Monday, November 28, 2011

Health care reform: impact on innovation and new technology

Gastrointest Endosc Clin N Am. 2012 Jan;22(1):109-20. Epub 2011 Oct 20.
The impact of health care reform on innovation and new technology.
Ganz RA.
Minnesota Gastroenterology, PA, Old Shakopee Road, Bloomington, MN, USA; University of Minnesota, Minneapolis, MN, USA.

Health care reform has created special challenges and hurdles to the introduction of new technology and innovative medical devices in gastroenterology and other medical fields. The implication of new regulations will be enormous as we begin to see venture-capital funding flee our specialty for more lucrative and "sure bets." This article, written by an experienced entrepreneur and practicing gastroenterologist, outlines some of the implications of this emerging challenge. Few other sources of information are available that truly articulate the insider view of coming changes.

From Johns Hopkins: Quality and safety in anesthesiology

Best Pract Res Clin Anaesthesiol. 2011 Dec;25(4):557-67.
A novel approach to implementation of quality and safety programmes in anaesthesiology.
Schwengel DA, Winters BD, Berkow LC, Mark L, Heitmiller ES, Berenholtz SM.
Department of Anesthesiology, Critical Care and Pediatrics, Johns Hopkins University, 600 N. Wolfe St., Blalock 1412, Baltimore, MD 21287, USA.

Far too many patients suffer preventable harm from medical errors that add to needless suffering and cost of care. Underdeveloped residency training programmes in patient safety are a major contributor to preventable harm. Consequently, the Institute of Medicine has called for health professionals to reform their educational programmes to advance health-care safety and quality. Additionally, the Accreditation Council for Graduate Medical Education (ACGME) now requires education in 'systems-based practice' and 'practice-based learning and improvement' as core competencies of residency training programmes. The specific aim of this article is to describe the implementation of a novel programme designed to enhance residency education, meet ACGME core competencies and improve quality and safety education in one residency programme at an academic medical institution.

From Brown U: Cardiovascular disease and risk in primary care settings

Am J Cardiol. 2011 Nov 21. [Epub ahead of print]
Cardiovascular Disease and Risk in Primary Care Settings in the United States.
Ndumele CD, Baer HJ, Shaykevich S, Lipsitz SR, Hicks LS.
Program in Public Health, Alpert School of Medicine, Brown University, Providence, Rhode Island.

Primary care site may play an important role in cardiovascular disease prevalence; however, the distribution of risk factors and outcomes across care sites is not known. In this study, a cross-sectional analysis of 21,778 adult participants from the National Health and Nutrition Examination Survey (NHANES; 1999 to 2008) using multivariate logistic regression was conducted to assess the relation between site of usual care and disease prevalence. Patients' self-reported histories of several chronic conditions (hypertension, diabetes, and hypercholesterolemia), awareness of chronic conditions, and associated cardiovascular events (angina, coronary heart disease, cardiovascular disease, myocardial infarction, and stroke) were examined. After adjustment for demographic and health care utilization characteristics, there were no significant differences in the prevalence of diabetes or hypercholesterolemia among patients receiving usual care at private doctors' offices, hospital outpatient clinics, community-based clinics, and emergency rooms (ER). However, participants without usual sources of care and those receiving usual care at ERs had significantly lower awareness of their chronic conditions than participants at other sites. The odds of having a history of each of the adverse cardiovascular events ranged from 2.21 to 4.18 times higher for patients receiving usual care at ERs relative to private doctors' offices. In conclusion, participants who report using ERs as their usual sites of care are disproportionately more likely to have histories of poor cardiovascular outcomes and are more likely to be unaware of having hypertension or hypercholesterolemia. As health care reform takes place and millions more begin seeking care, it is imperative to ensure access to longitudinal care sites designed for continuous disease management.

Childhood obesity: Parents fear being blamed. MDs must be sensitive and nonjudgmental

Fam Pract. 2011 Nov 24. [Epub ahead of print]
Parents' views and experiences of childhood obesity management in primary care: a qualitative study.
Turner KM, Salisbury C, Shield JP.
Academic Unit of Primary Health Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS.

Primary care has been viewed as an appropriate setting for childhood obesity management. Little is known about parents' views and experiences of obesity management within this clinical setting. These views and experiences need to be explored, as they could affect treatment success.

To explore parents' views and experiences of primary care as a treatment setting for childhood obesity.

In-depth interviews were held with 15 parents of obese children aged 5-10 years, to explore their views and experiences of primary care childhood obesity management. Parents were contacted via a hospital-based childhood obesity clinic, general practices and Mind, Exercise, Nutrition … Do it! (MEND) groups based in Bristol, England. The interviews were audio-taped transcribed verbatim and analysed thematically.

Parents viewed primary care as an appropriate setting in which to treat childhood obesity but were reluctant to consult due to a fear of being blamed for their child's weight and a concern about their child's mental well-being. They also questioned whether practitioners had the knowledge, time and resources to effectively manage childhood obesity. Parents varied in the extent to which they had found consulting a practitioner helpful, and their accounts suggested that GPs and school nurses offer different types of support.

Parents need to be reassured that practitioners will address their child's weight in a non-judgemental sensitive manner and are able to treat childhood obesity effectively. A multidisciplinary team approach might benefit a child, as different practitioners may vary in the type of care they provide.

Annual CT screening for lung cancer: This study shows 20% reduced mortality

Expert Rev Anticancer Ther. 2011 Dec;11(12):1833-6.
Finding needles in a haystack: annual low-dose computed tomography screening reduces lung cancer mortality in a high-risk group.
Duke SL, Eisen T.
Department of Oncology, Cambridge University Health Partners, Hills Road, Cambridge, CB2 0QQ, UK.

Evaluation of: Aberle DR, Adams AM, Berg CD et al.; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N. Engl. J. Med. 365(5), 395-409 (2011). Lung cancer is a global health issue. Compared with other common malignancies, the prognosis is poor as many patients present with advanced disease. The National Lung Screening Trial (NLST) aimed to identify and treat early lung cancers using annual low-dose computed tomography (CT) screening in a high-risk group. When compared with chest x-ray screening, low-dose CT screening reduced lung cancer mortality by 20%; the NLST is the first lung cancer screening trial to demonstrate such a mortality benefit. However, we must wait for cost-effectiveness data from the NLST, as well as the results of ongoing European studies comparing low-dose CT with observation alone, before firm conclusions can be drawn regarding the overall benefits of introducing a CT screening program to clinical practice.

Treating facial trauma: The otolaryngologists' experience

Otolaryngol Head Neck Surg. 2011 Nov 16. [Epub ahead of print]
The Otolaryngologist's Cost in Treating Facial Trauma: American Academy of Otolaryngology--Head and Neck Surgery Survey.
McCusker SB, Schmalbach CE.
Yokota Air Base, Japan.

Objectives. (1) To define practice patterns and perceptions of junior otolaryngologists treating maxillofacial/neck trauma. (2) To identify manners in which the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) can meet future trauma needs.Study Design. Cross-sectional survey.Setting. Academic and private otolaryngology practices.

Methods. A 26-question survey was designed to identify demographics, practice patterns, perceptions, and areas for improvement in maxillofacial/neck trauma care. It was distributed anonymously to AAO-HNS members completing residency from 2005 to 2009. Analysis included descriptive statistics and χ(2) comparisons.

Results. Of 1343 otolaryngologists, 444 (33%) responded. A total of 85% of responding physicians treat maxillofacial/neck trauma, and 64% identify trauma as an ideal part of their practice. Sense of duty (54%), institutional requirements (33%), and enjoyment (32%) are the most common reasons for treating trauma. Major deterrents include patient noncompliance (60%) and lifestyle limitations (47%). Five respondents (3.1%) have been involved in a trauma-related lawsuit. While insufficient reimbursement is a major deterrent to treating trauma (52%), only 36% would increase their volume if reimbursement improved. Increased educational opportunities represent the most common request to the AAO-HNS (59%), followed by AAO-HNS focus on improved reimbursement and tort reform (28%).

Conclusion. Most junior otolaryngologists treat maxillofacial/neck trauma on a monthly basis. A total of 64% identify trauma as a component of their ideal practice. They report being well to very well trained in all facets of trauma, with the exception of vascular and laryngotracheal injuries; but they desire additional education, such as courses and panels. Universal concerns include inadequate reimbursement, limited pool of treating physicians, and lack of practice guidelines.

From Sarah Feldman: Making sense of cervical cancer screening guidelines

N Engl J Med. 2011 Nov 23. [Epub ahead of print]
Making Sense of the New Cervical-Cancer Screening Guidelines.
Feldman S.
From the Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital, Boston.

"Health care is a limited resource, and providing the best care at the best price will become increasingly important. We need to use and understand actual data about risk and the long-term effects and costs of various strategies. Experts are often in the best position to review the data and make recommendations, but different expert panels may interpret data differently and emphasize different results in making their decisions. And even with the best consensus guidelines, some clinical judgment and personalized attention to each patient remains necessary."

Friday, November 18, 2011

Reforming Big Pharma-Physician Financial Relationships

J Law Med Ethics. 2011 Dec;39(4):662-670. doi: 10.1111/j.1748-720X.2011.00633.x.
Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan.
Rodwin MA.
Edmond J. Safra Research Lab Fellow at Harvard University and Professor of Law at Suffolk University Law School, is the author of Conflicts of Interest and the Future of Medicine: The United States, France and Japan (Oxford, 2011) and Medicine, Money and Morals: Physicians' Conflicts of Interest (1993).

This article compares the means that the United States, France, and Japan use to oversee pharmaceutical industry-physician financial relationships. These countries rely on professional and/or industry ethical codes, anti-kickback laws, and fair trade practice laws. They restrict kickbacks the most strictly, allow wide latitude on gifts, and generally permit drug firms to fund professional activities and associations. Consequently, to avoid legal liability, drug firms often replace kickbacks with gifts and grants. The paper concludes by proposing reforms that address problems that persist when firms replace kickbacks with gifts and grants based on the experience of the three countries.

© 2011 American Society of Law, Medicine & Ethics, Inc.

COPD and Hypoxemia

Int J Chron Obstruct Pulmon Dis. 2011;6:199-208. Epub 2011 Mar 14.
Hypoxemia in patients with COPD: cause, effects, and disease progression.
Kent BD, Mitchell PD, McNicholas WT.
Pulmonary and Sleep Disorders Unit, St. Vincent's University Hospital, Dublin, Ireland.

Chronic obstructive pulmonary disease (COPD) is a leading cause of death and disability internationally. Alveolar hypoxia and consequent hypoxemia increase in prevalence as disease severity increases. Ventilation/perfusion mismatch resulting from progressive airflow limitation and emphysema is the key driver of this hypoxia, which may be exacerbated by sleep and exercise. Uncorrected chronic hypoxemia is associated with the development of adverse sequelae of COPD, including pulmonary hypertension, secondary polycythemia, systemic inflammation, and skeletal muscle dysfunction. A combination of these factors leads to diminished quality of life, reduced exercise tolerance, increased risk of cardiovascular morbidity, and greater risk of death. Concomitant sleep-disordered breathing may place a small but significant subset of COPD patients at increased risk of these complications. Long-term oxygen therapy has been shown to improve pulmonary hemodynamics, reduce erythrocytosis, and improve survival in selected patients with severe hypoxemic respiratory failure. However, the optimal treatment for patients with exertional oxyhemoglobin desaturation, isolated nocturnal hypoxemia, or mild-to-moderate resting daytime hypoxemia remains uncertain.

Delivering mental health services within primary care: Best practices

Clin Med Res. 2011 Nov;9(3-4):171.
PS1-32: Psychology in Primary Care: An Evaluation of Best Practices.
Phillips K, Smith E, Stevens A.

Integrating psychology and mental health professionals into primary care settings has emerged as a means to improve the access to and utilization of mental health services. Three main delivery models of psychology in primary care settings have emerged: referring a patient to a psychologist/mental health professional located in a facility outside of the primary care physician's (PCP) office; referring a patient to a co-located psychologist/mental health professional who does not directly interface with PCP; integrated and co-located model where the PCP and the psychologist/ mental health professional discuss the patient's health. The overall purpose of this project was to compare patient utilization of psychology/mental health services across the Scott & White Health care system.

Using electronic medical records and the virtual data warehouse (VDW), mental health clinics/facilities were categorized into one of the three main psychology models. Patients that had depression, anxiety or ADHD DRG codes in their EMR and were aged 18 and older (n=37,310) were included in the analysis. The following additional variables were controlled for: gender, race/ethnicity, and chronic physical health conditions (i.e. arthritis, lung disease, heart disease, diabetes, hypertensive disease, and osteoporosis). ANOVA/ANCOVA analyses were performed to determine the differences across the three models in the length of time between the PPC referral and the first appointment with the psychologist/mental health professional.

Patients that were seen by psychologist in facilities with integrated co-located models of care experienced a shorter amount of time between their referral and their first appointment with the psychologist/mental health professional, compared to the other two models of care.

These initial results begin to inform best practices for delivering mental health services within primary care and provide physicians and health care systems with data on issues that facilitate integrated, person-centered care.

Does PPACA disincentivize comprehensive primary care?

J Am Board Fam Med. 2011 Nov;24(6):637-638.
Rewarding Family Medicine While Penalizing Comprehensiveness? Primary Care Payment Incentives and Health Reform: the Patient Protection and Affordable Care Act (PPACA).
Petterson S, Bazemore AW, Phillips RL, Xierali IM, Rinaldo J, Green LA, Puffer JC.
The Robert Graham Center.

Family physicians' scope of work is exceptionally broad, particularly with increasing rurality. Provisions for Medicare bonus payment specified in the health care reform bill (the Patient Protection and Affordable Care Act) used a narrow definition of primary care that inadvertently offers family physicians disincentives to delivering comprehensive primary care.

From LA Review of Books: Steven Brint's The Education Lottery

"The American education gospel is built around four core beliefs. First, it teaches that access to higher levels of education should be available to everyone, regardless of their background or previous academic performance. Every educational sinner should have a path to redemption. (Most of these paths now run through community colleges.) Second, the gospel teaches that opportunity for a better life is the goal of everyone and that education is the primary — and perhaps the only — road to opportunity. Third, it teaches that the country can solve its social problems — drugs, crime, poverty, and the rest — by providing more education to the poor. Education instills the knowledge, discipline, and the habits of life that lead to personal renewal and social mobility. And, finally, it teaches that higher levels of education for all will reduce social inequalities, as they will put everyone on a more equal footing."

"...we will need to turn our backs on assumptions of our most fervent boosters of universal higher education: that access alone is the primary purpose, and that when students and teachers are co-present, education occurs..."

Federal health care reform and the Necessary and Proper Clause

Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate
Gary Lawson & David B. Kopel
Tuesday, 08 November 2011

In Bad News for Mail Robbers: The Obvious Constitutionality of Health Care Reform, Professor Andrew Koppelman argues that the individual mandate in the Patient Protection and Affordable Care Act is constitutionally authorized by the Necessary and Proper Clause. This view is fundamentally wrong. The Necessary and Proper Clause is based on eighteenth-century agency law, including the fundamental agency doctrine of principals and incidents. Accordingly, the Clause only allows Congress to exercise powers that are incident to—meaning subordinate to or less “worthy” than—its principal enumerated powers. The power to compel private persons to engage in commercial transactions with other private persons is not an incidental power. Thus, the mandate is not authorized by the Necessary and Proper Clause, whether or not such a power is “necessary and proper for carrying into Execution” other powers. In addition, eighteenth-century public law carried administrative law principles—including the fiduciary norms at the heart of agency law—into delegations of power to political actors. One of the most basic of these fiduciary norms is the obligation to treat multiple principals equally. That equal treatment requirement is violated by the individual mandate, which compels transactions with a favored oligopoly of insurance companies. In short, the mandate is not an exercise of incidental power within the scope of the Necessary and Proper Clause, nor is the mandate “proper.”

Preferred citation: Gary Lawson & David B. Kopel, Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate, 121 YALE L.J. ONLINE 267 (2011),

Tuesday, November 15, 2011

Sarcopenia and genetics

Age (Dordr). 2011 Oct 27. [Epub ahead of print]
Genes and the ageing muscle: a review on genetic association studies.
Garatachea N, Lucía A.
University of Zaragoza, Huesca, Spain,

Western populations are living longer. Ageing decline in muscle mass and strength (i.e. sarcopenia) is becoming a growing public health problem, as it contributes to the decreased capacity for independent living. It is thus important to determine those genetic factors that interact with ageing and thus modulate functional capacity and skeletal muscle phenotypes in older people. It would be also clinically relevant to identify 'unfavourable' genotypes associated with accelerated sarcopenia. In this review, we summarized published information on the potential associations between some genetic polymorphisms and muscle phenotypes in older people. A special emphasis was placed on those candidate polymorphisms that have been more extensively studied, i.e. angiotensin-converting enzyme (ACE) gene I/D, α-actinin-3 (ACTN3) R577X, and myostatin (MSTN) K153R, among others. Although previous heritability studies have indicated that there is an important genetic contribution to individual variability in muscle phenotypes among old people, published data on specific gene variants are controversial. The ACTN3 R577X polymorphism could influence muscle function in old women, yet there is controversy with regards to which allele (R or X) might play a 'favourable' role. Though more research is needed, up-to-date MSTN genotype is possibly the strongest candidate to explain variance among muscle phenotypes in the elderly. Future studies should take into account the association between muscle phenotypes in this population and complex gene-gene and gene-environment interactions.

From U Mich and Western Mich U: Gender-related differences among med school faculty

Health Care Manag (Frederick). 2011 Oct;30(4):334-41.
An empirical investigation of the differences between male and female medical school physicians.
Deshpande SS, Deshpande SP.
Author Affiliations: Section of Plastic Surgery, Department of Surgery, University of Michigan, Ann Arbor (S. S. Deshpande), and Department of Management, Haworth College of Business, Western Michigan University, Kalamazoo (Dr S. P. Deshpande).

The purpose of this research was to investigate gender-related differences among medical school faculty in a variety of areas such as information technology, medical malpractice, compensation, patient care, and carrier satisfaction. The Center for Studying Health System Change's 2008 Health Tracking Physician survey data consisting of 326 medical school faculty belonging to the American Medical Association were used in this study. t Tests indicate that female physicians practicing in medical schools were younger, had less experience, reported lower compensation, and were more likely to be primary care physicians. Male medical school physicians were significantly more concerned about being involved in a malpractice lawsuit. They reported a significantly higher percentage on income based on productivity-related factors. Male physicians also reported getting a significantly higher level of goods and services from drug companies. They also provided more hours of medical service for no or reduced fee in the previous month and higher levels of career satisfaction. Implications of this research are discussed.

From U Milan: Time for new performance classification for high level male marathon runners?

J Strength Cond Res. 2011 Nov 10. [Epub ahead of print]
Is It Time to Consider a New Performance Classification for High-Level Male Marathon Runners?
Torre AL, Vernillo G, Agnello L, Berardelli C, Rampinini E.
1Department of Sport, Nutrition and Health Sciences, University of Milan, Milan, Italy; 2Faculty of Exercise Sciences, University of Milan, Milan, Italy; 3Department of Basic and Applied Medical Sciences, Chieti-Pescara University, Chieti Pescara, Italy; and 4Human Performance Laboratory, Mapei Sport Research Center, Castellanza, Varese, Italy.

Studies have attempted to describe human running performances by the analysis of world-record times. However, to date, no study has analyzed the evolution of high-level marathon performances over time. Thus, the purpose of this study was to analyze these performances across the past 42 years with the aim of delineating a time-based classification. To identify the nature of the phenomenon represented by the sequence of observations, we examined the data collected (i.e., 8,400 times from 1969 to 2010) as a time series. The leading time (LT) and the mean 200 times (T200) per year underwent a nonlinear but significant decrement (r = -0.92, p < 0.001 and r = -0.98, p < 0.001, respectively). In fact, from 1969 to 2010, the mean time differences were 3 minutes 20 seconds ± 1 minute 59 seconds and 7 minutes 1 second ± 2 minutes 48 seconds, corresponding to an improvement of 5 and 10 seconds per year for LT and T200, respectively. Furthermore, trend analysis suggested a disruption in marathon time improvements, indicating the presence of 3 points in the time series in which the performance significantly improved with respect to that of the previous years, corresponding to the years 1983-1984 (p < 0.001), 1997-1998 (p < 0.003), and 2003 (p < 0.001). In conclusion, despite the trend in high-level marathon performances being better explained by a nonlinear tendency, significant improvements in the ability of the high-level marathon runners to complete the distance were observed. These improvements are likely to be related to sociological, environmental, physiological, and training-method factors. Researchers and coaches should take into account these enhancements by using the time classification proposed in this study to better reflect the marathon performance profile of their athletes.

"The especially high rates of obesity in Texas have a profound impact on personal health and may result in increased health care costs that threaten public programs as well."

J Health Care Poor Underserved. 2011;22(4):1190-204.
Predictors of Body Mass Index among Low-Income Community-Dwelling Older Adults.
Ahn S, Huber C, Smith ML, Ory MG, Phillips CD.

Abstract:This study investigated demographic, behavioral, and functional predictors of overweight and obesity, using secondary data from 705 community-dwelling individuals aged 65 years and older receiving or seeking Medicaid personal care services. Half of the participants were obese, while an additional 28% were overweight. The relationships between body mass index (BMI) levels and selected independent variables were analyzed. Females were more likely to be obese, while those who were older (75 years or older), more cognitively impaired, and smoked were less likely to obese. Comparing obesity with being overweight, being female and reporting more pain symptoms increased the odds of being obese, whereas being older (75 years or older) and being more cognitively impaired decreased the odds. The especially high rates of obesity in Texas have a profound impact on personal health and may result in increased health care costs that threaten public programs as well.

From U Wisc-Madison: 14 factors causing a missed diagnosis of Cystic Fibrosis on newborn screening

Pediatr Pulmonol. 2011 Dec;46(12):1166-74. doi: 10.1002/ppul.21509. Epub 2011 Aug 24.
Factors accounting for a missed diagnosis of cystic fibrosis after newborn screening.
Rock MJ, Levy H, Zaleski C, Farrell PM.
School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin.

Newborn screening is a public health policy program involving the centralized testing laboratory, infant and their family, primary care provider, and subspecialist for confirmatory testing and follow-up of abnormal results. Cystic fibrosis (CF) newborn screening has now been enacted in all 50 states and the District of Columbia and throughout many countries in the world. Although CF neonatal screening will identify the vast majority of infants with CF, there are many factors in the newborn screening system that can lead to a missed diagnosis of CF. To inform clinicians, this article summarizes the CF newborn screening system and highlights 14 factors that can account for a missed diagnosis of CF. Care providers should maintain a high suspicion for CF if there are compatible symptoms, regardless of the results of the newborn screening test. These factors in newborn screening programs leading to a missed diagnosis of CF present opportunities for quality improvement in specimen collection, laboratory analysis of immunoreactive tryspinogen (IRT) and CF mutation testing, communication, and sweat testing. Pediatr Pulmonol. 2011; 46: 1166-1174. © 2011 Wiley Periodicals, Inc.

Trauma networks and the reform of trauma care in England

BMC Med. 2011 Nov 11;9(1):121. [Epub ahead of print]
Trauma networks: present and future challenges.
Kanakaris NK, Giannoudis PV.

ABSTRACT: In England, trauma is the leading cause of death across all age groups, with over 16,000 deaths per year. Major trauma implies the presence of multiple, serious injuries that could result in death or serious disability. Successive reports have documented the fact that the current ad hoc unstructured management of this patient group is associated with considerable avoidable death and disability. The reform of trauma care in England, especially of the severely injured patient, has already begun. Strong clinical leadership is embraced as the way forward. The present article summarises the steps that have been made over the last decade that led to the recent decision to move towards a long anticipated restructure of the National Health Service (NHS) trauma services with the introduction of Regional Trauma Networks (RTNs). While, for the first time, a genuine political will and support exists, the changes required to maintain the momentum for the implementation of the RTNs needs to be marshalled against arguments, myths and perceptions from the past. Such an approach may reverse the disinterest attitude of many, and will gradually evolve into a cultural shift of the public, clinicians and policymakers in the fullness of time.

From SUNY Downstate: Med mal from failure to notify test results

J Am Coll Radiol. 2011 Nov;8(11):776-9.
Failure to notify reportable test results: significance in medical malpractice.
Gale BD, Bissett-Siegel DP, Davidson SJ, Juran DC.
Department of Radiology, SUNY Downstate Medical Center, Brooklyn, New York.

Diagnostic physicians generally acknowledge their responsibility to notify referring clinicians whenever examinations demonstrate urgent or unexpected findings. During the past decade, clinicians have ordered dramatically greater numbers of diagnostic examinations. One study demonstrated that between 1996 and 2003, malpractice payments related to diagnosis increased by approximately 40%. Communication failures are a prominent cause of action in medical malpractice litigation. The aims of this study were to (1) define the magnitude of malpractice costs related to communication failures in test result notification and (2) determine if these costs are increasing significantly.

Linear regression analysis of National Practitioner Data Bank claims data from 1991 to 2009 suggested that claims payments increased at the national level by an average of $4.7 million annually (95% confidence interval, $2.98 million to $6.37 million). Controlled Risk Insurance Company/Risk Management Foundation claims data for 2004 to 2008 indicate that communication failures played a role, accounting for 4% of cases by volume and 7% of the total cost.

Faile communication of clinical data constitutes an increasing proportion of medical malpractice payments. The increase in cases may reflect expectations of more reliable notification of medical data. Another explanation may be that the remarkable growth in diagnostic test volume has led to a corresponding increase in reportable results. If notification reliability remained unchanged, this increased volume would predict more failed notifications.

There is increased risk for malpractice litigation resulting from diagnostic test result notification. The advent of semiautomated critical test result management systems may improve notification reliability, improve workflow and patient safety, and, when necessary, provide legal documentation.

Lung cancer and methylation profiling

Int J Oncol. 2011 Nov 7. doi: 10.3892/ijo.2011.1253. [Epub ahead of print]
Methylation profiling in non-small cell lung cancer: Clinical implications.
Morán A, Fernández-Marcelo T, Carro J, De Juan C, Pascua I, Head J, Gómez A, Hernando F, Torres AJ, Benito M, Iniesta P.
Department of Biochemistry and Molecular Biology, Faculty of Pharmacy, Complutense University, 28040-Madrid, Spain.

The aim of this study was to identify a panel of methylation markers that distinguish non-small cell lung cancers (NSCLCs) from normal lung tissues. We also studied the relation of the methylation profile to clinicopathological factors in NSCLC. We collected a series of 46 NSCLC samples and their corresponding control tissues and analyzed them to determine gene methylation status using the Illumina GoldenGate Methylation bead array, which screens up to 1505 CpG sites from 803 different genes. We found that 120 CpG sites, corresponding to 88 genes were hypermethylated in tumor samples and only 17 CpG sites (16 genes) were hypomethylated when compared with controls. Clustering analysis of these 104 genes discriminates almost perfectly between tumors and normal samples. Global hypermethylation was significantly associated with a worse prognosis in stage IIIA NSCLC patients (P=0.012). Moreover, hypermethylation of the CALCA and MMP-2 genes were statistically associated to a poor clinical evolution of patients, independently of TNM tumor stage (P=0.06, RR=2.64; P=0.04, RR=2.96, respectively). However, hypermethylation of RASSF1 turned out to be a protective variable (P=0.02; RR=0.53). In conclusion, our results could be useful for establishing a gene methylation pattern for the detection and prognosis of NSCLC.

From U Exeter: Radon gas and skin cancer?

Epidemiology. 2011 Nov 10. [Epub ahead of print]
Radon and Skin Cancer in Southwest England: An Ecologic Study.
Wheeler BW, Allen J, Depledge MH, Curnow A.
From the European Centre for Environment & Human Health, Peninsula College of Medicine & Dentistry, University of Exeter, Knowledge Spa, Royal Cornwall Hospital, Truro, United Kingdom.

Radon, a naturally occurring radioactive gas, is a carcinogen that causes a small proportion of lung cancers among exposed populations. Theoretical models suggest that radon may also be a risk factor for skin cancer, but epidemiologic evidence for this relationship is weak. In this study, we investigated ecologic associations between environmental radon concentration and the incidence of various types of skin cancer.

We analyzed data for 287 small areas (postcode sectors) in southwest England for the years 2000-2004. Poisson regression was used to compare registration rates of malignant melanoma, basal cell carcinoma, and squamous cell carcinoma across mean indoor radon concentrations from household surveys. Analyses were adjusted for potentially confounding factors, including age, sex, population socioeconomic status, and mean hours of bright sunshine.

No association was observed between mean postcode sector radon concentration and either malignant melanoma or basal cell carcinoma registration rates. However, sectors with higher radon levels had higher squamous cell carcinoma registration rates, with evidence of an exposure-response relationship. Comparing highest and lowest radon categories, postcode sectors with mean radon ≥230 Bq/m had registration rates 1.76 (95% confidence interval = 1.46-2.11) times those with mean radon 0-39 Bq/m. Associations persisted after adjustment for potential confounders.

This ecologic study suggests that environmental radon exposure may be a risk factor for squamous cell carcinoma. Further study is warranted to overcome ecologic design limitations and to determine whether this relationship is generalizable to national and international settings.

From UNC: Cancer staging and grading

Methods Mol Biol. 2012;823:1-18.
Tumor staging and grading: a primer.
Cowherd SM.
Internal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA,

Cancer staging and grading are used to predict the clinical behavior of malignancies, establish appropriate therapies, and facilitate exchange of precise information between clinicians. The internationally accepted criteria for cancer staging, the tumor-node-metastasis (TNM) system, includes: (1) tumor size and local growth (T); (2) extent of lymph node metastases (N); and (3) occurrence of distant metastases (M). Clinical stage is established before initiation of therapy and depends on the physical examination, laboratory findings, and imaging studies. Pathologic stage is determined following surgical exploration of disease spread and histological examination of tissue. The TNM classification system has evolved over 50 years to accommodate increasing knowledge about cancer biology. Efforts are ongoing to keep the system both synchronized with the most sophisticated cancer technology and simple for ease of clinician/patient use. Upcoming molecular technologies, such as genomic and proteomic profiling of tumors, microRNA profiling, and even ex vivo living tumor tissue treatment, could improve the current TNM staging system. This chapter describes the current TNM system using breast, lung, ovarian, and prostate cancer examples.

Tuesday, November 8, 2011

From U Texas Southwestern Med: Molecular biology of lung cancer

Clin Chest Med. 2011 Dec;32(4):703-40. Epub 2011 Oct 7.
Molecular biology of lung cancer: clinical implications.
Larsen JE, Minna JD.
Hamon Center for Therapeutic Oncology Research, Simmons Cancer Center, 6000 Harry Hines Boulevard, University of Texas Southwestern Medical Center, Dallas, TX 75390-8593, USA.

Lung cancer is a heterogeneous disease clinically, biologically, histologically, and molecularly. Understanding the molecular causes of this heterogeneity, which might reflect changes occurring in different classes of epithelial cells or different molecular changes occurring in the same target lung epithelial cells, is the focus of current research. Identifying the genes and pathways involved, determining how they relate to the biological behavior of lung cancer, and their utility as diagnostic and therapeutic targets are important basic and translational research issues. This article reviews current information on the key molecular steps in lung cancer pathogenesis, their timing, and clinical implications.

From Yale: Revised staging system for lung cancer

Clin Chest Med. 2011 Dec;32(4):741-8.
The revised stage classification system for primary lung cancer.
Boffa DJ.
Thoracic Surgery, Yale University School of Medicine, 330 Cedar Street, BB205, 208062, New Haven, CT 06520, USA.

The revised stage classification system has improved the ability of clinicians to estimate prognosis based on specific staging determinations. Several important questions have been addressed, although many remain and will likely fuel the discussion for subsequent revisions. Perhaps more than previous revisions, the current iteration may cause confusion because of the emphasis on stage-specific treatment recommendations. However, prognosis is only 1 of the factors in a multidisciplinary treatment plan, and clinicians are encouraged to apply randomized trial data whenever possible. This global staging effort is testament to the progress that is possible through international collaboration.

From Keck Med: Lung cancer-use/misuse of PET scans

Clin Chest Med. 2011 Dec;32(4):749-62.
The use and misuse of positron emission tomography in lung cancer evaluation.
Chang CF, Rashtian A, Gould MK.
Department of Medicine, Division of Pulmonary and Critical Care Medicine, Keck School of Medicine of USC, 2020 Zonal Avenue, IRD Room 723, Los Angeles, CA 90033, USA.

This article discusses the potential benefits and limitations of positron emission tomography (PET) for characterizing lung nodules, staging the mediastinum, identifying occult distant metastasis, determining prognosis and treatment response, guiding plans for radiation therapy, restaging during and after treatment, and selecting targets for tissue sampling. The key findings from the medical literature are presented regarding the capabilities and fallibilities of PET in lung cancer evaluation, including characterization of pulmonary nodules and staging in patients with known or suspected non-small-cell lung cancer. The discussion is limited to PET imaging with fluorodeoxyglucose.

From Yale: Lung cancer-diagnostic/therapeutic interventions

Clin Chest Med. 2011 Dec;32(4):763-71. Epub 2011 Oct 7.
The Pulmonologist's Diagnostic and Therapeutic Interventions in Lung Cancer.
Puchalski J, Feller-Kopman D.
Division of Pulmonary and Critical Care Medicine, Yale University School of Medicine, Boardman Building 205, 330 Cedar Street, New Haven, CT 06510, USA.

Diagnostic and therapeutic strategies for lung cancer have improved with advancing technology and the acquisition of the necessary skills by bronchoscopists to fully use these advanced techniques. The diagnostic yield for lung cancer has significantly increased with the advent of technologies such as endobronchial ultrasound, navigational systems, and improved imaging modalities. Similarly, the therapeutic benefit of bronchoscopy in advanced lung cancer has begun to be understood for its impact on quality and quantity of life. This article highlights the pulmonologists' diagnostic advances and therapeutic options, with an emphasis on outcomes.

From U Stellenbosch-SA: Functional evaluation before lung resection

Clin Chest Med. 2011 Dec;32(4):773-82.
Functional Evaluation before Lung Resection.
von Groote-Bidlingmaier F, Koegelenberg CF, Bolliger CT.
Division of Pulmonology, Department of Medicine, University of Stellenbosch, PO Box 19063, Tygerberg 7505, Cape Town, South Africa.

Lung cancer is the leading cause of cancer-related death worldwide, and lung resection remains the only curative approach. In the Western world, lung cancer is one of the main indications for lung resection, despite only 15% to 25% of all lung cancers being operable at the time of presentation. In most cases of operable lung cancer, a substantial part of functional lung tissue has to be resected, leading to a permanent loss of pulmonary function. Resection in patients with insufficient pulmonary reserves can result in permanent respiratory disability. This article reviews the current standards of preoperative assessment.

From U S Carolina: High risk patients with early stage lung cancer

Clin Chest Med. 2011 Dec;32(4):783-97. Epub 2011 Oct 7.
Evaluation and treatment of high-risk patients with early-stage lung cancer.
Mehta HJ, Ross C, Silvestri GA, Decker RH.
Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29425, USA.

Standard therapy for early-stage non-small cell lung cancer is lobectomy for patients who are able to tolerate such surgery. However, the risk of postoperative morbidity is not trivial, with a 30% to 40% incidence of postoperative complications and a 1% to 5% incidence of operative mortality. Some patients, though technically resectable, refuse surgery or are considered medically inoperable because of insufficient respiratory reserve, cardiovascular disease, or general frailty. This group is considered either "high risk" or "medically inoperable."

From Yale: Additional lung nodules in the patient with lung cancer

Clin Chest Med. 2011 Dec;32(4):811-25.
Additional pulmonary nodules in the patient with lung cancer: controversies and challenges.
Kim AW, Cooke DT.
Section of Thoracic Surgery, Department of Surgery, Yale School of Medicine, 330 Cedar Street, BB 205, New Haven, CT 06520, USA.

The optimal management of an additional pulmonary nodule in a patient with a known primary lung cancer is unclear. Additional pulmonary nodules are often identified during pathologic evaluation after resection of a primary tumor rather than before surgery. Although correlating these pathologic data with preoperative information can be useful, their applicability to management and decision making is often limited. This article focuses on the malignant additional pulmonary nodule in the same lobe as the known primary tumor, in a different lobe in the same lung as the known primary tumor, and in the contralateral lung.

From U S Carolina: Advances in treatment for early stage lung cancer

Clin Chest Med. 2011 Dec;32(4):827-38. Epub 2011 Oct 7.
A decade of advances in treatment of early-stage lung cancer.
Paoletti L, Pastis NJ, Denlinger CE, Silvestri GA.
Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, 96 Jonathan Lucas Street, CSB 812, Charleston, SC 29425, USA.

Emerging from the past decade, there has been a diversification of options for the treatment of early-stage lung cancer. Video-assisted thoracoscopic surgery is now more widely performed, with oncologic outcomes equivalent to those with open thoracotomy. Although lobectomy remains the standard approach to surgical resection, lesser resections, such as segmentectomy and wedge resection, are considerations for some patients. Advances in surgical, radiation, and medical therapies continue to evolve. Future research questions will focus on comparing long-term outcomes with these modalities, including survival, as well as patient-centered endpoints, such as quality of life.

From Yale: Advances in treatment for advanced lung cancer

Clin Chest Med. 2011 Dec;32(4):839-51.
A decade of advances in treatment for advanced non-small cell lung cancer.
Gettinger S, Lynch T.
Division of Medical Oncology, Yale University School of Medicine, 333 Cedar Street, FMP 127, New Haven, CT 06520, USA.

The last decade has heralded a paradigm shift in the evaluation and treatment of advanced non-small cell lung cancer (NSCLC). No longer are patients with NSCLC considered a homogeneous population treated in the same way; rather, clinical characteristics, histology, and an expanding array of molecular markers are increasingly being used to individualize therapy. Both histology and tumor epidermal growth factor receptor mutational status currently have firmly established roles in determining initial and salvage therapy for advanced NSCLC. Several other biomarkers are the focus of ongoing prospective randomized clinical trials customizing both traditional chemotherapy and newer molecularly targeted agents.

From Stanford: Small cell lung cancer treatment

Clin Chest Med. 2011 Dec;32(4):853-63. Epub 2011 Sep 28.
Current management of small cell lung cancer.
Neal JW, Gubens MA, Wakelee HA.
Stanford Cancer Institute, Department of Medicine, Stanford University, 875 Blake Wilbur Drive, Stanford, CA 94305-5826, USA.

Confined to one side of the chest, limited stage small cell lung cancer is treated with a combination of chemotherapy and radiotherapy, yet has a long-term survival rate of only 15%. Extensive stage disease has initial response rates to chemotherapy exceeding 70%. However, the disease almost invariably progresses and becomes fatal. Many recent clinical trials have failed to show superiority of newer chemotherapeutics or targeted therapies compared with the standard chemotherapy backbone of platinum plus etoposide. Numerous promising targeted therapies and other agents are still in development.

From U Penn: Gene therapy for lung neoplasms--includes other thoracic neoplasms

Clin Chest Med. 2011 Dec;32(4):865-85. Epub 2011 Oct 7.
Gene therapy for lung neoplasms.
Vachani A, Moon E, Wakeam E, Haas AR, Sterman DH, Albelda SM.
Division of Pulmonary, Allergy & Critical Care Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.

Both advanced-stage lung cancer and malignant pleural mesothelioma are associated with a poor prognosis. Advances in treatment regimens for both diseases have had only a modest effect on their progressive course. Gene therapy for thoracic malignancies represents a novel therapeutic approach and has been evaluated in several clinical trials. Strategies have included induction of apoptosis, tumor suppressor gene replacement, suicide gene expression, cytokine-based therapy, various vaccination approaches, and adoptive transfer of modified immune cells. This review considers the clinical results, limitations, and future directions of gene therapy trials for thoracic malignancies.

From U Utah: More on the hot topic of lung cancer screening

Hosp Pract (Minneap). 2011 Nov;39(4):107-12.
Lung cancer screening: a review of available data and current guidelines.
Reddy C, Chilla D, Boltax J.
University of Utah Health Sciences Center, Salt Lake City, UT.

Lung cancer is the leading cause of cancer mortality worldwide. A lack of clinical symptoms in early-stage disease frequently leads to diagnosis at a late stage, and a 15% 5-year survival rate in all patients so diagnosed. This has led to significant interest in effective screening methods to detect early-stage cancers, particularly for high-risk groups, such as current or former smokers. Early clinical trials focused on chest radiograph with or without sputum cytology and failed to show an improvement in mortality with screening. A meta-analysis also failed to show a difference in all-cause mortality. Subsequent protocols compared low-dose computed tomography (LDCT) scan with chest radiograph and documented increased detection of early-stage disease; however, they were not designed to prove a reduction in mortality. The most recent trials have focused on LDCT scans, including the National Lung Screening Trial. Data released from the National Lung Screening Trial demonstrated a statistically significant reduction in lung cancer deaths in patients screened with LDCT scans. When data from the study, including cost-effectiveness, are completely analyzed, they may lead to revision of current lung cancer screening recommendations to include LDCT scans in specific populations at high risk of developing lung cancer.

From U Adelaide: 1/3 of men diagnosed with cancer modify diet and/or seek spiritual guidance

Ann Oncol. 2011 Nov 5. [Epub ahead of print]
Prevalence and predictors of complementary and alternative medicine (CAM) use by men in Australian cancer outpatient services.
Klafke N, Eliott JA, Wittert GA, Olver IN.
School of Psychology, The University of Adelaide, Adelaide.

Although studies have shown that complementary and alternative medicine (CAM) use is common in cancer patients, no survey has assessed CAM use in men with a variety of cancers. In Australia, no data exist about male cancer patients' use of CAM.

A self-administered questionnaire was completed by 403 men attending four cancer outpatient services in Metropolitan Adelaide. Data were analyzed using Pearson's χ(2) tests and multivariate logistic regression analysis.

CAMs were currently used by 52.9%, or used at some point by 61.5%, of respondents. The most popular CAM treatments were dietary supplements (36.1%), prayer (25.9%), herbs and botanicals (21.4%), and relaxation techniques/meditation (15.2%). CAM use was directed by a cancer specialist in 9.9% of respondents. Independent predictors of CAM use were metastatic cancer (P = 0.022), actively practicing religion (P = 0.008), and tertiary education (P = 0.007).

CAM use in males is equally common across all cancer diagnoses, namely prostate, hematological malignancies, colorectal, lung, and other cancers. Oncologists should be aware that one-third of male patients modify their diet and/or search for spiritual guidance, particularly when diagnosed with metastatic cancer.

From Pozan U-Poland: Quality of life in patients with advanced lung cancer

Am J Hosp Palliat Care. 2011 Nov 3. [Epub ahead of print]
Quality of Life in Patients With Advanced Lung Cancer Treated at Home and at a Palliative Care Unit.
Leppert W, Turska A, Majkowicz M, Dziegielewska S, Pankiewicz P, Mess E.
Chair and Department of Palliative Medicine, Poznan University of Medical Sciences, Poznan, Poland.

Background: To assess quality of life (QOL) in patients with advanced lung cancer. Patients and

A prospective study of 78 patients cared at home and at a palliative care unit (PCU) with 2 QOL assessments was conducted.

Fifty patients completed the study. In the EORTC QLQ-C30 role, cognitive, social functioning, global QOL, fatigue, pain, dyspnea, and appetite deteriorated; nausea/vomiting improved; dyspnea was more intense in the case of in-home patients. In the EORTC QLQ-LC13 hemoptysis improved; pain in other parts was more intense in the PCU patients. Pain (Visual Analogue scale) was more intense in the PCU patients; the level of activity (Karnofsky) decreased in the case of patients treated at home.

QOL deteriorated with few differences between home and the PCU patients.

From Thorax: Therapeutic advances in lung cancer

Thorax. 2011 Nov 5. [Epub ahead of print]
Therapeutic advances in non-small cell lung cancer.
Vallières E, Peters S, Van Houtte P, Dalal P, Lim E.
Department of Thoracic Surgery, Swedish Cancer Institute, Seattle, Washington, USA.

Despite decades of research, therapeutic advances in non-small cell lung cancer (NSCLC) have progressed at a painstaking slow rate with few improvements in standard surgical resection for early stage disease and chemotherapy or radiotherapy for patients with advanced disease. In the past 18 months, however, we seemed to have reached an inflexion point: therapeutic advances that are centred on improvements in the understanding of patient selection, surgery that is undertaken through smaller incisions, identification of candidate mutations accompanied by the development of targeted anticancer treatments with a focus on personalised medicine, improvements to radiotherapy technology, emergence of radiofrequency ablation (RFA), and last but by no means least, the recognition of palliative care as a therapeutic modality in its own right. The contributors to this review are a distinguished international panel of experts who highlight recent advances in each of the major disciplines.