“Explanatory trials evaluating the efficacy and safety of adding a new drug or device to current clinical care (A vs A-plus) are traditionally powered to detect the smallest difference in clinical outcomes that would justify incorporating the new treatment into care, considering its added risks, costs, and burdens. For example, the median minimal clinically important difference in mortality targeted by acute care trials has been approximately 8%, implying that smaller differences in mortality might not justify incorporation of the new treatments into care. These types of trials ask, “is this new treatment better than current care by enough to offset … Read More
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“The insurance companies [Cigna and Kaiser Permanente] provided Ginger with access to millions of potential users. After its financial investments in Ginger, Cigna began offering no-cost access to Ginger’s behavioral health services in order to improve customers’ overall health and well-being, according to leadership from both organizations. Yes, it is possible that those customers will benefit from the platform. But given that Ginger’s valuation grew in multiples around the same time—at least in part because of the massive influx of customers from Cigna and Kaiser—it’s reasonable to suggest that the insurance company was double dipping. By sending its customers to … Read More
“Hypertension affects 46% of the adult population in the United States and is a leading risk factor for disability, cardiovascular morbidity, and mortality. Although treatment reduces morbidity and mortality, approximately 17% to 20% of patients using antihypertensive medications have apparent treatment-resistant hypertension, defined as inadequately controlled blood pressure (BP) with 3 antihypertensive medications, including a diuretic, or a requirement for at least 4 antihypertensive medications to achieve adequate control. Compared with patients who require fewer antihypertensive agents, those with apparent treatment-resistant hypertension are at increased risk for cardiovascular and all-cause mortality, independent of BP control. High-quality evidence supports the use … Read More
“The standard curative treatment for sickle cell disease is allogeneic hematopoietic stem-cell transplantation. Matched sibling donor transplantation is curative in more than 90% of patients, but limitations include a higher risk of complications in older patients, a risk of severe graft-versus-host disease (GVHD), and lack of an available matched sibling in approximately 80% of cases. [..] In utero and during infancy, the abnormal HbS protein is produced at very low levels because the erythrocytes have not yet shifted from expression of the γ-globin gene (HBG), which encodes the developmentally regulated component of HbF, to expression of the HBB gene, a … Read More
“While the aducanumab clinical trial data are complicated and the path to approval far from clear, approval is certainly possible, and other promising antibodies (such as Biogen’s BAN-2401 and Genentech’s gantenerumab) are just steps behind. Thus, the long-awaited advent of disease-modifying therapy for AD [Alzheimer disease] may be soon upon us, representing a major advance in the battle against AD and a beacon of much-needed hope for patients. [..] The approval of aducanumab or any disease-modifying therapy for AD likely will result in a considerable immediate demand for capacity to provide formal diagnoses of AD dementia, including cognitive and AD … Read More
“[Methods] we searched MEDLINE and Embase for articles published between March 1, 2015, and Aug 14, 2020, without any language restrictions. We included randomised controlled trials of cardiovascular outcomes of an LDL cholesterol-lowering drug recommended by the 2018 American College of Cardiology and American Heart Association guidelines, with a median follow-up of at least 2 years and data on older patients (aged ≥75 years). [..] [Findings] Data from six articles were included in the systematic review and meta-analysis, which included 24 trials from the Cholesterol Treatment Trialists’ Collaboration meta-analysis plus five individual trials. Among 244,090 patients from 29 trials, 21,492 … Read More
“We assessed the clinical effectiveness and cost-effectiveness of a brief falls-risk screening questionnaire, sent by mail, followed by an exercise program or a multifactorial intervention targeted to persons at increased risk for falls, as compared with no screening in community-dwelling older people. All participants received advice by mail. [Methods] [..] This was a three-group, pragmatic, cluster-randomized, controlled trial with parallel economic evaluation that included 63 general practices in seven rural and urban regions in England. Drawing from their patient registries, general practices contacted community-dwelling persons 70 years of age or older who were living in their own homes. Residents of … Read More
“The World Health Organization (WHO) updated its evidence-based guideline on chronic HCV infection in July 2018. [..] We discuss implications of the WHO recommendations for clinicians and patients in the United States. The WHO recommends offering treatment to all persons older than 12 years who have chronic HCV infection, and it notes 3 major considerations for this “treat all” strategy: the effectiveness and safety of direct-acting antiviral agents (DAAs), the emergence of pangenotypic drug regimens, and reduction in the cost of treatment. In current treatment regimens, combination therapy with oral DAAs has replaced interferon and ribavirin. The WHO recommends pangenotypic … Read More
“Numerous studies have shown that rehabilitation is associated with improved post-TKA [total knee arthroplasty] outcomes, whether comparing rehabilitation received at different settings or examining different physical therapy (PT) protocols. This typically requires active patient engagement by incorporating weight bearing exercise, active range of motion, and gait training. However, patients’ fear of falling and postsurgical pain accompanying weight bearing and range of motion exercises often limit patient’s ability to fully participate in PT and thus prolong a patient’s recovery. [..] This randomized clinical trial used a Food and Drug Administration–cleared treadmill using patented National Aeronautics and Space Administration technology to unload … Read More
“It is unclear whether adjuvant or early salvage radiotherapy following radical prostatectomy is more appropriate for men who present with localised or locally advanced prostate cancer. We aimed to prospectively plan a systematic review of randomised controlled trials (RCTs) comparing these radiotherapy approaches. [..] We identified three eligible trials and were able to obtain updated results for event-free survival for 2153 patients recruited between November, 2007, and December, 2016. Median follow-up ranged from 60 months to 78 months, with a maximum follow-up of 132 months. 1075 patients were randomly assigned to receive adjuvant radiotherapy and 1078 to a policy of … Read More