Archive for the ‘Journal of the American Medical Association’ Category

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.

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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

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.

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.

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).

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.

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

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.

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.

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.

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

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.

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.

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.

Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation

July 23, 2014 Comments off

Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation
Source: Journal of the American Medical Association

Our data demonstrate that uterine cancers occurred in 27 per 10 000 women undergoing morcellation. Other malignancies and precancerous abnormalities were also detected. Although morcellators have been in use since 1993, few studies have described the prevalence of unexpected pathology at the time of hysterectomy.2- 4 Prevalence information is the first step in determining the risk of spreading cancer with morcellation. Although data are limited, women with apparent uterine-confined neoplasms at the time of morcellation have been found to have intraperitoneal tumor dissemination at the time of reexploration.3,6

We recognize a number of limitations including the inability to verify pathological findings, possible misclassification of pathology, potential undercapture of morcellation, and the fact that our findings may not be generalizable to all hospitals. Last, we lack data on long-term follow-up, and the outcome of women with pathological abnormalities who underwent morcellation requires further study. Patients considering morcellation should be adequately counseled about the prevalence of cancerous and precancerous conditions prior to undergoing the procedure.

Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography

June 25, 2014 Comments off

Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography
Source: Journal of the American Medical Association

Mammography plays a key role in early breast cancer detection. Single-institution studies have shown that adding tomosynthesis to mammography increases cancer detection and reduces false-positive results.

To determine if mammography combined with tomosynthesis is associated with better performance of breast screening programs in the United States.

Design, Setting, and Participants
Retrospective analysis of screening performance metrics from 13 academic and nonacademic breast centers using mixed models adjusting for site as a random effect.

Exposures Period 1: digital mammography screening examinations 1 year before tomosynthesis implementation (start dates ranged from March 2010 to October 2011 through the date of tomosynthesis implementation); period 2: digital mammography plus tomosynthesis examinations from initiation of tomosynthesis screening (March 2011 to October 2012) through December 31, 2012.

Main Outcomes and Measures
Recall rate for additional imaging, cancer detection rate, and positive predictive values for recall and for biopsy.

A total of 454 850 examinations (n=281 187 digital mammography; n=173 663 digital mammography + tomosynthesis) were evaluated. With digital mammography, 29 726 patients were recalled and 5056 biopsies resulted in cancer diagnosis in 1207 patients (n=815 invasive; n=392 in situ). With digital mammography + tomosynthesis, 15 541 patients were recalled and 3285 biopsies resulted in cancer diagnosis in 950 patients (n=707 invasive; n=243 in situ). Model-adjusted rates per 1000 screens were as follows: for recall rate, 107 (95% CI, 89-124) with digital mammography vs 91 (95% CI, 73-108) with digital mammography + tomosynthesis; difference, –16 (95% CI, –18 to –14; P < .001); for biopsies, 18.1 (95% CI, 15.4-20.8) with digital mammography vs 19.3 (95% CI, 16.6-22.1) with digital mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001).

Conclusions and Relevance
Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes.

Physicians, Medical Ethics, and Execution by Lethal Injection

May 21, 2014 Comments off

Physicians, Medical Ethics, and Execution by Lethal Injection
Source: Journal of the American Medical Association

In an opinion dissenting from a Supreme Court decision to deny review in a death penalty case, Supreme Court Justice Harry Blackmun famously wrote, “From this day forward, I no longer shall tinker with the machinery of death.” In the wake of the recent botched execution by lethal injection in Oklahoma, however, a group of eminent legal professionals known as the Death Penalty Committee of The Constitution Project has published a sweeping set of 39 recommendations that not only tinker with, but hope to fix, the multitude of problems that affect this method of capital punishment.

Many of the recommendations this committee makes with regard to legal and administrative reforms appear worthwhile and reasonable. Their final recommendation, however, concerns the role of the medical profession in performing lethal injection. It states: “Jurisdictions should ensure that qualified medical personnel are present at executions and responsible for all medically-related elements of executions.”

In particular, the recommendation specifies that “Execution team members…are licensed, practicing doctors, nurses or emergency medical technicians who are responsible for performing functions in their day-to-day practice that are similar to those they will perform at the execution.” Regardless of this committee’s recommendations, physician participation in capital punishment is an ethical dilemma that the profession of medicine must address.


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