Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial.

BACKGROUND: There is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA). Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges. We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC). METHODS: The Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is a phase 2, open-label, evaluator-blinded trial involving 120 Ghanaian recent-ischemic-stroke survivors. Using a computer-generated sequence, patients will be randomly allocated 1:1 into either the intervention arm or UC. Patients in the intervention arm will receive Polycap DS® (containing aspirin, 100 mg; atenolol, 50 mg; ramipril, 5 mg; thiazide, 12.5 mg; simvastatin, 20 mg) taken as two capsules once daily. Patients in the UC will receive separate, individual secondary preventive medications prescribed at the physician's discretion. Both groups will be followed for 12 months to assess changes in carotid intimal thickness regression - a surrogate marker of atherosclerosis - as primary outcome measure. Secondary outcome measures include adherence to therapy, safety and tolerability, health-related quality of life, patient satisfaction, functional status, depression and cognitive dysfunction. DISCUSSION: An efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, parallel-group, randomized controlled trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in SSA. TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT03329599 . Registered on 11 February 2017.

Testing the risk compensation hypothesis for safety helmets in alpine skiing and snowboarding.

OBJECTIVE: The prevalence of helmet use by alpine skiers and snowboarders was estimated and self-reports on risk taking were assessed to test for potential risk compensation when using helmets in these sports. SETTING: Skiers and snowboarders were observed and interviewed at 34 resorts in the western United States and Canada. SUBJECTS: Respondents were 1779 adult skiers and snowboarders in the 2003 ski season. OUTCOME MEASURES: Observations of helmet use and questions about perceived speed and degree of challenge when not wearing a helmet (helmet wearers) or in previous ski seasons (non-helmet wearers). RESULTS: Helmet wearers reported that they skied/snowboarded at slower speeds (OR = 0.64, p<0.05) and challenged themselves less (OR = 0.76, p<0.05) than non-helmet wearers. Adoption of safety helmets in 2003 (23%) continued to increase over 2002 (OR = 0.46, p<0.05) and 2001 (OR = 0.84, p<0.05). CONCLUSIONS: No evidence of risk compensation among helmet wearers was found. Decisions to wear helmets may be part of a risk reduction orientation. Helmet use continues to trend upwards but adoption may be slowing.

Breast cancer yield for screening mammographic examinations with recommendation for short-interval follow-up.

PURPOSE: To compare cancer yield for screening examinations with recommendation for short-interval follow-up after diagnostic imaging work-up versus after screening mammography only. MATERIALS AND METHODS: From January 1996 to December 1999, Breast Imaging Reporting and Data System assessments and recommendations were collected prospectively for 1,171,792 screening examinations in 758,015 women aged 40-89 years at seven mammography registries in Breast Cancer Surveillance Consortium. Registries obtained waiver of signed consent or collected signed consent in accordance with institutional review boards at each location. Diagnosis of invasive cancer or ductal carcinoma in situ within 24 months of screening examination and tumor stage and size for invasive cancer were determined through linkage to pathology database or tumor registry. chi2 test was used to determine significant differences between groups. RESULTS: Overall, 5.2% of first and 1.7% of subsequent screens included recommendation for short-interval follow-up, which was similar to likelihood of recommendation for diagnostic evaluation (first screens, 4.6%; subsequent, 2.6%). Most recommendations for short-interval follow-up were based on screening mammography alone (86.2% of first screens, 77.5% of subsequent). Yield of cancer for screening examinations with probably benign finding (PBF) and recommendation for short-interval follow-up based on screening mammography alone tended to be lower than in those with PBF and recommendation for short-interval follow-up after additional work-up (first screens: 0.54% vs 0.96%, P=.10; subsequent: 1.50% vs 1.73%, P=.26). Proportion of stage II and higher disease tended to be higher for examinations with PBF and recommendation for short-interval follow-up based on screening mammography alone compared with those recommended for short-interval follow-up after additional work-up (first screens: 34.7% vs 24.4%, P=.43; subsequent: 27.5% vs 19.2%, P=.13). CONCLUSION: Many first screening examinations include recommendation for short-interval follow-up based on screening mammography alone. Cancer yield for these examinations is low and is lower than that with diagnostic work-up prior to short-interval follow-up recommendation. Absence of diagnostic work-up prior to short-interval follow-up recommendation may result in periodic surveillance of a high proportion of benign lesions.