DESIGN: Retrospective observational analysis.
SETTING: 56 acute stroke hospitals in eight countries.
PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.
OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.
RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.
CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.
DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.
OBJECTIVE: To report the first year's screening results for all men at enrollment in the study.
DESIGN, SETTING AND PARTICIPANTS: We recruited men aged 40-69 yr with germline BRCA1/2 mutations and a control group of men who have tested negative for a pathogenic BRCA1 or BRCA2 mutation known to be present in their families. All men underwent prostate-specific antigen (PSA) testing at enrollment, and those men with PSA >3 ng/ml were offered prostate biopsy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PSA levels, PCa incidence, and tumour characteristics were evaluated. The Fisher exact test was used to compare the number of PCa cases among groups and the differences among disease types.
RESULTS AND LIMITATIONS: We recruited 2481 men (791 BRCA1 carriers, 531 BRCA1 controls; 731 BRCA2 carriers, 428 BRCA2 controls). A total of 199 men (8%) presented with PSA >3.0 ng/ml, 162 biopsies were performed, and 59 PCas were diagnosed (18 BRCA1 carriers, 10 BRCA1 controls; 24 BRCA2 carriers, 7 BRCA2 controls); 66% of the tumours were classified as intermediate- or high-risk disease. The positive predictive value (PPV) for biopsy using a PSA threshold of 3.0 ng/ml in BRCA2 mutation carriers was 48%-double the PPV reported in population screening studies. A significant difference in detecting intermediate- or high-risk disease was observed in BRCA2 carriers. Ninety-five percent of the men were white, thus the results cannot be generalised to all ethnic groups.
CONCLUSIONS: The IMPACT screening network will be useful for targeted PCa screening studies in men with germline genetic risk variants as they are discovered. These preliminary results support the use of targeted PSA screening based on BRCA genotype and show that this screening yields a high proportion of aggressive disease.
PATIENT SUMMARY: In this report, we demonstrate that germline genetic markers can be used to identify men at higher risk of prostate cancer. Targeting screening at these men resulted in the identification of tumours that were more likely to require treatment.
METHODS: Patients aged 75 years and older who underwent bariatric procedures in two academic centers between 2006 and 2015 were studied.
RESULTS: A total of 19 patients aged 75 years and above were identified. Eleven (58%) were male, the median age was 76 years old (range 75-81), and the median preoperative body mass index (BMI) was 41.4 kg/m2 (range 35.8-57.5). All of the bariatric procedures were primary procedures and performed laparoscopically: sleeve gastrectomy (SG) (n = 11, 58%), adjustable gastric band (AGB) (n = 4, 21%), Roux-en-Y gastric bypass (RYGB) (n = 2, 11%), banded gastric plication (n = 1, 5%), and gastric plication (n = 1, 5%). The median operative time was 120 min (range 75-240), and the median length of stay was 2 days (range 1-7). Three patients (16%) developed postoperative atrial fibrillation which completely resolved at discharge. At 1 year, the median percentage of total weight loss (%TWL) was 18.4% (range 7.4-22.0). The 1-year %TWL varied among the bariatric procedures performed: SG (21%), RYGB (22%), AGB (7%), and gastric plication (8%). There were no 30-day readmissions, reoperations, or mortalities.
CONCLUSION: Our experience suggests that bariatric surgery in selected patients aged 75 years and older would be safe and effective despite being higher risk. Age alone should not be the limiting factor for selecting patients for bariatric surgery.