J Evid Inf Soc Work. 2015 Mar 6:1-13. [Epub ahead of print]

Evidence-Based Policy Versus Morality Policy: The Case of Syringe Access Programs.

de Saxe Zerden L1, O'Quinn E, Davis C.

Author information

• 1a School of Social Work, University of North Carolina at Chapel Hill , Chapel Hill , North Carolina , USA.

Abstract

Evidence-based practice (EBP) combines proven interventions with clinical experience, ethics, and client preferences to inform treatment and services. Although EBP is integrated into most aspects of social work and public health, at times EBP is at odds with social policy. In this article the authors explore the paradox of evidence-based policy using syringe access programs (SAP) as a case example, and review methods of bridging the gap between the emphasis on EBP and lack of evidence informing SAP policy. Analysis includes the overuse of morality policy and examines historical and current theories why this paradox exists. Action steps are highlighted for creating effective policy and opportunities for public health change. Strategies on reframing the problem and shifting target population focus to garner support for evidence-based policy change are included. This interdisciplinary understanding of the way in which these factors converge is a critical first step in moving beyond morality-based policy toward evidence-based policy.

"There has been a push in some places (including Los Angeles) to offer a similar reward for voting as you can receive from filling out a bracket: pride in doing your civic duty money."

Democracy: Still slightly more popular than college basketball!

"There has been a push in some places (including Los Angeles) to offer a similar reward for voting as you can receive from filling out a bracket: pride in doing your civic duty money. Clearly, most people are filling out brackets not because they have any idea how Marquette stacks up against Belmont but because they get $50 if they have better guesses than their co-workers.* LA's theory is that if you treat a ballot like a lottery ticket, there will be even more ballots cast."

J Law Med. 2014 Dec;22(2):241-54.

Criminalising research fraud.

Freckelton I.

Abstract

The incidence of research fraud has reached troubling levels. Too often peer review has failed to prevent it. The harm caused by such conduct extends to patients, co-authors, supervisors, employing institutions, funders, journals, publishers, and importantly the area and direction of the research itself and its potential influence are tarnished. A number of commentators have raised the option of criminal charges being preferred against those responsible for such fraud. This has occurred in the United States, in particular, but also in the United Kingdom, Korea and Australia in high-profile cases. There is much to be said for this form of prosecutorial response to the phenomenon of research fraud given its multi-level ramifications, the considered nature of the conduct, and the fact that it is engaged in by persons well positioned to appreciate the harm that their deceit may cause. The involvement of the criminal law enhances the potential for deterrence from yielding to the temptation and opportunity to engage in research fraud.

From Harvard: A Functional Landscape of Resistance to ALK Inhibition in Lung Cancer

Cancer Cell. 2015 Mar 9;27(3):397-408. doi: 10.1016/j.ccell.2015.02.005.

A Functional Landscape of Resistance to ALK Inhibition in Lung Cancer.

Wilson FH1, Johannessen CM2, Piccioni F2, Tamayo P2, Kim JW1, Van Allen EM1, Corsello SM1, Capelletti M3, Calles A3, Butaney M3, Sharifnia T1, Gabriel SB2, Mesirov JP2, Hahn WC1, Engelman JA4, Meyerson M5, Root DE2, Jänne PA6, Garraway LA7.

Author information

• 1Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA; The Broad Institute of MIT andHarvard, Cambridge, MA 02142, USA.
• 2The Broad Institute of MIT and Harvard, Cambridge, MA 02142, USA.
• 3Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA.
• 4Massachusetts General Hospital Cancer Center, Charlestown, MA 02129, USA.
• 5Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA; The Broad Institute of MIT andHarvard, Cambridge, MA 02142, USA; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
• 6Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA; Belfer Institute for AppliedCancer Science, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA.
• 7Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA; The Broad Institute of MIT andHarvard, Cambridge, MA 02142, USA. Electronic address: levi_garraway@dfci.harvard.edu.

Abstract

We conducted a large-scale functional genetic study to characterize mechanisms of resistance to ALK inhibition in ALK-dependent lung cancer cells. We identify members of known resistance pathways and additional putative resistance drivers. Among the latter were members of the P2Y purinergic receptor family of G-protein-coupled receptors (P2Y1, P2Y2, and P2Y6). P2Y receptors mediated resistance in part through a protein-kinase-C (PKC)-dependent mechanism. Moreover, PKC activation alone was sufficient to confer resistance to ALK inhibitors, whereas combined ALK and PKC inhibition restored sensitivity. We observed enrichment of gene signatures associated with several resistance drivers (including P2Y receptors) in crizotinib-resistant ALK-rearranged lung tumors compared to treatment-naive controls, supporting a role for these identified mechanisms in clinical ALK inhibitor resistance.

Diffuse Malignant Mesothelioma

Oncol Rep. 2015 Mar 4. doi: 10.3892/or.2015.3830. [Epub ahead of print]

Pemetrexed induces apoptosis in malignant mesothelioma and lung cancer cells through activation of reactive oxygen species and inhibition of sirtuin 1.

Hwang KE1, Kim YS1, Hwang YR1, Kwon SJ1, Park DS2, Cha BK3, Kim BR4, Yoon KH5, Jeong ET1, Kim HR1.

Author information

• 1Department of Internal Medicine, Institute of Wonkwang Medical Science, Wonkwang University School of Medicine, Jeonbuk 570-749, Republic of Korea.
• 2Department of Laboratory Medicine, Wonkwang University School of Medicine, Jeonbuk 570-749, Republic of Korea.
• 3Thoracic and Cardiovascular Surgery, Chonbuk National University Medical School, Jeonbuk 570-749, Republic of Korea.
• 4Department of Obstetrics and Gynecology, Wonkwang University School of Medicine, Jeonbuk 570-749, Republic of Korea.
• 5Department of Radiology, Wonkwang University School of Medicine, Jeonbuk 570-749, Republic of Korea.

Abstract

Pemetrexed is a multitargeted antifolate used for the treatment of malignant mesothelioma and non-small cell lung cancer (NSCLC). However, the mechanism by which pemetrexed induces apoptosis remains unclear. In the present study, we investigated the involvement of reactive oxygen species (ROS) and sirtuin 1 (SIRT1) in pemetrexed-induced apoptosis in MSTO-211 malignant mesothelioma cells and A549 NSCLC cells. Pemetrexed enhanced caspase-dependent apoptosis, induced intracellular ROS generation, and downregulated SIRT1 in the MSTO-211 and A549 cells. Pemetrexed-induced apoptosis, which was prevented by pretreatment with N-acetyl-cysteine (NAC), was mediated by effects on the mitochondria, including mitochondrial membrane potential transition (MPT) and cytosolic release of cytochrome c, and also involved regulation of SIRT1 expression. Interference with SIRT1 expression using siRNA enhanced pemetrexed-induced apoptosis through mitochondrial dysfunction and ROS generation, whereas resveratrol, an activator of SIRT1, protected against pemetrexed-induced apoptosis. These results show that pemetrexed induces apoptosis in MSTO-211 mesothelioma cells and A549 NSCLC cells through mitochondrial dysfunction mediated by ROS accumulation and SIRT1 downregulation.

"...there's more to life than gross domestic product."

Higher income offset by obesity, mental illness and less job satisfaction, economic index shows

"But we all know there's more to life than gross domestic product. Each quarter I write about the Fairfax-Lateral Economics Wellbeing Index which is a much deeper, richer measure of our national progress and welfare than GDP. It draws attention to things overlooked by conventional economic indicators. Like the value of our know-how – as our society and economy have become more dependent on ideas and technology this has grown far more important. The index reveals how the benefits of higher income have been dampened by obesity, mental illness and deteriorating job satisfaction. The wellbeing index now has figures going back a decade. Its five main components provide unique insights into how we are faring as a nation:"

Int J Prison Health. 2014 Mar 12;10(1):3-26.

Correctional mental health in the USA.

A Dlugacz H1.

Author information

• 1Psychiatric Social Worker and an Attorney, based at Beldock Levine & Hoffman LLP, New York, New York, USA; New York Medical College, New York, New York, USA and New York Law School, New York, New York, USA.

Abstract

Purpose - The purpose of this paper is to discuss five domains impacted by the transformation of correctional mental health care in the USA: public health, public safety, legal obligations, fiscal responsibility and ethical standards, as well as critical issues such as administrative segregation, suicide prevention and reentry planning. 

Design/methodology/approach - In the last four decades, the USA has seen a sizable growth in its criminal justice system and corrections population. It has also seen reductions in civil and community-based mental health care. Persons with mental disabilities have come to represent a highly disproportional segment of the corrections population. The paper discusses the implications and underlying causes of these developments as well as recent responses to them. 

Findings - This set of circumstances is starting to change the mission of correctional health services from crisis intervention and suicide prevention to include preparation for the inmate's almost inevitable return to the community. 

Originality/value - Such changes have led to further developments in correctional mental health care, in particular, policy designed to treat mental illness, reduce its destructive outcomes such as suicide, and facilitate successful reentry into the community in attempts to reduce recidivism and improve clinical outcomes. Mental health care professionals working within corrections have likewise faced ethical challenges in effectuating treatment.

Chest. 2015 Mar 12. doi: 10.1378/chest.15-0278. [Epub ahead of print]

Ethical and practical considerations in providing critical care to patients with Ebola virus disease.

Torabi-Parizi P, Davey RT Jr, Suffredini AF, Chertow DS.

Abstract

ABSTRACT:

Infectious disease epidemics in the past have given rise to psychological and emotional responses among health care workers stemming from fear of infection during patient care. Early experiences in the AIDS epidemic provide an example where fear of contagion resulted in differential treatment of human immunodeficiency virus (HIV)-infected patients. However, with a deeper understanding of AIDS pathogenesis and treatment, fear and discrimination diminished. Parallels exist between early experiences with AIDS and the present outbreak of Ebola virus disease (EVD) in West Africa particularly in regards to discussions of medical futility in seriously ill patients. We provide a historical perspective on health care workers' risk of infection during the provision of cardiopulmonary resuscitation, discuss physicians' duty to treat in the face of perceived or actual health care worker risk, and finally present the protocols implemented at the National Institutes of Health (NIH) to reduce health care worker risk while providing life-saving and life-sustaining care.

Payment for cancer biomarker testing; "...puts the ultimate success of personalized cancer therapy at greatest risk."

Arch Pathol Lab Med. 2015 Mar;139(3):300-4. doi: 10.5858/arpa.2014-0190-ED.

Payment for cancer biomarker testing.

Allen TC1.

Author information

• 1From the Department of Pathology, University of Texas Medical Branch, Galveston.

"...although personalized cancer therapy is successfully tackling biological, technical, and pharmacologic challenges, payment is emerging as the challenge most difficult to overcome, and the one that puts the ultimate success of personalized cancer therapy at greatest risk."

JAMA. 2014 Nov 26;312(20):2146-55. doi: 10.1001/jama.2014.10705.

The medical liability climate and prospects for reform.

Mello MM1, Studdert DM1, Kachalia A2.

Author information

• 1Stanford Law School, Stanford, California2Stanford University School of Medicine, Stanford, California.
• 2Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Abstract

For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects. These nontraditional reforms have considerable promise for addressing some of the system's most challenging issues, including high costs and barriers to accessing compensation. In this Special Communication, we review recent national trends in medical liability claims and costs, which indicate a sharp reduction in the rate of paid claims and flat or declining levels in compensation payments and liability insurance costs over the last 7 to 10 years. We discuss a number of nontraditional reform approaches--communication-and-resolution programs, presuit notification and apology laws, safe harbor legislation, judge-directed negotiation, and administrative compensation systems--and we conclude by describing several forces likely to shape change in the medical liability environment over the next decade.

Psychiatry Clin Neurosci. 2015 Mar 10. doi: 10.1111/pcn.12289. [Epub ahead of print]

Informed Consent Procedures with Cognitively Impaired Patients: A Review of Ethics and Best Practices.

Fields LM1, Calvert JD.

Author information

• 1Southern Methodist University.

Abstract

AIM:

The objectives of this paper are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent.

METHODS:

Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from healthcare organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to "informed consent" and "cognitive impairment" published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed.

RESULTS:

We selected 43 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent.

CONCLUSIONS:

Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount.

J Trauma Acute Care Surg. 2015 Feb;78(2):252-258.

Saving lives and saving money: Hospital-based violence intervention is cost-effective.

Juillard C1, Smith R, Anaya N, Garcia A, Kahn JG, Dicker RA.

Author information

• 1From the San Francisco General Hospital (C.J., R.A.D.), Global Health Sciences (N.A.), and Institute for Health Policy Studies (J.G.K.), University of California-San Francisco, San Francisco; and University of California, San Francisco-East Bay-Highland Hospital (R.S., A.G.), Oakland, California.

Abstract

BACKGROUND:

Victims of violence are at significant risk for injury recidivism, including fatality. We previously demonstrated that our hospital-based violence intervention program (VIP) resulted in a fourfold reduction in injury recidivism, avoiding trauma care costs of $41,000 per injury. Given limited trauma center resources, assessing cost-effectiveness of interventions is fundamental to inform use of these programs in other institutions. This study examines the cost-effectiveness of hospital-based VIP.

METHODS:

We used a decision tree and Markov disease state modeling to analyze cost utility for a hypothetical cohort of violently injured subjects, comparing VIP versus no VIP at a trauma center. Quality-adjusted life-years (QALYs) were calculated using differences in mortality and published health state utilities. Costs of trauma care and VIP were obtained from institutional data, and risk of recidivism with and without VIP were obtained from our trial. Outcomes were QALYs gained and net costs over a 5-year horizon. Sensitivity analyses examined the impact of uncertainty in input values on results.

RESULTS:

VIP results in an estimated 25.58 QALYs and net costs (program plus trauma care) of $5,892 per patient. Without VIP, these values are 25.34 and $5,923, respectively, suggesting that VIP yields substantial health benefits (24 QALYs) and savings ($4,100) if implemented for 100 individuals. In the sensitivity analysis, net QALYs gained with VIP nearly triple when the injury recidivism rate without VIP is highest. Cost-effectiveness remained robust over a range of values; $6,000 net cost savings occur when 5-year recidivism rate without VIP is at 7%.

CONCLUSION:

VIP costs less than having no VIP with significant gains in QALYs especially at anticipated program scale. Across a range of plausible values at which VIP would be less cost-effective (lower injury recidivism, cost of injury, and program effectiveness), VIP still results in acceptable cost per health outcome gained. VIP is effective and cost-effective and should be considered in any trauma center that takes care of violently injured patients. Our analyses can be used to estimate VIP costs and results in different settings.

“Sanctions? Don’t make my Iskander laugh.”

Russia’s anti-American fever goes beyond the Soviet era’s

Anti-American measures quickly suffused the nation, ranging from the symbolic to the truly significant. Some coffee shops in Crimea stopped serving Americanos. Activists projected racially charged images of Obama eating a banana onto the side of the U.S. Embassy in Moscow. Russians cheerfully flocked to exchange Western-branded clothing for ­T-shirts with pictures of an Iskander missile launcher that said “Sanctions? Don’t make my Iskander laugh.”

“This anti-Western propaganda radically changed the atmosphere in the society,” said Lev Gudkov, the director of the Levada Center, the opinion polling firm. “It has become militarist.”

HT:LR

Cancer: "Violence metaphors are not by default negative and Journey metaphors are not by default a positive means of conceptualising cancer."

BMJ Support Palliat Care. 2015 Mar 5. pii: bmjspcare-2014-000785. doi: 10.1136/bmjspcare-2014-000785. [Epub ahead of print]

The online use of Violence and Journey metaphors by patients with cancer, as compared with health professionals: a mixed methods study.

Semino E1, Demjén Z2, Demmen J3, Koller V1, Payne S4, Hardie A1, Rayson P5.

Author information

• 1Department of Linguistics and English Language, Lancaster University, Lancaster, UK.
• 2Department of Applied Linguistics and English Language, The Open University, Milton Keynes, UK.
• 3Department of Linguistics and Modern Languages, University of Huddersfield, Huddersfield, UK.
• 4International Observatory on End of Life Care, Lancaster University, Lancaster, UK.
• 5School of Computing and Communications, Lancaster University, Lancaster, UK.

Abstract

OBJECTIVE:

To compare the frequencies with which patients with cancer and health professionals use Violence and Journey metaphors when writing online; and to investigate the use of these metaphors by patients with cancer, in view of critiques of war-related metaphors for cancer and the adoption of the notion of the 'cancer journey' in UK policy documents.

DESIGN:

Computer-assisted quantitative and qualitative study of two data sets totalling 753 302 words.

SETTING:

A UK-based online forum for patients with cancer (500 134 words) and a UK-based website for health professionals (253 168 words).

PARTICIPANTS:

56 patients with cancer writing online between 2007 and 2012; and 307 health professionals writing online between 2008 and 2013.

RESULTS:

Patients with cancer use both Violence metaphors and Journey metaphors approximately 1.5 times per 1000 words to describe their illness experience. In similar online writing, health professionals use each type of metaphor significantly less frequently. Patients' Violence metaphors can express and reinforce negative feelings, but they can also be used in empowering ways. Journey metaphors can express and reinforce positive feelings, but can also be used in disempowering ways.

CONCLUSIONS:

Violence metaphors are not by default negative and Journey metaphors are not by default a positive means of conceptualising cancer. A blanket rejection of Violence metaphors and an uncritical promotion of Journey metaphors would deprive patients of the positive functions of the former and ignore the potential pitfalls of the latter. Instead, greater awareness of the function (empowering or disempowering) of patients' metaphor use can lead to more effective communication about the experience of cancer.

Biopsychosoc Med. 2015 Mar 5;9:7. doi: 10.1186/s13030-015-0034-4. eCollection 2015.

Parental stress and the onset and course of childhood asthma.

Yamamoto N1, Nagano J1.

Author information

• 1Faculty of Arts and Science, Kyushu University, 6-1 Kasuga Park, Kasuga, Fukuoka 816-8580 Japan.

Abstract

The influence of a caregiver's stress on the development of childhood asthma is an important aspect of the treatment and prevention of illness. Many cross-sectional studies have investigated the association between parenting attitude and/or caregiver's stress and childhood asthma morbidity, but prospective studies are more advantageous than cross-sectional studies in interpreting a causal relationship from the results. We here present an overview of prospective studies that have reported a relationship between parental stress and the morbidity or course of childhood asthma and discuss the role of parental mental health in its prevention and treatment. Almost all of the studies referred to in this paper show that caregiver (mostly mothers) stress contributed to the onset and to a poor prognosis, while only a few studies have examined the adverse effect of paternal stress on childhood asthma. Their results are inconsistent, and there is insufficient data examining specific stress-related properties that can be targeted in intervention studies. Not only maternal but also paternal influence should be considered in future studies, and it will be important to assess specific stress-related properties that can be the foundation of specific intervention methods.

AAPS PharmSciTech. 2014 Dec;15(6):1527-34. doi: 10.1208/s12249-014-0177-9. Epub 2014 Jul 22.

Nanomedicine scale-up technologies: feasibilities and challenges.

Paliwal R1, Babu RJ, Palakurthi S.

Author information

• 1Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, 1010 West Avenue B, MSC 131, Kingsville, Texas, 78363, USA.

Abstract

Nanomedicine refers to biomedical and pharmaceutical applications of nanosized cargos of drugs/vaccine/DNA therapeutics including nanoparticles, nanoclusters, and nanospheres. Such particles have unique characteristics related to their size, surface, drug loading, and targeting potential. They are widely used to combat disease by controlled delivery of bioactive(s) or for diagnosis of life-threatening problems in their very early stage. The bioactive agent can be combined with a diagnostic agent in a nanodevice for theragnostic applications. However, the formulation scientist faces numerous challenges related to their development, scale-up feasibilities, regulatory aspects, and commercialization. This article reviews recent progress in the method of development of nanoparticles with a focus on polymeric and lipid nanoparticles, their scale-up techniques, and challenges in their commercialization.

Has drinking a coke replaced sitting as the new smoking?

CBS NEWSMarch 10, 2015, 12:07 PM

Sugary sodas disappear from Burger King kids' menus

"Burger King has removed sugary drinks from its kids' menu boards and says sodas are no longer being promoted as part of kids' meals. Instead, children are offered the options of 100% apple juice, fat-free milk or low-fat chocolate milk."

J Empir Res Hum Res Ethics. 2015 Feb;10(1):31-6. doi: 10.1177/1556264614560146. Epub 2014 Dec 18.

An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States.

He S1, Botkin JR2, Hurdle JF3.

Author information

• 1Intermountain Healthcare, Salt Lake City, UT, USA.
• 2University of Utah, Salt Lake City, USA.
• 3University of Utah, Salt Lake City, USA john.hurdle@utah.edu.

Abstract

The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large academic medical centers have a high electronic IRB adoption rate; however, the capabilities of electronic IRB systems vary greatly. We discuss potential use-cases of a fully exploited electronic IRB system that promise to streamline the clinical research work flow. The key to that approach utilizes a structured and standardized information model for the IRB application.

Clin Trials. 2015 Mar 1. pii: 1740774515571140. [Epub ahead of print]

Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

Anderson ML1, Califf RM2, Sugarman J3; for the participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop.

Author information

• 1Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA Duke Clinical Research Institute, Durham, NC, USA monique.anderson@dm.duke.edu.
• 2Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA Duke Clinical Research Institute, Durham, NC, USA Duke Translational Medicine Institute, Duke University, Durham, NC, USA.
• 3Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.

Abstract

Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.

USNWR 2015 law school ranking

Best Law Schools

Ranked in 2015

HT:AB

Diffuse Malignant Mesothelioma

Diffuse Malignant Mesothelioma