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1.  Motor Vehicle Crashes in Diabetic Patients with Tight Glycemic Control: A Population-based Case Control Analysis 
PLoS Medicine  2009;6(12):e1000192.
Using a population-based case control analysis, Donald Redelmeier and colleagues found that tighter glycemic control, as measured by the HbA1c, is associated with an increased risk of a motor vehicle crash.
Background
Complications from diabetes mellitus can compromise a driver's ability to safely operate a motor vehicle, yet little is known about whether euglycemia predicts normal driving risks among adults with diabetes. We studied the association between glycosylated hemoglobin (HbA1c) and the risk of a motor vehicle crash using a population-based case control analysis.
Methods and Findings
We identified consecutive drivers reported to vehicle licensing authorities between January 1, 2005 to January 1, 2007 who had a diagnosis of diabetes mellitus and a HbA1c documented. The risk of a crash was calculated taking into account potential confounders including blood glucose monitoring, complications, and treatments. A total of 57 patients were involved in a crash and 738 were not involved in a crash. The mean HbA1c was lower for those in a crash than controls (7.4% versus 7.9%, unpaired t-test, p = 0.019), equal to a 26% increase in the relative risk of a crash for each 1% reduction in HbA1c (odds ratio = 1.26, 95% confidence interval 1.03–1.54). The trend was evident across the range of HbA1c values and persisted after adjustment for measured confounders (odds ratio = 1.25, 95% confidence interval 1.02–1.55). The two other significant risk factors for a crash were a history of severe hypoglycemia requiring outside assistance (odds ratio = 4.07, 95% confidence interval 2.35–7.04) and later age at diabetes diagnosis (odds ratio per decade = 1.29, 95% confidence interval 1.07–1.57).
Conclusions
In this selected population, tighter glycemic control, as measured by the HbA1c, is associated with an increased risk of a motor vehicle crash.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Around 8% of the US population has diabetes, a group of diseases in which the body cannot control levels of glucose (sugar) in the blood. It can lead to serious complications and premature death, but suitable treatment can control the disease and lower the risk of complications.
Type 1 diabetes occurs when the body's immune system prevents the production of insulin, the hormone that controls blood glucose. It accounts for 5%–10% of diabetes cases in adults and the vast majority of cases in childhood. Patients with type 1 diabetes need to inject insulin to survive. Type 2 diabetes is associated with older age, obesity, family history of diabetes, lack of physical activity, and race/ethnicity. As obesity rates rise worldwide, it is expected that the prevalence of type 2 diabetes will increase.
Why Was This Study Done?
Some complications of diabetes affect the ability to drive safely. Prolonged periods of high blood sugar levels can damage eyesight and nerves throughout the body, resulting in pain, tingling, and reduction of feeling or muscle control. Over time, some diabetics may become unaware of the early symptoms of an abnormally low blood sugar level (hypoglycemia) that can cause confusion, clumsiness, or fainting. Severe hypoglycemia can result in seizures or a coma.
It is common for driver licensing authorities to require evidence that a diabetic person's condition is well controlled before they issue a driving license. One measure of this is the percentage of hemoglobin in their blood that has joined up with glucose, known as HbA1c. This provides a measure of average blood glucose levels over the previous 8–12 weeks. A lower reading is considered an indicator of good diabetic control, but conversely, a blood glucose level that is too low can cause hypoglycemia. Normal nondiabetic HbA1c is between 3.5% and 5.5%, but 6.5% is considered good for people with diabetes.
In this study the researchers tested whether blood glucose levels, as measured by levels of HbA1c, were statistically associated with the risk of a motor vehicle crash.
What Did the Researchers Do and Find?
The authors studied 795 diabetic adults who had been in contact with the driver licensing authority in Ontario, Canada between January 1, 2005 and January 1, 2007 and for whom HbA1c levels were recorded. HbA1c levels varied between 4.4% and 14.7%.
Of the drivers considered, 57 were involved in a car crash and 738 were not. The authors found that lower HbA1c levels were associated with an increased risk of a motor vehicle crash, even when they took into account other factors such as time since diagnosis, treatment, age, age when diagnosed, and, if taking insulin, age insulin started.
The authors also found that the risk of a crash quadrupled when a driver had a history of severe hypoglycemia that required outside help and that there was an increase in risk when diabetes had first been diagnosed at an older age.
What Do These Findings Mean?
The authors conclude by emphasizing the difficulty in knowing whether someone with diabetes is fit to drive. They suggest that a patient's HbA1c level is neither necessary nor sufficient to determine whether a diabetic person is fit to drive and these results, which agree with some other studies, call into question the current legal framework of the US, UK, Canada, Germany, Holland, and Australia, which single out diabetic drivers for medical review.
The finding that lower HbA1c levels are associated with an increased risk of a crash is surprising, as it suggests that a driver is less safe if they control their diabetes well. However, a statistical link does not prove that one event causes another. Unknown social or medical factors might explain the results. In this case, the authors point out that a major drawback of their study is that it is not randomized and drivers have free will in choosing how tightly to control their diabetes and also how carefully they drive. The authors considered whether time spent driving might explain the results, but discounted this for several reasons. One more plausible explanation is that intensive treatment to attain a lower HbA1c level for better general health raises the risk of hypoglycemic episodes.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000192.
Wikipedia includes an article on diabetes (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The American Diabetes Association publishes information on diabetes in English and Spanish
The American Diabetes Association also publishes information on US states regulation of drivers with diabetes
The World Health Organization of the United Nations Diabetes Programme works to prevent diabetes, minimize complications, and maximize quality of life
doi:10.1371/journal.pmed.1000192
PMCID: PMC2780354  PMID: 19997624
2.  The role of the African-American physician in reducing traffic-related injury and death among African Americans: consensus report of the National Medical Association. 
ISSUE: Traffic-related injuries and fatalities disproportionately affect the African American community. These high rates of traffic-related death and injury among African Americans manifest in multiple areas of traffic safety, including: Failure to use seat belts and child restraints. High incidence of alcohol-impaired driving. Failure to follow child passenger and seat belt safety laws and recommendations. High rates of pedestrian accidents, ofen brought on by impairments of drivers and/or pedestrians. Research indicates that national public information campaigns, with general messages only slightly modified for African American audiences, have not been culturally appropriate or effective in changing traffic safety behavior. In addition, traditional distribution mechanisms for these messages have not effectively reached the target population. Evidence suggests that in the African American community, there is a pervasive lack of knowledge of the devastating impact of traffic-related accidents on the overall health status of the community. This lack of information has resulted in a tragic cycle, in which parents fail to model safe operation of motor vehicles, and generation after generation copy this behavior, increasing the community's vulnerability to serious injuries and untimely deaths. This trend toward improper traffic safety habits among African Americans persists despite federal, state and local laws to enforce and promote sound traffic safety practices. OBJECTIVE: To study the existence of disparities in traffic-related injury and death among African Americans and to determine what kinds of traffic safety messages and campaigns will be effective in encouraging African Americans to respond to safety laws in sufficient numbers to reduce the disproportionately high rate of injury and death. Traffic safety issues were examined to effectively recommend policy, address barriers, best practices, and intervention strategies for the National Medical Association, its physician members, their patients, and their communities. CONSENSUS PROCESS: A literature review, driven by research instruments from numerous organizations included reports and materials from the National Highway Traffic Safety Administration (NHTSA), American Academy of Pediatrics, National Committee for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention (CDC), Mothers Against Drunk Driving (MADD), and the National SAFE KIDS Campaign. Both the Meharry Medical College report, Achieving a Credible Health and Safety Approach to Increasing Seat Belt Use Among African-Americans, and the U.S. Department of Transportation's Blue Ribbon Panel to Increase Seat Belt Use Among African Americans: A Report to the Nation, provided substantial background for the panel. More than 60 pieces of traffic safety literature have been examined to date. Based on the literature review, a short list of the most relevant issues affecting African Americans and traffic safety was devised. It includes: The disproportionately high rate of traffic-related injury and death among African Americans. The cost in health, monetary costs and other associated costs of traffic safety accidents and injuries. The number of traffic-related injuries and deaths that could be prevented if more African Americans observed good traffic safety practices. Barriers to practicing good traffic safety habits among African Americans. Failure of laws and public information campaigns to influence improved traffic safety practices among African Americans sufficient to reduce disparities in traffic-related injury and death. In July 2001, NMA convened a consensus panel of experts in St. Thomas, U.S. Virgin Islands, to review a briefing document summarizing the most salient traffic safety issues among African Americans. The panel elaborated on key issues, including existing policy and standards for the use of child restraint devices to secure infants and toddlers, existing data regarding disparities in traffic-related injury and death among African Americans, and the cultural, age and developmental appropriateness of existing safety campaigns. SUMMARY: Public information campaigns have successfully improved traffic safety practices among the general public but in large part have been unsuccessful among minority populations-including African Americans. This may be due to: A failure to use techniques and messages that are culturally sensitive to African Americans. Campaigns that have targeted geographic and social centers where African Americans are not broadly present. Lack of awareness of the disproportionate effect motor vehicle crashes are having on African Americans. Scientifically based, culturally appropriate intervention strategies need to be devised and implemented by African American institutions and organizations to improve traffic safety practices and reduce the high rate of traffic-related injury and deaths among African Americans.
PMCID: PMC2594128  PMID: 11858225
3.  Physician Emigration from Sub-Saharan Africa to the United States: Analysis of the 2011 AMA Physician Masterfile 
PLoS Medicine  2013;10(9):e1001513.
Siankam Tankwanchi and colleagues used the AMA Physician Masterfile and the WHO Global Health Workforce Statistics on physicians in sub-Saharan Africa to determine trends in physician emigration to the United States.
Please see later in the article for the Editors' Summary
Background
The large-scale emigration of physicians from sub-Saharan Africa (SSA) to high-income nations is a serious development concern. Our objective was to determine current emigration trends of SSA physicians found in the physician workforce of the United States.
Methods and Findings
We analyzed physician data from the World Health Organization (WHO) Global Health Workforce Statistics along with graduation and residency data from the 2011 American Medical Association Physician Masterfile (AMA-PM) on physicians trained or born in SSA countries who currently practice in the US. We estimated emigration proportions, year of US entry, years of practice before emigration, and length of time in the US. According to the 2011 AMA-PM, 10,819 physicians were born or trained in 28 SSA countries. Sixty-eight percent (n = 7,370) were SSA-trained, 20% (n = 2,126) were US-trained, and 12% (n = 1,323) were trained outside both SSA and the US. We estimated active physicians (age ≤70 years) to represent 96% (n = 10,377) of the total. Migration trends among SSA-trained physicians increased from 2002 to 2011 for all but one principal source country; the exception was South Africa whose physician migration to the US decreased by 8% (−156). The increase in last-decade migration was >50% in Nigeria (+1,113) and Ghana (+243), >100% in Ethiopia (+274), and >200% (+244) in Sudan. Liberia was the most affected by migration to the US with 77% (n = 175) of its estimated physicians in the 2011 AMA-PM. On average, SSA-trained physicians have been in the US for 18 years. They practiced for 6.5 years before US entry, and nearly half emigrated during the implementation years (1984–1999) of the structural adjustment programs.
Conclusion
Physician emigration from SSA to the US is increasing for most SSA source countries. Unless far-reaching policies are implemented by the US and SSA countries, the current emigration trends will persist, and the US will remain a leading destination for SSA physicians emigrating from the continent of greatest need.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Population growth and aging and increasingly complex health care interventions, as well as existing policies and market forces, mean that many countries are facing a shortage of health care professionals. High-income countries are addressing this problem in part by encouraging the immigration of foreign health care professionals from low- and middle-income countries. In the US, for example, international medical graduates (IMGs) can secure visas and permanent residency by passing examinations provided by the Educational Commission of Foreign Medical Graduates and by agreeing to provide care in areas that are underserved by US physicians. Inevitably, the emigration of physicians from low- and middle-income countries undermines health service delivery in the emigrating physicians' country of origin because physician supply is already inadequate in those countries. Physician emigration from sub-Saharan Africa, which has only 2% of the global physician workforce but a quarter of the global burden of disease, is particularly worrying. Since 1970, as a result of large-scale emigration and limited medical education, there has been negligible or negative growth in the density of physicians in many countries in sub-Saharan Africa. In Liberia, for example, in 1973, there were 7.76 physicians per 100,000 people but by 2008 there were only 1.37 physicians per 100,000 people; in the US, there are 250 physicians per 100,000 people.
Why Was This Study Done?
Before policy proposals can be formulated to address global inequities in physician distribution, a clear picture of the patterns of physician emigration from resource-limited countries is needed. In this study, the researchers use data from the 2011 American Medical Association Physician Masterfile (AMA-PM) to investigate the “brain drain” of physicians from sub-Saharan Africa to the US. The AMA-PM collects annual demographic, academic, and professional data on all residents (physicians undergoing training in a medical specialty) and licensed physicians who practice in the US.
What Did the Researchers Do and Find?
The researchers used data from the World Health Organization (WHO) Global Health Workforce Statistics and graduation and residency data from the 2011 AMA-PM to estimate physician emigration rates from sub-Saharan African countries, year of US entry, years of service provided before emigration to the US, and length of time in the US. There were 10,819 physicians who were born or trained in 28 sub-Saharan African countries in the 2011 AMA-PM. By using a published analysis of the 2002 AMA-PM, the researchers estimated that US immigration among sub-Saharan African-trained physicians had increased over the past decade for all the countries examined except South Africa, where physician emigration had decreased by 8%. Overall, the number of sub-Saharan African IMGs in the US had increased by 38% since 2002. More than half of this increase was accounted for by Nigerian IMGs. Liberia was the country most affected by migration of its physicians to the US—77% of its estimated 226 physicians were in the 2011 AMA-PM. On average, sub-Saharan African IMGs had been in the US for 18 years and had practiced for 6.5 years before emigration. Finally, nearly half of the sub-Saharan African IMGs had migrated to US between 1984 and 1995, years during which structural adjustment programs, which resulted in deep cuts to public health care services, were implemented in developing countries by international financial institutions as conditions for refinancing.
What Do These Findings Mean?
Although the sub-Saharan African IMGs in the 2011 AMA-PM only represent about 1% of all the physicians and less than 5% of the IMGs in the AMA-PM, these findings reveal a major loss of physicians from sub-Saharan Africa. They also suggest that emigration of physicians from sub-Saharan Africa is a growing problem and is likely to continue unless job satisfaction for physicians is improved in their country of origin. Moreover, because the AMA-PM only lists physicians who qualify for a US residency position, more physicians may have moved from sub-Saharan Africa to the US than reported here and may be working in other jobs incommensurate with their medical degrees (“brain waste”). The researchers suggest that physician emigration from sub-Saharan Africa to the US reflects the complexities in the labor markets for health care professionals in both Africa and the US and can be seen as low- and middle-income nations subsidizing the education of physicians in high-income countries. Policy proposals to address global inequities in physician distribution will therefore need both to encourage the recruitment, training, and retention of health care professionals in resource-limited countries and to persuade high-income countries to train more home-grown physicians to meet the needs of their own populations.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001513.
The Foundation for Advancement of International Medical Education and Research is a non-profit foundation committed to improving world health through education that was established in 2000 by the Educational Commission for Foreign Medical Graduates
The Global Health Workforce Alliance is a partnership of national governments, civil society, international agencies, finance institutions, researchers, educators, and professional associations dedicated to identifying, implementing and advocating for solutions to the chronic global shortage of health care professionals (available in several languages)
Information on the American Medical Association Physician Masterfile and the providers of physician data lists is available via the American Medical Associations website
The World Health Organization (WHO) annual World Health Statistics reports present the most recent health statistics for the WHO Member States
The Medical Education Partnership Initiative is a US-sponsored initiative that supports medical education and research in sub-Saharan African institutions, aiming to increase the quantity, quality, and retention of graduates with specific skills addressing the health needs of their national populations
CapacityPlus is the USAID-funded global project uniquely focused on the health workforce needed to achieve the Millennium Development Goals
Seed Global Health cultivates the next generation of health professionals by allying medical and nursing volunteers with their peers in resource-limited settings
"America is Stealing the Worlds Doctors", a 2012 New York Times article by Matt McAllester, describes the personal experience of a young doctor who emigrated from Zambia to the US
Path to United States Practice Is Long Slog to Foreign Doctors, a 2013 New York Times article by Catherine Rampell, describes the hurdles that immigrant physicians face in practicing in the US
doi:10.1371/journal.pmed.1001513
PMCID: PMC3775724  PMID: 24068894
4.  Diabetes and Driving Safety: Science, Ethics, Legality & Practice 
Diabetes affects over 25 million people in the United States, most of whom are over the age of 16 and many of whom are licensed to drive a motor vehicle. Safe operation of a motor vehicle requires complex interactions of cognitive and motor functions and medical conditions that affect these functions often will increase the risk of motor vehicle accidents (MVA). In the case of diabetes, hypoglycemia is the most common factor that has been shown to increase MVA rates. When people with diabetes are compared with non-diabetic controls, systematic analyses show that the relative risk of MVA is increased by between 12 and 19% (RRR 1.12-1.19). In comparison, the RRR for Attention Deficit Hyperactivity Disorder is 4.4 and for Sleep Apnea is 2.4.
Epidemiologic research suggests that patients at risk for hypoglycemia-related MVAs may have some characteristics in common, including a history of severe hypoglycemia or of hypoglycemia-related driving mishaps. Experimental studies also have shown that people with a history of hypoglycemia-related driving mishaps have abnormal counter-regulatory responses to hypoglycemia and greater cognitive impairments during moderate hypoglycemia.
There are medical, ethical and legal issues for health care professionals who care for people with diabetes regarding their patients’ risk of hypoglycemia-related driving mishaps. This includes identifying those at increased risk and counseling them on preventive measures, including more frequent blood glucose testing, delaying driving with low or low normal blood glucose, and carrying readily available emergency supplies in the vehicle for the treatment of hypoglycemia.
doi:10.1097/MAJ.0b013e31828bf8d7
PMCID: PMC3652323  PMID: 23531955
Diabetes; driving; licensure; risk
5.  THE OLDER ADULT DRIVER WITH COGNITIVE IMPAIRMENT 
Although automobiles remain the transportation of choice for older adults, late life cognitive impairment and dementia often impair the ability to drive safely. There is, however, no commonly utilized method of assessing dementia severity in relation to driving, no consensus on the assessment of older drivers with cognitive impairment, and no gold standard for determining driving fitness. Yet, clinicians are called upon by patients, their families, other health professionals, and often the Department of Motor Vehicles (DMV) to assess their patients' fitness-to-drive and to make recommendations about driving privileges. Using the case of Mr W, we describe the challenges of driving with cognitive impairment for both the patient and caregiver, summarize the literature on dementia and driving, discuss evidenced-based assessment of fitness-to-drive, and address important ethical and legal issues. We describe the role of physician assessment, referral to neuropsychology, functional screens, dementia severity tools, driving evaluation clinics, and DMV referrals that may assist with evaluation. Finally, we discuss mobility counseling (eg, exploration of transportation alternatives) since health professionals need to address this important issue for older adults who lose the ability to drive. The application of a comprehensive, interdisciplinary approach to the older driver with cognitive impairment will have the best opportunity to enhance our patients' social connectedness and quality of life, while meeting their psychological and medical needs and maintaining personal and public safety.
doi:10.1001/jama.2010.481
PMCID: PMC2915446  PMID: 20424254
6.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
7.  How international is bioethics? A quantitative retrospective study 
BMC Medical Ethics  2006;7:1.
Background
Studying the contribution of individual countries to leading journals in a specific discipline can highlight which countries have the most impact on that discipline and whether a geographic bias exists. This article aims to examine the international distribution of publications in the field of bioethics.
Methods
Retrospective quantitative study of nine peer reviewed journals in the field of bioethics and medical ethics (Bioethics, Cambridge Quarterly of Healthcare Ethics, Hastings Center Report, Journal of Clinical Ethics, Journal of Medical Ethics, Kennedy Institute of Ethics Journal, Nursing Ethics, Christian Bioethics, and Theoretical Medicine and Bioethics).
Results
In total, 4,029 articles published between 1990 and 2003 were retrieved from the nine bioethical journals under study. The United States (59.3%, n = 2390), the United Kingdom (13.5%, n = 544), Canada (4%, n = 160) and Australia (3.8%, n = 154) had the highest number of publications in terms of absolute number of publications. When normalized to population size, smaller affluent countries, such as New Zealand, Finland and Sweden were more productive than the United States. The number of studies originating from the USA was decreasing in the period between 1990 and 2003.
Conclusion
While a lot of peer reviewed journals in the field of bioethics profile themselves as international journals, they certainly do not live up to what one would expect from an "international" journal. The fact that English speaking countries, and to a larger extent American authors, dominate the international journals in the field of bioethics is a clear geographic bias towards the bioethical discussions that are going on in these journals.
doi:10.1186/1472-6939-7-1
PMCID: PMC1351197  PMID: 16412229
8.  Obstructive sleep apnea and driving: A Canadian Thoracic Society and Canadian Sleep Society position paper 
Individuals with obstructive sleep apnea (OSA) experience sleep fragmentation and poor sleep quality that results in daytime sleepiness, which impairs performance during driving and leads to an increased risk for collisions. Not surprisingly, observational studies have shown that patients with OSA experience a two- to 10-fold higher risk for collision compared with healthy controls. Although treatment would clearly mitigate these risks, there is no current Canadian position on driving and OSA. This article, the first Canadian position statement addressing the issue, provides an overview of provincial regulations and proposes recommendations with regard to driving in patients with OSA.
Untreated patients with obstructive sleep apnea (OSA) are at increased risk for motor vehicle collisions; however, it is unclear how this should be translated into fitness-to-drive recommendations. Accordingly, the Canadian Thoracic Society (CTS) Sleep Disordered Breathing Clinical Assembly and the Canadian Sleep Society (CSS) assembled a CTS-CSS working group to propose recommendations with regard to driving in patients with OSA.
Recommendations for assessing fitness to drive in noncommercial drivers:
1. Severity of OSA alone is not a reliable predictor of collision risk and, therefore, should not be used in isolation to assess fitness to drive; 2. The severity of sleep apnea should be considered in the context of other factors to assess fitness to drive; 3. The decision to restrict driving is ultimately made by the motor vehicle licensing authority; however, they should take into account the information and recommendations provided by the sleep medicine physician and should follow provincial guidelines; 4. For patients prescribed continuous positive airway pressure (CPAP) therapy, objective CPAP compliance should be documented. Efficacy should also be documented in terms of reversing the symptoms and improvement in sleep apnea based on physiological monitoring; 5. For patients treated with surgery or an oral appliance, verification of adequate sleep apnea treatment should be obtained; and 6. A driver diagnosed with OSA may be recertified as fit to drive based on assessment of symptoms and demonstrating compliance with treatment. The assessment should be aligned with the provincial driver’s license renewal period.
Commercial vehicles:
Assessment of fitness to drive should be more stringent for patients operating commercial vehicles. In general, the CTS-CSS working group was in agreement with the Medical Expert Panel recommendations to the Federal Motor Carrier Safety Administration in the United States; these recommendations were adapted for Canadian practitioners.
PMCID: PMC4128516  PMID: 24724150
Collisions; Commercial drivers; Diagnosis; Driving; Sleep apnea; Sleepiness
9.  Neglect of Medical Evidence of Torture in Guantánamo Bay: A Case Series 
PLoS Medicine  2011;8(4):e1001027.
Vincent Iacopino and Stephen Xenakis review case records of nine individuals imprisoned at Guantánamo Bay which indicate that medical personnel assigned to the US Department of Defense neglected and/or concealed medical evidence of torture.
Background
In the wake of the September 11, 2001 attacks on the US, the government authorized the use of “enhanced interrogation” techniques that were previously recognized as torture. While the complicity of US health professionals in the design and implementation of US torture practices has been documented, little is known about the role of health providers, assigned to the US Department of Defense (DoD) at the US Naval Station Guantánamo Bay, Cuba (GTMO), who should have been in a position to observe and document physical and psychological evidence of torture and ill treatment.
Methods and Findings
We reviewed GTMO medical records and relevant case files (client affidavits, attorney–client notes and summaries, and legal affidavits of medical experts) of nine individuals for evidence of torture and ill treatment and documentation by medical personnel. In each of the nine cases, GTMO detainees alleged abusive interrogation methods that are consistent with torture as defined by the UN Convention Against Torture as well as the more restrictive US definition of torture that was operational at the time. The medical affidavits in each of the nine cases indicate that the specific allegations of torture and ill treatment are highly consistent with physical and psychological evidence documented in the medical records and evaluations by non-governmental medical experts. However, the medical personnel who treated the detainees at GTMO failed to inquire and/or document causes of the physical injuries and psychological symptoms they observed. Psychological symptoms were commonly attributed to “personality disorders” and “routine stressors of confinement.” Temporary psychotic symptoms and hallucinations did not prompt consideration of abusive treatment. Psychological assessments conducted by non-governmental medical experts revealed diagnostic criteria for current major depression and/or PTSD in all nine cases.
Conclusion
The findings in these nine cases from GTMO indicate that medical doctors and mental health personnel assigned to the DoD neglected and/or concealed medical evidence of intentional harm.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Torture has been used throughout history for interrogation, coercion, and punishment. Ingenious methods have been devised to inflict severe physical or mental pain or suffering intentionally on an individual to obtain a confession or information, or to punish, intimidate, or coerce. Nowadays, torture is prohibited under international law and under the domestic law of most countries, and is considered to be a violation of human rights. Article 5 of the United Nations (UN) Universal Declaration of Human Rights, which was adopted in December 1948, states: “No one should be subjected to torture or to cruel, inhuman or degrading treatment or punishment.” Similarly, signatories of the Geneva Conventions, which provide protection for people who fall into enemy hands during conflicts, have agreed not to torture prisoners. Torture is also prohibited by the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, which came into force in June 1987. Implementation of this Convention by participating states is monitored the UN Committee against Torture.
Why Was This Study Done?
After the September 11, 2001 attacks on the United States, the US government redefined acts such as waterboarding (simulated drowning), sleep deprivation, and prolonged isolation as “safe, legal, ethical, and effective” “enhanced interrogation” techniques (EITs). These EITs were previously recognized as torture by the UN Committee against Torture. US health professionals are known to have been complicit in the design and implementation of EITs. For example, the US Central Intelligence Agency (CIA) and Department of Defense (DoD) designated “non-clinical” health professionals to monitor the use of EITs at the US detainee facility at the US Navy Base at Guantánamo Bay, Cuba (GTMO), and the active role of these individuals during interrogations has been documented. Much less is known, however, about the role of health professionals assigned to the DoD to provide medical and mental health care to the GTMO detainees. Specifically, it is not known whether these health professionals accurately documented physical and psychological evidence of torture and ill treatment among the detainees. In this case series, the researchers review GTMO medical records and case files of nine detainees for evidence of documentation of ill treatment and torture by medical personnel.
What Did the Researchers Do and Find?
The researchers—non-governmental medical experts retained by legal representatives of GTMO detainees alleging torture and ill treatment—reviewed the medical records, client affidavits, attorney–client notes, and legal declarations of medical experts of nine GTMO detainees. In each case, the detainee alleged abusive interrogation methods consistent with torture as defined by the UN Convention against Torture. The researchers report that the medical affidavits for all the cases indicate that the allegations of torture and ill treatment were consistent with physical and psychological evidence of torture and ill treatment documented in the medical records and in evaluations by non-governmental experts. However, the medical personnel responsible for the detainees' routine medical and mental health care failed to inquire about and/or document the causes of the physical injuries and psychological symptoms that they observed. Instead, they attributed psychological symptoms to “personality disorders” and “routine stressors of confinement”. Moreover, psychotic symptoms such as hallucinations did not prompt consideration of abusive treatment. Importantly, psychological assessments conducted by non-governmental experts revealed diagnostic criteria for current major depression and/or post-traumatic stress disorder (PTSD, a common outcome of torture or ill treatment) in all the cases.
What Do These Findings Mean?
These findings indicate that health professionals assigned to the DoD to provide medical and mental health care to GTMO detainees neglected and/or concealed evidence of intentional harm. Because only nine cases are included in this case series, these findings may not be generalizable to other GTMO detainees. The findings are also limited by their reliance on medical records and case files that were sometimes heavily edited and on psychological assessments based on questionnaires rather than on direct examination. Nevertheless, these findings reveal new information about the potential extent of medical complicity in US torture practices, and they highlight the need for a thorough and impartial investigation of all the available information, including relevant classified information.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.pmed.1001027.
This study is further discussed in the April 2011 PLoS Medicine Editorial
Wikipedia has pages on torture, and on the Guantánamo Bay detention camp note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Office of the UN High Commissioner for Human Rights provides information about the UN Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment and the UN Committee against Torture (in several languages)
Physicians for Human Rights is a non-profit organization that mobilizes health professionals to advance health, dignity and justice, and promotes the right to health for all. Its Campaign against Torture seeks to restore the US commitment against torture
Amnesty International provides information about the Guantánamo Bay detention camp
doi:10.1371/journal.pmed.1001027
PMCID: PMC3084605  PMID: 21559073
10.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
11.  Motor-Vehicle Crash History and Licensing Outcomes for Older Drivers Reported as Medically Impaired in Missouri 
Accident; analysis and prevention  2008;41(2):246-252.
The identification and evaluation of medically impaired drivers is an important safety issue. Medical fitness to drive is applicable to all ages but is particularly salient for older adults. Voluntary procedures, whereby various professionals and family members may report medical fitness concerns to State driver license bureaus, are common in the United States. This paper examines traffic crashes of drivers reported during 2001–2005 under the State of Missouri’s voluntary reporting law (House Bill HB-1536) and the resulting licensing outcomes.
Missouri’s law is non-specific as to age, but the mean age of reported drivers was 80. Reports were submitted by police officers (30%), license office staff (27%), physicians (20%), family members (16%), and others (7%). The most common medical condition was dementia/cognitive (45%). Crash history for reported drivers was higher than that of controls, dating back to 1993, reaching a peak in 2001 when the crash involvement of reported drivers was 9.3% vs. 2.2% for controls—a fourfold difference. The crash involvement of reported drivers decreased rapidly after, indicating the impact of HB-1536 reporting with subsequent license revocation and to a lesser degree, mortality. Of the 4,100 reported individuals, 144 (3.5%) retained a driver’s license after the process.
doi:10.1016/j.aap.2008.11.003
PMCID: PMC2733533  PMID: 19245882
fitness to drive; aging; voluntary reporting; older driver; crash history; driver licensing; medical impairment; safety
12.  Cancer patient perceptions on the ethical and legal issues related to biobanking 
Background
Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.
Methods
We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.
Results
The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.
Conclusions
Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.
doi:10.1186/1755-8794-6-8
PMCID: PMC3599691  PMID: 23497701
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
13.  United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study 
PLoS Medicine  2012;9(7):e1001271.
Jill Fisher and Corey Kalbaugh describe their findings from a qualitative research study evaluating the motivations of private-sector physicians conducting contract research for the pharmaceutical industry.
Background
There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities.
Methods and Findings
We conducted a qualitative study in 2003–2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers.
Conclusions
Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies.
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
Before a new drug can be used routinely by physicians, it must be investigated in clinical trials—studies that test the drug's safety and effectiveness in people. In the past, clinical trials were usually undertaken in academic medical centers (institutes where physicians provide clinical care, do research, and teach), but increasingly, clinical trials are being conducted in the private sector as part of a growing contract research system. In the US, for example, most clinical trials completed in the 1980s took place in academic medical centers, but nowadays, more than 70% of trials are conducted by nonacademic (community) physicians working under contract to pharmaceutical companies. The number of private-sector nonacademic physicians serving as principal investigators (PIs) for US clinical trials (the PI takes direct responsibility for completion of the trial) increased from 4,000 in 1990 to 20,250 in 2010, and research contracts for clinical trials are now worth more than USṩ11 billion annually.
Why Was This Study Done?
To date, there has been little research on the implications of this change in the conduct of clinical trials. Academic PIs are often involved in both laboratory and clinical research and are therefore likely to identify closely with the science of trials. By contrast, nonacademic PIs may see clinical trials more as a business opportunity—pharmaceutical contract research is profitable to US physicians because they get paid for every step of the trial process. As a result, pharmaceutical companies may now have more control over clinical trial data and more opportunities to suppress negative data through selective publication of study results than previously. In this qualitative study, the researchers explore the outsourcing of clinical trials to private-sector research clinics through observations of, and in-depth interviews with, physicians and other research staff involved in the US clinical trials industry. A qualitative study collects non-quantitative data such as how physicians feel about doing contract research and about their responsibilities to their patients.
What Did the Researchers Do and Find?
Between October 2003 and September 2004, the researchers observed the interactions between PIs, trial coordinators (individuals who undertake many of the trial activities such as blood collection), and trial participants at 25 US research organizations in the southwestern US and interviewed 63 informants (including 12 PIs) about the trials they were involved in and their reasons for becoming involved. The researchers found that private-sector physicians became PIs on industry-sponsored clinical trials primarily because contract research was financially lucrative. The physicians perceived their roles in terms of business rather than science and claimed that they offered something to the pharmaceutical industry that academics do not—the ability to carry out a diverse range of trials quickly and effectively, regardless of their medical specialty. Finally, the physicians saw their primary ethical responsibility as providing accurate data to the companies that hired them and did not explicitly refer to their ethical responsibility to trial participants. One possible reason for this shift in ethical concerns is the belief among private-sector physicians that pharmaceutical companies must be making scientifically and ethically sound decisions when designing trials because of the amount of money they invest in them.
What Do These Findings Mean?
These findings suggest that private-sector physicians participate as PIs in pharmaceutical clinical trials primarily for financial reasons and see themselves as trial practitioners and businesspeople rather than as scientists. The accuracy of these findings is likely to be limited by the small number of PIs interviewed and by the time that has elapsed since the researchers collected their qualitative data. Moreover, these findings may not be generalizable to other regions of the US or to other countries. Nevertheless, they have potentially troubling implications for drug development. By hiring private-sector physicians who see themselves as involved more with the business than the science of contract research, pharmaceutical companies may be able to exert more control over the conduct of clinical trials and the publication of trial results than previously. Compared to the traditional investigatorinitiated system of clinical research, this new system of contract research means that clinical trials now lack the independence that is at the heart of best science practices, a development that casts doubt on the robustness of the knowledge being produced about the safety and effectiveness of new drugs.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001271.
The ClinicalTrials.gov website is a searchable register of federally and privately supported clinical trials in the US; it provides information about all aspects of clinical trials
The US National Institutes of Health provides information about clinical trials, including personal stories about clinical trials from patients and researchers
The UK National Health Service Choices website has information for patients about clinical trials and medical research, including personal stories about participating in clinical trials
The UK Medical Research Council Clinical Trials Unit also provides information for patients about clinical trials and links to information on clinical trials provided by other organizations
MedlinePlus has links to further resources on clinical trials (in English and Spanish)
doi:10.1371/journal.pmed.1001271
PMCID: PMC3404112  PMID: 22911055
14.  Mandatory reporting by physicians of patients potentially unfit to drive 
Open Medicine  2008;2(1):e8-e17.
Background
One strategy for the prevention of motor vehicle crashes is physician reporting of medically unfit drivers to vehicle licensing authorities, as mandated by law in Ontario, Canada. We studied drivers involved in life-threatening crashes who required hospital admission to determine how many had previously been seen and reported by a physician in the community.
Methods
We identified consecutive drivers involved in a crash who were admitted to Canada’s largest trauma centre between 30 June 1996 and 30 June 2001 to assess the prevalence of 3 chronic medical conditions reportable to vehicle licensing authorities (alcohol abuse, cardiac disease, and neurological disorders). We then conducted a case series analysis of linked health and transportation databases to determine how many drivers had previously been seen and reported by a physician in the community.
Results
A total of 1,605 injured drivers were identified, of whom 37% had a reportable condition (95% confidence interval [CI] 35–39). Those with a reportable condition had made a total of 20,505 previous visits to 2,332 physicians during the five years before the crash. The majority of patients with a reportable condition (85%, 95% CI 82–88) had seen a physician in the year before the crash but few (3%, 95% CI 2–4) had been reported to licensing authorities. Alcohol abuse was the most common underlying reportable condition (prevalent in 72% of trauma patients with a reportable condition) and the least common reason for a previous report (reported in 2% of those with a reportable condition).
Interpretation
Unsafe drivers often visit physicians and yet are rarely reported to licensing authorities even under mandatory reporting laws for preventive medical reporting.
PMCID: PMC3091591  PMID: 21602950
15.  Ethical and legal issues in aesthetic surgery 
Rapid growth and expansion of plastic surgery in general and aesthetic surgery in particular in the past decade has brought in its wake some confusions particularly raising questions for the surgeons conduct towards his colleagues and the patients in the light of ethical requirements. Some thoughts from eminent thinkers form a backdrop to consideration of theories of medical ethics. In this article raging and continuous debates on these subjects have been avoided to maintain the momentum. Apart from the western thoughts, directions from our old scriptures on ethical conduct have been included to accommodate prevelant Indian practices. The confusion created by specialists advertising their abilities directly to the lay public following removal of ethical bars by the American Courts as also latitudes allowed by the General Medical Council of Great Britain have been discussed. The medical fraternity however has its reservations. Unnecessary skirmishes with the law arose in cosmetic surgery from the freedom exercised by the police to file criminal proceedings against attending doctors in the event of a patient's death with or without any evidence of wrong doing. This has now been curtailed in the judgement of the Supreme Court of India[1] where norms have been laid down for such prosecution. This has helped doctors to function without fear of harassment. An effort has been made to state a simple day-to-day routine for an ethical doctor-patient relationship.
doi:10.4103/0970-0358.105973
PMCID: PMC3580358  PMID: 23450235
Aesthetic surgery; legal; medical ethics
16.  Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey 
BMJ Open  2014;4(4):e004780.
Objective
To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry.
Design/setting
Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013.
Participants
469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies (‘industry’, n=144), communication agencies (‘agency’, n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD.
Results
Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors’ Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents’ companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents’ departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results.
Conclusions
Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.
doi:10.1136/bmjopen-2013-004780
PMCID: PMC3996822  PMID: 24747794
Medical Journalism; Medical Ethics; Medical Education & Training
17.  Natural deaths while driving: would screening for risk be ethically justified? 
Journal of Medical Ethics  1998;24(4):248-251.
OBJECTIVES: To determine the epidemiology and the underlying pathological conditions of natural deaths among motor vehicle drivers. Sudden death while driving may cause damage to properties, other vehicles or road users. Although the Medical Commission on Accident Prevention recommended restrictions to drivers at risk of sudden death due to their medical conditions, these restrictions are useless if they do not result in greater safety to the public. DESIGN: A retrospective study of natural deaths of motor vehicle drivers. SETTING: Natural deaths of motor vehicle drivers reported to the coroner for Birmingham and Solihull. SUBJECTS: 86 consecutive natural deaths of motor vehicle drivers in a five-year period between 1984 and 1988. RESULTS: Of the 86 fatalities reviewed, 80 (93%) sudden deaths were caused by ischaemic heart disease. Fifty vehicles were involved in collision with 32 properties, 20 other vehicles and six pedestrians. Fifty-one out of 80 cardiac deaths had past cardiac history and three had reported chest pain prior to the sudden death. CONCLUSION: An applied normative ethical assessment based on the basic moral principles of autonomy, justice, beneficence and non-maleficence are discussed. We conclude that medical screening of drivers has little benefit for the drivers or other persons.
PMCID: PMC1377675  PMID: 9752627
18.  Impaired driving from medical conditions: A 70-year-old man trying to decide if he should continue driving 
Jama  2011;305(10):1018-1026.
Some medical disorders can impair performance, increasing the risk of driving safety errors that can lead to vehicle crashes. The causal pathway often involves a concatenation of factors or events, some of which can be prevented or controlled. Effective interventions can operate before, during, or after a crash occurs at the levels of driver capacity, vehicle and road design, and public policy. A variety of systemic, neurological, psychiatric, and developmental disorders put drivers at potential increased risk of a car crash in the short or long term. Medical diagnosis and age alone are usually insufficient criteria for determining fitness to drive. Strategies are needed for determining what types and levels of reduced function provide a threshold for disqualification in drivers with medical disorders. Evidence of decreased mileage, self-restriction to driving in certain situations, collisions, moving violations, aggressive driving, sleepiness, alcohol abuse, metabolic disorders, and multiple medications may trigger considerations of driver safety. A general framework for evaluating driver fitness relies on a functional evaluation of multiple domains (cognitive, motor, perceptual, and psychiatric) that are important for safe driving and can be applied across many disorders, including conditions that have rarely been studied with respect to driving, and in patients with multiple conditions and medications. Neurocognitive tests, driving simulation, and road tests provide complementary sources of evidence to evaluate driver safety. No single test is sufficient to determine who should drive and who should not.
doi:10.1001/jama.2011.252
PMCID: PMC3289256  PMID: 21364126
19.  BMI and Risk of Serious Upper Body Injury Following Motor Vehicle Crashes: Concordance of Real-World and Computer-Simulated Observations 
PLoS Medicine  2010;7(3):e1000250.
Shankuan Zhu and colleagues use computer crash simulations, as well as real-world data, to evaluate whether driver obesity is associated with greater risk of body injury in motor vehicle crashes.
Background
Men tend to have more upper body mass and fat than women, a physical characteristic that may predispose them to severe motor vehicle crash (MVC) injuries, particularly in certain body regions. This study examined MVC-related regional body injury and its association with the presence of driver obesity using both real-world data and computer crash simulation.
Methods and Findings
Real-world data were from the 2001 to 2005 National Automotive Sampling System Crashworthiness Data System. A total of 10,941 drivers who were aged 18 years or older involved in frontal collision crashes were eligible for the study. Sex-specific logistic regression models were developed to analyze the associations between MVC injury and the presence of driver obesity. In order to confirm the findings from real-world data, computer models of obese subjects were constructed and crash simulations were performed. According to real-world data, obese men had a substantially higher risk of injury, especially serious injury, to the upper body regions including head, face, thorax, and spine than normal weight men (all p<0.05). A U-shaped relation was found between body mass index (BMI) and serious injury in the abdominal region for both men and women (p<0.05 for both BMI and BMI2). In the high-BMI range, men were more likely to be seriously injured than were women for all body regions except the extremities and abdominal region (all p<0.05 for interaction between BMI and sex). The findings from the computer simulation were generally consistent with the real-world results in the present study.
Conclusions
Obese men endured a much higher risk of injury to upper body regions during MVCs. This higher risk may be attributed to differences in body shape, fat distribution, and center of gravity between obese and normal-weight subjects, and between men and women.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Worldwide, accidents involving motor vehicles kill 1.2 million people and injure as many as 50 million people every year. Collisions between motor vehicles, between vehicles and stationary objects, or between vehicles and pedestrians are responsible for one in 50 deaths and are the 11th leading cause of death globally. Many factors contribute to the risk of motor traffic accidents and the likelihood of subsequent injury or death. These risk factors include vehicle design, vehicle speeds, road design, driver impairment through, for example, alcohol use, and other driver characteristics such as age. Faced with an ever-increasing death toll on their roads, many countries have introduced lower speed limits, mandatory seat belt use, and greater penalties for drunk driving to reduce the carnage. Road design and traffic management initiatives have also been introduced to try to reduce the incidence of road traffic accidents and cars now include many features that provide protection in crashes for their occupants such as airbags and crumple zones.
Why Was This Study Done?
Although these measures have reduced the number of crashes and casualties, a better understanding of the risk factors associated with motor vehicle crashes is needed to deal with this important public-health problem. Another major public-health problem is obesity—having excess body fat. Obesity increases the risk of heart disease and diabetes but also contributes to the severity of motor vehicle crash injuries. Men with a high body mass index (an individual's weight in kilograms divided by height in meters squared; a BMI of 30 or more indicates obesity) have a higher risk of death after a motor vehicle accident than men with a normal BMI (18.5–24.9). This association between death and obesity is not seen in women, however, possibly because men and women accumulate fat on different parts of their body and the resultant difference in body shape could affect how male and female bodies move during traffic collisions and how much protection existing car safety features afford them. In this study, therefore, the researchers investigated how driver obesity affects the risk of serious injuries in different parts of the body following real and simulated motor vehicle crashes in men and women.
What Did the Researchers Do and Find?
The researchers extracted data about injuries and BMIs for nearly 11,000 adult men and women who were involved in a frontal motor vehicle collision between 2001 and 2005 from the Crashworthiness Data System of the US National Automotive Sampling System. They then used detailed statistical methods to look for associations between specific injuries and driver obesity. The researchers also constructed computer models of obese drivers and subjected these models to simulated crashes. Their analysis of the real-world data showed that obese men had a substantially higher risk of injury to the upper body (the head, face, chest, and spine) than men with a normal weight. Serious injury in the abdominal region was most likely at low and high BMIs for both men and women. Finally, obese men were more likely to be seriously injured than obese women for all body regions except the extremities and the abdominal region. The researchers' computer simulations confirmed many of these real-world findings.
What Do These Findings Mean?
These findings suggest that obese men have a higher risk of injury, particularly to their upper body, from motor vehicle crashes than men with a normal body weight or than obese women. The researchers suggest that this higher risk may be attributed to differences in body shape, fat distribution, and center of gravity between obese and normal weight individuals and between men and women. These findings, although limited by missing data, suggest that motor vehicle safety features should be adjusted to take into account the ongoing obesity epidemic. Currently, two-thirds of people in the US are overweight or obese, yet a crash test dummy with a normal BMI is still used during the design of car cabins. Finally, although more studies are needed to understand the biomechanical responses of the human body during vehicle collisions, the findings in this study could aid the identification of groups of people at particularly high risk of injury or death on the roads who could then be helped to reduce their risk.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000250.
Wikipedia has a page on traffic collision (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The World Health Organization has information about road traffic injuries as a public-health problem; its World report on road traffic injury prevention is available in several languages
The US Centers for Disease Control and Prevention provides detailed information about overweight and obesity (in several languages)
MedlinePlus provides links to further resources about obesity (in English and Spanish)
The US National Automotive Sampling System Crashworthiness Data System contains detailed data on thousands of US motor vehicle crashes
doi:10.1371/journal.pmed.1000250
PMCID: PMC2846859  PMID: 20361024
20.  Learning from the Legal History of Billing for Medical Fees 
Journal of General Internal Medicine  2008;23(8):1257-1260.
INTRODUCTION
When patients pay for care out-of-pocket, physicians must balance their professional obligations to serve with the commercial demands of medical practice. Consumer-directed health care makes this problem newly pressing, but law and ethics have thought for millennia about how doctors should bill patients.
Historical Background
At various points in European history, the law restricted doctors’ ability to bill for their services, but this legal aversion to commercializing medicine did not take root in the American colonies. Rather, US law has always treated selling medical services the way it treats other sales. Yet doctors acted differently in a crucial way. Driven by the economics of medical practice before the spread of health insurance, doctors charged patients according to what they thought each patient could afford. The use of sliding fee scales persisted until widespread health insurance drove a standardization of fees.
Current Practice
Today, encouraged by Medicare rules and managed care discounts, providers use a perverse form of a sliding scale that charges the most to patients who can afford the least. Primary care physicians typically charge uninsured patients one third to one half more than they receive from insurers for basic office or hospital visits, and markups are substantially higher (2 to 2.5 times) for high-tech tests and specialists’ invasive procedures.
CONCLUSION
Ethical and professional principles might require providers to return to discounting fees for patients in straitened circumstances, but imposing such a duty formally (by law or by ethical code) on doctors would be harder both in principle and in practice than to impose such a duty on hospitals. Still, professional ethics should encourage physicians to give patients in economic trouble at least the benefit of the lowest rate they accept from an established payer.
doi:10.1007/s11606-008-0605-1
PMCID: PMC2517971  PMID: 18414955
medical fees; billing; law; ethics
21.  Attention deficit hyperactivity disorder: legal and ethical aspects 
Archives of Disease in Childhood  2006;91(2):192-194.
Attention deficit–hyperactivity disorder (ADHD) remains a controversial disorder, despite it now being a well validated clinical diagnosis. Ethical and legal issues are important in determining how doctors should behave in offering a diagnosis or treatment that may generate strong and unpredictable reactions from children, their families, or other agencies. A model for routine ethical practice was proposed, based on three sets of assumptions. Firstly, that ethical practice is consistent with the four principles of beneficence, non‐maleficence, justice, and respect for autonomy. Secondly, ethical concerns lead to legal processes, whose task is to ensure ethical practice. Thirdly, that we are working in the interests of our patients. Current relevant literature was organised in terms of this model, and recommendations for practice derived from it. Though there is no general ethical problem regarding either the routine diagnosis or treatment of ADHD, ethical difficulties surround some special cases, especially when doctors are working in conjunction with other agencies or coping with non‐medical frameworks. Particular care needs to be taken with confidentiality and consent, the limits of which are currently confused. The model worked well with everyday ethical problems, though more difficult cases required careful individual scrutiny.
doi:10.1136/adc.2004.064576
PMCID: PMC2082674  PMID: 16428370
ADHD; ethics; hyperactivity; hyperkinesis; law
22.  Associations between Visual, Hearing, and Dual Sensory Impairments and History of Motor Vehicle Collision Involvement by Older Drivers 
Objectives
To examine the association between visual and hearing impairment and motor vehicle collision (MVC) involvement in older drivers.
Design
Retrospective cohort study.
Setting
North central Alabama
Participants
Population-based sample of 2,000 licensed-drivers, age 70 and older.
Measurements
Visual acuity was measured using the Electronic Visual Acuity test. Contrast sensitivity was measured using the Pelli-Robson chart. Presence of subjective hearing loss and other health conditions were determined using a general health questionnaire. Information regarding MVCs for all participants spanning the five years prior to study enrollment was obtained from the Alabama Department of Public Safety.
Results
Following adjustment for age, race, gender, number of miles driven, number of medical conditions, general cognitive status, and visual processing speed, older drivers having both visual acuity and hearing impairment (rate ratio RR 1.52, 95% confidence interval CI 1.01–2.30), contrast sensitivity impairment alone (RR 1.42, 95% CI 1.00–2.02), and both contrast sensitivity and hearing impairment (RR 2.41, 95% CI 1.62–3.57) had elevated MVC rates, compared to drivers with no visual or hearing impairments. Drivers with visual acuity loss alone or hearing loss alone did not have significantly different MVC rates when compared to the no impairment group after adjustment for multiple variables.
Conclusion
Older drivers with dual sensory impairment are at greater MVC risk than those with only a visual acuity or a hearing deficit alone. A combined screening approach of screening for both hearing impairment and visual impairment may be a useful tool to identify older drivers at risk for MVC involvement.
doi:10.1111/jgs.12091
PMCID: PMC3573212  PMID: 23350867
driver safety; dual sensory impairment; vision impairment; hearing impairment
23.  Protected Health Information on Social Networking Sites: Ethical and Legal Considerations 
Background
Social networking site use is increasingly common among emerging medical professionals, with medical schools even reporting disciplinary student expulsion. Medical professionals who use social networking sites have unique responsibilities since their postings could violate patient privacy. However, it is unknown whether students and residents portray protected health information and under what circumstances or contexts.
Objective
The objective of our study was to document and describe online portrayals of potential patient privacy violations in the Facebook profiles of medical students and residents.
Methods
A multidisciplinary team performed two cross-sectional analyses at the University of Florida in 2007 and 2009 of all medical students and residents to see who had Facebook profiles. For each identified profile, we manually scanned the entire profile for any textual or photographic representations of protected health information, such as portrayals of people, names, dates, or descriptions of procedures.
Results
Almost half of all eligible students and residents had Facebook profiles (49.8%, or n=1023 out of 2053). There were 12 instances of potential patient violations, in which students and residents posted photographs of care they provided to individuals. No resident or student posted any identifiable patient information or likeness in text form. Each instance occurred in developing countries on apparent medical mission trips. These portrayals increased over time (1 in the 2007 cohort; 11 in 2009; P = .03). Medical students were more likely to have these potential violations on their profiles than residents (11 vs 1, P = .04), and there was no difference by gender. Photographs included trainees interacting with identifiable patients, all children, or performing medical examinations or procedures such as vaccinations of children.
Conclusions
While students and residents in this study are posting photographs that are potentially violations of patient privacy, they only seem to make this lapse in the setting of medical mission trips. Trainees need to learn to equate standards of patient privacy in all medical contexts using both legal and ethical arguments to maintain the highest professional principles. We propose three practical guidelines. First, there should be a legal resource for physicians traveling on medical mission trips such as an online list of local laws, or a telephone legal contact. Second, institutions that organize medical mission trips should plan an ethics seminar prior the departure on any trip since the legal and ethical implications may not be intuitive. Finally, at minimum, traveling physicians should apply the strictest legal precedent to any situation.
doi:10.2196/jmir.1590
PMCID: PMC3221358  PMID: 21247862
Protected health information, medical missions, Internet
24.  Public Health Ethics Related Training for Public Health Workforce: An Emerging Need in the United States 
Background
Ethics is a discipline, which primarily deals with what is moral and immoral behavior. Public Health Ethics is translation of ethical theories and concepts into practice to address complex multidimensional public health problems. The primary purpose of this paper was to conduct a narrative literature review-addressing role of ethics in developing curriculum in programs and schools of public health, ethics-related instruction in schools and programs of public health and the role of ethics in developing a competent public health workforce.
Methods:
An open search of various health databases including Google scholar and Ebscohost yielded 15 articles related to use of ethics in public health practice or public health training and the salient features were reported.
Results:
Results indicated a variable amount of ethics’ related training in schools and programs of public health along with public health practitioner training across the nation. Bioethics, medical ethics and public health ethics were found to be subspecialties’ needing separate ethical frameworks to guide decision making.
Conclusions:
Ethics based curricular and non-curricular training for emerging public health professionals from schools and programs of public health in the United States is extremely essential. In the current age of public health challenges faced in the United States and globally, to have an ethically untrained public health force is arguably, immoral and unethical and jeopardizes population health. There is an urgent need to develop innovative ethic based curriculums in academia as well as finding effective means to translate these curricular competencies into public health practice.
PMCID: PMC3481609  PMID: 23113159
Ethics; Public health Ethics; Competencies; Public health workforce; USA
25.  Ethics, privacy and the legal framework governing medical data: opportunities or threats for biomedical and public health research? 
Archives of Public Health  2013;71(1):15.
Privacy is an important concern in any research programme that deals with personal medical data. In recent years, ethics and privacy have become key considerations when conducting any form of scientific research that involves personal data. These issues are now addressed in healthcare professional training programmes. Indeed, ethics, legal frameworks and privacy are often the subject of much confusion in discussions among healthcare professionals. They tend to group these different concepts under the same heading and delegate responsibility for “ethical” approval of their research programmes to ethics committees. Public health researchers therefore need to ask questions about how changes to legal frameworks and ethical codes governing privacy in the use of personal medical data are to be applied in practice. What types of data do these laws and codes cover? Who is involved? What restrictions and requirements apply to any research programme that involves medical data?
doi:10.1186/0778-7367-71-15
PMCID: PMC3691608  PMID: 23799934
Privacy; Medical data; Ethical considerations; Data analysis

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