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The U.S. health care system is undergoing a shift from individual clinical practice toward team-based care. This move toward team-based care requires fresh thinking about clinical leadership and responsibilities to ensure that the unique skills of each clinician are used to provide the best care for the patient as the patient's needs dictate, while the team as a whole must work together to ensure that all aspects of a patient's care are coordinated for the benefit of the patient. In this position paper, the American College of Physicians offers principles, definitions, and examples to dissolve barriers that prevent movement toward dynamic clinical care teams. These principles offer a framework for an evolving, updated approach to health care delivery, providing policy guidance that can be useful to clinical teams in organizing the care processes and clinician responsibilities consistent with professionalism. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials... [ABSTRACT FROM AUTHOR]

This paper focuses on the development and feasibility of a digitally-based educational intervention, titled Recognize & Resist (R&R), for writers of One Direction (1D) fanfiction on Wattpad.com. The goal of R&R is to reduce the prevalence of social norms that are supportive of sexual violence within 1D fanfiction. 1D fanfictions, or fictional romance stories written by fans of this British boy band, have hundreds of millions of views on Wattpad.com. Formative research has found that social norms supportive of sexual violence are prevalent in 1D fanfictions and that some authors have internalized these norms. R&R aims to motivate 1D fanfiction writers to highlight sexual consent and egalitarian gender roles in their writing. To evaluate the intervention’s feasibility, 15 1D fanfiction authors completed a survey and participated in an interview or focus group. Results demonstrate R&R’s feasibility, with high ratings of its acceptability and demand. Insights from the interviews and focus groups provide suggestions for revising R&R before rigorously evaluating its efficacy. Additionally, results demonstrate the utility of using popular culture as a vehicle for attitude-change regarding sensitive health issues. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this paper was to describe primary care prescribers' perspectives on electronic prescribing drug alerts at the point of prescribing.Design: We used a mixed-method study which included clinician surveys (web-based and paper) and focus groups with prescribers and staff.Participants: Prescribers (n = 157) working in one of 64 practices using 1 of 6 e-prescribing technologies in 6 US states completed the quantitative survey and 276 prescribers and staff participated in focus groups.Measurements: The study measures self-reported frequency of overriding of drug alerts; open-ended responses to: "What do you think of the drug alerts your software generates for you?"Results: More than 40% of prescribers indicated they override drug-drug interactions most of the time or always (range by e-prescribing system, 25% to 50%). Participants indicated that the software and the interaction alerts were beneficial to patient safety and valued seeing drug-drug interactions for medications prescribed by others. However, they noted that alerts are too sensitive and often unnecessary. Participant suggestions included: (1) run drug alerts on an active medication list and (2) allow prescribers to set the threshold for severity of alerts.Conclusions: Primary care prescribers recognize the patient safety value of drug prescribing alerts embedded within electronic prescribing software. Improvements to increase specificity and reduce alert overload are needed. [ABSTRACT FROM AUTHOR]

Hospitals clean environmental surfaces to lower microbial contamination and reduce the likelihood of transmitting infections. Despite current cleaning and hand hygiene protocols, hospital acquired infections (HAIs) continue to result in a significant loss of life and cost the U.S. healthcare system an estimated $45 billion annually. Stainless steel and chrome are often selected for hospital touch surfaces for their "clean appearance," comparatively smooth finish, resistance to standard cleaners, and relative effectiveness for removing visible dirt during normal cleaning. Designers use wood surfaces for aesthetics; plastic surfaces have become increasingly endemic for their relative lower initial cost; and "antimicrobial agents" are being incorporated into a variety of surface finishes. This paper concentrates on environmental surface materials with a history of bactericidal control of infectious agents and focuses on the methods necessary to validate their effectiveness in healthcare situations. Research shows copper-based metals to have innate abilities to kill bacteria in laboratory settings, but their effectiveness in patient care environments has not been adequately investigated. This article presents a research methodology to expand the evidence base from the laboratory to the built environment. For such research to have a meaningful impact on the design/specifying community, it should assess typical levels of environmental pathogens (i.e., surface "cleanliness") as measured by microbial burden (MB); evaluate the extent to which an intervention with copper-based materials in a randomized clinical trial affects the level of contamination; and correlate how the levels of MB affect the incidence of infections acquired during hospital stays. [ABSTRACT FROM AUTHOR]

Purpose: The aims for this paper are to summarize the current state of disparities in clinical research participation, discuss regulatory and interpersonal causes for these disparities, and to suggest an approach to address this problem by standardized training for consent administrators. Organizing Construct: A program based on the Precede-Proceed model for training consent administrators is proposed and described. Conclusions: The current process for informed consent for research is unstandardized and inadequate, and may contribute to racial and ethnic disparities. Researchers are urged to consider a formal training program for members of their research teams who will be obtaining participants' consent. Clinical Relevance: An educational program for consent administrators may help to reduce disparities in research participation by improving communication between research staff and potential participants. [ABSTRACT FROM AUTHOR]

Objective: To examine the generalizability of two National Institutes of Health (NIH)-funded double-blind randomized placebo-controlled clinical trials in patients with chronic Lyme disease and to determine whether selection factors resulted in the unfavorable outcomes. Design: Epidemiologic review of the generalizability of two trials conducted by Klempner et al. This paper considers whether the study group was representative of the general chronic Lyme disease population. Results: In their article in The New England Journal of Medicine, Klempner et al. failed to discuss the limitations of their clinical trials. This epidemiologic review argues that their results are not generalizable to the overall Lyme disease population. The treatment failure reported by the authors may be the result of enrolling patients who remained ill after an average of 4.7 years and an average of 3 previous courses of treatment. The poor outcome cited in these trials may be explained by having selected patients who had undergone delayed treatment or multiple treatments unsuccessfully. These selection factors were not addressed by the studies' authors, nor have they been discussed by reviewers. The trials have been over-interpreted by the NIH and widely publicized in a press release. The results have been extrapolated to other groups of Lyme disease patients by commentators, by a case discussant in an influential medical journal, and by health insurance companies to deny antibiotic treatment. Conclusion: The Klempner et al. trials are assumed to be internally valid based on a Randomized Control Trial (RCT) design. However, this review argues that the trials have limited generalizability beyond the select group of patients with characteristics like those in the trial. Applying the findings to target populations with characteristics that differ from those included in these trials is inappropriate and may limit options for chronic Lyme disease patients who might benefit from antibiotic treatment. [ABSTRACT FROM AUTHOR]

Traditionally, US teaching hospitals have subsidised research by charging higher costs for treatment; however, this approach is being challenged. The growth of managed-care organisations, concerned about maximising profits, has led many to argue that clinical research will be damaged, whether by the loss of internal funds for research or by reductions in the numbers of patients available for studies. This review examines the evidence on which this argument is based. There is some evidence that managed-care organisations are refusing to cover patients who are involved in clinical trials, although, in general, they are receptive towards research providing that it is explicit and seen as relevant. The indirect effects of competition are, arguably, more important. Although many academic centres have established strategies to protect research funds, those working in the most competitive healthcare environments are obtaining fewer externally funded research grants. They are also publishing fewer papers and are working in climates that are seen as less supportive, with less ability to undertake research that is not externally funded. There is little evidence that managed care is reducing access to patients for clinical research. The growth of managed care is, together with certain other trends, also influencing the nature of clinical research. The overall consequences of these different factors are difficult to predict, although there are grounds for concern about recruitment and retention of junior researchers. The relationship between the various actors involved in healthcare and research is dynamic and, as pressure is excerpted in a particular direction, others adapt. It may be some time before the consequences of policies being enacted now are apparent. [ABSTRACT FROM AUTHOR]

This article explores the moral issues and the preventive and treatment deficiencies for AIDS, as well as the systematic deficiencies beginning with a discussion of the implications of chronic illnesses like AIDS, which is now recognized as a chronic illness. The paper offers a framework for understanding AIDS in relation to several important health issues. The normal sequence of steps through which treatment drugs reach the public--screening by the U.S. Federal Drug Administration and then carefully controlled clinical trials has been altered by AIDS activists, who have created a national lobby bent on changing features of the health care system. AIDS has heightened tensions around certain moral dilemmas associated with current health care policy by raising issues of personal responsibility for illness and public responsibility for preventing and treating certain illnesses.

Acute ischemic stroke (AIS) is the leading cause of disability worldwide and among the leading causes of mortality. Although intravenous tissue plasminogen activator (IV-rtPA) was approved nearly 2 decades ago for treatment of AIS, only a minority of patients receive it due to a narrow time window for administration and several contraindications to its use. Endovascular approaches to recanalization in AIS developed in the 1980s, and recently, 5 major randomized trials showed an overwhelming superior benefit of combining endovascular mechanical thrombectomy with IV-rtPA over IV-rtPA alone. In this paper, we discuss the evolution of catheter-based treatment from first-generation thrombectomy devices to the game-changing stent retrievers, results from recent trials, and the evolving stroke systems of care to provide timely access to acute stroke intervention to patients in the United States. [ABSTRACT FROM AUTHOR]

Objective: To review the literature systematically to determine whether noninvasive or invasive risk stratification, such as with an electrophysiological study of patients with asymptomatic pre-excitation, reduces the risk of arrhythmic events and improves patient outcomes.Methods: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (all January 1, 1970, through August 31, 2014) were searched for randomized controlled trials and cohort studies examining noninvasive or invasive risk stratification in patients with asymptomatic pre-excitation. Studies were rejected for low-quality design or the lack of an outcome, population, intervention, or comparator of interest or if they were written in a language other than English.Results: Of 778 citations found, 9 studies met all the eligibility criteria and were included in this paper. Of the 9 studies, 1 had a dual design-a randomized controlled trial of ablation versus no ablation in 76 patients and an uncontrolled prospective cohort of 148 additional patients-and 8 were uncontrolled prospective cohort studies (n=1594). In studies reporting a mean age, the range was 32 to 50 years, and in studies reporting a median age, the range was 19 to 36 years. The majority of patients were male (range, 50% to 74%), and <10% had structural heart disease. In the randomized controlled trial component of the dual-design study, the 5-year Kaplan-Meier estimates of the incidence of arrhythmic events were 7% among patients who underwent ablation and 77% among patients who did not undergo ablation (relative risk reduction: 0.08; 95% confidence interval: 0.02 to 0.33; P<0.001). In the observational cohorts of asymptomatic patients who did not undergo catheter ablation (n=883, with follow-up ranging from 8 to 96 months), regular supraventricular tachycardia or benign atrial fibrillation (shortest RR interval >250 ms) developed in 0% to 16%, malignant atrial fibrillation (shortest RR interval ≤250 ms) in 0% to 9%, and ventricular fibrillation in 0% to 2%, most of whom were children in the last case.Conclusions: The existing evidence suggests risk stratification with an electrophysiological study of patients with asymptomatic pre-excitation may be beneficial, along with consideration of accessory-pathway ablation in those deemed to be at high risk of future arrhythmias. Given the limitations of the existing data, well-designed and well-conducted studies are needed. [ABSTRACT FROM AUTHOR]

Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. [ABSTRACT FROM AUTHOR]

Background: Results of 2 trials of postmenopausal hormone therapy (HT) challenged established practice patterns; 1 was not associated with changes in HT use, whereas the other was associated with substantial decline. Differential coverage by lay newspapers may have contributed to the differential impact.Objective: To examine newspaper coverage of HT before and after the publication of the Heart and Estrogen Replacement Study (HERS) in August 1998, and the main findings of the estrogen plus progestin therapy arm of the Women's Health Initiative (EPT-WHI) in July 2002.Design: Longitudinal review of newspaper articles, 1998 to 2003 (n=663).Setting: Twenty local and 6 regional/national newspapers.Measurements: Number and content of articles about HT.Results: The average number of articles about HT published during the month of the publication of the EPT-WHI was at least 8-fold greater than the number of articles published on the topic during any prior period. While the majority of articles in all periods presented information about the potential benefits of HT, information about harms became more common than information about benefits during the 2 months before the publication of the EPT-WHI, when the trial participants were notified of the early termination of the study. The presentation of specific health harms was more common after the publication of the EPT-WHI than after the publication of HERS. Few articles in any period used visual aids.Conclusions: The publication of the EPT-WHI was associated with a change in both the volume and content of newspaper coverage about HT. [ABSTRACT FROM AUTHOR]

Inmates with a history of opiate dependence represent a substantial proportion of the correctional population in the United States. Opiate use has negative consequences for both the inmate and society, including increased recidivism rates, increased infectious disease prevalence, avoidable emergency room use, decreased access to primary care services, and overdose. While there have been great successes in community-based treatment of opiate' dependence, these successes have not yet been achieved in correctional settings. This paper reviews the pharmacological treatment options for opiate-dependent inmates, along with potential application for community-to-correctional approaches. The recent approval by the Food and Drug Administration (FDA) of physician-prescribed buprenorphine and the new opportunities it presents to' corrections-based treatment are also explored in depth. Successful implementation of such strategies is likely to result in desirable health and social outcomes for both the inmate and the community at large. [ABSTRACT FROM AUTHOR]

The article discusses the role of precision medicine in U.S. health care services. Topics include the need for randomized clinical trial (RCT) evidence on the effectiveness of precision medicine, the use of genomic information as part of electronic health records (EHRs), and drug development in relation to precision medicine.

Background: Approximately 20% of community-dwelling older adults discharged from the emergency department (ED) return to an ED within 30 days, an occurrence partially resulting from poor care transitions. Prior published interventions to improve the ED-to-home transition have either lacked feasibility or effectiveness. The Care Transitions Intervention (CTI) has been validated to decrease rehospitalization among patients transitioning from the hospital to the home but has never been tested for patients transitioning from the ED to the home. Paramedics, traditionally involved only in emergency care, are well-positioned to deliver the CTI, but have never been previously evaluated in this role.Methods: This single-blinded randomized controlled trial tests whether the paramedic-delivered ED-to-home CTI reduces community-dwelling older adults' ED revisits in the 30 days after an index visit. We are prospectively recruiting patients aged≥ 60 years at 3 EDs in Rochester, NY and Madison, WI to enroll 2400 patient subjects. Subjects are randomized into control and treatment groups, with the latter receiving the adapted CTI. The intervention consists of the paramedic performing one home visit and up to three follow-up phone calls. During these interactions, the paramedic follows the CTI approach by coaching patients toward their goals, with a focus on their personal health record, medication management, red flags, and primary care follow-up. We follow patient participants for 30 days. All receive a survey during the index ED visit to capture baseline demographic and health information and two telephone-based surveys to assess process objectives and outcomes. We also perform a medical record review. The primary outcome is the odds of ED revisit within 30 days after discharge from the index ED visit.Discussion: This is the first study to test whether the CTI, applied to the ED-to-home transition and delivered by community paramedics, can decrease the rate at which older adults revisit an ED. Outcomes from this research will help address a major emergency care challenge by supporting older adults in the transition from the ED to home, thereby improving health outcomes for this population and reducing potentially avoidable ED visits.Trial Registration: ClinicalTrials.gov Registration: NCT02520661 . Trial registration date: August 13, 2015. [ABSTRACT FROM AUTHOR]

A biography of Paul Roman, a researcher in the alcohol and addictions field, is presented. A background on the education of Roman including at Cornell University in Ithaca, New York, University of Georgia and Tulane University in New Orleans, Louisiana is provided. Also noted is the membership of Roman in the National institute of Alcohol Abuse and Alcoholism (NIAAA) and his study of the National Institute on Drug Abuse (NIDA) Clinical Trials Network.

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity. [ABSTRACT FROM AUTHOR]

Objectives. To test the effectiveness of a preclinical, telephone-based patient navigation intervention to encourage colorectal cancer (CRC) screening among older Black men. Methods. We conducted a 3-parallel-arm, randomized trial among 731 self-identified Black men recruited at barbershops between 2010 and 2013 in New York City. Participants had to be aged 50 years or older, not be up-to-date on CRC screening, have uncontrolled high blood pressure, and have a working telephone. We randomized participants to 1 of 3 groups: (1) patient navigation by a community health worker for CRC screening (PN), (2) motivational interviewing for blood pressure control by a trained counselor (MINT), or (3) both interventions (PLUS). We assessed CRC screening completion at 6-month follow-up. Results. Intent-to-treat analysis revealed that participants in the navigation interventions were significantly more likely than those in the MINT-only group to be screened for CRC during the 6-month study period (17.5% of participants in PN, 17.8% in PLUS, 8.4% in MINT; P < .01). Conclusions. Telephone-based preclinical patient navigation has the potential to be effective for older Black men. Our results indicate the importance of community-based health interventions forimprovinghealth among minoritymen. [ABSTRACT FROM AUTHOR]

Background: Rates of chronic pain are rising sharply in the United States and worldwide. Presently, there is evidence of racial disparities in pain treatment and treatment outcomes in the United States but few interventions designed to address these disparities. There is growing consensus that chronic musculoskeletal pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental factors, some of which differ by race.Methods/design: The primary aim of this randomized controlled trial is to test the effectiveness of a non-pharmacological, self-regulatory intervention, administered proactively by telephone, at improving pain outcomes and increasing walking among African American patients with hip, back and knee pain. Participants assigned to the intervention will receive a telephone counselor delivered pedometer-mediated walking intervention that incorporates action planning and motivational interviewing. The intervention will consist of 6 telephone counseling sessions over an 8-10 week period. Participants randomly assigned to Usual Care will receive an informational brochure and a pedometer. The primary outcome is chronic pain-related physical functioning, assessed at 6 months, by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining whether the intervention reduces health care service utilization and use of opioid analgesics and whether key contributors to racial/ethnic disparities targeted by the intervention mediate improvement in chronic pain outcomes Measures will be assessed by mail and phone surveys at baseline, three months, and six months. Data analysis of primary aims will follow intent-to-treat methodology.Discussion: We will tailor our intervention to address key contributors to racial pain disparities and examine the effects of the intervention on important pain treatment outcomes for African Americans with chronic musculoskeletal pain.Trial Registration: ClinicalTrials.gov: NCT01983228 . Registered 6 November 2013. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor in response to an editorial on computer technology and clinical trial work in the March 9, 2005 edition of the "Journal of the American Medical Association."

Optimizing access to HIV pre-exposure prophylaxis (PrEP), an evidence-based HIV prevention resource, requires expanding healthcare providers’ adoption of PrEP into clinical practice. This qualitative study explored PrEP providers’ firsthand experiences relative to six commonly-cited barriers to prescription—financial coverage, implementation logistics, eligibility determination, adherence concerns, side effects, and anticipated behavior change (risk compensation)—as well as their recommendations for training PrEP-inexperienced providers. U.S.-based PrEP providers were recruited via direct outreach and referral from colleagues and other participants (2014–2015). One-on-one interviews were conducted in person or by phone, transcribed, and analyzed. The sample (n = 18) primarily practiced in the Northeastern (67%) or Southern (22%) U.S. Nearly all (94%) were medical doctors (MDs), most of whom self-identified as infectious disease specialists. Prior experience prescribing PrEP ranged from 2 to 325 patients. Overall, providers reported favorable experiences with PrEP implementation and indicated that commonly anticipated problems were minimal or manageable. PrEP was covered via insurance or other programs for most patients; however, pre-authorization requirements, laboratory/service provision costs, and high deductibles sometimes presented challenges. Various models of PrEP care and coordination with other providers were utilized, with several providers highlighting the value of clinical staff support. Eligibility was determined through joint decision-making with patients; CDC guidelines were commonly referenced but not considered absolute. Patient adherence was variable, with particularly strong adherence noted among patients who had actively sought PrEP (self-referred). Providers observed minimal adverse effects or increases in risk behavior. However, they identified several barriers with respect to accessing and engaging PrEP candidates. Providers offered a wide range of suggestions regarding content, strategy, and logistics surrounding PrEP training, highlighting sexual history-taking and sexual minority competence as areas to prioritize. These insights from early-adopting PrEP providers may facilitate adoption of PrEP into clinical practice by PrEP-inexperienced providers, thereby improving access for individuals at risk for HIV. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between non-adherence to clinical practice guidelines (CPGs) and time to return to work (RTW) for patients with workplace injuries.Data Sources/study Setting: Secondary analysis of medical billing and disability data for 148,199 for shoulder and back injuries from a workers' compensation insurer.Study Design: Cox proportional hazard regression is used to estimate the association between time to RTW and receipt of guideline-discordant care. We test the robustness of our findings to an omitted confounding variable.Data Collection: Collected by the insurer from the time an injury was reported, through recovery or last follow-up.Principal Findings: Receiving guideline-discordant care was associated with slower RTW for only some guidelines. Early receipt of care, and getting less than the recommended amount of care, were correlated with faster RTW. Excessive physical therapy, bracing, and injections were associated with slower RTW.Conclusions: There is not a consistent relationship between performance on CPGs and RTW. The association between performance on CPG and RTW is difficult to measure in observational data, because analysts cannot control for omitted variables that affect a patient's treatment and outcomes. CPGs supported by observational studies or randomized trials may have a more certain relationship to health outcomes. [ABSTRACT FROM AUTHOR]

Background: The National Institutes of Health (NIH) Health Care Systems Research Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the conduct of pragmatic research in health systems. This analysis applied the PRECIS-2 pragmatic trial criteria to five NIH Collaboratory pragmatic trials to better understand 1) the pragmatic aspects of the design and implementation of treatments delivered in real world settings and 2) the usability of the PRECIS-2 criteria for assessing pragmatic features across studies and across time.Methods/design: Using the PRECIS-2 criteria, five pragmatic trials were each rated by eight raters. For each trial, we reviewed the original grant application and a required progress report written at the end of a 1-year planning period that included changes to the protocol or implementation approach. We calculated median scores and interrater reliability for each PRECIS domain and for the overall trial at both time points, as well as the differences in scores between the two time points. We also reviewed the rater comments associated with the scores.Results: All five trials were rated to be more pragmatic than explanatory, with comments indicating that raters generally perceived them to closely mirror routine clinical care across multiple domains. The PRECIS-2 domains for which the trials were, on average, rated as most pragmatic on the 1 to 5 scale at the conclusion of the planning period included primary analysis (mean = 4.7 (range = 4.5 to 4.9)), recruitment (4.3 (3.6 to 4.8)), eligibility (4.1 (3.4 to 4.8)), setting (4.1 (4.0 to 4.4)), follow-up (4.1 (3.4 to 4.9)), and primary outcome (4.1 (3.5 to 4.9)). On average, the less pragmatic domains were organization (3.3 (2.6 to 4.4)), flexibility of intervention delivery (3.5 (2.1-4.5)), and flexibility of intervention adherence (3.8 (2.8-4.5)). Interrater agreement was modest but statistically significant for four trials (Gwet's AC1 statistic range 0.23 to 0.40) and the intraclass correlation coefficient ranged from 0.05 to 0.31. Rating challenges included assigning a single score for domains that may relate to both patients and care settings (that is, eligibility or recruitment) and determining to what extent aspects of complex research interventions differ from usual care.Conclusions: These five trials in diverse healthcare settings were rated as highly pragmatic using the PRECIS-2 criteria. Applying the tool generated insightful discussion about real-world design decisions but also highlighted challenges using the tool. PRECIS-2 raters would benefit from additional guidance about how to rate the interwoven patient and practice-level considerations that arise in pragmatic trials.Trial Registrations: Clinicaltrials.gov trial registrations: NCT02019225 , NCT01742065 , NCT02015455 , NCT02113592 , NCT02063867 . [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the impact of robotic-assisted percutaneous coronary intervention (RA-PCI) versus manual PCI (M-PCI) on the incidence of Longitudinal Geographic Miss (LGM).Background: The safety and feasibility of RA-PCI has been established in preclinical animal trials and human clinical trials. Patients with LGM have been shown to have worse clinical outcomes including significantly increased incidences of MACE.Methods: Patients with significant coronary artery disease underwent RA-PCI in the PRECISE study (n=164) and standard M-PCI in the STLLR trial (n = 1,509). Longitudinal geographic miss was defined as cases where the entire length of the injured or stenotic segment was not fully covered by the total length of the stent. The incidence of LGM was compared between RA-PCI and M-PCI cohorts.Results: The RA-PCI cohort had a significantly greater prevalence of previous MI, previous coronary revascularization, and unstable angina. The robotic cohort exhibited a lower incidence of LGM when compared to the M-PCI patients, 12.2% to 43.1%, respectively (P < 0.0001). To account for the differences in baseline characteristics between the two studies, a propensity score analysis was conducted. The propensity modeling showed similar rates of LGM in both a larger group of patients that met key PRECISE study inclusion/exclusion criteria adjusted for propensity score (9.3% vs 55.0%; P < 0.0001) and in a smaller, matched on propensity score, subset of patients (10.3% vs 64.1%; P < 0.0001).Conclusion: Robotic-assisted PCI had significantly lower incidence of LGM compared to standard M-PCI. Reducing LGM potentially improves long-term clinical outcomes through reduction in MACE. [ABSTRACT FROM AUTHOR]

Analyzing data from a survey of African American and White residents in South Carolina, this study attempts to understand how to better promote clinical trial participation specifically within the African American population. To explore why participation is lower in the African American population, the authors examined two sets of potential barriers: structural/procedural (limited accessibility, lack of awareness, doctors not discussing clinical trial options, lack of health insurance) and cognitive/psychological (lack of subjective and factual knowledge, misperceptions, distrust, fear, perceived risk). Findings revealed that African Americans were significantly less willing than Whites to participate in a clinical trial. African Americans also had lower subjective and factual knowledge about clinical trials and perceived greater risk involved in participating in a clinical trial. The authors found that lack of subjective knowledge and perceived risk were significant predictors of African Americans’ willingness to participate in a clinical trial. Implications of the findings are discussed in detail. [ABSTRACT FROM PUBLISHER]

Background The recent growth of implementation research in care delivery systems has led to a renewed interest in methodological approaches that deliver not only intervention outcome data but also deep understanding of the complex dynamics underlying the implementation process. We suggest that an ethnographic approach to process evaluation, when informed by and integrated with quantitative data, can provide this nuanced insight into intervention outcomes. The specific methods used in such ethnographic process evaluations are rarely presented in detail; our objective is to stimulate a conversation around the successes and challenges of specific data collection methods in health care settings. We use the example of a translational clinical trial among 11 community clinics in Portland, OR that are implementing an evidencebased, health-information technology (HIT)-based intervention focused on patients with diabetes. Discussion Our ethnographic process evaluation employed weekly diaries by clinic-based study employees, observation, informal and formal interviews, document review, surveys, and group discussions to identify barriers and facilitators to implementation success, provide insight into the quantitative study outcomes, and uncover lessons potentially transferable to other implementation projects. These methods captured the depth and breadth of factors contributing to intervention uptake, while minimizing disruption to clinic work and supporting mid-stream shifts in implementation strategies. A major challenge is the amount of dedicated researcher time required. Summary The deep understanding of the 'how' and 'why' behind intervention outcomes that can be gained through an ethnographic approach improves the credibility and transferability of study findings. We encourage others to share their own experiences with ethnography in implementation evaluation and health services research, and to consider adapting the methods and tools described here for their own research. [ABSTRACT FROM AUTHOR]

In the Comparative Risk Assessment (CRA) done as part of the Global Burden of Disease project (GBD-2010), the global and regional burdens of household air pollution (HAP) due to the use of solid cookfuels, were estimated along with 60+ other risk factors. This article describes how the HAP CRA was framed; how global HAP exposures were modeled; how diseases were judged to have sufficient evidence for inclusion; and how meta-analyses and exposure-response modeling were done to estimate relative risks. We explore relationships with the other air pollution risk factors: ambient air pollution, smoking, and secondhand smoke. We conclude with sensitivity analyses to illustrate some of the major uncertainties and recommendations for future work. We estimate that in 2010 HAP was responsible for 3.9 million premature deaths and ∼4.8% of lost healthy life years (DALYs), ranking it highest among environmental risk factors examined and one of the major risk factors of any type globally. [ABSTRACT FROM AUTHOR]

Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing treatments. Regulations are often blamed for impeding clinical research, but there are other elements of the clinical trials enterprise that also have the potential to add burdens, through either imposed requirements or incentives that do not favor clinical research (Figure 1).1,2,3 [ABSTRACT FROM AUTHOR]

We undertook a survey of the current capability in the United States to conduct controlled clinical trials. The intention was to use the results as a foundation for understanding how to create a controlled clinical trial capability sufficient to meet future needs of US health care. For this purpose, using the results from an advanced search of ClinicalTrials.gov on 16 August 2009, we created a database consisting of actively recruiting interventional trials having at least one US investigator center. As of 16 August 2009, there were 10,974 actively recruiting interventional trials having at least one investigator center in the United States. These trials were seeking to recruit a total of 2.8 million subjects. Of the trials, 68% involved the study of drugs or biologicals. The data indicate that clinical research conducted in the United States is dominated by research on regulated products. We estimated that 1 of every 200 persons in the United States would need to participate as a subject in a clinical trial if the current clinical research portfolio is to be successfully completed. [ABSTRACT FROM AUTHOR]

articipation in cancer clinical trials (CCTs) is estimated at 4%-5% of those eligible to participate. Current participants tend to be white, male and highly educated. Women, minorities and the medically underserved have lower rates of participation. Increasing CCT participation can potentially impact cancer treatment outcomes as well as overall survival and quality of life for those with cancer. The purpose of this presentation is to describe how the outcomes of two CCT education programs enhanced the implementation of the CCT component of a web-based cancer survivorship education program for Native Americans. Two CCT education programs were developed and implemented over the past five years. One program was designed to educate healthcare providers about CCTs while the second was designed to aid Native Americans in informed decision making about CCT participation. The third program, currently being implemented, is designed to enhance cancer survivorship for Native Americans and others through an interactive web-based education program. Each program uses a modular format to provide information on CCTs. The first two include didactic and interactive components provided in a seminar format; the third is a modular component of a larger educational intervention. Initial evaluation of the CCT education programs used paper/pencil surveys for demographics, pre/post-test knowledge and general satisfaction. In 2002, evaluation began with an audience response system (ARS) that allowed for general data collection as well as assessment of knowledge, attitudes and beliefs through the ARS polling functions. In addition to increasing knowledge about CCTs for healthcare professionals and Native Americans who participated in the curricula, evaluation allowed the project team to better understand the attitudes and beliefs about CCT participation of these populations. This information has been used to develop the CCT component for those taking part in the interactive web-based cancer survivorship/quality of life program. The educational materials from the two CCT curricula are available through the Web for use in education programs and the web-based program can be reviewed by any healthcare provider. Having previously evaluated and readily available CCT information can facilitate the oncology nurse's ability to educate patients, families and the public about CCTs and hopefully increase appropriate participation. [ABSTRACT FROM AUTHOR]

The article discusses the implementation process and causes of discordance between the blinded independent central review (BICR) readers in the U.S. It highlights the frequency of contributing factors and suggests ways to lessen sources of discordance. Several charts are offered which show the causes of discordance in raw and percentage data, and perception of lesions.

Non-occupational post-exposure prophylaxis (nPEP) use is an HIV prevention strategy that has been recommended by the CDC to prevent HIV infection after a high risk sexual exposure since 1997. In a behavioral intervention trial of 4,295 MSM we assessed perceptions and use of nPEP over 4 years in six cities across the United States. Overall, 1.9% of MSM reported use of nPEP prior to enrollment, and 6.3% at least once during the trial. Awareness of nPEP was reported by 47.5%, with higher awareness in two sites with funded nPEP programs. Three seroconversions occurred in the 384 visits where nPEP courses were reported, with no effect of nPEP on risk of HIV acquisition in this cohort (hazard ratio = 0.91, 95% confidence interval [0.29, 2.86]). NPEP users were a riskier group: increased odds of nPEP use were observed in association with multiple partners and unprotected receptive and insertive anal sex with HIV infected partners and partners with unknown HIV status. NPEP use was also associated with use of illicit drugs (injection drugs, crack cocaine, hallucinogens, and amphetamines). Importantly, willingness to use nPEP after high risk sex was associated with lower odds of high risk sex. After an episode of nPEP use, nPEP users remained more likely to report high risk sex than those in this cohort who had not previously used nPEP. However, within the subset of people who had previously reported high risk sex, previous nPEP use was not associated with higher odds of high risk sex, thus allaying fears that availability of nPEP would lead to an increase in high risk sex. [ABSTRACT FROM AUTHOR]

The Drug Information Portal is a free Web resource from the National Library of Medicine (NLM) that provides a user-friendly gateway to current information for more than 15,000 drugs. The site guides users to related resources of NLM, the National Institutes of Health (NIH), and other government agencies. Current drug-related information regarding consumer health, clinical trials, AIDS, MeSH pharmacological actions, MEDLINE/PubMed biomedical literature, and physical properties and structure is easily retrieved by searching on a drug name. A varied selection of focused topics in medicine and drugs is also available from displayed subject headings. This column provides background information about the Drug Information Portal, as well as search basics. [ABSTRACT FROM AUTHOR]

The current system of financing for clinical drug trials creates numerous perverse incentives. Since the trials are typically performed or controlled by the company who owns the patent, it has enormous incentives to report positive findings and conceal results that indicate the drug might be ineffective or even harmful. In addition, the large patent rents earned by drug companies are justified by the need to recoup research costs, approximately half of which are attributable to clinical trials. This article outlines a system of publicly financed clinical trials under which all results are fully available to the public. The system would be financed by paying lower drug prices under the Medicare drug program and other public health care programs. [ABSTRACT FROM AUTHOR]

Objective: The rise in popularity of complementary and alternative medicine (CAM) in the United States has stimulated increasing interest in researching CAM. One challenge to this research is determining the optimal dose of a CAM intervention. T'ai Chi Chuan (TCC) has received considerable attention as a mind–body practice; however, it remains unclear exactly how much TCC practice is necessary to elicit a discernable effect. Design: In this review, we selected 19 studies and examined the variation in the number and length of training sessions. Secondary and tertiary aims include examining attendance rates for each intervention and the instructions given to participants regarding home-based practice. The degree to which investigators monitored participants' home-based practice was also examined. Results: In the intent-to-treat analyses, the median time of TCC practice was 2877 minutes intended for participants across the selected interventions. Fourteen (14) of the publications provided information about participant attendance in the original publication, 2 provided additional information through further author inquiry, and 3 commented on TCC practice outside of the structured class environment through author inquiry. Conclusions: The data reported are inconsistent in reported attendance and home-based practice rates, making it difficult to speculate on the relationship between the amount of TCC and intervention effects. Further research could contribute to this area by determining the optimal dose of TCC instruction. [ABSTRACT FROM AUTHOR]

Aim To test a priori hypotheses concerning client–treatment matching in the treatment of alcohol problems and to evaluate the more general hypothesis that client–treatment matching adds to the overall effectiveness of treatment. Design Pragmatic, multi-centre, randomized controlled trial (the UK Alcohol Treatment Trial: UKATT) with open follow-up at 3 months after entry and blind follow-up at 12 months. Setting Five treatment centres, comprising seven treatment sites, including National Health Service (NHS), social services and joint NHS/non-statutory facilities. Treatments Motivational enhancement therapy and social behaviour and network therapy. Measurements Matching hypotheses were tested by examining interactions between client attributes and treatment types at both 3 and 12 months follow-up using the outcome variables of percentage days abstinent, drinks per drinking day and scores on the Alcohol Problems Questionnaire and Leeds Dependence Questionnaire. Findings None of five matching hypotheses was confirmed at either follow-up point on any outcome variable. Conclusion The findings strongly support the conclusion reached in Project MATCH in the United States that client–treatment matching, at least of the kind examined, is unlikely to result in substantial improvements to the effectiveness of treatment for alcohol problems. Possible reasons for this failure to support the general matching hypothesis are discussed, as are the implications of UKATT findings for the provision of treatment for alcohol problems in the United Kingdom. [ABSTRACT FROM AUTHOR]

Companies that conduct research are under no obligation to follow guidelines regarding treatment of human subjects in clinical trials. By contrast, clinical researchers funded by federal agencies or under U.S. Food and Drug Administration authority are required to follow federal regulations, and academics must adhere to their institutions' standards. We examined how one tobacco company, R. J. Reynolds, treated human subjects in internal research conducted from 1985 to 2000. We then compared this treatment with standards of the time. We focused on R. J. Reynolds because the company conducted a significant amount of research using human subjects. Tobacco industry documents were retrieved from the UCSF/Legacy Tobacco Documents Library, Tobacco Documents Online, and industry Web sites. Materials from 73 research projects, including informed consent forms, were analyzed. The U.S. Code of Federal Regulations, Title 45 Part 46, Protection of Human Subjects (the Common Rule) was the primary source for human subjects research guidelines and standards. R. J. Reynolds formed a human subjects review committee in 1985. The committee's structure and procedures did not meet generally accepted practices of the time regarding community representation, written procedures for adverse events, and other factors. In all 73 studies, consent procedures failed to meet five or more human subjects research standards. Policymakers should consider expanding the scope of federal human subjects research regulations to cover research undertaken by private firms such as tobacco companies. [ABSTRACT FROM AUTHOR]

Evidence-based guidelines for the management of patients with histoplasmosis were prepared by an Expert Panel of the Infectious Diseases Society of America. These updated guidelines replace the previous treatment guidelines published in 2000 (din Infect Dis 2000; 30:688-95). The guidelines are intended for use by health care providers who care for patients who either have these infections or may be at risk for them. Since 2000, several new antifungal agents have become available, and clinical trials and case series have increased our understanding of the management of histoplasmosis. Advances in immunosuppressive treatment for inflam- matory disorders have created new questions about the approach to prevention and treatment of histoplasmosis. New information, based on publications from the period 1999-2006, are incorporated into this guideline document. In addition, the panel added recommendations for management of histoplasmosis in children for those aspects that differ from aspects in adults. [ABSTRACT FROM AUTHOR]

This study assessed the cost-effectiveness of two low-intensity programs for quitting smokeless tobacco, based on results of a randomized trial with 1,069 volunteer participants. Cost data were collected for two levels of intervention: manual only (a self-help manual) and assisted self-help (the manual plus a videotape and two supportive phone calls from tobacco cessation counselors). Incremental cost-effectiveness ratios were calculated for assisted self-help vs. quitting on one's own, using the manual-only quit rate and data from another study as alternative proxies for no intervention. A threshold analysis was conducted to determine the spontaneous quit rate at which the manual-only intervention becomes more cost-effective than assisted self-help. The cost to provide and receive the assisted self-help intervention averaged US $56 per participant vs. $20 for the manual-only intervention (societal perspective, Year 2000 dollars). Estimates for incremental cost per quit for the assisted self-help intervention ranged from $922 to $1,758, depending on the proxy used for no intervention. The manual-only intervention was more cost-effective than assisted self-help if quitting among motivated chewers who do not receive treatment does not exceed 3.4%. Support from a wife or partner added little cost to a quit attempt for male chewers ($3-$4). Providing a manual, video, and brief phone counseling to smokeless tobacco users who want to quit is a reasonable use of health care resources. The self-help quitting guide also may be a cost-effective treatment, but it remains to be demonstrated whether it is more effective than quitting on one's own. [ABSTRACT FROM AUTHOR]

New technology is one of the primary drivers for increased healthcare costs in the United States. Both physician and industry play important roles in the development, adoption, utilization and choice of new technologies. The Federal Drug Administration regulates new drugs and new medical devices, but healthcare technology assessment remains limited. Healthcare technology assessment originated in federal agencies; today it is decentralized with increasing private sector efforts. Innovation is left to free market forces, including direct to consumer marketing and consumer choice. But to be fair to the consumer, he/she must have free knowledge of all the risks and benefits of a new technology in order to make an informed choice. Physicians, institutions and industry need to work together by providing proven, safe, clinically effective and cost effective new technologies, which require valid pre-market clinical trials and post-market continued surveillance with national and international registries allowing full transparency of new products to the consumer—the patient. [ABSTRACT FROM AUTHOR]

Policies consisting of or including prior authorisation (PA) of pharmaceutical prescriptions have been increasingly implemented by public and private insurers in the last decade, especially in the US, in order to control drug spending. We conducted a systematic review of published articles determining the effects of these policies on drug use, healthcare utilisation, healthcare expenditures and health outcomes. A literature search was carried out in the electronic databases PubMed (which includes MEDLINE), EconLit, Web of Science and online sources including Google Scholar, from 1 January 1985 to 12 September 2006. Reference lists of retrieved articles were also searched. Peer-reviewed studies that provided empirical results about the impact of pharmaceutical PA policies, including randomised and non-randomised controlled trials, repeated measures studies, interrupted time series analyses and before-and-after studies were included. Use of, and expenditure on, directly affected drugs per patient, and overall drug expenditure, significantly decreased after PA implementation, or increased after PA removal. Health outcome changes attributed to PA policies were not directly evaluated. In most cases, except for cimetidine, PA implementation was not associated with significant changes in the utilisation of other medical services. Although the literature indicates a reduction in drug expenditure and a nonnegative impact on use of other health services, policy recommendations still require improved study designs, and evidence cannot be easily transferred from one setting to another. The evidence still remains mainly limited to US Medicaid settings and to a small number of drug classes. There is a lack of consideration of implications of PA policies as heterogeneous interventions, outcome measurements require improvement, and there is a notable lack of evidence of medium- and long-term policy effects. [ABSTRACT FROM AUTHOR]

Aims The purpose of this systematic review was to examine the effectiveness of community health workers in supporting the care of persons with diabetes. Methods Computerized searches were conducted of multiple electronic bibliographic dababases until March 2004. We identified studies in any language and of any design that examined the effectiveness of diabetes-related interventions involving community health workers and reported outcomes in persons with diabetes. Results were synthesized narratively. Results Eighteen studies were identified, including eight randomized controlled trials. Most studies focused on minority populations in the USA. The roles and duties of community health workers in diabetes care were varied, ranging from substantial involvement in patient care to providing instrumental assistance in education sessions taught by other health professionals. Participants were generally satisfied with their contacts with community health workers and participant knowledge increased. Improvements in physiological measures were noted for some interventions and positive changes in lifestyle and self-care were noted in a number of studies. There were few data on economic outcomes, but several studies demonstrated a decrease in inappropriate health care utilization. Conclusions Diabetes programmes include community health workers as team members in a variety of roles. There are some preliminary data demonstrating improvements in participant knowledge and behaviour. Much additional research, however, is needed to understand the incremental benefit of community health workers in multicomponent interventions and to identify appropriate settings and optimal roles for community health workers in the care of persons with diabetes. [ABSTRACT FROM AUTHOR]

Background Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited. Methods After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)–based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient’s EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient’s eligibility and facilitated secure messaging to the trial’s coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation. Results The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P < .001) and enrollments (5 before and 11 after; P = .03), a 10-fold increase in those physicians’ referral rate (5.7/mo before and 59.5/mo after; rate ratio, 10.44; 95% confidence interval, 7.98-13.68; P<.001), and a doubling of their enrollment rate (2.9/mo before and 6.0/mo after; rate ratio, 2.06; 95% confidence interval, 1.22-3.46; P = .007). Conclusions Use of an EHR-based CTA led to significant increases in physicians’ participation in and recruitment rates to an ongoing clinical trial. Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment. [ABSTRACT FROM AUTHOR]

Abstract: Some of the characteristics of men, with known risk factors, who were most likely to respond to an invitation to be screened in a national randomized clinical trial to prevent heart disease were determined in 18,872 men, 35-57 years of age, members of the Kaiser Foundation Health Plan of Oregon. Demographic characteristics and risk factor variables (blood pressure, blood cholesterol, and cigarette smoking levels) were abstracted from medical records. The men were ranked high priority or low priority according to level of risk. All age-eligible men in the health plan received at least one invitation to be screened, with high-priority men receiving more invitations. Despite concentrated efforts to bring them in, less than one-half the high-priority men were screened. Participants were older and wealthier than non-participants, and more likely to have more dependents and to routinely use medical services. Whether or not a man received a medical care service within the preceding two years was a powerful discriminating variable in both the univariate and multivariate analyses reported. The findings suggest that health care programs serving a stable population group should give more consideration to screening in routine medical care. (Am J Public Health 69: 1011-1015, 1979.) [ABSTRACT FROM AUTHOR]

Changing patterns of laboratory utilization by physicians in prepaid group practice are analyzed. Significant differences among physicians are reported and only partially explained. The findings raise questions to be answered by further study. [ABSTRACT FROM AUTHOR]

The authors comment on a study published within the issue on the effect of electronic health records (HER), with or without clinical decision support (CDS), on physician adherence to evidence-based guidelines. They outline the differences between the design and guideline targets of the study and the randomized controlled trials of CDS systems that were reviewed in 2005. They also claim that the EHR and CDS systems used during the time of study were immature, did not cover many guidelines and had incomplete patient data.

The article discusses the importance of using longitudinal health care data in clinical research in the U.S. It says that the data can be used in providing early warnings and assessment of potential safety issues, exploring and verifying safety signals of the patients, and for better understanding of the disease characteristics, progression and treatment. However, there are some speculations that increased access to data may lead to faulty, misleading, and possibly threatening conclusions.

Focuses on error reduction, complex systems and organizational change in health care delivery in the U.S. Interventions that may be used to reduce the incidence and impact of errors in medical care; Use of randomized controlled trials to improve quality in medical care; Analysis of the Institute of Medicine's report 'Crossing the Quality Chasm.'