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In this study, Moore and colleagues estimated the costs of pivotal clinical trials for all new therapeutic agents approved by the US Food and Drug Administration from 2015 to 2016 and examined how key features of the pivotal trials were associated with these costs. A total of 138 pivotal clinical trials provided the basis for approval of 59 new therapeutic agents, with a median estimated cost of $19 million. Results showed pivotal clinical trial costs increased if more patients were needed to document treatment benefit, if active drug comparators were used, or to measure clinical end points rather than a change in a surrogate outcome. Ross provides the Editor’s Note.
Editor’s Note and Related Article
Mishra and colleagues performed this 12-month crossover study to evaluate whether the use of medical scribes in primary care improved physician productivity and patient satisfaction. Use of medical scribes, paraprofessionals who transcribe clinical visit information into electronic health records in real time under physician supervision, has been proposed as a strategy to alleviate documentation burden and improve physician efficiency. Through surveys, physicians reported that medical scribes were associated with decreased documentation burden and improved work efficiency, and patients reported that scribes had positive consequences on office visits. Bates and Landman provide the Invited Commentary.
Continuing Medical Education
In this double-blind, randomized clinical trial, Urquhart and colleagues examined the efficacy of low-dose amitriptyline vs an active comparator in reducing pain, disability, and work absence and hindrance in 146 participants with chronic low back pain. The primary outcome was pain intensity measured at 3 and 6 months using the visual analog scale and Descriptor Differential Scale. Results demonstrated there were no significant improvements in outcomes at 6 months, but there was a reduction in disability at 3 months, an improvement in pain intensity that was nonsignificant at 6 months, and minimal adverse events reported with a low-dose, modest sample size and active comparator.
This retrospective observational study by Johnston and colleagues analyzed data from the Medicare Current Beneficiary Survey to determine if patient cognitive and functional status and local area health care supply and economic conditions were associated with Medicare total annual cost of care. The total annual cost of care was measured as the total annual reimbursed amount per patient for Medicare Part A and Part B services, in all categories. Results demonstrated that neuropsychological and functional impairment were common in Medicare beneficiaries and were associated with increased annual Medicare spending. Bynum and Lewis provide the Invited Commentary.
Invited Commentary and Related Article
Hooton and colleagues performed this randomized clinical trial to assess the efficacy of increased daily water intake vs usual fluid intake on the frequency of recurrent cystitis in premenopausal women who drank low volumes of total fluid daily. Participants were randomly assigned to drink, in addition to their usual fluid intake, 1.5 L of water daily (water group) or no additional fluids (control group) for 12 months. Results showed the mean number of cystitis episodes were lower in the water group compared with the control group and that increased water intake may be an effective strategy to prevent recurrent cystitis in premenopausal women at high risk for recurrence who drink low volumes of fluid daily. Grady provides the Editor’s Note.
This cohort study by Vargas-Santos and colleagues used data from the UK Health Improvement Network to examine the association of allopurinol use in patients with gout with the risk of developing chronic kidney disease stage 3 or higher. A group of 4760 initiators of allopurinol was compared with a group of 4760 noninitiators of allopurinol, excluding those with chronic kidney disease stage 3 or higher or urate-lowering therapy use before their gout diagnosis. Results demonstrated that use of allopurinol of at least 300 mg/d was associated with lower risk of developing chronic kidney disease stage 3 or higher compared with nonusers and that allopurinol initiation at less than 300 mg/d was not associated with renal function decline. Zipurksy and Juurlink provide the Invited Commentary.
Roberts and colleagues analyzed Medicare claims and US Census data in this observational study that evaluated differences in hospital readmission rates associated with measurable patient characteristics not used by Medicare to adjust for risk of readmissions in pay-for-performance programs. Characteristics not used by Medicare but used in this study included clinical factors, such as disability, and social factors, such as poverty. Adjusting for these additional characteristics reduced overall hospital variation in readmission rates, narrowed differences in rates between hospitals serving higher vs lower proportions of high-risk Medicare patients, and reduced expected penalties among the 10% of hospitals with the largest penalty reductions. Bynum and Lewis provide the Invited Commentary.
This Special Communication by Gianfrancesco and colleagues explored potential biases in machine learning–based clinical decision support tools that use electronic health record data. Biases include those related to missing data and patients not identified by algorithms, sample size and underestimation, and misclassification and measurement error. Biases and deficiencies in the data used by machine learning algorithms may contribute to socioeconomic disparities in health care. As solutions to these biases, the authors recommended conducting follow-up studies to ensure results are meaningful, testing algorithms in socioeconomically diverse health care systems, and developing feedback loops to verify output.
Highlights. JAMA Intern Med. 2018;178(11):1437–1439. doi:10.1001/jamainternmed.2017.5239
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