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

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.

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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.

Ethics and Regulatory Complexities for Pragmatic Clinical Trials

May 15, 2014 Comments off

Ethics and Regulatory Complexities for Pragmatic Clinical Trials
Source: Journal of the American Medical Association

Some patients do not receive the best care possible, either because research to support clinical decision making with high-quality evidence is lacking or because evidence-based practices are not routinely implemented. Pragmatic clinical trials (PCTs), which include patients in routine clinical practice settings and typically incorporate comparative effectiveness research (CER)—that is, comparing the safety and effectiveness of diagnostic, therapeutic, or delivery system options—can help overcome these challenges. The advent of research methods that use cluster randomization and leverage patient data from electronic health records (EHRs) to increase the sample size of trials at much lower costs is enabling major national initiatives to generate the data needed to improve care. These include the Health Care Systems Research Collaboratory and the Patient-Centered Outcomes Research Network (PCORnet).

As evidenced by recent controversy, research that evaluates elements of usual medical practice may encounter ethical and regulatory challenges. But unless significant progress is made toward efficient functional approaches to these issues, the evidence gap for clinical practice will remain. Based on our experiences with the NIH Collaboratory and PCORnet, we describe 10 complexities that must be unraveled in ways that enable vital research while also protecting the rights, interests, and welfare of research participants.

Clinical Informatics — Prospects for a New Medical Subspecialty

May 14, 2014 Comments off

Clinical Informatics — Prospects for a New Medical Subspecialty
Source: Journal of the American Medical Association

Only a few years ago, the mention of informatics in clinical circles generated questions regarding the rigor or relevance of the field. With the expanding interest and investment in health information technology by hospitals, health systems, and practitioners, however, interest in and acceptance of clinical informatics has increased substantially. Since 1972, the National Institutes of Health, principally through the National Library of Medicine (NLM), has supported a number of centers of excellence that focus on workforce education in computer applications and the underlying science. Additional efforts to help ensure a supply of competently trained individuals capable of maintaining progress with respect to applied clinical informatics are a recent development.

Among the current challenges for clinical informatics is the relative lack of understanding throughout the medical profession about the distinction between informatics and information technology. Biomedical informatics is a scientific discipline focused on the effective use of knowledge and information in patient care, public health, and biomedicine. Its patient care and health foci are termed clinical informatics or health informatics, whereas other applied components include those in molecular biology (bioinformatics) and imaging (imaging informatics). Clinical informatics is not simply “computers in medicine” but rather is a body of knowledge, methods, and theories that focus on the effective use of information and knowledge to improve the quality, safety, and cost-effectiveness of patient care as well as the health of both individuals and populations.

The clinical goals of informatics encompass numerous applications and considerations that generally involve information technology, including the use of modern communications methods. Over the past half century, with increasing capabilities such as integrated decision support, management of human genomics with prospects for personalized medicine, and biosurveillance in support of public health, electronic health records have served as the central focus for the learning health care system that integrates care experiences and preventive services with analytical tools that allow better learning from the huge amount of information that is generated every day in health care environments.

Web-Based Alcohol Screening and Brief Intervention for University Students: A Randomized Trial

March 27, 2014 Comments off

Web-Based Alcohol Screening and Brief Intervention for University Students: A Randomized Trial
Source: Journal of the American Medical Association

Unhealthy alcohol use is a leading contributor to the global burden of disease, particularly among young people. Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered.

To evaluate a national web-based alcohol screening and brief intervention program.

Design, Setting, and Participants
A multisite, double-blind, parallel-group, individually randomized trial was conducted at 7 New Zealand universities. In April and May of 2010, invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening test were e-mailed to 14 991 students aged 17 to 24 years.

Participants who screened positive (AUDIT-C score ≥4) were randomized to undergo screening alone or to 10 minutes of assessment and feedback (including comparisons with medical guidelines and peer norms) on alcohol expenditure, peak blood alcohol concentration, alcohol dependence, and access to help and information.

Main Outcomes and Measures
A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes: consumption per typical occasion, drinking frequency, volume of alcohol consumed, an academic problems score, and whether participants exceeded medical guidelines for acute harm (binge drinking) and chronic harm (heavy drinking). A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias.

Of 5135 students screened, 3422 scored 4 or greater and were randomized, and 83% were followed up. There was a significant effect on 1 of the 6 prespecified outcomes. Relative to control participants, those who received intervention consumed less alcohol per typical drinking occasion (median 4 drinks [interquartile range {IQR}, 2-8] vs 5 drinks [IQR 2-8]; rate ratio [RR], 0.93 [99.17% CI, 0.86-1.00]; P = .005) but not less often (RR, 0.95 [99.17% CI, 0.88-1.03]; P = .08) or less overall (RR, 0.95 [99.17% CI, 0.81-1.10]; P = .33). Academic problem scores were not lower (RR, 0.91 [99.17% CI, 0.76-1.08]; P = .14) and effects on the risks of binge drinking (odds ratio [OR], 0.84 [99.17% CI, 0.67-1.05]; P = .04) and heavy drinking (OR, 0.77 [99.17% CI, 0.56-1.05]; P = .03) were not significantly significant. In a sensitivity analysis accounting for attrition, the effect on alcohol per typical drinking occasion was no longer statistically significant.

Conclusions and Relevance
A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems. There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion.

Approaches and Costs for Sharing Clinical Research Data

February 27, 2014 Comments off

Approaches and Costs for Sharing Clinical Research Data
Source: Journal of the American Medical Association

The generation, dissemination, and sharing of research data are key ingredients in contributing to scientific progress and the public good. Data sharing has been encouraged to facilitate open science within the clinical research enterprise, improve the development of drugs and devices, and benefit public health. But sharing data is complex. Investigators generally tend to guard research data to retain ownership and property rights, avoid competition, protect confidentiality and privacy, or avoid misuse by unqualified persons. Sharing research data also comes at a cost to the sharer. This Viewpoint examines some approaches and cost considerations involved in sharing participant-level clinical research data.

Ending Sales of Tobacco Products in Pharmacies

February 5, 2014 Comments off

Ending Sales of Tobacco Products in Pharmacies
Source: Journal of the American Medical Association

The new emphasis on restricting availability and reinforcing the social unacceptability of smoking casts a harsh light on pharmacies’ sale of cigarettes and other tobacco products. Advocates have long questioned the juxtaposition of the distribution of medications for promoting health with the sale of the single most deadly consumer product.5 Making cigarettes available in pharmacies in essence “renormalizes” the product by sending the subtle message that it cannot be all that unhealthy if it is available for purchase where medicines are sold. The argument that pharmacies also sell tobacco-cessation products only heightens the paradox. This is primarily a US problem: pharmacies in other developed countries do not sell cigarettes.

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

January 23, 2014 Comments off

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Source: Journal of the American Medical Association

Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the US Food and Drug Administration (FDA) has not been evaluated.

To characterize pivotal efficacy trials (clinical trials that serve as the basis of FDA approval) for newly approved novel therapeutic agents.

Design and Setting
Cross-sectional analysis using publicly available FDA documents for all novel therapeutic agents approved between 2005 and 2012.

Main Outcomes and Measures Pivotal efficacy trials were classified according to the following design features: randomization, blinding, comparator, and trial end point. Surrogate outcomes were defined as any end point using a biomarker expected to predict clinical benefit. The number of patients, trial duration, and trial completion rates were also determined.

Between 2005 and 2012, the FDA approved 188 novel therapeutic agents for 206 indications on the basis of 448 pivotal efficacy trials. The median number of pivotal trials per indication was 2 (interquartile range, 1-2.5), although 74 indications (36.8%) were approved on the basis of a single pivotal trial. Nearly all trials were randomized (89.3% [95% CI, 86.4%-92.2%]), double-blinded (79.5% [95% CI, 75.7%-83.2%]), and used either an active or placebo comparator (87.1% [95% CI, 83.9%-90.2%]). The median number of patients enrolled per indication among all pivotal trials was 760 (interquartile range, 270-1550). At least 1 pivotal trial with a duration of 6 months or greater supported the approval of 68 indications (33.8% [95% CI, 27.2%-40.4%]). Pivotal trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 91 indications (45.3% [95% CI, 38.3%-52.2%]), clinical outcomes for 67 (33.3% [95% CI, 26.8%-39.9%]), and clinical scales for 36 (17.9% [95% CI, 12.6%-23.3%]). Trial features differed by therapeutic and indication characteristics, such as therapeutic area, expected length of treatment, orphan status, and accelerated approval.

Conclusions and Relevance
The quality of clinical trial evidence used by the FDA as the basis for recent approvals of novel therapeutic agents varied widely across indications. This variation has important implications for patients and physicians as they make decisions about the use of newly approved therapeutic agents.

ICU Bed Supply, Utilization, and Health Care Spending: An Example of Demand Elasticity

January 10, 2014 Comments off

ICU Bed Supply, Utilization, and Health Care Spending: An Example of Demand Elasticity
Source: Journal of the American Medical Association

Intensive care is a substantial financial burden on the US health care system, with spending on critical illness exceeding $80 billion per year, approximately 3% of all health care spending and nearly 1% of the gross domestic product. In contrast, the United Kingdom spends only 0.1% of its gross domestic product on critical care services, with no evidence of worse patient outcomes and similar life expectancies as in the United States. Although there are many differences between these 2 countries, one significant difference is intensive care unit (ICU) bed supply. The United States has 25 ICU beds per 100 000 people, as compared with 5 per 100 000 in the United Kingdom. As a result, ICU case-mix differs substantially. In the United Kingdom, the majority of ICU patients are at high risk for death, whereas in the United States, many patients are admitted to the ICU for observation.4 At the same time, compared with patients in the United Kingdom, substantially more patients in the United States die in the ICU, suggesting that increased bed availability appears to reduce the incentive to keep dying patients out of the ICU.

The apparent influence of ICU bed supply on ICU bed utilization brings forward the concern of demand elasticity in the ICU, the notion that ICU beds create their own demand. In classical economics, demand elasticity measures how much the demand for a good or service changes in response to changes in another related factor. Demand elasticity is usually considered in terms of price; as price decreases, demand increases. However, it also is relevant to think of demand elasticity in terms of the supply of the good or service. Just as the creation of a new lane on the interstate highway can lead to increased traffic as new drivers seize the opportunity to travel on the larger road, new critical care beds can lead to increased use. As supply constraints are removed, clinicians are more likely to use the service, even for patients unlikely to benefit.

2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults

December 19, 2013 Comments off

2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults
Source: Journal of the American Medical Association

Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately. Patients want to be assured that blood pressure (BP) treatment will reduce their disease burden, while clinicians want guidance on hypertension management using the best scientific evidence. This report takes a rigorous, evidence-based approach to recommend treatment thresholds, goals, and medications in the management of hypertension in adults. Evidence was drawn from randomized controlled trials, which represent the gold standard for determining efficacy and effectiveness. Evidence quality and recommendations were graded based on their effect on important outcomes.

There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg; however, there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal, or in those younger than 30 years for a diastolic goal, so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion. The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease (CKD) as for the general hypertensive population younger than 60 years. There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide-type diuretic in the nonblack hypertensive population, including those with diabetes. In the black hypertensive population, including those with diabetes, a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy. There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes.

Although this guideline provides evidence-based recommendations for the management of high BP and should meet the clinical needs of most patients, these recommendations are not a substitute for clinical judgment, and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient.

Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials

October 4, 2013 Comments off

<strong>Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized Trials
Source: Journal of the American Medical Association

Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention.

To report a comprehensive, integrated overview of findings from the 2 Women’s Health Initiative (WHI) hormone therapy trials with extended postintervention follow-up.

Setting, and Participants A total of 27 347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers.

Women with an intact uterus received conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 8506) or placebo (n = 8102). Women with prior hysterectomy received CEE alone (0.625 mg/d) (n = 5310) or placebo (n = 5429). The intervention lasted a median of 5.6 years in CEE plus MPA trial and 7.2 years in CEE alone trial with 13 years of cumulative follow-up until September 30, 2010.

Main Outcomes and Measures
Primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively. A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and death.

During the CEE plus MPA intervention phase, the numbers of CHD cases were 196 for CEE plus MPA vs 159 for placebo (hazard ratio [HR], 1.18; 95% CI, 0.95-1.45) and 206 vs 155, respectively, for invasive breast cancer (HR, 1.24; 95% CI, 1.01-1.53). Other risks included increased stroke, pulmonary embolism, dementia (in women aged ≥65 years), gallbladder disease, and urinary incontinence; benefits included decreased hip fractures, diabetes, and vasomotor symptoms. Most risks and benefits dissipated postintervention, although some elevation in breast cancer risk persisted during cumulative follow-up (434 cases for CEE plus MPA vs 323 for placebo; HR, 1.28 [95% CI, 1.11-1.48]). The risks and benefits were more balanced during the CEE alone intervention with 204 CHD cases for CEE alone vs 222 cases for placebo (HR, 0.94; 95% CI, 0.78-1.14) and 104 vs 135, respectively, for invasive breast cancer (HR, 0.79; 95% CI, 0.61-1.02); cumulatively, there were 168 vs 216, respectively, cases of breast cancer diagnosed (HR, 0.79; 95% CI, 0.65-0.97). Results for other outcomes were similar to CEE plus MPA. Neither regimen affected all-cause mortality. For CEE alone, younger women (aged 50-59 years) had more favorable results for all-cause mortality, myocardial infarction, and the global index (nominal P < .05 for trend by age). Absolute risks of adverse events (measured by the global index) per 10 000 women annually taking CEE plus MPA ranged from 12 excess cases for ages of 50-59 years to 38 for ages of 70-79 years; for women taking CEE alone, from 19 fewer cases for ages of 50-59 years to 51 excess cases for ages of 70-79 years. Quality-of-life outcomes had mixed results in both trials.

Conclusions and Relevance
Menopausal hormone therapy has a complex pattern of risks and benefits. Findings from the intervention and extended postintervention follow-up of the 2 WHI hormone therapy trials do not support use of this therapy for chronic disease prevention, although it is appropriate for symptom management in some women.

Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance

August 13, 2013 Comments off

Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance
Source: Journal of the American Medical Association

Food and Drug Administration (FDA) guidance allows food manufacturers to determine whether additives to food are “generally recognized as safe” (GRAS). Manufacturers are not required to notify the FDA of a GRAS determination, although in some instances they notify the agency. The individuals that companies select to make these determinations may have financial conflicts of interest.

To determine the extent to which individuals selected by manufacturers to make GRAS determinations have conflicts of interest between their obligations to ensure that the use of the additive is safe and their financial relationships to the company.

Using conflict of interest criteria developed by a committee of the Institute of Medicine, we analyzed 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012.

Main Outcomes and Measures
Number of GRAS notices submitted to the FDA; frequency of various types of relationships between decision maker and additive manufacturer; frequency of participation on GRAS panels by individuals; and number of GRAS safety determinations identified by the FDA that were not submitted to the agency.

For the 451 GRAS notifications, 22.4% of the safety assessments were made by an employee of an additive manufacturer, 13.3% by an employee of a consulting firm selected by the manufacturer, and 64.3% by an expert panel selected by either a consulting firm or the manufacturer. A standing expert panel selected by a third party made none of these safety assessments. The 290 panels that made GRAS determinations had an average of 3.5 members, with a maximum of 7. Ten individuals served on 27 or more panels; 1 individual served on 128 panels (44.1%). At least 1 of the 10 individuals with the most frequent service was a member of 225 panels (77.6%).

Conclusions and Relevance
Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.

Related Commentary — Conflicts of Interest in the Regulation of Food Safety: A Threat to Scientific Integrity

Overdiagnosis and Overtreatment in Cancer: An Opportunity for Improvement

August 6, 2013 Comments off

Overdiagnosis and Overtreatment in Cancer: An Opportunity for Improvement
Source: Journal of the American Medical Association

Over the past 30 years, awareness and screening have led to an emphasis on early diagnosis of cancer. Although the goals of these efforts were to reduce the rate of late-stage disease and decrease cancer mortality, secular trends and clinical trials suggest that these goals have not been met; national data demonstrate significant increases in early-stage disease, without a proportional decline in later-stage disease. What has emerged has been an appreciation of the complexity of the pathologic condition called cancer. The word “cancer” often invokes the specter of an inexorably lethal process; however, cancers are heterogeneous and can follow multiple paths, not all of which progress to metastases and death, and include indolent disease that causes no harm during the patient’s lifetime. Better biology alone can explain better outcomes. Although this complexity complicates the goal of early diagnosis, its recognition provides an opportunity to adapt cancer screening with a focus on identifying and treating those conditions most likely associated with morbidity and mortality.

Changes in cancer incidence and mortality reveal patterns that emerged after inception of screening. Screening for breast cancer and prostate cancer appears to detect more cancers that are potentially clinically insignificant. Lung cancer may follow this pattern if high-risk screening is adopted. Barrett esophagus and ductal carcinoma of the breast are examples for which the detection and removal of lesions considered precancerous have not led to lower incidence of invasive cancer. In contrast, colon and cervical cancer are examples of effective screening programs in which early detection and removal of precancerous lesions have reduced incidence as well as late-stage disease. Thyroid cancers and melanoma are examples for which screening has expanded and, along with it, the detection of indolent disease.

Views of US Physicians About Controlling Health Care Costs

July 24, 2013 Comments off

Views of US Physicians About Controlling Health Care Costs
Source: Journal of the American Medical Association

Physicians’ views about health care costs are germane to pending policy reforms.

To assess physicians’ attitudes toward and perceived role in addressing health care costs.

Design, Setting, and Participants
A cross-sectional survey mailed in 2012 to 3897 US physicians randomly selected from the AMA Masterfile.

Main Outcomes and Measures
Enthusiasm for 17 cost-containment strategies and agreement with an 11-measure cost-consciousness scale.

A total of 2556 physicians responded (response rate = 65%). Most believed that trial lawyers (60%), health insurance companies (59%), hospitals and health systems (56%), pharmaceutical and device manufacturers (56%), and patients (52%) have a “major responsibility” for reducing health care costs, whereas only 36% reported that practicing physicians have “major responsibility.” Most were “very enthusiastic” for “promoting continuity of care” (75%), “expanding access to quality and safety data” (51%), and “limiting access to expensive treatments with little net benefit” (51%) as a means of reducing health care costs. Few expressed enthusiasm for “eliminating fee-for-service payment models” (7%). Most physicians reported being “aware of the costs of the tests/treatments [they] recommend” (76%), agreed they should adhere to clinical guidelines that discourage the use of marginally beneficial care (79%), and agreed that they “should be solely devoted to individual patients’ best interests, even if that is expensive” (78%) and that “doctors need to take a more prominent role in limiting use of unnecessary tests” (89%). Most (85%) disagreed that they “should sometimes deny beneficial but costly services to certain patients because resources should go to other patients that need them more.” In multivariable logistic regression models testing associations with enthusiasm for key cost-containment strategies, having a salary plus bonus or salary-only compensation type was independently associated with enthusiasm for “eliminating fee for service” (salary plus bonus: odds ratio [OR], 3.3, 99% CI, 1.8-6.1; salary only: OR, 4.3, 99% CI, 2.2-8.5). In multivariable linear regression models, group or government practice setting (β = 0.87, 95% CI, 0.29 to 1.45, P = .004; and β = 0.99, 95% CI, 0.20 to 1.79, P = .01, respectively) and having a salary plus bonus compensation type (β = 0.82; 95% CI, 0.32 to 1.33; P = .002) were positively associated with cost-consciousness. Finding the “uncertainty involved in patient care disconcerting” was negatively associated with cost-consciousness (β = −1.95; 95% CI, −2.71 to −1.18; P < .001).

Conclusion and Relevance
In this survey about health care cost containment, US physicians reported having some responsibility to address health care costs in their practice and expressed general agreement about several quality initiatives to reduce cost but reported less enthusiasm for cost containment involving changes in payment models.

The increasing cost of US health care strains the economy. Because physicians’ decisions play a key role in overall health care spending and quality, several recent initiatives have called on physicians to reduce waste and exercise wise stewardship of resources.1- 4 Given their roles, physicians’ perspectives on policies and strategies related to cost containment and their perceived responsibilities as stewards of health care resources in general are increasingly germane to recent pending and proposed policy reforms.5 We surveyed US physicians about their views on several potential proposed policies and strategies to contain health care spending, assessed physicians’ perceived roles and responsibilities in addressing health care costs, and ascertained physician characteristics associated with those views.

Association of All-Cause Mortality With Overweight and Obesity Using Standard Body Mass Index Categories: A Systematic Review and Meta-analysis

January 2, 2013 Comments off

Association of All-Cause Mortality With Overweight and Obesity Using Standard Body Mass Index Categories: A Systematic Review and Meta-analysis
Source: Journal of the American Medical Association

Estimates of the relative mortality risks associated with normal weight, overweight, and obesity may help to inform decision making in the clinical setting.

To perform a systematic review of reported hazard ratios (HRs) of all-cause mortality for overweight and obesity relative to normal weight in the general population.

Data Sources
PubMed and EMBASE electronic databases were searched through September 30, 2012, without language restrictions.

Study Selection
Articles that reported HRs for all-cause mortality using standard body mass index (BMI) categories from prospective studies of general populations of adults were selected by consensus among multiple reviewers. Studies were excluded that used nonstandard categories or that were limited to adolescents or to those with specific medical conditions or to those undergoing specific procedures. PubMed searches yielded 7034 articles, of which 141 (2.0%) were eligible. An EMBASE search yielded 2 additional articles. After eliminating overlap, 97 studies were retained for analysis, providing a combined sample size of more than 2.88 million individuals and more than 270 000 deaths.

Data Extraction
Data were extracted by 1 reviewer and then reviewed by 3 independent reviewers. We selected the most complex model available for the full sample and used a variety of sensitivity analyses to address issues of possible overadjustment (adjusted for factors in causal pathway) or underadjustment (not adjusted for at least age, sex, and smoking).

Random-effects summary all-cause mortality HRs for overweight (BMI of 25-<30), obesity (BMI of ≥30), grade 1 obesity (BMI of 30-<35), and grades 2 and 3 obesity (BMI of ≥35) were calculated relative to normal weight (BMI of 18.5-<25). The summary HRs were 0.94 (95% CI, 0.91-0.96) for overweight, 1.18 (95% CI, 1.12-1.25) for obesity (all grades combined), 0.95 (95% CI, 0.88-1.01) for grade 1 obesity, and 1.29 (95% CI, 1.18-1.41) for grades 2 and 3 obesity. These findings persisted when limited to studies with measured weight and height that were considered to be adequately adjusted. The HRs tended to be higher when weight and height were self-reported rather than measured.

Conclusions and Relevance
Relative to normal weight, both obesity (all grades) and grades 2 and 3 obesity were associated with significantly higher all-cause mortality. Grade 1 obesity overall was not associated with higher mortality, and overweight was associated with significantly lower all-cause mortality. The use of predefined standard BMI groupings can facilitate between-study comparisons.

Gender Differences in the Salaries of Physician Researchers

June 29, 2012 Comments off

Gender Differences in the Salaries of Physician Researchers

Source: Journal of the American Medical Association


It is unclear whether male and female physician researchers who perform similar work are currently paid equally.


To determine whether salaries differ by gender in a relatively homogeneous cohort of physician researchers and, if so, to determine if these differences are explained by differences in specialization, productivity, or other factors.

Design and Setting

A US nationwide postal survey was sent in 2009-2010 to assess the salary and other characteristics of a relatively homogeneous population of physicians. From all 1853 recipients of National Institutes of Health (NIH) K08 and K23 awards in 2000-2003, we contacted the 1729 who were alive and for whom we could identify a mailing address.


The survey achieved a 71% response rate. Eligibility for the present analysis was limited to the 800 physicians who continued to practice at US academic institutions and reported their current annual salary.

Main Outcome Measures

A linear regression model of self-reported current annual salary was constructed considering the following characteristics: gender, age, race, marital status, parental status, additional graduate degree, academic rank, leadership position, specialty, institution type, region, institution NIH funding rank, change of institution since K award, K award type, K award funding institute, years since K award, grant funding, publications, work hours, and time spent in research.


The mean salary within our cohort was $167 669 (95% CI, $158 417-$176 922) for women and $200 433 (95% CI, $194 249-$206 617) for men. Male gender was associated with higher salary (+$13 399; P = .001) even after adjustment in the final model for specialty, academic rank, leadership positions, publications, and research time. Peters-Belson analysis (use of coefficients derived from regression model for men applied to women) indicated that the expected mean salary for women, if they retained their other measured characteristics but their gender was male, would be $12 194 higher than observed.


Gender differences in salary exist in this select, homogeneous cohort of mid-career academic physicians, even after adjustment for differences in specialty, institutional characteristics, academic productivity, academic rank, work hours, and other factors.

Association Between Patient-Centered Medical Home Rating and Operating Cost at Federally Funded Health Centers

June 27, 2012 Comments off

Association Between Patient-Centered Medical Home Rating and Operating Cost at Federally Funded Health Centers

Source: Journal of the American Medical Association


Little is known about the cost associated with a health center’s rating as a patient-centered medical home (PCMH).


To determine whether PCMH rating is associated with operating cost among health centers funded by the US Health Resources and Services Administration.

Design, Setting, and Participants

Cross-sectional study of PCMH rating and operating cost in 2009. PCMH rating was assessed through surveys of health center administrators conducted by Harris Interactive of all 1009 Health Resources and Services Administration–funded community health centers. The survey provided scores from 0 (worst) to 100 (best) for total PCMH score and 6 subscales: access/communication, care management, external coordination, patient tracking, test/referral tracking, and quality improvement. Costs were obtained from the Uniform Data System reports submitted to the Health Resources and Services Administration. We used generalized linear models to determine the relationship between PCMH rating and operating cost.

Main Outcome Measures

Operating cost per physician full-time equivalent, operating cost per patient per month, and medical cost per visit.


Six hundred sixty-nine health centers (66%) were included in the study sample, with 340 excluded because of nonresponse or incomplete data. Mean total PCMH score was 60 (SD, 12; range, 21-90). For the average health center, a 10-point higher total PCMH score was associated with a $2.26 (4.6%) higher operating cost per patient per month (95% CI, $0.86-$4.12). Among PCMH subscales, a 10-point higher score for patient tracking was associated with higher operating cost per physician full-time equivalent ($27 300; 95% CI, $3047-$57 804) and higher operating cost per patient per month ($1.06; 95% CI, $0.29-$1.98). A 10-point higher score for quality improvement was also associated with higher operating cost per physician full-time equivalent ($32 731; 95% CI, $1571-$73 670) and higher operating cost per patient per month ($1.86; 95% CI, $0.54-$3.61). A 10-point higher PCMH subscale score for access/communication was associated with lower operating cost per physician full-time equivalent ($39 809; 95% CI, $1893-$63 169).


According to a survey of health center administrators, higher scores on a scale that assessed 6 aspects of the PCMH were associated with higher health center operating costs. Two subscales of the medical home were associated with higher cost and 1 with lower cost.

The patient-centered medical home (PCMH) is a model of care characterized by comprehensive primary care, quality improvement, care management, and enhanced access in a patient-centered environment. The PCMH is intuitively appealing and has improved clinical and organizational performance in several early studies, leading a broad range of stakeholders to call for its adoption.1

It is critical to understand the cost of the PCMH from the perspective of individual clinics. Such cost data are essential for practices to make informed decisions to adopt the PCMH and for policy makers and administrators to design financially sustainable medical home models. Most PCMH cost studies have focused on potential savings from reducing hospitalizations and emergency department visits.2 – 8 Although those are important cost outcomes, the savings accrue to payers and rarely affect the finances of the primary care provider.9 – 11 The majority of US primary care physicians do not benefit financially from prevented hospitalizations or emergency department visits.

We are aware of only 1 previous study that has examined the cost effect of the PCMH from the primary care provider perspective, using actual practice cost data from more than 1 site. Zuckerman et al12 studied 35 private primary care practices and found minimal evidence of an association between a clinic’s medical home rating and cost; however, the analysis was limited by the small number of practices, limited variation in PCMH rating, and discordant timing of data sources (2006 cost data and 2008 PCMH data).

The present study examines the association between PCMH rating and operating cost in primary care practices, specifically among federally funded health centers. In this article, unless otherwise noted, the terms health center and grantees are used to refer to organizations that receive grants under the Health Center Program as authorized under section 330 of the Public Health Service Act, as amended. It does not refer to Federally Qualified Health Center look-alikes or clinics that are sponsored by tribal or Urban Indian Health Organizations, except for those that receive Health Center Program grants.

See also: Financial Implications of the Patient-Centered Medical Home (editorial)

See: The price tag on a patient-centered medical home (EurekAlert!)

Neonatal Abstinence Syndrome and Associated Health Care Expenditures

April 30, 2012 Comments off

Neonatal Abstinence Syndrome and Associated Health Care Expenditures
Source: Journal of the American Medical Association

Context: Neonatal abstinence syndrome (NAS) is a postnatal drug withdrawal syndrome primarily caused by maternal opiate use. No national estimates are available for the incidence of maternal opiate use at the time of delivery or NAS.

Objectives: To determine the national incidence of NAS and antepartum maternal opiate use and to characterize trends in national health care expenditures associated with NAS between 2000 and 2009.

Design, Setting, and Patients: A retrospective, serial, cross-sectional analysis of a nationally representative sample of newborns with NAS. The Kids’ Inpatient Database (KID) was used to identify newborns with NAS by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code. The Nationwide Inpatient Sample (NIS) was used to identify mothers using diagnosis related groups for vaginal and cesarean deliveries. Clinical conditions were identified using ICD-9-CM diagnosis codes. NAS and maternal opiate use were described as an annual frequency per 1000 hospital births. Missing hospital charges (<5% of cases) were estimated using multiple imputation. Trends in health care utilization outcomes over time were evaluated using variance-weighted regression. All hospital charges were adjusted for inflation to 2009 US dollars.

Main Outcome Measures: Incidence of NAS and maternal opiate use, and related hospital charges.

Results: The separate years (2000, 2003, 2006, and 2009) of national discharge data included 2920 to 9674 unweighted discharges with NAS and 987 to 4563 unweighted discharges for mothers diagnosed with antepartum opiate use, within data sets including 784 191 to 1.1 million discharges for children (KID) and 816 554 to 879 910 discharges for all ages of delivering mothers (NIS). Between 2000 and 2009, the incidence of NAS among newborns increased from 1.20 (95% CI, 1.04-1.37) to 3.39 (95% CI, 3.12-3.67) per 1000 hospital births per year (P for trend < .001). Antepartum maternal opiate use also increased from 1.19 (95% CI, 1.01-1.35) to 5.63 (95% CI, 4.40-6.71) per 1000 hospital births per year (P for trend < .001). In 2009, newborns with NAS were more likely than all other hospital births to have low birthweight (19.1%; SE, 0.5%; vs 7.0%; SE, 0.2%), have respiratory complications (30.9%; SE, 0.7%; vs 8.9%; SE, 0.1%), and be covered by Medicaid (78.1%; SE, 0.8%; vs 45.5%; SE, 0.7%; all P < .001). Mean hospital charges for discharges with NAS increased from $39 400 (95% CI, $33 400-$45 400) in 2000 to $53 400 (95% CI, $49 000-$57 700) in 2009 (P for trend < .001). By 2009, 77.6% of charges for NAS were attributed to state Medicaid programs.

Conclusion: Between 2000 and 2009, a substantial increase in the incidence of NAS and maternal opiate use in the United States was observed, as well as hospital charges related to NAS.

See: About One Baby Born Each Hour Addicted to Opiate Drugs in U.S. (Science Daily)

Effect of a Text Messaging Intervention on Influenza Vaccination in an Urban, Low-Income Pediatric and Adolescent Population

April 28, 2012 Comments off
Source:  Journal of the American Medical Association
Influenza infection results in substantial costs, morbidity, and mortality. Vaccination against influenza is particularly important in children and adolescents who are a significant source of transmission to other high-risk populations, yet pediatric and adolescent vaccine coverage remains low. Traditional vaccine reminders have had a limited effect on low-income populations; however, text messaging is a novel, scalable approach to promote influenza vaccination.
To evaluate targeted text message reminders for low-income, urban parents to promote receipt of influenza vaccination among children and adolescents.
Design, Setting, and Participants
Randomized controlled trial of 9213 children and adolescents aged 6 months to 18 years receiving care at 4 community-based clinics in the United States during the 2010-2011 influenza season. Of the 9213 children and adolescents, 7574 had not received influenza vaccine prior to the intervention start date and were included in the primary analysis.
Parents of children assigned to the intervention received up to 5 weekly immunization registry–linked text messages providing educational information and instructions regarding Saturday clinics. Both the intervention and usual care groups received the usual care, an automated telephone reminder, and access to informational flyers posted at the study sites.
Main Outcome Measures
Receipt of an influenza vaccine dose recorded in the immunization registry via an electronic health record by March 31, 2011. Receipt was secondarily assessed at an earlier fall review date prior to typical widespread influenza activity.
Study children and adolescents were primarily minority, 88% were publicly insured, and 58% were from Spanish-speaking families. As of March 31, 2011, a higher proportion of children and adolescents in the intervention group (43.6%; n = 1653) compared with the usual care group (39.9%; n = 1509) had received influenza vaccine (difference, 3.7% [95% CI, 1.5%-5.9%]; relative rate ratio [RRR], 1.09 [95% CI, 1.04-1.15]; P = .001). At the fall review date, 27.1% (n = 1026) of the intervention group compared with 22.8% (n = 864) of the usual care group had received influenza vaccine (difference, 4.3% [95% CI, 2.3%-6.3%]; RRR, 1.19 [95% CI, 1.10-1.28]; P < .001).
Among children and adolescents in a low-income, urban population, a text messaging intervention compared with usual care was associated with an increased rate of influenza vaccination. However, the overall influenza vaccination rate remained low.

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