Saturday, January 29, 2011

Research integrity. That is what it is ALL about.

Pharm Stat. 2011 Jan;10(1):74-79. doi: 10.1002/pst.429.
The potential for bias in reporting of industry-sponsored clinical trials.
Pyke S, Julious SA, Day S, O'Kelly M, Todd S, Matcham J, Seldrup J.

Pfizer Ltd, Sandwich, UK.
Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell. In 2005 an Editorial in Journal of the American Medical Association made clear that, so great was their concern about misleading reporting of industry-sponsored studies, henceforth no article would be published that was not also guaranteed by independent statistical analysis. We examine the precursors to this Editorial, as well as its immediate and lasting effects for statisticians, for the manner in which statistical analysis is carried out, and for the industry more generally.

From Bryan Liang and colleagues: But will hospitals take advantage of AHRQ?

Patient Safety Data Sharing and Protection from Legal Discovery.
Suydam S, Liang BA, Anderson S, Weinger MB.
In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Advances in Patient Safety.

The Institute of Medicine report, To Err Is Human, recommended that collaborative networks of health care organizations should exchange information regarding medical errors to prevent the same errors from being repeated. Another recommendation, that Congress enact legislation protecting such exchanged information from legal discovery, has not occurred. Even if such legislation does pass, it may conflict with existing Federal discovery requirements. Nevertheless, existing State and Federal law may offer some protection. The most promising source of existing protection for all members of patient safety collaboratives is 42 U.S.C. §299c-3(c), which extends protection to data collection sponsored by the Agency for Healthcare Research and Quality (AHRQ). The Department of Health and Human Services' confidentiality certificates and State peer review protection laws may offer little if any protection. However, with AHRQ sponsorship and the proper structure, health care organizations may be able to safely exchange information with one another without fear of liability or disclosure of sensitive information.

Cystic fibrosis: Depression and anxiety in adolescent and young adult patients

Pediatr Pulmonol. 2011 Feb;46(2):153-9. doi: 10.1002/ppul.21334. Epub 2010 Nov 17.
Screening for symptoms of depression and anxiety in adolescents and young adults with cystic fibrosis.
Modi AC, Driscoll KA, Montag-Leifling K, Acton JD.

Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.
BACKGROUND: Although studies have assessed symptoms of depression and anxiety in individuals with cystic fibrosis (CF), few have been conducted since the advent of new medical treatments (e.g., nebulized antibiotics, ThAIRpy Vest). Study objectives were to: (1) document symptoms of depression and anxiety for adolescents and young adults with CF and compare with normative values, (2) examine the associations among depressive/anxiety symptoms and gender, age, lung function, and body mass index, and (3) determine the relations between adolescent and caregiver symptoms of depression and anxiety.

METHODS: Patients and caregivers completed the Hospital Anxiety and Depression Scale (HADS) anytime (e.g., beginning or end) during routine CF clinic appointments.

RESULTS: Participants included 59 adolescents/young adults with CF (M(age)  = 15.8 years, 54% female, 98% Caucasian, M(FEV1% predicted)  = 84.6) and caregivers of 40 adolescents. Although symptom scores were in the normative range for patients with CF (M(Depression)  = 2.27 and M(Anxiety)  = 5.59), 3% and 32% exhibited clinically elevated symptoms of depression and anxiety, respectively. Symptoms of depression and anxiety were significantly associated with age (r = 0.28, 0.36). Symptoms of depression and anxiety were also positively correlated (r = 0.48). Females endorsed higher anxiety symptoms than males. While adolescent and caregiver anxiety scores were not related, higher caregiver depressive symptoms were associated with older patient age and worse lung function.

CONCLUSIONS: Data from the current study suggest low levels of depressive symptoms and substantial levels of anxiety symptoms in adolescents and young adults with CF. Consistent with prior literature, depressive symptoms appear higher in older patients and are significantly associated with anxiety symptoms. Caregiver symptomology appears to be more affected by an adolescent's health status, suggesting a need to screen caregivers when health begins to decline.

More needs to be done to study this: Diabetes treatment by HDAC inhibition

Mol Med. 2011 Jan 25. doi: 10.2119/molmed.2011.00021. [Epub ahead of print]
HDAC inhibition as a novel treatment for diabetes mellitus.
Christensen DP, Dahllöf M, Lundh M, Rasmussen DN, Nielsen MD, Billestrup N, Grunnet LG, Mandrup-Poulsen T.

Center for Medical Research Methodology, Dept. of Biomedical Sciences, University of Copenhagen, Denmark.
Both common forms of diabetes have an inflammatory pathogenesis in which immune and metabolic factors converge on IL-1β as a key mediator of insulin resistance and beta-cell failure. In addition to improving insulin resistance and preventing β-cell inflammatory damage there is evidence of genetic association between diabetes and histone deacetylases (HDACs), and HDAC inhibitors promote b-cell development, proliferation, differentiation and function and positively impact on late diabetic microvascular complications. Here we review this evidence and propose that there is a strong rationale for preclinical studies and clinical trials with the aim of testing the utility of HDACi as a novel therapy for diabetes.

From Harvard: Recruitment maneuvers for ARDS patients

Minerva Anestesiol. 2011 Jan;77(1):85-89.
Lung recruitment maneuvers during acute respiratory distress syndrome: is it useful?
Kacmarek RM, Villar J.

Department of Anesthesiology, Harvard Medical School, Boston, MA, USA -
Although significant advances have been made in approaches to manage the acute respiratory distress syndrome (ARDS), reported overall mortality for ARDS is still high. Recruitment maneuvers (RM) have been recommended by some as potential adjuncts to lung protective ventilatory approaches in ARDS. In this point of view issues surrounding the use of RM in ARDS are addressed. Specifically, the ability of RM to open the lung, the safety of RM, and their affect on outcome are addressed. Finally, a specific approach to performing RM with the use of a decremental PEEP trial is outlined.

Related: Fragmentation of care and future physicians' skills

Acad Med. 2011 Feb;86(2):158-160.
Commentary: Health Care Reform and Primary Care: Training Physicians for Tomorrow's Challenges.
Caudill TS, Lofgren R, Jennings CD, Karpf M.

Dr. Caudill is chief of internal medicine and associate professor of medicine, UK HealthCare, University of Kentucky, Lexington, Kentucky. Dr. Lofgren is vice president for health care operations and chief clinical officer, UK HealthCare, University of Kentucky, Lexington, Kentucky. Dr. Jennings is senior associate dean for medical education, UK HealthCare, University of Kentucky, Lexington, Kentucky. Dr. Karpf is executive vice president for health affairs, UK HealthCare, University of Kentucky, Lexington, Kentucky.
Although Congress recently passed health insurance reform legislation, the real catalyst for change in the health care delivery system, the author's argue, will be changes to the reimbursement model. To rein in increasing costs, the Centers for Medicare and Medicaid aims to move Medicare from the current fee-for-service model to a reimbursement approach that shifts the risk to providers and encourages greater accountability both for the cost and the quality of care. This level of increased accountability can only be achieved by clinical integration among health care providers.Central to this reorganized delivery model are primary care providers who coordinate and organize the care of their patients, using best practices and evidence-based medicine while respecting the patient's values, wishes, and dictates. Thus, the authors ask whether primary care physicians will be available in sufficient numbers and if they will be adequately and appropriately trained to take on this role.Most workforce researchers report inadequate numbers of primary care doctors today, a shortage that will only be exacerbated in the future. Even more ominously, the authors argue that primary care physicians being trained today will not have the requisite skills to fulfill their contemplated responsibilities because of a variety of factors that encourage fragmentation of care. If this training issue is not debated vigorously to determine new and appropriate training approaches, the future workforce may eventually have the appropriate number of physicians but inadequately trained individuals, a situation that would doom any effort at system reform.

Good study on the elderly from USC, but the conclusion carries no surprises

Cardiol Res Pract. 2011 Jan 9;2011:983764.
Lifestyle Practices and Cardiovascular Disease Mortality in the Elderly: The Leisure World Cohort Study.
Paganini-Hill A.

Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA 90089, USA.
Modifiable behavioral risk factors are major contributing causes of death, but whether the effects are maintained in older adults is uncertain. We explored the association of smoking, alcohol consumption, caffeine intake, physical activity, and body mass index on cardiovascular disease (CVD) mortality in 13,296 older adults and calculated risk estimates using Cox regression analysis in four age groups (<70, 70-74, 75-79, and 80+ years). The most important factor was current smoking, which increased risk in all age-sex groups. In women, alcohol consumption (≤3 drinks/day) was related to decreased (15-30%) risk in those <80 years old; in men, 4+ drinks/day was associated with reduced (15-30%) risk. Active 70+ year olds had 20-40% lower risk. Both underweight and obese women were at increased risk. Lifestyle practices impact CVD death rates in older adults, even those aged 80+ years. Not smoking, moderate alcohol consumption, physical activity, and normal weight are important health promoters in our aging population.

Will non-platinum-based chemotherapy for lung cancer become common?

Anticancer Res. 2011 Jan;31(1):317-323.
Randomized Phase II Study of Paclitaxel and Carboplatin or Vinorelbine in Advanced Non-small Cell Lung Cancer.
Jahnke K, Keilholz U, Lüftner D, Thiel E, Schmittel A.

Department of Hematology and Oncology, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
BACKGROUND: A randomized phase II trial was conducted to determine if two non-platinum protocols are able to yield a similar efficacy and toxicity profile as compared to two platinum-based doublets in advanced non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS: A total of 61 patients were randomly assigned to a reference regimen of carboplatin and paclitaxel (repeated every 3 weeks) or to one of three experimental regimens: paclitaxel plus vinorelbine (repeated every 3 or 4 weeks) and carboplatin plus paclitaxel (repeated every 4 weeks).

RESULTS: The objective remission rate for all the patients was 34.1%. The median progression-free survival for all the patients was 3 months. The median overall survival and one-year overall survival were 6 months and 21.5%, respectively. Toxicity was moderate and manageable. Response, survival and toxicity did not significantly differ between the four treatment groups.

CONCLUSION: The efficacy and toxicity profile of platinum-free combinations is comparable to that of platinum-based doublets.

Wednesday, January 26, 2011

Smoking is associated with lung diseases other than cancer

Eur Respir J. 2011 Jan 13. [Epub ahead of print]
Interstitial lung diseases in a lung cancer screening trial.
Sverzellati N, Guerci L, Randi G, Calabrò E, La Vecchia C, Marchianò A, Pesci A, Zompatori M, Pastorino U.

University of Parma Italy.
We assessed the prevalence of interstitial lung disease (ILD) in a cohort of smokers included in a lung cancer screening trial. Two observers independently reviewed for the presence of the CT findings consistent with ILD the CT examinations of 692 heavy smokers recruited by the Multicentric Italian Lung Detection (MILD) trial. Four CT patterns were considered: usual interstitial pneumonia (UIP), other chronic interstitial pneumonia (OCIP), respiratory bronchiolitis (RB) and indeterminate. Subsequently, the evolution of ILD in those subjects undergone a repeat CT examination after three years was assessed. The UIP pattern and the OCIP pattern were identified in 2/692 (0.3%) and 26/692 (3.8%) patients, respectively; 109/692 (15.7%) patients showed CT abnormalities consistent with RB, while an indeterminate CT pattern was reported in 21/692 (3%) subjects Age, male sex and current smoking status were factors associated with the presence of OCIP and UIP (combined) pattern, although such relationship did not attain statistical significance. A progression of the disease was observed in 3/12 (25%) subjects with OCIP undergone repeat CT after three years. Thin-section CT features of ILD, probably representing smoking-related ILD, are not uncommon in a lung cancer screening population and should not be overlooked.

Diabetes and cognitive function in the elderly

Nat Rev Endocrinol. 2011 Feb;7(2):108-114.
Cognitive function, dementia and type 2 diabetes mellitus in the elderly.
Strachan MW, Reynolds RM, Marioni RE, Price JF.

Metabolic Unit, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK.
Increasing numbers of people are developing type 2 diabetes mellitus, but interventions to prevent and treat the classic microvascular and macrovascular complications have improved, so that people are living longer with the condition. This trend means that novel complications of type 2 diabetes mellitus, which are not targeted by current management strategies, could start to emerge. Cognitive impairment and dementia could come into this category. Type 2 diabetes mellitus is associated with a 1.5-2.5-fold increased risk of dementia. The etiology of dementia and cognitive impairment in people with type 2 diabetes mellitus is probably multifactorial. Chronic hyperglycemia is implicated, perhaps by promoting the development of cerebral microvascular disease. Data suggest that the brains of older people with type 2 diabetes mellitus might be vulnerable to the effects of recurrent, severe hypoglycemia. Other possible moderators of cognitive function include inflammatory mediators, rheological factors and dysregulation of the hypothalamic-pituitary-adrenal axis. Cognitive function should now be included as a standard end point in randomized trials of therapeutic interventions in patients with type 2 diabetes mellitus.

From Harvard: Cystic fibrosis and illness perception

Associations between illness perceptions and health-related quality of life in adults with cystic fibrosis.
Sawicki GS, Sellers DE, Robinson WM.

Division of Respiratory Diseases, Children's Hospital Boston, Harvard Medical School, Boston, MA, USA.
OBJECTIVE: The objective of this work was to examine the relationship between illness perception, health status, and health-related quality of life (HRQOL) in a cohort of adults with cystic fibrosis (CF).

METHODS: In the Project on Adult Care in Cystic Fibrosis, we administered five subscales (Illness Consequences, Illness Coherence, Illness Timeline-Cyclical, Personal Control, and Treatment Control) of the Illness Perception Questionnaire-Revised (IPQ-R). Multivariable linear regression analyses explored the associations between illness perception, health status, symptom burden, and physical and psychosocial HRQOL, as measured by various domains of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).

RESULTS: Among the 199 respondents (63% female; mean age, 36.8±10.2 years), IPQ-R scores did not differ on age, gender, or lung function. In multivariable regression models, neither clinical characteristics nor physical or psychological symptom burden scores were associated with CFQ-R physical domains. In contrast, higher scores on Illness Consequences were associated with lower psychosocial CFQ-R scores. Higher scores on the Illness Coherence and Personal Control scales were associated with higher psychosocial CFQ-R scores.

CONCLUSION: Adults with CF report a high understanding of their disease, feel that CF has significant consequences, and endorse both personal and treatment control over their outcomes. Illness perceptions did not vary with increased age or worsening disease severity, suggesting that illness perceptions may develop during adolescence. Illness perceptions were associated with psychosocial, but not physical, aspects of HRQOL. Efforts to modify illness perceptions as part of routine clinical care and counseling may lead to improved quality of life for adults with CF.

Primary care and health care reform

Issue Brief (Commonw Fund). 2011 Jan;1:1-28.
Realizing health reform's potential: how the Affordable Care Act will strengthen primary care and benefit patients, providers, and payers.
Abrams M, Nuzum R, Mika S, Lawlor G.

Patient-Centered Coordinated Care, The Commonwealth Fund.
Although primary care is fundamental to health system performance, the United States has undervalued and underinvested in primary care for decades. This brief describes how the Affordable Care Act will begin to address the neglect of America's primary care system and, wherever possible, estimates the potential impact these efforts will have on patients, providers, and payers. The health reform law includes numerous provisions for improving primary care: temporary increases in Medicare and Medicaid payments to primary care providers; support for innovation in the delivery of care, with an emphasis on achieving better health outcomes and patient care experiences; enhanced support of primary care providers; and investment in the continued development of the primary care workforce.

Pediatrics fellowship-Worth it?

Does Fellowship Pay: What Is the Long-term Financial Impact of Subspecialty Training in Pediatrics?
Rochlin JM, Simon HK.

Objectives: To (1) analyze the financial returns of fellowship training in pediatrics and to compare them with those generated from a career in general pediatrics and (2) evaluate the effects of including the newly enacted federal loan-repayment program and of changing the length of fellowship training. Background: Although the choice to enter fellowship is based on many factors, economic considerations are important. We are not aware of any study that has focused on the financial impact of fellowship training in pediatrics. Methods: Using standard financial techniques, we estimated the financial returns that a graduating pediatric resident might anticipate from additional fellowship training followed by a career as a pediatric subspecialist and compared them with the returns that might be expected from starting a career as a general pediatrician immediately after residency. Results: The financial returns of pediatric fellowship training varied greatly depending on which subspecialty fellowship was chosen. Pursuing a fellowship in most pediatric subspecialties was a negative financial decision when compared with pursuing no fellowship at all and practicing as a general pediatrician. Incorporating the federal loan-repayment program targeted toward pediatric subspecialists and decreasing the length of fellowship training from 3 to 2 years would substantially increase the financial returns of the pediatric subspecialties. Conclusions: Pediatric subspecialization yielded variable financial returns. The results from this study can be helpful to current pediatric residents as they contemplate their career options. In addition, our study may be valuable to policy makers evaluating health care reform and pediatric workforce-allocation issues.

From Mayo: Lung cancer treatment and quality of life

Cancer J. 2011 January/February;17(1):63-67.
Metrics to Assess Quality of Life After Management of Early-Stage Lung Cancer.
Sloan JA.

From the Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
Quality of life (QOL) is a key clinical outcome in patients with lung cancer because of the debilitating nature of the disease and its treatments. In recent years, advances have been made in the assessment of QOL via patient-reported outcomes. A brief history of the evolution of QOL measures in oncology clinical trials and practice is given with specific reference to early-stage lung cancer. The role that QOL can play as a prognostic factor, especially among lung cancer patients, is delineated. The most commonly seen symptoms among lung cancer patients are listed. This review is intended to provide the clinical researcher with a summary of the alternative measures that are both valid and reasonable to consider when assessing QOL in early-stage lung cancer patients. Suggestions for QOL assessment in both a research setting and clinical environment are considered. A review of the most popular QOL assessments in general application to lung cancer and disease-specific measures is provided. An algorithm for selecting appropriate QOL assessments for lung cancer clinical research is provided. The primary conclusion from this work is that scientifically sound investigations into the QOL of early-stage lung cancer patients are feasible and encouraged so that the care of these patients can be optimized.

Socioeconomic factors, race, and cancer treatment and survival

Cancer. 2011 Jan 24. doi: 10.1002/cncr.25854. [Epub ahead of print]
Effects of individual-level socioeconomic factors on racial disparities in cancer treatment and survival: Findings from the National Longitudinal Mortality Study, 1979-2003.
Du XL, Lin CC, Johnson NJ, Altekruse S.

University of Texas School of Public Health, Division of Epidemiology, Houston, Texas.
BACKGROUND: This is the first study to use the linked National Longitudinal Mortality Study and Surveillance, Epidemiology, and End Results (SEER) data to determine the effects of individual-level socioeconomic factors (health insurance, education, income, and poverty status) on racial disparities in receiving treatment and in survival.

METHODS: This study included 13,234 cases diagnosed with the 8 most common types of cancer (female breast, colorectal, prostate, lung and bronchus, uterine cervix, ovarian, melanoma, and urinary bladder) at age ≥25 years, identified from the National Longitudinal Mortality Study-SEER data during 1973 to 2003. Kaplan-Meier methods and Cox regression models were used for survival analysis.

RESULTS: Three-year all-cause observed survival for cases diagnosed with local-stage cancers of the 8 leading tumors combined was ≥82% regardless of race/ethnicity. More favorable survival was associated with higher socioeconomic status. Compared with whites, blacks were less likely to receive first-course cancer-directed surgery, perhaps reflecting a less favorable stage distribution at diagnosis. Hazard ratio (HR) for cancer-specific mortality was significantly higher among blacks compared with whites (HR, 1.2; 95% confidence interval [CI], 1.1-1.3) after adjusting for age, sex, and tumor stage, but not after further controlling for socioeconomic factors and treatment (HR, 1.0; 95% CI, 0.9-1.1). HRs for all-cause mortality among patients with breast cancer and for cancer-specific mortality in patients with prostate cancer were significantly higher for blacks compared with whites after adjusting for socioeconomic factors, treatment, and patient and tumor characteristics.

CONCLUSIONS: Favorable survival was associated with higher socioeconomic status. Racial disparities in survival persisted after adjusting for individual-level socioeconomic factors and treatment for patients with breast and prostate cancer.

Tuesday, January 25, 2011

Another obstacle to improving patient care?

Does Medical Error Disclosure Violate the Medical Malpractice Insurance Cooperation Clause?.
Banja JD.
In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Advances in Patient Safety.

Medical malpractice insurance policies customarily contain a “cooperation” clause requiring insureds to cooperate with the insurer's efforts to defend the insured against a claim. A common stipulation in this clause forbids the insured from “admitting liability” to an injured or harmed party. Health professionals often understand this clause to have a chilling effect on the truthful disclosure of medical error, which is morally required of physicians when they know that a harm-causing error has occurred. This paper offers a two-part response to the fear that medical error disclosure might result in a denial of malpractice insurance coverage. Part one describes various legal precedents wherein insurers successfully invoked the cooperation clause to deny coverage in instances of liability admission. This paper shows, however, that the legally sanctioned reasons for denying coverage in these cases address factors other than an insured's truthful and honest disclosure of what happened to a claimant. Consequently, these cases do not support the belief that legal precedents discourage the truthful disclosure of harm-causing medical errors. Part two of this paper proposes that the cooperation clause's prohibition of admission of liability in instances of medical error disclosure might well be unenforceable, and that the clause might not even be actuarially sound.

Treating lung cancer in the elderly

J Thorac Oncol. 2011 Jan 20. [Epub ahead of print]
Treatment of the Elderly When Cure is the Goal: The Influence of Age on Treatment Selection and Efficacy for Stage III Non-small Cell Lung Cancer.
Coate LE, Massey C, Hope A, Sacher A, Barrett K, Pierre A, Leighl N, Brade A, de Perrot M, Waddell T, Liu G, Feld R, Burkes R, Cho BC, Darling G, Sun A, Keshavjee S, Bezjak A, Shepherd FA.

Departments of *Medical Oncology and Hematology, †Biostatistics, ‡Radiation Oncology, and §Thoracic Surgery, University Health Network, Princess Margaret Hospital and Toronto General Hospitals Sites and the University of Toronto, Toronto, Ontario, Canada.
BACKGROUND: Treatment of elderly patients with stage III NSCLC is controversial. Limited data exist, as the elderly are underrepresented in clinical trials.

METHODS: After ethics approval, we performed a retrospective review of 1372 stage III NSCLC patients treated at our institution during the period 1997-2007. Patients with malignant effusions and microscopic N2 discovered only postoperatively were excluded, leaving 740 who were classified by treatment plan: palliative (palliative chemotherapy or radiation [≤40 Gy]); nonsurgical multimodality (>40 Gy radiation ± chemotherapy); or surgical multimodality (chemotherapy, radiation, and surgery). Demographics, treatment, toxicity, and survival were analyzed by age, 0 to 65 years, n = 384; 66 to 75 years, n = 256; 76+ years, n = 100, and compared using log-rank, univariate, and multivariate statistical tests.

RESULTS: Patients older than 65 years were more likely to have poor performance status (p < 0.0001), multiple comorbidities (p < 0.0001), and to receive palliative therapy only (p < 0.0001). Older and younger patients treated with curative intent with nonsurgical bimodality therapy or trimodality therapy including surgery had similar rates of grade 3/4 toxicity (0-65 years, 39%; 66-75 years, 43%; 76+ years, 5%; p = 0.18) and toxic death (0-65 years, 4%; 66-75 years, 4%; 76+ years, 0%; p = 0.76). Survival was worse with increasing age (p < 0.0001), likely due to greater use of palliative treatment in the elderly. When survival was analyzed for patients treated with curative intent, there was no difference between age groups for nonsurgical (p = 0.32) or surgical (p = 0.53) therapy.

CONCLUSION: In select fit elderly patients, combined modality therapy is tolerable and is associated with survival similar to that of younger patients.

Smoking and lung cancer recurrence in Japan

J Thorac Oncol. 2011 Jan 20. [Epub ahead of print]
The Prognostic Impact of Cigarette Smoking on Patients with Non-small Cell Lung Cancer.
Maeda R, Yoshida J, Ishii G, Hishida T, Nishimura M, Nagai K.

*Department of Thoracic Oncology, National Cancer Center Hospital East; and †Department of Pathology, Research Center for Innovative Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
INTRODUCTION: The purposes of this study are to investigate the association between cigarette smoking and clinicopathological characteristics of patients with non-small cell lung cancer (NSCLC) and to evaluate its significance as a predictor of recurrence after resection.

METHODS: A total of 2295 consecutive patients with NSCLC underwent complete resection with systematic node dissection between August 1992 and December 2006 at the National Cancer Center Hospital East.

RESULTS: A statistically significant difference in the 5-year overall survival rate was observed between never and ever smokers in patients with stage I (92% and 76%, respectively, p < 0.001) NSCLC, whereas no difference was observed in stage II (57% and 52%, respectively, p = 0.739) and stage III (30% and 33%, respectively, p = 0.897). In patients with stage I NSCLC, 5-year recurrence-free proportions (RFPs) for never and ever smokers were 89% and 80%, respectively (p < 0.001). In contrast, the 5-year RFPs for never smokers were lower than those for ever smokers in stage II (44% and 60%, respectively, p = 0.049) and stage III (17% and 31%, respectively, p = 0.004). In stage I patients, significant difference in 5-year RFP was observed between never and ever smokers (89% and 83%, respectively) in patients with adenocarcinoma, but not in patients with nonadenocarcinoma (82% and 76%, respectively).

CONCLUSIONS: Smoking history showed different impact on postoperative recurrence in patients with NSCLC between stage I and stages II and III, and depending on histology in stage I patients. Disease stages should be considered while evaluating smoking history as a predictor of recurrence.

TAZ and lung cancer

Oncogene. 2011 Jan 24. [Epub ahead of print]
TAZ is a novel oncogene in non-small cell lung cancer.
Zhou Z, Hao Y, Liu N, Raptis L, Tsao MS, Yang X.

Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada.
Transcriptional coactivator with PDZ-binding motif (TAZ) is a transcriptional coactivator involved in the differentiation of stem cell as well as the development of multiple organs. Recently, TAZ has also been identified as a major component of the novel Hippo-LATS tumor suppressor pathway and to function as an oncogene in breast cancer. We show for the first time that TAZ is an oncogene in non-small cell lung cancer (NSCLC). Our results show that TAZ is overexpressed in NSCLC cells and that lentivirus-mediated overexpression of TAZ in HBE135 immortalized human bronchial epithelial cells causes increased cell proliferation and transformation, which can be restored back to its original levels by knockdown of TAZ. In addition, short-hairpin RNA (shRNA)-mediated knockdown of TAZ expression in NSCLC cells suppresses their proliferation and anchorage-independent growth in vitro, and tumor growth in mice in vivo, which can be reversed by re-introduction of shRNA-resistant TAZ into TAZ-knockdown NSCLC cells. These results indicate that TAZ is an oncogene and has an important role in tumorigenicity of NSCLC cells. Therefore, TAZ may present a novel target for the future diagnosis, prognosis and therapy of lung cancer.

Mor Baan in Southern Thailand

J Community Health. 2011 Jan 23. [Epub ahead of print]
Existing Roles of Traditional Healers (mor baan) in Southern Thailand.
Suwankhong D, Liamputtong P, Rumbold B.

School of Public Health, La Trobe University, Bundoora, VIC, 3086, Australia.
Traditional healers ( mor baan ) played an important role in Thai health long before the introduction of Western medicine. Although modern health professional play a key role of health care provider of Thai health care system, traditional healers and their practice still exist in most rural areas of Thailand. In this article, we address the roles and practices of traditional healers in southern Thailand. An ethnographic method was employed. This approach is the hallmark method used to describe the role and the practice of traditional healers and to grasp in-depth understanding of their everyday life. Participation observation and unstructured interview with 18 traditional healers were conducted. Thematic analysis method was used to analyse the data. Most of the traditional healers chose their role because they were influenced by their ancestors, although a few others chose it because of individual interests and a desire to help ill people. All are trained in multiple skills, using supernatural spirits, ceremonies and natural plant products as resources for counteracting various health problems. They refer patients to modern hospitals or other healers if they cannot adequately manage illness themselves. Their service provision is flexible and based on a holistic approach that suits people's lifestyles and needs. The role of traditional healer tends not to attract the interest of younger generations, although traditional healers have contributed greatly to people's health. Their presence improves people's access to healthcare and offers an alternative to modern medicine, which often has a limited role. We conclude that the services of traditional healers should be incorporated into contemporary healthcare provision of Thai health care system.

From Harvard: Direct to consumer advertising and cancer

Nat Rev Cancer. 2011 Feb;11(2):142-50.
Cancer-related direct-to-consumer advertising: a critical review.
Kontos EZ, Viswanath K.

Lung Cancer Disparities Center, Harvard University, School of Public Health Department of Society, Human Development and Health, 401 Park Drive, Room 403F, Boston MA 02215, USA.
The direct-to-consumer advertising (DTCA) phenomenon has received attention because of its attempt to reach out to consumers by bypassing important gatekeepers such as physicians. The emergence of new information platforms and the introduction of genetic tests directly to the consumer have heightened the concern with DTCA and its potential consequences. These effects of DTCA are particularly important given the communication inequalities among social groups, with class, race and ethnicity influencing how people access, seek, process and act on information. This Science and Society article reviews the major issues regarding general and cancer-related DTCA and also offers data from a national survey in the United States as an example of the communication inequalities in genetic testing awareness.

From NIOSH: Occupational lung cancer in women

Am J Ind Med. 2011 Feb;54(2):102-17. doi: 10.1002/ajim.20905. Epub 2010 Oct 28.
Occupational lung cancer in US women, 1984-1998.
Robinson CF, Sullivan PA, Li J, Walker JT.

Surveillance Branch, Division of Surveillance, Hazard Evaluations, and Field Studies, The National Institute for Occupational Safety and Health, Cincinnati, Ohio.
BACKGROUND: Lung cancer is the leading cause of cancer death in US women, accounting for 72,130 deaths in 2006. In addition to smoking cessation, further reduction of the burden of lung cancer mortality can be made by preventing exposure to occupational lung carcinogens. Data for occupational exposures and health outcomes of US working women are limited.

METHODS: Population-based mortality data for 4,570,711 women who died between 1984 and 1998 in 27 US States were used to evaluate lung cancer proportionate mortality over time by the usual occupation and industry reported on death certificates. Lung cancer proportionate mortality ratios were adjusted for smoking, using data from the National Health Interview Survey (NHIS) and the American Cancer Society's Cancer Prevention Study II.

RESULTS: Analyses revealed that 194,382 white, 18,225 Black and 1,515 Hispanic women died 1984-1998 with lung cancer reported as the underlying cause of death. Following adjustment for smoking, significant excess proportionate lung cancer mortality was observed among US women working in the US manufacturing; transportation; retail trade; agriculture, forestry, and fishing; and nursing/personal care industries. Women employed in precision production, technical, managerial, professional specialty, and administrative occupations experienced some of the highest significantly excess proportionate lung cancer mortality during 1984-1998.

CONCLUSIONS: The results of our study point to significantly elevated risks for lung cancer after adjustment for smoking among women in several occupations and industries. Because 6-17% of lung cancer in US males is attributable to known exposures to occupational carcinogens, and since synergistic interactions between cigarette smoke and other occupational lung carcinogens have been noted, it is important to continue research into the effects of occupational exposures on working men and women.

Sunday, January 23, 2011

Cystic fibrosis: Liver disease and biopsy

Hepatology. 2011 Jan;53(1):193-201. doi: 10.1002/hep.24014. Epub 2010 Nov 17.
Importance of hepatic fibrosis in cystic fibrosis and the predictive value of liver biopsy.

Lewindon PJ, Shepherd RW, Walsh MJ, Greer RM, Williamson R, Pereira TN, Frawley K, Bell SC, Smith JL, Ramm GA.

Gastroenterology, Royal Children's Hospital, Brisbane, Queensland, Australia; Hepatic Fibrosis Group, Queensland Institute of Medical Research, Brisbane, Queensland, Australia.

Cystic fibrosis liver disease (CFLD), which results from progressive hepatobiliary fibrosis, is an important cause of morbidity and mortality, but it is difficult to identify before portal hypertension (PHT) ensues. Clinical signs, serum alanine aminotransferase (ALT) levels, and ultrasound (US) are widely applied, but their value in predicting the presence of cirrhosis, the development of PHT, or adverse outcomes is undetermined. The potential gold standard, liver biopsy, is not standard practice and, notwithstanding sampling error considerations, has not been systematically evaluated. Forty patients with cystic fibrosis (median age = 10.6 years) with abnormal clinical, biochemical, and US findings were subjected to dual-pass percutaneous liver biopsy. Clinical outcomes were recorded over 12 years of follow-up (median = 9.5 years for survivors). Logistic regression and receiver operating characteristic analyses were applied to predict hepatic fibrosis (which was assessed by fibrosis staging and quantitative immunohistochemistry) and the occurrence of PHT. PHT occurred in 17 of 40 patients (42%), including 6 of 7 (17%) who died during follow-up. Clinical examination, serum ALT levels, and US findings failed to predict either the presence of liver fibrosis or the development of PHT. Fibrosis staging on liver biopsy, where the accuracy was improved by dual passes (P = 0.002, nonconcordance = 38%), predicted the development of PHT (P < 0.001), which occurred more frequently and at a younger age in those with severe fibrosis. Conclusion: Clinical modalities currently employed to evaluate suspected CFLD help to identify a cohort of children at risk for liver disease and adverse outcomes but do not predict an individual's risk of liver fibrosis or PHT development. Liver fibrosis on biopsy predicts the development of clinically significant liver disease. Dual passes help to address sampling concerns. Liver biopsy has a relevant role in the management of patients with suspected CFLD and deserves more widespread application.

JAMA: Physician choice. Worth bothering with?

JAMA. 2011 Jan 12;305(2):195-6.
Is choice of physician and hospital an essential benefit?

Brook RH.

RAND Corporation, PO Box 2138, Santa Monica, CA 90407, USA.

PMID: 21224462 [PubMed - indexed for MEDLINE]

From Howard Brody and colleague: Possible med mal reforms

J Gen Intern Med. 2011 Jan 19. [Epub ahead of print]
Professionally Responsible Malpractice Reform.

Brody H, Hermer LD.

Institute for the Medical Humanities, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555-1311, USA,

Medical malpractice reform is both necessary and desirable, yet certain types of reform are clearly preferable to others. We argue that "traditional" tort reform remedies such as stringent damage caps not only fail to address the root causes of negligence and the adverse effects that fear of suit can have on physicians, but also fail to address the needs of patients. Physicians ought to view themselves as professionals who are dedicated to putting patients' interests ahead of their own. Professionally responsible malpractice reform should therefore be at least as patient-centered as it is physician-centered. Examples of more professionally responsible malpractice reform exist where institutions take a pro-active approach to identification, investigation, and remediation of possible malpractice. Such programs should be implemented more generally, and state laws enacted to facilitate them.

Medical malpractice: Educating residents

Acad Med. 2011 Jan 18. [Epub ahead of print]
Perspective: Malpractice in an Academic Medical Center: A Frequently Overlooked Aspect of Professionalism Education.

Hochberg MS, Seib CD, Berman RS, Kalet AL, Zabar SR, Pachter HL.

Dr. Hochberg is professor and vice chairman of surgery, New York University School of Medicine, New York, New York. Dr. Seib is a resident in surgery, University of California, San Francisco, School of Medicine, San Francisco, California. Dr. Berman is associate professor of surgery and surgical residency program director, New York University School of Medicine, New York, New York. Dr. Kalet is associate professor of medicine and surgery, New York University School of Medicine, New York, New York. Dr. Zabar is associate professor of medicine, New York University School of Medicine, New York, New York. Dr. Pachter is professor and chairman of surgery, New York University School of Medicine, New York, New York.

Understanding how medical malpractice occurs and is resolved is important to improving patient safety and preserving the viability of a physician's career in academic medicine. Every physician is likely to be sued by a patient, and how the physician responds can change his or her professional life. However, the principles of medical malpractice are rarely taught or addressed during residency training. In fact, many faculty at academic medical centers know little about malpractice.In this article, the authors propose that information about the inciting causes of malpractice claims and their resolution should be incorporated into residency professionalism curricula both to improve patient safety and to decrease physician anxiety about a crucial aspect of medicine that is not well understood. The authors provide information on national trends in malpractice litigation and residents' understanding of malpractice, then share the results of their in-depth review of surgical malpractice claims filed during 2001-2008 against their academic medical center. The authors incorporated those data into an evidence-driven curriculum for residents, which they propose as a model for helping residents better understand the events that lead to malpractice litigation, as well as its process and prevention.

Obstetrics and fear of litigation

Am J Perinatol. 2011 Jan 19. [Epub ahead of print]
Effect of Fear of Litigation on Obstetric Care: A Nationwide Analysis on Obstetric Practice.

Zwecker P, Azoulay L, Abenhaim HA.

Department of Family Medicine, Saint-Mary's Hospital, McGill University, Québec, Canada.

The aim of our study was to investigate the influence of malpractice premiums paid by obstetricians on obstetric care across the United States. We conducted a retrospective cross-sectional population-based study using patient-level data obtained from the Healthcare Cost and Utilization Project-Nationwide Inpatient Sample on every woman who delivered in 2006. Mode of delivery was compared with the average state medical liability insurance premium paid by obstetricians (Medical Liability Monitor and the National Association of Insurance Commissioners) using a generalized estimating equation to calculate crude and adjusted odds ratios. Our cohort included 890,266 women who delivered across 37 states in 2006. Average state malpractice premium of over $100,000 was associated with higher incidences of total cesarean deliveries (odds ratio [OR] 1.17, 95% confidence interval [CI]: 1.02, 1.35); lower incidences of vaginal births after cesarean deliveries (OR 0.60, 95% CI: 0.37, 0.98); and lower rates of instrumental deliveries (OR 0.72, 95% CI: 0.63, 0.83) compared with when the average state malpractice premium was less than $50,000. Fear of litigation appears to have a marked effect on obstetric practice, particularly total cesarean delivery, vaginal birth after cesarean, and instrumental delivery, when malpractice premiums rise above $100,000 per annum.

From Bryan Liang and colleagues: Legal implications of "electronic signatures"

Looking for Trouble in All the Right Places: The Legal Implications Associated with “Electronic Signatures” and High-risk Clinical Situations.

Escobar GJ, Folck BF, Gardner MN, Ma J, Palmer LI, Liang B, Nozick LK.
In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation (Volume 3: Implementation Issues). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Advances in Patient Safety.

Background: Voluntary reporting systems identify only a fraction of medical errors. Electronic identification mechanisms, which are more efficient, have been defined for adverse drug events. However, similar systems are lacking for other types of errors. Objective: The investigators sought to define probabilistic strategies that could support quality improvement and medical error detection by decreasing the need for unselected manual chart review. Design: Combinations of administrative data and laboratory test results (“electronic signatures”) were employed to identify discrete, high-risk clinical situations among health plan members of a large managed care organization. The design used was a retrospective cohort study linking hospitalization records, outpatient records, and laboratory results that were formatted using approaches developed for physiologic severity scoring. The original outcomes of interest for the study were clinical situations (e.g., birth injuries or delayed diagnosis of myocardial infarction) that have a strong association with human error. Results: When presented with preliminary results, senior leaders in the investigators' parent organizations raised a number of objections to any public presentation or publication of the results. Because of these objections, the quantitative results presented in this report focus on rapid detection of one outcome—prolonged neonatal assisted ventilation—that has a weak association with human error. Using recursive partitioning, the investigators were able to define subsets of newborns for whom the frequency of the outcome of interest was substantially higher than in the general population (1 percent). For example, an electronic signature identified a subset of infants (comprising 4 percent of the birth cohort) in which the outcome of interest occurred in 22 percent of the newborns. Conclusions: Use of probabilistic electronic strategies could yield significant benefits in medical error research as well as major operational improvements in medical error detection and reporting, quality assurance, and quality improvement. However, three barriers are likely to limit the use of such “electronic signatures”—fear of malpractice litigation, fear of lawsuits invoking “enterprise liability,” and high development costs. Entities most likely to benefit from these approaches are those with a critical mass of experienced personnel, a circumstance that can spread the development costs over a large number of hospitals and/or clinics.

The 1935-1936 National Health Survey

Am J Public Health. 2011 Jan 13. [Epub ahead of print]
Epidemiology and Health Care Reform: The National Health Survey of 1935-1936.

Weisz G.

McGill University.

The National Health Survey undertaken in 1935 and 1936 was the largest morbidity survey until that time. It was also the first national survey to focus on chronic disease and disability. The decision to conduct a survey of this magnitude was part of the larger strategy to reform health care in the United States. The focus on morbidity allowed reformers to argue that the health status of Americans was poor, despite falling mortality rates that suggested the opposite. The focus on chronic disease morbidity proved to be an especially effective way of demonstrating the poor health of the population and the strong links between poverty and illness. The survey, undertaken by a small group of reform-minded epidemiologists led by Edgar Sydenstricker, was made possible by the close interaction during the Depression of agencies and actors in the public health and social welfare sectors, a collaboration which produced new ways of thinking about disease burdens. (Am J Public Health. 2010;101(3):XXX-XXX. doi:10.2105/AJPH.2010.196519.).

Doughnuts? Donuts?

N Engl J Med. 2011 Jan 19. [Epub ahead of print]
Time to Fill the Doughnuts - Health Care Reform and Medicare Part D.

Shrank WH, Choudhry NK.

From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.

The passage of the Affordable Care Act (ACA) in March 2010 promised to put an end to the "doughnut hole," the gap in prescription-drug coverage that is the most controversial component of the Medicare Part D benefit.(1) Several months ago, seniors who had reached the spending threshold that marked the beginning of their doughnut hole began to receive their $250 rebate checks. Incrementally between now and 2020, the coverage gap will be filled with subsidies from manufacturers of brand-name drugs and from the federal government. Thus, the ACA, like Part D itself, has expanded coverage for prescription medications - but . . .

"Aftercare" in the UK

J Cancer Surviv. 2011 Jan 21. [Epub ahead of print]
Towards a personalised approach to aftercare: a review of cancer follow-up in the UK.

Davies NJ, Batehup L.

National Cancer Survivorship Initiative, Self-Management Workstream, Macmillan Cancer Support, London, England,

INTRODUCTION: Due to growth in cancer survivorship and subsequent resource limitations, the current UK position of follow-up services is unsustainable. With people living longer after a cancer diagnosis, supported self-management for ongoing treatment-related chronic conditions is a fundamental component of aftercare services. Alternative models to traditional hospital aftercare require consideration in terms of clinical effectiveness and cost-effectiveness.

METHODS: 'Evidence to Inform the Cancer Reform Strategy: The Clinical Effectiveness of Follow-Up Services after Treatment for Cancer' (Centre for Reviews and Dissemination 2007) has been updated using a number of quality-controlled databases. Correspondence with experts was also sought to identify current initiatives.

RESULT: The review highlights a shift towards patient empowerment via individualised and group education programmes aimed at increasing survivor's ability to better manage their condition and the effects of treatment, allowing for self-referral or rapid access to health services when needed. The role of specialist nurses as key facilitators of supportive aftercare is emphasised, as is a move towards technology-based aftercare in the form of telephone or web-based services.

CONCLUSIONS: The challenge will be replacing traditional clinic follow-up with alternative methods in a cost-effective way that is either as equally effective, or more so. To establish this, more rigorous trials are needed, with larger sample sizes and longer follow-up assessments. IMPLICATIONS FOR CANCER SURVIVORS: Increasing patient confidence to initiate follow-up specific to their needs is likely to increase the workload of primary care providers, who will need training for this.

Lung cancer histologic type--impact on clinical trials of advanced lung cancers

J Thorac Oncol. 2011 Feb;6(2):405.
Histologic Type Definition in Clinical Trials on Advanced Non-small Cell Lung Cancer.

Rossi G, Cavazza A.

Section of Pathologic Anatomy, Azienda Ospedaliero-Universitaria, Policlinico di Modena, Modena, Italy (Rossi) Operative Unit of Pathology, Azienda Ospedaliera St. Maria Nuova, Reggio Emilia, Italy (Cavazza)

From Psychooncology--Predictors of finding benefit after lung cancer diagnosis

Psychooncology. 2011 Jan 20. doi: 10.1002/pon.1904. [Epub ahead of print]
Predictors of finding benefit after lung cancer diagnosis.

Thornton AA, Owen JE, Kernstine K, Koczywas M, Grannis F, Cristea M, Reckamp K, Stanton AL.

Divisions of Psychology and Behavioral Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Los Angeles, CA, USA.

Objective: We examined benefit finding in patients with lung cancer, including level of benefit finding and change in benefit finding over time, and tested a predictive model postulating that greater impact of and engagement with the stressor promotes benefit finding. Methods: Patients diagnosed with a primary lung cancer within the past 6 months (M=16 weeks post-diagnosis) completed measures of benefit finding, cancer-related intrusions, perceived stressfulness, coping, and demographic and medical information at study entry (T1; n = 118) and 3 months later (T2; n = 79). Results: Level of benefit finding at both assessments was to a 'mild-to-moderate degree'. Benefit finding increased over time for patients with small cell carcinoma, but not for those with nonsmall cell carcinoma. The proposed model explained 33% of the variance in T1 benefit finding, and 64% (using T1 coping measures) and 71% (using T2 coping measures) of the variance in T2 benefit finding. Greater benefit finding was associated with having small cell lung cancer, higher cancer-related intrusions, lower perceived cancer-related stress, and greater approach-oriented coping. Positive reframing coping emerged as the single unique approach-oriented coping scale predicting benefit finding at T1, and emotional approach coping was the single unique approach-oriented coping scale predicting benefit finding at T2. Conclusion: Findings provide general support for a theoretical model positing that stressor impact and engagement with the stressor contribute to the development of benefit finding after cancer. Future research with larger, more diverse samples is needed to confirm and extend these findings.

Tuesday, January 18, 2011

Texas higher ed: budget cuts coming. From the Austin Statesman.

Revolution in lung cancer

Arch Pathol Lab Med. 2011 Jan;135(1):110-6.
Revolution in lung cancer: new challenges for the surgical pathologist.
Cagle PT, Allen TC, Dacic S, Beasley MB, Borczuk AC, Chirieac LR, Laucirica R, Ro JY, Kerr KM.

Abstract Context-Traditionally, lung cancer has been viewed as an aggressive, relentlessly progressive disease with few treatment options and poor survival. The traditional role of the pathologist has been primarily to differentiate small cell carcinoma from non-small cell carcinoma on biopsy and cytology specimens and to stage non-small cell carcinomas that underwent resection. In recent years, our concepts of lung cancer have undergone a revolution, including (1) the advent of successful, new, molecular-targeted therapies for lung cancer, many of which are associated with specific histologic cell types and subtypes; (2) new observations on the natural history of lung cancer derived from ongoing high-resolution computed tomography screening studies and recent histologic findings; and (3) proposals to revise the classification of lung cancers, particularly adenocarcinomas, in part because of the first 2 developments. Objective-To summarize the important, new developments in lung cancer, emphasizing the role of the surgical pathologist in personalized care for patients with lung cancer. Data Sources-Information about the new developments in lung cancer was obtained from the peer-review medical literature and the authors' experiences. Conclusions-For decades, we have perceived lung cancer as a relentlessly aggressive and mostly incurable disease for which the surgical pathologist had a limited role. Today, surgical pathologists have an important and expanding role in the diagnosis and treatment of lung cancer, and it is essential to keep informed of new advances.

AAA and the Science War-from the Chronicle of Higher Education

From Francisco Cigarroa: Reform of Texas health care

Tex Heart Inst J. 2010;37(6):665-6.
The University of Texas system: leadership for reform and rejuvenation of Texas health care.
Cigarroa FG.

Office of the Chancellor, The University of Texas System, Austin, Texas 78701.

Cystic fibrosis and CFTR modulators

ChemMedChem. 2011 Jan 14. [Epub ahead of print]
Combating Cystic Fibrosis: In Search for CF Transmembrane Conductance Regulator (CFTR) Modulators.
Noy E, Senderowitz H.

Department of Chemistry, Bar Ilan University, Ramat-Gan 52900 (Israel)

Lung cancer: Interventional bronchoscopy

Internist (Berl). 2011 Jan 15. [Epub ahead of print]
[Interventional bronchoscopy in lung cancer.]
[Article in German]

Bergner A, Huber RM.

Pneumologie, Klinikum der Universität München - Innenstadt, Ziemssenstraße 1, 80336, München, Deutschland,
Stenosis of central airways or hemoptysis are classical indications for interventional bronchoscopy in lung cancer. In the case of endoluminal tumor growth cryo-, laser- or brachytherapy are widely used. In the case of airway stenosis due to compression by extraluminal tumor masses balloon-dilatation and/or stenting and - with delayed effect - brachytherapy are first-choice therapies. Carcinoma in situ and early stage tumors can be treated curatively with brachytherapy or photodynamic therapy. Recently introduced bronchoscopic techniques like electro-magnetic navigation may result in new curative options for peripheral lung tumors.

NEJM: the Sentinel System

N Engl J Med. 2011 Jan 12. [Epub ahead of print]
Developing the Sentinel System - A National Resource for Evidence Development.
Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R.

From the Food and Drug Administration, Silver Spring, MD (R.E.B., J.W.); the Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC (J.S. Benner, M.M.); and the Department of Population Medicine, Harvard Pilgrim Health Care Institute, and Harvard Medical School - both in Boston (J.S. Brown, R.P.).
The Food and Drug Administration (FDA) now has the capacity to "query" the electronic health information of more than 60 million people, posing specific questions in order to monitor the safety of approved medical products. This pilot program, called Mini-Sentinel, uses a distributed data network (rather than a centralized database) that allows participating health plans and other organizations to create data files in a standard format and to maintain possession of those files. These organizations perform most analyses of their own data by running computer programs distributed by a coordinating center, and they provide consistent summarized results for the FDA's . . . .

Monday, January 17, 2011

Cystic fibrosis: organisms and adaptation

Clin Microbiol Rev. 2011 Jan;24(1):29-70.
Clinical significance of microbial infection and adaptation in cystic fibrosis.
Hauser AR, Jain M, Bar-Meir M, McColley SA.

Department of Microbiology/Immunology, Northwestern University, 303 E. Chicago Ave., Searle 6-495, Chicago, IL 60611.
Summary: A select group of microorganisms inhabit the airways of individuals with cystic fibrosis. Once established within the pulmonary environment in these patients, many of these microbes adapt by altering aspects of their structure and physiology. Some of these microbes and adaptations are associated with more rapid deterioration in lung function and overall clinical status, whereas others appear to have little effect. Here we review current evidence supporting or refuting a role for the different microbes and their adaptations in contributing to poor clinical outcomes in cystic fibrosis.

Osteopenia: What is it, how to treat it

Rev Endocr Metab Disord. 2011 Jan 14. [Epub ahead of print]
Diagnosis and treatment of osteopenia.
Karaguzel G, Holick MF.

Department of Medicine, Section of Endocrinology, Nutrition, and Diabetes, Vitamin D, Skin and Bone Research Laboratory, Boston University Medical Center, Boston, MA, USA.
Osteopenia is a term to define bone density that is not normal but also not as low as osteoporosis. By definition from the World Health Organization osteopenia is defined by bone densitometry as a T score -1 to -2.5. There are many causes for osteopenia including calcium and vitamin D deficiency and inactivity. Genetics plays an important role in a person's bone mineral density and often Caucasian women with a thin body habitus who are premenopausal are found to have osteopenia. Correction of calcium and vitamin D deficiency and walking 3 to 5 miles a week can often improve bone density in the hip and spine. There are a variety of pharmaceutical agents that have been recommended for the treatment of osteopenia and osteoporosis including hormone replacement therapy, selective estrogen receptor modulator therapy, anti-resorptive therapy. In addition patients with osteoporosis who have failed anti-resorptive therapy can have a significant improvement in their bone density with anabolic therapy.

Diabetics and fad diets

Curr Diab Rep. 2011 Jan 15. [Epub ahead of print]
Fad Diets in the Treatment of Diabetes.
Feinman RD.

Department of Cell Biology, SUNY Downstate Medical Center, 450 Clarkson Avenue, Brooklyn, NY, 11203, USA,
Use of the term "fad diet" reflects the contentious nature of the debate in the treatment of diabetes and generally targets diets based on carbohydrate restriction, the major challenge to traditional dietary therapy. Although standard low-fat diets more accurately conform to the idea of a practice supported by social pressure rather than scientific data, it is suggested that we might want to give up altogether unscientific terms like "fad" and "healthy." Far from faddish, diets based on carbohydrate restriction have been the historical treatment for diabetes and are still supported by basic biochemistry, and it is argued that they should be considered the "default" diet, the one to try first, in diseases of carbohydrate intolerance or insulin resistance. The barrier to acceptance of low-carbohydrate diets in the past has been concern about saturated fat, which might be substituted for the carbohydrate that is removed. However, recent re-analysis of much old data shows that replacing carbohydrate with saturated fat is, if anything, beneficial. The dialectic of impact of continued hemoglobin A(1c) versus effect of dietary saturated fat in the risk of cardiovascular disease is resolved in direction of glycemic control. Putting biased language behind us and facing the impact of recent results that point to the value of low-carbohydrate diets would offer patients the maximum number of options.

EGFR, ALK, and subtyping in lung cancer

Pathology. 2011 Feb;43(2):103-15.
What's new in non-small cell lung cancer for pathologists: the importance of accurate subtyping, EGFR mutations and ALK rearrangements.
Cooper WA, O'toole S, Boyer M, Horvath L, Mahar A.

*Tissue Pathology and Diagnostic Oncology, Australia †Sydney Cancer Centre, Royal Prince Alfred Hospital, Sydney, Australia ‡Discipline of Pathology, School of Medicine, University of Western Sydney, Sydney, Australia §Garvan Institute of Medical Research, Darlinghurst, Australia ||Sydney Medical School, University of Sydney, Sydney, Australia ¶St Vincent's Clinical School, University of New South Wales, Sydney, Australia.
In the past, the only critical point of distinction in the pathological diagnosis of lung cancer was between small cell and non-small cell lung cancer (NSCLC). The emergence of new targeted therapies and clinical trials demonstrating differing efficacy and toxicity of treatments according to specific histological subtypes of NSCLC, has resulted in an increasing need for improvements in pathological diagnosis. Accurate distinction between adenocarcinoma and squamous cell carcinoma is now critical as histological subtyping has the potential to influence clinical decision making and impact on patient outcome. While morphological criteria remain the most important feature to distinguish NSCLC subtypes, use of mucin and immunohistochemical stains (TTF-1, p63 and CK5/6) can be of assistance in difficult small biopsy cases. With the emergence of selective kinase inhibitors targeting epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), there is a corresponding need to identify the subset of NSCLCs harbouring specific genetic mutations associated with sensitivity to these agents, almost all of which are found in adenocarcinomas. In this review, the importance of accurately subtyping NSCLC is discussed, along with a suggested approach for distinguishing histological subtypes in small biopsy specimens. The significance of EGFR and ALK mutations in NSCLC and the impact of these genotypes on pathology and clinical practice are also reviewed.

Monday, January 10, 2011

Lung tissue mechanics: More needs to be done on this

J Appl Physiol. 2011 Jan 6. [Epub ahead of print]
Suki B, Bates JH.

1Boston University.
The mechanical properties of lung parenchymal tissue are both elastic and dissipative, as well as being highly nonlinear. These properties cannot be fully understood, however, in terms of the individual constituents of the tissue. Rather, the mechanical behavior of lung tissue emerges as a macroscopic phenomenon from the interactions of its microscopic components in a way that is neither intuitive nor easily understood. In this review, we first consider the quasi-static mechanical behavior of lung tissue and discuss computational models that show how smooth nonlinear stress-strain behavior can arise through a percolation-like process in which the sequential recruitment of collagen fibers with increasing strain causes them to progressively take over the load-bearing role from elastin. We also show how the concept of percolation can be used to link the pathologic progression of parenchymal disease at the micro scale to physiologic symptoms at the macro scale. We then examine the dynamic mechanical behavior of lung tissue, which invokes the notion of tissue resistance. Although usually modeled phenomenologically in terms of collections of springs and dashpots, lung tissue viscoelasticity again can be seen to reflect various types of complex dynamic interactions at the molecular level. Finally, we discuss the inevitability of why lung tissue mechanics needs to be complex.

Tianeptine and doctor shopping in France

Fundam Clin Pharmacol. 2011 Jan 7. doi: 10.1111/j.1472-8206.2010.00906.x. [Epub ahead of print]
Assessment of abuse of tianeptine from a reimbursement database using 'doctor-shopping' as an indicator.
Rouby F, Pradel V, Frauger E, Pauly V, Natali F, Reggio P, Thirion X, Micallef J.

CEIP-Addictovigilance PACA-Corse, Fédération de Pharmacologie et de Toxicologie, CHU Timone, Marseille, France Institut des Neurosciences Cognitives de la Méditerranée, Faculté de Médecine, Université de la Méditerranée-CNRS, UMR 6193, France CEIP-Addictovigilance PACA-Corse, Laboratoire de Santé Publique, Faculté de médecine, Marseille, France Direction Régionale du Service Médicale de la Région Provence-Alpes-Côte d'Azur et Corse (CNAMTS) 195 bd Chave 13392 Marseille Cedex 05, France.

Doctor-shopping is a patient behaviour characterized by simultaneous consultations of several physicians during the same period. Some case reports have described an abuse of tianeptine, an atypical antidepressant. Our objective was to assess the extent of abuse of this drug with a method quantifying doctor-shopping in comparison with other antidepressants and benzodiazepines (BZD). All dispensations of antidepressants and BZD during the year 2005 in a French area of 4.5 million inhabitants were extracted from a reimbursement database. For each patient, two quantities were computed: quantity dispensed and obtained by doctor-shopping. Tianeptine and other drugs were compared using their doctor-shopping indicator (DSI), defined as the percentage of drug obtained by doctor-shopping among dispensed quantity; 410 525 patients received at least one antidepressant dispensation during the year 2005. Tianeptine was the sixth most dispensed antidepressant. The DSI of tianeptine was 2.0%, ranking it first among antidepressant (the second being mianserine with a DSI of 1%). Flunitrazepam has the highest DSI (30.2%), the DSI of the five following BZD (clonazepam, zolpidem, oxazepam, diazepam, bromazepam) range from 3.0% to 2.0%. Tianeptine is associated with higher DSI, compared with other antidepressants, suggesting that it may be subject to abuse in the population. Moreover, its DSI as a measure of diversion is similar to the DSI of diazepam or bromazepam.

"Trying to keep things normal"-parenting a child with Cystic Fibrosis

Clin Child Psychol Psychiatry. 2011 Jan 6. [Epub ahead of print]
Unravelling complexities involved in parenting a child with cystic fibrosis: An interpretative phenomenological analysis.
Glasscoe C, Smith JA.

University of Liverpool, UK.
We conducted a qualitative study with caregivers for a contemporary understanding of the challenge of caring for a child with cystic fibrosis (CF). A single case is presented that details one woman's experience from her unique perspective of both, 'mother to a child with CF' and 'CF healthcare provider' using an interpretative phenomenological analysis. Emergent themes include: 'trying to keep things normal,' which includes different types of normality and routine management of treatment; 'when things become difficult,' which includes dealing with symptoms and battling with CF related decline; and, 'the complexity of decision making.' The discussion section expands on how, for this mother contrasting modes of managing CF (everyday life/full-on alert) co-existed and were further complicated by (i) role discrepancies (mother/nurse), and (ii) a dialectic between affect and reason. The CF parenting challenge increasingly involves responsibility for complex healthcare interventions and this study suggests a need for further enquiry into how caregivers are involved in the treatment plan and decision-making about treatment. Practice implications are proposed.

Med mal reforms-possible new approaches

Psychiatr Serv. 2011 Jan;62(1):6-8.
Law & psychiatry: reforming malpractice: the prospects for change.
Appelbaum PS.

Previous efforts to change the U.S. medical malpractice system have involved such initiatives as time limits on filing claims, caps on noneconomic damages, and limiting attorneys' fees. This column briefly reviews such past efforts and describes several new approaches. They include programs that encourage prompt disclosure of errors and offers of compensation, efforts to mediate complaints outside the courts, and use of administrative processes to adjudicate claims. "No-fault" systems, such as those in New Zealand, Sweden, and Denmark, may be most likely to satisfy the interests of both patients and physicians but may not be politically acceptable in the United States.

Radon and lung cancer

Cancer Epidemiol Biomarkers Prev. 2011 Jan 6. [Epub ahead of print]
Radon and Lung Cancer in the American Cancer Society Cohort.
Turner MC, Krewski D, Chen Y, Pope CA 3rd, Gapstur SM, Thun MJ.

1McLaughlin Centre for Population Health Risk Asseessment, Institute of Population Health, University of Ottawa.
BACKGROUND: Case-control studies conducted in North America, Europe, and Asia provided evidence of increased lung cancer risk due to radon in homes. Here, the association between residential radon and lung cancer mortality was examined in a large-scale cohort study.

METHODS: Nearly 1.2 million Cancer Prevention Study-II participants were recruited in 1982. Mean county-level residential radon concentrations were linked to study participants according to ZIP code information at enrollment (mean (SD) = 53.5 Bq/m3 (38.0)). Cox proportional hazards regression models were used to obtain adjusted hazard ratios and 95% confidence intervals (CI) for lung cancer mortality associated with radon. Potential effect modification by cigarette smoking, ambient sulfate concentrations, and other risk factors was assessed on both the additive and multiplicative scales.

RESULTS: Through 1988, 3,493 lung cancer deaths were observed among 811,961 participants included in the analysis. A significant positive linear trend was observed between categories of radon concentrations and lung cancer mortality (p = 0.02). A 15% (95% CI 1 - 31%) increase in the risk of lung cancer mortality was observed per each 100 Bq/m3 increase in radon. Participants with mean radon concentrations above the EPA guideline value (148 Bq/m3) experienced a 34% (95% CI 7 - 68%) increase in risk for lung cancer mortality relative to those below the guideline value.

CONCLUSIONS: This large prospective study showed a positive association between an ecological indicator of residential radon and lung cancer. Impact:These results further support efforts to reduce radon concentrations in homes to the lowest possible level.

Saturday, January 8, 2011

From Yale-Education level and diabetes

Int J Health Care Finance Econ. 2011 Jan 7. [Epub ahead of print]
Education and health: evidence on adults with diabetes.
Ayyagari P, Grossman D, Sloan F.

Yale School of Public Health, Yale University, 60 College Street, P.O. Box 208034, New Haven, CT, 06520-8034, USA,
Although the education-health relationship is well documented, pathways through which education influences health are not well understood. This study uses data from a 2003-2004 cross sectional supplemental survey of respondents to the longitudinal Health and Retirement Study (HRS) who had been diagnosed with diabetes mellitus to assess effects of education on health and mechanisms underlying the relationship. The supplemental survey provides rich detail on use of personal health care services (e.g., adherence to guidelines for diabetes care) and personal attributes which are plausibly largely time invariant and systematically related to years of schooling completed, including time preference, self-control, and self-confidence. Educational attainment, as measured by years of schooling completed, is systematically and positively related to time to onset of diabetes, and conditional on having been diagnosed with this disease on health outcomes, variables related to efficiency in health production, as well as use of diabetes specialists. However, the marginal effects of increasing educational attainment by a year are uniformly small. Accounting for other factors, including child health and child socioeconomic status which could affect years of schooling completed and adult health, adult cognition, income, and health insurance, and personal attributes from the supplemental survey, marginal effects of educational attainment tend to be lower than when these other factors are not included in the analysis, but they tend to remain statistically significant at conventional levels.

From JNCI-The question is "does", not "how"

J Natl Cancer Inst. 2011 Jan 6. [Epub ahead of print]
How Research Influences Policy Makers: Still Hazy After All These Years.
Lewis S.

Affiliations of author: Access Consulting Ltd, Saskatoon, Saskatchewan, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.

From Lopez-Terrada and Igbokwe: Molecular testing of solid tumors

Arch Pathol Lab Med. 2011 Jan;135(1):67-82.
Molecular testing of solid tumors.
Igbokwe A, Lopez-Terrada DH.

Abstract Context-Molecular testing of solid tumors is steadily becoming a vital component of the contemporary anatomic pathologist's armamentarium. These sensitive and specific ancillary tools are useful for confirming ambiguous diagnoses suspected by light microscopy and for guiding therapeutic decisions, assessing prognosis, and monitoring patients for residual neoplastic disease after therapy. Objective-To review current molecular biomarkers and tumor-specific assays most useful in solid tumor testing, specifically of breast, colon, lung, thyroid, and soft tissue tumors, malignant melanoma, and tumors of unknown origin. A few upcoming molecular diagnostic assays that may become standard of care in the near future will also be discussed. Data Sources-Original research articles, review articles, and the authors' personal practice experience. Conclusions-Molecular testing in anatomic pathology is firmly established and will continue to gain ground as the need for more specific diagnoses and new targeted therapies evolve. Knowledge of the more common and clinically relevant molecular tests available for solid tumor diagnosis and management, and their indications and limitations, is necessary if anatomic pathologists are to optimally use these tests and act as consultants for fellow clinicians directly involved in patient care.

HER2 and breast cancer

Arch Pathol Lab Med. 2011 Jan;135(1):55-62.
HER2: Biology, Detection, and Clinical Implications.
Gutierrez C, Schiff R.

Abstract Context-HER2 is a membrane tyrosine kinase and oncogene that is overexpressed and gene amplified in about 20% of breast cancers. When activated it provides the cell with potent proliferative and antiapoptosis signals and it is the major driver of tumor development and progression for this subset of breast cancer. When shown to be overexpressed or amplified by appropriate methods, HER2 is a valuable treatment target. Objectives-To review the basic biology of the HER2 signaling network, to discuss various approved methods for its detection in clinical specimens, and to describe the impressive results of therapies targeting HER2. Data Sources-Selected literature searchable on PubMed as well as older studies revealed by the literature review were reviewed. Conclusion-HER2 is an important member of a complex signaling network and when gene amplified, it results in an aggressive subtype of breast cancer. Patients with tumors found to overexpress HER2 protein or to be amplified for the gene are candidates for therapy that significantly reduces mortality.

Friday, January 7, 2011

NYT: The Texas Omen

Verbing. I'm with the First American here.

From Richard Epstein: Medical innovation occurs despite, not because of, government regulators

Cancer screening 2011

CA Cancer J Clin. 2011 Jan 4. [Epub ahead of print]
Cancer screening in the United States, 2011: A Review of Current American Cancer Society Guidelines and Issues in Cancer Screening.
Smith RA, Cokkinides V, Brooks D, Saslow D, Shah M, Brawley OW.

Director of Cancer Screening, Cancer Control Science Department, American Cancer Society, Atlanta, GA.
Each year the American Cancer Society (ACS) publishes a summary of its recommendations for early cancer detection, a report on data and trends in cancer screening rates, and select issues related to cancer screening. This article summarizes the current ACS guidelines, describes the anticipated impact of new health care reform legislation on cancer screening, and discusses recent public debates over the comparative effectiveness of different colorectal cancer screening tests. The latest data on the utilization of cancer screening from the National Health Interview Survey is described, as well as several recent reports on the role of health care professionals in adult utilization of cancer screening.

More patients, less payment--what is a hospital to do?

Health Aff (Millwood). 2011 Jan;30(1):76-80.
More patients, less payment: increasing hospital efficiency in the aftermath of health reform.
Litvak E, Bisognano M.

A major issue for the US health care system will be accommodating the needs of the estimated thirty-two million Americans who will gain insurance coverage under the Affordable Care Act by 2019. For hospitals, a traditional response to this increased demand might be to add resources, such as more staff and beds. We argue that such actions would be unaffordable and unnecessary. Research has demonstrated that large gains in efficiency can be made through streamlining patient flow and redesigning care processes. We argue that once managed efficiently, US hospitals, on average, could achieve at least an 80-90 percent bed occupancy rate-at least 15 percent higher than the current level-without adding beds at capital costs of approximately $1 million per bed. This article outlines a plan for hospitals to accommodate more patients without increasing beds or staff, and for policy makers to require hospitals to make these changes or provide incentives for them to do so.

NEJM: Sebelius on health care reform

N Engl J Med. 2011 Jan 5. [Epub ahead of print]
Implementing Health Care Reform - An Interview with HHS Secretary Kathleen Sebelius.
Iglehart JK.

After having served as a Democratic state legislator, insurance commissioner, and governor of the traditionally Republican state of Kansas, Kathleen Sebelius was sworn in as Secretary of Health and Human Services (HHS) on April 28, 2009. A sprawling agency that administers Medicare and Medicaid and oversees the Food and Drug Administration, the National Institutes of Health, and other agencies, HHS spends about 25% of the federal budget. Sebelius took charge of the department during a tumultuous period, as Congress debated the sweeping health care reform bill that HHS must now administer. Sebelius shared her opinions in an interview conducted by . . .

ACOs: HMOs with a new paint job? We'll see...

Health Aff (Millwood). 2011 Jan;30(1):32-40.
Accountable care organizations: the case for flexible partnerships between health plans and providers.
Goldsmith J.

Under the Affordable Care Act, the new Center for Medicare and Medicaid Innovation will guide a number of experimental programs in health care payment and delivery. Among the most ambitious of the reform models is the accountable care organization (ACO), which will offer providers economic rewards if they can reduce Medicare's cost growth in their communities. However, the dismal history of provider-led attempts to manage costs suggests that this program is unlikely to accomplish its objectives. What's more, if ACOs foster more market concentration among providers, they have the potential to shift costs onto private insurers. This paper proposes a more flexible payment model for providers and private insurers that would divide health care services into three categories: long-term, low-intensity primary care; unscheduled care, including unscheduled emergency services; and major clinical interventions that usually involve hospitalization or organized outpatient care. Each category of care would be paid for differently, with each containing different elements of financial risk for the providers. Health plans would then be encouraged to provide logistical and analytic support to providers in managing health costs in these categories.

Pneumonia: Hospital readmission within 30 days of discharge

J Hosp Med. 2011 Jan 5. [Epub ahead of print]
Development, validation, and results of a measure of 30-day readmission following hospitalization for pneumonia.
Lindenauer PK, Normand SL, Drye EE, Lin Z, Goodrich K, Desai MM, Bratzler DW, O'Donnell WJ, Metersky ML, Krumholz HM.

Center for Quality of Care Research, Baystate Medical Center, Springfield, Massachusetts.
BACKGROUND: Readmission following hospital discharge has become an important target of quality improvement.

OBJECTIVE: To describe the development, validation, and results of a risk-standardized measure of hospital readmission rates among elderly patients with pneumonia employed in federal quality measurement and efficiency initiatives.

DESIGN: A retrospective cohort study using hospital and outpatient Medicare claims from 2005 and 2006.

SETTING: A total of 4675 hospitals in the United States.

PATIENTS: Medicare beneficiaries aged >65 years with a principal discharge diagnosis of pneumonia.


MEASUREMENTS: Hospital-specific, risk-standardized 30-day readmission rates calculated as the ratio of predicted-to-expected readmissions, multiplied by the national unadjusted rate. Comparison of the areas under the receiver operating curve (ROC) and measurement of correlation coefficient in development and validation samples.

RESULTS: The development sample consisted of 226,545 hospitalizations at 4675 hospitals, with an overall unadjusted 30-day readmission rate of 17.4%. The median risk-standardized hospital readmission rate was 17.3%, and the odds of readmission for a hospital one standard deviation above average was 1.4 times that of a hospital one standard deviation below average. Performance of the medical record and administrative models was similar (areas under the ROC curve 0.59 and 0.63, respectively) and the correlation coefficient of estimated state-specific standardized readmission rates from the administrative and medical record models was 0.96.

CONCLUSIONS: Rehospitalization within 30 days of treatment for pneumonia is common, and rates vary across hospitals. A risk-standardized measure of hospital readmission rates derived from administrative claims has similar performance characteristics to one based on medical record. review

From Amsterdam: More about diabetes and depression

Diabet Med. 2011 Jan;28(1):86-9.
More co-morbid depression in patients with Type 2 diabetes with multiple complications. An observational study at a specialized outpatient clinic.
van Steenbergen-Weijenburg KM, van Puffelen AL, Horn EK, Nuyen J, van Dam PS, van Benthem TB, Beekman AT, Rutten FF, Hakkaart-van Roijen L, van der Feltz-Cornelis CM.

Department of Psychiatry and Medical Psychology, Onze Lieve Vrouwe Gasthuis, VU University Medical Centre, Amsterdam, the Netherlands.
AIMS: The impact of depression on patients with chronic medical illnesses such as diabetes is well documented. Depression is relatively common in diabetes patients with diabetes-related complications and they are more likely to be referred to specialized outpatient facilities. Only a few studies have addressed the association between depression and multiple diabetes-related complications at these specialized outpatient facilities. The aim of this study was to determine the association between diabetes with multiple complications and depression in patients with Type 2 diabetes at a specialized outpatient clinic.

METHODS: After giving informed consent, 1194 patients were screened for depression using the Patient Health Questionnaire (PHQ-9). Additional data on the type of diabetes and complications were taken from the medical records. Logistic regression analysis was conducted, with complications as the predictor variable and the probability of depression as the dependent variable.

RESULTS: A total of 596 (63%) patients with Type 2 diabetes participated in the study. The presence of two or more complications (OR 2.23, 95% CI 1.02–2.94) was significantly associated with depression. Neuropathy (OR 1.7, 95% CI 1.10–2.77) and nephropathy (OR 1.68, 95% CI 1.00–2.48) were especially related to depression.

CONCLUSIONS: Patients with Type 2 diabetes with two or more complications, especially neuropathy or nephropathy, are at high risk of depression. Knowing this can help clinicians identify patients at risk for depression and facilitate timely and adequate treatment.

Old news

BMJ. 2011 Jan 5;342:c7452. doi: 10.1136/bmj.c7452.
Wakefield's article linking MMR vaccine and autism was fraudulent.
Godlee F, Smith J, Marcovitch H.

BMJ, London, UK.

Cystic fibrosis in the young: acceptance and well-being

J Pediatr Psychol. 2011 Jan 5. [Epub ahead of print]
Acceptance and Well-Being in Adolescents and Young Adults with Cystic Fibrosis: A Prospective Study.
Casier A, Goubert L, Theunis M, Huse D, De Baets F, Matthys D, Crombez G.

Department of Experimental-Clinical and Health Psychology, Ghent University, Research Institute for Psychology and Health, Utrecht, University Hospital Ghent, Cystic Fibrosis Centre, Belgian Cystic Fibrosis Association, Brussels and Department of Pediatrics, University Hospital Ghent.
OBJECTIVE: To prospectively investigate the role of acceptance in well-being in adolescents and young adults with cystic fibrosis (CF).

METHOD: A total of 40 adolescents and young adults with CF (ages 14-22 years) completed questionnaires assessing acceptance, anxiety and depressive symptoms, physical functioning, role functioning, emotional functioning, and social functioning. After 6 months, 28 of them completed the questionnaires on anxiety and depressive symptoms, physical functioning, role functioning, emotional functioning, and social functioning a second time.

RESULTS: More acceptance (Time 1) was related to less depressive symptoms (Time 1 and 2), and to better role, emotional, and social functioning (Time 1).

CONCLUSIONS: Results indicate that accepting the limitations imposed by chronic disease and readjusting life goals may have a positive effect upon well-being in adolescents and young adults with CF. Further research is needed to clarify whether acceptance-based interventions are useful in promoting well-being in adolescents and young adults with CF.

From Denmark: Cost effectiveness of preop PET in lung cancer patients

Eur J Nucl Med Mol Imaging. 2011 Jan 6. [Epub ahead of print]
Preoperative staging of lung cancer with PET/CT: cost-effectiveness evaluation alongside a randomized controlled trial.
Søgaard R, Fischer BM, Mortensen J, Højgaard L, Lassen U.

Centre for Health Service Research and Technology Assessment, University of Southern Denmark, Copenhagen, Denmark,
PURPOSE: Positron emission tomography (PET)/CT has become a widely used technology for preoperative staging of non-small cell lung cancer (NSCLC). Two recent randomized controlled trials (RCT) have established its efficacy over conventional staging, but no studies have assessed its cost-effectiveness. The objective of this study was to assess the cost-effectiveness of PET/CT as an adjunct to conventional workup for preoperative staging of NSCLC.

METHODS: The study was conducted alongside an RCT in which 189 patients were allocated to conventional staging (n = 91) or conventional staging + PET/CT (n = 98) and followed for 1 year after which the numbers of futile thoracotomies in each group were monitored. A full health care sector perspective was adapted for costing resource use. The outcome parameter was defined as the number needed to treat (NNT)-here number of PET/CT scans needed-to avoid one futile thoracotomy. All monetary estimates were inflated to 2010 .

RESULTS: The incremental cost of the PET/CT-based regimen was estimated at 3,927 [95% confidence interval (CI) -3,331; 10,586] and the NNT at 4.92 (95% CI 3.00; 13.62). These resulted in an average incremental cost-effectiveness ratio of 19,314 , which would be cost-effective at a probability of 0.90 given a willingness to pay of 50,000 per avoided futile thoracotomy. When costs of comorbidity-related hospital services were excluded, the PET/CT regimen appeared dominant.

CONCLUSION: Applying a full health care sector perspective, the cost-effectiveness of PET/CT for staging NSCLC seems to depend on the willingness to pay in order to avoid a futile thoracotomy. However, given that four outliers in terms of extreme comorbidity were all randomized to the PET/CT arm, there is uncertainty about the conclusion. When hospital costs of comorbidity were excluded, the PET/CT regimen was found to be both more accurate and cost saving.

Surgical safety checklists could cut malpractice suits by nearly 1/3!

Ann Surg. 2011 Jan 4. [Epub ahead of print]
Prevention of Surgical Malpractice Claims by a Surgical Safety Checklist.
de Vries EN, Eikens-Jansen MP, Hamersma AM, Smorenburg SM, Gouma DJ, Boermeester MA.

*Department of Surgery, Academic Medical Centre, Amsterdam †MediRisk, Utrecht ‡Department of Quality and Process Innovation, Academic Medical Centre, Amsterdam, the Netherlands.
OBJECTIVE: To assess what proportion of surgical malpractice claims might be prevented by the use of a surgical safety checklist.

BACKGROUND: Surgical disciplines are overrepresented in the distribution of adverse events. The recently described multidisciplinary SURgical PAtient Safety System (SURPASS) checklist covers the entire surgical pathway from admission to discharge and is being validated in various ways. Malpractice claims constitute an important source of information on adverse events. In this study, surgical malpractice claims were evaluated in detail to assess the proportion and nature of claims that might have been prevented if the SURPASS checklist had been used.

METHODS: A retrospective claim record review was performed using the database of the largest Dutch insurance company for medical liability. All accepted or settled closed surgical malpractice claims filed as a consequence of an incident that occurred between January 1, 2004 and December 31, 2005 were included. Data on the type and outcome of the incident and contributing factors were extracted. All contributing factors were compared to the SURPASS checklist to assess which incidents the checklist might have prevented.

RESULTS: We included 294 claims. Failure in diagnosis and peroperative damage were the most common types of incident; cognitive contributing factors were present in two-thirds of claims. Of a total of 412 contributing factors, 29% might have been intercepted by the SURPASS checklist. The checklist might have prevented 40% of deaths and 29% of incidents leading to permanent damage.

CONCLUSION: Nearly one-third of all contributing factors in accepted surgical malpractice claims of patients that had undergone surgery might have been intercepted by using a comprehensive surgical safety checklist. A considerable amount of damage, both physical and financial, is likely to be prevented by using the SURPASS checklist.