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ABSTRACTObjectivesAlthough outcomes for the majority of women diagnosed with primary breast cancer are good, with five-year survival exceeding 90%, some women will experience cancer recurrence and ultimately die from the disease. It is important for patients, clinicians and health service planners to know the risk of recurrence once initial treatment for primary breast cancer is completed. However, none of Australia's State or Territory cancer registries routinely report on cancer recurrence which could be used to evaluate this issue. To address this absence of direct reporting, we aimed to determine the incidence of cancer recurrence in Australian clinical practice after completion of treatment for primary breast cancer, using a range of linked health data sources.
ApproachWe performed a retrospective cohort study using linked health data from New South Wales (NSW), Australia. Data were linked from six data collections: i) Cancer Registry, ii) Admitted Patient Data Collection, iii) Pharmaceutical Benefits Scheme claims, iv) Medicare (outpatient) claims, v) Death Registry; and the vi) NSW 45 and Up Study. We identified 2416 women diagnosed with primary invasive breast cancer during 2003-2008 in NSW who had not had a recurrence by 18 months post-diagnosis. Unit-level hospital, pharmacy and outpatient claims were used to identify services indicative of recurrence. Incidence of recurrence was calculated and multivariate Cox regression used to identify baseline and active treatment characteristics predictive of cancer recurrence up to six years post-diagnosis.
ResultsA total of 217 women (9.0%) had a hospital, pharmacy or outpatient claim indicating breast cancer recurrence between 18 months and six years post-diagnosis. Overall annual cumulative incidence of recurrence was 3.3%. Recurrence was significantly higher for women with node-positive (4.8% vs. 2.5% annually, adjHR=1.7, 95%CI=1.3-2.3) or hormone receptor-negative (3.8% vs. 3.1% annually, adjHR=1.3, 95%CI=1.0-1.7) tumours. Women with tumours >2cm at diagnosis were more likely to experience recurrence within six years compared with those with a smaller initial tumour (4.8% vs. 2.7 annually, adjHR=1.5; 95%CI=1.1-2.0).
ConclusionsWomen with breast cancer in this Australian cohort experienced recurrence at 3.3%pa in the years following completion of treatment. Those at greatest risk of recurrence were women with node-positive or hormone-receptor negative tumours, or tumours >2cm at initial diagnosis, consistent with international findings. This method for ascertaining breast cancer recurrence can be used to assess population-level changes over time and to investigate the impact of specific treatments on outcomes in the absence of available Cancer Registry data.

IntroductionStudies in the general population suggest that varenicline is more effective than nicotine replacement therapy (NRT) for smoking cessation. However, clinical guidelines recommend against the use of varenicline during pregnancy and suggest NRT be used when the expected benefits outweigh the potential risks.
Objectives and ApproachWe evaluated whether varenicline was more effective than NRT for smoking cessation when used during pregnancy. Routinely-collected records of all births (01/01/2011-12/31/2012) in New South Wales and Western Australia were used to identify a cohort of women who smoked during the first 20 weeks of pregnancy. Pharmaceutical dispensing data were then linked to identify varenicline or NRT dispensing in the first 20 weeks of pregnancy. Smoking cessation was defined as women reported not smoking after the first 20 weeks of pregnancy. Inverse probability of treatment weighting with propensity scores were used to account for differences between the two treatment groups.
ResultsOverall, 117 women used varenicline and 135 NRT in the first 20 weeks of pregnancy. In the unweighted sample, more women who used varenicline quit smoking after the first 20 weeks than women using NRT (28.2% vs. 11.1%, crude rate difference:17.1%, 95% confidence intervals[CI]:7.4-26.8%). In the weighted sample, quitting rate was 12.7% (95%CI:0.8-24.6%) higher in pregnant smokers who used varenicline (27.4% vs. 14.7%) when compared to those who used NRT.
Conclusion/ImplicationsPregnant smokers using varenicline were more likely to quit smoking than those using NRT. This information will assist healthcare providers to make informed recommendations, but data regarding safety of varenicline in pregnancy are also urgently needed. Future studies with greater statistical power are required to confirm our results.

IntroductionIn January 2005, the Australian Government increased the consumer medication co-payment by 21%. Previous research found that this affected population-level utilisation of statins, which fell by 5% following the co-payment increase. The subsequent health impact on individuals reducing or ceasing use of statins is unknown.
Objectives and ApproachTo explore the two-year risk of acute coronary syndrome (ACS) or stroke-related hospitalisation among individuals who discontinued, reduced or continued statin medicines after the 2005 PBS co-payments increase. This was achieved through a retrospective cohort study using linked administrative Commonwealth and State datasets for the Western Australian population. Outcomes were assessed using the Fine and Gray competing risks method, with death as the competing risk, adjusting for demographics, comorbidities and medication history.
ResultsThere were 207,066 individuals identified as using statins before the co-payment increase. After the increase, adherence reduced in 12.5% of this cohort, and 3.3% ceased use. There were 4,343 ACS and stroke-related hospitalisations for the cohort in the follow-up period. Multivariate analysis indicated ceasing statins increased the risk of hospitalisation for ACS or stroke-related events by 18% (95%CI=0.1-40%) compared to continuing therapy. The risk was greatest for males <70 years. No differences existed for women or older men who discontinued statins. There was no difference in hospitalisation risk for those who reduced statins compared to those who continued.
Conclusion / ImplicationsYounger men ceasing statins after the 2005 co-payments increase had a higher risk of ACS and stroke hospitalisations compared to individuals who continued using statins. The findings highlight the importance of continued adherence to prescribed statin medication, and that discontinuing therapy for non-clinical reasons (such as cost) can have negative consequences. Additionally, it demonstrates to policymakers that substantial increases in consumer co-payments can result in adverse health outcomes.

BACKGROUND: Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires several weeks of physical rehabilitation. Teriparatide, a recombinant form of the bioactive portion of parathyroid hormone (1–34 amino acids), is used to treat osteoporosis, prevent osteoporotic fractures, and enhance fracture healing due to its net anabolic effect on bone. The study aim is to investigate the effect of teriparatide on stress fracture healing in young, otherwise healthy adults undergoing military training. METHODS: In a two-arm, parallel, prospective, randomised controlled, intention-to-treat trial, Army recruits (n = 136 men and women, 18–40 years) with a magnetic resonance imaging (MRI) diagnosed lower body stress fracture (pelvic girdle, sacrum, coccyx, or lower limb) will be randomised to receive either usual Army standard care, or teriparatide and usual Army standard care. Teriparatide will be self-administered by subcutaneous injections (20 μg/day) for 16 weeks, continuing to 24 weeks where a fracture remains unhealed at week 16. The primary outcome will be the improvement in radiological healing by two grades or more, or reduction to grade zero, 8 weeks after randomisation, assessed using Fredericson grading of MRI by radiologists blind to the randomisation. Secondary outcomes will be time to radiological healing, assessed by MRI at 8, 10, 12, 14, 16, 20 and 24 weeks, until healed; time to clinical healing, assessed using a clinical severity score of injury signs and symptoms; time to discharge from Army physical rehabilitation; pain, assessed by visual analogue scale; health-related quality of life, using the Short Form (36) Health Survey; and adverse events. Exploratory outcomes will include blood and urine biochemistry; bone density and morphology assessed using dual-energy X-ray absorptiometry, peripheral quantitative computed tomography (pQCT), and high-resolution pQCT; ...

Background: Stress fractures are a common and potentially debilitating overuse injury to bone and occur frequently among military recruits and athletes. Recovery from a lower body stress fracture typically requires several weeks of physical rehabilitation. Teriparatide, a recombinant form of the bioactive portion of parathyroid hormone (1–34 amino acids), is used to treat osteoporosis, prevent osteoporotic fractures, and enhance fracture healing due to its net anabolic effect on bone. The study aim is to investigate the effect of teriparatide on stress fracture healing in young, otherwise healthy adults undergoing military training. Methods: In a two-arm, parallel, prospective, randomised controlled, intention-to-treat trial, Army recruits (n = 136 men and women, 18–40 years) with a magnetic resonance imaging (MRI) diagnosed lower body stress fracture (pelvic girdle, sacrum, coccyx, or lower limb) will be randomised to receive either usual Army standard care, or teriparatide and usual Army standard care. Teriparatide will be self-administered by subcutaneous injections (20 μg/day) for 16 weeks, continuing to 24 weeks where a fracture remains unhealed at week 16. The primary outcome will be the improvement in radiological healing by two grades or more, or reduction to grade zero, 8 weeks after randomisation, assessed using Fredericson grading of MRI by radiologists blind to the randomisation. Secondary outcomes will be time to radiological healing, assessed by MRI at 8, 10, 12, 14, 16, 20 and 24 weeks, until healed; time to clinical healing, assessed using a clinical severity score of injury signs and symptoms; time to discharge from Army physical rehabilitation; pain, assessed by visual analogue scale; health-related quality of life, using the Short Form (36) Health Survey; and adverse events. Exploratory outcomes will include blood and urine biochemistry; bone density and morphology assessed using dual-energy X-ray absorptiometry, peripheral quantitative computed tomography (pQCT), and high-resolution pQCT; physical activity measured using accelerometers; and long-term future fracture rate. Discussion: This study will evaluate whether teriparatide, in addition to standard care, is more effective for stress fracture healing than standard care alone in Army recruits who have sustained a lower body stress fracture. Trial registration: ClinicalTrials.govNCT04196855. Registered on 12 December 2019.