Sample records for clinical studies utilizing

  1. How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

    PubMed

    Naci, Huseyin; Ioannidis, John P A

    2015-01-01

    Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

  2. A Study of the Utilization Patterns of an Elementary School-Based Health Clinic over a 5-Year Period

    ERIC Educational Resources Information Center

    Johnson, Veda; Hutcherson, Valerie

    2006-01-01

    The purpose of this study was to determine the utilization pattern of an elementary school-based clinic over a 5-year period. It involved a retrospective analysis of computer-based data for all patient visits during this study period. Results revealed high clinic utilization with an average of over 5 encounters for all users each year. The most…

  3. Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

    PubMed

    Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

    2015-01-01

    Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

  4. Personal Care Participation Assessment and Resource Tool: Clinical utility for inpatient rehabilitation.

    PubMed

    Darzins, Susan W; Imms, Christine; Stefano, Marilyn Di; Radia-George, Camilla A

    2016-10-01

    Evidence supports validity of the Personal Care Participation Assessment and Resource Tool (PC-PART), but clinical utility remains unverified. This study aimed to investigate occupational therapists' perceptions about the PC-PART's clinical utility for inpatient rehabilitation. Using mixed methods, occupational therapists who had used the PC-PART as part of a research study in an inpatient rehabilitation setting completed a questionnaire ( n = 9) and participated in a focus group ( n = 6) to explore their perspectives about its clinical utility. Quantitative data were summarized and qualitative data analyzed using inductive thematic analysis. Quantitative data highlighted both positive and negative aspects of the PC-PART's clinical utility. Five themes emerged from the qualitative data: nature of information gathered; familiarity with the instrument; perceived time and effort; item phrasing, interpretation, and presentation; and external influences on clinical use. The PC-PART was perceived to support gathering of clinically useful information, helpful to intervention and discharge planning. Recommendations for improving some item phrasing, operational definitions, and instructions were identified. Although standardized assessments were valued, use in routine practice was challenging, requiring a knowledge translation strategy.

  5. Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity.

    PubMed

    Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C

    2017-01-01

    Advances from pharmacogenetics (PGx) have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

  6. Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research Practices Task Force Report.

    PubMed

    Wolowacz, Sorrel E; Briggs, Andrew; Belozeroff, Vasily; Clarke, Philip; Doward, Lynda; Goeree, Ron; Lloyd, Andrew; Norman, Richard

    Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most important and uncertain data inputs in cost-utility models. Clinical trials represent an important opportunity for the collection of health-utility data. However, trials designed primarily to evaluate efficacy and safety often present challenges to the optimal collection of HSU estimates for economic models. Careful planning is needed to determine which of the HSU estimates may be measured in planned trials; to establish the optimal methodology; and to plan any additional studies needed. This report aimed to provide a framework for researchers to plan the collection of health-utility data in clinical studies to provide high-quality HSU estimates for economic modeling. Recommendations are made for early planning of health-utility data collection within a research and development program; design of health-utility data collection during protocol development for a planned clinical trial; design of prospective and cross-sectional observational studies and alternative study types; and statistical analyses and reporting. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  7. CallWall: tracking resident calls to improve clinical utilization of pathology laboratories.

    PubMed

    Buck, Thomas P; Connor, Ian M; Horowitz, Gary L; Arnaout, Ramy A

    2011-07-01

    Clinical pathology (CP) laboratories are used for millions of tests each year. These lead to thousands of calls to CP residents. However, although laboratory utilization is a frequent topic of study, clinical utilization--the content of the interactions between clinicians and CP residents--is not. Because it reflects questions about laboratory utilization, clinical utilization could suggest ways to improve both training and care by reducing diagnostic error. To build and implement a secure, scalable Web-based system to allow CP residents at any hospital to track the calls they receive, the interaction's context, and the action taken as a result, with evidence where applicable, and to use this system to report on clinical utilization at a major academic hospital. Entries were analyzed from a nearly year-long period to describe the clinical utilization of CP at a large academic teaching hospital. Sixteen residents logged 847 calls during 10 months, roughly evenly distributed among transfusion medicine, chemistry, microbiology, and hematopathology. Calls covered 94 different analytes in chemistry and 71 different organisms or tests in microbiology. Analysis revealed areas where CP can improve clinical care through educating the clinical services, for example, about ordering Rh immune globulin, testosterone testing, and diagnosis of tick-borne diseases. Documenting calls also highlighted patterns among residents. Clinical utilization is a potentially rich knowledge base for improving patient care and resident training. Our resident call-tracking system is a useful way for measuring clinical utilization and mining it for actionable information.

  8. Defining personal utility in genomics: A Delphi study.

    PubMed

    Kohler, J N; Turbitt, E; Lewis, K L; Wilfond, B S; Jamal, L; Peay, H L; Biesecker, L G; Biesecker, B B

    2017-09-01

    Individual genome sequencing results are valued by patients in ways distinct from clinical utility. Such outcomes have been described as components of "personal utility," a concept that broadly encompasses patient-endorsed benefits, that is operationally defined as non-clinical outcomes. No empirical delineation of these outcomes has been reported. To address this gap, we administered a Delphi survey to adult participants in a National Institute of Health (NIH) clinical exome study to extract the most highly endorsed outcomes constituting personal utility. Forty research participants responded to a Delphi survey to rate 35 items identified by a systematic literature review of personal utility. Two rounds of ranking resulted in 24 items that represented 14 distinct elements of personal utility. Elements most highly endorsed by participants were: increased self-knowledge, knowledge of "the condition," altruism, and anticipated coping. Our findings represent the first systematic effort to delineate elements of personal utility that may be used to anticipate participant expectation and inform genetic counseling prior to sequencing. The 24 items reported need to be studied further in additional clinical genome sequencing studies to assess generalizability in other populations. Further research will help to understand motivations and to predict the meaning and use of results. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  9. Danish research-active clinical nurses overcome barriers in research utilization.

    PubMed

    Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K

    2003-03-01

    The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further empirical studies, based on Giddens theory of sociological reflectivity, might see clinical nurses in a more serious light and simultaneously perceive them as producers of knowledge.

  10. Predisposing characteristics, enabling resources and need as predictors of utilization and clinical outcomes for veterans receiving mental health services.

    PubMed

    Fasoli, DiJon R; Glickman, Mark E; Eisen, Susan V

    2010-04-01

    Though demand for mental health services (MHS) among US veterans is increasing, MHS utilization per veteran is decreasing. With health and social service needs competing for limited resources, it is important to understand the association between patient factors, MHS utilization, and clinical outcomes. We use a framework based on Andersen's behavioral model of health service utilization to examine predisposing characteristics, enabling resources, and clinical need as predictors of MHS utilization and clinical outcomes. This was a prospective observational study of veterans receiving inpatient or outpatient MHS through Veterans Administration programs. Clinician ratings (Global Assessment of Functioning [GAF]) and self-report assessments (Behavior and Symptom Identification Scale-24) were completed for 421 veterans at enrollment and 3 months later. Linear and logistic regression analyses were conducted to examine: (1) predisposing characteristics, enabling resources, and need as predictors of MHS inpatient, residential, and outpatient utilization and (2) the association between individual characteristics, utilization, and clinical outcomes. Being older, female, having greater clinical need, lack of enabling resources (employment, stable housing, and social support), and easy access to treatment significantly predicted greater MHS utilization at 3-month follow-up. Less clinical need and no inpatient psychiatric hospitalization predicted better GAF and Behavior and Symptom Identification Scale-24 scores. White race and residential treatment also predicted better GAF scores. Neither enabling resources, nor number of outpatient mental health visits predicted clinical outcomes. This application of Andersen's behavioral model of health service utilization confirmed associations between some predisposing characteristics, need, and enabling resources on MHS utilization but only predisposing characteristics, need, and utilization were associated with clinical outcomes.

  11. Developing a science of clinical utility in diagnostic classification systems field study strategies for ICD-11 mental and behavioral disorders.

    PubMed

    Keeley, Jared W; Reed, Geoffrey M; Roberts, Michael C; Evans, Spencer C; Medina-Mora, María Elena; Robles, Rebeca; Rebello, Tahilia; Sharan, Pratap; Gureje, Oye; First, Michael B; Andrews, Howard F; Ayuso-Mateos, José Luís; Gaebel, Wolfgang; Zielasek, Juergen; Saxena, Shekhar

    2016-01-01

    The World Health Organization (WHO) Department of Mental Health and Substance Abuse has developed a systematic program of field studies to evaluate and improve the clinical utility of the proposed diagnostic guidelines for mental and behavioral disorders in the Eleventh Revision of the International Classification of Diseases and Related Health Problems (ICD-11). The clinical utility of a diagnostic classification is critical to its function as the interface between health encounters and health information, and to making the ICD-11 be a more effective tool for helping the WHO's 194 member countries, including the United States, reduce the global disease burden of mental disorders. This article describes the WHO's efforts to develop a science of clinical utility in regard to one of the two major classification systems for mental disorders. We present the rationale and methodologies for an integrated and complementary set of field study strategies, including large international surveys, formative field studies of the structure of clinicians' conceptualization of mental disorders, case-controlled field studies using experimental methodologies to evaluate the impact of proposed changes to the diagnostic guidelines on clinicians' diagnostic decision making, and ecological implementation field studies of clinical utility in the global settings in which the guidelines will ultimately be implemented. The results of these studies have already been used in making decisions about the structure and content of ICD-11. If clinical utility is indeed among the highest aims of diagnostic systems for mental disorders, as their developers routinely claim, future revision efforts should continue to build on these efforts. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  12. Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

    PubMed

    Block, Darci R; Algeciras-Schimnich, Alicia

    2013-01-01

    Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

  13. Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial.

    PubMed

    Menchón, J M; Espadaler, J; Tuson, M; Saiz-Ruiz, J; Bobes, J; Vieta, E; Álvarez, E; Pérez, V

    2018-05-04

    Clinical utility of commercial multi-gene pharmacogenetic tests in depression is starting to be studied with some promising results on efficacy and tolerability. Among the next steps is the definition of the patient profile that is most likely to benefit from testing. Here we present a reanalysis of data from the AB-GEN randomized clinical trial showing that clinical utility of pharmacogenetic testing can be markedly influenced by patient characteristics such as age, baseline severity and duration of current depressive episode.Trial registration ClinicalTrials.gov NCT02529462.

  14. Analyzing Clinical Presentation, Service Utilization, and Clinical Outcome of Female Sexual Minority College Students

    ERIC Educational Resources Information Center

    Kay, Heather C.

    2013-01-01

    Researchers examining clinically-relevant trends for sexual minority women have found evidence of psychological distress and greater utilization of mental health services compared to heterosexually-identified women. However, the results of many research studies with this population have methodological limitations surrounding recruitment of…

  15. Clinical Utility of the CCAPS, CAS, and OQ-45

    ERIC Educational Resources Information Center

    MacFarlane, Ian M.; Henry, Courtney L.; Nash, Trisha; Kissel, Susan; Bush, David

    2015-01-01

    This article reports on a study evaluating the clinical utility of three clinical assessment measures commonly used in university counseling centers: the Outcome Questionnaire-45 (OQ-45), the Counseling Center Assessment of Psychological Symptoms, and the College Adjustment Scales. Results found subscales assessing depression and anxiety were…

  16. Clinical Utility of Cancellation on the WISC-IV

    ERIC Educational Resources Information Center

    Zhu, Jianjun; Chen, Hsinyi

    2013-01-01

    This study examined empirical evidence for clinical utility of the Wechsler Intelligence Scale for Children, fourth edition (WISC-IV) cancellation subtest by comparing data from 597 clinical and 597 matched control children. The results of dependent t and sequential logistic regression analyses demonstrated that (a) children with intellectual…

  17. ‘Someday it will be the norm’: physician perspectives on the utility of genome sequencing for patient care in the MedSeq Project

    PubMed Central

    Vassy, Jason L; Christensen, Kurt D; Slashinski, Melody J; Lautenbach, Denise M; Raghavan, Sridharan; Robinson, Jill Oliver; Blumenthal-Barby, Jennifer; Feuerman, Lindsay Zausmer; Lehmann, Lisa Soleymani; Murray, Michael F; Green, Robert C; McGuire, Amy L

    2015-01-01

    Aim To describe practicing physicians’ perceived clinical utility of genome sequencing. Materials & methods We conducted a mixed-methods analysis of data from 18 primary care physicians and cardiologists in a study of the clinical integration of whole-genome sequencing. Physicians underwent brief genomics continuing medical education before completing surveys and semi-structured interviews. Results Physicians described sequencing as currently lacking clinical utility because of its uncertain interpretation and limited impact on clinical decision-making, but they expressed the idea that its clinical integration was inevitable. Potential clinical uses for sequencing included complementing other clinical information, risk stratification, motivating patient behavior change and pharmacogenetics. Conclusion Physicians given genomics continuing medical education use the language of both evidence-based and personalized medicine in describing the utility of genome-wide testing in patient care. PMID:25642274

  18. Scientific ways to study intercessory prayer as an intervention in clinical research.

    PubMed

    Rath, Linda L

    2009-01-01

    The purpose of this article is to share a "research journey" to study the somewhat controversial subject of Christian intercessory prayer (CIP) utilized as a clinical intervention, and the knowledge gained along the way. This article will explore the steps in the development and implementation of clinical research to scientifically examine a phenomenon that many say cannot--and should not--be studied. The sequential steps in developing this area of study are detailed and explained from the conception of the initial idea through utilization of concept analysis and literature review to develop the researchable topic. The subsequent development of both qualitative and quantitative pilot studies to investigate CIP in depth is presented to illustrate how the intervention of CIP can successfully be incorporated into clinical research. This article provides guidelines for future researchers who may want to utilize CIP as an intervention.

  19. Identifying role of perceived quality and satisfaction on the utilization status of the community clinic services; Bangladesh context.

    PubMed

    Karim, Rizwanul M; Abdullah, Mamun S; Rahman, Anisur M; Alam, Ashraful M

    2016-06-24

    Bangladesh is one among the few countries of the world that provides free medical services at the community level through various public health facilities. It is now evident that, clients' perceived quality of services and their expectations of service standards affect health service utilization to a great extent. The aim of the study was to develop and validate the measures for perception and satisfaction of primary health care quality in Bangladesh context and to identify their aspects on the utilization status of the Community Clinic services. This mixed method cross sectional survey was conducted from January to June 2012, in the catchment area of 12 community clinics. Since most of the outcome indicators focus mainly on women and children, women having children less than 2 years of age were randomly assigned and interviewed for the study purpose. Data were collected through FGD, Key informants interview and a pretested semi- structured questionnaire. About 95 % of the respondents were Muslims and 5 % were Hindus. The average age of the respondents was 23.38 (SD 4.15) and almost all of them are home makers. The average monthly expenditure of their family was 95US $ (SD 32US$). At the beginning of the study, two psychometric research instruments; 24 items perceived quality of primary care services PQPCS scale (chronbach's α = .89) and 22 items community clinic service satisfaction CCSS scale (chronbach's α = .97), were constructed and validated. This study showed less educated, poor, landless mothers utilized the community clinic services more than their educated and wealthier counterpart. Women who lived in their own residence used the community clinic services more frequently than those who lived in a rental house. Perceptions concerning skill and competence of the health care provider and satisfaction indicating interpersonal communication and attitude of the care provider were important predictors for community clinic service utilization. Perception related to the quality of management, administration, physical environment of the service point and satisfaction addressing health promotion and women health issues played significant role on community clinic's services utilization. Besides parental education and income, client's perception and satisfaction played significant role in community clinic service utilization. Provider's perception of service quality should be studied. The study findings will enable policy-makers to improve quality of primary health care services, realizing providers' and patients' ideas of community clinic service quality.

  20. Key data elements for use in cost-utility modeling of biological treatments for rheumatoid arthritis.

    PubMed

    Ganz, Michael L; Hansen, Brian Bekker; Valencia, Xavier; Strandberg-Larsen, Martin

    2015-05-01

    Economic evaluation is becoming more common and important as new biologic therapies for rheumatoid arthritis (RA) are developed. While much has been published about how to design cost-utility models for RA to conduct these evaluations, less has been written about the sources of data populating those models. The goal is to review the literature and to provide recommendations for future data collection efforts. This study reviewed RA cost-utility models published between January 2006 and February 2014 focusing on five key sources of data (health-related quality-of-life and utility, clinical outcomes, disease progression, course of treatment, and healthcare resource use and costs). It provided recommendations for collecting the appropriate data during clinical and other studies to support modeling of biologic treatments for RA. Twenty-four publications met the selection criteria. Almost all used two steps to convert clinical outcomes data to utilities rather than more direct methods; most did not use clinical outcomes measures that captured absolute levels of disease activity and physical functioning; one-third of them, in contrast with clinical reality, assumed zero disease progression for biologic-treated patients; little more than half evaluated courses of treatment reflecting guideline-based or actual clinical care; and healthcare resource use and cost data were often incomplete. Based on these findings, it is recommended that future studies collect clinical outcomes and health-related quality-of-life data using appropriate instruments that can convert directly to utilities; collect data on actual disease progression; be designed to capture real-world courses of treatment; and collect detailed data on a wide range of healthcare resources and costs.

  1. Circulating tumor cells: clinical validity and utility.

    PubMed

    Cabel, Luc; Proudhon, Charlotte; Gortais, Hugo; Loirat, Delphine; Coussy, Florence; Pierga, Jean-Yves; Bidard, François-Clément

    2017-06-01

    Circulating tumor cells (CTCs) are rare tumor cells and have been investigated as diagnostic, prognostic and predictive biomarkers in many types of cancer. Although CTCs are not currently used in clinical practice, CTC studies have accumulated a high level of clinical validity, especially in breast, lung, prostate and colorectal cancers. In this review, we present an overview of the current clinical validity of CTCs in metastatic and non-metastatic disease, and the main concepts and studies investigating the clinical utility of CTCs. In particular, this review will focus on breast, lung, colorectal and prostate cancer. Three major topics concerning the clinical utility of CTC are discussed-(1) treatment based on CTCs used as liquid biopsy, (2) treatment based on CTC count or CTC variations, and (3) treatment based on CTC biomarker expression. A summary of published or ongoing phase II and III trials is also presented.

  2. Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

    PubMed

    Phillips, Kathryn A; Deverka, Patricia A; Sox, Harold C; Khoury, Muin J; Sandy, Lewis G; Ginsburg, Geoffrey S; Tunis, Sean R; Orlando, Lori A; Douglas, Michael P

    2017-10-01

    Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

  3. Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

    PubMed Central

    Phillips, Kathryn A.; Deverka, Patricia A.; Sox, Harold C.; Khoury, Muin J.; Sandy, Lewis G.; Ginsburg, Geoffrey S.; Tunis, Sean R.; Orlando, Lori A.; Douglas, Michael P.

    2017-01-01

    Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address. Genet Med advance online publication 13 April 2017 PMID:28406488

  4. Asthma Outcomes: Healthcare Utilization and Costs

    PubMed Central

    Akinbami, Lara J.; Sullivan, Sean D.; Campbell, Jonathan D.; Grundmeier, Robert W.; Hartert, Tina V.; Lee, Todd A.; Smith, Robert A.

    2014-01-01

    Background Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. Methods We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized) and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, society), (2) standardize the measurement period (ideally, 12 months), and (3) use standard units to measure healthcare utilization and other asthma-related events. Conclusions Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care. PMID:22386509

  5. Assessing the Impact of Peer Educator Outreach on the Likelihood and Acceleration of Clinic Utilization among Sex Workers.

    PubMed

    Krishnamurthy, Parthasarathy; Hui, Sam K; Shivkumar, Narayanan; Gowda, Chandrasekhar; Pushpalatha, R

    2016-01-01

    Peer-led outreach is a critical element of HIV and STI-reduction interventions aimed at sex workers. We study the association between peer-led outreach to sex workers and the time to utilize health facilities for timely STI syndromic-detection and treatment. Using data on the timing of peer-outreach interventions and clinic visits, we utilize an Extended Cox model to assess whether peer educator outreach intensity is associated with accelerated clinic utilization among sex workers. Our data comes from 2705 female sex workers registered into Pragati, a women-in-sex-work outreach program, and followed from 2008 through 2012. We analyze this data using an Extended Cox model with the density of peer educator visits in a 30-day rolling window as the key predictor, while controlling for the sex workers' age, client volume, location of sex work, and education level. The principal outcome of interest is the timing of the first voluntary clinic utilization. More frequent peer visit is associated with earlier first clinic visit (HR: 1.83, 95% CI, 1.75-1.91, p < .001). In addition, 18% of all syndrome-based STI detected come from clinic visits in which the sex worker reports no symptoms, underscoring the importance of inducing clinic visits in the detection of STI. Additional models to test the robustness of these findings indicate consistent beneficial effect of peer educator outreach. Peer outreach density is associated with increased likelihood of-and shortened duration to-clinic utilization among female sex workers, suggesting potential staff resourcing implications. Given the observational nature of our study, however, these findings should be interpreted as an association rather than as a causal relationship.

  6. From clinically relevant outcome measures to quality of life in epilepsy: A time trade-off study.

    PubMed

    de Kinderen, Reina J A; Wijnen, Ben F M; van Breukelen, Gerard; Postulart, Debby; Majoie, Marian H J M; Aldenkamp, Albert P; Evers, Silvia M A A

    2016-09-01

    A proposed method for bridging the gap between clinically relevant epilepsy outcome measures and quality-adjusted life years is to derive utility scores for epilepsy health states. The aim of this study is to develop such a utility-function and to investigate the impact of the epilepsy outcome measures on utility. Health states, based on clinically important epilepsy attributes (e.g. seizure frequency, seizure severity, side-effects), were valued by a sample of the Dutch population (N=525) based on the time trade-off method. In addition to standard demographics, every participant was asked to rate 10 or 11 different health state scenarios. A multilevel regression analysis was performed to account for the nested structure of the data. Results show that the best health state (no seizures and no side-effects) is estimated at 0.89 and the worst state (seizures type 5 twice a day plus severe side-effects) at 0.22 (scale: 0-1). An increase in seizure frequency, occurrence of side-effects, and seizure severity were all significantly associated with lower utility values. Furthermore, seizure severity has the largest impact on quality of life compared with seizure frequency and side-effects. This study provides a utility-function for transforming clinically relevant epilepsy outcome measures into utility estimates. We advise using our utility-function in economic evaluations, when quality of life is not directly measured in a study and hence, no health state utilities are available, or when there is convincing empirical evidence of the insensitivity of a generic quality-of-life-instrument within epilepsy. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Does the Primary Care Behavioral Health Model Reduce Emergency Department Visits?

    PubMed

    Serrano, Neftali; Prince, Ronald; Fondow, Meghan; Kushner, Kenneth

    2018-04-16

    To examine the impact of integrating behavioral health services using the primary care behavioral health (PCBH) model on emergency department (ED) utilization. Utilization data from three Dane County, Wisconsin hospitals and four primary care clinics from 2003 to 2011. We used a retrospective, quasi-experimental, controlled, pre-post study design. Starting in 2007, two clinics began integrating behavioral health into their primary care practices with a third starting in 2010. A fourth, nonimplementing, community clinic served as control. Change in emergency department and primary care utilization (number of visits) for patients diagnosed with mood and anxiety disorders was the outcomes of interest. Retrospective data were obtained from electronic patient records from the three main area hospitals along with primary care data from participating clinics. Following the introduction of the PCBH model, one clinic experienced a statistically significant (p < .01, 95 percent CI 6.3-16.3 percent), 11.3 percent decrease in the ratio of ED visits to primary care encounters, relative to a control site, but two other intervention clinics did not. The PCBH model may be associated with a reduction in ED utilization, but better-controlled studies are needed to confirm this result. © Health Research and Educational Trust.

  8. Resilients, overcontrollers and undercontrollers: A systematic review of the utility of a personality typology method in understanding adult mental health problems.

    PubMed

    Bohane, Laura; Maguire, Nick; Richardson, Thomas

    2017-11-01

    The person-centred typological approach to personality makes the distinction between overcontrolled and undercontrolled personality types. This review systematically searched for research on the utility of these personality types in adult mental health. A total of 43 papers were included, which were divided broadly into cross-sectional studies, longitudinal studies and studies with clinical populations. Three personality types have been largely replicated in both normal and clinical populations: resilients, overcontrollers and undercontrollers. These types show utility in predicting long-term functioning and mental health, understanding heterogeneous personalities within clinical subgroups and have implications for treatment. Some disagreement on the number of personality types deemed replicable across samples and differing methodologies do exist, with some finding a dimensional approach to personality to have greater predictive utility. These personality types have been shown to be important in a number of mental health problems such as eating disorders, which may prove helpful in developing new psychological interventions. These studies point to the importance of overcontrolled personality types as well as undercontrolled in mental health. More research is needed with a greater range of clinical populations. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. The clinical utility of health-related quality of life screening in a pediatric inflammatory bowel disease clinic.

    PubMed

    Ryan, Jamie L; Mellon, Michael W; Junger, Katherine W F; Hente, Elizabeth A; Denson, Lee A; Saeed, Shehzad A; Hommel, Kevin A

    2013-11-01

    Adjusting to symptom flares, treatment regimens, and side effects places youth with inflammatory bowel disease (IBD) at increased risk for emotional and behavioral problems and adverse disease outcomes. Implementation of psychosocial screening into clinical practice remains a challenge. This study examines the clinical utility of health-related quality of life (HRQOL) screening in predicting disease outcome and healthcare utilization. One hundred twelve youth of 7 to 18 years diagnosed with IBD and their parents. Youth completed standardized measures of HRQOL and depression. Parents completed a proxy report of HRQOL. Pediatric gastroenterologists provided the Physician Global Assessment. Families were recruited from a pediatric gastroenterology clinic. Retrospective chart reviews examined disease outcome and healthcare utilization for 12 months after baseline measurement. Linear regressions, controlling for demographic and disease parameters, revealed that baseline measurement of youth and parent proxy-reported HRQOL predicted the number of IBD-related hospital admissions, gastroenterology clinic visits, emergency department visits, psychology clinic visits, telephone contacts, and pain management referrals over the next 12 months. Disease outcome was not significant. Lower HRQOL was predictive of increased healthcare utilization among youth with IBD. Regular HRQOL screening may be the impetus to providing better case management and allocating resources based on ongoing care needs and costs. Proactive interventions focused on patients with poor HRQOL may be an efficient approach to saving on healthcare costs and resource utilization.

  10. The utility of observational studies in clinical decision making: lessons learned from statin trials.

    PubMed

    Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

    2010-05-01

    Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

  11. The validity and clinical utility of the Disabilities of the Arm Shoulder and Hand questionnaire for hand injuries in developing country contexts: A systematic review.

    PubMed

    de Klerk, Susan; Buchanan, Helen; Jerosch-Herold, Christina

    Systematic review. The Disabilities of the Arm Shoulder and Hand Questionnaire has multiple language versions from many countries around the world. In addition there is extensive research evidence of its psychometric properties. The purpose of this study was to systematically review the evidence available on the validity and clinical utility of the Disabilities of the Arm Shoulder and Hand as a measure of activity and participation in patients with musculoskeletal hand injuries in developing country contexts. We registered the review with international prospective register of systematic reviews prior to conducting a comprehensive literature search and extracting descriptive data. Two reviewers independently assessed methodological quality with the Consensus-Based Standards for the Selection of Health Measurement Instruments critical appraisal tool, the checklist to operationalize measurement characteristics of patient-rated outcome measures and the multidimensional model of clinical utility. Fourteen studies reporting 12 language versions met the eligibility criteria. Two language versions (Persian and Turkish) had an overall rating of good, and one (Thai) had an overall rating of excellent for cross-cultural validity. The remaining 9 language versions had an overall poor rating for cross-cultural validity. Content and construct validity and clinical utility yielded similar results. Poor quality ratings for validity and clinical utility were due to insufficient documentation of results and inadequate psychometric testing. With the increase in migration and globalization, hand therapists are likely to require a range of culturally adapted and translated versions of the Disabilities of the Arm Shoulder and Hand. Recommendations include rigorous application and reporting of cross-cultural adaptation, appropriate psychometric testing, and testing of clinical utility in routine clinical practice. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  12. Measurement properties of self-report physical activity assessment tools in stroke: a protocol for a systematic review

    PubMed Central

    Martins, Júlia Caetano; Aguiar, Larissa Tavares; Nadeau, Sylvie; Scianni, Aline Alvim; Teixeira-Salmela, Luci Fuscaldi; Faria, Christina Danielli Coelho de Morais

    2017-01-01

    Introduction Self-report physical activity assessment tools are commonly used for the evaluation of physical activity levels in individuals with stroke. A great variety of these tools have been developed and widely used in recent years, which justify the need to examine their measurement properties and clinical utility. Therefore, the main objectives of this systematic review are to examine the measurement properties and clinical utility of self-report measures of physical activity and discuss the strengths and limitations of the identified tools. Methods and analysis A systematic review of studies that investigated the measurement properties and/or clinical utility of self-report physical activity assessment tools in stroke will be conducted. Electronic searches will be performed in five databases: Medical Literature Analysis and Retrieval System Online (MEDLINE) (PubMed), Excerpta Medica Database (EMBASE), Physiotherapy Evidence Database (PEDro), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SciELO), followed by hand searches of the reference lists of the included studies. Two independent reviewers will screen all retrieve titles, abstracts, and full texts, according to the inclusion criteria and will also extract the data. A third reviewer will be referred to solve any disagreement. A descriptive summary of the included studies will contain the design, participants, as well as the characteristics, measurement properties, and clinical utility of the self-report tools. The methodological quality of the studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and the clinical utility of the identified tools will be assessed considering predefined criteria. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Discussion This systematic review will provide an extensive review of the measurement properties and clinical utility of self-report physical activity assessment tools used in individuals with stroke, which would benefit clinicians and researchers. Trial registration number PROSPERO CRD42016037146. PMID:28193848

  13. User-centered design to improve clinical decision support in primary care.

    PubMed

    Brunner, Julian; Chuang, Emmeline; Goldzweig, Caroline; Cain, Cindy L; Sugar, Catherine; Yano, Elizabeth M

    2017-08-01

    A growing literature has demonstrated the ability of user-centered design to make clinical decision support systems more effective and easier to use. However, studies of user-centered design have rarely examined more than a handful of sites at a time, and have frequently neglected the implementation climate and organizational resources that influence clinical decision support. The inclusion of such factors was identified by a systematic review as "the most important improvement that can be made in health IT evaluations." (1) Identify the prevalence of four user-centered design practices at United States Veterans Affairs (VA) primary care clinics and assess the perceived utility of clinical decision support at those clinics; (2) Evaluate the association between those user-centered design practices and the perceived utility of clinical decision support. We analyzed clinic-level survey data collected in 2006-2007 from 170 VA primary care clinics. We examined four user-centered design practices: 1) pilot testing, 2) provider satisfaction assessment, 3) formal usability assessment, and 4) analysis of impact on performance improvement. We used a regression model to evaluate the association between user-centered design practices and the perceived utility of clinical decision support, while accounting for other important factors at those clinics, including implementation climate, available resources, and structural characteristics. We also examined associations separately at community-based clinics and at hospital-based clinics. User-centered design practices for clinical decision support varied across clinics: 74% conducted pilot testing, 62% conducted provider satisfaction assessment, 36% conducted a formal usability assessment, and 79% conducted an analysis of impact on performance improvement. Overall perceived utility of clinical decision support was high, with a mean rating of 4.17 (±.67) out of 5 on a composite measure. "Analysis of impact on performance improvement" was the only user-centered design practice significantly associated with perceived utility of clinical decision support, b=.47 (p<.001). This association was present in hospital-based clinics, b=.34 (p<.05), but was stronger at community-based clinics, b=.61 (p<.001). Our findings are highly supportive of the practice of analyzing the impact of clinical decision support on performance metrics. This was the most common user-centered design practice in our study, and was the practice associated with higher perceived utility of clinical decision support. This practice may be particularly helpful at community-based clinics, which are typically less connected to VA medical center resources. Published by Elsevier B.V.

  14. Evidence for the Criterion Validity and Clinical Utility of the Pathological Narcissism Inventory

    ERIC Educational Resources Information Center

    Thomas, Katherine M.; Wright, Aidan G. C.; Lukowitsky, Mark R.; Donnellan, M. Brent; Hopwood, Christopher J.

    2012-01-01

    In this study, the authors evaluated aspects of criterion validity and clinical utility of the grandiosity and vulnerability components of the Pathological Narcissism Inventory (PNI) using two undergraduate samples (N = 299 and 500). Criterion validity was assessed by evaluating the correlations of narcissistic grandiosity and narcissistic…

  15. Estimation of utilities in attention-deficit hyperactivity disorder for economic evaluations.

    PubMed

    Lloyd, Andrew; Hodgkins, Paul; Sasane, Rahul; Akehurst, Ron; Sonuga-Barke, Edmund J S; Fitzgerald, Patrick; Nixon, Annabel; Erder, Haim; Brazier, John

    2011-01-01

    Attempts to estimate the cost effectiveness of attention-deficit hyperactivity disorder (ADHD) treatments in the past have relied on classifying ADHD patients as responders or non-responders to treatment. Responder status has been associated with a small gain in health-related quality of life (HR-QOL) [or utility, as measured using the generic QOL measure EQ-5D] of 0.06 (on a scale from 0 being dead to 1.0 being full health). The goal of the present study was to develop and validate several ADHD-related health states, and to estimate utility values measured amongst the general public for those states and to re-estimate utility values associated with responder status. Detailed qualitative interview data were collected from 20 young ADHD patients to characterize their HR-QOL. In addition, item-by-item clinical and HR-QOL data from a clinical trial were used to define and describe four health states (normal; borderline to mildly ill; moderately to markedly ill; and severely ill). ADHD experts assessed the content validity of the descriptions. The states were rated by 100 members of the UK general public using the time trade-off (TTO) interview and visual analog scale. Statistical mapping was also undertaken to estimate Clinical Global Impression-Improvement (CGI-I) utilities (i.e. response status) from Clinical Global Impression-Severity (CGI-S) defined states. The mapping work estimated changes in utilities from study baseline to last visit for patients with a CGI-I score of ≤ 2 or ≤ 3. The validity of the four health states developed in this study was supported by in-depth interviews with ADHD experts and patients, and clinical trial data. TTO-derived utilities for the four health states ranged from 0.839 (CGI-S state 'normal') to 0.444 (CGI-S state 'severely ill'). From the mapping work, the change in utility for treatment responders was 0.19 for patients with a CGI-I score of ≤ 2 and 0.15 for patients with a CGI-I score of ≤ 3. The present study provides utilities for different severity levels of ADHD estimated in a TTO study. This approach provides a more granular assessment of the impact of ADHD on HR-QOL than binary approaches employed in previous economic analyses. Change in utility for responders and non-responders at different levels of CGI-I was estimated, and thus these utilities may be used to compare health gains of different ADHD interventions.

  16. Molecular Indicators of Castration-Resistant Prostate Cancer

    DTIC Science & Technology

    2015-12-01

    hypothesis- generating. To evaluate the clinical utility of AR-V7/AR- FL ratio measurement, a more in-depth investigation will be necessary but would be...V7, supporting expanded validation studies aimed at evaluating the clinical utility of this blood-based treatment selection marker. References...engl j med 371;11 nejm.org september 11, 2014 1035 mained marginally predictive of shorter clinical or radiographic progression–free survival (hazard

  17. Health services utilization under Qassam rocket attacks.

    PubMed

    Goldberg, Lital; Dreiher, Jacob; Friger, Michael; Levin, Alexander; Shvartzman, Pesach

    2013-08-01

    The Qassam rocket attacks on southern Israel during the years 2000-2007 created a unique situation of life undera continuous threat. The effect of this unique situation on health services utilization has not been previously examined. To evaluate health utilization patterns in two primary care clinics in southern Israel: one under continuous attacks of Qassam rockets as compared with a similar clinic not under a rocket threat. We conducted a retrospective cross-sectional study in two primary care clinics in southern Israel, with 11,630 persons listed in the two clinics during the entire study period. The primary outcome measures were total annual number of visits per person to the clinic and for specific diagnoses, and the number of drug prescriptions issued, emergency room (ER) visits, hospitalization days, cardiac catheterizations and coronary bypass surgeries. In both clinics there was an increase over time in the mean annual number of visits per person. During the years of severe attacks there was an increase in visits with a chief complaint of depression and anxiety and an increase in the number of anxiolytic prescriptions in the study clinic compared with the control. During the same period there was a decrease in the number of ER visits in the study clinic compared with the control. The population under continuous life-threatening events showed more depression and anxiety problems. Under severe bombardment, the residents prefer not to leave home, unless necessary.

  18. Making medical decisions in dependence of genetic background: estimation of the utility of DNA testing in clinical, pharmaco-epidemiological or genetic studies.

    PubMed

    Nguyen, Thuy Trang; Schäfer, Helmut; Timmesfeld, Nina

    2013-05-01

    An index measuring the utility of testing a DNA marker before deciding between two alternative treatments is proposed which can be estimated from pharmaco-epidemiological case-control or cohort studies. In the case-control design, external estimates of the prevalence of the disease and of the frequency of the genetic risk variant are required for estimating the utility index. Formulas for point and interval estimates are derived. Empirical coverage probabilities of the confidence intervals were estimated under different scenarios of disease prevalence, prevalence of drug use, and population frequency of the genetic variant. To illustrate our method, we re-analyse pharmaco-epidemiological case-control data on oral contraceptive intake and venous thrombosis in carriers and non-carriers of the factor V Leiden mutation. We also re-analyse cross-sectional data from the Framingham study on a gene-diet interaction between an APOA2 polymorphism and high saturated fat intake on obesity. We conclude that the utility index may be helpful to evaluate and appraise the potential clinical and public health relevance of gene-environment interaction effects detected in genomic and candidate gene association studies and may be a valuable decision support for designing prospective studies on the clinical utility. © 2013 Wiley Periodicals, Inc.

  19. Pharmacological validation of a novel nonhuman primate measure of thermal responsivity with utility for predicting analgesic effects.

    PubMed

    Vardigan, Joshua D; Houghton, Andrea K; Lange, Henry S; Adarayan, Emily D; Pall, Parul S; Ballard, Jeanine E; Henze, Darrell A; Uslaner, Jason M

    2018-01-01

    The development of novel analgesics to treat acute or chronic pain has been a challenge due to a lack of translatable measurements. Preclinical end points with improved translatability are necessary to more accurately inform clinical testing paradigms, which may help guide selection of viable drug candidates. In this study, a nonhuman primate biomarker which is sensitive to standard analgesics at clinically relevant plasma concentrations, can differentiate analgesia from sedation and utilizes a protocol very similar to that which can be employed in human clinical studies is described. Specifically, acute heat stimuli were delivered to the volar forearm using a contact heat thermode in the same manner as the clinical setting. Clinically efficacious exposures of morphine, fentanyl, and tramadol produced robust analgesic effects, whereas doses of diazepam that produce sedation had no effect. We propose that this assay has predictive utility that can help improve the probability of success for developing novel analgesics.

  20. Pharmacological validation of a novel nonhuman primate measure of thermal responsivity with utility for predicting analgesic effects

    PubMed Central

    Vardigan, Joshua D; Houghton, Andrea K; Lange, Henry S; Adarayan, Emily D; Pall, Parul S; Ballard, Jeanine E; Henze, Darrell A; Uslaner, Jason M

    2018-01-01

    Introduction The development of novel analgesics to treat acute or chronic pain has been a challenge due to a lack of translatable measurements. Preclinical end points with improved translatability are necessary to more accurately inform clinical testing paradigms, which may help guide selection of viable drug candidates. Methods In this study, a nonhuman primate biomarker which is sensitive to standard analgesics at clinically relevant plasma concentrations, can differentiate analgesia from sedation and utilizes a protocol very similar to that which can be employed in human clinical studies is described. Specifically, acute heat stimuli were delivered to the volar forearm using a contact heat thermode in the same manner as the clinical setting. Results Clinically efficacious exposures of morphine, fentanyl, and tramadol produced robust analgesic effects, whereas doses of diazepam that produce sedation had no effect. Conclusion We propose that this assay has predictive utility that can help improve the probability of success for developing novel analgesics. PMID:29692626

  1. Borderline Personality Traits and Disorder: Predicting Prospective Patient Functioning

    ERIC Educational Resources Information Center

    Hopwood, Christopher J.; Zanarini, Mary C.

    2010-01-01

    Objective: Decisions about the composition of personality assessment in the "Diagnostic and Statistical Manual of Mental Disorders" (5th ed.; DSM-V) will be heavily influenced by the clinical utility of candidate constructs. In this study, we addressed 1 aspect of clinical utility by testing the incremental validity of 5-factor model (FFM)…

  2. Integrated care in rural health: Seeking sustainability.

    PubMed

    Peterson, Mary; Turgesen, Jeri; Fisk, Laura; McCarthy, Seamus

    2017-06-01

    The increased awareness of the financial impact associated with social determinants of health coincides with expectations of the Affordable Care Act (HR 3590) to improve care while reducing costs. The integration of behavioral health providers (BHPs) into primary care has demonstrated improved clinical outcomes. This study was designed with 2 aims, including the evaluation of the financial viability of an integrated care model in a rural setting and the demonstration of incorporating practice-based research into clinical work. A rural health plan caring for 22,000 members funded a pilot project placing BHPs in 3 clinics to provide integrated care. Patient utilization of medical services for 6 months following BHP services was compared with baseline utilization. The BHPs treated 256 unique patients, with a total of 459 consultations. The percentage of patients receiving BHP services varied between clinics (Clinic A = 1.4%, Clinic B = 2.7%, and Clinic C = 3.9%). A between-clinic analysis showed differences in medical claims data between baseline and post-BH services. The overall effect sizes for reduced medical utilization for patients at clinics B and C were very large, Hedge's g = -2.31 and -4.79, respectively. Utilization of 4 of the services (emergency, lab, outpatient, and primary care) showed the large reductions in their costs. In contrast, the data for Clinic A showed no change. Patients receiving behavioral health services within the integrated care model may decrease utilization of medical services following treatment, resulting in cost offset. Potential reasons for variability between clinics are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Accuracy of point-of-care serum creatinine devices for detecting patients at risk of contrast-induced nephropathy: a critical overview.

    PubMed

    Martínez Lomakin, Felipe; Tobar, Catalina

    2014-12-01

    Contrast-induced nephropathy (CIN) is a common event in hospitals, with reported incidences ranging from 1 to 30%. Patients with underlying kidney disease have an increased risk of developing CIN. Point-of-care (POC) creatinine devices are handheld devices capable of providing quantitative data on a patient's kidney function that could be useful in stratifying preventive measures. This overview aims to synthesize the current evidence on diagnostic accuracy and clinical utility of POC creatinine devices in detecting patients at risk of CIN. Five databases were searched for diagnostic accuracy studies or clinical trials that evaluated the usefulness of POC devices in detecting patients at risk of CIN. Selected articles were critically appraised to assess their individual risk of bias by the use of standard criteria; 13 studies were found that addressed the diagnostic accuracy or clinical utility of POC creatinine devices. Most studies incurred a moderate to high risk of bias. Overall concordance between POC devices and reference standards (clinical laboratory procedures) was found to be moderate, with 95% limits of agreement often lying between -35.4 and +35.4 µmol/L (-0.4 and +0.4 mg/dL). Concordance was shown to decrease with worsening kidney function. Data on the clinical utility of these devices were limited, but a significant reduction in time to diagnosis was reported in two studies. Overall, POC creatinine devices showed a moderate concordance with standard clinical laboratory creatinine measurements. Several biases could have induced optimism in these estimations. Results obtained from these devices may be unreliable in cases of severe kidney failure. Randomized trials are needed to address the clinical utility of these devices.

  4. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Harris, Lyndsay N; Ismaila, Nofisat; McShane, Lisa M; Andre, Fabrice; Collyar, Deborah E; Gonzalez-Angulo, Ana M; Hammond, Elizabeth H; Kuderer, Nicole M; Liu, Minetta C; Mennel, Robert G; Van Poznak, Catherine; Bast, Robert C; Hayes, Daniel F

    2016-04-01

    To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. © 2016 by American Society of Clinical Oncology.

  5. Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

    PubMed

    Wang, Bo; Canestaro, William J; Choudhry, Niteesh K

    2014-12-01

    Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add confusion to the clinical decision-making process. To evaluate the evidence that supports pharmacogenomic biomarker testing in drug labels and how frequently testing is recommended. Publicly available US Food and Drug Administration databases. We identified drug labels that described the use of a biomarker and evaluated whether the label contained or referenced convincing evidence of its clinical validity (ie, the ability to predict phenotype) and clinical utility (ie, the ability to improve clinical outcomes) using guidelines published by the Evaluation of Genomic Applications in Practice and Prevention Working Group. We graded the completeness of the citation of supporting studies and determined whether the label recommended incorporation of biomarker test results in therapeutic decision making. Of the 119 drug-biomarker combinations, only 43 (36.1%) had labels that provided convincing clinical validity evidence, whereas 18 (15.1%) provided convincing evidence of clinical utility. Sixty-one labels (51.3%) made recommendations about how clinical decisions should be based on the results of a biomarker test; 36 (30.3%) of these contained convincing clinical utility data. A full description of supporting studies was included in 13 labels (10.9%). Fewer than one-sixth of drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas more than half made recommendations based on biomarker test results. It may be premature to include biomarker testing recommendations in drug labels when convincing data that link testing to patient outcomes do not exist.

  6. Reliability, validity, and utility of the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) in assessments of bariatric surgery candidates.

    PubMed

    Tarescavage, Anthony M; Wygant, Dustin B; Boutacoff, Lana I; Ben-Porath, Yossef S

    2013-12-01

    In the current study, we examined the reliability, validity, and clinical utility of Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2011) scores in a sample of 759 bariatric surgery candidates. We provide descriptives for all scales, internal consistency and standard error of measurement estimates for all substantive scales, external correlates of substantive scales using chart review and self-report criteria, and relative risk ratios to assess the clinical utility of the instrument. Results generally support the reliability, validity, and clinical utility of MMPI-2-RF scale scores in the psychological evaluation of bariatric surgery candidates. Limitations, future directions, and practical application of these results are discussed. (c) 2013 APA, all rights reserved.

  7. Patterns and predictors of health service utilization in adolescents with pain: comparison between a community and a clinical pain sample.

    PubMed

    Toliver-Sokol, Marisol; Murray, Caitlin B; Wilson, Anna C; Lewandowski, Amy; Palermo, Tonya M

    2011-07-01

    There is limited research describing the patterns of healthcare utilization in adolescents with chronic pain. This study describes healthcare utilization in a clinical chronic pain sample, and compares the patterns of service use of this group to a community sample with intermittent pain complaints. We also investigated demographic and clinical factors that predicted healthcare visits and medication use in the clinical sample. Data on 117 adolescents (aged 12-18; n = 59 clinical pain sample, n = 58 community) were collected. Caregivers and adolescents reported on sociodemographics, medical visits, current medications, pain, activity limitations, and depression. As hypothesized, the clinical pain sample had higher rates of healthcare consultation on all types of medical visits (general, specialty care, complementary medicine, mental health, OT/PT), and higher medication use compared to the community sample. Regression analyses revealed that higher annual income, greater pain frequency, and higher levels of caregiver-reported activity limitations were associated with a greater number of healthcare visits for the total sample. Within the clinical pain sample, higher pain frequency and greater activity limitations (caregiver report) predicted more specialty care visits. Additionally, higher income and greater levels of depressive symptoms predicted a higher number of prescribed medications. This study contributes to the limited available data on health service and medication use in a clinical chronic pain sample versus a community sample of adolescents. We also identify clinical factors (pain frequency, parent-reported activity limitations, depressive symptoms) and demographic factors (gender, income) associated with healthcare utilization. Copyright © 2011 American Pain Society. Published by Elsevier Inc. All rights reserved.

  8. Measurement properties, feasibility and clinical utility of the Doloplus-2 pain scale in older adults with cognitive impairment: a systematic review.

    PubMed

    Rostad, Hanne Marie; Utne, Inger; Grov, Ellen Karine; Puts, Martine; Halvorsrud, Liv

    2017-11-02

    The Doloplus-2 is a pain assessment scale for assessing pain in older adults with cognitive impairment. It is used in clinical practice and research. However, evidence for its measurement properties, feasibility and clinical utility remain incomplete. This systematic review synthesizes previous research on the measurement properties, feasibility and clinical utility of the scale. We conducted a systematic search in three databases (CINAHL, Medline and PsycINFO) for studies published in English, French, German, Dutch/Flemish or a Scandinavian language between 1990 and April 2017. We also reviewed the Doloplus-2 homepage and reference lists of included studies to supplement our search. Two reviewers independently reviewed titles and abstracts and performed the quality assessment and data abstraction. A total of 24 studies were included in this systematic review. The quality of the studies varied, but many lacked sufficient detail about the samples and response rates. The Doloplus-2 has been studied using diverse samples in a variety of settings; most study participants were in long-term care and in people with dementia. Sixteen studies addressed various aspects of the scale's feasibility and clinical utility, but their results are limited and inconsistent across settings and samples. Support for the scale's reliability, validity and responsiveness varied widely across the studies. Generally, the reliability coefficients reached acceptable benchmarks, but the evidence for different aspects of the scale's validity and responsiveness was incomplete. Additional high-quality studies are warranted to determine in which populations of older adults with cognitive impairment the Doloplus-2 is reliable, valid and feasible. The ability of the Doloplus-2 to meaningfully quantify pain, measure treatment response and improve patient outcomes also needs further investigation. PROSPERO reg. no.: CRD42016049697 registered 20. Oct. 2016.

  9. Predictors of physical therapy clinic performance in the treatment of patients with low back pain syndromes.

    PubMed

    Resnik, Linda; Liu, Dawei; Mor, Vince; Hart, Dennis L

    2008-09-01

    Little is known about organizational and service delivery factors related to quality of care in physical therapy. This study sought to identify characteristics related to differences in practice outcomes and service utilization. The sample comprised 114 outpatient clinics and 1,058 therapists who treated 16,281 patients with low back pain syndromes during the period 2000-2001. Clinics participated with the Focus on Therapeutic Outcomes, Inc (FOTO) database. Hierarchical linear models were used to risk adjust treatment outcomes and number of visits per treatment episode. Aggregated residual scores from these models were used to classify each clinic into 1 of 3 categories in each of 3 types of performance groups: (1) effectiveness, (2) utilization, and (3) overall performance (ie, composite measure of effectiveness and utilization). Relationships between clinic classification and the following independent variables were examined by multinomial logistic regression: years of therapist experience, number of physical therapists, ratio of physical therapists to physical therapist assistants, proportion of patients with low back pain syndromes, number of new patients per physical therapist per month, utilization of physical therapist assistants, and setting. Clinics that were lower utilizers of physical therapist assistants were 6.6 times more likely to be classified into the high effectiveness group compared with the low effectiveness group, 6.7 times more likely to be classified in the low utilization group compared with the high utilization group, and 12.4 times more likely to be classified in the best performance group compared with the worst performance group. Serving a higher proportion of patients with low back pain syndromes was associated with an increased likelihood of being classified in the lowest or middle group. Years of physical therapist experience was inversely associated with being classified in the middle utilization group compared with the highest utilization group. These findings suggest that, in the treatment of patients with low back pain syndromes, clinics that are low utilizers of physical therapist assistants are more likely to provide superior care (ie, better patient outcomes and lower service use).

  10. Patient Portal Utilization Among Ethnically Diverse Low Income Older Adults: Observational Study

    PubMed Central

    Quandt, Sara A; Sandberg, Joanne C; Miller Jr, David P; Latulipe, Celine; Leng, Xiaoyan; Talton, Jenifer W; Melius, Kathryn P; Smith, Alden; Bertoni, Alain G

    2017-01-01

    Background Patient portals can improve patient communication with providers, provide patients with greater health information access, and help improve patient decision making, if they are used. Because research on factors facilitating and limiting patient portal utilization has not been conceptually based, no leverage points have been indicated for improving utilization. Objective The primary objective for this analysis was to use a conceptual framework to determine potentially modifiable factors affecting patient portal utilization by older adults (aged 55 years and older) who receive care at clinics that serve low income and ethnically diverse communities. The secondary objective was to delineate how patient portal utilization is associated with perceived usefulness and usability. Methods Patients from one urban and two rural clinics serving low income patients were recruited and completed interviewer-administered questionnaires on patient portal utilization. Results A total of 200 ethnically diverse patients completed questionnaires, of which 41 (20.5%) patients reported utilizing portals. Education, social support, and frequent Internet utilization improve the odds of patient portal utilization; receiving health care at a rural clinic decreases the odds of portal utilization. Conclusions Leverage points to address disparities in patient portal utilization include providing training for older adults in patient portal utilization, involving spouses or other care partners in this training, and making information technology access available at public places in rural and urban communities. PMID:29138129

  11. Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion.

    PubMed

    Reches, A; Kutcher, J; Elbin, R J; Or-Ly, H; Sadeh, B; Greer, J; McAllister, D J; Geva, A; Kontos, A P

    2017-01-01

    The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician's decision-making process. The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions.

  12. Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion

    PubMed Central

    Reches, A.; Kutcher, J.; Elbin, R. J.; Or-Ly, H.; Sadeh, B.; Greer, J.; McAllister, D. J.; Geva, A.; Kontos, A. P.

    2017-01-01

    ABSTRACT Background: The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician’s decision-making process. Objective: The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Methods: Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Results: Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. Conclusion: The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions. PMID:28055228

  13. Measurement properties of self-report physical activity assessment tools in stroke: a protocol for a systematic review.

    PubMed

    Martins, Júlia Caetano; Aguiar, Larissa Tavares; Nadeau, Sylvie; Scianni, Aline Alvim; Teixeira-Salmela, Luci Fuscaldi; Faria, Christina Danielli Coelho de Morais

    2017-02-13

    Self-report physical activity assessment tools are commonly used for the evaluation of physical activity levels in individuals with stroke. A great variety of these tools have been developed and widely used in recent years, which justify the need to examine their measurement properties and clinical utility. Therefore, the main objectives of this systematic review are to examine the measurement properties and clinical utility of self-report measures of physical activity and discuss the strengths and limitations of the identified tools. A systematic review of studies that investigated the measurement properties and/or clinical utility of self-report physical activity assessment tools in stroke will be conducted. Electronic searches will be performed in five databases: Medical Literature Analysis and Retrieval System Online (MEDLINE) (PubMed), Excerpta Medica Database (EMBASE), Physiotherapy Evidence Database (PEDro), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SciELO), followed by hand searches of the reference lists of the included studies. Two independent reviewers will screen all retrieve titles, abstracts, and full texts, according to the inclusion criteria and will also extract the data. A third reviewer will be referred to solve any disagreement. A descriptive summary of the included studies will contain the design, participants, as well as the characteristics, measurement properties, and clinical utility of the self-report tools. The methodological quality of the studies will be evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and the clinical utility of the identified tools will be assessed considering predefined criteria. This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. This systematic review will provide an extensive review of the measurement properties and clinical utility of self-report physical activity assessment tools used in individuals with stroke, which would benefit clinicians and researchers. PROSPERO CRD42016037146. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder.

    PubMed

    Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

    2018-01-01

    The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1-10. Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD.

  15. A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

    PubMed Central

    Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

    2018-01-01

    Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD. PMID:29379313

  16. Quality Management Tools: Facilitating Clinical Research Data Integrity by Utilizing Specialized Reports with Electronic Case Report Forms

    PubMed Central

    Trocky, NM; Fontinha, M

    2005-01-01

    Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical® (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer® and Integrated Review TM, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies. PMID:16779428

  17. Clinical utility of measures of breathlessness.

    PubMed

    Cullen, Deborah L; Rodak, Bernadette

    2002-09-01

    The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

  18. Prognostic and Prediction Tools in Bladder Cancer: A Comprehensive Review of the Literature.

    PubMed

    Kluth, Luis A; Black, Peter C; Bochner, Bernard H; Catto, James; Lerner, Seth P; Stenzl, Arnulf; Sylvester, Richard; Vickers, Andrew J; Xylinas, Evanguelos; Shariat, Shahrokh F

    2015-08-01

    This review focuses on risk assessment and prediction tools for bladder cancer (BCa). To review the current knowledge on risk assessment and prediction tools to enhance clinical decision making and counseling of patients with BCa. A literature search in English was performed using PubMed in July 2013. Relevant risk assessment and prediction tools for BCa were selected. More than 1600 publications were retrieved. Special attention was given to studies that investigated the clinical benefit of a prediction tool. Most prediction tools for BCa focus on the prediction of disease recurrence and progression in non-muscle-invasive bladder cancer or disease recurrence and survival after radical cystectomy. Although these tools are helpful, recent prediction tools aim to address a specific clinical problem, such as the prediction of organ-confined disease and lymph node metastasis to help identify patients who might benefit from neoadjuvant chemotherapy. Although a large number of prediction tools have been reported in recent years, many of them lack external validation. Few studies have investigated the clinical utility of any given model as measured by its ability to improve clinical decision making. There is a need for novel biomarkers to improve the accuracy and utility of prediction tools for BCa. Decision tools hold the promise of facilitating the shared decision process, potentially improving clinical outcomes for BCa patients. Prediction models need external validation and assessment of clinical utility before they can be incorporated into routine clinical care. We looked at models that aim to predict outcomes for patients with bladder cancer (BCa). We found a large number of prediction models that hold the promise of facilitating treatment decisions for patients with BCa. However, many models are missing confirmation in a different patient cohort, and only a few studies have tested the clinical utility of any given model as measured by its ability to improve clinical decision making. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  19. Seizure Action Plans Do Not Reduce Health Care Utilization in Pediatric Epilepsy Patients.

    PubMed

    Roundy, Lindsi M; Filloux, Francis M; Kerr, Lynne; Rimer, Alyssa; Bonkowsky, Joshua L

    2016-03-01

    Management of pediatric epilepsy requires complex coordination of care. We hypothesized that an improved seizure management care plan would reduce health care utilization and improve outcomes. The authors conducted a cohort study with historical controls of 120 epilepsy patients before and after implementation of a "Seizure Action Plan." The authors evaluated for differences in health care utilization including emergency department visits, hospitalizations, clinic visits, telephone calls, and the percentage of emergency department visits that resulted in hospitalization in patients who did or did not have a Seizure Action Plan. The authors found that there was no decrease in these measures of health care utilization, and in fact the number of follow-up clinic visits was increased in the group with Seizure Action Plans (4.2 vs 3.3, P = .006). However, the study was underpowered to detect smaller differences. This study suggests that pediatric epilepsy quality improvement measures may require alternative approaches to reduce health care utilization and improve outcomes. © The Author(s) 2015.

  20. Seizure Action Plans Do Not Reduce Health Care Utilization in Pediatric Epilepsy Patients

    PubMed Central

    Roundy, Lindsi M.; Filloux, Francis M.; Kerr, Lynne; Rimer, Alyssa; Bonkowsky, Joshua L.

    2015-01-01

    Management of pediatric epilepsy requires complex coordination of care. We hypothesized that an improved seizure management care plan would reduce healthcare utilization and improve outcomes. We conducted a cohort study with historical controls of 120 epilepsy patients before and after implementation of a “Seizure Action Plan.” We evaluated for differences in healthcare utilization including emergency department visits, hospitalizations, clinic visits, telephone calls, and the percentage of emergency department visits that resulted in hospitalization in patients who did or did not have a Seizure Action Plan. We found that there was no decrease in these measures of healthcare utilization, and in fact the number of follow-up clinic visits was increased in the group with Seizure Action Plans (4.2 versus 3.3, p 0.006). However, the study was underpowered to detect smaller differences. Our study suggests that pediatric epilepsy quality improvement measures may require alternative approaches to reduce healthcare utilization and improve outcomes. PMID:26245799

  1. Value analysis of postoperative staging imaging for asymptomatic, early-stage breast cancer: implications of clinical variation on utility and cost.

    PubMed

    Pellet, Andrew C; Erten, Mujde Z; James, Ted A

    2016-06-01

    Routine staging imaging for early-stage breast cancer is not recommended. Despite this, there is clinical practice variation with imaging studies obtained for asymptomatic patients with a positive sentinel node (SN+). We characterize the utility, cost, and clinical implications of imaging studies obtained in asymptomatic SN+ patients. A retrospective review was performed of asymptomatic, clinically node-negative patients who were found to have a positive sentinel node after surgery. The type of imaging, subsequent tests/interventions, frequency of additional malignancy detected, and costs were recorded. From April 2009 to April 2013, a total of 50 of 113 (44%) asymptomatic patients underwent staging imaging for a positive sentinel node; 11 (22%) patients had at least 1 subsequent imaging study or diagnostic intervention. No instance of metastatic breast cancer was identified, with a total cost of imaging calculated at $116,905. Staging imaging for asymptomatic SN+ breast cancer demonstrates clinical variation. These tests were associated with low utility, increased costs, and frequent false positives leading to subsequent testing/intervention. Evidence-based standardization may help increase quality by decreasing unnecessary variation and cost. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Integrating evidence-based practice into RN-to-BSN clinical nursing education.

    PubMed

    Oh, Eui Geum; Kim, Sunah; Kim, So Sun; Kim, Sue; Cho, Eun Yong; Yoo, Ji-Soo; Kim, Hee Soon; Lee, Ju Hee; You, Mi Ae; Lee, Hyejung

    2010-07-01

    This study examines the effects of integrating evidence-based practice (EBP) into clinical practicum on EBP efficacy and barriers to research utilization among Korean RN-to-BSN students. A one-group pretest-posttest design was used. Eighty-one students were recruited from a school of nursing in Korea. Evidence-based practice clinical practicum was composed of two consecutive programs during one semester. Lectures, individual mentoring on EBP practicum, small group, and wrap-up conferences were provided. Outcomes of EBP efficacy and barriers to research utilization were analyzed using paired t tests for 74 final participants. Evidence-based practice efficacy scores increased significantly (p < 0.05), and the barriers to research utilization scores decreased significantly after the EBP clinical practicum. The results highlight the effectiveness of EBP education among RN-to-BSN students. These results may help health educators develop effective educational strategies to integrate EBP concepts into a clinical practicum. Copyright 2010, SLACK Incorporated.

  3. Clinicians’ Use of Personality Disorder Models within a Particular Treatment Setting: A Longitudinal Comparison of Temporal Consistency and Clinical Utility

    PubMed Central

    Samuel, Douglas B.; Widiger, Thomas A.

    2012-01-01

    An active line of current investigation is how the five-factor model (FFM) of personality disorder might be applied by clinicians and particularly, how clinically useful this model is in comparison to the existing nomenclature. The current study is the first to investigate the temporal consistency of clinicians’ application of the FFM and the DSM-IV-TR to their own patients. Results indicated that FFM ratings were relatively stable over six-months of treatment, supporting their use by clinicians, but also indexed potentially important clinical changes. Additionally, ratings of utility provided by the clinicians suggested that the FFM was more useful for clinical decision making than was the DSM-IV-TR model. We understand the clinical utility findings within the context of previous research indicating that the FFM is most useful among patients who are not prototypic for a personality disorder. PMID:24288580

  4. Clinical Utility of the Cross-Cultural (Chinese) Personality Assessment Inventory (CPAI-2) in the Assessment of Substance Use Disorders among Chinese Men

    ERIC Educational Resources Information Center

    Cheung, Fanny M.; Cheung, Shu Fai; Leung, Freedom

    2008-01-01

    This study examined the clinical utility of the Cross-Cultural (Chinese) Personality Inventory (CPAI-2) in differentiating the personality characteristics of Chinese men with substance use disorders from other psychiatric patients and normal control participants. The CPAI-2 profile of 121 Chinese men with substance use disorders was contrasted…

  5. Retail clinic visits: are resident paneled patients more likely to make multiple visits?

    PubMed

    Angstman, Kurt B; Garrison, Gregory M; Rohrer, James E; Dupras, Denise M; O'Grady, Jason S

    2012-04-01

    Primary care resident physicians generally have significantly fewer hours in outpatient clinic per week than staff physicians. With the transient nature of a primary care resident's practice, do the patients of residents utilize the health care system differently? Our hypothesis was that patients paneled with a resident physician would be more likely to utilize retail clinics with repeat week day visits than those patients paneled with a staff primary care physician. A retrospective review of 16,318 retail clinic visits made in 2009 was studied. Since the patient making a repeat retail clinic visit had experience with the services available, they were making an informed decision on the type of care desired (their primary care provider or not). The patients who made repeat retail clinical visits were divided into groups by age, those younger than 18 years and those 18 years and older. Via multiple logistic regression, patients under 18 years demonstrated that a patient paneled with a resident physician was no more likely to have repeat visits to the retail clinic than a staff physician's patient, when controlling for all other variables. Similarly, those ages 18 years and older also demonstrated no differences in resident or staff paneled patients in utilization of retail clinics during the work day. Multivariate analysis found no difference in the utilization of repeat retail clinic visits during 2009 with resident paneled patients as compared to staff physician patients.

  6. Nutritive utilization of protein and digestive utilization of fat in two commercial diets designed for clinical enteral nutrition.

    PubMed

    Alférez, M J; Campos, M S; Barrionuevo, M; López-Aliaga, I

    1990-01-01

    The digestive and metabolic utilization of protein (50% lactoalbumin + 50% casein) and fat (43.0% butter, 29.5% olive oil, 14.7% soy oil, 9.8% MCT and 3.0% lecithin) provided by two commercial diets used in clinical enteral nutrition (normoproteic, 16.1% protein and 20.8% fat, and hyperproteic, 23.1% protein and 14.9% fat), was studied in adult rats (mean body weight 180 g). The diet containing the greater amount of protein improved the digestive utilization of nitrogen, and although nitrogen retention was optimal, it failed to rise further when the dietary protein supply was increased. The digestive utilization of fat in both diets was excellent.

  7. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Harris, Lyndsay N.; McShane, Lisa M.; Andre, Fabrice; Collyar, Deborah E.; Gonzalez-Angulo, Ana M.; Hammond, Elizabeth H.; Kuderer, Nicole M.; Liu, Minetta C.; Mennel, Robert G.; Van Poznak, Catherine; Bast, Robert C.; Hayes, Daniel F.

    2016-01-01

    Purpose To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. PMID:26858339

  8. A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

    PubMed

    Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

    2015-01-01

    The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.

  9. Adolescent idiopathic scoliosis screening for school, community, and clinical health promotion practice utilizing the PRECEDE-PROCEED model

    PubMed Central

    Mirtz, Timothy A; Thompson, Mark A; Greene, Leon; Wyatt, Lawrence A; Akagi, Cynthia G

    2005-01-01

    Background Screening for adolescent idiopathic scoliosis (AIS) is a commonly performed procedure for school children during the high risk years. The PRECEDE-PROCEDE (PP) model is a health promotion planning model that has not been utilized for the clinical diagnosis of AIS. The purpose of this research is to study AIS in the school age population using the PP model and its relevance for community, school, and clinical health promotion. Methods MEDLINE was utilized to locate AIS data. Studies were screened for relevance and applicability under the auspices of the PP model. Where data was unavailable, expert opinion was utilized based on consensus. Results The social assessment of quality of life is limited with few studies approaching the long-term effects of AIS. Epidemiologically, AIS is the most common form of scoliosis and leading orthopedic problem in children. Behavioral/environmental studies focus on discovering etiologic relationships yet this data is confounded because AIS is not a behavioral. Illness and parenting health behaviors can be appreciated. The educational diagnosis is confounded because AIS is an orthopedic disorder and not behavioral. The administration/policy diagnosis is hindered in that scoliosis screening programs are not considered cost-effective. Policies are determined in some schools because 26 states mandate school scoliosis screening. There exists potential error with the Adam's test. The most widely used measure in the PP model, the Health Belief Model, has not been utilized in any AIS research. Conclusion The PP model is a useful tool for a comprehensive study of a particular health concern. This research showed where gaps in AIS research exist suggesting that there may be problems to the implementation of school screening. Until research disparities are filled, implementation of AIS screening by school, community, and clinical health promotion will be compromised. Lack of data and perceived importance by school/community health planners may influence clinical health promotion practices. PMID:16318632

  10. Organizational Characteristics of Veterans Affairs Clinics With High and Low Utilization of Clozapine.

    PubMed

    Gören, Jessica L; Rose, Adam J; Engle, Ryann L; Smith, Eric G; Christopher, Melissa L D; Rickles, Nathaniel M; Semla, Todd P; McCullough, Megan B

    2016-11-01

    Twenty to thirty percent of patients with schizophrenia experience treatment resistance. Clozapine is the only medication proven effective for treatment-resistant schizophrenia. However, in most settings less than 25% of patients with treatment-resistant schizophrenia receive clozapine. This study was conducted to identify facilitators of and barriers to clozapine use to inform development of interventions to maximize appropriate clozapine utilization. Seventy semistructured phone interviews were conducted with key informants of clozapine processes at U.S. Department of Veterans Affairs medical centers in various U.S. regions, including urban and rural areas, with high (N=5) and low (N=5) rates of clozapine utilization. Interviewees included members of mental health leadership, psychiatrists, clinical pharmacists, and advanced practice nurses. Interviews were analyzed by using an emergent thematic strategy to identify barriers and facilitators related to clozapine prescribing. High utilization was associated with integration of nonphysician psychiatric providers and clear organizational processes and infrastructure for treatment of severe mental illness, for example, use of clozapine clinics and mental health intensive case management. Low utilization was associated with a lack of champions to support clozapine processes and with limited-capacity care systems. Obstacles identified at both high- and low-utilization sites included complex, time-consuming paperwork; reliance on a few individuals to facilitate processes; and issues related to transportation for patients living far from care facilities. Implementation efforts to organize, streamline, and simplify clozapine processes; development of a multidisciplinary clozapine clinic; increased capacity of existing clinics; and provision of transportation are reasonable targets to increase clozapine utilization.

  11. Mental Subnormality in the Community: A Clinical and Epidemiologic Study.

    ERIC Educational Resources Information Center

    Birch, Herbert G.; And Others

    The book reports a clinical and epidemiologic study of the prevalence, distribution, and antecedents of mental subnormality in 8 to 10 year old children living in Aberdeen, Scotland (population 187,000). Utilizing three types of data (differential clinical diagnoses, biological background information, and social characteristics), the study…

  12. Virtual Patient Simulations for Medical Education: Increasing Clinical Reasoning Skills through Deliberate Practice

    ERIC Educational Resources Information Center

    McCoy, Lise

    2014-01-01

    Virtual Patient Simulations (VPS) are web-based exercises involving simulated patients in virtual environments. This study investigates the utility of VPS for increasing medical student clinical reasoning skills, collaboration, and engagement. Many studies indicate that VPS provide medical students with essential practice in clinical decision…

  13. Current and Emerging Technology Approaches in Genomics

    PubMed Central

    Conley, Yvette P.; Biesecker, Leslie G.; Gonsalves, Stephen; Merkle, Carrie J.; Kirk, Maggie; Aouizerat, Bradley E.

    2013-01-01

    Purpose To introduce current and emerging approaches that are being utilized in the field of genomics so the reader can conceptually evaluate the literature and appreciate how these approaches are advancing our understanding of health-related issues. Organizing Construct Each approach is described and includes information related to how it is advancing research, its potential clinical utility, exemplars of current uses, challenges related to technologies used for these approaches, and when appropriate information related to understanding the evidence base for clinical utilization of each approach is provided. Web-based resources are included for the reader who would like more in-depth information and to provide opportunity to stay up to date with these approaches and their utility. Conclusions The chosen approaches– genome sequencing, genome-wide association studies, epigenomics, and gene expression– are extremely valuable approaches for collecting research data to help us better understand the pathophysiology of a variety of health-related conditions, but they are also gaining in utility for clinical assessment and testing purposes. Clinical Relevance Our increased understanding of the molecular underpinnings of disease will assist with better development of screening tests, diagnostic tests, tests that allow us to prognosticate, tests that allow for individualized treatments, and tests to facilitate post-treatment surveillance. PMID:23294727

  14. Impact of an Onsite Clinic on Utilization of Preventive Services.

    PubMed

    Ostovari, Mina; Yu, Denny; Yih, Yuehwern; Steele-Morris, Charlotte Joy

    2017-07-01

    To assess impact of an onsite clinic on healthcare utilization of preventive services for employees of a public university and their dependents. Descriptive statistics, logistic regression and classification tree techniques were used to assess health claim data to identify changes in patterns of healthcare utilization and factors impacting usage of onsite clinic. Utilization of preventive services significantly increased for women and men employees by 9% and 14% one year after implementation of the onsite clinic. Hourly-paid employees, employees without diabetes, employees with spouse opt out or no coverage were more likely to go to the onsite clinic. Adapted framework for assessing performance of onsite clinics based on usage of health informatics would help to identify health utilization patterns and interaction between onsite clinic and offsite health providers.

  15. Clinical Utility of Epstein-Barr Virus DNA Testing in the Treatment of Nasopharyngeal Carcinoma Patients.

    PubMed

    Kim, Kelly Y; Le, Quynh-Thu; Yom, Sue S; Ng, Raymond H W; Chan, K C Allen; Bratman, Scott V; Welch, John J; Divi, Rao L; Petryshyn, Raymond A; Conley, Barbara A

    2017-08-01

    Epstein-Barr virus (EBV) DNA analysis has been shown to be useful for early detection, prognostication, and monitoring of treatment response of nasopharyngeal carcinoma (NPC), and the recent literature provides growing evidence of the clinical utility of EBV DNA testing, particularly to inform treatment decisions for NPC patients. Despite the fact that NPC is a rare disease, the NRG Oncology cooperative group has successfully activated a phase 2/3 randomized clinical trial for NPC with international partners and in that process has discovered that the development of a harmonized EBV DNA test is absolutely critical for integration into clinical trials and for future deployment in clinical and central laboratories. In November 2015, the National Cancer Institute (NCI) convened a workshop of international experts in the treatment of NPC and EBV testing to provide a forum for discussing the state of EBV DNA testing and its clinical utility, and to stimulate consideration of future studies and clinical practice guidelines for EBV DNA. This review provides a summary of that discussion. Published by Elsevier Inc.

  16. Is medical perspective on clinical governance practices associated with clinical units' performance and mortality? A cross-sectional study through a record-linkage procedure.

    PubMed

    Sarchielli, Guido; De Plato, Giovanni; Cavalli, Mario; Albertini, Stefano; Nonni, Ilaria; Bencivenni, Lucia; Montali, Arianna; Ventura, Antonio; Montali, Francesca

    2016-01-01

    Assessment of the knowledge and application as well as perceived utility by doctors of clinical governance tools in order to explore their impact on clinical units' performance measured through mortality rates and efficiency indicators. This research is a cross-sectional study with a deterministic record-linkage procedure. The sample includes n = 1250 doctors (n = 249 chiefs of clinical units; n = 1001 physicians) working in six public hospitals located in the Emilia-Romagna Region in Italy. Survey instruments include a checklist and a research-made questionnaire which were used for data collection about doctors' knowledge and application as well as perceived utility of clinical governance tools. The analysis was based on clinical units' performance indicators which include patients' mortality, extra-region active mobility rate, average hospital stay, bed occupancy, rotation and turnover rates, and the comparative performance index as efficiency indicators. The clinical governance tools are known and applied differently in all the considered clinical units. Significant differences emerged between roles and organizational levels at which the medical leadership is carried out. The levels of knowledge and application of clinical governance practices are correlated with the clinical units' efficiency indicators (bed occupancy rate, bed turnover interval, and extra-region mobility). These multiple linear regression analyses highlighted that the clinical governance knowledge and application is correlated with clinical units' mortality rates (odds ratio, -8.677; 95% confidence interval, -16.654, -0.700). The knowledge and application, as well as perceived utility by medical professionals of clinical governance tools, are associated with the mortality rates of their units and with some efficiency indicators. However, the medical frontline staff seems to not consider homogeneously useful the clinical governance tools application on its own clinical practice.

  17. Multispecialty retrospective review of the clinical utility of pelvic magnetic resonance imaging in the setting of pelvic pain.

    PubMed

    Moore, John R; Pathak, Ram A; Snowden, Caroline; Bolan, Candice W; Young, Paul R; Broderick, Gregory A

    2017-12-01

    Pelvic pain is a common complaint, and management of it is often difficult. We sought to evaluate the utility of magnetic resonance imaging (MRI) in the diagnosis of male pelvic pain. Though MRIs are commonly ordered to evaluate pelvic pain, there are very few studies obtaining the efficacy of pelvic MRI in determining a definitive diagnosis. The primary aim of our study was to evaluate the clinical utility of pelvic MRI for a diagnosis code that included pain. After receiving institutional review board approval, a retrospective study was performed of all pelvic MRIs completed at our institution from January 2, 2010 to December 31, 2014. These were further delineated into ordering providers by specialty and urology-specific International Classification of Diseases, Ninth Revision (ICD-9) code diagnoses (male pelvic pain, prostatitis, groin pain, scrotal pain, testicular pain, and penile pain). Clinical utility was defined as positive if MRI findings resulted in a change in management. Subanalysis was performed on patients with an ICD-9 co-diagnosis of previous oncologic concern. A total of 2,643 pelvic MRIs were ordered at our institution over a 5-year period. Of these, 597 pelvic MRIs (23%) were ordered for a diagnosis code that included pain (hip pain, rectal pain, joint pain, penile pain, scrotal pain, male pelvic pain and orchitis). Total utility for MRIs to find anatomic abnormalities potentially responsible for the present pain was 34% (205/597). When ordered by urologic providers, utility was 23%. Oncologists represented the highest positivity rate at 57%. Chronic pelvic pain is a multispecialty complaint that is difficult to treat. We were surprised to find the large number of both specialists and generalists invested in the management of pelvic pain. The increasing availability of MRI technology makes it a likely candidate to test for a clinically significant anatomic reason for pain. Though MRI is a test with minimal adverse effect and no increased risk of radiation exposure, the cost on the healthcare system should be offset by a clear clinical utility. We found total utility to be 34% across all ordering providers and an increase in positivity with concern of oncologic disease. Therefore, we would recommend pelvic MRIs in the evaluation of patients with refractory pelvic pain.

  18. A Process Improvement Study on a Military System of Clinics to Manage Patient Demand and Resource Utilization Using Discrete-Event Simulation, Sensitivity Analysis, and Cost-Benefit Analysis

    DTIC Science & Technology

    2015-03-12

    26 Table 3: Optometry Clinic Frequency Count... Optometry Clinic Frequency Count.................................................................. 86 Table 22: Probability Distribution Summary Table...Clinic, the Audiology Clinic, and the Optometry Clinic. Methodology Overview The overarching research goal is to identify feasible solutions to

  19. Retail Clinic Visits For Low-Acuity Conditions Increase Utilization And Spending.

    PubMed

    Ashwood, J Scott; Gaynor, Martin; Setodji, Claude M; Reid, Rachel O; Weber, Ellerie; Mehrotra, Ateev

    2016-03-01

    Retail clinics have been viewed by policy makers and insurers as a mechanism to decrease health care spending, by substituting less expensive clinic visits for more expensive emergency department or physician office visits. However, retail clinics may actually increase spending if they drive new health care utilization. To assess whether retail clinic visits represent new utilization or a substitute for more expensive care, we used insurance claims data from Aetna for the period 2010-12 to track utilization and spending for eleven low-acuity conditions. We found that 58 percent of retail clinic visits for low-acuity conditions represented new utilization and that retail clinic use was associated with a modest increase in spending, of $14 per person per year. These findings do not support the idea that retail clinics decrease health care spending. Project HOPE—The People-to-People Health Foundation, Inc.

  20. Herbal supplement use among adult dental patients in a USA dental school clinic: prevalence, patient demographics, and clinical implications.

    PubMed

    Abebe, Worku; Herman, Wayne; Konzelman, Joseph

    2011-03-01

    This study assessed the frequency and patterns of utilization of herbal supplement products by adult dental patients at a USA dental school clinic. A self-reporting questionnaire was used to collect patient demographics and frequency of herbal supplement utilization along with other information. The questionnaire was distributed and collected at a dental visit. Herbal utilization was related to patient demographics using descriptive analysis. The clinical implications of the findings are discussed. Out of 1,240 questionnaires, 1,119 were returned as completed. Of these, 12.6% reported using ≥1 of 21 herbal products. The majority of the users were middle-aged educated caucasian women. Green tea, garlic, echinacea, ginkgo biloba, and ginseng were the top 5 products used. Mostly, supplements were consumed in combination with drugs. The type, prevalence, and frequency of herbal supplement utilization by adult dental patients in this USA dental clinic were generally similar to those reported for other population groups. This observation, coupled with the documented effects of the commonly used herbal products, should alert dental health caregivers to inquire about herbal supplement use when evaluating or treating their patients. Copyright © 2011 Mosby, Inc. All rights reserved.

  1. Translating state-of-the-art spinal cord MRI techniques to clinical use: A systematic review of clinical studies utilizing DTI, MT, MWF, MRS, and fMRI

    PubMed Central

    Martin, Allan R.; Aleksanderek, Izabela; Cohen-Adad, Julien; Tarmohamed, Zenovia; Tetreault, Lindsay; Smith, Nathaniel; Cadotte, David W.; Crawley, Adrian; Ginsberg, Howard; Mikulis, David J.; Fehlings, Michael G.

    2015-01-01

    Background A recent meeting of international imaging experts sponsored by the International Spinal Research Trust (ISRT) and the Wings for Life Foundation identified 5 state-of-the-art MRI techniques with potential to transform the field of spinal cord imaging by elucidating elements of the microstructure and function: diffusion tensor imaging (DTI), magnetization transfer (MT), myelin water fraction (MWF), MR spectroscopy (MRS), and functional MRI (fMRI). However, the progress toward clinical translation of these techniques has not been established. Methods A systematic review of the English literature was conducted using MEDLINE, MEDLINE-in-Progress, Embase, and Cochrane databases to identify all human studies that investigated utility, in terms of diagnosis, correlation with disability, and prediction of outcomes, of these promising techniques in pathologies affecting the spinal cord. Data regarding study design, subject characteristics, MRI methods, clinical measures of impairment, and analysis techniques were extracted and tabulated to identify trends and commonalities. The studies were assessed for risk of bias, and the overall quality of evidence was assessed for each specific finding using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results A total of 6597 unique citations were identified in the database search, and after full-text review of 274 articles, a total of 104 relevant studies were identified for final inclusion (97% from the initial database search). Among these, 69 studies utilized DTI and 25 used MT, with both techniques showing an increased number of publications in recent years. The review also identified 1 MWF study, 11 MRS studies, and 8 fMRI studies. Most of the studies were exploratory in nature, lacking a priori hypotheses and showing a high (72%) or moderately high (20%) risk of bias, due to issues with study design, acquisition techniques, and analysis methods. The acquisitions for each technique varied widely across studies, rendering direct comparisons of metrics invalid. The DTI metric fractional anisotropy (FA) had the strongest evidence of utility, with moderate quality evidence for its use as a biomarker showing correlation with disability in several clinical pathologies, and a low level of evidence that it identifies tissue injury (in terms of group differences) compared with healthy controls. However, insufficient evidence exists to determine its utility as a sensitive and specific diagnostic test or as a tool to predict clinical outcomes. Very low quality evidence suggests that other metrics also show group differences compared with controls, including DTI metrics mean diffusivity (MD) and radial diffusivity (RD), the diffusional kurtosis imaging (DKI) metric mean kurtosis (MK), MT metrics MT ratio (MTR) and MT cerebrospinal fluid ratio (MTCSF), and the MRS metric of N-acetylaspartate (NAA) concentration, although these results were somewhat inconsistent. Conclusions State-of-the-art spinal cord MRI techniques are emerging with great potential to improve the diagnosis and management of various spinal pathologies, but the current body of evidence has only showed limited clinical utility to date. Among these imaging tools DTI is the most mature, but further work is necessary to standardize and validate its use before it will be adopted in the clinical realm. Large, well-designed studies with a priori hypotheses, standardized acquisition methods, detailed clinical data collection, and robust automated analysis techniques are needed to fully demonstrate the potential of these rapidly evolving techniques. PMID:26862478

  2. Building the Evidence Base for Decision-making in Cancer Genomic Medicine Using Comparative Effectiveness Research

    PubMed Central

    Goddard, Katrina A.B.; Knaus, William A.; Whitlock, Evelyn; Lyman, Gary H.; Feigelson, Heather Spencer; Schully, Sheri D.; Ramsey, Scott; Tunis, Sean; Freedman, Andrew N.; Khoury, Muin J.; Veenstra, David L.

    2013-01-01

    Background The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. Objectives To identify approaches to help stakeholders make evidence-based decisions, and to describe potential challenges and opportunities using CER to produce evidence-based guidance. Methods We identified general CER approaches for genomic applications through literature review, the authors’ experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Results Evidence generation and synthesis approaches include comparative observational and randomized trials, patient reported outcomes, decision modeling, and economic analysis. We identified significant challenges to conducting CER in cancer genomics: the rapid pace of innovation, the lack of regulation, the limited evidence for clinical utility, and the beliefs that genomic tests could have personal utility without having clinical utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. Conclusions CER offers a variety of methodological approaches to address stakeholders’ needs. Innovative approaches are needed to ensure an effective translation of genomic discoveries. PMID:22516979

  3. A model (CMBP) for collaboration between university college and nursing practice to promote research utilization in students' clinical placements: a pilot study.

    PubMed

    Elsborg Foss, Jette; Kvigne, Kari; Wilde Larsson, Bodil; Athlin, Elsy

    2014-08-01

    A collaborative project was initiated in Norway between a university college and a hospital in order to improve RNs' and nursing students' research utilization in clinical placements. This paper describes the model (CMBP) that was developed, its first application, and evaluation. The evaluation aimed at describing nurses' and students' experiences of the CMBP related to collaboration, facilitation, learning, and impact on nursing care. Thirty-eight students from the second and third year of nursing education, and four nurses answered questionnaires with closed and open ended questions. In addition two of the nurses wrote diaries. Data were subjected to qualitative and quantitative analysis. Almost all participants reported that collaboration between nursing college and nursing practice had been beneficial. Most students and all nurses reported about valuable learning, increased understanding of research utilization, and improved quality of nursing care. Both students and RNs recommended the CMBP to be used in all clinical placements to support academic learning and increase research utilization in clinical practice. Despite study limitations the findings indicate that the CMBP has a potential to be a useful model for teaching RNs' and students EBP. However, further refinement of the model is needed, followed by a more comprehensive implementation and evaluation. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

    PubMed

    Wailoo, Allan J; Hernandez-Alava, Monica; Manca, Andrea; Mejia, Aurelio; Ray, Joshua; Crawford, Bruce; Botteman, Marc; Busschbach, Jan

    2017-01-01

    Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. The validity and clinical utility of purging disorder.

    PubMed

    Keel, Pamela K; Striegel-Moore, Ruth H

    2009-12-01

    To review evidence of the validity and clinical utility of Purging Disorder and examine options for the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-V). Articles were identified by computerized and manual searches and reviewed to address five questions about Purging Disorder: Is there "ample" literature? Is the syndrome clearly defined? Can it be measured and diagnosed reliably? Can it be differentiated from other eating disorders? Is there evidence of syndrome validity? Although empirical classification and concurrent validity studies provide emerging support for the distinctiveness of Purging Disorder, questions remain about definition, diagnostic reliability in clinical settings, and clinical utility (i.e., prognostic validity). We discuss strengths and weaknesses associated with various options for the status of Purging Disorder in the DSM-V ranging from making no changes from DSM-IV to designating Purging Disorder a diagnosis on equal footing with Anorexia Nervosa and Bulimia Nervosa.

  6. Knowledge, attitudes, practices, and barriers related to research utilization: a survey among pharmacists in Malaysia.

    PubMed

    Tan, Sin Yee; Hatah, Ernieda

    2017-04-01

    Background Research utilization is part of evidence-based practice referring to the process of reviewing and critiquing scientific research and applying the findings to one's own clinical practice. Many studies on research utilization have been conducted with doctors and nurses, but to our knowledge, none have been investigated amongst pharmacists. Objective To assess research utilization and its barriers among pharmacists and identify potential influencing factors. Setting Malaysia. Methods This cross-sectional survey was administered online and by mail to a convenient sample of pharmacists working in hospitals, health clinics, and retail pharmacies in rural and urban areas. Main outcome measure Pharmacists' research utilization knowledge, attitudes, and practices. Results Six hundred surveys were mailed to potential respondents, and 466 were returned (77.7% response rate). Twenty-eight respondents completed the survey online. The respondents' research utilization knowledge, attitudes, and practices were found to be moderate. Research utilization was associated with respondents' knowledge and attitude scores (P < 0.001). When factors related to research utilization were modelled, higher educational level was associated with higher level of research utilization (P < 0.001) while less involvement in journal clubs, more years of service (3-7 years and more than 7 years) were associated with low and moderate research utilization, respectively. The main reported barrier to research utilization was lack of sufficient authority to change patient care procedures. Conclusion Pharmacists' research utilization knowledge, attitudes, and practices can be improved by encouraging pharmacists to pursue higher degrees, promoting active participation in institutions' journal clubs, and introducing senior clinical pharmacist specialization.

  7. Ecological Validity and Clinical Utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue

    PubMed Central

    Junghaenel, Doerte U.; Schneider, Stefan; Stone, Arthur A.; Christodoulou, Christopher; Broderick, Joan E.

    2014-01-01

    Objective This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. Methods One-hundred women completed daily diaries and weekly PROMIS assessments over 4 weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. Results PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps < .0001) and post-menstrual (ps < .0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. Conclusions PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. PMID:24630180

  8. Germline determinants of clinical outcome of cutaneous melanoma

    PubMed Central

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

  9. Clinical utility and impact of autopsies on clinical practice among doctors in a large teaching hospital in Ghana

    PubMed Central

    Tette, Edem; Yawson, Alfred E.; Tettey, Yao

    2014-01-01

    Background Autopsies can provide a good indication of the quality of patient care, in terms of the accuracy of clinical diagnosis and the quality of treatment given. Designs This was a cross-sectional study among clinicians at the Korle-Bu Teaching Hospital (KBTH) in 2012. Data were collected with a 69-item, self-administered, structured questionnaire. A total of 215 questionnaires were sent out and 119 clinicians responded. Data were collected on the benefits and utility of autopsies for medical practice, care of patients, and management of clinical wards. Survey data were analyzed by simple descriptive statistics (i.e. proportions, ratios, and percentages). Data were analyzed using SPSS version 21. Objective This study examined the views of clinicians regarding the utility of autopsies and their influence on clinical practice in a large teaching hospital in Ghana. Results Overall, clinicians in KBTH agreed that autopsy reports are useful in answering clinical questions (55/119; 46.2%), confirming or verifying clinical diagnoses (54/119; 45.4%), providing information on unsuspected diagnoses (40/119; 33.6%), and for medical education (90/119; 75.6%). Overall, 70/119 (58.8%) of clinicians agreed that autopsy findings improve completeness and reliability of death certification and provide information on clinical effectiveness of treatment and patient management. However, only 23/119 (19.3%) of sampled clinicians had personal interactions with a pathologist during autopsy processes and 93/119 (78.2%) had not attended any autopsy demonstrations in the past 6 months. Attendance of pathologists at clinicopathological meetings of clinical departments of KBTH was minimal. Unfortunately, the use of autopsy reports for auditing clinical diagnostic performance was not seen as essential. Conclusion Strengthening the interaction between doctors and pathologists is essential in improving the autopsy process and utilization in the hospital. KBTH should create opportunities for doctors to attend autopsy demonstrations and for pathologists to attend clinicopathological meetings in the hospital. PMID:24499743

  10. A Healthcare Utilization Analysis Framework for Hot Spotting and Contextual Anomaly Detection

    PubMed Central

    Hu, Jianying; Wang, Fei; Sun, Jimeng; Sorrentino, Robert; Ebadollahi, Shahram

    2012-01-01

    Patient medical records today contain vast amount of information regarding patient conditions along with treatment and procedure records. Systematic healthcare resource utilization analysis leveraging such observational data can provide critical insights to guide resource planning and improve the quality of care delivery while reducing cost. Of particular interest to providers are hot spotting: the ability to identify in a timely manner heavy users of the systems and their patterns of utilization so that targeted intervention programs can be instituted, and anomaly detection: the ability to identify anomalous utilization cases where the patients incurred levels of utilization that are unexpected given their clinical characteristics which may require corrective actions. Past work on medical utilization pattern analysis has focused on disease specific studies. We present a framework for utilization analysis that can be easily applied to any patient population. The framework includes two main components: utilization profiling and hot spotting, where we use a vector space model to represent patient utilization profiles, and apply clustering techniques to identify utilization groups within a given population and isolate high utilizers of different types; and contextual anomaly detection for utilization, where models that map patient’s clinical characteristics to the utilization level are built in order to quantify the deviation between the expected and actual utilization levels and identify anomalies. We demonstrate the effectiveness of the framework using claims data collected from a population of 7667 diabetes patients. Our analysis demonstrates the usefulness of the proposed approaches in identifying clinically meaningful instances for both hot spotting and anomaly detection. In future work we plan to incorporate additional sources of observational data including EMRs and disease registries, and develop analytics models to leverage temporal relationships among medical encounters to provide more in-depth insights. PMID:23304306

  11. A healthcare utilization analysis framework for hot spotting and contextual anomaly detection.

    PubMed

    Hu, Jianying; Wang, Fei; Sun, Jimeng; Sorrentino, Robert; Ebadollahi, Shahram

    2012-01-01

    Patient medical records today contain vast amount of information regarding patient conditions along with treatment and procedure records. Systematic healthcare resource utilization analysis leveraging such observational data can provide critical insights to guide resource planning and improve the quality of care delivery while reducing cost. Of particular interest to providers are hot spotting: the ability to identify in a timely manner heavy users of the systems and their patterns of utilization so that targeted intervention programs can be instituted, and anomaly detection: the ability to identify anomalous utilization cases where the patients incurred levels of utilization that are unexpected given their clinical characteristics which may require corrective actions. Past work on medical utilization pattern analysis has focused on disease specific studies. We present a framework for utilization analysis that can be easily applied to any patient population. The framework includes two main components: utilization profiling and hot spotting, where we use a vector space model to represent patient utilization profiles, and apply clustering techniques to identify utilization groups within a given population and isolate high utilizers of different types; and contextual anomaly detection for utilization, where models that map patient's clinical characteristics to the utilization level are built in order to quantify the deviation between the expected and actual utilization levels and identify anomalies. We demonstrate the effectiveness of the framework using claims data collected from a population of 7667 diabetes patients. Our analysis demonstrates the usefulness of the proposed approaches in identifying clinically meaningful instances for both hot spotting and anomaly detection. In future work we plan to incorporate additional sources of observational data including EMRs and disease registries, and develop analytics models to leverage temporal relationships among medical encounters to provide more in-depth insights.

  12. Systematic review of the clinical and economic value of gene expression profiles for invasive early breast cancer available in Europe.

    PubMed

    Blok, E J; Bastiaannet, E; van den Hout, W B; Liefers, G J; Smit, V T H B M; Kroep, J R; van de Velde, C J H

    2018-01-01

    Gene expression profiles with prognostic capacities have shown good performance in multiple clinical trials. However, with multiple assays available and numerous types of validation studies performed, the added value for daily clinical practice is still unclear. In Europe, the MammaPrint, OncotypeDX, PAM50/Prosigna and Endopredict assays are commercially available. In this systematic review, we aim to assess these assays on four important criteria: Assay development and methodology, clinical validation, clinical utility and economic value. We performed a literature search covering PubMed, Embase, Web of Science and Cochrane, for studies related to one or more of the four selected assays. We identified 147 papers for inclusion in this review. MammaPrint and OncotypeDX both have evidence available, including level IA clinical trial results for both assays. Both assays provide prognostic information. Predictive value has only been shown for OncotypeDX. In the clinical utility studies, a higher reduction in chemotherapy was achieved by OncotypeDX, although the number of available studies differ considerably between tests. On average, economic evaluations estimate that genomic testing results in a moderate increase in total costs, but that these costs are acceptable in relation to the expected improved patient outcome. PAM50/prosigna and EndoPredict showed comparable prognostic capacities, but with less economical and clinical utility studies. Furthermore, for these assays no level IA trial data are available yet. In summary, all assays have shown excellent prognostic capacities. The differences in the quantity and quality of evidence are discussed. Future studies shall focus on the selection of appropriate subgroups for testing and long-term outcome of validation trials, in order to determine the place of these assays in daily clinical practice. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Symptomatic complex partial status epilepticus manifesting as utilization behavior of a mobile phone.

    PubMed

    Carota, Antonio; Novy, Jan; Rossetti, Andrea O

    2009-03-01

    Utilization behavior (UB) consists of reaching out and using objects in the environment in an automatic manner and out of context. This behavior has been correlated to frontal lobe dysfunction, especially of the right hemisphere. We describe a 60-year-old woman, affected by a glioblastoma located in the right frontal region, who presented with intermittent UB of the mobile phone as the main clinical manifestation of partial complex status epilepticus. Video/EEG studies showed a striking correlation between mobile phone utilization and ictal epileptic activity. Clinical and EEG findings were markedly reduced after the introduction of antiepileptic drugs. This case study suggests that UB may be added to the symptoms described for partial seizures originating from frontal areas.

  14. Technology Readiness of Early Career Nurse Trainees: Utilization of the Technology Readiness Index (TRI).

    PubMed

    Odlum, Michelle

    2016-01-01

    Health Information Technology (HIT) adoption by clinicians, including nurses, will lead to reduction in healthcare costs and clinical errors and improve health outcomes. Understanding the importance of technology adoption, the current study utilized the Technology Readiness Index to explore technology perceptions of nursing students. Our analysis identifies factors that may influence perceptions of technology, including decreased optimism for students with clinical experience and increased discomfort of US born students. Our study provides insight to inform training programs to further meet the increasing demands of skilled nursing staff.

  15. Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

    PubMed Central

    Turan, Janet M.; Onono, Maricianah; Steinfeld, Rachel L.; Shade, Starley B.; Owuor, Kevin; Washington, Sierra; Bukusi, Elizabeth A.; Ackers, Marta L.; Kioko, Jackson; Interis, Evelyn C.; Cohen, Craig R.

    2015-01-01

    Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

  16. Case study method and problem-based learning: utilizing the pedagogical model of progressive complexity in nursing education.

    PubMed

    McMahon, Michelle A; Christopher, Kimberly A

    2011-08-19

    As the complexity of health care delivery continues to increase, educators are challenged to determine educational best practices to prepare BSN students for the ambiguous clinical practice setting. Integrative, active, and student-centered curricular methods are encouraged to foster student ability to use clinical judgment for problem solving and informed clinical decision making. The proposed pedagogical model of progressive complexity in nursing education suggests gradually introducing students to complex and multi-contextual clinical scenarios through the utilization of case studies and problem-based learning activities, with the intention to transition nursing students into autonomous learners and well-prepared practitioners at the culmination of a nursing program. Exemplar curricular activities are suggested to potentiate student development of a transferable problem solving skill set and a flexible knowledge base to better prepare students for practice in future novel clinical experiences, which is a mutual goal for both educators and students.

  17. A Predictive Algorithm to Detect Opioid Use Disorder: What Is the Utility in a Primary Care Setting?

    PubMed

    Lee, Chee; Sharma, Maneesh; Kantorovich, Svetlana; Brenton, Ashley

    2018-01-01

    The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use in the primary care setting. A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 1822 patients across 18 family medicine/primary care clinics in the United States. Using the profile, patients were categorized into low, moderate, and high risk for opioid use. Physicians who ordered testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. Approximately 47% of primary care physicians surveyed used the profile to guide clinical decision-making. These physicians rated the benefit of the profile on patient care an average of 3.6 on a 5-point scale (1 indicating no benefit and 5 indicating significant benefit). Eighty-eight percent of all clinicians surveyed felt the test exhibited some benefit to their patient care. The most frequent utilization for the profile was to guide a change in opioid prescribed. Physicians reported greater benefit of profile utilization for minority patients. Patients whose treatment was guided by the profile had pain levels that were reduced, on average, 2.7 levels on the numeric rating scale. The profile provided primary care physicians with a useful tool to stratify the risk of opioid use disorder and was rated as beneficial for decision-making and patient improvement by the majority of physicians surveyed. Physicians reported the profile resulted in greater clinical improvement for minorities, highlighting the objective use of this profile to guide judicial use of opioids in high-risk patients. Significantly, when physicians used the profile to guide treatment decisions, patient-reported pain was greatly reduced.

  18. The development of an instrument to match individuals with disabilities and service animals.

    PubMed

    Zapf, S A; Rough, R B

    There has been an increase in the use of service animals assisting persons with disabilities in the past decade. However many of the service dog agencies do not utilize an assessment that is designed to match the person to the animal in the rehabilitation and psycho-social domains. The purpose of this study was to develop the Service Animal Adaptive Intervention Assessment (SAAIA) and to measure the content validity, inter-rater reliability and clinical utility of the assessment. Two subject groups were used. Subject group one had 43 subjects who measured the content validity and clinical utility of the SAAIA Survey. Subject group two had 12 subjects who measured the inter-rater reliability by completing the SAAIA using information obtained through a video-taped client case scenario. Content validity results indicated a good to high percentage of agreement and a fair percentage of agreement for clinical utility. Inter-rater reliability results indicate good to high agreement on six of the eight variables of the SAAIA. However, the Kappa score indicates low inter-rater reliability. Results indicate the SAAIA has good content validity and inter-rater reliability and fair clinical utility based on percent agreement. However, further research is needed on the reliability of the SAAIA.

  19. Quantitative appraisal of the Amyloid Imaging Taskforce appropriate use criteria for amyloid-PET.

    PubMed

    Altomare, Daniele; Ferrari, Clarissa; Festari, Cristina; Guerra, Ugo Paolo; Muscio, Cristina; Padovani, Alessandro; Frisoni, Giovanni B; Boccardi, Marina

    2018-04-18

    We test the hypothesis that amyloid-PET prescriptions, considered appropriate based on the Amyloid Imaging Taskforce (AIT) criteria, lead to greater clinical utility than AIT-inappropriate prescriptions. We compared the clinical utility between patients who underwent amyloid-PET appropriately or inappropriately and among the subgroups of patients defined by the AIT criteria. Finally, we performed logistic regressions to identify variables associated with clinical utility. We identified 171 AIT-appropriate and 67 AIT-inappropriate patients. AIT-appropriate and AIT-inappropriate cases did not differ in any outcomes of clinical utility (P > .05). Subgroup analysis denoted both expected and unexpected results. The logistic regressions outlined the primary role of clinical picture and clinical or neuropsychological profile in identifying patients benefitting from amyloid-PET. Contrary to our hypothesis, also AIT-inappropriate prescriptions were associated with clinical utility. Clinical or neuropsychological variables, not taken into account by the AIT criteria, may help further refine criteria for appropriateness. Copyright © 2018. Published by Elsevier Inc.

  20. Perceived Barriers to Clinic Appointments for Adolescents with Sickle Cell Disease

    PubMed Central

    Crosby, Lori E.; Modi, Avani C.; Lemanek, Kathleen L.; Guilfoyle, Shanna M.; Kalinyak, Karen A.; Mitchell, Monica J.

    2009-01-01

    Purpose The purpose of the study was to examine perceived barriers to clinic attendance and strategies to overcome these barriers for adolescents with sickle cell disease (SCD). Materials and Methods This was a two-phased study which utilized focus groups (n = 13) and individual semi-structured interviews (n = 32) with adolescent patients (aged 13–21 years) from three pediatric sickle cell clinics in the Mid-west. Results Adolescents identified competing activities, health status, patient-provider relationships, adverse clinic experiences, and forgetting as barriers to clinic attendance. Calendars/reminders and parent reminders were the most commonly reported strategies to facilitate clinic attendance. Adolescents also reported the need for flexible scheduling and improved patient-provider communication. Discussion Adolescents with SCD and their families may benefit from on-going education about the importance of attending routine clinic visits. Adherence to clinic appointments for adolescents may be enhanced by developing interventions to decrease forgetting (e.g., phone call reminders, text-messaging) and increase patient satisfaction with clinic visits. Scheduling appointments to accommodate busy schedules/scheduling conflicts (e.g., late clinic hours), providing teen-friendly clinic environments and utilizing technology may also facilitate attendance. PMID:19636266

  1. Factors shaping effective utilization of health information technology in urban safety-net clinics.

    PubMed

    George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

    2013-09-01

    Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

  2. Which information resources are used by general practitioners for updating knowledge regarding diabetes?

    PubMed

    Tabatabaei-Malazy, Ozra; Nedjat, Saharnaz; Majdzadeh, Reza

    2012-04-01

    Little is known about the degree of utilization of information resources on diabetes by general practitioners (GPs) and its impact on their clinical behavior in developing countries. Such information is vital if GPs' diabetes knowledge is to be improved. This cross-sectional study recruited 319 GPs in the summer of 2008. Questions were about the updates on diabetes knowledge in the previous two years, utilization of information resources (domestic and foreign journals, congresses, the Internet, reference books, mass media, and peers), attitude toward the importance of each resource, and impact of each resource on clinical behavior. A total of 62% of GPs had used information resources for improving their knowledge on diabetes in the previous two years. Domestic journals accounted for the highest utilization (30%) and the highest importance score (83 points from 100); with the importance score not being affected by sex, years elapsed after graduation, and numbers of diabetic visits. Clinical behavior was not influenced by the information resources listed; whereas knowledge upgrade, irrespective of the sources utilized, had a significantly positive correlation with clinical behavior. Domestic journals constituted the main information resource utilized by the GPs; this resource, however, in tandem with the other information resources on diabetes exerted no significant impact on the GPs' clinical behavior. In contrast to the developed countries, clinical guidelines do not have any place as a source of information and or practice. Indubitably, the improvement of diabetes knowledge transfer requires serious interventions to improve information resources as well as the structure of scientific gatherings and collaborations.

  3. The MMPI-2 Restructured Clinical Scales in the Assessment of Posttraumatic Stress Disorder and Comorbid Disorders

    PubMed Central

    Wolf, Erika J.; Miller, Mark W.; Orazem, Robert J.; Weierich, Mariann R.; Castillo, Diane T.; Milford, Jaime; Kaloupek, Danny G.; Keane, Terence M.

    2008-01-01

    This study examined the psychometric properties of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) Restructured Clinical Scales (RCSs) in individuals with posttraumatic stress disorder (PTSD) receiving clinical services at Veterans Affairs medical centers. Study 1 included 1,098 men who completed the MMPI-2 and were assessed for a range of psychological disorders via structured clinical interview. Study 2 included 136 women who completed the MMPI-2 and were interviewed with the Clinician Administered Scale for PTSD. The utility of the RCSs was compared to that of the Clinical Scales (CSs) and the Keane PTSD (PK) scale. The RCSs demonstrated good psychometric properties along with patterns of associations with other measures of psychopathology that corresponded to current theory regarding the structure of comorbidity. A notable advantage of the RCSs compared to the MMPI-2 CSs was their enhanced construct validity and clinical utility in the assessment of comorbid internalizing and externalizing psychopathology. The PK scale demonstrated incremental validity in the prediction of PTSD beyond that of the RCSs or CSs. PMID:19086756

  4. An integrative review on coping skills in nursing students: implications for policymaking.

    PubMed

    Labrague, L J; McEnroe-Petitte, D M; Al Amri, M; Fronda, D C; Obeidat, A A

    2018-06-01

    This study critically appraised both quantitative and qualitative studies describing coping strategies utilized by nursing students when faced with stress. Stress in nursing students during clinical training is well documented in the nursing literature. The need to utilize positive-coping strategies is necessary to effectively deal with stress and its accompanying stressors. An integrative review method was used in this review. PsycINFO, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), MEDLINE and Scopus were the databases used in searching for relevant literature using the following search terms; 'coping', 'nursing students', clinical training', 'ways of coping' and 'clinical practice'. A total of 27 studies published from 2001 to 2016 were included in this review. Findings demonstrated that nursing students utilized problem-focused coping strategies rather than emotion-focused coping strategies. Specific coping behaviours utilized included problem-solving behaviours, self-confident approaches and seeking of support from family and friends. The review contributes to the growing literature on coping strategies in nursing students and may have implications on nursing education and nursing policy. This review also demonstrated a scarcity of studies that links specific coping strategies to nursing school stressors and examines predictors of coping skills in nursing students. Institutionalization of structured student orientation programme, implementation of well-planned mentoring programmes and establishment of support unit/centres may be helpful in supporting nursing students during their clinical placement. By developing empirically based interventions, nursing faculty can assist nursing students in strengthening their positive-coping skills to effectively deal with various stressors encountered. © 2017 International Council of Nurses.

  5. A systematic review of health economic models and utility estimation methods in schizophrenia.

    PubMed

    Németh, Bertalan; Fasseeh, Ahmad; Molnár, Anett; Bitter, István; Horváth, Margit; Kóczián, Kristóf; Götze, Árpád; Nagy, Balázs

    2018-06-01

    There is a growing need for economic evaluations describing the disease course, as well as the costs and clinical outcomes related to the treatment of schizophrenia. Areas covered: A systematic review on studies describing health economic models in schizophrenia and a targeted literature review on utility mapping algorithms in schizophrenia were carried out. Models found in the review were collated and assessed in detail according to their type and various other attributes. Fifty-nine studies were included in the review. Modeling techniques varied from simple decision trees to complex simulation models. The models used various clinical endpoints as value drivers, 47% of the models used quality-adjusted life years, and eight percent used disability-adjusted life years to measure benefits, while others applied various clinical outcomes. Most models considered patients switching between therapies, and therapeutic adherence, compliance or persistence. The targeted literature review identified four main approaches to map PANSS scores to utility values. Expert commentary: Health economic models developed for schizophrenia showed great variability, with simulation models becoming more frequently used in the last decade. Using PANSS scores as the basis of utility estimations is justifiable.

  6. Home Lighting Assessment for Clients With Low Vision

    PubMed Central

    Bhorade, Anjali; Gordon, Mae; Hollingsworth, Holly; Engsberg, Jack E.; Baum, M. Carolyn

    2013-01-01

    OBJECTIVE. The goal was to develop an objective, comprehensive, near-task home lighting assessment for older adults with low vision. METHOD. A home lighting assessment was developed and tested with older adults with low vision. Interrater and test–retest reliability studies were conducted. Clinical utility was assessed by occupational therapists with expertise in low vision rehabilitation. RESULTS. Interrater reliability was high (intraclass correlation coefficient [ICC] = .83–1.0). Test–retest reliability was moderate (ICC = .67). Responses to a Clinical Utility Feedback Form developed for this study indicated that the Home Environment Lighting Assessment (HELA) has strong clinical utility. CONCLUSION. The HELA provides a structured tool to describe the quantitative and qualitative aspects of home lighting environments where near tasks are performed and can be used to plan lighting interventions. The HELA has the potential to affect assessment and intervention practices of rehabilitation professionals in the area of low vision and improve near-task performance of people with low vision. PMID:24195901

  7. The use of the sexual function questionnaire as a screening tool for women with sexual dysfunction.

    PubMed

    Quirk, Frances; Haughie, Scott; Symonds, Tara

    2005-07-01

    To determine if the validated Sexual Function Questionnaire (SFQ), developed to assess efficacy in female sexual dysfunction (FSD) clinical trials, may also have utility in identifying target populations for such studies. Data from five clinical trials and two general population surveys were used to analyze the utility of the SFQ as a tool to discriminate between the presence of specific components of FSD (i.e., hypoactive sexual desire disorder, female sexual arousal disorder, female orgasmic disorder, and dyspareunia). Sensitivity/specificity analysis and logistic regression analysis, using data from all five clinical studies and the general population surveys, confirmed that the SFQ domains have utility in detecting the presence of specific components of FSD and provide scores indicative of the presence of a specific sexual disorder. The SFQ is a valuable new tool for detecting the presence of FSD and identifying the specific components of sexual functions affected (desire, arousal, orgasm, or dyspareunia).

  8. Pain control and chaplaincy in Aotearoa New Zealand.

    PubMed

    Carey, Lindsay B; Polita, Carla; Marsden, Candace Renee; Krikheli, Lillian

    2014-10-01

    This paper summarizes the results of 100 New Zealand health care chaplains with regard to their involvement in issues concerning pain control within the New Zealand health care context. Both quantitative (via survey) and qualitative methods (in-depth interviewing) were utilized. The findings of this study indicated that approximately 52 % of surveyed hospital chaplains had provided some form of pastoral intervention directly to patients and/or their families dealing with issues concerning pain and that approximately 30 % of hospital chaplains had assisted clinical staff with issues concerning pain. NZ chaplaincy personnel involved in pain-related issues utilized a number of pastoral interventions to assist patients, their families and clinical staff. Differences of involvement between professionally stipended hospital chaplains and their volunteer chaplaincy assistants are noted, as are the perspectives of interviewed chaplains about their pastoral interventions with issues relating to pain. Some implications of this study with respect to chaplaincy utility, training and collaboration with clinical staff are noted, as are comparisons with international findings.

  9. Individual and Composite Study Endpoints: Separating the Wheat from the Chaff

    PubMed Central

    Goldberg, Robert; Gore, Joel M.; Barton, Bruce; Gurwitz, Jerry

    2014-01-01

    We provide an overview of the individual and combined clinical endpoints and patient reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. PMID:24486289

  10. Utilization of Mammography Services among Elderly Rural and Urban African American Women

    ERIC Educational Resources Information Center

    Agho, Augustine O; Mosley, Barbara W; Rivers, Patrick A; Parker, Shandowyn

    2007-01-01

    Purpose: This study was a two-year educational intervention and research project aimed at increasing the awareness of breast cancer and the utilization of Clinical Breast Examination (CBE) services and Self-Breast Examination (SBE) among elderly rural and urban African American women who are Medicare beneficiaries. Design: The study was…

  11. Translational manipulation under anesthesia for patients with frozen shoulder: a case series study with five-year health care utilization and post-manipulative arthroscopic findings.

    PubMed

    Hando, Ben R; Rhon, Daniel I; Boyles, Robert E; Whitman, Julie M; English, Jenny L

    2017-12-01

    Case series study. Although there have been no reported complications from translational manipulation under anesthesia (tMUA) for individuals with adhesive capsulitis (AC) there are no cases reporting surgical findings post tMUA. Also, there are no studies evaluating health care utilization following tMUA. The purpose of this study was to: (1) report clinical outcomes following tMUA, (2) describe relevant health care costs and utilization following tMUA, and (3) summarize findings from two cases receiving joint arthroscopy following tMUA. Fourteen Individuals with AC underwent tMUA. Range of motion (ROM) and Shoulder Pain and Disability Index (SPADI) values were collected at baseline and six weeks follow-up. Shoulder-related health care cost and utilization were analyzed for a five-year period following tMUA. Two additional patients with AC underwent tMUA followed by arthroscopic assessment for evidence of iatrogenic injury. Thirteen patients completed the six-week follow-up. Mean change scores for ROM and SPADI values were flexion; +38.5°, abduction; +71.1°, external rotation (shoulder abducted); +49.8°, internal rotation (shoulder abducted); +26.6°, SPADI scores; +44.4. 13 patient records were analyzed for health care utilization. Ten of the 13 patients utilized no additional shoulder-related health care. Surgical evaluation revealed no evidence of iatrogenic injury. Clinical outcomes were similar to previous studies. Utilization data indicated that for the majority of patients, little shoulder-related health care was utilized. Surgical evaluation provided further evidence that tMUA performed by a physical therapist is safe. Future research will be required to establish a causal relationship between tMUA and the results observed in this study. Therapy, Level 4.

  12. Does patient-perceived handicap correspond to the modified clinical test for the sensory interaction on balance?

    PubMed

    Loughran, Sean; Gatehouse, Stuart; Kishore, Ameet; Swan, Iain R C

    2006-01-01

    To determine whether patient self-reported handicap correlates with scores obtained from the modified Clinical Test for the Sensory Interaction on Balance as assessed by the Neurocom VSR Balance Master platform. Prospective observational. Balance clinic in tertiary referral center. Patients referred with dizziness or imbalance as their primary complaint. The modified Clinical Test for the Sensory Interaction on Balance scores as assessed by the Neurocom VSR Balance Master platform, the Dizziness Handicap Inventory, and the Health Utilities Index Marks 2 and 3. One hundred fifty-nine patients were entered into the study. The mean age of participants was 54.5 years, with a female-to-male ratio of 2.1:1. The scores for the Dizziness Handicap Inventory and Health Utilities Index are similar between sexes, and although the Dizziness Handicap Inventory score did not correlate with age, Health Utilities Index 2 and 3 scores did show a negative correlation with increasing age. There are weak, positive correlations between the Dizziness Handicap Inventory and the firm surface conditions of the modified Clinical Test for the Sensory Interaction on Balance but no useful correlation with the foam conditions. Similar weak negative correlations were found between the Health Utilities Index 2 and 3 and the modified Clinical Test for the Sensory Interaction on Balance scores. Patient-perceived handicap of imbalance appears to correlate poorly with assessment of postural stability using the modified Clinical Test for the Sensory Interaction on Balance.

  13. A Study to Identify Those Variables Which Contribute to the Utilization of Wellness Clinic Services by Active Duty Army Family Members

    DTIC Science & Technology

    1985-07-01

    utilization of organizational assets. The marketing mix model consisting of the four key vari- ables of price, promotion, product, and place, is commonly...minimal marketing efforts may bring significant increases in useage. The author included some specific recommendations for marketing the Wellness Clinic. 12...care This five factor model indicates that the two major approa- ches to analyzing preventive health care consumer decisionmaking, marketing and health

  14. Ecological validity and clinical utility of Patient-Reported Outcomes Measurement Information System (PROMIS®) instruments for detecting premenstrual symptoms of depression, anger, and fatigue.

    PubMed

    Junghaenel, Doerte U; Schneider, Stefan; Stone, Arthur A; Christodoulou, Christopher; Broderick, Joan E

    2014-04-01

    This study examined the ecological validity and clinical utility of NIH Patient Reported-Outcomes Measurement Information System (PROMIS®) instruments for anger, depression, and fatigue in women with premenstrual symptoms. One-hundred women completed daily diaries and weekly PROMIS assessments over 4weeks. Weekly assessments were administered through Computerized Adaptive Testing (CAT). Weekly CATs and corresponding daily scores were compared to evaluate ecological validity. To test clinical utility, we examined if CATs could detect changes in symptom levels, if these changes mirrored those obtained from daily scores, and if CATs could identify clinically meaningful premenstrual symptom change. PROMIS CAT scores were higher in the pre-menstrual than the baseline (ps<.0001) and post-menstrual (ps<.0001) weeks. The correlations between CATs and aggregated daily scores ranged from .73 to .88 supporting ecological validity. Mean CAT scores showed systematic changes in accordance with the menstrual cycle and the magnitudes of the changes were similar to those obtained from the daily scores. Finally, Receiver Operating Characteristic (ROC) analyses demonstrated the ability of the CATs to discriminate between women with and without clinically meaningful premenstrual symptom change. PROMIS CAT instruments for anger, depression, and fatigue demonstrated validity and utility in premenstrual symptom assessment. The results provide encouraging initial evidence of the utility of PROMIS instruments for the measurement of affective premenstrual symptoms. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior: a systematic literature review.

    PubMed

    Nguyen, Elaine; Weeda, Erin R; Sobieraj, Diana M; Bookhart, Brahim K; Piech, Catherine Tak; Coleman, Craig I

    2016-07-01

    To evaluate current knowledge of the impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior. The literature was searched (Medline and Web of Science, January 2000-November 2015) to identify United States' studies evaluating ≥25 patients and measuring the impact of non-medical switching of drugs (switching to a chemically distinct but similar medication for reasons other than lack of clinical efficacy/response, side effects or poor adherence) on ≥1 clinical, economic, resource utilization or medication-taking behavior outcome. The direction of association between non-medical switching and outcomes was classified as negative or positive if a statistically significant worsening or improvement was reported, or neutral if no significant difference was observed. Twenty-nine studies contributed 96 outcomes (60.4% clinical; 21.9% resource utilization; 13.5% economic; 4.2% medication-taking behavior) within six disease categories (cardio-metabolic, immune-mediated, acid suppression, psychiatric, hormone replacement therapy and pain). The direction of association was more frequently negative (33.3%) or neutral (55.2%) than it was positive (11.5%). Stratified by outcome type, non-medical switching was negatively associated with clinical, economic, healthcare utilization and medication-taking behavior outcomes in 20.7%, 69.2%, 38.1% and 75.0% of cases, respectively; and positively in only 4.8%-17.2% of outcomes subgroups. Of 32 outcomes in patients demonstrating stable/well controlled disease, 68.8% and 31.3% had a negative and neutral direction of association. In patients without demonstrated disease stability, outcomes were negatively, neutrally and positively impacted by non-medical switching in 15.6%, 67.2% and 17.2% of 64 outcomes. Our inability to evaluate specific disease state categories and studies/outcomes received equal weight regardless of sample size or magnitude of effect. Non-medical switching was more often associated with negative or neutral effects than positive effects on an array of important outcomes. Among patients with stable/well controlled disease, non-medical switching was associated with mostly negative effects.

  16. Clinical Utility and "DSM-V"

    ERIC Educational Resources Information Center

    Mullins-Sweatt, Stephanie N.; Widiger, Thomas A.

    2009-01-01

    The construction of the American Psychiatric Association's diagnostic manual has been guided primarily by concerns of construct validity rather than of clinical utility, despite claims by its authors that the highest priority has in fact been clinical utility. The purpose of this article was to further articulate the concept and importance of…

  17. The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

    PubMed

    Mullins-Sweatt, Stephanie N; Lengel, Gregory J; DeShong, Hilary L

    2016-01-01

    The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

  18. A Qualitative Study of Underutilization of the AIDS Drug Assistance Program

    PubMed Central

    Olson, Kristin M.; Godwin, Noah C.; Wilkins, Sara Anne; Mugavero, Michael J.; Moneyham, Linda D.; Slater, Larry Z.; Raper, James L.

    2014-01-01

    In our previous work, we demonstrated underutilization of the AIDS Drug Assistance Program (ADAP) at an HIV clinic in Alabama. In order to understand barriers and facilitators to utilization of ADAP, we conducted focus groups of ADAP enrollees. Focus groups were stratified by sex, race, and historical medication possession ratio as a measure of program utilization. We grouped factors according to the social-ecological model. We found that multiple levels of influence, including patient and clinic-related factors, influenced utilization of antiretroviral medications. Patients introduced issues that illustrated high-priority needs for ADAP policy and implementation, suggesting that in order to improve ADAP utilization, the following issues must be addressed: patient transportation, ADAP medication refill schedules and procedures, mailing of medications, and the ADAP recertification process. These findings can inform a strategy of approaches to improve ADAP utilization, which may have widespread implications for ADAP programs across the United States. PMID:24503498

  19. U.S. military mental health care utilization and attrition prior to the wars in Iraq and Afghanistan.

    PubMed

    Garvey Wilson, Abigail L; Messer, Stephen C; Hoge, Charles W

    2009-06-01

    Health care utilization studies of mental disorders focus largely on the ICD-9 category 290-319, and do not generally include analysis of visits for mental health problems identified under V-code categories. Although active duty service members represent a large young adult employed population who use mental health services at similar rates as age-matched civilian populations, V-codes are used in a larger proportion of mental health visits in military mental health care settings than in civilian settings. However, the utilization of these diagnoses has not been systematically studied. The purpose of this study is to characterize outpatient behavioral health visits in military health care facilities prior to Operation Iraqi Freedom, including the use of diagnoses outside of the ICD-9 290-319 range, in order to evaluate the overall burden of mental health care. This study establishes baseline rates of mental health care utilization in military mental health clinics in 2000 and serves as a comparison for future studies of the mental health care burden of the current war. All active duty service members who received care in military outpatient clinics in 2000 (n = 1.35 million) were included. Primary diagnoses were grouped according to mental health relevance in the following categories: mental disorders (ICD-9 290-319), mental health V-code diagnoses (used primarily by behavioral health providers that were indicative of a potential mental health problem), and all other diagnoses. Rates of service utilization within behavioral health clinics were compared with rates in other outpatient clinics for each of the diagnostic groups, reported as individuals or visits per 1,000 person-years. Cox proportional hazard regression was used to produce hazard ratios as measures of association between each of the diagnostic groups and attrition from military service. Time to attrition in months was the difference between the date of military separation and the date of first clinic visit in 2000. Data were obtained from the Defense Medical Surveillance System. The total number of individuals who utilized behavioral health services in 2000 was just over 115 per 1,000 person-years, almost 12% of the military population. Out of every 1,000 person-years, 57.5 individuals received care from behavioral health providers involving an ICD-9 290-319 mental disorder diagnosis, and an additional 26.7 per 1,000 person-years received care in behavioral health clinics only for V-code diagnoses. Attrition from service was correlated with both categories of mental health-related diagnoses. After 1 year, approximately 38% of individuals who received a mental disorder diagnosis left the military, compared with 23% of those who received mental health V-code diagnoses and 14% of those who received health care for any other reason (which included well visits for routine physicals). This study establishes baseline rates of pre-war behavioral healthcare utilization among military service members, and the relationship of mental health care use and attrition from service. The research indicates that in the military population the burden of mental illness in outpatient clinics is significantly greater when V-code diagnoses are included along with conventional mental disorder diagnostic codes.

  20. Socioeconomic factors affecting patients’ utilization of primary care services at a Tertiary Teaching Hospital in Riyadh, Saudi Arabia

    PubMed Central

    Alsubaie, Abdulaziz M.; Almohaimede, Khaled A.; Aljadoa, Abdulrahman F.; Jarallah, Osamah J.; Althnayan, Yasser I.; Alturki, Yousef A.

    2016-01-01

    Background: Primary care services utilization is dependent on socioeconomic factors. It is proven that variation in socioeconomic factors result in discrepancies in the use of such services. Admittedly, research is limited on the socioeconomic factors affecting the utilization of primary care services in Saudi Arabia. Objectives: The aim of this research was to study the effect of the main socioeconomic factors affecting patients' utilization of primary care services at a tertiary teaching hospital, Riyadh, Saudi Arabia. Materials and Methods: A cross-sectional study was conducted from January to February 2014 in a primary care clinic of a tertiary teaching hospital in Riyadh city; subjects selected using a random consecutive sampling technique. A self-administered questionnaire in Arabic was given to the participants to collect the data which comprised sociodemographic data, utilization measures, and health needs. The data were analyzed using SPSS version 21. Results: A total of 358 subjects participated in the study. The main factors that best determine the utilization of primary health care clinic in a tertiary teaching hospital were the possession of a health insurance (P = 0.046, odds ratio [OR] = 8.333), and bad self-health-perception (P < 0.014, OR: 2.088). Chronic illness was also associated with higher utilization (OR = 2.003). Conclusion: Our results reveal that chronic health problems, self-health-perception, and health insurance are the most significant socioeconomic factors affecting the utilization of primary care services. PMID:26929723

  1. Comparative prediction of nonepileptic events using MMPI-2 clinical scales, Harris Lingoes subscales, and restructured clinical scales.

    PubMed

    Yamout, Karim Z; Heinrichs, Robin J; Baade, Lyle E; Soetaert, Dana K; Liow, Kore K

    2017-03-01

    The Minnesota Multiphasic Personality Inventory-2 (MMPI-2) is a psychological testing tool used to measure psychological and personality constructs. The MMPI-2 has proven helpful in identifying individuals with nonepileptic events/nonepileptic seizures. However, the MMPI-2 has had some updates that enhanced its original scales. The aim of this article was to test the utility of updated MMPI-2 scales in predicting the likelihood of non-epileptic seizures in individuals admitted to an EEG video monitoring unit. We compared sensitivity, specificity, and likelihood ratios of traditional MMPI-2 Clinical Scales against more homogenous MMPI-2 Harris-Lingoes subscales and the newer Restructured Clinical (RC) scales. Our results showed that the Restructured Scales did not show significant improvement over the original Clinical scales. However, one Harris-Lingoes subscale (HL4 of Clinical Scale 3) did show improved predictive utility over the original Clinical scales as well as over the newer Restructured Clinical scales. Our study suggests that the predictive utility of the MMPI-2 can be improved using already existing scales. This is particularly useful for those practitioners who are not invested in switching over to the newly developed MMPI-2 Restructured Form (MMPI-2 RF). Copyright © 2016 Elsevier Inc. All rights reserved.

  2. A review of the literature regarding stress among nursing students during their clinical education.

    PubMed

    Alzayyat, A; Al-Gamal, E

    2014-09-01

    There has been increased attention in the literature about stress among nursing students. It has been evident that clinical education is the most stressful experience for nursing students. The aim of this paper was to critically review studies related to degrees of stress and the type of stressors that can be found among undergraduate nursing students during their clinical education. The search strategy involved the utilization of the following databases: MEDLINE (Medical Literature on-Line), CINAHL (Cumulative Index to Nursing and Allied Health Literature), PsycINFO (Psychology Information) and PubMed. Keywords were stress, undergraduate nursing students, clinical practice. The review included those studies published between 2002 and 2013, conducted in any country as long as reported in English, and including a focus on the clinical practice experience of nursing students. Thirteen studies met the eligibility criteria. Four themes were identified: initial clinical experience, comparison between different academic years, cross-cultural comparison, and eustress aspects of clinical experience. This review expands current knowledge in the area of stress in clinical settings and calls for further research. Nursing teachers should utilize the findings of this review to direct their students during clinical practice. Moreover, hospital administrators need to promote policies to promote a training environment where students are supported and inspired. © 2014 International Council of Nurses.

  3. External validation and clinical utility of a prediction model for 6-month mortality in patients undergoing hemodialysis for end-stage kidney disease.

    PubMed

    Forzley, Brian; Er, Lee; Chiu, Helen Hl; Djurdjev, Ognjenka; Martinusen, Dan; Carson, Rachel C; Hargrove, Gaylene; Levin, Adeera; Karim, Mohamud

    2018-02-01

    End-stage kidney disease is associated with poor prognosis. Health care professionals must be prepared to address end-of-life issues and identify those at high risk for dying. A 6-month mortality prediction model for patients on dialysis derived in the United States is used but has not been externally validated. We aimed to assess the external validity and clinical utility in an independent cohort in Canada. We examined the performance of the published 6-month mortality prediction model, using discrimination, calibration, and decision curve analyses. Data were derived from a cohort of 374 prevalent dialysis patients in two regions of British Columbia, Canada, which included serum albumin, age, peripheral vascular disease, dementia, and answers to the "the surprise question" ("Would I be surprised if this patient died within the next year?"). The observed mortality in the validation cohort was 11.5% at 6 months. The prediction model had reasonable discrimination (c-stat = 0.70) but poor calibration (calibration-in-the-large = -0.53 (95% confidence interval: -0.88, -0.18); calibration slope = 0.57 (95% confidence interval: 0.31, 0.83)) in our data. Decision curve analysis showed the model only has added value in guiding clinical decision in a small range of threshold probabilities: 8%-20%. Despite reasonable discrimination, the prediction model has poor calibration in this external study cohort; thus, it may have limited clinical utility in settings outside of where it was derived. Decision curve analysis clarifies limitations in clinical utility not apparent by receiver operating characteristic curve analysis. This study highlights the importance of external validation of prediction models prior to routine use in clinical practice.

  4. Cost utility of maintenance treatment of recurrent depression with sertraline versus episodic treatment with dothiepin.

    PubMed

    Hatziandreu, E J; Brown, R E; Revicki, D A; Turner, R; Martindale, J; Levine, S; Siegel, J E

    1994-03-01

    The objective of this study was to model, for patients at risk of recurrent depression, the cost-utility of maintenance therapy with sertraline compared with treatment of acute episodes with dothiepin ('episodic treatment'). Using clinical decision analysis techniques, a Markov state-transition model was constructed to estimate the lifetime costs and quality-adjusted life-years (QALYs) of the 2 therapeutic strategies. The model follows 2 cohorts of 35-year-old women at high risk for recurrent depression over their lifetimes. Model construction and relevant data (probabilities) for performing the analysis were based on existing clinical knowledge. Two physician panels were used to obtain estimates of recurrence probabilities not available in the literature, health utilities, and resource consumption. Costs were obtained from published sources. The baseline analysis showed that it costs 2172 British pounds sterling ($US3692, 1991 currency) to save an additional QALY with sertraline maintenance treatment. Sensitivity analysis showed that the incremental cost-utility ratio ranged from 557 British pounds sterling to 5260 British pounds sterling per QALY. Overall, the resulting ratios are considered to be well within the range of cost-utility ratios that support the adoption and appropriate utilisation of a technology. Based on the study assumptions, long term maintenance treatment with sertraline appears to be clinically and economically justified choice for patients at high risk of recurrent depression.

  5. Arthritis, comorbidities, and care utilization in veterans of operations enduring and Iraqi Freedom.

    PubMed

    Rivera, Jessica C; Amuan, Megan E; Morris, Ruth M; Johnson, Anthony E; Pugh, Mary Jo

    2017-03-01

    Veteran populations are known to have frequencies of arthritis higher than civilian populations. The aim of this study is to define the prevalence of arthritis among a cohort of veterans from ongoing U.S. military operations. A retrospective cohort study using Veterans Administration data sources for service connected disability, comorbidities, clinic utilization, and pharmacy utilization was conducted including veterans who deployed in service to operations in Afghanistan or Iraq, comparing veterans with a diagnosis of arthritis, arthritis plus back pain, and veterans with no pain diagnoses. The frequency of arthritis was 11.8%. Veterans with arthritis and arthritis plus back pain had greater frequencies of diabetes, hyperlipidemia, hypertension, and obesity compare to veterans with no pain diagnosis. Veterans with arthritis plus back pain had the highest pain clinic utilization and prescription use of opioids and anti-inflammatories. Veterans with no pain diagnosis had higher frequencies of diagnosis and clinic utilization for mental health disorders. Arthritis is prevalent among the latest generation of combat veterans and is associated with diabetes, obesity, and cardiovascular comorbidities. The need for arthritis care and associated comorbidities is expected to increase as the Veterans Administration and the civilian health care sector assumes care of these veterans. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:682-687, 2017. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

  6. The Utilization of a Clinical Decision Support System to Manage Adult Type 2 Diabetes: A Correlational Study

    ERIC Educational Resources Information Center

    Faught, I. Charie

    2012-01-01

    While the Institute of Medicine (2001) has promoted health information technology to improve the process of care such as compliance with clinical practice guidelines and quicker access to clinical information, diagnostic tests, and treatment results, very little was known about how a clinical decision support system can contribute to diabetes…

  7. Problem-solving strategies in psychiatry: differences between experts and novices in diagnostic accuracy and reasoning.

    PubMed

    Gabriel, Adel; Violato, Claudio

    2013-01-01

    The purpose of this study was to examine and compare diagnostic success and its relationship with the diagnostic reasoning process between novices and experts in psychiatry. Nine volunteers, comprising five expert psychiatrists and four clinical clerks, completed a think-aloud protocol while attempting to make a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of a selected case with both Axis I and Axis III diagnoses. Expert psychiatrists made significantly more successful diagnoses for both the primary psychiatric and medical diagnoses than clinical clerks. Expert psychiatrists also gave fewer differential options. Analyzing the think-aloud protocols, expert psychiatrists were much more organized, made fewer mistakes, and utilized significantly less time to access their knowledge than clinical clerks. Both novices and experts seemed to use the hypothetic-deductive and scheme-inductive approaches to diagnosis. However, experts utilized hypothetic-deductive approaches significantly more often than novices. The hypothetic-deductive diagnostic strategy was utilized more than the scheme-inductive approach by both expert psychiatrists and clinical clerks. However, a specific relationship between diagnostic reasoning and diagnostic success could not be identified in this small pilot study. The author recommends a larger study that would include a detailed analysis of the think-aloud protocols.

  8. Patterns of health service utilization at a medical school clinic in Ghana.

    PubMed

    Yawson, A E; Malm, K L; Adu, A A; Wontumi, G-M; Biritwum, R B

    2012-09-01

    The University of Ghana Medical School (UGMS) Clinic provides healthcare service which is free at point of service to students, staff, retired staff and dependents of staff of the College of Health Sciences. However, since 1983, no in-depth review of health service provision or utilization has been undertaken. This study reviewed client characteristics, utilization and disease patterns at the clinic and also compared the disease patterns to that of other primary health facilities nationwide. This was an analytical cross-sectional study undertaken at the UGMS clinic in Korle-Bu. It was a retrospective review of records of all clients attending the facility from January 2002 to December, 2004. More males than females attended the clinic and majority (63.9%) of clients were between 15-44 years (median age was 26 years). Dependents of staff constituted the highest attendants (41%) to the clinic. Among staff, junior staffs were in the majority. Malaria, respiratory tract infection and musculoskeletal pain were the most common conditions seen. Overall, 83% of clients were treated and discharged per visit without the need for review visits. Dependents of staff used the facility the most and they live in many different part of the city of Accra, and to ask them to attend the clinic for care is not efficient. It will be better to provide or supplement their securing of insurance so that they could access health care close to their homes and save time and attention to students and staff.

  9. The incremental impact of cardiac MRI on clinical decision-making.

    PubMed

    Rajwani, Adil; Stewart, Michael J; Richardson, James D; Child, Nicholas M; Maredia, Neil

    2016-01-01

    Despite a significant expansion in the use of cardiac MRI (CMR), there is inadequate evaluation of its incremental impact on clinical decision-making over and above other well-established modalities. We sought to determine the incremental utility of CMR in routine practice. 629 consecutive CMR studies referred by 44 clinicians from 9 institutions were evaluated. Pre-defined algorithms were used to determine the incremental influence on diagnostic thinking, influence on clinical management and thus the overall clinical utility. Studies were also subdivided and evaluated according to the indication for CMR. CMR provided incremental information to the clinician in 85% of cases, with incremental influence on diagnostic thinking in 85% of cases and incremental impact on management in 42% of cases. The overall incremental utility of CMR exceeded 90% in 7 out of the 13 indications, whereas in settings such as the evaluation of unexplained ventricular arrhythmia or mild left ventricular systolic dysfunction, this was <50%. CMR was frequently able to inform and influence decision-making in routine clinical practice, even with analyses that accepted only incremental clinical information and excluded a redundant duplication of imaging. Significant variations in yield were noted according to the indication for CMR. These data support a wider integration of CMR services into cardiac imaging departments. These data are the first to objectively evaluate the incremental value of a UK CMR service in clinical decision-making. Such data are essential when seeking justification for a CMR service.

  10. Predictors of Psychology Graduate Student Interest in the Field of Developmental Disabilities

    ERIC Educational Resources Information Center

    Viecili, Michelle A.; MacMullin, Jennifer A.; Weiss, Jonathan A.; Lunsky, Yona

    2010-01-01

    This study examined predictors of interest in the future provision of clinical services to people with developmental disabilities by Canadian graduate students in psychology. Utilizing a cross-sectional survey, 458 psychology students from clinical, clinical neuropsychology, and counseling psychology programs from across Canada provided…

  11. A web-based screening and accrual strategy for a cancer prevention clinical trial in healthy smokers.

    PubMed

    Mohebati, Arash; Knutson, Allison; Zhou, Xi Kathy; Smith, Judith J; Brown, Powel H; Dannenberg, Andrew J; Szabo, Eva

    2012-09-01

    Screening and recruitment of qualified subjects for clinical trials is an essential component of translational research, and it can be quite challenging if the most efficient recruitment method is not utilized. In this report, we describe a successful web-based screening and accrual method used in a randomized prospective chemoprevention clinical trial with urinary biomarker endpoints. The targeted study population was a group of at-risk healthy current smokers with no evidence of lung disease. Craigslist was used as the sole recruitment modality for this study. All interested subjects were directed to a pre-screening website, in which subject questionnaire responses were linked to the study coordinator's secure e-mail account. Of the 429 initial inquiries, 189 individuals were initially eligible based on the questionnaire response. One hundred twenty-two people were telephone-screened, of whom 98 subjects were consented, 84 were randomized and 77 subjects completed the study successfully. Utilizing this single web-based advertising strategy, accrual for the trial was completed 7 months prior to the projected date. Craigslist is a cost effective and efficient web-based resource that can be utilized in accruing subjects to some chemoprevention trials. Published by Elsevier Inc.

  12. A web-based screening and accrual strategy for a cancer prevention clinical trial in healthy smokers

    PubMed Central

    Mohebati, Arash; Knutson, Allison; Zhou, Xi Kathy; Smith, Judith J.; Brown, Powel H.; Dannenberg, Andrew J.; Szabo, Eva

    2012-01-01

    Screening and recruitment of qualified subjects for clinical trials is an essential component of translational research, and it can be quite challenging if the most efficient recruitment method is not utilized. In this report, we describe a successful web-based screening and accrual method used in a randomized prospective chemoprevention clinical trial with urinary biomarker endpoints. The targeted study population was a group of at-risk healthy current smokers with no evidence of lung disease. Craigslist was used as the sole recruitment modality for this study. All interested subjects were directed to a pre-screening website, in which subject questionnaire responses were linked to the study coordinator's secure e-mail account. Of the 429 initial inquiries, 189 individuals were initially eligible based on the questionnaire response. One hundred twenty-two people were telephone-screened, of whom 98 subjects were consented, 84 were randomized and 77 subjects completed the study successfully. Utilizing this single web-based advertising strategy, accrual for the trial was completed 7 months prior to the projected date. Craigslist is a cost effective and efficient web-based resource that can be utilized in accruing subjects to some chemoprevention trials. PMID:22771576

  13. Pancreatic cancer early detection: Expanding higher-risk group with clinical and metabolomics parameters

    PubMed Central

    Urayama, Shiro

    2015-01-01

    Pancreatic ductal adenocarcinoma (PDAC) is the fourth and fifth leading cause of cancer death for each gender in developed countries. With lack of effective treatment and screening scheme available for the general population, the mortality rate is expected to increase over the next several decades in contrast to the other major malignancies such as lung, breast, prostate and colorectal cancers. Endoscopic ultrasound, with its highest level of detection capacity of smaller pancreatic lesions, is the commonly employed and preferred clinical imaging-based PDAC detection method. Various molecular biomarkers have been investigated for characterization of the disease, but none are shown to be useful or validated for clinical utilization for early detection. As seen from studies of a small subset of familial or genetically high-risk PDAC groups, the higher yield and utility of imaging-based screening methods are demonstrated for these groups. Multiple recent studies on the unique cancer metabolism including PDAC, demonstrate the potential for utility of the metabolites as the discriminant markers for this disease. In order to generate an early PDAC detection screening strategy available for a wider population, we propose to expand the population of higher risk PDAC group with combination clinical and metabolomics parameters. PMID:25684935

  14. Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

    PubMed

    Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

    2010-10-01

    New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

  15. Whole exome sequencing in neurogenetic odysseys: An effective, cost- and time-saving diagnostic approach.

    PubMed

    Córdoba, Marta; Rodriguez-Quiroga, Sergio Alejandro; Vega, Patricia Analía; Salinas, Valeria; Perez-Maturo, Josefina; Amartino, Hernán; Vásquez-Dusefante, Cecilia; Medina, Nancy; González-Morón, Dolores; Kauffman, Marcelo Andrés

    2018-01-01

    Diagnostic trajectories for neurogenetic disorders frequently require the use of considerable time and resources, exposing patients and families to so-called "diagnostic odysseys". Previous studies have provided strong evidence for increased diagnostic and clinical utility of whole-exome sequencing in medical genetics. However, specific reports assessing its utility in a setting such as ours- a neurogeneticist led academic group serving in a low-income country-are rare. To assess the diagnostic yield of WES in patients suspected of having a neurogenetic condition and explore the cost-effectiveness of its implementation in a research group located in an Argentinean public hospital. This is a prospective study of the clinical utility of WES in a series of 40 consecutive patients selected from a Neurogenetic Clinic of a tertiary Hospital in Argentina. We evaluated patients retrospectively for previous diagnostic trajectories. Diagnostic yield, clinical impact on management and economic diagnostic burden were evaluated. We demonstrated the clinical utility of Whole Exome Sequencing in our patient cohort, obtaining a diagnostic yield of 40% (95% CI, 24.8%-55.2%) among a diverse group of neurological disorders. The average age at the time of WES was 23 (range 3-70). The mean time elapsed from symptom onset to WES was 11 years (range 3-42). The mean cost of the diagnostic workup prior to WES was USD 1646 (USD 1439 to 1853), which is 60% higher than WES cost in our center. WES for neurogenetics proved to be an effective, cost- and time-saving approach for the molecular diagnosis of this heterogeneous and complex group of patients.

  16. Outcomes Among Chronically Ill Adults in a Medical Home Prototype

    PubMed Central

    Liss, David T.; Fishman, Paul A.; Rutter, Carolyn M.; Grembowski, David; Ross, Tyler R.; Johnson, Eric A.; Reid, Robert J.

    2014-01-01

    Objectives To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Study Design Nonequivalent pretest-posttest control group design. Methods PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Results Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care–sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. Conclusions A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses. PMID:24304182

  17. RPMIS: The Roswell Park Management Information System

    PubMed Central

    Priore, R.L.; Lane, W.W.; Edgerton, F.T.; Naeher, C.H.; Reese, P.A.

    1978-01-01

    This paper presents a generalized approach to data entry and editing utilizing formatted video computer terminals. The purpose of the system developed is to facilitate the creation of many small data bases, with a minimum of implementation time, while maintaining extensive editing capability and preserving ease of use by data entry personnel. RPMIS has demonstrated its utility in shortening the time between research activities and clinical application of results. The system allows entry and retrieval of overlapping subsets of the patient's record in an order and format most appropriate to the individual application. It is used for production of synoptic presentations of information from the labs, the ward and the clinic. RPMIS was designed for the clinical trials setting and has been well received and implemented for numerous such studies. Additional uses have included several registries, screening clinics, retrospective studies, and epidemiologic investigations. The system has found fortuitous use in maintaining curriculum vitae, publications lists and continuing medical education credits.

  18. Detecting Blood-Based Biomarkers in Metastatic Breast Cancer: A Systematic Review of Their Current Status and Clinical Utility

    PubMed Central

    Berghuis, A. M. Sofie; Koffijberg, Hendrik; Prakash, Jai; Terstappen, Leon W. M. M.; IJzerman, Maarten J.

    2017-01-01

    Reviews on circulating biomarkers in breast cancer usually focus on one single biomarker or a selective group of biomarkers. An overview summarizing the discovery and evaluation of all blood-based biomarkers in metastatic breast cancer is lacking. This systematic review aims to identify the available evidence of known blood-based biomarkers in metastatic breast cancer, regarding their clinical utility and state-of-the-art position in the validation process. The initial search yielded 1078 original studies, of which 420 were assessed for eligibility. A total of 320 studies were included in the final synthesis. A Development, Evaluation and Application Chart (DEAC) of all biomarkers was developed. Most studies focus on identifying new biomarkers and search for relations between these biomarkers and traditional molecular characteristics. Biomarkers are usually investigated in only one study (68.8%). Only 9.8% of all biomarkers was investigated in more than five studies. Circulating tumor cells, gene expression within tumor cells and the concentration of secreted proteins are the most frequently investigated biomarkers in liquid biopsies. However, there is a lack of studies focusing on identifying the clinical utility of these biomarkers, by which the additional value still seems to be limited according to the investigated evidence. PMID:28208771

  19. Feasibility and Clinical Utility of High-definition Transcranial Direct Current Stimulation in the Treatment of Persistent Hallucinations in Schizophrenia.

    PubMed

    Bose, A; Shivakumar, V; Chhabra, H; Parlikar, R; Sreeraj, V S; Dinakaran, D; Narayanaswamy, J C; Venkatasubramanian, G

    2017-12-01

    Persistent auditory verbal hallucination is a clinically significant problem in schizophrenia. Recent studies suggest a promising role for add-on transcranial direct current stimulation (tDCS) in treatment. An optimised version of tDCS, namely high-definition tDCS (HD-tDCS), uses smaller electrodes arranged in a 4x1 ring configuration and may offer more focal and predictable neuromodulation than conventional tDCS. This case report illustrates the feasibility and clinical utility of add-on HD-tDCS over the left temporoparietal junction in a 4x1 ring configuration to treat persistent auditory verbal hallucination in schizophrenia.

  20. Prospective Clinical Evaluation of the Serologic Tuberculous Glycolipid Test in Combination with the Nucleic Acid Amplification Test

    PubMed Central

    Maekura, Ryoji; Kohno, Hiroaki; Hirotani, Atsushi; Okuda, Yoshinari; Ito, Masami; Ogura, Takeshi; Yano, Ikuya

    2003-01-01

    We have conducted a prospective controlled multicenter study to evaluate differences in the levels of clinical utility of the tuberculous glycolipid (TBGL) serodiagnostic test and the nucleic acid amplification test in patients with smear-negative active pulmonary tuberculosis (TB). The TBGL test and the PCR test were individually not so useful for the rapid diagnosis of smear-negative active pulmonary TB. However, clinical utility was considerably improved by using the TBGL test and the PCR test in combination, especially in patients with smear-negative and culture-negative active pulmonary TB and in patients with minimally advanced lesions. PMID:12624077

  1. Evaluation of a Shared Decision-Making Intervention on the Utilization of Evidence-Based Psychotherapy in a VA Outpatient PTSD Clinic.

    PubMed

    Hessinger, Jonathan D; London, Melissa J; Baer, Sheila M

    2017-03-13

    The Veterans Health Administration (VHA) has continued to emphasize the availability, access, and utilization of high quality mental health care particularly in the treatment of posttraumatic stress disorder (PTSD). While dissemination and availability of evidence-based psychotherapies (EBPs) have only increased, treatment engagement and utilization have continued to be oft-noted challenges. Administrators, researchers, and individual clinicians have continued to develop and explore novel systemic and individualized interventions to address these issues. Pilot studies utilizing shared decision-making models to aid in veteran treatment selection have demonstrated the impact this approach may have on selection of and engagement in EBPs for PTSD. Based on these promising studies, a Department of Veterans Affairs (VA) outpatient PTSD clinic began to implement a shared-decision making intervention as part of a clinic redesign. In seeking to evaluate the impact of this intervention, archival clinical data from 1,056 veterans were reviewed by the authors for rates of treatment selection, EBP initiation, session attendance, and EBP completion. Time elapsed from consult until EBP initiation was also computed by the authors. These variables were then compared on the basis of whether the veteran received the shared-decision making intervention. Veterans who received the intervention were more likely to select and thus initiate an EBP for PTSD sooner than veterans who did not receive this intervention. Veterans, whether receiving the intervention or not, did not differ in therapy session attendance and completion. Implications of these findings and directions for future study are further discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  2. A Randomized Phase 2 Trial of 177Lu Radiolabeled Anti-PSMA Monoclonal Antibody J591 in Patients with High-Risk Castrate, Biochemically Relapsed Prostate Cancer

    DTIC Science & Technology

    2014-09-01

    antibody (J591) against the external portion of PSMA that binds to viable PSMA-expressing cells and is internalized. Studies utilizing J591...metastatic CRPC to bone (Rad223, Xofigo ®) leading to excitement within the field. A more tumor-targeted approach utilizing J591 is of increased...has generated renewed scientific and clinical interest. In addition, recent studies utilizing J591-based immuno- PET imaging providing additional

  3. Children with intellectual disability and hospice utilization

    PubMed Central

    Lindley, Lisa C.; Colman, Mari Beth; Meadows, John T.

    2016-01-01

    Over 42,000 children die each year in the United States, including those with intellectual disability (ID). Survival is often reduced when children with intellectual disability also suffer from significant motor dysfunction, progressive congenital conditions, and comorbidities. Yet, little is known about hospice care for children with intellectual disability. The purpose of this study was to explore the relationship between intellectual disability and hospice utilization. Additionally, we explored whether intellectual disability combined with motor dysfunction, progressive congenital conditions, and comorbidities influenced pediatric hospice utilization. Using a retrospective cohort design and data from the 2009 to 2010 California Medicaid claims files, we conducted a multivariate analysis of hospice utilization. This study shows that intellectual disability was negatively related to hospice enrollment and length of stay. We also found that when children had both intellectual disability and comorbidities, there was a positive association with enrolling in hospice care. A number of clinical implications can be drawn from the study findings that hospice and palliative care nurses use to improve their clinical practice of caring for children with ID and their families at end of life. PMID:28260997

  4. Children with intellectual disability and hospice utilization.

    PubMed

    Lindley, Lisa C; Colman, Mari Beth; Meadows, John T

    2017-02-01

    Over 42,000 children die each year in the United States, including those with intellectual disability (ID). Survival is often reduced when children with intellectual disability also suffer from significant motor dysfunction, progressive congenital conditions, and comorbidities. Yet, little is known about hospice care for children with intellectual disability. The purpose of this study was to explore the relationship between intellectual disability and hospice utilization. Additionally, we explored whether intellectual disability combined with motor dysfunction, progressive congenital conditions, and comorbidities influenced pediatric hospice utilization. Using a retrospective cohort design and data from the 2009 to 2010 California Medicaid claims files, we conducted a multivariate analysis of hospice utilization. This study shows that intellectual disability was negatively related to hospice enrollment and length of stay. We also found that when children had both intellectual disability and comorbidities, there was a positive association with enrolling in hospice care. A number of clinical implications can be drawn from the study findings that hospice and palliative care nurses use to improve their clinical practice of caring for children with ID and their families at end of life.

  5. An examination of the relationships between physicians' clinical and hospital-utilization performance.

    PubMed Central

    Saywell, R M; Bean, J A; Ludke, R L; Redman, R W; McHugh, G J

    1981-01-01

    To examine the relationships between measures of attending physician teams' clinical and utilization performance, inpatient hospital audits were conducted in 22 Maryland and western Pennsylvania nonfederal short-term hospitals. A total of 6,980 medical records were abstracted from eight diagnostic categories using the Payne and JCAH PEP medical audit procedures. The results indicate weak statistical associations between the two medical care evaluation audits; between clinical performance and utilization performance, as measured by appropriateness of admissions and length of stay; and between three utilization measures. Based on these findings, it does not appear valid to use performance in one area to evaluate performance in the other in order to measure or evaluate and ultimately improve physicians; clinical or utilization performance. PMID:6946048

  6. Diagnostic utility of FDG-PET in the differential diagnosis between different forms of primary progressive aphasia.

    PubMed

    Bouwman, Femke; Orini, Stefania; Gandolfo, Federica; Altomare, Daniele; Festari, Cristina; Agosta, Federica; Arbizu, Javier; Drzezga, Alexander; Nestor, Peter; Nobili, Flavio; Walker, Zuzana; Morbelli, Silvia; Boccardi, Marina

    2018-05-09

    A joint effort of the European Association of Nuclear Medicine (EANM) and the European Academy of Neurology (EAN) aims at clinical guidance for the use of FDG-PET in neurodegenerative diseases. This paper addresses the diagnostic utility of FDG-PET over clinical/neuropsychological assessment in the differentiation of the three forms of primary progressive aphasia (PPA). Seven panelists were appointed by the EANM and EAN and a literature search was performed by using harmonized PICO (Population, Intervention, Comparison, Outcome) question keywords. The studies were screened for eligibility, and data extracted to assess their methodological quality. Critical outcomes were accuracy indices in differentiating different PPA clinical forms. Subsequently Delphi rounds were held with the extracted data and quality assessment to reach a consensus based on both literature and expert opinion. Critical outcomes for this PICO were available in four of the examined papers. The level of formal evidence supporting clinical utility of FDG-PET in differentiating among PPA variants was considered as poor. However, the consensual recommendation was defined on Delphi round I, with six out of seven panelists supporting clinical use. Quantitative evidence demonstrating utility or lack thereof is still missing. Panelists decided consistently to provide interim support for clinical use based on the fact that a typical atrophy or metabolic pattern is needed for PPA according to the diagnostic criteria, and the synaptic failure detected by FDG-PET is an earlier phenomenon than atrophy. Also, a normal FDG-PET points to a non-neurodegenerative cause.

  7. Adding Specialized Clinics for Remote-Dwellers with Chronic Kidney Disease: A Cost-Utility Analysis

    PubMed Central

    Wiebe, Natasha; Klarenbach, Scott W.; Chui, Betty; Ayyalasomayajula, Bharati; Hemmelgarn, Brenda R.; Jindal, Kailash; Manns, Braden; Tonelli, Marcello

    2012-01-01

    Summary Background and objectives This study aimed to determine whether opening a new clinic in a remote region would be a cost-effective means of improving care for remote-dwellers with CKD. Design, setting, participants, & measurements This study is a cost-utility analysis from a public payer’s perspective over a lifetime horizon, using administrative data from a large cohort of adults with stage 3b-4 CKD in Alberta, Canada. The association between the distance from each simulated patient’s residence and the practice location of the closest nephrologist and clinical outcomes (quality of care, hospitalization, dialysis, and death) were examined. A Markov 6-month cycle economic decision model was analyzed; estimates of the effect of a new clinic were based on the association between residence location, resource use, and outcomes. Costs are reported in 2009 Canadian dollars. Results The costs for equipping and operating a clinic for 321 remote-dwelling patients were estimated at $25,000 and $250,000/yr, respectively. The incremental cost-utility ratios (ICURs) ranged from $4000 to $8000/quality-adjusted life-year under most scenarios. However, if reducing distance to nephrologist care does not alter mortality or hospitalization among remote-dwellers, the cost-effectiveness becomes less attractive. All other one-way sensitivity analyses had negligible effects on the ICUR. Conclusions Given the low costs of equipping and operating new clinics, and the very attractive ICUR relative to other currently funded interventions, establishing new clinics for remote-dwellers could play an important role in efficiently improving outcomes for patients with CKD. High-quality controlled studies are required to confirm this hypothesis. PMID:22076876

  8. Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

    PubMed

    Toivo, Terhi; Dimitrow, Maarit; Puustinen, Juha; Savela, Eeva; Pelkonen, Katariina; Kiuru, Valtteri; Suominen, Tuula; Kinnunen, Sirkka; Uunimäki, Mira; Kivelä, Sirkka-Liisa; Leikola, Saija; Airaksinen, Marja

    2018-03-16

    The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

  9. Assessing the community clinic replacement effect on private Medicaid practices in oral health care within rural environments.

    PubMed

    Squillace, Joe

    2013-01-01

    Children in Medicaid/CHIP public coverage programs who reside in rural counties have limited access to dental care services. Shortages of dental professionals in rural areas impede utilization of dental care. Public and private initiatives are attempting to address this crisis. Missourians instituted deregulatory policies and invested in community-based initiatives. Using a Medicaid/CHIP claims administrative dataset from 2004 to 2007, this research explored patterns of utilization to assess the impact of these efforts. The number of participating private dental office providers declined over the study period, and the number of children utilizing clinics increased. Trends are being observed within the public health dental care market demonstrating clinics are replacing private dentists as providers of Medicaid/CHIP dental services. Allowing greater market entry through deregulation could provide states with greater improvements to their public dental health infrastructure. © 2012 American Association of Public Health Dentistry.

  10. Use of Six Sigma for eliminating missed opportunities for prevention services.

    PubMed

    Gittner, LisaAnn S; Husaini, Baqar A; Hull, Pamela C; Emerson, Janice S; Tropez-Sims, Suzanne; Reece, Michelle C; Zoorob, Roger; Levine, Robert S

    2015-01-01

    Delivery of primary care preventative services can be significantly increased utilizing Six Sigma methods. Missed preventative service opportunities were compared in the study clinic with the community clinic in the same practice. The study clinic had 100% preventative services, compared with only 16.3% in the community clinic. Preventative services can be enhanced to Six Sigma quality when the nurse executive and medical staff agree on a single standard of nursing care executed via standing orders.

  11. Evaluating the Impact of Integrated Care on Service Utilization in Serious Mental Illness.

    PubMed

    Waters, Heidi C; Furukawa, Michael F; Jorissen, Shari L

    2018-06-14

    Serious mental illness (SMI) affects 5% of the United States population and is associated with increased morbidity and mortality, and use of high-cost healthcare services including hospitalizations and emergency department visits. Integrating behavioral and physical healthcare may improve care for consumers with SMI, but prior research findings have been mixed. This quantitative retrospective cohort study assessed whether there was a predictive relationship between integrated healthcare clinic enrollment and inpatient and emergency department utilization for consumers with SMI when controlling for demographic characteristics and disease severity. While findings indicated no statistically significant impact of integrated care clinic enrollment on utilization, the sample had lower levels of utilization than would have been expected. Since policy and payment structures continue to support integrated care models, further research on different programs are encouraged, as each setting and practice pattern is unique.

  12. Clinical implications of risk aversion: an online study of risk-avoidance and treatment utilization in pathological anxiety.

    PubMed

    Lorian, Carolyn N; Grisham, Jessica R

    2011-08-01

    Previous research suggests that the pervasive tendency to avoid perceived risks (i.e., the safety bias) may be implicated in the maintenance of pathological anxiety. These studies have not explored, however, the potential clinical implications of such a bias, such as the influence of risk aversion on treatment seeking. The aim of this study was to investigate how risk-avoidance is related to willingness to seek treatment in an online sample of clinically anxious individuals with social phobia (SP), obsessive-compulsive disorder (OCD) and generalized anxiety disorder (GAD). Healthy control participants (n=117) and those endorsing criteria for one or more anxiety disorder(s) (n=92; SP, n=33; OCD, n=19; GAD, n=40) were recruited from various online sources. Respondents completed an online survey comprised of a validated diagnostic interview, self-report measures assessing for symptom severity, risk-taking across various domains, a generalized index of risk-taking and treatment utilization. Consistent with hypotheses, SP and GAD individuals reported significantly more risk-avoidance when compared to non-clinical controls. Furthermore, willingness to seek treatment was found to be positively associated with social risk-taking and generalized risk-taking orientation in clinically anxious individuals who had never sought treatment. These results suggest that certain individual cognitive factors may contribute to the decision to seek treatment and may provide an interesting avenue of future investigation for increasing service utilization and treatment seeking in anxious populations. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Socio-demographic, clinical characteristics and utilization of mental health care services associated with SF-6D utility scores in patients with mental disorders: contributions of the quantile regression.

    PubMed

    Prigent, Amélie; Kamendje-Tchokobou, Blaise; Chevreul, Karine

    2017-11-01

    Health-related quality of life (HRQoL) is a widely used concept in the assessment of health care. Some generic HRQoL instruments, based on specific algorithms, can generate utility scores which reflect the preferences of the general population for the different health states described by the instrument. This study aimed to investigate the relationships between utility scores and potentially associated factors in patients with mental disorders followed in inpatient and/or outpatient care settings using two statistical methods. Patients were recruited in four psychiatric sectors in France. Patient responses to the SF-36 generic HRQoL instrument were used to calculate SF-6D utility scores. The relationships between utility scores and patient socio-demographic, clinical characteristics, and mental health care utilization, considered as potentially associated factors, were studied using OLS and quantile regressions. One hundred and seventy six patients were included. Women, severely ill patients and those hospitalized full-time tended to report lower utility scores, whereas psychotic disorders (as opposed to mood disorders) and part-time care were associated with higher scores. The quantile regression highlighted that the size of the associations between the utility scores and some patient characteristics varied along with the utility score distribution, and provided more accurate estimated values than OLS regression. The quantile regression may constitute a relevant complement for the analysis of factors associated with utility scores. For policy decision-making, the association of full-time hospitalization with lower utility scores while part-time care was associated with higher scores supports the further development of alternatives to full-time hospitalizations.

  14. Medicare Long-Term CPAP Coverage Policy: A Cost-Utility Analysis

    PubMed Central

    Billings, Martha E.; Kapur, Vishesh K.

    2013-01-01

    Study Objectives: CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Design: Cost-utility and cost-effectiveness analysis. Setting: U.S. Medicare Population. Patients or Participants: N/A. Interventions: N/A. Measurements and Results: We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Conclusions: Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change. Citation: Billings ME; Kapur VK. Medicare long-term CPAP coverage policy: a cost-utility analysis. J Clin Sleep Med 2013;9(10):1023-1029. PMID:24127146

  15. A Predictive Algorithm to Detect Opioid Use Disorder

    PubMed Central

    Lee, Chee; Sharma, Maneesh; Kantorovich, Svetlana

    2018-01-01

    Purpose: The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use in the primary care setting. Methods: A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 1822 patients across 18 family medicine/primary care clinics in the United States. Using the profile, patients were categorized into low, moderate, and high risk for opioid use. Physicians who ordered testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. Results: Approximately 47% of primary care physicians surveyed used the profile to guide clinical decision-making. These physicians rated the benefit of the profile on patient care an average of 3.6 on a 5-point scale (1 indicating no benefit and 5 indicating significant benefit). Eighty-eight percent of all clinicians surveyed felt the test exhibited some benefit to their patient care. The most frequent utilization for the profile was to guide a change in opioid prescribed. Physicians reported greater benefit of profile utilization for minority patients. Patients whose treatment was guided by the profile had pain levels that were reduced, on average, 2.7 levels on the numeric rating scale. Conclusions: The profile provided primary care physicians with a useful tool to stratify the risk of opioid use disorder and was rated as beneficial for decision-making and patient improvement by the majority of physicians surveyed. Physicians reported the profile resulted in greater clinical improvement for minorities, highlighting the objective use of this profile to guide judicial use of opioids in high-risk patients. Significantly, when physicians used the profile to guide treatment decisions, patient-reported pain was greatly reduced. PMID:29383324

  16. A critical appraisal of the clinical utility of proton therapy in oncology

    PubMed Central

    Wang, Dongxu

    2015-01-01

    Proton therapy is an emerging technology for providing radiation therapy to cancer patients. The depth dose distribution of a proton beam makes it a preferable radiation modality as it reduces radiation to the healthy tissue outside the tumor, compared with conventional photon therapy. While theoretically beneficial, its clinical values are still being demonstrated from the increasing number of patients treated with proton therapy, from several dozen proton therapy centers around the world. High equipment and facility costs are often the major obstacle for its wider adoption. Because of the high cost and lack of definite clinical evidence of its superiority, proton therapy treatment faces criticism on its cost-effectiveness. Technological development is causing a gradual lowering of costs, and research and clinical studies are providing further evidence on its clinical utility. PMID:26604838

  17. Competitive Advantage of PET/MRI

    PubMed Central

    Jadvar, Hossein; Colletti, Patrick M.

    2013-01-01

    Multimodality imaging has made great strides in the imaging evaluation of patients with a variety of diseases. Positron emission tomography/computed tomography (PET/CT) is now established as the imaging modality of choice in many clinical conditions, particularly in oncology. While the initial development of combined PET/magnetic resonance imaging (PET/MRI) was in the preclinical arena, hybrid PET/MR scanners are now available for clinical use. PET/MRI combines the unique features of MRI including excellent soft tissue contrast, diffusion-weighted imaging, dynamic contrast-enhanced imaging, fMRI and other specialized sequences as well as MR spectroscopy with the quantitative physiologic information that is provided by PET. Most evidence for the potential clinical utility of PET/MRI is based on studies performed with side-by-side comparison or software-fused MRI and PET images. Data on distinctive utility of hybrid PET/MRI are rapidly emerging. There are potential competitive advantages of PET/MRI over PET/CT. In general, PET/MRI may be preferred over PET/CT where the unique features of MRI provide more robust imaging evaluation in certain clinical settings. The exact role and potential utility of simultaneous data acquisition in specific research and clinical settings will need to be defined. It may be that simultaneous PET/MRI will be best suited for clinical situations that are disease-specific, organ-specific, related to diseases of the children or in those patients undergoing repeated imaging for whom cumulative radiation dose must be kept as low as reasonably achievable. PET/MRI also offers interesting opportunities for use of dual modality probes. Upon clear definition of clinical utility, other important and practical issues related to business operational model, clinical workflow and reimbursement will also be resolved. PMID:23791129

  18. Competitive advantage of PET/MRI.

    PubMed

    Jadvar, Hossein; Colletti, Patrick M

    2014-01-01

    Multimodality imaging has made great strides in the imaging evaluation of patients with a variety of diseases. Positron emission tomography/computed tomography (PET/CT) is now established as the imaging modality of choice in many clinical conditions, particularly in oncology. While the initial development of combined PET/magnetic resonance imaging (PET/MRI) was in the preclinical arena, hybrid PET/MR scanners are now available for clinical use. PET/MRI combines the unique features of MRI including excellent soft tissue contrast, diffusion-weighted imaging, dynamic contrast-enhanced imaging, fMRI and other specialized sequences as well as MR spectroscopy with the quantitative physiologic information that is provided by PET. Most evidence for the potential clinical utility of PET/MRI is based on studies performed with side-by-side comparison or software-fused MRI and PET images. Data on distinctive utility of hybrid PET/MRI are rapidly emerging. There are potential competitive advantages of PET/MRI over PET/CT. In general, PET/MRI may be preferred over PET/CT where the unique features of MRI provide more robust imaging evaluation in certain clinical settings. The exact role and potential utility of simultaneous data acquisition in specific research and clinical settings will need to be defined. It may be that simultaneous PET/MRI will be best suited for clinical situations that are disease-specific, organ-specific, related to diseases of the children or in those patients undergoing repeated imaging for whom cumulative radiation dose must be kept as low as reasonably achievable. PET/MRI also offers interesting opportunities for use of dual modality probes. Upon clear definition of clinical utility, other important and practical issues related to business operational model, clinical workflow and reimbursement will also be resolved. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  19. Optimizing the interpretation of CT for appendicitis: modeling health utilities for clinical practice.

    PubMed

    Blackmore, C Craig; Terasawa, Teruhiko

    2006-02-01

    Error in radiology can be reduced by standardizing the interpretation of imaging studies to the optimum sensitivity and specificity. In this report, the authors demonstrate how the optimal interpretation of appendiceal computed tomography (CT) can be determined and how it varies in different clinical scenarios. Utility analysis and receiver operating characteristic (ROC) curve modeling were used to determine the trade-off between false-positive and false-negative test results to determine the optimal operating point on the ROC curve for the interpretation of appendicitis CT. Modeling was based on a previous meta-analysis for the accuracy of CT and on literature estimates of the utilities of various health states. The posttest probability of appendicitis was derived using Bayes's theorem. At a low prevalence of disease (screening), appendicitis CT should be interpreted at high specificity (97.7%), even at the expense of lower sensitivity (75%). Conversely, at a high probability of disease, high sensitivity (97.4%) is preferred (specificity 77.8%). When the clinical diagnosis of appendicitis is equivocal, CT interpretation should emphasize both sensitivity and specificity (sensitivity 92.3%, specificity 91.5%). Radiologists can potentially decrease medical error and improve patient health by varying the interpretation of appendiceal CT on the basis of the clinical probability of appendicitis. This report is an example of how utility analysis can be used to guide radiologists in the interpretation of imaging studies and provide guidance on appropriate targets for the standardization of interpretation.

  20. Patient perspective on quality of geriatric care and rehabilitation--development and psychometric testing of a questionnaire.

    PubMed

    Wressle, Ewa; Eriksson, Lennart; Fahlander, Amie; Rasmusson, Ing-Marie; Tedemalm, Ulla; Tängmark, Karin

    2006-06-01

    The aim was to develop and test a questionnaire for use in telephone interviews concerning patient evaluation of geriatric care and rehabilitation. Instrument development was performed comprising qualitative interviews, construction of items, content validation, pilot study and data collection for evaluation of care and rehabilitation, clinical utility, reliability and construct validity. Qualitative interviews were performed with 12 elderly participants. The qualitative interviews formed the basis for the construction of 45 items. An expert panel performed a content validation of the questionnaire resulting in a revised version. A pilot study comprised 29 participants recently discharged from geriatric wards and the main data collection comprised 221 participants. Inclusion criteria were being able to perform a telephone interview and willingness to participate. Clinical utility was examined through questions to the interviewers, answered in writing. Cronbach's alpha coefficient was 0.79. According to a factor analysis and the evaluation of clinical utility, the underlying dimensions of the final revised questionnaire concern 'Respect and safety', 'Information and participation' and 'Rehabilitation interventions', scored in 18 items. In addition, one global item concerns satisfaction with care, resulting in 19 items in total. The revised questionnaire was named PaPeR, Patient Perspective on care and Rehabilitation. The questionnaire is considered valid, reliable and judged to have good clinical utility. The time consumption for the telephone interview is about 10-20 minutes. The questionnaire is useful in defining areas for potential quality improvement in geriatric wards.

  1. Implementation of a Mobile Clinical Decision Support Application to Augment Local Antimicrobial Stewardship.

    PubMed

    Hoff, Brian M; Ford, Diana C; Ince, Dilek; Ernst, Erika J; Livorsi, Daniel J; Heintz, Brett H; Masse, Vincent; Brownlee, Michael J; Ford, Bradley A

    2018-01-01

    Medical applications for mobile devices allow clinicians to leverage microbiological data and standardized guidelines to treat patients with infectious diseases. We report the implementation of a mobile clinical decision support (CDS) application to augment local antimicrobial stewardship. We detail the implementation of our mobile CDS application over 20 months. Application utilization data were collected and evaluated using descriptive statistics to quantify the impact of our implementation. Project initiation focused on engaging key stakeholders, developing a business case, and selecting a mobile platform. The preimplementation phase included content development, creation of a pathway for content approval within the hospital committee structure, engaging clinical leaders, and formatting the first version of the guide. Implementation involved a media campaign, staff education, and integration within the electronic medical record and hospital mobile devices. The postimplementation phase required ongoing quality improvement, revision of outdated content, and repeated staff education. The evaluation phase included a guide utilization analysis, reporting to hospital leadership, and sustainability and innovation planning. The mobile application was downloaded 3056 times and accessed 9259 times during the study period. The companion web viewer was accessed 8214 times. Successful implementation of a customizable mobile CDS tool enabled our team to expand beyond microbiological data to clinical diagnosis, treatment, and antimicrobial stewardship, broadening our influence on antimicrobial prescribing and incorporating utilization data to inspire new quality and safety initiatives. Further studies are needed to assess the impact on antimicrobial utilization, infection control measures, and patient care outcomes.

  2. Utility of Gram staining for diagnosis of Malassezia folliculitis.

    PubMed

    Tu, Wei-Ting; Chin, Szu-Ying; Chou, Chia-Lun; Hsu, Che-Yuan; Chen, Yu-Tsung; Liu, Donald; Lee, Woan-Ruoh; Shih, Yi-Hsien

    2018-02-01

    Malassezia folliculitis (MalF) mimics acne vulgaris and bacterial folliculitis in clinical presentations. The role of Gram staining in rapid diagnosis of MalF has not been well studied. In our study, 32 patients were included to investigate the utility of Gram staining for MalF diagnosis. The final diagnoses of MalF were determined according to clinical presentation, pathological result and treatment response to antifungal agents. Our results show that the sensitivity and specificity of Gram staining are 84.6% and 100%, respectively. In conclusion, Gram staining is a rapid, non-invasive, sensitive and specific method for MalF diagnosis. © 2017 Japanese Dermatological Association.

  3. Complete hazard ranking to analyze right-censored data: An ALS survival study.

    PubMed

    Huang, Zhengnan; Zhang, Hongjiu; Boss, Jonathan; Goutman, Stephen A; Mukherjee, Bhramar; Dinov, Ivo D; Guan, Yuanfang

    2017-12-01

    Survival analysis represents an important outcome measure in clinical research and clinical trials; further, survival ranking may offer additional advantages in clinical trials. In this study, we developed GuanRank, a non-parametric ranking-based technique to transform patients' survival data into a linear space of hazard ranks. The transformation enables the utilization of machine learning base-learners including Gaussian process regression, Lasso, and random forest on survival data. The method was submitted to the DREAM Amyotrophic Lateral Sclerosis (ALS) Stratification Challenge. Ranked first place, the model gave more accurate ranking predictions on the PRO-ACT ALS dataset in comparison to Cox proportional hazard model. By utilizing right-censored data in its training process, the method demonstrated its state-of-the-art predictive power in ALS survival ranking. Its feature selection identified multiple important factors, some of which conflicts with previous studies.

  4. cnvScan: a CNV screening and annotation tool to improve the clinical utility of computational CNV prediction from exome sequencing data.

    PubMed

    Samarakoon, Pubudu Saneth; Sorte, Hanne Sørmo; Stray-Pedersen, Asbjørg; Rødningen, Olaug Kristin; Rognes, Torbjørn; Lyle, Robert

    2016-01-14

    With advances in next generation sequencing technology and analysis methods, single nucleotide variants (SNVs) and indels can be detected with high sensitivity and specificity in exome sequencing data. Recent studies have demonstrated the ability to detect disease-causing copy number variants (CNVs) in exome sequencing data. However, exonic CNV prediction programs have shown high false positive CNV counts, which is the major limiting factor for the applicability of these programs in clinical studies. We have developed a tool (cnvScan) to improve the clinical utility of computational CNV prediction in exome data. cnvScan can accept input from any CNV prediction program. cnvScan consists of two steps: CNV screening and CNV annotation. CNV screening evaluates CNV prediction using quality scores and refines this using an in-house CNV database, which greatly reduces the false positive rate. The annotation step provides functionally and clinically relevant information using multiple source datasets. We assessed the performance of cnvScan on CNV predictions from five different prediction programs using 64 exomes from Primary Immunodeficiency (PIDD) patients, and identified PIDD-causing CNVs in three individuals from two different families. In summary, cnvScan reduces the time and effort required to detect disease-causing CNVs by reducing the false positive count and providing annotation. This improves the clinical utility of CNV detection in exome data.

  5. [Home health resource utilization measures using a case-mix adjustor model].

    PubMed

    You, Sun-Ju; Chang, Hyun-Sook

    2005-08-01

    The purpose of this study was to measure home health resource utilization using a Case-Mix Adjustor Model developed in the U.S. The subjects of this study were 484 patients who had received home health care more than 4 visits during a 60-day episode at 31 home health care institutions. Data on the 484 patients had to be merged onto a 60-day payment segment. Based on the results, the researcher classified home health resource groups (HHRG). The subjects were classified into 34 HHRGs in Korea. Home health resource utilization according to clinical severity was in order of Minimum (C0) < 'Low (C1) < 'Moderate (C2) < 'High (C3), according to dependency in daily activities was in order of Minimum (F0) < 'High (F3) < 'Medium (F2) < 'Low (F1) < 'Maximum (F4). Resource utilization by HHRGs was the highest 564,735 won in group C0F0S2 (clinical severity minimum, dependency in daily activity minimum, service utilization moderate), and the lowest 97,000 won in group C2F3S1, so the former was 5.82 times higher than the latter. Resource utilization in home health care has become an issue of concern due to rising costs for home health care. The results suggest the need for more analytical attention on the utilization and expenditures for home care using a Case-Mix Adjustor Model.

  6. Comparison of Multiple Chronic Obstructive Pulmonary Disease (COPD) Indices in Chinese COPD Patients.

    PubMed

    Zhang, Jinsong; Miller, Anastasia; Li, Yongxia; Lan, Qinqin; Zhang, Ning; Chai, Yanling; Hai, Bing

    2018-04-01

    Chronic obstructive pulmonary disease (COPD) is a serious chronic condition with a global impact. Symptoms of COPD include progressive dyspnea, breathlessness, cough, and sputum production, which have a considerable impact on the lives of patients. In addition to the human cost of living with COPD and the resulting death, COPD entails a huge economic burden on the Chinese population, with patients spending up to one-third of the average family income on COPD management in some regions is clinically beneficial to adopt preventable measures via prudent COPD care utilization, monetary costs, and hospitalizations. Toward this end, this study compared the relative effectiveness of six indices in predicting patient healthcare utilization, cost of care, and patient health outcome. The six assessment systems evaluated included the three multidimensional Body mass index, Obstruction, Dyspnea, Exercise capacity index, Dyspnea, Obstruction, Smoking, Exacerbation (DOSE) index, and COPD Assessment Test index, or the unidimensional measures that best predict the future of patient healthcare utilization, cost of care, and patient health outcome among Chinese COPD patients. Multiple linear regression models were created for each healthcare utilization, cost, and outcome including a single COPD index and the same group of demographic variables for each of the outcomes. We conclude that the DOSE index facilitates the prediction of patient healthcare utilization, disease expenditure, and negative clinical outcomes. Our study indicates that the DOSE index has a potential role beyond clinical predictions. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

  7. Clinical and Experimental Research Utilizing the DACL.

    ERIC Educational Resources Information Center

    Strickland, Bonnie R.

    Since the development of the Lubin Depression Adjective Check Lists (DACL) in 1965, researchers have used this instrument in many empirical and clinical studies. Scores on the DACL have correlated with other measures of depression and have also been related to personal characteristics of depressed individuals. The DACL has been used in studies to…

  8. Prevention and diagnosis of invasive fungal disease in high-risk patients within an integrative care pathway.

    PubMed

    Barnes, Rosemary A; Stocking, Kate; Bowden, Sarah; Poynton, Matthew H; White, P Lewis

    2013-09-01

    The aim of this study was to assess the clinical utility of enhanced diagnostics on the management of invasive fungal disease in high risk patients within an integrated care pathway and to audit compliance and efficacy of antifungal prophylaxis. A cohort of 549 high risk haematology and stem-cell transplant recipients was followed over a 5 year period. The routine standard of care involved the use of antimould prophylaxis and a neutropenic care pathway utilizing twice weekly antigen and PCR testing. Prophylaxis with itraconazole was poorly tolerated and therapeutic levels could not be maintained. Antigen testing and PCR showed good clinical utility in the management of invasive aspergilosis with high sensitivity (98%) and negative predictive value (99.6%) when both tests were used together, allowing a diagnosis IA to be excluded and obviating the need for empirical antifungal agents. When used serially, multiple positive PCR and antigen test results enabled accurate diagnosis of IA with a specificity of 95% and a positive likelihood ratio of 11. Biomarkers preceded clinical signs in 85% of proven and probable invasive disease. The combination of both tests showed optimum clinical utility for the diagnosis and management of IA in this high risk group. Copyright © 2013 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

  9. Factors affecting utilization of dental health services and satisfaction among adolescent females in Riyadh City

    PubMed Central

    Al-Hussyeen, Al Johara A.

    2009-01-01

    Objectives This study was conducted to determine factors affecting utilization of dental health services among intermediate female school students in Riyadh. In addition to assessing their satisfaction with the dental care received during the last dental visit. Subjects and methods Self-administered questionnaires were distributed among students attending eight public and four private schools. These schools were selected randomly to represent the four different administrative zones in Riyadh. Results Of 600 questionnaires distributed, 531 were complete and suitable for analysis. Nearly three quarters of the students visited the dentist more than once during the last 2 years. A bout 75% had their treatment in private dental clinics and 63% made their visits for routine treatment. The quality of dental care was found to be the most encouraging factor for utilization of dental services, whereas, far geographic location of the dental clinics was the most discouraging factor. For those who received treatment in the government clinics, the most discouraging factor was post operative complications (P < 0.0001), while the most encouraging factor was the availability of friendly staff (P < 0.0001). The high cost of dental care was the most discouraging factor for utilizing the dental services for those who visited private clinics (P < 0.0001), while the high quality of dental care was the most encouraging factor (P < 0.009). Students who made their visits because of pain highly considered modern clinics and those recommended by friends as highly encouraging factors (P < 0.002), while they considered the high cost of dental care as discouraging factor for using dental services (P < 0.038). Students who visited the dentist for routine treatment gave the quality of dental care as encouraging for the use of dental clinics (P < 0.0001). Satisfaction with dental care was found to be significantly associated with high quality of dental care, convenient appointment, friendly staff, modern dental clinics and clinics recommended by friends. Conclusion Quality of dental care, reasonable fees for dental services and close location of dental clinics to students’ homes are encouraging factors for utilization of dental services. PMID:23960475

  10. Factors affecting utilization of dental health services and satisfaction among adolescent females in Riyadh City.

    PubMed

    Al-Hussyeen, Al Johara A

    2010-01-01

    This study was conducted to determine factors affecting utilization of dental health services among intermediate female school students in Riyadh. In addition to assessing their satisfaction with the dental care received during the last dental visit. Self-administered questionnaires were distributed among students attending eight public and four private schools. These schools were selected randomly to represent the four different administrative zones in Riyadh. Of 600 questionnaires distributed, 531 were complete and suitable for analysis. Nearly three quarters of the students visited the dentist more than once during the last 2 years. A bout 75% had their treatment in private dental clinics and 63% made their visits for routine treatment. The quality of dental care was found to be the most encouraging factor for utilization of dental services, whereas, far geographic location of the dental clinics was the most discouraging factor. For those who received treatment in the government clinics, the most discouraging factor was post operative complications (P < 0.0001), while the most encouraging factor was the availability of friendly staff (P < 0.0001). The high cost of dental care was the most discouraging factor for utilizing the dental services for those who visited private clinics (P < 0.0001), while the high quality of dental care was the most encouraging factor (P < 0.009). Students who made their visits because of pain highly considered modern clinics and those recommended by friends as highly encouraging factors (P < 0.002), while they considered the high cost of dental care as discouraging factor for using dental services (P < 0.038). Students who visited the dentist for routine treatment gave the quality of dental care as encouraging for the use of dental clinics (P < 0.0001). Satisfaction with dental care was found to be significantly associated with high quality of dental care, convenient appointment, friendly staff, modern dental clinics and clinics recommended by friends. Quality of dental care, reasonable fees for dental services and close location of dental clinics to students' homes are encouraging factors for utilization of dental services.

  11. The frequency modulated auditory evoked response (FMAER), a technical advance for study of childhood language disorders: cortical source localization and selected case studies

    PubMed Central

    2013-01-01

    Background Language comprehension requires decoding of complex, rapidly changing speech streams. Detecting changes of frequency modulation (FM) within speech is hypothesized as essential for accurate phoneme detection, and thus, for spoken word comprehension. Despite past demonstration of FM auditory evoked response (FMAER) utility in language disorder investigations, it is seldom utilized clinically. This report's purpose is to facilitate clinical use by explaining analytic pitfalls, demonstrating sites of cortical origin, and illustrating potential utility. Results FMAERs collected from children with language disorders, including Developmental Dysphasia, Landau-Kleffner syndrome (LKS), and autism spectrum disorder (ASD) and also normal controls - utilizing multi-channel reference-free recordings assisted by discrete source analysis - provided demonstratrions of cortical origin and examples of clinical utility. Recordings from inpatient epileptics with indwelling cortical electrodes provided direct assessment of FMAER origin. The FMAER is shown to normally arise from bilateral posterior superior temporal gyri and immediate temporal lobe surround. Childhood language disorders associated with prominent receptive deficits demonstrate absent left or bilateral FMAER temporal lobe responses. When receptive language is spared, the FMAER may remain present bilaterally. Analyses based upon mastoid or ear reference electrodes are shown to result in erroneous conclusions. Serial FMAER studies may dynamically track status of underlying language processing in LKS. FMAERs in ASD with language impairment may be normal or abnormal. Cortical FMAERs can locate language cortex when conventional cortical stimulation does not. Conclusion The FMAER measures the processing by the superior temporal gyri and adjacent cortex of rapid frequency modulation within an auditory stream. Clinical disorders associated with receptive deficits are shown to demonstrate absent left or bilateral responses. Serial FMAERs may be useful for tracking language change in LKS. Cortical FMAERs may augment invasive cortical language testing in epilepsy surgical patients. The FMAER may be normal in ASD and other language disorders when pathology spares the superior temporal gyrus and surround but presumably involves other brain regions. Ear/mastoid reference electrodes should be avoided and multichannel, reference free recordings utilized. Source analysis may assist in better understanding of complex FMAER findings. PMID:23351174

  12. The effect of increasing the coinsurance rate on outpatient utilization of healthcare services in South Korea.

    PubMed

    Lee, Hyo Jung; Jang, Sung-In; Park, Eun-Cheol

    2017-02-20

    The Korean healthcare system is composed of costly and inefficient structures that fail to adequately divide the functions and roles of medical care organizations. To resolve this matter, the government reformed the cost-sharing policy in November of 2011 for the management of outpatients visiting general or tertiary hospitals with comparatively mild diseases. The purpose of the present study was to examine the impact of increasing the coinsurance rate of prescription drug costs for 52 mild diseases at general or tertiary hospitals on outpatient healthcare service utilization. The present study used health insurance claim data collected from 2010 to 2013. The study population consisted of 505,691 outpatients and was defined as those aged 20-64 years who had visited medical care organizations for the treatment of 52 diseases both before and after the program began. To examine the effect of the cost-sharing policy on outpatient healthcare service utilization (percentage of general or tertiary hospital utilization, number of outpatient visits, and outpatient medical costs), a segmented regression analysis was performed. After the policy to increase the coinsurance rate on prescription drug costs was implemented, the number of outpatient visits at general or tertiary hospitals decreased (β = -0.0114, p < 0.0001); however, the number increased at hospitals and clinics (β = 0.0580, p < 0.0001). Eventually, the number of outpatient visits to hospitals and clinics began to decrease after policy initiation (β = -0.0018, p < 0.0001). Outpatient medical costs decreased for both medical care organizations (general or tertiary hospitals: β = -2913.4, P < 0.0001; hospitals or clinics: β = -591.35, p < 0.0001), and this decreasing trend continued with time. It is not clear that decreased utilization of general or tertiary hospitals has transferred to that of clinics or hospitals due to the increased cost-sharing policy of prescription drug costs. This result indicates the cost-sharing policy, intended to change patient behaviors for healthcare service utilization, has had limited effects on rebuilding the healthcare system and the function of medical care organizations.

  13. Whole exome sequencing in neurogenetic odysseys: An effective, cost- and time-saving diagnostic approach

    PubMed Central

    Córdoba, Marta; Rodriguez-Quiroga, Sergio Alejandro; Vega, Patricia Analía; Salinas, Valeria; Perez-Maturo, Josefina; Amartino, Hernán; Vásquez-Dusefante, Cecilia; Medina, Nancy; González-Morón, Dolores; Kauffman, Marcelo Andrés

    2018-01-01

    Background Diagnostic trajectories for neurogenetic disorders frequently require the use of considerable time and resources, exposing patients and families to so-called “diagnostic odysseys”. Previous studies have provided strong evidence for increased diagnostic and clinical utility of whole-exome sequencing in medical genetics. However, specific reports assessing its utility in a setting such as ours- a neurogeneticist led academic group serving in a low-income country—are rare. Objectives To assess the diagnostic yield of WES in patients suspected of having a neurogenetic condition and explore the cost-effectiveness of its implementation in a research group located in an Argentinean public hospital. Methods This is a prospective study of the clinical utility of WES in a series of 40 consecutive patients selected from a Neurogenetic Clinic of a tertiary Hospital in Argentina. We evaluated patients retrospectively for previous diagnostic trajectories. Diagnostic yield, clinical impact on management and economic diagnostic burden were evaluated. Results We demonstrated the clinical utility of Whole Exome Sequencing in our patient cohort, obtaining a diagnostic yield of 40% (95% CI, 24.8%-55.2%) among a diverse group of neurological disorders. The average age at the time of WES was 23 (range 3–70). The mean time elapsed from symptom onset to WES was 11 years (range 3–42). The mean cost of the diagnostic workup prior to WES was USD 1646 (USD 1439 to 1853), which is 60% higher than WES cost in our center. Conclusions WES for neurogenetics proved to be an effective, cost- and time-saving approach for the molecular diagnosis of this heterogeneous and complex group of patients. PMID:29389947

  14. Clinical application of plasma thermograms. Utility, practical approaches and considerations.

    PubMed

    Garbett, Nichola C; Mekmaysy, Chongkham S; DeLeeuw, Lynn; Chaires, Jonathan B

    2015-04-01

    Differential scanning calorimetry (DSC) studies of blood plasma are part of an emerging area of the clinical application of DSC to biofluid analysis. DSC analysis of plasma from healthy individuals and patients with various diseases has revealed changes in the thermal profiles of the major plasma proteins associated with the clinical status of the patient. The sensitivity of DSC to the concentration of proteins, their interactions with other proteins or ligands, or their covalent modification underlies the potential utility of DSC analysis. A growing body of literature has demonstrated the versatility and performance of clinical DSC analysis across a range of biofluids and in a number of disease settings. The principles, practice and challenges of DSC analysis of plasma are described in this article. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Clinical application of plasma thermograms. Utility, practical approaches and considerations

    PubMed Central

    Garbett, Nichola C.; Mekmaysy, Chongkham S.; DeLeeuw, Lynn; Chaires, Jonathan B.

    2014-01-01

    Differential scanning calorimetry (DSC) studies of blood plasma are part of an emerging area of the clinical application of DSC to biofluid analysis. DSC analysis of plasma from healthy individuals and patients with various diseases has revealed changes in the thermal profiles of the major plasma proteins associated with the clinical status of the patient. The sensitivity of DSC to the concentration of proteins, their interactions with other proteins or ligands, or their covalent modifications underlies the potential utility of DSC analysis. A growing body of literature has demonstrated the versatility and performance of clinical DSC analysis across a range of biofluids and in a number of disease settings. The principles, practice and challenges of DSC analysis of plasma are described in this article. PMID:25448297

  16. Clinical utility of MRI and SPECT in the diagnosis of cognitive impairment referred to memory clinic.

    PubMed

    Guinane, John; Ng, Boon Lung

    2018-05-01

    ABSTRACTBackground:Despite of their limited availability and potential for significant variation between and within each modality, this is the first study to prospectively measure the clinical utility of MRI and/or SPECT brain scanning in addition to the routine diagnostic workup of patients presenting to memory clinic. A single center study was conducted over a convenience of 12-month sampling period. For each patient referred for MRI and/or SPECT scanning, the primary geriatrician or psychogeriatrician was asked to assign an initial diagnosis. The initial diagnosis was then compared with the final consensus diagnosis after any scans or neuropsychology testing had been completed. During the 12-month study period, 66 patients (26%) were referred for scans out of a total of 253 patients included in the study. There were 16/44 (36%) positive MRI outcomes and 13/35 (37%) positive SPECT outcomes. The diagnosis changed consistent with the MRI scan findings in 11/44 (25%) and changed consistent with the SPECT scan findings in 9/35 (26%). Potentially reversible pathology was identified in a single patient, 1/50 (2%), via an MRI scan that suggested normal pressure hydrocephalus. The number needed to test for one positive outcome was 3.8 (95% CI 2.0-23.3), 6.0 (95% CI NA), and 1.7 (95% CI 1.3-2.5) for MRI only, SPECT only, and MRI and SPECT together, respectively. The clinical utility of MRI and/or SPECT scanning in this study may be broadly superior to the available international evidence, and further research is needed to identify predictors of positive scan outcomes.

  17. Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

    NASA Astrophysics Data System (ADS)

    Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

    2004-04-01

    Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

  18. Ubiquitous Multicriteria Clinic Recommendation System.

    PubMed

    Chen, Toly

    2016-05-01

    Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant.

  19. Clinical outcome of surgical treatment of the symptomatic accessory navicular.

    PubMed

    Kopp, Franz J; Marcus, Randall E

    2004-01-01

    When conservative treatment fails to provide relief for a symptomatic accessory navicular, surgical intervention may be necessary. Numerous studies have been published, reporting the results of the traditional Kidner procedure and alternative surgical techniques, all of which produce mostly satisfactory clinical outcomes. The purpose of this study was to report the clinical results, utilizing the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale, of surgical management for symptomatic accessory navicular with simple excision and anatomic repair of the tibialis posterior tendon. The authors retrospectively reviewed the results of 13 consecutive patients (14 feet) who underwent surgical treatment for symptomatic accessory navicular. The patients ranged in age from 16 to 64 years (average, 34.1 years; mean, 28.2 years) at the time of surgery. All patients had a type II accessory navicular. The average follow-up of the patients involved in the study was 103.4 months (range, 45-194 months). The AOFAS Midfoot Scale was utilized to determine both preoperative and postoperative clinical status of the 14 feet included in the study. The average preoperative AOFAS score was 48.2 (range, 20-75; mean, 38.8). The average postoperative AOFAS score was 94.5 (range, 83-100; mean, 94.3). At last follow-up, 13 of 14 feet were without any pain, no patients had activity limitations, and only two of 14 feet required shoe insert modification. Postoperatively, no patients had a clinically notable change in their preoperative midfoot longitudinal arch alignment. All of the patients in the study were satisfied with the outcome of their surgery and would undergo the same operation again under similar circumstances. When conservative measures fail to relieve the symptoms of a painful accessory navicular, simple excision of the accessory navicular and anatomic repair of the posterior tibialis tendon is a successful intervention. Overall, the procedure provides reliable pain relief and patient satisfaction. In the current study, the clinical status of each patient improved significantly postoperatively, quantified utilizing the AOFAS Midfoot Scale.

  20. Population Preferences for Health Care in Liberia: Insights for Rebuilding a Health System

    PubMed Central

    Kruk, Margaret E; Rockers, Peter C; Tornorlah Varpilah, S; Macauley, Rose

    2011-01-01

    Objective To quantify the influence of health system attributes, particularly quality of care, on preferences for health clinics in Liberia, a country with a high burden of disease that is rebuilding its health system after 14 years of civil war. Data Sources/Study Setting Informed by focus group discussions, a discrete choice experiment (DCE) was designed to assess preferences for structure and process of care at health clinics. The DCE was fielded in rural, northern Liberia as part of a 2008 population-based survey on health care utilization. Data Collection The survey response rate was 98 percent with DCE data available for 1,431 respondents. Mixed logit models were used to estimate the influence of six attributes on choice of hypothetical clinics for a future illness. Principal Findings Participants' choice of clinic was most influenced by provision of a thorough physical exam and consistent availability of medicines. Respectful treatment and government (versus NGO) management marginally increased utility, whereas waiting time was not significant. Conclusions Liberians value technical quality of care over convenience, courtesy, and public management in selecting clinics for curative care. This suggests that investments in improved competence of providers and availability of medicines may increase population utilization of essential services as well as promote better clinical outcomes. PMID:21517835

  1. Population preferences for health care in liberia: insights for rebuilding a health system.

    PubMed

    Kruk, Margaret E; Rockers, Peter C; Tornorlah Varpilah, S; Macauley, Rose

    2011-12-01

    OBJECTIVE. To quantify the influence of health system attributes, particularly quality of care, on preferences for health clinics in Liberia, a country with a high burden of disease that is rebuilding its health system after 14 years of civil war. DATA SOURCES/STUDY SETTING. Informed by focus group discussions, a discrete choice experiment (DCE) was designed to assess preferences for structure and process of care at health clinics. The DCE was fielded in rural, northern Liberia as part of a 2008 population-based survey on health care utilization. DATA COLLECTION. The survey response rate was 98 percent with DCE data available for 1,431 respondents. Mixed logit models were used to estimate the influence of six attributes on choice of hypothetical clinics for a future illness. PRINCIPAL FINDINGS. Participants' choice of clinic was most influenced by provision of a thorough physical exam and consistent availability of medicines. Respectful treatment and government (versus NGO) management marginally increased utility, whereas waiting time was not significant. CONCLUSIONS. Liberians value technical quality of care over convenience, courtesy, and public management in selecting clinics for curative care. This suggests that investments in improved competence of providers and availability of medicines may increase population utilization of essential services as well as promote better clinical outcomes. © Health Research and Educational Trust.

  2. Management Control Systems and Clinical Experience of Managers in Public Hospitals

    PubMed Central

    Naranjo-Gil, David

    2018-01-01

    Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector. PMID:29673192

  3. Management Control Systems and Clinical Experience of Managers in Public Hospitals.

    PubMed

    Lunkes, Rogério Joao; Naranjo-Gil, David; Lopez-Valeiras, Ernesto

    2018-04-17

    Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector.

  4. The clinical application of research utilization: amphotericin B.

    PubMed

    Reedy, A M; Shivnan, J C; Hanson, J L; Haisfield, M E; Gregory, R E

    1994-05-01

    To describe the first application of the research utilization process by clinical nurses using the Stetler-Marram Model of Research Utilization to the practice of amphotericin B administration; to share the findings; and to discuss issues encountered in the process and their solutions. Published articles identified through computerized literature searches, published abstracts and books, personal communication with one author, and an informal survey of other cancer centers' amphotericin B infusion practices; research articles were selected for review if studies included settings and patient populations similar to those of the authors and if they used experimental designs. Studies were reviewed for scientific merit and clinical applicability according to the Stetler-Marram model; findings were used to develop a specific nursing protocol for infusion times of amphotericin B based on clinical criteria. The Stetler-Marram model helped staff nurses decide how to apply research findings to practice, although using it was difficult and required mentorship. A research base exists for amphotericin B administration time but not for test doses or premedications to prevent or minimize side effects. Staff nurses can use the Stetler-Marram model but need resources and support from individuals, committees, and administration. A specific protocol representing a practice change was implemented and may be applicable to other settings.

  5. Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics.

    PubMed

    Yoon, Jean; Lo, Jeanie; Gehlert, Elizabeth; Johnson, Erin E; O'Toole, Thomas P

    2017-06-01

    The study compared health care utilization and costs among homeless veterans randomly assigned to peer mentors or usual care and described contacts with peer mentors. Homeless patients at four Department of Veterans Affairs clinics were randomly assigned to a peer mentor (N=195) or to usual care (N=180). Administrative data on utilization and costs over a six-month follow-up were combined with peer mentors' reports of patient contacts. Most patients (87%) in the peer mentor group had at least one peer contact. Patients in this group spent the largest proportions of time discussing housing and health issues with peer mentors and had more outpatient encounters than those in usual care, although differences were not significant. No other between-group differences were found in utilization or costs. Although significant impacts of peer mentors on health care patterns or costs were not detected, some patients had frequent contact with peer mentors.

  6. Inferring Clinical Workflow Efficiency via Electronic Medical Record Utilization

    PubMed Central

    Chen, You; Xie, Wei; Gunter, Carl A; Liebovitz, David; Mehrotra, Sanjay; Zhang, He; Malin, Bradley

    2015-01-01

    Complexity in clinical workflows can lead to inefficiency in making diagnoses, ineffectiveness of treatment plans and uninformed management of healthcare organizations (HCOs). Traditional strategies to manage workflow complexity are based on measuring the gaps between workflows defined by HCO administrators and the actual processes followed by staff in the clinic. However, existing methods tend to neglect the influences of EMR systems on the utilization of workflows, which could be leveraged to optimize workflows facilitated through the EMR. In this paper, we introduce a framework to infer clinical workflows through the utilization of an EMR and show how such workflows roughly partition into four types according to their efficiency. Our framework infers workflows at several levels of granularity through data mining technologies. We study four months of EMR event logs from a large medical center, including 16,569 inpatient stays, and illustrate that over approximately 95% of workflows are efficient and that 80% of patients are on such workflows. At the same time, we show that the remaining 5% of workflows may be inefficient due to a variety of factors, such as complex patients. PMID:26958173

  7. Health Literacy Among a Formerly Incarcerated Population Using Data from the Transitions Clinic Network.

    PubMed

    Hadden, Kristie B; Puglisi, Lisa; Prince, Latrina; Aminawung, Jenerius A; Shavit, Shira; Pflaum, David; Calderon, Joe; Wang, Emily A; Zaller, Nickolas

    2018-06-25

    Health literacy is increasingly understood to be a mediator of chronic disease self-management and health care utilization. However, there has been very little research examining health literacy among incarcerated persons. This study aimed to describe the health literacy and relevant patient characteristics in a recently incarcerated primary care patient population in 12 communities in 6 states and Puerto Rico. Baseline data were collected from 751 individuals through the national Transitions Clinic Network (TCN), a model which utilizes a community health worker (CHW) with a previous history of incarceration to engage previously incarcerated people with chronic medical diseases in medical care upon release. Participants in this study completed study measures during or shortly after their first medical visit in the TCN. Data included demographics, health-related survey responses, and a measure of health literacy, The Newest Vital Sign (NVS). Bivariate and linear regression models were fit to explore associations among health literacy and the time from release to first clinic appointment, number of emergency room visits before first clinic appointment and confidence in adhering to medication. Our study found that almost 60% of the sample had inadequate health literacy. Inadequate health literacy was associated with decreased confidence in taking medications following release and an increased likelihood of visiting the emergency department prior to primary care. Early engagement may improve health risks for this population of individuals that is at high risk of death, acute care utilization, and hospitalization following release.

  8. Calculus detection calibration among dental hygiene faculty members utilizing dental endoscopy: a pilot study.

    PubMed

    Partido, Brian B; Jones, Archie A; English, Dana L; Nguyen, Carol A; Jacks, Mary E

    2015-02-01

    Dental and dental hygiene faculty members often do not provide consistent instruction in the clinical environment, especially in tasks requiring clinical judgment. From previous efforts to calibrate faculty members in calculus detection using typodonts, researchers have suggested using human subjects and emerging technology to improve consistency in clinical instruction. The purpose of this pilot study was to determine if a dental endoscopy-assisted training program would improve intra- and interrater reliability of dental hygiene faculty members in calculus detection. Training included an ODU 11/12 explorer, typodonts, and dental endoscopy. A convenience sample of six participants was recruited from the dental hygiene faculty at a California community college, and a two-group randomized experimental design was utilized. Intra- and interrater reliability was measured before and after calibration training. Pretest and posttest Kappa averages of all participants were compared using repeated measures (split-plot) ANOVA to determine the effectiveness of the calibration training on intra- and interrater reliability. The results showed that both kinds of reliability significantly improved for all participants and the training group improved significantly in interrater reliability from pretest to posttest. Calibration training was beneficial to these dental hygiene faculty members, especially those beginning with less than full agreement. This study suggests that calculus detection calibration training utilizing dental endoscopy can effectively improve interrater reliability of dental and dental hygiene clinical educators. Future studies should include human subjects, involve more participants at multiple locations, and determine whether improved rater reliability can be sustained over time.

  9. Hepatitis C Virus Resistance Testing in Genotype 1: The Changing Role in Clinical Utility.

    PubMed

    Molino, Suzanne; Martin, Michelle T

    2017-09-01

    To review the role and utility of baseline resistance testing with currently available and pipeline genotype 1 hepatitis C virus (HCV) treatment. Authors reviewed liver meeting abstracts for data on currently-available and pipeline genotype 1 retreatment regimens from January 1, 2015, to March 23, 2017. Additional trials were identified from a review of clinicaltrials.gov using the pipeline medication names. Authors identified reports of current and pipeline genotype 1 retreatment regimens. Seven references were clinical study results presented at the meetings of the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver, and 2 studies were from clinicaltrials.gov . Retreatment trial data of currently available salvage regimens indicate that baseline NS5A resistance-associated substitutions (RASs) may decrease sustained virological response (SVR) rates when retreating with ledipasvir/sofosbuvir but are not affected when using elbasvir/grazoprevir + sofosbuvir + ribavirin, paritaprevir/ritonavir/ombitasvir + dasabuvir + sofosbuvir, or sofosbuvir/velpatasvir + ribavirin. Pipeline data indicate that baseline NS5A RASs do not affect SVR rates when retreating with sofosbuvir/velpatasvir/voxilaprevir or glecaprevir/pibrentasvir. Baseline resistance testing was used for decisional support for 3 clinical scenarios in patients with HCV genotype 1 infection at the time of manuscript submission. Pending the approval of 2 new direct-acting antiviral regimens in the third quarter of 2017, the rapidly evolving HCV treatment guidelines will likely reflect a decreased clinical utility for resistance testing.

  10. Equitable health services for the young? A decomposition of income-related inequalities in young adults' utilization of health care in Northern Sweden.

    PubMed

    Mosquera, Paola A; Waenerlund, Anna-Karin; Goicolea, Isabel; Gustafsson, Per E

    2017-01-18

    Despite the goal of the Swedish health system to offer health care according to the principle of horizontal equity, little is known about the equality in access to health care use among young people. To explore this issue, the present study aimed i) to assess horizontal inequity in health care utilization among young people in Northern Sweden; and ii) to explore the contribution of different factors to explain the observed inequalities. Participants (N = 3016 youths aged 16-25 years) came from the "Health on Equal terms" survey conducted in 2014 in the four northernmost counties in Sweden. Concentration indices (C) and horizontal inequity indices (HI) were calculated to measure inequalities in the utilization of two health care services (general practitioners (GP) and youth clinics). The HI was calculated based on health care utilization and variables representing socioeconomic status (household income), health care needs factors and non-need factors affecting health care use. A decomposition analysis was carried out to explain the income-related inequalities. Results showed a significant positive income-related inequality for youth clinic utilization in women (C = 0.166) and total sample (C = 0.097), indicating that services were concentrated among the better-off. In contrast, general practitioner visits showed inequality pointing toward a higher utilization among less affluent individuals; significant in women (C = -0.079), men (C = -0.101) and pooled sample (C = -0.097). After taking health care needs into consideration, the utilization of youth clinics remained significantly pro-rich in women (HI = 0.121) and total sample (HI = 0.099); and consistently pro-poor for the GP visits in the pooled sample (HI = -0.058). The decomposition analyses suggest that socioeconomic inequalities explain a considerable portion of the pro-rich utilization of youth clinics services among young women. The corresponding analyses for GP visits showed that need factors and socioeconomic conditions accounted for the pro-poor concentration of GP visits. The distribution of GP visits among young people in Northern Sweden slightly favored the low-income group, and thus seems to meet the premises of horizontal equity. In contrast, the findings suggest substantial pro-rich horizontal inequity in the utilization of youth clinics among young women, which are largely rooted in socioeconomic inequalities.

  11. Burden of illness and health care resource utilization in adult psychiatric outpatients with attention-deficit/hyperactivity disorder in Europe.

    PubMed

    Karlsdotter, Kristina; Bushe, Chris; Hakkaart, L; Sobanski, Esther; Kan, C C; Lebrec, Jeremie; Kraemer, Susanne; Dieteren, Nicole A H M; Deberdt, Walter

    2016-09-01

    To assess the burden of illness and health care resource utilization of adult nonpsychotic psychiatric outpatients with attention-deficit/hyperactivity disorder (ADHD) in Europe. This was a multicountry, cross-sectional, observational study where unselected routine patients from clinical psychiatric outpatient settings were screened and assessed for ADHD. Patients were evaluated using the Clinical Global Impressions of Severity (CGI-S) scale, the Sheehan Disability Scale (SDS), and the EuroQol-5 Dimensions questionnaire. Data on comorbidities, functional impairment, and health care resource utilization were captured. The study enrolled 2284 patients, of whom 1986 completed the study. The prevalence of ADHD was 17.4%, of whom 46.0% had a previous ADHD diagnosis. Patients with ADHD had a high clinical burden with psychiatric comorbidities, especially depression (43.0%) and anxiety disorders (36.4%). Substance abuse (9.2% vs. 3.4%) and alcohol abuse (10.3% vs. 5.2%) were more common in the ADHD cohort vs. the non-ADHD cohort. Only 11.5% of the patients with ADHD had no other psychiatric disorder. Various measures indicated a significantly poorer level of functioning for patients with ADHD than without ADHD, as indicated by higher scores for CGI-S (3.8 vs. 3.3) and SDS (18.9 vs. 11.6) and higher percentages of debt (35.5% vs. 24.3%) and criminality (13.8% vs. 6.1%). Lastly, the health care resource utilization was considerable and similar between adult psychiatric outpatients diagnosed and not diagnosed with ADHD. Although care was taken when choosing the sites for this study, to make it representative of the general outpatient adult psychiatric population, caution should be advised in generalizing the findings of our study to the general ADHD or psychiatric outpatient population. This was an observational study, thus no inference on causality can be drawn. Having ADHD imposes a considerable health and social burden on patient and health care resource utilization comparable to other chronic psychiatric disorders.

  12. Warfarin Pharmacogenetics

    PubMed Central

    Johnson, Julie A.; Cavallari, Larisa H.

    2014-01-01

    The cytochrome P450 (CYP) 2C9 and vitamin K epoxide reductase complex 1 (VKORC1) genotypes have been strongly and consistently associated with warfarin dose requirements, and dosing algorithms incorporating genetic and clinical information have been shown to be predictive of stable warfarin dose. However, clinical trials evaluating genotype-guided warfarin dosing produced mixed results, calling into question the utility of this approach. Recent trials used surrogate markers as endpoints rather than clinical endpoints, further complicating translation of the data to clinical practice. The present data do not support genetic testing to guide warfarin dosing, but in the setting where genotype data are available, use of such data in those of European ancestry is reasonable. Outcomes data are expected from an on-going trial, observational studies continue, and more work is needed to define dosing algorithms that incorporate appropriate variants in minority populations; all these will further shape guidelines and recommendations on the clinical utility of genotype-guided warfarin dosing. PMID:25282448

  13. The headache under-response to treatment (HURT) questionnaire, an outcome measure to guide follow-up in primary care: development, psychometric evaluation and assessment of utility.

    PubMed

    Steiner, T J; Buse, D C; Al Jumah, M; Westergaard, M L; Jensen, R H; Reed, M L; Prilipko, L; Mennini, F S; Láinez, M J A; Ravishankar, K; Sakai, F; Yu, S-Y; Fontebasso, M; Al Khathami, A; MacGregor, E A; Antonaci, F; Tassorelli, C; Lipton, R B

    2018-02-14

    Headache disorders are both common and burdensome but, given the many people affected, provision of health care to all is challenging. Structured headache services based in primary care are the most efficient, equitable and cost-effective solution but place responsibility for managing most patients on health-care providers with limited training in headache care. The development of practical management aids for primary care is therefore a purpose of the Global Campaign against Headache. This manuscript presents an outcome measure, the Headache Under-Response to Treatment (HURT) questionnaire, describing its purpose, development, psychometric evaluation and assessment for clinical utility. The objective was a simple-to-use instrument that would both assess outcome and provide guidance to improving outcome, having utility across the range of headache disorders, across clinical settings and across countries and cultures. After literature review, an expert consensus group drawn from all six world regions formulated HURT through item development and item reduction using item-response theory. Using the American Migraine Prevalence and Prevention Study's general-population respondent panel, two mailed surveys assessed the psychometric properties of HURT, comparing it with other instruments as external validators. Reliability was assessed in patients in two culturally-contrasting clinical settings: headache specialist centres in Europe (n = 159) and primary-care centres in Saudi Arabia (n = 40). Clinical utility was assessed in similar settings (Europe n = 201; Saudi Arabia n = 342). The final instrument, an 8-item self-administered questionnaire, addressed headache frequency, disability, medication use and effect, patients' perceptions of headache "control" and their understanding of their diagnoses. Psychometric evaluation revealed a two-factor model (headache frequency, disability and medication use; and medication efficacy and headache control), with scale properties apparently stable across disorders and correlating well and in the expected directions with external validators. The literature review found few instruments linking assessment to clinical advice or suggested actions: HURT appeared to fill this gap. In European specialist care, it showed utility as an outcome measure across headache disorders. In Saudi Arabian primary care, HURT (translated into Arabic) was reliable and responsive to clinical change. With demonstrated validity and clinical utility across disorders, cultures and settings, HURT is available for clinical and research purposes.

  14. Working memory, reasoning, and expertise in medicine-insights into their relationship using functional neuroimaging.

    PubMed

    Hruska, Pam; Krigolson, Olav; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Hecker, Kent G

    2016-12-01

    Clinical reasoning is dependent upon working memory (WM). More precisely, during the clinical reasoning process stored information within long-term memory is brought into WM to facilitate the internal deliberation that affords a clinician the ability to reason through a case. In the present study, we examined the relationship between clinical reasoning and WM while participants read clinical cases with functional magnetic resonance imaging (fMRI). More specifically, we examined the impact of clinical case difficulty (easy, hard) and clinician level of expertise (2nd year medical students, senior gastroenterologists) on neural activity within regions of cortex associated with WM (i.e., the prefrontal cortex) during the reasoning process. fMRI was used to scan ten second-year medical students and ten practicing gastroenterologists while they reasoned through sixteen clinical cases [eight straight forward (easy) and eight complex (hard)] during a single 1-h scanning session. Within-group analyses contrasted the easy and hard cases which were then subsequently utilized for a between-group analysis to examine effects of expertise (novice > expert, expert > novice). Reading clinical cases evoked multiple neural activations in occipital, prefrontal, parietal, and temporal cortical regions in both groups. Importantly, increased activation in the prefrontal cortex in novices for both easy and hard clinical cases suggests novices utilize WM more so than experts during clinical reasoning. We found that clinician level of expertise elicited differential activation of regions of the human prefrontal cortex associated with WM during clinical reasoning. This suggests there is an important relationship between clinical reasoning and human WM. As such, we suggest future models of clinical reasoning take into account that the use of WM is not consistent throughout all clinical reasoning tasks, and that memory structure may be utilized differently based on level of expertise.

  15. Variability in objective and subjective measures affects baseline values in studies of patients with COPD

    PubMed Central

    Ha, Jae Wook; Couper, David J.; O’Neal, Wanda K.; Barr, R. Graham; Bleecker, Eugene R.; Carretta, Elizabeth E.; Cooper, Christopher B.; Doerschuk, Claire M.; Drummond, M Bradley; Han, MeiLan K.; Hansel, Nadia N.; Kim, Victor; Kleerup, Eric C.; Martinez, Fernando J.; Rennard, Stephen I.; Tashkin, Donald; Woodruff, Prescott G.; Paine, Robert; Curtis, Jeffrey L.; Kanner, Richard E.

    2017-01-01

    Rationale Understanding the reliability and repeatability of clinical measurements used in the diagnosis, treatment and monitoring of disease progression is of critical importance across all disciplines of clinical practice and in clinical trials to assess therapeutic efficacy and safety. Objectives Our goal is to understand normal variability for assessing true changes in health status and to more accurately utilize this data to differentiate disease characteristics and outcomes. Methods Our study is the first study designed entirely to establish the repeatability of a large number of instruments utilized for the clinical assessment of COPD in the same subjects over the same period. We utilized SPIROMICS participants (n = 98) that returned to their clinical center within 6 weeks of their baseline visit to repeat complete baseline assessments. Demographics, spirometry, questionnaires, complete blood cell counts (CBC), medical history, and emphysema status by computerized tomography (CT) imaging were obtained. Results Pulmonary function tests (PFTs) were highly repeatable (ICC’s >0.9) but the 6 minute walk (6MW) was less so (ICC = 0.79). Among questionnaires, the Saint George’s Respiratory Questionnaire (SGRQ) was most repeatable. Self-reported clinical features, such as exacerbation history, and features of chronic bronchitis, often produced kappa values <0.6. Reported age at starting smoking and average number of cigarettes smoked were modestly repeatable (kappa = 0.76 and 0.79). Complete blood counts (CBC) variables produced intraclass correlation coefficients (ICC) values between 0.6 and 0.8. Conclusions PFTs were highly repeatable, while subjective measures and subject recall were more variable. Analyses using features with poor repeatability could lead to misclassification and outcome errors. Hence, care should be taken when interpreting change in clinical features based on measures with low repeatability. Efforts to improve repeatability of key clinical features such as exacerbation history and chronic bronchitis are warranted. PMID:28934249

  16. Health State Utility Value in Chronic Obstructive Pulmonary Disease (COPD); The Challenge of Heterogeneity: A Systematic Review and Meta-Analysis.

    PubMed

    Moayeri, Foruhar; Hsueh, Ya-Seng Arthur; Clarke, Philip; Hua, Xinyang; Dunt, David

    2016-06-01

    Chronic obstructive pulmonary disease (COPD) has a considerable impact on quality of life and well-being of patients. Health state utility value (HSUV) is a recognized measure for health economic appraisals and is extensively used as an indicator for decision-making studies. This study is a systematic review of literature aimed to estimate mean utility value in COPD using meta-analysis and explore degree of heterogeneity in the utility values across a variety of clinical and study characteristic. The literature review covers studies that used EQ-5D to estimate utility value for patient level research in COPD. Studies that reported utility values elicited by EQ-5D in COPD patients were selected for random-effect meta-analysis addressing inter-study heterogeneity and subgroup analyses. Thirty-two studies were included in the general utility meta-analysis. The estimated general utility value was 0.673 (95% CI 0.653 to 0.693). Meta-analyses of COPD stages utility values showed influence of airway obstruction on utility value. The utility values ranged from 0.820 (95% CI 0.767 to 0.872) for stage I to 0.624 (95% CI 0.571 to 0.677) for stage IV. There was substantial heterogeneity in utility values: I(2) = 97.7%. A more accurate measurement of utility values in COPD is needed to refine valid and generalizable scores of HSUV. Given the limited success of the factors studied to reduce heterogeneity, an approach needs to be developed how best to use mean utility values for COPD in health economic evaluation.

  17. Determinants of psychology service utilization in a palliative care outpatient population.

    PubMed

    Azuero, Casey; Allen, Rebecca Sue; Kvale, Elizabeth; Azuero, Andres; Parmelee, Patricia

    2014-06-01

    Research has demonstrated that treating cancer patients' psychological and physical health leads to improved overall health. This may be especially true for palliative care patients facing serious illness. This study examines the proportion and determinants of psychology service utilization in an outpatient palliative care population. Data from an existing clinical database in an outpatient palliative clinic utilizing a collaborative care model to deliver psychology services were explored. This study was framed by Andersen's Behavioral Model of Health Service Use, which incorporates three main components: predisposing, enabling, and need factors to model health service utilization. The sample (N = 149) was majority middle aged, female, and White with a primary diagnosis of cancer. Cross-tabulations were conducted to determine how many patients who met screening criteria for depression or anxiety sought psychology services. Logistic regression analyses were conducted to assess for predisposing, enabling, and need factor determinants of psychology service utilization. Among patients who met criteria for moderate depression or anxiety, 50% did not access readily available psychology services. Enabling factors were the strongest determinant of psychology utilization. Factors associated with need for psychology services (i.e., emotional distress and psychological symptom burden) did not reach significance in determining psychology service use. This study extends current knowledge about psychology utilization to palliative care outpatients receiving care within a collaborative care model. Directions for future research include further investigation of care models that optimize enabling strategies to enhance access to these services, and examination of patient-reported barriers to receiving this care. Copyright © 2013 John Wiley & Sons, Ltd.

  18. Improving surgeon utilization in an orthopedic department using simulation modeling

    PubMed Central

    Simwita, Yusta W; Helgheim, Berit I

    2016-01-01

    Purpose Worldwide more than two billion people lack appropriate access to surgical services due to mismatch between existing human resource and patient demands. Improving utilization of existing workforce capacity can reduce the existing gap between surgical demand and available workforce capacity. In this paper, the authors use discrete event simulation to explore the care process at an orthopedic department. Our main focus is improving utilization of surgeons while minimizing patient wait time. Methods The authors collaborated with orthopedic department personnel to map the current operations of orthopedic care process in order to identify factors that influence poor surgeons utilization and high patient waiting time. The authors used an observational approach to collect data. The developed model was validated by comparing the simulation output with the actual patient data that were collected from the studied orthopedic care process. The authors developed a proposal scenario to show how to improve surgeon utilization. Results The simulation results showed that if ancillary services could be performed before the start of clinic examination services, the orthopedic care process could be highly improved. That is, improved surgeon utilization and reduced patient waiting time. Simulation results demonstrate that with improved surgeon utilizations, up to 55% increase of future demand can be accommodated without patients reaching current waiting time at this clinic, thus, improving patient access to health care services. Conclusion This study shows how simulation modeling can be used to improve health care processes. This study was limited to a single care process; however the findings can be applied to improve other orthopedic care process with similar operational characteristics. PMID:29355193

  19. An appraisal of the utility or futility of ENT consultant postal questionnaires.

    PubMed

    Ryan, Stephen; Saunders, J; Clarke, E; Fenton, J E

    2013-03-01

    Despite an increase in ENT postal questionnaires, the quality of their methodology has been questioned (Ramphul et al. in J Laryngol Otol 119:175-178, 1). This retrospective study examined whether quality and utility of such questionnaires published since 2005 has improved. Seventeen consultant postal questionnaires published between 2005 and 2012 were reviewed. Quality of questionnaires was assessed using a 30-point score based on compliance with 15 criteria previously established to evaluate postal questionnaire study-design (Ramphul et al. in J Laryngol Otol 119:175-178, 1). Citation rates were used as an indicator of utility. The specific comments made in each citing paper was reviewed providing information on whether questionnaire findings (a) had an impact on clinical practice, (b) were the citing comments positive, (c) negative or (d) non-specific. Recurrent methodological flaws were identified in all questionnaires. The average score assigned was 44 %, versus 32 % previously reported (Ramphul et al. in J Laryngol Otol 119:175-178, 1) (P < 0.01, Student's t test). The low citation rate demonstrates poor utility for postal questionnaires. Citations were general non-specific referencing with no clear indication that questionnaire findings positively impacted clinical practice. In conclusion, although the quality of ENT postal questionnaire has improved since the original study (Ramphul et al. in J Laryngol Otol 119:175-178, 1), important recurring methodological flaws still exist. The poor utility, based on low citation rates, also reflects the continued deficiencies in design quality. It is recommended that authors of questionnaire-based research should ensure that guidelines for questionnaire design are adhered in order to improve the validity of findings and hence impact on clinical practice.

  20. Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development

    PubMed Central

    Park, Yu Rang; Yoon, Young Jo; Koo, HaYeong; Yoo, Soyoung; Choi, Chang-Min; Beck, Sung-Ho

    2018-01-01

    Background Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. Objective The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. Methods This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. Results In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. Conclusions The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws. PMID:29691212

  1. Clinical utility of a single-item test for DSM-5 alcohol use disorder among outpatients with anxiety and depressive disorders.

    PubMed

    Bartoli, Francesco; Crocamo, Cristina; Biagi, Enrico; Di Carlo, Francesco; Parma, Francesca; Madeddu, Fabio; Capuzzi, Enrico; Colmegna, Fabrizia; Clerici, Massimo; Carrà, Giuseppe

    2016-08-01

    There is a lack of studies testing accuracy of fast screening methods for alcohol use disorder in mental health settings. We aimed at estimating clinical utility of a standard single-item test for case finding and screening of DSM-5 alcohol use disorder among individuals suffering from anxiety and mood disorders. We recruited adults consecutively referred, in a 12-month period, to an outpatient clinic for anxiety and depressive disorders. We assessed the National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item test, using the Mini- International Neuropsychiatric Interview (MINI), plus an additional item of Composite International Diagnostic Interview (CIDI) for craving, as reference standard to diagnose a current DSM-5 alcohol use disorder. We estimated sensitivity and specificity of the single-item test, as well as positive and negative Clinical Utility Indexes (CUIs). 242 subjects with anxiety and mood disorders were included. The NIAAA single-item test showed high sensitivity (91.9%) and specificity (91.2%) for DSM-5 alcohol use disorder. The positive CUI was 0.601, whereas the negative one was 0.898, with excellent values also accounting for main individual characteristics (age, gender, diagnosis, psychological distress levels, smoking status). Testing for relevant indexes, we found an excellent clinical utility of the NIAAA single-item test for screening true negative cases. Our findings support a routine use of reliable methods for rapid screening in similar mental health settings. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. The utility of decision support, clinical guidelines, and financial incentives as tools to achieve improved clinical performance.

    PubMed

    Goldfarb, S

    1999-03-01

    Whether one seeks to reduce inappropriate utilization of resources, improve diagnostic accuracy, increase utilization of effective therapies, or reduce the incidence of complications, the key to change is physician involvement in change. Unfortunately, a simple approach to the problem of inducing change in physician behavior is not available. There is a generally accepted view that expert, best-practice guidelines will improve clinical performance. However, there may be a bias to report positive results and a lack of careful analysis of guideline usage in routine practice in a "postmarketing" study akin to that seen in the pharmaceutical industry. Systems that allow the reliable assessment of quality of outcomes, efficiency of resource utilization, and accurate assessment of the risks associated with the care of given patient populations must be widely available before deciding whether an incentive-based system for providing the full range of medical care is feasible. Decision support focuses on providing information, ideally at the "point of service" and in the context of a particular clinical situation. Rules are self-imposed by physicians and are therefore much more likely to be adopted. As health care becomes corporatized, with increasing numbers of physicians employed by large organizations with the capacity to provide detailed information on the nature and quality of clinical care, it is possible that properly constructed guidelines, appropriate financial incentives, and robust forms of decision support will lead to a physician-led, process improvement approach to more rational and affordable health care.

  3. Outcomes among chronically ill adults in a medical home prototype.

    PubMed

    Liss, David T; Fishman, Paul A; Rutter, Carolyn M; Grembowski, David; Ross, Tyler R; Johnson, Eric A; Reid, Robert J

    2013-10-01

    To compare quality, utilization, and cost outcomes for patients with selected chronic illnesses at a patient-centered medical home (PCMH) prototype site with outcomes for patients with the same chronic illnesses at 19 nonintervention control sites. Nonequivalent pretest-posttest control group design. PCMH redesign results were investigated for patients with preexisting diabetes, hypertension, and/or coronary heart disease. Data from automated databases were collected for eligible enrollees in an integrated healthcare delivery system. Multivariable regression models tested for adjusted differences between PCMH patients and controls during the baseline and follow-up periods. Dependent measures under study included clinical processes and, outcomes, monthly healthcare utilization, and costs. Compared with controls over 2 years, patients at the PCMH prototype clinic had slightly better clinical outcome control in coronary heart disease (2.20 mg/dL lower mean low-density lipoprotein cholesterol; P <.001). PCMH patients changed their patterns of primary care utilization, as reflected by 86% more secure electronic message contacts (P <.001), 10% more telephone contacts (P = .003), and 6% fewer in-person primary care visits (P <.001). PCMH patients had 21% fewer ambulatory care-sensitive hospitalizations (P <.001) and 7% fewer total inpatient admissions (P = .002) than controls. During the 2-year redesign, we observed 17% lower inpatient costs (P <.001) and 7% lower total healthcare costs (P <.001) among patients at the PCMH prototype clinic. A clinic-level population-based PCMH redesign can decrease downstream utilization and reduce total healthcare costs in a subpopulation of patients with common chronic illnesses.

  4. Prenatal health care beyond the obstetrics service: Utilization and predictors of unscheduled care

    PubMed Central

    Magriples, Urania; Kershaw, Trace S.; Rising, Sharon Schindler; Massey, Zohar; Ickovics, Jeannette R.

    2008-01-01

    OBJECTIVE The objective of the study was to describe the patient characteristics of prenatal care utilization within and outside of routine obstetric care, and the clinical and psychosocial factors that predict care utilization. STUDY DESIGN Four hundred twenty pregnant women enrolled in a randomized controlled trial receiving prenatal care in a university-affiliated clinic. All hospital encounters were obtained by review of computerized databases. The Kotelchuck index (KI) was computed, and the characteristics of inadequate, adequate, or excessive prenatal care were described. Demographic and psychosocial predictors of unscheduled visits were evaluated. RESULTS A total of 50.5% of women were adequate users by KI, with 19% being inadequate. An average of 5 additional unscheduled encounters occurred (standard deviation 4.2; range, 0−26). Almost 75% of participants made an unscheduled obstetric visit, with 38% making 2 or more unscheduled visits. Overweight/obese, younger women, high symptom distress, and excessive and inadequate prenatal users were more likely to utilize the labor floor before delivery. CONCLUSION Unscheduled care is common during pregnancy. PMID:18166312

  5. Using Mobile Health Clinics to Reach College Students: A National Demonstration Project

    ERIC Educational Resources Information Center

    Fennell, Reginald; Escue, Christopher

    2013-01-01

    Background: The mobile health unit (MHU) was a grant-funded national initiative to explore the utilization of a mobile clinic to provide health promotion and clinical services for college students in the United States. Purpose: In 2010 and 2011, a 38-foot mobile clinic tested the feasibility of utilizing the clinic to deliver health promotion and…

  6. An introduction to clinical microeconomic analysis: purposes and analytic methods.

    PubMed

    Weintraub, W S; Mauldin, P D; Becker, E R

    1994-06-01

    The recent concern with health care economics has fostered the development of a new discipline that is generally called clinical microeconomics. This is a discipline in which microeconomic methods are used to study the economics of specific medical therapies. It is possible to perform stand alone cost analyses, but more profound insight into the medical decision making process may be accomplished by combining cost studies with measures of outcome. This is most often accomplished with cost-effectiveness or cost-utility studies. In cost-effectiveness studies there is one measure of outcome, often death. In cost-utility studies there are multiple measures of outcome, which must be grouped together to give an overall picture of outcome or utility. There are theoretical limitations to the determination of utility that must be accepted to perform this type of analysis. A summary statement of outcome is quality adjusted life years (QALYs), which is utility time socially discounted survival. Discounting is used because people value a year of future life less than a year of present life. Costs are made up of in-hospital direct, professional, follow-up direct, and follow-up indirect costs. Direct costs are for medical services. Indirect costs reflect opportunity costs such as lost time at work. Cost estimates are often based on marginal costs, or the cost for one additional procedure of the same type. Finally an overall statistic may be generated as cost per unit increase in effectiveness, such as dollars per QALY.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. Maintenance of Certification: How Performance in Practice Changes Improve Tobacco Cessation in Addiction Psychiatrists’ Practice

    PubMed Central

    Ford, James H.; Oliver, Karen A.; Giles, Miriam; Cates-Wessel, Kathryn; Krahn, Dean; Levin, Frances R.

    2017-01-01

    Background and Objectives In 2000, the American Board of Medical Specialties implemented the Maintenance of Certification (MOC), a structured process to help physicians identify and implement a quality improvement project to improve patient care. This study reports on findings from an MOC Performance in Practice (PIP) module designed and evaluated by addiction psychiatrists who are members of the American Academy of Addiction Psychiatry (AAAP). Method A 3-phase process was utilized to recruit AAAP members to participate in the study. The current study utilized data from 154 self-selected AAAP members who evaluated the effectiveness of the MOC Tobacco Cessation PIP. Results Of the physicians participating, 76% (n 120) completed the Tobacco PIP. A paired t-test analysis revealed that reported changes in clinical measure documentation were significant across all six measures. Targeted improvement efforts focused on a single clinical measure. Results found that simple change projects designed to improve clinical practice led to substantial changes in self-reported chart documentation for the selected measure. Conclusions The current findings suggest that addiction psychiatrists can leverage the MOC process to improve clinical care. PMID:27973746

  8. Monitoring worksite clinic performance using a cost-benefit tool.

    PubMed

    Tao, Xuguang; Chenoweth, David; Alfriend, Amy S; Baron, David M; Kirkland, Tracie W; Scherb, Jill; Bernacki, Edward J

    2009-10-01

    The purpose of this study was to explore the usefulness of continuously assessing the return on investment (ROI) of worksite medical clinics as a means of evaluating clinic performance. Visit data from January 1, 2007, to December 31, 2008, were collected from all the on-site clinics operated for the Pepsi Bottling Group. An average system-wide ROI was calculated from the time of each clinic's opening and throughout the study period. A multivariate linear regression model was used to determine the association of average ROI with penetration/utilization rate and plant size. A total of 26 on-site clinics were actively running as of December 2008. The average ROI at the time of start up was 0.4, which increased to 1.2 at approximately 4 months and 1.6 at the end of the first year of operation. Overall, it seems that the cost of operating a clinic becomes equal to the cost of similar care purchased in the community (ROI = 1) at approximately 3 months after a clinic's opening and flattens out at the end of the first year. The magnitude of the ROI was closely related to the number of visits (a function of the penetration/utilization rate) and the size of the plant population served. Serial monitoring of ROIs is a useful metric in assessing on-site clinic performance and quantifying the effect of new initiatives aimed at increasing a clinic's cost effectiveness.

  9. Emerging Utility of Virtual Reality as a Multidisciplinary Tool in Clinical Medicine.

    PubMed

    Pourmand, Ali; Davis, Steven; Lee, Danny; Barber, Scott; Sikka, Neal

    2017-10-01

    Among the more recent products borne of the evolution of digital technology, virtual reality (VR) is gaining a foothold in clinical medicine as an adjunct to traditional therapies. Early studies suggest a growing role for VR applications in pain management, clinical skills training, cognitive assessment and cognitive therapy, and physical rehabilitation. To complete a review of the literature, we searched PubMed and MEDLINE databases with the following search terms: "virtual reality," "procedural medicine," "oncology," "physical therapy," and "burn." We further limited our search to publications in the English language. Boolean operators were used to combine search terms. The included search terms yielded 97 potential articles, of which 45 were identified as meeting study criteria, and are included in this review. These articles provide data, which strongly support the hypothesis that VR simulations can enhance pain management (by reducing patient perception of pain and anxiety), can augment clinical training curricula and physical rehabilitation protocols (through immersive audiovisual environments), and can improve clinical assessment of cognitive function (through improved ecological validity). Through computer-generated, life-like digital landscapes, VR stands to change the current approach to pain management, medical training, neurocognitive diagnosis, and physical rehabilitation. Additional studies are needed to help define best practices in VR utilization, and to explore new therapeutic uses for VR in clinical practice.

  10. Validity of EuroQOL-5D, time trade-off, and standard gamble for age-related macular degeneration in the Singapore population

    PubMed Central

    Au Eong, K G; Chan, E W; Luo, N; Wong, S H; Tan, N W H; Lim, T H; Wagle, A M

    2012-01-01

    Background/aims Utility values of age-related macular degeneration (AMD) in Asian patients are unknown. This study aims to assess utility values and construct validity of the EuroQOL-5D (EQ-5D), time trade-off (TTO), and standard gamble (SG) instruments in the Singapore multi-ethnic AMD population. Methods Cross-sectional, two-centre, institution-based study. Visual acuity (VA), clinical AMD severity, and utility scores on the EQ-5D, TTO, and SG were obtained from 338 AMD patients. VA was analysed in terms of the better-seeing eye (BEVA), worse-seeing eye (WEVA), and weighted average of both eyes (WVA). We evaluated SG on the perfect health-death (SG(death)) and binocular perfect vision-binocular blindness (SG(blindness)) scales. Construct validity was determined by testing a priorihypotheses relating the EQ-5D, TTO, and SG utility scores to VA and clinical AMD severity. Results The mean utilities on the EQ-5D, TTO, SG(death), and SG(blindness) were 0.89, 0.81, 0.86, and 0.90, respectively. EQ-5D scores correlated weakly with BEVA, WEVA, and WVA (Pearson's correlation coefficients −0.291, −0.247, and −0.305 respectively, P<0.001 for all). SG(death) and SG(blindness) demonstrated no correlation with BEVA, WEVA, or WVA (Pearson's correlation coefficients, range −0.06 to −0.125). TTO showed weak association only with WEVA and WVA (correlation coefficients −0.237, −0.228, P<0.0001), but not with BEVA (correlation coefficient −0.161). Clinical AMD severity correlated with EQ-5D and SG(death), but not with TTO and SG(blindness) (P=0.004, 0.002, 0.235, and 0.069, respectively). Conclusions AMD has a negative impact on utilities, although utility scores were high compared with Western cohorts. EQ-5D, TTO, and SG showed suboptimal construct validity, suggesting that health status utilities may not be sufficiently robust for cost-utility analyses in this population. PMID:22222257

  11. Diagnostic accuracy of clinical tests for assessment of hamstring injury: a systematic review.

    PubMed

    Reiman, Michael P; Loudon, Janice K; Goode, Adam P

    2013-04-01

    Systematic literature review. The diagnosis of a hamstring injury has traditionally relied on various clinical measures (eg, palpation, swelling, manual resistance), as well as the use of diagnostic imaging. But a few studies have suggested the use of specific clinical tests that may be helpful for the diagnostic process. To summarize the current literature on the diagnostic accuracy of orthopaedic special tests for hamstring injuries and to determine their clinical utility. A computer-assisted literature search of the MEDLINE, CINAHL, and Embase databases (along with a manual search of grey literature) was conducted using key words related to diagnostic accuracy of hamstring injuries. To be considered for inclusion in the review, the study required (1) patients with hamstring or posterior thigh pain; (2) a cohort, case-control, or cross-sectional design; (3) inclusion of at least 1 clinical examination test used to evaluate hamstring pathology; (4) comparison against an acceptable reference standard; (5) reporting of diagnostic accuracy of the measures (sensitivity [SN], specificity [SP], or likelihood ratios); and (6) publication in English. SN, SP, and positive and negative likelihood ratios were calculated for each diagnostic test. The search strategy identified 602 potential articles, of which only 3 articles met the inclusion criteria, with only 1 of these 3 articles being of high quality. Two of the studies investigated a single special test, whereas the third article examined a composite clinical assessment employing various special tests. The SN values ranged from 0.55 (95% confidence interval [CI]: 0.46, 0.69) for the active range-of-motion test to 1.00 (95% CI: 0.97, 1.00) for the taking-off-the-shoe test. The SP values ranged from 0.03 (95% CI: 0.00, 0.22) for the composite clinical assessment to 1.00 (95% CI: 0.97, 1.00) for the taking-off-the-shoe test, active range-of-motion test, passive range-of-motion test, and resisted range-of-motion test. The use of a single special test demonstrated stronger SP than SN properties, whereas the composite clinical assessment demonstrated stronger SN than SP properties. Very few studies have investigated the utilization of clinical special tests for the diagnosis of hamstring injuries. Further studies of higher quality design are suggested prior to advocating independent clinical utilization of these special tests. Diagnosis, level 3b.

  12. Integrating Telehealth Technology into a Clinical Pharmacy Telephonic Diabetes Management Program

    PubMed Central

    Klug, Cindy; Bonin, Kerry; Bultemeier, Nanette; Rozenfeld, Yelena; Stuckman Vasquez, Rebecca; Johnson, Mark; Cherry, Julie Cheitlin

    2011-01-01

    Background Use of home monitoring technologies can enhance care coordination and improve clinical outcomes in patients with diabetes and other chronic diseases. This study was designed to explore the feasibility of incorporating a telehealth system into an existing telephonic diabetes management program utilizing clinical pharmacists. Methods This observational study was conducted at three Providence Medical Group primary care clinics. Adults with a diagnosis of diabetes and a recent hemoglobin A1c (HbA1c) >8% were referred by their primary care provider to participate in the study. Participants utilized the telehealth system developed by Intel Corporation and were followed by clinical pharmacists who provide telephonic diabetes management. The primary clinical outcome measure was change in mean HbA1c. Secondary outcomes included blood glucose levels, participant self-management knowledge, and the degree of participant engagement. Results Mean HbA1c level decreased by 1.3% at the study end (p = .001). Based on participant satisfaction surveys and qualitative responses, participants were satisfied with the telehealth system. Mean blood glucose values decreased significantly over the 16-week study period from 178 mg/dl [standard deviation (SD) 67] at week 1 to 163 mg/dl (SD 64) at week 16 (p = .0002). Participants entered the study with moderate to good knowledge about managing their diabetes based on three questions, and no statistically significant improvement in knowledge was found post-study. Conclusion Telehealth technology can be a positive adjunct to the primary care team in managing diabetes or other chronic conditions to improve clinical outcomes. PMID:22027325

  13. Changing Management of the Patent Ductus Arteriosus: Effect on Neonatal Outcomes and Resource Utilization.

    PubMed

    Chock, Valerie Y; Goel, Veena V; Palma, Jonathan P; Luh, Thomas M; Wang, Nichole A; Gaskari, Shabnam; Punn, Rajesh; Silverman, Norman H; Benitz, William E

    2017-08-01

    Objective  This historical cohort study investigated how a shift toward a more conservative approach of awaiting spontaneous closure of the patent ductus arteriosus (PDA) in preterm infants has affected neonatal outcomes and resource utilization. Methods  We retrospectively studied very low birth weight infants diagnosed with a PDA by echocardiogram (ECHO) in 2006-2008 (era 1), when medical or surgical PDA management was emphasized, to those born in 2010-2012 (era 2) when conservative PDA management was encouraged. Multiple regression analyses adjusted for gestational age were performed to assess differences in clinical outcomes and resource utilization between eras. Results  More infants in era 2 (35/89, 39%) compared with era 1 (22/120, 18%) had conservative PDA management ( p  < 0.01). Despite no difference in surgical ligation rate, infants in era 2 had ligation later (median 24 vs. 8 days, p  < 0.0001). There was no difference in clinical outcomes between eras, while number of ECHOs per patient was the only resource measure that increased in era 2 (median 3 vs. 2 ECHOs, p  = 0.003). Conclusion  In an era of more conservative PDA management, no increase in adverse clinical outcomes or significant change in resource utilization was found. Conservative PDA management may be a safe alternative for preterm infants. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  14. Clinical utility of genetic testing in pediatric drug-resistant epilepsy: a pilot study.

    PubMed

    Ream, Margie A; Mikati, Mohamad A

    2014-08-01

    The utility of genetic testing in pediatric drug-resistant epilepsy (PDRE), its yield in "real life" clinical practice, and the practical implications of such testing are yet to be determined. To start to address the above gaps in our knowledge as they apply to a patient population seen in a tertiary care center. We retrospectively reviewed our experience with the use of clinically available genetic tests in the diagnosis and management of PDRE in one clinic over one year. Genetic testing included, depending on clinical judgment, one or more of the following: karyotype, chromosomal microarray, single gene sequencing, gene sequencing panels, and/or whole exome sequencing (WES). We were more likely to perform genetic testing in patients with developmental delay, epileptic encephalopathy, and generalized epilepsy. In our unique population, the yield of specific genetic diagnosis was relatively high: karyotype 14.3%, microarray 16.7%, targeted single gene sequencing 15.4%, gene panels 46.2%, and WES 16.7%. Overall yield of diagnosis from at least one of the above tests was 34.5%. Disease-causing mutations that were not clinically suspected based on the patients' phenotypes and representing novel phenotypes were found in 6.9% (2/29), with an additional 17.2% (5/29) demonstrating pharmacologic variants. Three patients were incidentally found to be carriers of recessive neurologic diseases (10.3%). Variants of unknown significance (VUSs) were identified in 34.5% (10/29). We conclude that genetic testing had at least some utility in our patient population of PDRE, that future similar larger studies in various populations are warranted, and that clinics offering such tests must be prepared to address the complicated questions raised by the results of such testing. Copyright © 2014. Published by Elsevier Inc.

  15. WE-G-217BCD-04: Diagnostic Image Quality Evaluation of a Dedicated Extremity Cone- Beam CT Scanner: Pre-Clinical Studies and First Clinical Results.

    PubMed

    Muhit, A; Zbijewski, W; Stayman, J; Thawait, G; Yorkston, J; Foos, D; Packard, N; Yang, D; Senn, R; Carrino, J; Siewerdsen, J

    2012-06-01

    To assess the diagnostic performance of a prototype cone-beam CT (CBCT) scanner developed for musculoskeletal extremity imaging. Studies involved controlled observer studies conducted subsequent to rigorous technical assessment as well as patient images from the first clinical trial in imaging the hand and knee. Performance assessment included: 1.) rigorous technical assessment; 2.) controlled observer studies using CBCT images of cadaveric specimens; and 3.) first clinical images. Technical assessment included measurement of spatial resolution (MTF), constrast, and noise (SDNR) versus kVp and dose using standard CT phantoms. Diagnostic performance in comparison to multi- detector CT (MDCT) was assessed in controlled observer studies involving 12 cadaveric hands and knees scanned with and without abnormality (fracture). Observer studies involved five radiologists rating pertinent diagnostics tasks in 9-point preference and 10-point diagnostic satisfaction scales. Finally, the first clinical images from an ongoing pilot study were assessed in terms of diagnostic utility in disease assessment and overall workflow in patient setup. Quantitative assessment demonstrated sub-mm spatial resolution (MTF exceeding 10% out to 15-20 cm-1) and SDNR sufficient for relevant soft-tissue visualization tasks at dose <10 mGy. Observer studies confirmed optimal acquisition techniques and demonstrated superior utility of combined soft-tissue visualization and isotropic spatial resolution in diagnostic tasks. Images from the patient trial demonstrate exquisite contrast and detail and the ability to detect tissue impingement in weight-bearing exams. The prototype CBCT scanner provides isotropic spatial resolution superior to standard-protocol MDCT with soft-tissue visibility sufficient for a broad range of diagnostic tasks in musculoskeletal radiology. Dosimetry and workflow were advantageous in comparison to whole-body MDCT. Multi-mode and weight-bearing capabilities add valuable functionality. An ongoing clinical study further assesses diagnostic utility and defines the role of such technology in the diagnostic arsenal. - Research Grant, Carestream Health - Research Grant, National Institutes of Health 2R01-CA-112163. © 2012 American Association of Physicists in Medicine.

  16. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications

    PubMed Central

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino

    2015-01-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283

  17. Clinical initiatives linking Japanese and Swedish healthcare resources on cancer studies utilizing Biobank Repositories.

    PubMed

    Nishimura, Toshihide; Kawamura, Takeshi; Sugihara, Yutaka; Bando, Yasuhiko; Sakamoto, Shigeru; Nomura, Masaharu; Ikeda, Norihiko; Ohira, Tatsuo; Fujimoto, Junichiro; Tojo, Hiromasa; Hamakubo, Takao; Kodama, Tatsuhiko; Andersson, Roland; Fehniger, Thomas E; Kato, Harubumi; Marko-Varga, György

    2014-12-01

    The Tokyo Medical University Hospital in Japan and the Lund University hospital in Sweden have recently initiated a research program with the objective to impact on patient treatment by clinical disease stage characterization (phenotyping), utilizing proteomics sequencing platforms. By sharing clinical experiences, patient treatment principles, and biobank strategies, our respective clinical teams in Japan and Sweden will aid in the development of predictive and drug related protein biomarkers. Data from joint lung cancer studies are presented where protein expression from Neuro- Endocrine lung cancer (LCNEC) phenotype patients can be separated from Small cell- (SCLC) and Large Cell lung cancer (LCC) patients by deep sequencing and spectral counting analysis. LCNEC, a subtype of large cell carcinoma (LCC), is characterized by neuroendocrine differentiation that small cell lung carcinoma (SCLC) shares. Pre-therapeutic histological distinction between LCNEC and SCLC has so far been problematic, leading to adverse clinical outcome. An establishment of protein targets characteristic of LCNEC is quite helpful for decision of optimal therapeutic strategy by diagnosing individual patients. Proteoform annotation and clinical biobanking is part of the HUPO initiative (http://www.hupo.org) within chromosome 10 and chromosome 19 consortia.

  18. Clinical variables impacting on the estimation of utilities in chronic obstructive pulmonary disease

    PubMed Central

    Miravitlles, Marc; Huerta, Alicia; Valle, Manuel; García-Sidro, Patricia; Forné, Carles; Crespo, Carlos; López-Campos, José Luis

    2015-01-01

    Purpose Health utilities are widely used in health economics as a measurement of an individual’s preference and show the value placed on different health states over a specific period. Thus, health utilities are used as a measure of the benefits of health interventions in terms of quality-adjusted life years. This study aimed to determine the demographic and clinical variables significantly associated with health utilities for chronic obstructive pulmonary disease (COPD) patients. Patients and methods This was a multicenter, observational, cross-sectional study conducted between October 2012 and April 2013. Patients were aged ≥40 years, with spirometrically confirmed COPD. Utility values were derived from the preference-based generic questionnaire EQ-5D-3L applying weighted Spanish societal preferences. Demographic and clinical variables associated with utilities were assessed by univariate and multivariate linear regression models. Results Three hundred and forty-six patients were included, of whom 85.5% were male. The mean age was 67.9 (standard deviation [SD] =9.7) years and the mean forced expiratory volume in 1 second (%) was 46.2% (SD =15.5%); 80.3% were former smokers, and the mean smoking history was 54.2 (SD =33.2) pack-years. Median utilities (interquartile range) were 0.81 (0.26) with a mean value of 0.73 (SD =0.29); 22% of patients had a utility value of 1 (ceiling effect) and 3.2% had a utility value lower than 0. The factors associated with utilities in the multivariate analysis were sex (beta =-0.084, 95% confidence interval [CI]: −0.154; -0.013 for females), number of exacerbations the previous year (−0.027, 95% CI: −0.044; -0.010), and modified Medical Research Council Dyspnea Scale (mMRC) score (−0.123 [95% CI: −0.185; −0.061], −0.231 [95% CI: −0.301; −0.161], and −0.559 [95% CI: −0.660; −0.458] for mMRC scores 2, 3, and 4 versus 1), all P<0.05. Conclusion Multivariate analysis showed that female sex, frequent exacerbations, and an increased level of dyspnea were the main factors associated with reduced utility values in patients with COPD. PMID:25733826

  19. Moving Beyond Maximum Tolerated Dose for Targeted Oncology Drugs: Use of Clinical Utility Index to Optimize Venetoclax Dosage in Multiple Myeloma Patients.

    PubMed

    Freise, K J; Jones, A K; Verdugo, M E; Menon, R M; Maciag, P C; Salem, A H

    2017-12-01

    Exposure-response analyses of venetoclax in combination with bortezomib and dexamethasone in previously treated patients with multiple myeloma (MM) were performed on a phase Ib venetoclax dose-ranging study. Logistic regression models were utilized to determine relationships, identify subpopulations with different responses, and optimize the venetoclax dosage that balanced both efficacy and safety. Bortezomib refractory status and number of prior treatments were identified to impact the efficacy response to venetoclax treatment. Higher venetoclax exposures were estimated to increase the probability of achieving a very good partial response (VGPR) or better through venetoclax doses of 1,200 mg. However, the probability of neutropenia (grade ≥3) was estimated to increase at doses >800 mg. Using a clinical utility index, a venetoclax dosage of 800 mg daily was selected to optimally balance the VGPR or better rates and neutropenia rates in MM patients administered 1-3 prior lines of therapy and nonrefractory to bortezomib. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  20. The association between hospital outcomes and diagnostic imaging: early findings.

    PubMed

    Lee, David W; Foster, David A

    2009-11-01

    Resource use variation across the United States prompts the important question of whether "more is better" when it comes to health care services. The aim of this study was to examine correlations between the use of 4 common imaging modalities (CT, MR, ultrasound, and radiography) and in-hospital mortality and costs. Using clinical and utilization data for 1.1 million inpatient admissions at 102 US hospitals during 2007, two hospital-specific, risk-adjusted imaging utilization measures for each modality were constructed that controlled for patients' demographic and clinical characteristics and for hospital characteristics were constructed for each modality. First, logistic regression was used to estimate the odds that each type of imaging service would be provided during an admission. Second, the mean number of services per admission was estimated using output from a two-part ordinary least squares model. Hospital-specific, risk-adjusted inpatient mortality and total hospital costs were also computed, and correlations between the imaging utilization measures and the mortality and cost outcome measures were then assessed using Pearson's correlation coefficients (P < .05). The correlation analyses were weighted by hospital admission volume. Hospitals in which patients were more likely to receive imaging services during admissions had lower mortality, even after controlling for potential confounders. Correlation coefficients were -0.2 for all modalities (P = .02-.05). Weaker correlations existed between mean services per admission and mortality, while costs trended insignificantly higher with greater utilization. This study lays the foundation for further exploration of the relationship between resource use and the clinical and economic outcomes associated with imaging utilization.

  1. Health information exchanges--Unfulfilled promise as a data source for clinical research.

    PubMed

    Parker, Carol; Weiner, Michael; Reeves, Mathew

    2016-03-01

    To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical research outside of the evaluation of HIEs themselves, as well as the limited number of specific HIEs that are involved in generating published research. Significant barriers exist that prevent HIEs from developing into an invaluable resource for clinical research including technological infrastructure limitations, business processes limiting secondary use of data, and lack of participating provider support. Research to better understand challenges to developing the necessary infrastructure and policies to foster HIE engagement in research would be valuable as HIEs represent an opportunity to engage non-traditional health care provider research partners. Copyright © 2015. Published by Elsevier Ireland Ltd.

  2. Clinical applications of the human brainstem responses to auditory stimuli

    NASA Technical Reports Server (NTRS)

    Galambos, R.; Hecox, K.

    1975-01-01

    A technique utilizing the frequency following response (FFR) (obtained by auditory stimulation, whereby the stimulus frequency and duration are mirror-imaged in the resulting brainwaves) as a clinical tool for hearing disorders in humans of all ages is presented. Various medical studies are discussed to support the clinical value of the technique. The discovery and origin of the FFR and another significant brainstem auditory response involved in studying the eighth nerve is also discussed.

  3. Cost and Utilization of Retail Clinics vs. Other Providers for Treatment of Pediatric Acute Otitis Media.

    PubMed

    Duncan, Ian; Clark, Kara; Wang, Stacy

    2016-10-01

    A common acute condition seen by providers in retails clinics is the evaluation and treatment of acute otitis media (AOM) in children younger than age 20. Annual direct treatment costs for AOM were US $5.3 billion in 1998 dollars. Based on the experience of a large retail pharmacy employer, the authors compared AOM episodes in covered dependents younger than age 20 in retail clinic states to those in states without retail clinic access. Relative costs as well as frequency of visits and antibiotic prescriptions were analyzed for both retail clinic-based, and non-retail clinic-based episodes. Rates of AOM episodes were lower in retail clinic than in non-retail clinic states (62.5 vs. 76.9 per 1000 members per year; P < .0001). The average number of visits per episode was similar between retail clinic and non-retail clinic states (1.417 vs. 1.430, respectively; P = 0.657), suggesting that retail clinics do not result in an increase in overall utilization. On a risk-adjusted basis, retail clinic episodes cost approximately $30-$130 less than community episodes, depending on year. In retail clinic states, the antibiotic prescription fill rate was 95.4% for retail clinic episodes and 82.8% for community episodes, consistent with rates in the literature. This study confirms results of earlier studies that retail clinics are a less costly setting than the community for the treatment of episodes of otitis media There also is little evidence that retail clinics lead to duplication of services (patients receiving follow-up care in other settings).

  4. Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol

    PubMed Central

    Mashamba-Thompson, T P; Drain, P K; Sartorius, B

    2016-01-01

    Introduction Poor healthcare access is a major barrier to receiving antenatal care and a cause of high maternal mortality in South Africa (SA). ‘Point-of-care’ (POC) diagnostics is a powerful emerging healthcare approach to improve healthcare access. This study focuses on evaluating the accessibility and utility of POC diagnostics for maternal health in rural SA primary healthcare (PHC) clinics in order to generate a model framework of implementation of POC diagnostics in rural South African clinics. Method and analyses We will use several research methods, including a systematic review, quasi-experiments, survey, key informant interviews and audits. We will conduct a systematic review and experimental study to determine the impact of POC diagnostics on maternal health. We will perform a cross-sectional case study of 100 randomly selected rural primary healthcare clinics in KwaZulu-Natal to measure the context and patterns of POC diagnostics access and usage by maternal health providers and patients. We will conduct interviews with relevant key stakeholders to determine the reasons for POC deficiencies regarding accessibility and utility of HIV-related POC diagnostics for maternal health. We will also conduct a vertical audit to investigate all the quality aspects of POC diagnostic services including diagnostic accuracy in a select number of clinics. On the basis of information gathered, we will propose a model framework for improved implementation of POC diagnostics in rural South African public healthcare clinics. Statistical (Stata-13) and thematic (NVIVO) data analysis will be used in this study. Ethics and dissemination The study protocol was approved by the Ethics Committee of the University of KwaZulu-Natal (BE 484/14) and the KwaZulu-Natal Department of Health based on the Helsinki Declaration (HRKM 40/15). Findings of this study will be disseminated electronically and in print. They will be presented to conferences related to HIV/AIDS, diagnostics, maternal health and strengthening of health systems. PMID:27354074

  5. Fs-laser ablation of teeth is temperature limited and provides information about the ablated components.

    PubMed

    de Menezes, Rebeca Ferraz; Harvey, Catherine Malinda; de Martínez Gerbi, Marleny Elizabeth Márquez; Smith, Zachary J; Smith, Dan; Ivaldi, Juan C; Phillips, Alton; Chan, James W; Wachsmann-Hogiu, Sebastian

    2017-10-01

    The goal of this work is to investigate the thermal effects of femtosecond laser (fs-laser) ablation for the removal of carious dental tissue. Additional studies identify different tooth tissues through femtosecond laser induced breakdown spectroscopy (fsLIBS) for the development of a feedback loop that could be utilized during ablation in a clinical setting. Scanning Election Microscope (SEM) images reveal that minimal morphological damages are incurred at repetition rates below the carbonization threshold of each tooth tissue. Thermal studies measure the temperature distribution and temperature decay during laser ablation and after laser cessation, and demonstrate that repetition rates at or below 10kHz with a laser fluence of 40 J/cm 2 would inflict minimal thermal damage on the surrounding nerve tissues and provide acceptable clinical removal rates. Spectral analysis of the different tooth tissues is also conducted and differences between the visible wavelength fsLIBS spectra are evident, though more robust classification studies are needed for clinical translation. These results have initiated a set of precautionary recommendations that would enable the clinician to utilize femtosecond laser ablation for the removal of carious lesions while ensuring that the solidity and utility of the tooth remain intact. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  6. Medical team interdependence as a determinant of use of clinical resources.

    PubMed Central

    Sicotte, C; Pineault, R; Lambert, J

    1993-01-01

    OBJECTIVE. Our objective, based on organization theory, is to examine whether interdependence among physicians leads to coordination problems that in turn may explain variations observed in the use of clinical resources. DATA SOURCES/STUDY SETTING. Secondary data about episodes of in-hospital care were collected over a 14-month period in two midsize acute care hospitals located in two suburbs of Montreal, Quebec. STUDY DESIGN. Hierarchical regression analysis was used to assess the marginal effect of medical team interdependence on clinical resource utilization after taking into account the effect attributable to the nature of several morbidities taken as specific and distinct tasks. PRINCIPAL FINDINGS. Medical team interdependence is found within medical specialties as well as between specialties. The largest portion of resource utilization was explained by morbidity characteristics, whereas team interdependence had a weaker, but systematic effect for all morbidities studied (15 regression models out of 18 performed). Task coordination was found to become more difficult as the number of physicians coming from different specialties increased in the context of teamwork. CONCLUSIONS. Results suggest that team practice does not entirely overcome coordination problems inherent to task (morbidity) interdependence. In considering the individual (especially the attending) physician as the main factor responsible for resource utilization, other factors related to team practice may too readily be overlooked. PMID:8270423

  7. The predictive utility of neuropsychological symptom validity testing as it relates to psychological presentation.

    PubMed

    Zakzanis, Konstantine K; Gammada, Emnet; Jeffay, Eliyas

    2012-01-01

    The present study examined the relationship between multiple neuropsychological symptom validity tests (SVTs) and psychological presentation. More formally, we set out to determine if performance on neuropsychological SVTs was related to psychological symptom credibility and which specific neuropsychological SVTs were most associated with noncredible psychological presentation. Archival records from 106 litigating examinees were utilized in this study. Our results illustrate that neuropsychological SVTs are modestly related to psychological symptom credibility and that specific neuropsychological SVTs are variably associated to this end. We conclude that when multiple, but not independent, neuropsychological SVTs are employed within the context of a neuropsychological examination, they do have clinical utility as it relates to credibility of psychological presentation and these constructs do share variance reciprocally in clinically meaningful ways. When independently employed, however, the observed relationship is modest at best. Hence, to place clinical opinion on firmer scientific grounds within the context of a neuropsychological examination, multiple cognitive SVTs, in hand with psychological test instruments that include validity indexes, are essential to derive opinion that is based on science rather than faith in the instance of litigation when an incentive to manifest disability for the sake of an external reward holds probable.

  8. Assessment of critical thinking: a Delphi study.

    PubMed

    Paul, Sheila A

    2014-11-01

    Nurse educators are responsible for preparing nurses who critically analyze patient information and provide meaningful interventions in today's complex health care system. By using the Delphi research method, this study, utilized the specialized and experiential knowledge of Certified Nurse Educators. This original Delphi research study asked Certified Nurse Educators how to assess the critical-thinking ability of nursing students in the clinical setting. The results showed that nurse educators need time, during the clinical experience, to accurately assess each individual nursing student. This study demonstrated the need for extended student clinical time, and a variety of clinical learning assessment tools. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Methods of Academic Course Planning for Cancer Biology PhD Students to Enhance Knowledge of Clinical Oncology.

    PubMed

    Mattes, Malcolm D; Swart, Elizabeth; Markwell, Steven M; Wen, Sijin; Vona-Davis, Linda C

    2017-09-15

    Little is known about how clinical oncology concepts are taught to PhD students or the most effective methods of doing so. In this study, electronic surveys were sent to faculty and students at PhD training programs, assessing their institution's methods of clinical oncology education and their perspective on optimal approaches to clinical oncology education. Only 40.0% of students reported any clinical oncology component to their institution's training, and only 26.5% had a clinician on their graduate advisory committee. Forty-three percent of students believed that they had a good understanding for translating basic science research into clinical practice, and 77.2% of all participants believed dual degree MD/PhD students were superior to PhD students in this regard. Lectures on clinical oncology research topics were the most valuable type of experience for all participants and were also the most common type of experience utilized. Working with a clinician to develop a clinical trial with correlative endpoints was also highly valued, but was only utilized by approximately 10% of programs. Faculty rated the value of nearly all types of clinical oncology exposure significantly lower than did students. Inclusion of the approaches identified in this study is likely to enhance PhD training in oncology-related disciplines. Cancer Res; 77(18); 4741-4. ©2017 AACR . ©2017 American Association for Cancer Research.

  10. Do Professional Interpreters Improve Clinical Care for Patients with Limited English Proficiency? A Systematic Review of the Literature

    PubMed Central

    Karliner, Leah S; Jacobs, Elizabeth A; Chen, Alice Hm; Mutha, Sunita

    2007-01-01

    Objective To determine if professional medical interpreters have a positive impact on clinical care for limited English proficiency (LEP) patients. Data Sources A systematic literature search, limited to the English language, in PubMed and PsycINFO for publications between 1966 and September 2005, and a search of the Cochrane Library. Study Design Any peer-reviewed article which compared at least two language groups, and contained data about professional medical interpreters and addressed communication (errors and comprehension), utilization, clinical outcomes, or satisfaction were included. Of 3,698 references, 28 were found by multiple reviewers to meet inclusion criteria and, of these, 21 assessed professional interpreters separately from ad hoc interpreters. Data were abstracted from each article by two reviewers. Data were collected on the study design, size, comparison groups, analytic technique, interpreter training, and method of determining the participants' need for an interpreter. Each study was evaluated for the effect of interpreter use on four clinical topics that were most likely to either impact or reflect disparities in health and health care. Principal Findings In all four areas examined, use of professional interpreters is associated with improved clinical care more than is use of ad hoc interpreters, and professional interpreters appear to raise the quality of clinical care for LEP patients to approach or equal that for patients without language barriers. Conclusions Published studies report positive benefits of professional interpreters on communication (errors and comprehension), utilization, clinical outcomes and satisfaction with care. PMID:17362215

  11. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).

    PubMed

    Phibbs, Ciaran S; Love, Sean R; Jacobson, Alan K; Edson, Robert; Su, Pon; Uyeda, Lauren; Matchar, David B

    2016-09-01

    Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

  12. Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis: cluster randomized clinical trial.

    PubMed

    Carmona-Terés, Victoria; Lumillo-Gutiérrez, Iris; Jodar-Fernández, Lina; Rodriguez-Blanco, Teresa; Moix-Queraltó, Joanna; Pujol-Ribera, Enriqueta; Mas, Xavier; Batlle-Gualda, Enrique; Gobbo-Montoya, Milena; Berenguera, Anna

    2015-02-25

    The prevalence of osteoarthritis and knee osteoarthritis in the Spanish population is estimated at 17% and 10.2%, respectively. The clinical guidelines concur that the first line treatment for knee osteoarthritis should be non-pharmacological and include weight loss, physical activity and self-management of pain. Health Coaching has been defined as an intervention that facilitates the achievement of health improvement goals, the reduction of unhealthy lifestyles, the improvement of self-management for chronic conditions and quality of life enhancement. The aim of this study is to analyze the effectiveness, cost-effectiveness and cost-utility of a health coaching intervention on quality of life, pain, overweight and physical activity in patients from 18 primary care centres of Barcelona with knee osteoarthritis. Methodology from the Medical Research Council on developing complex interventions. Phase 1: Intervention modelling and operationalization through a qualitative, socioconstructivist study using theoretical sampling with 10 in-depth interviews to patients with knee osteoarthritis and 4 discussion groups of 8-12 primary care professionals, evaluated using a sociological discourse analysis. Phase 2: Effectiveness, cost-effectiveness and cost-utility study with a community-based randomized clinical trial. 360 patients with knee osteoarthritis (180 in each group). Randomization unit: Primary Care Centre. Intervention Group: will receive standard care plus 20-hour health coaching and follow-up sessions. will receive standard care. quality of life as measured by the WOMAC index. Data Analyses: will include standardized response mean and multilevel analysis of repeated measures. Economic analysis: based on cost-effectiveness and cost-utility measures. Phase 3: Evaluation of the intervention programme with a qualitative study. Methodology as in Phase 1. If the analyses show the cost-effectiveness and cost-utility of the intervention the results can be incorporated into the clinical guidelines for the management of knee osteoarthritis in primary care. ISRCTN57405925. Registred 20 June 2014.

  13. Examining the Utility of Topic Models for Linguistic Analysis of Couple Therapy

    ERIC Educational Resources Information Center

    Doeden, Michelle A.

    2012-01-01

    This study examined the basic utility of topic models, a computational linguistics model for text-based data, to the investigation of the process of couple therapy. Linguistic analysis offers an additional lens through which to examine clinical data, and the topic model is presented as a novel methodology within couple and family psychology that…

  14. Treatment Utilization on College Campuses: Who Seeks Help for What?

    ERIC Educational Resources Information Center

    Nordberg, Samuel S.; Hayes, Jeffrey A.; McAleavey, Andrew A.; Castonguay, Louis G.; Locke, Benjamin D.

    2013-01-01

    The purpose of this study was to develop a better understanding of why college students seek psychological treatment by examining indicators of psychological distress. A secondary goal was to assess the utility of screening for treatment need via a brief self-report measure of distress. Two samples (1 clinical, 1 nonclinical; N= 8,380) were…

  15. Magnetic resonance neurography and diffusion tensor imaging: origins, history, and clinical impact of the first 50,000 cases with an assessment of efficacy and utility in a prospective 5000-patient study group.

    PubMed

    Filler, Aaron

    2009-10-01

    Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. The history, physical basis, and dyadic tensor concept underlying the methods are reviewed. Over a 15-year period, these techniques-magnetic resonance neurography (MRN) and diffusion tensor imaging-were deployed in the clinical and research community in more than 2500 published research reports and applied to approximately 50,000 patients. Within this group, approximately 5000 patients having MRN were carefully tracked on a prospective basis. A uniform Neurography imaging methodology was applied in the study group, and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging, and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. MRN demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerves at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathological diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. A review of clinical outcome studies with diffusion tensor imaging also shows convincing utility. MRN and diffusion tensor imaging neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomic pathological information. There is no alternative diagnostic method in many situations. With the elapsing of 15 years, tens of thousands of imaging studies, and thousands of publications, these methods should no longer be considered experimental.

  16. A structured review of health utility measures and elicitation in advanced/metastatic breast cancer.

    PubMed

    Hao, Yanni; Wolfram, Verena; Cook, Jennifer

    2016-01-01

    Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy - General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities.

  17. A structured review of health utility measures and elicitation in advanced/metastatic breast cancer

    PubMed Central

    Hao, Yanni; Wolfram, Verena; Cook, Jennifer

    2016-01-01

    Background Health utilities are increasingly incorporated in health economic evaluations. Different elicitation methods, direct and indirect, have been established in the past. This study examined the evidence on health utility elicitation previously reported in advanced/metastatic breast cancer and aimed to link these results to requirements of reimbursement bodies. Methods Searches were conducted using a detailed search strategy across several electronic databases (MEDLINE, EMBASE, Cochrane Library, and EconLit databases), online sources (Cost-effectiveness Analysis Registry and the Health Economics Research Center), and web sites of health technology assessment (HTA) bodies. Publications were selected based on the search strategy and the overall study objectives. Results A total of 768 publications were identified in the searches, and 26 publications, comprising 18 journal articles and eight submissions to HTA bodies, were included in the evidence review. Most journal articles derived utilities from the European Quality of Life Five-Dimensions questionnaire (EQ-5D). Other utility measures, such as the direct methods standard gamble (SG), time trade-off (TTO), and visual analog scale (VAS), were less frequently used. Several studies described mapping algorithms to generate utilities from disease-specific health-related quality of life (HRQOL) instruments such as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Breast Cancer 23 (EORTC QLQ-BR23), Functional Assessment of Cancer Therapy – General questionnaire (FACT-G), and Utility-Based Questionnaire-Cancer (UBQ-C); most used EQ-5D as the reference. Sociodemographic factors that affect health utilities, such as age, sex, income, and education, as well as disease progression, choice of utility elicitation method, and country settings, were identified within the journal articles. Most submissions to HTA bodies obtained utility values from the literature rather than exploring the HRQOL data obtained during clinical development. This was critiqued by the National Institute for Health and Clinical Excellence (NICE). Furthermore, the impact of age on utilities was highlighted by NICE and it was suggested that an age match of the study population should be attempted. Conclusion Health utilities are recorded across the globe to varying extents and using differing elicitation methods. Manufacturers seeking reimbursement need to be aware of the country-specific requirements for elicitation of health utilities. PMID:27382319

  18. Interpersonal discrimination and health-related quality of life among black and white men and women in the United States.

    PubMed

    Sellers, Sherrill; Cherepanav, Dasha; Hanmer, Janel; Fryback, Dennis G; Palta, Mari

    2013-08-01

    We assessed associations between discrimination and health-related quality of life among black and white men and women in the United States. We examined data from the National Health Measurement Study, a nationally representative sample of 3,648 adults aged 35-89 in the non-institutionalized US population. These data include self-reported lifetime and everyday discrimination as well as several health utility indexes (EQ-5D, HUI3, and SF-6D). Multiple regression was used to compute mean health utility scores adjusted for age, income, education, and chronic diseases for each race-by-gender subgroup. Black men and women reported more discrimination compared to white men and women. Health utility tended to be worse as reported discrimination increased. With a few exceptions, differences between mean health utility scores in the lowest and highest discrimination groups exceeded the 0.03 difference generally considered to be a clinically significant difference. Persons who experienced discrimination tended to score lower on health utility measures. The study also revealed a complex relationship between experiences of discrimination and race and gender. Because of these differential social and demographic relationships caution is urged when interpreting self-rated health measures in research, clinical, and policy settings.

  19. Erratum to: Interpersonal discrimination and health-related quality of life among black and white men and women in the United States.

    PubMed

    Sellers, Sherrill L; Cherepanov, Dasha; Hanmer, Janel; Fryback, Dennis G; Palta, Mari

    2013-08-01

    We assessed associations between discrimination and health-related quality of life among black and white men and women in the United States. We examined data from the National Health Measurement Study, a nationally representative sample of 3,648 adults aged 35-89 in the non-institutionalized US population. These data include self-reported lifetime and everyday discrimination as well as several health utility indexes (EQ-5D, HUI3, and SF-6D). Multiple regression was used to compute mean health utility scores adjusted for age, income, education, and chronic diseases for each race-by-gender subgroup. Black men and women reported more discrimination than white men and women. Health utility tended to be worse as reported discrimination increased. With a few exceptions, differences between mean health utility scores in the lowest and highest discrimination groups exceeded the 0.03 difference generally considered to be a clinically significant difference. Persons who experienced discrimination tended to score lower on health utility measures. The study also revealed a complex relationship between experiences of discrimination and race and gender. Because of these differential social and demographic relationships caution is urged when interpreting self-rated health measures in research, clinical, and policy settings.

  20. A prospective evaluation of whole-exome sequencing as a first-tier molecular test in infants with suspected monogenic disorders.

    PubMed

    Stark, Zornitza; Tan, Tiong Y; Chong, Belinda; Brett, Gemma R; Yap, Patrick; Walsh, Maie; Yeung, Alison; Peters, Heidi; Mordaunt, Dylan; Cowie, Shannon; Amor, David J; Savarirayan, Ravi; McGillivray, George; Downie, Lilian; Ekert, Paul G; Theda, Christiane; James, Paul A; Yaplito-Lee, Joy; Ryan, Monique M; Leventer, Richard J; Creed, Emma; Macciocca, Ivan; Bell, Katrina M; Oshlack, Alicia; Sadedin, Simon; Georgeson, Peter; Anderson, Charlotte; Thorne, Natalie; Melbourne Genomics Health Alliance; Gaff, Clara; White, Susan M

    2016-11-01

    To prospectively evaluate the diagnostic and clinical utility of singleton whole-exome sequencing (WES) as a first-tier test in infants with suspected monogenic disease. Singleton WES was performed as a first-tier sequencing test in infants recruited from a single pediatric tertiary center. This occurred in parallel with standard investigations, including single- or multigene panel sequencing when clinically indicated. The diagnosis rate, clinical utility, and impact on management of singleton WES were evaluated. Of 80 enrolled infants, 46 received a molecular genetic diagnosis through singleton WES (57.5%) compared with 11 (13.75%) who underwent standard investigations in the same patient group. Clinical management changed following exome diagnosis in 15 of 46 diagnosed participants (32.6%). Twelve relatives received a genetic diagnosis following cascade testing, and 28 couples were identified as being at high risk of recurrence in future pregnancies. This prospective study provides strong evidence for increased diagnostic and clinical utility of singleton WES as a first-tier sequencing test for infants with a suspected monogenic disorder. Singleton WES outperformed standard care in terms of diagnosis rate and the benefits of a diagnosis, namely, impact on management of the child and clarification of reproductive risks for the extended family in a timely manner.Genet Med 18 11, 1090-1096.

  1. The clinical utility of a 30-minute neuropsychological assessment battery in inpatient stroke rehabilitation.

    PubMed

    Jaywant, Abhishek; Toglia, Joan; Gunning, Faith M; O'Dell, Michael W

    2018-07-15

    Cognitive assessment is an important component of inpatient stroke rehabilitation. Few studies have empirically evaluated the clinical utility of specific neuropsychological measures in this setting. We investigated the psychometric properties and clinical utility of a 30-minute neuropsychological battery developed by the National Institute of Neurologic Disorders and Stroke (NINDS) and the Canadian Stroke Network (CSN). Clinical data were analyzed from 100 individuals with mild-moderate stroke severity on an acute inpatient rehabilitation unit who completed the NINDS-CSN battery at admission. The battery comprised the Symbol-Digit Modalities Test (SDMT), Trail Making Test, Controlled Oral Word Association Test, Animal Naming, and the Hopkins Verbal Learning Test-Revised. We evaluated the battery's distribution of scores, frequency of impaired performance, internal consistency, and ability to predict rehabilitation gain and independence in cognitively-based instrumental activities of daily living (IADL) at discharge. Results indicated that the NINDS-CSN battery was sensitive to cognitive impairment, demonstrated moderately strong internal consistency, and predicted discharge IADL. The SDMT demonstrated the strongest sensitivity to impairment and predictive validity. The NINDS-CSN battery is a clinically useful assessment battery in acute inpatient stroke rehabilitation. Complex attention and processing speed performance may be most informative in predicting amount of rehabilitation gain and IADL functioning at discharge. Copyright © 2018 Elsevier B.V. All rights reserved.

  2. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.

    PubMed

    Merker, Jason D; Oxnard, Geoffrey R; Compton, Carolyn; Diehn, Maximilian; Hurley, Patricia; Lazar, Alexander J; Lindeman, Neal; Lockwood, Christina M; Rai, Alex J; Schilsky, Richard L; Tsimberidou, Apostolia M; Vasalos, Patricia; Billman, Brooke L; Oliver, Thomas K; Bruinooge, Suanna S; Hayes, Daniel F; Turner, Nicholas C

    2018-06-01

    Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

  3. Utilization of a clinical microbiology service at a Cambodian paediatric hospital and its impact on appropriate antimicrobial prescribing.

    PubMed

    Fox-Lewis, Shivani; Pol, Sreymom; Miliya, Thyl; Day, Nicholas P J; Turner, Paul; Turner, Claudia

    2018-02-01

    Antimicrobial resistance threatens human health worldwide. Antimicrobial misuse is a major driver of resistance. Promoting appropriate antimicrobial use requires an understanding of how clinical microbiology services are utilized, particularly in resource-limited settings. To assess the appropriateness of antimicrobial prescribing and the factors affecting utilization of the established clinical microbiology service (CMS). The CMS comprises the microbiology laboratory, clinical microbiologists (infection doctors) and antimicrobial treatment guidelines. This mixed-methods study was conducted at a non-governmental Cambodian paediatric hospital. Empirical and post-culture antimicrobial prescriptions were reviewed from medical records. The random sample included 10 outpatients per week in 2016 (retrospective) and 20 inpatients per week for 4 weeks in the medical, neonatal and intensive care wards (prospective). Post-culture prescriptions were assessed in patients with positive blood and cerebrospinal fluid cultures from 1 January 2014 to 31 December 2016. Focus group discussions and semi-structured interviews with clinicians explored barriers and facilitators to use of the CMS. Only 31% of outpatients were prescribed empirical antimicrobials. Post-culture prescriptions (394/443, 89%) were more likely to be appropriate than empirical prescriptions (447/535, 84%), based on treatment guidelines, microbiology advice and antimicrobial susceptibility test results (P = 0.015). Being comprehensive, accessible and trusted enabled CMS utilization. Clinical microbiologists provided a crucial human interface between the CMS and physicians. The main barriers were a strong clinical hierarchy and occasional communication difficulties. Antimicrobial prescribing in this hospital was largely appropriate. A culturally appropriate human interface linking the laboratory and physicians is essential in providing effective microbiology services and ensuring appropriate antimicrobial prescribing in resource-limited settings. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.

  4. Teaching Perspectives and Usage of Journal Writing by Clinical Faculty

    ERIC Educational Resources Information Center

    Alschuler, Mari L.

    2012-01-01

    The purpose of this study was to investigate the associations between teaching perspectives (TPs), faculty usage and perceptions of reflective journaling (RJ), and demographic characteristics among clinical faculty in nursing, social work, and counseling. A combination of causal-comparative and correlational designs was utilized, with stratified…

  5. Projective Drawings of Individuals Grieving the Loss of a Pet

    ERIC Educational Resources Information Center

    Packman, Wendy; Kelley, Elizabeth; Rudolph, Brittany; Long, Janet; Wallace, Jo; Hsu, Melanie; Carmack, Betty J.; Field, Nigel

    2017-01-01

    This study examined the relationship among projective drawings and mental health symptomatology to determine if projective drawings provide clinical utility in pet bereavement. Projective drawings, standardized questionnaires, and clinical interview results were collected from 33 adults grieving the loss of a pet. Drawings were coded into a…

  6. The Clinical Utility of Personality Subtypes in Patients with Anorexia Nervosa

    ERIC Educational Resources Information Center

    Wildes, Jennifer E.; Marcus, Marsha D.; Crosby, Ross D.; Ringham, Rebecca M.; Dapelo, Marcela Marin; Gaskill, Jill A.; Forbush, Kelsie T.

    2011-01-01

    Objective: Elucidation of clinically relevant subtypes has been proposed as a means of advancing treatment research, but classifying anorexia nervosa (AN) patients into restricting and binge-eating/purging types has demonstrated limited predictive validity. This study aimed to evaluate whether an approach to classifying eating disorder patients on…

  7. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

    PubMed

    Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

    2012-01-18

    Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. ClinicalTrials.gov: NCT00849563.

  8. Prospective evaluation of the clinical utility of laryngeal electromyography.

    PubMed

    Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

    2014-12-01

    To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  9. Direct endoscopic necrosectomy versus step-up approach for walled-off pancreatic necrosis: comparison of clinical outcome and health care utilization.

    PubMed

    Kumar, Nitin; Conwell, Darwin L; Thompson, Christopher C

    2014-11-01

    Infected walled-off pancreatic necrosis (WOPN) is a complication of acute pancreatitis requiring intervention. Surgery is associated with considerable morbidity. Percutaneous catheter drainage (PCD), initial therapy in the step-up approach, minimizes complications. Direct endoscopic necrosectomy (DEN) has demonstrated safety and efficacy. We compared outcome and health care utilization of DEN versus step-up approach. This was a matched cohort study using a prospective registry. Twelve consecutive DEN patients were matched with 12 step-up approach patients. Outcomes were clinical resolution after primary therapeutic modality, new organ failure, mortality, endocrine or exocrine insufficiency, length of stay, and health care utilization. Clinical resolution in 11 of 12 patients after DEN versus 3 of 12 step-up approach patients after PCD (P < 0.01). Nine step-up approach patients required surgery; 7 of these experienced complications. Direct endoscopic necrosectomy resulted in less new antibiotic use, pulmonary failure, endocrine insufficiency, and shorter length of stay (P < 0.05). Health care utilization was lower after DEN by 5.2:1 (P < 0.01). Direct endoscopic necrosectomy may be superior to step-up approach for WOPN with suspected or established infection. Primary PCD generally delayed definitive therapy. Given the higher efficacy, shorter length of stay, and lower health care utilization, DEN could be the first-line therapy for WOPN, with primary PCD for inaccessible or immature collections.

  10. EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation.

    PubMed

    Wong, Carlos K H; Lang, Brian H H; Yu, Hill M S; Lam, Cindy L K

    2017-08-01

    The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules. Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires-the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D-were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test-retest reliability was assessed using intra-class correlation coefficient. No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test-retest reliability (0.794; range 0.696-0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores. While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration. NCT02398721, ClinicalTrials.gov.

  11. Evaluation of the Missoula-VITAS Quality of Life Index--revised: research tool or clinical tool?

    PubMed

    Schwartz, Carolyn E; Merriman, Melanie P; Reed, George; Byock, Ira

    2005-02-01

    Quality of life (QOL) is a central outcome measure in caring for seriously ill patients. The Missoula-VITAS Quality of Life Index (MVQOLI) is a 25-item patient-centered index that weights each of five QOL dimensions (symptoms, function, interpersonal, wellbeing, transcendence) by its importance to the respondent. The measure has been used to assess QOL for hospice patients, and has been found to be somewhat complex to use and analyze. This study aimed to simplify the measure, and evaluate the reliability and validity of a revised version as either a research or clinical tool (i.e., "psychometric" versus "clinimetric"). Two data collection efforts are described. The psychometric study collected QOL data from 175 patients at baseline, 3-5 days, and 21 days later. The implementation study evaluated the feasibility and utility of the MVQOLI-R during over six weeks of use. End-stage renal patients on dialysis, hospice, or long-term care patients participated in the psychometric study. The implementation study was done in hospice, home health, and palliative care settings. The MVQOLI-R and the Memorial Symptom Assessment Scale. The psychometric and implementation studies suggest that the MVQOLI-R performs well as a clinical tool but is not powerful as an outcome research instrument. The MVQOLI-R has the heterogeneous structure of clinimetric tools, and demonstrated both relevance and responsiveness. Additionally, in a clinical setting the MVQOLI-R was useful therapeutically for stimulating communication about the psychosocial and spiritual issues important to the tasks of life completion and life closure. The MVQOLI-R has clinical utility as a patient QOL assessment tool and may have therapeutic utility as a tool for fostering discussion among patients and their clinicians, as well as for helping patients identify sources of suffering and opportunities during this time in their lives.

  12. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  13. Old wine in new bottles: validating the clinical utility of SPECT in predicting cognitive performance in mild traumatic brain injury.

    PubMed

    Romero, Kristoffer; Lobaugh, Nancy J; Black, Sandra E; Ehrlich, Lisa; Feinstein, Anthony

    2015-01-30

    The neural underpinnings of cognitive dysfunction in mild traumatic brain injury (TBI) are not fully understood. Consequently, patient prognosis using existing clinical imaging is somewhat imprecise. Single photon emission computed tomography (SPECT) is a frequently employed investigation in this population, notwithstanding uncertainty over the clinical utility of the data obtained. In this study, subjects with mild TBI underwent (99m)Tc-ECD SPECT scanning, and were administered a brief battery of cognitive tests and self-report symptom scales of concussion and emotional distress. Testing took place 2 weeks (n=84) and 1 year (n=49) post-injury. Multivariate analysis (i.e., partial least squares analysis) revealed that frontal perfusion in right superior frontal and middle frontal gyri predicted poorer performance on the Stroop test, an index of executive function, both at initial and follow-up testing. Conversely, SPECT scans categorized as normal or abnormal by radiologists did not differentiate cognitively impaired from intact subjects. These results demonstrate the clinical utility of SPECT in mild TBI, but only when data are subjected to blood flow quantification analysis. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  14. The clinical utility index as a practical multiattribute approach to drug development decisions.

    PubMed

    Poland, B; Hodge, F L; Khan, A; Clemen, R T; Wagner, J A; Dykstra, K; Krishna, R

    2009-07-01

    We identify some innovative approaches to predicting overall patient benefit from investigational drugs to support development decisions. We then illustrate calculation of a probabilistic clinical utility index (CUI), an implementation of multiattribute utility that focuses on clinical attributes. We recommend use of the CUI for the support of early drug development decisions because of its practicality, reasonable accuracy, and transparency to decision makers, at stages in which financial factors that may dominate later-phase decisions are less critical.

  15. Clinical Utility and Pitfalls of Ultrasound Guided Foreign Body Removal in War Fighters

    DTIC Science & Technology

    2015-12-01

    1 AD_________________ AWARD NUMBER: W81XWH-08-2-0162 TITLE: Clinical Utility and Pitfalls of Ultrasound Guided Foreign Body Removal in War...Clinical Utility and Pitfalls of Ultrasound Guided Foreign Body Removal in War Fighters 5a. CONTRACT NUMBER 5b. GRANT NUMBER: W81XWH-08-2-0162 5c...Purpose: To demonstrate that 1) ultrasound guided foreign body removal (USFBR) is superior to conventional surgery in the cadaver model, 2) USFBR can be

  16. The Mini Alcohol Craving Experience Questionnaire: Development and Clinical Application.

    PubMed

    Coates, Jason M; Gullo, Matthew J; Feeney, Gerald F X; Kavanagh, David J; Young, Ross McD; Dingle, Genevieve A; May, Jon; Andrade, Jackie; Statham, Dixie J; Connor, Jason P

    2017-01-01

    Standardized alcohol craving scales are rarely used outside of research environments despite recognized clinical utility. Scale length is a key barrier to more widespread application. A brief measure of alcohol craving is needed to improve research and treatment of alcohol use disorders (AUDs). Grounded in the Elaborated Intrusion Theory of Desire, the Alcohol Craving Experience (ACE) Questionnaire comprises two 11-item self-report scales that assess past-week frequency and maximum strength of alcohol craving. This study aimed to create a brief version of the ACE while maintaining psychometric integrity and clinical utility. Patients attending a university hospital alcohol and drug outpatient service for the treatment of AUD completed the ACE as part of a questionnaire battery. Three patient samples were utilized: 519 patients with pretreatment and outcome data, 228 patients with pretreatment data, and 66 patients who completed the ACE at treatment sessions 1 and 2. The Frequency scale of the ACE possessed greater clinical utility and predictive validity than the Strength scale. Revision of the Frequency measure produced a 5-item "Mini Alcohol Craving Experience" (MACE) Questionnaire. Satisfactory validity (construct, predictive, concurrent, convergent, and incremental) and reliability (internal and test-retest) were maintained. A 1 standard deviation increase in pretreatment MACE score was associated with a 54 percentage increase in the odds of patient lapse or dropout. The MACE provides a brief, theoretically, and psychometrically robust measure of alcohol craving suitable for use with AUD populations in time-limited clinical and research settings. Copyright © 2016 by the Research Society on Alcoholism.

  17. Physiotherapy in Primary Care Triage - the effects on utilization of medical services at primary health care clinics by patients and sub-groups of patients with musculoskeletal disorders: a case-control study.

    PubMed

    Bornhöft, Lena; Larsson, Maria E H; Thorn, Jörgen

    2015-01-01

    Primary Care Triage is a patient sorting system used in some primary health care clinics (PHCCs) in Sweden where patients with musculoskeletal disorders (MSD) are triaged directly to physiotherapists. The purpose of this study was to investigate whether sorting/triaging patients seeking a PHCC for MSD directly to physiotherapists affects their utilization of medical services at the clinic for the MSD and to determine whether the effects of the triaging system vary for different sub-groups of patients. A retrospective case-control study design was used at two PHCCs. At the intervention clinic, 656 patients with MSD were initially triaged to physiotherapists. At the control clinic, 1673 patients were initially assessed by general practitioners (GPs). The main outcome measures were the number of patients continuing to visit GPs after the initial assessment, the number of patients receiving referrals to specialists/external examinations, doctors' notes for sick-leave or prescriptions for analgesics during one year, all for the original MSD. Significantly fewer patients triaged to physiotherapists required multiple GP visits for the MSD or received MSD-related referrals to specialists/external examinations, sick-leave recommendations or prescriptions during the following year compared to the GP-assessed group. This applies to all sub-groups except for the group with lower extremity disorders, which did not reach significance for either multiple GP visits or sick-leave recommendations. The reduced utilization of medical services by patients with MSD who were triaged to physiotherapists at a PHCC is likely due to altered management of MSD with initial assessment by physiotherapists.

  18. Clinical and economic evaluation of an evidence-based institutional epoetin-utilization management program.

    PubMed

    Buckley, Mitchell S; Kane-Gill, Sandra L; Patel, Shardool A

    2013-03-01

    Anemia is common in several patient populations, including those with chronic kidney disease, cancer, and HIV/AIDS, and may require treatment with erythropoietin-stimulating agents (ESAs). Given the potential risks of the ESA, epoetin, and the significant costs associated with this agent, a large teaching medical institution developed a the drug-utilization management program using evidence-based guidelines on appropriate use. This study was designed to determine the clinical and financial impact of the drug-utilization management program. This retrospective cohort study was conducted at the medical institution that implemented the program using clinical pharmacists. Patients were included if epoetin was administered during their hospital stay (evaluation period, December 1, 2010, to December 31, 2011). The rate of inappropriate epoetin prescribing and the economic impact of guideline implementation were evaluated using comparisons of data from cohorts prescribed epoetin before and after guideline implementation. Data from 796 patients were included in the analyses (pre-implementation, 496; post-implementation, 300). The proportion of patients prescribed epoetin was significantly smaller after guideline implementation (2.4% vs 1.6%; P < 0.001). The reduction in the total number of epoetin units administered was 45%. The significant reduction (25%) in inappropriate prescribing after guideline implementation was primarily attributed to a 17% decrease in epoetin use in nonspecific anemia. The reduction in inappropriate epoetin prescribing translated into a 23.8% reduction in costs (P < 0.001) associated with inappropriate epoetin use. The estimated annual cost-savings of this program was $198,352 ($16,529/mo). The implementation of a drug-utilization management program using clinical pharmacists who evaluated epoetin was associated with a decrease in inappropriate epoetin prescribing and with significant cost-savings. Copyright © 2013 Elsevier HS Journals, Inc. All rights reserved.

  19. Productivity, quality, and patient satisfaction: comparison of part-time and full-time primary care physicians.

    PubMed

    Fairchild, D G; McLoughlin, K S; Gharib, S; Horsky, J; Portnow, M; Richter, J; Gagliano, N; Bates, D W

    2001-10-01

    Although few data are available, many believe that part-time primary care physicians (PCPs) are less productive and provide lower quality care than full-time PCPs. Some insurers exclude part-time PCPs from their provider networks. To compare productivity, quality of preventive care, patient satisfaction, and risk-adjusted resource utilization of part-time and full-time PCPs. Retrospective cohort study. Boston. PCPs affiliated with 2 academic outpatient primary care networks. PCP productivity, patient satisfaction, resource utilization, and compliance with screening guidelines. Part-time PCP productivity was greater than that of full-time PCPs (2.1 work relative value units (RVUs)/bookable clinical hour versus 1.3 work RVUs/bookable clinical hour, P< .01). A similar proportion of part-time PCPs (80%) and full-time PCPs (75%) met targets for mammography, Pap smears, and cholesterol screening (P = .67). After adjusting for clinical case mix, practice location, gender, board certification status, and years in practice, resource utilization of part-time PCPs (138 dollars [95% confidence interval (CI), 108 dollars to 167 dollars]) was similar to that of full-time PCPs (139 dollars [95% CI, 108 dollars to 170 dollars], P = .92). Patient satisfaction was similar for part-time and full-time PCPs. In these academic primary care practices, rates of patient satisfaction, compliance with screening guidelines, and resource utilization were similar for part-time PCPs compared to full-time PCPs. Productivity per clinical hour was markedly higher for part-time PCPs. Despite study limitations, these data suggest that academic part-time PCPs are at least as efficient as full-time PCPs and that the quality of their work is similar.

  20. Health Care Utilization and Costs Associated with Adherence to Clinical Practice Guidelines for Early Magnetic Resonance Imaging among Workers with Acute Occupational Low Back Pain

    PubMed Central

    Graves, Janessa M; Fulton-Kehoe, Deborah; Jarvik, Jeffrey G; Franklin, Gary M

    2014-01-01

    Objective To estimate health care utilization and costs associated with adherence to clinical practice guidelines for the use of early magnetic resonance imaging (MRI; within the first 6 weeks of injury) for acute occupational low back pain (LBP). Data Sources Washington State Disability Risk Identification Study Cohort (D-RISC), consisting of administrative claims and patient interview data from workers’ compensation claimants (2002–2004). Study Design In this prospective, population-based cohort study, we compared health care utilization and costs among workers whose imaging was adherent to guidelines (no early MRI) to workers whose imaging was not adherent to guidelines (early MRI in the absence of red flags). Data Collection/Extraction Methods We identified workers (age >18) with work-related LBP using administrative claims. We obtained demographic, injury, health, and employment information through telephone interviews to adjust for baseline differences between groups. We ascertained health care utilization and costs from administrative claims for 1 year following injury. Principal Findings Of 1,770 workers, 336 (19.0 percent) were classified as nonadherent to guidelines. Outpatient and physical/occupational therapy utilization was 52–54 percent higher for workers whose imaging was not adherent to guidelines compared to workers with guideline-adherent imaging; utilization of chiropractic care was significantly lower (18 percent). Conclusions Nonadherence to guidelines for early MRI was associated with increased likelihood of lumbosacral injections or surgery and higher costs for out-patient, inpatient, and nonmedical services, and disability compensation. PMID:23910019

  1. Resource utilization after introduction of a standardized clinical assessment and management plan.

    PubMed

    Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E

    2010-01-01

    A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.

  2. Factors associated with patterns of plural healthcare utilization among patients taking antiretroviral therapy in rural and urban South Africa: a cross-sectional study

    PubMed Central

    2012-01-01

    Background In low-resource settings, patients’ use of multiple healthcare sources may complicate chronic care and clinical outcomes as antiretroviral therapy (ART) continues to expand. However, little is known regarding patterns, drivers and consequences of using multiple healthcare sources. We therefore investigated factors associated with patterns of plural healthcare usage among patients taking ART in diverse South African settings. Methods A cross-sectional study of patients taking ART was conducted in two rural and two urban sub-districts, involving 13 accredited facilities and 1266 participants selected through systematic random sampling. Structured questionnaires were used in interviews, and participant’s clinic records were reviewed. Data collected included household assets, healthcare access dimensions (availability, affordability and acceptability), healthcare utilization and pluralism, and laboratory-based outcomes. Multiple logistic regression models were fitted to identify predictors of healthcare pluralism and associations with treatment outcomes. Prior ethical approval and informed consent were obtained. Results Nineteen percent of respondents reported use of additional healthcare providers over and above their regular ART visits in the prior month. A further 15% of respondents reported additional expenditure on self-care (e.g. special foods). Access to health insurance (Adjusted odds ratio [aOR] 6.15) and disability grants (aOR 1.35) increased plural healthcare use. However, plural healthcare users were more likely to borrow money to finance healthcare (aOR 2.68), and incur catastrophic levels of healthcare expenditure (27%) than non-plural users (7%). Quality of care factors, such as perceived disrespect by staff (aOR 2.07) and lack of privacy (aOR 1.50) increased plural healthcare utilization. Plural healthcare utilization was associated with rural residence (aOR 1.97). Healthcare pluralism was not associated with missed visits or biological outcomes. Conclusion Increased plural healthcare utilization, inequitably distributed between rural and urban areas, is largely a function of higher socioeconomic status, better ability to finance healthcare and factors related to poor quality of care in ART clinics. Plural healthcare utilization may be an indication of patients’ dissatisfaction with perceived quality of ART care provided. Healthcare expenditure of a catastrophic nature remained a persistent complication. Plural healthcare utilization did not appear to influence clinical outcomes. However, there were potential negative impacts on the livelihoods of patients and their households. PMID:22747971

  3. Factors associated with patterns of plural healthcare utilization among patients taking antiretroviral therapy in rural and urban South Africa: a cross-sectional study.

    PubMed

    Moshabela, Mosa; Schneider, Helen; Silal, Sheetal P; Cleary, Susan M

    2012-07-02

    In low-resource settings, patients' use of multiple healthcare sources may complicate chronic care and clinical outcomes as antiretroviral therapy (ART) continues to expand. However, little is known regarding patterns, drivers and consequences of using multiple healthcare sources. We therefore investigated factors associated with patterns of plural healthcare usage among patients taking ART in diverse South African settings. A cross-sectional study of patients taking ART was conducted in two rural and two urban sub-districts, involving 13 accredited facilities and 1266 participants selected through systematic random sampling. Structured questionnaires were used in interviews, and participant's clinic records were reviewed. Data collected included household assets, healthcare access dimensions (availability, affordability and acceptability), healthcare utilization and pluralism, and laboratory-based outcomes. Multiple logistic regression models were fitted to identify predictors of healthcare pluralism and associations with treatment outcomes. Prior ethical approval and informed consent were obtained. Nineteen percent of respondents reported use of additional healthcare providers over and above their regular ART visits in the prior month. A further 15% of respondents reported additional expenditure on self-care (e.g. special foods). Access to health insurance (Adjusted odds ratio [aOR] 6.15) and disability grants (aOR 1.35) increased plural healthcare use. However, plural healthcare users were more likely to borrow money to finance healthcare (aOR 2.68), and incur catastrophic levels of healthcare expenditure (27%) than non-plural users (7%). Quality of care factors, such as perceived disrespect by staff (aOR 2.07) and lack of privacy (aOR 1.50) increased plural healthcare utilization. Plural healthcare utilization was associated with rural residence (aOR 1.97). Healthcare pluralism was not associated with missed visits or biological outcomes. Increased plural healthcare utilization, inequitably distributed between rural and urban areas, is largely a function of higher socioeconomic status, better ability to finance healthcare and factors related to poor quality of care in ART clinics. Plural healthcare utilization may be an indication of patients' dissatisfaction with perceived quality of ART care provided. Healthcare expenditure of a catastrophic nature remained a persistent complication. Plural healthcare utilization did not appear to influence clinical outcomes. However, there were potential negative impacts on the livelihoods of patients and their households.

  4. Factors influencing the mammography utilization among Taiwanese women with intellectual disabilities, a nationwide population-based study.

    PubMed

    Lai, Hsien-Tang; Kung, Pei-Tseng; Tsai, Wen-Chen

    2014-12-01

    Women with intellectual disabilities (ID) have cognitive impairment and communication difficulties; for both caregivers and clinical personnel, discovering the early symptoms of breast cancer among women with ID is challenging. The mammography utilization rate of women with ID was significantly lower than that of women in the general population. This study employed a 2008 database of people with disabilities in Taiwan as a research target and analyzed the mammography utilization rate of women with ID aged 50–69 years. In addition, relevant factors influencing mammography utilization among women with ID were also investigated. A total of 4370 participants were recruited and the majority were illiterate or had elementary-level educations (82.27%). The majority of the participants had ID that was more severe than mild (83.80%). The mammography utilization rate of women with ID was 4.32%, which was significantly lower than that of women in the general population (12%). The mammography utilization rate among women with ID who were married, had higher education levels, and had been diagnosed with cancer, diabetes, or mild ID was significantly higher. However, the mammography utilization rate among women with ID, who had elementary-level educations or were illiterate, was only 4.03%. The utilization rate among women with profound ID was only 2.65%. Women with ID who had undergone pap smears or had utilized adult preventive health services demonstrated a significantly higher mammography utilization rate. This study identified that education level, a diagnosis of diabetes, and the application of pap smears or adult preventive health services were primary factors that influenced the mammography utilization rate among women with ID. This study also observed that in Taiwan, the mammography utilization rate of women with ID was lower than that of pap smears and adult preventive health services, and was only half of that of people with disabilities. An unequal situation existed in regard to the acceptance of breast cancer screening among women with ID, and a different form of strategic planning must be adopted in public health policy. Because ID differs from other disabilities and most women with ID are illiterate, tailored courses are required to train primary caregivers and clinical personnel in providing knowledge and services. The objectives are to diagnose breast cancer at an early stage to decrease the risk of mortality and ensure their rights to health.

  5. Evidence-based use of electronic clinical tracking systems in advanced practice registered nurse education: an integrative review.

    PubMed

    Branstetter, M Laurie; Smith, Lynette S; Brooks, Andrea F

    2014-07-01

    Over the past decade, the federal government has mandated healthcare providers to incorporate electronic health records into practice by 2015. This technological update in healthcare documentation has generated a need for advanced practice RN programs to incorporate information technology into education. The National Organization of Nurse Practitioner Faculties created core competencies to guide program standards for advanced practice RN education. One core competency is Technology and Information Literacy. Educational programs are moving toward the utilization of electronic clinical tracking systems to capture students' clinical encounter data. The purpose of this integrative review was to evaluate current research on advanced practice RN students' documentation of clinical encounters utilizing electronic clinical tracking systems to meet advanced practice RN curriculum outcome goals in information technology as defined by the National Organization of Nurse Practitioner Faculties. The state of the science depicts student' and faculty attitudes, preferences, opinions, and data collections of students' clinical encounters. Although electronic clinical tracking systems were utilized to track students' clinical encounters, these systems have not been evaluated for meeting information technology core competency standards. Educational programs are utilizing electronic clinical tracking systems with limited evidence-based literature evaluating the ability of these systems to meet the core competencies in advanced practice RN programs.

  6. Utility analysis and calibration of QOL assessment in disease management.

    PubMed

    Liu, Mo

    2018-05-02

    In clinical trials, the assessment of health-related quality of life (QOL) (or patient-reported outcome [PRO] measure) has become very popular especially for clinical studies conducted for evaluating clinical benefits of patients with chronic, severe, and/or life threatening diseases. Health-related QOL information and PRO measures are useful for disease management for achieving best clinical practice. In this article, we will focus on health-related QOL assessment. The concept, design, and analysis of health-related QOL in clinical trials are reviewed. Validation of the use of health-related QOL instrument in terms of some key performance characteristics such as accuracy, reliability, sensitivity, and responsibility for assuring quality, integrity, and validity of collected QOL data are discussed. The concept of utility analysis and calibration (e.g., with respect to life events) for achieving the optimization of disease management are proposed. The change of the QOL could be translated into different life events for effective disease management. These translations could evaluate the treatment effect by more directly displaying the change of the QOL.

  7. Comparative effectiveness of instructional methods: oral and pharyngeal cancer examination.

    PubMed

    Clark, Nereyda P; Marks, John G; Sandow, Pamela R; Seleski, Christine E; Logan, Henrietta L

    2014-04-01

    This study compared the effectiveness of different methods of instruction for the oral and pharyngeal cancer examination. A group of thirty sophomore students at the University of Florida College of Dentistry were randomly assigned to three training groups: video instruction, a faculty-led hands-on instruction, or both video and hands-on instruction. The training intervention involved attending two sessions spaced two weeks apart. The first session used a pretest to assess students' baseline didactic knowledge and clinical examination technique. The second session utilized two posttests to assess the comparative effectiveness of the training methods on didactic knowledge and clinical technique. The key findings were that students performed the clinical examination significantly better with the combination of video and faculty-led hands-on instruction (p<0.01). All students improved their clinical exam skills, knowledge, and confidence in performing the oral and pharyngeal cancer examination independent of which training group they were assigned. Utilizing both video and interactive practice promoted greater performance of the clinical technique on the oral and pharyngeal cancer examination.

  8. M-OSCE as a method to measure dental hygiene students' critical thinking: a pilot study.

    PubMed

    McComas, Martha J; Wright, Rebecca A; Mann, Nancy K; Cooper, Mary D; Jacks, Mary E

    2013-04-01

    Educators in all academic disciplines have been encouraged to utilize assessment strategies to evaluate students' critical thinking. The purpose of this study was to assess the viability of the modified objective structured clinical examination (m-OSCE) to evaluate critical thinking in dental hygiene education. This evaluation utilized a convenience sample of senior dental hygiene students. Students participated in the m-OSCE in which portions of a patient case were revealed at four stations. The exam consisted of multiple-choice questions intended to measure students' ability to utilize critical thinking skills. Additionally, there was one fill-in-the-blank question and a treatment plan that was completed at the fifth station. The results of this study revealed that the m-OSCE did not reliably measure dental hygiene students' critical thinking. Statistical analysis found no satisfactory reliability within the multiple-choice questions and moderately reliable results within the treatment planning portion of the examination. In addition, the item analysis found gaps in students' abilities to transfer clinical evidence/data to basic biomedical knowledge as demonstrated through the multiple-choice questioning results. This outcome warrants further investigation of the utility of the m-OSCE, with a focus on modifications to the evaluation questions, grading rubric, and patient case.

  9. Prevention and early intervention for behaviour problems in children with developmental disabilities.

    PubMed

    Einfeld, Stewart L; Tonge, Bruce J; Clarke, Kristina S

    2013-05-01

    To review the recent evidence regarding early intervention and prevention studies for children with developmental disabilities and behaviour problems from 2011 to 2013. Recent advances in the field are discussed and important areas for future research are highlighted. Recent reviews and studies highlight the utility of antecedent interventions and skills training interventions for reducing behaviour problems. There is preliminary evidence for the effectiveness of parent training interventions when delivered in minimally sufficient formats or in clinical settings. Two recent studies have demonstrated the utility of behavioural interventions for children with genetic causes of disability. Various forms of behavioural and parent training interventions are effective at reducing the behaviour problems in children with developmental disabilities. However, research on prevention and early intervention continues to be relatively scarce. Further large-scale dissemination studies and effectiveness studies in clinical or applied settings are needed.

  10. Impact of an emergency department pain management protocol on the pattern of visits by patients with sickle cell disease.

    PubMed

    Givens, Melissa; Rutherford, Cynthia; Joshi, Girish; Delaney, Kathleen

    2007-04-01

    This study explores how implementation of pain management guidelines in concert with clinic case management affected emergency department (ED) utilization, clinic visits, and hospital admissions for patients with sickle cell disease. A pain management guideline that eliminated meperidine and encouraged timely use of morphine or hydromorphone for pain control in sickle cell crisis was introduced as a quality improvement project. This study is a retrospective review of ED visits, clinic visits, and admissions from 1 year before and 3 years after the guideline implementation. Working with the ED, the Hematology Clinic began to proactively seek the return of their patients for clinic follow-up. A formal case management program for sickle cell patients was initiated in June 2003. A total of 1584 visits by 223 patients were collected, 1097 to the ED and 487 to the Hematology Clinic. Total hospital visits did not change significantly in any of the 4 years, p > 0.10 for each comparison. Total ED visits decreased significantly over the 4-year study period (p < 0.001), whereas clinic visits steadily increased (p < 0.001). Return visits to the ED within 30 days also declined significantly, p < 0.001. Both the absolute number of admissions per year and the total admissions per hospital visit per year declined significantly over the study period, p = 0.001. Although total admissions per hospital visit did not change, the proportion of ED visits that resulted in admission in year 1 (29%) was significantly lower than the proportion admitted in year 2 (43%), p = 0.04. A pain protocol using morphine or hydromorphone coupled with increased access to outpatient clinics decreased ED visits, hospitalizations, and increased utilization of a more stable primary care clinic setting by patients with sickle cell disease.

  11. Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

    PubMed

    Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

    2016-04-01

    The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

  12. Examination of the Korean Modified Checklist of Autism in Toddlers: Item Response Theory

    ERIC Educational Resources Information Center

    Seung, HyeKyeung; Ji, Juye; Kim, Soo-Jin; Sung, Inkyung; Youn, Young-Ah; Hong, Gyunghun; Lee, Hyeonjin; Lee, Young Hwan; Lee, Hyunsuk; Youm, Hyun Kyung

    2015-01-01

    The study examined the clinical utility and psychometric properties of the Korean Modified Checklist of Autism in Toddlers (K-M-CHAT)-2. A sample of 2300 parents of 16- to 36-month-old children was recruited across South Korea. A phone interview was utilized to follow up with participants who initially screened positive for autism spectrum…

  13. A Multimethod Assessment of Juvenile Psychopathy: Comparing the Predictive Utility of the PCL:YV, YPI, and NEO PRI

    ERIC Educational Resources Information Center

    Cauffman, Elizabeth; Kimonis, Eva R.; Dmitrieva, Julia; Monahan, Kathryn C.

    2009-01-01

    The current study compares 3 distinct approaches for measuring juvenile psychopathy and their utility for predicting short- and long-term recidivism among a sample of 1,170 serious male juvenile offenders. The assessment approaches compared a clinical interview method (the Psychopathy Checklist: Youth Version [PCL:YV]; Forth, Kosson, & Hare,…

  14. Does the Cultural Formulation Interview for the fifth revision of the diagnostic and statistical manual of mental disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site.

    PubMed

    Aggarwal, Neil K; Desilva, Ravi; Nicasio, Andel V; Boiler, Marit; Lewis-Fernández, Roberto

    2015-01-01

    Cross-cultural mental health researchers often analyze patient explanatory models of illness to optimize service provision. The Cultural Formulation Interview (CFI) is a cross-cultural assessment tool released in May 2013 with DSM-5 to revise shortcomings from the DSM-IV Outline for Cultural Formulation (OCF). The CFI field trial took place in 6 countries, 14 sites, and with 321 patients to explore its feasibility, acceptability, and clinical utility with patients and clinicians. We sought to analyze if and how CFI feasibility, acceptability, and clinical utility were related to patient-clinician communication. We report data from the New York site which enrolled 7 clinicians and 32 patients in 32 patient-clinician dyads. We undertook a data analysis independent of the parent field trial by conducting content analyses of debriefing interviews with all participants (n = 64) based on codebooks derived from frameworks for medical communication and implementation outcomes. Three coders created codebooks, coded independently, established inter-rater coding reliability, and analyzed if the CFI affects medical communication with respect to feasibility, acceptability, and clinical utility. Despite racial, ethnical, cultural, and professional differences within our group of patients and clinicians, we found that promoting satisfaction through the interview, eliciting data, eliciting the patient's perspective, and perceiving data at multiple levels were common codes that explained how the CFI affected medical communication. We also found that all but two codes fell under the implementation outcome of clinical utility, two fell under acceptability, and none fell under feasibility. Our study offers new directions for research on how a cultural interview affects patient-clinician communication. Future research can analyze how the CFI and other cultural interviews impact medical communication in clinical settings with subsequent effects on outcomes such as medication adherence, appointment retention, and health condition.

  15. Does the Cultural Formulation Interview (CFI) for the Fifth Revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site

    PubMed Central

    Aggarwal, Neil K.; DeSilva, Ravi; Nicasio, Andel V.; Boiler, Marit; Lewis-Fernández, Roberto

    2014-01-01

    Objectives Cross-cultural mental health researchers often analyze patient explanatory models of illness to optimize service provision. The Cultural Formulation Interview (CFI) is a cross-cultural assessment tool released in May 2013 with DSM-5 to revise shortcomings from the DSM-IV Outline for Cultural Formulation (OCF). The CFI field trial took place in 6 countries, 14 sites, and with 321 patients to explore its feasibility, acceptability, and clinical utility with patients and clinicians. We sought to analyze if and how CFI feasibility, acceptability, and clinical utility were related to patient-clinician communication. Design We report data from the New York site which enrolled 7 clinicians and 32 patients in 32 patient-clinician dyads. We undertook a data analysis independent of the parent field trial by conducting content analyses of debriefing interviews with all participants (n=64) based on codebooks derived from frameworks for medical communication and implementation outcomes. Three coders created codebooks, coded independently, established inter-rater coding reliability, and analyzed if the CFI affects medical communication with respect to feasibility, acceptability, and clinical utility. Results Despite racial, ethnic, cultural, and professional differences within our group of patients and clinicians, we found that promoting satisfaction through the interview, eliciting data, eliciting the patient’s perspective, and perceiving data at multiple levels were common codes that explained how the CFI affected medical communication. We also found that all but 2 codes fell under the implementation outcome of clinical utility, 2 fell under acceptability, and none fell under feasibility. Conclusion Our study offers new directions for research on how a cultural interview affects patient-clinician communication. Future research can analyze how the CFI and other cultural interviews impact medical communication in clinical settings with subsequent effects on outcomes such as medication adherence, appointment retention, and health condition. PMID:25372242

  16. Controlled trials to improve antibiotic utilization: a systematic review of experience, 1984-2004.

    PubMed

    Parrino, Thomas A

    2005-02-01

    To review the effectiveness of interventions designed to improve antibiotic prescribing patterns in clinical practice and to draw inferences about the most practical methods for optimizing antibiotic utilization in hospital and ambulatory settings. A literature search using online databases for the years 1975-2004 identified controlled trials of strategies for improving antibiotic utilization. Due to variation in study settings and design, quantitative meta-analysis was not feasible. Therefore, a qualitative literature review was conducted. Forty-one controlled trials met the search criteria. Interventions consisted of education, peer review and feedback, physician participation, rewards and penalties, administrative methods, and combined approaches. Social marketing directed at patients and prescribers was effective in varying contexts, as was implementation of practice guidelines. Authorization systems with structured order entry, formulary restriction, and mandatory consultation were also effective. Peer review and feedback were more effective when combined with dissemination of relevant information or social marketing than when used alone. Several practices were effective in improving antibiotic utilization: social marketing, practice guidelines, authorization systems, and peer review and feedback. Online systems providing clinical information, structured order entry, and decision support may be the most promising approach. Further studies, including economic analyses, are needed to confirm or refute this hypothesis.

  17. Health care access and utilization patterns in unstably housed HIV-infected individuals in New York City.

    PubMed

    Cunningham, Chinazo O; Sohler, Nancy L; McCoy, Kate; Heller, Daliah; Selwyn, Peter A

    2005-10-01

    As part of a multisite initiative to evaluate outreach targeting underserved HIV-infected individuals, we describe baseline characteristics of unstably housed HIV-infected individuals from New York City, and their health care access and utilization patterns. Interviews with 150 HIV-infected single room occupancy (SRO) hotel residents on health care access and utilization, barriers to accessing health care, demographic characteristics, history of incarceration, severity of HIV disease, depressive symptoms, substance use, and exposure to violence were conducted. Most participants were 40 years of age or older, male, black or Latino, had public insurance, a history of substance use, depressive symptoms, and a CD4(+) count above 200 cells/mm(3). Access to and utilization of care was high with 91% reporting having a regular provider, 95% identifying a non-emergency department (ED) clinic or office as their usual location of care, 89% reporting at least one ambulatory visit, and 82% reporting optimal (>/=2) ambulatory visits during the previous 6 months. Additionally, 45% reported at least one ED visit, and 30% at least one hospitalization within the previous 6 months. Among black and Latino marginalized SRO hotel residents in New York City, this study found surprisingly high measures of access to and utilization of ambulatory care services, along with high use of acute care services. Understanding HIV-related health services access and utilization patterns among marginalized populations is essential to improve their HIV care. These patterns of high levels of access to and utilization of health care services contradict clinical experiences and other studies, and require further exploration.

  18. Contemporary Trends of the Epidemiology, Clinical Characteristics, and Resource Utilization of Necrotizing Fasciitis in Texas: A Population-Based Cohort Study

    PubMed Central

    Oud, Lavi; Watkins, Phillip

    2015-01-01

    Introduction. There are limited population-level reports on the contemporary trends of the epidemiology, clinical features, resource utilization, and outcomes of necrotizing fasciitis (NF). Methods. We conducted a cohort study of Texas inpatient population, identifying hospitalizations with a diagnosis of NF during the years 2001–2010. The incidence, clinical features, resource utilization, and outcomes of NF hospitalizations were examined. Results. There were 12,172 NF hospitalizations during study period, with ICU admission in 50.3%. The incidence of NF rose 2.7%/year (P = 0.0001). Key changes between 2001-2002 and 2009-2010 included rising incidence of NF (5.9 versus 7.6 per 100,000 [P < 0.0001]), chronic comorbidities (69.4% versus 76.7% [P < 0.0001]), and development of ≥1 organ failure (28.5% versus 51.7% [P < 0.0001]). Inflation-adjusted hospital charges rose 37% (P < 0.0001). Hospital mortality (9.3%) remained unchanged during study period. Discharges to long-term care facilities rose from 12.2 to 30% (P < 0.0001). Conclusions. The present cohort of NF is the largest reported to date. There has been increasing incidence, chronic illness, and severity of illness of NF over the past decade, with half of NF hospitalizations admitted to ICU. Hospital mortality remained unchanged, while need for long-term care rose nearly 2.5-fold among survivors, suggesting increasing residual morbidity. The sources of the observed findings require further study. PMID:25893115

  19. Music therapists' research activity and utilization barriers: a survey of the membership.

    PubMed

    Waldon, Eric G

    2015-01-01

    Music therapists have access to a rapidly expanding body of research supporting the use of music-based interventions. What is not known is the extent to which music therapists access these resources and what factors may prevent them from incorporating research findings into clinical work. After constructing the Music Therapists' Research Activity and Utilization Barrier (MTRAUB) database, the purposes of this study involved: assessing the extent to which American Music Therapy Association (AMTA) members engage in certain research-related activities; and identifying respondents' perceived barriers to integrating research into clinical practice. This study employed a quantitative, non-experimental approach using an online survey. Respondents included professional, associate, student/graduate student, retired, inactive, and honorary life members of AMTA. Instrumentation involved a researcher-designed Background Questionnaire as well as the Barriers to Research Utilization Scale (BARRIERS; Funk, Champagne, Wiese, & Tornquist, 1991), a tool designed to assess perceived barriers to incorporating research into practice. Of the 3,194 survey invitations distributed, 974 AMTA members replied (a response rate of 30%). Regarding research-related activities, descriptive findings indicate that journal reading is the most frequently reported research-related activity while conducting research is the least frequently reported activity. Results from the BARRIERS Scale indicated that Organizational and Communication factors are perceived as interfering most prominently with the ability to utilize research in clinical practice. Findings suggest that research-related activity and perceived barriers vary as a function of educational attainment, work setting, and occupational role. The author discusses these differential findings in detail, suggests supportive mechanisms to encourage increased research activity and utilization, and offers recommendations for further analysis of the MTRAUB data. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. A Community-Wide Perspective into Changing Trends in the Utilization of Diagnostic and Interventional Procedures in Patients Hospitalized with Acute Myocardial Infarction

    PubMed Central

    Hahn, Jessica; Lessard, Darleen; Yarzebski, Jorge; Goldberg, Jordan; Pruell, Sean; Spencer, Frederick A.; Gore, Joel M.; Goldberg, Robert J.

    2007-01-01

    Background Limited data are available describing contemporary trends in the utilization of diagnostic and interventional procedures in patients hospitalized with acute myocardial infarction (AMI). The objectives of our population-based investigation were to examine long-term trends (1986–2003) in the utilization of cardiac catheterization, percutaneous coronary interventions (PCI), and coronary artery bypass graft surgery (CABG) in a community sample of patients hospitalized with AMI. We examined the demographic and clinical characteristics of patients who received these diagnostic and interventional procedures and determined whether the profile of patients undergoing these procedures had changed over time. Methods The study sample consisted of 9,422 greater Worcester (MA) residents hospitalized with confirmed AMI at all metropolitan Worcester medical centers in 10 annual periods between 1986 and 2003. Information on patient demographics, clinical course, and treatment practices was obtained through the review of hospital medical records. Results Marked increases were observed in the utilization of cardiac catheterization (18.4% to 55.8%) and PCI (2.0% to 42.1%) between 1986 and 2003, respectively. Utilization of CABG showed modest increases in the early 1990's while its use was relatively stable thereafter. Several demographic and clinical characteristics were associated with the receipt of these diagnostic and interventional procedures. Conclusions The results of this study of patients hospitalized with AMI in a large Northeast community suggest evolving trends in the use of cardiac catheterization, PCI, and CABG. Despite these changing patterns, our findings suggest that there remains room for improvement in the therapeutic management of patients hospitalized with AMI, including certain high risk groups. PMID:17383299

  1. Maraviroc Observational Study: The Impact of Expanded Resistance Testing and Clinical Considerations for Antiretroviral Regimen Selection in Treatment-Experienced Patients

    PubMed Central

    Wilkins, Sara-Anne; Tamhane, Ashutosh; Nevin, Christa R.; Mugavero, Michael J.; Raper, James L.; Napolitano, Laura A.; Saag, Michael S.

    2013-01-01

    Abstract Maraviroc (MVC) use has trailed that of other post-2006 antiretroviral therapy (ART) options for treatment-experienced patients. We explored the impact of free tropism testing on MVC utilization in our cohort and explored barriers to MVC utilization. The Maraviroc Outcomes Study (MOS) is an investigator-initiated industry-sponsored trial where consecutive ART-experienced patients receiving routine care with viral loads ≥1,000 copies/ml, and whose provider requested resistance testing and received standardized resistance testing (SRT; phenotype, genotype, coreceptor/tropism). Sociodemographic, clinical, and ART characteristics of those receiving SRT were compared to a historical cohort (HC). Subsequently, providers were surveyed regarding factors influencing selection of salvage ART therapy. The HC (n=165) had resistance testing 7/08–9/09, while prospective SRT (n=83) patients were enrolled 9/09–8/10. In the HC, 92% had genotypes, 2% had tropism assays, and 62% (n=102) changed ART after resistance testing (raltegravir 37%, etravirine 25%, darunavir 24%, MVC 1%). In the SRT cohort, 57% (n=48) changed regimens after standardized resistance testing (darunavir 48%, raltegravir 40%, and etravirine 19%). CCR5-tropic virus was identified in 43% of the SRT group, and MVC was used in 10% [or 20% of R5 tropic patients who underwent a subsequent regimen change (n=25)], a statistically significant (p=0.01) increase in utilization. The factors most strongly influencing utilization were unique patient circumstances (60%), clinical experience (55%), and potential side effects (40%). The addition of routine tropism testing to genotypic/phenotypic testing was associated with increased MVC utilization, raising the possibility that tropism testing may present a barrier to MVC use; however, additional barriers exist, and merit further evaluation. PMID:22881368

  2. Impact of a complex chronic care patient case conference on quality and utilization.

    PubMed

    Weppner, William G; Davis, Kyle; Tivis, Rick; Willis, Janet; Fisher, Amber; King, India; Smith, C Scott

    2018-05-23

    There is need for effective venues to allow teams to coordinate care for high-risk or high-need patients. In addition, health systems need to assess the impact of such approaches on outcomes related to chronic health conditions and patient utilization. We evaluate the clinical impact of a novel case conference involving colocated trainees and supervisors in an interprofessional academic primary care clinic. The study utilized a prospective cohort with control group. Intervention patients (N = 104) were matched with controls (N = 104) from the same provider's panel using propensity scores based on age, gender, risk predictors, and prior utilization patterns. Clinical outcomes and subsequent utilization patterns were compared prior to and up to 6 months following the conference. In terms of utilization, intervention patients demonstrated increased visits with primary care team members (p = .0002) compared with controls, without a corresponding increase in the number of primary care providers' visits. There was a trend towards decreased urgent care and emergency visits (p = .07) and a significant decrease in the rate of hospitalizations (p = .04). Patients with poorly-controlled hypertension saw significant decreases in mean systolic blood pressure from 167 to 146 mm Hg. However, there were no differences between the intervention and control groups. Intervention patients with diabetes demonstrated a nonsignificant trend towards decreased hemoglobin A1c from 9.8 to 9.4, when compared with controls. Interprofessional case conferences have potential to improve care coordination and may be associated with improved disease management, decreased unplanned care, and overall reduced hospitalizations.

  3. Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

    PubMed

    Park, Yu Rang; Yoon, Young Jo; Koo, HaYeong; Yoo, Soyoung; Choi, Chang-Min; Beck, Sung-Ho; Kim, Tae Won

    2018-04-24

    Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws. ©Yu Rang Park, Young Jo Yoon, HaYeong Koo, Soyoung Yoo, Chang-Min Choi, Sung-Ho Beck, Tae Won Kim. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.04.2018.

  4. Evaluating the MEDLINE Core Clinical Journals filter: data-driven evidence assessing clinical utility.

    PubMed

    Klein-Fedyshin, Michele; Ketchum, Andrea M; Arnold, Robert M; Fedyshin, Peter J

    2014-12-01

    MEDLINE offers the Core Clinical Journals filter to limit to clinically useful journals. To determine its effectiveness for searching and patient-centric decision making, this study compared literature used for Morning Report in Internal Medicine with journals in the filter. An EndNote library with references answering 327 patient-related questions during Morning Report from 2007 to 2012 was exported to a file listing variables including designated Core Clinical Journal, Impact Factor, date used and medical subject. Bradford's law of scattering was applied ranking the journals and reflecting their clinical utility. Recall (sensitivity) and precision of the Core Morning Report journals and non-Core set was calculated. This study applied bibliometrics to compare the 628 articles used against these criteria to determine journals impacting decision making. Analysis shows 30% of clinically used articles are from the Core Clinical Journals filter and 16% of the journals represented are Core titles. When Bradford-ranked, 55% of the top 20 journals are Core. Articles <5 years old furnish 63% of sources used. Among the 63 Morning Report subjects, 55 have <50% precision and 41 have <50% recall including 37 subjects with 0% precision and 0% recall. Low usage of publications within the Core Clinical Journals filter indicates less relevance for hospital-based care. The divergence from high-impact medicine titles suggests clinically valuable journals differ from academically important titles. With few subjects demonstrating high recall or precision, the MEDLINE Core Clinical Journals filter may require a review and update to better align with current clinical needs. © 2014 John Wiley & Sons, Ltd.

  5. Perceptions of the Importance and Utilization of Clinical Supervision among Certified Rural School Counselors

    ERIC Educational Resources Information Center

    Duncan, Kelly; Brown-Rice, Kathleen; Bardhoshi, Gerta

    2014-01-01

    This study explored rural school counselors' perceptions of clinical supervision. School counselors working in rural communities commonly encounter issues that challenge their ability to provide competent counseling services to the students they serve. School counselors serving in these areas are often the only rural mental health provider in…

  6. Trends in Handheld Computing Among Medical Students

    PubMed Central

    Grasso, Michael A.; Yen, M. Jim; Mintz, Matthew L.

    2005-01-01

    The purpose of this study was to identify trends in the utilization and acceptance of handheld computers (personal digital assistants) among medical students during preclinical and clinical training. These results can be used to identify differences between preclinical and clinical users, differences between current use and idealized use, and perceived limitations of these devices. PMID:16779255

  7. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.

    PubMed

    Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

    2014-12-01

    The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. NCT02209116. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial

    PubMed Central

    Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

    2014-01-01

    Introduction The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. Methods and analysis This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. Ethics and dissemination The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. Trial registration number NCT02209116. PMID:25448628

  9. Questionnaire-based assessment of executive functioning: Case studies.

    PubMed

    Kronenberger, William G; Castellanos, Irina; Pisoni, David B

    2018-01-01

    Delays in the development of executive functioning skills are frequently observed in pediatric neuropsychology populations and can have a broad and significant impact on quality of life. As a result, assessment of executive functioning is often relevant for the development of formulations and recommendations in pediatric neuropsychology clinical work. Questionnaire-based measures of executive functioning behaviors in everyday life have unique advantages and complement traditional neuropsychological measures of executive functioning. Two case studies of children with spina bifida are presented to illustrate the clinical use of a new questionnaire measure of executive and learning-related functioning, the Learning, Executive, and Attention Functioning Scale (LEAF). The LEAF emphasizes clinical utility in assessment by incorporating four characteristics: brevity in administration, breadth of additional relevant content, efficiency of scoring and interpretation, and ease of availability for use. LEAF results were consistent with another executive functioning checklist in documenting everyday behavior problems related to working memory, planning, and organization while offering additional breadth of assessment of domains such as attention, processing speed, and novel problem-solving. These case study results demonstrate the clinical utility of questionnaire-based measurement of executive functioning in pediatric neuropsychology and provide a new measure for accomplishing this goal.

  10. Pathways from Autism Spectrum Disorder (ASD) Diagnosis to Genetic Testing

    PubMed Central

    Barton, Krysta S.; Tabor, Holly K.; Starks, Helene; Garrison, Nanibaa’ A.; Laurino, Mercy; Burke, Wylie

    2017-01-01

    Purpose This study examines challenges faced by families and health providers related to genetic testing for autism spectrum disorder (ASD). Methods This qualitative study of 14 parents and 15 health providers identified an unstandardized three-step process for families who pursue ASD genetic testing. Results Step 1 is the clinical diagnosis of ASD, confirmed by providers practicing alone or in a team. Step 2 is the offer of genetic testing to find an etiology. For those offered testing, step 3 involves the parents’ decision whether to pursue testing. Despite professional guidelines and recommendations, interviews describe considerable variability in approaches to genetic testing for ASD, a lack of consensus among providers, and questions about clinical utility. Many families in our study were unaware of the option for genetic testing; testing decisions by parents appear to be influenced by both provider recommendations and insurance coverage. Conclusion Consideration of genetic testing for ASD should take into account different views about the clinical utility of testing and variability in insurance coverage. Ideally, policy makers from the range of clinical specialties involved in ASD care should revisit policies to clarify the purpose of genetic testing for ASD and promote consensus about its appropriate use. PMID:29048417

  11. Assessment of perceptions of clinical management in courses oriented by competency.

    PubMed

    Gomes, Romeu; Padilha, Roberto de Queiroz; Lima, Valéria Vernaschi; Silva, Cosme Marcelo Furtado Passos da

    2018-01-01

    The study aims to assess perceptions of mastery of abilities in clinical management in participants of courses oriented by competency and based on active methodologies of teaching and learning, before and after the offered training process. Three conceptual frameworks were utilized: clinical management, expectation of auto-efficacy, and the holistic concept of competency. Methodologically, an electronic instrument was made available to students of the training courses, adapted to the Likert scale, in two stages: before the courses were undertaken and after their completion. The group of subjects that participated simultaneously in both stages was comprised of 825 trainees. Average, mean, standard deviation, and the Wilcoxon test were utilized in the analysis. Generally, in terms of findings, the perception of mastery of abilities in clinical management increased after the courses, proving a positive contribution of the training process of the students. Among other aspects of their results, it is concluded that the educational initiatives studied, oriented by competency and based in active methodologies of teaching and learning, can obtain the increase in perception of their participants regarding the mastery of abilities present in the competency profile, confirming the study's hypothesis.

  12. Health care utilization and costs associated with adherence to clinical practice guidelines for early magnetic resonance imaging among workers with acute occupational low back pain.

    PubMed

    Graves, Janessa M; Fulton-Kehoe, Deborah; Jarvik, Jeffrey G; Franklin, Gary M

    2014-04-01

    To estimate health care utilization and costs associated with adherence to clinical practice guidelines for the use of early magnetic resonance imaging (MRI; within the first 6 weeks of injury) for acute occupational low back pain (LBP). Washington State Disability Risk Identification Study Cohort (D-RISC), consisting of administrative claims and patient interview data from workers' compensation claimants (2002-2004). In this prospective, population-based cohort study, we compared health care utilization and costs among workers whose imaging was adherent to guidelines (no early MRI) to workers whose imaging was not adherent to guidelines (early MRI in the absence of red flags). We identified workers (age>18) with work-related LBP using administrative claims. We obtained demographic, injury, health, and employment information through telephone interviews to adjust for baseline differences between groups. We ascertained health care utilization and costs from administrative claims for 1 year following injury. Of 1,770 workers, 336 (19.0 percent) were classified as nonadherent to guidelines. Outpatient and physical/occupational therapy utilization was 52-54 percent higher for workers whose imaging was not adherent to guidelines compared to workers with guideline-adherent imaging; utilization of chiropractic care was significantly lower (18 percent). Nonadherence to guidelines for early MRI was associated with increased likelihood of lumbosacral injections or surgery and higher costs for out-patient, inpatient, and nonmedical services, and disability compensation. © Health Research and Educational Trust.

  13. Reducing barriers to mental health and social services for Iraq and Afghanistan veterans: outcomes of an integrated primary care clinic.

    PubMed

    Seal, Karen H; Cohen, Greg; Bertenthal, Daniel; Cohen, Beth E; Maguen, Shira; Daley, Aaron

    2011-10-01

    Despite high rates of post-deployment psychosocial problems in Iraq and Afghanistan veterans, mental health and social services are under-utilized. To evaluate whether a Department of Veterans Affairs (VA) integrated care (IC) clinic (established in April 2007), offering an initial three-part primary care, mental health and social services visit, improved psychosocial services utilization in Iraq and Afghanistan veterans compared to usual care (UC), a standard primary care visit with referral for psychosocial services as needed. Retrospective cohort study using VA administrative data. Five hundred and twenty-six Iraq and Afghanistan veterans initiating primary care at a VA medical center between April 1, 2005 and April 31, 2009. Multivariable models compared the independent effects of primary care clinic type (IC versus UC) on mental health and social services utilization outcomes. After 2007, compared to UC, veterans presenting to the IC primary care clinic were significantly more likely to have had a within-30-day mental health evaluation (92% versus 59%, p < 0.001) and social services evaluation [77% (IC) versus 56% (UC), p < 0.001]. This exceeded background system-wide increases in mental health services utilization that occurred in the UC Clinic after 2007 compared to before 2007. In particular, female veterans, younger veterans, and those with positive mental health screens were independently more likely to have had mental health and social service evaluations if seen in the IC versus UC clinic. Among veterans who screened positive for  ≥ 1 mental health disorder(s), there was a median of 1 follow-up specialty mental health visit within the first year in both clinics. Among Iraq and Afghanistan veterans new to primary care, an integrated primary care visit further improved the likelihood of an initial mental health and social services evaluation over background increases, but did not improve retention in specialty mental health services.

  14. Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

    PubMed

    Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J

    2014-03-15

    This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

  15. A decision-support system for the analysis of clinical practice patterns.

    PubMed

    Balas, E A; Li, Z R; Mitchell, J A; Spencer, D C; Brent, E; Ewigman, B G

    1994-01-01

    Several studies documented substantial variation in medical practice patterns, but physicians often do not have adequate information on the cumulative clinical and financial effects of their decisions. The purpose of developing an expert system for the analysis of clinical practice patterns was to assist providers in analyzing and improving the process and outcome of patient care. The developed QFES (Quality Feedback Expert System) helps users in the definition and evaluation of measurable quality improvement objectives. Based on objectives and actual clinical data, several measures can be calculated (utilization of procedures, annualized cost effect of using a particular procedure, and expected utilization based on peer-comparison and case-mix adjustment). The quality management rules help to detect important discrepancies among members of the selected provider group and compare performance with objectives. The system incorporates a variety of data and knowledge bases: (i) clinical data on actual practice patterns, (ii) frames of quality parameters derived from clinical practice guidelines, and (iii) rules of quality management for data analysis. An analysis of practice patterns of 12 family physicians in the management of urinary tract infections illustrates the use of the system.

  16. Neurophysiology of the pelvic floor in clinical practice: a systematic literature review

    PubMed Central

    Bianchi, Francesca; Squintani, Giovanna Maddalena; Osio, Maurizio; Morini, Alberto; Bana, Cristina; Ardolino, Gianluca; Barbieri, Sergio; Bertolasi, Laura; Caramelli, Riccardo; Cogiamanian, Filippo; Currà, Antonio; de Scisciolo, Giuseppe; Foresti, Camillo; Frasca, Vittorio; Frasson, Emma; Inghilleri, Maurizio; Maderna, Luca; Motti, Luisa; Onesti, Emanuela; Romano, Marcello Calogero; Del Carro, Ubaldo

    2017-01-01

    Summary Neurophysiological testing of the pelvic floor is recognized as an essential tool to identify pathophysiological mechanisms of pelvic floor disorders, support clinical diagnosis, and aid in therapeutic decisions. Nevertheless, the diagnostic value of these tests in specific neurological diseases of the pelvic floor is not completely clarified. Seeking to fill this gap, the members of the Neurophysiology of the Pelvic Floor Study Group of the Italian Clinical Neurophysiology Society performed a systematic review of the literature to gather available evidence for and against the utility of neurophysiological tests. Our findings confirm the utility of some tests in specific clinical conditions [e.g. concentric needle electromyography, evaluation of sacral reflexes and of pudendal somatosensory evoked potentials (pSEPs) in cauda equina and conus medullaris lesions, and evaluation of pSEPs and perineal sympathetic skin response in spinal cord lesions], and support their use in clinical practice. Other tests, particularly those not currently supported by high-level evidence, when employed in individual patients, should be evaluated in the overall clinical context, or otherwise used for research purposes.

  17. Medicare long-term CPAP coverage policy: a cost-utility analysis.

    PubMed

    Billings, Martha E; Kapur, Vishesh K

    2013-10-15

    CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. Cost-utility and cost-effectiveness analysis. U.S. Medicare Population. N/A. N/A. We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs $30,544 more per QALY. Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change.

  18. A CAD system and quality assurance protocol for bone age assessment utilizing digital hand atlas

    NASA Astrophysics Data System (ADS)

    Gertych, Arakadiusz; Zhang, Aifeng; Ferrara, Benjamin; Liu, Brent J.

    2007-03-01

    Determination of bone age assessment (BAA) in pediatric radiology is a task based on detailed analysis of patient's left hand X-ray. The current standard utilized in clinical practice relies on a subjective comparison of the hand with patterns in the book atlas. The computerized approach to BAA (CBAA) utilizes automatic analysis of the regions of interest in the hand image. This procedure is followed by extraction of quantitative features sensitive to skeletal development that are further converted to a bone age value utilizing knowledge from the digital hand atlas (DHA). This also allows providing BAA results resembling current clinical approach. All developed methodologies have been combined into one CAD module with a graphical user interface (GUI). CBAA can also improve the statistical and analytical accuracy based on a clinical work-flow analysis. For this purpose a quality assurance protocol (QAP) has been developed. Implementation of the QAP helped to make the CAD more robust and find images that cannot meet conditions required by DHA standards. Moreover, the entire CAD-DHA system may gain further benefits if clinical acquisition protocol is modified. The goal of this study is to present the performance improvement of the overall CAD-DHA system with QAP and the comparison of the CAD results with chronological age of 1390 normal subjects from the DHA. The CAD workstation can process images from local image database or from a PACS server.

  19. Health anxiety and medical utilization: The moderating effect of age among patients in primary care.

    PubMed

    Fergus, Thomas A; Griggs, Jackson O; Cunningham, Scott C; Kelley, Lance P

    2017-10-01

    Health anxiety is commonly seen in medical clinics and is related to the overutilization of primary care services, but existing studies have not yet considered the possible moderating effect of age. We examined if age moderated the association between health anxiety and medical utilization. A secondary aim was to examine potential racial/ethnic differences in health anxiety. An ethnoracially diverse group of patients (N=533) seeking treatment from a primary care clinic completed a self-report measure of health anxiety. Three indices of medical utilization were assessed using medical records, including the number of: (a) clinic visits over the past two years, (b) current medications, and (c) lab tests over the past two years. Age moderated the effect of health anxiety on multiple indices of medical utilization. Supplemental analyses found that the moderating effect of age was specific to a somatic/body preoccupation, rather than health worry, dimension of health anxiety. Mean-level differences in health anxiety were either not supported (health anxiety composite, somatic/body preoccupation) or were small in magnitude (health worry) among self-identifying Black, Latino, and White participants. Results indicate that assessing for health anxiety could be particularly important for older adult patients who frequently seek out medical services. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Optimal threshold estimator of a prognostic marker by maximizing a time-dependent expected utility function for a patient-centered stratified medicine.

    PubMed

    Dantan, Etienne; Foucher, Yohann; Lorent, Marine; Giral, Magali; Tessier, Philippe

    2018-06-01

    Defining thresholds of prognostic markers is essential for stratified medicine. Such thresholds are mostly estimated from purely statistical measures regardless of patient preferences potentially leading to unacceptable medical decisions. Quality-Adjusted Life-Years are a widely used preferences-based measure of health outcomes. We develop a time-dependent Quality-Adjusted Life-Years-based expected utility function for censored data that should be maximized to estimate an optimal threshold. We performed a simulation study to compare estimated thresholds when using the proposed expected utility approach and purely statistical estimators. Two applications illustrate the usefulness of the proposed methodology which was implemented in the R package ROCt ( www.divat.fr ). First, by reanalysing data of a randomized clinical trial comparing the efficacy of prednisone vs. placebo in patients with chronic liver cirrhosis, we demonstrate the utility of treating patients with a prothrombin level higher than 89%. Second, we reanalyze the data of an observational cohort of kidney transplant recipients: we conclude to the uselessness of the Kidney Transplant Failure Score to adapt the frequency of clinical visits. Applying such a patient-centered methodology may improve future transfer of novel prognostic scoring systems or markers in clinical practice.

  1. The Scientific Foundation for Personal Genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention Multidisciplinary Workshop

    PubMed Central

    Khoury, Muin J.; McBride, Colleen M.; Schully, Sheri D.; Ioannidis, John P. A.; Feero, W. Gregory; Janssens, A. Cecile J. W.; Gwinn, Marta; Simons-Morton, Denise G.; Bernhardt, Jay M.; Cargill, Michele; Chanock, Stephen J.; Church, George M.; Coates, Ralph J.; Collins, Francis S.; Croyle, Robert T.; Davis, Barry R.; Downing, Gregory J.; DuRoss, Amy; Friedman, Susan; Gail, Mitchell H.; Ginsburg, Geoffrey S.; Green, Robert C.; Greene, Mark H.; Greenland, Philip; Gulcher, Jeffrey R.; Hsu, Andro; Hudson, Kathy L.; Kardia, Sharon L. R.; Kimmel, Paul L.; Lauer, Michael S.; Miller, Amy M.; Offit, Kenneth; Ransohoff, David F.; Roberts, J. Scott; Rasooly, Rebekah S.; Stefansson, Kari; Terry, Sharon F.; Teutsch, Steven M.; Trepanier, Angela; Wanke, Kay L.; Witte, John S.; Xu, Jianfeng

    2010-01-01

    The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed. PMID:19617843

  2. Cardiac magnetic resonance in hypertrophic cardiomyopathy: current state of the art.

    PubMed

    Kwon, Deborah H; Desai, Milind Y

    2010-01-01

    Hypertrophic cardiomyopathy is a complex disorder with significant heterogeneity in clinical characteristics and natural history. Traditionally, the diagnosis has been based on clinical assessment and echocardiography; however, persistent challenges in its noninvasive evaluation remain. Hence, improved diagnostic techniques could lead to better risk stratification of patients, which would potentially identify patients likely to benefit from effective therapies. Recent studies have demonstrated the increasing utility of cardiac magnetic resonance in the management of this disease. With the increasing utilization of genetics, cardiac magnetic resonance is likely to play an even more important role in discerning the subtle morphologic differences seen in such patients with similar genotypic profiles.

  3. Evaluation of the utility of cephalometric parameters in constructing complete denture. Part I: placement of posterior teeth.

    PubMed

    Bassi, F; Deregibus, A; Previgliano, V; Bracco, P; Preti, G

    2001-03-01

    Various types of parameters, including cephalometric ones, have been used in the construction of complete denture. This study aimed to evaluate the utility of cephalometric parameters for this purpose. The position of the posterior teeth in a group of 42 edentulous patients, successfully rehabilitated with complete denture according to clinical parameters, was evaluated by cephalometrics. The following were determined: vertical dimension of occlusion (VDO); orientation of the occlusal plane; and subdivision of the denture space. The cephalometric parameters do not correspond to the clinical positioning of the posterior teeth in successful rehabilitation with complete denture.

  4. Transformative learning and research utilization in nursing practice: a missing link?

    PubMed

    Matthew-Maich, Nancy; Ploeg, Jenny; Jack, Susan; Dobbins, Maureen

    2010-03-01

    Poor or inconsistent research utilization into clinical practice is a recurrent theme across study contexts, rendering leaders disillusioned with how best to foster the uptake of research into nursing practice. This makes it imperative to look to new approaches. Research utilization involves a learning process engaging attitudes, beliefs, and behaviors; yet, this is often overlooked in approaches and models used to facilitate research use. This oversight may offer some explanation to the limited progress in research utilization to date. Transformation Theory offers an explanatory theory and specific strategies (critical reflection and critical discourse) to explore attitudes, beliefs, and behaviors so that they are understood, validated, and can better guide actions. The purpose of this article was to explore what Transformation Theory can contribute to research utilization initiatives in nursing practice. Transformation Theory and transformative learning strategies are discussed and critically analyzed in consideration of their potential roles in fostering research utilization in clinical nursing practice. (1) Research utilization is a learning process that involves knowledge, skills, feelings, attitudes, and beliefs. (2) Transformative learning strategies of critical reflection and discourse can facilitate insight into experiences, finding shared meanings among groups of people, and understanding/validating beliefs, attitudes, and feelings so they can more consciously guide future actions. This dimension is frequently neglected in research utilization efforts. (3) In combination with research utilization theories, Transformation Theory may be a missing link to make research utilization initiatives more effective in rendering and sustaining nursing practice change, thus enhancing client care and well-being. (4) Research and further consideration are both warranted and needed.

  5. Measurement properties of the upright motor control test for adults with stroke: a systematic review.

    PubMed

    Gorgon, Edward James R; Lazaro, Rolando T

    2016-01-01

    The Upright Motor Control Test (UMCT) has been used in clinical practice and research to assess functional strength of the hemiparetic lower limb in adults with stroke. It is unclear if evidence is sufficient to warrant its use. The purpose of this systematic review was to synthesize available evidence on the measurement properties of the UMCT for stroke rehabilitation. Electronic databases that indexed biomedical literature were systematically searched from inception until October 2015 (week 4): Embase, PubMed, Web of Science, CINAHL, PEDro, Cochrane Library, Scopus, ScienceDirect, SPORTDiscus, LILACS, DOAJ, and Google Scholar. All studies that had used the UMCT in the time period covered underwent hand searching for any additional study. Observational studies involving adults with stroke that explored any measurement property of the UMCT were included. The COnsensus-based Standards for the selection of health Measurement INstruments was used to assess the methodological quality of included studies. The CanChild Outcome Measures Rating Form was used for extracting data on measurement properties and clinical utility. The search yielded three methodologic studies that addressed criterion-related validity and contruct validity. Two studies of fair methodological quality demonstrated moderate-level evidence that Knee Extension and Knee Flexion subtest scores were predictive of community-level and household-level ambulation. One study of fair methodological quality provided limited-level evidence for the correlation of Knee Extension subtest scores with a laboratory measure of ground reaction forces. No published studies formally assessed reliability, responsiveness, or clinical utility. Limited information on responsiveness and clinical utility dimensions could be inferred from the included studies. The UMCT is a practical assessment tool for voluntary control or functional strength of the hemiparetic lower limb in standing in adults with stroke. Although different levels of evidence suggest that the Knee Extension and Knee Flexion subtests may possess criterion and construct validity, the lack of published literature examining content validity, reliability, and responsiveness raises questions regarding the use of the UMCT in routine clinical practice. These key findings highlight the need to further investigate the UMCT's measurement properties toward enhancing its standardization.

  6. Mayo Registry for Telemetry Efficacy in Arrest Study: An Assessment of the Utility of Telemetry in Predicting Clinical Decompensation.

    PubMed

    Snipelisky, David; Ray, Jordan; Matcha, Gautam; Roy, Archana; Harris, Dana; Bosworth, Veronica; Dumitrascu, Adrian; Clark, Brooke; Vadeboncoeur, Tyler; Kusumoto, Fred; Bowman, Cammi; Burton, M Caroline

    2018-03-01

    Our study assesses the utility of telemetry in identifying decompensation in patients with documented cardiopulmonary arrest. A retrospective review of inpatients who experienced a cardiopulmonary arrest from May 1, 2008, until June 30, 2014, was performed. Telemetry records 24 hours prior to and immediately preceding cardiopulmonary arrest were reviewed. Patient subanalyses based on clinical demographics were made as well as analyses of survival comparing patients with identifiable rhythm changes in telemetry to those without. Of 242 patients included in the study, 75 (31.0%) and 110 (45.5%) experienced telemetry changes at the 24-hour and immediately preceding time periods, respectively. Of the telemetry changes, the majority were classified as nonmalignant (n = 50, 66.7% and n = 66, 55.5% at 24 hours prior and immediately preceding, respectively). There was no difference in telemetry changes between intensive care unit (ICU) and non-ICU patients and among patients stratified according to the American Heart Association telemetry indications. There was no difference in survival when comparing patients with telemetry changes immediately preceding and at 24 hours prior to an event (n = 30, 27.3% and n = 15, 20.0%) to those without telemetry changes during the same periods (n = 27, 20.5% and n = 42, 25.2%; P = .22 and .39). Telemetry has limited utility in predicting clinical decompensation in the inpatient setting.

  7. Novel Signs and Their Clinical Utility in Diagnosing Complex Regional Pain Syndrome (CRPS): A Prospective Observational Cohort Study.

    PubMed

    Kuttikat, Anoop; Shaikh, Maliha; Oomatia, Amin; Parker, Richard; Shenker, Nicholas

    2017-06-01

    Delays in diagnosis occur with complex regional pain syndrome (CRPS). We define and prospectively demonstrate that novel bedside tests measuring body perception disruption can identify patients with CRPS postfracture. The objectives of our study were to define and validate 4 bedside tests, to identify the prevalence of positive tests in patients with CRPS and other chronic pain conditions, and to assess the clinical utility (sensitivity, specificity, positive predictive value, negative predictive value) for identifying CRPS within a Fracture cohort. This was a single UK teaching hospital prospective cohort study with 313 recruits from pain-free volunteers and patients with chronic pain conditions.Four novel tests were Finger Perception (FP), Hand Laterality identification (HL), Astereognosis (AS), and Body Scheme (BS) report. Five questionnaires (Brief Pain Inventory, Upper Extremity Functional Index, Lower Extremity Functional Index, Neglect-like Symptom Questionnaire, Hospital Anxiety and Depression Score) assessed the multidimensional pain experience. FP and BS were the best performing tests. Prospective monitoring of fracture patients showed that out of 7 fracture patients (total n=47) who had both finger misperception and abnormal BS report at initial testing, 3 developed persistent pain with 1 having a formal diagnosis of CRPS. Novel signs are reliable, easy to perform, and present in chronic pain patients. FP and BS have significant clinical utility in predicting persistent pain in a fracture group thereby allowing targeted early intervention.

  8. Cost utility analysis of caudal epidural injections in the treatment of lumbar disc herniation, axial or discogenic low back pain, central spinal stenosis, and post lumbar surgery syndrome.

    PubMed

    Manchikanti, Laxmaiah; Falco, Frank J E; Pampati, Vidyasagar; Cash, Kimberly A; Benyamin, Ramsin M; Hirsch, Joshua A

    2013-01-01

    In this era of escalating health care costs and the questionable effectiveness of multiple interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine, and has an influence coverage decisions. Even though multiple cost effectiveness analysis studies have been performed over the years, extensive literature is lacking for interventional techniques. Cost utility analysis studies of epidural injections for managing chronic low back pain demonstrated highly variable results including a lack of cost utility in randomized trials and contrasting results in observational studies. There has not been any cost utility analysis studies of epidural injections in large randomized trials performed in interventional pain management settings. To assess the cost utility of caudal epidural injections in managing chronic low back pain secondary to lumbar disc herniation, axial or discogenic low back pain, lumbar central spinal stenosis, and lumbar post surgery syndrome. This analysis is based on 4 previously published randomized trials. A private, specialty referral interventional pain management center in the United States. Four randomized trials were conducted assessing the clinical effectiveness of caudal epidural injections with or without steroids for lumbar disc herniation, lumbar discogenic or axial low back pain, lumbar central spinal stenosis, and post surgery syndrome. A cost utility analysis was performed with direct payment data for a total of 480 patients over a period of 2 years from these 4 trials. Outcome included various measures with significant improvement defined as at least a 50% improvement in pain reduction and disability status. The results of 4 randomized controlled trials of low back pain with 480 patients with a 2 year follow-up with the actual reimbursement data showed cost utility for one year of quality-adjusted life year (QALY) of $2,206 for disc herniation, $2,136 for axial or discogenic pain without disc herniation, $2,155 for central spinal stenosis, and $2,191 for post surgery syndrome. All patients showed significant improvement clinically and showed positive results in the cost utility analysis with an average cost per one year QALY of $2,172.50 for all patients and $1,966.03 for patients judged to be successful. The results of this assessment show a better cost utility or lower cost of managing chronic, intractable low back pain with caudal epidural injections at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, and surgery in most cases. The limitations of this cost utility analysis include that it is a single center evaluation, even though 480 patients were included in the analysis. Further, only the costs of interventional procedures and physician visits were included. The benefits of returning to work were not assessed.   This cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per one year of QALY.

  9. Health care utilization and outpatient, out-of-pocket costs for active convulsive epilepsy in rural northeastern South Africa: a cross-sectional Survey.

    PubMed

    Wagner, Ryan G; Bertram, Melanie Y; Gómez-Olivé, F Xavier; Tollman, Stephen M; Lindholm, Lars; Newton, Charles R; Hofman, Karen J

    2016-06-28

    Epilepsy is a common neurological disorder, with over 80 % of cases found in low- and middle-income countries (LMICs). Studies from high-income countries find a significant economic burden associated with epilepsy, yet few studies from LMICs, where out-of-pocket costs for general healthcare can be substantial, have assessed out-of-pocket costs and health care utilization for outpatient epilepsy care. Within an established health and socio-demographic surveillance system in rural South Africa, a questionnaire to assess self-reported health care utilization and time spent traveling to and waiting to be seen at health facilities was administered to 250 individuals, previously diagnosed with active convulsive epilepsy. Epilepsy patients' out-of-pocket, medical and non-medical costs and frequency of outpatient care visits during the previous 12-months were determined. Within the last year, 132 (53 %) individuals reported consulting at a clinic, 162 (65 %) at a hospital and 34 (14 %) with traditional healers for epilepsy care. Sixty-seven percent of individuals reported previously consulting with both biomedical caregivers and traditional healers. Direct outpatient, median costs per visit varied significantly (p < 0.001) between hospital (2010 International dollar ($) 9.08; IQR: $6.41-$12.83) and clinic consultations ($1.74; IQR: $0-$5.58). Traditional healer fees per visit were found to cost $52.36 (IQR: $34.90-$87.26) per visit. Average annual outpatient, clinic and hospital out-of-pocket costs totaled $58.41. Traveling to and from and waiting to be seen by the caregiver at the hospital took significantly longer than at the clinic. Rural South Africans with epilepsy consult with both biomedical caregivers and traditional healers for both epilepsy and non-epilepsy care. Traditional healers were the most expensive mode of care, though utilized less often. While higher out-of-pocket costs were incurred at hospital visits, more people with ACE visited hospitals than clinics for epilepsy care. Promoting increased use and effective care at clinics and reducing travel and waiting times could substantially reduce the out-of-pocket costs of outpatient epilepsy care.

  10. Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review

    PubMed Central

    Antoniou, Miranta; Jorgensen, Andrea L; Kolamunnage-Dona, Ruwanthi

    2016-01-01

    Background Personalized medicine is a growing area of research which aims to tailor the treatment given to a patient according to one or more personal characteristics. These characteristics can be demographic such as age or gender, or biological such as a genetic or other biomarker. Prior to utilizing a patient’s biomarker information in clinical practice, robust testing in terms of analytical validity, clinical validity and clinical utility is necessary. A number of clinical trial designs have been proposed for testing a biomarker’s clinical utility, including Phase II and Phase III clinical trials which aim to test the effectiveness of a biomarker-guided approach to treatment; these designs can be broadly classified into adaptive and non-adaptive. While adaptive designs allow planned modifications based on accumulating information during a trial, non-adaptive designs are typically simpler but less flexible. Methods and Findings We have undertaken a comprehensive review of biomarker-guided adaptive trial designs proposed in the past decade. We have identified eight distinct biomarker-guided adaptive designs and nine variations from 107 studies. Substantial variability has been observed in terms of how trial designs are described and particularly in the terminology used by different authors. We have graphically displayed the current biomarker-guided adaptive trial designs and summarised the characteristics of each design. Conclusions Our in-depth overview provides future researchers with clarity in definition, methodology and terminology for biomarker-guided adaptive trial designs. PMID:26910238

  11. Challenges and unanswered questions for the next decade of circulating tumour cell research in lung cancer

    PubMed Central

    Mohan, Sumitra; Chemi, Francesca

    2017-01-01

    Since blood borne circulating tumour cells (CTCs) initially shed from the primary tumour can seed and initiate metastasis at distant sites a better understanding of the biology of CTCs and their dissemination could provide valuable information that could guide therapeutic intervention and real time monitoring of disease progression. Although CTC enumeration has provided a reliable prognostic readout for a number of cancers, including lung cancer, the precise clinical utility of CTCs remains to be established. The rarity of CTCs together with the vanishingly small amounts of nucleic acids present in a single cell as well as cell to cell heterogeneity has stimulated the development of a wide range of powerful cellular and molecular methodologies applied to CTCs. These technical developments are now enabling researchers to focus on understanding the biology of CTCs and their clinical utility as a predictive and pharmacodynamics markers. This review summarises recent advances in the field of CTC research with focus on technical and biological challenges as well the progress made towards clinical utility of characterisation of CTCs with emphasis on studies in lung cancer. PMID:28904889

  12. The utility of pre-test clinical scoring for clinical diagnosis of heparin-induced thrombocytopenia in cardiac surgery patients of a tertiary care centre in north India.

    PubMed

    Sachan, D; Gupta, N; Agarwal, P; Chaudhary, R

    2011-08-01

    Heparin-induced thrombocytopenia (HIT) should be diagnosed clinically as well as by laboratory assays for timely recognition, prevention and management of complications. To evaluate the clinical utility of pre-test clinical scoring system in combination with two immunoassays for the diagnosis of HIT in cardiac surgery patients. A total of 100 consecutive patients undergoing cardiac surgery were studied. Pre-test clinical scoring was carried out in patients with thrombocytopenia and further tested by two immunoassays, i.e., Heparin platelet factor 4 (H-PF4) enzyme-linked immunosorbent assay (ELISA) and particle gel immunoassay (PaGIA). Of the 100 patients studied, 42 patients developed thrombocytopenia post-operatively. On pre-test clinical scoring, low T-score was observed in 6 patients, intermediate in 28 and high score in 8 patients, whereas 19 patients (45.2%) were positive by H-PF4 ELISA and 10 (23.8%) by PaGIA for H-PF4 antibody. The difference in the incidence of clinically significant HIT antibodies in the three categories was statistically significant. A good correlation was also observed with ELISA optical density, T-scoring and PaGIA. Pre-test clinical scoring correlates well with the development of H-PF4 antibodies which are incriminated in the causation of thrombotic complications in patients with HIT. We also propose a protocol for diagnosing patients with clinical suspicion of HIT using pre-test clinical scoring and immunoassay. © 2011 The Authors. Transfusion Medicine © 2011 British Blood Transfusion Society.

  13. Novel joint selection methods can reduce sample size for rheumatoid arthritis clinical trials with ultrasound endpoints.

    PubMed

    Allen, John C; Thumboo, Julian; Lye, Weng Kit; Conaghan, Philip G; Chew, Li-Ching; Tan, York Kiat

    2018-03-01

    To determine whether novel methods of selecting joints through (i) ultrasonography (individualized-ultrasound [IUS] method), or (ii) ultrasonography and clinical examination (individualized-composite-ultrasound [ICUS] method) translate into smaller rheumatoid arthritis (RA) clinical trial sample sizes when compared to existing methods utilizing predetermined joint sites for ultrasonography. Cohen's effect size (ES) was estimated (ES^) and a 95% CI (ES^L, ES^U) calculated on a mean change in 3-month total inflammatory score for each method. Corresponding 95% CIs [nL(ES^U), nU(ES^L)] were obtained on a post hoc sample size reflecting the uncertainty in ES^. Sample size calculations were based on a one-sample t-test as the patient numbers needed to provide 80% power at α = 0.05 to reject a null hypothesis H 0 : ES = 0 versus alternative hypotheses H 1 : ES = ES^, ES = ES^L and ES = ES^U. We aimed to provide point and interval estimates on projected sample sizes for future studies reflecting the uncertainty in our study ES^S. Twenty-four treated RA patients were followed up for 3 months. Utilizing the 12-joint approach and existing methods, the post hoc sample size (95% CI) was 22 (10-245). Corresponding sample sizes using ICUS and IUS were 11 (7-40) and 11 (6-38), respectively. Utilizing a seven-joint approach, the corresponding sample sizes using ICUS and IUS methods were nine (6-24) and 11 (6-35), respectively. Our pilot study suggests that sample size for RA clinical trials with ultrasound endpoints may be reduced using the novel methods, providing justification for larger studies to confirm these observations. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  14. Characteristics of private-sector managed care for mental health and substance abuse treatment.

    PubMed

    Garnick, D W; Hendricks, A M; Dulski, J D; Thorpe, K E; Horgan, C

    1994-12-01

    This study examined diversity during the late 1980s in managed care programs for mental health, alcohol abuse, and drug abuse to identify ways in which research can generate more meaningful data on the effectiveness of utilization review programs. Telephone interviews were conducted with representatives of utilization review programs for employee health insurance plans in 31 firms that employed 2.1 million people in 1990. Questions addressed qualifications of personnel, clinical criteria to authorize care, integration with employee assistance plans, penalties for not complying with utilization review procedures, outpatient review, and carve out of mental health and substance abuse review. Large variations in utilization review programs were found. Programs employed a range of review personnel and used a variety of clinical criteria to authorize care. More than two-thirds did not carve out mental health and substance abuse review from medical-surgical review. Some firms' employee assistance plans were integrated with utilization review programs, while others remained unintegrated. Penalties for not following program procedures varied widely, as did review of outpatient services. Because of trends toward even more diversity in utilization review programs in the 1990s, research that identifies the specific features of managed care programs that hold most promise for controlling costs while maintaining quality of care will increasingly be needed.

  15. Radiochemistry, pre-clinical studies and first clinical investigation of 90Y-labeled hydroxyapatite (HA) particles prepared utilizing 90Y produced by (n,γ) route.

    PubMed

    Vimalnath, K V; Chakraborty, Sudipta; Rajeswari, A; Sarma, H D; Nuwad, Jitendra; Pandey, Usha; Kamaleshwaran, K; Shinto, Ajit; Dash, Ashutosh

    2015-05-01

    The scope of using no carrier added (NCA) (90)Y [T(1/2) = 64.1 h, Eβ(max) = 2.28 MeV] obtained from (90)Sr/(90)Y generator in radiation synovectomy (RSV) is widely accepted. In the present study, the prospect of using (90)Y produced by (n,γ) route in a medium flux research reactor for use in RSV was explored. Yttrium-90 was produced by thermal neutron irradiation of Y(2)O(3) target at a neutron flux of ~1×10(14) n/cm(2).s for 14 d. The influence of various experimental parameters were systematically investigated and optimized to arrive at the most favorable conditions for the formulation of (90)Y labeled hydroxyapatite (HA) using HA particles of 1-10 μm size range. An optimized kit formulation strategy was developed for convenient one-step compounding of (90)Y-HA, which is easily adaptable at hospital radiopharmacy. The pre-clinical biological evaluation of (90)Y-HA particles was studied by carrying out biodistribution and bioluminiscence imaging studies in Wistar rats. The first clinical investigation using the radiolabeled preparation was performed on a patient suffering from chronic arthritis in knee joint by administering 185 MBq (90)Y-HA formulated at the hospital radiopharmacy deploying the proposed strategy. Yttrium-90 was produced with a specific activity of 851 ± 111 MBq/mg and radionuclidic purity of 99.95 ± 0.02%. (90)Y-labeled HA particles (185 ± 10 MBq doses) were formulated in high radiochemical purity (>99%) and excellent in vitro stability. The preparation showed promising results in pre-clinical studies carried out in Wistar rats. The preliminary results of the first clinical investigation of (90)Y-HA preparation in a patient with rheumatoid arthritis in knee joints demonstrated the effectiveness of the formulation prepared using (90)Y produced via (n,γ) route in the management of the disease. The studies revealed that effective utilization of (90)Y produced via (n,γ) route in a medium flux research reactor coupled with the developed strategy of using HA kits for convenient formulation of (90)Y-HA at the hospital radiopharmacy can contribute to sustainable growth in the clinical utilization of (90)Y in RSV in the foreseeable future. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Electrocardiographic Characteristics of Potential Organ Donors and Associations with Cardiac Allograft Utilization

    PubMed Central

    Khush, Kiran K.; Menza, Rebecca; Nguyen, John; Goldstein, Benjamin A.; Zaroff, Jonathan G.; Drew, Barbara J.

    2012-01-01

    Background Current regulations require that all cardiac allograft offers for transplantation must include an interpreted 12-lead electrocardiogram (ECG). However, little is known about the expected ECG findings in potential organ donors, or the clinical significance of any identified abnormalities in terms of cardiac allograft function and suitability for transplantation. Methods and Results A single experienced reviewer interpreted the first ECG obtained after brainstem herniation in 980 potential organ donors managed by the California Transplant Donor Network from 2002-2007. ECG abnormalities were summarized, and associations between specific ECG findings and cardiac allograft utilization for transplantation were studied. ECG abnormalities were present in 51% of all cases reviewed. The most common abnormalities included voltage criteria for left ventricular hypertrophy (LVH), prolongation of the corrected QT interval (QTc), and repolarization changes (ST/T wave abnormalities). Fifty seven percent of potential cardiac allografts in this cohort were accepted for transplantation. LVH on ECG was a strong predictor of allograft non-utilization. No significant associations were seen between QTc prolongation, repolarization changes and allograft utilization for transplantation, after adjusting for donor clinical variables and echocardiographic findings. Conclusions We have performed the first comprehensive study of ECG findings in potential donors for cardiac transplantation. Many of the common ECG abnormalities seen in organ donors may result from the heightened state of sympathetic activation that occurs after brainstem herniation, and are not associated with allograft utilization for transplantation. PMID:22615333

  17. Controlling inpatient psychiatric utilization through managed care.

    PubMed

    Wickizer, T M; Lessler, D; Travis, K M

    1996-03-01

    There is little current understanding of how managed care strategies affect hospital inpatient psychiatric care for mentally ill patients. This study examined one prominent form of managed care, utilization management, which reviews requests for psychiatric care and authorizes provision of care deemed appropriate and clinically necessary. The authors analyzed data on 2,265 utilization management reviews conducted during 1989-1992 for patients insured by a single large commercial insurance company. Three utilization management procedures were examined: preadmission review, continued-stay review, and case management. The performance indicators analyzed included percent of admission requests granted, number of days requested and approved, and number of treatment extensions granted. Utilization management initially approved inpatient psychiatric treatment for nearly all (98.8%) of the patients but authorized, on average, only one-third of the days requested (6.9 versus 19.0). On average, 23.5 (total) days of care were requested and 16.8 days were approved. Care for patients with alcohol or drug dependence diagnoses was more restricted than was care for other patients. These data suggest that managed care does restrict inpatient psychiatric care, primarily by managing length of stay. The fact that almost all patients were approved for the same initial length of stay implies adherence to strict treatment protocols that do not distinguish among different clinical or patient factors. There is a need for careful study of the effects of managed care on outcomes and quality of psychiatric care.

  18. Does Integrated Behavioral Health Care Reduce Mental Health Disparities for Latinos? Initial Findings

    PubMed Central

    Bridges, Ana J.; Andrews, Arthur R.; Villalobos, Bianca T.; Pastrana, Freddie A.; Cavell, Timothy A.; Gomez, Debbie

    2014-01-01

    Integrated behavioral health care (IBHC) is a model of mental health care service delivery that seeks to reduce stigma and service utilization barriers by embedding mental health professionals into the primary care team. This study explored whether IBHC service referrals, utilization, and outcomes were comparable for Latinos and non-Latino White primary care patients. Data for the current study were collected from 793 consecutive patients (63.8% Latino; M age = 29.02 years [SD = 17.96]; 35.1% under 18 years; 65.3% women; 54.3% uninsured) seen for behavioral health services in 2 primary care clinics during a 10.5 month period. The most common presenting concerns were depression (21.6%), anxiety (18.5%), adjustment disorder (13.0%), and externalizing behavior problems (9.8%). Results revealed that while Latino patients had significantly lower self-reported psychiatric distress, significantly higher clinician-assigned global assessment of functioning scores, and fewer received a psychiatric diagnosis at their initial visit compared to non-Latino White patients, both groups had comparable utilization rates, comparable and clinically significant improvements in symptoms (Cohen’s d values > .50), and expressed high satisfaction with integrated behavioral services. These data provide preliminary evidence suggesting integration of behavioral health services into primary care clinics may help reduce mental health disparities for Latinos. PMID:25309845

  19. Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection

    Cancer.gov

    Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection, a 2013 workshop sponsored by the Epidemiology and Genomics Research Program.

  20. Non-hip, non-spine fractures drive healthcare utilization following a fracture: the Global Longitudinal study of Osteoporosis in Women (GLOW)

    PubMed Central

    Ioannidis, G.; Flahive, J.; Pickard, L.; Papaioannou, A.; Chapurlat, R. D.; Saag, K. G.; Silverman, S.; Anderson, F. A.; Gehlbach, S. H.; Hooven, F. H.; Boonen, S.; Compston, J. E.; Cooper, C.; Díez-Perez, A.; Greenspan, S. L.; LaCroix, A. Z.; Lindsay, R.; Netelenbos, J. C.; Pfeilschifter, J.; Rossini, M.; Roux, C.; Sambrook, P. N.; Siris, E. S.; Watts, N. B.

    2016-01-01

    Summary We evaluated healthcare utilization associated with treating different fracture types in over 51,000 women aged ≥55 years. Over the course of 1 year, there were five times more non-hip, non-spine fractures than hip or spine fractures, resulting in twice as many days of hospitalization and rehabilitation/nursing home care for non-hip, non-spine fractures. Purpose To evaluate the medical healthcare utilization associated with treating several types of fractures in women aged 55 years or older from various geographic regions. Methods Information from the Global Longitudinal study of Osteoporosis in Women (GLOW) was collected via self-administered patient questionnaires at baseline and year 1 (n=51,491). Self-reported clinically recognized low-trauma fractures at year 1 were classified as incident spine, hip, wrist/hand, arm/shoulder, pelvis, rib, leg, and other fractures. Healthcare utilization data were self-reported and included whether the fracture was treated at a doctor’s office/clinic or at a hospital. Patients were also asked if they had undergone surgery or been treated at a rehabilitation center or nursing home. Results Over the 1-year study period, there were 195 spine, 134 hip, and 1,654 non-hip, non-spine fractures. In the GLOW cohort, clinical vertebral fractures resulted in 617 days of hospitalization and 512 days of rehabilitation/nursing home care, while hip fractures accounted for 1,306 days of hospitalization and 1,650 days of rehabilitation/nursing home care. Of particular interest is the result that non-hip, non-spine fractures resulted in 3,805 days in hospital and 5,186 days of rehabilitation/nursing home care. Conclusions While hip and vertebral fractures are well recognized for their associated increase in health resource utilization, non-hip, non-spine fractures, by virtue of their 5-fold greater number, require significantly more healthcare resources. PMID:22525976

  1. (Very) Early technology assessment and translation of predictive biomarkers in breast cancer.

    PubMed

    Miquel-Cases, Anna; Schouten, Philip C; Steuten, Lotte M G; Retèl, Valesca P; Linn, Sabine C; van Harten, Wim H

    2017-01-01

    Predictive biomarkers can guide treatment decisions in breast cancer. Many studies are undertaken to discover and translate these biomarkers, yet few biomarkers make it to practice. Before use in clinical decision making, predictive biomarkers need to demonstrate analytical validity, clinical validity and clinical utility. While attaining analytical and clinical validity is relatively straightforward, by following methodological recommendations, the achievement of clinical utility is extremely challenging. It requires demonstrating three associations: the biomarker with the outcome (prognostic association), the effect of treatment independent of the biomarker, and the differential treatment effect between the prognostic and the predictive biomarker (predictive association). In addition, economical, ethical, regulatory, organizational and patient/doctor-related aspects are hampering the translational process. Traditionally, these aspects do not receive much attention until formal approval or reimbursement of a biomarker test (informed by Health Technology Assessment (HTA)) is at stake, at which point the clinical utility and sometimes price of the test can hardly be influenced anymore. When HTA analyses are performed earlier, during biomarker research and development, they may prevent further development of those biomarkers unlikely to ever provide sufficient added value to society, and rather facilitate translation of the promising ones. Early HTA is particularly relevant for the predictive biomarker field, as expensive medicines are under pressure and the need for biomarkers to guide their appropriate use is huge. Closer interaction between clinical researchers and HTA experts throughout the translational research process will ensure that available data and methodologies will be used most efficiently to facilitate biomarker translation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  2. Utility of routine psychological screening in the childhood cancer survivor clinic.

    PubMed

    Recklitis, Christopher; O'Leary, Tara; Diller, Lisa

    2003-03-01

    This study examined the utility of routine psychologic screening in a childhood cancer survivor clinic by evaluating patient acceptance, comparing subjects' symptoms to normative data, examining the utility of specific tests, and identifying risk factors associated with psychological distress. During their annual clinic visit, 101 adult survivors of childhood cancer (median age, 25 years) completed the Symptom Checklist 90 Revised (SCL-90), as well as the Short Form 36 (SF-36), Beck Depression Inventory (BDI), and one additional suicide question. Psychological distress was operationally defined according to the published SCL-90 clinical case rule, classifying subjects with a consistent pattern of symptom elevations as clinical cases. The majority of subjects (80%) completed the screening in less than 30 minutes and reported little (15%) or no (84%) distress. Sixty-four percent believed it would help "very much" or "moderately" in getting to know them, and 35% thought it would help "slightly." On the SCL-90, 32 subjects (31.7%) had a positive screen, indicating significant psychological distress. All subjects with clinically significant symptoms on the BDI and SF-36 Mental Health Scale were cases on the SCL-90 (case-positive). Suicidal symptoms were reported in 13.9% of the sample, all of whom were SCL-90 cases. In a logistic regression model, subjects' dissatisfaction with physical appearance, poor physical health, and treatment with cranial radiation were associated with psychological distress. Results demonstrate that routine psychological screening can be successfully integrated into the cancer survivor clinic and may be effective in identifying those survivors with significant distress who require further evaluation.

  3. Neuron-Type-Specific Utility in a Brain-Machine Interface: a Pilot Study.

    PubMed

    Garcia-Garcia, Martha G; Bergquist, Austin J; Vargas-Perez, Hector; Nagai, Mary K; Zariffa, Jose; Marquez-Chin, Cesar; Popovic, Milos R

    2017-11-01

    Firing rates of single cortical neurons can be volitionally modulated through biofeedback (i.e. operant conditioning), and this information can be transformed to control external devices (i.e. brain-machine interfaces; BMIs). However, not all neurons respond to operant conditioning in BMI implementation. Establishing criteria that predict neuron utility will assist translation of BMI research to clinical applications. Single cortical neurons (n=7) were recorded extracellularly from primary motor cortex of a Long-Evans rat. Recordings were incorporated into a BMI involving up-regulation of firing rate to control the brightness of a light-emitting-diode and subsequent reward. Neurons were classified as 'fast-spiking', 'bursting' or 'regular-spiking' according to waveform-width and intrinsic firing patterns. Fast-spiking and bursting neurons were found to up-regulate firing rate by a factor of 2.43±1.16, demonstrating high utility, while regular-spiking neurons decreased firing rates on average by a factor of 0.73±0.23, demonstrating low utility. The ability to select neurons with high utility will be important to minimize training times and maximize information yield in future clinical BMI applications. The highly contrasting utility observed between fast-spiking and bursting neurons versus regular-spiking neurons allows for the hypothesis to be advanced that intrinsic electrophysiological properties may be useful criteria that predict neuron utility in BMI implementation.

  4. Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients

    PubMed Central

    2012-01-01

    Background Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. Method/design For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework. Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. Discussion The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making. PMID:23216708

  5. Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients.

    PubMed

    Fung, Colman S C; Chin, Weng Yee; Dai, Daisy S K; Kwok, Ruby L P; Tsui, Eva L H; Wan, Yuk Fai; Wong, Wendy; Wong, Carlos K H; Fong, Daniel Y T; Lam, Cindy L K

    2012-12-05

    Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework.Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making.

  6. Clinical utility and validity of the Functional Disability Inventory (FDI) among a multicenter sample of youth with chronic pain

    PubMed Central

    Kashikar-Zuck, Susmita; Flowers, Stacy R.; Claar, Robyn Lewis; Guite, Jessica W.; Logan, Deirdre E.; Lynch-Jordan, Anne M; Palermo, Tonya M.; Wilson, Anna C.

    2011-01-01

    The Functional Disability Inventory (FDI) is a well-established and commonly used measure of physical functioning and disability in youth with chronic pain. Further validation of the measure has been called for, in particular, examination of the clinical utility and factor structure of the measure. To address this need, we utilized a large multicenter dataset of pediatric patients with chronic pain who had completed the FDI and other measures assessing pain and emotional functioning. Clinical reference points to allow for interpretation of raw scores were developed to enhance clinical utility of the measure and exploratory factor analysis was performed to examine its factor structure. Participants included 1300 youth ages 8 to 18 years (M=14.2 years; 76% female) with chronic pain. Examination of the distribution of FDI scores and validation with measures of depressive symptoms and pain intensity yielded three distinct categories of disability: No/Minimal Disability, Moderate Disability and Severe Disability. Factor analysis of FDI scores revealed a two-factor solution representing vigorous Physical Activities and non-physically strenuous Daily Activities. The three-level classification system and factor structure were further explored via comparison across the four most commonly encountered pain conditions in clinical settings (head, back, abdominal and widespread pain). Our findings provide important new information regarding the clinical utility and validity of the FDI. This will greatly enhance the interpretability of scores for research and clinical use in a wide range of pediatric pain conditions. In particular these findings will facilitate use of the FDI as an outcome measure in future clinical trials. PMID:21458162

  7. Economic Evaluation of Hospital and Community Pharmacy Services.

    PubMed

    Gammie, Todd; Vogler, Sabine; Babar, Zaheer-Ud-Din

    2017-01-01

    To review the international body of literature from 2010 to 2015 concerning methods of economic evaluations used in hospital- and community-based studies of pharmacy services in publicly funded health systems worldwide, their clinical outcomes, and economic effectiveness. The literature search was undertaken between May 2, 2015, and September 4, 2015. Keywords included "health economics" and "evaluation" "assessment" or "appraisal," "methods," "hospital" or "community" or "residential care," "pharmacy" or "pharmacy services" and "cost minimisation analysis" or "cost utility analysis" or "cost effectiveness analysis" or "cost benefit analysis." The databases searched included MEDLINE, PubMed, Google Scholar, Science Direct, Springer Links, and Scopus, and journals searched included PLoS One, PLoS Medicine, Nature, Health Policy, Pharmacoeconomics, The European Journal of Health Economics, Expert Review of Pharmacoeconomics and Outcomes Research, and Journal of Health Economics. Studies were selected on the basis of study inclusion criteria. These criteria included full-text original research articles undertaking an economic evaluation of hospital- or community-based pharmacy services in peer-reviewed scientific journals and in English, in countries with a publicly funded health system published between 2010 and 2015. 14 articles were included in this review. Cost-utility analysis (CUA) was the most utilized measure. Cost-minimization analysis (CMA) was not used by any studies. The limited use of cost-benefit analyses (CBAs) is likely a result of technical challenges in quantifying the cost of clinical benefits, risks, and outcomes. Hospital pharmacy services provided clinical benefits including improvements in patient health outcomes and reductions in adverse medication use, and all studies were considered cost-effective due to meeting a cost-utility (per quality-adjusted life year) threshold or were cost saving. Community pharmacy services were considered cost-effective in 8 of 10 studies. Economic evaluations of hospital and community pharmacy services are becoming increasingly commonplace to enable an understanding of which health care services provide value for money and to inform policy makers as to which services will be cost-effective in light of limited health care resources.

  8. A Randomized Control Study Comparing Outcomes in Student Nurses Who Utilize Video during Simulation Debriefing as Compared to Those Who Utilize Traditional Debriefing

    ERIC Educational Resources Information Center

    Dusaj, Tresa Kaur

    2014-01-01

    Clinical placement sites for nursing students have become limited around the country. An alternative teaching strategy must be employed to allow for students to gain valuable knowledge and skills. High fidelity human patient simulation is one such strategy that allows students to safely practice nursing interventions in a controlled environment…

  9. Chromosomal Microarray With Clinical Diagnostic Utility in Children With Developmental Delay or Intellectual Disability.

    PubMed

    Lee, Jin Sook; Hwang, Hee; Kim, Soo Yeon; Kim, Ki Joong; Choi, Jin Sun; Woo, Mi Jung; Choi, Young Min; Jun, Jong Kwan; Lim, Byung Chan; Chae, Jong Hee

    2018-09-01

    Chromosomal microarray (CMA) testing is a first-tier test for patients with developmental delay, autism, or congenital anomalies. It increases diagnostic yield for patients with developmental delay or intellectual disability. In some countries, including Korea, CMA testing is not yet implemented in clinical practice. We assessed the diagnostic utility of CMA testing in a large cohort of patients with developmental delay or intellectual disability in Korea. We conducted a genome-wide microarray analysis of 649 consecutive patients with developmental delay or intellectual disability at the Seoul National University Children's Hospital. Medical records were reviewed retrospectively. Pathogenicity of detected copy number variations (CNVs) was evaluated by referencing previous reports or parental testing using FISH or quantitative PCR. We found 110 patients to have pathogenic CNVs, which included 100 deletions and 31 duplications of 270 kb to 30 Mb. The diagnostic yield was 16.9%, demonstrating the diagnostic utility of CMA testing in clinic. Parental testing was performed in 66 patients, 86.4% of which carried de novo CNVs. In eight patients, pathogenic CNVs were inherited from healthy parents with a balanced translocation, and genetic counseling was provided to these families. We verified five rarely reported deletions on 2p21p16.3, 3p21.31, 10p11.22, 14q24.2, and 21q22.13. This study demonstrated the clinical utility of CMA testing in the genetic diagnosis of patients with developmental delay or intellectual disability. CMA testing should be included as a clinical diagnostic test for all children with developmental delay or intellectual disability. © The Korean Society for Laboratory Medicine.

  10. Robotic and endoscopic transoral thyroidectomy: feasibility and description of the technique in the cadaveric model.

    PubMed

    Kahramangil, Bora; Mohsin, Khuzema; Alzahrani, Hassan; Bu Ali, Daniah; Tausif, Syed; Kang, Sang-Wook; Kandil, Emad; Berber, Eren

    2017-12-01

    Numerous new approaches have been described over the years to improve the cosmetic outcomes of thyroid surgery. Transoral approach is a new technique that aims to achieve superior cosmetic outcomes by concealing the incision in the oral cavity. Transoral thyroidectomy through vestibular approach was performed in two institutions on cadaveric models. Procedure was performed endoscopically in one institution, while the robotic technique was utilized at the other. Transoral thyroidectomy was successfully performed at both institutions with robotic and endoscopic techniques. All vital structures were identified and preserved. Transoral thyroidectomy has been performed in animal and cadaveric models, as well as in some clinical studies. Our initial experience indicates the feasibility of this approach. More clinical studies are required to elucidate its full utility.

  11. Health services utilization of women following a traumatic birth.

    PubMed

    Turkstra, E; Creedy, D K; Fenwick, J; Buist, A; Scuffham, P A; Gamble, J

    2015-12-01

    This cohort study compared 262 women with high childbirth distress to 138 non-distressed women. At 12 months, high distress women had lower health-related quality of life compared to non-distressed women (EuroQol five-dimensional (EQ-5D) scale 0.90 vs. 0.93, p = 0.008), more visits to general practitioners (3.5 vs. 2.6, p = 0.002) and utilized more additional services (e.g. maternal health clinics), with no differences for infants. Childbirth distress has lasting adverse health effects for mothers and increases health-care utilization.

  12. Clinical information transfer and data capture in the acute myocardial infarction pathway: an observational study.

    PubMed

    Kesavan, Sujatha; Kelay, Tanika; Collins, Ruth E; Cox, Benita; Bello, Fernando; Kneebone, Roger L; Sevdalis, Nick

    2013-10-01

    Acute myocardial infarctions (MIs) or heart attacks are the result of a complete or an incomplete occlusion of the lumen of the coronary artery with a thrombus. Prompt diagnosis and early coronary intervention results in maximum myocardial salvage, hence time to treat is of the essence. Adequate, accurate and complete information is vital during the early stages of admission of an MI patient and can impact significantly on the quality and safety of patient care. This study aimed to record how clinical information between different clinical teams during the journey of a patient in the MI care pathway is captured and to review the flow of information within this care pathway. A prospective, descriptive, structured observational study to assess (i) current clinical information systems (CIS) utilization and (ii) real-time information availability within an acute cardiac care setting was carried out. Completeness and availability of patient information capture across four key stages of the MI care pathway were assessed prospectively. Thirteen separate information systems were utilized during the four phases of the MI pathway. Observations revealed fragmented CIS utilization, with users accessing an average of six systems to gain a complete set of patient information. Data capture was found to vary between each pathway stage and in both patient cohort risk groupings. The highest level of information completeness (100%) was observed only in the discharge stage of the MI care pathway. The lowest level of information completeness (58%) was observed in the admission stage. The study highlights fragmentation, CIS duplication, and discrepancies in the current clinical information capture and data transfer across the MI care pathway in an acute cardiac care setting. The development of an integrated and user-friendly electronic data capture and transfer system would reduce duplication and would facilitate efficient and complete information provision at the point of care. © 2012 John Wiley & Sons Ltd.

  13. Physician perceptions of the role and value of basic science knowledge in daily clinical practice.

    PubMed

    Fischer, Jennifer A; Muller-Weeks, Susan

    2012-01-01

    The role of basic science education in a clinical setting remains unclear. Research to understand how academic clinicians perceive and use this part of their education can aid curricular development. To assess physician's attitudes toward the value of science knowledge in their clinical practice. Academic physicians from three medical schools completed a questionnaire about the utility of basic science education in core clinical tasks and in practice-based learning and improvement. A total of 109 clinical faculty returned the survey. Overall, 89% of the respondents indicated that basic science education is valuable to their clinical practice. When asked about the utility of basic science information in relation to direct patient care, greater than 50% of the doctors felt they use this when diagnosing and communicating with patients. This rose to greater than 60% when asked about choosing treatment options for their patients. Individuals also responded that basic science knowledge is valuable when developing evidence-based best practices. Specifically, 89% felt that they draw upon this information when training students/residents and 84% use this information when reading journal articles. This study shows that basic science education is perceived by responding academic physicians to be important to their clinical work.

  14. Pay-for-performance in a community substance abuse clinic

    PubMed Central

    Vandrey, Ryan; Stitzer, Maxine L.; Acquavita, Shauna P.; Quinn-Stabile, Patricia

    2011-01-01

    Pay-for-performance (P4P) strategies improve employee productivity and morale in business settings and are increasingly being implemented in medical care settings. This study investigated whether P4P could improve treatment utilization and retention at a community drug treatment clinic. Counselors had the opportunity to earn cash bonuses based on therapy attendance rates of individual clients as well as the quarterly retention rates of their caseload. Using a pre-post study design, average therapy sessions attended during the first month of treatment increased from 4.6 sessions prior to the intervention to 5.5 sessions per client during the intervention. The 90-day client retention rate increased from 40% to 53%. Additional analyses suggest that the improvement in 90-day retention was mediated by the increase in attendance during the first month of treatment. This project demonstrates that implementing a P4P incentive program in community drug abuse treatment clinics is feasible and effective at improving utilization and retention. PMID:21489739

  15. Evaluation of an Ongoing Diabetes Group Medical Visit in a Family Medicine Practice.

    PubMed

    Cunningham, Amy T; Delgado, David J; Jackson, Joseph D; Crawford, Albert G; Jabbour, Serge; Lieberthal, Robert D; Diaz, Victor; LaNoue, Marianna

    2018-01-01

    Group medical visits (GMVs), which combine 1-on-1 clinical consultations and group self-management education, have emerged as a promising vehicle for supporting type 2 diabetes management in primary care. However, few evaluations exist of ongoing diabetes GMVs embedded in medical practices. This study used a quasi-experimental design to evaluate diabetes GMV at a large family medicine practice. We examined program attendance and attrition, used propensity score matching to create a matched comparison group, and compared participants and the matched group on clinical, process of care, and utilization outcomes. GMV participants (n = 230) attended an average of 1 session. Participants did not differ significantly from the matched comparison group (n = 230) on clinical, process of care or utilization outcomes. The diabetes GMV was not associated with improvements in outcomes. Further studies should examine diabetes GMV implementation challenges to enhance their effectiveness in everyday practice. © Copyright 2018 by the American Board of Family Medicine.

  16. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

    DTIC Science & Technology

    2016-10-01

    Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...impacting both the initial choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that...predict reclassification from Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study

  17. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

    DTIC Science & Technology

    2016-10-01

    Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...choice of therapy and decision-making during AS. The objective of the study is to utilize analytically validated assays that take into account tumor...Gleason 6 cancer to Gleason 7 or greater. The analysis plan was determined before specimens were selected for the study , and included 7 breaking

  18. A cost-utility analysis of the use of preoperative computed tomographic angiography in abdomen-based perforator flap breast reconstruction.

    PubMed

    Offodile, Anaeze C; Chatterjee, Abhishek; Vallejo, Sergio; Fisher, Carla S; Tchou, Julia C; Guo, Lifei

    2015-04-01

    Computed tomographic angiography is a diagnostic tool increasingly used for preoperative vascular mapping in abdomen-based perforator flap breast reconstruction. This study compared the use of computed tomographic angiography and the conventional practice of Doppler ultrasonography only in postmastectomy reconstruction using a cost-utility model. Following a comprehensive literature review, a decision analytic model was created using the three most clinically relevant health outcomes in free autologous breast reconstruction with computed tomographic angiography versus Doppler ultrasonography only. Cost and utility estimates for each health outcome were used to derive the quality-adjusted life-years and incremental cost-utility ratio. One-way sensitivity analysis was performed to scrutinize the robustness of the authors' results. Six studies and 782 patients were identified. Cost-utility analysis revealed a baseline cost savings of $3179, a gain in quality-adjusted life-years of 0.25. This yielded an incremental cost-utility ratio of -$12,716, implying a dominant choice favoring preoperative computed tomographic angiography. Sensitivity analysis revealed that computed tomographic angiography was costlier when the operative time difference between the two techniques was less than 21.3 minutes. However, the clinical advantage of computed tomographic angiography over Doppler ultrasonography only showed that computed tomographic angiography would still remain the cost-effective option even if it offered no additional operating time advantage. The authors' results show that computed tomographic angiography is a cost-effective technology for identifying lower abdominal perforators for autologous breast reconstruction. Although the perfect study would be a randomized controlled trial of the two approaches with true cost accrual, the authors' results represent the best available evidence.

  19. Accurate Identification of Fatty Liver Disease in Data Warehouse Utilizing Natural Language Processing.

    PubMed

    Redman, Joseph S; Natarajan, Yamini; Hou, Jason K; Wang, Jingqi; Hanif, Muzammil; Feng, Hua; Kramer, Jennifer R; Desiderio, Roxanne; Xu, Hua; El-Serag, Hashem B; Kanwal, Fasiha

    2017-10-01

    Natural language processing is a powerful technique of machine learning capable of maximizing data extraction from complex electronic medical records. We utilized this technique to develop algorithms capable of "reading" full-text radiology reports to accurately identify the presence of fatty liver disease. Abdominal ultrasound, computerized tomography, and magnetic resonance imaging reports were retrieved from the Veterans Affairs Corporate Data Warehouse from a random national sample of 652 patients. Radiographic fatty liver disease was determined by manual review by two physicians and verified with an expert radiologist. A split validation method was utilized for algorithm development. For all three imaging modalities, the algorithms could identify fatty liver disease with >90% recall and precision, with F-measures >90%. These algorithms could be used to rapidly screen patient records to establish a large cohort to facilitate epidemiological and clinical studies and examine the clinic course and outcomes of patients with radiographic hepatic steatosis.

  20. Medical Management: Process Analysis Study Report

    DTIC Science & Technology

    2011-10-28

    in Medical Management (care coordinator, case manager, PCM, clinic nurses , referral management shop, utilization management?, etc). The goal is to...Enterprise Nursing Procedure Manual, revealed that fact from the Navy’s perspective. An OASD(HA) TRICARE Management Activity (TMA) Senior...Requirements Analyst, Clinical Information Management (IM) and retired Army Colonel Nurse , Patricia Kinder, essentially told us no single application suite

  1. Validity of the WISC-IV Spanish for a Clinically Referred Sample of Hispanic Children

    ERIC Educational Resources Information Center

    San Miguel Montes, Liza E.; Allen, Daniel N.; Puente, Antonio E.; Neblina, Cris

    2010-01-01

    The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included…

  2. Factors Influencing M.S.W. Students' Interest in Clinical Practice

    ERIC Educational Resources Information Center

    Perry, Robin

    2009-01-01

    This study utilizes linear and log-linear stochastic models to examine the impact that a variety of variables (including graduate education) have on M.S.W. students' desires to work in clinical practice. Data was collected biannually (between 1992 and 1998) from a complete population sample of all students entering and exiting accredited graduate…

  3. The Use of the Ambulatory Setting for Patient Self-Education.

    ERIC Educational Resources Information Center

    Newkirk, Gary; And Others

    1979-01-01

    A self-instructional health education program that utilizes a slide-tape device was studied to determine whether it could be educationally effective in an ambulatory clinical setting without being an inconvenience to patients. Infant and child nutrition was chosen as the topic to be used in the waiting room of a pediatric clinic. (JMD)

  4. Studying the Child Obesity Epidemic With Natural Experiments. NBER Working Paper No. 14989

    ERIC Educational Resources Information Center

    Sandy, Robert; Liu, Gilbert; Ottensmann, John; Tchernis, Rusty; Wilson, Jeffrey; Ford, O.T.

    2009-01-01

    We utilize clinical records of successive visits by children to pediatric clinics in Indianapolis to estimate the effects on their body mass of environmental changes near their homes. We compare results for fixed-residence children with those for cross-sectional data. Our environmental factors are fast food restaurants, supermarkets, parks,…

  5. The Effect of Formulary Restrictions on Patient and Payer Outcomes: A Systematic Literature Review.

    PubMed

    Park, Yujin; Raza, Syed; George, Aneesh; Agrawal, Rumjhum; Ko, John

    2017-08-01

    Formulary restrictions are implemented to reduce pharmacy costs and ensure appropriate use of pharmaceutical products. As adoption of formulary restrictions increases with rising pharmacy costs, there is a need to better understand the potential effect of formulary restrictions on patient and payer outcomes. To conduct a systematic literature review that assesses the effect of formulary restrictions on the following outcomes: medication adherence, clinical outcomes, treatment satisfaction, drug utilization, health care resource utilization, and economic outcomes. Studies published in 2005 or later were identified from the MEDLINE, Embase, and Cochrane databases and the National Health Service Economic Evaluation Database, using 2 sets of search terms. A total of 17 formulary restriction terms (e.g., step therapy [ST] and prior authorization [PA]) and 55 outcome terms were included, resulting in 935 unique search term combinations. Two reviewers independently conducted analyses of the titles, abstracts, and full-text articles. The search was limited to English-language articles that evaluated the effect of ST and/or PA placed by U.S. third-party payers on the following outcomes: patient outcomes (medication adherence, clinical outcomes, and treatment satisfaction) and payer outcomes (drug utilization, health care resource utilization, and economic outcomes). Of 2,321 reviewed articles, 59 articles met the study inclusion criteria. The included studies assessed the effect of ST (n = 18), PA (n = 35), or both (n = 6) on medication adherence (n = 14), clinical outcomes (n = 12), treatment satisfaction (n = 2), drug utilization (n = 39), health care resource utilization (n = 18), and economic outcomes (n = 42). The 59 articles measured 164 outcomes across the patient, health care resource utilization, and economic outcome categories of interest. Of the total number of outcomes, 50.6% (n = 83) were negative in direction or were unfavorable, whereas 40.2% (n = 66) were positive in direction or were favorable, when the perspectives of patients and payers were considered. Of the total number of drug utilization outcomes reported (n = 46), the majority showed lower drug utilization (> 90%). However, in some of the articles, pharmacy cost savings resulting from lower drug utilization appeared to be offset by increased medical costs. Formulary coverage decisions may have unintended consequences on patient and payer outcomes despite lower drug utilization and pharmacy cost savings; therefore, careful evaluation of restrictions before policy implementation and continued reevaluation after implementation is warranted. This study was funded by Novartis Pharmaceuticals. Park and Ko are employed by Novartis Pharmaceuticals in East Hanover, New Jersey, and Ko holds stock in Novartis. Raza, George, and Agrawal are employed by Novartis Healthcare in Hyderabad, India. Study concept and design were contributed primarily by Park and Ko, along with the other authors. Raza, George, and Agrawal collected the data, along with Park and Ko. Data interpretation was performed by Agrawal, Raza, George, Park, and Ko. The manuscript was written and revised by Raza, George, and Park, along with Ko and Agrawal. Results from this systematic literature review were presented at the AMCP Annual Meeting 2016; San Francisco, California; April 19-22, 2016.

  6. Using circulating tumor cells to inform on prostate cancer biology and clinical utility

    PubMed Central

    Li, Jing; Gregory, Simon G.; Garcia-Blanco, Mariano A.; Armstrong, Andrew J.

    2016-01-01

    Substantial advances in the molecular biology of prostate cancer have led to the approval of multiple new systemic agents to treat men with metastatic castration-resistant prostate cancer (mCRPC). These treatments encompass androgen receptor directed therapies, immunotherapies, bone targeting radiopharmaceuticals and cytotoxic chemotherapies. There is, however, great heterogeneity in the degree of patient benefit with these agents, thus fueling the need to develop predictive biomarkers that are able to rationally guide therapy. Circulating tumor cells (CTCs) have the potential to provide an assessment of tumor-specific biomarkers through a non-invasive, repeatable “liquid biopsy” of a patient’s cancer at a given point in time. CTCs have been extensively studied in men with mCRPC, where CTC enumeration using the Cellsearch® method has been validated and FDA approved to be used in conjunction with other clinical parameters as a prognostic biomarker in metastatic prostate cancer. In addition to enumeration, more sophisticated molecular profiling of CTCs is now feasible and may provide more clinical utility as it may reflect tumor evolution within an individual particularly under the pressure of systemic therapies. Here, we review technologies used to detect and characterize CTCs, and the potential biological and clinical utility of CTC molecular profiling in men with metastatic prostate cancer. PMID:26079252

  7. A Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis on the clinical utility of sperm DNA fragmentation testing in specific male infertility scenarios.

    PubMed

    Esteves, Sandro C; Agarwal, Ashok; Cho, Chak-Lam; Majzoub, Ahmad

    2017-09-01

    Sperm DNA fragmentation (SDF) is recognized as a leading cause of male infertility because it can impair the paternal genome through distinct pathophysiological mechanisms. Current evidence supports SDF as a major factor in the pathophysiology of several conditions, including varicocele, unexplained infertility, assisted reproductive technology failure, and environmental lifestyle factors, although the mechanisms involved have not been fully described yet. Measurement of the levels of DNA fragmentation in semen provides valuable information on the integrity of paternal chromatin and may guide therapeutic strategies. A recently published clinical practice guideline (CPG) highlighted how to use the information provided by SDF testing in daily practice, which triggered a series of commentaries by leading infertility experts. These commentaries contained an abundance of information and conflicting views about the clinical utility of SDF testing, which underline the complex nature of SDF. A search of papers published in response to the CPG entitled "Clinical utility of sperm DNA fragmentation testing: practice recommendations based on clinical scenarios" was performed within the Translational Andrology and Urology ( TAU ) website (http://tau.amegroups.com/). The start and end dates for the search were May 2017 and August 2017, respectively. Each commentary meeting our inclusion criteria was rated as "supportive without reservation", "supportive with reservation", "not supportive" or "neutral". We recorded whether articles discussed either SDF characteristics as a laboratory test method or clinical scenarios, or both. Subsequently, we extracted the particulars from each commentary and utilized the 'Strengths-Weaknesses-Opportunities-Threats' (SWOT) analysis to understand the perceived advantages and drawbacks of SDF as a specialized sperm function method in clinical practice. Fifty-eight fertility experts from six continents and twenty-two countries contributed commentaries. Overall, participants (87.9%; n=51) were supportive of the recommendations provided by the CPG on the utility of SDF testing based on clinical scenarios. The majority of participants made explicit remarks about both the clinical scenarios and SDF assays' characteristics. Among 'not supportive' and 'supportive with reservation' participants, 75% (n=30/40) and 77.5% (n=31/40) expressed concerns related to technical limitations of SDF testing methods and clinical utility of the test in one or more clinical scenarios discussed in the CPG, respectively. The SWOT analysis revealed that the CPG provides a reasonable evidence-based proposal for integration of SDF testing in the routine daily practice. It also uncovered gaps of knowledge and threats limiting the widespread application of SDF in everyday practice, thus allowing the identification of opportunities to further refine SDF testing and its clinical utility. The understanding of the role of SDF in male infertility requires an in-depth analysis of the multifactorial pathophysiological processes and the theories involved. The SWOT analysis allowed an objective evaluation of CPG on the clinical utility of SDF testing based on clinical scenarios and its accompanying commentaries written by global experts in all possible angles. Implementation of SDF testing in the clinic may not only increase the outcome of ART but more importantly improve the health of both fathers to be and resulting offspring.

  8. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review.

    PubMed

    Miron, Richard J; Fujioka-Kobayashi, Masako; Bishara, Mark; Zhang, Yufeng; Hernandez, Maria; Choukroun, Joseph

    2017-02-01

    The growing multidisciplinary field of tissue engineering aims at predictably regenerating, enhancing, or replacing damaged or missing tissues for a variety of conditions caused by trauma, disease, and old age. One area of research that has gained tremendous awareness in recent years is that of platelet-rich fibrin (PRF), which has been utilized across a wide variety of medical fields for the regeneration of soft tissues. This systematic review gathered all the currently available in vitro, in vivo, and clinical literature utilizing PRF for soft tissue regeneration, augmentation, and/or wound healing. In total, 164 publications met the original search criteria, with a total of 48 publications meeting inclusion criteria (kappa score = 94%). These studies were divided into 7 in vitro, 11 in vivo, and 31 clinical studies. In summary, 6 out of 7 (85.7%) and 11 out of 11 (100%) of the in vitro and in vivo studies, respectively, demonstrated a statistically significant advantage for combining PRF to their regenerative therapies. Out of the remaining 31 clinical studies, a total of 8 reported the effects of PRF in a randomized clinical trial, with 5 additional studies (13 total) reporting appropriate controls. In those clinical studies, 9 out of the 13 studies (69.2%) demonstrated a statistically relevant positive outcome for the primary endpoints measured. In total, 18 studies (58% of clinical studies) reported positive wound-healing events associated with the use of PRF, despite using controls. Furthermore, 27 of the 31 clinical studies (87%) supported the use of PRF for soft tissue regeneration and wound healing for a variety of procedures in medicine and dentistry. In conclusion, the results from the present systematic review highlight the positive effects of PRF on wound healing after regenerative therapy for the management of various soft tissue defects found in medicine and dentistry.

  9. Synergistic Combination of Electrolysis and Electroporation for Tissue Ablation.

    PubMed

    Stehling, Michael K; Guenther, Enric; Mikus, Paul; Klein, Nina; Rubinsky, Liel; Rubinsky, Boris

    2016-01-01

    Electrolysis, electrochemotherapy with reversible electroporation, nanosecond pulsed electric fields and irreversible electroporation are valuable non-thermal electricity based tissue ablation technologies. This paper reports results from the first large animal study of a new non-thermal tissue ablation technology that employs "Synergistic electrolysis and electroporation" (SEE). The goal of this pre-clinical study is to expand on earlier studies with small animals and use the pig liver to establish SEE treatment parameters of clinical utility. We examined two SEE methods. One of the methods employs multiple electrochemotherapy-type reversible electroporation magnitude pulses, designed in such a way that the charge delivered during the electroporation pulses generates the electrolytic products. The second SEE method combines the delivery of a small number of electrochemotherapy magnitude electroporation pulses with a low voltage electrolysis generating DC current in three different ways. We show that both methods can produce lesion with dimensions of clinical utility, without the need to inject drugs as in electrochemotherapy, faster than with conventional electrolysis and with lower electric fields than irreversible electroporation and nanosecond pulsed ablation.

  10. Synergistic Combination of Electrolysis and Electroporation for Tissue Ablation

    PubMed Central

    Mikus, Paul; Klein, Nina; Rubinsky, Liel; Rubinsky, Boris

    2016-01-01

    Electrolysis, electrochemotherapy with reversible electroporation, nanosecond pulsed electric fields and irreversible electroporation are valuable non-thermal electricity based tissue ablation technologies. This paper reports results from the first large animal study of a new non-thermal tissue ablation technology that employs “Synergistic electrolysis and electroporation” (SEE). The goal of this pre-clinical study is to expand on earlier studies with small animals and use the pig liver to establish SEE treatment parameters of clinical utility. We examined two SEE methods. One of the methods employs multiple electrochemotherapy-type reversible electroporation magnitude pulses, designed in such a way that the charge delivered during the electroporation pulses generates the electrolytic products. The second SEE method combines the delivery of a small number of electrochemotherapy magnitude electroporation pulses with a low voltage electrolysis generating DC current in three different ways. We show that both methods can produce lesion with dimensions of clinical utility, without the need to inject drugs as in electrochemotherapy, faster than with conventional electrolysis and with lower electric fields than irreversible electroporation and nanosecond pulsed ablation. PMID:26866693

  11. The burden of insomnia in Japan

    PubMed Central

    Mishima, Kazuo; DiBonaventura, Marco daCosta; Gross, Hillary

    2015-01-01

    Objectives Several studies have suggested that patients who experience insomnia report a number of significant impairments. However, despite this literature, fewer studies have focused on the burden of insomnia among patients in Japan. The objective of the current study is to extend this work in Japan to further understand the effect of insomnia on health-related quality of life (hrQOL). Further, another objective is to understand general predictors of hrQOL among patients with insomnia. Methods Data from the 2012 Japan National Health and Wellness Survey, an annual, cross-sectional study of adults aged 18 years or older, were used (N=30,000). All National Health and Wellness Survey respondents were categorized based on the incidence of self-reported insomnia diagnosis and prescription medication usage (clinical insomniacs under treatment versus [vs] good sleepers without insomnia or insomnia symptoms). Comparisons among different groups were made using multiple regression models controlling for demographics and health history. Results Clinical insomniacs (n=1,018; 3.4%) reported significantly worse hrQOL compared with good sleepers (n=20,542) (mental component summary: 34.2 vs 48.0; physical component summary: 48.0 vs 52.8; health utilities: 0.61 vs 0.76; all P<0.05). Health behaviors (smoking, exercise, alcohol use) and comorbidities were the strongest predictors of health utilities for clinical insomniacs. For all three clinical insomniac subgroups of interest, those with a physical comorbidity but not a psychiatric one, those with a psychiatric comorbidity but not a physical one, and those without either a physical or psychiatric comorbidity, large decrements in health utilities were observed for respondents who did not engage in any positive health behaviors (0.61, 0.57, 0.64, respectively) relative to good sleepers (0.78). However, the gap in health utility scores between these subgroups and good sleepers diminishes with an increasing number of positive health behaviors (eg, clinical insomniacs with a physical comorbidity but not a psychiatric comorbidity performing all three positive health behaviors =0.67 vs good sleepers =0.78). Discussion A significant burden remains for those with insomnia who are treated. Given the particularly low levels of hrQOL among treated insomnia patients who have poor health behavior profiles and have psychiatric comorbidities, physicians should place particular emphasis on these patients who are most in need of intervention. Improved treatments may help to address the unmet needs of these patient populations. PMID:25610008

  12. A Four- and Five-Factor Structural Model for Wechsler Tests: Does It Really Matter Clinically?

    ERIC Educational Resources Information Center

    Schwartz, David M.

    2013-01-01

    The purpose of this commentary is to focus on the clinical utility of the four- and five-factor structural models for the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) and Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV). It provides a discussion of important considerations when evaluating the clinical utility of the…

  13. Pathologists' roles in clinical utilization management. A financing model for managed care.

    PubMed

    Zhao, J J; Liberman, A

    2000-03-01

    In ancillary or laboratory utilization management, the roles of pathologists have not been explored fully in managed care systems. Two possible reasons may account for this: pathologists' potential contributions have not been defined clearly, and effective measurement of and reasonable compensation for the pathologist's contribution remains vague. The responsibilities of pathologists in clinical practice may include clinical pathology and laboratory services (which have long been well-defined and are compensated according to a resource-based relative value system-based coding system), laboratory administration, clinical utilization management, and clinical research. Although laboratory administration services have been compensated with mechanisms such as percentage of total service revenue or fixed salary, the involvement of pathologists seems less today than in the past, owing to increased clinical workload and time constraints in an expanding managed care environment, especially in community hospital settings. The lack of financial incentives or appropriate compensation mechanisms for the services likely accounts for the current situation. Furthermore, the importance of pathologist-driven utilization management in laboratory services lacks recognition among hospital administrators, managed care executives, and pathologists themselves, despite its potential benefits for reducing cost and enhancing quality of care. We propose a financial compensation model for such services and summarize its advantages.

  14. Mobile phone technology and hospitalized patients: a cross-sectional surveillance study of bacterial colonization, and patient opinions and behaviours.

    PubMed

    Brady, R R; Hunt, A C; Visvanathan, A; Rodrigues, M A; Graham, C; Rae, C; Kalima, P; Paterson, H M; Gibb, A P

    2011-06-01

    Healthcare workers' mobile phones provide a reservoir of bacteria known to cause nosocomial infections. UK National Health Service restrictions on the utilization of mobile phones within hospitals have been relaxed; however, utilization of these devices by inpatients and the risk of cross-contamination are currently unknown. Here, we examine demographics and characteristics of mobile phone utilization by inpatients and phone surface microbial contamination. One hundred and two out of 145 (70.3%) inpatients who completed a questionnaire detailing their opinions and utilization of mobile phones, also provided their mobile phones for bacteriological analysis and comparative bacteriological swabs from their nasal cavities; 92.4% of patients support utilization of mobile phones by inpatients; indeed, 24.5% of patients stated that mobile phones were vital to their inpatient stay. Patients in younger age categories were more likely to possess a mobile phone both inside and outside hospital (p <0.01) but there was no gender association. Eighty-six out of 102 (84.3%) patients' mobile phone swabs were positive for microbial contamination. Twelve (11.8%) phones grew bacteria known to cause nosocomial infection. Seven (6.9%) phones and 32 (31.4%) nasal swabs demonstrated Staphylococcus aureus contamination. MSSA/MRSA contamination of phones was associated with concomitant nasal colonization. Patient utilization of mobile phones in the clinical setting is popular and common; however, we recommend that patients are educated by clear guidelines and advice on inpatient mobile phone etiquette, power charging safety, regular cleaning of phones and hand hygiene, and advised not to share phones or related equipment with other inpatients in order to prevent transmission of bacteria. 2011 The Authors. Clinical Microbiology and Infection; 2011 European Society of Clinical Microbiology and Infectious Diseases.

  15. Diabetes diagnosis, resource utilization, and health outcomes.

    PubMed

    Gulliford, Martin C; Latinovic, Radoslav; Charlton, Judith

    2008-01-01

    To determine the effect of a clinical diagnosis of diabetes mellitus (DM) on healthcare utilization and health outcomes. Cohort study. A total of 197 United Kingdom family practices with 4974 subjects (mean age, 62.8 years; 52.2% men) with type 2 DM and 9948 matched nondiabetic control subjects. Healthcare utilization and the occurrence of complications were estimated from 2 years before to 2 years after the first clinical diagnosis of DM. From 24 months before the DM diagnosis, primary care consultations were increased in prediagnosis cases compared with controls (relative rate [RR], 1.31; 95% confidence interval [CI], 1.27-1.35), as were emergency and hospital care consultations, hospital specialist referrals, and prescription drug items. At diagnosis of DM, utilization of all forms of healthcare was increased (RR, 4.27; 95% CI, 4.17-4.36 for primary care consultations; RR, 2.49; 95% CI, 2.46-2.52 for prescription drug items). In the quarter following diagnosis, healthcare utilization was increased for acute myocardial infarction (RR, 6.29; 95% CI, 2.69-14.73), cerebrovascular disease (RR, 5.14; 95% CI, 3.37-7.84), ischemic heart disease (RR, 3.65; 95% CI, 2.77-4.80), and peripheral nerve disorders (RR, 5.01; 95% CI, 2.81-8.95). First diagnoses of myocardial infarction, cerebrovascular disease, and peripheral nerve disorders were increased during the period from 6 months before to 6 months after diagnosis. Clinical diagnosis of DM is often the end of a process leading to established complications and is associated with greatly increased utilization of care. This adds to the justification of strategies for earlier detection of hyperglycemic states.

  16. The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

    PubMed

    Fleeman, N; McLeod, C; Bagust, A; Beale, S; Boland, A; Dundar, Y; Jorgensen, A; Payne, K; Pirmohamed, M; Pushpakom, S; Walley, T; de Warren-Penny, P; Dickson, R

    2010-01-01

    To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources. The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members. A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out. For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing. Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

  17. The laboratory test utilization management toolbox

    PubMed Central

    Baird, Geoffrey

    2014-01-01

    Efficiently managing laboratory test utilization requires both ensuring adequate utilization of needed tests in some patients and discouraging superfluous tests in other patients. After the difficult clinical decision is made to define the patients that do and do not need a test, a wealth of interventions are available to the clinician and laboratorian to help guide appropriate utilization. These interventions are collectively referred to here as the utilization management toolbox. Experience has shown that some tools in the toolbox are weak and other are strong, and that tools are most effective when many are used simultaneously. While the outcomes of utilization management studies are not always as concrete as may be desired, what data is available in the literature indicate that strong utilization management interventions are safe and effective measures to improve patient health and reduce waste in an era of increasing financial pressure. PMID:24969916

  18. Reversible Nerve Conduction Block Using Kilohertz Frequency Alternating Current

    PubMed Central

    Kilgore, Kevin L.; Bhadra, Niloy

    2013-01-01

    Objectives The features and clinical applications of balanced-charge kilohertz frequency alternating currents (KHFAC) are reviewed. Preclinical studies of KHFAC block have demonstrated that it can produce an extremely rapid and reversible block of nerve conduction. Recent systematic analysis and experimentation utilizing KHFAC block has resulted in a significant increase in interest in KHFAC block, both scientifically and clinically. Materials and Methods We review the history and characteristics of KHFAC block, the methods used to investigate this type of block, the experimental evaluation of block, and the electrical parameters and electrode designs needed to achieve successful block. We then analyze the existing clinical applications of high frequency currents, comparing the early results with the known features of KHFAC block. Results Although many features of KHFAC block have been characterized, there is still much that is unknown regarding the response of neural structures to rapidly fluctuating electrical fields. The clinical reports to date do not provide sufficient information to properly evaluate the mechanisms that result in successful or unsuccessful treatment. Conclusions KHFAC nerve block has significant potential as a means of controlling nerve activity for the purpose of treating disease. However, early clinical studies in the use of high frequency currents for the treatment of pain have not been designed to elucidate mechanisms or allow direct comparisons to preclinical data. We strongly encourage the careful reporting of the parameters utilized in these clinical studies, as well as the development of outcome measures that could illuminate the mechanisms of this modality. PMID:23924075

  19. A systematic review of near real-time and point-of-care clinical decision support in anesthesia information management systems.

    PubMed

    Simpao, Allan F; Tan, Jonathan M; Lingappan, Arul M; Gálvez, Jorge A; Morgan, Sherry E; Krall, Michael A

    2017-10-01

    Anesthesia information management systems (AIMS) are sophisticated hardware and software technology solutions that can provide electronic feedback to anesthesia providers. This feedback can be tailored to provide clinical decision support (CDS) to aid clinicians with patient care processes, documentation compliance, and resource utilization. We conducted a systematic review of peer-reviewed articles on near real-time and point-of-care CDS within AIMS using the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Studies were identified by searches of the electronic databases Medline and EMBASE. Two reviewers screened studies based on title, abstract, and full text. Studies that were similar in intervention and desired outcome were grouped into CDS categories. Three reviewers graded the evidence within each category. The final analysis included 25 articles on CDS as implemented within AIMS. CDS categories included perioperative antibiotic prophylaxis, post-operative nausea and vomiting prophylaxis, vital sign monitors and alarms, glucose management, blood pressure management, ventilator management, clinical documentation, and resource utilization. Of these categories, the reviewers graded perioperative antibiotic prophylaxis and clinical documentation as having strong evidence per the peer reviewed literature. There is strong evidence for the inclusion of near real-time and point-of-care CDS in AIMS to enhance compliance with perioperative antibiotic prophylaxis and clinical documentation. Additional research is needed in many other areas of AIMS-based CDS.

  20. Comorbidity profile and healthcare utilization in elderly patients with serious mental illnesses.

    PubMed

    Hendrie, Hugh C; Lindgren, Donald; Hay, Donald P; Lane, Kathleen A; Gao, Sujuan; Purnell, Christianna; Munger, Stephanie; Smith, Faye; Dickens, Jeanne; Boustani, Malaz A; Callahan, Christopher M

    2013-12-01

    Patients with serious mental illness are living longer. Yet, there remain few studies that focus on healthcare utilization and its relationship with comorbidities in these elderly mentally ill patients. Comparative study. Information on demographics, comorbidities, and healthcare utilization was taken from an electronic medical record system. Wishard Health Services senior care and community mental health clinics. Patients age 65 years and older-255 patients with serious mental illness (schizophrenia, major recurrent depression, and bipolar illness) attending a mental health clinic and a representative sample of 533 nondemented patients without serious mental illness attending primary care clinics. Patients having serious mental illness had significantly higher rates of medical emergency department visits (p = 0.0027) and significantly longer lengths of medical hospitalizations (p <0.0001) than did the primary care control group. The frequency of medical comorbidities such as diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, thyroid disease, and cancer was not significantly different between the groups. Hypertension was lower in the mentally ill group (p <0.0001). Reported falls (p <0.0001), diagnoses of substance abuse (p = 0.02), and alcoholism (p = 0.0016) were higher in the seriously mentally ill. The differences in healthcare utilization between the groups remained significant after adjusting for comorbidity levels, lifestyle factors, and attending primary care. Our findings of higher rates of emergency care, longer hospitalizations, and increased frequency of falls, substance abuse, and alcoholism suggest that seriously mentally ill older adults remain a vulnerable population requiring an integrated model of healthcare. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  1. Health services outcomes for a diabetes disease management program for the elderly.

    PubMed

    Berg, Gregory D; Wadhwa, Sandeep

    2007-08-01

    Our objective was to investigate the utilization, drug, and clinical outcomes of a telephonic nursing disease management (DM) program for elderly patients with diabetes. We employed a 24-month, matched-cohort study employing propensity score matching. The setting involved Medicare + Choice recipients residing in Ohio, Kentucky, and Indiana. There were 610 intervention group members over the age of 65 matched to a control group of members over the age of 65. The DM diabetes program employed a structured, evidence-based, telephonic nursing intervention designed to provide patient education, counseling, and monitoring services. Measurements consisted of Medical service utilization, including hospitalizations, emergency department visits, physician evaluation and management visits, skilled nursing facility days, drug utilization, and selected clinical indicators. Among the results, the intervention group had considerably and significantly lower rates of acute service utilization compared to the control group, including a 17.5% reduction in hospitalizations, 22.4% reduction in bed days, 12.3% increase in physician evaluation and management visits, 23.7% increase in angiotensin-converting enzyme (ACE) inhibitor use, 13.3% increase in blood glucose regulator use, 11.8% increase in hemoglobin A1c (HbA1c) tests, 10.3% increase in lipid panels, 26.0% increase in eye exams, and 35.5% increase in microalbumin tests. In conclusion, the study demonstrates that a commercially delivered diabetes DM program significantly reduces hospitalizations and bed-days while increasing the use of ACE inhibitors and blood glucose regulators along with selected clinical procedures such as HbA1c tests, lipid panels, eye exams, and microalbumin tests.

  2. Open Knee: Open Source Modeling & Simulation to Enable Scientific Discovery and Clinical Care in Knee Biomechanics

    PubMed Central

    Erdemir, Ahmet

    2016-01-01

    Virtual representations of the knee joint can provide clinicians, scientists, and engineers the tools to explore mechanical function of the knee and its tissue structures in health and disease. Modeling and simulation approaches such as finite element analysis also provide the possibility to understand the influence of surgical procedures and implants on joint stresses and tissue deformations. A large number of knee joint models are described in the biomechanics literature. However, freely accessible, customizable, and easy-to-use models are scarce. Availability of such models can accelerate clinical translation of simulations, where labor intensive reproduction of model development steps can be avoided. The interested parties can immediately utilize readily available models for scientific discovery and for clinical care. Motivated by this gap, this study aims to describe an open source and freely available finite element representation of the tibiofemoral joint, namely Open Knee, which includes detailed anatomical representation of the joint's major tissue structures, their nonlinear mechanical properties and interactions. Three use cases illustrate customization potential of the model, its predictive capacity, and its scientific and clinical utility: prediction of joint movements during passive flexion, examining the role of meniscectomy on contact mechanics and joint movements, and understanding anterior cruciate ligament mechanics. A summary of scientific and clinically directed studies conducted by other investigators are also provided. The utilization of this open source model by groups other than its developers emphasizes the premise of model sharing as an accelerator of simulation-based medicine. Finally, the imminent need to develop next generation knee models are noted. These are anticipated to incorporate individualized anatomy and tissue properties supported by specimen-specific joint mechanics data for evaluation, all acquired in vitro from varying age groups and pathological states. PMID:26444849

  3. Association Between Intensive Care Unit Utilization During Hospitalization and Costs, Use of Invasive Procedures, and Mortality.

    PubMed

    Chang, Dong W; Shapiro, Martin F

    2016-10-01

    Maximizing the value of critical care services requires understanding the relationship between intensive care unit (ICU) utilization, clinical outcomes, and costs. To examine whether hospitals had consistent patterns of ICU utilization across 4 common medical conditions and the association between higher use of the ICU and hospital costs, use of invasive procedures, and mortality. Retrospective cohort study of 156 842 hospitalizations in 94 acute-care nonfederal hospitals for diabetic ketoacidosis (DKA), pulmonary embolism (PE), upper gastrointestinal bleeding (UGIB), and congestive heart failure (CHF) in Washington state and Maryland from 2010 to 2012. Hospitalizations for DKA, PE, UGIB, and CHF were identified from the presence of compatible International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Multilevel logistic regression models were used to determine the predicted hospital-level ICU utilization during hospitalizations for the 4 study conditions. For each condition, hospitals were ranked based on the predicted ICU utilization rate to examine the variability in ICU utilization across institutions. The primary outcomes were associations between hospital-level ICU utilization rates and risk-adjusted hospital mortality, use of invasive procedures, and hospital costs. The 94 hospitals and 156 842 hospitalizations included in the study represented 4.7% of total hospitalizations in this study. ICU admission rates ranged from 16.3% to 81.2% for DKA, 5.0% to 44.2% for PE, 11.5% to 51.2% for UGIB, and 3.9% to 48.8% for CHF. Spearman rank coefficients between DKA, PE, UGIB, and CHF showed significant correlations in ICU utilization for these 4 medical conditions among hospitals (ρ ≥ 0.90 for all comparisons; P < .01 for all). For each condition, hospital-level ICU utilization rate was not associated with hospital mortality. Use of invasive procedures and costs of hospitalization were greater in institutions with higher ICU utilization for all 4 conditions. For medical conditions where ICU care is frequently provided, but may not always be necessary, institutions that utilize ICUs more frequently are more likely to perform invasive procedures and have higher costs but have no improvement in hospital mortality. Hospitals had similar ICU utilization patterns across the 4 medical conditions, suggesting that systematic institutional factors may influence decisions to potentially overutilize ICU care. Interventions that seek to improve the value of critical care services will need to address these factors that lead clinicians to admit patients to higher levels of care when equivalent care can be delivered elsewhere in the hospital.

  4. Cost-utility Analysis of Supported Self-management with Motiva-tional Interviewing for Patients with Psoriasis.

    PubMed

    Larsen, Marie H; Wahl, Astrid K; Krogstad, Anne-Lene; Aas, Eline

    2016-06-15

    There are few studies evaluating the cost-effectiveness of self-management interventions for patients with psoriasis. Motivational interviewing (MI) as a telephone follow-up after climate-heliotherapy was effective on several clinical parameters, but its cost-effectiveness is unknown. A cost-utility analysis was conducted alongside a randomized controlled trial (RCT) comparing MI with usual care. A total of 169 Norwegian patients were included. A within-trial analysis compared the costs and quality-adjusted life years (QALYs). Utilities were measured with the 15D instrument, supplemented with Dermatological Life Quality Index (DLQI). A time-integrated summary score defined the clinical effects. QALYs were adjusted for baseline differences. MI provided equivalent quality of life and utility (15D: -0.0022 QALYs (95% Cl -0.02, 0.01), p = 0.77, and DLQI: -0.62 QALYs (95%CI -0.65, 0.41), p = 0.24, at lower costs €-1103 (-2293, 87), p = 0.058, compared with treatment-as-usual. The MI intervention was thus cost-effective. This result was more evident when using the DLQI as outcome measure compared with 15D.

  5. Accessibility and utilization patterns of a mobile medical clinic among vulnerable populations.

    PubMed

    Gibson, Britton A; Ghosh, Debarchana; Morano, Jamie P; Altice, Frederick L

    2014-07-01

    We mapped mobile medical clinic (MMC) clients for spatial distribution of their self-reported locations and travel behaviors to better understand health-seeking and utilization patterns of medically vulnerable populations in Connecticut. Contrary to distance decay literature, we found that a small but significant proportion of clients was traveling substantial distances to receive repeat care at the MMC. Of 8404 total clients, 90.2% lived within 5 miles of a MMC site, yet mean utilization was highest (5.3 visits per client) among those living 11-20 miles of MMCs, primarily for those with substance use disorders. Of clients making >20 visits, 15.0% traveled >10 miles, suggesting that a significant minority of clients traveled to MMC sites because of their need-specific healthcare services, which are not only free but available at an acceptable and accommodating environment. The findings of this study contribute to the important research on healthcare utilization among vulnerable population by focusing on broader dimensions of accessibility in a setting where both mobile and fixed healthcare services coexist. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. [Impact of driving cessation on daily transportation utility in elderly people with cognitive decline: a survey of patients in the memory clinic of an urban university hospital].

    PubMed

    Kawano, Naoko; Makino, Taeko; Suzuki, Yusuke; Umegaki, Hiroyuki

    2009-09-01

    In the present study our goal was to explore the impact of driving cessation on daily transportation utility in older people with cognitive decline. A total of 101 older persons participated in our survey of responding of a questionnaire about driving and other methods for traveling, administered at the memory clinic of the geriatric outpatient unit of Nagoya University Hospital. Of this total, 48 (47.5%) still had driving licenses, 16 (15.8%) had licenses that had expired, and 37 (36.6%) had no driving experience. The majority of license holders (77.1%) were active drivers, and we found that license holders tend to utilize public transport loss than older people without driving experience. Furthermore, among those who had ceased driving, there was a contrast in daily transportation utility between those with dementia and those without dementia, with the former accessing public transport less frequently. When clinicians advise drivers with dementia to cease driving, these patients need special attention to assist them in providing alternative ways of transportation.

  7. An evaluation of public, private, and mobile health clinic usage for children under age 5 in Aceh after the tsunami: implications for future disasters

    PubMed Central

    Rassekh, Bahie Mary; Shu, Winnie; Santosham, Mathuram; Burnham, Gilbert; Doocy, Shannon

    2014-01-01

    Background: Aceh, Indonesia, was the hardest-hit area in the 26 December 2004 Indian Ocean earthquake and tsunami, with more than 500,000 people displaced, 120,000 people dead, and total damages and losses estimated at $4.5 billion. The relief effort following the tsunami was also immense. Objectives: This study aimed to determine and assess utilization patterns of formal public versus private and mobile health services for children under age 5 with diarrhea, cough and difficulty breathing, fever, or skin disease and to identify determinants of care usage. Methods: A household survey of 962 households was administered to caretakers of children aged 1–5 years. A sample of clusters within Banda Aceh and Aceh Besar were selected and those caretakers within the cluster who fit the inclusion criteria were interviewed. Results: Of those caretakers who utilized formal health services as the first line of care for their sick child, 62% used a public health facility, 30% used a private health facility, and 8% used a mobile clinic. In terms of significant factors associated with public, private, and mobile care utilization, mobile clinics were at one side of the spectrum and private clinics were at the other side overall, with public care somewhere in between. This was true for several variables. Mobile clinic users reported the lowest cost of services and medicine and the highest perceived level of accessibility, and private care users reported the highest perceived level of satisfaction. Conclusions: Utilization of formal health services for children was quite high after the tsunami. The caretaker's perceived satisfaction with public health services could have been improved. Mobile clinics were an accessible source of health care and could be used in future disaster relief efforts to target those populations that seek less care for their sick children, including displaced populations, and those children whose parents have died. PMID:25750788

  8. Open Globe Injury Patient Identification in Warfare Clinical Notes1

    PubMed Central

    Apostolova, Emilia; White, Helen A.; Morris, Patty A.; Eliason, David A.; Velez, Tom

    2017-01-01

    The aim of this study is to utilize the Defense and Veterans Eye Injury and Vision Registry clinical data derived from DoD and VA medical systems which include documentation of care while in combat, and develop methods for comprehensive and reliable Open Globe Injury (OGI) patient identification. In particular, we focus on the use of free-form clinical notes, since structured data, such as diagnoses or procedure codes, as found in early post-trauma clinical records, may not be a comprehensive and reliable indicator of OGIs. The challenges of the task include low incidence rate (few positive examples), idiosyncratic military ophthalmology vocabulary, extreme brevity of notes, specialized abbreviations, typos and misspellings. We modeled the problem as a text classification task and utilized a combination of supervised learning (SVMs) and word embeddings learnt in a unsupervised manner, achieving a precision of 92.50% and a recall of89.83%o. The described techniques are applicable to patient cohort identification with limited training data and low incidence rate. PMID:29854104

  9. Decision theory and the evaluation of risks and benefits of clinical trials.

    PubMed

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. Copyright © 2012 Elsevier Ltd. All rights reserved.

  10. Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis

    PubMed Central

    Nicholas, Timothy; Tsai, Kuenhi; Macha, Sreeraj; Sinha, Vikram; Stone, Julie; Corrigan, Brian; Bani, Massimo; Muglia, Pierandrea; Watson, Ian A.; Kern, Volker D.; Sheveleva, Elena; Marek, Kenneth; Stephenson, Diane T.; Romero, Klaus

    2017-01-01

    Abstract Given the recognition that disease‐modifying therapies should focus on earlier Parkinson's disease stages, trial enrollment based purely on clinical criteria poses significant challenges. The goal herein was to determine the utility of dopamine transporter neuroimaging as an enrichment biomarker in early motor Parkinson's disease clinical trials. Patient‐level longitudinal data of 672 subjects with early‐stage Parkinson's disease in the Parkinson's Progression Markers Initiative (PPMI) observational study and the Parkinson Research Examination of CEP‐1347 Trial (PRECEPT) clinical trial were utilized in a linear mixed‐effects model analysis. The rate of worsening in the motor scores between subjects with or without a scan without evidence of dopamine transporter deficit was different both statistically and clinically. The average difference in the change from baseline of motor scores at 24 months between biomarker statuses was –3.16 (90% confidence interval [CI] = –0.96 to –5.42) points. Dopamine transporter imaging could identify subjects with a steeper worsening of the motor scores, allowing trial enrichment and 24% reduction of sample size. PMID:28749580

  11. An Update on Renal Artery Denervation and Its Clinical Impact on Hypertensive Disease

    PubMed Central

    Kuang, Ye Min; Gan, Gary C. H.; Burgess, David; Denniss, Alan Robert

    2015-01-01

    Hypertension is a globally prevalent condition, with a heavy clinical and economic burden. It is the predominant risk factor for premature cardiovascular and cerebrovascular disease, and is associated with a variety of clinical disorders including stroke, congestive cardiac failure, ischaemic heart disease, chronic renal failure, and peripheral arterial disease. A significant subset of hypertensive patients have resistant hypertensive disease. In this group of patients, catheter-based renal artery denervation has emerged as a potential therapy, with favourable clinical efficacy and safety in early trials. Additional benefits of this therapy are also being identified and include effects on left ventricular remodeling, cardiac performance, and symptom status in congestive cardiac failure. Utility of renal denervation for the management of resistant hypertension, however, has become controversial since the release of the Symplicity HTN-3 trial, the first large-scale blinded randomised study investigating the efficacy and safety of renal artery denervation. The aim of this paper is to evaluate the history, utility, and clinical efficacy of renal artery denervation technology, including an in-depth appraisal of the current literature and principal trials. PMID:26495305

  12. Cervicitis: limited clinical utility for the detection of Mycoplasma genitalium in a cross-sectional study of women attending a New Zealand sexual health clinic.

    PubMed

    Oliphant, Jeannie; Azariah, Sunita

    2013-07-01

    Although multiple studies have confirmed Mycoplasma genitalium as a cause of nongonococcal urethritis in men, there is less evidence of its pathogenicity in women. Our aims were to determine the prevalence of M. genitalium in a sample of women attending a sexual health clinic and to assess whether there was any association between the detection of M. genitalium and a diagnosis of cervicitis in this population. A cross-sectional study recruited women who required screening for sexually transmissible infections. Endocervical swabs to detect the presence of M. genitalium were taken in addition to routine testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Data were collected on demographics, sexual behaviour, clinical symptoms and the presence of clinical or microscopic cervicitis. The prevalence of M. genitalium was 8.4% (n=22, 95% confidence interval (CI): 5.4-12.5%) in the study sample of 261 women. There was an association between the finding of cervical contact bleeding (odds ratio OR): 5.45; 95% CI: 1.93-15.42, P=0.001) and microscopic cervicitis (OR: 2.64; 95% CI: 0.95-7.34, P=0.06) and the presence of M. genitalium when compared with women with no diagnosed infection; however, the latter finding was not statistically significant. Although the prevalence of M. genitalium was high at 8.4%, the overall lack of any association between the findings of cervicitis and the detection of M. genitalium support the conclusion that cervicitis has poor clinical utility as an indicator for the presence of M. genitalium infection.

  13. Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial.

    PubMed

    Alexander, John C; Minhajuddin, Abu; Joshi, Girish P

    2017-08-01

    Use of healthcare-related smartphone applications is common. However, there is concern that inaccurate information from these applications may lead patients to make erroneous healthcare decisions. The objective of this study is to study smartphone applications purporting to measure vital sign data using only onboard technology compared with monitors used routinely in clinical practice. This is a prospective trial comparing correlation between a clinically utilized vital sign monitor (Propaq CS, WelchAllyn, Skaneateles Falls, NY, USA) and four smartphone application-based monitors Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter, and Pulse Oximeter Pro. We performed measurements of heart rate (HR), systolic blood pressures (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO 2 ) using standard monitor and four smartphone applications. Analysis of variance was used to compare measurements from the applications to the routine monitor. The study was completed on 100 healthy volunteers. Comparison of routine monitor with the smartphone applications shows significant differences in terms of HR, SpO 2 and DBP. The SBP values from the applications were not significantly different from those from the routine monitor, but had wide limits of agreement signifying a large degree of variation in the compared values. The degree of correlation between monitors routinely used in clinical practice and the smartphone-based applications studied is insufficient to recommend clinical utilization. This lack of correlation suggests that the applications evaluated do not provide clinically meaningful data. The inaccurate data provided by these applications can potentially contribute to patient harm.

  14. Validation and diagnostic utility of the dementia rating scale in a mixed dementia population.

    PubMed

    McCulloch, Katie; Collins, Robert L; Maestas, Kacey L; LeMaire, Ashley W; Pacheco, Vitor

    2014-01-01

    The Dementia Severity Rating Scale (DSRS), a previously validated caregiver-based measure assessing dementia severity, was recently revised to improve clarity. Our study aims included: (1) identifying the DSRS factor structure, (2) examining the relation between neuropsychological measures, the Mini-Mental State Examination, and clinical diagnoses with the DSRS, and (3) determining the clinical utility of the DSRS in a mixed clinical sample. A total of 270 veterans were referred to a cognitive disorders clinic at a VA medical center and completed neuropsychological, affective, and cognitive screening measures. Caregivers completed the DSRS. Principal components analysis identified a 2-factor solution. After controlling for age and education, memory and language were related to the Cognitive factor, whereas attention, processing speed, visuospatial processing, and executive functioning were related to both Cognitive and Self-Care factors. Neither factors correlated with depression. The total DSRS score was able to differentiate patients by the Mini-Mental State Examination scores and diagnoses of mild cognitive impairment and dementia (mixed vascular Alzheimer, vascular dementia, and Alzheimer disease). A cut-score >15 was optimal for detecting dementia in a mixed clinical sample (sensitivity=0.41, specificity=0.79), with a posttest probability of 74%. This study suggests that the DSRS improves detection of dementia and requires minimal effort to implement.

  15. Clinical utility of therapeutic drug monitoring in biological disease modifying anti-rheumatic drug treatment of rheumatic disorders: a systematic narrative review.

    PubMed

    Van Herwaarden, Noortje; Van Den Bemt, Bart J F; Wientjes, Maike H M; Kramers, Cornelis; Den Broeder, Alfons A

    2017-08-01

    Biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) have improved the treatment outcomes of inflammatory rheumatic diseases including Rheumatoid Arthritis and spondyloarthropathies. Inter-individual variation exists in (maintenance of) response to bDMARDs. Therapeutic Drug Monitoring (TDM) of bDMARDs could potentially help in optimizing treatment for the individual patient. Areas covered: Evidence of clinical utility of TDM in bDMARD treatment is reviewed. Different clinical scenarios will be discussed, including: prediction of response after start of treatment, prediction of response to a next bDMARD in case of treatment failure of the first, prediction of successful dose reduction or discontinuation in case of low disease activity, prediction of response to dose-escalation in case of active disease and prediction of response to bDMARD in case of flare in disease activity. Expert opinion: The limited available evidence does often not report important outcomes for diagnostic studies, such as sensitivity and specificity. In most clinical relevant scenarios, predictive value of serum (anti-) drug levels is absent, therefore the use of TDM of bDMARDs cannot be advocated. Well-designed prospective studies should be done to further investigate the promising scenarios to determine the place of TDM in clinical practice.

  16. Posaconazole exposure-response relationship: evaluating the utility of therapeutic drug monitoring.

    PubMed

    Dolton, Michael J; Ray, John E; Marriott, Deborah; McLachlan, Andrew J

    2012-06-01

    Posaconazole has become an important part of the antifungal armamentarium in the prophylaxis and salvage treatment of invasive fungal infections (IFIs). Structurally related to itraconazole, posaconazole displays low oral bioavailability due to poor solubility, with significant drug interactions and gastrointestinal disease also contributing to the generally low posaconazole plasma concentrations observed in patients. While therapeutic drug monitoring (TDM) of plasma concentrations is widely accepted for other triazole antifungal agents such as voriconazole, the utility of TDM for posaconazole is controversial due to debate over the relationship between posaconazole exposure in plasma and clinical response to therapy. This review examines the available evidence for a relationship between plasma concentration and clinical efficacy for posaconazole, as well as evaluating the utility of TDM and providing provisional target concentrations for posaconazole therapy. Increasing evidence supports an exposure-response relationship for plasma posaconazole concentrations for prophylaxis and treatment of IFIs; a clear relationship has not been identified between posaconazole concentration and toxicity. Intracellular and intrapulmonary concentrations have been studied for posaconazole but have not been correlated to clinical outcomes. In view of the high mortality and cost associated with the treatment of IFIs, increasing evidence of an exposure-response relationship for posaconazole efficacy in the prevention and treatment of IFIs, and the common finding of low posaconazole concentrations in patients, TDM for posaconazole is likely to be of significant clinical utility. In patients with subtherapeutic posaconazole concentrations, increased dose frequency, administration with high-fat meals, and withdrawal of interacting medications from therapy are useful strategies to improve systemic absorption.

  17. Productivity, Quality, and Patient Satisfaction

    PubMed Central

    Fairchild, David G; McLoughlin, Karen Sax; Gharib, Soheyla; Horsky, Jan; Portnow, Michelle; Richter, James; Gagliano, Nancy; Bates, David W

    2001-01-01

    CONTEXT Although few data are available, many believe that part-time primary care physicians (PCPs) are less productive and provide lower quality care than full-time PCPs. Some insurers exclude part-time PCPs from their provider networks. OBJECTIVE To compare productivity, qualtiy of preventive care, patient satisfaction, and risk-adjusted resource utilization of part-time and full-time PCPs. DESIGN Retrospective cohort study. SETTING Boston. PARTICIPANTS PCPs affiliated with 2 academic outpatient primary care networks. MEASUREMENTS PCP productivity, patient satisfaction, resource utilization, and compliance with screening guidelines. RESULTS Part-time PCP productivity was greater than that of full-time PCPs (2.1 work relative value units (RVUs)/bookable clinical hour versus 1.3 work RVUs/bookable clinical hour, P < .01). A similar proportion of part-time PCPs (80%) and full-time PCPs (75%) met targets for mammography, Pap smears, and cholesterol screening (P = .67). After adjusting for clinical case mix, practice location, gender, board certification status, and years in practice, resource utilization of part-time PCPs ($138 [95% confidence interval (CI), $108 to $167]) was similar to that of full-time PCPs ($139 [95% CI, $108 to $170], P = .92). Patient satisfation was similar for part-time and full-time PCPs. CONCLUSIONS In these academic primary care practices, rates of patient satisfaction, compliance with screenig guidelines, and resource utilization were similar for part-time PCPs compared to full-time PCPs. Productivity per clinical hour was markedly higher for part-time PCPs are atleast as efficient as full-time PCPs and that the quality of their work is similar. PMID:11679033

  18. Pharmacogenetics in Europe: barriers and opportunities.

    PubMed

    Gurwitz, D; Zika, E; Hopkins, M M; Gaisser, S; Ibarreta, D

    2009-01-01

    This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC) has conducted a review of the 'state of the art' and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. It therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics. Copyright 2009 S. Karger AG, Basel.

  19. Study Designs and Statistical Analyses for Biomarker Research

    PubMed Central

    Gosho, Masahiko; Nagashima, Kengo; Sato, Yasunori

    2012-01-01

    Biomarkers are becoming increasingly important for streamlining drug discovery and development. In addition, biomarkers are widely expected to be used as a tool for disease diagnosis, personalized medication, and surrogate endpoints in clinical research. In this paper, we highlight several important aspects related to study design and statistical analysis for clinical research incorporating biomarkers. We describe the typical and current study designs for exploring, detecting, and utilizing biomarkers. Furthermore, we introduce statistical issues such as confounding and multiplicity for statistical tests in biomarker research. PMID:23012528

  20. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer: A Multi-Institutional Validation Trial

    DTIC Science & Technology

    2017-10-01

    mRNA and has been shown in many studies to improve predictive accuracy for cancer on initial biopsy,3,7-9 and to be correlated with more aggressive... Study (PASS). We are in the process of evaluating these three biomarker panels in tissue, blood, and urine samples with well annotated clinical and...during AS. The objective of the study is to utilize analytically validated assays that take into account tumor heterogeneity to measure biomarkers in

  1. Genomic characterization of malonate positive Cronobacter sakazakii serotype O:2, sequence type 64 strains, isolated from clinical, food, and environment samples.

    PubMed

    Gopinath, Gopal R; Chase, Hannah R; Gangiredla, Jayanthi; Eshwar, Athmanya; Jang, Hyein; Patel, Isha; Negrete, Flavia; Finkelstein, Samantha; Park, Eunbi; Chung, TaeJung; Yoo, YeonJoo; Woo, JungHa; Lee, YouYoung; Park, Jihyeon; Choi, Hyerim; Jeong, Seungeun; Jun, Soyoung; Kim, Mijeong; Lee, Chaeyoon; Jeong, HyeJin; Fanning, Séamus; Stephan, Roger; Iversen, Carol; Reich, Felix; Klein, Günter; Lehner, Angelika; Tall, Ben D

    2018-01-01

    Malonate utilization, an important differential trait, well recognized as being possessed by six of the seven Cronobacter species is thought to be largely absent in Cronobacter sakazakii (Csak). The current study provides experimental evidence that confirms the presence of a malonate utilization operon in 24 strains of sequence type (ST) 64, obtained from Europe, Middle East, China, and USA; it offers explanations regarding the genomic diversity and phylogenetic relatedness among these strains, and that of other C. sakazakii strains. In this study, the presence of a malonate utilization operon in these strains was initially identified by DNA microarray analysis (MA) out of a pool of 347 strains obtained from various surveillance studies involving clinical, spices, milk powder sources and powdered infant formula production facilities in Ireland and Germany, and dried dairy powder manufacturing facilities in the USA. All ST64 C. sakazakii strains tested could utilize malonate. Zebrafish embryo infection studies showed that C. sakazakii ST64 strains are as virulent as other Cronobacter species. Parallel whole genome sequencing (WGS) and MA showed that the strains phylogenetically grouped as a separate clade among the Csak species cluster. Additionally, these strains possessed the Csak O:2 serotype. The nine-gene, ~ 7.7 kbp malonate utilization operon was located in these strains between two conserved flanking genes, gyrB and katG. Plasmidotyping results showed that these strains possessed the virulence plasmid pESA3, but in contrast to the USA ST64 Csak strains, ST64 Csak strains isolated from sources in Europe and the Middle East, did not possess the type six secretion system effector vgrG gene. Until this investigation, the presence of malonate-positive Csak strains, which are associated with foods and clinical cases, was under appreciated. If this trait was used solely to identify Cronobacter strains, many strains would likely be misidentified. Parallel WGS and MA were useful in characterizing the total genome content of these Csak O:2, ST64, malonate-positive strains and further provides an understanding of their phylogenetic relatedness among other virulent C. sakazakii strains.

  2. Meditation Awareness Training for the Treatment of Sex Addiction: A Case Study

    PubMed Central

    Van Gordon, William; Shonin, Edo; Griffiths, Mark D.

    2016-01-01

    Background Sex addiction is a disorder that can have serious adverse functional consequences. Treatment effectiveness research for sex addiction is currently underdeveloped, and interventions are generally based on the guidelines for treating other behavioral (as well as chemical) addictions. Consequently, there is a need to clinically evaluate tailored treatments that target the specific symptoms of sex addiction. It has been proposed that second-generation mindfulness-based interventions (SG-MBIs) may be an appropriate treatment for sex addiction because in addition to helping individuals increase perceptual distance from craving for desired objects and experiences, some SG-MBIs specifically contain meditations intended to undermine attachment to sex and/or the human body. The current study conducts the first clinical investigation into the utility of mindfulness for treating sex addiction. Case presentation An in-depth clinical case study was conducted involving an adult male suffering from sex addiction that underwent treatment utilizing an SG-MBI known as Meditation Awareness Training (MAT). Following completion of MAT, the participant demonstrated clinically significant improvements in addictive sexual behavior, as well as reductions in depression and psychological distress. The MAT intervention also led to improvements in sleep quality, job satisfaction, and non-attachment to self and experiences. Salutary outcomes were maintained at 6-month follow-up. Discussion and conclusion The current study extends the literature exploring the applications of mindfulness for treating behavioral addiction, and findings indicate that further clinical investigation into the role of mindfulness for treating sex addiction is warranted. PMID:27348560

  3. A multi-institution evaluation of clinical profile anonymization

    PubMed Central

    Heatherly, Raymond; Rasmussen, Luke V; Peissig, Peggy L; Pacheco, Jennifer A; Harris, Paul; Denny, Joshua C

    2016-01-01

    Background and objective: There is an increasing desire to share de-identified electronic health records (EHRs) for secondary uses, but there are concerns that clinical terms can be exploited to compromise patient identities. Anonymization algorithms mitigate such threats while enabling novel discoveries, but their evaluation has been limited to single institutions. Here, we study how an existing clinical profile anonymization fares at multiple medical centers. Methods: We apply a state-of-the-art k-anonymization algorithm, with k set to the standard value 5, to the International Classification of Disease, ninth edition codes for patients in a hypothyroidism association study at three medical centers: Marshfield Clinic, Northwestern University, and Vanderbilt University. We assess utility when anonymizing at three population levels: all patients in 1) the EHR system; 2) the biorepository; and 3) a hypothyroidism study. We evaluate utility using 1) changes to the number included in the dataset, 2) number of codes included, and 3) regions generalization and suppression were required. Results: Our findings yield several notable results. First, we show that anonymizing in the context of the entire EHR yields a significantly greater quantity of data by reducing the amount of generalized regions from ∼15% to ∼0.5%. Second, ∼70% of codes that needed generalization only generalized two or three codes in the largest anonymization. Conclusions: Sharing large volumes of clinical data in support of phenome-wide association studies is possible while safeguarding privacy to the underlying individuals. PMID:26567325

  4. Rating scales for musician's dystonia

    PubMed Central

    Berque, Patrice; Jabusch, Hans-Christian; Altenmüller, Eckart; Frucht, Steven J.

    2013-01-01

    Musician's dystonia (MD) is a focal adult-onset dystonia most commonly involving the hand. It has much greater relative prevalence than non-musician’s focal hand dystonias, exhibits task specificity at the level of specific musical passages, and is a particularly difficult form of dystonia to treat. For most MD patients, the diagnosis confirms the end of their music performance careers. Research on treatments and pathophysiology is contingent upon measures of motor function abnormalities. In this review, we comprehensively survey the literature to identify the rating scales used in MD and the distribution of their use. We also summarize the extent to which the scales have been evaluated for their clinical utility, including reliability, validity, sensitivity, specificity to MD, and practicality for a clinical setting. Out of 135 publications, almost half (62) included no quantitative measures of motor function. The remaining 73 studies used a variety of choices from among 10 major rating scales. Most used subjective scales involving either patient or clinician ratings. Only 25% (18) of the studies used objective scales. None of the scales has been completely and rigorously evaluated for clinical utility. Whether studies involved treatments or pathophysiologic assays, there was a heterogeneous choice of rating scales used with no clear standard. As a result, the collective interpretive value of those studies is limited because the results are confounded by measurement effects. We suggest that the development and widespread adoption of a new clinically useful rating scale is critical for accelerating basic and clinical research in MD. PMID:23884039

  5. Meditation Awareness Training for the Treatment of Sex Addiction: A Case Study.

    PubMed

    Van Gordon, William; Shonin, Edo; Griffiths, Mark D

    2016-06-01

    Background Sex addiction is a disorder that can have serious adverse functional consequences. Treatment effectiveness research for sex addiction is currently underdeveloped, and interventions are generally based on the guidelines for treating other behavioral (as well as chemical) addictions. Consequently, there is a need to clinically evaluate tailored treatments that target the specific symptoms of sex addiction. It has been proposed that second-generation mindfulness-based interventions (SG-MBIs) may be an appropriate treatment for sex addiction because in addition to helping individuals increase perceptual distance from craving for desired objects and experiences, some SG-MBIs specifically contain meditations intended to undermine attachment to sex and/or the human body. The current study conducts the first clinical investigation into the utility of mindfulness for treating sex addiction. Case presentation An in-depth clinical case study was conducted involving an adult male suffering from sex addiction that underwent treatment utilizing an SG-MBI known as Meditation Awareness Training (MAT). Following completion of MAT, the participant demonstrated clinically significant improvements in addictive sexual behavior, as well as reductions in depression and psychological distress. The MAT intervention also led to improvements in sleep quality, job satisfaction, and non-attachment to self and experiences. Salutary outcomes were maintained at 6-month follow-up. Discussion and conclusion The current study extends the literature exploring the applications of mindfulness for treating behavioral addiction, and findings indicate that further clinical investigation into the role of mindfulness for treating sex addiction is warranted.

  6. Convergent Validity of the Early Memory Index in Two Primary Care Samples.

    PubMed

    Porcerelli, John H; Cogan, Rosemary; Melchior, Katherine A; Jasinski, Matthew J; Richardson, Laura; Fowler, Shannon; Morris, Pierre; Murdoch, William

    2016-01-01

    Karliner, Westrich, Shedler, and Mayman (1996) developed the Early Memory Index (EMI) to assess mental health, narrative coherence, and traumatic experiences in reports of early memories. We assessed the convergent validity of EMI scales with data from 103 women from an urban primary care clinic (Study 1) and data from 48 women and 24 men from a suburban primary care clinic (Study 2). Patients provided early memory narratives and completed self-report measures of psychopathology, trauma, and health care utilization. In both studies, lower scores on the Mental Health scale and higher scores on the Traumatic Experiences scale were related to higher scores on measures of psychopathology and childhood trauma. Less consistent associations were found between the Mental Health and Traumatic Experiences scores and measures of health care utilization. The Narrative Coherence scale showed inconsistent relationships across measures in both samples. In analyses assessing the overall fit between hypothesized and actual correlations between EMI scores and measures of psychopathology, severity of trauma symptoms, and health care utilization, the Mental Health scale of the EMI demonstrated stronger convergent validity than the EMI Traumatic Experiences scale. The results provide support for the convergent validity of the Mental Health scale of the EMI.

  7. Retail clinic utilization associated with lower total cost of care.

    PubMed

    Sussman, Andrew; Dunham, Lisette; Snower, Kristen; Hu, Min; Matlin, Olga S; Shrank, William H; Choudhry, Niteesh K; Brennan, Troyen

    2013-04-01

    To better understand the impact of retail clinic use on a patient's annual total cost of care. A propensity score matched-pair, cohort design was used to analyze healthcare spending patterns among CVS Caremark employees in the year following a visit to a MinuteClinic, the retail clinics inside CVS pharmacies. De-identified medical and pharmacy claims for CVS Caremark employees and their dependents who received care at a retail clinic between June 1, 2009, and May 31, 2010, were matched to those of subjects who received care elsewhere. High-dimensional propensity score and greedy matching techniques were used to create a 1-to-1 matched cohort that was analyzed using generalized linear regression models. Individuals using a retail clinic had a lower total cost of care (-$262; 95% confidence interval, -$510 to -$31; P = .025) in the year following their clinic visit than individuals who received care in other settings. This savings was primarily due to lower medical expenses at physicians' offices ($77 savings, P = .008) and hospital inpatient care ($121 savings, P = .049). The 6022 retail clinic users also had 142 (12%) fewer emergency department visits (P = .01), though this was not related to significant cost savings. This study found that retail clinic use was associated with lower overall total cost of care compared with that at alternative sites. Savings may extend beyond the retail clinic visit itself to other types of medical utilization.

  8. Ureteric Embolization for Lower Urinary Tract Fistulae: Use of Two Amplatzer Vascular Plugs and N-Butyl Cyanoacrylate Employing the 'Sandwich' Technique

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Saad, Wael E. A., E-mail: ws6r@virginia.edu; Kalagher, S.; Turba, U. C.

    2013-08-01

    PurposeThis study describes and evaluated the effectiveness of occluding distal ureters in the clinical setting of urinary vaginal (vesicovaginal or enterovesicovaginal) fistulae utilizing a new technique which combines Amplatzer vascular plugs and N-butyl cyanoacrylate.MaterialsThis is a retrospective study (January 2007-December 2010) of patients with urinary-vaginal fistulae undergoing distal ureter embolization utilizing an Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique. An 8-12-mm type-I or type-II Amplatzer vascular plug was delivered using the sheath and deployed in the ureter distal to the pelvic brim. Instillation of 0.8-1.5 cc of N-butyl cyanoacrylate into ureter proximal to the Amplatzer plug was performed. This was followed bymore » another set of 8-12-mm type-I or type-II Amplatzer vascular plugs in a technique referred to as the 'sandwich technique.'ResultsFive ureters in three patients were occluded utilizing the above-described technique during the 4-year study period. Mean maximum size Amplatzer used per ureter was 10.8 mm (range, 8-12). One ureter required three Amplatzer plugs and the rest required two. Two patients (3 ureters) were clinically successful with complete resolution of symptoms in 36-48 h. The third patient (2 ureters) was partly successful and required a second Amplatzer- N-butyl cyanoacrylate sandwich technique embolization. The mean clinical follow-up was 11.3 months (range, 1.7-29.2).ConclusionsThe Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique for occluding the distal ureter is safe and effective with a quick (probably due to the N-butyl cyanoacrylate) and durable (probably due to the Amplatzer plugs) clinical response.« less

  9. Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study

    PubMed Central

    Kong, Xuan; Gozani, Shai N

    2018-01-01

    Objective The objective of this study was to assess the effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) in a real-world chronic pain sample. Background There is a need for nonpharmacological treatment options for chronic pain. FS-TENS improved multisite chronic pain in a previous interventional study. Large observational studies are needed to further characterize its effectiveness. Methods This retrospective observational cohort study examined changes in chronic pain measures following 60 days of FS-TENS use. The study data were obtained from FS-TENS users who uploaded their device utilization and clinical data to an online database. The primary outcome measures were changes in pain intensity and pain interference with sleep, activity, and mood on an 11-point numerical rating scale. Dose–response associations were evaluated by stratifying subjects into low (≤30 days), intermediate (31–56 days), and high (≥57 days) utilization subgroups. FS-TENS effectiveness was quantified by baseline to follow-up group differences and a responder analysis (≥30% improvement in pain intensity or ≥2-point improvement in pain interference domains). Results Utilization and clinical data were collected from 11,900 people using FS-TENS for chronic pain, with 713 device users meeting the inclusion and exclusion criteria. Study subjects were generally older, overweight adults. Subjects reported multisite pain with a mean of 4.8 (standard deviation [SD] 2.5) pain sites. A total of 97.2% of subjects identified low back and/or lower extremity pain, and 72.9% of subjects reported upper body pain. All pain measures exhibited statistically significant group differences from baseline to 60-day follow-up. The largest changes were pain interference with activity (−0.99±2.69 points) and mood (−1.02±2.78 points). A total of 48.7% of subjects exhibited a clinically meaningful reduction in pain interference with activity or mood. This proportion increased to 57.1% for the high utilization subgroup. Conclusion FS-TENS is a practical option for treating multisite chronic pain. The greatest impact is on pain interference with activity and mood. FS-TENS utilization and effectiveness exhibit a dose–response association, suggesting that daily use maximizes pain relief. PMID:29670397

  10. The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature

    PubMed Central

    Liu, Xinliang; Kolber, Morey J.

    2016-01-01

    Background Low back pain (LBP) is common and associated healthcare costs are significant. While clinical practice guidelines have been established in an attempt to reduce costs and healthcare utilization, it is unclear if adherence to physical therapy guidelines for those with LBP is efficacious. Therefore, the purpose of this study was to assess current evidence and evaluate the impact of physical therapy guideline adherence on subsequent healthcare costs and utilization for patients with LBP. Methods An electronic search was conducted in PubMed, CINAHL (EBSCO Host), AMED (Ovid), and PEDro. Studies included in this review were published in peer reviewed journals and the primary mode of treatment was administered by a physical therapist. Also, the definition of adherence was clearly defined based on claims data and at least one measure of cost or utilization reported. Quality assessment was evaluated via a modified Downs and Black checklist. Due to the conceptual heterogeneity in variable measurements, data were qualitatively synthesized and stratified by reported utilization and cost measures. Results A total of 256 results were identified and after omitting duplicates, 4 articles were retained, which were all retrospective in nature. Quality scores ranged between 19 and 21 points out of a possible 26 on the modified Downs and Black checklist. All identified studies used the same definition of guideline adherence, which focused on billing active codes and minimizing use of passive codes. The results demonstrated trends that, with a few exceptions, suggested those patients with LBP that were treated with an adherent guideline program demonstrated decreased healthcare utilization and an overall healthcare savings. Conclusion Preliminary evidence suggests that adherence to established clinical practice guidelines may assist with decreasing healthcare utilization and costs. Additional research based on prospective randomized controlled trials are needed to provide high quality evidence regarding the impact of guideline adherence among patients with LBP. PMID:27285608

  11. Clinical utilization and cost outcomes from an integrative medicine independent physician association: an additional 3-year update.

    PubMed

    Sarnat, Richard L; Winterstein, James; Cambron, Jerrilyn A

    2007-05-01

    Our initial report analyzed clinical and cost utilization data from the years 1999 to 2002 for an integrative medicine independent physician association (IPA) whose primary care physicians (PCPs) were exclusively doctors of chiropractic. This report updates the subsequent utilization data from the IPA for the years 2003 to 2005 and includes first-time comparisons in data points among PCPs of different licensures who were oriented toward complementary and alternative medicine (CAM). Independent physician association-incurred claims and stratified random patient surveys were descriptively analyzed for clinical utilization, cost offsets, and member satisfaction compared with conventional medical IPA normative values. Comparisons to our original publication's comparative blinded data, using nonrandom matched comparison groups, were descriptively analyzed for differences in age/sex demographics and disease profiles to examine sample bias. Clinical and cost utilization based on 70,274 member-months over a 7-year period demonstrated decreases of 60.2% in-hospital admissions, 59.0% hospital days, 62.0% outpatient surgeries and procedures, and 85% pharmaceutical costs when compared with conventional medicine IPA performance for the same health maintenance organization product in the same geography and time frame. During the past 7 years, and with a larger population than originally reported, the CAM-oriented PCPs using a nonsurgical/nonpharmaceutical approach demonstrated reductions in both clinical and cost utilization when compared with PCPs using conventional medicine alone. Decreased utilization was uniformly achieved by all CAM-oriented PCPs, regardless of their licensure. The validity and generalizability of this observation are guarded given the lack of randomization, lack of statistical analysis possible, and potentially biased data in this population.

  12. EAP-based critical incident stress management: utilization of a practice-based assessment of incident severity level in responding to workplace trauma.

    PubMed

    DeFraia, Gary S

    2013-01-01

    Central to the field of trauma psychology is assessment of the impact of critical incidents on individuals, as measured by individual symptoms of stress. Accordingly, the trauma literature reflects a proliferation of clinical impact of event scales. Workplace incidents however, affect not only individual employees, but also work organizations, requiring a multi-level response. Critical incident stress management (CISM) is the most prevalent multi-level incident response strategy utilized by organizations, often through specialized CISM units operating within their employee assistance programs (EAPs). While EAP-based CISM units seeks to support both individuals and organizations, studies focused on individual stress dominate the literature, mirroring assessment scales that tend to emphasize clinical as opposed to organizational practice. This research contributes to less-prevalent studies exploring incident characteristics as disruptive to organizations, rather than clinical symptoms as disruptive to individuals. To measure incident disruption, an EAP-based CISM unit developed a critical incident severity scale. By analyzing this unit's extensive practice database, this exploratory study examines how critical incident severity level varies among various types of incidents. Employing the methodology of clinical data mining, this practice-based research generates evidence-informed practice recommendations in the areas of EAP-based CISM intake assessment, organizational consultation and incident response planning.

  13. Genome-wide association studies in cardiac electrophysiology: recent discoveries and implications for clinical practice.

    PubMed

    Milan, David J; Lubitz, Steven A; Kääb, Stefan; Ellinor, Patrick T

    2010-08-01

    Genome-wide association studies have been increasingly used to study the genetics of complex human diseases. Within the field of cardiac electrophysiology, this technique has been applied to conditions such as atrial fibrillation, and several electrocardiographic parameters including the QT interval. While these studies have identified multiple genomic regions associated with each trait, questions remain, including the best way to explore the pathophysiology of each association and the potential for clinical utility. This review will summarize recent genome-wide association study results within cardiac electrophysiology and discuss their broader implications in basic science and clinical medicine. Copyright 2010 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  14. [STRATEGY OF USE AND MAINTENANCE OF CLINICAL HOSPITAL CENTER RIJEKA IN ACCORDANCE WITH KEY PERFORMANCE INDICATORS FOR STRATEGIC HEALTHCARE FACILITIES MAINTENANCE].

    PubMed

    Sjekavica, Mariela; Haller, Herman; Cerić, Anita

    2015-01-01

    Building usage is the phase in the building life cycle that is most time-consuming, most functional, most significant due to building purpose and often systematically ignored. Maintenance is the set of activities that ensure the planned duration of facility exploitation phase in accordance with the requirements for quality maintenance of a large number of important building features as well as other elements immanent to the nature of facilities' life. The aim of the study is to show the analysis of the current state of organized, planned and comprehensive managerial approach in hospital utilization and maintenance in the Republic of Croatia, given on the case study of Clinical hospital center in Rijeka. The methodology used consists of relevant literature section of theory of facility utilization, maintenance and management in general, hospital buildings especially, display of practice on case study, and comparison of key performance indicators values obtained through interview with those that author Igal M. Shohet defined in his study by field surveys and statistical analyses. Despite many positive indicators of Clinical hospital center Rijeka maintenance, an additional research is needed in order to define a more complete national hospital maintenance strategy.

  15. Basophil-activation tests in Hymenoptera allergy.

    PubMed

    Dubois, Anthony E J; van der Heide, Sicco

    2007-08-01

    Despite recent advances in our understanding of basophil biology and discovery of new markers for basophil activation, tests measuring basophil activation are not widely utilized in Hymenoptera allergy. Studies of the basophil-activation test in Hymenoptera allergy were examined and the clinical utility of this test was assessed. It has been demonstrated that the results of basophil-activation tests correlate quite well with those of serum IgE testing or skin-prick tests. Many studies compare test outcomes with history in patients and nonallergic controls, so that specificity in sensitized but clinically nonreactive individuals remains unknown. Although one study showed that the basophil-activation test might predict immunotherapy side effects, this could not be confirmed in a second study, and no role has been established for the basophil-activation test in the monitoring of venom immunotherapy. The basophil-activation test has no extra value in assessing sting challenges, although experience is limited. The measurement of basophil-activation markers may be useful in detecting IgE-mediated sensitization but the relevance for application of the basophil-activation test in prediction of clinical reactivity in Hymenoptera allergy is very limited. For this reason, this test currently has no established role in the diagnosis and management of patients with insect sting allergy.

  16. Psychometric Evaluation of Children with Auditory Processing Disorder (APD): Comparison with Normal-Hearing and Clinical Non-APD Groups

    ERIC Educational Resources Information Center

    Iliadou, Vasiliki; Bamiou, Doris Eva

    2012-01-01

    Purpose: To investigate the clinical utility of the Children's Auditory Processing Performance Scale (CHAPPS; Smoski, Brunt, & Tannahill, 1992) to evaluate listening ability in 12-year-old children referred for auditory processing assessment. Method: This was a prospective case control study of 97 children (age range = 11;4 [years;months] to…

  17. Medical Student Attitudes to the Autopsy and Its Utility in Medical Education: A Brief Qualitative Study at One UK Medical School

    ERIC Educational Resources Information Center

    Bamber, Andrew R.; Quince, Thelma A.; Barclay, Stephen I. G.; Clark, John D. A.; Siklos, Paul W. L.; Wood, Diana F.

    2014-01-01

    Attending postmortems enables students to learn anatomy and pathology within a clinical context, provides insights into effects of treatment and introduces the reality that patients die. Rates of clinical autopsies have declined and medical schools have cut obligatory autopsy sessions from their curricula making it difficult to assess medical…

  18. Legionella pneumophila pneumonia associated with acute respiratory distress syndrome successfully treated with imipenem.

    PubMed

    Mofredj, A; Baraka, D

    1997-01-01

    Although utility of beta-lactams in the treatment of legionnaire's disease could not be demonstrated, clinical cures of human legionellosis with imipenem have been reported. We report the case of a 45-year-old man who presented clinical and radiological features of 'typical' bacterial pneumonia. He was successfully treated with imipenem. Serologic studies showed seroconversion for Legionella pneumophila.

  19. A Study of the Efficacy of an Integrated Nutrition Assessment, Interviewing and Counseling, and Medical Nutrition Therapy (MNT) Course Utilizing Problem-Based Learning

    ERIC Educational Resources Information Center

    Stanczyk, Kathy K.

    2014-01-01

    Dietetics graduates have been argued to enter supervised professional practice, or a Dietetic Internship, with deficient clinical reasoning skills. Some researchers have suggested that one factor contributing to deficient clinical reasoning skills has been the fragmented course sequencing of a traditional dietetics curriculum, with multiple…

  20. Clinical librarian support for rapid review of clinical utility of cancer molecular biomarkers.

    PubMed

    Geng, Yimin; Fowler, Clara S; Fulton, Stephanie

    2015-01-01

    The clinical librarian used a restricted literature searching and quality-filtering approach to provide relevant clinical evidence for the use of cancer molecular biomarkers by institutional policy makers and clinicians in the rapid review process. The librarian-provided evidence was compared with the cited references in the institutional molecular biomarker algorithm. The overall incorporation rate of the librarian-provided references into the algorithm was above 80%. This study suggests the usefulness of clinical librarian expertise for clinical practice. The searching and filtering methods for high-level evidence can be adopted by information professionals who are involved in the rapid literature review.

  1. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1—Psychometric Characteristics of 5 Paradigms

    PubMed Central

    Reddy, L. Felice; Horan, William P.; Barch, Deanna M.; Buchanan, Robert W.; Dunayevich, Eduardo; Gold, James M.; Lyons, Naomi; Marder, Stephen R.; Treadway, Michael T.; Wynn, Jonathan K.; Young, Jared W.; Green, Michael F.

    2015-01-01

    Impairments in willingness to exert effort contribute to the motivational deficits characteristic of the negative symptoms of schizophrenia. The current study evaluated the psychometric properties of 5 new or adapted paradigms to determine their suitability for use in clinical trials of schizophrenia. This study included 94 clinically stable participants with schizophrenia and 40 healthy controls. The effort-based decision-making battery was administered twice to the schizophrenia group (baseline, 4-week retest) and once to the control group. The 5 paradigms included 1 that assesses cognitive effort, 1 perceptual effort, and 3 that assess physical effort. Each paradigm was evaluated on (1) patient vs healthy control group differences, (2) test-retest reliability, (3) utility as a repeated measure (ie, practice effects), and (4) tolerability. The 5 paradigms showed varying psychometric strengths and weaknesses. The Effort Expenditure for Rewards Task showed the best reliability and utility as a repeated measure, while the Grip Effort Task had significant patient-control group differences, and superior tolerability and administration duration. The other paradigms showed weaker psychometric characteristics in their current forms. These findings highlight challenges in adapting effort and motivation paradigms for use in clinical trials. PMID:26142081

  2. Pacemaker remote monitoring in the pediatric population: is it a real solution?

    PubMed

    Leoni, Loira; Padalino, Massimo; Biffanti, Roberta; Ferretto, Sonia; Vettor, Giulia; Corrado, Domenico; Stellin, Giovanni; Milanesi, Ornella; Iliceto, Sabino

    2015-05-01

    Clinical utility of remote monitoring of implantable cardiac devices has been previously demonstrated in several trials in the adult population. The aim of this study was to assess the clinical utility of remote monitoring in a pediatric population undergoing pacemakers implantation. The study population included 73 consecutive pediatric patients who received an implantable pacemaker. The remote device check was programmed for every 3 months and all patients had a yearly out-patient visit. Data on device-related events, hospitalization, and other clinical information were collected during remote checks and out-patient visits. During a mean follow-up of 18 ± 10 months, 470 remote transmissions were collected and analyzed. Two deaths were reported. Eight transmissions (1.7%) triggered an urgent out-patient visit. Twenty percent of transmissions reported evidence of significant clinical or technical events. All young patients and their families were very satisfied when using remote monitoring to replace out-patient visits. The ease in use, together with satisfaction and acceptance of remote monitoring in pediatric patients, brought very good results. The remote management of our pediatric population was safe and remote monitoring adequately replaced the periodic out-patient device checks without compromising patient safety. ©2015 Wiley Periodicals, Inc.

  3. Children with problematic sexualized behaviors in the child welfare system.

    PubMed

    Baker, Amy J L; Gries, Len; Schneiderman, Mel; Parker, Rob; Archer, Marc; Friedrich, Bill

    2008-01-01

    This study assessed the utility of the Child Sexual Behavior Inventory (CSBI) in a child welfare sample. In this study, 97 children from ages 10 to 12 from either foster boarding homes or a residential treatment center participated. Researchers interviewed foster parents or primary therapists about children's sexual behavior, traumatic events, clinical symptoms, and their attitudes toward the child. Findings revealed that problematic sexualized behaviors were more prevalent in the residential treatment center (RTC) sample than they were in a normative sample. The pattern of associations between sexual behavior problems, traumatic events, and clinical syndromes in both the RTC and the foster boarding home (FBH) samples was similar to what has been found in samples in which biological custodial parents were the respondents. Analyses comparing youth who met the criterion for having problematic sexualized behaviors and youth who did not meet the criterion revealed that the two groups differed on clinical symptoms, prior traumatic events, and negative reports by caregivers. Results confirm the utility of the CSBI measure for this population and highlight several important clinical and programmatic concerns for addressing problematic sexual behavior in children in the child welfare system.

  4. Robotic and endoscopic transoral thyroidectomy: feasibility and description of the technique in the cadaveric model

    PubMed Central

    Kahramangil, Bora; Mohsin, Khuzema; Alzahrani, Hassan; Bu Ali, Daniah; Tausif, Syed; Kang, Sang-Wook; Kandil, Emad

    2017-01-01

    Background Numerous new approaches have been described over the years to improve the cosmetic outcomes of thyroid surgery. Transoral approach is a new technique that aims to achieve superior cosmetic outcomes by concealing the incision in the oral cavity. Methods Transoral thyroidectomy through vestibular approach was performed in two institutions on cadaveric models. Procedure was performed endoscopically in one institution, while the robotic technique was utilized at the other. Results Transoral thyroidectomy was successfully performed at both institutions with robotic and endoscopic techniques. All vital structures were identified and preserved. Conclusions Transoral thyroidectomy has been performed in animal and cadaveric models, as well as in some clinical studies. Our initial experience indicates the feasibility of this approach. More clinical studies are required to elucidate its full utility. PMID:29302476

  5. Classification of superficial lesions of the eye with an optical biopsy system: First trials with the Los Alamos instrument

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Glickman, R.D.; Gritz, D.C.; Held, K.S.

    the clinical diagnosis of a lesion often requires that a histological analysis be made of a physical specimen of the suspect tissue. In the present work, the authors have utilized an optical biopsy system (OBS) developed at Los Alamos National Laboratory which is safe for patient use and provides a large amount of optical data from the sampled tissue. An earlier version of this system has been used to study age-related changes in the ocular lens (10). The purpose of the present study is to establish the potential clinical utility of the OBS by determining if characteristic features in themore » optical signatures, obtained from a variety of ophthalmic lesions, are correlated with the histological features of tissue biopsies obtained from these patients.« less

  6. Assessment of Clinical Skills Using Simulator Technologies

    ERIC Educational Resources Information Center

    Srinivasan, Malathi; Hwang, Judith C.; West, Daniel; Yellowlees, Peter M.

    2006-01-01

    Objective: Simulation technologies are used to assess and teach competencies through the provision of reproducible stimuli. They have exceptional utility in assessing responses to clinical stimuli that occur sporadically or infrequently. In this article, the authors describe the utility of emerging simulation technologies, and discuss critical…

  7. The factor structure and clinical utility of formal thought disorder in first episode psychosis.

    PubMed

    Roche, Eric; Lyne, John Paul; O'Donoghue, Brian; Segurado, Ricardo; Kinsella, Anthony; Hannigan, Ailish; Kelly, Brendan D; Malone, Kevin; Clarke, Mary

    2015-10-01

    Formal thought disorder (FTD) is a core feature of psychosis, however there are gaps in our knowledge about its prevalence and factor structure. We had two aims: first, to establish the factor structure of FTD; second, to explore the clinical utility of dimensions of FTD in order to further the understanding of its nosology. A cross-validation study was undertaken to establish the factor structure of FTD in first episode psychosis (FEP). The relative utility of FTD categories vs. dimensions across diagnostic categories was investigated. The prevalence of clinically significant FTD in this FEP sample was 21%, although 41% showed evidence of disorganised speech, 20% displayed verbosity and 24% displayed impoverished speech. A 3-factor model was identified as the best fit for FTD, with disorganisation, poverty and verbosity dimensions (GFI=0.99, RMR=0.07). These dimensions of FTD accurately distinguished affective from non-affective diagnostic categories. A categorical approach to FTD assessment was useful in identifying markers of clinical acuteness, as identified by short duration of untreated psychosis (OR=2.94, P<0.01) and inpatient treatment status (OR=3.98, P<0.01). FTD is moderately prevalent and multi-dimensional in FEP. Employing both a dimensional and categorical assessment of FTD gives valuable clinical information, however there may be a need to revise our conceptualisation of the nosology of FTD. The prognostic value of FTD, as well as its neural basis, requires elucidation. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results.

    PubMed

    Cepeda, M Soledad; Lobanov, Victor; Berlin, Jesse A

    2013-04-01

    The ClinicalTrials.gov web site provides a convenient interface to look up study results, but it does not allow downloading data in a format that can be readily used for quantitative analyses. To develop a system that automatically downloads study results from ClinicalTrials.gov and provides an interface to retrieve study results in a spreadsheet format ready for analysis. Sherlock(®) identifies studies by intervention, population, or outcome of interest and in seconds creates an analytic database of study results ready for analyses. The outcome classification algorithms used in Sherlock were validated against a classification by an expert. Having a database ready for analysis that can be updated automatically, dramatically extends the utility of the ClinicalTrials.gov trial registry. It increases the speed of comparative research, reduces the need for manual extraction of data, and permits answering a vast array of questions.

  9. Improving clinical cognitive testing

    PubMed Central

    Gale, Seth A.; Barrett, A.M.; Boeve, Bradley F.; Chatterjee, Anjan; Coslett, H. Branch; D'Esposito, Mark; Finney, Glen R.; Gitelman, Darren R.; Hart, John J.; Lerner, Alan J.; Meador, Kimford J.; Pietras, Alison C.; Voeller, Kytja S.; Kaufer, Daniel I.

    2015-01-01

    Objective: To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Methods: Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Results: Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. Conclusions: We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. PMID:26163433

  10. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

    PubMed

    Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

    2012-10-04

    Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

  11. Amyloid PET in clinical practice: Its place in the multidimensional space of Alzheimer's disease☆

    PubMed Central

    Vandenberghe, Rik; Adamczuk, Katarzyna; Dupont, Patrick; Laere, Koen Van; Chételat, Gaël

    2013-01-01

    Amyloid imaging is currently introduced to the market for clinical use. We will review the evidence demonstrating that the different amyloid PET ligands that are currently available are valid biomarkers for Alzheimer-related β amyloidosis. Based on recent findings from cross-sectional and longitudinal imaging studies using different modalities, we will incorporate amyloid imaging into a multidimensional model of Alzheimer's disease. Aside from the critical role in improving clinical trial design for amyloid-lowering drugs, we will also propose a tentative algorithm for when it may be useful in a memory clinic environment. Gaps in our evidence-based knowledge of the added value of amyloid imaging in a clinical context will be identified and will need to be addressed by dedicated studies of clinical utility. PMID:24179802

  12. Heart failure in primary care: co-morbidity and utilization of health care resources.

    PubMed

    Carmona, Montserrat; García-Olmos, Luis M; García-Sagredo, Pilar; Alberquilla, Ángel; López-Rodríguez, Fernando; Pascual, Mario; Muñoz, Adolfo; Salvador, Carlos H; Monteagudo, José L; Otero-Puime, Ángel

    2013-10-01

    In order to ensure proper management of primary care (PC) services, the efficiency of the health professionals tasked with such services must be known. Patients with heart failure (HF) are characterized by advanced age, high co-morbidity and high resource utilization. To ascertain PC resource utilization by HF patients and variability in the management of such patients by GPs. Descriptive, cross-sectional study targeting a population attended by 129 GPs over the course of 1 year. All patients with diagnosis of HF in their clinical histories were included, classified using the Adjusted Clinical Group system and then grouped into six resource utilization bands (RUBs). Resource utilization and Efficiency Index were both calculated. One hundred per cent of patients with HF were ranked in RUBs 3, 4 and 5. The highest GP visit rate was 20 and the lowest in excess of 10 visits per year. Prescription drug costs for these patients ranged from €885 to €1422 per patient per year. Health professional efficiency varied notably, even after adjustment for co-morbidity (Efficiency Index Variation Ratio of 28.27 for visits and 404.29 for prescription drug cost). Patients with HF register a high utilization of resources, and there is great variability in the management of such patients by health professionals, which cannot be accounted for by the degree of case complexity.

  13. Evidence of a broken healthcare delivery system in korea: unnecessary hospital outpatient utilization among patients with a single chronic disease without complications.

    PubMed

    Lee, Jin Yong; Jo, Min-Woo; Yoo, Weon-Seob; Kim, Hyun Joo; Eun, Sang Jun

    2014-12-01

    This study aims to estimate the volume of unnecessarily utilized hospital outpatient services in Korea and quantify the total cost resulting from the inappropriate utilization. The analysis included a sample of 27,320,505 outpatient claims from the 2009 National Inpatient Sample database. Using the Charlson Comorbidity Index (CCI), patients were considered to have received 'unnecessary hospital outpatient utilization' if they had a CCI score of 0 and were concurrently admitted to hospital for treatment of a single chronic disease - hypertension (HTN), diabetes mellitus (DM), or hyperlipidemia (HL) - without complication. Overall, 85% of patients received unnecessary hospital services. Also hospitals were taking away 18.7% of HTN patients, 18.6% of DM and 31.6% of HL from clinics. Healthcare expenditures from unnecessary hospital outpatient utilization were estimated at: HTN (94,058 thousands USD, 38.6% of total expenditure); DM (17,795 thousands USD, 40.6%) and HL (62,876 thousands USD, 49.1%). If 100% of patients who received unnecessary hospital outpatient services were redirected to clinics, the estimated savings would be 104,226 thousands USD. This research proves that approximately 85% of hospital outpatient utilizations are unnecessary and that a significant amount of money is wasted on unnecessary healthcare services; thus burdening the National Health Insurance Service (NHIS) and patients.

  14. Application of Lean Sigma to the Audiology Clinic at a Large Academic Center.

    PubMed

    Huddle, Matthew G; Tirabassi, Amy; Turner, Laurie; Lee, Emily; Ries, Kathryn; Lin, Sandra Y

    2016-04-01

    To apply Lean Sigma--a quality improvement strategy to eliminate waste and reduce variation and defects--to improve audiology scheduling and utilization in a large tertiary care referral center. The project goals included an increase in utilization rates of audiology block time and a reduction in appointment lead time. Prospective quality improvement study. Academic tertiary care center. All patients scheduling audiology clinic visits July 2013 to July 2014. Value stream mapping was performed for the audiology scheduling process, and wasteful steps were identified for elimination. Interventions included a 2-week block release, audiology template revision, and reduction of underutilized blocks. Schedule utilization and lead time for new patient diagnostic audiogram were measured for 5 months postintervention and compared with 5 months preintervention. Overall, 2995 preintervention and 3714 postintervention booked appointments were analyzed. Block utilization increased from 77% to 90% after intervention (P < .0001). Utilization of joint-with-provider visits increased from 39% to 67% (P < .0001). Booked appointments increased from 2995 to 3714, with joint-with-provider booked appointments increasing from 317 to 1193. Appointment lead time averaged 24 days postintervention, compared with 29 days preintervention (P = .06). Average monthly relative value units measured 13,321 preintervention and 14,778 postintervention (P = .09). Lean Sigma techniques were successfully used to increase appointment block utilization and streamline scheduling practices. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  15. Utilization of gene mapping and candidate gene mutation screening for diagnosing clinically equivocal conditions: a Norrie disease case study.

    PubMed

    Chini, Vasiliki; Stambouli, Danai; Nedelea, Florina Mihaela; Filipescu, George Alexandru; Mina, Diana; Kambouris, Marios; El-Shantil, Hatem

    2014-06-01

    Prenatal diagnosis was requested for an undiagnosed eye disease showing X-linked inheritance in a family. No medical records existed for the affected family members. Mapping of the X chromosome and candidate gene mutation screening identified a c.C267A[p.F89L] mutation in NPD previously described as possibly causing Norrie disease. The detection of the c.C267A[p.F89L] variant in another unrelated family confirms the pathogenic nature of the mutation for the Norrie disease phenotype. Gene mapping, haplotype analysis, and candidate gene screening have been previously utilized in research applications but were applied here in a diagnostic setting due to the scarcity of available clinical information. The clinical diagnosis and mutation identification were critical for providing proper genetic counseling and prenatal diagnosis for this family.

  16. Integration of single-fiber reflectance spectroscopy into ultrasound-guided endoscopic lung cancer staging of mediastinal lymph nodes

    NASA Astrophysics Data System (ADS)

    Kanick, Stephen Chad; van der Leest, Cor; Aerts, Joachim G. J. V.; Hoogsteden, Henk C.; Kaščáková, Slávka; Sterenborg, Henricus J. C. M.; Amelink, Arjen

    2010-01-01

    We describe the incorporation of a single-fiber reflectance spectroscopy probe into the endoscopic ultrasound fine-needle aspiration (EUS-FNA) procedure utilized for lung cancer staging. A mathematical model is developed to extract information about the physiological and morphological properties of lymph tissue from single-fiber reflectance spectra, e.g., microvascular saturation, blood volume fraction, bilirubin concentration, average vessel diameter, and Mie slope. Model analysis of data from a clinical pilot study shows that the single-fiber reflectance measurement is capable of detecting differences in the physiology between normal and metastatic lymph nodes. Moreover, the clinical data show that probe manipulation within the lymph node can perturb the in vivo environment, a concern that must be carefully considered when developing a sampling strategy. The data show the feasibility of this novel technique; however, the potential clinical utility has yet to be determined.

  17. Recommendations for clinical biomarker specimen preservation and stability assessments.

    PubMed

    Dakappagari, Naveen; Zhang, Hui; Stephen, Laurie; Amaravadi, Lakshmi; Khan, Masood U

    2017-04-01

    With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types.

  18. The relationship between baseline Organizational Readiness to Change Assessment subscale scores and implementation of hepatitis prevention services in substance use disorders treatment clinics: a case study

    PubMed Central

    2010-01-01

    Background The Organizational Readiness to Change Assessment (ORCA) is a measure of organizational readiness for implementing practice change in healthcare settings that is organized based on the core elements and sub-elements of the Promoting Action on Research Implementation in Health Services (PARIHS) framework. General support for the reliability and factor structure of the ORCA has been reported. However, no published study has examined the utility of the ORCA in a clinical setting. The purpose of the current study was to examine the relationship between baseline ORCA scores and implementation of hepatitis prevention services in substance use disorders (SUD) clinics. Methods Nine clinic teams from Veterans Health Administration SUD clinics across the United States participated in a six-month training program to promote evidence-based practices for hepatitis prevention. A representative from each team completed the ORCA evidence and context subscales at baseline. Results Eight of nine clinics reported implementation of at least one new hepatitis prevention practice after completing the six-month training program. Clinic teams were categorized by level of implementation-high (n = 4) versus low (n = 5)-based on how many hepatitis prevention practices were integrated into their clinics after completing the training program. High implementation teams had significantly higher scores on the patient experience and leadership culture subscales of the ORCA compared to low implementation teams. While not reaching significance in this small sample, high implementation clinics also had higher scores on the research, clinical experience, staff culture, leadership behavior, and measurement subscales as compared to low implementation clinics. Conclusions The results of this study suggest that the ORCA was able to measure differences in organizational factors at baseline between clinics that reported high and low implementation of practice recommendations at follow-up. This supports the use of the ORCA to describe factors related to implementing practice recommendations in clinical settings. Future research utilizing larger sample sizes will be essential to support these preliminary findings. PMID:20546584

  19. A Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis on the clinical utility of sperm DNA fragmentation testing in specific male infertility scenarios

    PubMed Central

    Agarwal, Ashok; Cho, Chak-Lam; Majzoub, Ahmad

    2017-01-01

    Background Sperm DNA fragmentation (SDF) is recognized as a leading cause of male infertility because it can impair the paternal genome through distinct pathophysiological mechanisms. Current evidence supports SDF as a major factor in the pathophysiology of several conditions, including varicocele, unexplained infertility, assisted reproductive technology failure, and environmental lifestyle factors, although the mechanisms involved have not been fully described yet. Measurement of the levels of DNA fragmentation in semen provides valuable information on the integrity of paternal chromatin and may guide therapeutic strategies. A recently published clinical practice guideline (CPG) highlighted how to use the information provided by SDF testing in daily practice, which triggered a series of commentaries by leading infertility experts. These commentaries contained an abundance of information and conflicting views about the clinical utility of SDF testing, which underline the complex nature of SDF. Methods A search of papers published in response to the CPG entitled “Clinical utility of sperm DNA fragmentation testing: practice recommendations based on clinical scenarios” was performed within the Translational Andrology and Urology (TAU) website (http://tau.amegroups.com/). The start and end dates for the search were May 2017 and August 2017, respectively. Each commentary meeting our inclusion criteria was rated as “supportive without reservation”, “supportive with reservation”, “not supportive” or “neutral”. We recorded whether articles discussed either SDF characteristics as a laboratory test method or clinical scenarios, or both. Subsequently, we extracted the particulars from each commentary and utilized the ‘Strengths-Weaknesses-Opportunities-Threats’ (SWOT) analysis to understand the perceived advantages and drawbacks of SDF as a specialized sperm function method in clinical practice. Results Fifty-eight fertility experts from six continents and twenty-two countries contributed commentaries. Overall, participants (87.9%; n=51) were supportive of the recommendations provided by the CPG on the utility of SDF testing based on clinical scenarios. The majority of participants made explicit remarks about both the clinical scenarios and SDF assays’ characteristics. Among ‘not supportive’ and ‘supportive with reservation’ participants, 75% (n=30/40) and 77.5% (n=31/40) expressed concerns related to technical limitations of SDF testing methods and clinical utility of the test in one or more clinical scenarios discussed in the CPG, respectively. The SWOT analysis revealed that the CPG provides a reasonable evidence-based proposal for integration of SDF testing in the routine daily practice. It also uncovered gaps of knowledge and threats limiting the widespread application of SDF in everyday practice, thus allowing the identification of opportunities to further refine SDF testing and its clinical utility. Conclusions The understanding of the role of SDF in male infertility requires an in-depth analysis of the multifactorial pathophysiological processes and the theories involved. The SWOT analysis allowed an objective evaluation of CPG on the clinical utility of SDF testing based on clinical scenarios and its accompanying commentaries written by global experts in all possible angles. Implementation of SDF testing in the clinic may not only increase the outcome of ART but more importantly improve the health of both fathers to be and resulting offspring. PMID:29082207

  20. Anterior Cervical Discectomy and Fusion for Adjacent Segment Disease: Clinical Outcomes and Cost Utility of Surgical Intervention.

    PubMed

    O'Neill, Kevin R; Wilson, Robert J; Burns, Katharine M; Mioton, Lauren M; Wright, Brian T; Adogwa, Owoicho; McGirt, Matthew J; Devin, Clinton J

    2016-07-01

    Retrospective review. Determine clinical outcomes and cost utility of anterior cervical discectomy and fusion (ACDF) for the treatment of adjacent segment disease (ASD). The incidence of symptomatic ASD after ACDF has been estimated to occur in up to 26% of patients. Commonly, these patients will undergo an additional ACDF procedure. However, there are currently no studies available that adequately describe the clinical outcomes or cost utility of performing ACDF for ASD. A retrospective review of 40 patients undergoing ACDF for ASD was performed. Baseline and 2-year neck and arm pain (NRS-NP, NRS-AP), neck disability index (NDI), physical and mental quality of life (SF-12 PCS & MCS), and Zung depression score (ZDS) were assessed. Two-year total neck-related medical resource utilization, amount of missed work, and health-state values were determined. Quality-adjusted life years (QALYs) were calculated from EQ-5D assessments with US valuation. Comprehensive costs (indirect, direct, and total cost) and the value (cost-per-QALY gained) of performing ACDF for ASD were assessed. Performing ACDF to treat ASD resulted in significant improvements (P<0.05) in NRS-NP, NRS-AP, NDI, SF-12 PCS, and ZDS outcome measures. Patient-reported health states also significantly improved, with a mean cumulative 2-year gain of 0.54 QALYs. The mean 2-year cost of surgery was $32,616 (direct cost: $25,391; indirect cost: $7225). ACDF for the treatment of ASD was associated with a mean 2-year cost per QALY gained of $60,526. Performing ACDF for ASD resulted in significant improvements in patient pain, disability, and quality of life. Further, the mean 2-year cost-per-QALY was determined to be $60,526, which suggests surgical intervention to be cost effective. This study is the first to provide evidence that performing an ACDF for ASD is both clinically and cost effective.

  1. Neuropsychological function and cerebral glucose utilization in isolated memory impairment and Alzheimer's disease.

    PubMed

    Berent, S; Giordani, B; Foster, N; Minoshima, S; Lajiness-O'Neill, R; Koeppe, R; Kuhl, D E

    1999-01-01

    We hypothesized that 20 patients with isolated memory impairment (IMI) would demonstrate [18F]-2-fluoro-2-deoxy-D-glucose utilization and a progression of neuropsychological symptoms consistent with Alzheimer's disease (AD). IMI subjects performed similarly to AD in recall and verbal fluency, but comparable to normal subjects in other areas of cognitive functioning. A positron emission tomography (PET) diagnostic index based on parietal Z-scores categorized IMI patients into normal and abnormal metabolic patterns. Ten of the original 20 IMI patients (50%) reflected PET AD abnormalities. Clinical information was available for IMI patients at three-year follow-up. Ten (50%) had converted to AD, three were found to have pseudodementia and the seven remained IMI. Of the 10 IMI patients with an originally normal PET index, three (30%) were diagnosed with AD at three years. Of the 10 with an abnormal index originally, seven (70%) converted to AD. The finding that memory deficit in IMI was as pronounced as that in AD patients is consistent with the notion that memory is an initial symptom of AD. A substantial number of the IMI patients reflected regional hypometabolism similar to AD, suggesting that IMI is likely an early stage in progressive dementia. A large percentage of IMI patients converted clinically to AD within three years of initial study, though we observed impaired memory functioning well before a clinical diagnosis of AD could be made. In addition to potential clinical utility, IMI and PET represent an opportunity to study dementia in relation to brain chemistry at a time when brain pathology is in the process of development.

  2. Kennedy Axis V: Clinimetric properties assessed by mental health nurses.

    PubMed

    Faay, Margo D M; van de Sande, Roland; Gooskens, Floor; Hafsteinsdóttir, Thóra B

    2013-10-01

    The Kennedy Axis V is a routine outcome measurement instrument which can assist the assessment of the short-term risk for violence and other adverse patient outcomes. The purpose of this study was to evaluate the interrater reliability and clinical utility of the instrument when used by mental health nurses in daily care of patients with mental illness. This cross-sectional study was conducted in inpatient and outpatient adult psychiatric care units and in one adolescent inpatient unit at a university hospital in the Netherlands. Interrater reliability was measured based on the independent scores of two different nurses for the same patients. The clinical utility of the instrument was evaluated by means of a clinical utility questionnaire. To gain a deeper understanding of rating difficulties at the adolescent unit, additional data were collected in two focus group interviews. The overall results revealed a substantial level of agreement between nurses (intraclass correlation coefficient and Pearson 0.79). Some rating challenges were identified, including difficulties with scoring the instrument and using tailor-made interventions related to the scores. These challenges can be resolved using refined training and implementation strategies. When the Kennedy Axis V is accompanied by a solid implementation strategy in adult mental health care, the instrument can be used for short-term risk assessment and thereby contribute in efforts to reduce violence, suicide, self-harm, severe self-neglect, and enhanced objectivity in clinical decision-making. © 2012 The Authors; International Journal of Mental Health Nursing © 2012 Australian College of Mental Health Nurses Inc.

  3. Simultaneous dual-color fluorescence microscope: a characterization study.

    PubMed

    Li, Zheng; Chen, Xiaodong; Ren, Liqiang; Song, Jie; Li, Yuhua; Zheng, Bin; Liu, Hong

    2013-01-01

    High spatial resolution and geometric accuracy is crucial for chromosomal analysis of clinical cytogenetic applications. High resolution and rapid simultaneous acquisition of multiple fluorescent wavelengths can be achieved by utilizing concurrent imaging with multiple detectors. However, such class of microscopic systems functions differently from traditional fluorescence microscopes. To develop a practical characterization framework to assess and optimize the performance of a high resolution and dual-color fluorescence microscope designed for clinical chromosomal analysis. A dual-band microscopic imaging system utilizes a dichroic mirror, two sets of specially selected optical filters, and two detectors to simultaneously acquire two fluorescent wavelengths. The system's geometric distortion, linearity, the modulation transfer function, and the dual detectors' alignment were characterized. Experiment results show that the geometric distortion at lens periphery is less than 1%. Both fluorescent channels show linear signal responses, but there exists discrepancy between the two due to the detectors' non-uniform response ratio to different wavelengths. In terms of the spatial resolution, the two contrast transfer function curves trend agreeably with the spatial frequency. The alignment measurement allows quantitatively assessing the cameras' alignment. A result image of adjusted alignment is demonstrated to show the reduced discrepancy by using the alignment measurement method. In this paper, we present a system characterization study and its methods for a specially designed imaging system for clinical cytogenetic applications. The presented characterization methods are not only unique to this dual-color imaging system but also applicable to evaluation and optimization of other similar multi-color microscopic image systems for improving their clinical utilities for future cytogenetic applications.

  4. Job stress and mental health of permanent and fixed-term workers measured by effort-reward imbalance model, depressive complaints, and clinic utilization.

    PubMed

    Inoue, Mariko; Tsurugano, Shinobu; Yano, Eiji

    2011-01-01

    The number of workers with precarious employment has increased globally; however, few studies have used validated measures to investigate the relationship of job status to stress and mental health. Thus, we conducted a study to compare differential job stress experienced by permanent and fixed-term workers using an effort-reward imbalance (ERI) model questionnaire, and by evaluating depressive complaints and clinic utilization. Subjects were permanent or fixed-term male workers at a Japanese research institute (n=756). Baseline data on job stress and depressive complaints were collected in 2007. We followed up with the same population over a 1-year period to assess their utilization of the company clinic for mental health concerns. The ERI ratio was higher among permanent workers than among fixed-term workers. More permanent workers presented with more than two depressive complaints, which is the standard used for the diagnosis of depression. ERI scores indicated that the effort component of permanent work was associated with distress, whereas distress in fixed-term work was related to job promotion and job insecurity. Moreover, over the one-year follow-up period, fixed-term workers visited the on-site clinic for mental concerns 4.04 times more often than permanent workers even after adjusting for age, lifestyle, ERI, and depressive complaints. These contrasting findings reflect the differential workloads and working conditions encountered by permanent and fixed-term workers. The occupational setting where employment status was intermingled, may have contributed to the high numbers of mental health-related issues experienced by workers with different employment status.

  5. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

    PubMed Central

    Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

    2016-01-01

    Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

  6. Diagnostic utility of the HIV dementia scale and the international HIV dementia scale in screening for HIV-associated neurocognitive disorders among Spanish-speaking adults

    PubMed Central

    López, Enrique; Steiner, Alexander J.; Smith, Kimberly; Thaler, Nicholas S.; Hardy, David J.; Levine, Andrew J.; Al-Kharafi, Hussah T.; Yamakawa, Cristina; Goodkin, Karl

    2018-01-01

    Given that neurocognitive impairment is a frequent complication of HIV-1 infection in Spanish-speaking adults, the limited number of studies assessing HIV-associated neurocognitive disorders (HAND) in this population raises serious clinical concern. In addition to being appropriately translated, instruments need to be modified, normed, and validated accordingly. The purpose of the current study was to examine the diagnostic utility of the HIV Dementia Scale (HDS) and International HIV Dementia Scale (IHDS) to screen for HAND in Spanish-speaking adults living with HIV infection. Participants were classified as either HAND (N = 47) or No-HAND (N = 53) after completing a comprehensive neuropsychological evaluation. Receiver operating characteristic analyses found the HDS (AUC = .706) was more sensitive to detecting HAND than the IHDS (AUC = .600). Optimal cutoff scores were 9.5 for the HDS (PPV = 65.2%, NPV = 71.4%) and 9.0 for the IHDS (PPV = 59.4%, NPV = 59.1%). Canonical Correlation Analysis found the HDS converged with attention and executive functioning. Findings suggest that while the IHDS may not be an appropriate screening instrument with this population, the HDS retains sufficient statistical validity and clinical utility to screen for HAND in Spanish-speaking adults as a time-efficient and cost-effective measure in clinical settings with limited resources. PMID:27712132

  7. Clinical utility of colour flow Doppler ultrasonography in planning anterolateral thigh flap harvest.

    PubMed

    Patel, Rajan S; Higgins, Kevin M; Enepekides, Danny J; Hamilton, Paul A

    2010-10-01

    The anatomic variability of cutaneous perforators contributes to the technical challenges of anterolateral thigh (ALT) free flap harvest. The objective of this study was to assess the accuracy and clinical utility of preoperative colour flow Doppler (CFD) ultrasonography in evaluating planned ALT flap donor sites. A prospective study of the infrainguinal vasculature (profunda femoris and lateral circumflex femoral arteries) in 16 consecutive patients scheduled for ALT free flap transfer for reconstruction of head and neck surgical defects was undertaken. All patients underwent CFD ultrasonography. The location of perforators and the thigh thickness determined by CFD ultrasonography were correlated with the actual intraoperative findings using a scatter plot and paired t-test. Two patients were diagnosed with bilateral silent infrainguinal claudication, which precluded safe use of the ALT donor site. In two other patients, the planned ALT donor site ipsilateral to the defect was not used because of silent infrainguinal claudication diagnosed by CFD ultrasonography. In the 14 patients who underwent ALT flap harvest, CFD ultrasonography identified 48 perforators, which coincided with 43 actual perforators found intraoperatively. CFD ultrasonography demonstrated a statistically significant correlation with the actual perforator locations (Spearman coefficient .76; p = .55). Although CFD ultrasonography tended to underestimate flap thickness, there was a statistically significant correlation (Spearman coefficient .94; p ≤ .0001) with the actual flap thickness. CFD ultrasonography has clinical utility in facilitating decision making and planning ALT flap harvest.

  8. Pupillary motility: bringing neuroscience to the psychiatry clinic of the future.

    PubMed

    Graur, Simona; Siegle, Greg

    2013-08-01

    Modern pupillometry has expanded the study and utility of pupil responses in many new domains, including psychiatry, particularly for understanding aspects of cognitive and emotional information processing. Here, we review the applications of pupillometry in psychiatry for understanding patients' information processing styles, predicting treatment, and augmenting function. In the past year pupillometry has been shown to be useful in specifying cognitive/affective occurrences during experimental tasks and informing clinical diagnoses. Such studies demonstrate the potential of pupillary motility to be used in clinical psychiatry much as it has been in neurology for the past century.

  9. A method for analyzing the financial viability of a rural provider-based geriatric clinic.

    PubMed

    McAtee, Robin E; Beverly, Claudia J

    2005-01-01

    Little is known about the financial impact of rural provider-based geriatric outpatient clinics on their parent hospitals since the implementation of the outpatient prospective payment system. In this study, systems theory was used to develop a methodology for determining the financial viability of one such clinic in a rural hospital using data commonly found in rural hospital financial systems. Formulas were developed to identify the overall financial viability and a case-study model was utilized to test the formulas; however, this hospital did not track a key data element, resulting in an incomplete analysis.

  10. It's not that Difficult: An Interrater Reliability Study of the DSM–5 Section III Alternative Model for Personality Disorders

    DOE PAGES

    Garcia, Darren J.; Skadberg, Rebecca M.; Schmidt, Megan; ...

    2018-03-05

    The Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM–5]; American Psychiatric Association, 2013) Section III Alternative Model for Personality Disorders (AMPD) represents a novel approach to the diagnosis of personality disorder (PD). In this model, PD diagnosis requires evaluation of level of impairment in personality functioning (Criterion A) and characterization by pathological traits (Criterion B). Questions about clinical utility, complexity, and difficulty in learning and using the AMPD have been expressed in recent scholarly literature. We examined the learnability, interrater reliability, and clinical utility of the AMPD using a vignette methodology and graduate student raters. Results showed thatmore » student clinicians can learn Criterion A of the AMPD to a high level of interrater reliability and agreement with expert ratings. Interrater reliability of the 25 trait facets of the AMPD varied but showed overall acceptable levels of agreement. Examination of severity indexes of PD impairment showed the level of personality functioning (LPF) added information beyond that of global assessment of functioning (GAF). Clinical utility ratings were generally strong. Lastly, the satisfactory interrater reliability of components of the AMPD indicates the model, including the LPF, is very learnable.« less

  11. Was it worth it? Patients' perspectives on the perceived value of genomic-based individualized medicine.

    PubMed

    Halverson, Colin Me; Clift, Kristin E; McCormick, Jennifer B

    2016-04-01

    The value of genomic sequencing is often understood in terms of its ability to affect diagnosis or treatment. In these terms, successes occur only in a minority of cases. This paper presents views from patients who had exome sequencing done clinically to explore how they perceive the utility of genomic medicine. The authors used semi-structured, qualitative interviews in order to study patients' attitudes toward genomic sequencing in oncology and rare-disease settings. Participants from 37 cases were interviewed. In terms of the testing's key values-regardless of having received what clinicians described as meaningful results-participants expressed four qualities that are separate from traditional views of clinical utility: Participants felt they had been empowered over their own health. They felt they had contributed altruistically to the progress of genomic technology in medicine. They felt their suffering had been legitimated. They also felt a sense of closure, having done everything they could. Patients expressed overwhelmingly positive attitudes toward sequencing. Their rationale was not solely based on the results' clinical utility. It is important for clinicians to understand this non-medical reasoning as it pertains to patient decision-making and informed consent.

  12. It's not that Difficult: An Interrater Reliability Study of the DSM–5 Section III Alternative Model for Personality Disorders

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Garcia, Darren J.; Skadberg, Rebecca M.; Schmidt, Megan

    The Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM–5]; American Psychiatric Association, 2013) Section III Alternative Model for Personality Disorders (AMPD) represents a novel approach to the diagnosis of personality disorder (PD). In this model, PD diagnosis requires evaluation of level of impairment in personality functioning (Criterion A) and characterization by pathological traits (Criterion B). Questions about clinical utility, complexity, and difficulty in learning and using the AMPD have been expressed in recent scholarly literature. We examined the learnability, interrater reliability, and clinical utility of the AMPD using a vignette methodology and graduate student raters. Results showed thatmore » student clinicians can learn Criterion A of the AMPD to a high level of interrater reliability and agreement with expert ratings. Interrater reliability of the 25 trait facets of the AMPD varied but showed overall acceptable levels of agreement. Examination of severity indexes of PD impairment showed the level of personality functioning (LPF) added information beyond that of global assessment of functioning (GAF). Clinical utility ratings were generally strong. Lastly, the satisfactory interrater reliability of components of the AMPD indicates the model, including the LPF, is very learnable.« less

  13. A quantitative and qualitative evaluation of trainee opinions of four methods of personality disorder diagnosis.

    PubMed

    Nelson, Sharon M; Huprich, Steven K; Shankar, Sneha; Sohnleitner, Aimee; Paggeot, Amy V

    2017-07-01

    Four methods of how to assess and diagnose personality disorders have received much attention within the literature: the Shedler-Westen Assessment Procedure (Shedler & Westen, 1998), the DSM-5 Section III Personality Disorders section (APA, 2011), the DSM-5 Section III trait model (APA, 2013), and the Psychodynamic Diagnostic Manual (PDM; PDM Task Force, 2006) descriptions of 15 personality disorders. Given that much of the debate has been driven by clinician concerns, it is important to consider clinical utility when evaluating the usefulness of each method. The present study compares the 4 models on ratings of several dimensions of clinical utility provided by 329 graduate student clinicians and psychology interns from across the United States. Findings suggest that participants rated the DSM-5 trait model significantly higher in most clinical utility domains. Additionally, qualitative analyses of the open-ended responses provided by participants indicated that each method had strengths and weaknesses. Most notably, participants commented positively on the PDM's level of comprehensiveness and appreciated the SWAP-II's inclusion of a health category, despite the ease of use not being as highly rated for these methods. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  14. Understanding the health care utilization of children who require medical technology: A descriptive study of children who require tracheostomies.

    PubMed

    Spratling, Regena

    2017-04-01

    Children who require medical technology have complex chronic illnesses. This medical technology, including ventilators, oximeters, tracheostomy tubes, and feeding tubes, allows children and their families to live at home; however, the management of the children's care by informal caregivers is complex with the need for intensive, specialized care. The purpose of this study was to examine the sociodemographic and clinical characteristics that affect health care utilization in a population of children who require medical technology. A retrospective electronic health record (EHR) review was completed on the EHR records on 171 children who require medical technology, specifically tracheostomies, at an outpatient technology dependent pulmonary clinic over a three year period (January 2010-December 2012). Descriptive statistics were used to analyze sociodemographic and clinical characteristics, including medical diagnoses, and emergency department (ED) visits and hospitalizations. Of the 171 children requiring medical technology studied, there were numerous medical diagnoses (n=791), 99% had chronic illnesses affecting two or more body systems, and 88% required two or more technologies, including a tracheostomy and a feeding tube. In addition, 91% of the children had at least one ED visit or hospitalization and were treated in the ED approximately three times over the three year period. The findings from this study noted an increased utilization of health care by these children, and identified common symptoms and medical technologies for which caregivers may need interventions, focusing on education in managing symptoms and medical technology prior to presentation to the ED or hospital. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Stratified cost-utility analysis of C-Leg versus mechanical knees: Findings from an Italian sample of transfemoral amputees.

    PubMed

    Cutti, Andrea Giovanni; Lettieri, Emanuele; Del Maestro, Martina; Radaelli, Giovanni; Luchetti, Martina; Verni, Gennero; Masella, Cristina

    2017-06-01

    The fitting rate of the C-Leg electronic knee (Otto-Bock, D) has increased steadily over the last 15 years. Current cost-utility studies, however, have not considered the patients' characteristics. To complete a cost-utility analysis involving C-Leg and mechanical knee users; "age at the time of enrollment," "age at the time of first prosthesis," and "experience with the current type of prosthesis" are assumed as non-nested stratification parameters. Cohort retrospective. In all, 70 C-Leg and 57 mechanical knee users were selected. For each stratification criteria, we evaluated the cost-utility of C-Leg versus mechanical knees by computing the incremental cost-utility ratio, that is, the ratio of the "difference in cost" and the "difference in utility" of the two technologies. Cost consisted of acquisition, maintenance, transportation, and lodging expenses. Utility was measured in terms of quality-adjusted life years, computed on the basis of participants' answers to the EQ-5D questionnaire. Patients over 40 years at the time of first prosthesis were the only group featuring an incremental cost-utility ratio (88,779 €/quality-adjusted life year) above the National Institute for Health and Care Excellence practical cost-utility threshold (54,120 €/quality-adjusted live year): C-Leg users experience a significant improvement of "mobility," but limited outcomes on "usual activities," "self-care," "depression/anxiety," and reduction of "pain/discomfort." The stratified cost-utility results have relevant clinical implications and provide useful information for practitioners in tailoring interventions. Clinical relevance A cost-utility analysis that considered patients characteristics provided insights on the "affordability" of C-Leg compared to mechanical knees. In particular, results suggest that C-Leg has a significant impact on "mobility" for first-time prosthetic users over 40 years, but implementation of specific low-cost physical/psychosocial interventions is required to retun within cost-utility thresholds.

  16. Molecular Indicators of Castration-Resistant Prostate Cancer

    DTIC Science & Technology

    2014-10-01

    associated with primary resistance to enzalutamide and abiraterone, supporting the clinical utility of this blood-based predictive biomarker...AR-V7 in CTCs from patients with CRPC is associated with primary resistance to enzalutamide and abiraterone, supporting the clinical utility of this...r na l o f m e dic i n e n engl j med nejm.org8 mained marginally predictive of shorter clinical or radiographic progression–free survival (hazard

  17. Online Prediction of Health Care Utilization in the Next Six Months Based on Electronic Health Record Information: A Cohort and Validation Study.

    PubMed

    Hu, Zhongkai; Hao, Shiying; Jin, Bo; Shin, Andrew Young; Zhu, Chunqing; Huang, Min; Wang, Yue; Zheng, Le; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Rogow, Todd; Stearns, Frank; Sylvester, Karl G; Widen, Eric; Ling, Xuefeng

    2015-09-22

    The increasing rate of health care expenditures in the United States has placed a significant burden on the nation's economy. Predicting future health care utilization of patients can provide useful information to better understand and manage overall health care deliveries and clinical resource allocation. This study developed an electronic medical record (EMR)-based online risk model predictive of resource utilization for patients in Maine in the next 6 months across all payers, all diseases, and all demographic groups. In the HealthInfoNet, Maine's health information exchange (HIE), a retrospective cohort of 1,273,114 patients was constructed with the preceding 12-month EMR. Each patient's next 6-month (between January 1, 2013 and June 30, 2013) health care resource utilization was retrospectively scored ranging from 0 to 100 and a decision tree-based predictive model was developed. Our model was later integrated in the Maine HIE population exploration system to allow a prospective validation analysis of 1,358,153 patients by forecasting their next 6-month risk of resource utilization between July 1, 2013 and December 31, 2013. Prospectively predicted risks, on either an individual level or a population (per 1000 patients) level, were consistent with the next 6-month resource utilization distributions and the clinical patterns at the population level. Results demonstrated the strong correlation between its care resource utilization and our risk scores, supporting the effectiveness of our model. With the online population risk monitoring enterprise dashboards, the effectiveness of the predictive algorithm has been validated by clinicians and caregivers in the State of Maine. The model and associated online applications were designed for tracking the evolving nature of total population risk, in a longitudinal manner, for health care resource utilization. It will enable more effective care management strategies driving improved patient outcomes.

  18. Online Prediction of Health Care Utilization in the Next Six Months Based on Electronic Health Record Information: A Cohort and Validation Study

    PubMed Central

    Hu, Zhongkai; Hao, Shiying; Jin, Bo; Shin, Andrew Young; Zhu, Chunqing; Huang, Min; Wang, Yue; Zheng, Le; Dai, Dorothy; Culver, Devore S; Alfreds, Shaun T; Rogow, Todd; Stearns, Frank

    2015-01-01

    Background The increasing rate of health care expenditures in the United States has placed a significant burden on the nation’s economy. Predicting future health care utilization of patients can provide useful information to better understand and manage overall health care deliveries and clinical resource allocation. Objective This study developed an electronic medical record (EMR)-based online risk model predictive of resource utilization for patients in Maine in the next 6 months across all payers, all diseases, and all demographic groups. Methods In the HealthInfoNet, Maine’s health information exchange (HIE), a retrospective cohort of 1,273,114 patients was constructed with the preceding 12-month EMR. Each patient’s next 6-month (between January 1, 2013 and June 30, 2013) health care resource utilization was retrospectively scored ranging from 0 to 100 and a decision tree–based predictive model was developed. Our model was later integrated in the Maine HIE population exploration system to allow a prospective validation analysis of 1,358,153 patients by forecasting their next 6-month risk of resource utilization between July 1, 2013 and December 31, 2013. Results Prospectively predicted risks, on either an individual level or a population (per 1000 patients) level, were consistent with the next 6-month resource utilization distributions and the clinical patterns at the population level. Results demonstrated the strong correlation between its care resource utilization and our risk scores, supporting the effectiveness of our model. With the online population risk monitoring enterprise dashboards, the effectiveness of the predictive algorithm has been validated by clinicians and caregivers in the State of Maine. Conclusions The model and associated online applications were designed for tracking the evolving nature of total population risk, in a longitudinal manner, for health care resource utilization. It will enable more effective care management strategies driving improved patient outcomes. PMID:26395541

  19. A value-based medicine analysis of ranibizumab for the treatment of subfoveal neovascular macular degeneration.

    PubMed

    Brown, Melissa M; Brown, Gary C; Brown, Heidi C; Peet, Jonathan

    2008-06-01

    To assess the conferred value and average cost-utility (cost-effectiveness) for intravitreal ranibizumab used to treat occult/minimally classic subfoveal choroidal neovascularization associated with age-related macular degeneration (AMD). Value-based medicine cost-utility analysis. MARINA (Minimally Classic/Occult Trial of the Anti-Vascular Endothelial Growth Factor Antibody Ranibizumab in the Treatment of Neovascular AMD) Study patients utilizing published primary data. Reference case, third-party insurer perspective, cost-utility analysis using 2006 United States dollars. Conferred value in the forms of (1) quality-adjusted life-years (QALYs) and (2) percent improvement in health-related quality of life. Cost-utility is expressed in terms of dollars expended per QALY gained. All outcomes are discounted at a 3% annual rate, as recommended by the Panel on Cost-effectiveness in Health and Medicine. Data are presented for the second-eye model, first-eye model, and combined model. Twenty-two intravitreal injections of 0.5 mg of ranibizumab administered over a 2-year period confer 1.039 QALYs, or a 15.8% improvement in quality of life for the 12-year period of the second-eye model reference case of occult/minimally classic age-related subfoveal choroidal neovascularization. The reference case treatment cost is $52652, and the cost-utility for the second-eye model is $50691/QALY. The quality-of-life gain from the first-eye model is 6.4% and the cost-utility is $123887, whereas the most clinically simulating combined model yields a quality-of-life gain of 10.4% and cost-utility of $74169. By conventional standards and the most commonly used second-eye and combined models, intravitreal ranibizumab administered for occult/minimally classic subfoveal choroidal neovascularization is a cost-effective therapy. Ranibizumab treatment confers considerably greater value than other neovascular macular degeneration pharmaceutical therapies that have been studied in randomized clinical trials.

  20. Utilization of dental health care services in context of the HIV epidemic- a cross-sectional study of dental patients in the Sudan.

    PubMed

    Nasir, Elwalid Fadul; Astrøm, Anne Nordrehaug; David, Jamil; Ali, Raouf Wahab

    2009-11-16

    HIV infected patients should be expected in the Sudanese dental health care services with an increasing frequency. Dental care utilization in the context of the HIV epidemic is generally poorly understood. Focusing on Sudanese dental patients with reported unknown HIV status, this study assessed the extent to which Andersen's model in terms of predisposing (socio-demographics), enabling (knowledge, attitudes and perceived risk related to HIV) and need related factors (oral health status) predict dental care utilization. It was hypothesized that enabling factors would add to the explanation of dental care utilization beyond that of predisposing and need related factors. Dental patients were recruited from Khartoum Dental Teaching Hospital (KDTH) and University of Science and Technology (UST) during March-July 2008. A total of 1262 patients (mean age 30.7, 56.5% females and 61% from KDTH) were examined clinically (DMFT) and participated in an interview. A total of 53.9% confirmed having attended a dental clinic for treatment at least once in the past 2 years. Logistic regression analysis revealed that predisposing factors; travelling inside Sudan (OR = 0.5) were associated with lower odds and females were associated with higher odds (OR = 2.0) for dental service utilization. Enabling factors; higher knowledge of HIV transmission (OR = 0.6) and higher HIV related experience (OR = 0.7) were associated with lower odds, whereas positive attitudes towards infected people and high perceived risk of contagion (OR = 1.3) were associated with higher odds for dental care utilization. Among need related factors dental caries experience was strongly associated with dental care utilization (OR = 4.8). Disparity in the history of dental care utilization goes beyond socio-demographic position and need for dental care. Public awareness of HIV infection control and confidence on the competence of dentists should be improved to minimize avoidance behaviour and help establish dental health care patterns in Sudan.

  1. Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.

    PubMed

    Conrado, Daniela J; Nicholas, Timothy; Tsai, Kuenhi; Macha, Sreeraj; Sinha, Vikram; Stone, Julie; Corrigan, Brian; Bani, Massimo; Muglia, Pierandrea; Watson, Ian A; Kern, Volker D; Sheveleva, Elena; Marek, Kenneth; Stephenson, Diane T; Romero, Klaus

    2018-01-01

    Given the recognition that disease-modifying therapies should focus on earlier Parkinson's disease stages, trial enrollment based purely on clinical criteria poses significant challenges. The goal herein was to determine the utility of dopamine transporter neuroimaging as an enrichment biomarker in early motor Parkinson's disease clinical trials. Patient-level longitudinal data of 672 subjects with early-stage Parkinson's disease in the Parkinson's Progression Markers Initiative (PPMI) observational study and the Parkinson Research Examination of CEP-1347 Trial (PRECEPT) clinical trial were utilized in a linear mixed-effects model analysis. The rate of worsening in the motor scores between subjects with or without a scan without evidence of dopamine transporter deficit was different both statistically and clinically. The average difference in the change from baseline of motor scores at 24 months between biomarker statuses was -3.16 (90% confidence interval [CI] = -0.96 to -5.42) points. Dopamine transporter imaging could identify subjects with a steeper worsening of the motor scores, allowing trial enrichment and 24% reduction of sample size. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  2. Rethinking the Role of the Public Health Clinic: Comparison of Outpatient Utilization in the Public Health Clinics and Private Clinics in Korea.

    PubMed

    Kim, Agnus M; Cho, Seongcheol; Kim, Hyun Joo; Jo, Min-Woo; Eun, Sang Jun; Lee, Jin Yong

    2018-06-22

    Korea has experienced an overall expansion of access to care in the past few decades, which necessitated the reconsideration of the role of the public health clinics (PHC) as a primary care provider. The recent controversy about the outpatient copayment waiver for the elderly in the PHC is in the same vein. This study compared the outpatient utilization of the PHC and private clinics, and investigated its factors. Data were acquired from the National Patient Sample in 2013. Compared with private clinics, the patients in the PHC were more elderly and had less severe conditions. Being elderly, the status of National Health Insurance (NHI) beneficiaries, less comorbidities, and low total claim costs were found to be factors for choosing the PHC over private clinics. These results suggest that the elderly, who are the main beneficiaries of copayment waivers in the PHC, are the most likely to use the outpatient service by the PHC. The functions of the PHC need to be rearranged according to the recent advancements in the health care system in Korea. Diverting the resources and efforts from outpatient care to functions that best serve the health of the population should be considered.

  3. Basic immunology of antibody targeted radiotherapy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wong, Jeffrey Y.C.

    2006-10-01

    Antibody targeted radiotherapy brings an important new treatment modality to Radiation oncology clinic. Radiation dose to tumor and normal tissues are determined by a complex interplay of antibody, antigen, tumor, radionuclide, and host-related factors. A basic understanding of these immunologic and physiologic factors is important to optimally utilize this therapy in the clinic. Preclinical and clinical studies need to be continued to broaden our understanding and to develop new strategies to further improve the efficacy of this promising form of targeted therapy.

  4. Cost Utility Analysis of Percutaneous Adhesiolysis in Managing Pain of Post-lumbar Surgery Syndrome and Lumbar Central Spinal Stenosis.

    PubMed

    Manchikanti, Laxmaiah; Helm, Standiford; Pampati, Vidyasagar; Racz, Gabor B

    2015-06-01

    The increase in the number of interventions for the management of chronic pain and associated escalation of healthcare costs has captured the attention of health policymakers, in no small part due to the lack of documentation of efficacy, cost-effectiveness, or cost utility analysis. A recent cost utility analysis of caudal epidural injections in managing chronic low back pain of various pathologies showed a high cost utility with improvement in quality of life years, competitive with various other modalities of treatments. However, there are no analyses derived from high-quality controlled studies related to the cost utility of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome or lumbar central spinal stenosis. This analysis is based on 2 previously published controlled studies. To assess the cost utility of percutaneous adhesiolysis procedures in managing chronic low back and lower extremity pain secondary to post-lumbar surgery syndrome and lumbar central spinal stenosis. A private, specialty referral interventional pain management center in the United States. Two controlled studies were conducted assessing the clinical effectiveness of percutaneous adhesiolysis for post-lumbar surgery syndrome and lumbar central spinal stenosis in an interventional pain management setting utilizing contemporary interventional pain management practices. A cost utility analysis was performed with direct payment data for a total of 130 patients in treatment groups over a 2-year period. Various outcome measures were included with significant improvement, defined as at least 50% improvement with reduction in pain and disability status. The results of 2 controlled studies of low back pain with 60 and 70 patients and a 2-year follow-up with the actual reimbursement data showed cost utility for 1 year of quality-adjusted life year (QALY) of USD $2,652 for post-lumbar surgery syndrome and USD $2,649 for lumbar central spinal stenosis. The results of this assessment show that the cost utility of managing chronic, intractable low back pain with percutaneous adhesiolysis at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, spinal cord stimulation, and surgery. The limitations of this cost utility analysis are that it is a single-center evaluation, with the inclusion of costs of adhesiolysis procedures in an ambulatory surgery center and physician visits, rather than all related costs including drug therapy and costs of disability in multiple settings. This cost utility analysis of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome and lumbar central spinal stenosis shows the clinical effectiveness and cost utility of these procedures at USD $2,650 per one year of QALY when performed in an ambulatory surgery center. © 2014 World Institute of Pain.

  5. Atomoxetine pharmacogenetics: associations with pharmacokinetics, treatment response and tolerability.

    PubMed

    Brown, Jacob T; Bishop, Jeffrey R

    2015-01-01

    Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder and is predominantly metabolized by the CYP2D6 enzyme. Differences in pharmacokinetic parameters as well as clinical treatment outcomes across CYP2D6 genotype groups have resulted in dosing recommendations within the product label, but clinical studies supporting the use of genotype guided dosing are currently lacking. Furthermore, pharmacokinetic and clinical studies have primarily focused on extensive as compared with poor metabolizers, with little information known about other metabolizer categories as well as genes involved in the pharmacodynamics of atomoxetine. This review describes the pharmacogenetic associations with atomoxetine pharmacokinetics, treatment response and tolerability with considerations for the clinical utility of this information.

  6. The comparability of solicited versus clinic subjects in alcohol treatment research.

    PubMed

    Pearlman, S; Zweben, A; Li, S

    1989-05-01

    The increasing use of media advertisements to recruit subjects in alcohol treatment research has raised concerns about the comparability of such solicited subjects and subjects drawn from more traditional clinic populations. This paper, based on a study that involved both solicited and clinic subjects, identifies differences between the two types of subjects in terms of sociodemographic variables; pre-treatment drinking and marital adjustment; several dimensions of 'self-definition'; and three outcome measures. These findings suggest that there may be significant differences between solicited and clinic subjects and that these differences should be taken into account in the design of studies utilizing solicited subjects in order to determine the generalizability of the results.

  7. Association of hypoglycaemia severity with clinical, patient‐reported and economic outcomes in US patients with type 2 diabetes using basal insulin

    PubMed Central

    Lee, Lulu K.; Gupta, Shaloo; Preblick, Ron

    2018-01-01

    Aims To evaluate the clinical and patient‐reported outcomes and healthcare utilization and costs associated with patient‐reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. Materials and methods This was an observational, cross‐sectional, survey‐based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid‐acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non‐severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health‐related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. Results Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non‐severe or no hypoglycaemia. Patients with non‐severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. Conclusions Patients with T2D using basal insulin ± OADs or rapid‐acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non‐severe or no hypoglycaemia. The study also demonstrated the impact that non‐severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs. PMID:29316141

  8. Utilization and acceptance of virtual patients in veterinary basic sciences - the vetVIP-project.

    PubMed

    Kleinsorgen, Christin; Kankofer, Marta; Gradzki, Zbigniew; Mandoki, Mira; Bartha, Tibor; von Köckritz-Blickwede, Maren; Naim, Hassan Y; Beyerbach, Martin; Tipold, Andrea; Ehlers, Jan P

    2017-01-01

    Context: In medical and veterinary medical education the use of problem-based and cased-based learning has steadily increased over time. At veterinary faculties, this development has mainly been evident in the clinical phase of the veterinary education. Therefore, a consortium of teachers of biochemistry and physiology together with technical and didactical experts launched the EU-funded project "vetVIP", to create and implement veterinary virtual patients and problems for basic science instruction. In this study the implementation and utilization of virtual patients occurred at the veterinary faculties in Budapest, Hannover and Lublin. Methods: This report describes the investigation of the utilization and acceptance of students studying veterinary basic sciences using optional online learning material concurrently to regular biochemistry and physiology didactic instruction. The reaction of students towards this offer of clinical case-based learning in basic sciences was analysed using quantitative and qualitative data. Quantitative data were collected automatically within the chosen software-system CASUS as user-log-files. Responses regarding the quality of the virtual patients were obtained using an online questionnaire. Furthermore, subjective evaluation by authors was performed using a focus group discussion and an online questionnaire. Results: Implementation as well as usage and acceptance varied between the three participating locations. High approval was documented in Hannover and Lublin based upon the high proportion of voluntary students (>70%) using optional virtual patients. However, in Budapest the participation rate was below 1%. Due to utilization, students seem to prefer virtual patients and problems created in their native language and developed at their own university. In addition, the statement that assessment drives learning was supported by the observation that peak utilization was just prior to summative examinations. Conclusion: Veterinary virtual patients in basic sciences can be introduced and used for the presentation of integrative clinical case scenarios. Student post-course comments also supported the conclusion that overall the virtual cases increased their motivation for learning veterinary basic sciences.

  9. The Clinical Utility of Vestibular-Evoked Myogenic Potentials in the Diagnosis of Ménière’s Disease

    PubMed Central

    Maheu, Maxime; Alvarado-Umanzor, Jenny Marylin; Delcenserie, Audrey; Champoux, François

    2017-01-01

    Ménière’s disease (MD) is a condition that has been proposed over 150 years ago, which involves audiological and vestibular manifestations, such as aural fullness, tinnitus, vertigo, and fluctuating hearing thresholds. Over the past few years, many researchers have assessed different techniques to help diagnose this pathology. Vestibular-evoked myogenic potential (VEMP) is an electrophysiological method assessing the saccule (cVEMP) and the utricule (oVEMP). Its clinical utility in the diagnosis of multiple pathologies, such as superior canal dehiscence, has made this tool a common method used in otologic clinics. The main objective of the present review is to determine the current state of knowledge of the VEMP in the identification of MD, such as the type of stimuli, the frequency tuning, and the interaural asymmetry ratio of the cVEMP and the oVEMP. Results show that the type of stimulation, the frequency sensitivity shift and the interaural asymmetry ratio (IAR) could be useful tool to diagnose and describe the evolution of MD. It is, however, important to emphasize that further studies are needed to confirm the utility of VEMP in the identification of MD in its early stage, using either bone-conduction vibration or air-conduction stimulation, which is of clinical importance when it comes to early intervention. PMID:28861037

  10. Feasibility and clinical utility of ultra-widefield indocyanine green angiography.

    PubMed

    Klufas, Michael A; Yannuzzi, Nicolas A; Pang, Claudine E; Srinivas, Sowmya; Sadda, Srinivas R; Freund, K Bailey; Kiss, Szilárd

    2015-03-01

    To evaluate the feasibility and clinical utility of a novel noncontact scanning laser ophthalmoscope-based ultra-widefield indocyanine green angiographic system. Ultra-widefield indocyanine green angiographic images were captured using a modified Optos P200Tx that produced high-resolution images of the choroidal vasculature with up to a 200° field. Ultra-widefield indocyanine green angiography was performed on patients with a variety of retinal conditions to assess utility of this imaging technique for diagnostic purposes and disease treatment monitoring. Ultra-widefield indocyanine green angiography was performed on 138 eyes of 69 patients. Mean age was 58 ± 16.9 years (range, 24-85 years). The most common ocular pathologies imaged included central serous chorioretinopathy (24 eyes), uveitis (various subtypes, 16 eyes), age-related macular degeneration (12 eyes), and polypoidal choroidal vasculopathy (4 eyes). In all eyes evaluated with ultra-widefield indocyanine green angiography, high-resolution images of choroidal and retinal circulation were obtained with sufficient detail out to 200° of the fundus. In this series of 138 eyes, scanning laser ophthalmoscope-based ultra-widefield indocyanine green angiography was clinically practical and provided detailed images of both the central and peripheral choroidal circulation. Future studies are needed to refine the clinical value of this imaging modality and the significance of peripheral choroidal vascular changes in the diagnosis, monitoring, and treatment of ocular diseases.

  11. The Clinical Research Landscape in Rhode Island.

    PubMed

    Mao, George; Ramratnam, Bharat

    2017-01-06

    To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

  12. Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Van Poznak, Catherine; Somerfield, Mark R.; Bast, Robert C.; Cristofanilli, Massimo; Goetz, Matthew P.; Gonzalez-Angulo, Ana M.; Hicks, David G.; Hill, Elizabeth G.; Liu, Minetta C.; Lucas, Wanda; Mayer, Ingrid A.; Mennel, Robert G.; Symmans, William F.; Hayes, Daniel F.; Harris, Lyndsay N.

    2015-01-01

    Purpose To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer. Methods A literature search and prospectively defined study selection identified systematic reviews, meta-analyses, randomized controlled trials (RCTs), prospective–retrospective studies, and prospective comparative observational studies published from 2006 through September 2014. Results The literature search revealed 17 articles that met criteria for further review: 11 studies reporting discordances between primary tumors and metastases in expression of hormone receptors or human epidermal growth factor receptor 2 (HER2), one RCT that addressed the use of a biomarker to decide whether to change or continue a treatment regimen, and five prospective–retrospective studies that evaluated the clinical utility of biomarkers. Recommendations In patients with accessible metastases, biopsy for confirmation of disease process and retesting of estrogen receptor, progesterone receptor, and HER2 status should be offered, but evidence is lacking to determine whether changing anticancer treatment on the basis of change in receptor status affects clinical outcomes. With discordance of results between primary and metastatic tissues, the Panel consensus is to use preferentially the estrogen receptor, progesterone receptor, and HER2 status of the metastasis to direct therapy if supported by the clinical scenario and patient's goals for care. Carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 may be used as adjunctive assessments, but not alone, to contribute to decisions regarding therapy. Recommendations for tumor rebiopsy and use of circulating tumor markers are based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments. PMID:26195705

  13. Utility as a rationale for choosing observer performance assessment paradigms for detection tasks in medical imaging.

    PubMed

    Wunderlich, Adam; Abbey, Craig K

    2013-11-01

    Studies of lesion detectability are often carried out to evaluate medical imaging technology. For such studies, several approaches have been proposed to measure observer performance, such as the receiver operating characteristic (ROC), the localization ROC (LROC), the free-response ROC (FROC), the alternative free-response ROC (AFROC), and the exponentially transformed FROC (EFROC) paradigms. Therefore, an experimenter seeking to carry out such a study is confronted with an array of choices. Traditionally, arguments for different approaches have been made on the basis of practical considerations (statistical power, etc.) or the gross level of analysis (case-level or lesion-level). This article contends that a careful consideration of utility should form the rationale for matching the assessment paradigm to the clinical task of interest. In utility theory, task performance is commonly evaluated with total expected utility, which integrates the various event utilities against the probability of each event. To formalize the relationship between expected utility and the summary curve associated with each assessment paradigm, the concept of a "natural" utility structure is proposed. A natural utility structure is defined for a summary curve when the variables associated with the summary curve axes are sufficient for computing total expected utility, assuming that the disease prevalence is known. Natural utility structures for ROC, LROC, FROC, AFROC, and EFROC curves are introduced, clarifying how the utilities of correct and incorrect decisions are aggregated by summary curves. Further, conditions are given under which general utility structures for localization-based methodologies reduce to case-based assessment. Overall, the findings reveal how summary curves correspond to natural utility structures of diagnostic tasks, suggesting utility as a motivating principle for choosing an assessment paradigm.

  14. 76 FR 73648 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4... collection; Title of Information Collection: Request for Certification as a Rural Health Clinic Form and... of Rural Health Clinic (RHC) Services under the Medicare/ Medicaid Program, is utilized as an...

  15. Clinical 68Ga-PET: Is radiosynthesis module an absolute necessity?

    PubMed

    Chakravarty, Rubel; Chakraborty, Sudipta; Radhakrishnan, E R; Kamaleshwaran, Koramadai; Shinto, Ajit; Dash, Ashutosh

    2017-03-01

    The commercially available 68 Ge/ 68 Ga generators are generally used in clinical context in conjunction with automated or semi-automated modules for the syntheses of 68 Ga radiopharmaceuticals. It is desirable to develop strategies for the formulation of 68 Ga-radiopharmaceuticals without use of such expensive modules in order to make 68 Ga-based clinical positron emission tomography (PET) more popular and affordable worldwide. An organic matrix based 68 Ge/ 68 Ga generator was used for preparation of clinically relevant doses of four different 68 Ga-based radiopharmaceuticals, namely 68 Ga-DOTA-NOC, 68 Ga-NODAGA-RGD 2 , 68 Ga-PSMA-11 and 68 Ga-BPAMD. Detailed performance evaluation of the generator was carried out over the period of 9months. The radiolabeling conditions were optimized in a hospital radiopharmacy directly utilizing 68 Ga eluted from the generator without use of any synthesis module. Quality control tests of the radiopharmaceuticals were carried out to assess their suitability for clinical use. The clinical utility of the synthesized radiopharmaceuticals was ascertained by performing PET scans in human patients. During the period of evaluation, 68 Ga could be obtained from the generator in 4mL of 0.05M HCl with 60-85% elution yield and >99.99% radionuclidic purity. While directly using 68 Ga eluted from the generator, the 68 Ga-based radiopharmaceuticals could be prepared with >95% radiochemical purity and they met all the requirements for clinical administration. The clinical efficacy of the radiopharmaceuticals synthesized was established by PET scans in human patients. The performance of the generator remained consistent over the 9-month period and >100 clinical doses of different radiopharmaceuticals were prepared with excellent reproducibility and clinical effectiveness. The promising results obtained in this study would make 68 Ga-radiopharmacy more practical and cost effective in clinical context. To the best of our knowledge, this is the first report on the clinical scale syntheses and utilization of 68 Ga-based radiopharmaceuticals without using any synthesis module. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Measuring the impact of a health information exchange intervention on provider-based notifiable disease reporting using mixed methods: a study protocol.

    PubMed

    Dixon, Brian E; Grannis, Shaun J; Revere, Debra

    2013-10-30

    Health information exchange (HIE) is the electronic sharing of data and information between clinical care and public health entities. Previous research has shown that using HIE to electronically report laboratory results to public health can improve surveillance practice, yet there has been little utilization of HIE for improving provider-based disease reporting. This article describes a study protocol that uses mixed methods to evaluate an intervention to electronically pre-populate provider-based notifiable disease case reporting forms with clinical, laboratory and patient data available through an operational HIE. The evaluation seeks to: (1) identify barriers and facilitators to implementation, adoption and utilization of the intervention; (2) measure impacts on workflow, provider awareness, and end-user satisfaction; and (3) describe the contextual factors that impact the effectiveness of the intervention within heterogeneous clinical settings and the HIE. The intervention will be implemented over a staggered schedule in one of the largest and oldest HIE infrastructures in the U.S., the Indiana Network for Patient Care. Evaluation will be conducted utilizing a concurrent design mixed methods framework in which qualitative methods are embedded within the quantitative methods. Quantitative data will include reporting rates, timeliness and burden and report completeness and accuracy, analyzed using interrupted time-series and other pre-post comparisons. Qualitative data regarding pre-post provider perceptions of report completeness, accuracy, and timeliness, reporting burden, data quality, benefits, utility, adoption, utilization and impact on reporting workflow will be collected using semi-structured interviews and open-ended survey items. Data will be triangulated to find convergence or agreement by cross-validating results to produce a contextualized portrayal of the facilitators and barriers to implementation and use of the intervention. By applying mixed research methods and measuring context, facilitators and barriers, and individual, organizational and data quality factors that may impact adoption and utilization of the intervention, we will document whether and how the intervention streamlines provider-based manual reporting workflows, lowers barriers to reporting, increases data completeness, improves reporting timeliness and captures a greater portion of communicable disease burden in the community.

  17. System Transformation in Patient-Centered Medical Home (PCMH): Variable Impact on Chronically Ill Patients' Utilization.

    PubMed

    Carlin, Caroline S; Flottemesch, Thomas J; Solberg, Leif I; Werner, Ann M

    2016-01-01

    Research connecting patient-centered medical homes (PCMHs) with improved quality and reduced utilization is inconsistent, possibly because individual domains of change, and the stage of change, are not incorporated in the research design. The objective of this study was to examine the association between stage and domain of change and patterns of health care utilization. This was a cross-sectional observational study that including 87 Minnesota clinics certified as medical homes. Patients included those receiving management for diabetes or cardiovascular disease with insurance coverage by payers participating in the study. PCMH transformation stage was defined by practice systems in place, with measurements summarized in 5 domains. Health care utilization was measured by total utilization, frequency of outpatient visits and prescriptions, and occurrence of inpatient and emergency department visits. PCMH transformation was associated with few changes in utilization, but there were important differences by the underlying domains of change. We demonstrate meaningful differences in the impact of PCMH transformation by diagnosis cohort and comorbidity status of the patient. Because the association of health care utilization with PCMH transformation varied by transformation domain and patient diagnosis, practice leaders need to be supported by research incorporating detailed measures of PCMH transformation. © Copyright 2016 by the American Board of Family Medicine.

  18. Clinical Infectious Outcomes Associated with Biofilm-related Infections: a Retrospective Chart Review

    DTIC Science & Technology

    2015-06-07

    Chronic infections, Risk factors, Trauma-related infections, Burn Background The ability of microorganisms to form biofilms, a sessile mode of growth...patients [8]. With the present study, clinical information recovered from chart review was able to differentiate colonizing from infecting organisms...potential influences. Utilization of a randomly selected sample had conse- quences in microorganism representation as well as demographics. Species were

  19. Trametes versicolor Mushroom Immune Therapy in Breast Cancer

    PubMed Central

    Standish, Leanna J.; Wenner, Cynthia A.; Sweet, Erin S.; Bridge, Carly; Nelson, Ana; Martzen, Mark; Novack, Jeffrey; Torkelson, Carolyn

    2009-01-01

    Data from multiple epidemiologic and clinical studies on immune effects of conventional cancer treatment and the clinical benefits of polysaccharide immune therapy suggest that immune function has a role in breast cancer prevention. Immune therapy utilizing the polysaccharide constituents of Trametes versicolor (Tv) as concurrent adjuvant cancer therapy may be warranted as part of a comprehensive cancer treatment and secondary prevention strategy. PMID:19087769

  20. Clinical utility of FDG PET in Parkinson's disease and atypical parkinsonism associated with dementia.

    PubMed

    Walker, Zuzana; Gandolfo, Federica; Orini, Stefania; Garibotto, Valentina; Agosta, Federica; Arbizu, Javier; Bouwman, Femke; Drzezga, Alexander; Nestor, Peter; Boccardi, Marina; Altomare, Daniele; Festari, Cristina; Nobili, Flavio

    2018-05-19

    There are no comprehensive guidelines for the use of FDG PET in the following three clinical scenarios: (1) diagnostic work-up of patients with idiopathic Parkinson's disease (PD) at risk of future cognitive decline, (2) discriminating idiopathic PD from progressive supranuclear palsy, and (3) identifying the underlying neuropathology in corticobasal syndrome. We therefore performed three literature searches and evaluated the selected studies for quality of design, risk of bias, inconsistency, imprecision, indirectness and effect size. Critical outcomes were the sensitivity, specificity, accuracy, positive/negative predictive value, area under the receiving operating characteristic curve, and positive/negative likelihood ratio of FDG PET in detecting the target condition. Using the Delphi method, a panel of seven experts voted for or against the use of FDG PET based on published evidence and expert opinion. Of 91 studies selected from the three literature searches, only four included an adequate quantitative assessment of the performance of FDG PET. The majority of studies lacked robust methodology due to lack of critical outcomes, inadequate gold standard and no head-to-head comparison with an appropriate reference standard. The panel recommended the use of FDG PET for all three clinical scenarios based on nonquantitative evidence of clinical utility. Despite widespread use of FDG PET in clinical practice and extensive research, there is still very limited good quality evidence for the use of FDG PET. However, in the opinion of the majority of the panellists, FDG PET is a clinically useful imaging biomarker for idiopathic PD and atypical parkinsonism associated with dementia.

  1. Safety and Efficacy of Transvenous Lead Extraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience.

    PubMed

    Sharma, Saumya; Ekeruo, Ijeoma A; Nand, Nikita P; Sundara Raman, Ajay; Zhang, Xu; Reddy, Sunil K; Hariharan, Ramesh

    2018-02-01

    The goal of this study is to assess the safety and efficacy of mechanical lead extraction utilizing the Evolution system. Compared with other techniques commonly used for lead extraction, data regarding the safety and efficacy of mechanical lead extraction using the Evolution system is limited and needs further evaluation. Between June 1, 2009 and September 30, 2016, we retrospectively analyzed 400 consecutive patients who exclusively underwent mechanical lead extraction utilizing the Evolution system. A total of 400 patients underwent mechanical lead extraction of 683 leads. Mean age of extracted leads was 6.77 ± 4.42 years (range 1 to 31 years). The extracted device system was an implantable cardioverter-defibrillator in 274 patients (68.5%) and a pacemaker system in 126 patients (31.5%). Complete lead removal rate was 97% with a clinical success rate of 99.75%. Incomplete lead removal with <4-cm remnant was associated with older leads (lead age >8 years). Failure to achieve clinical success was noted in 1 patient (0.25%). Cardiac papillary avulsion, system-related infection, and cardiac tamponade were the major complications noted in 6 patients (1.5%). Minor complications were encountered in 24 patients (6%), of which hematoma requiring evacuation was the most common minor complication. There were no patient deaths. In our single-center study, lead extractions utilizing the Evolution mechanical lead extraction system were safe and effective and resulted in high clinical and procedural success, with low complication rates and no fatalities. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Characteristics, resource utilization and safety profile of patients prescribed with neuropathic pain treatments: a real-world evidence study on general practices in Europe - the role of the lidocaine 5% medicated plaster.

    PubMed

    Katz, Pablo; Pegoraro, Valeria; Liedgens, Hiltrud

    2017-08-01

    To identify characteristics, resource utilization, and safety profile of patients prescribed with lidocaine 5% medicated plaster, pregabalin, gabapentin, amitriptyline and duloxetine when experiencing pain in the real-world setting of general practitioners (GPs) in Europe. Retrospective analysis on real world data from IMS Health Longitudinal Patient Database. Patients with at least one prescription of the drugs of interest during 2014 were selected and those with a non-neuropathic pain-related diagnosis were excluded. Patients' demographic and clinical characteristics, resource utilization data and adverse drug reactions (ADRs) as described in the leaflet were extracted. The association between treatments and ADR occurrence was evaluated applying multivariate logistic models. A total of 70,515 patients were selected from Italy, Germany, the UK, Spain and Belgium. Lidocaine 5% medicated plaster patients were the oldest in Italy, the UK and Spain and the most health impaired in Italy, Spain and Belgium. No relevant differences in the number of co-prescriptions, specialist visits, examinations and hospitalizations were found. Significantly less lidocaine 5% plasters patients experienced ADRs, with odds ratios in favor of lidocaine 5% medicated plasters ranging from 3.41 (p = .036) to 52.33 (p < .001). Evidence from daily clinical practice in GP settings agrees with the findings from more controlled clinical-trial settings, with lidocaine 5% medicated plaster patients showing a better safety profile, but also a comparable level of resource utilization. A possible re-evaluation of the scientific value coming from this retrospective study in building up a diagnostic as well as a therapeutic algorithm is suggested.

  3. Etiologic features and utilization of antiepileptic drugs in people with chronic epilepsy in China: Report from the Epilepsy Cohort of Huashan Hospital (ECoH).

    PubMed

    Ge, Yan; Yu, Peimin; Ding, Ding; Wang, Ping; Shi, Yunbo; Zhao, Ting; Tang, Xinghua; Hong, Zhen

    2015-10-01

    Chronic epilepsy is estimated to affect more than 2 million people in China. However, data of its clinical characteristics was rarely reported in China. In the present study, we summarized the etiologic features and utilization patterns of antiepileptic drugs (AEDs) in people with chronic epilepsy in a tertiary medical center in China. We prospectively recruited people with chronic epilepsy treated at the Epilepsy Outpatient Clinic of Huashan Hospital during October 2009 to August 2013. Demographic data, clinical characteristics, AED treatment, epilepsy-associated risk factors and medical history, and results of supplementary examinations of each participant were collected retrospectively via an interviewer-administered questionnaire and confirmed by the medical records. Among 554 people with chronic epilepsy, 58.0% of them were male, 66.8% had focal seizure, and 29.2% had symptomatic cause. Developmental anomalies of cerebral structure (16.7%) and cerebral trauma (16.7%) shared the leading cause of symptomatic epilepsy among children with epilepsy. While cerebral trauma (29.1%) and cerebrovascular disorder (36.4%) were the most common causes in groups of adults and elderly. Fifty percent of participants were taking AED monotherapy. Proportions of people with idiopathic, cryptogenic and symptomatic epilepsy treated by multitherapy were 35%, 46% and 45.6%, respectively. Valproic acid (VPA) was the most frequently utilized AED as monotherapy (32.7%) and within multitherapy (62.5%). This hospital-based study reported that etiologic features were diverse in different age groups of people with chronic epilepsy. VPA was widely utilized to treat chronic epilepsy in mainland China. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Changing Patterns of Mental Health Care Use: The Role of Integrated Mental Health Services in Veteran Affairs Primary Care.

    PubMed

    Leung, Lucinda B; Yoon, Jean; Rubenstein, Lisa V; Post, Edward P; Metzger, Maureen E; Wells, Kenneth B; Sugar, Catherine A; Escarce, José J

    2018-01-01

    Aiming to foster timely, high-quality mental health care for Veterans, VA's Primary Care-Mental Health Integration (PC-MHI) embeds mental health specialists in primary care and promotes care management for depression. PC-MHI and patient-centered medical home providers work together to provide the bulk of mental health care for primary care patients with low-to-moderate-complexity mental health conditions. This study examines whether increasing primary care clinic engagement in PC-MHI services is associated with changes in patient health care utilization and costs. We performed a retrospective longitudinal cohort study of primary care patients with identified mental health needs in 29 Southern California VA clinics from October 1, 2008 to September 30, 2013, using electronic administrative data (n = 66,638). We calculated clinic PC-MHI engagement as the proportion of patients receiving PC-MHI services among all primary care clinic patients in each year. Capitalizing on variation in PC-MHI engagement across clinics, our multivariable regression models predicted annual patient use of 1) non-primary care based mental health specialty (MHS) visits, 2) total mental health visits (ie, the sum of MHS and PC-MHI visits), and 3) health care utilization and costs. We controlled for year- and clinic-fixed effects, other clinic interventions, and patient characteristics. Median clinic PC-MHI engagement increased by 8.2 percentage points over 5 years. At any given year, patients treated at a clinic with 1 percentage-point higher PC-MHI engagement was associated with 0.5% more total mental health visits (CI, 0.18% to 0.90%; P = .003) and 1.0% fewer MHS visits (CI, -1.6% to -0.3%; P = .002); this is a substitution rate, at the mean, of 1.5 PC-MHI visits for each MHS visit. There was no PC-MHI effect on other health care utilization and costs. As intended, greater clinic engagement in PC-MHI services seems to increase realized accessibility to mental health care for primary care patients, substituting PC-MHI for MHS visits, without increasing acute care use or total costs. Thus, PC-MHI services within primary care clinics may improve mental health care value at the patient population level. More research is needed to understand the relationship between clinic PC-MHI engagement and clinical quality of mental health care. © Copyright 2018 by the American Board of Family Medicine.

  5. Electroencephalography signatures of attention-deficit/hyperactivity disorder: clinical utility.

    PubMed

    Alba, Guzmán; Pereda, Ernesto; Mañas, Soledad; Méndez, Leopoldo D; González, Almudena; González, Julián J

    2015-01-01

    The techniques and the most important results on the use of electroencephalography (EEG) to extract different measures are reviewed in this work, which can be clinically useful to study subjects with attention-deficit/hyperactivity disorder (ADHD). First, we discuss briefly and in simple terms the EEG analysis and processing techniques most used in the context of ADHD. We review techniques that both analyze individual EEG channels (univariate measures) and study the statistical interdependence between different EEG channels (multivariate measures), the so-called functional brain connectivity. Among the former ones, we review the classical indices of absolute and relative spectral power and estimations of the complexity of the channels, such as the approximate entropy and the Lempel-Ziv complexity. Among the latter ones, we focus on the magnitude square coherence and on different measures based on the concept of generalized synchronization and its estimation in the state space. Second, from a historical point of view, we present the most important results achieved with these techniques and their clinical utility (sensitivity, specificity, and accuracy) to diagnose ADHD. Finally, we propose future research lines based on these results.

  6. Epidemiological review of scorpion stings in Qatar. The need for regional management guidelines in emergency departments.

    PubMed

    Alkahlout, Baha H; Abid, Muhammad M; Kasim, Mohammad M; Haneef, Shumaila M

    2015-07-01

    To review the epidemiology of scorpion sting in Qatar, to explore both the clinical significance, and the role of the emergency department (ED) in the management of such cases. In this retrospective study, we reviewed the records of all scorpion sting cases presented to the ED of Hamad General Hospital, Doha, Qatar between October 2010 and May 2013. A total of 111 cases of scorpion stings were reviewed, 81 (72.9%) were males and 30 (27.1%) were females, with a mean age of 38 years. Localized pain was the most frequent presenting complaint (89 [80.2%]), whereas localized redness (44 [39.6%]) and swelling (38 [34.2%]) were the most common clinical signs. Abroug's classification was used, and all cases  were found to be class I. All patients received symptomatic treatment and were sent home. Scorpion sting problem in Qatar has a low clinical significance. Data from such studies should be utilized to create more specific (local) management guidelines, which should be more efficient with more rational utilization of ED resources.

  7. Impact of Advanced (Open) Access Scheduling on Patients With Chronic Diseases

    PubMed Central

    Degani, N

    2013-01-01

    Background The goal of advanced access scheduling is to eliminate wait times for physician visits by ensuring access to same-day appointments, regardless of urgency or health care need. The intent is to reduce delays in access, leading to improvements in clinical care and patient satisfaction, and reductions in the use of urgent care. Objective To evaluate whether implementation of an advanced access scheduling system reduced other types of health service utilization and/or improved clinical measures and patient satisfaction among adults with chronic diseases. Data Sources and Review Methods A literature search was performed on January 29, 2012, for studies published from 1946 (OVID) or 1980 (EMBASE) to January 29, 2012. Systematic reviews, randomized controlled trials, and observational studies were eligible if they evaluated advanced access implementation in adults with chronic diseases and reported health resource utilization, patient outcomes, or patient satisfaction. Results were summarized descriptively. Results One systematic review in a primary care population and 4 observational studies (5 papers) in chronic disease and/or geriatric populations were identified. The systematic review concluded that advanced access did not improve clinical outcomes, but there was no evidence of harm. Findings from the observational studies in chronic disease populations were consistent with those of the systematic review. Advanced access implementation was not consistently associated with changes in clinical outcomes, patient satisfaction, or health service utilization. Limitations All studies were retrospective: 3 studies (4 papers) included historical controls only, and 1 included contemporaneous controls. Findings were inconsistent across studies for a number of outcomes. Conclusions Based on low to very low quality evidence, advanced access did not have a statistically (or clinically) significant impact on health service utilization among patients with diabetes and/or coronary artery disease (CAD). Very low quality evidence showed a significant reduction in the proportion of patients with diabetes and CAD admitted to hospital whose length of stay was greater than 3 days. Evidence was inconsistent for changes in clinical outcomes for patients with diabetes or CAD. Very low quality evidence showed no increase in patient satisfaction with an advanced access scheduling system. Plain Language Summary Timeliness of health care access—reducing wait times and delays for those receiving and providing care—is a key measure of health system quality. However, in international comparison studies, Canada ranked either last or next to last when it came to timely access to regular doctors. Efforts in Ontario to address delays in access have included the implementation of the Advanced Access and Efficiency for Primary Care initiative through the Quality Improvement and Innovation Partnership, later incorporated into Health Quality Ontario. Advanced access is a physician appointment scheduling system that aims to eliminate wait times for physician visits and ensure same-day access for all patients, regardless of urgency or health care need. While it can generally be agreed that timely access to health care is necessary for all patients, same-day access may not always be required. Indeed, advanced access may adversely affect the care of patients with chronic diseases if clinics implement strict same-day appointment rules and patients cannot pre-book follow-up appointments. This review evaluated the effect of advanced access scheduling on clinical outcomes, patient satisfaction, and health service utilization in patients with selected chronic diseases, as part of the Optimizing Chronic Disease Management in the Outpatient (Community) Setting mega-analysis. In patients with diabetes or coronary artery disease, advanced access implementation had little or no impact on acute health care use (hospitalizations, emergency department visits, and/or urgent care visits) and had inconsistent effects on clinical outcomes (blood glucose, low-density lipoprotein [LDL] cholesterol, and blood pressure). Two studies reported reduced monitoring of patients with chronic diseases after implementation of advanced access. Another study reported improved patient management (regular blood glucose and cholesterol testing) after advanced access implementation, but this was attributed to improved provider continuity rather than to reduced appointment wait times. There was no increase in patient satisfaction with the advanced access scheduling system. The quality of the evidence ranged from low to very low. PMID:24133569

  8. Medicare Utilization and Expenditures Around Incident Dementia in a Multiethnic Cohort.

    PubMed

    Zhu, Carolyn W; Cosentino, Stephanie; Ornstein, Katherine; Gu, Yian; Scarmeas, Nikolaos; Andrews, Howard; Stern, Yaakov

    2015-11-01

    Few studies have examined patterns of health care utilization and costs during the period around incident dementia. Participants were drawn from the Washington Heights-Inwood Columbia Aging Project, a multiethnic, population-based, prospective study of cognitive aging of Medicare beneficiaries in a geographically defined area of northern Manhattan. Medicare utilization and expenditure were examined in individuals with clinically diagnosed dementia from 2 years before until 2 years after the initial diagnosis. A sample of non-demented individuals who were matched on socio-demographic and clinical characteristics at study enrollment was used as controls. Multivariable regression analysis estimated effects on Medicare utilization and expenditures associated with incident dementia. During the 2 years before incident dementia, rates of inpatient admissions and outpatient visits were similar between dementia patients and non-demented controls, but use of home health and skilled nursing care and durable medical equipment were already higher in dementia patients. Results showed a small but significant excess increase associated with incident dementia in inpatient admissions but not in other areas of care. In the 2 years before incident dementia, total Medicare expenditures were already higher in dementia patients than in non-demented controls. But we found no excess increases in Medicare expenditures associated with incident dementia. Demand for medical care already is increasing and costs are higher at the time of incident dementia. There was a small but significant excess risk of inpatient admission associated with incident dementia. Published by Oxford University Press on behalf of the Gerontological Society of America 2015.

  9. Targeting IL-2: an unexpected effect in treating immunological diseases.

    PubMed

    Ye, Congxiu; Brand, David; Zheng, Song G

    2018-01-01

    Regulatory T cells (Treg) play a crucial role in maintaining immune homeostasis since Treg dysfunction in both animals and humans is associated with multi-organ autoimmune and inflammatory disease. While IL-2 is generally considered to promote T-cell proliferation and enhance effector T-cell function, recent studies have demonstrated that treatments that utilize low-dose IL-2 unexpectedly induce immune tolerance and promote Treg development resulting in the suppression of unwanted immune responses and eventually leading to treatment of some autoimmune disorders. In the present review, we discuss the biology of IL-2 and its signaling to help define the key role played by IL-2 in the development and function of Treg cells. We also summarize proof-of-concept clinical trials which have shown that low-dose IL-2 can control autoimmune diseases safely and effectively by specifically expanding and activating Treg. However, future studies will be needed to validate a better and safer dosing strategy for low-dose IL-2 treatments utilizing well-controlled clinical trials. More studies will also be needed to validate the appropriate dose of IL-2/anti-cytokine or IL-2/anti-IL-2 complex in the experimental animal models before moving to the clinic.

  10. Interdisciplinary Concepts for Design and Implementation of Mixed Reality Interactive Neurorehabilitation Systems for Stroke

    PubMed Central

    Lehrer, Nicole; Duff, Margaret; Venkataraman, Vinay; Turaga, Pavan; Ingalls, Todd; Rymer, W. Zev; Wolf, Steven L.; Rikakis, Thanassis

    2015-01-01

    Interactive neurorehabilitation (INR) systems provide therapy that can evaluate and deliver feedback on a patient's movement computationally. There are currently many approaches to INR design and implementation, without a clear indication of which methods to utilize best. This article presents key interactive computing, motor learning, and media arts concepts utilized by an interdisciplinary group to develop adaptive, mixed reality INR systems for upper extremity therapy of patients with stroke. Two INR systems are used as examples to show how the concepts can be applied within: (1) a small-scale INR clinical study that achieved integrated improvement of movement quality and functionality through continuously supervised therapy and (2) a pilot study that achieved improvement of clinical scores with minimal supervision. The notion is proposed that some of the successful approaches developed and tested within these systems can form the basis of a scalable design methodology for other INR systems. A coherent approach to INR design is needed to facilitate the use of the systems by physical therapists, increase the number of successful INR studies, and generate rich clinical data that can inform the development of best practices for use of INR in physical therapy. PMID:25425694

  11. Interdisciplinary concepts for design and implementation of mixed reality interactive neurorehabilitation systems for stroke.

    PubMed

    Baran, Michael; Lehrer, Nicole; Duff, Margaret; Venkataraman, Vinay; Turaga, Pavan; Ingalls, Todd; Rymer, W Zev; Wolf, Steven L; Rikakis, Thanassis

    2015-03-01

    Interactive neurorehabilitation (INR) systems provide therapy that can evaluate and deliver feedback on a patient's movement computationally. There are currently many approaches to INR design and implementation, without a clear indication of which methods to utilize best. This article presents key interactive computing, motor learning, and media arts concepts utilized by an interdisciplinary group to develop adaptive, mixed reality INR systems for upper extremity therapy of patients with stroke. Two INR systems are used as examples to show how the concepts can be applied within: (1) a small-scale INR clinical study that achieved integrated improvement of movement quality and functionality through continuously supervised therapy and (2) a pilot study that achieved improvement of clinical scores with minimal supervision. The notion is proposed that some of the successful approaches developed and tested within these systems can form the basis of a scalable design methodology for other INR systems. A coherent approach to INR design is needed to facilitate the use of the systems by physical therapists, increase the number of successful INR studies, and generate rich clinical data that can inform the development of best practices for use of INR in physical therapy. © 2015 American Physical Therapy Association.

  12. Glutamate-Modulating Drugs as a Potential Therapeutic Strategy in Obsessive-Compulsive Disorder

    PubMed Central

    Marinova, Zoya; Chuang, De-Maw; Fineberg, Naomi

    2017-01-01

    Objective: Abstract: Obsessive-compulsive disorder (OCD) is a mental disease commonly associated with severe distress and impairment of social functioning. Serotonin reuptake inhibitors and/or cognitive behavioural therapy are the therapy of choice, however up to 40% of patients do not respond to treatment. Glutamatergic signalling has also been implicated in OCD. The aim of the current study was to review the clinical evidence for therapeutic utility of glutamate-modulating drugs as an augmentation or monotherapy in OCD patients. Methods: We conducted a search of the MEDLINE database for clinical studies evaluating the effect of glutamate-modulating drugs in OCD. Results: Memantine is the compound most consistently showing a positive effect as an augmentation therapy in OCD. Anti-convulsant drugs (lamotrigine, topiramate) and riluzole may also provide therapeutic benefit to some OCD patients. Finally, ketamine may be of interest due to its potential for a rapid onset of action. Conclusion: Further randomized placebo-controlled trials in larger study populations are necessary in order to draw definitive conclusions on the utility of glutamate-modulating drugs in OCD. Furthermore, genetic and epigenetic factors, clinical symptoms and subtypes predicting treatment response to glutamate-modulating drugs need to be investigated systematically. PMID:28322166

  13. The cost of chronic pain: an analysis of a regional pain management service in Ireland.

    PubMed

    Gannon, Brenda; Finn, David P; O'Gorman, David; Ruane, Nancy; McGuire, Brian E

    2013-10-01

    The objective of the study was to collect data on the direct and indirect economic cost of chronic pain among patients attending a pain management clinic in Ireland. A tertiary pain management clinic serving a mixed urban and rural area in the West of Ireland. Data were collected from 100 patients using the Client Services Receipt Inventory and focused on direct and indirect costs of chronic pain. Patients were questioned about health service utilization, payment methods, and relevant sociodemographics. Unit costs were multiplied by resource use data to obtain full costs. Cost drivers were then estimated. Our study showed a cost per patient of US$24,043 over a 12-month period. Over half of this was attributable to wage replacement costs and lost productivity in those unable to work because of pain. Hospital stays and outpatient hospital services were the main drivers for health care utilization costs, together accounting for 63% of the direct medical costs per study participant attending the pain clinic. The cost of chronic pain among intensive service users is significant, and when extrapolated to a population level, these costs represent a very substantial economic burden. Wiley Periodicals, Inc.

  14. MRI to assess renal structure and function.

    PubMed

    Artunc, Ferruh; Rossi, Cristina; Boss, Andreas

    2011-11-01

    In addition to excellent anatomical depiction, MRI techniques have expanded to study functional aspects of renal physiology, such as renal perfusion, glomerular filtration rate (GFR) or tissue oxygenation. This review will focus on current developments with an emphasis on clinical applicability. The method of GFR determination is largely heterogeneous and still has weaknesses. However, the technique of employing liver disappearance curves has been shown to be accurate in healthy persons and patients with chronic kidney disease. In potential kidney donors, complete evaluation of kidney anatomy and function can be accomplished in a single-stop investigation. Techniques without contrast media can be utilized to measure renal tissue oxygenation (blood oxygen level-dependent MRI) or perfusion (arterial spin labeling) and could aid in the diagnosis and treatment of ischemic renal diseases, such as renal artery stenosis. Diffusion imaging techniques may provide information on spatially restricted water diffusion and tumor cellularity. Functional MRI opens new horizons in studying renal physiology and pathophysiology in vivo. Although extensively utilized in research, labor-intensive postprocessing and lack of standardization currently limit the clinical applicability of functional MRI. Further studies are necessary to evaluate the clinical value of functional magnetic resonance techniques for early discovery and characterization of kidney disease.

  15. Health care provider experiences in primary care memory clinics: a phenomenological study.

    PubMed

    Sheiban, Linda; Stolee, Paul; McAiney, Carrie; Boscart, Veronique

    2018-05-19

    There is a growing need for community-based services for persons with Alzheimer's disease and related dementias (ADRD). Memory clinic (MC) teams in primary care settings have been established to provide care to people with ADRD. To consider wider adoption of these MC teams, insight is needed into the experiences of practitioners working in these models. The purpose of the current study is to explore the experiences of health care providers (HCPs) who work in primary care Memory Clinic (MC) teams to provide care to persons with Alzheimer's disease and related dementias (ADRD). This study utilized a phenomenological methodology to explore experiences of 12 HCPs in two primary care MCs. Semi-structured interviews were completed with each HCP. Interviews were recorded and transcribed verbatim. Colaizzi's steps for analyzing phenomenological data was utilized by the authors. Three themes emerged from the analysis to describe HCP experiences: supporting patients and family members during ADRD diagnosis and treatment, working in a team setting, and personal and professional rewards of caring for people with ADRD and their family members. Findings provide insight into current practices in primary care MCs and on the motivation of HCPs working with persons with ADRD.

  16. Health-related utility values of patients with primary Sjögren's syndrome and its predictors.

    PubMed

    Lendrem, Dennis; Mitchell, Sheryl; McMeekin, Peter; Bowman, Simon; Price, Elizabeth; Pease, Colin T; Emery, Paul; Andrews, Jacqueline; Lanyon, Peter; Hunter, John; Gupta, Monica; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Vadivelu, Saravanan; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Griffiths, Bridget; Ng, Wan-Fai

    2014-07-01

    EuroQoL-5 dimension (EQ-5D) is a standardised preference-based tool for measurement of health-related quality of life and EQ-5D utility values can be converted to quality-adjusted life years (QALYs) to aid cost-utility analysis. This study aimed to evaluate the EQ-5D utility values of 639 patients with primary Sjögren's syndrome (PSS) in the UK. Prospective data collected using a standardised pro forma were compared with UK normative data. Relationships between utility values and the clinical and laboratory features of PSS were explored. The proportion of patients with PSS reporting any problem in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 42.2%, 16.7%, 56.6%, 80.6% and 49.4%, respectively, compared with 5.4%, 1.6%, 7.9%, 30.2% and 15.7% for the UK general population. The median EQ-5D utility value was 0.691 (IQR 0.587-0.796, range -0.239 to 1.000) with a bimodal distribution. Bivariate correlation analysis revealed significant correlations between EQ-5D utility values and many clinical features of PSS, but most strongly with pain, depression and fatigue (R values>0.5). After adjusting for age and sex differences, multiple regression analysis identified pain and depression as the two most important predictors of EQ-5D utility values, accounting for 48% of the variability. Anxiety, fatigue and body mass index were other statistically significant predictors, but they accounted for <5% in variability. This is the first report on the EQ-5D utility values of patients with PSS. These patients have significantly impaired utility values compared with the UK general population. EQ-5D utility values are significantly related to pain and depression scores in PSS. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Utility of an abbreviated version of the stanford-binet intelligence scales (5th ed.) in estimating 'full scale' IQ for young children with autism spectrum disorder.

    PubMed

    Twomey, Conal; O'Connell, Helen; Lillis, Mary; Tarpey, Sarah Louise; O'Reilly, Gary

    2018-03-01

    The fifth edition of the Stanford-Binet Intelligence scales allows 'full scale' IQ (FSIQ) to be estimated using an abridged version of the test-the abbreviated battery IQ (ABIQ). Set within a public early intervention team service, the current cross-sectional study investigated the utility of the ABIQ in estimating FSIQ for 40 children with autism spectrum disorder (ASD) aged 3-5 years. A strong ABIQ-FSIQ association was yielded (r = 0.89; r 2  = 0.808) and the ABIQ did not over-estimate mean FSIQ above a clinically-relevant threshold; however, clinically significant over-estimation occurred in 17.5% of individual cases. While the findings provide support for the utility of the ABIQ in estimating FSIQ for young children with ASD, caution relating to the over-estimation of FSIQ is warranted. Careful clinical judgment-ideally based on examination of previous cognitive assessment results (if available), thorough interactional observations, and close multi-disciplinary consultation-is necessary to determine the applicability of the ABIQ to individual cases. Autism Res 2018, 11: 503-508. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. We investigated the utility of a shortened version of the Stanford-Binet Intelligence Scales in estimating IQ for 40 young children with autism spectrum disorder (ASD). The findings provide qualified support for the instrument: acceptably accurate IQ estimation was achieved for most cases; but not so for a sizeable minority (17.5%). Careful clinical judgment is necessary to determine the applicability of the ABIQ to individual cases. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

  18. Characteristics of NIH- and industry-sponsored head and neck cancer clinical trials.

    PubMed

    Devaiah, Anand; Murchison, Charles

    2016-09-01

    Compare U.S. clinical trials sponsored by the National Institutes of Health (NIH) and industry, especially with regard to trial design, interventions studied, and results reporting rates. U.S. head and neck cancer clinical trials. We used information from ClinicalTrials.gov to compare NIH- and industry-sponsored head and neck cancer clinical trials, specifically analyzing differences in trial design and interventions studied. We examined publication rates and positive results rates using PubMed.gov. About 50% of NIH- and industry-sponsored clinical trials have their results reported in peer-reviewed literature. Industry-sponsored trials had higher rates of positive results than NIH-sponsored trials. NIH- and industry-sponsored clinical trials had similar trial designs, although industry-sponsored trials had significantly lower rates of randomization. Industry trials utilized radiation in 19% of trials and surgery in 2% of trials. NIH trials also had low utilization of both radiation and surgery (27% and 12% of trials, respectively). NIH- and industry-sponsored trials published their results in journals with comparable impact factors. There is significant underreporting of results in U.S. head and neck cancer clinical trials, whether sponsored by NIH or industry. Industry trials have significantly higher rates of positive results, although it is unclear what contributes to this. Both NIH- and industry-sponsored trials underutilize surgery and radiation as treatment modalities, despite the fact that these are standard-of-care therapies for head and neck cancer. We recommend that the NIH and industry report all results from clinical trials and use surgery and radiation as treatment arms in order to arrive at more balanced therapeutic recommendations. N/A. Laryngoscope, 126:E300-E303, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  19. Compliance Patterns and Utilization of e-Health for Glucose Monitoring: Standalone Internet Gateway and Tablet Device.

    PubMed

    Rho, Mi Jung; Kim, Hun-Sung; Yoon, Kun-Ho; Choi, In Young

    2017-04-01

    Knowledge regarding compliance patterns and service utilization in e-health is important for the development of effective services. To develop proper e-health, the characteristics of compliance patterns and utilization of e-health should be studied. We studied these for glucose monitoring of diabetic patients from primary clinics. Data were collected from 160 outpatients who participated in e-health for glucose monitoring funded by the Korean government. Specifically, this study focused on two device types: a standalone Internet gateway and a tablet device. The SPSS 18.0 software was used for statistical analyses of demographic characteristics, survival data, and Cox proportional hazards regression model. Standalone Internet gateway users demonstrated a more stable compliance pattern than did tablet device users. The compliance rate differed according to the device type. Typically, compliance decreases considerably around 8 months. In these results, standalone Internet gateway users utilized the service for longer periods than tablet device users. Gateway type and location also influenced utilization (p < 0.05). The service should be designed according to the device type to develop appropriate service models. Thus, service designers should understand the different characteristics of service devices. This study provides insight into compliance patterns and utilization to develop appropriate service models and service interventions depending on the device.

  20. Assessing Telemedicine Utilization by Using Medicaid Claims Data.

    PubMed

    Douglas, Megan Daugherty; Xu, Junjun; Heggs, Akilah; Wrenn, Glenda; Mack, Dominic H; Rust, George

    2017-02-01

    This study characterized telemedicine utilization among Medicaid enrollees by patients' demographic characteristics, geographic location, enrollment type, eligibility category, and clinical conditions. This study used 2008-2009 Medicaid claims data from 28 states and the District of Columbia to characterize telemedicine claims (indicated by GT for professional fee claims or Q3014 for facility fees) on the basis of patients' demographic characteristics, geographic location, enrollment type, eligibility category, and clinical condition as indicated by ICD-9 codes. States lacking Medicaid telemedicine reimbursement policies were excluded. Chi-square tests were used to compare telemedicine utilization rates and one-way analysis of variance was used to estimate mean differences in number of telemedicine encounters among subgroups. A total of 45,233,602 Medicaid enrollees from the 22 states with telemedicine reimbursement policies were included in the study, and .1% were telemedicine users. Individuals ages 45 to 64 (16.4%), whites (11.3%), males (8.5%), rural residents (26.0%), those with managed care plans (7.9%), and those categorized as aged, blind, and disabled (28.1%) were more likely to receive telemedicine (p<.001). Nearly 95% of telemedicine claims were associated with a behavioral health diagnosis, of which over 50% were for bipolar disorder and attention-deficit disorder or attention-deficit hyperactivity disorder (29.3% and 23.4%, respectively). State-level variation was high, ranging from .0 to 59.91 claims per 10,000 enrollees (Arkansas and Arizona, respectively). Despite the touted potential for telemedicine to improve health care access, actual utilization of telemedicine in Medicaid programs was low. It was predominantly used to treat behavioral health diagnoses. Reimbursement alone is insufficient to support broad utilization for Medicaid enrollees.

  1. Assessing Telemedicine Utilization by Using Medicaid Claims Data

    PubMed Central

    Douglas, Megan Daugherty; Xu, Junjun; Heggs, Akilah; Wrenn, Glenda; Mack, Dominic H.; Rust, George

    2017-01-01

    Objective This study characterized telemedicine utilization among Medicaid enrollees by patients’ demographic characteristics, geographic location, enrollment type, eligibility category, and clinical conditions. Methods This study used 2008–2009 Medicaid claims data from 28 states and the District of Columbia to characterize telemedicine claims (indicated by GT for professional fee claims or Q3014 for facility fees) on the basis of patients’ demographic characteristics, geographic location, enrollment type, eligibility category, and clinical condition as indicated by ICD-9 codes. States lacking Medicaid telemedicine reimbursement policies were excluded. Chi-square tests were used to compare telemedicine utilization rates and one-way analysis of variance was used to estimate mean differences in number of telemedicine encounters among subgroups. Results A total of 45,233,602 Medicaid enrollees from the 22 states with telemedicine reimbursement policies were included in the study, and .1% were telemedicine users. Individuals ages 45 to 64 (16.4%), whites (11.3%), males (8.5%), rural residents (26.0%), those with managed care plans (7.9%), and those categorized as aged, blind, and disabled (28.1%) were more likely to receive telemedicine (p<.001). Nearly 95% of telemedicine claims were associated with a behavioral health diagnosis, of which over 50% were for bipolar disorder and attention-deficit disorder or attention-deficit hyperactivity disorder (29.3% and 23.4%, respectively). State-level variation was high, ranging from .0 to 59.91 claims per 10,000 enrollees (Arkansas and Arizona, respectively). Conclusions Despite the touted potential for telemedicine to improve health care access, actual utilization of telemedicine in Medicaid programs was low. It was predominantly used to treat behavioral health diagnoses. Reimbursement alone is insufficient to support broad utilization for Medicaid enrollees. PMID:27691381

  2. Physiological time-series analysis: what does regularity quantify?

    NASA Technical Reports Server (NTRS)

    Pincus, S. M.; Goldberger, A. L.

    1994-01-01

    Approximate entropy (ApEn) is a recently developed statistic quantifying regularity and complexity that appears to have potential application to a wide variety of physiological and clinical time-series data. The focus here is to provide a better understanding of ApEn to facilitate its proper utilization, application, and interpretation. After giving the formal mathematical description of ApEn, we provide a multistep description of the algorithm as applied to two contrasting clinical heart rate data sets. We discuss algorithm implementation and interpretation and introduce a general mathematical hypothesis of the dynamics of a wide class of diseases, indicating the utility of ApEn to test this hypothesis. We indicate the relationship of ApEn to variability measures, the Fourier spectrum, and algorithms motivated by study of chaotic dynamics. We discuss further mathematical properties of ApEn, including the choice of input parameters, statistical issues, and modeling considerations, and we conclude with a section on caveats to ensure correct ApEn utilization.

  3. A Question of Control? Examining the Role of Control Conditions in Experimental Psychopathology using the Example of Cognitive Bias Modification Research.

    PubMed

    Blackwell, Simon E; Woud, Marcella L; MacLeod, Colin

    2017-10-26

    While control conditions are vitally important in research, selecting the optimal control condition can be challenging. Problems are likely to arise when the choice of control condition is not tightly guided by the specific question that a given study aims to address. Such problems have become increasingly apparent in experimental psychopathology research investigating the experimental modification of cognitive biases, particularly as the focus of this research has shifted from theoretical questions concerning mechanistic aspects of the association between cognitive bias and emotional vulnerability, to questions that instead concern the clinical efficacy of 'cognitive bias modification' (CBM) procedures. We discuss the kinds of control conditions that have typically been employed in CBM research, illustrating how difficulties can arise when changes in the types of research questions asked are not accompanied by changes in the control conditions employed. Crucially, claims made on the basis of comparing active and control conditions within CBM studies should be restricted to those conclusions allowed by the specific control condition employed. CBM studies aiming to establish clinical utility are likely to require quite different control conditions from CBM studies aiming to illuminate mechanisms. Further, conclusions concerning the clinical utility of CBM interventions cannot necessarily be drawn from studies in which the control condition has been chosen to answer questions concerning mechanisms. Appreciating the need to appropriately alter control conditions in the transition from basic mechanisms-focussed investigations to applied clinical research could greatly facilitate the translational process.

  4. Racial Differences in the Usage of Information Technology: Evidence from a National Physician Survey

    PubMed Central

    Lee, Doohee; Rutsohn, Phil

    2012-01-01

    Information technology (IT) is a key mechanism for improving the quality of healthcare and containing costs, but racial differences in the utilization of IT among practicing physicians are unknown. The current study, using a national physician survey (n = 6,628), investigated racial differences in the utilization of IT. White physicians and minority physicians were directly compared. We first conducted both descriptive and inferential analyses to detect the difference in IT utilization by race and then performed multiple logistic regressions to test whether race remains significant in relation to IT utilization. Results reveal racial differences in the usage of IT. Compared to their minority counterparts, white physicians underutilized a preventive service reminder system. On the other hand, white physicians favored utilizing electronic communications with patients and exchanging clinical data and images with other providers. PMID:22783155

  5. Georgia Study of Handicapped Children.

    ERIC Educational Resources Information Center

    Wishik, Samuel M.

    Voluntary reporting, household canvass, and diagnostic clinics were utilized in studying the prevalence, disabilities, and needs of handicapped children in two Georgia counties (population 48,200); community resources were surveyed. Of the population under 21, 10% had handicaps and, of these, two-thirds had multiple handicaps with an average of…

  6. Implications of utility and deontology for the clinical nurse specialist.

    PubMed

    Ayres, L

    1989-01-01

    Faced with prospective payment plans and personnel shortages nurses in advanced clinical practice are under pressure to find practical solutions. These solutions may reflect the institutional philosophy of utility rather than the traditional nursing ethic of deontology, illustrating the need to examine the differences between utilitarian and deontological principles as they affect nursing practice. This paper discusses deontology and utility as they apply to nursing practice, considers how these different philosophical positions may affect advanced practitioners, and describes the current status of ethics in nursing.

  7. Perspective on Clinical Application of Biomarkers in AKI

    PubMed Central

    Mansour, Sherry G.

    2017-01-01

    Several biomarkers of renal injury have been identified but the utility of these biomarkers is largely confined to research studies, whereas widespread clinical applicability is limited. This is partly because the use of serum creatinine as the comparator has several limitations and restricts the full interpretation of biomarker performance. To highlight the potential for clinical application of biomarkers, the most pertinent biomarker data are summarized here, using clinically relevant scenarios in which biomarkers could assist with diagnostic and management dilemmas. The paradigms proposed in this review aim to enhance the clinical diagnosis, management, and prognosis of AKI through the combined use of available clinical markers and novel inflammatory, injury, and repair biomarkers. PMID:28220028

  8. Assessing Anxiety in Youth with the Multidimensional Anxiety Scale for Children (MASC)

    PubMed Central

    Wei, Chiaying; Hoff, Alexandra; Villabø, Marianne A.; Peterman, Jeremy; Kendall, Philip C.; Piacentini, John; McCracken, James; Walkup, John T.; Albano, Anne Marie; Rynn, Moira; Sherrill, Joel; Sakolsky, Dara; Birmaher, Boris; Ginsburg, Golda; Keaton, Courtney; Gosch, Elizabeth; Compton, Scott N.; March, John

    2013-01-01

    The present study examined the psychometric properties, including discriminant validity and clinical utility, of the youth self-report and parent-report forms of the Multidimensional Anxiety Scale for Children (MASC) among youth with anxiety disorders. The sample included parents and youth (N= 488, 49.6% male) ages 7 – 17 who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). Although the typical low agreement between parent and youth self-reports was found, the MASC evidenced good internal reliability across MASC subscales and informants. The main MASC subscales (i.e., Physical Symptoms, Harm Avoidance, Social Anxiety, and Separation/Panic) were examined. The Social Anxiety and Separation/Panic subscales were found to be significantly predictive of the presence and severity of social phobia and separation anxiety disorder, respectively. Using multiple informants improved the accuracy of prediction. The MASC subscales demonstrated good psychometric properties and clinical utilities in identifying youth with anxiety disorders. PMID:23845036

  9. An epidemiologic cohort study reviewing the practice of blood product transfusions among a population of pediatric oncology patients.

    PubMed

    Lieberman, Lani; Liu, Yang; Portwine, Carol; Barty, Rebecca L; Heddle, Nancy M

    2014-10-01

    Despite the high utilization of blood products by pediatric oncology patients, literature in this population remains scarce. The primary objective of this study was to assess red blood cell (RBC) and platelet (PLT) utilization rates and transfusion thresholds in pediatric oncology patients. The secondary objective was to describe transfusion-related complications including RBC alloantibody development and transfusion reactions. This epidemiologic cohort study involved pediatric oncology patients at a Canadian academic children's hospital between April 2002 and December 2011. Demographic, clinical, laboratory, and transfusion variables were collected from the Transfusion Registry for Utilization Statistics and Tracking database, a large database that captures more than 50 demographic and clinical variables as well as comprehensive transfusion information and laboratory test results. Of 647 pediatric oncology patients, 430 (66%) received a RBC or PLT transfusion or both during this time period. The median transfusion threshold before a RBC and PLT transfusion was a hemoglobin (Hb) value of 72 g/L (interquartile range [IQR], 68-76 g/L) and a PLT count of 16 × 10(9) /L (IQR, 10 × 10(9) -23 × 10(9) /L), respectively. Ninety-two percent of the issued RBC and PLT products (7507/8154) were cytomegalovirus negative and 90% were irradiated (7299/8154). RBC alloantibody development and transfusion reactions were reported infrequently in 0.5% (2/423) and 4.5% (8/179) of the patients, respectively. This study assessed utilization rates, transfusion thresholds, alloantibody development, and transfusion reactions in pediatric oncology patients. The descriptive results from this epidemiologic study provide baseline information to generate hypotheses to be tested in future interventional studies. © 2014 AABB.

  10. Real-Time Electronic Tracking of Diarrheal Episodes and Laxative Therapy Enables Verification of Clostridium difficile Clinical Testing Criteria and Reduction of Clostridium difficile Infection Rates.

    PubMed

    Truong, Cynthia Y; Gombar, Saurabh; Wilson, Richard; Sundararajan, Gopalakrishnan; Tekic, Natasa; Holubar, Marisa; Shepard, John; Madison, Alexandra; Tompkins, Lucy; Shah, Neil; Deresinski, Stan; Schroeder, Lee F; Banaei, Niaz

    2017-05-01

    Health care-onset health care facility-associated Clostridium difficile infection (HO-CDI) is overdiagnosed for several reasons, including the high prevalence of C. difficile colonization and the inability of hospitals to limit testing to patients with clinically significant diarrhea. We conducted a quasiexperimental study from 22 June 2015 to 30 June 2016 on consecutive inpatients with C. difficile test orders at an academic hospital. Real-time electronic patient data tracking was used by the laboratory to enforce testing criteria (defined as the presence of diarrhea [≥3 unformed stools in 24 h] and absence of laxative intake in the prior 48 h). Outcome measures included C. difficile test utilization, HO-CDI incidence, oral vancomycin utilization, and clinical complications. During the intervention, 7.1% (164) and 9.1% (211) of 2,321 C. difficile test orders were canceled due to absence of diarrhea and receipt of laxative therapy, respectively. C. difficile test utilization decreased upon implementation from an average of 208.8 tests to 143.0 tests per 10,000 patient-days ( P < 0.001). HO-CDI incidence rate decreased from an average of 13.0 cases to 9.7 cases per 10,000 patient-days ( P = 0.008). Oral vancomycin days of therapy decreased from an average of 13.8 days to 9.4 days per 1,000 patient-days ( P = 0.009). Clinical complication rates were not significantly different in patients with 375 canceled orders compared with 869 episodes with diarrhea but negative C. difficile results. Real-time electronic clinical data tracking is an effective tool for verification of C. difficile clinical testing criteria and safe reduction of inflated HO-CDI rates. Copyright © 2017 American Society for Microbiology.

  11. Clinical utility of bone turnover markers in the management of common metabolic bone diseases in adults.

    PubMed

    Glendenning, Paul; Chubb, S A Paul; Vasikaran, Samuel

    2018-06-01

    Bone turnover marker (BTMs) concentrations in blood and urine reflect bone-remodelling activity, and may be useful adjuncts in the diagnosis and management of metabolic bone diseases. Newer biomarkers, mainly bone regulatory proteins, are currently being investigated to elucidate their role in bone metabolism and disease and may in future be useful in clinical diagnosis and management of metabolic bone disease. BTM concentrations increase around menopause in women, and at a population level the degree of increase in BTMs reflect bone loss. However, lack of adequate data precludes their use in individual patients for fracture risk assessment in clinical practice. The rapid and large changes in BTMs following anti-resorptive and anabolic therapies for osteoporosis treatment indicate they may be useful for monitoring therapy in clinical practice. The offset of drug effect on BTMs could be helpful for adjudicating the duration of bisphosphonate drug holidays. BTMs may offer useful additional data in skeletal diseases that are typically characterised by increased bone remodelling: chronic kidney disease (CKD), primary hyperparathyroidism (PHPT) and Paget's disease. In CKD, bone specific alkaline phosphatase (bAP) is currently endorsed for use for the assessment of mineral bone disease. The role of BTMsin predicting the bone mineral density response to successful parathyroidectomy in PHPT shows some utility but the data are not consistent and studies are limited in size and/or duration. In Paget's disease of bone, BTMs are used to confirm diagnosis, evaluate extent of disease or degree of activity and for monitoring the response to bisphosphonate treatment. Whilst BTMs are currently used in specific clinical practice instances when investigating or managing metabolic bone disease, further data are needed to consolidate their clinical use where evidence of utility is limited. Copyright © 2018 Elsevier B.V. All rights reserved.

  12. Utility of Post-Mortem Genetic Testing in Cases of Sudden Arrhythmic Death Syndrome.

    PubMed

    Lahrouchi, Najim; Raju, Hariharan; Lodder, Elisabeth M; Papatheodorou, Efstathios; Ware, James S; Papadakis, Michael; Tadros, Rafik; Cole, Della; Skinner, Jonathan R; Crawford, Jackie; Love, Donald R; Pua, Chee J; Soh, Bee Y; Bhalshankar, Jaydutt D; Govind, Risha; Tfelt-Hansen, Jacob; Winkel, Bo G; van der Werf, Christian; Wijeyeratne, Yanushi D; Mellor, Greg; Till, Jan; Cohen, Marta C; Tome-Esteban, Maria; Sharma, Sanjay; Wilde, Arthur A M; Cook, Stuart A; Bezzina, Connie R; Sheppard, Mary N; Behr, Elijah R

    2017-05-02

    Sudden arrhythmic death syndrome (SADS) describes a sudden death with negative autopsy and toxicological analysis. Cardiac genetic disease is a likely etiology. This study investigated the clinical utility and combined yield of post-mortem genetic testing (molecular autopsy) in cases of SADS and comprehensive clinical evaluation of surviving relatives. We evaluated 302 expertly validated SADS cases with suitable DNA (median age: 24 years; 65% males) who underwent next-generation sequencing using an extended panel of 77 primary electrical disorder and cardiomyopathy genes. Pathogenic and likely pathogenic variants were classified using American College of Medical Genetics (ACMG) consensus guidelines. The yield of combined molecular autopsy and clinical evaluation in 82 surviving families was evaluated. A gene-level rare variant association analysis was conducted in SADS cases versus controls. A clinically actionable pathogenic or likely pathogenic variant was identified in 40 of 302 cases (13%). The main etiologies established were catecholaminergic polymorphic ventricular tachycardia and long QT syndrome (17 [6%] and 11 [4%], respectively). Gene-based rare variants association analysis showed enrichment of rare predicted deleterious variants in RYR2 (p = 5 × 10 -5 ). Combining molecular autopsy with clinical evaluation in surviving families increased diagnostic yield from 26% to 39%. Molecular autopsy for electrical disorder and cardiomyopathy genes, using ACMG guidelines for variant classification, identified a modest but realistic yield in SADS. Our data highlighted the predominant role of catecholaminergic polymorphic ventricular tachycardia and long QT syndrome, especially the RYR2 gene, as well as the minimal yield from other genes. Furthermore, we showed the enhanced utility of combined clinical and genetic evaluation. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  13. Advanced Practice Registered Nurses and Physician Assistants in Sleep Centers and Clinics: A Survey of Current Roles and Educational Background

    PubMed Central

    Colvin, Loretta; Cartwright, Ann; Collop, Nancy; Freedman, Neil; McLeod, Don; Weaver, Terri E.; Rogers, Ann E.

    2014-01-01

    Study Objectives: To survey Advanced Practice Registered Nurse (APRN) and Physician Assistant (PA) utilization, roles and educational background within the field of sleep medicine. Methods: Electronic surveys distributed to American Academy of Sleep Medicine (AASM) member centers and APRNs and PAs working within sleep centers and clinics. Results: Approximately 40% of responding AASM sleep centers reported utilizing APRNs or PAs in predominantly clinical roles. Of the APRNs and PAs surveyed, 95% reported responsibilities in sleep disordered breathing and more than 50% in insomnia and movement disorders. Most APRNs and PAs were prepared at the graduate level (89%), with sleep-specific education primarily through “on the job” training (86%). All APRNs surveyed were Nurse Practitioners (NPs), with approximately double the number of NPs compared to PAs. Conclusions: APRNs and PAs were reported in sleep centers at proportions similar to national estimates of NPs and PAs in physicians' offices. They report predominantly clinical roles, involving common sleep disorders. Given current predictions that the outpatient healthcare structure will change and the number of APRNs and PAs will increase, understanding the role and utilization of these professionals is necessary to plan for the future care of patients with sleep disorders. Surveyed APRNs and PAs reported a significant deficiency in formal and standardized sleep-specific education. Efforts to provide formal and standardized educational opportunities for APRNs and PAs that focus on their clinical roles within sleep centers could help fill a current educational gap. Citation: Colvin L, Cartwright Ann, Collop N, Freedman N, McLeod D, Weaver TE, Rogers AE. Advanced practice registered nurses and physician assistants in sleep centers and clinics: a survey of current roles and educational background. J Clin Sleep Med 2014;10(5):581-587. PMID:24812545

  14. A multi-institution evaluation of clinical profile anonymization.

    PubMed

    Heatherly, Raymond; Rasmussen, Luke V; Peissig, Peggy L; Pacheco, Jennifer A; Harris, Paul; Denny, Joshua C; Malin, Bradley A

    2016-04-01

    There is an increasing desire to share de-identified electronic health records (EHRs) for secondary uses, but there are concerns that clinical terms can be exploited to compromise patient identities. Anonymization algorithms mitigate such threats while enabling novel discoveries, but their evaluation has been limited to single institutions. Here, we study how an existing clinical profile anonymization fares at multiple medical centers. We apply a state-of-the-artk-anonymization algorithm, withkset to the standard value 5, to the International Classification of Disease, ninth edition codes for patients in a hypothyroidism association study at three medical centers: Marshfield Clinic, Northwestern University, and Vanderbilt University. We assess utility when anonymizing at three population levels: all patients in 1) the EHR system; 2) the biorepository; and 3) a hypothyroidism study. We evaluate utility using 1) changes to the number included in the dataset, 2) number of codes included, and 3) regions generalization and suppression were required. Our findings yield several notable results. First, we show that anonymizing in the context of the entire EHR yields a significantly greater quantity of data by reducing the amount of generalized regions from ∼15% to ∼0.5%. Second, ∼70% of codes that needed generalization only generalized two or three codes in the largest anonymization. Sharing large volumes of clinical data in support of phenome-wide association studies is possible while safeguarding privacy to the underlying individuals. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. Genetic Literacy and Patient Perceptions of IBD Testing Utility and Disease Control: A Randomized Vignette Study of Genetic Testing

    PubMed Central

    Hooker, Gillian W.; Peay, Holly; Erby, Lori; Bayless, Theodore; Biesecker, Barbara B.; Roter, Debra L.

    2014-01-01

    Background Findings from inflammatory bowel disease (IBD) genome-wide association studies are being translated clinically into prognostic and diagnostic indicators of disease. Yet, patient perception and understanding of these tests and their applicability to providing risk information is unclear. The goal of this study was to determine, using hypothetical scenarios, whether patients with IBD perceive genetic testing to be useful for risk assessment, whether genetic test results impact perceived control, and whether low genetic literacy may be a barrier to patient understanding of these tests. Methods Two hundred fifty seven patients with IBD from the Johns Hopkins gastroenterology clinics were randomized to receive a vignette depicting either a genetic testing scenario or a standard blood testing scenario. Participants were asked questions about the vignette and responses were compared between groups. Results Perceptions of test utility for risk assessment were higher among participants responding to the genetic vignette (P < 0.001). There were no significant differences in perceptions of control over IBD after hypothetical testing between vignettes (P = 0.24). Participant responses were modified by genetic literacy, measured using a scale developed for this study. Participants randomized to the genetic vignette who scored higher on the genetic literacy scale perceived greater utility of testing for risk assessment (P = 0.008) and more control after testing (P = 0.02). Conclusions Patients with IBD perceive utility in genetic testing for providing information relevant to family members, and this appreciation is promoted by genetic literacy. Low genetic literacy among patients poses a potential threat to effective translation of genetic and genomic tests. PMID:24691112

  16. Outcomes Assessment of Treating Completely Edentulous Patients with a Fixed Implant-Supported Profile Prosthesis Utilizing a Graftless Approach. Part 1: Clinically Related Outcomes.

    PubMed

    Alzoubi, Fawaz; Bedrossian, Edmond; Wong, Allen; Farrell, Douglas; Park, Chan; Indresano, Thomas

    To assess outcomes of treating completely edentulous patients with a fixed implant-supported profile prosthesis utilizing a graftless approach for the maxilla and for the mandible, with emphasis on clinically related outcomes, specifically implant and prosthesis survival. This was a retrospective study with the following inclusion criteria: completely edentulous patients rehabilitated with a fixed implant-supported profile denture utilizing a graftless approach. Patients fulfilling the inclusion criteria were asked to participate in the study during their follow-up visits, and hence a consecutive sampling strategy was used. Data regarding implant and prosthesis cumulative survival rates (CSRs) were gathered and calculated. Thirty-four patients were identified with a total of 220 implants placed. An overall CSR of 98.2% was recorded with an observation of up to 10 years. For tilted, axial, and zygomatic implants, CSRs of 96.9%, 98.0%, and 100%, respectively, were observed for up to 10 years. For provisional prostheses, CSRs of 92.3% at 1 year, and 84.6% at 2 years were observed. For final prostheses, a CSR of 93.8% was observed at 10 years. The results suggest that treating completely edentulous patients with a fixed profile prosthesis utilizing a graftless approach in the maxilla and the mandible can be a reliable treatment option.

  17. Public and private healthcare services utilization by non-institutional elderly in Hong Kong: is the inverse care law operating?

    PubMed

    Yam, Ho-Kwan; Mercer, Stewart W; Wong, Lai-Yi; Chan, Wan-Kin; Yeoh, Eng-Kiong

    2009-08-01

    To assess the factors associated with healthcare services utilization by the non-institutional elderly across five types of service utilization (Western medicine doctors in Government clinics, private Western medicine doctors, Chinese medicine practitioners, Emergency Units, and hospitalization). A secondary data analysis of a territory-wide cross-sectional survey collected by the Government among a representative sample of 4812 elderly (aged 60 and above) in Hong Kong. Our analysis, based on Anderson's behavioral framework, shows that need factors (relating to actual or perceived illness and diseases) are significantly related to the healthcare services utilization examined. However, enabling factors, such as monthly household income per capita, play a significant role in determining the utilization. Although the lower-income elderly consult more Government clinics and less private clinics than the more affluent, they have a lower total utilization of healthcare services despite having significantly greater healthcare needs. This suggests a mismatch of need and supply within the mixed economy of private and public healthcare services and suggests the existence of an 'inverse care law' in Hong Kong amongst elderly citizens. The findings raise concerns of inequities in Hong Kong's healthcare system, raising implications for future healthcare reforms.

  18. Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

    PubMed

    Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

    2013-09-01

    To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

  19. Minimal clinically important difference in the fibromyalgia impact questionnaire.

    PubMed

    Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

    2009-06-01

    The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

  20. Improving the performance of surgery-based clinical pathways: a simulation-optimization approach.

    PubMed

    Ozcan, Yasar A; Tànfani, Elena; Testi, Angela

    2017-03-01

    This paper aims to improve the performance of clinical processes using clinical pathways (CPs). The specific goal of this research is to develop a decision support tool, based on a simulation-optimization approach, which identify the proper adjustment and alignment of resources to achieve better performance for both the patients and the health-care facility. When multiple perspectives are present in a decision problem, critical issues arise and often require the balancing of goals. In our approach, meeting patients' clinical needs in a timely manner, and to avoid worsening of clinical conditions, we assess the level of appropriate resources. The simulation-optimization model seeks and evaluates alternative resource configurations aimed at balancing the two main objectives-meeting patient needs and optimal utilization of beds and operating rooms.Using primary data collected at a Department of Surgery of a public hospital located in Genoa, Italy. The simulation-optimization modelling approach in this study has been applied to evaluate the thyroid surgical treatment together with the other surgery-based CPs. The low rate of bed utilization and the long elective waiting lists of the specialty under study indicates that the wards were oversized while the operating room capacity was the bottleneck of the system. The model enables hospital managers determine which objective has to be given priority, as well as the corresponding opportunity costs.

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