Parity as a factor affecting the white-coat effect in pregnant women: the BOSHI study.

Parity has previously been reported to affect the difference in blood pressure (BP) measured in the office and at home, also known as the white-coat effect, during pregnancy. The objective of this study was to identify possible factors that cause the white-coat effect during pregnancy, focusing on parity. In total, 530 pregnant women (31.3±4.7 years old) who delivered at a maternal clinic were eligible for the study. The association between parity and the white-coat effect (clinic BP compared with home BP) was investigated for each trimester of pregnancy by multivariate analysis of covariance adjusted for age, body mass index, family history of hypertension and smoking habits. The magnitudes of the white-coat effect for systolic BP in the first, second and third trimesters were 4.1±9.8, 3.4±7.1 and 1.8±6.0 mm Hg, respectively and those for diastolic BP were 3.8±7.4, 1.6±5.8 and 2.4±4.9 mm Hg, respectively. Parity was significantly and negatively associated with the white-coat effect for systolic BP in the first trimester of pregnancy (nulliparous women: 5.07±0.61 mm Hg and multiparous women: 2.78±0.74 mm Hg, P=0.02) as well as for diastolic BP in the second and third trimesters of pregnancy. Age, body mass index, family history of hypertension and smoking were not significantly associated with the white-coat effect in any trimester of pregnancy. Parity may have an influence on the white-coat effect in pregnancy; however, the observed effect, on average 1-2 mm Hg, was small.

A randomized controlled trial to verify the efficacy of the use of ultrasonography in breast cancer screening aged 40-49 (J-START): 76 196 women registered.

OBJECTIVE: The objective of the Japan Strategic Anti-cancer Randomized Trial was to verify the efficacy of the use of ultrasonography in breast cancer screening among women aged 40-49 years. The purpose of this paper was to report the design and recruitment result of this study. METHODS: In this study of women in their 40s, the participants were divided into two groups, one of which (the intervention group) was subjected to mammography and ultrasonography (using a standardized ultrasonography examination), while the other (the control group) was examined with mammography, in a randomized controlled trial, with the objective of verifying the accuracy and efficacy of examinations by comparing the two groups. RESULTS: The cumulative total number of participants registered in the study was 76 196 (38 313 in the intervention group and 37 883 in the control group). 71.0% of participants registered to the study were under individual randomized controlled trial, 25.0% were under cluster randomized controlled trial and 3.9% were under non-randomized controlled group. The study was designed so that participants registered at their first examination underwent examinations by the same method for the subsequent two years. 74.1% of participants scheduled for a second examination had undertaken it, while information regarding the presence of interval cancer had been obtained from a further 20.6% using a questionnaire. At July 2013, the status of 5.3% of all participants was unclear. CONCLUSIONS: It was the first large-scale randomized controlled trial carried out in Japan. The scheduled second examinations were completed at the end of fiscal 2012. Once the proportion of participants whose status is unclear has fallen to ≤5%, the authors plan to collate the data relating to the primary end points, and publish the results.

Randomized controlled trial on effectiveness of ultrasonography screening for breast cancer in women aged 40-49 (J-START): research design.

In cancer screening, it is essential to undertake effective screening with appropriate methodology, which should be supported by evidence of a reduced mortality rate. At present, mammography is the only method for breast cancer screening with such evidence. However, mammography does not achieve sufficient accuracy in breasts with high density at ages below 50. Although ultrasonography achieves better accuracy in Breast Cancer detection even in dense breasts, the effectiveness has not been verified. We have planned a randomized controlled trial to assess the effectiveness of ultrasonography in women aged 40-49, with a design to study 50,000 women with mammography and ultrasonography (intervention group), and 50,000 controls with mammography only (control group). The participants are scheduled to take second round screening with the same modality 2 years on. The primary endpoints are sensitivity and specificity, and the secondary endpoint is the rate of advanced breast cancers.