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Industry-sponsored biomedical research is under the microscope. In an attempt to achieve just results in extraordinary cases, critics are suggesting regulations that would pervert the U.S. clinical trial process. However, the arguments made to justify such regulation are weak at best. All the proposals to regulate industry sponsorship of clinical trials that we surveyed (over a hundred articles and ten books, most written in the past decade) suffer from some form of fallacious reasoning. In the interest of advocating sound policy, this article points out some of the most common reasoning errors found in the literature on financial conflicts of interest in clinical trials. [ABSTRACT FROM AUTHOR]

In this article, we outline the contrasting perspectives of patients and receptionists and the different ways they experience waiting rooms in three U.S. medical clinics. We are doing this to show that a consideration of waiting rooms and the receptionists who work there is an important step in understanding the patient care-seeking experience. We describe the kinds of conflicts that emerge around patient waiting and the emotional labor that receptionists perform to reduce these conflicts by managing patient feelings. By doing this we expand the frame of the clinic visit to include the emotionally important space of the waiting room and revisit the concept of “emotional labor” as a way to understand non-medical care giving in clinic settings and the cultivation of emotions in others. In doing so we show the important role that clinic receptionists may play in shaping how and when patients receive health care. [ABSTRACT FROM AUTHOR]

The article focuses on good clinical practice with regards to child psychotherapy in the U.S. It states that medical practitioners must dedicate their professional lives in improving the lives of children when it comes in treating child traumatism and mental health. It notes that in order to achieve the said goals, one must erupt spontaneously from clusters of professionals who recognize possibility and are willing to do what it takes to create the synergy necessary to overcome self-generated and self-perpetuating barriers to success.

The Global Initiative on Asthma (GINA) was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, the National Institutes of Health (USA) and the WHO. Its first effort was the production of a consensus report on asthma treatment, which aimed to bridge the gap between the various treatment options and the incorporation and implementation of innovative treatment forms into daily clinical practice. The first report published in 1995, A Global Strategy for Asthma Management and Prevention, has been translated into several languages, widely adopted and provided the foundation for several asthma guidelines worldwide. The GINA and other guidelines were primarily based on consensus of expert opinion in order to employ a severity-based classification system as a guide to treatment. However, in the late 1990s, guidelines underwent a major paradigm shift from opinion- to evidence-based classification as the foundation for asthma management. A second major shift involved the classification of asthma according to the level of disease control as a guide to treatment, which was realized for the first time in the revised 2006 GINA guidelines. Since their first appearance, asthma guidelines have played a leading role in disseminating information about asthma. In addition, they have had a substantial impact on standardizing asthma care around the world, which is likely to continue in the future. This article addresses the history of guideline development and issues related to asthma guidelines, with particular emphasis on the GINA guidelines. [ABSTRACT FROM AUTHOR]

Primary care givers commonly interpret shortages of time with patients as placing them between a rock and a hard place in respect of their professional obligations to fairly distribute available healthcare resources (justice) and to offer a quality of attentive care appropriate to patients' states of personal vulnerability (compassion). The author argues that this a false and highly misleading conceptualisation of the basic structure of the ethical dilemma raised by the rationing of time in clinical settings. Drawing on an analysis of the Aristotelian virtue of nemesis, or "the sense of justice", it is argued that, far from being a moral orientation distinct from justice, compassion is a justice response insofar as it is conceptualised as a rational, appropriate response to others' adversity. The author then proceeds to point out that the perspective on justice and compassion as attributes of healthcare professionalism suggests a novel critical viewpoint on the ethics of managed forms of clinical rationing and the "scarcity paradigm" they engender: clinical conditions where primary care givers' time is intentionally rendered a commodity in chronically short supply run a deficit of justice, because they fail to make adequate accommodations for the provision of the quality of care human beings deserve in situations of illness and injury, and when they are dying. [ABSTRACT FROM AUTHOR]

The article offers information about implementation science as well as its significance on urban health research. It considers implementation science as an interdisciplinary field, which was intended to bridge the science-to-practice gap. It then mentions two translation roadblocks in the U.S. identified by the Institute of Medicine's Clinical Research Roundtable, which were the translation of new understandings of disease mechanisms into new diagnosis methods and the translation of results from clinical studies into clinical practice. It further emphasizes the importance of research effectiveness as well as research that focuses on implementation.

The American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) is both dominant and controversial as a clinical tool for social workers. However, few studies have assessed how social workers actually use DSM-IV in their clinical practice. A national study using a 72-item questionnaire was conducted with a random sample of 558 of the 7,000 social workers listed in the 1999 Register of Clinical Social Workers. The questionnaire assessed frequency and importance of using DSM-IV. Findings reflected that 78.9% of social workers used DSM often to always, 85.9% gave a DSM diagnosis often to always, but only 50% of social workers would use DSM if not required. Most common reasons for using DSM were to bill insurance (92.6% rated often to always) and to assess clients (78% rated often to always). Likewise, when rating importance of using DSM, the two most important reasons were to bill insurance (90.9% rated very to extremely important) and to assess clients (58% rated very to extremely important). Agency social workers rated 6 of 11 reasons more important than private practice social workers although both settings rated billing for insurance as most important. Study confirms the importance of DSM in assessing clients and billing for insurance. The authors recommend research to better understand how social workers define assessment and clarify insurance/employer pressure to use DSM. [ABSTRACT FROM AUTHOR]

The Quality Enhancement Research Initiative (QUERI) program and implementation research have both come of age in the 10 years since QUERI was established. Looking forward, if QUERI and the field of implementation science are to mature successfully, we will need to address a series of challenges. First, we need to more clearly demonstrate how applying principles of implementation science leads to more effective implementation and communicate those lessons to our partners and funders. Second, we will need to engage in the ongoing debate over methodological standards in quality improvement and implementation research. Third, a program like QUERI needs to become more relevant to the daily decisions of key stakeholders. Fourth, if we hope to sustain interest in implementation science, we will need to demonstrate the business case for more effective implementation. Fifth, we need to think creatively about how to nurture the next generations of implementation researchers and front-line "connectors," who are critical for accelerating implementation. Finally, we need to strengthen the connections between implementation research and the other operational and research activities that influence change in healthcare systems. The excitement of entering adulthood is tempered by the challenge of new responsibilities and expectations. What is essential is that we continue to learn and move forward. For implementation science and for QUERI, the next decade looks to be one filled with exciting possibilities, new partnerships, increasing relevance, and real accomplishment. [ABSTRACT FROM AUTHOR]

The article focuses on the significance of the efficacy of non-invasive positive pressure ventilation (NPPV) in patients who develop postoperative acute respiratory failure (ARF) after oesophagectomy in the U.S. As stated, patients in the NPPV group proved a better and maintained status in oxygeneration and a decrease in ICU length of stay. The design was taken because the authors had noted an obvious benefit of NPPV in clinical practice, supported by the publication of scientific results.

Provides an overview of the special issue of the periodical "Perspectives in Biology and Medicine," which deals with the development of clinical research as a basis for understanding the successes and problems of clinical research enterprise in the United States. Application of biomedical research to patients; Problem of clinical or patient-oriented research into the contemporary context; Relationships between basic laboratory research and clinical research.

Objectives. We tested the efficacy of a combined pharmacologic and behavioral smoking cessation intervention among women in a state prison in the southern United States. Methods. The study design was a randomized controlled trial with a 6-month waitlist control group. The intervention was a 10-week group intervention combined with nicotine replacement therapy. Two hundred and fifty participants received the intervention, and 289 were in the control group. Assessments occurred at baseline; end of treatment; 3, 6, and 12 months after treatment; and at weekly sessions for participants in the intervention group. Results. The intervention was efficacious compared with the waitlist control group. Point prevalence quit rates for the intervention group were 18% at end of treatment, 17% at 3-month follow-up, 14% at 6-month follow-up, and 12% at 12-month follow-up, quit rates that are consistent with outcomes from community smoking-cessation interventions. Conclusions. Female prisoners are interested in smoking cessation interventions and achieved point-prevalence quit rates similar to community samples. Augmenting tobacco control policies in prison with smoking cessation interventions has the potential to address a significant public health need. (Am J Public Health. 2008;98:1894-1901. doi:10.2105/AJPH.2007.128207) [ABSTRACT FROM AUTHOR]

In this article, I examine the accounts of transsexual/transgender patients and their involvement with medical professionals in the Midwestern United States. Data are taken from 22 in-depth interviews and one year of participant observation of three transsexual/transgender organizations. I show that trans-patients are made aware of larger political, religious, and cultural ideologies through their medical experiences. Trans-patients internalize these views, which affect how they make sense of their medical treatment and how they choose to alter their behavior in future medical encounters. Trans-patients, in an attempt to gain credibility and avoid stigmas, prepare how they will approach doctors to improve their likelihood of receiving desired treatments. The data will reveal that through their approach, trans-patients both support and challenge existing medical knowledge. Patients support medical discourse by using established medical language in their interaction with doctors. Patients challenge medical knowledge by resisting established medical decisions. [ABSTRACT FROM AUTHOR]

Articles on clinical pharmacy services in the home began appearing 3 decades ago but numbers have greatly increased in the last decade. This overview of the English language literature identified 66 reports describing 57 home-based clinical pharmacy programs. Most programs were provided in the context of a time-limited research project. Medication reviews (defined as comprehensive assessment of the appropriateness of the medication regimen) and medication management (defined as assessment and support of medication compliance) were the most common services provided. Primary care, post-hospital discharge, and home healthcare were the typical service contexts, and elderly patients at high risk of medication problems were the primary target population. The early literature predominantly focused on medication management and patient counseling services based in the US; however, since 1991, reports of medication review programs in the UK and Australia have dominated. Barriers to home-based clinical services have been identified at the healthcare system, pharmacy, pharmacist, physician, and patient levels. The most common barriers are lack of (or inadequate) remuneration and the related barriers of community pharmacy or pharmacist time constraints, and the cost and time to attain and maintain pharmacist qualifications. Other important barriers are difficulty in accessing the physician to discuss drug therapy recommendations, and inadequate patient referrals. Additional barriers pertaining to the delivery of the clinical service include inadequate clinical training of community pharmacists, service provision by a pharmacist unknown to the patient, and limited access to patient information for the pharmacist. Patient barriers are lack of awareness, reluctance to accept an intervention from the pharmacist, inaccessibility, and forgetting appointments or refusing the service after initial agreement. The most commonly cited facilitators pertain to the pharmacist-physician relationship; foremost among these is having an established working relationship between the pharmacist and family physician. Others are face-to-face meetings between pharmacist and prescribing physician, and facilitator positions in Divisions of General Practice. A few facilitators of the referral system, pharmacist motivation, and service delivery have also been identified. Evaluative data were provided for 48 programs; 21 programs were evaluated within a randomized controlled trial. Thirteen of these trials found at least one statistically significant difference between groups; however, although important outcomes such as hospitalization and quality of life were often examined, the only parameter that was affected on a consistent basis was medication compliance (four of six trials). The literature on clinical pharmacy services in the home is growing and maturing. While medication review is the most common type of service reported, several other types of clinical services have been explored in this setting. Although evaluation of impact has become more rigorous over time, the overall evidence is limited and many questions remain about optimal practice models and target patient populations. Given the time intensity of home-based services, it is important that more research be conducted to provide firm evidence of value. [ABSTRACT FROM AUTHOR]

Background: The synthesis of basic and clinical science knowledge during the clerkship years has failed to meet educational expectations.Objectives: We hypothesized that a small-group course emphasizing the basic science underpinnings of disease, Foundations of Clinical Medicine (FCM), could be integrated into third year clerkships and would not negatively impact the United States Medical Licensure Examination (USMLE) step 2 scores.Design: In 2001-2002, all third year students met weekly in groups of 8-12 clustered within clerkships to discuss the clinical and basic science aspects of prescribed, discipline-specific cases.Participants: Students completing USMLE step 2 between 1999 and 2004 (n = 743).Measurements: Course evaluations were compared with the overall institutional average. Bivariate analyses compared the mean USMLE steps 1 and 2 scores across pre- and post-FCM student cohorts. We used multiple linear regression to assess the association between USMLE step 2 scores and FCM cohort controlling for potential confounders.Results: Students' average course evaluation score rose from 66 to 77 (2001-2004) compared to an institutional average of 73. The unadjusted mean USMLE step 1 score was higher for the post-FCM cohort (212.9 vs 207.5, respectively, p < .001) and associated with step 2 scores (estimated coefficient = 0.70, p < .001). Post-FCM cohort (2002-2004; n = 361) mean step 2 scores topped pre-FCM (1999-2001; n = 382) scores (215.9 vs 207.7, respectively, p < .001). FCM cohort remained a significant predictor of higher step 2 scores after adjustment for USMLE step 1 and demographic characteristics (estimated coefficient = 4.3, p = .002).Conclusions: A curriculum integrating clinical and basic sciences during third year clerkships is feasible and associated with improvement in standardized testing. [ABSTRACT FROM AUTHOR]

The article provides information on the translational research used by the Ludwig Institute for Cancer Research (LICR) in the U.S. The author stated that control is the key to the translational research of LICR's board of director Lloyd Old, which means retaining the intellectual-property rights and having a support staff that allows LICR researchers to do at least some early-phrase clinical trials, rather than leaving it entirely at the hands of pharmaceutical companies. However, some observers have indicated that the organization may benefit scientifically by being more open to review.

Background: Low health literacy and low cognitive abilities both predict mortality, but no study has jointly examined these relationships.Methods: We conducted a prospective cohort study of 3,260 community-dwelling adults age 65 and older. Participants were interviewed in 1997 and administered the Short Test of Functional Health Literacy in Adults and the Mini Mental Status Examination. Mortality was determined using the National Death Index through 2003.Measurements and Main Results: In multivariate models with only literacy (not cognition), the adjusted hazard ratio was 1.50 (95% confidence of interval [CI] 1.24-1.81) for inadequate versus adequate literacy. In multivariate models without literacy, delayed recall of 3 items and the ability to serial subtract numbers were associated with higher mortality (e.g., adjusted hazard ratios [AHR] 1.74 [95% CI 1.30-2.34] for recall of zero versus 3 items, and 1.32 [95% CI 1.09-1.60] for 0-2 vs 5 correct subtractions). In multivariate analysis with both literacy and cognition, the AHRs for the cognition items were similar, but the AHR for inadequate literacy decreased to 1.27 (95% CI 1.03 - 1.57).Conclusions: Both health literacy and cognitive abilities independently predict mortality. Interventions to improve patient knowledge and self-management skills should consider both the reading level and cognitive demands of the materials. [ABSTRACT FROM AUTHOR]

Background: The effects of disclosing financial interests to potential research participants are not well understood.Objective: To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research.Design and Participants: Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements.Measurements: Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial.Results: Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments.Conclusions: Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research. [ABSTRACT FROM AUTHOR]

During the past decade, there has been a marked increase in the prevalence of community-acquired methicillin-resistant Staphylococcus aureus infection in the United States and elsewhere. The most common such infections are those involving the skin and skin structures. Although a number of these lesions (including small furuncles and abscesses) respond well to surgical incision and drainage, oral antimicrobial agents are commonly used to treat these infections in outpatients. Unfortunately, with the exception of linezolid, none of the agents presently being used in this fashion has been subjected to rigorous clinical trial. Thus, current therapy is based largely on anecdotal evidence. For more-serious infections requiring hospitalization, parenteral antimicrobials such as vancomycin, teicoplanin, daptomycin, linezolid, and tigecycline are presently available and have demonstrated effectiveness in randomized, prospective, double-blind trials. [ABSTRACT FROM AUTHOR]

The need to evaluate the performance of clinical ethics services is widely acknowledged although work in this area is more developed in the United States. In the USA many studies that assess clinical ethics services have utilized empirical methods and assessment criteria. The value of these approaches is thought to rest on their ability to measure the value of services in a demonstrable fashion. However, empirical measures tend to lack ethical content, making their contribution to developments in ethical governance unclear. The steady increase of clinical ethics committees in the UK must be accompanied by efforts to evaluate their performance. As part of this evaluative work it is important to examine how the practice of clinical ethics committees can be informed by empirical measures. [ABSTRACT FROM AUTHOR]

In Atkins v. Virginia2002, the U.S. Supreme Court held that the Eighth Amendment prohibits executing offenders who are mentally retarded. Rather than adopting a uniform definition of mental retardation, the court charged each state with defining mental retardation in a manner that enforces the constitutional restriction. An unanswered question is how states define mental retardation after Atkins, which has implications for capital defendants and forensic evaluators who conduct capital mitigation evaluations. This project identified the statutory definitions of mental retardation in each state, and grouped the definitions based on consistency with accepted clinical criteria for mental retardation. Results show that definitions of mental retardation vary considerably by state. The large majority of states, both overall and specifically among death penalty states, use criteria for mental retardation that are not entirely consistent with accepted clinical standards. As such, it is not clear whether the majority of states are effectuating the intent of Atkins. The implications of these findings for both policy and practice are discussed. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article presents a clinical study in the U.S. on neurocognitive outcomes for children with functional single ventricle (FSV) malformations. It aims to outline some of the data measuring neurodevelopmental outcome for children following the Fontan operation. It also explores strategies that contributes in improving neurodevelopmental outcomes for children with FSV abnormalities.

Background: International collaborations between medical institutions occur frequently in research and clinical training, but less often in undergraduate medical education. Collaborative programs in psychosocial, ethical and cultural topics are rare. "The Profession of Medicine", an elective undergraduate course based on the "Patient, Physician and Society" curriculum at Northwestern University's Feinberg School of Medicine in Chicago, USA, was introduced in 2005 at the Charité-Universitätsmedizin Berlin, Germany, in order to provide students with a learning opportunity in this field and to introduce an international context to student education. Methods: The five-day course is offered to preclinical medical students twice a year and includes topics such as cultural diversity, end of life issues, mistakes in medicine, vulnerable populations, and interactions with the pharmaceutical industry. The course language is English, in a format consisting of both plenary and small group sessions. To date, one-fifth of the instructors have been from the U.S. institution. Educational methods include small group discussions, presentations by guest speakers, movie and video clips, role plays, and reading and writing assignments. Results: The participants have evaluated the course very favourably, with average scores ranging from 1.2 to 1.5 (1 = best/agree the most and 5 = worst/agree the least). Pre- and post-course self-assessment with regard to knowledge, interest and professional attitude revealed a statistically significant increase for all course topics. Conclusions: In sum, the integration of Northwestern University's Feinberg School of Medicine's "Patient, Physician and Society" course concept into the Charité - Universitätsmedizin Berlin has been an effective method to develop students' professional skills and to stimulate international educational collaboration. [ABSTRACT FROM AUTHOR]

Mild traumatic brain injury is now claimed to be the signature injury of the Iraq and Afghanistan conflicts. During World War I, shell shock came to occupy a similar position of prominence, and postconcussional syndrome assumed some importance in World War II. In this article, the nature of shell shock, its clinical presentation, the military context, hypotheses of causation, and issues of management are explored to discover whether there are contemporary relevancies to the current issue of mild traumatic brain injury. When shell shock was first postulated, it was assumed to be the product of a head injury or toxic exposure. However, subsequent clinical studies suggested that this view was too simplistic, and explanations soon oscillated between the strictly organic and the psychological as well as the behavioral. Despite a vigorous debate, physicians failed to identify or confirm characteristic distinctions. The experiences of the armed forces of both the United States and the United Kingdom during World Wars I and II led to two conclusions: that there were dangers in labeling anything as a unique "signature" injury and that disorders that cross any divide between physical and psychological require a nuanced view of their interpretation and treatment. These findings suggest that the hard-won lessons of shell shock continue to have relevance today. [ABSTRACT FROM AUTHOR]

Colorectal cancer (CRC) screening has been supported by strong research evidence and recommended in clinical practice guidelines for more than a decade. Yet screening rates in the United States remain low, especially relative to other preventable diseases such as breast and cervical cancer. To understand the reasons, the National Cancer Institute and Agency for Healthcare Research and Quality sponsored a review of CRC screening implementation in primary care and a program of research funded by these organizations. The evidence base for improving CRC screening supports the value of a New Model of Primary Care Delivery: 1. a team approach, in which responsibility for screening tasks is shared among other members of the practice, would help address physicians' lack of time for preventive care; 2. information systems can identify eligible patients and remind them when screening is due; 3. involving patients in decisions about their own care may enhance screening participation; 4. monitoring practice performance, supported by information systems, can help target patients at increased risk because of family history or social disadvantage; 5. reimbursement for services outside the traditional provider-patient encounter, such as telephone and e-mail contacts, may foster enhanced screening delivery; 6. training opportunities in communication, cultural competence, and use of information technologies would improve provider competence in core elements of screening programs. Improvement in CRC screening rates largely depends on the efforts of primary care practices to implement effective systems and procedures for screening delivery. Active engagement and support of practices are essential for the enormous potential of CRC screening to be realized. [ABSTRACT FROM AUTHOR]

Between just 1995 and 2003, the number of new chemical entities fell from 45 to 25, while the costs increased by two and a half times in the same period. Firms in the USA accounted for more than half of biotech drugs from 1982 to 2003. European firms are losing competitiveness. In this hostile environment for investment in pharmaceutical R&D, providing quick access to market for real innovations is the main challenge for regulatory agencies. More initiatives, more entrepreneurial spirit and easier work regulation are needed to facilitate the growth of firms in this field, especially in emerging economies like the Spanish. A new open source model proposes the use of pre-competitive public platforms formed by young and qualified human capital carrying out research in areas not sufficiently attractive for private initiatives, followed by the introduction of pharmaceutical companies to carry out the clinical research. The last step would be fast and effective approval by assessment agencies. Governments should, therefore, facilitate the regulation of socially effective innovations, bringing in manufacturers to take part in the post-clinical trial period after entering the market. The gathering of incentives between regulatory agencies and pharmaceutical industry must be approached through innovation and authorization stimulating systems. [ABSTRACT FROM AUTHOR]

The prevalence of hypertension is increasing steadily in the US, particularly among African Americans. It is now clear that a large proportion of patients are inadequately controlled, with many patients requiring at least two agents to achieve their target BP. Calcium channel blockers (CCBs), comprising two subclasses – dihydropyridines and non-dihydropyridines – have been for many years one of the mainstays of hypertension therapy. However, the use of CCBs as monotherapy has recently been overshadowed by the introduction of newer classes of agents such as angiotensin receptor blockers. Examining the pharmacologic and clinical effects of CCBs in essential hypertension and among specific patient groups (e.g. African Americans, patients with renal disease) paves the way for understanding why these agents are currently enjoying a resurgence in popularity as the basis for several fixed-dose combination regimens that promise to improve BP control and reduce the risk of cardiovascular events. [ABSTRACT FROM AUTHOR]

This article considers ethical dilemmas concerning the protection of confidentiality that often arise in carrying out ethnographic research. A number of problematic assumptions are highlighted that generally (implicitly or explicitly) guide the practice of contemporary research ethics review committees: (1) ethical rules are context free; (2) there is always an ethical 'right answer'; (3) there is an objective position from which to judge what one ought ethically to do. Notably, this is a position of emotional detachment from the situation; (4) this objectively identified ethical position can be articulated in explicit and unambiguous public language. The troublesome character of these assumptions is raised in the context of fifteen years of ethnographic research among African American families in clinical settings within the urban United States, with special attention to an ongoing relationship with one research participant the author has known for eight years. Finally the article suggests an alternative ethical framework drawn from recent philosophical work in an Aristotelian-inspired 'virtue ethics'. [ABSTRACT FROM AUTHOR]

The article presents the historical investigation about poliomyelitis, one of the most dreadful diseases in the U.S. The disease has taken away and even shaken the generation's hope that broke the heart of the Americans. It emphasizes that the main focus of medicine was to eradicate the poliovirus by searching for the antidote against polio. History teachers may collect some views from older people who are familiar with polio and who may have been victims of the virus. 2005 is the 50th anniversary of the introduction of the Salk polio vaccine.

The article discusses the position of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) concerning issues about dietary supplement safety and regulation. ASCPT has established the ASCPT Task Force on Dietary Supplements, under the U.S. Committee on Government Affairs, to examine the issue and provide recommendations for changes in Dietary Supplement Health and Education Act (DSHEA). Its goal is to increase the safety of the dietary supplements for the consumers.

The number of men in the United States &ges;65 years of age is projected to increase from 14,452,000 in 2000 to 31,343,000 in 2030. Approximately 30% of men 60-70 years of age and 70% of men 70-80 years of age have low bio available or free testosterone levels. Symptoms and findings of testosterone deficiency are similar to those associated with aging. They include loss of energy, depressed mood, decreased libido, erectile dysfunction, decreased muscle mass and strength, increased fat mass, frailty, osteopenia, and osteoporosis. Several small clinical trials indicate that testosterone replacement therapy can improve many of these findings; however, the studies have not been powered to assess potential risks, such as the need for invasive treatment of benign prostatic hyperplasia, development of a clinical prostate cancer, or cardiovascular events. Thus, the benefit/risk ratio of testosterone replacement therapy in aging [ABSTRACT FROM AUTHOR]

Between 50 and 100 million Americans have used the Internet to obtain health information. Breast cancer is one of the most common diagnoses sought online, and breast oncologists are likely to encounter more and more patients who have used the Internet. The effects that this is having on patients and on the clinical encounter in oncology are unclear. Here, the author reviews recent research about the growing importance of online health information and the small amount of literature on breast cancer and the Internet. Other recent developments, such as efforts to recruit patients to clinical trials via the Internet and online support groups for cancer patients, also are reviewed. Finally, the author offers his views on how best to manage patients' growing interest in Internet information. [ABSTRACT FROM AUTHOR]

The time is now ripe for the ALS community in the United States to set up a national ALS Study Group. NIH and other granting agencies should fund a program to set up and run the ALS Study Group for five years renewable. This program should result in a competitive request for applications. The benefits likely to derive from a national ALS Study Group would include cheaper and more cost-effective clinical therapeutic trials, the development of better techniques for pilot trials, an increased number of potential new drugs brought from bench to bedside for ALS trials, increased research on biological and surrogate markers of disease, and increased physician-initiated research. [ABSTRACT FROM AUTHOR]

Examines the reliability of results from clinical trials in amyotrophic lateral sclerosis therapeutics in the U.S. Basis of modern pre-clinical therapeutics; Limitations of pre-clinical models; Excellence of transgenic rodent models as an excellent tool to reveal potential new human therapies.

Examines the changes in policies regarding children in research between 1966 and 2003 in the United States. Shift in focus from protection to access; Research projects considered unethical; Motivations for change in policies; Effects of the policies.

Describes the golden years of patient-oriented clinical research in the United States. Salient themes, phenomena and issues in clinical research; Advances in biology and medicine; Changes in the organization and financing of research units; Moral and political convictions growing out of the war about the importance and possibilities of the scientific enterprise; Role played by private and federal funding for research and training.

Explores two sources of contemporary neglect of public health ethics. Background on individual autonomy and public health in the U.S.; Views on compulsion in clinical medicine and public health; Way in which discussion of health and justice focus on access to clinical care marginalize public health; Norms for health policies.

Objective: To evaluate the association between contracting practices of managed care organizations (MCOs) with cardiac surgeons and the quality of the cardiac surgeons.Data Sources/study Setting: The study included all cardiac surgeons offering coronary artery bypass graft (CABG) surgery and 78 percent of MCOs in New York State in 1998. Primary data: The MCOs' panel composition with respect to hospitals and cardiac surgeons. Secondary data: New York State (NYS) Cardiac Surgery Reports.Study Design: Statistical analyses of the probability of a contract between cardiac surgeons and MCOs conditional on the surgeon's risk-adjusted mortality rates (RAMR), outlier and low volume status, and controlling for other confounding variables, were performed.Principal Findings: Contract probability exhibited a tendency to decrease with RAMR, low volume and low-quality outlier status and to increase with high-quality outlier status. These effects were statistically significant for RAMR and high-quality outliers in Downstate and for low volume in Downstate and Upstate.Conclusions: In some, but not all cases, MCOs are seeking higher-quality providers. Further research is required to understand regional variability and the effect of market structure on the quality profile of MCOs. [ABSTRACT FROM AUTHOR]

Assessing the effectiveness of newer treatments for rare diseases can be challenging because of the small number of patients treated at individual centers. We enrolled patients undergoing percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy (HOCM) at five international centers (1 Japan, 2 United Kingdom, and 2 United States). Our study group developed standard data definitions regarding clinical symptom severity, previous HOCM treatment, procedure status, and outcome, and entered patient data directly into a shared, web-based registry system. In the first 10 months of 1998, 51 patients were enrolled in our registry, with 47 ultimately receiving the PTSMA procedure. Although HOCM is consider a single disease, there were significant differences among centers in patient characteristics (age, gender, and family history of HOCM), symptom severity, diagnostic techniques (measurements taken after provocation), and treatment (amount of alcohol used, timing of injection, and number of branches attempted). [ABSTRACT FROM AUTHOR]

Objective: To assess the effects of CAHPS health plan performance information on plan choices and decision processes by New Jersey Medicaid beneficiaries.Data Sources/study Setting: The study sample was a statewide sample of all new Medicaid cases that chose Medicaid health plans during April 1998. The study used state data on health maintenance organization (HMO) enrollments and survey data for a subset of these cases.Study Design: An experimental design was used, with new Medicaid cases randomly assigned to experimental or control groups. The experimental group received a CAHPS report along with the standard enrollment materials, and the control group did not.Data Collection: The HMO enrollment data were obtained from the state in June 1998, and evaluation survey data were collected from July to October 1998.Principal Findings: No effects of CAHPS information on HMO choices were found for the total sample. Further examination revealed that only about half the Medicaid cases said they received and read the plan report and there was an HMO with dominant Medicaid market share but low CAHPS performance scores. The subset of cases who read the report and did not choose this dominant HMO chose HMOs with higher CAHPS scores, on average, than did those in an equivalent control group.Conclusions: Health plan performance information can influence plan choices by Medicaid beneficiaries, but will do so only if they actually read it. These findings suggest a need for enhancing dissemination of the information as well as further education to encourage informed choices. [ABSTRACT FROM AUTHOR]

Objective: To investigate the impact of quality information on the willingness of consumers to enroll in health plans that restrict provider access.Data Sources and Setting: A survey administered to respondents between the ages of 25 and 64 in the West Los Angeles area with private health insurance.Study Design: An experimental approach is used to measure the effect of variation in provider network features and information about the quality of network physicians on hypothetical plan choices. Conditional logit models are used to analyze the experimental choice data. Next, choice model parameter estimates are used to simulate the impact of changes in plan features on the market shares of competing health plans and to calculate the quality level required to make consumers indifferent to changes in provider access.Principal Findings: The presence of quality information reduced the importance of provider network features in plan choices as hypothesized. However, there were not statistically meaningful differences by type of quality measure (i.e., consumer assessed versus expert assessed). The results imply that large quality differences are required to make consumers indifferent to changes in provider access. The impact of quality on plan choices depended more on the particular measure and less on the type of measure. Quality ratings based on the proportion of survey respondents "extremely satisfied with results of care" had the greatest impact on plan choice while the proportion of network doctors "affiliated with university medical centers" had the least. Other consumer and expert assessed measures had more comparable effects.Conclusions: Overall the results provide empirical evidence that consumers are willing to trade high quality for restrictions on provider access. This willingness to trade implies that relatively small plans that place restrictions on provider access can successfully compete against less restrictive plans when they can demonstrate high quality. However, the results of this study suggest that in many cases, the level of quality required for consumers to accept access restrictions may be so high as to be unattainable. The results provide empirical support for the current focus of decision support efforts on consumer assessed quality measures. At the same time, however, the results suggest that consumers would also value quality measures based on expert assessments. This finding is relevant given the lack of comparative quality information based on expert judgment and research suggesting that consumers have apprehensions about their ability to meaningfully interpret performance-based quality measures. [ABSTRACT FROM AUTHOR]

This article describes a study evaluating the Consumer Assessment of Behavioral Health Survey (CABHS) and the Mental Health Statistics Improvement Program (MHSIP) surveys. The purpose of the study was to provide data that could be used to develop recommendations for an improved instrument. Subjects were 3,443 adults in six behavioral health plans. The surveys did not differ significantly in response rate or consumer burden. Both surveys reliably assessed access to treatment and aspects of appropriateness and quality. The CABHS survey reliably assessed features of the insurance plan; the MHSIP survey reliably assessed treatment outcome. Analyses of comparable items suggested which survey items had greater validity. Results are discussed in terms of consistency with earlier research using these and other consumer surveys. Implications and recommendations for survey development, quality improvement, and national policy initiatives to evaluate health plan performance are presented. [ABSTRACT FROM AUTHOR]

This study examines the extent to which managed care behavioral controls are associated with treatment intensity in outpatient substance abuse treatment facilities. Data are from the 1995 National Drug Abuse Treatment System Survey, a nationally representative survey that includes over 600 provider organizations with a response rate of 86%. Treatment intensity is measured in three ways: (1) the number of months clients spend in outpatient drug treatment, (2) the number of individual treatment sessions clients receive over the course of treatment, and (3) the number of group treatment sessions clients receive over the course of treatment. After accounting for selection bias and controlling for market, organization, and client characteristics, there is no significant relationship between the scope of managed care oversight and treatment intensity. However, the stringency of managed care oversight activities is negatively associated with the number of individual and group treatment sessions received over the course of treatment. [ABSTRACT FROM AUTHOR]

Focuses on the principles applied in clinical medicine in Belmont, Tennessee. Discussion of the principle of beneficence; Recognition of the importance of the freedom of choice; Focus of medicine on functional abnormalities and pathophysiology of the disease; Development of medical ethics; Concepts of benevolence and the avoidance of harm. INSET: A Fifty-Year Perspective.

Assesses the impact of continuous health care quality improvement on clinical practice in the United States. Improvement of outcomes of care while reducing costs; Reduction of in-hospital complications from peritoneal dialysis; Types of clinical applications for continuous quality improvement.

While the EuroQOL instrument (EQ-5D) is being considered and used in clinical trials in the United States and Canada, and in large international multicentre studies, population weights for the instrument have never been established in North America. The primary purpose of this investigation was to derive a set of US-based population weights for the standard set of health states described in the EQ-5D health questionnaire. Valuations for EQ-5D health states were obtained via a postal survey using the visual analogue scale (VAS) format. A sample of 3,500 adults from the continental US were surveyed. A response rate of 25.8% was obtained. Mean and median valuations for 45 distinct health states, including dead and unconscious, were calculated. An ordinary least squares (OLS) regression-based weighting scheme was constructed to impute scores for states not directly valued in the questionnaire formats. Valuations for the standard EQ-5D health states displayed similar characteristics to VAS valuations obtained in previous investigations in European countries. The OLS model fit the observed data relatively well, achieving an adjusted R2 of 0.42. However, the diagnostic testing indicated that the initial model was misspecified. Subsequent alternative models alleviated some, but not all, of the problems of misspecification. The EQ-5D valuations from adult Americans in this sample appeared to behave in much the same fashion as in previous valuation studies. However, the generalisability of results to the entire adult American population may be limited. Violations of assumptions of the OLS regression model indicate the need for further investigation into the modelling technique used in deriving a single index score. [ABSTRACT FROM AUTHOR]

Background. Although most tick bites in humans in areas of the northeastern United States in which Lyme disease is highly endemic are due to Ixodes dammini, no study documents the frequency of I. Dammini bites in low prevalence or emerging areas for Lyme disease. Data on the proportion of tick bites in humans that are due to I. Dammini in a region may have implications for public health policy and clinical management. Methods. A statewide survey of the tick species that parasitized humans in Marine was conducted during 1989 and 1990. Tick submissions from throughout the state were elicited through media announcements. All ticks that had been removed from humans were identified, and data were collected that included bite seasonality and geography and demographics of tick bite victims. Results. Of 709 ticks submitted, only 17% were I. dammini. Ixodes cookie, a vecor for Powassan encephalitis, accounted for 34% of bites, and Dermacentor variabilis accounted were occasionally implicated. Conclusions. The likelihood that a tick bite was due to I. dammini was lower in Maine than in areas in the northeastern United States in which Lyme disease is highly endemic. Other tick vectors, associated with diseases other than Lyme disease, were more frequently implicated. Regional tick bite surveys may prove useful in assessing the risk of Lyme disease following a tick bite. [ABSTRACT FROM AUTHOR]