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Sharing and Reporting the Results of Clinical Trials

December 3, 2014 Comments off

Sharing and Reporting the Results of Clinical Trials
Source: Journal of the American Medical Association

The principle of data sharing dates to the dawn of scientific discovery—it is how researchers from different disciplines and countries form collaborations, learn from others, identify new scientific opportunities, and work to turn newly discovered information into shared knowledge and practical advances. When research involves human volunteers who agree to participate in clinical trials to test new drugs, devices, or other interventions, this principle of data sharing properly assumes the role of an ethical mandate. These participants are often informed that such research might not benefit them directly, but may affect the lives of others. If the clinical research community fails to share what is learned, allowing data to remain unpublished or unreported, researchers are reneging on the promise to clinical trial participants, are wasting time and resources, and are jeopardizing public trust.

Designing Smarter Pay-for-Performance Programs

November 14, 2014 Comments off

Designing Smarter Pay-for-Performance Programs
Source: Journal of the American Medical Association

Over the past decade, public and private payers have experimented with the use of financial incentives to motivate physicians to achieve quality and efficiency. The idea behind pay for performance is simple. Because individuals and organizations respond to incentives, physicians whose patients achieve desirable outcomes should be paid more as an incentive to improve their performance. Yet the results of pay-for-performance programs have been largely disappointing. One argument is that neither the right set of incentives nor the right set of metrics has been identified. Another explanation, which has received far less attention, is that the right set of patients has not been identified for targeted efforts.

Association Between Hospital Conversions to For-Profit Status and Clinical and Economic Outcomes

October 28, 2014 Comments off

Association Between Hospital Conversions to For-Profit Status and Clinical and Economic Outcomes
Source: Journal of the American Medical Association

Importance
An increasing number of hospitals have converted to for-profit status, prompting concerns that these hospitals will focus on payer mix and profits, avoiding disadvantaged patients and paying less attention to quality of care.

Objective
To examine characteristics of US acute care hospitals associated with conversion to for-profit status and changes following conversion.

Design, Setting, and Participants Retrospective cohort study conducted among 237 converting hospitals and 631 matched control hospitals. Participants were 1 843 764 Medicare fee-for-service beneficiaries at converting hospitals and 4 828 138 at control hospitals.

Exposures Conversion to for-profit status, 2003-2010.

Main Outcomes and Measures
Financial performance measures, quality process measures, mortality rates, Medicare volume, and patient population for the 2 years prior and the 2 years after conversion, excluding the conversion year, assessed using difference-in-difference models.

Results
Hospitals that converted to for-profit status were more often small or medium in size, located in the south, in an urban or suburban location, and were less often teaching institutions. Converting hospitals improved their total margins (ratio of net income to net revenue plus other income) more than controls (2.2% vs 0.4% improvement; difference in differences, 1.8% [ 95% CI, 0.5% to 3.1%]; P = .007). Converting hospitals and controls both improved their process quality metrics (6.0% vs 5.6%; difference in differences, 0.4% [95% CI, −1.1% to 2.0%]; P = .59). Mortality rates did not change at converting hospitals relative to controls for Medicare patients overall (increase of 0.1% vs 0.2%; difference in differences, −0.2% [95% CI, −0.5% to 0.2%], P = .42) or for dual-eligible or disabled patients. There was no change in converting hospitals relative to controls in annual Medicare volume (−111 vs −74 patients; difference in differences, −37 [95% CI, −224 to 150]; P = .70), Disproportionate Share Hospital Index (1.7% vs 0.4%; difference in differences, 1.3% [95% CI, −0.9% to 3.4%], P = .26), the proportion of patients with Medicaid (−0.2% vs 0.4%; difference in differences, −0.6% [95% CI, −2.0% to 0.8%]; P = .38) or the proportion of patients who were black (−0.4% vs −0.1%; difference in differences, −0.3% [95% CI, −1.9% to 1.3%]; P = .72) or Hispanic (0.1% vs −0.1%; difference in differences, 0.2% [95% CI, −0.3% to 0.7%]; P = .50).

Conclusions and Relevance
Hospital conversion to for-profit status was associated with improvements in financial margins but not associated with differences in quality or mortality rates or with the proportion of poor or minority patients receiving care.

Critiquing US Health Care

October 17, 2014 Comments off

Critiquing US Health Care
Source: Journal of the American Medical Association

Critics of US health care usually begin by noting that this country spends a much greater share of its gross domestic product (GDP) on health care than any other country but lags in life expectancy at birth. This critique implicitly (and sometimes explicitly) assumes that there should be a positive correlation between health care expenditures and life expectancy. Such an assumption is fully justified for low-income countries with minimal health care; additional care and financial resources usually have substantial favorable effects on life expectancy.

In theory, this positive relationship should continue at all levels of income, albeit with possible diminishing returns. In practice, however, many nonmedical determinants of health can vary across developed countries, possibly confounding a simple 1-to-1 relationship between health care expenditures and life expectancy. As an empirical matter, the assumption of a positive correlation is not supported by comparisons across developed countries or within the United States across states.

Effect of Enhanced Information, Values Clarification, and Removal of Financial Barriers on Use of Prenatal Genetic Testing: A Randomized Clinical Trial

October 1, 2014 Comments off

Effect of Enhanced Information, Values Clarification, and Removal of Financial Barriers on Use of Prenatal Genetic Testing: A Randomized Clinical Trial
Source: Journal of the American Medical Association

Importance
Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood.

Objective
To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels.

Design,
Setting, and Participants Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks’ gestation (n = 710).

Interventions
A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353).

Main Outcomes and Measures
The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks’ gestation.

Results
Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret.

Conclusions and Relevance
Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing.

Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

September 30, 2014 Comments off

Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices
Source: Journal of the American Medical Association

Importance
Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is “substantially equivalent” to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence.

Objective
To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available.

Design
Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices.

Main Outcomes and Measures
For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided.

Results
Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness.

Conclusions and Relevance
Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.

Climate Change: Challenges and Opportunities for Global Health

September 30, 2014 Comments off

Climate Change: Challenges and Opportunities for Global Health
Source: Journal of the American Medical Association

Importance
Health is inextricably linked to climate change. It is important for clinicians to understand this relationship in order to discuss associated health risks with their patients and to inform public policy.

Objectives
To provide new US-based temperature projections from downscaled climate modeling and to review recent studies on health risks related to climate change and the cobenefits of efforts to mitigate greenhouse gas emissions.

Data Sources, Study Selection, and Data Synthesis
We searched PubMed from 2009 to 2014 for articles related to climate change and health, focused on governmental reports, predictive models, and empirical epidemiological studies. Of the more than 250 abstracts reviewed, 56 articles were selected. In addition, we analyzed climate data averaged over 13 climate models and based future projections on downscaled probability distributions of the daily maximum temperature for 2046-2065. We also compared maximum daily 8-hour average with air temperature data taken from the National Oceanic and Atmospheric Administration National Climate Data Center.

Results
By 2050, many US cities may experience more frequent extreme heat days. For example, New York and Milwaukee may have 3 times their current average number of days hotter than 32°C (90°F). The adverse health aspects related to climate change may include heat-related disorders, such as heat stress and economic consequences of reduced work capacity; and respiratory disorders, including those exacerbated by fine particulate pollutants, such as asthma and allergic disorders; infectious diseases, including vectorborne diseases and water-borne diseases, such as childhood gastrointestinal diseases; food insecurity, including reduced crop yields and an increase in plant diseases; and mental health disorders, such as posttraumatic stress disorder and depression, that are associated with natural disasters. Substantial health and economic cobenefits could be associated with reductions in fossil fuel combustion. For example, the cost of greenhouse gas emission policies may yield net economic benefit, with health benefits from air quality improvements potentially offsetting the cost of US carbon policies.

Conclusions and Relevance
Evidence over the past 20 years indicates that climate change can be associated with adverse health outcomes. Health care professionals have an important role in understanding and communicating the related potential health concerns and the cobenefits from reducing greenhouse gas emissions.

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