The effect of calcium supplementation on blood pressure in non-pregnant women with previous pre-eclampsia: An exploratory, randomized placebo controlled study.

BACKGROUND: Epidemiological findings suggest that the link between poverty and pre-eclampsia might be dietary calcium deficiency. Calcium supplementation has been associated with a modest reduction in pre-eclampsia, and also in blood pressure (BP). METHODS: This exploratory sub-study of the WHO Calcium and Pre-eclampsia (CAP) trial aims to determine the effect of 500mg/day elemental calcium on the blood pressure of non-pregnant women with previous pre-eclampsia. Non-pregnant women with at least one subsequent follow-up trial visit at approximately 12 or 24weeks after randomization were included. RESULTS: Of 836 women randomized by 9 September 2014, 1st visit data were available in 367 women of whom 217 had previously had severe pre-eclampsia, 2nd visit data were available in 201 women. There was an overall trend to reduced BP in the calcium supplementation group (1-2.5mmHg) although differences were small and not statistically significant. In the subgroup with previous severe pre-eclampsia, the mean diastolic BP change in the calcium group (-2.6mmHg) was statistically larger than in the placebo group (+0.8mmHg), (mean difference -3.4, 95% CI -0.4 to -6.4; p=0.025). The effect of calcium on diastolic BP at 12weeks was greater than in those with non-severe pre-eclampsia (p=0.020, ANOVA analysis). CONCLUSIONS: There is an overall trend to reduced BP but only statistically significant in the diastolic BP of women with previous severe pre-eclampsia. This is consistent with our hypothesis that this group is more sensitive to calcium supplementation, however results need to be interpreted with caution.

Short-term prediction of major lower-limb amputation based on clinical indicators on admission: a single institutional experience in a developing country.

AIM: The aim of this study was to analyze the possibility of predicting short-term major lower-limb amputation (SMLA) in patients with vascular diagnoses, based only on clinical variables measured on admission. METHODS: A longitudinal, retrospective cohort study of patients with peripheral vascular diagnoses admitted at our Institute was carried out. A stratified sample of 463 patients admitted during 1997, 2000 and 2003, was studied. Logistic regression was used to identify significant predictors of amputation; twelve clinical variables measured on admission were considered as potential predictors. RESULTS: Of the 463 patients, 93 (20%) were amputated. Significant predictors of amputation identified by the logistic regression analysis were ''type of lesion'' (none; neuro-infectious; ischemic; mixture), ''initial diagnosis'' (phlebolymphopathies, acute arterial insufficiency, chronic arterial insufficiency, diabetic foot, others), ''plantar region lesion'' (no; yes), ''diabetes'' (no; yes), ''number of toes affected'' (none; 1-2; 3 or more), and ''area of leg affected'' (none; lower third; + lower third). More than 80% of patients were correctly classified with the final model: sensitivity was 42% and specificity 96%. CONCLUSIONS: It seems that SMLA in patients with vascular diagnoses can be predicted reasonably well using as predictors only clinical variables measured on admission. This is a potentially useful result for Angiology Services located in developing/poor communities. The amputation probability for each patient obtained from the logistic regression model can be used in several ways: 1) the medical care of patients can be customized so that the amputation rate of the whole Service can be reduced, and 2) the amputation probability of the statistical model can be used as an estimation of the severity of the disease in each patient, which in turn can be used to standardize the amputation rates computed on different years; this would allow a better assessment of the Institutional performance over time.

Rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in South Africa and Vietnam: a randomised controlled equivalence trial.

BACKGROUND: We assessed whether the safety of first-trimester manual vacuum aspiration abortion done by health-care providers who are not doctors (mid-level providers) is equivalent to that of procedures done by doctors in South Africa and Vietnam, where mid-level providers are government trained and accredited to do first-trimester abortions. METHODS: We did a randomised, two-sided controlled equivalence trial to compare rates of complication in abortions done by the two groups of providers. An a-priori margin of equivalence of 4.5% with 80% power and 95% CI (alpha=0.05) was used. 1160 women participated in South Africa and 1734 in Vietnam. Women presenting for an induced abortion at up to 12 weeks' gestation were randomly assigned to a doctor or a mid-level provider for manual vacuum aspiration and followed-up 10-14 days later. The primary outcome was complication of abortion. Complications were recorded during the abortion procedure, before discharge from the clinic, and at follow-up. Per-protocol and intention-to-treat analyses were done. This trial is registered at with the identifier . FINDINGS: In both countries, rates of complication satisfied the predetermined statistical criteria for equivalence: rates per 100 patients in South Africa were 1.4 (eight of 576) for mid-level providers and 0 for doctors (difference 1.4, 95% CI 0.4 to 2.7); in Vietnam, rates were 1.2 (ten of 824) for mid-level providers and 1.2 (ten of 812) for doctors (difference 0.0, 95% CI -1.2 to 1.1). There was one immediate complication related to analgesics. Delayed complications were caused by retained products and infection. INTERPRETATION: With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.

Cochran Q test with Turbo BASIC.

A microcomputer program written in Turbo BASIC for the sequential application of the Cochran Q test is given. A clinical application where the test is used in order to explore the structure of the agreement between observers is also presented. A program listing is available on request.