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1.  Mastery Learning of Advanced Cardiac Life Support Skills by Internal Medicine Residents Using Simulation Technology and Deliberate Practice 
BACKGROUND
Internal medicine residents must be competent in advanced cardiac life support (ACLS) for board certification.
OBJECTIVE
To use a medical simulator to assess postgraduate year 2 (PGY-2) residents' baseline proficiency in ACLS scenarios and evaluate the impact of an educational intervention grounded in deliberate practice on skill development to mastery standards.
DESIGN
Pretest-posttest design without control group. After baseline evaluation, residents received 4, 2-hour ACLS education sessions using a medical simulator. Residents were then retested. Residents who did not achieve a research-derived minimum passing score (MPS) on each ACLS problem had more deliberate practice and were retested until the MPS was reached.
PARTICIPANTS
Forty-one PGY-2 internal medicine residents in a university-affiliated program.
MEASUREMENTS
Observational checklists based on American Heart Association (AHA) guidelines with interrater and internal consistency reliability estimates; deliberate practice time needed for residents to achieve minimum competency standards; demographics; United States Medical Licensing Examination Step 1 and Step 2 scores; and resident ratings of program quality and utility.
RESULTS
Performance improved significantly after simulator training. All residents met or exceeded the mastery competency standard. The amount of practice time needed to reach the MPS was a powerful (negative) predictor of posttest performance. The education program was rated highly.
CONCLUSIONS
A curriculum featuring deliberate practice dramatically increased the skills of residents in ACLS scenarios. Residents needed different amounts of training time to achieve minimum competency standards. Residents enjoy training, evaluation, and feedback in a simulated clinical environment. This mastery learning program and other competency-based efforts illustrate outcome-based medical education that is now prominent in accreditation reform of residency education.
doi:10.1111/j.1525-1497.2006.00341.x
PMCID: PMC1828088  PMID: 16637824
mastery learning; medical simulation; residency education
2.  Wound Care Specialization: The Current Status and Future Plans to Move Wound Care into the Medical Community 
Advances in Wound Care  2012;1(5):184-188.
Background
There has been an explosion of basic science results in the field of wound care over the past 20 years. Initially, wound dressings were the only therapeutic option available to the wound practitioner. With advanced basic science knowledge, technical innovation, and the recent participation of pharmaceutical companies, the wound clinician now has an arsenal of dressings, biological tissue replacements, gene therapy, and cell-based treatment options. What has not, however, kept pace with these changes is the education and practical training for those treating nonhealing wounds. The pace of innovation in wound diagnostic tools has also lagged, creating even more pressure on the clinician to use experience, skill, and training to properly diagnose the root cause for the nonhealing wound. As wound healing is not considered a medical specialty, there is no formal training process for physicians, and subsequently, allied health practitioners are often the only ones available to provide care for these complex patients. Wound care training, however, is also not part of any formal curriculum for these healthcare providers as well, creating confusion for patients, payors, regulators, researchers, and product manufacturers.
The Problem
In all other fields of medicine there is a formal process in place for physicians to train, certify, and credential. Medicine is constantly evolving and there have been several new fields of specialty care created over the past two decades that can serve as examples for the wound care field to follow. Without academic-based, clinical residency/fellowship training in wound healing ultimately leading to formal certification, the field will be unable to achieve an appropriate status in the medical establishment. Achieving this goal will impact product innovation, payment, and the sustainability of the field.
Basic/Clinical Science Advances
The enhanced understanding of normal and dysregulated wound healing processes, which have been uncovered by basic scientists, has translated to the bedside through the creation of multiple advanced biological solutions for patients with nonhealing wounds.
Clinical Care Relevance
These advanced wound care therapeutics will require physician involvement in a way not previously seen in wound care. It will no longer be possible to practice wound care “part time” in the near future. The amount of new information and massive base of core knowledge required will mandate a full-time commitment. The increase in patients with this condition because of an aging population, increased numbers of diabetic patients, and the ever growing epidemic of obesity will mandate that all clinicians providing wound care will need to increase their skill sets through formal training. In addition, underserved patient populations are disproportionately affected and their outcomes are comparatively worse, further complicating the problem at a healthcare structural and policy level.
Conclusion
The American College of Wound Healing and Tissue Repair was founded in Illinois as a nonprofit organization whose express function is to organize university-based medical school programs around a common curriculum for physicians who want to specialize in wound healing. Currently, two wound care fellows have graduated from the University of Illinois at Chicago and other programs are under development. The ultimate process will be achieved when certification is accredited by an organization such as the American Board of Medical Specialties. This article outlines the current process in place to achieve this goal within 10 years.
doi:10.1089/wound.2011.0346
PMCID: PMC3839023  PMID: 24527303
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.  Transforming the present--discovering the future: the University of Pittsburgh's NLM grant on education and training of health sciences librarians. 
BACKGROUND: The University of Pittsburgh was awarded a grant by the National Library of Medicine to study the education and training needs of present and future medical librarians and health information specialists through a collaboration of the university's School of Information Sciences and Health Sciences Library System. Goals and objectives for the year-long project included (1) assessment of education and training needs of medical librarians, (2) development of a master of library science curriculum and an internship program that would prepare graduates to take leadership roles in medical librarianship or information management, (3) development of continuing education programs for medical librarians in different formats, and (4) development of targeted recruitment efforts to attract minority group members and individuals with undergraduate science majors. The importance of this project, present practice, and success factors for programs seeking excellence in the preparation of health sciences information professionals are reviewed. A needs assessment involving a national advisory panel and a follow-up study of individuals who have participated in previous specialized training programs in health sciences information, compared with a peer group of medical librarians who did not participate in such programs, is described. This paper presents the goals and objectives of the project, describes the methods used, and outlines a curriculum, continuing education initiatives, and recruitment activities.
PMCID: PMC226192  PMID: 8913555
5.  The Role of Medical Education in Reducing Health Care Disparities: The First Ten Years of the UCLA/Drew Medical Education Program 
BACKGROUND
The University of California, Los Angeles (UCLA)/Charles R. Drew University Medical Education Program was developed to train physicians for practice in underserved areas. The UCLA/Drew Medical Education Program students receive basic science instruction at UCLA and complete their required clinical rotations in South Los Angeles, an impoverished urban community. We have previously shown that, in comparison to their UCLA counterparts, students in the Drew program had greater odds of maintaining their commitment to medically disadvantaged populations over the course of medical education.
OBJECTIVE
To examine the independent association of graduation from the UCLA/Drew program with subsequent choice of physician practice location. We hypothesized that participation in the UCLA/Drew program predicts future practice in medically disadvantaged areas, controlling for student demographics such as race/ethnicity and gender, indicators of socioeconomic status, and specialty choice.
DESIGN
Retrospective cohort study.
PARTICIPANTS
Graduates (1,071) of the UCLA School of Medicine and the UCLA/Drew Medical Education Program from 1985–1995, practicing in California in 2003 based on the address listed in the American Medical Association (AMA) Physician Masterfile.
MEASUREMENTS
Physician address was geocoded to a California Medical Service Study Area (MSSA). A medically disadvantaged community was defined as meeting any one of the following criteria: (a) federally designated HPSA or MUA; (b) rural area; (c) high minority area; or (d) high poverty area.
RESULTS
Fifty-three percent of UCLA/Drew graduates are located in medically disadvantaged areas, in contrast to 26.1% of UCLA graduates. In multivariate analyses, underrepresented minority race/ethnicity (OR: 1.57; 95% CI: 1.10–2.25) and participation in the Drew program (OR: 2.47; 95% CI: 1.59–3.83) were independent predictors of future practice in disadvantaged areas.
CONCLUSIONS
Physicians who graduated from the UCLA/Drew Medical Education Program have higher odds of practicing in underserved areas than those who completed the traditional UCLA curriculum, even after controlling for other factors such as race/ethnicity. The association between participation in the UCLA/Drew Medical Education Program and physician practice location suggests that medical education programs may reinforce student goals to practice in disadvantaged communities.
doi:10.1007/s11606-007-0154-z
PMCID: PMC1852922  PMID: 17443370
medical education; health care disparities; UCLA/Drew program
6.  The Role of Medical Education in Reducing Health Care Disparities: The First Ten Years of the UCLA/Drew Medical Education Program 
BACKGROUND
The University of California, Los Angeles (UCLA)/Charles R. Drew University Medical Education Program was developed to train physicians for practice in underserved areas. The UCLA/Drew Medical Education Program students receive basic science instruction at UCLA and complete their required clinical rotations in South Los Angeles, an impoverished urban community. We have previously shown that, in comparison to their UCLA counterparts, students in the Drew program had greater odds of maintaining their commitment to medically disadvantaged populations over the course of medical education.
OBJECTIVE
To examine the independent association of graduation from the UCLA/Drew program with subsequent choice of physician practice location. We hypothesized that participation in the UCLA/Drew program predicts future practice in medically disadvantaged areas, controlling for student demographics such as race/ethnicity and gender, indicators of socioeconomic status, and specialty choice.
DESIGN
Retrospective cohort study.
PARTICIPANTS
Graduates (1,071) of the UCLA School of Medicine and the UCLA/Drew Medical Education Program from 1985–1995, practicing in California in 2003 based on the address listed in the American Medical Association (AMA) Physician Masterfile.
MEASUREMENTS
Physician address was geocoded to a California Medical Service Study Area (MSSA). A medically disadvantaged community was defined as meeting any one of the following criteria: (a) federally designated HPSA or MUA; (b) rural area; (c) high minority area; or (d) high poverty area.
RESULTS
Fifty-three percent of UCLA/Drew graduates are located in medically disadvantaged areas, in contrast to 26.1% of UCLA graduates. In multivariate analyses, underrepresented minority race/ethnicity (OR: 1.57; 95% CI: 1.10–2.25) and participation in the Drew program (OR: 2.47; 95% CI: 1.59–3.83) were independent predictors of future practice in disadvantaged areas.
CONCLUSIONS
Physicians who graduated from the UCLA/Drew Medical Education Program have higher odds of practicing in underserved areas than those who completed the traditional UCLA curriculum, even after controlling for other factors such as race/ethnicity. The association between participation in the UCLA/Drew Medical Education Program and physician practice location suggests that medical education programs may reinforce student goals to practice in disadvantaged communities.
doi:10.1007/s11606-007-0154-z
PMCID: PMC1852922  PMID: 17443370
medical education; health care disparities; UCLA/Drew program
7.  Developing a Practical and Sustainable Faculty Development Program With a Focus on Teaching Quality Improvement and Patient Safety: An Alliance for Independent Academic Medical Centers National Initiative III Project 
The Ochsner Journal  2012;12(4):338-343.
Background
Teaching the next generation of physicians requires more than traditional teaching models. The Accreditation Council for Graduate Medical Education's Next Accreditation System places considerable emphasis on developing a learning environment that fosters resident education in quality improvement and patient safety. The goal of this project was to develop a comprehensive and sustainable faculty development program with a focus on teaching quality improvement and patient safety.
Methods
A multidisciplinary team representing all stakeholders in graduate medical education developed a validated survey to assess faculty and house officer baseline perceptions of their experience with faculty development opportunities, quality improvement tools and training, and resident participation in quality improvement and patient safety programs at our institution. We then developed a curriculum to address these 3 areas.
Results
Our pilot survey revealed a need for a comprehensive program to teach faculty and residents the art of teaching. Two other areas of need are (1) regular resident participation in quality improvement and patient safety efforts and (2) effective tools for developing skills and habits to analyze practices using quality improvement methods.
Resident and faculty pairs in 17 Ochsner training programs developed and began quality improvement projects while completing the first learning module. Resident and faculty teams also have been working on the patient safety modules and incorporating aspects of patient safety into their individual work environments.
Conclusion
Our team's goal is to develop a sustainable and manageable faculty development program that includes modules addressing quality improvement and patient safety in accordance with Accreditation Council for Graduate Medical Education accreditation requirements.
PMCID: PMC3527861  PMID: 23267260
Faculty development; graduate medical education; performance improvement; quality improvement
8.  Graduate and Undergraduate Geriatric Dentistry Education in a Selected Dental School in Japan 
Geriatric dentistry and its instruction are critical in a rapidly aging population. Japan is the world’s fastest-aging society, and thus geriatric dentistry education in Japan can serve as a global model for other countries that will soon encounter the issues that Japan has already confronted. This study aimed to evaluate geriatric dental education with respect to the overall dental education system, undergraduate geriatric dentistry curricula, mandatory internships, and graduate geriatric education of a selected dental school in Japan.
Bibliographic data and local information were collected. Descriptive and statistical analyses (Fisher and Chi-square test) were conducted.
Japanese dental schools teach geriatric dentistry in 10 geriatric dentistry departments as well as in prosthodontic departments. There was no significant differences found between the number of public and private dental schools with geriatric dentistry departments (p = 0.615). At Showa University School of Dentistry, there are more didactic hours than practical training hours; however, there is no significant didactic/practical hour distribution difference between the overall dental curriculum and fourth-year dental students’ geriatric dental education curriculum (p=0.077). Graduate geriatric education is unique because it is a four-year Ph.D. course of study; there is neither a Master’s degree program nor a certificate program in Geriatric Dentistry. Overall, both undergraduate and graduate geriatric dentistry curricula are multidisciplinary.
This study contributes to a better understanding of geriatric dental education in Japan; the implications of this study include developing a clinical/didactic curriculum, designing new national/international dental public health policies, and calibrating the competency of dentists in geriatric dentistry.
doi:10.1111/j.1600-0579.2010.00664.x
PMCID: PMC3191939  PMID: 21985207
geriatric dentistry; geriatric dental education; curriculum
9.  Drugs Used for Parenteral Sedation in Dental Practice 
Anesthesia Progress  1988;35(5):199-205.
The relative efficacy and safety of drugs and combinations used clinically in dentistry as premedicants to alleviate patient apprehension are largely unsubstantiated. To evaluate the efficacy and safety of agents used for parenteral sedation through controlled clinical trials, it is first necessary to identify which drugs, doses, and routes of administration are actually used in practice. A survey instrument was developed to characterize the drugs used clinically for anesthesia and sedation by dentists with advanced training in pain control. A random sample of 500 dentists who frequently use anesthesia and sedation in practice was selected from the Fellows of the American Dental Society of Anesthesiology. The first mailing was followed by a second mailing to nonrespondents after 30 days. The respondents report a variety of parenteral sedation techniques in combination with local anesthesia (the response categories are not mutually exclusive): nitrous oxide (64%), intravenous conscious sedation (59%), intravenous “deep” sedation (47%), and outpatient general anesthesia (27%). Drugs most commonly reported for intravenous sedation include diazepam, methohexital, midazolam, and combinations of these drugs with narcotics. A total of 82 distinct drugs and combinations was reported for intravenous sedation and anesthesia. Oral premedication and intramuscular sedation are rarely used by this group. Most general anesthesia reported is done on an outpatient basis in private practice. These results indicate that a wide variety of drugs is employed for parenteral sedation in dental practice, but the most common practice among dentists with advanced training in anesthesia is local anesthesia supplemented with intravenous sedation consisting of a benzodiazepine and an opioid or a barbiturate.
PMCID: PMC2167868  PMID: 3250279
10.  Attitudes and interests toward research among students at two colleges of acupuncture and Oriental medicine 
Explore (New York, N.Y.)  2010;6(1):22-28.
Background
Collaborative input from clinicians of acupuncture and Oriental medicine (AOM) is required for sound AOM research, and AOM training institutions have begun to include research education into their curriculum. However, few attempts have been made to systematically evaluate AOM practitioners’ perspectives on the value of research to their profession.
Methods
We conducted surveys of AOM students at two institutions that have begun to integrate research training into their curriculum, the New England School of Acupuncture and the Oregon College of Oriental Medicine. Surveys were conducted to assess current attitudes regarding the value of research, and to serve as a reference point for documenting the impact of ongoing research training programs on these attitudes. Surveys at both institutions were independently developed and administered, but shared 7 questions that were phrased very similarly. This paper summarizes responses to these questions.
Results
Surveys at both institutions suggest interest in research among AOM students is high in first year students; students in later years showed a lower level of interest, but the cross-sectional design of this survey does not allow any temporal effects to be inferred. Results also indicate that AOM students believe research is highly relevant to how both the public and the health insurance industry view their system of health care, but not highly relevant to their own clinical practice of AOM. The belief that research is of limited relevance to clinical practice was associated with widespread belief that scientific methods may not be consistent with the principles of AOM.
Conclusions
Results of these surveys provide important preliminary information about AOM students attitudes towards research, and thus the value and future specific needs of research training programs targeting this population. Repeated implementation of validated versions of our surveys are needed to confirm the trends we report and to evaluate the impact of research training programs already in place on AOM students attitudes towards research.
doi:10.1016/j.explore.2009.10.003
PMCID: PMC2846631  PMID: 20129309
student survey; research education; complementary and alternative medicine; acupuncture
11.  Progress Toward Improving the Quality of Cardiac Arrest Medical Team Responses at an Academic Teaching Hospital 
Background
Internal medicine (IM) residents who undergo simulation-based advanced cardiac life support (ACLS) training are significantly more likely to manage actual events according to American Heart Association (AHA) standards than nontrained residents. How long ACLS skills are retained is unknown.
Methods
We conducted a retrospective case-control study of ACLS responses from January to June 2008 and reviewed medical records to assess adherence to AHA standards. Cases and controls are team responses to ACLS events divided into those directed by postgraduate year 2 (PGY-2) IM resident leaders versus those managed by PGY-3 IM resident leaders. Residents in 2008 completed an educational program featuring deliberate practice in ACLS using a human patient simulator during their second year. Medical records of ACLS events were reviewed to assess adherence to AHA guidelines. We evaluated the effects of simulation training on quality of ACLS care during the 2008 period and in comparison with historical 2004 data.
Results
In 2008, 1 year after simulation training, PGY-3 residents showed the same adherence to AHA standards (88% [SD, 17%]) as that of PGY-2 residents who were newly simulator trained (86% [SD, 18%]) (P  =  .77). Previously, in 2004, PGY-2 simulator-trained residents showed significantly higher adherence to AHA standards (68% [SD, 20%]) than nonsimulator-trained PGY-3 residents (44% [SD, 20%]) (P < .001). All resident groups in 2008 outperformed their 2004 peers.
Conclusions
Improved quality of ACLS care was maintained by 2008 PGY-3 simulator-trained residents 1 year after training, likely due to skill retention rather than increased clinical experience, as a prior cohort of PGY-3 residents did not perform as well as PGY-2 residents in actual ACLS care. Our results confirm prior work regarding the impact of simulation-based education to improve the quality of actual patient care.
doi:10.4300/JGME-D-10-00144.1
PMCID: PMC3184920  PMID: 22655144
12.  Medical Informatics Education at Medical Faculty of Sarajevo University - 15 Years Experience 
Acta Informatica Medica  2008;16(1):4-9.
CONFLICT OF INTEREST: NONE DECLARED
In Bosnia and Herzegovina, Medical informatics has been a separate subject for the last 15 years with regard to Medical curriculum at the biomedical faculties in the country (1,2). Education in the field of Medical informatics is based on the concept which is used in developed countries, according to the recommendations of the working groups EDU – Education of Medical Informatics, of the European Federation for Medical Informatics (EFMI) and International Medical Informatics Association (IMIA). Theoretical and practical teaching and training performance as a whole is performed by use of the computer equipment, and the final knowledge check of the students is also performed using the Data Base Management System MS Access specifically designed to cover full teaching and training material by using question sets in the data base which encircled nearly 1500 question combinations. The distance learning is logical step that can further improve this method of education. In this paper, authors present 15 years of experience of Medical informatics education at biomedical faculties in Bosnia and Herzegovina. Medical Informatics, as an obligatory subject, was introduced to the biomedical faculties in Sarajevo (medical, dental and pharmaceutical as well as the High medical school) in 1992 and 1993. Students have practical computer exercises for a period of 7 weeks. Students had training in Excel, Word etc. During the semester, the students perform specific operation such as creation of data carrier for manipulation with medical information. The information was analyzed by statistical program such as Excel. From 2002 years Medical Informatics is divided in two parts in order to facilitate data processing and other procedure that are necessary to perform at time when student’s knowledge of medicine is sufficient for practicing specific tasks that include management the data about patient, anamnesis and similar parameters cause we noticed that students without such knowledge cannot figure out the whole picture without difficulties. The Theoretical part of examination is done using the multiple choice answer form provided by special software with randomly selected questions for each student. Such way of practical and theoretical path of final exam make possible to perform such procedures such as electronic registration for exam and distance testing. Possibilities of introduction of distance learning in medical curriculum are the title of project which has been realizing at Cathedra for medical Informatics, Medical faculty since year 2002. Our undergraduate and postgraduate students are satisfied with contents and organization of the teaching process.
doi:10.5455/aim.2008.16.4-9
PMCID: PMC3789160  PMID: 24109152
Medical informatics; education; distance learning
13.  Linking a Motivational Interviewing Curriculum to the Chronic Care Model 
Journal of General Internal Medicine  2010;25(Suppl 4):620-626.
BACKGROUND
Unhealthy lifestyle choices frequently cause or worsen chronic diseases. Many internal medicine residents are inadequately trained to provide effective health behavior counseling, in part, due to prioritization of acute care in the traditional model of medical education and to other systemic barriers to teaching psychosocial aspects of patient care.
AIM
To address this gap in training, we developed and piloted a curriculum for a Primary Care Internal Medicine residency program that links a practical form of motivational interviewing (MI) training to the self-management support (SMS) component of the chronic care model.
PARTICIPANTS AND SETTING
All 30 primary care residents at Alameda County Medical Center were trained in the curriculum since it was initiated in 2007 during the California Academic Chronic Care Collaborative.
PROGRAM DESCRIPTION
Residents participated in three modules during which the chronic care model was introduced and motivational interviewing skills were linked to the model’s self-management support component. This training was then reinforced in the clinical setting. Case-based interactive instruction, teaching videotapes, group role-plays, faculty demonstration, and observation of resident-patient interactions in the clinical setting were used to teach the curriculum.
PROGRAM ASSESSMENT
A preliminary, qualitative assessment of this curriculum was done from a program standpoint and from the perspective of the learners. Residents reported increased sense of confidence when approaching patients about health behavior change. Faculty directly observed residents during clinical encounters using MI and SMS skills to work more collaboratively with patients and to improve patient readiness for self-management goal setting.
CONCLUSION
A curriculum that links motivational interviewing skills to the chronic care model’s self-management support component and is reinforced in the clinical setting is feasible to develop and implement. This curriculum may improve residents’ confidence with health behavior counseling and with preparing patients to become active participants in management of their chronic conditions.
doi:10.1007/s11606-010-1426-6
PMCID: PMC2940440  PMID: 20737238
chronic care model; self-management support; motivational interviewing; residency training; primary care
14.  Quality and Safety Training in Primary Care: Making an Impact 
Purpose
Preparing residents for future practice, knowledge, and skills in quality improvement and safety (QI/S) is a requisite element of graduate medical education. Despite many challenges, residency programs must consider new curricular innovations to meet the requirements. We report the effectiveness of a primary care QI/S curriculum and the role of the chief resident in quality and patient safety in facilitating it.
Method
Through the Veterans Administration Graduate Medical Education Enhancement Program, we added a position for a chief resident in quality and patient safety, and 4 full-time equivalent internal medicine residents, to develop the Primary Care Interprofessional Patient-Centered Quality Care Training Curriculum. The curriculum includes a first-or second-year, 1-month block rotation that serves as a foundational experience in QI/S and interprofessional care. The responsibilities of the chief resident in quality and patient safety included organizing and teaching the QI/S curriculum and mentoring resident projects. Evaluation included prerotation and postrotation surveys of self-assessed QI/S knowledge, abilities, skills, beliefs, and commitment (KASBC); an end-of-the-year KASBC; prerotation and postrotation knowledge test; and postrotation and faculty surveys.
Results
Comparisons of prerotation and postrotation KASBC indicated significant self-assessed improvements in 4 of 5 KASBC domains: knowledge (P < .001), ability (P < .001), skills (P < .001), and belief (P < .03), which were sustained on the end-of-the-year survey. The knowledge test demonstrated increased QI/S knowledge (P  =  .002). Results of the postrotation survey indicate strong satisfaction with the curriculum, with 76% (25 of 33) and 70% (23 of 33) of the residents rating the quality and safety curricula as always or usually educational. Most faculty members acknowledged that the chief resident in quality and patient safety enhanced both faculty and resident QI/S interest and participation in projects.
Conclusions
Our primary care QI/S curriculum was associated with improved and persistent resident self-perceived knowledge, abilities, and skills and increased knowledge-based scores of QI/S. The chief resident in quality and patient safety played an important role in overseeing the curriculum, teaching, and providing leadership.
doi:10.4300/JGME-D-11-00322.1
PMCID: PMC3546584  PMID: 24294431
15.  Variability in Ultrasound Education among Emergency Medicine Residencies 
Objective:
Education in emergency ultrasound (EUS) has become an essential part of emergency medicine (EM) resident training. In 2009, comprehensive residency training guidelines were published to ensure proficiency in ultrasound education. The American College of Emergency Physicians (ACEP) recommends that 150 ultrasound exams be performed for physician competency. Our goal is to evaluate the current ultrasound practices among EM residency programs and assess the need for further formalization of EUS training.
Methods:
We generated a survey using an online survey tool and administered via the internet. The survey consisted of 25 questions that included multiple choice and free text answers. These online survey links were sent via email to EM ultrasound directors at all 149 American College of Graduate Medical Education EM residency programs in April 2008. We surveyed programs regarding EUS curriculum and residency proficiency requirements and descriptive statistics were used to report the survey findings.
Results:
Sixty-five residency programs responded to the survey. The average number of ultrasound exams required by programs for EUS competency was 137 scans. However, the majority of programs 42/65 (64%) require their residents to obtain 150 scans or greater for competency. Fifty-one out of 64 (79%) programs reported having a structured ultrasound curriculum while 14/64 (21%) of programs reported that EUS training is primarily resident self-directed. In terms of faculty credentialing, 29/62 (47%) of residency programs have greater than 50% of faculty credentialed. Forty-four out of 61 (72%) programs make EUS a required rotation. Thirty-four out of 63 (54%) programs felt that they were meeting all their goals for resident EUS education.
Conclusion:
Currently discrepancies exist between EM residency programs in ultrasound curriculum and perceived needs for achieving proficiency in EUS. Although a majority of residency programs require 150 ultrasound exams or more to achieve resident competency, overall the average number of scans required by all programs is 137 exams. This number is less than that recommended by ACEP for physician competency. These data suggest that guidelines are needed to help standardize ultrasound training for all EM residency programs.
PMCID: PMC2967679  PMID: 21079699
16.  Differences and Similarities in the Practice of Medicine Between Australia and the United States of America: Challenges and Opportunities for The University of Queensland and the Ochsner Clinical School 
The Ochsner Journal  2011;11(3):253-258.
Background
In 2008, The University of Queensland (UQ) in Australia and the Ochsner Health System (OHS) in Louisiana entered into a partnership that will allow a cohort of United States (US) citizens to enroll in an Australian medical degree program in which students will study for their first 2 years of medical school in Brisbane, Australia, and then complete the final 2 years of clinical education at OHS in New Orleans. The program's goal is to create graduates eligible to practice in Australia, New Zealand, and/or the US.
Methods
We reviewed the UQ School of Medicine–established Ochsner Clinical School (OCS) and the translation of the UQ clinical curriculum to the US.
Results
The curriculum presented both challenges and opportunities, revealing the similarities and differences in the practice of medicine between Australia and the US. This paper highlights some of them, in terms of the healthcare systems, the health professional workforce, and medical education. For example, the healthcare system and medical school curriculum in Australia have a strong focus on primary care.
Conclusions
This new model in education may help train more primary care physicians for the US, providing physicians with a unique global perspective to face the future challenges of medical practice.
PMCID: PMC3179196  PMID: 21960759
Australia; medical education; medical practice; United States
17.  Family physicians’ attitudes toward education in research skills during residency 
Canadian Family Physician  2008;54(3):413-414.
OBJECTIVE
To determine the attitudes of practising Canadian family physicians toward education in research skills during residency, to identify what determines these attitudes, and to investigate the effect of education in research skills on future research activity.
DESIGN
Mailed survey.
SETTING
Primary care.
PARTICIPANTS
Stratified random sample of 247 practising physicians who were members of the College of Family Physicians of Canada.
MAIN OUTCOME MEASURES
Physicians’ attitudes toward education in research skills during residency, their perceptions of the value of research in primary care, and their current involvement in research activities.
RESULTS
Overall response rate was 56%. Nearly all respondents agreed that critical appraisal skills are essential to the practice of modern family medicine. Most agreed that it is very important that the evidence base for primary care medicine be developed by family physicians, yet only one-third agreed that research skills ought to receive more emphasis during residency training, and fewer than one-quarter agreed that practising family physicians should have strong research skills. Fewer than half the respondents agreed that a core goal of family medicine residency training should be to promote and develop an active interest in research. While three-quarters agreed that research projects during residency can be formative learning experiences, only about 40% indicated that research projects should be required, and only about 20% considered their own resident research projects to have been highly influential learning experiences. Respondents whose residency programs had research in the curriculum were significantly more likely to have found their research projects to be highly influential learning experiences (P <.05), and those who had successfully completed research projects were less likely to believe that they lacked the necessary skills and expertise to conduct their own research studies. Those who had successfully completed resident research projects participated in postresidency research activity at a significantly higher rate than those who did not complete projects (P <.01).
CONCLUSION
Despite a conviction that research is important in primary care, only a few practising family physicians in our sample believed that strong research skills are important or that education in research skills should receive more emphasis during residency training. Resident research projects are not invariably influential learning experiences, although some evidence indicates that successful completion of a project makes future participation in research more likely.
PMCID: PMC2278359  PMID: 18337536
18.  Overcoming Barriers to Implementation of Evidence-Based Practice Concepts in Athletic Training Education: Perceptions of Select Educators 
Journal of Athletic Training  2011;46(5):514-522.
Context:
The need to include evidence-based practice (EBP) concepts in entry-level athletic training education is evident as the profession transitions toward using evidence to inform clinical decision making.
Objective:
To evaluate athletic training educators' experience with implementation of EBP concepts in Commission on Accreditation of Athletic Training Education (CAATE)-accredited entry-level athletic training education programs in reference to educational barriers and strategies for overcoming these barriers.
Design:
Qualitative interviews of emergent design with grounded theory.
Setting:
Undergraduate CAATE-accredited athletic training education programs.
Patients or Other Participants:
Eleven educators (3 men, 8 women). The average number of years teaching was 14.73 ± 7.06.
Data Collection and Analysis:
Interviews were conducted to evaluate perceived barriers and strategies for overcoming these barriers to implementation of evidence-based concepts in the curriculum. Interviews were explored qualitatively through open and axial coding. Established themes and categories were triangulated and member checked to determine trustworthiness.
Results:
Educators identified 3 categories of need for EBP instruction: respect for the athletic training profession, use of EBP as part of the decision-making toolbox, and third-party reimbursement. Barriers to incorporating EBP concepts included time, role strain, knowledge, and the gap between clinical and educational practices. Suggested strategies for surmounting barriers included identifying a starting point for inclusion and approaching inclusion from a faculty perspective.
Conclusions:
Educators must transition toward instruction of EBP, regardless of barriers present in their academic programs, in order to maintain progress with other health professions' clinical practices and educational standards. Because today's students are tomorrow's clinicians, we need to include EBP concepts in entry-level education to promote critical thinking, inspire potential research interest, and further develop the available body of knowledge in our growing clinical practice.
PMCID: PMC3418958  PMID: 22488139
athletic trainers; competencies; pedagogy
19.  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
20.  The use of anaesthetic agents to provide anxiolysis and sedation in dentistry and oral surgery 
The Australasian Medical Journal  2013;6(12):713-718.
Throughout the world there is considerable variation in the techniques used to manage anxious dental patients requiring treatment. Traditionally anxious or phobic dental patients may have been sent for general anaesthesia to allow dental treatment be undertaken. While this is still the case for the more invasive oral surgical procedures, such as wisdom teeth extraction, sedation in general dentistry is becoming more popular.
Various sedation techniques using many different anaesthetic agents have gained considerable popularity over the past 30 years. While the practice of sedating patients for dental procedures is invaluable in the management of suitably assessed patients, patient safety must always be the primary concern. Medical, dental and psychosocial considerations must be taken into account when evaluating the patient need and the patient suitability for sedation or general anaesthesia.
The regulations that govern the practice of dental sedation vary throughout the world, in particular regarding the techniques used and the training necessary for dental practitioners to sedate patients. It is necessary for medical and dental practitioners to be up to date on current practice to ensure standards of practice, competence and safety throughout our profession.
This article, the first in a two-part series, will provide information to practitioners on the practice of sedation in dentistry, the circumstances where it may be appropriate instead of general anaesthesia and the risks involved with sedation. It will also discuss the specific training and qualifications required for dental practitioners to provide sedation. The second article in this series will outline the different techniques used to administer inhalation, oral and intravenous sedation in dentistry and will focus on specific methods that are practiced.
doi:10.4066/AMJ.2013.1836
PMCID: PMC3877855  PMID: 24391684
Conscious sedation; sedation; dentistry; anaesthetic agents; fear; dental phobia; anxiolysis; access to treatment
21.  Fellow or foe: the impact of fellowship training programs on the education of Canadian urology residents 
Objective
Throughout North America, increasing emphasis is being placed on surgical fellowships. Surgical educators and trainees have raised concerns that the escalating focus on fellowships may threaten the educational mission of more novice trainees. Our objective was to collect opinions from multiple perspectives (faculty, fellows and residents) regarding fellowship structure, fellow selection and the impact of clinical fellowships on urology resident training.
Methods
We anonymously surveyed 52 members of a major academic urology training program (University of Toronto) with established fellowship training programs for their opinions regarding fellowship structure, fellow selection, and the impact on resident training and education.
Results
The overall response rate was 88%. We identified significant differences of opinion among faculty, fellows and residents regarding fellowship structure, fellow selection and the impact on resident education. Specifically, faculty and fellows supported the addition of more fellows, felt that certain complex cases should be designated as “fellow cases” and that residents' research opportunities were not restricted. Residents felt that fellows “steal” operative cases, that performing operations with the fellow is not equivalent to performing operations with faculty alone and that fellowship candidates should perform an operation with division faculty as part of the application process. There was agreement that fellowship programs add value to residents' overall education, that fellows should participate in the call schedule and that fellows' role in the operating room needs to be better defined with respect to case volume and selection. Proficiency in technical skills, clinical knowledge, teaching and teamwork were cited as the most attractive characteristics of an effective clinical fellow.
Conclusion
Residency and fellowship program directors must clearly define the role of the fellow and outline the limits of surgical practice, establish clear and consistent guidelines outlining responsibilities (operative, clinical and on-call), and open lines of communication to ensure that all opinions are recognized and addressed. Finally, they must select fellows with proficient technical skills, clinical knowledge, teaching ability and work ethic to ensure that they focus on “specialized” training.
PMCID: PMC2422895  PMID: 18542725
22.  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
23.  Financial incentives for return of service in underserved areas: a systematic review 
Background
In many geographic regions, both in developing and in developed countries, the number of health workers is insufficient to achieve population health goals. Financial incentives for return of service are intended to alleviate health worker shortages: A (future) health worker enters into a contract to work for a number of years in an underserved area in exchange for a financial pay-off.
Methods
We carried out systematic literature searches of PubMed, the Excerpta Medica database, the Cumulative Index to Nursing and Allied Health Literature, and the National Health Services Economic Evaluation Database for studies evaluating outcomes of financial-incentive programs published up to February 2009. To identify articles for review, we combined three search themes (health workers or students, underserved areas, and financial incentives). In the initial search, we identified 10,495 unique articles, 10,302 of which were excluded based on their titles or abstracts. We conducted full-text reviews of the remaining 193 articles and of 26 additional articles identified in reference lists or by colleagues. Forty-three articles were included in the final review. We extracted from these articles information on the financial-incentive programs (name, location, period of operation, objectives, target groups, definition of underserved area, financial incentives and obligation) and information on the individual studies (authors, publication dates, types of study outcomes, study design, sample criteria and sample size, data sources, outcome measures and study findings, conclusions, and methodological limitations). We reviewed program results (descriptions of recruitment, retention, and participant satisfaction), program effects (effectiveness in influencing health workers to provide care, to remain, and to be satisfied with work and personal life in underserved areas), and program impacts (effectiveness in influencing health systems and health outcomes).
Results
Of the 43 reviewed studies 34 investigated financial-incentive programs in the US. The remaining studies evaluated programs in Japan (five studies), Canada (two), New Zealand (one) and South Africa (one). The programs started between 1930 and 1998. We identified five different types of programs (service-requiring scholarships, educational loans with service requirements, service-option educational loans, loan repayment programs, and direct financial incentives). Financial incentives to serve for one year in an underserved area ranged from year-2000 United States dollars 1,358 to 28,470. All reviewed studies were observational. The random-effects estimate of the pooled proportion of all eligible program participants who had either fulfilled their obligation or were fulfilling it at the time of the study was 71% (95% confidence interval 60–80%). Seven studies compared retention in the same (underserved) area between program participants and non-participants. Six studies found that participants were less likely than non-participants to remain in the same area (five studies reported the difference to be statistically significant, while one study did not report a significance level); one study did not find a significant difference in retention in the same area. Thirteen studies compared provision of care or retention in any underserved area between participants and non-participants. Eleven studies found that participants were more likely to (continue to) practice in any underserved area (nine studies reported the difference to be statistically significant, while two studies did not provide the results of a significance test); two studies found that program participants were significantly less likely than non-participants to remain in any underserved area. Seven studies investigated the satisfaction of participants with their work and personal lives in underserved areas.
Conclusion
Financial-incentive programs for return of service are one of the few health policy interventions intended to improve the distribution of human resources for health on which substantial evidence exists. However, the majority of studies are from the US, and only one study reports findings from a developing country, limiting generalizability. The existing studies show that financial-incentive programs have placed substantial numbers of health workers in underserved areas and that program participants are more likely than non-participants to work in underserved areas in the long run, even though they are less likely to remain at the site of original placement. As none of the existing studies can fully rule out that the observed differences between participants and non-participants are due to selection effects, the evidence to date does not allow the inference that the programs have caused increases in the supply of health workers to underserved areas.
doi:10.1186/1472-6963-9-86
PMCID: PMC2702285  PMID: 19480656
24.  Hospital Performance, the Local Economy, and the Local Workforce: Findings from a US National Longitudinal Study 
PLoS Medicine  2010;7(6):e1000297.
Blustein and colleagues examine the associations between changes in hospital performance and their local economic resources. Locationally disadvantaged hospitals perform poorly on key indicators, raising concerns that pay-for-performance models may not reduce inequality.
Background
Pay-for-performance is an increasingly popular approach to improving health care quality, and the US government will soon implement pay-for-performance in hospitals nationwide. Yet hospital capacity to perform (and improve performance) likely depends on local resources. In this study, we quantify the association between hospital performance and local economic and human resources, and describe possible implications of pay-for-performance for socioeconomic equity.
Methods and Findings
We applied county-level measures of local economic and workforce resources to a national sample of US hospitals (n = 2,705), during the period 2004–2007. We analyzed performance for two common cardiac conditions (acute myocardial infarction [AMI] and heart failure [HF]), using process-of-care measures from the Hospital Quality Alliance [HQA], and isolated temporal trends and the contributions of individual resource dimensions on performance, using multivariable mixed models. Performance scores were translated into net scores for hospitals using the Performance Assessment Model, which has been suggested as a basis for reimbursement under Medicare's “Value-Based Purchasing” program. Our analyses showed that hospital performance is substantially associated with local economic and workforce resources. For example, for HF in 2004, hospitals located in counties with longstanding poverty had mean HQA composite scores of 73.0, compared with a mean of 84.1 for hospitals in counties without longstanding poverty (p<0.001). Hospitals located in counties in the lowest quartile with respect to college graduates in the workforce had mean HQA composite scores of 76.7, compared with a mean of 86.2 for hospitals in the highest quartile (p<0.001). Performance on AMI measures showed similar patterns. Performance improved generally over the study period. Nevertheless, by 2007—4 years after public reporting began—hospitals in locationally disadvantaged areas still lagged behind their locationally advantaged counterparts. This lag translated into substantially lower net scores under the Performance Assessment Model for hospital reimbursement.
Conclusions
Hospital performance on clinical process measures is associated with the quantity and quality of local economic and human resources. Medicare's hospital pay-for-performance program may exacerbate inequalities across regions, if implemented as currently proposed. Policymakers in the US and beyond may need to take into consideration the balance between greater efficiency through pay-for-performance and socioeconomic equity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
These days, many people are rewarded for working hard and efficiently by being given bonuses when they reach preset performance targets. With a rapidly aging population and rising health care costs, policy makers in many developed countries are considering ways of maximizing value for money, including rewarding health care providers when they meet targets, under “pay-for-performance.” In the UK, for example, a major pay-for-performance initiative—the Quality and Outcomes Framework—began in 2004. All the country's general practices (primary health care facilities that deal with all medical ailments) now detail their achievements in terms of numerous clinical quality indicators for common chronic conditions (for example, the regularity of blood sugar checks for people with diabetes). They are then rewarded on the basis of these results.
Why Was This Study Done?
In the US, the government is poised to implement a nationwide pay-for-performance program in hospitals within Medicare, the government program that provides health insurance to Americans aged 65 years or older, as well as people with disabilities. However, some observers are concerned about the effect that the proposed pay-for-performance program might have on the distribution of health care resources in the US. Pay-for-performance assumes that health care providers have the economic and human resources that they need to perform or to improve their performance. But, if a hospital's capacity to perform depends on local resources, payment based on performance might worsen existing health care inequalities because hospitals in under-resourced areas might lose funds to hospitals in more affluent regions. In other words, the government might act as a reverse Robin Hood, taking from the poor and giving to the rich. In this study, the researchers examine the association between hospital performance and local economic and human resources, to explore whether this scenario is a plausible result of the pending change in US hospital reimbursement.
What Did the Researchers Do and Find?
US hospitals have voluntarily reported their performance on indicators of clinical care (“process-of-care measures”) for acute myocardial infarction (AMI, heart attack), heart failure (HF), and pneumonia under the Hospital Quality Alliance (HQA) program since 2004. The researchers identified 2,705 hospitals that had fully reported process-of-care measures for AMI and HF in both 2004 and 2007. They then used the “Performance Assessment Model” (a methodology developed by the US Centers for Medicare and Medicaid Services to score hospital performance) to calculate scores for each hospital. Finally, they looked for associations between these scores and measures of the hospital's local economic and human resources such as population poverty levels and the percentage of college graduates in the workforce. Hospital performance was associated with local and economic workforce capacity, they report. Thus, hospitals in counties with longstanding poverty had lower average performance scores for HF and AMI than hospitals in affluent counties. Similarly, hospitals in counties with a low percentage of college graduates in the workforce had lower average performance scores than hospitals in counties where more of the workforce had been to college. Finally, although performance improved generally over the study period, hospitals in disadvantaged areas still lagged behind hospitals in advantaged areas in 2007.
What Do These Findings Mean?
These findings indicate that hospital performance (as measured by the clinical process measures considered here) is associated with the quantity and quality of local human and economic resources. Thus, the proposed Medicare hospital pay-for-performance program may exacerbate existing US health care inequalities by leading to the transfer of funds from hospitals in disadvantaged locations to those in advantaged locations. Although further studies are needed to confirm this conclusion, these findings have important implications for pay-for-performance programs in health care. They suggest that US policy makers may need to modify how they measure performance improvement—the current Performance Assessment Model gives hospitals that start from a low baseline less credit for improvements than those that start from a high baseline. This works against hospitals in disadvantaged locations, which start at a low baseline. Second and more generally, they suggest that there may be a tension between the efficiency goals of pay-for-performance and other equity goals of health care systems. In a world where resources vary across regions, the expectation that regions can perform equally may not be realistic.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000297.
KaiserEDU.org is an online resource for learning about the US health care system. It includes educational modules on such topics as the Medicare program and efforts to improve the quality of care
The Hospital Quality Alliance provides information on the quality of care in US hospitals
Information about the UK National Health Service Quality and Outcomes Framework pay-for-performance initiative for general practice surgeries is available
doi:10.1371/journal.pmed.1000297
PMCID: PMC2893955  PMID: 20613863
25.  Quality Education and Safe Systems Training (QuESST): Development and Assessment of a Comprehensive Cross-Disciplinary Resident Quality and Patient Safety Curriculum 
Background
Over the past decade, regulatory bodies have heightened their emphasis on health care quality and safety. Education of physicians is a priority in this effort, with the Accreditation Council for Graduate Medical Education requiring that trainees attain competence in practice-based learning and improvement and systems-based practice. To date, several studies about the use of resident education related to quality and safety have been published, but no comprehensive interdisciplinary curricula seem to exist. Effective, formal, comprehensive cross-disciplinary resident training in quality and patient safety appear to be a vital need.
Methods
To address the need for comprehensive resident training in quality and patient safety, we developed and assessed a formal standardized cross-disciplinary curriculum entitled Quality Education and Safe Systems Training (QuESST). The curriculum was offered to first-year residents in a large urban medical center. Preintervention and postintervention assessments and participant perception surveys evaluated the effectiveness and educational value of QuESST.
Results
A total of 138 first-year medical and pharmacy residents participated in the QuESST course. Paired analysis of preintervention and postintervention assessments showed significant improvement in participants' knowledge of quality and patient safety. Participants' perceptions about the value of the curriculum were favorable, as evidenced by a mean response of 1.8 on a scale of 1 (strongly agree) to 5 (strongly disagree) that the course should be taught to subsequent residency classes.
Conclusion
QuESST is an effective comprehensive quality curriculum for residents. Based on these findings, our institution has made QuESST mandatory for all future first-year resident cohorts. Other institutions should explore the value of QuESST or a similar curriculum for enhancing resident competence in quality and patient safety.
doi:10.4300/JGME-D-10-00028.1
PMCID: PMC2941382  PMID: 21975624

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