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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

Context

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

Objectives

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.

Participants

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.

Results

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.

Conclusion

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

Context

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

Objective

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.

Results

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).

Conclusions

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
Context
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.
Objective
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.
Intervention
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.
Results
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).
Conclusions
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.

Variability in Reexcision Following Breast Conservation Surgery

February 4, 2012 Comments off
Source:  Journal of the American Medical Association
In conclusion, we found individual surgeons and institutions were associated with variation in reexcision rates following initial partial mastectomy for invasive breast cancer. This variability cannot be explained entirely by patients’ clinical factors. Our study highlights the value of multicenter observational studies in demonstrating variability in health care across geographic regions and different health systems, with uniform data collection instruments. The long-term effect of this variability is beyond the scope of our study, but it is feasible that outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care. Even in the absence of effects on local control, the wide level of unexplained clinical variation itself represents a potential barrier to high-quality and cost-effective care of patients with breast cancer. Continued comparative effectiveness research of breast cancer surgery requires further attention to better determine the association of initial surgical care with long-term patient outcomes.

Prevalence of Oral HPV Infection in the United States, 2009-2010

February 3, 2012 Comments off
Source:  Journal of the American Medical Association
The prevalence of oral HPV infection among men and women aged 14 to 69 years in the United States is approximately 7%, substantially lower than the reported prevalence of genital HPV infection. Infection with HPV-16 was detected in 1% of men and women, corresponding to an estimated 2.13 million infected individuals in the United States. We identified sexual behavior and current smoking, including intensity, to be potentially modifiable risk factors for oral HPV infection. Notably, prevalence was as high as 20% among those with more than 20 lifetime sexual partners or among current smokers of more than 20 cigarettes per day. Prevalence of HPV had a striking bimodal pattern with age among men and was significantly higher among men than women, consistent with higher rates of HPV-positive OSCC among individuals aged 50 to 64 years and among men.

Access to Emergency Contraception for Adolescents

January 17, 2012 Comments off
Source:  Journal of the American Medical Association
Although we found approximately 80% same-day availability of emergency contraception in US metropolitan areas, misinformation regarding access was common—particularly in low-income neighborhoods. Although our design did not permit us to determine why disparities in access to emergency contraception exist, possible explanations include differences in pharmacy staffing or training, frequency of requests for information, or organizational cultures around customer service. Our study assessed only telephone calling and not in-person visits. Limitations withstanding, the finding that misinformation regarding emergency contraception access is more common in low-income neighborhoods, which have higher teen pregnancy rates, suggests that targeted education for consumers and pharmacy staff may be necessary.

ADHD Medications and Risk of Serious Cardiovascular Events in Young and Middle-aged Adults

December 14, 2011 Comments off

ADHD Medications and Risk of Serious Cardiovascular Events in Young and Middle-aged AdultsSource: Journal of the American Medical Association

In conclusion, in this cohort of young and middle-aged adults, current or new use of ADHD medications identified from filled prescriptions, compared with nonuse or remote use, was not associated with an increased risk of serious cardiovascular events. A modestly elevated risk cannot be ruled out, given limited power and a lack of complete information on some potentially important risk factors and other factors related to use of these medications.

Should Patients Get Direct Access to Their Laboratory Test Results? An Answer With Many Questions

December 3, 2011 Comments off

Should Patients Get Direct Access to Their Laboratory Test Results? An Answer With Many Questions
Source: Journal of the American Medical Association

In the outpatient setting, between 8% and 26% of abnormal test results, including those suspicious for malignancy, are not followed up in a timely manner. Despite the use of electronic health records (EHRs) to facilitate communication of test results, follow-up remains a significant safety challenge. In an effort to mitigate delays, some systems have adopted a time-delayed direct notification of test results to patients (ie, releasing them after 3 to 7 days to allow physicians to review them).

On September 14, 2011, the Department of Health and Human Services jointly with the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights5​ proposed a rule allowing patients to access test results directly from the laboratory by request (paper or electronic). The proposal will affect 39 states and territories in which either no current laws regulate direct test-result delivery to patients, or the practice is banned outright by state law. The rule ensures that all Clinical Laboratory Improvement Amendments (CLIAs) and CLIA-exempt clinical laboratories abide by Health Insurance Portability and Accountability Act (HIPAA) regulations, thus standardizing patients’ rights to access protected health information. The rule does not specify a waiting period before sending results or specify which types of tests would require physician review first.

Although the new rule could be considered a monumental step forward to improve the safety of test-result follow-up, there is lack of consensus in the literature about best practices in direct patient notification of abnormal results. To our knowledge, there is also no empirical evidence as to how physicians in systems that currently perform direct notification have perceived and adapted to this strategy. In this commentary, we consider patient and clinician perspectives on the potential effects of this approach and lay groundwork for issues to consider in the implementation of this proposed rule.

Screening by Chest Radiograph and Lung Cancer Mortality

October 28, 2011 Comments off

Screening by Chest Radiograph and Lung Cancer Mortality
Source: Journal of the American Medical Association

Annual screening with chest radiograph did not reduce lung cancer mortality compared with usual care.

Understanding the Mental Health Effects of Indirect Exposure to Mass Trauma Through the Media

September 14, 2011 Comments off

Understanding the Mental Health Effects of Indirect Exposure to Mass Trauma Through the Media
Source: Journal of the American Medical Association

Exposure to mass trauma is common. In the United States, 15% of women and 19% of men have reported lifetime exposure to natural disasters alone.1​ Since the advent of 24-hour television news, exposure to mass violence and natural disasters through the media is even more widespread. Although exposure to trauma has a wide range of psychopathological consequences, posttraumatic stress disorder (PTSD) has been shown to be the most common.2

PTSD is unique among psychiatric disorders because it requires exposure and fearful response to traumatic events as the proximate precipitants of the syndrome. The clinical presentation of PTSD includes a diverse array of distressing and disabling ongoing symptoms in the realms of reexperiencing phenomena (eg, nightmares), hyperarousal (eg, startle response), avoidance of reminders of the exposure, and general affective numbing. Yet community surveys have consistently demonstrated that most adults exhibit resilience following exposure to trauma, even among those who develop symptoms consistent with PTSD in the immediate aftermath, with many recovering over time without clinical intervention. A significant minority, however, will develop PTSD, which is the posttrauma clinical trajectory associated with a considerable health burden, including psychiatric comorbidities, severe psychosocial dysfunction, and increased rates of suicidal behaviors.

Progress in Disaster Planning and Preparedness Since 2001

September 14, 2011 Comments off

Progress in Disaster Planning and Preparedness Since 2001
Source: Journal of the American Medical Association

The September 11, 2001, terrorist attacks and the anthrax letters of 2001 were followed by a decade of major domestic and international disasters. Whether wrought by terrorist attacks, nuclear or chemical incidents, rapidly moving pandemics, record-breaking hurricanes, massive earthquakes, or other natural catastrophes, deadly disasters will continue to occur, and prompt and effective response will be required when lives are at stake.

The good news is that disaster preparedness has improved during the past 10 years. For the health care community, 3 important developments are worth noting: (1) medical and public health professionals have joined the ranks of the disaster preparedness community; (2) the US federal government has increased its investment in preparedness, resulting in major improvements at the state and local levels; and (3) to an increasing extent, community participants who should be involved in disaster preparedness are getting involved.

Adjunctive Risperidone Treatment for Antidepressant-Resistant Symptoms of Chronic Military Service–Related PTSD: A Randomized Trial

August 11, 2011 Comments off

Adjunctive Risperidone Treatment for Antidepressant-Resistant Symptoms of Chronic Military Service–Related PTSD: A Randomized Trial
Source: Journal of the American Medical Association

Context Serotonin reuptake-inhibiting (SRI) antidepressants are the only FDA-approved pharmacotherapies for the treatment of posttraumatic stress disorder (PTSD).

Objective To determine efficacy of the second-generation antipsychotic risperidone as an adjunct to ongoing pharmacologic and psychosocial treatments for veterans with chronic military-related PTSD.

Design, Setting, and Participants A 6-month, randomized, double-blind, placebo-controlled multicenter trial conducted between February 2007 and February 2010 at 23 Veterans Administration outpatient medical centers. Of the 367 patients screened, 296 were diagnosed with military-related PTSD and had ongoing symptoms despite at least 2 adequate SRI treatments, and 247 contributed to analysis of the primary outcome measure.

Intervention Risperidone (up to 4 mg once daily) or placebo.

Main Outcome Measures The Clinician-Administered PTSD Scale (CAPS) (range, 0-136). Other measures included the Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Scale (HAMA), Clinical Global Impression scale (CGI), and Veterans RAND 36-Item Health Survey (SF-36V).

Results Change in CAPS scores from baseline to 24 weeks in the risperidone group was −16.3 (95% CI, −19.7 to −12.9) and in the placebo group, −12.5 (95% CI, −15.7 to −9.4); the mean difference was 3.74 (95% CI, −0.86 to 8.35; t = 1.6; P = .11). Mixed model analysis of all time points also showed no significant difference in CAPS score (risperidone: mean, 64.43; 95% CI, 61.98 to 66.89, vs placebo: mean, 67.16; 95% CI, 64.71 to 69.62; mean difference, 2.73; 95% CI, −0.74 to 6.20; P = .12). Risperidone did not reduce symptoms of depression (MADRS mean difference, 1.19; 95% CI, −0.29 to 2.68; P = .11) or anxiety (HAMA mean difference, 1.16; 95% CI, −0.18 to 2.51; P = .09; patient-rated CGI mean difference, 0.20; 95% CI, −0.06 to 0.45; P = .14; observer-rated CGI mean difference, 0.18; 95% CI, 0.01 to 0.34; P = .04), or increase quality of life (SF-36V physical component mean difference, −1.13, 95% CI, −2.58 to 0.32; P = .13; SF-36V mental component mean difference, −0.26; 95% CI, −2.13 to 1.61; P = .79). Adverse events were more common with risperidone vs placebo, including self-reported weight gain (15.3% vs 2.3%), fatigue (13.7% vs 0.0%), somnolence (9.9% vs 1.5%), and hypersalivation (9.9% vs 0.8%), respectively.

Conclusion Among patients with military-related PTSD with SRI-resistant symptoms, 6-month treatment with risperidone compared with placebo did not reduce PTSD symptoms.

Association of Occult Metastases in Sentinel Lymph Nodes and Bone Marrow With Survival Among Women With Early-Stage Invasive Breast Cancer

July 28, 2011 Comments off

Association of Occult Metastases in Sentinel Lymph Nodes and Bone Marrow With Survival Among Women With Early-Stage Invasive Breast Cancer
Source: Journal of the American Medical Association

Context Immunochemical staining of sentinel lymph nodes (SLNs) and bone marrow identifies breast cancer metastases not seen with routine pathological or clinical examination.

Objective To determine the association between survival and metastases detected by immunochemical staining of SLNs and bone marrow specimens from patients with early-stage breast cancer.

Design, Setting, and Patients From May 1999 to May 2003, 126 sites in the American College of Surgeons Oncology Group Z0010 trial enrolled women with clinical T1 to T2N0M0 invasive breast carcinoma in a prospective observational study.

Interventions All 5210 patients underwent breast-conserving surgery and SLN dissection. Bone marrow aspiration at the time of operation was initially optional and subsequently mandatory (March 2001). Sentinel lymph node specimens (hematoxylin-eosin negative) and bone marrow specimens were sent to a central laboratory for immunochemical staining; treating clinicians were blinded to results.

Main Outcome Measures Overall survival (primary end point) and disease-free survival (a secondary end point).

Results Of 5119 SLN specimens (98.3%), 3904 (76.3%) were tumor-negative by hematoxylin-eosin staining. Of 3326 SLN specimens examined by immunohistochemistry, 349 (10.5%) were positive for tumor. Of 3413 bone marrow specimens examined by immunocytochemistry, 104 (3.0%) were positive for tumors. At a median follow-up of 6.3 years (through April 2010), 435 patients had died and 376 had disease recurrence. Immunohistochemical evidence of SLN metastases was not significantly associated with overall survival (5-year rates: 95.7%; 95% confidence interval [CI], 95.0%-96.5% for immunohistochemical negative and 95.1%; 95% CI, 92.7%-97.5% for immunohistochemical positive disease; P = .64; unadjusted hazard ratio [HR], 0.90; 95% CI, 0.59-1.39; P = .64). Bone marrow metastases were associated with decreased overall survival (unadjusted HR for mortality, 1.94; 95% CI, 1.02-3.67; P = .04), but neither immunohistochemical evidence of tumor in SLNs (adjusted HR, 0.88; 95% CI, 0.45-1.71; P = .70) nor immunocytochemical evidence of tumor in bone marrow (adjusted HR, 1.83; 95% CI, 0.79-4.26; P = .15) was statistically significant on multivariable analysis.

Conclusion Among women receiving breast-conserving therapy and SLN dissection, immunohistochemical evidence of SLN metastasis was not associated with overall survival over a median of 6.3 years, whereas occult bone marrow metastasis, although rare, was associated with decreased survival.

Trial Registration clinicaltrials.gov Identifier: NCT00003854

Effect of the Gonadotropin-Releasing Hormone Analogue Triptorelin on the Occurrence of Chemotherapy-Induced Early Menopause in Premenopausal Women With Breast Cancer

July 27, 2011 Comments off

Effect of the Gonadotropin-Releasing Hormone Analogue Triptorelin on the Occurrence of Chemotherapy-Induced Early Menopause in Premenopausal Women With Breast Cancer
Source: Journal of the American Medical Association

The use of triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause.

Dietary Supplements—Regulatory Issues and Implications for Public Health

July 20, 2011 Comments off

Dietary Supplements—Regulatory Issues and Implications for Public Health
Source: Journal of the American Medical Association

In October 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA), and 17 years later, health experts, policy makers, and industry lobbyists continue to spar over the legislation. Classifying dietary supplements as a subcategory of food, DSHEA allowed supplement manufacturers to market products without submitting proof of safety or efficacy to the US Food and Drug Administration (FDA).​ Currently, for a tainted or otherwise hazardous product to be removed from the supplement marketplace, an agency such as the FDA or the Drug Enforcement Administration must offer evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets. For US health professionals, the fact that more than 150 million US residents use dietary supplements should be a point of concern as many users will almost certainly forgo conventional medical treatment in favor of using products that may offer no medicinal value and taking health advice from medically untrained sales representatives.

Food and Drug Administration Regulation of Food Safety

July 3, 2011 Comments off

Food and Drug Administration Regulation of Food Safety
Source: Journal of the American Medical Association

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually.1​ Despite many triumphs in improving food safety, progress in recent years has stalled, with the incidence of food-borne infection remaining steady during the past decade.1 Recent outbreaks linked to spinach, peanut butter, eggs, and the recent Escherichia coli outbreak that originated in Europe have heightened public concern. On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) increasing the US Food and Drug Administration’s (FDA’s) power to regulate food safety, with a focus on prevention, enhanced recall authority, and oversight of imported food.2​ The FSMA is a remarkable step forward for the food safety system, affording the FDA much-needed authority. However, the act leaves critical gaps in the regulatory system, including fragmentation among federal agencies, and its potential may be threatened if Congress does not provide sufficient funding to ensure inspections and compliance.

Food and Drug Administration Regulation of Food Safety

June 18, 2011 Comments off

Food and Drug Administration Regulation of Food Safety
Source: Journal of the American Medical Association

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually.1​ Despite many triumphs in improving food safety, progress in recent years has stalled, with the incidence of food-borne infection remaining steady during the past decade. Recent outbreaks linked to spinach, peanut butter, eggs, and the recent Escherichia coli outbreak that originated in Europe have heightened public concern. On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) increasing the US Food and Drug Administration’s (FDA’s) power to regulate food safety, with a focus on prevention, enhanced recall authority, and oversight of imported food.2 The FSMA is a remarkable step forward for the food safety system, affording the FDA much-needed authority. However, the act leaves critical gaps in the regulatory system, including fragmentation among federal agencies, and its potential may be threatened if Congress does not provide sufficient funding to ensure inspections and compliance.

Hospital Mortality, Length of Stay, and Preventable Complications Among Critically Ill Patients Before and After Tele-ICU Reengineering of Critical Care Processes

May 20, 2011 Comments off

Hospital Mortality, Length of Stay, and Preventable Complications Among Critically Ill Patients Before and After Tele-ICU Reengineering of Critical Care Processes
Source: Journal of the American Medical Association

Patient needs and societal costs of adult critical care have increased as predicted from population-based models,1​,2,3​ and more efficient methods of delivery of care are needed. A tele-intensive care unit (ICU) is a promising technological approach designed to systematically alter processes of care that affect outcomes. Tele-ICU can be defined as the provision of care to critically ill patients by health care professionals located remotely. Tele-ICU clinicians use audio, video, and electronic links to assist bedside caregivers in monitoring patients, to oversee best practice adherence, and to help create and execute care plans. Tele-ICU programs have the potential to target processes that are associated with better outcomes, including shorter response times to alarms4 and abnormal laboratory values,5​ more rapid initiation of life-saving therapies,6,7​ and higher rates of adherence to critical care best practices.8

Studies of the effects of tele-ICU programs to date have focused primarily on community and rural hospitals and have yielded both positive and negative results. Several studies have highlighted low levels of acceptance of the tele-ICU intervention but few studies have identified the care processes or ICU structural elements that were part of the intervention; these issues have limited the ability to compare studies and identify processes associated with improved outcomes.9​ To provide insight into which tele-ICU–related process changes are associated with better outcomes, we examined the association of a tele-ICU intervention with the risk of dying in the hospital and length of stay, and the contributions of best practice adherence and preventable complications to these associations. Our study focused on changes in the processes of care rather than ICU structure because the critical care team structure and governance had been previously well characterized10 and were not changed during the intervention.

In conclusion, an adult tele-ICU intervention at an academic medical center that had been previously well staffed with a dedicated intensivist model and had robust best practice programs in place before the intervention was associated with lower mortality and shorter lengths of stay. Only part of these associations could be attributed to following best practice guidelines and lower rates of preventable complications. This suggests that there are benefits of a tele-ICU intervention beyond what is provided by daytime bedside intensivist staffing and traditional approaches to quality improvement such as the process changes presented in Table 1.

See also: The Use and Misuse of ICU Telemedicine

Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD

May 20, 2011 Comments off

Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD
Source: Journal of the American Medical Association

This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years.

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