JAMA internal medicine
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JAMA internal medicine · Nov 2015
Randomized Controlled TrialA Randomized Trial Testing US Food and Drug Administration "Breakthrough" Language.
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JAMA internal medicine · Nov 2015
Randomized Controlled Trial Multicenter StudyMediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.
Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. ⋯ This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies.
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JAMA internal medicine · Nov 2015
Randomized Controlled TrialShared Decision Making for Antidepressants in Primary Care: A Cluster Randomized Trial.
For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. ⋯ The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression.
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JAMA internal medicine · Nov 2015
Randomized Controlled TrialCognitive Behavior Therapy for Depression and Self-Care in Heart Failure Patients: A Randomized Clinical Trial.
Depression and inadequate self-care are common and interrelated problems that increase the risks of hospitalization and mortality in patients with heart failure (HF). ⋯ A CBT intervention that targets both depression and heart failure self-care is effective for depression but not for HF self-care or physical functioning relative to enhanced UC. Additional benefits include reduced anxiety and fatigue, improved social functioning, and better health-related quality of life.
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JAMA internal medicine · Oct 2015
Randomized Controlled TrialTreatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial.
Experts debate optimal 25-hydroxyvitamin D (25[OH]D) levels for musculoskeletal health. ⋯ High-dose cholecalciferol therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass, or falls. We found no data to support experts' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women. Instead, we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL.