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1.  Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures 
PLoS Medicine  2012;9(8):e1001280.
Aaron Kesselheim and colleagues investigate conflict of interest disclosures in articles authored by physicians and scientists identified in whistleblower complaints alleging illegal off-label marketing by pharmaceutical companies.
Background
Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author.
Methods and Findings
We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996–2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02–0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥25 articles disclosed in about one-third of articles (range: 10/36–8/25 [28%–32%]).
Conclusions
One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much lower rate of adequate disclosure than has been identified in previous studies. The non-disclosure patterns suggest shortcomings with authors and the rigor of journal practices.
Please see later in the article for the Editors' Summary
Editor's Summary
Background
Off-label use of pharmaceuticals is the practice of prescribing a drug for a condition or age group, or in a dose or form of administration, that has not been specifically approved by a formal regulatory body, such as the US Food and Drug Administration (FDA). Off-label prescribing is common all over the world. In the US, although it is legal for doctors to prescribe drugs off-label and discuss such clinical uses with colleagues, it is illegal for pharmaceutical companies to directly promote off-label uses of any of their products. Revenue from off-label uses can be lucrative for drug companies and even surpass the income from approved uses. Therefore, many pharmaceutical companies have paid physicians and scientists to promote off-label use of their products as part of their marketing programs.
Why Was This Study Done?
Recently, a number of pharmaceutical companies have been investigated in the US for illegal marketing programs that promote off-label uses of their products and have had to pay billions of dollars in court settlements. As part of these investigations, doctors and scientists were identified who were paid by the companies to deliver lectures and conduct other activities to support off-label uses. When the same physicians and scientists also wrote articles about these drugs for medical journals, their financial relationships would have constituted clear conflicts of interest that should have been declared alongside the journal articles. So, in this study, the researchers identified such authors, examined their publications, and assessed the adequacy of conflict of interest disclosures made in these publications.
What Did the Researchers Do and Find?
The researchers used disclosed information from the US Department of Justice, media reports, and data from a non-governmental organization that tracks federal fraud actions, to find whistleblower complaints alleging illegal off-label promotion. Then they identified the doctors and scientists described in the complaints as having financial relationships with the defendant drug companies and searched Medline for articles authored by these experts in the subsequent three years. Using a four step approach, the researchers assessed the adequacy of conflict of interest disclosures made in articles relating to the off-label uses in question.
Using these methods, the researchers examined 26 complaints alleging illegal off-label promotion and identified the 91 doctors and scientists recorded as being involved in this practice. The researchers found 39 (43%) of these 91 experts had authored 404 related publications. In the complaints, these 39 experts were alleged to have engaged in 42 relationships with the relevant drug company: the most common activity was acting as a paid speaker (n = 26, 62%) but also writing reviews or articles on behalf of the company (n = 7), acting as consultants or advisory board members (n = 3), and receiving gifts/honoraria (n = 3), research support funds (n = 2), and educational support funds (n = 1). However, the researchers found that only 62 (15%) of the 404 related articles had adequate disclosures—43% (148) had no disclosure at all, 4% had statements denying any conflicts of interest, 40% had disclosures that did not mention the drug manufacturer, and 13% had disclosures that mentioned the manufacturer but inadequately conveyed the nature of the relationship between author and drug manufacturer reported in the complaint. The researchers also found that adequate disclosure rates varied significantly by article type, with commentaries significantly less likely to have adequate disclosure compared to articles reporting studies or trials.
What Do These Findings Mean?
These findings show the substantial deficiencies in the adequacy of conflict-of-interest disclosures made by authors who had been paid by pharmaceutical manufacturers as part of off-label marketing activities: only one in seven authors fully disclosed their conflict of interest in their published articles. This low figure is troubling and suggests that approaches to controlling the effects of conflicts of interest that rely on author candidness are inadequate and furthermore, journal practices are not robust enough and need to be improved. In the meantime, readers have no option but to interpret conflict of interest disclosures, particularly in relation to off-label uses, with caution.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001280.
The US FDA provides a guide on the use of off-label drugs
The US Agency for Healthcare Research and Quality offers a patient guide to off-label drugs
ProPublica offers a web-based tool to identify physicians who have financial relationships with certain pharmaceutical companies
Wikipedia has a good description of off-label drug use (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Institute for Medicine as a Profession maintains a list of policies regulating physicians' financial relationships that are in place at US-based academic medical centers
doi:10.1371/journal.pmed.1001280
PMCID: PMC3413710  PMID: 22899894
2.  Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia 
BMJ quality & safety  2013;22(7):532-540.
Objectives
(1) To determine the distribution of formal patient complaints across Australia's medical workforce and (2) to identify characteristics of doctors at high risk of incurring recurrent complaints.
Methods
We assembled a national sample of all 18 907 formal patient complaints filed against doctors with health service ombudsmen (‘Commissions’) in Australia over an 11-year period. We analysed the distribution of complaints among practicing doctors. We then used recurrent-event survival analysis to identify characteristics of doctors at high risk of recurrent complaints, and to estimate each individual doctor's risk of incurring future complaints.
Results
The distribution of complaints among doctors was highly skewed: 3% of Australia's medical workforce accounted for 49% of complaints and 1% accounted for a quarter of complaints. Short-term risks of recurrence varied significantly among doctors: there was a strong dose-response relationship with number of previous complaints and significant differences by doctor specialty and sex. At the practitioner level, risks varied widely, from doctors with <10% risk of further complaints within 2 years to doctors with >80% risk.
Conclusions
A small group of doctors accounts for half of all patient complaints lodged with Australian Commissions. It is feasible to predict which doctors are at high risk of incurring more complaints in the near future. Widespread use of this approach to identify high-risk doctors and target quality improvement efforts coupled with effective interventions, could help reduce adverse events and patient dissatisfaction in health systems.
doi:10.1136/bmjqs-2012-001691
PMCID: PMC3711360  PMID: 23576774
Health services research; Patient satisfaction; Quality improvement; Health policy
3.  Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety 
Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine.
In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm.
Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME).
To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization.
In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort.
Resident physician workload and supervision
By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs
Resident physician work hours
Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors.
The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours
Moonlighting by resident physicians
The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting
Safety of resident physicians
The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request
Training in effective handovers and quality improvement
Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services
Monitoring and oversight of the ACGME
While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards
Future financial support for implementation
The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs
Recommendations for future research
Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.
doi:10.2147/NSS.S19649
PMCID: PMC3630963  PMID: 23616719
resident; hospital; working hours; safety
4.  Task Shifting for Scale-up of HIV Care: Evaluation of Nurse-Centered Antiretroviral Treatment at Rural Health Centers in Rwanda 
PLoS Medicine  2009;6(10):e1000163.
Fabienne Shumbusho and colleagues evaluate a task-shifting model of nurse-centered antiretroviral treatment prescribing in rural primary health centers in Rwanda and find that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
Background
The shortage of human resources for health, and in particular physicians, is one of the major barriers to achieve universal access to HIV care and treatment. In September 2005, a pilot program of nurse-centered antiretroviral treatment (ART) prescription was launched in three rural primary health centers in Rwanda. We retrospectively evaluated the feasibility and effectiveness of this task-shifting model using descriptive data.
Methods and Findings
Medical records of 1,076 patients enrolled in HIV care and treatment services from September 2005 to March 2008 were reviewed to assess: (i) compliance with national guidelines for ART eligibility and prescription, and patient monitoring and (ii) key outcomes, such as retention, body weight, and CD4 cell count change at 6, 12, 18, and 24 mo after ART initiation. Of these, no ineligible patients were started on ART and only one patient received an inappropriate ART prescription. Of the 435 patients who initiated ART, the vast majority had adherence and side effects assessed at each clinic visit (89% and 84%, respectively). By March 2008, 390 (90%) patients were alive on ART, 29 (7%) had died, one (<1%) was lost to follow-up, and none had stopped treatment. Patient retention was about 92% by 12 mo and 91% by 24 mo. Depending on initial stage of disease, mean CD4 cell count increased between 97 and 128 cells/µl in the first 6 mo after treatment initiation and between 79 and 129 cells/µl from 6 to 24 mo of treatment. Mean weight increased significantly in the first 6 mo, between 1.8 and 4.3 kg, with no significant increases from 6 to 24 mo.
Conclusions
Patient outcomes in our pilot program compared favorably with other ART cohorts in sub-Saharan Africa and with those from a recent evaluation of the national ART program in Rwanda. These findings suggest that nurses can effectively and safely prescribe ART when given adequate training, mentoring, and support.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Infection with the human immunodeficiency virus (HIV) is a serious health problem in sub-Saharan Africa. The virus attacks white blood cells that protect against infection, most commonly a type of white blood cell called CD4. When a person has been infected with HIV for a long time, the number of CD4 cells they have goes down, resulting in acquired immune deficiency syndrome (AIDS), in which the person's immune system no longer functions effectively.
The World Health Organization (WHO) has divided the disease into four stages as it progresses, according to symptoms including weight loss and so-called opportunistic infections. These are known as clinical stage I, II, III, or IV but were revised and renamed 1, 2, 3, and 4 in September 2005. HIV infection and AIDS cannot be cured but they can be managed with antiretroviral treatment (ART). The WHO currently recommends that ART is begun when the CD4 count falls below 350.
Rwanda is a country situated in the central Africa with a population of around 9 million inhabitants; over 3% of the rural population and 7% of the urban population are infected with HIV. In 2007, the WHO estimated that 220,000 Rwandan children had lost one or both parents to AIDS.
Why Was This Study Done?
The WHO estimates that 9.7 million people with HIV in low- to middle-income countries need ART but at the end of 2007, only 30% of these, including in Rwanda, had access to treatment. In many low-income countries a major factor in this is a lack of doctors. Rwanda, for example, has one doctor per 50,000 inhabitants and one nurse per 3,900 inhabitants.
This situation has led the WHO to recommend “task shifting,” i.e., that the task of prescribing ART should be shifted from doctors to nurses so that more patients can be treated. This type of reorganization is well studied in high-income countries, but the researchers wanted to help develop a system for treating AIDS that would be effective and timely in a predominantly rural, low-income setting such as Rwanda.
What Did the Researchers Do and Find?
In conjunction with the Rwandan Ministry of Health, the researchers developed and piloted a task-shifting program, in which one nurse in each of three rural Rwandan primary health centers (PHCs) was trained to examine HIV patients and prescribe ART in simple cases. Nurses had to complete more than 50 consultations observed by the doctor before being permitted to consult patients independently. More complex cases were referred to a doctor. The authors developed standard checklists, instructions, and evaluation forms to guide nurses and the doctors who supervised them once a week.
The authors evaluated the pilot program by reviewing the records of 1,076 patients who enrolled on it between September 2005 and March 2008. They looked to see whether the nurses had followed guidelines and monitored the patients correctly. They also considered health outcomes for the patients, such as their death rate, their body weight, their CD4 cell count, and whether they maintained contact with caregivers.
They found that by March 2008, 451 patients had been eligible for ART. 435 received treatment and none of the patients were prescribed ART when they should not have been. Only one prescription did not follow national guidelines.
At every visit, nurses were supposed to assess whether patients were taking their drugs and to monitor side effects. They did this and maintained records correctly for the vast majority of the 435 patients who were prescribed ART. 390 patients (over 90%) of the 435 prescribed receiving ART continued to take it and maintain contact with the pilot PHC's program. 29 patients died. Only one was lost to follow up and the others transferred to another ART site. The majority gained weight in the first six months and their CD4 cell counts rose. Outcomes, including death rate, were similar to those treated on the (doctor-led) Rwandan national ART program and other sub-Saharan African national (doctor-led) programs.
What Do These Findings Mean?
The study suggests that nurses are able to prescribe ART safely and effectively in a rural sub-Saharan setting, given sufficient training, mentoring, and support. Nurse-led prescribing of ART could mean that timely, appropriate treatment reaches many more HIV patients. It would reduce the burden of HIV care for doctors, freeing their time for other duties, and the study is already being used by the Rwandan Ministry of Health as a basis for plans to adopt a task-shifting strategy for the national ART program.
The study does have some limitations. The pilot program was funded and designed as a health project to deliver ART in rural areas, rather than a research project to compare nurse-led and doctor-led ART programs. There was no group of equivalent patients treated by doctors rather than nurses for direct comparison, although the authors did compare outcomes with those achieved nationally for doctor-led ART. The most promising sites, nurses, and patients were selected for the pilot and careful monitoring may have been an additional motivation for the nurses and doctors taking part. Health professionals in a scaled-up program may not be as committed as those in the pilot, who were carefully monitored. In addition, the nature of the pilot, which lasted for under three years and recruited new patients throughout, meant that patients were followed up for relatively short periods.
The authors also warn that they did not consider in this study the changes task shifting will make to doctors' roles and the skills required of both doctors and nurses. They recommend that task shifting should be implemented as part of a wider investment in health systems, human resources, training, adapted medical records, tools, and protocols.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000163.
PLoS Medicine includes a page collecting together its recent articles on HIV infection and AIDS that includes research articles, perspectives, editorials, and policy forums
SciDev.net provides news, views, and information about science, technology, and the developing world, including a section specific to HIV/AIDs
The World Health Organization (WHO) has published a downloadable booklet Task Shifting to Tackle Health Worker Shortages
The WHO offers information on HIV and AIDS (in Arabic, Chinese, English, French, Russian, and Spanish) as well as health information and fact sheets on individual countries, including on Rwanda
The UNAIDS/WHO working group on HIV/AIDS and Sexually Transmitted Infections (STI) Surveillance gathers and publishes data on the prevalence of HIV and AIDS in individual countries, including on Rwanda
AIDS.ORG provides information to help prevent HIV infections and to improve the lives of those affected by HIV and AIDS. Factsheets on many aspects of HIV and AIDS are available. It is the official online publisher of AIDS Treatment News
doi:10.1371/journal.pmed.1000163
PMCID: PMC2752160  PMID: 19823569
5.  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
6.  The impact of complaints procedures on the welfare, health and clinical practise of 7926 doctors in the UK: a cross-sectional survey 
BMJ Open  2015;5(1):e006687.
Objectives
The primary aim was to investigate the impact of complaints on doctors’ psychological welfare and health. The secondary aim was to assess whether doctors report exposure to a complaints process is associated with defensive medical practise.
Design
This was a cross-sectional anonymous survey study. Participants were stratified into recent/current, past, no complaints. Each group completed tailored versions of the survey.
Participants
95 636 doctors were invited to participate. A total of 10 930(11.4%) responded, 7926 (8.3%) completed the full survey and were included in the complete analysis.
Main outcome measures
Anxiety and depression were assessed using the standardised Generalised Anxiety Disorder scale and Physical Health Questionnaire. Defensive practise was evaluated using a new measure. Single-item questions measured stress-related illnesses, complaints-related experience, attitudes towards complaints and views on improving complaints processes.
Results
16.9% of doctors with current/recent complaints reported moderate/severe depression (relative risk (RR) 1.77 (95% CI 1.48 to 2.13) compared to doctors with no complaints (9.5%)). Fifteen per cent reported moderate/severe anxiety (RR=2.08 (95% CI 1.61 to 2.68) compared to doctors with no complaints (7.3%)). Distress increased with complaint severity, with highest levels after General Medical Council (GMC) referral (26.3% depression, 22.3% anxiety). Doctors with current/recent complaints were 2.08 (95% CI 1.61 to 2.68) times more likely to report thoughts of self-harm or suicidal ideation. Most doctors reported defensive practise: 82–89% hedging and 46–50% avoidance. Twenty per cent felt victimised after whistleblowing, 38% felt bullied, 27% spent over 1 month off work. Over 80% felt processes would improve with transparency, managerial competence, capacity to claim lost earnings and action against vexatious complainants.
Conclusions
Doctors with recent/current complaints have significant risks of moderate/severe depression, anxiety and suicidal ideation. Morbidity was greatest in cases involving the GMC. Most doctors reported practising defensively, including avoidance of procedures and high-risk patients. Many felt victimised as whistleblowers or reported bullying. Suggestions to improve complaints processes included transparency and managerial competence.
doi:10.1136/bmjopen-2014-006687
PMCID: PMC4316558  PMID: 25592686
OCCUPATIONAL & INDUSTRIAL MEDICINE
7.  Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints 
PLoS Medicine  2011;8(4):e1000431.
Aaron Kesselheim and colleagues analyzed unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing, and develop a taxonomy of the various off-label practices.
Background
Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing.
Methods and Findings
We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996–October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non–mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non–mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%).
Conclusions
Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Before a pharmaceutical company can market a new prescription drug in the US, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the pharmaceutical company must test the drug's safety and efficacy in a series of clinical trials in which groups of patients with specific diseases are given the drug according to strict protocols. The results of these trials are reviewed by Federal Drug Administration (FDA, the body that regulates drugs in the US) and, when the FDA is satisfied that the drug is safe and effective for the conditions in which it is tested, it approves the drug for sale. An important part of the approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups in which the drug can be used and the approved doses of the drug.
Why Was This Study Done?
Physicians can, however, legally use FDA-approved drugs “off-label.” That is, they can prescribe drugs for a different disease, in a different group of patients, or at a different dose to that specified in the drug's label. However, because drugs' manufacturers stand to benefit financially from off-label use through increased drugs sales, the FDA prohibits them from directly promoting unapproved uses. The fear is that such marketing would encourage the widespread use of drugs in settings where their efficacy and safety has not been rigorously tested, exposing patients to uncertain benefits and possible adverse effects. Despite the regulatory restrictions, off-label marketing seems to be common. In 2010, for example, at least six pharmaceutical companies settled US government investigations into alleged off-label marketing programs. Unfortunately, the tactics used by pharmaceutical companies for off-label marketing have been poorly understood in the medical community, in part because pharmaceutical industry insiders (“whistleblowers”) are the only ones who can present in-depth knowledge of these tactics. In recent years, as more whistleblowers have come forward to allege off-label marketing, developing a more complete picture of the practice is now possible. In this study, the researchers attempt to systematically classify the strategies and practices used in off-labeling marketing by examining complaints filed by whistleblowers in federal enforcement actions where off-label marketing by pharmaceutical companies has been alleged.
What Did the Researchers Do and Find?
In their analysis of 41 whistleblower complaints relating to 18 alleged cases of off-label marketing in federal fraud cases unsealed between January 1996 and October 2010, the researchers identified three non–mutually exclusive goals of off-label marketing schemes. The commonest goal (85% of cases) was expansion of drug use to unapproved diseases (for example, gabapentin, which is approved for the treatment of specific types of epilepsy, was allegedly promoted as a therapy for patients with psychiatric diseases such as depression). The other goals were expansion to unapproved disease subtypes (for example, some antidepressant drugs approved for adults were allegedly promoted to pediatricians for use in children) and expansion to unapproved drug dosing strategies, typically higher doses. The researchers also identified four non–mutually exclusive types of marketing practices designed to achieve these goals. All of the whistleblowers alleged prescriber-related practices (including providing financial incentives and free samples to physicians), and most alleged internal practices intended to bolster off-label marketing, such as sales quotas that could only be met if the manufacturer's sales representatives promoted off-label drug use. Payer-related practices (for example, discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions) and consumer-related practices (most commonly, the review of confidential patient charts to identify consumers who could be off-label users) were also alleged.
What Do These Findings Mean?
These findings suggest that off-labeling marketing practices extend to many parts of the health care delivery system. Because these practices were alleged by whistleblowers and were not the subject of testimony in a full trial, some of the practices identified by the researchers were not confirmed. Conversely, because most of the whistleblowers were US-based sales representatives, there may be other goals and strategies that this study has not identified. Nevertheless, these findings provide a useful snapshot of off-label marketing strategies and practices allegedly employed in the US over the past 15 years, which can now be used to develop new regulatory strategies aimed at effective oversight of off-label marketing. Importantly, however, these findings suggest that no regulatory strategy will be complete and effective unless physicians themselves fully understand the range of off-label marketing practices and their consequences for public health and act as a bulwark against continued efforts to engage in off-label promotion.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000431.
The US Food and Drug Administration provides detailed information about drug approval in the US for consumers and for health professionals; its Bad Ad Program aims to educate health care providers about the role they can play in ensuring that prescription drug advertising and promotion is truthful and not misleading.
The American Cancer Society has a page about off-label drug use
Wikipedia has pages on prescription drugs, on pharmaceutical marketing, and on off-label drug use (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
Taxpayers Against Fraud is a nonprofit organization dedicated to helping whistleblowers, and it presents up-to-date information about False Claims Act cases
The Government Accountability Project is a nonprofit organization that seeks to promote corporate and government accountability by protecting whistleblowers, advancing occupational free speech, and empowering citizen activists
Healthy Skepticism is an international nonprofit membership association that aims to improve health by reducing harm from misleading health information
doi:10.1371/journal.pmed.1000431
PMCID: PMC3071370  PMID: 21483716
8.  Why Reassurance Fails in Patients with Unexplained Symptoms—An Experimental Investigation of Remembered Probabilities 
PLoS Medicine  2006;3(8):e269.
Background
Providing reassurance is one of physicians' most frequently used verbal interventions. However, medical reassurance can fail or even have negative effects. This is frequently the case in patients with medically unexplained symptoms. It is hypothesized that these patients are more likely than patients from other groups to incorrectly recall the likelihoods of medical explanations provided by doctors.
Methods and Findings
Thirty-three patients with medically unexplained symptoms, 22 patients with major depression, and 30 healthy controls listened to an audiotaped medical report, as well as to two control reports. After listening to the reports, participants were asked to rate what the doctor thinks the likelihood is that the complaints are caused by a specific medical condition.
Although the doctor rejected most of the medical explanations for the symptoms in his verbal report, the patients with medically unexplained complaints remembered a higher likelihood for medical explanations for their symptoms. No differences were found between patients in the other groups, and for the control conditions. When asked to imagine that the reports were applicable to themselves, patients with multiple medical complaints reported more concerns about their health state than individuals in the other groups.
Conclusions
Physicians should be aware that patients with medically unexplained symptoms recall the likelihood of medical causes for their complaints incorrectly. Therefore, physicians should verify correct understanding by using check-back questions and asking for summaries, to improve the effect of reassurance.
Those patients for whom there is no medical explanation for their symptoms are likely to have more difficulty than other patients in remembering information intended to reassure them about their condition.
Editors' Summary
Background.
Being told by the doctor that that niggling headache or persistent stomach ache is not caused by a medical condition reassures most patients. But for some—those with a history of medically unexplained complaints—being told that tests have revealed no underlying cause for their symptoms provides little or no reassurance. Such patients have what is sometimes called “somatization syndrome.” In somatization, mental factors such as stress manifest themselves as physical symptoms. Patients with somatization syndrome start to report multiple medically unexplained symptoms as young adults. These symptoms, which change over time, include pain at different sites in the body and digestive, reproductive, and nervous system problems. What causes this syndrome is unknown and there is no treatment other than helping patients to control their symptoms.
Why Was This Study Done?
Patients with medically unexplained complaints make up a substantial and expensive part of the workload of general medical staff. Part of this expense is because patients with somatization syndrome are not reassured by their medical practitioners telling them there is no physical cause for their symptoms, which leads to requests for further tests. It is unclear why medical reassurance fails in these patients, but if this puzzle could be solved, it might help doctors to deal better with them. In this study, the researchers tested the idea that these patients do not accept medical reassurance because they incorrectly remember what their doctors have told them about the likelihood that specific medical conditions could explain their symptoms.
What Did the Researchers Do and Find?
The researchers recruited patients with medically unexplained symptoms and, for comparison, patients with depression and healthy individuals. All the participants were assessed for somatization syndrome and their general memory tested. They then listened to three audiotapes. In one, a doctor gave test results to a patient with abdominal pain (a medical situation). The other two tapes dealt with a social situation (the lack of an invitation to a barbecue) and a neutral situation (a car breakdown). Each tape contained ten messages, including four that addressed possible explanations for the problem. Two were unambiguous and negative—for example, “the reason for your complaints is definitely not stomach flu.” Two were ambiguous but highly unlikely—“we don't think that you have bowel cancer; this is very unlikely.” The researchers then assessed how well the participants remembered the likelihood that any given explanation was responsible for the patient's symptoms, the missing invitation, or the broken-down car. The patients with somatization syndrome overestimated the likelihood of medical causes for symptoms, particularly (and somewhat surprisingly) when the doctor's assessment had been unambiguous. By contrast, the other participants correctly remembered the doctor's estimates as low. The three study groups were similar in their recall of the likelihood estimates from the social or neutral situation. Finally, when asked to imagine that the medical situation was personally applicable, the patients with unexplained symptoms reacted more emotionally than the other study participants by reporting more concerns with their health.
What Do These Findings Mean?
These results support the researchers' hypothesis that people with somatization syndrome remember the chance that a given symptom has a specific medical cause incorrectly. This is not because of a general memory deficit or an inability to commit health-related facts to memory. The results also indicate that these patients react emotionally to medical situations, so they may find it hard to cope when a doctor fails to explain all their symptoms. Some of these characteristics could, of course, reflect the patients' previous experiences with medical professionals, and the experiment will need to be repeated with additional taped situations and more patients before firm recommendations can be made to help people with somatization syndrome. Nevertheless, given that medical reassurance and the presentation of negative results led to overestimates of the likelihood of medical explanations for symptoms in patients with somatization syndrome, the researchers recommend that doctors bear this bias in mind. To reduce it, they suggest, doctors could ask patients for summaries about what they have been told. This would make it possible to detect when patients have misremembered the likelihood of various medical explanations, and provide an opportunity to correct the situation.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030269.
• MedlinePlus encyclopedia entry on somatization disorder
• Wikipedia page on somatization disorder (note that Wikipedia is a free online encyclopedia that anyone can edit)
• Prodigy Knowledge's information for patients on somatization and somatoform disorders
doi:10.1371/journal.pmed.0030269
PMCID: PMC1523375  PMID: 16866576
9.  The PRONE score: an algorithm for predicting doctors’ risks of formal patient complaints using routinely collected administrative data 
BMJ Quality & Safety  2015;24(6):360-368.
Background
Medicolegal agencies—such as malpractice insurers, medical boards and complaints bodies—are mostly passive regulators; they react to episodes of substandard care, rather than intervening to prevent them. At least part of the explanation for this reactive role lies in the widely recognised difficulty of making robust predictions about medicolegal risk at the individual clinician level. We aimed to develop a simple, reliable scoring system for predicting Australian doctors’ risks of becoming the subject of repeated patient complaints.
Methods
Using routinely collected administrative data, we constructed a national sample of 13 849 formal complaints against 8424 doctors. The complaints were lodged by patients with state health service commissions in Australia over a 12-year period. We used multivariate logistic regression analysis to identify predictors of subsequent complaints, defined as another complaint occurring within 2 years of an index complaint. Model estimates were then used to derive a simple predictive algorithm, designed for application at the doctor level.
Results
The PRONE (Predicted Risk Of New Event) score is a 22-point scoring system that indicates a doctor's future complaint risk based on four variables: a doctor's specialty and sex, the number of previous complaints and the time since the last complaint. The PRONE score performed well in predicting subsequent complaints, exhibiting strong validity and reliability and reasonable goodness of fit (c-statistic=0.70).
Conclusions
The PRONE score appears to be a valid method for assessing individual doctors’ risks of attracting recurrent complaints. Regulators could harness such information to target quality improvement interventions, and prevent substandard care and patient dissatisfaction. The approach we describe should be replicable in other agencies that handle large numbers of patient complaints or malpractice claims.
doi:10.1136/bmjqs-2014-003834
PMCID: PMC4453507  PMID: 25855664
Quality improvement; Risk management; Governance; Healthcare quality improvement
10.  Moving from Data on Deaths to Public Health Policy in Agincourt, South Africa: Approaches to Analysing and Understanding Verbal Autopsy Findings 
PLoS Medicine  2010;7(8):e1000325.
Peter Byass and colleagues compared two methods of assessing data from verbal autopsies, review by physicians or probabilistic modeling, and show that probabilistic modeling is the most efficient means of analyzing these data
Background
Cause of death data are an essential source for public health planning, but their availability and quality are lacking in many parts of the world. Interviewing family and friends after a death has occurred (a procedure known as verbal autopsy) provides a source of data where deaths otherwise go unregistered; but sound methods for interpreting and analysing the ensuing data are essential. Two main approaches are commonly used: either physicians review individual interview material to arrive at probable cause of death, or probabilistic models process the data into likely cause(s). Here we compare and contrast these approaches as applied to a series of 6,153 deaths which occurred in a rural South African population from 1992 to 2005. We do not attempt to validate either approach in absolute terms.
Methods and Findings
The InterVA probabilistic model was applied to a series of 6,153 deaths which had previously been reviewed by physicians. Physicians used a total of 250 cause-of-death codes, many of which occurred very rarely, while the model used 33. Cause-specific mortality fractions, overall and for population subgroups, were derived from the model's output, and the physician causes coded into comparable categories. The ten highest-ranking causes accounted for 83% and 88% of all deaths by physician interpretation and probabilistic modelling respectively, and eight of the highest ten causes were common to both approaches. Top-ranking causes of death were classified by population subgroup and period, as done previously for the physician-interpreted material. Uncertainty around the cause(s) of individual deaths was recognised as an important concept that should be reflected in overall analyses. One notably discrepant group involved pulmonary tuberculosis as a cause of death in adults aged over 65, and these cases are discussed in more detail, but the group only accounted for 3.5% of overall deaths.
Conclusions
There were no differences between physician interpretation and probabilistic modelling that might have led to substantially different public health policy conclusions at the population level. Physician interpretation was more nuanced than the model, for example in identifying cancers at particular sites, but did not capture the uncertainty associated with individual cases. Probabilistic modelling was substantially cheaper and faster, and completely internally consistent. Both approaches characterised the rise of HIV-related mortality in this population during the period observed, and reached similar findings on other major causes of mortality. For many purposes probabilistic modelling appears to be the best available means of moving from data on deaths to public health actions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Whenever someone dies in a developed country, the cause of death is determined by a doctor and entered into a “vital registration system,” a record of all the births and deaths in that country. Public-health officials and medical professionals use this detailed and complete information about causes of death to develop public-health programs and to monitor how these programs affect the nation's health. Unfortunately, in many developing countries dying people are not attended by doctors and vital registration systems are incomplete. In most African countries, for example, less than one-quarter of deaths are recorded in vital registration systems. One increasingly important way to improve knowledge about the patterns of death in developing countries is “verbal autopsy” (VA). Using a standard form, trained personnel ask relatives and caregivers about the symptoms that the deceased had before his/her death and about the circumstances surrounding the death. Physicians then review these forms and assign a specific cause of death from a shortened version of the International Classification of Diseases, a list of codes for hundreds of diseases.
Why Was This Study Done?
Physician review of VA forms is time-consuming and expensive. Consequently, computer-based, “probabilistic” models have been developed that process the VA data and provide a likely cause of death. These models are faster and cheaper than physician review of VAs and, because they do not rely on the views of local doctors about the likely causes of death, they are more internally consistent. But are physician review and probabilistic models equally sound ways of interpreting VA data? In this study, the researchers compare and contrast the interpretation of VA data by physician review and by a probabilistic model called the InterVA model by applying these two approaches to the deaths that occurred in Agincourt, a rural region of northeast South Africa, between 1992 and 2005. The Agincourt health and sociodemographic surveillance system is a member of the INDEPTH Network, a global network that is evaluating the health and demographic characteristics (for example, age, gender, and education) of populations in low- and middle-income countries over several years.
What Did the Researchers Do and Find?
The researchers applied the InterVA probabilistic model to 6,153 deaths that had been previously reviewed by physicians. They grouped the 250 cause-of-death codes used by the physicians into categories comparable with the 33 cause-of-death codes used by the InterVA model and derived cause-specific mortality fractions (the proportions of the population dying from specific causes) for the whole population and for subgroups (for example, deaths in different age groups and deaths occurring over specific periods of time) from the output of both approaches. The ten highest-ranking causes of death accounted for 83% and 88% of all deaths by physician interpretation and by probabilistic modelling, respectively. Eight of the most frequent causes of death—HIV, tuberculosis, chronic heart conditions, diarrhea, pneumonia/sepsis, transport-related accidents, homicides, and indeterminate—were common to both interpretation methods. Both methods coded about a third of all deaths as indeterminate, often because of incomplete VA data. Generally, there was close agreement between the methods for the five principal causes of death for each age group and for each period of time, although one notable discrepancy was pulmonary (lung) tuberculosis, which accounted for 6.4% and 21.3% of deaths in this age group, respectively, according to the physicians and to the model. However, these deaths accounted for only 3.5% of all the deaths.
What Do These Findings Mean?
These findings reveal no differences between the cause-specific mortality fractions determined from VA data by physician interpretation and by probabilistic modelling that might have led to substantially different public-health policy programmes being initiated in this population. Importantly, both approaches clearly chart the rise of HIV-related mortality in this South African population between 1992 and 2005 and reach similar findings on other major causes of mortality. The researchers note that, although preparing the amount of VA data considered here for entry into the probabilistic model took several days, the model itself runs very quickly and always gives consistent answers. Given these findings, the researchers conclude that in many settings probabilistic modeling represents the best means of moving from VA data to public-health actions.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000325.
The importance of accurate data on death is further discussed in a perspective previously published in PLoS Medicine Perspective by Colin Mathers and Ties Boerma
The World Health Organization (WHO) provides information on the vital registration of deaths and on the International Classification of Diseases; the WHO Health Metrics Network is a global collaboration focused on improving sources of vital statistics; and the WHO Global Health Observatory brings together core health statistics for WHO member states
The INDEPTH Network is a global collaboration that is collecting health statistics from developing countries; it provides more information about the Agincourt health and socio-demographic surveillance system and access to standard VA forms
Information on the Agincourt health and sociodemographic surveillance system is available on the University of Witwatersrand Web site
The InterVA Web site provides resources for interpreting verbal autopsy data and the Umeå Centre for Global Health Reseach, where the InterVA model was developed, is found at http://www.globalhealthresearch.net
A recent PLoS Medicine Essay by Peter Byass, lead author of this study, discusses The Unequal World of Health Data
doi:10.1371/journal.pmed.1000325
PMCID: PMC2923087  PMID: 20808956
11.  Analysis of complaints to a tertiary care pain clinic over a nine-year period 
BACKGROUND:
The present study is the result of an internal audit and examines the profiles of complainants and the sources and nature of complaints toward the staff in a tertiary care pain clinic, the Comprehensive Pain Program of the Toronto Western Hospital in Toronto, Ontario.
METHODS:
All sources of complaints over a nine-year period were reviewed, which included the following: Toronto Western Hospital Patient Relations (PR) records, with a subset of the files qualitatively analyzed in depth regarding the nature of complaints and complainants; complaints that bypassed PR and were addressed directly to the program director against members of the staff; complaints to the College of Physicians and Surgeons of Ontario; and complaints recorded anonymously at rateMDs.com.
RESULTS:
Although the prevalence of PR complaints was very low (1.73 complaints per 1000 visits), several other sources of complaints were identified. The typical complainant was a Canadian-born woman acting on her behalf or on behalf of a family member. More than one-half of the complaints were directed against the physicians regarding their opinion of psychological factors augmenting the patient’s presentation and/or inappropriate use of opioids. Defensive techniques instituted by the Comprehensive Pain Program staff in reaction to the complaints are discussed, and pertinent literature is reviewed.
CONCLUSION:
The present study is the first to examine the nature of complaints and complainants from a Canadian pain clinic. Further studies are needed to explore the complex issues of patient and staff interactions, and complaints in the era of ‘patient-centred care’.
PMCID: PMC2855291  PMID: 20195554
Chronic pain; Complaints; Pain clinic
12.  Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012 
PLoS Medicine  2016;13(1):e1001945.
Background
European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.
Methods and Findings
We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing.
Conclusion
The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.
In a document analysis of legal cases, Shai Mulinari and colleagues characterize off-label drug promotion by pharmaceutical companies in the UK.
Editors' Summary
Background
Before a pharmaceutical company can market a new prescription drug, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the company must test the drug’s safety and efficacy in series of clinical trials in which patients with specific diseases receive the drug under carefully controlled conditions. Regulatory bodies such as the US FDA, the UK MHRA and the European Medicines Agency (EMA) then review the results of these trials and, when they are satisfied that the drug is safe and effective for the conditions in which it was tested, give the pharmaceutical company approval to market the drug in the relevant country. An important part of the approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups in which the drug can be used and the drug’s approved doses.
Why Was This Study Done?
Physicians can use approved drugs “off-label.” That is, they can prescribe drugs for a different disease, in a different group of patients, or at a different dose to that specified in the label. However, in the UK, the US, and other countries, national law prohibits the promotion of off-label uses of prescription drugs by pharmaceutical companies, which stand to benefit financially from off-label use through increased drugs sales. The primary rationale for banning off-label promotion is that it might encourage the widespread use of drugs in settings where they have not been rigorously tested, thereby exposing patients to uncertain benefits and possible adverse effects. In the US, the FDA regulates and prosecutes off-label promotion, but enforcement actions against companies can also be brought by federal and state prosecutors and private citizens. In the UK, the MHRA has delegated an important part of its responsibility for supervising off-label marketing to a self-regulatory body set up by the pharmaceutical industry—the PMCPA. Here, by reviewing off-label promotion rulings made by the PMCPA between 2003 and 2012, the researchers compare off-label promotion cases ruled on in the UK with whistleblower (company insider)-initiated cases from the US and shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.
What Did the Researchers Do and Find?
The researchers identified 74 UK off-label promotion rulings over the ten-year study period involving 43 companies (including 19 that were ruled in breach more than once) and 65 drugs. They coded and analyzed each off-label promotion ruling using a typology (a classification according to general type) previously developed to analyze US whistleblower-initiated off-label promotion cases. Half of the rulings cited efforts to expand drug use to unapproved indications (for example, using a drug to treat all patients with MS rather than only patients with recent relapses); 39% and 38% of the rulings cited efforts to expand drug use beyond approved diseases and dosing strategies, respectively. The most commonly cited off-label promotional tactic was attempts to influence prescribers using advertisements and other print material; competing companies lodged 57% of complaints whereas prescribers (the prime target of off-label promotion) lodged only 22% of the complaints. Unlike US whistleblower complaints, which often alleged promotional tactics targeting consumers, payers and company staff, few UK rulings described practices targeting these classes of individuals. Finally, although several US whistleblower-initiated cases alleged multifaceted and covert marketing activities, the UK cases typically related to one or a few claims made in printed material.
What Do These Findings Mean?
Because this study only describes PMCPA rulings and whistleblower-initiated US cases of off-label promotion, these findings provide an incomplete view of off-label marketing violations (some of which may not be deliberate) in the UK and US. The findings suggest that the UK self-regulatory approach, which relies mainly on complaints from company outsiders, is capable of detecting and dealing with instances of off-label promotion with high visibility (for example, advertisements). However, the UK self-regulatory approach may be less capable of uncovering complex marketing campaigns than the US government-led approach. The researchers suggest, therefore, that the UK authorities should consider the introduction of increased incentives and protections for whistleblowers and of US-style governmental investigation (the PMCPA rulings are based on complainant and company submissions alone) and that both the MHRA and PMCPA should strengthen their regulatory oversight of promotional material. Finally, prescribers—the main target of off-label promotion in the UK—should be encouraged to identify and report off-label promotion.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001945.
The PLOS Medicine Research Article by Aaron Kesselheim and colleagues provides information about whistleblower-initiated cases on off-label promotion in the US
Wikipedia provides information on prescription drugs, pharmaceutical marketing (mainly in the US), and off-label drug use (mainly in the US) (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US FDA Office of Prescription Drug Promotion aims to protect public health by assuring prescription drug information is truthful, balanced, and accurately communicated; the FDA’s Bad Ads Program aims to educate health care professionals about the role they can play in ensuring that drug advertising and promotion is truthful and not misleading
Information on the UK regulatory framework is available from the MHRA; the MHRA website also includes information on advertising investigations by the MHRA.
Information on the UK self-regulatory body, the PMCPA, is available; the PMCPA website includes information about the UK Code of Practice for medicines promotion
Healthy Skepticism is an international non-profit membership association that aims to improve health by reducing harm from misleading health information
doi:10.1371/journal.pmed.1001945
PMCID: PMC4727894  PMID: 26812151
13.  Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review 
PLoS Medicine  2010;7(10):e1000352.
Geoff Spurling and colleagues report findings of a systematic review looking at the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. They fail to find evidence of improvements in prescribing after exposure, and find some evidence of an association with higher prescribing frequency, higher costs, or lower prescribing quality.
Background
Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
Methods and Findings
We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.
Conclusions
With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
A prescription drug is a medication that can be supplied only with a written instruction (“prescription”) from a physician or other licensed healthcare professional. In 2009, 3.9 billion drug prescriptions were dispensed in the US alone and US pharmaceutical companies made US$300 billion in sales revenue. Every year, a large proportion of this revenue is spent on drug promotion. In 2004, for example, a quarter of US drug revenue was spent on pharmaceutical promotion. The pharmaceutical industry claims that drug promotion—visits from pharmaceutical sales representatives, advertisements in journals and prescribing software, sponsorship of meetings, mailed information—helps to inform and educate healthcare professionals about the risks and benefits of their products and thereby ensures that patients receive the best possible care. Physicians, however, hold a wide range of views about pharmaceutical promotion. Some see it as a useful and convenient source of information. Others deny that they are influenced by pharmaceutical company promotion but claim that it influences other physicians. Meanwhile, several professional organizations have called for tighter control of promotional activities because of fears that pharmaceutical promotion might encourage physicians to prescribe inappropriate or needlessly expensive drugs.
Why Was This Study Done?
But is there any evidence that pharmaceutical promotion adversely influences prescribing? Reviews of the research literature undertaken in 2000 and 2005 provide some evidence that drug promotion influences prescribing behavior. However, these reviews only partly assessed the relationship between information from pharmaceutical companies and prescribing costs and quality and are now out of date. In this study, therefore, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) to reexamine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
What Did the Researchers Do and Find?
The researchers searched the literature for studies of licensed physicians who were exposed to promotional and other information from pharmaceutical companies. They identified 58 studies that included a measure of exposure to any type of information directly provided by pharmaceutical companies and a measure of physicians' prescribing behavior. They then undertook a “narrative synthesis,” a descriptive analysis of the data in these studies. Ten of the studies, they report, examined the relationship between exposure to pharmaceutical company information and prescribing quality (as judged, for example, by physician drug choices in response to clinical vignettes). All but one of these studies suggested that exposure to drug company information was associated with lower prescribing quality or no association was detected. In the 51 studies that examined the relationship between exposure to drug company information and prescribing frequency, exposure to information was associated with more frequent prescribing or no association was detected. Thus, for example, 17 out of 29 studies of the effect of pharmaceutical sales representatives' visits found an association between visits and increased prescribing; none found an association with less frequent prescribing. Finally, eight studies examined the relationship between exposure to pharmaceutical company information and prescribing costs. With one exception, these studies indicated that exposure to information was associated with a higher cost of prescribing or no association was detected. So, for example, one study found that physicians with low prescribing costs were more likely to have rarely or never read promotional mail or journal advertisements from pharmaceutical companies than physicians with high prescribing costs.
What Do These Findings Mean?
With rare exceptions, these findings suggest that exposure to pharmaceutical company information is associated with either no effect on physicians' prescribing behavior or with adverse affects (reduced quality, increased frequency, or increased costs). Because most of the studies included in the review were observational studies—the physicians in the studies were not randomly selected to receive or not receive drug company information—it is not possible to conclude that exposure to information actually causes any changes in physician behavior. Furthermore, although these findings provide no evidence for any net improvement in prescribing after exposure to pharmaceutical company information, the researchers note that it would be wrong to conclude that improvements do not sometimes happen. The findings support the case for reforms to reduce negative influence to prescribing from pharmaceutical promotion.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000352.
Wikipedia has pages on prescription drugs and on pharmaceutical marketing (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The UK General Medical Council provides guidelines on good practice in prescribing medicines
The US Food and Drug Administration provides information on prescription drugs and on its Bad Ad Program
Healthy Skepticism is an international nonprofit membership association that aims to improve health by reducing harm from misleading health information
The Drug Promotion Database was developed by the World Health Organization Department of Essential Drugs & Medicines Policy and Health Action International Europe to address unethical and inappropriate drug promotion
doi:10.1371/journal.pmed.1000352
PMCID: PMC2957394  PMID: 20976098
14.  An analytic observational study on complaints management in the general practice out of hours care setting: who complains, why, and what can we do about it? 
BMC Family Practice  2016;17:87.
Background
General Practice Co-Operatives provide most out of hours care in communities in Ireland. Limited data exists on patient complaints. This study reports on complaints at Kildare and West Wicklow Doctors on Call (‘K Doc’), a GP Co-Operative in Ireland, examining the impact of a formal risk reduction strategy implemented (2010-2013). The aim of the study was to determine if it was possible to reduce the rate of written complaints per 1000 consultations through a formal approach encompassing evaluation of complaints, improved communication in relation to complaints, and more direct use of insights gained from complaints analysis in continuing professional development at the Co-Operative.
Methods
Initially, complaints submitted over an 18 month period (01.06.08 to 31.12.09) were analysed. Complaint rate (number of complaints per 1000 consultations), complainant demographics, aspects of complaint response at the Co-Operative, and nature of complaint were recorded. Based on analysis, a risk reduction strategy was undertaken, including procedural change, focused training and education. Areas selected for improvement during a second phase of data collection included complaints rate, timeliness of Co-Operative response to complaint, and rate of complaint notification to patient’s GP. Further analysis was then carried out over a 45 month period (01.01.10 to 30.09.13).
Results
From 2008-2013, 216,716 patient consultations occurred. Complaints were received from 131 individuals, regarding 125 patients. Following introduction of risk reduction strategy, complaints rate reduced by 36 %, from 0.77 to 0.49 per 1000 consultations (p = 0.02) between the two periods of data collection. Timeliness of response from Co-Operative to the complainant improved from 63 % to 75 %. Notification of complaint to the patient’s GP improved from 48 % to 96 %.
Most complaints were not associated with medically significant events. The largest categories of complaint related to clinical care (55 % n = 69), cost (46 %, n = 58), communication (42 %, n = 53), and process of care (15 %, n = 19). Mothers of affluent paediatric patients were most likely to make formal complaints.
Conclusions
This study reports a statistically significant reduction in complaints rate of 36 % following introduction of risk reduction strategies at a GP Co –Operative. Out of hours consulting is known to be an area of high medical risk. Findings are of interest where number and costs of complaints against GPs are elsewhere reported to be rising, contributing to medical inflation, and to public concern.
doi:10.1186/s12875-016-0484-1
PMCID: PMC4955145  PMID: 27439760
GP Co-operative; Out of hours consulting; Intervention; Complaints; Risk reduction
15.  The Psychological Attitude of Patients toward Health Practitioners in Lebanon 
Background:
Patients often complain about their doctor's attitude toward them. They describe the interaction that they have with some doctors as quick, cold, discourteous, or hardhearted. Although this does not apply to all Lebanese doctors, it does apply to some.
Aims:
The purpose of this study was to (1) examine the general perception of satisfaction, trust, and openness that Lebanese patients hold toward the work, office, personal, and social characteristics of their doctors — physician or dentist; and (2) identify the aspects on which a Lebanese health practitioner should focus to improve his/her practice.
Materials and Methods:
A convenient sample of 450 individuals from an area housing nine hospitals and hundreds of private clinics in Greater Beirut were surveyed regarding the qualities of their health practitioners. They were asked to complete a nine-page, 85-item, anonymous, and voluntary questionnaire that dealt with the medical and dental practice in Lebanon. Participants were older than 18 years and mentally competent. None was physicians, dentists, or nurses. The questionnaire was open-ended and initially pretested and piloted among a random sample.
Results:
Four hundred-fifteen (92%) individuals responded. Participants were from different ages, genders, geographical areas, educational backgrounds, and professions. The doctor traits most preferred by the Lebanese public were found to be: Empathy (90%), professionalism (87%), miscellaneous traits (86%), and academics (81%).
Conclusion:
The results support the conventional wisdom that the idealized perception of a doctor as a care-giving, compassionate, knowledgeable, well-appearing, and healthy role model still holds true within the Lebanese community.
doi:10.4103/1947-2714.168663
PMCID: PMC4677470  PMID: 26713291
Dentist; doctor-patient relationship; empathy; Lebanon; physician; professionalism
16.  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
17.  Trends in NHS doctor and dentist referrals to occupational health 
Background
Ill-health in doctors can affect performance and fitness to practice, and consequently patient care and safety, placing an important responsibility on National Health Service (NHS) occupational health (OH) services. Anecdotal discussions amongst NHS occupational physicians suggest an increase in the number of doctor attendances over time, with continuing focus on mental illness.
Aims
To analyse OH referrals in doctors and dentists over 3 years.
Methods
A retrospective evaluation of all doctor and dentist referrals to the OH service in one Scottish NHS board from April 2011 to March 2014, comparing this to management-reported sickness absence (SA) data held by the organization.
Results
We found no significant change in overall OH referrals for doctors and dentists during the evaluation period. Mental illness was the commonest referral reason in all 3 years at 32, 38 and 30%, respectively, but no significant change in mental health referrals was demonstrated within the study period. SA events significantly increased during the three study years (356, 426 and 469, respectively; P < 0.05). OH referrals for those absent from work increased significantly between Years 1 and 3 (16 and 30, respectively; P < 0.05).
Conclusions
SA events and OH referrals for those absent from work significantly increased between April 2011 and March 2014, but there was no commensurate (statistically significant) increase in overall OH referrals. These findings do not support anecdotal suggestions of increasing OH (or mental ill-health) attendances but can be used as a benchmark for other NHS organizations and for future trend comparisons.
doi:10.1093/occmed/kqw016
PMCID: PMC4861137  PMID: 26928858
Dentists; doctors; occupational health services; sickness absence.
18.  Health care restructuring and family physician care for those who died of cancer 
Background
During the 1990s, health care restructuring in Nova Scotia resulted in downsized hospitals, reduced inpatient length of stay, capped physician incomes and restricted practice locations. Concurrently, the provincial homecare program was redeveloped and out-of-hospital cancer deaths increased from 20% (1992) to 30% (1998). These factors all pointed to a transfer of end-of-life inpatient hospital care to more community-based care. The purpose of this study was to describe the trends in the provision of Family Physician (FP) visits to advanced cancer patients in Nova Scotia (NS) during the years of health care restructuring.
Methods
Design Secondary multivariate analysis of linked population-based datafiles including the Queen Elizabeth II Health Sciences Centre Oncology Patient Information System (NS Cancer Registry, Vital Statistics), the NS Hospital Admissions/Separations file and the Medical Services Insurance Physician Services database. Setting Nova Scotia, an eastern Canadian province (population: 950,000). Subjects: All patients who died of lung, colorectal, breast or prostate cancer between April 1992 and March 1998 (N = 7,212). Outcome Measures Inpatient and ambulatory FP visits, ambulatory visits by location (office, home, long-term care facility, emergency department), time of day (regular hours, after hours), total length of inpatient hospital stay and number of hospital admissions during the last six months of life.
Results
In total, 139,641 visits were provided by family physicians: 15% of visits in the office, 10% in the home, 5% in the emergency department (ED), 5% in a long-term-care centre and 64% to hospital inpatients. There was no change in the rate of FP visits received for office, home and long-term care despite the fact that there were 13% fewer hospital admissions, and length of hospital stay declined by 21%. Age-sex adjusted estimates using negative binomial regression indicate a decline in hospital inpatient FP visits over time compared to 1992–93 levels (for 1997–98, adjusted RR = 0.88, 95%CI = 0.81–0.95) and an increase in FP ED visits (for 1997–98, adjusted RR = 1.18, 95%CI = 1.05–1.34).
Conclusion
Despite hospital downsizing and fewer deaths occurring in hospitals, FP ambulatory visits (except for ED visits) did not rise correspondingly. Although such restructuring resulted in more people dying out of hospital, it does not appear FPs responded by providing more medical care to them in the community.
doi:10.1186/1471-2296-6-1
PMCID: PMC545965  PMID: 15631626
19.  Doctors' experiences and their perception of the most stressful aspects of complaints processes in the UK: an analysis of qualitative survey data 
BMJ Open  2016;6(7):e011711.
Objectives
To examine doctors' experiences of complaints, including which aspects are most stressful. We also investigated how doctors felt complaints processes could be improved.
Design and methods
A qualitative study based on a cross-sectional survey of members of the British Medical Association (BMA). We asked the following: (1) Try to summarise as best as you can your experience of the complaints process and how it made you feel. (2) What were the most stressful aspects of the complaint? (3) What would you improve in the complaints system?
Participants
We sent the survey to 95 636 doctors, and received 10 930 (11.4%) responses. Of these, 6146 had a previous, recent or current complaint and 3417 (31.3%) of these respondents answered questions 1 and 2. We randomly selected 1000 answers for analysis, and included 100 using the saturation principle. Of this cohort, 93 responses for question 3 were available.
Main results
Doctors frequently reported feeling powerless, emotionally distressed, and experiencing negative feelings towards both those managing complaints and the complainants themselves. Many felt unsupported, fearful of the consequences and that the complaint was unfair. The most stressful aspects were the prolonged duration and unpredictability of procedures, managerial incompetence, poor communication and perceiving that processes are biased in favour of complainants. Many reported practising defensively or considering changing career after a complaint, and few found any positive outcomes from complaints investigations. Physicians suggested procedures should be more transparent, competently managed, time limited, and that there should be an open dialogue with complainants and policies for dealing with vexatious complaints. Some felt more support for doctors was needed.
Conclusions
Complaints seriously impact on doctors' psychological wellbeing, and are associated with defensive practise. This is not beneficial to patient care. To improve procedures, doctors propose they are simplified, time limited and more transparent.
doi:10.1136/bmjopen-2016-011711
PMCID: PMC4947769  PMID: 27377638
Regulation; Physician impairment; MEDICAL LAW
20.  Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study 
PLoS Medicine  2014;11(10):e1001743.
Aaron Kesselheim and colleagues compared US medical students' survey responses regarding pharmaceutical company interactions with the schools' AMSA PharmFree scorecard and Institute on Medicine as a Profession's (IMAP) scores.
Please see later in the article for the Editors' Summary
Background
Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors.
Methods and Findings
Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11–0.44; marketing representative access policies, r = 0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis.
Conclusions
As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling prescription drugs and medical devices is big business. To promote their products, pharmaceutical and medical device companies build relationships with physicians by providing information on new drugs, by organizing educational meetings and sponsored events, and by giving gifts. Financial relationships begin early in physicians' careers, with companies providing textbooks and other gifts to first-year medical students. In medical school settings, manufacturers may help to inform trainees and physicians about developments in health care, but they also create the potential for harm to patients and health care systems. These interactions may, for example, reduce trainees' and trained physicians' skepticism about potentially misleading promotional claims and may encourage physicians to prescribe new medications, which are often more expensive than similar unbranded (generic) drugs and more likely to be recalled for safety reasons than older drugs. To address these and other concerns about the potential career-long effects of interactions between medical trainees and industry, many teaching hospitals and medical schools have introduced policies to limit such interactions. The development of these policies has been supported by expert professional groups and medical societies, some of which have created scales to evaluate the strength of the implemented industry interaction policies.
Why Was This Study Done?
The impact of policies designed to limit interactions between students and industry on student behavior is unclear, and it is not known which aspects of the policies are most predictive of student behavior. This information is needed to ensure that the policies are working and to identify ways to improve them. Here, the researchers investigate which medical school characteristics and which aspects of industry interaction policies are most predictive of students' reported behaviors and beliefs by comparing information collected in a national survey of US medical students with the strength of their schools' industry interaction policies measured on two scales—the American Medical Student Association (AMSA) PharmFree Scorecard and the Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database.
What Did the Researchers Do and Find?
The researchers compared information about reported gift acceptance, interactions with marketing representatives, and the perceived adequacy of faculty–industry separation collected from 1,610 medical students at 121 US medical schools with AMSA and IMAP scores for the schools evaluated a year earlier. Students at schools with the highest ranked interaction policies based on the AMSA score were 63% less likely to accept gifts as students at the lowest ranked schools. Students at the highest ranked schools based on the IMAP score were about half as likely to accept gifts as students at the lowest ranked schools, although this finding was not statistically significant (it could be a chance finding). Similarly, students at the highest ranked schools were 70% less likely to interact with sales representatives as students at the lowest ranked schools. These associations became statistically nonsignificant after controlling for the amount of research funding each school received from the US National Institutes of Health (NIH). Policies limiting gifts, meals, and being a part of speaking bureaus (where companies pay speakers to present information about the drugs for dinners and other events) were associated with students' reports of receiving no gifts and of non-interaction with sales representatives. Finally, policies regulating industry involvement in educational activities were associated with the perceived separation between faculty and industry, which was regarded as adequate by most of the students at schools with such policies.
What Do These Findings Mean?
These findings suggest that policies designed to limit industry interactions with medical students need to address multiple aspects of these interactions to achieve changes in the behavior and attitudes of trainees, but that policies limiting gifts, meals, and speaking bureaus may be particularly important. These findings also suggest that the level of NIH funding plays an important role in students' self-reported behaviors and their perceptions of industry, possibly because institutions with greater NIH funding have the resources needed to implement effective policies. The accuracy of these findings may be limited by recall bias (students may have reported their experiences inaccurately), and by the possibility that industry interaction policies may have changed in the year that elapsed between policy grading and the student survey. Nevertheless, these findings suggest that limitations on gifts should be emphasized when academic medical centers refine their policies on interactions between medical students and industry and that particular attention should be paid to the design and implementation of policies that regulate industry interactions in institutions with lower levels of NIH funding.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001743.
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice document, which describes what is required of all registered doctors in the UK
Information about the American Medical Student Association (AMSA) Just Medicine campaign (formerly the PharmFree campaign) and about the AMSA Scorecard is available
Information about the Institute on Medicine as a Profession (IMAP) and about its Conflicts of Interest Policy Database is also available
“Understanding and Responding to Pharmaceutical Promotion: A Practical Guide” is a manual prepared by Health Action International and the World Health Organization that medical schools can use to train students how to recognize and respond to pharmaceutical promotion
The US Institute of Medicine's report “Conflict of Interest in Medical Research, Education, and Practice” recommends steps to identify, limit, and manage conflicts of interest
The ALOSA Foundation provides evidence-based, non-industry-funded education about treating common conditions and using prescription drugs
doi:10.1371/journal.pmed.1001743
PMCID: PMC4196737  PMID: 25314155
21.  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
22.  Physicians using spinal manipulative treatment in The Netherlands: a description of their characteristics and their patients 
Background
Various health care professionals apply Spinal Manipulative Treatment (SMT) in daily practice. While the characteristics of chiropractors and manual therapists and the characteristics of their patient populations are well described, there is little research about physicians who use SMT techniques. A distinct group of physicians in The Netherlands has been trained in musculoskeletal (MSK) medicine, which includes the use of SMT. Our objective was to describe the characteristics of these physicians and their patient population.
Methods
All registered MSK physicians were approached with questionnaires and telephone interviews to collect data about their characteristics. Data about patient characteristics were extracted from a web-based register. In this register physicians recorded basic patient data (age, gender, the type and duration of the main complaint, concomitant complaints and the type of referral) at the first consultation. Patients were invited to fill in web-based questionnaires to provide baseline data about previous treatments and the severity of their main complaint. Functional impairment was measured with Patient Reported Outcome Measures (PROMs).
Results
Questionnaires were sent to 138 physicians of whom 90 responded (65%). Most physicians were trained in MSK medicine after a career in other medical specialities. They reported to combine their SMT treatment with a variety of diagnostic and treatment options part of which were only permissible for physicians, such as prescription medication and injections. The majority of patients presented with complaints of long duration (62.1% > 1 year), most frequently low back pain (48.1%) or neck pain (16.9%), with mean scores of 6.0 and 6.2, respectively, on a 0 to10 numerical rating scale (NRS) for pain intensity. Mean scores on all PROMs showed moderate impairment. Patients most frequently reported previous treatment by physical therapists (68.1%), manual therapists (37.7%) or chiropractors (17.0%).
Conclusion
Our study showed that MSK physicians in The Netherlands used an array of SMT techniques. They embedded their SMT techniques in a broad array of other diagnostic and treatment options, part of which were limited to medical doctors. Most patients consulted MSK physicians with spinal pain of long duration with moderate functional impairment.
doi:10.1186/s12891-017-1863-z
PMCID: PMC5718083  PMID: 29207995
Spinal manipulative treatment; Musculoskeletal medicine; MSK medicine; Patient characteristics; Chiropractic treatment; Manual therapy
23.  Doctors’ perception of support and the processes involved in complaints investigations and how these relate to welfare and defensive practice: a cross-sectional survey of the UK physicians 
BMJ Open  2017;7(11):e017856.
Objective
How adverse outcomes and complaints are managed may significantly impact on physician well-being and practice. We aimed to investigate how depression, anxiety and defensive medical practice are associated with doctors actual and perceived support, behaviour of colleagues and process issues regarding how complaints investigations are carried out.
Design
A survey study. Respondents were classified into three groups: no complaint, recent/current complaint (within 6 months) or past complaint. Each group completed specific surveys.
Setting
British Medical Association (BMA) members were invited to complete an online survey.
Participants
95 636 members of the BMA were asked to participate. 7926 (8.3%) completed the survey, of whom 1780 (22.5%) had no complaint, 3889 (49.1%) had a past complaint and 2257 (28.5%) had a recent/current complaint. We excluded those with no complaints leaving 6144 in the final sample.
Primary outcomes measures
We measured anxiety and depression using the Generalised Anxiety Disorder Scale 7 and Physical Health Questionnaire 9. Defensive practice was assessed using a new measure for avoidance and hedging.
Results
Most felt supported by colleagues (61%), only 31% felt supported by management. Not following process (56%), protracted timescales (78%), vexatious complaints (49%), feeling bullied (39%) or victimised for whistleblowing (20%), and using complaints to undermine (31%) were reported. Perceived support by management (relative risk (RR) depression: 0.77, 95% CI 0.71 to 0.83; RR anxiety: 0.80, 95% CI 0.74 to 0.87), speaking to colleagues (RR depression: 0.64, 95% CI 0.48 to 0.84 and RR anxiety: 0.69, 95% CI 0.51 to 0.94, respectively), fair/accurate documentation (RR depression: 0.80, 95% CI 0.75 to 0.86; RR anxiety: 0.81, 95% CI 0.75 to 0.87), and being informed about rights (RR depression 0.96 (0.89 to 1.03) and anxiety 0.94 (0.87 to 1.02), correlated positively with well-being and reduced defensive practice. Doctors worried most about professional humiliation following a complaint investigation (80%).
Conclusion
Poor process, prolonged timescales and vexatious use of complaints systems are associated with decreased psychological welfare and increased defensive practice. In contrast, perceived support from colleagues and management is associated with a reduction in these effects.
doi:10.1136/bmjopen-2017-017856
PMCID: PMC5719304  PMID: 29162574
defensive practice; physician health; anxiety; depression; medical regulation
24.  Comparison of Knowledge and Attitudes Regarding Hepatitis B Among Healthcare Professionals in Pakistan 
Cureus  null;9(2):e1049.
Aim
Hepatitis B virus (HBV) is a blood-borne infectious disease. It is one of the most common causes of end-stage liver disease, including cirrhosis and hepatocellular carcinoma. Healthcare professionals, including medical and dental students, are at a high risk of acquiring this infection. The aim of this study was to compare and contrast the knowledge and attitudes toward HBV infection amongst doctors, dentists, nurses, and undergraduate final year medical and dental students.
Subjects and method
A cross-sectional study was carried out on a sample size of 381 medical professionals, which included doctors (59), dentists (77), nurses (71), final year medical students (126), and final year dental students (48) at Combined Military Hospital Lahore Medical College and Institute of Dentistry (CMH LMC). A questionnaire comprising 27 multiple choice questions was distributed amongst the groups mentioned above. The questionnaire aimed to assess basic knowledge, attitudes towards those infected, and knowledge about vaccination against HBV.
Results
The total response rate was 88.8% (382/430 respondents returned the questionnaire). The mean ± standard deviation (SD) score for all healthcare professionals in knowledge was 15.54 ± 3.69 and attitude were 4.67 ± 1.37, which indicated that majority of the healthcare professionals were well informed about hepatitis B and generally exhibited positive attitudes. However, results revealed that medical students lacked adequate knowledge about various aspects of HBV infection, including modes of transmission and prevention methods against the disease. On the other hand, dental students were better informed and exhibited a more positive attitude towards the disease.
Conclusion
According to the results of our study, medical students showed poor knowledge about hepatitis B disease, including its modes of transmission and the option of vaccination. Lack of knowledge contributed significantly to their negative attitudes towards those suffering from the disease, which has the potential to considerably affect the quality of patient care and the doctor-patient relationship. Major steps should be taken towards improving the curriculum followed at medical colleges in Pakistan. More emphasis should be laid on providing knowledge during early academic years and increasing the amount of clinical exposure. Frequent workshops and seminars should be organized in order to provide up-to-date knowledge about HBV infection and means of prevention to both healthcare professionals and students.
doi:10.7759/cureus.1049
PMCID: PMC5364084  PMID: 28367387
doctors; dentists; nurses; medical students; dental students; hepatitis b virus; vaccination; attitude; awareness; healthcare professionals
25.  Maternal postpartum morbidity in Marrakech: what women feel what doctors diagnose? 
Background
Information about postpartum maternal morbidity in developing countries is limited and often based on information obtained from hospitals. As a result, the reports do not usually reflect the true magnitude of obstetric complications and poor management at delivery. In Morocco, little is known about obstetric maternal morbidity. Our aim was to measure and identify the causes of postpartum morbidity 6 weeks after delivery and to compare women’s perception of their health during this period to their medical diagnoses.
Methods
We did a cross-sectional study of all women, independent of place of delivery, in Al Massira district, Marrakech, from December 2010 to March 2012. All women were clinically examined 6 to 8 weeks postpartum for delivery-related morbidities. We coupled a clinical examination with a questionnaire and laboratory tests (hemoglobin).
Results
During postpartum consultation, 44% of women expressed at least one complaint. Complaints related to mental health were most often reported (10%), followed by genital infections (8%). Only 9% of women sought treatment for their symptoms before the postpartum visit. Women who were aged ≥30 years, employed, belonged to highest socioeconomic class, and had obstetric complications during birth or delivered in a private facility or at home were more likely to report a complaint. Overall, 60% of women received a medical diagnosis related to their complaint, most of which were related to gynecological problems (22%), followed by laboratory-confirmed anemia (19%). Problems related to mental health represented only 5% of the diagnoses. The comparative analysis between perceived and diagnosed morbidity highlighted discrepancies between complaints that women expressed during their postpartum consultation and those they received from a physician.
Conclusions
A better understanding of postpartum complaints is one of the de facto essential elements to ensuring quality of care for women. Sensitizing and training clinicians in mental health services is important to respond to women’s needs and improve the quality of maternal care.
doi:10.1186/1471-2393-13-225
PMCID: PMC3878998  PMID: 24314155
Maternal health; Postpartum maternal morbidity; Women’s perceptions; Morocco

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