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Context Patient-reported outcomes (PROs) can play an important role in patient-centered health care by focusing on the patient's health goals guiding therapeutic decisions. When aggregated, PROs also can be used for other purposes, including comparative effectiveness research, practice improvement, assessment of the performance of clinicians and organizations, and as a metric for value-based payments. The feasibility of integrating the use of PROs for these various purposes on a wide scale has not yet been demonstrated. Our study was conducted to inform policymakers of prudent next steps for implementing PROs in clinical practice and performance measurement programs in order to maximize their impact on the quality of health care. Methods We conducted a qualitative study, interviewing 58 experts and leaders from 37 organizations (response rate: 88%) in the United States, England, and the Netherlands. Respondents included clinical practitioners ( n = 30), measure developers ( n = 11), and leaders of performance measurement programs ( n = 17). We used a qualitative content analysis to assess current strategies for applying PROs in clinical practice and performance measurement and to identify barriers to and facilitators of further implementation. Findings The use of PROs in clinical practice and for performance measurement has developed both separately and in parallel. Experts across the stakeholder spectrum support the collection of PRO data in an integrated manner that would enable using the data for these distinct purposes. We identified 2 main concerns about the feasibility for integrated use of PRO data: the complexity of establishing routine data collection and the tension among stakeholders when using PRO data for different purposes. These contrasting stakeholder views suggested varying interests among clinicians, measure developers, and purchasers of care. Conclusions Data collection approaches that support the use of PROs in health care are underdeveloped, need better integration with clinical care, and must be tailored to the characteristics of the health care system. Enabling the sustainable use of PROs will require a shared vision of clinical professionals, purchasers, and patients, with a prudent selection of the steps in implementing PROs that will maximize their impact on the quality of health care. [ABSTRACT FROM AUTHOR]

Lung cancer remains the leading cause of cancer deaths in the US with >150,000 deaths per year. In order to more effectively reduce lung cancer mortality, more sophisticated screening paradigms are needed. Previously, our group demonstrated the use of low-coherence enhanced backscattering (LEBS) spectroscopy to detect and quantify the micro/nano-architectural correlates of colorectal and pancreatic field carcinogenesis. In the lung, the buccal (cheek) mucosa has been suggested as an excellent surrogate site in the “field of injury”. We, therefore, wanted to assess whether LEBS could similarly sense the presence of lung. To this end, we applied a fiber-optic LEBS probe to a dataset of 27 smokers without diagnosed lung cancer (controls) and 46 with lung cancer (cases), which was divided into a training and a blinded validation set (32 and 41 subjects, respectively). LEBS readings of the buccal mucosa were taken from the oral cavity applying gentle contact. The diagnostic LEBS marker was notably altered in patients harboring lung cancer compared to smoking controls. The prediction rule developed on training set data provided excellent diagnostics with 94% sensitivity, 80% specificity, and 95% accuracy. Applying the same threshold to the blinded validation set yielded 79% sensitivity and 83% specificity. These results were not confounded by patient demographics or impacted by cancer type or location. Moreover, the prediction rule was robust across all stages of cancer including stage I. We envision the use of LEBS as the first part of a two-step paradigm shift in lung cancer screening in which patients with high LEBS risk markers are funnelled into more invasive screening for confirmation. [ABSTRACT FROM AUTHOR]

Objective: Recent treatment patterns and cost data associated with HIV in the United States are limited. This study assessed first-line persistence and healthcare costs of HIV-1 in patients by treatment line and CD4 cell count. Methods: MarketScan Commercial Claims and Encounters Database (2007–2011) and Lab Database (2007–2010) were used to construct two HIV-1 cohorts: 1) newly treated HIV-1–infected patients with ≥6 months' continuous enrollment prior to first third-agent drug claim (Newly Treated Cohort) and 2) CD4 cell count test results (CD4 Measurements Cohort). All patients were ≥18 years old and without hepatitis co-infection. The Kaplan-Meier method was used to measure treatment switch rates. Generalized linear models (gamma distribution, log link) were used to compare healthcare costs by treatment line and CD4 cell count controlling for potential confounders. Results: Newly treated patients (n = 8,617) had mean age of 41, 82% were male, and 20% had experienced AIDS-defining events at baseline. Over 20% of newly treated patients switched initial treatment regimen within 2 years. Average unadjusted (and covariate-adjusted) total healthcare cost/year was $33,674 ($28,861) for first-line, $39,191 ($35,805) for second-line, and $39,882 ($40,804) for third-line treatment. Covariate-adjusted costs of care on second- and third-line treatments were significantly more expensive than first-line treatment (24% [p<0.001] and 41% [p = 0.006] higher, respectively). The CD4 Measurements Cohort included 803 CD4 measurements (mean age 49, 76% male, 8% experienced an AIDS-defining event). Costs associated with CD4 measurements <100 cells/µL were 92% higher than those with >350 cells/µL (p<0.001). For higher CD4 cell counts, the majority of expenditures were for antiretrovirals (64% of total for CD4 >350 cells/µL). Conclusions: Despite modern advances in antiretroviral therapy and medical care, direct medical costs of HIV-1–infected patients increase after treatment switch and with lower CD4 counts, consistent with previous costing studies. [ABSTRACT FROM AUTHOR]

Background: The extent to which patients with COPD are receiving indicated treatment with medications to improve lung function and recent trends in the use of these medications is not well documented in the United States. The objective of this study was to examine trends in prescription medications for COPD among adults in the United States from 1999 to 2010. Methods: We performed a trend analysis using data from up to 1426 participants aged ≥20 years with self-reported COPD from six national surveys (National Health and Nutrition Examination Survey 1999–2010). Results: During 2009–2010, the age-adjusted percentage of participants who used any kind of medication was 44.2%. Also during 2009–2010, the most commonly used medications were short-acting agents (36.0%), inhaled corticosteroids (ICS) (18.3%), and LABAs (16.7%). The use of long-acting beta-2 agonists (LABAs) (p for trend <0.001), ICS (p for trend = 0.013) increased significantly over the 12-year period. Furthermore, the use of tiotropium increased rapidly during this period (p for trend <0.001). For the years 2005–2010, the use of LABAs, ICS and tiotropium increased with age. Compared with whites, Mexican Americans were less likely to use short-acting agents, LABAs, ICS, tiotropium, and any kind of COPD medication. Among participants aged 20–79 years with spirometry measurements during 2007–2010, the use of any medication was reported by 19.0% of those with a moderate/severe obstructive impairment and by 72.6% of those with self-reported COPD and any obstructive impairment. Conclusion: The percentages of adults with COPD who reported having various classes of prescription medications that improve airflow limitations changed markedly from 1999–2000 to 2009–2010. However, many adults with COPD did not report having recommended prescription medications. [ABSTRACT FROM AUTHOR]

Background: Previous studies have found that up to 60% of children with neurologic conditions have tried complementary and alternative medicine (CAM). Objective: To assess the use of CAM among patients presenting to neurology clinics at two academic centers in Canada. Methods: A survey instrument was developed to inquire about use of CAM products and therapies, including reasons for use, perceived helpfulness, and concurrent use with conventional medicine, and administered to patients or their parents/guardians at the Stollery Children's Hospital in Edmonton and the Children's Hospital of Eastern Ontario (CHEO) in Ottawa. Results: Overall CAM use at the Stollery was 78%, compared to 48% at CHEO. The most common CAM products used were multi-vitamins (84%), vitamin C (37%), homeopathic remedies (24%), and fish oil/omega 3 s (22%). The most common CAM practices used were massage (47%), chiropractic (37%), faith healing (18%), aromatherapy (16%), homeopathy (16%), and relaxation (16%). Many patients used CAM products at the same time as conventional medicine but just over half (57%) discussed this concurrent use with their physician. Conclusion: CAM use is common in pediatric neurology patients and most respondents felt that it was helpful, with few or no harms associated. However, this use is often undisclosed, increasing possibility of interactions with conventional drugs. We urge clinicians to inquire about CAM use during routine history taking at every patient visit. Parents would clearly like more information about CAM from their specialty clinics; such information would be easier to share if more primary data were available about the safety and effectiveness of commonly used therapies. [ABSTRACT FROM AUTHOR]

Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA) may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation. [ABSTRACT FROM AUTHOR]

Efforts to support and use comparative effectiveness research (CER), some more successful than others, have been promulgated at various times over the last forty years. Following a resurgence of interest in CER, recent health care reforms provided substantial support to strengthen its role in US health care. While CER has generally captured bipartisan support, detractors have raised concerns that it will be used to ration services and heighten government control over health care. Such concerns almost derailed the initiative during passage of the health care reform legislation and are still present today. Given recent investments in CER and the debates surrounding its development, the time is ripe to reflect on past efforts to introduce CER in the United States. This article examines previous initiatives, highlighting their prescribed role in US health care, the reasons for their success or failure, and the political lessons learned. Current CER initiatives have corrected for many of the pitfalls experienced by previous efforts. However, past experiences point to a number of issues that must still be addressed to ensure the long-term success and sustainability of CER, including adopting realistic aims about its impact, demonstrating the impact of Patient-Centered Outcomes Research Institute (PCORI) and communicating the benefits of CER, and maintaining strong political and stakeholder support. [ABSTRACT FROM AUTHOR]

Background PAD is a disabling, chronic condition of the lower extremities that affects approximately 8 million people in the United States. The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease (PAD) improves self-efficacy for walking, desire for physical competence, satisfaction for physical functioning, social functioning, and acceptance of PAD related pain and discomfort. Methods The design was a 6-month randomized controlled clinical trial of 194 patients with PAD. Participants were randomized to 1 of 2 parallel groups: a home-based group-mediated cognitive behavioral walking intervention or an attention control condition. Results Of the 194 participants randomized, 178 completed the baseline and 6-month follow-up visit. The mean age was 70.66 (±9.44) and was equally represented by men and women. Close to half of the cohort was African American. Following 6-months of treatment, the intervention group experienced greater improvement on self-efficacy (p = .0008), satisfaction with functioning (p = .0003), pain acceptance (p = .0002), and social functioning (p = .0008) than the control group; the effects were consistent across a number of potential moderating variables. Change in these outcomes was essentially independent of change in 6-minute walk performance. [ABSTRACT FROM AUTHOR]

Purpose Differences in stroke care quality for patients in rural and urban locations have been suggested, but whether differences exist across Veteran Administration Medical Centers (VAMCs) is unknown. This study examines whether rural-urban disparities exist in inpatient quality among veterans with acute ischemic stroke. Methods In this retrospective study, inpatient stroke care quality was assessed in a national sample of veterans with acute ischemic stroke using 14 quality indicators (QIs). Rural-Urban Commuting Areas codes defined each VAMC's rural-urban status. A hierarchical linear model assessed the rural-urban differences across the 14 QIs, adjusting for patient and facility characteristics, and clustering within VAMCs. Findings Among 128 VAMCs, 18 (14.1%) were classified as rural VAMCs and admitted 284 (7.3%) of the 3,889 ischemic stroke patients. Rural VAMCs had statistically significantly lower unadjusted rates on 6 QIs: Deep vein thrombosis (DVT) prophylaxis, antithrombotic at discharge, antithrombotic at day 2, lipid management, smoking cessation counseling, and National Institutes of Health Stroke Scale completion, but they had higher rates of stroke education, functional assessment, and fall risk assessment. After adjustment, differences in 2 QIs remained significant-patients treated in rural VAMCs were less likely to receive DVT prophylaxis, but more likely to have documented functional assessment. Conclusions After adjustment for key demographic, clinical, and facility-level characteristics, there does not appear to be a systematic difference in inpatient stroke quality between rural and urban VAMCs. Future research should seek to understand the few differences in care found that could serve as targets for future quality improvement interventions. [ABSTRACT FROM AUTHOR]

American health care institutions increasingly recognize narrative medicine as a means to developing quality patient care. More commonly applied in health care professional development settings, narrative medicine is less overtly employed with patient populations. In this article, we describe the application of various narrative practices in the patient care and medical education programs of a major health care center in Minnesota. We discuss the impact of these programs on their participants in relation to the evidence based in current scholarship. Further, we examine narrative externalization of illness in Katherine Butler Hathaway’s disability memoir “The Little Locksmith,” a text which implicates the work of metaphor-making as a transformative step in healing. While several reports demonstrate that patients can find creative writing during times of illness to be therapeutic, there are many for whom the practice is problematic or unattractive, obstacles to practice implementation that the authors discuss. However, based on the experience of our institution, for health care institutions seeking to build a legacy of leadership in empathic patient care, narrative—employed in mentoring physicians in training and in establishing strong, dialogic relationships with patients and colleagues—should serve as a central strategy, or scaffold. [ABSTRACT FROM AUTHOR]

Background: Among African-Americans adults, arterial hypertension is both more prevalent and associated with more complications than among white adults. Hypertension is also epidemic among black adults in sub-Saharan Africa. The treatment of hypertension among black adults may be complicated by lesser response to certain classes of anti-hypertensive agents. Methods: We systematically searched literature for clinical trials of ACE-inhibitors among hypertensive adults comparing blood pressure response between whites and blacks. Meta-analysis was performed to determine the difference in systolic and diastolic blood pressure response. Further analysis including meta-regressions, funnel plots, and one-study-removed analyses were performed to investigate possible sources of heterogeneity or bias. Results: In a meta-analysis of 13 trials providing 17 different patient groups for evaluation, black race was associated with a lesser reduction in systolic (mean difference: 4.6 mmHg (95% CI 3.5-5.7)) and diastolic (mean difference: 2.8 mmHg (95% CI 2.2-3.5)) blood pressure response to ACE-inhibitors, with little heterogeneity. Meta-regression revealed only ACE-inhibitor dosage as a significant source of heterogeneity. There was little evidence of publication bias. Conclusions: Black race is consistently associated with a clinically significant lesser reduction in both systolic and diastolic blood pressure to ACE-inhibitor therapy in clinical trials in the USA and Europe. In black adults requiring monotherapy for uncomplicated hypertension, drugs other than ACE-inhibitors may be preferred, though the proven benefits of ACE-inhibitors in some sub-groups and the large overlap of response between blacks and whites must be remembered. These data are particularly important for interpretation of clinical drug trials for hypertensive black adults in sub-Saharan Africa and for the development of treatment recommendations in this population. [ABSTRACT FROM AUTHOR]

Over the past 85 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Satiety Board. [ABSTRACT FROM AUTHOR]

Despite the proliferation of studies documenting the relationship between physical limitation and depressive symptoms in the United States, we currently do not know (1) whether physical impairment is associated with other dimensions of emotional well-being and (2) if these associations differ for men and women as well as married and nonmarried adults. We use panel data from two national samples to examine gender and marital status variations in the impact of physical limitation on four indicators of mental health. We find that physical limitation is associated with increases in depressive symptoms and negative feelings as well as decreases in positive emotions. Although the patterns are complex, we also find gender and marital status differences in these associations. Our results provide additional support for Aneshensel’s (1992; Aneshensel, Rutter, and Lachenbruch 1991) argument about the highly contingent nature of stress reactivity and contribute to theory about both gender and marital status differences in the impact of stress on mental health. [ABSTRACT FROM PUBLISHER]

Objective: To identify the 100 top-cited articles published in orthodontics journals and to analyze their characteristics to investigate the achievement and development of orthodontics research in past decades. Methods and Materials: The Institute for Scientific Information Web of Knowledge Database and the 2011 Journal Citation Report Science Editions were used to retrieve the 100 top-cited articles published in orthodontics journals since 1975. Some basic information was collected by the Analyze Tool on the Web of Science, including citation time, publication title, journal name, publication year, and country and institution of origin. A further study was then performed to determine authorship, article type, field of study, study design, and level of evidence. Results: The 100 target articles were retrieved from three journals: American Journal of Orthodontics and Dentofacial Orthopedics (n = 74), The Angle Orthodontist (n=15), and European Journal of Orthodontics (n = 11). Since 1975, the articles cited 89 to 545 times mainly originated from the United States, and the overwhelming majority of articles were clinical. The most common study design was case series; 40 articles were classified as level IV and 12 as level V evidence. Conclusions: The 100 top-cited articles in orthodontics are generally old articles, rarely possessing high-level evidence. [ABSTRACT FROM AUTHOR]

Objectives. We investigated how quality of care affects choosing a nursing home. Methods. We examined nursing home choice in California, Ohio, New York, and Texas in 2001, a period before the federal Nursing Home Compare report card was published. Thus, consumers were less able to observe clinical quality or clinical quality was masked. We modeled nursing home choice by estimating a conditional multinomial logit model. Results. In all states, consumers were more likely to choose nursing homes of high hotel services quality but not clinical care quality. Nursing home choice was also significantly associated with shorter distance from prior residence, not-for-profit status, and larger facility size. Conclusions. In the absence of quality report cards, consumers choose a nursing home on the basis of the quality dimensions that are easy for them to observe, evaluate, and apply to their situation. Future research should focus on identifying the quality information that offers the most value added to consumers. [ABSTRACT FROM AUTHOR]

Background Our goal was to compare hospital scores from the most widely used commercial website in the USA to hospital scores from more systematic measures of patient experience and outcomes, and to assess what drives variation in the commercial website scores. Methods For a national sample of US hospitals, we compared scores on Yelp.com, which aggregates website visitor ratings (1-5 stars), with traditional measures of hospital quality. We calculated correlations between hospital Yelp scores and the following: hospital percent high ratings (9 or 10, scale 0-10) on the 'Overall' item on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey; hospital individual HCAHPS domain scores (eg, nurse communication, pain control); hospital 30-day mortality; and hospital 30-day readmission rates. Results Of hospitals reporting HCAHPS (n=3796), 962 (25%) had scores on Yelp. Among hospitals with >5 Yelp ratings, the correlation of percent high ratings between Yelp and HCAHPS was 0.49 (p<0.001). The percent high ratings within each HCAHPS domain increased monotonically with increasing Yelp scores (p=0.001 for all domains). Percent high ratings in Yelp and HCAHPS were statistically significantly correlated with lower mortality for myocardial infarction (MI; -0.19 for Yelp and -0.13 for HCAHPS) and pneumonia (-0.14 and -0.18), and fewer readmissions for MI (-0.17 and -0.39), heart failure (-0.31 and -0.39), and pneumonia (-0.18 and -0.27). Conclusions These data suggest that rater experiences for Yelp and HCAHPS may be similar, and that consumers posting ratings on Yelp may observe aspects of care related to important patient outcomes. [ABSTRACT FROM AUTHOR]

Objective: To examine variations in processes of paediatric inpatient rehabilitation care related to school re-entry and management of cognitive and communication impairments after traumatic brain injury. Design: Retrospective cohort study. Methods: Adherence to care processes recommended for children (aged 0-17) with moderate-to-severe traumatic brain injury and admitted for inpatient rehabilitation was assessed. Quality-of-care indicators for processes supporting school re-entry and cognitive and communication rehabilitation were applied to measure variations in care delivered to 174 children across nine facilities using medical record review. Main outcomes and results: Adherence rates (the number of times recommended care was delivered or attempted divided by the number of times care was indicated) were calculated, revealing substantial variations in care within and between facilities. Overall, children received 51.3% (95% CI = 31.9-70.7) and 72.3% (95% CI = 61.1-83.5), of the care recommended for school re-entry and cognitive and communication rehabilitation, respectively. Conclusion: Substantial variations exist in the delivery of paediatric inpatient rehabilitation care processes for managing school re-entry and cognitive and communication impairments after traumatic brain injury. Measures of association of these care processes with patient outcomes are necessary. Reduction in this variation is essential to improving quality of care. [ABSTRACT FROM AUTHOR]

The purpose of this study was to complete an integrated literature review of the relationship between staffing and quality outcomes in nursing homes. The majority of the reviewed studies showed better outcomes with higher nursing staff but depended heavily on cross-sectional observational studies and failed to differentiate RNs from other nursing staff. A total of 28 articles relating nurse staffing and quality outcomes were systematically reviewed and synthesized. However, each study examined different aspects of staffing and different resident or organizational outcomes, making determination of appropriate staffing levels difficult. The reviewed studies have not clearly defined the relationship between differing levels of nurse-staffing skill mix and specific structure, process, outcome, and composite indicators of quality. The inconsistent findings suggest that further research is needed in this area. [ABSTRACT FROM AUTHOR]

The article discusses the family practice management (FPM) survey of electronic health records (EHR) user satisfaction, which recorded 3,088 responses from family physicians. 31 EHR systems were surveyed and ranked according to the 19 survey statements. Its findings mentions most satisfying aspects of EHRs and assist family medicine practice to determine the purchase of EHR system. Limitations of the survey include cell size causing bias and no reporting for different versions of same product.

This prescriptive article considers five major areas of concern for juvenile justice and mental health professionals-juvenile therapeutic jurisprudence, disproportionate minority contact, psychopharmacology and psychiatry, rehabilitation, and culture in the context of political contraindications for progress. It proposes that institutions that are instrumental in advancing the welfare of urban minority youth will not realize their transformative potential in these areas if they work in isolation. Public systems in the business of promoting healthy well-being for urban minority adolescents must share a cooperative work and responsibility ethic. To date, no model provides instruction on how to effectively promote and implement partnerships between the mental health and juvenile justice systems. A collaborative control governance framework is offered as a formal method to foster interorganizational cooperation from a client-centered perspective for urban ethnic minority youth in at-risk environments. [ABSTRACT FROM AUTHOR]

In this article, the authors discuss the challenges associated with the federal funding for human embryonic stem cell research in the U.S. According to authors embryonic stem cell science has not directly produced any major advances in clinical medicine. They believe that though much will be learned through the study of human embryonic stem cells (hESCs) but it has produced no new therapeutics that have passed the U.S. Food and Drug Administration (FDA) review. They also believe that democratic disagreements cannot be reduced to technical questions and delegated to scientific experts.

The article discusses the Patient-Centered Outcomes Research Institute's (PCORI) goal and how it was established. PCORI is a private, non-profit organization that assists patients, clinicians, purchasers and policy makers in health decisions, by advancing the quality and relevance of information about disorders, diseases and other health conditions and how they could be diagnosed, treated, monitored and managed. It was established by the Patient Protection and Affordable Care Act (ACA) of 2010.

Background: The ClinicalTrials.gov registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalTrials.gov as a research resource. Methods/Principal Results: The purpose of our project was twofold. First, we sought to extend the usability of ClinicalTrials.gov for research purposes by developing a database for aggregate analysis of ClinicalTrials.gov (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed and annotated MeSH and non-MeSH disease condition terms, and an algorithm was created to classify studies into clinical specialties based on both MeSH and non-MeSH annotations. False positives and false negatives were evaluated by comparing algorithmic classification with manual classification for three specialties. Conclusions/Significance: The resulting AACT database features study design attributes parsed into discrete fields, integrated metadata, and an integrated MeSH thesaurus, and is available for download as Oracle extracts (.dmp file and text format). This publicly-accessible dataset will facilitate analysis of studies and permit detailed characterization and analysis of the U.S. clinical trials enterprise as a whole. In addition, the methodology we present for creating specialty datasets may facilitate other efforts to analyze studies by specialty groups. [ABSTRACT FROM AUTHOR]

Background: The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program. Methods: We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results. Results: 231 (22.3%; 95% CI 19.8%-24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%-80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%-39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%-44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001). Conclusions: In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics. [ABSTRACT FROM AUTHOR]

Despite various weaknesses, the impact factor (IF) is still used as an important indictor for scientific quality in specific subject categories. In the current study, the IFs of rheumatology journals over the past 10 years were serially analyzed and compared with that from other fields. For the past 10 years (1999-2008), the IFs published by the Institute for Scientific Information in the Science Citation Index-Journal Citation Report were analyzed. For the majority of rheumatology journals, the IF shows a gradually increasing trend. The mean and median level of increase of IF from 1999 to 2008 is 233.9 and 66.5%, respectively. The increase in IF from 1999 or the first year with IF documentation to that in 2008 was higher for European journals than for the USA journals. The aggregate IF and the median IF of rheumatology journals remained within the top 30% and top 15% in clinical medical and all the scientific categories, respectively. Over the past 10 years, rheumatology journals showed a general increase in IF and rheumatology remained a leading discipline. For journals in the English language, those from Europe had an even higher increase than those from USA. [ABSTRACT FROM AUTHOR]

The article presents the clinical practice guideline on vascular access for haemodialysis (HD) in the U.S. It includes recommending to an individual who starts haemodialysis should make arteriovenous fistula as first choice, patients on a long term haemodialysis should monitor and maintain their vascular access, and buttonhole is the preferred technique for needling. It also suggest that systematic observation and advanced surveillance must be used to prevent failure.

The article presents the practice guidelines for post-operative care of the kidney transplant recipient (KTR) in the U.S. It includes clinic infrastructure for follow-up for KTR, uncomplicated patients should be reviewed less frequently in clinic, and patients should have access to services and results. It also suggests the treatment of chronic allograft injury.

This study systematically compared health indicators in the United States and England from childhood through old age (ages 0–80 years). Data were from the 1999–2006 National Health and Nutrition Examination Survey for the United States (n = 39,849) and the 2003–2006 Health Survey for England (n = 69,084). Individuals in the United States have higher rates of most chronic diseases and markers of disease than their same-age counterparts in England. Differences at young ages are as large as those at older ages for most conditions, including obesity, low high-density lipoprotein cholesterol, high cholesterol ratio, high C-reactive protein, hypertension (for females), diabetes, asthma, heart attack or angina (for females), and stroke (for females). For males, heart attack or angina is higher in the United States only at younger ages, and hypertension is higher in England than in the United States at young ages. The patterns were similar when the sample was restricted to whites, the insured, nonobese, nonsmoking nondrinkers, and specific income categories and when stratified by normal weight, overweight, and obese weight categories. The findings from this study indicate that US health disadvantages compared with England arise at early ages and that differences in the body weight distributions of the 2 countries do not play a clear role. [ABSTRACT FROM PUBLISHER]

We are at the beginning of an era in which the pressure to secure the biggest possible "bang" for the health care "buck" is perhaps higher than it ever has been, on both sides of the Atlantic, and within the health policy discourse, incentives, for both professionals and patients, are occupying an increasingly prominent position. In this article, we consider issues related to motivating the professional and the patient to perform targeted actions, drawing on some of the evidence that has thus far been reported on experiences in the United Kingdom arid the United States, and we present an admittedly somewhat speculative taxonomy of hypothesized effectiveness for some of the different methods by which each of these two broad types of incentives can be offered. We go on to summarize some of the problems of, and objections to, the use of incentives in health and health care, such as those relating to motivational crowding and gaming, but we conclude by positing that, following appropriate consideration, caution, and methodological and empirical investigation, health-related incentives, at least in some contexts, may contribute positively to the social good. [ABSTRACT FROM AUTHOR]

Childhood depression is a diagnosis made with increasing frequency. Mass media, including magazines, are a significant source of knowledge about health and illness available in mass society, including childhood depression. This study is a frame analysis of the portrayal of childhood depression in the textual content of magazines available in English in North America in the years 1983-2008. Childhood depression is portrayed as a real, biologically rooted, unitary and somewhat common condition that is undertreated and can be dangerous. The job of the parent in the face of the symptoms of depression such as sadness and irritability in a child is limited to taking the child to an expert (usually a doctor) for treatment. This portrayal reflects three contemporary theories (medicalization, intensive mothering and the diseasing of childhood) and has probable practical consequences for the actions of parents and for the ways in which they approach clinicians regarding the health of their children. It also has consequences for the well-being of children. [ABSTRACT FROM AUTHOR]

Background: Translating the extraordinary scientific and technological advances occurring in medical research laboratories into care for patients in communities throughout the country has been a major challenge. One contributing factor has been the relative absence of community practitioners from the US biomedical research enterprise. Identifying and addressing the barriers that prevent their participation in research should help bridge the gap between basic research and practice to improve quality of care for all Americans. Methods: We interviewed over 200 clinicians and other healthcare stakeholders from 2004 through 2005 to develop a conceptual framework and set of strategies for engaging a stable cadre of community clinicians in a clinical research program. Results: Lack of engagement of community practitioners, lack of necessary infrastructure, and the current misalignment of financial incentives and research participation emerged as the three primary barriers to community clinician research participation. Although every effort was made to learn key motivators for engagement in clinical research from interviewees, we did not observe their behavior and self-report by clinicians does not always track with their behavior. Conclusions: A paradigm shift involving acknowledgement of the value of clinicians in the context of community research, establishment of a stable infrastructure to support a cohort of clinicians across time and research studies, and realignment of incentives to encourage participation in clinical research is required. [ABSTRACT FROM AUTHOR]

HIV quality performance measurements are critical to evaluating a care program's success in areas of testing, access to and retention in care, care processes and outcomes. Kaiser Permanente (KP) provides care to over 8 million Americans and over 19,000 HIV-infected adults. We undertook a quality performance measurement program to assess the care and outcomes for our HIV-positive patient population. We also examined HIV testing practices among our HIV-uninfected patients presenting with a sexually transmitted infection. Our metrics were extracted electronically (encompassing two time periods: July 1, 2005 through June 30, 2006 and the entire calendar year 2007) and did not require any manual data extraction, which was a primary objective of our strategy. For most individual care measures, improvement over time was noted, with 85% or more performance seen on some measures (accessing care and initiating antiretroviral therapy). Opportunities for improvement were identified on other measures, such as diagnosing HIV at an earlier stage of infection, and more consistent Pneumocystis jiroveci pneumonia prophylaxis. Over 90% of our patients on antiretroviral therapy had maximal viral control, along with high median antiretroviral medication adherence. Our results compare favorably to those of other organizations, with a KP HIV mortality rate less than 50% of the overall U.S. rate. These results have implications for improving our care process going forward, as well as for the new U.S. domestic HIV/AIDS Strategy. [ABSTRACT FROM AUTHOR]

This study involved university-community collaboration with an international home care company for the purpose of developing a tool to identify talented caregivers. Tested was the hypothesis that workers' ability to provide care in person-centered ways would be positively associated with their ability to describe others in complex ways-that is, their person-perception skills. Company coordinators functioning as supervisors used an innovative 10-item instrument to screen 554 home health aides for their person centeredness. The most and least person-centered workers were evaluated for their person-perception skills. Person centeredness was positively associated with the complexity of home care workers' descriptions of others. [ABSTRACT FROM AUTHOR]

The article presents a rebuttal to Patrick G. O'Malley's response to the paper "Noninvasive Imaging of Atherosclerosis Among Asymptomatic Individuals," by Paolo Raggi in this issue. O'Malley's arguments are based on an erroneous interpretation of the role of imaging. Diagnostic tests do not have the purpose of saving lives. They are used to help the physician find and focus on a problem.

The article presents the nature and scope of the clinical performance measures for adults with peripheral artery disease(PAD) which was developed by the Peripheral Artery Disease Performance Measures Writing Committee in the U.S. It says that the performance measures deal with lower extremity and aortic disease, as covered by the ACC/AHA 2005 guidelines for the patients with PAD. Mandatory sequential steps in the development of performance systems, PAD guidelines, and outcome measures are cited.

Recent draft Food and Drug Administration (FDA) guidelines on adaptive clinical trial design and conduct provide a useful background for both academic and industry clinical research leaders. The guidelines help to define the scope of the term 'adaptive design' and clarify how adaptive designs can be a critical component of a development program. Adaptive designs are appealing because they hold the promise of conducting trials that can answer the scientific questions of interest with savings of time and resources while exposing fewer subjects to potentially risky therapies. Adaptive designs have been successfully used in clinical trials in all phases of development for many years, enabled by a variety of increasingly flexible and powerful statistical tools. Recent developments that enable adaptations based on emerging treatment differences have demonstrated potential to streamline the research enterprise, but issues remain in their implementation. Proper implementation of adaptive designs requires an adequate understanding of the inherent trade-offs that accompany their use. In exchange for potential efficiencies in resource utilization, adaptive trials suffer from limitations in scientific conclusions, complications and inefficiencies in the statistical analysis, and logistical difficulties relative to fixed sample or fixed duration trials. While scarce resources and ethical imperatives motivate serious consideration of adaptive designs, researchers should be fully aware of the advantages and disadvantages of adaptive designs and adopt them cautiously. [ABSTRACT FROM AUTHOR]

Background: Melasma, a disorder of facial hyperpigmentation, presents a treatment obstacle to many physicians. Combination therapy with hydroquinone, tretinoin, and fluocinolone acetonide has proven effective, but it is generally more expensive than other treatments. Objective: To assess the cost-effectiveness of daily triple combination therapy (TCT) compared with daily use of each possible pair of agents (dyads) and twice daily use of hydroquinone (HQ) alone from a payer's perspective. Methods: Efficacy data were obtained from two clinical trials with the primary endpoint being complete clearance at 8 weeks. For all treatments, total cost per successful treatment was calculated. The incremental cost-effectiveness ratio (ICER) was calculated for each dyad and for HQ monotherapy in comparison with TCT. Sensitivity analyses for efficacy and number of office visits were similarly performed. Results and Conclusion: TCT consistently had the lowest cost per primary success in all the analyses performed. Furthermore, ICERs were low, indicating that TCT's superior efficacy is attained at marginal cost increases. Our results indicate that TCT is the most cost-effective treatment when compared with any of its dyads or with hydroquinone alone. [ABSTRACT FROM AUTHOR]

The total number of hip and knee arthroplasties has been increasing steadily in the USA every year. The University of California Irvine recognized a high volume activity that could be improved with the implementation of clinical pathways. Data collection was obtained by monitoring the clinical path on 138 patients. Baseline preoperative data and telephonic postoperative data were collected at 90 days postdischarge utilizing quality-of-life/functionality validated tools. Clinical path utilization was 100%. Ambulation day 1 was at 80% for hips and 85% for knees. Blood transfusions were at 56% for hips and 36% for knees. These percentages are well above the US national reported value for autologous blood transfusions of 30%. The short form 36 health survey questionnaire (SF-36) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) preoperative and postoperative data were available on 47 patients (35%) at 90 days. The WOMAC osteoarthritis index showed a percent mean difference improvement of 82% (pre = 35.8, post = 65.3). The SF-36 revealed statistical significance in physical functioning, role physical, social functioning, bodily pain, energy/vitality and mental health. In conclusion, clinical pathways are a reliable measure of health care. Analysis of clinical path variance and functional outcomes provide the necessary data for making sound business/health-care decisions. [ABSTRACT FROM AUTHOR]

ACADEMIC EMERGENCY MEDICINE 2010; 17:940–950 © 2010 by the Society for Academic Emergency Medicine Objectives: The objectives of this study were to determine concordance of emergency department (ED) management of acute myocardial infarction (AMI) with guideline recommendations and to identify ED and patient characteristics predictive of higher guideline concordance. Methods: The authors conducted a chart review study of ED AMI care as part of the National Emergency Department Safety Study (NEDSS). Using a primary hospital discharge diagnosis of AMI (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM], codes 410.XX), a random sample of ED visits for AMI in 58 urban EDs across 20 U.S. states between 2003 and 2006 were identified. Concordance with American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations was evaluated using five individual quality measures and a composite concordance score. Concordance scores were calculated as the percentage of eligible patients who received guidelines-recommended care. These percentage scores were rescaled from 0 to 100, with 100 indicating perfect concordance. Results: The cohort consisted of 3,819 subjects; their median age was 65 years, and 62% were men. The mean (± standard deviation [SD]) ED composite concordance score was 61 ± 8), with a broad range of values (42 to 84). Except for aspirin use (mean concordance, 82), ED concordance scores were low (beta-blocker use, 56; timely electrocardiogram [ECG], 41; timely fibrinolytic therapy, 26; timely ED disposition for primary percutaneous coronary intervention [PCI] candidates, 43). In multivariable analyses, older age (beta-coefficient per 10-year increase, −1.5; 95% confidence interval [CI] = −2.4 to −0.5) and southern EDs (beta-coefficient, −5.2; 95% CI = −9.6 to −0.9) were associated with lower guideline concordance, whereas ST-segment elevation on initial ED ECG was associated with higher guideline concordance (beta-coefficient, 3.6; 95% CI = 1.5 to 5.7). Conclusions: Overall ED concordance with guideline-recommended processes of care was low to moderate. Emergency physicians should continue to work with other stakeholders in AMI care, such as emergency medical services (EMS) and cardiologists, to develop strategies to improve care processes. [ABSTRACT FROM AUTHOR]

New drug development is a time-consuming and expensive process. Recently, there has been stagnation in the development of novel compounds. Moreover, the attrition rate in clinical research is also on the rise. Fearing more stagnation, the Food and Drug Administration released the critical path initiative in 2004 and critical path opportunity list in 2006 thus highlighting the need of advancing innovative trial designs. One of the innovations suggested was the adaptive designed clinical trials, a method promoting introduction of pre-specified modifications in the design or statistical procedures of an on-going trial depending on the data generated from the concerned trial thus making a trial more flexible. The adaptive design trials are proposed to boost clinical research by cutting on the cost and time factor. Although the concept of adaptive designed clinical trials is round-the-corner for the last 40 years, there is still lack of uniformity and understanding on this issue. This review highlights important adaptive designed methodologies besides covering the regulatory positions on this issue. [ABSTRACT FROM AUTHOR]

Aims: Urinary incontinence (UI) is common among women in the United States and worldwide. Although the biomedical model for female UI has been thoroughly examined, the cultural model women living with UI ascribe to has been less well described. The purpose of this study was to elicit salient features of a cultural model for long-term (>5 years) female UI and, in so doing, increase understanding of the conceptualization of female UI from an emic (patient-derived) perspective. Cultural models theory provided the overall framework for the study. Methods: Freelist ( n = 25) and pilesort ( n = 13) exercises were completed by community-dwelling women with long-term UI. In the freelist exercise, participants listed 81 unique terms in response to the request: Please list all the terms you think of when you hear the phrase urinary incontinence. The most salient terms included: wet, embarrassed, diapers/pads, leakage, old age, urinate, annoyance, inconvenience. We then used the most culturally salient items from the freelist in three pilesort tasks. Results: Results of the pilesort exercises suggest that some aspects of the cultural model are shared, whereas others are highly heterogeneous. Conclusions: A small core of salient emic terms reflects a shared cultural understanding of female UI. The cultural model includes emotional and physical elements. These findings are important in reframing and reexamining our understanding of female UI. Next steps include testing the cultural model by including salient terms used by women living with long-term UI in focus groups and clinical encounters. [ABSTRACT FROM AUTHOR]

Background. Many trials have been carried out to determine the effectiveness of antimicrobial agents in treating skin and soft tissue infections. The results of these studies are often utilized to make determinations about the use of these antimicrobials against other types of infections. Despite the importance of these trials in determining clinical care, we hypothesized that many of these studies failed to include a variety of infections of significant enough severity to effectively draw objective conclusions about antimicrobial efficacy. Methods. We conducted a modified PubMed search to identify studies of antimicrobial agents in treating soft tissue infections that were published from 1998 through 2008. We then evaluated these trials for specific recommended study criteria, which were based on published US Food and Drug Administration guidelines for the conduct of trials of antimicrobials for soft tissue infection. Results. Seventeen studies were identified for inclusion in the trial. Upon review, only 30% of trials required both local and systemic signs of infection for inclusion in the trial. One trial stratified results on the basis of operative intervention, less than half reported patient comorbidities, and only 53% provided a specific definition for "cure." Conclusions. Our meta-analysis of current trials evaluating antimicrobial therapy for skin and soft tissue infections revealed substantial shortcomings in the design of most of these trials. These data provide evidence for the importance of designing specialist panels to objectively evaluate studies and photographs of included infections to ensure that conclusions drawn from these trials concerning clinical practice are justified. [ABSTRACT FROM AUTHOR]

The Questionnaire on Smoking Urges is now very widely used as a measure of craving but is considerably longer than alternatives in current use. Longer scales carry a significant cost in studies and clinical practice. This study compared the ten-item Questionnaire on Smoking Urges (QSU-brief) with six shorter measures of craving in terms of sensitivity to abstinence and reliability. Sixty smokers were randomly assigned to continue smoking ( N = 30) or abstain completely for 24 h ( n = 30), by which time the craving would be expected to have increased. Craving was measured at baseline and after 24 h. The craving measures tested were the QSU-brief, the Minnesota Nicotine Withdrawal Scale (MNWS), the Mood and Physical Symptoms Scale (MPSS), the Shiffman Scale (SS), the Wisconsin Smoking Withdrawal Scale and the Cigarette Withdrawal Scale and a simple rating of ‘craving’ (CR). All measures showed significant increases in scores following smoking abstinence. The two-item MPSS measure was similar to the QSU-brief (eta-squared 0.41 versus 0.45, respectively), and the CR was only slightly lower (eta-squared 0.37). The MNWS showed the least sensitivity (eta-squared 0.22). Stability while still smoking was good with the exception of the SS which showed a significant reduction on retest. The ten-item QSU-brief is not more sensitive to abstinence or reliable than the two-item MPSS or a single rating of craving. [ABSTRACT FROM AUTHOR]

Research has shown that cognitive-behavioral therapy (CBT) is effective in the treatment of schizophrenia (Wykes et al. in Schizophr Bull 34(3):523–537, ). The majority of this research has been conducted in the United Kingdom (Beck and Rector in Am J Psychother 54:291–300, ) where the National Health Service recommends that CBT be delivered to all people with schizophrenia (NICE in Schizophrenia: core interventions in the treatment and management of schizophrenia in primary and secondary care (update). , ). In contrast, the corresponding American Psychiatric Association guidelines describe CBT as an adjunctive technique that “may benefit” patients (Lehman et al. in Am J Psychiatry 161:1–56, , p. 35). Anecdotal evidence also suggests a difference between UK and US clinicians’ use of and views on CBT with schizophrenia (Tarrier in Clinical handbook of psychological disorders: a step-by-step treatment manual. Guilford, New York, ). In the present study 214 clinicians in the UK and US completed an internet survey examining this apparent discrepancy. UK and US participants were equally aware that empirical research supports the efficacy of CBT with schizophrenia. However, UK participants were more likely to practice CBT, rated CBT effectiveness more highly, and were more optimistic about the chances of recovery. These findings suggest fundamental differences in the attitudes and practices of UK and US clinicians. [ABSTRACT FROM AUTHOR]

The article offers information on how culture can be used to help reduce the unequal burden of cancer in the U.S. The authors state that one of the prime factor in the persistence of health disparities is culture. They suggest elimination of disconnection between evidence-based, quality and cancer care to diverse population for clinical practice.

The article investigates into the validity of a clinical trial on the use of rivaroxaban to prevent ischaemic stroke in non-valvular atrial fibrillation, following recall of the point of care device used in the trial in December 2014. Topics discussed include evidences pointing to a defective point-of-care device used in the warfarin arm of the trial, importance of the trial for drug approval from the U.S. and European regulators, and implications for the research and medical care sector.

Standard approaches for determining weights when calculating a composite measure of health care quality from individual quality indicators (QIs) include equal weighting, opportunity-based weights, and judgment-based weights. Benefit-of-the-doubt approaches have not been used in the health services area, though one has been used to calculate composite measures for profiling countries. Underlying these approaches is the assumption that relative performance on a set of indicators is, at least to some extent, a revealed preference by the organizational unit about the relative importance of the indicators. A benefit-of-the-doubt approach recognizes these revealed preferences by assigning higher weights to indicators on which performance is better and lower weights to indicators on which performance is poorer. We consider two benefit-of-the-doubt approaches. The first uses simple linear programming (LP) models; the second uses data envelopment analysis (DEA), the way in which the benefit-of-the-doubt approach has been previously implemented. In both cases, constraints are added to limit weight adjustments to some percentage of policy-determined baseline weights. Using both standard and benefit-of-the-doubt approaches, composite scores are calculated from data on five QIs from 32 Department of Veterans Affairs (VA) nursing homes. We examine the tradeoff between the level of allowable weight adjustment and impact on facility rankings. If weights are constrained to be within 75% of baseline weights, all approaches identify pretty much the same high performing facilities. Weights from benefit-of-the-doubt approaches, because they are able to reflect local preferences and conditions, should be attractive to facilities and, in a collaborative environment, to policy makers. [ABSTRACT FROM AUTHOR]

Background: Treatment strategies for the highly invasive brain tumor, glioblastoma multiforme, require that cells which have invaded into the surrounding brain be specifically targeted. The inherent tumor-tropism of neural stem cells (NSCs) to primary and invasive tumor foci can be exploited to deliver therapeutics to invasive brain tumor cells in humans. Use of the strategy of converting prodrug to drug via therapeutic transgenes delivered by immortalized therapeutic NSC lines have shown efficacy in animal models. Thus therapeutic NSCs are being proposed for use in human brain tumor clinical trials. In the context of NSC-based therapies, MRI can be used both to non-invasively follow dynamic spatio-temporal patterns of the NSC tumor targeting allowing for the optimization of treatment strategies and to assess efficacy of the therapy. Ironlabeling of cells allows their presence to be visualized and tracked by MRI. Thus we aimed to iron-label therapeutic NSCs without affecting their cellular physiology using a method likely to gain United States Federal Drug Administration (FDA) approval. Methodology: For human use, the characteristics of therapeutic Neural Stem Cells must be clearly defined with any pertubation to the cell including iron labeling requiring reanalysis of cellular physiology. Here, we studied the effect of ironloading of the therapeutic NSCs, with ferumoxide-protamine sulfate complex (FE-Pro) on viability, proliferation, migratory properties and transgene expression, when compared to non-labeled cells. FE-Pro labeled NSCs were imaged by MRI at tumor sites, after intracranial administration into the hemisphere contralateral to the tumor, in an orthotopic human glioma xenograft mouse model. Conclusion: FE-Pro labeled NSCs retain their proliferative status, tumor tropism, and maintain stem cell character, while allowing in vivo cellular MRI tracking at 7 Tesla, to monitor their real-time migration and distribution at brain tumor sites. Of significance, this work directly supports the use of FE-Pro-labeled NSCs for real-time tracking in the clinical trial under development: ''A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically modified Neural Stem Cells Expressing Escherichia coli Cytosine Deaminase for Treatment of Recurrent High-Grade Gliomas''. [ABSTRACT FROM AUTHOR]