Acad Med. 2014 Feb 19. [Epub ahead of print]

Bushido and Medical Professionalism in Japan.

Nishigori H¹, Harrison R, Busari J, Dornan T.

Author information

• ¹Dr. Nishigori is associate professor, Center for Medical Education, Kyoto University, Kyoto, Japan. Dr. Harrison is associate professor, Division of Hospital Medicine, Oregon Health & Sciences University School of Medicine, Portland, Oregon. She was also visiting associate professor, International Research Center for Medical Education, the University of Tokyo, from April to July 2009. Dr. Busari is associate professor, Department of Educational Development and Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands. Dr. Dornan is professor of medical education, Department of Educational Development and Research, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.

Abstract

Medical professionalism has become a core topic in medical education. As it has been considered mostly from a Western perspective, there is a need to examine how the same or similar concepts are reflected in a wider range of cultural contexts. To gain insights into medical professionalism concepts in Japanese culture, the authors compare the tenets of a frequently referenced Western guide to professionalism (the physician charter proposed by the American Board of Internal Medicine Foundation, American College of Physicians Foundation, and the European Federation of Internal Medicine) with the concepts of Bushido, a Japanese code of personal conduct originating from the ancient samurai warriors. The authors also present survey evidence about how a group of present-day Japanese doctors view the values of Bushido.Cultural scholars have demonstrated Bushido's continuing influence on Japanese people today. The authors explain the seven main virtues of Bushido (e.g., rectitude), describe the similarities and differences between Bushido and the physician charter, and speculate on factors that may account for the differences, including the influence of religion, how much the group versus the individual is emphasized in a culture, and what emphasis is given to virtue-based versus duty-based ethics.The authors suggest that for those who are teaching and practicing in Japan today, Bushido's virtues are applicable when considering medical professionalism and merit further study. They urge that there be a richer discussion, from the viewpoints of different cultures, on the meaning of professionalism in today's health care practice.

Study: ACGME's resident duty hour limitations "did not meaningfully affect medical knowledge..."

Acad Med. 2014 Feb 19. [Epub ahead of print]

Assessing the Effects of the 2003 Resident Duty Hours Reform on Internal Medicine Board Scores.

Silber JH¹, Romano PS, Itani KM, Rosen AK, Small D, Lipner RS, Bosk CL, Wang Y, Halenar MJ, Korovaichuk S, Even-Shoshan O, Volpp KG.

Author information

• ¹Dr. Silber is professor, Departments of Pediatrics and Anesthesiology & Critical Care, Perelman School of Medicine; professor, Department of Health Care Management, The Wharton School; director, Center for Outcomes Research, The Children's Hospital of Philadelphia; and senior fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania. Dr. Romano is professor of medicine and pediatrics and director, Primary Care Outcomes Research Faculty Development Program, Division of General Medicine and Center for Healthcare Policy and Research, University of California Davis School of Medicine, Sacramento, California. Dr. Itani is professor, Department of Surgery, Boston University School of Medicine, and chief of surgery, VA Boston Health Care System and Boston University, Boston, Massachusetts. Dr. Rosen is professor, Department of Health Policy and Management, Boston University School of Public Health, affiliated with the Center for Organization, Leadership and Management Research, VA Boston Healthcare System, Boston, Massachusetts. Dr. Small is associate professor, Department of Statistics, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania. Dr. Lipner is senior vice president of evaluation, research and development, American Board of Internal Medicine, Philadelphia, Pennsylvania. Dr. Bosk is professor, Departments of Sociology and Medical Ethics & Health Policy, and senior fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania. Ms. Wang is a statistical programmer, Center for Outcomes Research, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Mr. Halenar is a research assistant, Center for Health Equity Research and Promotion, Veteran's Administration Hospital, Philadelphia, Pennsylvania. Ms. Korovaichuk is a research assistant, Center for Outcomes Research, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Ms. Even-Shoshan is associate director, Center for Outcomes Research, The Children's Hospital of Philadelphia, and senior fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania. Dr. Volpp is professor, Department of Health Care Management, The Wharton School, and Department of Medicine, Perelman School of Medicine; and senior fellow, Leonard Davis Institute of Health Economics, University of Pennsylvania; and affiliated with the Center for Health Equity Research and Promotion, Veterans Administration Hospital, Philadelphia, Pennsylvania.

Abstract

PURPOSE:

To determine whether the 2003 Accreditation Council for Graduate Medical Education (ACGME) duty hours reform affected medical knowledge as reflected by written board scores for internal medicine (IM) residents.

METHOD:

The authors conducted a retrospective cohort analysis of postgraduate year 1 (PGY-1) Internal Medicine residents who started training before and after the 2003 duty hour reform using a merged data set of American Board of Internal Medicine (ABIM) Board examination and the National Board of Medical Examiners (NMBE) United States Medical Licensing Examination (USMLE) Step 2 Clinical Knowledge test scores. Specifically, using four regression models, the authors compared IM residents beginning PGY-1 training in 2000 and completing training unexposed to the 2003 duty hours reform (PGY-1 2000 cohort, n = 5,475) to PGY-1 cohorts starting in 2001 through 2005 (n = 28,008), all with some exposure to the reform.

RESULTS:

The mean ABIM board score for the unexposed PGY-1 2000 cohort (n = 5,475) was 491, SD = 85. Adjusting for demographics, program, and USMLE Step 2 exam score, the mean differences (95% CI) in ABIM board scores between the PGY-1 2001, 2002, 2003, 2004 and 2005 cohorts minus the PGY-1 2000 cohort were -5.43 (-7.63, -3.23), -3.44 (-5.65, -1.24), 2.58 (0.36, 4.79), 11.10 (8.88, 13.33) and 11.28 (8.98, 13.58) points respectively. None of these differences exceeded one-fifth of an SD in ABIM board scores.

CONCLUSIONS:

The duty hours reforms of 2003 did not meaningfully affect medical knowledge as measured by scores on the ABIM board examinations.

Mult Scler. 2014 Feb 20. [Epub ahead of print]

Biomarker time out.

Petzold A¹, Bowser R, Calabresi P, Zetterberg H, Uitdehaag BM.

Author information

• ¹Department of Molecular Neuroscience, UCL, ION, The Wolfson Center for Neurodegeneration, London, UK.

Abstract

The advancement of knowledge relies on scientific investigations. The timing between asking a question and data collection defines if a study is prospective or retrospective. Prospective studies look forward from a point in time, are less prone to bias and are considered superior to retrospective studies.This conceptual framework conflicts with the nature of biomarker research. New candidate biomarkers are discovered in a retrospective manner. There are neither resources nor time for prospective testing in all cases. Relevant sources for bias are not covered. Ethical questions arise through the time penalty of an overly dogmatic concept.The timing of sample collection can be separated from testing biomarkers. Therefore the moment of formulating a hypothesis may be after sample collection was completed. A conceptual framework permissive to asking research questions without the obligation to bow to the human concept of calendar time would simplify biomarker research, but will require new safeguards against bias.

Biol Lett. 2014 Feb 19;10(2):20131103. Print 2014.

To keep on track during flight, fruitflies discount the skyward view.

Mazo C1, Theobald JC.

Author information

• 1Department of Biological Sciences, Florida International University, , Miami, FL 33199, USA.

Abstract

When small flying insects go off their intended course, they use the resulting pattern of motion on their eye, or optic flow, to guide corrective steering. A change in heading generates a unique, rotational motion pattern and a change in position generates a translational motion pattern, and each produces corrective responses in the wingbeats. Any image in the flow field can signal rotation, but owing to parallax, only the images of nearby objects can signal translation. Insects that fly near the ground might therefore respond more strongly to translational optic flow that occurs beneath them, as the nearby ground will produce strong optic flow. In these experiments, rigidly tethered fruitflies steered in response to computer-generated flow fields. When correcting for unintended rotations, flies weight the motion in their upper and lower visual fields equally. However, when correcting for unintended translations, flies weight the motion in the lower visual fields more strongly. These results are consistent with the interpretation that fruitflies stabilize by attending to visual areas likely to contain the strongest signals during natural flight conditions.

From Keio U: Islet number rather than islet size is a major determinant of beta and alpha cell mass in humans

J Clin Endocrinol Metab. 2014 Feb 11:jc20133731. [Epub ahead of print]

Islet number rather than islet size is a major determinant of beta and alpha cell mass in humans.

Kou K1, Saisho Y, Sato S, Yamada T, Itoh H.

Author information

• 1Department of Internal Medicine, Keio University School of Medicine.

Abstract

Objective: To clarify the relative contribution of islet number and islet size to beta and alpha cell mass in humans. 

Research Design and Methods: We obtained the pancreas at autopsy from 72 Japanese adults with no history of diabetes or pancreatitis (age 47 ± 12 years, BMI 24.1 ± 5.0). Pancreatic sections were stained for insulin or glucagon, and fractional beta cell area (%BCA) and alpha cell area (%ACA) were measured. Islet number and islet size as well as beta cell turnover were also quantified. HbA1c measured within 1 year prior to death was obtained in 38 individuals. 

Results: There was considerable inter-individual variation in islet density and mean islet size, with a significant negative correlation between the two (r = -0.25, P = 0.03). There were significant positive correlations between islet density and %BCA or %ACA (r = 0.63, P <0.001 and r = 0.41, P = 0.001), whereas mean islet size correlated with neither of them. Islet density as well as %BCA, but not mean islet size, was negatively correlated with HbA1c (r = -0.37, P = 0.02 and r = -0.36, P = 0.03). 

Conclusion: The present study suggests that islet number rather than islet size is a major determinant of beta and alpha cell mass in humans. Inter-individual difference in islet number may contribute to susceptibility to development of glucose intolerance.

Scand J Public Health. 2014 Mar;42(13_suppl):28-40.

Evidence on public policy: Methodological issues, political issues and examples.

Attanasio OP.

Author information

• University College London and Institute for Fiscal Studies, London, UK.

Abstract

In this paper I discuss how evidence on public policy is generated and in particular the issue of evaluation of public policies. In economics, the issue of attribution and the identification of causal links has recently received considerable attention. Important methodological issues have been tackled and new techniques have been proposed and used. Randomized Control Trials have become some sort of gold standard. However, they are not exempt from problems and have important limitations: in some case they cannot be constructed and, more generally, problems of external validity and transferability of results can be important. The paper then moves on to discuss the political economy of policy evaluations for policy evaluations to have an impact for the conduct of actual policy, it is important that the demand for evaluation comes directly from the policy making process and is generated endogenously within it. In this sense it is important that the institutional design of policy making is such that policy making institutions are incentivized to use rigorous evaluation in the process of designing policies and allocating resources to alternative options. Economists are currently involved in the design and evaluation of many policies, including policies about health, nutrition and education. The role they can play in these fields is not completely obvious. The paper argues that their main contribution is in the modelling of how individual reacts to incentives (including those provided by public policies).

Cult Med Psychiatry. 2014 Feb 20. [Epub ahead of print]

Considering Ethics, Aesthetics and the Dignity of the Individual.

Strebler A1, Valentin C.

Author information

• 1Laboratory of Ethics, Legal Medicine and Public Health, 6th Floor, 45 rue des Saints Peres, 75006, Paris, France, aline.strebler@parisdescartes.fr.

Abstract

FROM VULNERABLE MAN TO CAPABLE MAN:

There are variations on vulnerability that are often based on opposing authorities. In his book Parcours de la reconnaissance, Paul Ricœur offers a reflection grounded in a survey from Aristotle to Levinas, with way stations in phenomenology, from Hegel to Husserl. He sketches the silhouette of capable man. In a reversal of thinking and positioning, weakness, which could be considered the hallmark of disability in all its forms, becomes a source of mutual wealth and an argument in favour of reciprocity and dialogue. Relying on clinical examples, we propose art as a mediator of the doctor-patient relationship, which in its present unique form forces us to question the dynamics of empathy. A. Strebler A FEW GRAMS OF GOLD IN AN INSECURE WORLD: Vulnerability has long gone hand in hand with precarity. It is disturbing in a world where all is 'comfort and beauty, calm and bliss.' Additionally, vulnerability is a type of wound and wounds are what knit the relationship between patient and care provider. Similarly disturbing is poverty: the pauper is "without": without work, without a home, without a legal residency permit, without money… Poverty is also a wound, and yet it may serve as a path to "truth," according to the philosopher Simone Weil. These two concepts, equally vulnerable, question man's finite nature, and may serve as an introduction to the art of living together. In the midst of this ambiguity, the word "art" stands out. It is a counter-power, a challenge to established authority and politico-economic forms of government; it is inessential, unclassifiable, ungraspable, unthinkable and cannot be evaluated. Art avenges the abyss of ambiguity. C. Valentin This article, composed of two core pieces, was written for a common project leading to the creation of a university degree at Paris 5 University (chaired by Pr. Hervé): Ethics, Aesthetics and the Dignity of the Individual. Together, they serve as a forum for reflection and dialogue in which scientists, artists, care workers, teachers, legal professionals interact… It is from this apparent melting pot that a true art of living together emerges.

From Mayo Clinic-Arizona: Sarcopenia in Solid Organ Transplantation

Nutr Clin Pract. 2014 Feb 14. [Epub ahead of print]

Sarcopenia in Solid Organ Transplantation.

Carey EJ.

Author information

• Division of Hepatology, Mayo Clinic in Arizona, Phoenix.

Abstract

Sarcopenia is a relatively new concept in the medical literature, initially intended to describe the loss of lean body mass that occurs with aging. More recently, sarcopenia has been described in various forms of chronic disease, including patients with end-stage organ disease awaiting transplantation. The presence of sarcopenia is an important marker in transplant patients, since it has been linked to poorer pre- and posttransplant outcomes compared with patients with preserved muscle mass. The mechanisms and natural history of sarcopenia in transplant patients are incompletely understood, and there are currently no therapies proven to mitigate or reverse the process. This article reviews the current understanding of the prevalence and clinical significance of sarcopenia in transplant patients and highlights important areas of future research.

ISRN Obes. 2013 Apr 24;2013:473764. eCollection 2013.

Effects of Visceral Fat Accumulation Awareness on a Web-Based Weight-Loss Program: Japanese Study of Visceral Adiposity and Lifestyle Information-Utilization and Evaluation (J-VALUE).

Sakane N1, Dohi S2, Sakata K3, Hagiwara SI4, Morimoto T5, Uchida T5, Katashima M5, Yanagisawa Y5, Yasumasu T5, Study Group JV1.

Author information

• 1Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukouhata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, Japan.
• 2Health Management Department, Mitsui Chemicals Inc., Shiodome City Center 1-5-2, higashi-Shinbashi, Minato-ku, Tokyo 105-7117, Japan.
• 3Nippon Steel & Sumitomo Metal Corporation, 5-33 Kitahama 4-Chome, Chuo-ku, Osaka 541-0041, Japan.
• 4EG Health Care Center, Honda Engineering Co., Ltd, 6-1 Hagadai, Haga-machi, Haga-gun, Tochigi 321-3395, Japan.
• 5Kao Corporation, 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, Japan.

Abstract

A reduction of visceral fat is important for improvement of metabolic risk. This study was designed to compare the effects of a web-based program alone or together with measurement and self-awareness of accumulated visceral fat in Japanese workers. A new noninvasive device to measure visceral fat accumulation was introduced, and efficacy on weight-loss and improvement of healthy behaviors were examined. This study was conducted according to Helsinki declaration and approved by the ethical committee of Japan Hospital Organization, National Kyoto Hospital. Two-hundred and sixteen overweight and obese males with BMI of more than 23 participated from 8 healthcare offices of 3 Japanese private companies. Subjects were randomly allocated into control group, Web-based weight-loss program (Web), or Web + Visceral fat measurement group (Web + VFA). Eighty-one percent of participants completed the study. Reductions of body weight, waist circumference, and BMI were the largest in Web + VFA group, and the differences between groups were significant by ANOVA. Improvements of healthy behaviors were the largest in Web + VFA group, and the differences of healthy eating improvement scores between Web + VFA and control groups were significant. Our findings suggest that measurement and awareness of visceral fat are effective in weight reduction in overweight and obese males in the workplace.

Tele-recruitment for Blood Donor Retention

Indian J Hematol Blood Transfus. 2014 Mar;30(1):22-25. Epub 2012 Oct 9.

Tele-recruitment for Donor Retention.

Agrawal A1, Tiwari A2.

Author information

• 1IMA Blood Bank of Uttarakhand, 47, Ballupur Road, Dehradun, India.
• 2MEDANTA-The Medicity, Gurgaon, India.

Abstract

Blood transfusion services are the integral part of health care system and these services have safe blood transfusion as the major goal. Voluntary blood donation is the key to safe blood and this safety is further enhanced when the voluntary blood donors become repeat/regular donors. Retention of donors is therefore a very crucial strategy to ensure enhanced blood safety. Tele-recruitment is an effective medium of recruiting and more importantly retaining donors via means of telephone/Short Message Service. This study was carried out at a standalone blood bank during the period from January to December 2011 with objectives of donor retention, relationship management with the support of personnel with good communication skills, Donor data base, Integrated software and communication facility. For Initial 4 months there was no tele-recruiter, then for 2 months two tele-recruiter and for next 6 months three tele-recruiter were dedicated. Only impact of tele-recruitment on in-house donation was taken into consideration. 2,091 donors were recruited through tele-recruitment in this eight-month period. This was 63 % of in-house donations and 13 % of total donations. In other words out of every five in-house donations, three donations were from people contacted through tele-recruitment. Repeat voluntary blood donation is the safest donation. Tele-recruitment does this by converting 'first-time' donors into repeat/regular donors. Simple intervention like reminder calls on telephone can be highly effective tool to retain donors. Tele-recruitment helped the blood center establish relationships with individual donors, and, maybe, even the society at large. Tele-recruitment is a very low-cost model which can be easily replicated in all kind of blood banks, be it standalone, or a hospital based. Even the blood centers which are largely dependent on replacement donors can possibly have good results and convert replacement donors into repeat/regular voluntary blood donors.

PLoS One. 2014 Feb 13;9(2):e89090. doi: 10.1371/journal.pone.0089090. eCollection 2014.

Coping with stress and types of burnout: explanatory power of different coping strategies.

Montero-Marin J1, Prado-Abril J2, Piva Demarzo MM3, Gascon S4, García-Campayo J5.

Author information

• 1Faculty of Health Sciences and Sports, University of Zaragoza, Huesca, Spain ; Department of Psychiatry, University of Zaragoza, Zaragoza, Spain ; REDIAPP "Red de Investigación en Actividades Preventivas y Promoción de la Salud" (Research Network on Preventative Activities and Health Promotion), Zaragoza, Spain.
• 2Psychiatry Service, Miguel Servet University Hospital, Zaragoza, Spain.
• 3Department of Preventive Medicine, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brasil.
• 4Department of Psychology, University of Zaragoza, Teruel, Spain ; REDIAPP "Red de Investigación en Actividades Preventivas y Promoción de la Salud" (Research Network on Preventative Activities and Health Promotion), Zaragoza, Spain.
• 5Department of Psychiatry, University of Zaragoza, Zaragoza, Spain ; Psychiatry Service, Miguel Servet University Hospital, Zaragoza, Spain ; REDIAPP "Red de Investigación en Actividades Preventivas y Promoción de la Salud" (Research Network on Preventative Activities and Health Promotion), Zaragoza, Spain.

Abstract

BACKGROUND:

Burnout occurs when professionals use ineffective coping strategies to try to protect themselves from work-related stress. The dimensions of 'overload', 'lack of development' and 'neglect', belonging to the 'frenetic', 'under-challenged' and 'worn-out' subtypes, respectively, comprise a brief typological definition of burnout. The aim of the present study was to estimate the explanatory power of the different coping strategies on the development of burnout subtypes.

METHODS:

This was a cross-sectional survey with a random sample of university employees, stratified by occupation (n = 429). Multivariate linear regression models were constructed between the 'Burnout Clinical Subtypes Questionnaire', with its three dimensions -overload, lack of development and neglect- as dependent variables, and the 'Coping Orientation for Problem Experiences', with its fifteen dimensions, as independent variables. Adjusted multiple determination coefficients and beta coefficients were calculated to evaluate and compare the explanatory capacity of the different coping strategies.

RESULTS:

The 'Coping Orientation for Problem Experiences' subscales together explained 15% of the 'overload' (p<0.001), 9% of the 'lack of development' (p<0.001), and 21% of the 'neglect' (p<0.001). 'Overload' was mainly explained by 'venting of emotions' (Beta = 0.34; p<0.001); 'lack of development' by 'cognitive avoidance' (Beta = 0.21; p<0.001); and 'neglect' by 'behavioural disengagement' (Beta = 0.40; p<0.001). Other interesting associations were observed.

CONCLUSIONS:

These findings further our understanding of the way in which the effectiveness of interventions for burnout may be improved, by influencing new treatments and preventive programmes using features of the strategies for handling stress in the workplace.

How can across-state-line telemedicine comport with individual state-controlled physician licensure?

Timothy Craig Allen (2014) Digital Pathology and Federalism. Archives of Pathology & Laboratory Medicine: February 2014, Vol. 138, No. 2, pp. 162-165.

Digital Pathology and Federalism

Timothy Craig Allen , MD, JD

From the Department of Pathology, University of Texas Health Science Center at Tyler. Dr Allen is now located at the University of Texas Medical Branch at Galveston, Texas.

"... a hostile takeover of the soul..."

The War on Reason

Scientists and philosophers argue that human beings are little more than puppets of their biochemistry. Here's why they're wrong.

PAUL BLOOMFEB 19 2014

The New York University psychologist Jonathan Haidt suggests we should reject the notion that we are in control of our decisions and instead think of the conscious self as a lawyer who, when called upon to defend the actions of a client, mainly provides after-the-fact justifications for decisions that have already been made.

Such statements have produced a powerful backlash. What they represent, many people feel, are efforts at a hostile takeover of the soul: an assault on religious belief, on traditional morality, and on common sense. Derisory terms like neurotrash, brain porn, and (for the British) neurobollocks are often thrown around. Some people, such as the novelist Marilynne Robinson and the writer and critic Leon Wieseltier, argue that science has inappropriately ventured outside its scope and has still failed to capture the rich and transcendent nature of human experience. The author and clinical neuroscientist Raymond Tallis worries that such theories suggest no meaningful gap separates man and beast, a position that he argues, in Aping Mankind, is “not merely intellectually derelict but dangerous.”

From U Penn: Use of flow cytometry in the diagnosis of lymphoproliferative disorders in fluid specimens

Diagn Cytopathol. 2014 Feb 19. doi: 10.1002/dc.23106. [Epub ahead of print]

Use of flow cytometry in the diagnosis of lymphoproliferative disorders in fluid specimens.

Yu GH1, Vergara N, Moore EM, King RL.

Author information

• 1Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.

Abstract

The diagnostic evaluation of fluid specimens, including serous effusions and cerebrospinal fluids (CSFs), can be challenging for a number of reasons. The evaluation of lymphoid proliferations in these specimens can be particularly problematic, given the frequent presence of coexisting inflammatory conditions and the manner in which these specimens are processed. As a result, immunophenotypic analysis of hematopoietic cell populations by flow cytometry has emerged as a useful ancillary study in the diagnosis of these specimens, both in patients with and without a previous history of a lymphoproliferative disorder. In this study, we review our experience with flow cytometry in fluid specimens over a four-year period. Flow cytometry was performed in 184 of 6,925 total cases (2.7% of all fluids). Flow cytometry was performed in 4.8% of pleural fluids (positive findings in 38%, negative in 40%, and atypical in 18%), 1.1% of peritoneal fluids (positive in 40%, negative in 50%, and atypical in 10%), 1.9% of pericardial fluids (positive in 67%, negative in 33%), and 1.9% of CSFs (positive in 23%, negative in 55%, atypical in 3%). The specimen submitted was inadequate for analysis in 9.2% of cases, most commonly with CSF specimens, but was not related to the volume of fluid submitted. Atypical flow cytometry findings and atypical morphologic findings in the context of negative flow cytometry results led to the definitive diagnosis of a lymphoproliferative disorder in a significant number of cases when repeat procedures and ancillary studies were performed.

Except that Caronia may have made the concept of companion diagnostic tests obsolete...

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary.

Editors

Roundtable on Translating Genomic-Based Research for Health; Board on Health Sciences Policy; Institute of Medicine (US).

Source

Washington (DC): National Academies Press (US); 2014.
The National Academies Collection: Reports funded by National Institutes of Health.

Excerpt

Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration. Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests is the summary of a workshop held by the Roundtable on Translating Genomic-Based Research for Health on February 27, 2013 to examine and discuss challenges and potential solutions for the codevelopment of targeted therapeutics and companion molecular tests for the prediction of drug response. Prior to the workshop, key stakeholders, including laboratory and medical professional societies, were individually asked to provide possible solutions to resolve the concerns raised about co-development of companion diagnostic tests and therapies. Workshop speakers were charged with addressing these solutions in their presentations by providing insight on (1) whether the proposed solutions address the problems described, (2) whether there are other solutions to propose, and (3) what steps could be taken to effectively implement the proposed solutions.

J Clin Oncol. 2014 Feb 18. [Epub ahead of print]

Prognostic Impact of Minimal Pleural Effusion in Non-Small-Cell Lung Cancer.

Ryu JS1, Ryu HJ, Lee SN, Memon A, Lee SK, Nam HS, Kim HJ, Lee KH, Cho JH, Hwang SS.

Author information

• 1Jeong-Seon Ryu, Azra Memon, Seul-Ki Lee, Hae-Seong Nam, Hyun-Jung Kim, and Jae-Hwa Cho, Center for Lung Cancer, Inha University Hospital; Si-Nae Lee, Kyung-Hee Lee, and Seung-Sik Hwang, Inha University Hospital, Incheon, S. Korea; and Hyo Jin Ryu, University of California, Los Angeles, CA.

Abstract

PURPOSE:

Minimal (< 10 mm thick) pleural effusion (PE) may represent an early phase of malignant PE, but its clinical relevance has rarely been studied. Therefore, we examined the proportion of minimal PE in patients with non-small-cell lung cancer (NSCLC) and its impact on survival. We also considered possible accumulation mechanisms in our data set.

PATIENTS AND METHODS:

On the basis of PE status from chest computed tomography scans at diagnosis, 2,061 patients were classified into three groups: no PE, minimal PE, and malignant PE. Twenty-one variables associated with four factors-patient, stage migration, tumor, and treatment-were investigated for correlation with survival.

RESULTS:

Minimal PE presented in 272 patients (13.2%). Of 2,061 patients, the proportion of each stage was the following: 5.2% stage I, 10.9% stage II, 13.2% stage IIIA, 23.8% stage IIIB, and 13.9% stage IV. Minimal PE correlated significantly with shorter survival time than did no PE (median survival time, 7.7 v 17.7 months; log-rank P < .001), even after full adjustment with all variables (adjusted hazard ratio, 1.40; 95% CI, 1.21 to 1.62). Prognostic impact of minimal PE was higher in early versus advanced stages (Pinteraction = .001). In 237 patients (87.8%) with minimal PE, pleural invasion or attachment as a direct mechanism was observed, and it was an independent factor predicting worse survival (P = .03).

CONCLUSION:

Minimal PE is a commonly encountered clinical concern in staging NSCLCs. Its presence is an important prognostic factor of worse survival, especially in early-stage disease.

"Regrets, I've had a few; but then again, too few to mention." --My Way (1969)

Regret is the Perfect Emotion for Our Self-Absorbed Times

B

BY JUDITH SHULEVITZ

"We are a nation gnawed by regret. The most visible symptom of this condition is celebrity regret, which sloshes through nearly every news cycle."

J Pediatr Surg. 2013 Dec;48(12):2401-7. doi: 10.1016/j.jpedsurg.2013.08.015.

The increasing incidence of adolescent bariatric surgery.

Zwintscher NP1, Azarow KS, Horton JD, Newton CR, Martin MJ.

Author information

• 1Department of Surgery, Madigan Army Medical Center, Tacoma, WA. Electronic address: npzwintscher@gmail.com.

Abstract

BACKGROUND:

Morbid obesity continues to be a significant problem within the United States, as overweight/obesity rates are nearing 33%. Bariatricsurgery has had success in treating obesity in adults and is becoming a viable treatment option for obese adolescents.

METHODS:

We studied 1615 inpatient admissions for children ≤20 years of age undergoing a bariatric procedure for morbid obesity in 2009 using the Kids' Inpatient Database (KID). Patients had a principal diagnosis of obesity and a bariatric procedure listed as one of their first 5 procedures. Procedures (open gastric bypass, laparoscopic gastric bypass, sleeve gastrectomy, laparoscopic gastroplasty, and laparoscopic gastric band) and complications were defined by ICD-9 codes.

RESULTS:

There were 90 open gastric bypasses, 906 laparoscopic gastric bypasses, 150 sleeve gastrectomies, 18 laparoscopic gastroplasties, and 445 laparoscopic gastric bandings. The length of stay for each procedure was 2.44, 2.20, 2.33, 1.10, and 1.02 days, respectively (P<0.001). The complication rates were 3.3%, 3.5%, 0.7%, 0.0%, 0.2%, respectively (P=0.004).

CONCLUSIONS:

Bariatric surgery is an increasingly utilized option for the treatment of morbid obesity among adolescents. The procedures can be performed safely as evidenced by low complication rates. Additional long-term follow-up is necessary.

Bioethics. 2014 Feb 19. doi: 10.1111/bioe.12084. [Epub ahead of print]

Ethical Considerations for Outcome-adaptive Trial Designs: A Clinical Researcher's Perspective.

Saxman SB.

Abstract

In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as 'outcome-adaptive randomization.' In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While the design merits of outcome-adaptive trials have been debated, little attention has been paid to significant ethical concerns that arise in the conduct of such studies. These include loss of equipoise, lack of processes for adequate informed consent, and inequalities inherent in the research design which could lead to perceptions of injustice that may have negative implications for patients and the research enterprise. This article examines the ethical difficulties inherent in outcome-adaptive trials.

Clin Genet. 2014 Feb 18. doi: 10.1111/cge.12364. [Epub ahead of print]

A "cure" for Down syndrome: What do parents want?

Inglis A, Lohn Z, Austin JC, Hippman C.

Author information

• University of British Columbia Department of Psychiatry, Vancouver, Canada; University of British Columbia Department of Medical Genetics, Vancouver, Canada.

Abstract

Recent advancements in molecular genetics raise the possibility that therapeutics or a "cure" for Down syndrome (DS) may become available. However, there are no data regarding how parents of children with DS perceive the possibility of mitigating specific manifestations such as the intellectual disability (ID) associated with DS, or curing the condition entirely. To explore these issues, we distributed a questionnaire to members of the Lower Mainland Down Syndrome Society in British Columbia, Canada. Questionnaires were completed by 101 parents (response rate = 41%). A majority (61%) viewed the possibility of reversing ID in DS positively, but only 41% said that they would "cure" their child of DS if it were possible. Twenty-seven percent of respondents said they would not "cure" their child, and 32% were unsure if they would "cure" their child. The most commonly cited motivation for opting for a "cure" was to increase their child's independence. However, parental attitudes' towards a "cure" for DS were complex, affected by ethical issues, perceived societal values, and pragmatic factors such as the age of the individual and long-term care-giving burden. These findings could be used by healthcare professionals supporting families who include a member with DS and to direct future research.