80-2.13). They were less likely to occur in patients with eczema (OR = 0.61, 95% CI = 0.57-0.65) and Asian race (OR = 0.50, 95% CI = 0.44-0.56). Nickel (US, 16.0%; Canada, 22.4%) and methylisothiazolinone (US, 13.4%; Canada, 11.0%) were the top allergens. The third most frequent was neomycin (US, 11.7%) and fragrance mix I (Canada, 10.2%).

National differences in allergen prevalence and trends exist in North America.

National differences in allergen prevalence and trends exist in North America.

Vitamin E (tocopherol) a naturally occurring mixture of antioxidants commonly used in topical skin care products, may cause allergic contact dermatitis.

The aim of this study was to characterize positive patch test reactions to tocopherol and tocopherol acetate.

This is a retrospective analysis of North American Contact Dermatitis Group patch test data to tocopherols (DL-α-tocopherol 100% and/or DL-α-tocopherol acetate 100%) from 2001 to 2016.

Of the 38,699 patients patch tested to tocopherol and/or tocopherol acetate, 349 (0.9%) had positive reactions; of these, 87.6% were currently relevant. selleck chemical Most (51.4%) were weak (+) and/or not related to occupation (99.1%). Compared with tocopherol-negative patients, tocopherol-positive individuals were more likely to be female (72.5% vs 67.2%, P = 0.0355), have a final primary diagnosis of allergic contact dermatitis (74.2% vs 52.6%, P < 0.0001), and have dermatitis in a scattered generalized distribution (23.8% vs 18.2%, P = 0.0072); they were also less likely to have hand involvement (16.6% vs 22.3%, P = 0.0064). The most common source of tocopherol was personal care products, especially moisturizers.

Positive patch test reactions to tocopherols were relatively rare given their widespread use. When positive, current clinical relevance was high. Tocopherol-positive patients were more likely to be female and presented with dermatitis on the face or in a scattered generalized pattern.

Positive patch test reactions to tocopherols were relatively rare given their widespread use. When positive, current clinical relevance was high. Tocopherol-positive patients were more likely to be female and presented with dermatitis on the face or in a scattered generalized pattern.

To estimate risks of myocardial infarction, ischemic stroke, and cardiovascular-related and all-cause mortality after Roux-en-Y gastric bypass (RYGB) for obesity compared with non-operated obese patients and matched non-obese population controls.

Few studies have assessed the influence of RYGB on fatal and non-fatal myocardial infarction and ischemic stroke, and the results vary between studies.

All patients aged 20-65 years with obesity diagnosis in the nationwide Swedish Patient Registry in 2001-2013 were included. These participants were divided into those who underwent RYGB within 2 years of obesity diagnosis (n=28,204) and non-operated (n=40,827), and were matched for age, sex, and region with two non-obese population controls. Participants were followed until onset of outcome disease, death, or end of follow-up. Multivariable Cox regression provided hazard ratios (HR) with 95% confidence intervals (95% CI).

Compared with non-operated patients with obesity, RYGB patients had a reduced risk of myocardial infarction (HR=0.44 [95% CI=0.28-0.63]), similar risk of ischemic stroke (HR=0.79 [95% CI=0.54-1.14]), and decreased risks of cardiovascular-related (HR=0.47 [95% CI=0.35-0.65]) and all-cause mortality (HR=0.66 [95% CI=0.54-0.81]) within the first 3 years of follow-up, but not later. Compared with non-obese population controls, RYGB patients had excess risks of ischemic stroke (HR=1.57 [95% CI=1.08-2.29]), cardiovascular-related mortality (HR=1.82 [95% CI=1.29-2.60]), and all-cause mortality (HR=1.42 [95% CI=1.16-1.74]), but not of myocardial infarction (HR=1.02 [95% CI=0.72-1.46]).

RYGB for obesity might not decrease the risk of ischemic stroke, but seems to decrease the risk of myocardial infarction back to population levels.

RYGB for obesity might not decrease the risk of ischemic stroke, but seems to decrease the risk of myocardial infarction back to population levels.

To develop an evidence-based framework for evaluation of therapeutic devices, based on ethical principles and clinical evidence considerations.

Nearly all medical products which do not work solely through chemical action are regulated as medical devices. Their huge range of purposes, mechanisms of action and risks pose challenges for regulation. High-profile implantable device failures have fuelled concerns about the level of clinical evidence needed for market approval. Calls for more rigorous evaluation lack clarity about what kind of evaluation is appropriate, and are commonly interpreted as meaning more randomized controlled trials (RCTs). These are valuable where devices are genuinely new and claim to offer measurable therapeutic benefits. Where this is not the case, RCTs may be inappropriate and wasteful.

Starting with a set of ethical principles and basic precepts of clinical epidemiology, we developed a sequential decision-making algorithm for identifying when an RCT should be performed to evaluate new therapeutic devices, and when other methods, such as observational study designs and registry-based approaches, are acceptable.

The algorithm clearly defines a group of devices where an RCT is deemed necessary, and the associated framework indicates that an IDEAL 2b study should be the default clinical evaluation method where it is not.

The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.

The algorithm and recommendations are based on the principles of the IDEAL-D framework for medical device evaluation and appear eminently practicable. Their use would create a safer system for monitoring innovation, and facilitate more rapid detection of potential hazards to patients and the public.