stillbirth prevention: Raising public awareness of stillbirth in Australia.

Prevention of stillbirth remains one of the greatest challenges in modern maternity care. Despite this, public awareness is low and silence is common within families, the community and even healthcare professionals. Australian families and parent advocacy groups given a voice through the Senate Enquiry have made passionate and articulate calls for a national stillbirth awareness campaign. This fourth paper in the Stillbirth in Australia series outlines why stillbirth needs a national public awareness campaign; and provides an overview of good practice in the design, development and evaluation of public awareness campaigns. The cognitive and affective steps required to move from campaign awareness to action and eventually to stillbirth prevention are described. Using these best practice principles, learning from previous campaigns combined with close collaboration with aligned agencies and initiatives should assist a National Stillbirth Prevention Campaign to increase community awareness of stillbirth, help break the silence and contribute to stillbirth prevention across Australia.

A randomized and clinical effectiveness trial comparing two pharmacogenetic algorithms and standard care for individualizing warfarin dosing (CoumaGen-II).

BACKGROUND: Warfarin is characterized by marked variations in individual dose requirements and a narrow therapeutic window. Pharmacogenetics (PG) could improve dosing efficiency and safety, but clinical trials evidence is meager. METHODS AND RESULTS: A Randomized and Clinical Effectiveness Trial Comparing Two Pharmacogenetic Algorithms and Standard Care for Individualizing Warfarin Dosing (CoumaGen-II) comprised 2 comparisons: (1) a blinded, randomized comparison of a modified 1-step (PG-1) with a 3-step algorithm (PG-2) (N=504), and (2) a clinical effectiveness comparison of PG guidance with use of either algorithm with standard dosing in a parallel control group (N=1866). A rapid method provided same-day CYP2C9 and VKORC1 genotyping. Primary outcomes were percentage of out-of-range international normalized ratios at 1 and 3 months and percentage of time in therapeutic range. Primary analysis was modified intention to treat. In the randomized comparison, PG-2 was noninferior but not superior to PG-1 for percentage of out-of-range international normalized ratios at 1 month and 3 months and for percentage of time in therapeutic range at 3 months. However, the combined PG cohort was superior to the parallel controls (percentage of out-of-range international normalized ratios 31% versus 42% at 1 month; 30% versus 42% at 3 months; percentage of time in therapeutic range 69% versus 58%, 71% versus 59%, respectively, all P<0.001). Differences persisted after adjustment for age, sex, and clinical indication. There were fewer percentage international normalized ratios ≥4 and ≤1.5 and serious adverse events at 3 months (4.5% versus 9.4% of patients, P<0.001) with PG guidance. CONCLUSIONS: These findings suggest that PG dosing should be considered for broader clinical application, a proposal that is being tested further in 3 major randomized trials. The simpler 1-step PG algorithm provided equivalent results and may be preferable for clinical application. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927862.