BackgroundThere is concern that the rate of planned births (by pre-labour caesarean section or induction of labour) is increasing and that the gestation at which they are being conducted is decreasing. The aim of this study was to describe trends in the distribution of gestational age, and assess the contribution of planned birth to any such changes.MethodsWe utilised the New South Wales (NSW) Perinatal Data Collection to undertake a population-based study of all births in NSW, Australia 1994–2009. Trends in gestational age were determined by year, labour onset and plurality of birth.ResultsFrom 1994–2009, there was a gradual and steady left-shift in overall distribution of gestational age at birth, with a decline in the modal gestational age from 40 to 39 weeks. For singletons, there was a steady but significant reduction in the proportion of spontaneous births. Labour inductions increased in the proportion performed, with a gradual and changing shift in the distribution from a majority at 40 weeks to an increase at both 37–39 weeks and 41 weeks gestation. The proportion of pre-labour caesareans also increased steadily at each gestational age and doubled since 1994, with most performed at 39 weeks in 2009 compared with 38 weeks up to 2001.ConclusionsFindings suggest a changing pattern towards births at earlier gestations, fewer births commencing spontaneously and increasing planned births. Factors associated with changing clinical practice and long-term implications on the health and well-being of mothers and babies should be assessed.

BackgroundBlood pressure is considered to be a leading example of a valid surrogate endpoint. The aims of this study were to (i) formally evaluate systolic and diastolic blood pressure reduction as a surrogate endpoint for stroke prevention and (ii) determine what blood pressure reduction would predict a stroke benefit.MethodsWe identified randomised trials of at least six months duration comparing any pharmacologic anti-hypertensive treatment to placebo or no treatment, and reporting baseline blood pressure, on-trial blood pressure, and fatal and non-fatal stroke. Trials with fewer than five strokes in at least one arm were excluded. Errors-in-variables weighted least squares regression modelled the reduction in stroke as a function of systolic blood pressure reduction and diastolic blood pressure reduction respectively. The lower 95% prediction band was used to determine the minimum systolic blood pressure and diastolic blood pressure difference, the surrogate threshold effect (STE), below which there would be no predicted stroke benefit. The STE was used to generate the surrogate threshold effect proportion (STEP), a surrogacy metric, which with the R-squared trial-level association was used to evaluate blood pressure as a surrogate endpoint for stroke using the Biomarker-Surrogacy Evaluation Schema (BSES3).ResultsIn 18 qualifying trials representing all pharmacologic drug classes of antihypertensives, assuming a reliability coefficient of 0.9, the surrogate threshold effect for a stroke benefit was 7.1 mmHg for systolic blood pressure and 2.4 mmHg for diastolic blood pressure. The trial-level association was 0.41 and 0.64 and the STEP was 66% and 78% for systolic and diastolic blood pressure respectively. The STE and STEP were more robust to measurement error in the independent variable than R-squared trial-level associations. Using the BSES3, assuming a reliability coefficient of 0.9, systolic blood pressure was a B + grade and diastolic blood pressure was an A grade surrogate endpoint for stroke prevention. In comparison, using the same stroke data sets, no STEs could be estimated for cardiovascular (CV) mortality or all-cause mortality reduction, although the STE for CV mortality approached 25 mmHg for systolic blood pressure.ConclusionsIn this report we provide the first surrogate threshold effect (STE) values for systolic and diastolic blood pressure. We suggest the STEs have face and content validity, evidenced by the inclusivity of trial populations, subject populations and pharmacologic intervention populations in their calculation. We propose that the STE and STEP metrics offer another method of evaluating the evidence supporting surrogate endpoints. We demonstrate how surrogacy evaluations are strengthened if formally evaluated within specific-context evaluation frameworks using the Biomarker- Surrogate Evaluation Schema (BSES3), and we discuss the implications of our evaluation of blood pressure on other biomarkers and patient-reported instruments in relation to surrogacy metrics and trial design.

BackgroundCosmetic breast augmentation (breast implants) is one of the most common plastic surgery procedures worldwide and uptake in high income countries has increased in the last two decades. Women need information about all associated outcomes in order to make an informed decision regarding whether to undergo cosmetic breast surgery. We conducted a systematic review to assess breastfeeding outcomes among women with breast implants compared to women without.MethodsA systematic literature search of Medline, Pubmed, CINAHL and Embase databases was conducted using the earliest inclusive dates through December 2013. Eligible studies included comparative studies that reported breastfeeding outcomes (any breastfeeding, and among women who breastfed, exclusive breastfeeding) for women with and without breast implants. Pairs of reviewers extracted descriptive data, study quality, and outcomes. Rate ratios (RR) and 95% confidence intervals (CI) were pooled across studies using the random-effects model. The Newcastle-Ottawa scale (NOS) was used to critically appraise study quality, and the National Health and Medical Research Council Level of Evidence Scale to rank the level of the evidence. This systematic review has been registered with the international prospective register of systematic reviews (PROSPERO): CRD42014009074.ResultsThree small, observational studies met the inclusion criteria. The quality of the studies was fair (NOS 4-6) and the level of evidence was low (III-2 - III-3). There was no significant difference in attempted breastfeeding (one study, RR 0.94, 95% CI 0.76, 1.17). However, among women who breastfed, all three studies reported a reduced likelihood of exclusive breastfeeding amongst women with breast implants with a pooled rate ratio of 0.60 (95% CI 0.40, 0.90).ConclusionsThis systematic review and meta-analysis suggests that women with breast implants who breastfeed were less likely to exclusively feed their infants with breast milk compared to women without breast implants.

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