national newborn hearing screening program in Israel

Abstract Background The Israeli Newborn Hearing Screening Program (NHSP) began operating nationally in January 2010. The program includes the Otoacoustic Emissions (OAE) test for all newborns and Automated Auditory Brainstem Response (A-ABR) test for failed OAE and infants at risk for auditory neuropathy spectrum disorders. NHSP targets are diagnosis of hearing impairment by age three months and initiation of habilitation by six months. Objectives (1) Review NHSP coverage; (2) Assess NHSP impact on age at diagnosis for hearing impairment and age at initiation of habilitation; (3) Identify contributing factors and barriers to NHSP success. Methods (1) Analysis of screening coverage and referral rates for the NHSP; (2) Analysis of demographic data, results of coverage, age at diagnosis and initiation of habilitation for hearing impaired infants pre-implementation and post-implementation of NHSP from 10 habilitation centers; (3) Telephone interviews with parents whose infants failed the screening and were referred for further testing. Results The NHSP coverage was 98.7% (95.1 to 100%) for approximately 179,000 live births per year for 2014–2016 and average referral rates were under 3%. After three years of program implementation, median age at diagnosis was 3.7 months compared to 9.5 months prior to NHSP. The median age at initiation of habilitation after three years of NHSP was 9.4 months compared to 19.0 prior to NHSP. Parents (84% of 483 sampled) with infants aged 4–6 months participated in the telephone survey. While 84% of parents reported receiving a verbal explanation of the screening results, more than half of the parents reported not receiving written material. Parental report of understanding the test results and a heightened level of concern over the failed screen were associated with timely follow-up. Conclusions The findings indicate high screening coverage. The program reduced ages at diagnosis and initiation of habilitation for hearing impaired infants. Further steps needed to streamline the NHSP are improving communication among caregivers to parents to reduce anxiety; increasing efficiency in transferring information between service providers using advanced technology while ensuring continuum of care; reducing wait time for follow-up testing in order to meet program objectives. Establishment of a routine monitoring system is underway

The possible association between exposure to air pollution and the risk for congenital malformations

Background: Over the last decade, there is growing evidence that exposure to air pollution may be associated with increased risk for congenital malformations. Objectives: To evaluate the possible association between exposures to air pollution during pregnancy and congenital malformations among infants born following spontaneously conceived (SC) pregnancies and assisted reproductive technology (ART) pregnancies. Methods: This is an historical cohort study comprising 216,730 infants: 207,825 SC infants and 8905 ART conceived infants, during the periods 1997–2004. Air pollution data including sulfur dioxide (SO2), particulate matter <10 µm (PM10), nitrogen oxides (NOx) and ozone (O3) were obtained from air monitoring stations database for the study period. Using a geographic information system (GIS) and the Kriging procedure, exposure to air pollution during the first trimester and the entire pregnancy was assessed for each woman according to her residential location. Logistic regression models with generalized estimating equation (GEE) approach were used to evaluate the adjusted risk for congenital malformations. Results: In the study cohort increased concentrations of PM10 and NOx pollutants in the entire pregnancy were associated with slightly increased risk for congenital malformations: OR 1.06(95% CI, 1.01–1.11) for 10 µg/m3 increase in PM10 and OR 1.03(95% CI, 1.01–1.04) for 10 ppb increase in NOx. Specific malformations were evident in the circulatory system (for PM10 and NOx exposure) and genital organs (for NOx exposure). SO2 and O3 pollutants were not significantly associated with increased risk for congenital malformations. In the ART group higher concentrations of SO2 and O3 in entire pregnancy were associated (although not significantly) with an increased risk for congenital malformations: OR 1.06(95% CI, 0.96–1.17) for 1 ppb increase in SO2 and OR 1.15(95% CI, 0.69–1.91) for 10 ppb increase in O3. Conclusions: Exposure to higher levels of PM10 and NOx during pregnancy was associated with an increased risk for congenital malformations. Specific malformations were evident in the circulatory system and genital organs. Among ART pregnancies possible adverse association of SO2 and O3 exposure was also observed. Further studies are warranted, including more accurate exposure assessment and a larger sample size for ART pregnancies, in order to confirm these findings

Ongoing pregnancy rates in women with low and extremely low AMH levels. A multivariate analysis of 769 cycles.

BACKGROUND: The ideal test for ovarian reserve should permit the identification of women who have no real chance of pregnancy with IVF treatments consequent upon an extremely reduced ovarian reserve. The aim of the current study was to evaluate pregnancy rates in patients with low AMH levels (0.2-1 ng/ml) and extremely low AMH levels (<0.2 ng/ml) and to determine the cumulative pregnancy rates following consecutive IVF treatments. METHODS: We conducted an historical cohort analysis at a tertiary medical center. Serum AMH levels were measured at initial clinic visit and prior to all following treatment cycles in 181 women (769 cycles) with an initial AMH level ≤1 ng/ml, undergoing IVF-ICSI. Main outcome measures were laboratory outcomes and pregnancy rates. RESULTS: Seventy patients undergoing 249 cycles had extremely low AMH levels (≤0.2 ng/ml), whereas 111 patients undergoing 520 cycles had low AMH levels (0.21-1.0 ng/ml). Number of oocytes retrieved per cycle, fertilized oocytes and number of transferred embryos were significantly lower in the extremely low AMH levels group compared to the low AMH levels (P<0.003). Crude ongoing pregnancy rates were 4.4% for both groups of patients. Among 48 cycles of women aged ≥42 with AMH levels of ≤0.2 ng/ml no pregnancies were observed. But, in patients with AMH levels of 0.2-1.0 ng/ml, 3 ongoing pregnancies out of 192 cycles (1.6%) were observed. However, in a multivariate regression analysis adjusted for age and cycle characteristics, no significant differences in ongoing pregnancy rates per cycle between the two groups were evident. Cumulative pregnancy rates of 20% were observed following five cycles, for both groups of patients. CONCLUSIONS: Patients with extremely low AMH measurements have reasonable and similar pregnancy rates as patients with low AMH. Therefore, AMH should not be used as the criterion to exclude couples from performing additional IVF treatments

Bariatric surgery in patients with type 1 diabetes: special considerations are warranted

Objective: We examined short and long-term outcomes of bariatric surgery in patients with obesity and type 1 diabetes mellitus (T1DM). Methods: We reviewed the records of all adults insured by Maccabi Healthcare Services during 2010 -2015, with body mass index (BMI) ⩾30 kg/m2 and T1DM; and compared weight reduction and glucose control according to the performance of bariatric surgery. BMI and glycated hemoglobin (HbA1c) levels were extracted for baseline and every 6 months, for a mean 3.5 years. Results: Of 52 patients, 26(50%) underwent bariatric surgery. Those who underwent surgery were more often female and with a longer duration of diabetes. Immediately postoperative, 4(15%) developed diabetic ketoacidosis, while 6(23%) experienced severe hypoglycemic episodes. The mean BMI decreased among surgery patients: from 39.5±4.4 to 30.1±5.0 kg/m2 ( p < 0.0001); and increased among those who did not undergo surgery: from 33.6±3.9 to 35.1±4.4 kg/m2 ( p = 0.49). The mean HbA1c level decreased during the first 6 months postoperative: from 8.5±0.9% to 7.9±0.9%; however, at the end of follow-up, was similar to baseline, 8.6±2.0% (p = 0.87). For patients who did not undergo surgery, the mean HbA1c increased from 7.9±1.9% to 8.6±1.5% ( p = 0.09). Conclusions: Among individuals with obesity and T1DM, weight loss was successful after bariatric surgery, but glucose control did not improve. The postoperative risks of diabetic ketoacidosis and severe hypoglycemic episodes should be considering when performing bariatric surgery in this population