BMJ : British medical journal
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To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs' originally approved indications. ⋯ Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population.
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The high prevalence of cigarette smoking and tobacco related morbidity and mortality in people with chronic mental illness is well documented. This review summarizes results from studies of smoking cessation treatments in people with schizophrenia, depression, anxiety disorders, and post-traumatic stress disorder. It also summarizes experimental studies aimed at identifying biopsychosocial mechanisms that underlie the high smoking rates seen in people with these disorders. ⋯ Similar biopsychosocial mechanisms are thought to be involved in the initiation and persistence of smoking in patients with different disorders. An appreciation of these common factors may aid the development of novel tobacco treatments for people with chronic mental illness. Novel nicotine and tobacco products such as electronic cigarettes and very low nicotine content cigarettes may also be used to improve smoking cessation rates in people with chronic mental illness.
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To validate all diagnostic prediction models for ruling out pulmonary embolism that are easily applicable in primary care. ⋯ Five diagnostic pulmonary embolism prediction models that are easily applicable in primary care were validated in this setting. Whereas efficiency was comparable for all rules, the Wells rules gave the best performance in terms of lower failure rates.
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Osteoporosis is a systemic skeletal disorder characterized by bone loss, which leads to impaired bone strength and an increased risk of fractures. Two million fractures are attributed to osteoporosis annually in the United States and they are associated with serious morbidity and mortality. Bisphosphonates reduce the risk of fracture by suppressing bone resorption and increasing bone strength, and they have been widely used for the prevention and treatment of osteoporosis. ⋯ There are several important considerations including appropriate patient selection, pretreatment evaluation, potential adverse effects, patient preferences, and adherence. This review will discuss the evidence informing the clinical strategy for using bisphosphonates in patients with osteoporosis and those at high risk of fracture, focusing on the benefits and risks of treatment. We will also consider issues related to the monitoring and duration of treatment.