Association between vaccination with the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy: a population-based study.

BACKGROUND: An excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. METHODS: Using the database of the largest healthcare provider in Israel, we retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21-days after the first vaccine dose and within 30-days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed. FINDINGS: Overall, 132 cases of Bell's palsy were reported in 2,594,990 vaccinees with the first dose, and 152 cases in 2,434,674 vaccinees after the second dose. The age and sex weighted SIRs were 1.36(95% CI, 1.14-1.61) and 1.16(0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71(1.10-2.54) at age 45-64, and 2.51(1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 vaccinees detected in females aged ≥65 years. In patients with previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 vaccinees and 10 cases in 7,045 vaccinees after the first and the second dose, respectively. The age and sex weighted SIRs were 1.15(0.36-2.76) and 2.15(1.09-3.83) after the first and second vaccine dose, respectively. INTERPRETATION: This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy that has high recovery rate if timely treated with corticosteroids. FUNDING: No external funding was available for this study.

The risk of all-cause mortality is inversely related to serum 25(OH)D levels.

CONTEXT AND OBJECTIVES: Vitamin D plays a key role in maintaining bone health, but evidence for its nonskeletal effects is inconsistent. This study aims to examine the association between serum 25-hydroxyvitamin D [25(OH)D] levels and all-cause mortality in a large general population cohort. DESIGN, PARTICIPANTS, AND SETTING: Using the computerized database of the largest health care provider in Israel, we identified a cohort of subjects 20 years old or older with serum 25(OH)D levels measured between January 2008 and December 2009. Vital status was ascertained through August 2011. RESULTS: Median follow-up was 28.5 months (interquartile range 23.8-33.5 months); 7,247 of 182,152 participants (4.0%) died. Subjects who died had significantly lower serum 25(OH)D levels (mean 44.8 ± 24.2 nmol/liter) than those alive at the end of follow-up (51.0 ± 23.2 nmol/liter), P < 0.001. After adjustment for age, gender, ethnicity, and seasonality, the hazard ratio (HR) for all-cause mortality was 2.02 [95% confidence interval (CI) 1.89-2.15] for the lowest serum 25(OH)D quartile (<33.8 nmol/liter) compared with the highest. After further adjustment for comorbidity, use of vitamin D supplements and statins, smoking, socioeconomic status, and body mass index, the HR was 1.81 (95% CI 1.69-1.95). This remained, even after adjustment for serum low-density lipoprotein, high-density lipoprotein, calcium level (corrected for serum albumin levels), and glomerular filtration rate, 1.85 (95% CI 1.70-2.01). The fully adjusted HR associated with being in the second 25(OH)D quartile (33.8-49.4 nmol/liter) was 1.25 (95% CI 1.16-1.34). CONCLUSIONS: All-cause mortality is independently and inversely associated with serum 25(OH)D levels at levels less than 50 nmol/liter.

The longitudinal variability of serum 25(OH)D levels.

BACKGROUND: The extent to which a single serum 25(OH)D measurement represents long-term vitamin D status remains unclear. This study aims to assess the variability of serum 25(OH)D between tests taken at different time intervals. METHODS: Using the computerized database of the largest healthcare provider in Israel, we identified subjects in whom a serum 25(OH)D test was performed on at least two different occasions between January 2008 and September 2011 (n = 188,771). For these subjects we selected the first and the last dated tests, then we identified those who were not treated with supplements during the last 6 months before the first and before the last test (n = 94,418). Of these we analyzed subjects in whom the first and the last tests were performed in the same month of the year (n = 8881). RESULTS: The mean serum 25(OH)D level at the first test was 51.7 ± 24.0 nmol/L and was 56.7 ± 24.7 at the last test (P<0.001); the overall correlation was 0.63 (P < 0.001). For vitamin D status in two categories (<50 versus ≥ 50 nmol/L), the percentage of agreement between the first and last tests was 74.4%, and was 50.8% for vitamin D status in four categories (<30, 30-49.9, 50-74.9, and ≥ 75 nmol/L). The correlation decreased with increasing time between the tests ranging from 0.83 for tests done at the same year to 0.55 after 3 years. The more the first levels were higher or lower, the more likely subjects remain in their first category (≥ 50 versus <50 nmol/L). CONCLUSIONS: Long-term month specific serum 25(OH)D levels are relatively stable.

The relationship between serum 25(OH)D and parathyroid hormone levels.

OBJECTIVE: Low 25(OH)D levels are associated with increased parathyroid hormone levels leading to progressive bone loss. The serum levels of 25(OH)D sufficient to keep the parathyroid hormone level at a range that will prevent bone loss are still unclear. The current study was aimed at evaluating the relationship between 25(OH)D levels and concomitant parathyroid hormone levels. METHODS: The computerized laboratory database of Clalit Health Services, a not-for-profit health maintenance organization covering more than half of the Israeli population, was searched for all 25(OH)D and parathyroid hormone tests performed in 2009. Concomitant tests of parathyroid hormone and 25(OH)D were identified in 19,172 people. RESULTS: Serum parathyroid hormone levels were inversely correlated with 25(OH)D levels (r = -0.176, P < .001); 25(OH)D levels less than 50 nmol/L were associated with a steep increase in parathyroid hormone levels and hyperparathyroidism, which decreased with increasing 25(OH)D levels and reached a plateau at 25(OH)D levels of 75 to 85 nmol/L. The quadratic fit with plateau model showed that parathyroid hormone stabilizes at 25(OH)D level of 78.9 nmol/L. However, after excluding 5449 people with hypercalcemia or renal failure, the parathyroid hormone plateau was attained at a significantly lower 25(OH)D cut point of 46.2 nmol/L. CONCLUSION: Our data suggest that a 25(OH)D threshold of 50 nmol/L is sufficient for parathyroid hormone suppression and prevention of secondary hyperparathyroidism in persons with normal renal function. 25(OH)D levels greater than 75 nmol/L do not seem to be associated with additional change in parathyroid hormone levels.

Vitamin D Status in Israeli subjects before the initiation and after the cessation of vitamin D supplements.

Vitamin D supplements are often recommended to restore sufficiency, although the adherence to treatment is low. This study assessed vitamin D status at different time intervals following the cessation of treatment. The database of Clalit-Health-Services (CHS), a not-for-profit HMO covering more than half of the Israeli population, was retrospectively searched for all members with available serum 25OHD test results in 2009 (245,493). We then identified those who filled any cholecalciferol prescription in 2008-2009 (121,817). Subjects were included in the final analysis only if they started treatment in 2009, had serum 25OHD < 50 nmol/l before the first prescription in 2009, and had at least one additional test result after the last dated prescription in 2009 (5,461). Serum 25OHD increased from 32 ± 11 nmol/l at baseline to 58.6 ± 22.3 nmol/l after treatment (P < 0.001). The proportion of subjects with sufficient vitamin D after treatment increased with increasing cholecalciferol daily dose and treatment duration (P < 0.001) and decreased with increasing time from cessation of treatment (P < 0.001). The effect of time from treatment cessation persisted after controlling for baseline serum 25OHD, daily cholecalciferol dose, treatment duration, seasonality, gender, age, ethnicity, and BMI; the ORs for sufficient vitamin D were 2.02 (95% CI 1.66-2.45), 1.67 (1.39-2.01), and 1.23 (1.04-1.47) for >30-60, 61-99, and 100-155 days compared to >155 days, respectively. Long-term vitamin D treatment is needed to maintain sufficient levels in those with baseline serum 25OHD below 50 nmol/l.

Robotic-assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy--a retrospective matched control study.

OBJECTIVE: Compare robotic-assisted laparoscopic myomectomy (RALM) to a matched control standard laparoscopic myomectomy (LM). DESIGN: A retrospective matched control study. SETTING: Private practice setting. PATIENT(S): Premenopausal and postmenopausal women who underwent either robotic-assisted or standard laparoscopic myomectomy. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Retrospective chart review was performed. Cases of laparoscopic robotic-assisted myomectomies were compared with a matched control group of standard LM. Comparisons were based on Fisher's exact, Mann-Whitney, and exact chi-square tests. RESULT(S): Between January 2006 and August 2007, 15 consecutive RALMs were performed at our institution, compared with 35 matched control standard LMs. The two groups were matched by age, body mass index, parity, previous abdominopelvic surgery, size, number, and location of myomas. Mean surgical time for the RALM was 234 minutes (range 140-445) compared with 203 minutes (range 95-330) for standard LMs. Blood loss, hospitalization time, and postoperative complications were not significantly different. CONCLUSION(S): The RALM required a significant prolonged surgical time over LM. It appears that in the hands of a skilled laparoscopic surgeon, the RALM does not offer any major advantage. This technology, however, offers exciting potential applications while learning endoscopic surgery. Further studies are warranted to asses the utility of RALM for general gynecologic surgeons.

Quality control in a National Program for the Early Detection of Breast Cancer: women's satisfaction with the mammography process.

INTRODUCTION: The experience of the mammography testing process and related satisfaction influence women's willingness to undergo the test again. The study goal was to assess women's overall satisfaction with the mammography examination service provided by participating units in the National Program for the Early Detection of Breast Cancer in Israel. METHODS: Between August 2003 and March 2004, a random sample of 3,295 women from 38 mammography units nationwide was drawn. Women were interviewed within 48 hours of their mammography, regarding their assessment of the examination process: discomfort, overall satisfaction, and intention to rescreen. Overall satisfaction and process items were measured on an ordinal scale ranging from 1 (lowest) to 6 (highest). Multivariate binomial regression was performed to identify significant predictors of being less satisfied and to estimate the associated relative risks with 95% confidence interval (CI). RESULTS: A response of "very satisfied" (score 6), indicating overall satisfaction with the mammography process, was reported by 77% (95% CI, 73%-80%) of the women, 19% (95% CI, 17%-21%) said they were satisfied. Willingness to rescreen was reported by 95%. Negative assessment of staff attitude was the most influential predictor of being less satisfied. Twenty-six percent of women reported experiencing very discomforting pain. This response was associated with a diagnostic test indication, and with process items directly related to the test (technician's attitude toward the patient; information provided by her; privacy during the test). CONCLUSIONS: Women's satisfaction was high, as was intention to rescreen. The gap between intention and rescreening begs further investigations as to other types of barriers preventing women from adherence to rescreening.

BRCA1/2 mutation carriers: living with susceptibility.

OBJECTIVES: To examine whether being a BRCA1/2 mutation carrier affects a wide array of aspects of life, and if so, how. METHODS: Participants were grouped according to their carrier status (carrier and noncarrier status), health status (affected or unaffected by cancer), and their enrollment at the counseling service (probands and other family members). One hundred and sixty-five women completed a self-administered questionnaire following their genetic consultation session. RESULTS: Probands/nonprobands and carriers/noncarriers did not differ with regard to demographic characteristics, health behaviors including medical checkups, the distress they experience or their resources (sense of coherence, social integration, religiosity). Individuals affected by cancer did differ on some of these aspects from participants without cancer. CONCLUSIONS: From the results of this study, being a carrier could not be considered a psychosocial risk factor, nor does it seem to have an effect on carriers' resources and lifestyle.