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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

Importance
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.

Objective
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.

Results
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

Importance
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.

Objective
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.

Interventions
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.

Results
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.

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