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.

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.

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.

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

Multimodality approach to classifying hand utilization for the clinical breast examination.

PubMed

Laufer, Shlomi; Cohen, Elaine R; Maag, Anne-Lise D; Kwan, Calvin; Vanveen, Barry; Pugh, Carla M

2014-01-01

The clinical breast examination (CBE) is performed to detect breast pathology. However, little is known regarding clinical technique and how it relates to diagnostic accuracy. We sought to quantify breast examination search patterns and hand utilization with a new data collection and analysis system. Participants performed the CBE while the sensor mapping and video camera system collected performance data. From this data, algorithms were developed that measured the number of hands used during the exam and active examination time. This system is a feasible and reliable method to collect new information on CBE techniques.

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

Isolation of rare circulating tumor cells in cancer patients: technical aspects and clinical implications.

PubMed

Danova, Marco; Torchio, Martina; Mazzini, Giuliano

2011-06-01

Circulating tumor cells (CTCs) may be detected in the blood of patients with epithelial tumors using different analytical approaches. The relative number of CTCs is low and they include a heterogeneous population of cells with diverse biological and molecular characteristics, often different from those of the respective primary tumor. Until recently, they have been difficult to detect and, even though discordant results have been reported when different methods of detection were used, they may provide prognostic and predictive information. Several antibody- or molecular-based CTC detection methods have been developed, offering hope for individualized risk assessment by utilizing CTCs as biomarkers of disease progression and drug response. Pilot studies have also shown that by utilizing methods that permit, besides enumeration, a molecular characterization of CTCs, one could better identify high-risk patients, predict response to targeted therapies, analyze gene expression profiles (in order to identify new potential drug targets) and increase our knowledge of the metastatic process. In this article we review the techniques currently utilized for isolation and characterization of CTCs and we discuss their potential utility in clinical oncology focusing on the future perspectives in this field.

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.

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

Behavioral Health Integration in Large Multi-group Pediatric Practice.

PubMed

Schlesinger, Abigail Boden

2017-03-01

There is increasing interest in methods to improve access to behavioral health services for children and adolescents. Children's Community Pediatric Behavioral Health Service (CCPBHS) is an integrated behavioral health service whose method of (a) creating a leadership team with empowered administrative and clinical stakeholders who can act on a commitment to change and (b) having a clear mission statement with integrated administrative and clinical care processes can serve as a model for implementing integration efforts within the medical home. Community Pediatrics Behavioral Health Service (CPBHS) is a sustainable initiative that improved the utilization of physical health and behavioral health systems for youth and improved the utilization of evidence-based interventions for youth served in primary care.

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.

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.

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

Alternative Methods by Which Basic Science Pharmacy Faculty Can Relate to Clinical Practice, Executive Summary and Final Report, October 1, 1978 - March 15, 1980.

ERIC Educational Resources Information Center

Kabat, Hugh F.; And Others

The areas of basic science pharmacy instruction and clinical pharmacy practice and their interrelationships were identified in order to help develop didactic and clinical experience alternatives. A 10-member advisory committee ranked basic pharmaceutical science topical areas in terms of their applicability to clinical practice utilizing a Delphi…

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

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.

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.

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.

A new cannulation method for isolated mitral valve surgery--"apicoaortic-pa" cannulation.

PubMed

Wada, J; Komatsu, S; Nakae, S; Kazui, T

1976-06-01

The present paper describes experimental and clinical studies of a new method "Apicoaortic-PA" cannulation for mitral valve surgery. Our experimental study showed that this method was more rapid and more physiological for cardiopulmonary bypass. We used this technique in 55 cases of isolated mitral valve surgery with successful results. Our general philosophy of surgical approach to the mitral valve diseases is also discussed. We advocate the utilization of the "Apicoaortic Pulmonary Artery" cannulation method for clinical use in isolated mitral valve surgery through the left thoracotomy.

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.

Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma.

PubMed

Yu, Yuncui; Jia, Lulu; Meng, Yao; Hu, Lihua; Liu, Yiwei; Nie, Xiaolu; Zhang, Meng; Zhang, Xuan; Han, Sheng; Peng, Xiaoxia; Wang, Xiaoling

2018-04-01

Establishing a comprehensive clinical evaluation system is critical in enacting national drug policy and promoting rational drug use. In China, the 'Clinical Comprehensive Evaluation System for Pediatric Drugs' (CCES-P) project, which aims to compare drugs based on clinical efficacy and cost effectiveness to help decision makers, was recently proposed; therefore, a systematic and objective method is required to guide the process. An evidence-based multi-criteria decision analysis model that involved an analytic hierarchy process (AHP) was developed, consisting of nine steps: (1) select the drugs to be reviewed; (2) establish the evaluation criterion system; (3) determine the criterion weight based on the AHP; (4) construct the evidence body for each drug under evaluation; (5) select comparative measures and calculate the original utility score; (6) place a common utility scale and calculate the standardized utility score; (7) calculate the comprehensive utility score; (8) rank the drugs; and (9) perform a sensitivity analysis. The model was applied to the evaluation of three different inhaled corticosteroids (ICSs) used for asthma management in children (a total of 16 drugs with different dosage forms and strengths or different manufacturers). By applying the drug analysis model, the 16 ICSs under review were successfully scored and evaluated. Budesonide suspension for inhalation (drug ID number: 7) ranked the highest, with comprehensive utility score of 80.23, followed by fluticasone propionate inhaled aerosol (drug ID number: 16), with a score of 79.59, and budesonide inhalation powder (drug ID number: 6), with a score of 78.98. In the sensitivity analysis, the ranking of the top five and lowest five drugs remains unchanged, suggesting this model is generally robust. An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P.

Should Athletic Training Educators Utilize Grades When Evaluating Student Clinical Performance?

ERIC Educational Resources Information Center

Scriber, Kent; Gray, Courtney; Millspaugh, Rose

2010-01-01

Objective: To explore and address some of the challenges for assessing, interpreting, and grading athletic training students' clinical performance and to suggest athletic training educators consider using a more universal assessment method for professional consistency. Background: In years past students learned from teachers or mentors on an…

Beyond discrimination: A comparison of calibration methods and clinical usefulness of predictive models of readmission risk.

PubMed

Walsh, Colin G; Sharman, Kavya; Hripcsak, George

2017-12-01

Prior to implementing predictive models in novel settings, analyses of calibration and clinical usefulness remain as important as discrimination, but they are not frequently discussed. Calibration is a model's reflection of actual outcome prevalence in its predictions. Clinical usefulness refers to the utilities, costs, and harms of using a predictive model in practice. A decision analytic approach to calibrating and selecting an optimal intervention threshold may help maximize the impact of readmission risk and other preventive interventions. To select a pragmatic means of calibrating predictive models that requires a minimum amount of validation data and that performs well in practice. To evaluate the impact of miscalibration on utility and cost via clinical usefulness analyses. Observational, retrospective cohort study with electronic health record data from 120,000 inpatient admissions at an urban, academic center in Manhattan. The primary outcome was thirty-day readmission for three causes: all-cause, congestive heart failure, and chronic coronary atherosclerotic disease. Predictive modeling was performed via L1-regularized logistic regression. Calibration methods were compared including Platt Scaling, Logistic Calibration, and Prevalence Adjustment. Performance of predictive modeling and calibration was assessed via discrimination (c-statistic), calibration (Spiegelhalter Z-statistic, Root Mean Square Error [RMSE] of binned predictions, Sanders and Murphy Resolutions of the Brier Score, Calibration Slope and Intercept), and clinical usefulness (utility terms represented as costs). The amount of validation data necessary to apply each calibration algorithm was also assessed. C-statistics by diagnosis ranged from 0.7 for all-cause readmission to 0.86 (0.78-0.93) for congestive heart failure. Logistic Calibration and Platt Scaling performed best and this difference required analyzing multiple metrics of calibration simultaneously, in particular Calibration Slopes and Intercepts. Clinical usefulness analyses provided optimal risk thresholds, which varied by reason for readmission, outcome prevalence, and calibration algorithm. Utility analyses also suggested maximum tolerable intervention costs, e.g., $1720 for all-cause readmissions based on a published cost of readmission of $11,862. Choice of calibration method depends on availability of validation data and on performance. Improperly calibrated models may contribute to higher costs of intervention as measured via clinical usefulness. Decision-makers must understand underlying utilities or costs inherent in the use-case at hand to assess usefulness and will obtain the optimal risk threshold to trigger intervention with intervention cost limits as a result. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Do circulating tumor cells, exosomes, and circulating tumor nucleic acids have clinical utility? A report of the association for molecular pathology.

PubMed

Gold, Bert; Cankovic, Milena; Furtado, Larissa V; Meier, Frederick; Gocke, Christopher D

2015-05-01

Diagnosing and screening for tumors through noninvasive means represent an important paradigm shift in precision medicine. In contrast to tissue biopsy, detection of circulating tumor cells (CTCs) and circulating tumor nucleic acids provides a minimally invasive method for predictive and prognostic marker detection. This allows early and serial assessment of metastatic disease, including follow-up during remission, characterization of treatment effects, and clonal evolution. Isolation and characterization of CTCs and circulating tumor DNA (ctDNA) are likely to improve cancer diagnosis, treatment, and minimal residual disease monitoring. However, more trials are required to validate the clinical utility of precise molecular markers for a variety of tumor types. This review focuses on the clinical utility of CTCs and ctDNA testing in patients with solid tumors, including somatic and epigenetic alterations that can be detected. A comparison of methods used to isolate and detect CTCs and some of the intricacies of the characterization of the ctDNA are also provided. Copyright © 2015 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

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.

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

Telepathology in cytopathology: challenges and opportunities.

PubMed

Collins, Brian T

2013-01-01

Telepathology in cytopathology is becoming more commonly utilized, and newer technologic infrastructures afford the laboratory a variety of options. The options and design of a telepathology system are driven by the clinical needs. This is primarily focused on providing rapid on-site evaluation service for fine needle aspiration. The clinical requirements and needs of a system are described. Available tools to design and implement a telepathology system are covered, including methods of image capture, network connectivity and remote viewing options. The primary telepathology method currently used and described involves the delivery via a network connection of a live video image to a remote site which is passively viewed by an internet web-based browser. By utilizing live video information and a voice connection to the on-site location, the remote viewer can collect clinical information and direct their view of the slides. Telepathology systems for use in cytopathology can be designed and implemented with commercially available infrastructure. It is necessary for the laboratory to validate the designed system and adhere to the required regulatory requirements. Telepathology for cytopathology can be reliably utilized by adapting existing technology, and newer advances hold great promise for further applications in the cytopathology laboratory. Copyright © 2013 S. Karger AG, Basel.

Survey design research: a tool for answering nursing research questions.

PubMed

Siedlecki, Sandra L; Butler, Robert S; Burchill, Christian N

2015-01-01

The clinical nurse specialist is in a unique position to identify and study clinical problems in need of answers, but lack of time and resources may discourage nurses from conducting research. However, some research methods can be used by the clinical nurse specialist that are not time-intensive or cost prohibitive. The purpose of this article is to explain the utility of survey methodology for answering a number of nursing research questions. The article covers survey content, reliability and validity issues, sample size considerations, and methods of survey delivery.

NASPGHAN Capsule Endoscopy Clinical Report.

PubMed

Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S

2017-03-01

Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.

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

PD-atricians: Leveraging Physicians and Participatory Design to Develop Novel Clinical Information Tools

PubMed Central

Pollack, Ari H; Miller, Andrew; Mishra, Sonali R.; Pratt, Wanda

2016-01-01

Participatory design, a method by which system users and stakeholders meaningfully contribute to the development of a new process or technology, has great potential to revolutionize healthcare technology, yet has seen limited adoption. We conducted a design session with eleven physicians working to create a novel clinical information tool utilizing participatory design methods. During the two-hour session, the physicians quickly engaged in the process and generated a large quantity of information, informing the design of a future tool. By utilizing facilitators experienced in design methodology, with detailed domain expertise, and well integrated into the healthcare organization, the participatory design session engaged a group of users who are often disenfranchised with existing processes as well as health information technology in general. We provide insight into why participatory design works with clinicians and provide guiding principles for how to implement these methods in healthcare organizations interested in advancing health information technology. PMID:28269900

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

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

PubMed

Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

2018-05-09

Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

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.

Faculty Development for Fostering Clinical Reasoning Skills in Early Medical Students Using a Modified Bayesian Approach.

PubMed

Addy, Tracie Marcella; Hafler, Janet; Galerneau, France

2016-01-01

Clinical reasoning is a necessary skill for medical students to acquire in the course of their education, and there is evidence that they can start this process at the undergraduate level. However, physician educators who are experts in their given fields may have difficulty conveying their complex thought processes to students. Providing faculty development that equips educators with tools to teach clinical reasoning may support skill development in early medical students. We provided faculty development on a modified Bayesian method of teaching clinical reasoning to clinician educators who facilitated small-group, case-based workshops with 2nd-year medical students. We interviewed them before and after the module regarding their perceptions on teaching clinical reasoning. We solicited feedback from the students about the effectiveness of the method in developing their clinical reasoning skills. We carried out this project during an institutional curriculum rebuild where clinical reasoning was a defined goal. At the time of the intervention, there was also increased involvement of the Teaching and Learning Center in elevating the status of teaching and learning. There was high overall satisfaction with the faculty development program. Both the faculty and the students described the modified Bayesian approach as effective in fostering the development of clinical reasoning skills. Through this work, we learned how to form a beneficial partnership between a clinician educator and Teaching and Learning Center to promote faculty development on a clinical reasoning teaching method for early medical students. We uncovered challenges faced by both faculty and early learners in this study. We observed that our faculty chose to utilize the method of teaching clinical reasoning in a variety of manners in the classroom. Despite obstacles and differing approaches utilized, we believe that this model can be emulated at other institutions to foster the development of clinical reasoning skills in preclerkship students.

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

Development and Initial Testing of a Structured Clinical Observation Tool to Assess Pharmacotherapy Competence

ERIC Educational Resources Information Center

Young, John Q.; Lieu, Sandra; O'Sullivan, Patricia; Tong, Lowell

2011-01-01

Objective: The authors developed and tested the feasibility and utility of a new direct-observation instrument to assess trainee performance of a medication management session. Methods: The Psychopharmacotherapy-Structured Clinical Observation (P-SCO) instrument was developed based on multiple sources of expertise and then implemented in 4…

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,…

Circumferential finger measurements utilizing a torque meter to increase reliability.

PubMed

King, T I

1993-01-01

The purpose of this study was to compare the reliabilities of two methods of measuring finger circumference. Traditionally, finger circumference is determined clinically by the use of a tape measure. In this study, a tape-measure device for recording finger circumference utilizing a torque meter was compared with the traditional method to determine reliability differences. Ninety-two occupational therapists and occupational therapy students obtained circumferential measurements of the author's left index finger at the middle of the proximal phalanx utilizing the two methods. The readings obtained for each method were analyzed to determine the coefficient of variation and to compare their variances. The coefficient of variation for the traditional method was 2.92 and for the device utilizing the torque meter was 0.75. The F ratio was 15.63, which is significant at the 0.01 level. The results of this study indicate greater interrater reliability using a device that can accurately measure torque and allow the therapist to control the amount of tension applied when obtaining circumferential measurements using a tape measure.

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.

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.

Evaluation of service quality in family planning clinics in Lusaka, Zambia.

PubMed

Hancock, Nancy L; Vwalika, Bellington; Sitali, Elizabeth Siyama; Mbwili-Muleya, Clara; Chi, Benjamin H; Stuart, Gretchen S

2015-10-01

To determine the quality of contraceptive services in family planning clinics in Lusaka, Zambia, using a standardized approach. We utilized the Quick Investigation of Quality, a cross-sectional survey tool consisting of a facility assessment, client-provider observation and client exit interview, in public-sector family planning clinics. Data were collected on availability of seven contraceptive methods, information given to clients, interpersonal relations between providers and clients, providers' technical competence and mechanisms for continuity and follow-up. Data were collected from five client-provider observations and client exit interviews in each of six public-sector family planning clinics. All clinics had at least two contraceptive methods continuously available for the preceding 6 months. Most providers asked clients about concerns with their contraceptive method (80%) and told clients when to return to the clinic (87%). Most clients reported that the provider advised what to do if a problem develops (93%), described possible side effects (89%), explained how to use the method effectively (85%) and told them when to come for follow-up (83%). Clients were satisfied with services received (93%). This application of the Quick Investigation of Quality showed that the participating family planning clinics in Lusaka, Zambia, were prepared to offer high-quality services with the available commodities and that clients were satisfied with the received services. Despite the subjective client satisfaction, quality improvement efforts are needed to increase contraceptive availability. Although clients perceived the quality of care received to be high, family planning service quality could be improved to continuously offer the full spectrum of contraceptive options. The Quick Investigation of Quality was easily implemented in Lusaka, Zambia, and this simple approach could be utilized in a variety of settings as a modality for quality improvement. Copyright © 2015 Elsevier Inc. All rights reserved.

Voice recognition software for clinical use.

PubMed

Korn, K

1998-11-01

The current generation voice recognition products truly offer the promise of voice recognition systems, that are financially and operationally acceptable for use in a health care facility. Although the initial capital outlay for the purchase of such equipment may be substantial, the long-term benefit is felt to outweigh the expense. The ability to utilize computer equipment for educational purposes and information management alone helps to rationalize the cost. In addition, it is important to remember that the Internet has become a substantial source of information which provides another functional use for this equipment. Although one can readily see the implication for such a program in clinical practice, other uses for the program should not be overlooked. Uses far beyond the writing of clinic notes and correspondence can be easily envisioned. Utilization of voice recognition software offers clinical practices the ability to produce quality printed records in a timely and cost-effective manner. After learning procedures for the selected product and appropriately formatting word processing software and printers, printed progress notes should be able to be produced in less time than traditional dictation and transcription methods. Although certain procedures and practices may need to be altered, or may preclude optimal utilization of this type of system, many advantages are apparent. It is recommended that facilities consider utilization of Voice Recognition products such as Dragon Systems Naturally Speaking Software, or at least consider a trial of this method with one of the limited-feature products, if current dictation practices are unsatisfactory or excessively costly. Free downloadable trial software or single user software can provide a reduced-cost method for trial evaluation of such products if a major commitment is not felt to be desired. A list of voice recognition software manufacturer web sites may be accessed through the following: http://www.dragonsys.com/ http://www.software.ibm/com/is/voicetype/ http://www.lhs.com/

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.

A Comparative Analysis of Health-Related Quality of Life and Family Impact between Children with ADHD Treated in a General Pediatric Clinic and a Psychiatric Clinic Utilizing the PedsQL

ERIC Educational Resources Information Center

Limbers, Christine A.; Ripperger-Suhler, Jane; Boutton, Kelly; Ransom, Daniel; Varni, James W.

2011-01-01

Objective: To evaluate health-related quality of life (HRQOL) from the perspective of children with ADHD and their parents being seen in a Pediatric Clinic in comparison to healthy children and children with ADHD being seen in a Psychiatric Clinic. Method: Participants were children with a physician diagnosis of ADHD ages 5-18 years and their…

The impact of clinical nurse specialists on clinical pathways in the application of evidence-based practice.

PubMed

Gurzick, Martha; Kesten, Karen S

2010-01-01

The purpose of this article was to address the call for evidence-based practice through the development of clinical pathways and to assert the role of the clinical nurse specialist (CNS) as a champion in clinical pathway implementation. In the current health care system, providing quality of care while maintaining cost-effectiveness is an ever-growing battle that institutions face. The CNS's role is central to meeting these demands. An extensive literature review has been conducted to validate the use of clinical pathways as a means of improving patient outcomes. This literature also suggests that clinical pathways must be developed, implemented, and evaluated utilizing validated methods including the use of best practice standards. Execution of clinical pathways should include a clinical expert, who has the ability to look at the system as a whole and can facilitate learning and change by employing a multitude of competencies while maintaining a sphere of influence over patient and families, nurses, and the system. The CNS plays a pivotal role in influencing effective clinical pathway development, implementation, utilization, and ongoing evaluation to ensure improved patient outcomes and reduced costs. This article expands upon the call for evidence-based practice through the utilization of clinical pathways to improve patient outcomes and reduce costs and stresses the importance of the CNS as a primary figure for ensuring proper pathway development, implementation, and ongoing evaluation. Copyright 2010 Elsevier Inc. All rights reserved.

A student-led process to enhance the learning and teaching of teamwork skills in medicine.

PubMed

Balasooriya, Chinthaka; Olupeliyawa, Asela; Iqbal, Maha; Lawley, Claire; Cohn, Amanda; Ma, David; Luu, Queenie

2013-01-01

The development of teamwork skills is a critical aspect of modern medical education. This paper reports on a project that aimed to identify student perceptions of teamwork-focused learning activities and generate student recommendations for the development of effective educational strategies. The project utilized a unique method, which drew on the skills of student research assistants (RAs) to explore the views of their peers. Using structured interview guides, the RAs interviewed their colleagues to clarify their perceptions of the effectiveness of current methods of teamwork teaching and to explore ideas for more effective methods. The RAs shared their deidentified findings with each other, identified preliminary themes, and developed a number of recommendations which were finalized through consultation with faculty. The key themes that emerged focused on the need to clarify the relevance of teamwork skills to clinical practice, reward individual contributions to group process, facilitate feedback and reflection on teamwork skills, and systematically utilize clinical experiences to support experiential learning of teamwork. Based on these findings, a number of recommendations for stage appropriate teamwork learning and assessment activities were developed. Key among these were recommendations to set up a peer-mentoring system for students, suggestions for more authentic teamwork assessment methods, and strategies to utilize the clinical learning environment in developing teamwork skills. The student-led research process enabled identification of issues that may not have been otherwise revealed by students, facilitated a better understanding of teamwork teaching and developed ownership of the curriculum among students. The project enabled the development of recommendations for designing learning, teaching, and assessment methods that were likely to be more effective from a student perspective.

Teaching and the Case Method. Text, Cases, and Readings. Third Edition.

ERIC Educational Resources Information Center

Barnes, Louis B.; And Others

This volume includes text, cases, and readings for a college faculty seminar to develop the knowledge, skills, and attitudes necessary for utilization of the case method approach to instruction. It builds on a long-term clinical research effort on the dynamics of the case method of teaching and application at Harvard Business School. In addition…

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

Improving Terminology Mapping in Clinical Text with Context-Sensitive Spelling Correction.

PubMed

Dziadek, Juliusz; Henriksson, Aron; Duneld, Martin

2017-01-01

The mapping of unstructured clinical text to an ontology facilitates meaningful secondary use of health records but is non-trivial due to lexical variation and the abundance of misspellings in hurriedly produced notes. Here, we apply several spelling correction methods to Swedish medical text and evaluate their impact on SNOMED CT mapping; first in a controlled evaluation using medical literature text with induced errors, followed by a partial evaluation on clinical notes. It is shown that the best-performing method is context-sensitive, taking into account trigram frequencies and utilizing a corpus-based dictionary.

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis

PubMed Central

Mowery, D.; South, B. R.; Kvist, M.; Dalianis, H.

2015-01-01

Summary Objectives We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. Methods We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Results Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. Conclusions There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices. PMID:26293867

SU-F-J-112: Clinical Feasibility Test of An RF Pulse-Based MRI Method for the Quantitative Fat-Water Segmentation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yee, S; Wloch, J; Pirkola, M

Purpose: Quantitative fat-water segmentation is important not only because of the clinical utility of fat-suppressed MRI images in better detecting lesions of clinical significance (in the midst of bright fat signal) but also because of the possible physical need, in which CT-like images based on the materials’ photon attenuation properties may have to be generated from MR images; particularly, as in the case of MR-only radiation oncology environment to obtain radiation dose calculation or as in the case of hybrid PET/MR modality to obtain attenuation correction map for the quantitative PET reconstruction. The majority of such fat-water quantitative segmentations havemore » been performed by utilizing the Dixon’s method and its variations, which have to enforce the proper settings (often predefined) of echo time (TE) in the pulse sequences. Therefore, such methods have been unable to be directly combined with those ultrashort TE (UTE) sequences that, taking the advantage of very low TE values (∼ 10’s microsecond), might be beneficial to directly detect bones. Recently, an RF pulse-based method (http://dx.doi.org/10.1016/j.mri.2015.11.006), termed as PROD pulse method, was introduced as a method of quantitative fat-water segmentation that does not have to depend on predefined TE settings. Here, the clinical feasibility of this method is verified in brain tumor patients by combining the PROD pulse with several sequences. Methods: In a clinical 3T MRI, the PROD pulse was combined with turbo spin echo (e.g. TR=1500, TE=16 or 60, ETL=15) or turbo field echo (e.g. TR=5.6, TE=2.8, ETL=12) sequences without specifying TE values. Results: The fat-water segmentation was possible without having to set specific TE values. Conclusion: The PROD pulse method is clinically feasible. Although not yet combined with UTE sequences in our laboratory, the method is potentially compatible with UTE sequences, and thus, might be useful to directly segment fat, water, bone and air.« less

Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Introduction: The Oncology Section of APTA developed a clinical practice guideline to aid the clinician in diagnosing secondary upper-quadrant cancer-related lymphedema. Methods: Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in their diagnostic process. Overall, clinical practice recommendations were formulated on the basis of the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. Recommendations: In an effort to make these clinically applicable, recommendations were based on the characteristics as to the location and stage of a patient's upper-quadrant lymphedema. PMID:28748128

Advanced methods for teaching electronic-nose technologies to diagnosticians and clinical laboratory technicians

Treesearch

Alphus D. Wilson

2012-01-01

Electronic-detection technologies and instruments increasingly are being utilized in the biomedical field to perform a wide variety of clinical operations and laboratory analyses to facilitate the delivery of health care to patients. The introduction of improved electronic instruments for diagnosing diseases and for administering treatments has required new training of...

Description of a Standardized Treatment Center that Utilizes Evidence-Based Clinic Operations to Facilitate Implementation of an Evidence-Based Treatment

ERIC Educational Resources Information Center

Donohue, Brad; Allen, Daniel N.; Romero, Valerie; Hill, Heather H.; Vasaeli, Kathryn; Lapota, Holly; Tracy, Kendra; Gorney, Suzanne; Abdel-al, Ruweida; Caldas, Diana; Herdzik, Karen; Bradshaw, Kelsey; Valdez, Robby; Van Hasselt, Vincent B.

2009-01-01

Developers of evidence-based therapies are enhancing methods of teaching therapists to implement "best practices" with integrity. However, there is a relative dearth of information available as to clinic operations and related contextual factors necessary to sustain successful implementation of these treatments. This article describes various…

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

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.

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

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.

Comparative effectiveness research and its utility in In-clinic practice

PubMed Central

Dang, Amit; Kaur, Kirandeep

2016-01-01

One of the important components of patient-centered healthcare is comparative effectiveness research (CER), which aims at generating evidence from the real-life setting. The primary purpose of CER is to provide comparative information to the healthcare providers, patients, and policy makers about the standard of care available. This involves research on clinical questions unanswered by the explanatory trials during the regulatory approval process. Main methods of CER involve randomized controlled trials and observational methods. The limitations of these two methods have been overcome with the help of new statistical methods. After the evidence generation, it is equally important to communicate the results to all the interested organizations. CER is beginning to have its impact in the clinical practice as its results become part of the clinical practice guidelines. CER will have far-reaching scientific and financial impact. CER will make both the treating physician and the patient equally responsible for the treatment offered. PMID:26955571

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.

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

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom*

PubMed Central

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

Objective To develop a study aiming at optimizing myocardial perfusion imaging. Materials and Methods Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The 99mTc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. Results The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. Conclusion The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol. PMID:25741088

Patient Smartphone Ownership and Interest in Mobile Apps to Monitor Symptoms of Mental Health Conditions: A Survey in Four Geographically Distinct Psychiatric Clinics

PubMed Central

Chan, Steven Richard; Yee-Marie Tan, Shih; Behrens, Jacob; Mathew, Ian; Conrad, Erich J; Hinton, Ladson; Yellowlees, Peter; Keshavan, Matcheri

2014-01-01

Background Despite growing interest in mobile mental health and utilization of smartphone technology to monitor psychiatric symptoms, there remains a lack of knowledge both regarding patient ownership of smartphones and their interest in using such to monitor their mental health. Objective To provide data on psychiatric outpatients’ prevalence of smartphone ownership and interest in using their smartphones to run applications to monitor their mental health. Methods We surveyed 320 psychiatric outpatients from four clinics around the United States in order to capture a geographically and socioeconomically diverse patient population. These comprised a state clinic in Massachusetts (n=108), a county clinic in California (n=56), a hybrid public and private clinic in Louisiana (n=50), and a private/university clinic in Wisconsin (n=106). Results Smartphone ownership and interest in utilizing such to monitor mental health varied by both clinic type and age with overall ownership of 62.5% (200/320), which is slightly higher than the average United States’ rate of ownership of 58% in January 2014. Overall patient interest in utilizing smartphones to monitor symptoms was 70.6% (226/320). Conclusions These results suggest that psychiatric outpatients are interested in using their smartphones to monitor their mental health and own the smartphones capable of running mental healthcare related mobile applications. PMID:26543905

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.

The Significance of A Neglected Romanian Book - "The Methods of the Clinical Laboratory", by Ioan Manta and Alexandru Ciplea.

PubMed

Barsu, Cristian

2017-04-06

"The Methods of Clinical Laboratory" was the first comprehensive Romanian book in the medical laboratory field, having utility in clinical practice. It was written by Prof. Ioan Manta (1900-1979) and Alexandru Ciplea (1912-1988), both from the Cluj Faculty of Medicine. The volume was published for the first time in 1944, during the refuge of this Faculty in Sibiu, and for the second time in 1947, in Cluj. Our aim is to make a brief analysis of its structure and to put into evidence the importance of this book for the Romanian laboratory medicine, some techniques (e.g. microscopic techniques) keeping their validity until today. The authors made over 800 detailed presentations about: laboratory sampling and preservation techniques, different types of tests and methods for qualitative and quantitative determinations, techniques to prepare various solutions, microbiological culture media, laboratory stains and reagents, as well as maneuvering of some laboratory equipments. For each method, Manta and Ciplea presented: the principle of working method, reagents required, the working technique, mode of calculation, the result and its interpretation. It also includes some laboratory apparatus descriptions, as well as their mode of working. With regard to the scientific value and to the practical utility of this book, it remains a very important milestone in the Romanian medical literature of the XX-th century.

Multi-Phenotypic subtyping of circulating tumor cells using sequential fluorescent quenching and restaining

NASA Astrophysics Data System (ADS)

Adams, Daniel L.; Alpaugh, R. Katherine; Tsai, Susan; Tang, Cha-Mei; Stefansson, Steingrimur

2016-09-01

In tissue biopsies formalin fixed paraffin embedded cancer blocks are micro-sectioned producing multiple semi-identical specimens which are analyzed and subtyped proteomically, and genomically, with numerous biomarkers. In blood based biopsies (BBBs), blood is purified for circulating tumor cells (CTCs) and clinical utility is typically limited to cell enumeration, as only 2-3 positive fluorescent markers and 1 negative marker can be used. As such, increasing the number of subtyping biomarkers on each individual CTC could dramatically enhance the clinical utility of BBBs, allowing in depth interrogation of clinically relevant CTCs. We describe a simple and inexpensive method for quenching the specific fluors of fluorescently stained CTCs followed by sequential restaining with additional biomarkers. As proof of principle a CTC panel, immunosuppression panel and stem cell panel were used to sequentially subtype individual fluorescently stained patient CTCs, suggesting a simple and universal technique to analyze multiple clinically applicable immunomarkers from BBBs.

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.

Oxygen utilization of the human left ventricle - An indirect method for its evaluation and clinical considerations

NASA Technical Reports Server (NTRS)

Ghista, D. N.; Sandler, H.

1974-01-01

An analytical method is presented for determining the oxygen consumption rate of the intact heart working (as opposed to empty but beating) human left ventricle. Use is made of experimental recordings obtained for the chamber pressure and the associated dimensions of the LV. LV dimensions are determined by cineangiocardiography, and the chamber pressure is obtained by means of fluid-filled catheters during retrograde or transeptal catheterization. An analytical method incorporating these data is then employed for the evaluation of the LV coronary oxygen consumption in five subjects. Oxygen consumption for these subjects was also obtained by the conventional clinical method in order to evaluate the reliability of the proposed method.

Metadata registry and management system based on ISO 11179 for cancer clinical trials information system

PubMed Central

Park, Yu Rang; Kim*, Ju Han

2006-01-01

Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers. PMID:17238675

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

The Rivalry between Simulation and Problem-Based Learning: A Study of Learning Transfer in Physician Assistant Students

ERIC Educational Resources Information Center

Meyer, Kimberly E.

2010-01-01

The purpose of this dissertation was to evaluate learning transfer achieved by physician assistant students comparing two instructional methods, human patient simulation and electronic clinical case studies. This prospective, randomized, mixed-methods study utilized first and second-year physician assistant student volunteers taking a pretest and…

An Overview on Prenatal Screening for Chromosomal Aberrations.

PubMed

Hixson, Lucas; Goel, Srishti; Schuber, Paul; Faltas, Vanessa; Lee, Jessica; Narayakkadan, Anjali; Leung, Ho; Osborne, Jim

2015-10-01

This article is a review of current and emerging methods used for prenatal detection of chromosomal aneuploidies. Chromosomal anomalies in the developing fetus can occur in any pregnancy and lead to death prior to or shortly after birth or to costly lifelong disabilities. Early detection of fetal chromosomal aneuploidies, an atypical number of certain chromosomes, can help parents evaluate their pregnancy options. Current diagnostic methods include maternal serum sampling or nuchal translucency testing, which are minimally invasive diagnostics, but lack sensitivity and specificity. The gold standard, karyotyping, requires amniocentesis or chorionic villus sampling, which are highly invasive and can cause abortions. In addition, many of these methods have long turnaround times, which can cause anxiety in mothers. Next-generation sequencing of fetal DNA in maternal blood enables minimally invasive, sensitive, and reasonably rapid analysis of fetal chromosomal anomalies and can be of clinical utility to parents. This review covers traditional methods and next-generation sequencing techniques for diagnosing aneuploidies in terms of clinical utility, technological characteristics, and market potential. © 2015 Society for Laboratory Automation and Screening.

Clinical utility of the Structured Observation of Motor Performance in Infants within the child health services

PubMed Central

Persson, Kristina; Sonnander, Karin; Magnusson, Margaretha; Sarkadi, Anna; Lucas, Steven

2017-01-01

Aim This study aimed to evaluate the clinical utility of the Structured Observation of Motor Performance in Infants (SOMP-I) when used by nurses in routine child healthcare by analyzing the nurses’ SOMP-I assessments and the actions taken when motor problems were suspected. Method Infants from three child health centers in Uppsala County, Sweden, were consecutively enrolled in a longitudinal study. The 242 infants were assessed using SOMP-I by the nurse responsible for the infant as part of the regular well-child visits at as close to 2, 4, 6 and 10 months of age as possible. The nurses noted actions taken such as giving advice, scheduling an extra follow-up or referring the infant to specialized care. The infants’ motor development was reassessed at 18 months of age through review of medical records or parental report. Results The assessments of level of motor development at 2 and 10 months showed a distribution corresponding to the percentile distribution of the SOMP-I method. Fewer infants than expected were assessed as delayed at 4 and 6 months or deficient in quality at all assessment ages. When an infant was assessed as delayed in level or deficient in quality, the likelihood of the nurse taking actions increased. This increased further if both delay and quality deficit were found at the same assessment or if one or both were found at repeated assessments. The reassessment of the motor development at 18 months did not reveal any missed infants with major motor impairments. Interpretation The use of SOMP-I appears to demonstrate favorable clinical utility in routine child healthcare as tested here. Child health nurses can assess early motor performance using this standardized assessment method, and using the method appears to support them the clinical decision-making. PMID:28723929

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…

Sexual History Inquiry and HIV Counseling: Improving Clinical Skills and Medical Knowledge through an Interactive Workshop Utilizing Standardized Patients

ERIC Educational Resources Information Center

Haist, Steven A.; Lineberry, Michelle J.; Griffith, Charles H.; Hoellein, Andrew R.; Talente, Gregg M.; Wilson, John F.

2008-01-01

Background: Sexual history and HIV counseling (SHHIVC) are essential clinical skills. Our project's purpose was to evaluate a standardized patient educational intervention teaching third-year medical students SHHIVC. Methods: A four-hour standardized patient workshop was delivered to one-half of the class each of three consecutive years at one…

Traumatic Brain Injury Detection Using Electrophysiological Methods

PubMed Central

Rapp, Paul E.; Keyser, David O.; Albano, Alfonso; Hernandez, Rene; Gibson, Douglas B.; Zambon, Robert A.; Hairston, W. David; Hughes, John D.; Krystal, Andrew; Nichols, Andrew S.

2015-01-01

Measuring neuronal activity with electrophysiological methods may be useful in detecting neurological dysfunctions, such as mild traumatic brain injury (mTBI). This approach may be particularly valuable for rapid detection in at-risk populations including military service members and athletes. Electrophysiological methods, such as quantitative electroencephalography (qEEG) and recording event-related potentials (ERPs) may be promising; however, the field is nascent and significant controversy exists on the efficacy and accuracy of the approaches as diagnostic tools. For example, the specific measures derived from an electroencephalogram (EEG) that are most suitable as markers of dysfunction have not been clearly established. A study was conducted to summarize and evaluate the statistical rigor of evidence on the overall utility of qEEG as an mTBI detection tool. The analysis evaluated qEEG measures/parameters that may be most suitable as fieldable diagnostic tools, identified other types of EEG measures and analysis methods of promise, recommended specific measures and analysis methods for further development as mTBI detection tools, identified research gaps in the field, and recommended future research and development thrust areas. The qEEG study group formed the following conclusions: (1) Individual qEEG measures provide limited diagnostic utility for mTBI. However, many measures can be important features of qEEG discriminant functions, which do show significant promise as mTBI detection tools. (2) ERPs offer utility in mTBI detection. In fact, evidence indicates that ERPs can identify abnormalities in cases where EEGs alone are non-disclosing. (3) The standard mathematical procedures used in the characterization of mTBI EEGs should be expanded to incorporate newer methods of analysis including non-linear dynamical analysis, complexity measures, analysis of causal interactions, graph theory, and information dynamics. (4) Reports of high specificity in qEEG evaluations of TBI must be interpreted with care. High specificities have been reported in carefully constructed clinical studies in which healthy controls were compared against a carefully selected TBI population. The published literature indicates, however, that similar abnormalities in qEEG measures are observed in other neuropsychiatric disorders. While it may be possible to distinguish a clinical patient from a healthy control participant with this technology, these measures are unlikely to discriminate between, for example, major depressive disorder, bipolar disorder, or TBI. The specificities observed in these clinical studies may well be lost in real world clinical practice. (5) The absence of specificity does not preclude clinical utility. The possibility of use as a longitudinal measure of treatment response remains. However, efficacy as a longitudinal clinical measure does require acceptable test–retest reliability. To date, very few test–retest reliability studies have been published with qEEG data obtained from TBI patients or from healthy controls. This is a particular concern because high variability is a known characteristic of the injured central nervous system. PMID:25698950

Traumatic brain injury detection using electrophysiological methods.

PubMed

Rapp, Paul E; Keyser, David O; Albano, Alfonso; Hernandez, Rene; Gibson, Douglas B; Zambon, Robert A; Hairston, W David; Hughes, John D; Krystal, Andrew; Nichols, Andrew S

2015-01-01

Measuring neuronal activity with electrophysiological methods may be useful in detecting neurological dysfunctions, such as mild traumatic brain injury (mTBI). This approach may be particularly valuable for rapid detection in at-risk populations including military service members and athletes. Electrophysiological methods, such as quantitative electroencephalography (qEEG) and recording event-related potentials (ERPs) may be promising; however, the field is nascent and significant controversy exists on the efficacy and accuracy of the approaches as diagnostic tools. For example, the specific measures derived from an electroencephalogram (EEG) that are most suitable as markers of dysfunction have not been clearly established. A study was conducted to summarize and evaluate the statistical rigor of evidence on the overall utility of qEEG as an mTBI detection tool. The analysis evaluated qEEG measures/parameters that may be most suitable as fieldable diagnostic tools, identified other types of EEG measures and analysis methods of promise, recommended specific measures and analysis methods for further development as mTBI detection tools, identified research gaps in the field, and recommended future research and development thrust areas. The qEEG study group formed the following conclusions: (1) Individual qEEG measures provide limited diagnostic utility for mTBI. However, many measures can be important features of qEEG discriminant functions, which do show significant promise as mTBI detection tools. (2) ERPs offer utility in mTBI detection. In fact, evidence indicates that ERPs can identify abnormalities in cases where EEGs alone are non-disclosing. (3) The standard mathematical procedures used in the characterization of mTBI EEGs should be expanded to incorporate newer methods of analysis including non-linear dynamical analysis, complexity measures, analysis of causal interactions, graph theory, and information dynamics. (4) Reports of high specificity in qEEG evaluations of TBI must be interpreted with care. High specificities have been reported in carefully constructed clinical studies in which healthy controls were compared against a carefully selected TBI population. The published literature indicates, however, that similar abnormalities in qEEG measures are observed in other neuropsychiatric disorders. While it may be possible to distinguish a clinical patient from a healthy control participant with this technology, these measures are unlikely to discriminate between, for example, major depressive disorder, bipolar disorder, or TBI. The specificities observed in these clinical studies may well be lost in real world clinical practice. (5) The absence of specificity does not preclude clinical utility. The possibility of use as a longitudinal measure of treatment response remains. However, efficacy as a longitudinal clinical measure does require acceptable test-retest reliability. To date, very few test-retest reliability studies have been published with qEEG data obtained from TBI patients or from healthy controls. This is a particular concern because high variability is a known characteristic of the injured central nervous system.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed

Gadd, C S; Baskaran, P; Lobach, D F

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings.

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

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

Droplet Microfluidics for Chip-Based Diagnostics

PubMed Central

Kaler, Karan V. I. S.; Prakash, Ravi

2014-01-01

Droplet microfluidics (DMF) is a fluidic handling technology that enables precision control over dispensing and subsequent manipulation of droplets in the volume range of microliters to picoliters, on a micro-fabricated device. There are several different droplet actuation methods, all of which can generate external stimuli, to either actively or passively control the shape and positioning of fluidic droplets over patterned substrates. In this review article, we focus on the operation and utility of electro-actuation-based DMF devices, which utilize one or more micro-/nano-patterned substrates to facilitate electric field-based handling of chemical and/or biological samples. The underlying theory of DMF actuations, device fabrication methods and integration of optical and opto-electronic detectors is discussed in this review. Example applications of such electro-actuation-based DMF devices have also been included, illustrating the various actuation methods and their utility in conducting chip-based laboratory and clinical diagnostic assays. PMID:25490590

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

[Economic efficiency of computer monitoring of health].

PubMed

Il'icheva, N P; Stazhadze, L L

2001-01-01

Presents the method of computer monitoring of health, based on utilization of modern information technologies in public health. The method helps organize preventive activities of an outpatient clinic at a high level and essentially decrease the time and money loss. Efficiency of such preventive measures, increased number of computer and Internet users suggests that such methods are promising and further studies in this field are needed.

Oropharyngeal dysphagia: surveying practice patterns of the speech-language pathologist.

PubMed

Martino, Rosemary; Pron, Gaylene; Diamant, Nicholas E

2004-01-01

The present study was designed to obtain a comprehensive view of the dysphagia assessment practice patterns of speech-language pathologists and their opinion on the importance of these practices using survey methods and taking into consideration clinician, patient, and practice-setting variables. A self-administered mail questionnaire was developed following established methodology to maximize response rates. Eight dysphagia experts independently rated the new survey for content validity. Test-retest reliability was assessed with a random sample of 23 participants. The survey was sent to 50 speech-language pathologists randomly selected from the Canadian professional association database of members who practice in dysphagia. Surveys were mailed according to the Dillman Total Design Method and included an incentive offer. High survey (64%) and item response (95%) rates were achieved and clinicians were reliable reporters of their practice behaviors (ICC>0.60). Of all the clinical assessment items, 36% were reported with high (>80%) utilization and 24% with low (<20%) utilization, the former pertaining to tongue motion and vocal quality after food/fluid intake and the latter to testing of oral sensation without food. One-third (33%) of instrumental assessment items were highly utilized and included assessment of bolus movement and laryngeal response to bolus misdirection. Overall, clinician experience and teaching institutions influenced greater utilization. Opinions of importance were similar to utilization behaviors (r = 0.947, p = 0.01). Of all patients referred for dysphagia assessment, full clinical assessments were administered to 71% of patients but instrumental assessments to only 36%. A hierarchical model of practice behavior is proposed to explain this pattern of progressively decreasing item utilization.

New approaches to increase intestinal length: Methods used for intestinal regeneration and bioengineering

PubMed Central

Shirafkan, Ali; Montalbano, Mauro; McGuire, Joshua; Rastellini, Cristiana; Cicalese, Luca

2016-01-01

Inadequate absorptive surface area poses a great challenge to the patients suffering a variety of intestinal diseases causing short bowel syndrome. To date, these patients are managed with total parenteral nutrition or intestinal transplantation. However, these carry significant morbidity and mortality. Currently, by emergence of tissue engineering, anticipations to utilize an alternative method to increase the intestinal absorptive surface area are increasing. In this paper, we will review the improvements made over time in attempting elongating the intestine with surgical techniques as well as using intestinal bioengineering. Performing sequential intestinal lengthening was the preliminary method applied in humans. However, these methods did not reach widespread use and has limited outcome. Subsequent experimental methods were developed utilizing scaffolds to regenerate intestinal tissue and organoids unit from the intestinal epithelium. Stem cells also have been studied and applied in all types of tissue engineering. Biomaterials were utilized as a structural support for naive cells to produce bio-engineered tissue that can achieve a near-normal anatomical structure. A promising novel approach is the elongation of the intestine with an acellular biologic scaffold to generate a neo-formed intestinal tissue that showed, for the first time, evidence of absorption in vivo. In the large intestine, studies are more focused on regeneration and engineering of sphincters and will be briefly reviewed. From the review of the existing literature, it can be concluded that significant progress has been achieved in these experimental methods but that these now need to be fully translated into a pre-clinical and clinical experimentation to become a future viable therapeutic option. PMID:27011901

New model helps find missing link between financial and clinical health care management.

PubMed

Dasso, E; Wilson, T

2001-01-01

U.S. health care is missing a link between the financial managers and clinical health managers of defined patient populations. Utilization and cost management try to bridge the gap by focusing on restricted access to care or tightly managed provider reimbursement to control costs. But frequently, they do not take clinical outcomes or health status into consideration. Take a look at another method based on the science of epidemiology that brings a more balanced knowledge of the clinical world to financial managers and more financial insight to clinicians.

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design

PubMed Central

Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D’Arcy, Ryan C N; Song, Xiaowei

2018-01-01

Introduction Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors’ quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Methods and analysis Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. Ethics and dissemination The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging scientists, computing scientists and clinical professionals in neurology and neuroradiology and includes patient representatives. Research outputs will be disseminated following knowledge translation plans towards improving stroke patient care. Significant findings will be published in scientific journals. Anticipated deliverables include computer solutions for improved clinical assessment of haematoma using NCCT. PMID:29674371

Latin American Clinical Epidemiology Network Series - Paper 4: Economic evaluation of Kangaroo Mother Care: cost utility analysis of results from a randomized controlled trial conducted in Bogotá.

PubMed

Ruiz, Juan Gabriel; Charpak, Nathalie; Castillo, Mario; Bernal, Astrid; Ríos, John; Trujillo, Tammy; Córdoba, María Adelaida

2017-06-01

Although kangaroo mother care (KMC) has been shown to be safe and effective in randomized controlled trials (RCTs), there are no published complete economic evaluations including the three components of the full intervention. A cost utility analysis performed on the results of an RCT conducted in Bogotá, Colombia between 1993 and 1996. Hospital and ambulatory costs were estimated by microcosting in a sample of preterm infants from a University Hospital in Bogotá in 2011 and at a KMC clinic in the same period. Utility scores were assigned by experts by means of (1) direct ordering and scoring discrete health states and (2) constructing a multi-attribute utility function. Ninety-five percent confidence intervals (CIs) for the incremental cost-utility ratios (ICURs) were computed by the Fiellers theorem method. One-way sensitivity analysis on price estimates for valuing costs was performed. ICUR at 1 year of corrected age was $ -1,546 per extra quality-adjusted life year gained using the KMC method (95% CI $ -7,963 to $ 4,910). In Bogotá, the use of KMC is dominant: more effective and cost-saving. Although results from an economic analysis should not be extrapolated to different systems and communities, this dominant result suggests that KMC could be cost-effective in similar low and middle income countries settings. Copyright © 2016 Elsevier Inc. All rights reserved.

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)

Assessing Integration of Clinical and Public Health Skills in Preventive Medicine Residencies: Using Competency Mapping

PubMed Central

Sarigiannis, Amy N.; Boulton, Matthew L.

2012-01-01

Objectives. We evaluated the utility of a competency mapping process for assessing the integration of clinical and public health skills in a newly developed Community Health Center (CHC) rotation at the University of Michigan School of Public Health Preventive Medicine residency. Methods. Learning objectives for the CHC rotation were derived from the Accreditation Council for Graduate Medical Education core clinical preventive medicine competencies. CHC learning objectives were mapped to clinical preventive medicine competencies specific to the specialty of public health and general preventive medicine. Objectives were also mapped to The Council on Linkages Between Academia and Public Health Practice’s tier 2 Core Competencies for Public Health Professionals. Results. CHC learning objectives mapped to all 4 (100%) of the public health and general preventive medicine clinical preventive medicine competencies. CHC population-level learning objectives mapped to 32 (94%) of 34 competencies for public health professionals. Conclusions. Utilizing competency mapping to assess clinical–public health integration in a new CHC rotation proved to be feasible and useful. Clinical preventive medicine learning objectives for a CHC rotation can also address public health competencies. PMID:22690972

The effect of user fees on the utilization of family planning services. A clinical study.

PubMed

Bailey, W; Wynter, H H; Lee, A; Oliver, P; Jackson, J

1994-06-01

A new fee structure was introduced to the Advanced Training and Research in Fertility Management Unit in 1992. The study looked at the effect of the new fees on attendance and the choice of contraceptive methods through an examination of clinical records and a questionnaire survey. There was a decline in attendance of roughly 28 per cent between 1992 and 1993. The decline affected mainly new clients and those who accepted injectables. A reduction in the price of injectables is suggested since the fee for this short-term method is more in line with those charged for long-term and permanent methods.

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.

Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

PubMed

Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

2018-04-17

In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

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.

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.

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions

PubMed Central

2017-01-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy. PMID:29209469

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions.

PubMed

Nantha, Yogarabindranath Swarna

2017-11-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy.

3D reconstruction of cystoscopy videos for comprehensive bladder records

PubMed Central

Lurie, Kristen L.; Angst, Roland; Zlatev, Dimitar V.; Liao, Joseph C.; Ellerbee Bowden, Audrey K.

2017-01-01

White light endoscopy is widely used for diagnostic imaging of the interior of organs and body cavities, but the inability to correlate individual 2D images with 3D organ morphology limits its utility for quantitative or longitudinal studies of disease physiology or cancer surveillance. As a result, most endoscopy videos, which carry enormous data potential, are used only for real-time guidance and are discarded after collection. We present a computational method to reconstruct and visualize a 3D model of organs from an endoscopic video that captures the shape and surface appearance of the organ. A key aspect of our strategy is the use of advanced computer vision techniques and unmodified, clinical-grade endoscopy hardware with few constraints on the image acquisition protocol, which presents a low barrier to clinical translation. We validate the accuracy and robustness of our reconstruction and co-registration method using cystoscopy videos from tissue-mimicking bladder phantoms and show clinical utility during cystoscopy in the operating room for bladder cancer evaluation. As our method can powerfully augment the visual medical record of the appearance of internal organs, it is broadly applicable to endoscopy and represents a significant advance in cancer surveillance opportunities for big-data cancer research. PMID:28736658

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

IMPROVING THE REPORTING OF THERAPEUTIC EXERCISE INTERVENTIONS IN REHABILITATION RESEARCH.

PubMed

Page, Phil; Hoogenboom, Barb; Voight, Michael

2017-04-01

The foundation of evidence-based practice lies in clinical research, which is based on the utilization of the scientific method. The scientific method requires that all details of the experiment be provided in publications to support replication of the study in order to evaluate and validate the results. More importantly, clinical research can only be translated into practice when researchers provide explicit details of the study. Too often, rehabilitation exercise intervention studies lack the appropriate detail to allow clinicians to replicate the exercise protocol in their patient populations. Therefore, the purpose of this clinical commentary is to provide guidelines for optimal reporting of therapeutic exercise interventions in rehabilitation research. 5.

A semantic framework to protect the privacy of electronic health records with non-numerical attributes.

PubMed

Martínez, Sergio; Sánchez, David; Valls, Aida

2013-04-01

Structured patient data like Electronic Health Records (EHRs) are a valuable source for clinical research. However, the sensitive nature of such information requires some anonymisation procedure to be applied before releasing the data to third parties. Several studies have shown that the removal of identifying attributes, like the Social Security Number, is not enough to obtain an anonymous data file, since unique combinations of other attributes as for example, rare diagnoses and personalised treatments, may lead to patient's identity disclosure. To tackle this problem, Statistical Disclosure Control (SDC) methods have been proposed to mask sensitive attributes while preserving, up to a certain degree, the utility of anonymised data. Most of these methods focus on continuous-scale numerical data. Considering that part of the clinical data found in EHRs is expressed with non-numerical attributes as for example, diagnoses, symptoms, procedures, etc., their application to EHRs produces far from optimal results. In this paper, we propose a general framework to enable the accurate application of SDC methods to non-numerical clinical data, with a focus on the preservation of semantics. To do so, we exploit structured medical knowledge bases like SNOMED CT to propose semantically-grounded operators to compare, aggregate and sort non-numerical terms. Our framework has been applied to several well-known SDC methods and evaluated using a real clinical dataset with non-numerical attributes. Results show that the exploitation of medical semantics produces anonymised datasets that better preserve the utility of EHRs. Copyright © 2012 Elsevier Inc. All rights reserved.

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

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.

Accurate diagnosis of thyroid follicular lesions from nuclear morphology using supervised learning.

PubMed

Ozolek, John A; Tosun, Akif Burak; Wang, Wei; Chen, Cheng; Kolouri, Soheil; Basu, Saurav; Huang, Hu; Rohde, Gustavo K

2014-07-01

Follicular lesions of the thyroid remain significant diagnostic challenges in surgical pathology and cytology. The diagnosis often requires considerable resources and ancillary tests including immunohistochemistry, molecular studies, and expert consultation. Visual analyses of nuclear morphological features, generally speaking, have not been helpful in distinguishing this group of lesions. Here we describe a method for distinguishing between follicular lesions of the thyroid based on nuclear morphology. The method utilizes an optimal transport-based linear embedding for segmented nuclei, together with an adaptation of existing classification methods. We show the method outputs assignments (classification results) which are near perfectly correlated with the clinical diagnosis of several lesion types' lesions utilizing a database of 94 patients in total. Experimental comparisons also show the new method can significantly outperform standard numerical feature-type methods in terms of agreement with the clinical diagnosis gold standard. In addition, the new method could potentially be used to derive insights into biologically meaningful nuclear morphology differences in these lesions. Our methods could be incorporated into a tool for pathologists to aid in distinguishing between follicular lesions of the thyroid. In addition, these results could potentially provide nuclear morphological correlates of biological behavior and reduce health care costs by decreasing histotechnician and pathologist time and obviating the need for ancillary testing. Copyright © 2014 Elsevier B.V. All rights reserved.

Development of a pioneering clinical support system utilizing information technology.

PubMed

Hayashi, Doubun; Imai, Yasushi; Morita, Hiroyuki; Fujita, Hideo; Monzen, Koshiro; Harada, Tomohiro; Nojiri, Takefumi; Yamazaki, Tadashi; Yamazaki, Tsutomu; Nagai, Ryozo

2004-03-01

Nowadays, evidence-based medicine has entered the mainstream of clinical judgement and the human genome has been completely decoded. Even the concept of individually designed medicine, that is, tailor-made medicine, is now being discussed. Due to their complexity, however, management methods for clinical information have yet to be established. We have conducted a study on a universal technique which enables one to select or produce by employing information processing technology clinical findings from various clinical information generated in vast quantity in day-to-day clinical practice, and to share such information and/or the results of analysis between two or more institutions. In this study, clinically useful findings have been successfully obtained by systematizing actual clinical information and genomic information obtained by an appropriate collecting and management method of information with due consideration to ethical issues. We report here these medical achievements as well as technological ones which will play a role in propagating such medical achievements.

Determination of optimal glycerol concentration for optical tissue clearing

NASA Astrophysics Data System (ADS)

Youn, Eungjun; Son, Taeyoon; Kim, Han-Sung; Jung, Byungjo

2012-02-01

The laser scattering in tissue is significant in diagnostic and therapeutic purposes of laser. Many studies have been conducted to minimize laser scattering in tissue and therefore, to maximize the clinical efficacy by enhancing photon density. Optical clearing agents (OCAs) have been employed for optical tissue clearing (OTC). This study was aimed to investigate the optimal concentration of an OCA, glycerol, in topical application,, so that it can be utilized for clinical diagnosis and therapy in dermatology. Glycerol was topically applied to avoid possible edema caused by dermal injection. The effect of OTC was quantitatively evaluated as a function of the concentration of glycerol with various methods. Optical methods such as optical coherence tomography (OCT) and an integrating sphere were used to assess the enhancement of light penetration depth and refractive index matching. In addition, a non-optical method, ultrasound scanner, was utilized to evaluate quantitatively collagen dissociation. The results revealed that 70 % glycerol was the optimal concentration of OTC for topical application. This study may provide a guideline regarding to the use of glycerol for optimal diagnostic and therapeutic effects in dermatology.

Temporal and social contexts of heroin-using populations. An illustration of the snowball sampling technique.

PubMed

Kaplan, C D; Korf, D; Sterk, C

1987-09-01

Snowball sampling is a method that has been used in the social sciences to study sensitive topics, rare traits, personal networks, and social relationships. The method involves the selection of samples utilizing "insider" knowledge and referral chains among subjects who possess common traits that are of research interest. It is especially useful in generating samples for which clinical sampling frames may be difficult to obtain or are biased in some way. In this paper, snowball samples of heroin users in two Dutch cities have been analyzed for the purpose of providing descriptions and limited inferences about the temporal and social contexts of their lifestyles. Two distinct heroin-using populations have been discovered who are distinguished by their life cycle stage. Significant contextual explanations have been found involving the passage from adolescent peer group to criminal occupation, the functioning of network "knots" and "outcroppings," and the frequency of social contact. It is suggested that the snowball sampling method may have utility in studying the temporal and social contexts of other populations of clinical interest.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed Central

Gadd, C. S.; Baskaran, P.; Lobach, D. F.

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings. Images Figure 1 PMID:9929188

Accuracy and Utility of Estimating Lean Body Mass and Nutritional Status in Patients with Chronic Kidney Disease on Long-Term Hemodialysis Using Anthropometric Skinfold Thickness Measurements.

PubMed

Leong, Khai Gene; Chee, Jia Lian; Karahalios, Amalia; Skelley, Annabelle; Wong, Kim

2018-01-01

Malnutrition is common in patients on hemodialysis (prevalence of 30% to 50%) and is associated with higher mortality. Lean body mass (LBM) assessment is an accurate way of assessing nutritional status. The dual-energy X-ray absorptiometry (DEXA) scan is a reliable method in assessing body compositions and LBM; however, it is expensive and largely inaccessible. Anthropometric skinfold thickness measurement (ASFM) is useful in assessing LBM. It is cheaper and accessible, but underutilized clinically. The subjective global score (SGA) is a well-established method of assessing nutritional status. All three methods of assessing nutritional status were compared. In this pilot observational study, there was a significant correlation between LBM% estimated by DEXA and ASFM (mean difference -1.46% [95% CI -4.09 to 1.18]; LOA -14.0 to 11.1). Nutritional status by SGA could only detect those severely malnourished when using LBM% by ASFM as comparison. Our study demonstrated that ASFM is a useful method of assessing LBM and nutritional status, which can be easily utilized clinically. Copyright© by the American Nephrology Nurses Association.

Relations between Brain Structure and Attentional Function in Spina Bifida: Utilization of Robust Statistical Approaches

PubMed Central

Kulesz, Paulina A.; Tian, Siva; Juranek, Jenifer; Fletcher, Jack M.; Francis, David J.

2015-01-01

Objective Weak structure-function relations for brain and behavior may stem from problems in estimating these relations in small clinical samples with frequently occurring outliers. In the current project, we focused on the utility of using alternative statistics to estimate these relations. Method Fifty-four children with spina bifida meningomyelocele performed attention tasks and received MRI of the brain. Using a bootstrap sampling process, the Pearson product moment correlation was compared with four robust correlations: the percentage bend correlation, the Winsorized correlation, the skipped correlation using the Donoho-Gasko median, and the skipped correlation using the minimum volume ellipsoid estimator Results All methods yielded similar estimates of the relations between measures of brain volume and attention performance. The similarity of estimates across correlation methods suggested that the weak structure-function relations previously found in many studies are not readily attributable to the presence of outlying observations and other factors that violate the assumptions behind the Pearson correlation. Conclusions Given the difficulty of assembling large samples for brain-behavior studies, estimating correlations using multiple, robust methods may enhance the statistical conclusion validity of studies yielding small, but often clinically significant, correlations. PMID:25495830

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

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

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.

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis.

PubMed

Velupillai, S; Mowery, D; South, B R; Kvist, M; Dalianis, H

2015-08-13

We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices.

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.

A comparison of direct and indirect methods for the estimation of health utilities from clinical outcomes.

PubMed

Hernández Alava, Mónica; Wailoo, Allan; Wolfe, Fred; Michaud, Kaleb

2014-10-01

Analysts frequently estimate health state utility values from other outcomes. Utility values like EQ-5D have characteristics that make standard statistical methods inappropriate. We have developed a bespoke, mixture model approach to directly estimate EQ-5D. An indirect method, "response mapping," first estimates the level on each of the 5 dimensions of the EQ-5D and then calculates the expected tariff score. These methods have never previously been compared. We use a large observational database from patients with rheumatoid arthritis (N = 100,398). Direct estimation of UK EQ-5D scores as a function of the Health Assessment Questionnaire (HAQ), pain, and age was performed with a limited dependent variable mixture model. Indirect modeling was undertaken with a set of generalized ordered probit models with expected tariff scores calculated mathematically. Linear regression was reported for comparison purposes. Impact on cost-effectiveness was demonstrated with an existing model. The linear model fits poorly, particularly at the extremes of the distribution. The bespoke mixture model and the indirect approaches improve fit over the entire range of EQ-5D. Mean average error is 10% and 5% lower compared with the linear model, respectively. Root mean squared error is 3% and 2% lower. The mixture model demonstrates superior performance to the indirect method across almost the entire range of pain and HAQ. These lead to differences in cost-effectiveness of up to 20%. There are limited data from patients in the most severe HAQ health states. Modeling of EQ-5D from clinical measures is best performed directly using the bespoke mixture model. This substantially outperforms the indirect method in this example. Linear models are inappropriate, suffer from systematic bias, and generate values outside the feasible range. © The Author(s) 2013.

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

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

[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.

A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations.

PubMed

Stephenson, Megan L; Wing, Deborah A

2015-01-01

Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.

Recent advances in the diagnosis of drug allergy.

PubMed

Primeau, M N; Adkinson, N F

2001-08-01

The diagnosis of immunologic drug reactions is based primarily on a detailed clinical history and historical data on relative immunogenicity of the culprit drugs. Except for a few standardized skin tests, most of the other methods for diagnosing drug allergy have unproven diagnostic or predictive clinical utility. Many tests for drug-specific immune responses are suggestive if positive, but have unknown negative predictive values. The present review addresses the most recent published literature regarding the diagnosis of drug allergy. Recent advances in the use of the lymphocyte transformation test, and delayed intradermal skin tests and patch tests for the diagnosis of delayed cutaneous reactions to penicillins suggest that these tests may have clinical utility, although confirmatory reports are still missing. For the diagnosis of acute vaccine reactions, gelatin-specific IgE as measured by radioallergosorbent test has now been shown to be reliably associated with allergic reactions to gelatin-containing vaccines.

Exploring Occupational Therapists’ Perceptions of the Usefulness of Musculoskeletal Sonography in Upper-Extremity Rehabilitation

PubMed Central

McLaughlin Gray, Julie; Frank, Gelya; Wolkoff, Monique

2015-01-01

OBJECTIVE. To identify the potential utility of musculoskeletal sonographic imaging in upper-extremity rehabilitation. METHOD. Two occupational therapists in an outpatient hand rehabilitation clinic were recruited by convenience, were trained in the use of sonography, and implemented sonographic imaging in their clinical practice. Qualitative data were obtained during and after the implementation period by means of questionnaires and interviews. Data collection, analysis, and interpretation were completed in an iterative process that culminated in a thematic analysis of the therapists’ perceptions. RESULTS. The data indicate four potential areas of utility for musculoskeletal sonography in upper-extremity rehabilitation: (1) mastering anatomy and pathology, (2) augmenting clinical reasoning, (3) supplementing intervention, and (4) building evidence. CONCLUSION. Numerous potential uses were identified that would benefit both therapist and client. Further exploration of complexities and efficacy for increasing patient outcomes is recommended to determine best practices for the use of musculoskeletal sonography in upper-extremity rehabilitation. PMID:26114469

Current status of antifungal susceptibility testing methods.

PubMed

Arikan, Sevtap

2007-11-01

Antifungal susceptibility testing is a very dynamic field of medical mycology. Standardization of in vitro susceptibility tests by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee for Antimicrobial Susceptibility Testing (EUCAST), and current availability of reference methods constituted the major remarkable steps in the field. Based on the established minimum inhibitory concentration (MIC) breakpoints, it is now possible to determine the susceptibilities of Candida strains to fluconazole, itraconazole, voriconazole, and flucytosine. Moreover, utility of fluconazole antifungal susceptibility tests as an adjunct in optimizing treatment of candidiasis has now been validated. While the MIC breakpoints and clinical significance of susceptibility testing for the remaining fungi and antifungal drugs remain yet unclear, modifications of the available methods as well as other methodologies are being intensively studied to overcome the present drawbacks and limitations. Among the other methods under investigation are Etest, colorimetric microdilution, agar dilution, determination of fungicidal activity, flow cytometry, and ergosterol quantitation. Etest offers the advantage of practical application and favorable agreement rates with the reference methods that are frequently above acceptable limits. However, MIC breakpoints for Etest remain to be evaluated and established. Development of commercially available, standardized colorimetric panels that are based on CLSI method parameters has added more to the antifungal susceptibility testing armamentarium. Flow cytometry, on the other hand, appears to offer rapid susceptibility testing but requires specified equipment and further evaluation for reproducibility and standardization. Ergosterol quantitation is another novel approach, which appears potentially beneficial particularly in discrimination of azole-resistant isolates from heavy trailers. The method is yet investigational and requires to be further studied. Developments in methodology and applications of antifungal susceptibility testing will hopefully provide enhanced utility in clinical guidance of antifungal therapy. However, and particularly in immunosuppressed host, in vitro susceptibility is and will remain only one of several factors that influence clinical outcome.

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.

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

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

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.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

PubMed Central

Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

2013-01-01

Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

Clinical and diagnostic utility of saliva as a non-invasive diagnostic fluid:
a systematic review

PubMed Central

Nunes, Lazaro Alessandro Soares; Mussavira, Sayeeda

2015-01-01

This systematic review presents the latest trends in salivary research and its applications in health and disease. Among the large number of analytes present in saliva, many are affected by diverse physiological and pathological conditions. Further, the non-invasive, easy and cost-effective collection methods prompt an interest in evaluating its diagnostic or prognostic utility. Accumulating data over the past two decades indicates towards the possible utility of saliva to monitor overall health, diagnose and treat various oral or systemic disorders and drug monitoring. Advances in saliva based systems biology has also contributed towards identification of several biomarkers, development of diverse salivary diagnostic kits and other sensitive analytical techniques. However, its utilization should be carefully evaluated in relation to standardization of pre-analytical and analytical variables, such as collection and storage methods, analyte circadian variation, sample recovery, prevention of sample contamination and analytical procedures. In spite of all these challenges, there is an escalating evolution of knowledge with the use of this biological matrix. PMID:26110030

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

Milestones: Critical Elements in Clinical Informatics Fellowship Programs

PubMed Central

Lehmann, Christoph U.; Munger, Benson

2016-01-01

Summary Background Milestones refer to points along a continuum of a competency from novice to expert. Resident and fellow assessment and program evaluation processes adopted by the ACGME include the mandate that programs report the educational progress of residents and fellows twice annually utilizing Milestones developed by a specialty specific ACGME working group of experts. Milestones in clinical training programs are largely unmapped to specific assessment tools. Residents and fellows are mainly assessed using locally derived assessment instruments. These assessments are then reviewed by the Clinical Competency Committee which assigns and reports trainee ratings using the specialty specific reporting Milestones. Methods and Results The challenge and opportunity facing the nascent specialty of Clinical Informatics is how to optimally utilize this framework across a growing number of accredited fellowships. The authors review how a mapped milestone framework, in which each required sub-competency is mapped to a single milestone assessment grid, can enable the use of milestones for multiple uses including individualized learning plans, fellow assessments, and program evaluation. Furthermore, such a mapped strategy will foster the ability to compare fellow progress within and between Clinical Informatics Fellowships in a structured and reliable fashion. Clinical Informatics currently has far less variability across programs and thus could easily utilize a more tightly defined set of milestones with a clear mapping to sub-competencies. This approach would enable greater standardization of assessment instruments and processes across programs while allowing for variability in how those sub-competencies are taught. Conclusions A mapped strategy for Milestones offers significant advantages for Clinical Informatics programs. PMID:27081414

Polymyxin B Etest Fails to Distinguish Carbapenem-resistant Enterobacteriaceae with Elevated Polymyxin B MICs

PubMed Central

Kulengowski, Brandon; Brignola, Matthew; Gallagher, Chanah; Rutter, W Cliff; Ribes, Julie A; Burgess, David S

2017-01-01

Abstract Background Polymyxins are being revitalized to combat carbapenem-resistant Enterobacteriaceae (CRE). However, evaluating the activity of these agents by traditional broth dilution methods is not practical for busy clinical laboratories. We compared polymyxin B (PMB) activity utilizing two quantitative susceptibility testing methods, Etest® and broth microdilution (BMD), against CRE isolates from patients at an academic medical center. Methods PMB activity against 70 recent CRE clinical isolates was determined by BMD and Etest® according to CLSI guidelines. P. aeruginosa ATCC® 27853 was used as a quality control strain. The CLSI PMB susceptibility breakpoint of non-fermenting gram-negative bacteria (<2 mg/L) was used. Essential agreement between methods was defined as an MIC measured within 1 log2 dilution. Categorical agreement was defined between methods as classification of isolates in the same susceptibility category (susceptible or resistant). Major and very major error rates were calculated, and McNemar’s test was used for determining a difference between methods. Results CRE isolates were primarily Enterobacter spp. (43%), followed by K. pneumoniae (41%) and E. coli (9%). Essential agreement between testing methods was low (9%), but categorical agreement was 81% (P = 0.0002). Although false non-susceptibility was never observed by Etest® (BMD as reference), the rate of very major errors by Etest® was high (19%). Etest® miscalled 87% of PMB-resistant CRE. Conclusion Etest® reporting of false susceptibility may result in inappropriate antibiotic utilization and treatment failure clinically. We do not recommend using Etest® for PMB susceptibility testing for routine patient care. Disclosures All authors: No reported disclosures.

Optimized multiparametric flow cytometric analysis of circulating endothelial cells and their subpopulations in peripheral blood of patients with solid tumors: a technical analysis.

PubMed

Zhou, Fangbin; Zhou, Yaying; Yang, Ming; Wen, Jinli; Dong, Jun; Tan, Wenyong

2018-01-01

Circulating endothelial cells (CECs) and their subpopulations could be potential novel biomarkers for various malignancies. However, reliable enumerable methods are warranted to further improve their clinical utility. This study aimed to optimize a flow cytometric method (FCM) assay for CECs and subpopulations in peripheral blood for patients with solid cancers. An FCM assay was used to detect and identify CECs. A panel of 60 blood samples, including 44 metastatic cancer patients and 16 healthy controls, were used in this study. Some key issues of CEC enumeration, including sample material and anticoagulant selection, optimal titration of antibodies, lysis/wash procedures of blood sample preparation, conditions of sample storage, sufficient cell events to enhance the signal, fluorescence-minus-one controls instead of isotype controls to reduce background noise, optimal selection of cell surface markers, and evaluating the reproducibility of our method, were integrated and investigated. Wilcoxon and Mann-Whitney U tests were used to determine statistically significant differences. In this validation study, we refined a five-color FCM method to detect CECs and their subpopulations in peripheral blood of patients with solid tumors. Several key technical issues regarding preanalytical elements, FCM data acquisition, and analysis were addressed. Furthermore, we clinically validated the utility of our method. The baseline levels of mature CECs, endothelial progenitor cells, and activated CECs were higher in cancer patients than healthy subjects ( P <0.01). However, there was no significant difference in resting CEC levels between healthy subjects and cancer patients ( P =0.193). We integrated and comprehensively addressed significant technical issues found in previously published assays and validated the reproducibility and sensitivity of our proposed method. Future work is required to explore the potential of our optimized method in clinical oncologic applications.

Longitudinal comparative evaluation of the equivalence of an integrated peer-support and clinical staffing model for residential mental health rehabilitation: a mixed methods protocol incorporating multiple stakeholder perspectives.

PubMed

Parker, Stephen; Dark, Frances; Newman, Ellie; Korman, Nicole; Meurk, Carla; Siskind, Dan; Harris, Meredith

2016-06-02

A novel staffing model integrating peer support workers and clinical staff within a unified team is being trialled at community based residential rehabilitation units in Australia. A mixed-methods protocol for the longitudinal evaluation of the outcomes, expectations and experiences of care by consumers and staff under this staffing model in two units will be compared to one unit operating a traditional clinical staffing. The study is unique with regards to the context, the longitudinal approach and consideration of multiple stakeholder perspectives. The longitudinal mixed methods design integrates a quantitative evaluation of the outcomes of care for consumers at three residential rehabilitation units with an applied qualitative research methodology. The quantitative component utilizes a prospective cohort design to explore whether equivalent outcomes are achieved through engagement at residential rehabilitation units operating integrated and clinical staffing models. Comparative data will be available from the time of admission, discharge and 12-month period post-discharge from the units. Additionally, retrospective data for the 12-month period prior to admission will be utilized to consider changes in functioning pre and post engagement with residential rehabilitation care. The primary outcome will be change in psychosocial functioning, assessed using the total score on the Health of the Nation Outcome Scales (HoNOS). Planned secondary outcomes will include changes in symptomatology, disability, recovery orientation, carer quality of life, emergency department presentations, psychiatric inpatient bed days, and psychological distress and wellbeing. Planned analyses will include: cohort description; hierarchical linear regression modelling of the predictors of change in HoNOS following CCU care; and descriptive comparisons of the costs associated with the two staffing models. The qualitative component utilizes a pragmatic approach to grounded theory, with collection of data from consumers and staff at multiple time points exploring their expectations, experiences and reflections on the care provided by these services. It is expected that the new knowledge gained through this study will guide the adaptation of these and similar services. For example, if differential outcomes are achieved for consumers under the integrated and clinical staffing models this may inform staffing guidelines.

Teaching alternatives to the standard inferior alveolar nerve block in dental education: outcomes in clinical practice.

PubMed

Johnson, Thomas M; Badovinac, Rachel; Shaefer, Jeffry

2007-09-01

Surveys were sent to Harvard School of Dental Medicine students and graduates from the classes of 2000 through 2006 to determine their current primary means of achieving mandibular anesthesia. Orthodontists and orthodontic residents were excluded. All subjects received clinical training in the conventional inferior alveolar nerve block and two alternative techniques (the Akinosi mandibular block and the Gow-Gates mandibular block) during their predoctoral dental education. This study tests the hypothesis that students and graduates who received training in the conventional inferior alveolar nerve block, the Akinosi mandibular block, and the Gow-Gates mandibular block will report more frequent current utilization of alternatives to the conventional inferior alveolar nerve block than clinicians trained in the conventional technique only. At the 95 percent confidence level, we estimated that between 3.7 percent and 16.1 percent (mean=8.5 percent) of clinicians trained in using the Gow-Gates technique use this injection technique primarily, and between 35.4 percent and 56.3 percent (mean=47.5 percent) of those trained in the Gow-Gates method never use this technique. At the same confidence level, between 0.0 percent and 3.8 percent (mean=0.0 percent) of clinicians trained in using the Akinosi technique use this injection clinical technique primarily, and between 62.2 percent and 81.1 percent (mean=72.3 percent) of those trained in the Akinosi method never use this technique. No control group that was completely untrained in the Gow-Gates or Akinosi techniques was available for comparison. However, we presume that zero percent of clinicians who have not been trained in a given technique will use the technique in clinical practice. The confidence interval for the Gow-Gates method excludes this value, while the confidence interval for the Akinosi technique includes zero percent. We conclude that, in the study population, formal clinical training in the Gow-Gates and Akinosi injection techniques lead to a small but significant increase in current primary utilization of the Gow-Gates technique. No significant increase in current primary utilization of the Akinosi technique was found.

Development and validation of a single robust HPLC method for the characterization of a pharmaceutical starting material and impurities from three suppliers using three separate synthetic routes.

PubMed

Sheldon, E M; Downar, J B

2000-08-15

Novel approaches to the development of analytical procedures for monitoring incoming starting material in support of chemical/pharmaceutical processes are described. High technology solutions were utilized for timely process development and preparation of high quality clinical supplies. A single robust HPLC method was developed and characterized for the analysis of the key starting material from three suppliers. Each supplier used a different process for the preparation of this material and, therefore, each suppliers' material exhibited a unique impurity profile. The HPLC method utilized standard techniques acceptable for release testing in a QC/manufacturing environment. An automated experimental design protocol was used to characterize the robustness of the HPLC method. The method was evaluated for linearity, limit of quantitation, solution stability, and precision of replicate injections. An LC-MS method that emulated the release HPLC method was developed and the identities of impurities were mapped between the two methods.

Ten tips for receiving feedback effectively in clinical practice

PubMed Central

Algiraigri, Ali H.

2014-01-01

Background Despite being recognized as a fundamental part of the educational process and emphasized for several decades in medical education, the influence of the feedback process is still suboptimal. This may not be surprising, because the focus is primarily centered on only one half of the process – the teachers. The learners are the targets of the feedback process and improvement needs to be shifted. Learners need to be empowered with the skills needed to receive and utilize feedback and compensate for less than ideal feedback delivery due to the busy clinical environment. Methods Based on the available feedback literature and clinical experience regarding feedback, the author developed 10 tips to empower learners with the necessary skills to seek, receive, and handle feedback effectively, regardless of how it is delivered. Although, most of the tips are directed at the individual clinical trainee, this model can be utilized by clinical educators involved in learner development and serve as a framework for educational workshops or curriculum. Results Ten practical tips are identified that specifically address the learner's role in the feedback process. These tips not only help the learner to ask, receive, and handle the feedback, but will also ease the process for the teachers. Collectively, these tips help to overcome most, if not all, of the barriers to feedback and bridge the gaps in busy clinical practices. Conclusions Feedback is a crucial element in the educational process and it is shown that we are still behind in the optimal use of it; thus, learners need to be taught how to better receive and utilize feedback. The focus in medical education needs to balance the two sides of the feedback process. It is time now to invest on the learner's development of skills that can be utilized in a busy day-to-day clinical practice. PMID:25079664

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.

Malignant central airway obstruction

PubMed Central

Mudambi, Lakshmi; Miller, Russell

2017-01-01

This review comprehensively describes recent advances in the management of malignant central airway obstruction (CAO). Malignant CAO can be a dramatic and devastating manifestation of primary lung cancer or metastatic disease. A variety of diagnostic modalities are available to provide valuable information to plan a therapeutic intervention. Clinical heterogeneity in the presentation of malignant CAO provides opportunities to adapt and utilize endoscopic technology and tools in many ways. Mechanical debulking, thermal tools, cryotherapy and airway stents are methods and instruments used to rapidly restore airway patency. Delayed bronchoscopic methods, such as photodynamic therapy (PDT) and brachytherapy can also be utilized in specific non-emergent situations to establish airway patency. Although data regarding the success and complications of therapeutic interventions are retrospective and characterized by clinical and outcome measure variability, the symptoms of malignant CAO can often be successfully palliated. Assessment of risks and benefits of interventions in each individual patient during the decision-making process forms the critical foundation of the management of malignant CAO. PMID:29214067

Multimethod Investigation of Interpersonal Functioning in Borderline Personality Disorder

PubMed Central

Stepp, Stephanie D.; Hallquist, Michael N.; Morse, Jennifer Q.; Pilkonis, Paul A.

2011-01-01

Even though interpersonal functioning is of great clinical importance for patients with borderline personality disorder (BPD), the comparative validity of different assessment methods for interpersonal dysfunction has not yet been tested. This study examined multiple methods of assessing interpersonal functioning, including self- and other-reports, clinical ratings, electronic diaries, and social cognitions in three groups of psychiatric patients (N=138): patients with (1) BPD, (2) another personality disorder, and (3) Axis I psychopathology only. Using dominance analysis, we examined the predictive validity of each method in detecting changes in symptom distress and social functioning six months later. Across multiple methods, the BPD group often reported higher interpersonal dysfunction scores compared to other groups. Predictive validity results demonstrated that self-report and electronic diary ratings were the most important predictors of distress and social functioning. Our findings suggest that self-report scores and electronic diary ratings have high clinical utility, as these methods appear most sensitive to change. PMID:21808661

Characterization of Change and Significance for Clinical Findings in Radiology Reports Through Natural Language Processing.

PubMed

Hassanpour, Saeed; Bay, Graham; Langlotz, Curtis P

2017-06-01

We built a natural language processing (NLP) method to automatically extract clinical findings in radiology reports and characterize their level of change and significance according to a radiology-specific information model. We utilized a combination of machine learning and rule-based approaches for this purpose. Our method is unique in capturing different features and levels of abstractions at surface, entity, and discourse levels in text analysis. This combination has enabled us to recognize the underlying semantics of radiology report narratives for this task. We evaluated our method on radiology reports from four major healthcare organizations. Our evaluation showed the efficacy of our method in highlighting important changes (accuracy 99.2%, precision 96.3%, recall 93.5%, and F1 score 94.7%) and identifying significant observations (accuracy 75.8%, precision 75.2%, recall 75.7%, and F1 score 75.3%) to characterize radiology reports. This method can help clinicians quickly understand the key observations in radiology reports and facilitate clinical decision support, review prioritization, and disease surveillance.

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

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

Compass: a hybrid method for clinical and biobank data mining.

PubMed

Krysiak-Baltyn, K; Nordahl Petersen, T; Audouze, K; Jørgensen, Niels; Angquist, L; Brunak, S

2014-02-01

We describe a new method for identification of confident associations within large clinical data sets. The method is a hybrid of two existing methods; Self-Organizing Maps and Association Mining. We utilize Self-Organizing Maps as the initial step to reduce the search space, and then apply Association Mining in order to find association rules. We demonstrate that this procedure has a number of advantages compared to traditional Association Mining; it allows for handling numerical variables without a priori binning and is able to generate variable groups which act as "hotspots" for statistically significant associations. We showcase the method on infertility-related data from Danish military conscripts. The clinical data we analyzed contained both categorical type questionnaire data and continuous variables generated from biological measurements, including missing values. From this data set, we successfully generated a number of interesting association rules, which relate an observation with a specific consequence and the p-value for that finding. Additionally, we demonstrate that the method can be used on non-clinical data containing chemical-disease associations in order to find associations between different phenotypes, such as prostate cancer and breast cancer. Copyright © 2013 Elsevier Inc. All rights reserved.

Multicenter Comparison of Machine Learning Methods and Conventional Regression for Predicting Clinical Deterioration on the Wards.

PubMed

Churpek, Matthew M; Yuen, Trevor C; Winslow, Christopher; Meltzer, David O; Kattan, Michael W; Edelson, Dana P

2016-02-01

Machine learning methods are flexible prediction algorithms that may be more accurate than conventional regression. We compared the accuracy of different techniques for detecting clinical deterioration on the wards in a large, multicenter database. Observational cohort study. Five hospitals, from November 2008 until January 2013. Hospitalized ward patients None Demographic variables, laboratory values, and vital signs were utilized in a discrete-time survival analysis framework to predict the combined outcome of cardiac arrest, intensive care unit transfer, or death. Two logistic regression models (one using linear predictor terms and a second utilizing restricted cubic splines) were compared to several different machine learning methods. The models were derived in the first 60% of the data by date and then validated in the next 40%. For model derivation, each event time window was matched to a non-event window. All models were compared to each other and to the Modified Early Warning score, a commonly cited early warning score, using the area under the receiver operating characteristic curve (AUC). A total of 269,999 patients were admitted, and 424 cardiac arrests, 13,188 intensive care unit transfers, and 2,840 deaths occurred in the study. In the validation dataset, the random forest model was the most accurate model (AUC, 0.80 [95% CI, 0.80-0.80]). The logistic regression model with spline predictors was more accurate than the model utilizing linear predictors (AUC, 0.77 vs 0.74; p < 0.01), and all models were more accurate than the MEWS (AUC, 0.70 [95% CI, 0.70-0.70]). In this multicenter study, we found that several machine learning methods more accurately predicted clinical deterioration than logistic regression. Use of detection algorithms derived from these techniques may result in improved identification of critically ill patients on the wards.

Should "standard gamble" and "'time trade off" utility measurement be used more in mental health research?

PubMed

Flood, Chris

2010-06-01

This review and discussion paper demonstrates that utility and preference measurement in mental health research is increasing. However there is still a general reluctance around using the methods due to methodological challenges and concerns around the capacity of users to understand utility methods during the research process. This paper sets out to describe and review some of the previously documented difficulties of using utility measurements in mental health services research and to highlight where they have been used successfully as measures. Additionally the paper aims to discuss a means of improving the methods used to capture service user utility and preference measurement and why decision making would be better informed as a result. International literature on utility measurement is reviewed, specifically examining the use of standard gamble and time trade off methods in mental health. Utility measurement in mental health is increasing though as the review demonstrates, concerns still exist over its application. A number of methods can be used to improve the approach overall and these are discussed as well as specific areas worthy of utility measurement including 'disutility' of admission, medication and medication side effects. Overall this paper argues that it is necessary to persist with efforts to conduct utility measurement calculation albeit with a critical eye on the methods in an attempt to ensure improvements are continually made. Utility and preference scores may be limited in that they only provide a rough score but they are defended as a means of providing some form of strength of preference for health states. The review is limited to English only texts. The debate on whether to use standard gamble and time trade off has implications for health services resource allocations, decision making, health economics research, policy making and health services research generally involving psychiatric service users. The paper argues that the absence of utility measurement in mental health runs the risk of mental health being disadvantaged in decisions around resource allocation. Institutions involved in decision making like the United Kingdom's National Institute for Health and Clinical Excellence, would be better served in their decision making and calculation of Quality Adjusted Life Years if more utility measurement in psychiatric research was carried out. Other arguments for using utility measurement include the desirability of using utility measurement to elicit a patient dimension of risk. Future utility research should aim for better involvement of service users in the design stage, the changing of time frames offered to users in health state scenarios used, a greater need for comparative work of utilities scoring across illness and between standard gamble and time trade off and more staff training in the use of utility methodology with mental health service users.

Molecular Diagnosis and Biomarker Identification on SELDI proteomics data by ADTBoost method.

PubMed

Wang, Lu-Yong; Chakraborty, Amit; Comaniciu, Dorin

2005-01-01

Clinical proteomics is an emerging field that will have great impact on molecular diagnosis, identification of disease biomarkers, drug discovery and clinical trials in the post-genomic era. Protein profiling in tissues and fluids in disease and pathological control and other proteomics techniques will play an important role in molecular diagnosis with therapeutics and personalized healthcare. We introduced a new robust diagnostic method based on ADTboost algorithm, a novel algorithm in proteomics data analysis to improve classification accuracy. It generates classification rules, which are often smaller and easier to interpret. This method often gives most discriminative features, which can be utilized as biomarkers for diagnostic purpose. Also, it has a nice feature of providing a measure of prediction confidence. We carried out this method in amyotrophic lateral sclerosis (ALS) disease data acquired by surface enhanced laser-desorption/ionization-time-of-flight mass spectrometry (SELDI-TOF MS) experiments. Our method is shown to have outstanding prediction capacity through the cross-validation, ROC analysis results and comparative study. Our molecular diagnosis method provides an efficient way to distinguish ALS disease from neurological controls. The results are expressed in a simple and straightforward alternating decision tree format or conditional format. We identified most discriminative peaks in proteomic data, which can be utilized as biomarkers for diagnosis. It will have broad application in molecular diagnosis through proteomics data analysis and personalized medicine in this post-genomic era.

The value of vital sign trends for detecting clinical deterioration on the wards

PubMed Central

Churpek, Matthew M; Adhikari, Richa; Edelson, Dana P

2016-01-01

Aim Early detection of clinical deterioration on the wards may improve outcomes, and most early warning scores only utilize a patient’s current vital signs. The added value of vital sign trends over time is poorly characterized. We investigated whether adding trends improves accuracy and which methods are optimal for modelling trends. Methods Patients admitted to five hospitals over a five-year period were included in this observational cohort study, with 60% of the data used for model derivation and 40% for validation. Vital signs were utilized to predict the combined outcome of cardiac arrest, intensive care unit transfer, and death. The accuracy of models utilizing both the current value and different trend methods were compared using the area under the receiver operating characteristic curve (AUC). Results A total of 269,999 patient admissions were included, which resulted in 16,452 outcomes. Overall, trends increased accuracy compared to a model containing only current vital signs (AUC 0.78 vs. 0.74; p<0.001). The methods that resulted in the greatest average increase in accuracy were the vital sign slope (AUC improvement 0.013) and minimum value (AUC improvement 0.012), while the change from the previous value resulted in an average worsening of the AUC (change in AUC −0.002). The AUC increased most for systolic blood pressure when trends were added (AUC improvement 0.05). Conclusion Vital sign trends increased the accuracy of models designed to detect critical illness on the wards. Our findings have important implications for clinicians at the bedside and for the development of early warning scores. PMID:26898412

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.

Assessing the clinical utility of agoraphobia in the context of panic disorder.

PubMed

Schmidt, Norman B; Cromer, Kiara R

2008-01-01

In the DSM-IV, a panic disorder (PD) diagnosis includes specification of agoraphobia, which is primarily an index of situational avoidance due to fear of panic. No other anxiety diagnosis requires specification of level of avoidance. This raises the question as to whether agoraphobia provides unique information beyond the core features of PD (i.e., panic attacks and panic-related worry). The incremental validity of agoraphobia, defined using DSM-IV specifiers versus level of situational avoidance, was examined in relation to the expression and treatment of PD (N=146). Analyses indicate that agoraphobia status adds uniquely to the prediction of PD symptoms, impairment, and response to treatment. However, level of situational avoidance, defined either as a continuous or dichotomous variable, appears to have greater utility compared to the DSM-IV method of classifying agoraphobia. In summary, the agoraphobia specifier seems to have clinical utility but this could be improved by focusing on a dimensional assessment of situational avoidance.

Rapid extraction from and direct identification in clinical samples of methicillin-resistant staphylococci using the PCR.

PubMed

Jaffe, R I; Lane, J D; Albury, S V; Niemeyer, D M

2000-09-01

Methicillin-resistant staphylococci (MRS) are one of the most common causes of nosocomial infections and bacteremia. Standard bacterial identification and susceptibility testing frequently require as long as 72 h to report results, and there may be difficulty in rapidly and accurately identifying methicillin resistance. The use of the PCR is a rapid and simple process for the amplification of target DNA sequences, which can be used to identify and test bacteria for antimicrobial resistance. However, many sample preparation methods are unsuitable for PCR utilization in the clinical laboratory because they either are not cost-effective, take too long to perform, or do not provide a satisfactory DNA template for PCR. Our goal was to provide same-day results to facilitate rapid diagnosis and therapy. In this report, we describe a rapid method for extraction of bacterial DNA directly from blood culture bottles that gave quality DNA for PCR in as little as 20 min. We compared this extraction method to the standard QIAGEN method for turnaround time (TAT), cost, purity, and use of template in PCR. Specific identification of MRS was determined using intragenic primer sets for bacterial and Staphylococcus 16S rRNA and mecA gene sequences. The PCR primer sets were validated with 416 isolates of staphylococci, including methicillin-resistant Staphylococcus aureus (n = 106), methicillin-sensitive S. aureus (n = 134), and coagulase-negative Staphylococcus (n = 176). The total supply cost of our extraction method and PCR was $2.15 per sample with a result TAT of less than 4 h. The methods described herein represent a rapid and accurate DNA extraction and PCR-based identification system, which makes the system an ideal candidate for use under austere field conditions and one that may have utility in the clinical laboratory.

A Review of the Oncology Patient's Challenges for Utilizing Fertility Preservation Services

PubMed Central

Flink, Dina M.; Sheeder, Jeanelle

2017-01-01

Purpose: The American Society of Clinical Oncology issued practice guidelines in 2006 to provide critical information about fertility impact to adolescents and young adults (AYA) at the time of cancer diagnosis. Survivors continue to express concerns about their long-term reproductive health after cancer therapy even as treatment options for fertility preservation evolve. An underutilization of fertility preservation methods by cancer patients continues to persist. A review of the literature cites barriers and challenges that limit fertility information and preservation options for AYA cancer patients. Methods: A review of medical literature was conducted to examine current practice for patients receiving fertility information and the barriers to patients receiving fertility preservation services. Results: A total of 69 publications were included in this review. The review summarizes (1) patient experiences with receiving fertility information and (2) patient desires, barriers, and challenges to utilizing fertility preservation services. Conclusions: Despite advances in fertility preservation, there are challenges for patients to utilizing fertility preservation services. Barriers include the following: urgency to initiate treatment, inadequate information, clinic time constraints, and perceptions around patients' gender, age, cost, parity, race, relationship, and sociodemographic status influence whether patients receive fertility preservation consultation. Patients report a lack of adequate information to make informed fertility decisions. PMID:27529573

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

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.

Translational bioinformatics in the era of real-time biomedical, health care and wellness data streams

PubMed Central

Miotto, Riccardo; Glicksberg, Benjamin S.; Morgan, Joseph W.; Dudley, Joel T.

2017-01-01

Monitoring and modeling biomedical, health care and wellness data from individuals and converging data on a population scale have tremendous potential to improve understanding of the transition to the healthy state of human physiology to disease setting. Wellness monitoring devices and companion software applications capable of generating alerts and sharing data with health care providers or social networks are now available. The accessibility and clinical utility of such data for disease or wellness research are currently limited. Designing methods for streaming data capture, real-time data aggregation, machine learning, predictive analytics and visualization solutions to integrate wellness or health monitoring data elements with the electronic medical records (EMRs) maintained by health care providers permits better utilization. Integration of population-scale biomedical, health care and wellness data would help to stratify patients for active health management and to understand clinically asymptomatic patients and underlying illness trajectories. In this article, we discuss various health-monitoring devices, their ability to capture the unique state of health represented in a patient and their application in individualized diagnostics, prognosis, clinical or wellness intervention. We also discuss examples of translational bioinformatics approaches to integrating patient-generated data with existing EMRs, personal health records, patient portals and clinical data repositories. Briefly, translational bioinformatics methods, tools and resources are at the center of these advances in implementing real-time biomedical and health care analytics in the clinical setting. Furthermore, these advances are poised to play a significant role in clinical decision-making and implementation of data-driven medicine and wellness care. PMID:26876889

Blood Pressure Measurement: Clinic, Home, Ambulatory, and Beyond

PubMed Central

Drawz, Paul E.; Abdalla, Mohamed; Rahman, Mahboob

2014-01-01

Blood pressure has traditionally been measured in the clinic setting using the auscultory method and a mercury sphygmomanometer. Technological advances have led to improvements in measuring clinic blood pressure and allowed for measuring blood pressures outside the clinic. This review outlines various methods for evaluating blood pressure and the clinical utility of each type of measurement. Home blood pressures and 24 hour ambulatory blood pressures have improved our ability to evaluate risk for target organ damage and hypertension related morbidity and mortality. Measuring home blood pressures may lead to more active participation in health care by patients and has the potential to improve blood pressure control. Ambulatory blood pressure monitoring enables the measuring nighttime blood pressures and diurnal changes, which may be the most accurate predictors of risk associated with elevated blood pressure. Additionally, reducing nighttime blood pressure is feasible and may be an important component of effective antihypertensive therapy. Finally, estimating central aortic pressures and pulse wave velocity are two of the newer methods for assessing blood pressure and hypertension related target organ damage. PMID:22521624

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.

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.

Patient-specific parameter estimation in single-ventricle lumped circulation models under uncertainty

PubMed Central

Schiavazzi, Daniele E.; Baretta, Alessia; Pennati, Giancarlo; Hsia, Tain-Yen; Marsden, Alison L.

2017-01-01

Summary Computational models of cardiovascular physiology can inform clinical decision-making, providing a physically consistent framework to assess vascular pressures and flow distributions, and aiding in treatment planning. In particular, lumped parameter network (LPN) models that make an analogy to electrical circuits offer a fast and surprisingly realistic method to reproduce the circulatory physiology. The complexity of LPN models can vary significantly to account, for example, for cardiac and valve function, respiration, autoregulation, and time-dependent hemodynamics. More complex models provide insight into detailed physiological mechanisms, but their utility is maximized if one can quickly identify patient specific parameters. The clinical utility of LPN models with many parameters will be greatly enhanced by automated parameter identification, particularly if parameter tuning can match non-invasively obtained clinical data. We present a framework for automated tuning of 0D lumped model parameters to match clinical data. We demonstrate the utility of this framework through application to single ventricle pediatric patients with Norwood physiology. Through a combination of local identifiability, Bayesian estimation and maximum a posteriori simplex optimization, we show the ability to automatically determine physiologically consistent point estimates of the parameters and to quantify uncertainty induced by errors and assumptions in the collected clinical data. We show that multi-level estimation, that is, updating the parameter prior information through sub-model analysis, can lead to a significant reduction in the parameter marginal posterior variance. We first consider virtual patient conditions, with clinical targets generated through model solutions, and second application to a cohort of four single-ventricle patients with Norwood physiology. PMID:27155892

Evaluation of infectious diseases and clinical microbiology specialists' preferences for hand hygiene: analysis using the multi-attribute utility theory and the analytic hierarchy process methods.

PubMed

Suner, Aslı; Oruc, Ozlem Ege; Buke, Cagri; Ozkaya, Hacer Deniz; Kitapcioglu, Gul

2017-08-31

Hand hygiene is one of the most effective attempts to control nosocomial infections, and it is an important measure to avoid the transmission of pathogens. However, the compliance of healthcare workers (HCWs) with hand washing is still poor worldwide. Herein, we aimed to determine the best hand hygiene preference of the infectious diseases and clinical microbiology (IDCM) specialists to prevent transmission of microorganisms from one patient to another. Expert opinions regarding the criteria that influence the best hand hygiene preference were collected through a questionnaire via face-to-face interviews. Afterwards, these opinions were examined with two widely used multi-criteria decision analysis (MCDA) methods, the Multi-Attribute Utility Theory (MAUT) and the Analytic Hierarchy Process (AHP). A total of 15 IDCM specialist opinions were collected from diverse private and public hospitals located in İzmir, Turkey. The mean age of the participants was 49.73 ± 8.46, and the mean experience year of the participants in their fields was 17.67 ± 11.98. The findings that we obtained through two distinct decision making methods, the MAUT and the AHP, suggest that alcohol-based antiseptic solution (ABAS) has the highest utility (0.86) and priority (0.69) among the experts' choices. In conclusion, the MAUT and the AHP, decision models developed here indicate that rubbing the hands with ABAS is the most favorable choice for IDCM specialists to prevent nosocomial infection.

Electronic-nose devices - Potential for noninvasive early disease-detection applications

Treesearch

Alphus Dan Wilson

2017-01-01

Significant progress in the development of portable electronic devices is showing considerable promise to facilitate clinical diagnostic processes. The increasing global trend of shifts in healthcare policies and priorities toward shortening and improving the effectiveness of diagnostic procedures by utilizing non-invasive methods should provide multiple benefits of...

Cognitive-Behavioral Treatment of Depressed Affect among Epileptics: Preliminary Findings.

ERIC Educational Resources Information Center

Davis, Gay R.; And Others

1984-01-01

Evaluated a program where cognitive-behavioral methods were utilized in a structured learning format with clinically depressed epileptics (N=13). Results indicated that cognitive behavioral interventions result in significant decreases in depression and increases in related areas of psychosocial functioning that are maintained over time. (LLL)

An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder

ERIC Educational Resources Information Center

Algorta, Guillermo Perez; Youngstrom, Eric A.; Phelps, James; Jenkins, Melissa M.; Youngstrom, Jennifer Kogos; Findling, Robert L.

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient…

Advocacy and Institutional Racism.

ERIC Educational Resources Information Center

Brophy, Michael C.; And Others

The purpose of this paper is to provide a perspective on advocacy and advocate counseling for participants in the University of Maryland Sixth Annual Community-Clinical Workshop, 1976. It attempts to define relevant terms and outline a method of self-advocacy which can, if utilized properly, lessen the impact of institutional racism. The terms,…

Network-Centric Data Mining for Medical Applications

ERIC Educational Resources Information Center

Davis, Darcy A.

2012-01-01

Faced with unsustainable costs and enormous amounts of under-utilized data, health care needs more efficient practices, research, and tools to harness the benefits of data. These methods create a feedback loop where computational tools guide and facilitate research, leading to improved biological knowledge and clinical standards, which will in…

Experimental Evaluation of the Training Structure of the Picture Exchange Communication System (PECS)

ERIC Educational Resources Information Center

Cummings, Anne R.; Carr, James E.; LeBlanc, Linda A.

2012-01-01

The Picture Exchange Communication System (PECS) is a picture-based alternative communication method that is widely accepted and utilized with individuals with disabilities. Although prior studies have examined the clinical efficacy of PECS, none have experimentally evaluated its manualized training structure. We experimentally evaluated the…

Teledynamic Evaluation of Oropharyngeal Swallowing

ERIC Educational Resources Information Center

Malandraki, Georgia A.; McCullough, Gary; He, Xuming; McWeeny, Elizabeth; Perlman, Adrienne L.

2011-01-01

Purpose: The objective of the present investigation was to test the feasibility and clinical utility of a real-time Internet-based protocol for remote, telefluoroscopic evaluation of oropharyngeal swallowing. Method: In this prospective cohort study, the authors evaluated 32 patients with a primary diagnosis of stroke or head/neck cancer. All…

Complexity Measures in Magnetoencephalography: Measuring "Disorder" in Schizophrenia

PubMed Central

Brookes, Matthew J.; Hall, Emma L.; Robson, Siân E.; Price, Darren; Palaniyappan, Lena; Liddle, Elizabeth B.; Liddle, Peter F.; Robinson, Stephen E.; Morris, Peter G.

2015-01-01

This paper details a methodology which, when applied to magnetoencephalography (MEG) data, is capable of measuring the spatio-temporal dynamics of ‘disorder’ in the human brain. Our method, which is based upon signal entropy, shows that spatially separate brain regions (or networks) generate temporally independent entropy time-courses. These time-courses are modulated by cognitive tasks, with an increase in local neural processing characterised by localised and transient increases in entropy in the neural signal. We explore the relationship between entropy and the more established time-frequency decomposition methods, which elucidate the temporal evolution of neural oscillations. We observe a direct but complex relationship between entropy and oscillatory amplitude, which suggests that these metrics are complementary. Finally, we provide a demonstration of the clinical utility of our method, using it to shed light on aberrant neurophysiological processing in schizophrenia. We demonstrate significantly increased task induced entropy change in patients (compared to controls) in multiple brain regions, including a cingulo-insula network, bilateral insula cortices and a right fronto-parietal network. These findings demonstrate potential clinical utility for our method and support a recent hypothesis that schizophrenia can be characterised by abnormalities in the salience network (a well characterised distributed network comprising bilateral insula and cingulate cortices). PMID:25886553

An algorithm for management of deep brain stimulation battery replacements: devising a web-based battery estimator and clinical symptom approach.

PubMed

Montuno, Michael A; Kohner, Andrew B; Foote, Kelly D; Okun, Michael S

2013-01-01

Deep brain stimulation (DBS) is an effective technique that has been utilized to treat advanced and medication-refractory movement and psychiatric disorders. In order to avoid implanted pulse generator (IPG) failure and consequent adverse symptoms, a better understanding of IPG battery longevity and management is necessary. Existing methods for battery estimation lack the specificity required for clinical incorporation. Technical challenges prevent higher accuracy longevity estimations, and a better approach to managing end of DBS battery life is needed. The literature was reviewed and DBS battery estimators were constructed by the authors and made available on the web at http://mdc.mbi.ufl.edu/surgery/dbs-battery-estimator. A clinical algorithm for management of DBS battery life was constructed. The algorithm takes into account battery estimations and clinical symptoms. Existing methods of DBS battery life estimation utilize an interpolation of averaged current drains to calculate how long a battery will last. Unfortunately, this technique can only provide general approximations. There are inherent errors in this technique, and these errors compound with each iteration of the battery estimation. Some of these errors cannot be accounted for in the estimation process, and some of the errors stem from device variation, battery voltage dependence, battery usage, battery chemistry, impedance fluctuations, interpolation error, usage patterns, and self-discharge. We present web-based battery estimators along with an algorithm for clinical management. We discuss the perils of using a battery estimator without taking into account the clinical picture. Future work will be needed to provide more reliable management of implanted device batteries; however, implementation of a clinical algorithm that accounts for both estimated battery life and for patient symptoms should improve the care of DBS patients. © 2012 International Neuromodulation Society.

Evaluation of direct-to-consumer low-volume lab tests in healthy adults

PubMed Central

Kidd, Brian A.; Hoffman, Gabriel; Zimmerman, Noah; Li, Li; Morgan, Joseph W.; Glowe, Patricia K.; Botwin, Gregory J.; Parekh, Samir; Babic, Nikolina; Doust, Matthew W.; Stock, Gregory B.; Schadt, Eric E.; Dudley, Joel T.

2016-01-01

BACKGROUND. Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services. METHODS. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services. RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001). Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results. CONCLUSION. While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management. FUNDING. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt). PMID:27018593

Mapping the functional assessment of cancer therapy-breast (FACT-B) to the 5-level EuroQoL Group's 5-dimension questionnaire (EQ-5D-5L) utility index in a multi-ethnic Asian population.

PubMed

Cheung, Yin Bun; Luo, Nan; Ng, Raymond; Lee, Chun Fan

2014-12-12

To develop an algorithm for mapping the Functional Assessment of Cancer Therapy-Breast (FACT-B) to the 5-level EuroQoL Group's 5-dimension questionnaire (EQ-5D-5L) utility index. A survey of 238 breast cancer patients in Singapore was conducted. Models using various regression methods with or without recognizing the upper boundary of utility values at 1 were fitted to predict the EQ-5D-5L utility index based on the five subscale scores of the FACT-B. Data from a follow-up survey of these patients were used to validate the results. A model that maps the physical, emotional, functional well-being and the breast cancer concerns subscales of the FACT-B to the EQ-5D-5L utility index was derived. The social well-being subscale was not associated to the utility index. Although theoretical assumptions may not be valid, ordinary least square outperformed other regression methods. The mean predicted utility index within each performance status level at follow-up deviated from the observed mean less than the minimally important difference of EQ-5D for cancer patients. The mapping algorithm converts the FACT-B to the EQ-5D utility index. This enables oncologists, clinical researchers and policy makers to obtain a quantitative utility summary of a patient's health status when only the FACT-B is assessed.

Relations between volumetric measures of brain structure and attentional function in spina bifida: utilization of robust statistical approaches.

PubMed

Kulesz, Paulina A; Tian, Siva; Juranek, Jenifer; Fletcher, Jack M; Francis, David J

2015-03-01

Weak structure-function relations for brain and behavior may stem from problems in estimating these relations in small clinical samples with frequently occurring outliers. In the current project, we focused on the utility of using alternative statistics to estimate these relations. Fifty-four children with spina bifida meningomyelocele performed attention tasks and received MRI of the brain. Using a bootstrap sampling process, the Pearson product-moment correlation was compared with 4 robust correlations: the percentage bend correlation, the Winsorized correlation, the skipped correlation using the Donoho-Gasko median, and the skipped correlation using the minimum volume ellipsoid estimator. All methods yielded similar estimates of the relations between measures of brain volume and attention performance. The similarity of estimates across correlation methods suggested that the weak structure-function relations previously found in many studies are not readily attributable to the presence of outlying observations and other factors that violate the assumptions behind the Pearson correlation. Given the difficulty of assembling large samples for brain-behavior studies, estimating correlations using multiple, robust methods may enhance the statistical conclusion validity of studies yielding small, but often clinically significant, correlations. PsycINFO Database Record (c) 2015 APA, all rights reserved.

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

A generic minimization random allocation and blinding system on web.

PubMed

Cai, Hongwei; Xia, Jielai; Xu, Dezhong; Gao, Donghuai; Yan, Yongping

2006-12-01

Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

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

Cardio-Vascular Disease and Cancer

PubMed Central

Mitchell-Fearon, K.; Willie-Tyndale, D.; Waldron, N.; Holder-Nevins, D.; James, K.; Laws, H.; Eldemire-Shearer, D.

2015-01-01

Objective: To report the level of utilization of clinical preventive services by older adults in Jamaica and to identify independent factors associated with utilization. Method: A nationally representative, community-based survey of 2,943 older adults was undertaken. Utilization frequency for six preventive, cardiovascular or cancer-related services was calculated. Logistic regression models were used to determine the independent factors associated with each service. Results: A dichotomy in annual utilization rates exists with cardiovascular services having much higher uptake than those for cancer (83.1% for blood pressure, 76.7% blood glucose, 68.1% cholesterol, 35.1% prostate, 11.3% mammograms, and 9.6% papanicolaou smears). Age, source of routine care, and having a chronic disease were most frequently associated with uptake. Discussion: Education of providers and patients on the need for utilizing preventive services in older adults is important. Improved access to services in the public sector may also help increase uptake of services. PMID:28138475

A Conceptual and Empirical Review of the Meaning, Measurement, Development, and Teaching of Intervention Competence in Clinical Psychology

PubMed Central

Barber, Jacques P.

2009-01-01

Through the course of this paper we discuss several fundamental issues related to the intervention competence of psychologists. Following definitional clarification and proposals for more strictly distinguishing competence from adherence, we interpret Dreyfus and Dreyfus’s (1986) five stage theory of competence development (from novice to expert) within a strictly clinical framework. Existing methods of competence assessment are then evaluated, and we argue for the use of new and multiple assessment modalities. Next, we utilize the previous sections as a foundation to propose methods for training and evaluating competent psychologists. Lastly, we discuss several potential impediments to large scale competence assessment and education, such as the heterogeneity of therapeutic orientations and what could be termed a lack of transparency in clinical training. PMID:18952334

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

Early Effects of a ‘Train the Trainer’ Approach to Ponseti Method Dissemination: A Case Study of Sri Lanka

PubMed Central

Jayawardena, Asitha; Wijayasinghe, Sunil R.; Tennakoon, Dimuthu; Cook, Thomas; Morcuende, Jose A.

2013-01-01

Background The Ponseti method has been established as the standard of care for the treatment of clubfoot in many developed countries for its utility, cost-effectiveness, and efficiency. However, despite its being described as the gold-standard for clubfoot treatment, there are still many areas of the world bereft in formal training in the Ponseti method. This is especially important since 80% of patients with clubfoot are born in developing countries where the need is the greater for experienced providers. This study analyzes a ‘Train the Trainer’ approach, specifically in the island nation of SriLanka, as a model for future dissemination of the Ponseti method throughout the developing world. Methods A rapid ethnographic study design that included interviews, focus groups, and direct observation of 162 patients and healthcare practitioners directly involved with clubfoot care was conducted. Results The average age of the patients at the time of the interview was 75.4 weeks old (SD = 149.2), traveled 45.2 kilometers (SD = 49.8) to receive their care, and received 4 casts (SD = 2.2) for correction of the deformity. Since the initiation of the ‘Train the Trainer’ educational program, clubfoot clinics reportedly grew from 6-7 patients per week to over 60 patients per week. The majority of this patient population growth was attributed to word of mouth. Major barriers to the method included casting materials, bracing materials, and a lack of a dedicated area of the clinic to conduct tenotomies under local anesthesia. Of note, cost was not cited as a major barrier. Conclusion Early evaluation suggests great utility of the ‘Train the Trainer’ method – especially regarding an increased patient demand for treatment. However, further studies are necessary to understand the long-term utility of this training methodology. PMID:24027476

Management of convulsive status epilepticus in children: an adapted clinical practice guideline for pediatricians in Saudi Arabia

PubMed Central

Bashiri, Fahad A.; Hamad, Muddathir H.; Amer, Yasser S.; Abouelkheir, Manal M.; Mohamed, Sarar; Kentab, Amal Y.; Salih, Mustafa A.; Nasser, Mohammad N. Al; Al-Eyadhy, Ayman A.; Othman, Mohammed A. Al; Al-Ahmadi, Tahani; Iqbal, Shaikh M.; Somily, Ali M.; Wahabi, Hayfaa A.; Hundallah, Khalid J.; Alwadei, Ali H.; Albaradie, Raidah S.; Al-Twaijri, Waleed A.; Jan, Mohammed M.; Al-Otaibi, Faisal; Alnemri, Abdulrahman M.; Al-Ansary, Lubna A.

2017-01-01

Objective: To increase the use of evidence-based approaches in the diagnosis, investigations and treatment of Convulsive Status Epilepticus (CSE) in children in relevant care settings. Method: A Clinical Practice Guideline (CPG) adaptation group was formulated at a university hospital in Riyadh. The group utilized 2 CPG validated tools including the ADAPTE method and the AGREE II instrument. Results: The group adapted 3 main categories of recommendations from one Source CPG. The recommendations cover; (i)first-line treatment of CSE in the community; (ii)treatment of CSE in the hospital; and (iii)refractory CSE. Implementation tools were built to enhance knowledge translation of these recommendations including a clinical algorithm, audit criteria, and a computerized provider order entry. Conclusion: A clinical practice guideline for the Saudi healthcare context was formulated using a guideline adaptation process to support relevant clinicians managing CSE in children. PMID:28416791

Improving the clinical assessment of consciousness with advances in electrophysiological and neuroimaging techniques

PubMed Central

2010-01-01

In clinical neurology, a comprehensive understanding of consciousness has been regarded as an abstract concept - best left to philosophers. However, times are changing and the need to clinically assess consciousness is increasingly becoming a real-world, practical challenge. Current methods for evaluating altered levels of consciousness are highly reliant on either behavioural measures or anatomical imaging. While these methods have some utility, estimates of misdiagnosis are worrisome (as high as 43%) - clearly this is a major clinical problem. The solution must involve objective, physiologically based measures that do not rely on behaviour. This paper reviews recent advances in physiologically based measures that enable better evaluation of consciousness states (coma, vegetative state, minimally conscious state, and locked in syndrome). Based on the evidence to-date, electroencephalographic and neuroimaging based assessments of consciousness provide valuable information for evaluation of residual function, formation of differential diagnoses, and estimation of prognosis. PMID:20113490

High fidelity simulation effectiveness in nursing students' transfer of learning.

PubMed

Kirkman, Tera R

2013-07-13

Members of nursing faculty are utilizing interactive teaching tools to improve nursing student's clinical judgment; one method that has been found to be potentially effective is high fidelity simulation (HFS). The purpose of this time series design study was to determine whether undergraduate nursing students were able to transfer knowledge and skills learned from classroom lecture and a HFS clinical to the traditional clinical setting. Students (n=42) were observed and rated on their ability to perform a respiratory assessment. The observations and ratings took place at the bedside, prior to a respiratory lecture, following the respiratory lecture, and following simulation clinical. The findings indicated that there was a significant difference (p=0.000) in transfer of learning demonstrated over time. Transfer of learning was demonstrated and the use of HFS was found to be an effective learning and teaching method. Implications of results are discussed.

Electrochemical impedance spectroscopy investigation on the clinical lifetime of ProTaper rotary file system.

PubMed

Penta, Virgil; Pirvu, Cristian; Demetrescu, Ioana

2014-01-01

The main objective of the current paper is to show that electrochemical impedance spectroscopy (EIS) could be a method for evaluating and predicting of ProTaper rotary file system clinical lifespan. This particular aspect of everyday use of the endodontic files is of great importance in each dental practice and has profound clinical implications. The method used for quantification resides in the electrochemical impedance spectroscopy theory and has in its main focus the characteristics of the surface titanium oxide layer. This electrochemical technique has been adapted successfully to identify the quality of the Ni-Ti files oxide layer. The modification of this protective layer induces changes in corrosion behavior of the alloy modifying the impedance value of the file. In order to assess the method, 14 ProTaper sets utilized on different patients in a dental clinic have been submitted for testing using EIS. The information obtained in regard to the surface oxide layer has offered an indication of use and proves that the said layer evolves with each clinical application. The novelty of this research is related to an electrochemical technique successfully adapted for Ni-Ti file investigation and correlation with surface and clinical aspects.

The structure and content of telephonic scripts found useful in a Medicaid Chronic Disease Management Program.

PubMed

Roth, Alexis M; Ackermann, Ronald T; Downs, Stephen M; Downs, Anne M; Zillich, Alan J; Holmes, Ann M; Katz, Barry P; Murray, Michael D; Inui, Thomas S

2010-06-01

In 2003, the Indiana Office of Medicaid Policy and Planning launched the Indiana Chronic Disease Management Program (ICDMP), a programme intended to improve the health and healthcare utilization of 15,000 Aged, Blind and Disabled Medicaid members living with diabetes and/or congestive heart failure in Indiana. Within ICDMP, programme components derived from the Chronic Care Model and education based on an integrated theoretical framework were utilized to create a telephonic care management intervention that was delivered by trained, non-clinical Care Managers (CMs) working under the supervision of a Registered Nurse. CMs utilized computer-assisted health education scripts to address clinically important topics, including medication adherence, diet, exercise and prevention of disease-specific complications. Employing reflective listening techniques, barriers to optimal self-management were assessed and members were encouraged to engage in health-improving actions. ICDMP evaluation results suggest that this low-intensity telephonic intervention shifted utilization and lowered costs. We discuss this patient-centred method for motivating behaviour change, the theoretical constructs underlying the scripts and the branched-logic format that makes them suitable to use as a computer-based application. Our aim is to share these public-domain materials with other programmes.

Medicine Based Evidence for Individualized Decision Making: Case Study of Systemic Lupus Erythematosus.

PubMed

Wivel, Ashley E; Lapane, Kate; Kleoudis, Christi; Singer, Burton H; Horwitz, Ralph I

2017-11-01

To guide management decisions for an index patient, evidence is required from comparisons between approximate matches to the profile of the index case, where some matches contain responses to treatment and others act as controls. We describe a method for constructing clinically relevant histories/profiles using data collected but unreported from 2 recent phase 3 randomized controlled trials assessing belimumab in subjects with clinically active and serologically positive systemic lupus erythematosus. Outcome was the Systemic lupus erythematosus Responder Index (SRI) measured at 52 weeks. Among 1175 subjects, we constructed an algorithm utilizing 11 trajectory variables including 4 biological, 2 clinical, and 5 social/behavioral. Across all biological and social/behavioral variables, the proportion of responders based on the SRI whose value indicated clinical worsening or no improvement ranged from 27.5% to 42.3%. Kappa values suggested poor agreement, indicating that each biological and patient-reported outcome provides different information than gleaned from the SRI. The richly detailed patient profiles needed to guide decision-making in clinical practice are sharply at odds with the limited information utilized in conventional randomized controlled trial analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Targeted methods for quantitative analysis of protein glycosylation

PubMed Central

Goldman, Radoslav; Sanda, Miloslav

2018-01-01

Quantification of proteins by LC-MS/MS-MRM has become a standard method with broad projected clinical applicability. MRM quantification of protein modifications is, however, far less utilized, especially in the case of glycoproteins. This review summarizes current methods for quantitative analysis of protein glycosylation with a focus on MRM methods. We describe advantages of this quantitative approach, analytical parameters that need to be optimized to achieve reliable measurements, and point out the limitations. Differences between major classes of N- and O-glycopeptides are described and class-specific glycopeptide assays are demonstrated. PMID:25522218

A practical method to rapidly dissolve metallic stents.

PubMed

Bradshaw, Scott H; Kennedy, Lloyd; Dexter, David F; Veinot, John P

2009-01-01

Metallic stents are commonly used in many clinical applications including peripheral vascular disease intervention, biliary obstruction, endovascular repair of aneurysms, and percutaneous coronary interventions. In the examination of vascular stent placement, it is important to determine if the stent is open or has become obstructed. This is increasingly important in the era of drug-eluting stent usage in coronary arteries. We describe a practical, rapid and cost-effective method to dissolve most metallic stents leaving the vascular and luminal tissues intact. This practical method may replace the laborious and expensive plastic embedding methods currently utilized.

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…

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.

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.

The use of comparative duplex PCR in monitoring of patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.

PubMed

Slavícková, A; Forsterová, K; Ivánek, R; Cerný, J; Klener, P

2005-01-01

Various quantitative PCR approaches have been utilized during the last years to provide information about the treatment efficacy and the risk of recurrent disease in haematological malignancies. Apart from the frequently used real-time PCR, cost-saving modified standard PCR methods may be applied as well. This report evaluates the utility of the end-point comparative duplex PCR. We have used this method for monitoring of 35 patients with either NHL or CLL and observed a good correlation between quantitative molecular results and clinical outcome. There was also an agreement between comparative duplex PCR and real-time PCR in patients who were monitored by both methods. We therefore believe that use of this technique should be strongly considered instead of simple qualitative detection in monitoring of therapeutic outcome in NHL or CLL patients.

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

Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Driscoll, B.; Keller, H.; Jaffray, D.

2013-08-15

Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producingmore » predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.« less

Engineered matrices for bone regeneration

NASA Astrophysics Data System (ADS)

Winn, Shelley R.; Hu, Yunhua; Pugh, Amy; Brown, Leanna; Nguyen, Jesse T.; Hollinger, Jeffrey O.

2000-06-01

Traditional therapies of autografts and allogeneic banked bone can promote reasonable clinical outcome to repair damaged bone. However, under certain conditions the success of these traditional approaches plummets, providing the incentive for researchers to develop clinical alternatives. The evolving field of tissue engineering in the musculoskeletal system attempts to mimic many of the components from the intact, healthy subject. Those components consist of a biologic scaffold, cells, extracellular matrix, and signaling molecules. The bone biomimetic, i.e., an engineered matrix, provides a porous structural architecture for the regeneration and ingrowth of osseous tissue at the site of injury. To further enhance the regenerative cascade, our strategy has involved porous biodegradable scaffolds containing and releasing signaling molecules and providing a suitable environment for cell attachment, growth and differentiation. In addition, the inclusion of genetically modified osteogenic precursor cells has brought the technology closer to developing a tissue-engineered equivalent. The presentation will describe various formulations and the methods utilized to evaluate the clinical utility of these biomimetics.

Integrating Soluble Biomarkers and Imaging Technologies in the Identification of Vulnerable Atherosclerotic Patients

PubMed Central

Páramo, José A.; Rodríguez JA, José A.; Orbe, Josune

2006-01-01

The clinical utility of a biomarker depends on its ability to identify high-risk individuals to optimally manage the patient. A new biomarker would be of clinical value if it is accurate and reliable, provides good sensitivity and specificity, and is available for widespread application. Data are accumulating on the potential clinical utility of integrating imaging technologies and circulating biomarkers for the identification of vulnerable (high-risk) cardiovascular patients. A multi-biomarker strategy consisting of markers of inflammation, hemostasis and thrombosis, proteolysis and oxidative stress, combined with new imaging modalities (optical coherence tomography, virtual histology plus IVUS, PET) can increase our ability to identify such thombosis-prone patients. In an ideal scenario, cardiovascular biomarkers and imaging combined will provide a better diagnostic tool to identify high-risk individuals and also more efficient methods for effective therapies to reduce such cardiovascular risk. However, additional studies are required in order to show that this approach can contribute to improved diagnostic and therapeutic of atherosclerotic disease. PMID:19690647

Integrating soluble biomarkers and imaging technologies in the identification of vulnerable atherosclerotic patients.

PubMed

Páramo, José A; Rodríguez Ja, José A; Orbe, Josune

2007-02-07

The clinical utility of a biomarker depends on its ability to identify high-risk individuals to optimally manage the patient. A new biomarker would be of clinical value if it is accurate and reliable, provides good sensitivity and specificity, and is available for widespread application. Data are accumulating on the potential clinical utility of integrating imaging technologies and circulating biomarkers for the identification of vulnerable (high-risk) cardiovascular patients. A multi-biomarker strategy consisting of markers of inflammation, hemostasis and thrombosis, proteolysis and oxidative stress, combined with new imaging modalities (optical coherence tomography, virtual histology plus IVUS, PET) can increase our ability to identify such thombosis-prone patients. In an ideal scenario, cardiovascular biomarkers and imaging combined will provide a better diagnostic tool to identify high-risk individuals and also more efficient methods for effective therapies to reduce such cardiovascular risk. However, additional studies are required in order to show that this approach can contribute to improved diagnostic and therapeutic of atherosclerotic disease.

Integrating DXplain into a clinical information system using the World Wide Web.

PubMed

Elhanan, G; Socratous, S A; Cimino, J J

1996-01-01

The World Wide Web(WWW) offers a cross-platform environment and standard protocols that enable integration of various applications available on the Internet. The authors use the Web to facilitate interaction between their Web-based Clinical Information System and a decision-support system-DXplain, at the Massachusetts General Hospital-using local architecture and Common Gateway Interface programs. The current application translates patients laboratory test results into DXplain's terms to generate diagnostic hypotheses. Two different access methods are utilized for this model; Hypertext Transfer Protocol (HTTP) and TCP/IP function calls. While clinical aspects cannot be evaluated as yet, the model demonstrates the potential of Web-based applications for interaction and integration and how local architecture, with a controlled vocabulary server, can further facilitate such integration. This model serves to demonstrate some of the limitations of the current WWW technology and identifies issues such as control over Web resources and their utilization and liability issues as possible obstacles for further integration.

Physician Service Attribution Methods for Examining Provision of Low-Value Care

PubMed Central

Chang, Eva; Buist, Diana SM; Handley, Matthew; Pardee, Roy; Gundersen, Gabrielle; Reid, Robert J.

2016-01-01

Objectives: There has been significant research on provider attribution for quality and cost. Low-value care is an area of heightened focus, with little of the focus being on measurement; a key methodological decision is how to attribute delivered services and procedures. We illustrate the difference in relative and absolute physician- and panel-attributed services and procedures using overuse in cervical cancer screening. Study Design: A retrospective, cross-sectional study in an integrated health care system. Methods: We used 2013 physician-level data from Group Health Cooperative to calculate two utilization attributions: (1) panel attribution with the procedure assigned to the physician’s predetermined panel, regardless of who performed the procedure; and (2) physician attribution with the procedure assigned to the performing physician. We calculated the percentage of low-value cervical cancer screening tests and ranked physicians within the clinic using the two utilization attribution methods. Results: The percentage of low-value cervical cancer screening varied substantially between physician and panel attributions. Across the whole delivery system, median panel- and physician-attributed percentages were 15 percent and 10 percent, respectively. Among sampled clinics, panel-attributed percentages ranged between 10 percent and 17 percent, and physician-attributed percentages ranged between 9 percent and 13 percent. Within a clinic, median panel-attributed screening percentage was 17 percent (range 0 percent–27 percent) and physician-attributed percentage was 11 percent (range 0 percent–24 percent); physician rank varied by attribution method. Conclusions: The attribution method is an important methodological decision when developing low-value care measures since measures may ultimately have an impact on national benchmarking and quality scores. Cross-organizational dialogue and transparency in low-value care measurement will become increasingly important for all stakeholders. PMID:28203612

Dynamic Functional Imaging of Brain Glucose Utilization using fPET-FDG

PubMed Central

Villien, Marjorie; Wey, Hsiao-Ying; Mandeville, Joseph B.; Catana, Ciprian; Polimeni, Jonathan R.; Sander, Christin Y.; Zürcher, Nicole R.; Chonde, Daniel B.; Fowler, Joanna S.; Rosen, Bruce R.; Hooker, Jacob M.

2014-01-01

Glucose is the principal source of energy for the brain and yet the dynamic response of glucose utilization to changes in brain activity is still not fully understood. Positron emission tomography (PET) allows quantitative measurement of glucose metabolism using 2-[18F]-fluorodeoxyglucose (FDG). However, FDG PET in its current form provides an integral (or average) of glucose consumption over tens of minutes and lacks the temporal information to capture physiological alterations associated with changes in brain activity induced by tasks or drug challenges. Traditionally, changes in glucose utilization are inferred by comparing two separate scans, which significantly limits the utility of the method. We report a novel method to track changes in FDG metabolism dynamically, with higher temporal resolution than exists to date and within a single session. Using a constant infusion of FDG, we demonstrate that our technique (termed fPET-FDG) can be used in an analysis pipeline similar to fMRI to define within-session differential metabolic responses. We use visual stimulation to demonstrate the feasibility of this method. This new method has a great potential to be used in research protocols and clinical settings since fPET-FDG imaging can be performed with most PET scanners and data acquisition and analysis is straightforward. fPET-FDG is a highly complementary technique to MRI and provides a rich new way to observe functional changes in brain metabolism. PMID:24936683

Pattern recognition of estradiol, testosterone and dihydrotestosterone in children's saliva samples using stochastic microsensors

NASA Astrophysics Data System (ADS)

Staden, Raluca-Ioana Stefan-Van; Gugoaşă, Livia Alexandra; Calenic, Bogdan; Legler, Juliette

2014-07-01

Stochastic microsensors based on diamond paste and three types of electroactive materials (maltodextrin (MD), α-cyclodextrin (α-CD) and 5,10,15,20-tetraphenyl-21H,23H porphyrin (P)) were developed for the assay of estradiol (E2), testosterone (T2) and dihydrotestosterone (DHT) in children's saliva. The main advantage of utilization of such tools is the possibility to identify and quantify all three hormones within minutes in small volumes of childen's saliva. The limits of quantification obtained for DHT, T2, and E2 (1 fmol/L for DHT, 1 pmol/L for T2, and 66 fmol/L for E2) determined using the proposed tools allows the utilization of these new methods with high reliability for the screening of saliva samples from children. This new method proposed for the assay of the three hormones overcomes the limitations (regarding limits of determination) of ELISA method which is the standard method used in clinical laboratories for the assay of DHT, T2, and E2 in saliva samples. The main feature of its utilization for children's saliva is to identify earlier problems related to early puberty and obesity.

Application of 4G wireless network-based system for remote diagnosis and nursing of stomal complications

PubMed Central

Xu, Xiulian; Cao, Yingjuan; Luan, Xiaorong

2014-01-01

Background: This study aims to apply 4G wireless network in the remote diagnosis of stoma complications for the first time. Background: Remote diagnosis and nursing care for a variety of illnesses are urgently needed in clinical settings. Objectives: Combining with relevant clinical manifestations, an Android phone-based intelligent diagnosis system was designed to construct a universe, easy access to exploitation and human-computer interaction database and exploitation environment for applications and programs. Methods: “Production rule” and forward reasoning method were utilized to design arborescence structures and logic reasoner associated with stoma complications. Stoma physicians were responsible for delivering evaluation scores on patients’ health status using analytic hierarchy process. The emphasis of this study is to exploit an “Android phone-based system for remote diagnosis of stoma”, which is of certain universe usage. Results: Such system was tested in the Medicine Information Center of Qilu Hospital of Shandong University and initially applied in the city of De Zhou, Shandong province, China. Conclusions: These results collectively demonstrated that the system is easy to carry, of high utility and free from the limitations of wire network environment, etc. It provides clinical evidence for establishing a novel type model for the exchange between patients and physicians. PMID:25550986

METHOD FOR MICRORNA ISOLATION FROM CLINICAL SERUM SAMPLES

PubMed Central

Li, Yu; Kowdley, Kris V.

2012-01-01

MicroRNAs are a group of intracellular non-coding RNA molecules that have been implicated in a variety of human diseases. Due to their high stability in blood, microRNAs released into circulation could be potentially utilized as non-invasive biomarkers for diagnosis or prognosis. Current microRNA isolation protocols are specifically designed for solid tissues and are impractical for biomarker development utilizing small-volume serum samples on a large scale. Thus, a protocol for microRNA isolation from serum is needed to accommodate these conditions in biomarker development. To establish such a protocol, we developed a simplified approach to normalize sample input by using single synthetic spike-in microRNA. We evaluated three commonly used commercial microRNA isolation kits for the best performance by comparing RNA quality and yield. The manufacturer’s protocol was further modified to improve the microRNA yield from 200 μL of human serum. MicroRNAs isolated from a large set of clinical serum samples were tested on the miRCURY LNA real-time PCR panel and confirmed to be suitable for high-throughput microRNA profiling. In conclusion, we have established a proven method for microRNA isolation from clinical serum samples suitable for microRNA biomarker development. PMID:22982505

Mixture-based gatekeeping procedures in adaptive clinical trials.

PubMed

Kordzakhia, George; Dmitrienko, Alex; Ishida, Eiji

2018-01-01

Clinical trials with data-driven decision rules often pursue multiple clinical objectives such as the evaluation of several endpoints or several doses of an experimental treatment. These complex analysis strategies give rise to "multivariate" multiplicity problems with several components or sources of multiplicity. A general framework for defining gatekeeping procedures in clinical trials with adaptive multistage designs is proposed in this paper. The mixture method is applied to build a gatekeeping procedure at each stage and inferences at each decision point (interim or final analysis) are performed using the combination function approach. An advantage of utilizing the mixture method is that it enables powerful gatekeeping procedures applicable to a broad class of settings with complex logical relationships among the hypotheses of interest. Further, the combination function approach supports flexible data-driven decisions such as a decision to increase the sample size or remove a treatment arm. The paper concludes with a clinical trial example that illustrates the methodology by applying it to develop an adaptive two-stage design with a mixture-based gatekeeping procedure.

Compositions and methods for pathogen transport

DOE Office of Scientific and Technical Information (OSTI.GOV)

El-Etr, Sahar; Farquar, George R.

This disclosure provides a method for transporting a pathogen under ambient conditions, by culturing the pathogen with an amoeba under conditions that favor the incorporation of the pathogen into a trophozoite, starving the amoeba until it encysts, then culturing under conditions that favor conversion of the amoeba back to a trophozoite. In one aspect, the conditions that favor incorporation of the pathogen into the cyst of the amoeba comprises contacting the pathogen with the amoeba in an iron rich environment. Virus and/or bacteria are pathogens that can be transported by the disclosed method. Amoeba that are useful in the disclosedmore » methods include, without limitation Acanthamoeba castellanii, Hartmannella vermiformis and Naegleria gruberi. The disclosed methods have utility in: transporting pathogens from military field hospitals and clinics to the laboratory; transporting pathogens from global satellite laboratories to clinical laboratories; long term storage of pathogens; enriching contaminated patient samples for pathogens of interest; biosurveillance and detection efforts.« less

Imaging of neurodegenerative cognitive and behavioral disorders: practical considerations for dementia clinical practice.

PubMed

Atri, Alireza

2016-01-01

This chapter reviews clinical applications and imaging findings useful in medical practice relating to neurodegenerative cognitive/dementing disorders. The preponderance of evidence and consensus guidelines support an essential role of multitiered neuroimaging in the evaluation and management of neurodegenerative cognitive/dementia syndrome that range in severity from mild impairments to frank dementia. Additionally, imaging features are incorporated in updated clinical and research diagnostic criteria for most dementias, including Alzheimer's disease (AD), Dementia with Lewy bodies (DLB), Frontotemporal Lobar Degenerations/Frontotemporal Dementia (FTD), and Vascular Cognitive Impairment (VCI). Best clinical practices dictate that structural imaging, preferably with magnetic resonance imaging (MRI) when possible and computed tomography when not, be obtained as a first-tier approach during the course of a thorough clinical evaluation to improve diagnostic confidence and assess for nonneurodegenerative treatable conditions that may cause or substantially contribute to cognitive/behavioral symptoms or which may dictate a substantial change in management. These conditions include less common structural (e.g., mass lesions such as tumors and hematomas; normal-pressure hydrocephalus), inflammatory, autoimmune and infectious conditions, and more common comorbid contributing conditions (e.g., vascular cerebral injury causing leukoaraiosis, infarcts, or microhemorrhages) that can produce a mixed dementia syndrome. When, after appropriate clinical, cognitive/neuropsychologic, and structural neuroimaging assessment, a dementia specialist remains in doubt regarding etiology and appropriate management, second-tier imaging with molecular methods, preferably with fluorodexoyglucose positron emission tomography (PET) (or single-photon emission computed tomography if PET is unavailable) can provide more diagnostic specificity (e.g., help differentiate between atypical AD and FTD as the etiology for a frontal/dysexecutive syndrome). The potential clinical utility of other promising methods, whether already approved for use (e.g., amyloid PET) or as yet only used in research (e.g., tau PET, functional MRI, diffusor tensor imaging), remains to be proven for widespread use in community practice. However, these constitute unreimbursed third-tier options that merit further study for clinical and cost-effective utility. In the future, combination use of imaging methods will likely improve diagnostic accuracy. © 2016 Elsevier B.V. All rights reserved.

Sound therapies for tinnitus management.

PubMed

Jastreboff, Margaret M

2007-01-01

Many people with bothersome (suffering) tinnitus notice that their tinnitus changes in different acoustical surroundings, it is more intrusive in silence and less profound in the sound enriched environments. This observation led to the development of treatment methods for tinnitus utilizing sound. Many of these methods are still under investigation in respect to their specific protocol and effectiveness and only some have been objectively evaluated in clinical trials. This chapter will review therapies for tinnitus using sound stimulation.

Dobutamine Stress Echocardiography and Tissue Synchronization Imaging

PubMed Central

Tas, Hakan; Gundogdu, Fuat; Gurlertop, Yekta; Karakelleoglu, Sule

2008-01-01

Dobutamine stress echocardiography has emerged as a reliable method for the diagnosis of coronary artery disease and the management of its treatment. Several studies have shown that that this technique works with 80–85% accuracy in comparison with other imaging methods. There are few studies aimed at developing the clinical utility of dobutamine stress echocardiography for the evaluation of normal and abnormal segments that result from dobutamine stress with Tissue Synchronization Imaging. PMID:25610034

Food allergy: opportunities and challenges in the clinical practice of allergy and immunology.

PubMed

James, John M

2004-10-01

Food allergy offers numerous opportunities and challenges for the allergy and clinical immunology specialist. Physicians with board certification in allergy and clinical immunology should be the main source of reliable clinical information to educate patients with food-related disorders. There has been a wealth of reliable information published related to food allergy that can be utilized by health care providers in clinical practice. This includes information about the cross-reactivity of food allergens, the evaluation of potential new therapies, and the practical application of new diagnostic methods and management strategies. This article addresses some of the new developments in food allergy, with an emphasis on cross-reactvity of food allergens, recombinant food allergens, and potential future therapies for food allergy.

A fluid collection system for dermal wounds in clinical investigations

PubMed Central

Klopfer, Michael; Li, G.-P.; Widgerow, Alan; Bachman, Mark

2016-01-01

In this work, we demonstrate the use of a thin, self adherent, and clinically durable patch device that can collect fluid from a wound site for analysis. This device is manufactured from laminated silicone layers using a novel all-silicone double-molding process. In vitro studies for flow and delivery were followed by a clinical demonstration for exudate collection efficiency from a clinically presented partial thickness burn. The demonstrated utility of this device lends itself for use as a research implement used to clinically sample wound exudate for analysis. This device can serve as a platform for future integration of wearable technology into wound monitoring and care. The demonstrated fabrication method can be used for devices requiring thin membrane construction. PMID:27051470

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

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.

Utility of 16S rDNA Sequencing for Identification of Rare Pathogenic Bacteria.

PubMed

Loong, Shih Keng; Khor, Chee Sieng; Jafar, Faizatul Lela; AbuBakar, Sazaly

2016-11-01

Phenotypic identification systems are established methods for laboratory identification of bacteria causing human infections. Here, the utility of phenotypic identification systems was compared against 16S rDNA identification method on clinical isolates obtained during a 5-year study period, with special emphasis on isolates that gave unsatisfactory identification. One hundred and eighty-seven clinical bacteria isolates were tested with commercial phenotypic identification systems and 16S rDNA sequencing. Isolate identities determined using phenotypic identification systems and 16S rDNA sequencing were compared for similarity at genus and species level, with 16S rDNA sequencing as the reference method. Phenotypic identification systems identified ~46% (86/187) of the isolates with identity similar to that identified using 16S rDNA sequencing. Approximately 39% (73/187) and ~15% (28/187) of the isolates showed different genus identity and could not be identified using the phenotypic identification systems, respectively. Both methods succeeded in determining the species identities of 55 isolates; however, only ~69% (38/55) of the isolates matched at species level. 16S rDNA sequencing could not determine the species of ~20% (37/187) of the isolates. The 16S rDNA sequencing is a useful method over the phenotypic identification systems for the identification of rare and difficult to identify bacteria species. The 16S rDNA sequencing method, however, does have limitation for species-level identification of some bacteria highlighting the need for better bacterial pathogen identification tools. © 2016 Wiley Periodicals, Inc.

Assessment of Psychiatrically Hospitalized Suicidal Adolescents: Self-Report Instruments as Predictors of Suicidal Thoughts and Behavior

ERIC Educational Resources Information Center

Huth-Bocks, Alissa C.; Kerr, David C. R.; Ivey, Asha Z.; Kramer, Anne C.; King, Cheryl A.

2007-01-01

Objective: The validity and clinical utility of the Reynolds Adolescent Depression Scale, Beck Hopelessness Scale, Suicidal Ideation Questionnaire-Junior, and Suicide Probability Scale (SPS) were examined longitudinally among suicidal adolescents. Method: Between 1998 and 2000, 289 psychiatrically hospitalized, suicidal youth, ages 12 to 17 years,…

Error Variability and the Differentiation between Apraxia of Speech and Aphasia with Phonemic Paraphasia

ERIC Educational Resources Information Center

Haley, Katarina L.; Jacks, Adam; Cunningham, Kevin T.

2013-01-01

Purpose: This study was conducted to evaluate the clinical utility of error variability for differentiating between apraxia of speech (AOS) and aphasia with phonemic paraphasia. Method: Participants were 32 individuals with aphasia after left cerebral injury. Diagnostic groups were formed on the basis of operationalized measures of recognized…

Children Home Alone Unsupervised: Modeling Parental Decisions and Associated Factors in Botswana, Mexico, and Vietnam

ERIC Educational Resources Information Center

Ruiz-Casares, Monica; Heymann, Jody

2009-01-01

Objective: This paper examines different child care arrangements utilized by working families in countries undergoing major socio-economic transitions, with a focus on modeling parental decisions to leave children home alone. Method: The study interviewed 537 working caregivers attending government health clinics in Botswana, Mexico, and Vietnam.…

Usefulness of a Clinician Rating Scale in Identifying Preschool Children with ADHD

ERIC Educational Resources Information Center

Gopin, Chaya; Healey, Dione; Castelli, Katia; Marks, David; Halperin, Jeffrey M.

2010-01-01

Objective: To ascertain the psychometric properties and clinical utility of the Behavioral Rating Inventory for Children (BRIC), a novel clinician inventory for preschoolers. Method: Completion of the BRIC for 214 preschoolers follows 2 evaluation sessions, generally separated by less than 2 weeks. Items are submitted to a Principal Components…

Processing Speed Measures as Clinical Markers for Children with Language Impairment

ERIC Educational Resources Information Center

Park, Jisook; Miller, Carol A.; Mainela-Arnold, Elina

2015-01-01

Purpose: This study investigated the relative utility of linguistic and nonlinguistic processing speed tasks as predictors of language impairment (LI) in children across 2 time points. Method: Linguistic and nonlinguistic reaction time data, obtained from 131 children (89 children with typical development [TD] and 42 children with LI; 74 boys and…

Quantitative imaging methods in osteoporosis.

PubMed

Oei, Ling; Koromani, Fjorda; Rivadeneira, Fernando; Zillikens, M Carola; Oei, Edwin H G

2016-12-01

Osteoporosis is characterized by a decreased bone mass and quality resulting in an increased fracture risk. Quantitative imaging methods are critical in the diagnosis and follow-up of treatment effects in osteoporosis. Prior radiographic vertebral fractures and bone mineral density (BMD) as a quantitative parameter derived from dual-energy X-ray absorptiometry (DXA) are among the strongest known predictors of future osteoporotic fractures. Therefore, current clinical decision making relies heavily on accurate assessment of these imaging features. Further, novel quantitative techniques are being developed to appraise additional characteristics of osteoporosis including three-dimensional bone architecture with quantitative computed tomography (QCT). Dedicated high-resolution (HR) CT equipment is available to enhance image quality. At the other end of the spectrum, by utilizing post-processing techniques such as the trabecular bone score (TBS) information on three-dimensional architecture can be derived from DXA images. Further developments in magnetic resonance imaging (MRI) seem promising to not only capture bone micro-architecture but also characterize processes at the molecular level. This review provides an overview of various quantitative imaging techniques based on different radiological modalities utilized in clinical osteoporosis care and research.

3D cinematic rendering of the calvarium, maxillofacial structures, and skull base: preliminary observations.

PubMed

Rowe, Steven P; Zinreich, S James; Fishman, Elliot K

2018-06-01

Three-dimensional (3D) visualizations of volumetric data from CT have gained widespread clinical acceptance and are an important method for evaluating complex anatomy and pathology. Recently, cinematic rendering (CR), a new 3D visualization methodology, has become available. CR utilizes a lighting model that allows for the production of photorealistic images from isotropic voxel data. Given how new this technique is, studies to evaluate its clinical utility and any potential advantages or disadvantages relative to other 3D methods such as volume rendering have yet to be published. In this pictorial review, we provide examples of normal calvarial, maxillofacial, and skull base anatomy and pathological conditions that highlight the potential for CR images to aid in patient evaluation and treatment planning. The highly detailed images and nuanced shadowing that are intrinsic to CR are well suited to the display of the complex anatomy in this region of the body. We look forward to studies with CR that will ascertain the ultimate value of this methodology to evaluate calvarium, maxillofacial, and skull base morphology as well as other complex anatomic structures.

Clinical guideline for nurse-led early extubation after coronary artery bypass: an evaluation.

PubMed

Hawkes, Claire; Foxcroft, David R; Yerrell, Paul

2010-09-01

This paper is a report of an investigation of the development, implementation and outcomes of a clinical guideline for nurse-led early extubation of adult coronary artery bypass graft patients. Healthcare knowledge translation and utilization is an emerging but under-developed research area. The complex context for guideline development and use is methodologically challenging for robust and rigorous evaluation. This study contributes one such evaluation. This was a mixed methods evaluation, with a dominant quantitative study with a secondary qualitative study in a single UK cardiac surgery centre. An interrupted time series study (N = 567 elective coronary artery bypass graft patients) with concurrent within person controls was used to measure the impact of the guideline on the primary outcome: time to extubation. Semi-structured interviews with 11 clinical staff, informed by applied practitioner ethnography, explored the process of guideline development and implementation. The data were collected between January 2001 and January 2003. There was no change in the interrupted time series study primary outcome as a consequence of the guideline implementation. The qualitative study identified three themes: context, process and tensions highlighting that the guideline did not require clinicians to change their practice, although it may have helped maintain practice through its educative role. Further investigation and development of appropriate methods to capture the dynamism in healthcare contexts and its impact on guideline implementation seems warranted. Multi-site mixed methods investigations and programmes of research exploring knowledge translation and utilization initiatives, such as guideline implementation, are needed.

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.

Payer view of personalized medicine.

PubMed

Pezalla, Edmund J

2016-12-01

The process and methods used by payers when evaluating coverage of personalized medicine testing are described. Personalized medicine encompasses a number of diagnostic tools that measure drug metabolism, genetic risk for disease development, and tumor type or markers that can guide oncology treatments. However, whole genome testing, tumor marker testing, and testing for drug metabolism are additional costs to the healthcare system. In order to justify these costs, payers and health technology assessment bodies must evaluate the individual tests or groups of tests on their own merits. In order for a test to be covered by payers, test developers must demonstrate clinical utility as measured by improved outcomes or well-informed decision-making. In the United States, payers generally focus on clinical benefit to individual patients and benefits to the healthcare system. Clinical benefits include improved outcomes. Benefits to the healthcare system are generally considered to be cost offsets, which may be due to reductions in the use of unnecessary interventions or to more efficient use of resources. Provider organizations have been assuming more responsibility and liability for healthcare costs through various risk arrangements, including accountable care organizations and patient-centered medical homes. Diagnostic tests that increase efficiency, reduce unnecessary interventions, and improve outcomes will be chosen by specialists in provider organizations. For personalized medicine approaches to be adopted and covered by health plans, the methods must be shown to be analytically and clinically valid and provide clinical utility at a reasonable level of cost-effectiveness to payers. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

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

Overcoming Barriers to the Use of Osteopathic Manipulation Techniques in the Emergency Department

PubMed Central

Roberge, Raymond J.; Roberge, Marc R.

2009-01-01

Background: Osteopathic Manipulation Techniques (OMT) have been shown to be effective therapeutic modalities in various clinical settings, but appear to be underutilized in the emergency department (ED) setting. Objective: To examine barriers to the use of OMT in the ED and provide suggestions to ameliorate these barriers. Methods: Literature review Results: While the medical literature cites numerous obstacles to the use of OMT in the ED setting, most can be positively addressed through education, careful planning, and ongoing research into use of these techniques. Recent prospective clinical trials of OMT have demonstrated the utility of these modalities. Conclusion: Osteopathic Manipulation Techniques are useful therapeutic modalities that could be utilized to a greater degree in the ED. As the number of osteopathic emergency physicians increases, the opportunity to employ these techniques should increase. PMID:19718381

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

How to Appropriately Extrapolate Costs and Utilities in Cost-Effectiveness Analysis.

PubMed

Bojke, Laura; Manca, Andrea; Asaria, Miqdad; Mahon, Ronan; Ren, Shijie; Palmer, Stephen

2017-08-01

Costs and utilities are key inputs into any cost-effectiveness analysis. Their estimates are typically derived from individual patient-level data collected as part of clinical studies the follow-up duration of which is often too short to allow a robust quantification of the likely costs and benefits a technology will yield over the patient's entire lifetime. In the absence of long-term data, some form of temporal extrapolation-to project short-term evidence over a longer time horizon-is required. Temporal extrapolation inevitably involves assumptions regarding the behaviour of the quantities of interest beyond the time horizon supported by the clinical evidence. Unfortunately, the implications for decisions made on the basis of evidence derived following this practice and the degree of uncertainty surrounding the validity of any assumptions made are often not fully appreciated. The issue is compounded by the absence of methodological guidance concerning the extrapolation of non-time-to-event outcomes such as costs and utilities. This paper considers current approaches to predict long-term costs and utilities, highlights some of the challenges with the existing methods, and provides recommendations for future applications. It finds that, typically, economic evaluation models employ a simplistic approach to temporal extrapolation of costs and utilities. For instance, their parameters (e.g. mean) are typically assumed to be homogeneous with respect to both time and patients' characteristics. Furthermore, costs and utilities have often been modelled to follow the dynamics of the associated time-to-event outcomes. However, cost and utility estimates may be more nuanced, and it is important to ensure extrapolation is carried out appropriately for these parameters.

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

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

Clinical utility of automated assessment of left ventricular ejection fraction using artificial intelligence-assisted border detection.

PubMed

Rahmouni, Hind W; Ky, Bonnie; Plappert, Ted; Duffy, Kevin; Wiegers, Susan E; Ferrari, Victor A; Keane, Martin G; Kirkpatrick, James N; Silvestry, Frank E; St John Sutton, Martin

2008-03-01

Ejection fraction (EF) calculated from 2-dimensional echocardiography provides important prognostic and therapeutic information in patients with heart disease. However, quantification of EF requires planimetry and is time-consuming. As a result, visual assessment is frequently used but is subjective and requires extensive experience. New computer software to assess EF automatically is now available and could be used routinely in busy digital laboratories (>15,000 studies per year) and in core laboratories running large clinical trials. We tested Siemens AutoEF software (Siemens Medical Solutions, Erlangen, Germany) to determine whether it correlated with visual estimates of EF, manual planimetry, and cardiac magnetic resonance (CMR). Siemens AutoEF is based on learned patterns and artificial intelligence. An expert and a novice reader assessed EF visually by reviewing transthoracic echocardiograms from consecutive patients. An experienced sonographer quantified EF in all studies using Simpson's method of disks. AutoEF results were compared to CMR. Ninety-two echocardiograms were analyzed. Visual assessment by the expert (R = 0.86) and the novice reader (R = 0.80) correlated more closely with manual planimetry using Simpson's method than did AutoEF (R = 0.64). The correlation between AutoEF and CMR was 0.63, 0.28, and 0.51 for EF, end-diastolic and end-systolic volumes, respectively. The discrepancies in EF estimates between AutoEF and manual tracing using Simpson's method and between AutoEF and CMR preclude routine clinical use of AutoEF until it has been validated in a number of large, busy echocardiographic laboratories. Visual assessment of EF, with its strong correlation with quantitative EF, underscores its continued clinical utility.

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

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

Mass spectrometric detection of ricin and its activity in food and clinical samples.

PubMed

Kalb, Suzanne R; Barr, John R

2009-03-15

Ricin is a potent toxin capable of inhibiting protein synthesis and causing death or respiratory failure. Because of its high availability and lethality, ricin is considered a likely agent for bioterrorism. Rapidly determining contamination of food product with ricin and human exposure to ricin is therefore an important public health goal. In this work, we report the development of a method that detects ricin and its activity in food or clinical samples. This method involves immunocapture of the toxin, an examination of the activity of the ricin protein upon a DNA substrate that mimics the toxin's natural RNA target, and analysis of tryptic fragments of the toxin itself. It is the combination of these three techniques, all performed on the same sample, which allows for a sensitive and selective analysis of ricin isolated from a food or clinical sample. This measurement includes a measure of the toxin's activity. The utility of this method was demonstrated on ricin spiked into food and clinical samples consisting of milk, apple juice, serum, and saliva.

The value of vital sign trends for detecting clinical deterioration on the wards.

PubMed

Churpek, Matthew M; Adhikari, Richa; Edelson, Dana P

2016-05-01

Early detection of clinical deterioration on the wards may improve outcomes, and most early warning scores only utilize a patient's current vital signs. The added value of vital sign trends over time is poorly characterized. We investigated whether adding trends improves accuracy and which methods are optimal for modelling trends. Patients admitted to five hospitals over a five-year period were included in this observational cohort study, with 60% of the data used for model derivation and 40% for validation. Vital signs were utilized to predict the combined outcome of cardiac arrest, intensive care unit transfer, and death. The accuracy of models utilizing both the current value and different trend methods were compared using the area under the receiver operating characteristic curve (AUC). A total of 269,999 patient admissions were included, which resulted in 16,452 outcomes. Overall, trends increased accuracy compared to a model containing only current vital signs (AUC 0.78 vs. 0.74; p<0.001). The methods that resulted in the greatest average increase in accuracy were the vital sign slope (AUC improvement 0.013) and minimum value (AUC improvement 0.012), while the change from the previous value resulted in an average worsening of the AUC (change in AUC -0.002). The AUC increased most for systolic blood pressure when trends were added (AUC improvement 0.05). Vital sign trends increased the accuracy of models designed to detect critical illness on the wards. Our findings have important implications for clinicians at the bedside and for the development of early warning scores. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Genetic Manipulation of NK Cells for Cancer Immunotherapy: Techniques and Clinical Implications.

PubMed

Carlsten, Mattias; Childs, Richard W

2015-01-01

Given their rapid and efficient capacity to recognize and kill tumor cells, natural killer (NK) cells represent a unique immune cell to genetically reprogram in an effort to improve the outcome of cell-based cancer immunotherapy. However, technical and biological challenges associated with gene delivery into NK cells have significantly tempered this approach. Recent advances in viral transduction and electroporation have now allowed detailed characterization of genetically modified NK cells and provided a better understanding for how these cells can be utilized in the clinic to optimize their capacity to induce tumor regression in vivo. Improving NK cell persistence in vivo via autocrine IL-2 and IL-15 stimulation, enhancing tumor targeting by silencing inhibitory NK cell receptors such as NKG2A, and redirecting tumor killing via chimeric antigen receptors, all represent approaches that hold promise in preclinical studies. This review focuses on available methods for genetic reprograming of NK cells and the advantages and challenges associated with each method. It also gives an overview of strategies for genetic reprograming of NK cells that have been evaluated to date and an outlook on how these strategies may be best utilized in clinical protocols. With the recent advances in our understanding of the complex biological networks that regulate the ability of NK cells to target and kill tumors in vivo, we foresee genetic engineering as an obligatory pathway required to exploit the full potential of NK-cell based immunotherapy in the clinic.

Supporting new graduate professional development: a clinical learning framework.

PubMed

Fitzgerald, Cate; Moores, Alis; Coleman, Allison; Fleming, Jennifer

2015-02-01

New graduate occupational therapists are required to competently deliver health-care practices within complex care environments. An occupational therapy clinical education programme within a large public sector health service sought to investigate methods to support new graduates in their clinical learning and professional development. Three cycles of an insider action research approach each using the steps of planning, action, critical observation and reflection were undertaken to investigate new graduate learning strategies, develop a learning framework and pilot its utility. Qualitative research methods were used to analyse data gathered during the action research cycles. Action research identified variations in current practices to support new graduate learning and to the development of the Occupational Therapy Clinical Learning Framework (OTCLF). Investigation into the utility of the OTCLF revealed two themes associated with its implementation namely (i) contribution to learning goal development and (ii) compatibility with existing learning supports. The action research cycles aimed to review current practices to support new graduate learning. The learning framework developed encourages reflection to identify learning needs and the review, discussion of, and engagement in, goal setting and learning strategies. Preliminary evidence indicates that the OTCLF has potential as an approach to guide new graduate goal development supported by supervision. Future opportunity to implement a similar learning framework in other allied health professions was identified, enabling a continuation of the cyclical nature of enquiry, integral to this research approach within the workplace. © 2014 Occupational Therapy Australia.

Rank-based estimation in the {ell}1-regularized partly linear model for censored outcomes with application to integrated analyses of clinical predictors and gene expression data.

PubMed

Johnson, Brent A

2009-10-01

We consider estimation and variable selection in the partial linear model for censored data. The partial linear model for censored data is a direct extension of the accelerated failure time model, the latter of which is a very important alternative model to the proportional hazards model. We extend rank-based lasso-type estimators to a model that may contain nonlinear effects. Variable selection in such partial linear model has direct application to high-dimensional survival analyses that attempt to adjust for clinical predictors. In the microarray setting, previous methods can adjust for other clinical predictors by assuming that clinical and gene expression data enter the model linearly in the same fashion. Here, we select important variables after adjusting for prognostic clinical variables but the clinical effects are assumed nonlinear. Our estimator is based on stratification and can be extended naturally to account for multiple nonlinear effects. We illustrate the utility of our method through simulation studies and application to the Wisconsin prognostic breast cancer data set.

Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design.

PubMed

Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D'Arcy, Ryan C N; Song, Xiaowei

2018-04-19

Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors' quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging scientists, computing scientists and clinical professionals in neurology and neuroradiology and includes patient representatives. Research outputs will be disseminated following knowledge translation plans towards improving stroke patient care. Significant findings will be published in scientific journals. Anticipated deliverables include computer solutions for improved clinical assessment of haematoma using NCCT. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Microdose clinical trial: quantitative determination of nicardipine and prediction of metabolites in human plasma.

PubMed

Yamane, Naoe; Takami, Tomonori; Tozuka, Zenzaburo; Sugiyama, Yuichi; Yamazaki, Akira; Kumagai, Yuji

2009-01-01

A sample treatment procedure and high-sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for quantitative determination of nicardipine in human plasma were developed for a microdose clinical trial with nicardipine, a non-radioisotope labeled drug. The calibration curve was linear in the range of 1-500 pg/mL using 1 mL of plasma. Analytical method validation for the clinical dose, for which the calibration curve was linear in the range of 0.2-100 ng/mL using 20 microL of plasma, was also conducted. Each method was successfully applied to making determinations in plasma using LC/MS/MS after administration of a microdose (100 microg) and clinical dose (20 mg) to each of six healthy volunteers. We tested new approaches in the search for metabolites in plasma after microdosing. In vitro metabolites of nicardipine were characterized using linear ion trap-fourier transform ion cyclotron resonance mass spectrometry (LIT-FTICRMS) and the nine metabolites predicted to be in plasma were analyzed using LC/MS/MS. There is a strong possibility that analysis of metabolites by LC/MS/MS may advance to utilization in microdose clinical trials with non-radioisotope labeled drugs.

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom.

PubMed

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

To develop a study aiming at optimizing myocardial perfusion imaging. Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The (99m)Tc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol.

Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran.

PubMed

Lewis, J H; Larrey, D; Olsson, R; Lee, W M; Frison, L; Keisu, M

2008-07-01

Causality assessment in drug-induced liver injury is often based on circumstantial evidence rather than a formal, systematic review. The Roussel Uclaf Causality Assessment Method (RUCAM) provides a more objective means of assessing causality of a suspected hepatotoxin but, to our knowledge, has never been used in the assessment of a single drug with unknown hepatotoxic potential in a clinical trial setting. We studied the utility of RUCAM in assessing the hepatic events during the long-term clinical trials of the oral direct thrombin inhibitor ximelagatran, which has been associated with an increased incidence of alanine aminotransferase (ALT) elevations. A total of 233 subjects with elevated ALT values signalling possibly severe hepatic injury were eligible for RUCAM analysis (198 ximelagatran and 35 comparator anticoagulants). RUCAM scores, calculated independently by the assessors, using the existing numerical criteria provided in its methodology, suggested a possible or probable causal relationship between ALT and ximelagatran in 37 and 27% of cases, respectively. Causality was excluded or unlikely in the remaining 36% of cases. However, in the course of utilizing RUCAM, several limitations to the methodology came to light, including awarding additional points for age > 55 years, an unspecified use of alcohol, and a latency period of < 90 days, which may have had the unintentional effect of raising the overall score. Moreover, rechallenge is highly rewarded by RUCAM but is seldom done in clinical practice or in clinical trials. We also found ambiguities in the extent to which other causes of liver injury were excluded, what constitutes a significant hepatotoxic concomitant medication, and whether a clinical trial drug should be considered as having an unknown hepatotoxic potential for purposes of RUCAM scoring. Increasing familiarity with the RUCAM over the course of the study allowed for only a slight improvement in concordance between and among the assessors regarding the scoring. While the results indicate that RUCAM can provide for an objective assessment of causality of the hepatotoxicity of a drug under development in the clinical trial setting, this study highlights a number of problems with the current scoring system that should be addressed by future enhancements of the methodology.

Utility of PCR, Culture, and Antigen Detection Methods for Diagnosis of Legionellosis.

PubMed

Chen, Derrick J; Procop, Gary W; Vogel, Sherilynn; Yen-Lieberman, Belinda; Richter, Sandra S

2015-11-01

The goal of this retrospective study was to evaluate the performance of different diagnostic tests for Legionnaires' disease in a clinical setting where Legionella pneumophila PCR had been introduced. Electronic medical records at the Cleveland Clinic were searched for Legionella urinary antigen (UAG), culture, and PCR tests ordered from March 2010 through December 2013. For cases where two or more test methods were performed and at least one was positive, the medical record was reviewed for relevant clinical and epidemiologic factors. Excluding repeat testing on a given patient, 19,912 tests were ordered (12,569 UAG, 3,747 cultures, and 3,596 PCR) with 378 positive results. The positivity rate for each method was 0.4% for culture, 0.8% for PCR, and 2.7% for UAG. For 37 patients, at least two test methods were performed with at least one positive result: 10 (27%) cases were positive by all three methods, 16 (43%) were positive by two methods, and 11 (30%) were positive by one method only. For the 32 patients with medical records available, clinical presentation was consistent with proven or probable Legionella infection in 84% of the cases. For those cases, the sensitivities of culture, PCR, and UAG were 50%, 92%, and 96%, respectively. The specificities were 100% for culture and 99.9% for PCR and UAG. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Utility of PCR, Culture, and Antigen Detection Methods for Diagnosis of Legionellosis

PubMed Central

Chen, Derrick J.; Procop, Gary W.; Vogel, Sherilynn; Yen-Lieberman, Belinda

2015-01-01

The goal of this retrospective study was to evaluate the performance of different diagnostic tests for Legionnaires' disease in a clinical setting where Legionella pneumophila PCR had been introduced. Electronic medical records at the Cleveland Clinic were searched for Legionella urinary antigen (UAG), culture, and PCR tests ordered from March 2010 through December 2013. For cases where two or more test methods were performed and at least one was positive, the medical record was reviewed for relevant clinical and epidemiologic factors. Excluding repeat testing on a given patient, 19,912 tests were ordered (12,569 UAG, 3,747 cultures, and 3,596 PCR) with 378 positive results. The positivity rate for each method was 0.4% for culture, 0.8% for PCR, and 2.7% for UAG. For 37 patients, at least two test methods were performed with at least one positive result: 10 (27%) cases were positive by all three methods, 16 (43%) were positive by two methods, and 11 (30%) were positive by one method only. For the 32 patients with medical records available, clinical presentation was consistent with proven or probable Legionella infection in 84% of the cases. For those cases, the sensitivities of culture, PCR, and UAG were 50%, 92%, and 96%, respectively. The specificities were 100% for culture and 99.9% for PCR and UAG. PMID:26292304

Utilization management affects health care practices at Walter Reed Army Medical Center: analytical methods applied to decrease length of stay and assign appropriate level of care.

PubMed

Phillips, J S; Hamm, C K; Pierce, J R; Kussman, M J

1999-12-01

The Department of Defense has embraced utilization management (UM) as an important tool to control and possibly decrease medical costs. Budgetary withholds have been taken by the Office of the Assistant Secretary of Defense (Health Affairs) to encourage the military services to implement UM programs. In response, Walter Reed Army Medical Center implemented a UM program along with other initiatives to effect changes in the delivery of inpatient care. This paper describes this UM program and other organizational initiatives, such as the introduction of new levels of care in an attempt to effect reductions in length of stay and unnecessary admissions. We demonstrate the use of a diversity of databases and analytical methods to quantify improved utilization and management of resources. The initiatives described significantly reduced hospital length of stay and inappropriate inpatient days. Without solid command and clinical leadership support and empowerment of the professional staffs, these significant changes and improvements could not have occurred.

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

Building a comprehensive syntactic and semantic corpus of Chinese clinical texts.

PubMed

He, Bin; Dong, Bin; Guan, Yi; Yang, Jinfeng; Jiang, Zhipeng; Yu, Qiubin; Cheng, Jianyi; Qu, Chunyan

2017-05-01

To build a comprehensive corpus covering syntactic and semantic annotations of Chinese clinical texts with corresponding annotation guidelines and methods as well as to develop tools trained on the annotated corpus, which supplies baselines for research on Chinese texts in the clinical domain. An iterative annotation method was proposed to train annotators and to develop annotation guidelines. Then, by using annotation quality assurance measures, a comprehensive corpus was built, containing annotations of part-of-speech (POS) tags, syntactic tags, entities, assertions, and relations. Inter-annotator agreement (IAA) was calculated to evaluate the annotation quality and a Chinese clinical text processing and information extraction system (CCTPIES) was developed based on our annotated corpus. The syntactic corpus consists of 138 Chinese clinical documents with 47,426 tokens and 2612 full parsing trees, while the semantic corpus includes 992 documents that annotated 39,511 entities with their assertions and 7693 relations. IAA evaluation shows that this comprehensive corpus is of good quality, and the system modules are effective. The annotated corpus makes a considerable contribution to natural language processing (NLP) research into Chinese texts in the clinical domain. However, this corpus has a number of limitations. Some additional types of clinical text should be introduced to improve corpus coverage and active learning methods should be utilized to promote annotation efficiency. In this study, several annotation guidelines and an annotation method for Chinese clinical texts were proposed, and a comprehensive corpus with its NLP modules were constructed, providing a foundation for further study of applying NLP techniques to Chinese texts in the clinical domain. Copyright © 2017. Published by Elsevier Inc.

Clinical utility of bone scintigraphy in patients with limb pain of suspected musculoskeletal origin

PubMed Central

Ferrari, Robert

2015-01-01

Objective To determine the clinical utility of bone scintigraphy in patients with limb pain of suspected musculoskeletal origin. Material and Methods All patients aged ≥18 years who were referred for diagnosis and management of limb pain were diagnosed on the basis of history, physical examination, and investigations excluding bone scintigraphy. After the presumptive diagnosis was made (the pre-test diagnosis), all subjects underwent bone scintigraphy, or if they had a previous bone scintigram for their pain condition, the results of that scintigram were reviewed. Then, the pre-test diagnosis was reviewed in light of the bone scintigraphy findings and repeat clinical assessment as needed. The post-test diagnosis was considered either as unchanged diagnosis or changed diagnosis for the region or regions of interest. Results There were 118 females (54.8%) and 97 males (45.2%). The mean age of the entire group was 36±8.1 years (range: 18–87 years). The mean duration of the symptoms was 17.4±11.2 months (range: 1–264 months). Of the 215 subjects, 212 had a bone scintigram. Of these 212 subjects, none had a changed diagnosis. Conclusion In the evaluation of limb pain of suspected musculoskeletal origin, scintigraphy is unlikely to alter the pre-test diagnosis or affect treatment decisions after history, physical examination, and non-scintigraphic investigations. The clinical utility of scinitigraphy in this setting is low. PMID:27708914

Early cancer diagnoses through BRCA1/2 screening of unselected adult biobank participants

PubMed Central

Buchanan, Adam H; Manickam, Kandamurugu; Meyer, Michelle N; Wagner, Jennifer K; Hallquist, Miranda L G; Williams, Janet L; Rahm, Alanna Kulchak; Williams, Marc S; Chen, Zong-Ming E; Shah, Chaitali K; Garg, Tullika K; Lazzeri, Amanda L; Schwartz, Marci L B; Lindbuchler, D'Andra M; Fan, Audrey L; Leeming, Rosemary; Servano, Pedro O; Smith, Ashlee L; Vogel, Victor G; Abul-Husn, Noura S; Dewey, Frederick E; Lebo, Matthew S; Mason-Suares, Heather M; Ritchie, Marylyn D; Davis, F Daniel; Carey, David J; Feinberg, David T; Faucett, W Andrew; Ledbetter, David H; Murray, Michael F

2018-01-01

Purpose The clinical utility of screening unselected individuals for pathogenic BRCA1/2 variants has not been established. Data on cancer risk management behaviors and diagnoses of BRCA1/2-associated cancers can help inform assessments of clinical utility. Methods Whole-exome sequences of participants in the MyCode Community Health Initiative were reviewed for pathogenic/likely pathogenic BRCA1/2 variants. Clinically confirmed variants were disclosed to patient–participants and their clinicians. We queried patient–participants’ electronic health records for BRCA1/2-associated cancer diagnoses and risk management that occurred within 12 months after results disclosure, and calculated the percentage of patient–participants of eligible age who had begun risk management. Results Thirty-seven MyCode patient–participants were unaware of their pathogenic/likely pathogenic BRCA1/2 variant, had not had a BRCA1/2-associated cancer, and had 12 months of follow-up. Of the 33 who were of an age to begin BRCA1/2-associated risk management, 26 (79%) had performed at least one such procedure. Three were diagnosed with an early-stage, BRCA1/2-associated cancer—including a stage 1C fallopian tube cancer—via these procedures. Conclusion Screening for pathogenic BRCA1/2 variants among unselected individuals can lead to occult cancer detection shortly after disclosure. Comprehensive outcomes data generated within our learning healthcare system will aid in determining whether population-wide BRCA1/2 genomic screening programs offer clinical utility. PMID:29261187

Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel

PubMed Central

Chirenje, Zvavahera M; Mâsse, Benoît R; Maslankowski, Lisa A; Ramjee, Gita; Coletti, Anne S; Tembo, Tchangani N; Magure, Tsitsi M; Soto-Torres, Lydia; Kelly, Cliff; Hillier, Sharon; Karim, Abdool

2012-01-01

Background The majority of new HIV infections are acquired through heterosexual transmission. There is urgent need for prevention methods to compliment behavior change and condom use. Topical microbicide represent a potential strategy for reduction of HIV transmission in women. Methods Monthly Colposcopy evaluations were performed during pelvic examinations among 299 women enrolled in the Phase 2 portion of HPTN 035 study at four sites (1 in USA, 3 in Southern Africa). This was a phase 2/2b, multisite, randomized, and controlled clinical trial with four arms: BufferGel, 0.5% PRO2000 Gel, placebo gel and no gel. At two of the sites, pelvic examinations were conducted by the use of naked eye without colposcopy. Results A colposcopy finding of any kind was detected in 48% of participants at baseline compared to 40% at 3 months (p =0.04). The lower rates were also observed in vaginal discharge (22% at baseline, 16% at 3 months, p=0.06), erythema (15% at baseline, 8% at 3 months, p=0.004). The trend towards significance at p=0.05 disappear when utilizing stringent statistical significance levels. A pelvic finding of any kind was detected in 71% of colposcopy participants compared to 41% of participants who had naked eye examination only conducted at two sites that performed both colposcopy and naked eye without colposcopy. Use of colposcopy yielded significantly higher rates of participants with deep epithelial disruption, erythema and ecchymosis. We observed no cases of incident Chlamydia, Gonorrhea, or Syphilis during the three month follow up. There were 2 cases of incident HIV during 3-month study period neither of which was associated with any abnormal colposcopy evaluation findings. Conclusion No safety signals were observed in the 4 study arms, allowing seamless transition from phase 2 to 2b. Colposcopy utility in microbicide clinical trials has minimal value given high rates of background noise findings of no relevant clinical significance. PMID:22944480

[Clinical study using activity-based costing to assess cost-effectiveness of a wound management system utilizing modern dressings in comparison with traditional wound care].

PubMed

Ohura, Takehiko; Sanada, Hiromi; Mino, Yoshio

2004-01-01

In recent years, the concept of cost-effectiveness, including medical delivery and health service fee systems, has become widespread in Japanese health care. In the field of pressure ulcer management, the recent introduction of penalty subtraction in the care fee system emphasizes the need for prevention and cost-effective care of pressure ulcer. Previous cost-effectiveness research on pressure ulcer management tended to focus only on "hardware" costs such as those for pharmaceuticals and medical supplies, while neglecting other cost aspects, particularly those involving the cost of labor. Thus, cost-effectiveness in pressure ulcer care has not yet been fully established. To provide true cost effectiveness data, a comparative prospective study was initiated in patients with stage II and III pressure ulcers. Considering the potential impact of the pressure reduction mattress on clinical outcome, in particular, the same type of pressure reduction mattresses are utilized in all the cases in the study. The cost analysis method used was Activity-Based Costing, which measures material and labor cost aspects on a daily basis. A reduction in the Pressure Sore Status Tool (PSST) score was used to measure clinical effectiveness. Patients were divided into three groups based on the treatment method and on the use of a consistent algorithm of wound care: 1. MC/A group, modern dressings with a treatment algorithm (control cohort). 2. TC/A group, traditional care (ointment and gauze) with a treatment algorithm. 3. TC/NA group, traditional care (ointment and gauze) without a treatment algorithm. The results revealed that MC/A is more cost-effective than both TC/A and TC/NA. This suggests that appropriate utilization of modern dressing materials and a pressure ulcer care algorithm would contribute to reducing health care costs, improved clinical results, and, ultimately, greater cost-effectiveness.

Optical spectroscopy for the detection of ischemic tissue injury

DOEpatents

Demos, Stavros [Livermore, CA; Fitzgerald, Jason [Sacramento, CA; Troppmann, Christoph [Sacramento, CA; Michalopoulou, Andromachi [Athens, GR

2009-09-08

An optical method and apparatus is utilized to quantify ischemic tissue and/or organ injury. Such a method and apparatus is non-invasive, non-traumatic, portable, and can make measurements in a matter of seconds. Moreover, such a method and apparatus can be realized through optical fiber probes, making it possible to take measurements of target organs deep within a patient's body. Such a technology provides a means of detecting and quantifying tissue injury in its early stages, before it is clinically apparent and before irreversible damage has occurred.

PRIM versus CART in subgroup discovery: when patience is harmful.

PubMed

Abu-Hanna, Ameen; Nannings, Barry; Dongelmans, Dave; Hasman, Arie

2010-10-01

We systematically compare the established algorithms CART (Classification and Regression Trees) and PRIM (Patient Rule Induction Method) in a subgroup discovery task on a large real-world high-dimensional clinical database. Contrary to current conjectures, PRIM's performance was generally inferior to CART's. PRIM often considered "peeling of" a large chunk of data at a value of a relevant discrete ordinal variable unattractive, ultimately missing an important subgroup. This finding has considerable significance in clinical medicine where ordinal scores are ubiquitous. PRIM's utility in clinical databases would increase when global information about (ordinal) variables is better put to use and when the search algorithm keeps track of alternative solutions.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative

PubMed Central

Francis, Maureen D.; Wieland, Mark L.; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A.; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L.

2015-01-01

Background Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. Methods This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. Results UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Conclusions Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model. PMID:26217420

Trends in Retail Clinic Use Among The Commercially Insured

PubMed Central

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

2012-01-01

Objective To describe trends in retail clinic usage among commercially insured patients and to identify which patient characteristics predict retail clinic use Study Design We performed a retrospective cohort analysis of commercial insurance claims sampled from a population of 13.3 million patients in 21 markets in 2007-9. Methods We identified 11 simple acute conditions that can be managed at a retail clinic. We described trends in retail clinic utilization for these conditions. We used multiple logistic regressions to identify predictors of retail clinic versus another care site for these conditions and assessed whether those predictors changed over time. Results Retail clinic use increased ten-fold from 2007 to 2009. By 2009 6.9% of all visits for the 11 conditions were to a retail clinic. Proximity to a retail clinic was the strongest predictor of use. Patients living within 1 mile of a retail clinic were 10.0% more likely to use one than those living 10-20 miles away (p-value <0.001). Women (+0.9%, p-value <0.001), young adults (+1.6%, p-value <0.001), those without a chronic condition (+1.1%, p-value <0.001), and high-income (+1.3%, p-value <0.001) patients were more likely to use retail clinics. All these associations became stronger over time. There was no association between primary care physician availability and retail clinic use. Conclusions If these trends continue health plans can expect to see a dramatic increase in retail clinic utilization. While usage is increasing on average, it is particularly increasing among young, healthy, and higher income patients who live close to retail clinics. PMID:22200061

A systematic review of suggestive seizure induction for the diagnosis of psychogenic nonepileptic seizures.

PubMed

Popkirov, Stoyan; Grönheit, Wenke; Wellmer, Jörg

2015-09-01

Suggestive seizure induction is a widely used method for diagnosing psychogenic nonepileptic seizures (PNES). Despite seven decades of multidisciplinary research, however, there is still no unified protocol, no definitive agreement on the ethical framework and no consensus on diagnostic utility. This systematic review surveys the evidence at hand and addresses clinically relevant aspects of suggestive seizure induction. In addition to its use for facilitating the diagnostic process, its mechanism of action and utility in elucidating the psychopathology of PNES will be discussed. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

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.

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

Magnetic resonance imaging in Alzheimer's Disease Neuroimaging Initiative 2.

PubMed

Jack, Clifford R; Barnes, Josephine; Bernstein, Matt A; Borowski, Bret J; Brewer, James; Clegg, Shona; Dale, Anders M; Carmichael, Owen; Ching, Christopher; DeCarli, Charles; Desikan, Rahul S; Fennema-Notestine, Christine; Fjell, Anders M; Fletcher, Evan; Fox, Nick C; Gunter, Jeff; Gutman, Boris A; Holland, Dominic; Hua, Xue; Insel, Philip; Kantarci, Kejal; Killiany, Ron J; Krueger, Gunnar; Leung, Kelvin K; Mackin, Scott; Maillard, Pauline; Malone, Ian B; Mattsson, Niklas; McEvoy, Linda; Modat, Marc; Mueller, Susanne; Nosheny, Rachel; Ourselin, Sebastien; Schuff, Norbert; Senjem, Matthew L; Simonson, Alix; Thompson, Paul M; Rettmann, Dan; Vemuri, Prashanthi; Walhovd, Kristine; Zhao, Yansong; Zuk, Samantha; Weiner, Michael

2015-07-01

Alzheimer's Disease Neuroimaging Initiative (ADNI) is now in its 10th year. The primary objective of the magnetic resonance imaging (MRI) core of ADNI has been to improve methods for clinical trials in Alzheimer's disease (AD) and related disorders. We review the contributions of the MRI core from present and past cycles of ADNI (ADNI-1, -Grand Opportunity and -2). We also review plans for the future-ADNI-3. Contributions of the MRI core include creating standardized acquisition protocols and quality control methods; examining the effect of technical features of image acquisition and analysis on outcome metrics; deriving sample size estimates for future trials based on those outcomes; and piloting the potential utility of MR perfusion, diffusion, and functional connectivity measures in multicenter clinical trials. Over the past decade the MRI core of ADNI has fulfilled its mandate of improving methods for clinical trials in AD and will continue to do so in the future. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

PubMed

Ma, Yunbei; Zhou, Xiao-Hua

2017-02-01

For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

Fast Acquisition and Reconstruction of Optical Coherence Tomography Images via Sparse Representation

PubMed Central

Li, Shutao; McNabb, Ryan P.; Nie, Qing; Kuo, Anthony N.; Toth, Cynthia A.; Izatt, Joseph A.; Farsiu, Sina

2014-01-01

In this paper, we present a novel technique, based on compressive sensing principles, for reconstruction and enhancement of multi-dimensional image data. Our method is a major improvement and generalization of the multi-scale sparsity based tomographic denoising (MSBTD) algorithm we recently introduced for reducing speckle noise. Our new technique exhibits several advantages over MSBTD, including its capability to simultaneously reduce noise and interpolate missing data. Unlike MSBTD, our new method does not require an a priori high-quality image from the target imaging subject and thus offers the potential to shorten clinical imaging sessions. This novel image restoration method, which we termed sparsity based simultaneous denoising and interpolation (SBSDI), utilizes sparse representation dictionaries constructed from previously collected datasets. We tested the SBSDI algorithm on retinal spectral domain optical coherence tomography images captured in the clinic. Experiments showed that the SBSDI algorithm qualitatively and quantitatively outperforms other state-of-the-art methods. PMID:23846467

Feasibility study of structured diagnosis methods for functional dyspepsia in Korean medicine clinics.

PubMed

Park, Jeong Hwan; Kim, Soyoung; Park, Jae-Woo; Ko, Seok-Jae; Lee, Sanghun

2017-12-01

Functional dyspepsia (FD) is the seventh most common disease encountered in Korean medicine (KM) clinics. Despite the large number of FD patients visiting KM clinics, the accumulated medical records have no utility in evidence development, due to being unstructured. This study aimed to construct a standard operating procedure (SOP) with appropriate structured diagnostic methods for FD, and assess the feasibility for use in KM clinics. Two rounds of professional surveys were conducted by 10 Korean internal medicine professors to select the representative diagnostic methods. A feasibility study was conducted to evaluate compliance and time required for using the structured diagnostic methods by three specialists in two hospitals. As per the results of the professional survey, five questionnaires and one basic diagnostic method were selected. An SOP was constructed based on the survey results, and a feasibility study showed that the SOP compliance score (out of 5) was 3.45 among the subjects, and 3.25 among the practitioners. The SOP was acceptable and was not deemed difficult to execute. The total execution time was 136.5 minutes, out of which the gastric emptying test time was 129 minutes. This feasibility study of the SOP with structured diagnostic methods for FD confirmed it was adequate for use in KM clinics. It is expected that these study findings will be helpful to clinicians who wish to conduct observational studies as well as to generate quantitative medical records to facilitate Big Data research.

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.

Exploring the Utility of Narrative Analysis in Diagnostic Decision Making: Picture-Bound Reference, Elaboration, and Fetal Alcohol Spectrum Disorders

ERIC Educational Resources Information Center

Thorne, John C.; Coggins, Truman E.; Olson, Heather Carmichael; Astley, Susan J.

2007-01-01

Purpose: To evaluate classification accuracy and clinical feasibility of a narrative analysis tool for identifying children with a fetal alcohol spectrum disorder (FASD). Method: Picture-elicited narratives generated by 16 age-matched pairs of school-aged children (FASD vs. typical development [TD]) were coded for semantic elaboration and…

Case-Based Analogical Reasoning: A Pedagogical Tool for Promotion of Clinical Reasoning

ERIC Educational Resources Information Center

Speicher, Timothy E.; Bell, Alexandra; Kehrhahn, Marijke; Casa, Douglas J.

2012-01-01

Context: One of the most common instructional methods utilized to promote learning transfer in health profession education is examination of a single patient case. However, in non-healthcare settings this practice has shown to be less effective in promoting learning than the examination of multiple cases with cueing. Objective(s): The primary…

Properties of the Narrative Scoring Scheme Using Narrative Retells in Young School-Age Children

ERIC Educational Resources Information Center

Heilmann, John; Miller, Jon F.; Nockerts, Ann; Dunaway, Claudia

2010-01-01

Purpose: To evaluate the clinical utility of the narrative scoring scheme (NSS) as an index of narrative macrostructure for young school-age children. Method: Oral retells of a wordless picture book were elicited from 129 typically developing children, ages 5-7. A series of correlations and hierarchical regression equations were completed using…

A Qualitative Study of Interphysician Telephone Consultations: Extending the Opinion Leader Theory

ERIC Educational Resources Information Center

Wadhwa, Anupma; Ford-Jones, Elizabeth Lee; Lingard, Lorelei

2005-01-01

Introduction: It has been suggested that the use of opinion leaders in the dissemination of information may be an effective method of changing clinical practice. Recent reviews on this topic, however, have found mixed results and have concluded that further research is needed to explore the circumstances that effectively utilize opinion leaders.…

Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Abstract The Oncology Section of the American Physical Therapy Association (APTA) developed a clinical practice guideline to aid the clinician in diagnosing secondary upper quadrant cancer-related lymphedema. Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in the diagnostic process. Overall clinical practice recommendations were formulated based on the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. In an effort to maximize clinical applicability, recommendations were based on the characteristics as to the location and stage of a patient's upper quadrant lymphedema. PMID:28838217

A morphological method for ammonia detection in liver

PubMed Central

Gutiérrez-de-Juan, Virginia; López de Davalillo, Sergio; Fernández-Ramos, David; Barbier-Torres, Lucía; Zubiete-Franco, Imanol; Fernández-Tussy, Pablo; Simon, Jorge; Lopitz-Otsoa, Fernando; de las Heras, Javier; Iruzubieta, Paula; Arias-Loste, María Teresa; Villa, Erica; Crespo, Javier; Andrade, Raúl; Lucena, M. Isabel; Varela-Rey, Marta; Lu, Shelly C.; Mato, José M.; Delgado, Teresa Cardoso

2017-01-01

Hyperammonemia is a metabolic condition characterized by elevated levels of ammonia and a common event in acute liver injury/failure and chronic liver disease. Even though hepatic ammonia levels are potential predictive factors of patient outcome, easy and inexpensive methods aiming at the detection of liver ammonia accumulation in the clinical setting remain unavailable. Thus, herein we have developed a morphological method, based on the utilization of Nessler´s reagent, to accurately and precisely detect the accumulation of ammonia in biological tissue. We have validated our method against a commercially available kit in mouse tissue samples and, by using this modified method, we have confirmed the hepatic accumulation of ammonia in clinical and animal models of acute and chronic advanced liver injury as well as in the progression of fatty liver disease. Overall, we propose a morphological method for ammonia detection in liver that correlates well with the degree of liver disease severity and therefore can be potentially used to predict patient outcome. PMID:28319158

A pilot study to explore the feasibility of using theClinical Care Classification System for developing a reliable costing method for nursing services.

PubMed

Dykes, Patricia C; Wantland, Dean; Whittenburg, Luann; Lipsitz, Stuart; Saba, Virginia K

2013-01-01

While nursing activities represent a significant proportion of inpatient care, there are no reliable methods for determining nursing costs based on the actual services provided by the nursing staff. Capture of data to support accurate measurement and reporting on the cost of nursing services is fundamental to effective resource utilization. Adopting standard terminologies that support tracking both the quality and the cost of care could reduce the data entry burden on direct care providers. This pilot study evaluated the feasibility of using a standardized nursing terminology, the Clinical Care Classification System (CCC), for developing a reliable costing method for nursing services. Two different approaches are explored; the Relative Value Unit RVU and the simple cost-to-time methods. We found that the simple cost-to-time method was more accurate and more transparent in its derivation than the RVU method and may support a more consistent and reliable approach for costing nursing services.

A morphological method for ammonia detection in liver.

PubMed

Gutiérrez-de-Juan, Virginia; López de Davalillo, Sergio; Fernández-Ramos, David; Barbier-Torres, Lucía; Zubiete-Franco, Imanol; Fernández-Tussy, Pablo; Simon, Jorge; Lopitz-Otsoa, Fernando; de Las Heras, Javier; Iruzubieta, Paula; Arias-Loste, María Teresa; Villa, Erica; Crespo, Javier; Andrade, Raúl; Lucena, M Isabel; Varela-Rey, Marta; Lu, Shelly C; Mato, José M; Delgado, Teresa Cardoso; Martínez-Chantar, María-Luz

2017-01-01

Hyperammonemia is a metabolic condition characterized by elevated levels of ammonia and a common event in acute liver injury/failure and chronic liver disease. Even though hepatic ammonia levels are potential predictive factors of patient outcome, easy and inexpensive methods aiming at the detection of liver ammonia accumulation in the clinical setting remain unavailable. Thus, herein we have developed a morphological method, based on the utilization of Nessler´s reagent, to accurately and precisely detect the accumulation of ammonia in biological tissue. We have validated our method against a commercially available kit in mouse tissue samples and, by using this modified method, we have confirmed the hepatic accumulation of ammonia in clinical and animal models of acute and chronic advanced liver injury as well as in the progression of fatty liver disease. Overall, we propose a morphological method for ammonia detection in liver that correlates well with the degree of liver disease severity and therefore can be potentially used to predict patient outcome.

The Human Microbiome and Understanding the 16S rRNA Gene in Translational Nursing Science.

PubMed

Ames, Nancy J; Ranucci, Alexandra; Moriyama, Brad; Wallen, Gwenyth R

As more is understood regarding the human microbiome, it is increasingly important for nurse scientists and healthcare practitioners to analyze these microbial communities and their role in health and disease. 16S rRNA sequencing is a key methodology in identifying these bacterial populations that has recently transitioned from use primarily in research to having increased utility in clinical settings. The objectives of this review are to (a) describe 16S rRNA sequencing and its role in answering research questions important to nursing science; (b) provide an overview of the oral, lung, and gut microbiomes and relevant research; and (c) identify future implications for microbiome research and 16S sequencing in translational nursing science. Sequencing using the 16S rRNA gene has revolutionized research and allowed scientists to easily and reliably characterize complex bacterial communities. This type of research has recently entered the clinical setting, one of the best examples involving the use of 16S sequencing to identify resistant pathogens, thereby improving the accuracy of bacterial identification in infection control. Clinical microbiota research and related requisite methods are of particular relevance to nurse scientists-individuals uniquely positioned to utilize these techniques in future studies in clinical settings.

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

Utilizing Chinese Admission Records for MACE Prediction of Acute Coronary Syndrome

PubMed Central

Hu, Danqing; Huang, Zhengxing; Chan, Tak-Ming; Dong, Wei; Lu, Xudong; Duan, Huilong

2016-01-01

Background: Clinical major adverse cardiovascular event (MACE) prediction of acute coronary syndrome (ACS) is important for a number of applications including physician decision support, quality of care assessment, and efficient healthcare service delivery on ACS patients. Admission records, as typical media to contain clinical information of patients at the early stage of their hospitalizations, provide significant potential to be explored for MACE prediction in a proactive manner. Methods: We propose a hybrid approach for MACE prediction by utilizing a large volume of admission records. Firstly, both a rule-based medical language processing method and a machine learning method (i.e., Conditional Random Fields (CRFs)) are developed to extract essential patient features from unstructured admission records. After that, state-of-the-art supervised machine learning algorithms are applied to construct MACE prediction models from data. Results: We comparatively evaluate the performance of the proposed approach on a real clinical dataset consisting of 2930 ACS patient samples collected from a Chinese hospital. Our best model achieved 72% AUC in MACE prediction. In comparison of the performance between our models and two well-known ACS risk score tools, i.e., GRACE and TIMI, our learned models obtain better performances with a significant margin. Conclusions: Experimental results reveal that our approach can obtain competitive performance in MACE prediction. The comparison of classifiers indicates the proposed approach has a competitive generality with datasets extracted by different feature extraction methods. Furthermore, our MACE prediction model obtained a significant improvement by comparison with both GRACE and TIMI. It indicates that using admission records can effectively provide MACE prediction service for ACS patients at the early stage of their hospitalizations. PMID:27649220

An International Ki67 Reproducibility Study in Adrenal Cortical Carcinoma.

PubMed

Papathomas, Thomas G; Pucci, Eugenio; Giordano, Thomas J; Lu, Hao; Duregon, Eleonora; Volante, Marco; Papotti, Mauro; Lloyd, Ricardo V; Tischler, Arthur S; van Nederveen, Francien H; Nose, Vania; Erickson, Lori; Mete, Ozgur; Asa, Sylvia L; Turchini, John; Gill, Anthony J; Matias-Guiu, Xavier; Skordilis, Kassiani; Stephenson, Timothy J; Tissier, Frédérique; Feelders, Richard A; Smid, Marcel; Nigg, Alex; Korpershoek, Esther; van der Spek, Peter J; Dinjens, Winand N M; Stubbs, Andrew P; de Krijger, Ronald R

2016-04-01

Despite the established role of Ki67 labeling index in prognostic stratification of adrenocortical carcinomas and its recent integration into treatment flow charts, the reproducibility of the assessment method has not been determined. The aim of this study was to investigate interobserver variability among endocrine pathologists using a web-based virtual microscopy approach. Ki67-stained slides of 76 adrenocortical carcinomas were analyzed independently by 14 observers, each according to their method of preference including eyeballing, formal manual counting, and digital image analysis. The interobserver variation was statistically significant (P<0.001) in the absence of any correlation between the various methods. Subsequently, 61 static images were distributed among 15 observers who were instructed to follow a category-based scoring approach. Low levels of interobserver (F=6.99; Fcrit=1.70; P<0.001) as well as intraobserver concordance (n=11; Cohen κ ranging from -0.057 to 0.361) were detected. To improve harmonization of Ki67 analysis, we tested the utility of an open-source Galaxy virtual machine application, namely Automated Selection of Hotspots, in 61 virtual slides. The software-provided Ki67 values were validated by digital image analysis in identical images, displaying a strong correlation of 0.96 (P<0.0001) and dividing the cases into 3 classes (cutoffs of 0%-15%-30% and/or 0%-10%-20%) with significantly different overall survivals (P<0.05). We conclude that current practices in Ki67 scoring assessment vary greatly, and interobserver variation sets particular limitations to its clinical utility, especially around clinically relevant cutoff values. Novel digital microscopy-enabled methods could provide critical aid in reducing variation, increasing reproducibility, and improving reliability in the clinical setting.

Physician Service Attribution Methods for Examining Provision of Low-Value Care.

PubMed

Chang, Eva; Buist, Diana Sm; Handley, Matthew; Pardee, Roy; Gundersen, Gabrielle; Reid, Robert J

2016-01-01

There has been significant research on provider attribution for quality and cost. Low-value care is an area of heightened focus, with little of the focus being on measurement; a key methodological decision is how to attribute delivered services and procedures. We illustrate the difference in relative and absolute physician- and panel-attributed services and procedures using overuse in cervical cancer screening. A retrospective, cross-sectional study in an integrated health care system. We used 2013 physician-level data from Group Health Cooperative to calculate two utilization attributions: (1) panel attribution with the procedure assigned to the physician's predetermined panel, regardless of who performed the procedure; and (2) physician attribution with the procedure assigned to the performing physician. We calculated the percentage of low-value cervical cancer screening tests and ranked physicians within the clinic using the two utilization attribution methods. The percentage of low-value cervical cancer screening varied substantially between physician and panel attributions. Across the whole delivery system, median panel- and physician-attributed percentages were 15 percent and 10 percent, respectively. Among sampled clinics, panel-attributed percentages ranged between 10 percent and 17 percent, and physician-attributed percentages ranged between 9 percent and 13 percent. Within a clinic, median panel-attributed screening percentage was 17 percent (range 0 percent-27 percent) and physician-attributed percentage was 11 percent (range 0 percent-24 percent); physician rank varied by attribution method. The attribution method is an important methodological decision when developing low-value care measures since measures may ultimately have an impact on national benchmarking and quality scores. Cross-organizational dialogue and transparency in low-value care measurement will become increasingly important for all stakeholders.

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.

Dynamic functional imaging of brain glucose utilization using fPET-FDG

DOE PAGES

Villien, Marjorie; Wey, Hsiao-Ying; Mandeville, Joseph B.; ...

2014-06-14

We report that glucose is the principal source of energy for the brain and yet the dynamic response of glucose utilization to changes in brain activity is still not fully understood. Positron emission tomography (PET) allows quantitative measurement of glucose metabolism using 2-[18F]-fluorodeoxyglucose (FDG). However, FDG PET in its current form provides an integral (or average) of glucose consumption over tens of minutes and lacks the temporal information to capture physiological alterations associated with changes in brain activity induced by tasks or drug challenges. Traditionally, changes in glucose utilization are inferred by comparing two separate scans, which significantly limits themore » utility of the method. We report a novel method to track changes in FDG metabolism dynamically, with higher temporal resolution than exists to date and within a single session. Using a constant infusion of FDG, we demonstrate that our technique (termed fPET-FDG) can be used in an analysis pipeline similar to fMRI to define within-session differential metabolic responses. We use visual stimulation to demonstrate the feasibility of this method. Ultimately, this new method has a great potential to be used in research protocols and clinical settings since fPET-FDG imaging can be performed with most PET scanners and data acquisition and analysis are straightforward. fPET-FDG is a highly complementary technique to MRI and provides a rich new way to observe functional changes in brain metabolism.« less

Clinical applications of selected binaural effects.

PubMed

Noffsinger, D

1982-01-01

Examination was made of the behaviors exhibited on selected binaural tasks by 556 persons with diagnosed peripheral hearing loss or central nervous system damage. The tasks used included loudness balancing (LB), intracranial midline imaging (MI), masking level differences (MLD), and binaural beats (BB). The methods used were chosen for their clinical utility. Loudness balancing and midline imaging were of the most diagnostic value when hearing loss was present. Masking level differences were best at detecting pathology which did not produce hearing loss. None of the techniques were sensitive to cortical damage.

Clinical utility of an automated instrument for gram staining single slides.

PubMed

Baron, Ellen Jo; Mix, Samantha; Moradi, Wais

2010-06-01

Gram stains of 87 different clinical samples were prepared by the laboratory's conventional methods (automated or manual) and by a new single-slide-type automated staining instrument, GG&B AGS-1000. Gram stains from either heat- or methanol-fixed slides stained with the new instrument were easy to interpret, and results were essentially the same as those from the methanol-fixed slides prepared as a part of the routine workflow. This instrument is well suited to a rapid-response laboratory where Gram stain requests are commonly received on a stat basis.

Chronic disorders of consciousness: role of neuroimaging

NASA Astrophysics Data System (ADS)

Kremneva, E.; Sergeev, D.; Zmeykina, E.; Legostaeva, L.; Piradov, M.

2017-08-01

Chronic disorders of consciousness are clinically challenging conditions, and advanced methods of imaging for better understanding of diagnosis and prognosis are needed. Recent functional neuroradiological studies utilizing PET and fMRI demonstrated that besides widespread neuronal loss disruption of interconnection between certain cortical networks after the injury may also play the leading role in the development of behaviourally assessed unresponsiveness. Functional and structural connectivity, evaluated by neuroimaging approaches, may correlate with clinical status and may also play prognostic role. Integration of data from various diagnostic modalities is needed for further progress in this area.

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.

Assessment of the Utility of Cytology and Flow Cytometry of Cerebrospinal Fluid Samples in Clinical Practice.

PubMed

Nam, Anna S; Giorgadze, Tamara; Tam, Wayne; Chadburn, Amy

2018-01-01

We sought to assess the utility and limitations of both flow cytometry (FC) and cytology for the analysis of cerebrospinal fluid (CSF) in a practical clinical setting. A total of 393 consecutive CSF samples from 171 patients submitted for both cytomorphologic and FC assessments were analyzed. Both FC and cytology findings were negative for malignancy in 315/393 samples (80%), and either positive (POS) or suspicious/atypical (SUSP/AT) in 7% of samples. This resulted in high agreement between FC and cytology (87%). Minor discrepancies were present in 4% of the cases. In 28 samples, an abnormal population was detected by FC but not by cytology. FC and cytology are important complementary methods for analyzing CSF samples. In cases where cytology is SUSP/AT and FC is inconclusive or negative, additional specimens should be submitted for immunostaining, cytogenetics, and/or molecular studies. © 2018 S. Karger AG, Basel.

Learning neuroendoscopy with an exoscope system (video telescopic operating monitor): Early clinical results.

PubMed

Parihar, Vijay; Yadav, Y R; Kher, Yatin; Ratre, Shailendra; Sethi, Ashish; Sharma, Dhananjaya

2016-01-01

Steep learning curve is found initially in pure endoscopic procedures. Video telescopic operating monitor (VITOM) is an advance in rigid-lens telescope systems provides an alternative method for learning basics of neuroendoscopy with the help of the familiar principle of microneurosurgery. The aim was to evaluate the clinical utility of VITOM as a learning tool for neuroendoscopy. Video telescopic operating monitor was used 39 cranial and spinal procedures and its utility as a tool for minimally invasive neurosurgery and neuroendoscopy for initial learning curve was studied. Video telescopic operating monitor was used in 25 cranial and 14 spinal procedures. Image quality is comparable to endoscope and microscope. Surgeons comfort improved with VITOM. Frequent repositioning of scope holder and lack of stereopsis is initial limiting factor was compensated for with repeated procedures. Video telescopic operating monitor is found useful to reduce initial learning curve of neuroendoscopy.

An examination of generalized anxiety disorder and dysthymia utilizing the Rorschach inkblot method.

PubMed

Slavin-Mulford, Jenelle; Clements, Alyssa; Hilsenroth, Mark; Charnas, Jocelyn; Zodan, Jennifer

2016-06-30

This study examined transdiagnostic features of generalized anxiety disorder (GAD) and dysthymia in an outpatient clinical sample. Fifteen patients who met DSM-IV criteria for GAD and twenty-one patients who met DSM-IV criteria for dysthymia but who did not have comorbid anxiety disorder were evaluated utilizing the Rorschach. Salient clinical variables were then compared. Results showed that patients with GAD scored significantly higher on variables related to cognitive agitation and a desire/need for external soothing. In addition, there was a trend for patients with GAD to produce higher scores on a measure of ruminative focus on negative aspects of the self. Thus, not surprisingly, GAD patients' experienced more distress than the dysthymic patients. The implications of these findings are discussed with regards to better understanding the shared and distinct features of GAD and dysthymia. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The experience of older patients with cancer in phase 1 clinical trials: a qualitative case series.

PubMed

Kvale, Elizabeth A; Woodby, Lesa; Williams, Beverly Rosa

2010-11-01

This article explores the experiences of older patients with cancer in phase 1 clinical trials. Conducting a case series of face-to-face, in-depth, open-ended interviews and using qualitative methods of analysis, we find that the psychosocial process of social comparison is relevant for understanding older adults' phase 1 clinical trial participation. Social comparison influences decisions to enroll in a phase 1 clinical trial, shapes perceptions of supportive care needs, and encourages the utilization of hope. Additional research should develop strategies for addressing supportive care needs among this patient cohort whose use of social comparison can inhibit articulation of pain, suffering, and symptom burden as well as use of informal support systems.

Precision and accuracy of clinical quantification of myocardial blood flow by dynamic PET: A technical perspective.

PubMed

Moody, Jonathan B; Lee, Benjamin C; Corbett, James R; Ficaro, Edward P; Murthy, Venkatesh L

2015-10-01

A number of exciting advances in PET/CT technology and improvements in methodology have recently converged to enhance the feasibility of routine clinical quantification of myocardial blood flow and flow reserve. Recent promising clinical results are pointing toward an important role for myocardial blood flow in the care of patients. Absolute blood flow quantification can be a powerful clinical tool, but its utility will depend on maintaining precision and accuracy in the face of numerous potential sources of methodological errors. Here we review recent data and highlight the impact of PET instrumentation, image reconstruction, and quantification methods, and we emphasize (82)Rb cardiac PET which currently has the widest clinical application. It will be apparent that more data are needed, particularly in relation to newer PET technologies, as well as clinical standardization of PET protocols and methods. We provide recommendations for the methodological factors considered here. At present, myocardial flow reserve appears to be remarkably robust to various methodological errors; however, with greater attention to and more detailed understanding of these sources of error, the clinical benefits of stress-only blood flow measurement may eventually be more fully realized.

Illustrating idiographic methods for translation research: moderation effects, natural clinical experiments, and complex treatment-by-subgroup interactions.

PubMed

Ridenour, Ty A; Wittenborn, Andrea K; Raiff, Bethany R; Benedict, Neal; Kane-Gill, Sandra

2016-03-01

A critical juncture in translation research involves the preliminary studies of intervention tools, provider training programs, policies, and other mechanisms used to leverage knowledge garnered at one translation stage into another stage. Potentially useful for such studies are rigorous techniques for conducting within-subject clinical trials, which have advanced incrementally over the last decade. However, these methods have largely not been utilized within prevention or translation contexts. The purpose of this manuscript is to demonstrate the flexibility, wide applicability, and rigor of idiographic clinical trials for preliminary testing of intervention mechanisms. Specifically demonstrated are novel uses of state-space modeling for testing intervention mechanisms of short-term outcomes, identifying heterogeneity in and moderation of within-person treatment mechanisms, a horizontal line plot to refine sampling design during the course of a clinic-based experimental study, and the need to test a treatment's efficacy as treatment is administered along with (e.g., traditional 12-month outcomes).

Measuring use of electronic health record functionality using system audit information.

PubMed

Bowes, Watson A

2010-01-01

Meaningful and efficient methods for measuring Electronic Health Record (EHR) adoption and functional usage patterns have recently become important for hospitals, clinics, and health care networks in the United State due to recent government initiatives to increase EHR use. To date, surveys have been the method of choice to measure EHR adoption. This paper describes another method for measuring EHR adoption which capitalizes on audit logs, which are often common components of modern EHRs. An Audit Data Mart is described which identified EHR functionality within 836 Departments, within 22 Hospitals and 170 clinics at Intermountain Healthcare, a large integrated delivery system. The Audit Data Mart successfully identified important and differing EHR functional usage patterns. These patterns were useful in strategic planning, tracking EHR implementations, and will likely be utilized to assist in documentation of "Meaningful Use" of EHR functionality.

An ex vivo approach to botanical-drug interactions: A proof of concept study

PubMed Central

Wang, Xinwen; Zhu, Hao-Jie; Munoz, Juliana; Gurley, Bill J.; Markowitz, John S.

2015-01-01

Ethnopharmacological relevance Botanical medicines are frequently used in combination with therapeutic drugs, imposing a risk for harmful botanical-drug interactions (BDIs). Among the existing BDI evaluation methods, clinical studies are the most desirable, but due to their expense and protracted time-line for completion, conventional in vitro methodologies remain the most frequently used BDI assessment tools. However, many predictions generated from in vitro studies are inconsistent with clinical findings. Accordingly, the present study aimed to develop a novel ex vivo approach for BDI assessment and expand the safety evaluation methodoloy in applied ethnopharmacological research. Materials and Methods This approach differs from conventional in vitro methods in that rather than botanical extracts or individual phytochemicals being prepared in artificial buffers, human plasma/serum collected from a limited number of subjects administered botanical supplements was utilized to assess BDIs. To validate the methodology, human plasma/serum samples collected from healthy subjects administered either milk thistle or goldenseal extracts were utilized in incubation studies to determine their potential inhibitory effects on CYP2C9 and CYP3A4/5, respectively. Silybin A and B, two principal milk thistle phytochemicals, and hydrastine and berberine, the purported active constituents in goldenseal, were evaluated in both phosphate buffer and human plasma based in vitro incubation systems. Results Ex vivo study results were consistent with formal clinical study findings for the effect of milk thistle on the disposition of tolbutamide, a CYP2C9 substrate, and for goldenseal’s influence on the pharmacokinetics of midazolam, a widely accepted CYP3A4/5 substrate. Compared to conventional in vitro BDI methodologies of assessment, the introduction of human plasma into the in vitro study model changed the observed inhibitory effect of silybinA, silybin B and hydrastine and berberine on CYP2C9 and CYP3A4/5, respectively, results which more closely mirrored those generated in clinical study. Conclusions Data from conventional buffer-based in vitro studies were less predictive than the ex vivo assessments. Thus, this novel ex vivo approach may be more effective at predicting clinically relevant BDIs than conventional in vitro methods. PMID:25623616

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.

[Isolation and identification methods of enterobacteria group and its technological advancement].

PubMed

Furuta, Itaru

2007-08-01

In the last half-century, isolation and identification methods of enterobacteria groups have markedly improved by technological advancement. Clinical microbiology tests have changed overtime from tube methods to commercial identification kits and automated identification. Tube methods are the original method for the identification of enterobacteria groups, that is, a basically essential method to recognize bacterial fermentation and biochemical principles. In this paper, traditional tube tests are discussed, such as the utilization of carbohydrates, indole, methyl red, and citrate and urease tests. Commercial identification kits and automated instruments by computer based analysis as current methods are also discussed, and those methods provide rapidity and accuracy. Nonculture techniques of nucleic acid typing methods using PCR analysis, and immunochemical methods using monoclonal antibodies can be further developed.

Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease

PubMed Central

Sayiner, Mehmet; Stepanova, Maria; Pham, Huong; Noor, Bashir; Walters, Mercedes; Younossi, Zobair M

2016-01-01

Background Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease associated with increased liver-related mortality. Additionally, NAFLD could potentially impair health-related quality of life. Although an approved treatment for NAFLD does not exist, a number of new drugs for treatment of NAFLD are being developed. As the efficacy and safety of these regimens are being established, their cost-effectiveness, which requires the use of quality of life metrics and health utility scores to quality-adjusted outcomes, must also be assessed. The aim of this study was to report quality of life and health utilities in patients with NAFLD with and without cirrhosis for future use. Methods Patients with NAFLD were seen in an outpatient clinic setting. Each patient had extensive clinical data and completed the Short Form-36 (SF-36 V.1) questionnaire. The SF-6D health utility scores were calculated. Results There were 89 patients with the spectrum of NAFLD completed the SF-36 questionnaire: 59 with non-cirrhotic NAFLD and 30 with cirrhosis. Patients with NAFLD had significantly lower quality of life and health utility scores than the general population (all p<0.0001). Furthermore, patients with cirrhosis had lower quality of life and utility scores than non-cirrhotic NAFLD patients: SF-6D 0.660±0.107 in non-cirrhotic NAFLD vs 0.551±0.138 in cirrhotic NAFLD (p=0.0003). Conclusions Health utilities and quality of life scores are impaired in patients with cirrhotic NAFLD. These values should be used in cost-effectiveness analysis of the upcoming treatment regimens for advanced NAFLD. PMID:27648297

Understanding low uptake of contraceptives in resource-limited settings: a mixed-methods study in rural Burundi.

PubMed

Ndayizigiye, M; Fawzi, M C Smith; Lively, C Thompson; Ware, N C

2017-03-15

Family planning can reduce deaths, improve health, and facilitate economic development in resource-limited settings. Yet, modern contraceptive methods are often underused. This mixed-methods study, conducted in rural Burundi, sought to explain low uptake of contraceptives by identifying utilization barriers. Results may inform development of family planning interventions in Burundi and elsewhere. We investigated uptake of contraceptives among women of reproductive age in two rural districts of Burundi, using an explanatory sequential, mixed-methods research design. We first assessed availability and utilization rates of modern contraceptives through a facility-based survey in 39 health clinics. Barriers to uptake of contraceptives were then explored through qualitative interviews (N = 10) and focus groups (N = 7). Contraceptives were generally available in the 39 clinics studied, yet uptake of family planning averaged only 2.96%. Greater uptake was positively associated with the number of health professionals engaged and trained in family planning service provision, and with the number of different types of contraceptives available. Four uptake barriers were identified: (1) lack of providers to administer contraception, (2) lack of fit between available and preferred contraceptive methods, (3) a climate of fear surrounding contraceptive use, and (4) provider refusal to offer family planning services. Where resources are scarce, availability of modern contraceptives alone will likely not ensure uptake. Interventions addressing multiple uptake barriers simultaneously have the greatest chance of success. In rural Burundi, examples are community distribution of contraceptive methods, public information campaigns, improved training for health professionals and community health workers, and strengthening of the health infrastructure.

Polarized hyperspectral imaging system for in vivo detection of vulvar lichen sclerosis

NASA Astrophysics Data System (ADS)

Qu, Yingjie; Ren, Wenqi; Liu, Songde; Liu, Peng; Xie, Lan; Zhang, Xiaoyuan; Zhang, Shiwu; Chang, Shufang; Xu, Ronald

2016-03-01

Vulvar lichen sclerosis (VLS) is a chronic, inflammatory and mucocutaneous disease of extragenital skin, which often goes undetected for years. The underlying causes are associated with the decrease of VEGF that reduces the blood oxygenation of vulva and the structural changes in the collagen fibrils, which can lead to scarring of the affected area. However, few methods are available for quantitative detection of VLS. Clinician's examinations are subjective and may lead to misdiagnosis. Spectroscopy is a potentially effective method for noninvasive detection of VLS. In this paper, we developed a polarized, hyperspectral imaging system for quantitative assessment. The system utilized a hyperspectral camera to collect the reflectance images of the entire vulva under Xenon lamp illumination with and without a polarizer in front of the fiber. One image (Ipar) acquired with the AOTF parallel to the polarization of illumination and the other image (Iper) acquired with the AOTF perpendicular to the illumination. This paper compares polarized images of VLS in a pilot clinical study. The collected reflectance data under Xenon lamp illumination without a polarizer are calibrated and the hyperspectral signals are extracted. An IRB approved clinical trial was carried out to evaluate the clinical utility for VLS detection. Our pilot study has demonstrated the technical potential of using this polarized hyperspectral imaging system for in vivo detection of vulvar lichen sclerosis.

Location of residence associated with the likelihood of patient visit to the preoperative assessment clinic

PubMed Central

Seidel, Judy E; Beck, Cynthia A; Pocobelli, Gaia; Lemaire, Jane B; Bugar, Jennifer M; Quan, Hude; Ghali, William A

2006-01-01

Background Outpatient preoperative assessment clinics were developed to provide an efficient assessment of surgical patients prior to surgery, and have demonstrated benefits to patients and the health care system. However, the centralization of preoperative assessment clinics may introduce geographical barriers to utilization that are dependent on where a patient lives with respect to the location of the preoperative assessment clinic. Methods The association between geographical distance from a patient's place of residence to the preoperative assessment clinic, and the likelihood of a patient visit to the clinic prior to surgery, was assessed for all patients undergoing surgery at a tertiary health care centre in a major Canadian city. The odds of attending the preoperative clinic were adjusted for patient characteristics and clinical factors. Results Patients were less likely to visit the preoperative assessment clinic prior to surgery as distance from the patient's place of residence to the clinic increased (adjusted OR = 0.52, 95% CI 0.44–0.63 for distances between 50–100 km, and OR = 0.26, 95% CI 0.21–0.31 for distances greater than 250 km). This 'distance decay' effect was remarkable for all surgical specialties. Conclusion The present study demonstrates that the likelihood of a patient visiting the preoperative assessment clinic appears to depend on the geographical location of patients' residences. Patients who live closest to the clinic tend to be seen more often than patients who live in rural and remote areas. This observation may have implications for achieving the goals of equitable access, and optimal patient care and resource utilization in a single universal insurer health care system. PMID:16504058

Structural equation modeling in pediatric psychology: overview and review of applications.

PubMed

Nelson, Timothy D; Aylward, Brandon S; Steele, Ric G

2008-08-01

To describe the use of structural equation modeling (SEM) in the Journal of Pediatric Psychology (JPP) and to discuss the usefulness of SEM applications in pediatric psychology research. The use of SEM in JPP between 1997 and 2006 was examined and compared to leading journals in clinical psychology, clinical child psychology, and child development. SEM techniques were used in <4% of the empirical articles appearing in JPP between 1997 and 2006. SEM was used less frequently in JPP than in other clinically relevant journals over the past 10 years. However, results indicated a recent increase in JPP studies employing SEM techniques. SEM is an under-utilized class of techniques within pediatric psychology research, although investigations employing these methods are becoming more prevalent. Despite its infrequent use to date, SEM is a potentially useful tool for advancing pediatric psychology research with a number of advantages over traditional statistical methods.

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

Detoxification in Naturopathic Medicine: A Survey

PubMed Central

Montalto, Melissa; Lovejoy, Jennifer; Weber, Wendy

2011-01-01

Abstract Objectives This study sought to assess the use of clinical detoxification therapies used by licensed naturopathic doctors (NDs) in the United States. Design This was a qualitative, descriptive, online survey of a convenience sample of NDs. Methods An online survey was conducted of NDs who were licensed in the United States. Responses were analyzed descriptively regarding the use of clinical detoxification therapies. Respondents were recruited from a membership list provided by the American Association of Naturopathic Physicians, and from alumni e-mail lists of Council of Naturopathic Medical Education accredited naturopathic medical schools. Results Surveys were sent out to 1442 e-mail addresses (261 were returned to sender); a total of 196 respondents completed the survey (16.6%). Ninety-two percent (92%) of respondents reported using clinical detoxification therapies. Over 75% of respondents utilized detoxification therapies primarily to treat patients for environmental exposures, general cleansing/preventive medicine, gastrointestinal disorders, and autoimmune disease. Regarding methods used, >75% reported using dietary measures, reducing environmental exposures, and using botanicals as detoxification therapies. Eighty-three percent (83%) of NDs surveyed reported using follow-up measurements to determine efficacy of detoxification therapies. The most common were patient symptom questionnaires (66%), patient medical histories (54%), and urinary provocative challenge testing (53%). Conclusions The majority of NDs responding to this survey reported routine use of clinical detoxification therapies to treat a range of medical conditions utilizing multiple therapeutic approaches. Although the majority of NDs reported using some follow-up measurements after detoxification therapy, few of these are an objective means to determine treatment efficacy. Further research is needed in the field of complementary and alternative medicine clinical detoxification to determine the safety and efficacy of these approaches. PMID:22103982

Utilization of breast cancer screening methods in a developing nation: results from a nationally representative sample of Malaysian households.

PubMed

Dunn, Richard A; Tan, Andrew K G

2011-01-01

As is the case in many developing nations, previous studies of breast cancer screening behavior in Malaysia have used relatively small samples that are not nationally representative, thereby limiting the generalizability of results. Therefore, this study uses nationally representative data from the Malaysia Non-Communicable Disease Surveillance-1 to investigate the role of socio-economic status on breast cancer screening behavior in Malaysia, particularly differences in screening behaviour between ethnic groups. The decisions of 816 women above age 40 in Malaysia to screen for breast cancer using mammography, clinical breast exams (CBE), and breast self-exams (BSE) are modeled using logistic regression. Results indicate that after adjusting for differences in age, education, household income, marital status, and residential location, Malay women are less likely than Chinese and Indian women to utilize mammography, but more likely to perform BSE. Education level and urban residence are positively associated with utilization of each method, but these relationships vary across ethnicity. Higher education levels are strongly related to using each screening method among Chinese women, but have no statistically significant relationship to screening among Malays. © 2011 Wiley Periodicals, Inc.

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…

Islet Oxygen Consumption Rate (OCR) Dose Predicts Insulin Independence in Clinical Islet Autotransplantation.

PubMed

Papas, Klearchos K; Bellin, Melena D; Sutherland, David E R; Suszynski, Thomas M; Kitzmann, Jennifer P; Avgoustiniatos, Efstathios S; Gruessner, Angelika C; Mueller, Kathryn R; Beilman, Gregory J; Balamurugan, Appakalai N; Loganathan, Gopalakrishnan; Colton, Clark K; Koulmanda, Maria; Weir, Gordon C; Wilhelm, Josh J; Qian, Dajun; Niland, Joyce C; Hering, Bernhard J

2015-01-01

Reliable in vitro islet quality assessment assays that can be performed routinely, prospectively, and are able to predict clinical transplant outcomes are needed. In this paper we present data on the utility of an assay based on cellular oxygen consumption rate (OCR) in predicting clinical islet autotransplant (IAT) insulin independence (II). IAT is an attractive model for evaluating characterization assays regarding their utility in predicting II due to an absence of confounding factors such as immune rejection and immunosuppressant toxicity. Membrane integrity staining (FDA/PI), OCR normalized to DNA (OCR/DNA), islet equivalent (IE) and OCR (viable IE) normalized to recipient body weight (IE dose and OCR dose), and OCR/DNA normalized to islet size index (ISI) were used to characterize autoislet preparations (n = 35). Correlation between pre-IAT islet product characteristics and II was determined using receiver operating characteristic analysis. Preparations that resulted in II had significantly higher OCR dose and IE dose (p<0.001). These islet characterization methods were highly correlated with II at 6-12 months post-IAT (area-under-the-curve (AUC) = 0.94 for IE dose and 0.96 for OCR dose). FDA/PI (AUC = 0.49) and OCR/DNA (AUC = 0.58) did not correlate with II. OCR/DNA/ISI may have some utility in predicting outcome (AUC = 0.72). Commonly used assays to determine whether a clinical islet preparation is of high quality prior to transplantation are greatly lacking in sensitivity and specificity. While IE dose is highly predictive, it does not take into account islet cell quality. OCR dose, which takes into consideration both islet cell quality and quantity, may enable a more accurate and prospective evaluation of clinical islet preparations.

Use of Developmental Milestones in Pediatric Residency Training and Practice: Time to Rethink the Meaning of the Mean

PubMed Central

Sices, Laura

2009-01-01

Objective Pediatricians frequently report the use of developmental milestones in monitoring young children’s development, despite evidence that use of screening tools improves detection of developmental delays. Methods Core texts in the field of pediatrics and developmental-behavioral pediatrics were reviewed for content and presentation on child development. Most texts included and many focused on developmental milestones, many with an emphasis on 50th percentile milestone data. Problems and limitations in the use of 50th percentile milestones to monitor young children’s development and to identify children whose development is suspicious for delay, include questionable utility in clinical decision making and the potential to increase parental anxiety. Results The recommendation is made to reconsider a focus on 50th percentile milestone data in pediatric training and practice, in favor of measures that have better clinical utility and are more psychometrically sound. Conclusion A conceptual approach to the presentation of developmental milestones differentiates the use of the 10th, 50th, and 90th percentiles of age of achievement of skills, based on the clinical purpose of surveillance. PMID:17353732

A Next-Generation Sequencing Primer—How Does It Work and What Can It Do?

PubMed Central

Alekseyev, Yuriy O.; Fazeli, Roghayeh; Yang, Shi; Basran, Raveen; Miller, Nancy S.

2018-01-01

Next-generation sequencing refers to a high-throughput technology that determines the nucleic acid sequences and identifies variants in a sample. The technology has been introduced into clinical laboratory testing and produces test results for precision medicine. Since next-generation sequencing is relatively new, graduate students, medical students, pathology residents, and other physicians may benefit from a primer to provide a foundation about basic next-generation sequencing methods and applications, as well as specific examples where it has had diagnostic and prognostic utility. Next-generation sequencing technology grew out of advances in multiple fields to produce a sophisticated laboratory test with tremendous potential. Next-generation sequencing may be used in the clinical setting to look for specific genetic alterations in patients with cancer, diagnose inherited conditions such as cystic fibrosis, and detect and profile microbial organisms. This primer will review DNA sequencing technology, the commercialization of next-generation sequencing, and clinical uses of next-generation sequencing. Specific applications where next-generation sequencing has demonstrated utility in oncology are provided. PMID:29761157

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

PubMed

Kalil, Andre C; Sun, Junfeng

2014-10-01

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

Highly Effective Birth Control Use Before and After Women's Incarceration

PubMed Central

Chen, Hsiang-Feng; Cropsey, Karen L.; Clarke, Jennifer G.; Kelly, Patricia J.

2015-01-01

Abstract Background: We examined factors associated with women's use of highly effective birth control before and after incarceration, since women with ongoing criminal justice involvement bear a disproportionate burden of sexual and reproductive health problems, including high rates of unintended pregnancy and inconsistent contraceptive use. Methods: Using a longitudinal study design, we conducted surveys with 102 women in an urban midwestern jail and then followed up with 66 of them 6 months after incarceration. We used stepwise logistic regression to assess individual, interpersonal, resource-based, organizational, and environmental factors associated with utilizing highly effective birth control. Results: Forty-two percent of women reported utilizing highly effective birth control (e.g., sterilization or other highly effective reversible methods) prior to incarceration, and 54% reported using these methods after release from jail (p<0.001). Ninety percent of women reported not wanting to get pregnant. Consistent use of birth control (p=0.001) and alcohol problems (p=0.027) were associated with utilization of highly effective birth control prior to incarceration. Previous pregnancies (p=0.012) were the only factor associated with utilization of highly effective birth control after release from jail. Conclusions: Clinicians and public health practitioners can use findings from this study to develop clinical and intervention efforts aimed at improving unintended-pregnancy prevention among incarcerated women both during their confinement and during the tumultuous period after their release from jail. PMID:25555175

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…

Nonprobability and probability-based sampling strategies in sexual science.

PubMed

Catania, Joseph A; Dolcini, M Margaret; Orellana, Roberto; Narayanan, Vasudah

2015-01-01

With few exceptions, much of sexual science builds upon data from opportunistic nonprobability samples of limited generalizability. Although probability-based studies are considered the gold standard in terms of generalizability, they are costly to apply to many of the hard-to-reach populations of interest to sexologists. The present article discusses recent conclusions by sampling experts that have relevance to sexual science that advocates for nonprobability methods. In this regard, we provide an overview of Internet sampling as a useful, cost-efficient, nonprobability sampling method of value to sex researchers conducting modeling work or clinical trials. We also argue that probability-based sampling methods may be more readily applied in sex research with hard-to-reach populations than is typically thought. In this context, we provide three case studies that utilize qualitative and quantitative techniques directed at reducing limitations in applying probability-based sampling to hard-to-reach populations: indigenous Peruvians, African American youth, and urban men who have sex with men (MSM). Recommendations are made with regard to presampling studies, adaptive and disproportionate sampling methods, and strategies that may be utilized in evaluating nonprobability and probability-based sampling methods.

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.

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

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

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).

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea

2013-11-19

Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.

Recruitment methods in a clinical trial of provoked vulvodynia: Predictors of enrollment.

PubMed

Bachour, Candi C; Bachmann, Gloria A; Foster, David C; Wan, Jim Y; Rawlinson, Leslie A; Brown, Candace S

2017-02-01

Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown. To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health-sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia. Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts. Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p < 0.001). There were no statistically significant differences in efficiency between recruitment methods ( p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.

Medical Students' Knowledge of Fertility Awareness-Based Methods of Family Planning.

PubMed

Danis, Peter G; Kurz, Sally A; Covert, Laura M

2017-01-01

Traditional medical school curricula have not addressed fertility awareness-based methods (FABMs) of family planning. The objective of this study was to assess (1) 3-year medical students' knowledge of FABMs of family planning, (2) their confidence in utilizing that knowledge in patient care, and (3) to implement focused education on FABMs to improve knowledge and confidence. Third-year medical students at one institution in the United States were given a 10-question assessment at the beginning of their OB-GYN rotation. Two lectures about FABMs and their clinical applications were given during the rotation. Students were given the same questions at the end of the rotation. Each questionnaire consisted of eight questions to assess a student's knowledge of FABMs and two questions to assess the student's confidence in sharing and utilizing that information in a clinical setting. McNemar's test was used to analyze the data. Two hundred seventy-seven students completed a pretest questionnaire and 196 students completed the posttest questionnaire. Medical knowledge improved from an initial test score of 38.99% to final test score of 53.57% ( p  < 0.05). Confidence in sharing FABM information with patients (0 = very uncomfortable; 5 = very comfortable) improved from 1.51 to 3.00 ( p  < 0.05). Confidence in utilizing FABM to diagnose and treat gynecologic/reproductive problems (0 = not very confident and 5 = very confident) improved from 1.01 to 3.15 ( p  < 0.05). Medical schools may not include FABMs in OB-GYN curriculum; however, to patients, these methods remain a sought after and valid form of family planning. This study shows that brief, focused education can increase medical students' knowledge of and confidence with FABMs of family planning.

Research to Establish the Validity, Reliability, and Clinical Utility of a Comprehensive Language Assessment of Mandarin

ERIC Educational Resources Information Center

Liu, Xueman Lucy; de Villiers, Jill; Ning, Chunyan; Rolfhus, Eric; Hutchings, Teresa; Lee, Wendy; Jiang, Fan; Zhang, Yi Wen

2017-01-01

Purpose: With no existing gold standard for comparison, challenges arise for establishing the validity of a new standardized Mandarin language assessment normed in mainland China. Method: A new assessment, Diagnostic Receptive and Expressive Assessment of Mandarin (DREAM), was normed with a stratified sample of 969 children ages 2;6 (years;months)…

Investigating Preservice Teachers' Understanding of Balance Concepts Utilizing a Clinical Interview Method and a Virtual Tool

ERIC Educational Resources Information Center

Wilhelm, Jennifer; Matteson, Shirley; She, Xiaobo

2013-01-01

Our study was enacted in university mathematics education classes in the USA with preservice teachers (PSTs). This research focused on PSTs' interview responses that were used to assess their understanding of balance when challenged with tasks involving virtual manipulatives. Siegler's rules were used in analyzing PSTs' responses to…

An Alternative Method To Assess Student's Knowledge about the Concept of Limit in Engineering Teaching.

ERIC Educational Resources Information Center

Troncoso, Carlos; Lavalle, Andrea; Curia, Leopoldo; Daniele, Elaine; Chrobak, Ricardo

The present work has the purpose of showing the evolution of topics or mathematical concepts that are both relevant and with marked grades of abstraction. In this report is specifically described the utilization of metacognitive tools. These include concept maps, the Gowin heuristic vee, and the clinical interview. They are efficient in showing…

The Photo Essay: A Visual Research Method for Educating Obstetricians and Other Health Care Professionals

ERIC Educational Resources Information Center

Quinn, Gwendolyn P.; Albrecht, Terrance L.; Mahan, Charles; Bell-Ellison, Bethany A.; Akintobi, Tabia Henry; Reynolds, Beth; Jeffers, Delores

2006-01-01

When it comes to issues related to low-income women seeking early, adequate, or continuous prenatal care, the public health and medical communities continue to tell women to take responsibility for their actions. Rarely are messages aimed at providers. To help physicians see how factors in their offices and clinics can affect service utilization,…

[Utility of MALDI-TOF MS for the identification of anaerobic bacteria].

PubMed

Zárate, Mariela S; Romano, Vanesa; Nievas, Jimena; Smayevsky, Jorgelina

2014-01-01

The analysis by MALDI-TOF MS (Matrix-assited laser desorption/ionization time-of-flight mass spectrometry) has become a reference method for the identification of microorganisms in Clinical Microbiology. However, data on some groups of microorganisms are still controversial. The aim of this study is to determine the utility of MALDI-TOF MS for the identification of clinical isolates of anaerobic bacteria. One-hundred and six anaerobic bacteria isolates were analyzed by MALDI-TOF MS and by conventional biochemical tests. In those cases where identification by conventional methodology was not applicable or in the face of discordance between sequencing methodologies, 16 S rRNA gene sequence analysis was performed. The conventional method and MALDI-TOF MS agreed at genus and species level by 95.3 %. Concordance in gram-negative bacilli was 91.4% and 100% among gram-positive bacilli; there was also concordance both in the 8 isolates studied in gram-positive cocci and in the single gram-negative cocci included. The data obtained in this study demonstrate that MALDI-TOF MS offers the possibility of adequate identification of anaerobic bacteria. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Gene expression-based molecular diagnostic system for malignant gliomas is superior to histological diagnosis.

PubMed

Shirahata, Mitsuaki; Iwao-Koizumi, Kyoko; Saito, Sakae; Ueno, Noriko; Oda, Masashi; Hashimoto, Nobuo; Takahashi, Jun A; Kato, Kikuya

2007-12-15

Current morphology-based glioma classification methods do not adequately reflect the complex biology of gliomas, thus limiting their prognostic ability. In this study, we focused on anaplastic oligodendroglioma and glioblastoma, which typically follow distinct clinical courses. Our goal was to construct a clinically useful molecular diagnostic system based on gene expression profiling. The expression of 3,456 genes in 32 patients, 12 and 20 of whom had prognostically distinct anaplastic oligodendroglioma and glioblastoma, respectively, was measured by PCR array. Next to unsupervised methods, we did supervised analysis using a weighted voting algorithm to construct a diagnostic system discriminating anaplastic oligodendroglioma from glioblastoma. The diagnostic accuracy of this system was evaluated by leave-one-out cross-validation. The clinical utility was tested on a microarray-based data set of 50 malignant gliomas from a previous study. Unsupervised analysis showed divergent global gene expression patterns between the two tumor classes. A supervised binary classification model showed 100% (95% confidence interval, 89.4-100%) diagnostic accuracy by leave-one-out cross-validation using 168 diagnostic genes. Applied to a gene expression data set from a previous study, our model correlated better with outcome than histologic diagnosis, and also displayed 96.6% (28 of 29) consistency with the molecular classification scheme used for these histologically controversial gliomas in the original article. Furthermore, we observed that histologically diagnosed glioblastoma samples that shared anaplastic oligodendroglioma molecular characteristics tended to be associated with longer survival. Our molecular diagnostic system showed reproducible clinical utility and prognostic ability superior to traditional histopathologic diagnosis for malignant glioma.

Improving Gene Therapy Efficiency through the Enrichment of Human Hematopoietic Stem Cells.

PubMed

Masiuk, Katelyn E; Brown, Devin; Laborada, Jennifer; Hollis, Roger P; Urbinati, Fabrizia; Kohn, Donald B

2017-09-06

Lentiviral vector (LV)-based hematopoietic stem cell (HSC) gene therapy is becoming a promising clinical strategy for the treatment of genetic blood diseases. However, the current approach of modifying 1 × 10 8 to 1 × 10 9 CD34 + cells per patient requires large amounts of LV, which is expensive and technically challenging to produce at clinical scale. Modification of bulk CD34 + cells uses LV inefficiently, because the majority of CD34 + cells are short-term progenitors with a limited post-transplant lifespan. Here, we utilized a clinically relevant, immunomagnetic bead (IB)-based method to purify CD34 + CD38 - cells from human bone marrow (BM) and mobilized peripheral blood (mPB). IB purification of CD34 + CD38 - cells enriched severe combined immune deficiency (SCID) repopulating cell (SRC) frequency an additional 12-fold beyond standard CD34 + purification and did not affect gene marking of long-term HSCs. Transplant of purified CD34 + CD38 - cells led to delayed myeloid reconstitution, which could be rescued by the addition of non-transduced CD38 + cells. Importantly, LV modification and transplantation of IB-purified CD34 + CD38 - cells/non-modified CD38 + cells into immune-deficient mice achieved long-term gene-marked engraftment comparable with modification of bulk CD34 + cells, while utilizing ∼7-fold less LV. Thus, we demonstrate a translatable method to improve the clinical and commercial viability of gene therapy for genetic blood cell diseases. Copyright © 2017 The American Society of Gene and Cell Therapy. Published by Elsevier Inc. All rights reserved.

Dense chitosan surgical membranes produced by a coincident compression-dehydration process

PubMed Central

Dooley, Thomas P.; Ellis, April L.; Belousova, Maria; Petersen, Don; DeCarlo, Arthur A.

2012-01-01

High density chitosan membranes were produced via a novel manufacturing process for use as implantable resorbable surgical membranes. The innovative method utilizes the following three sequential steps: (1) casting an acidic chitosan solution within a silicon mold, followed by freezing; (2) neutralizing the frozen acidic chitosan solution in alkaline solution to facilitate polymerization; and (3) applying coincident compression-dehydration under a vacuum. Resulting membranes of 0.2 – 0.5 mm thickness have densities as high as 1.6 g/cm3. Inclusion of glycerol prior to the compression-dehydration step provides additional physical and clinical handling benefits. The biomaterials exhibit tensile strength with a maximum load as high as 10.9 N at ~ 2.5 mm width and clinically-relevant resistance to suture pull-out with a maximum load as high as 2.2 N. These physical properties were superior to those of a commercial reconstituted collagen membrane. The dense chitosan membranes have excellent clinical handling characteristics, such as pliability and “memory” when wet. They are semi-permeable to small molecules, biodegradable in vitro in lysozyme solution, and the rates of degradation are inversely correlated to the degree of deacetylation. Furthermore, the dense chitosan membranes are biocompatible and resorbable in vivo as demonstrated in a rat oral wound healing model. The unique combination of physical, in vitro, in vivo, and clinical handling properties demonstrate the high utility of dense chitosan membranes produced by this new method. The materials may be useful as surgical barrier membranes, scaffolds for tissue engineering, wound dressings, and as delivery devices for active ingredients. PMID:23565872

Eliciting preferences for priority setting in genetic testing: a pilot study comparing best-worst scaling and discrete-choice experiments.

PubMed

Severin, Franziska; Schmidtke, Jörg; Mühlbacher, Axel; Rogowski, Wolf H

2013-11-01

Given the increasing number of genetic tests available, decisions have to be made on how to allocate limited health-care resources to them. Different criteria have been proposed to guide priority setting. However, their relative importance is unclear. Discrete-choice experiments (DCEs) and best-worst scaling experiments (BWSs) are methods used to identify and weight various criteria that influence orders of priority. This study tests whether these preference eliciting techniques can be used for prioritising genetic tests and compares the empirical findings resulting from these two approaches. Pilot DCE and BWS questionnaires were developed for the same criteria: prevalence, severity, clinical utility, alternatives to genetic testing available, infrastructure for testing and care established, and urgency of care. Interview-style experiments were carried out among different genetics professionals (mainly clinical geneticists, researchers and biologists). A total of 31 respondents completed the DCE and 26 completed the BWS experiment. Weights for the levels of the six attributes were estimated by conditional logit models. Although the results derived from the DCE and BWS experiments differed in detail, we found similar valuation patterns in the DCE and BWS experiments. The respondents attached greatest value to tests with high clinical utility (defined by the availability of treatments that reduce mortality and morbidity) and to testing for highly prevalent conditions. The findings from this study exemplify how decision makers can use quantitative preference eliciting methods to measure aggregated preferences in order to prioritise alternative clinical interventions. Further research is necessary to confirm the survey results.

Automatic learning-based beam angle selection for thoracic IMRT

DOE Office of Scientific and Technical Information (OSTI.GOV)

Amit, Guy; Marshall, Andrea; Purdie, Thomas G., E-mail: tom.purdie@rmp.uhn.ca

Purpose: The treatment of thoracic cancer using external beam radiation requires an optimal selection of the radiation beam directions to ensure effective coverage of the target volume and to avoid unnecessary treatment of normal healthy tissues. Intensity modulated radiation therapy (IMRT) planning is a lengthy process, which requires the planner to iterate between choosing beam angles, specifying dose–volume objectives and executing IMRT optimization. In thorax treatment planning, where there are no class solutions for beam placement, beam angle selection is performed manually, based on the planner’s clinical experience. The purpose of this work is to propose and study a computationallymore » efficient framework that utilizes machine learning to automatically select treatment beam angles. Such a framework may be helpful for reducing the overall planning workload. Methods: The authors introduce an automated beam selection method, based on learning the relationships between beam angles and anatomical features. Using a large set of clinically approved IMRT plans, a random forest regression algorithm is trained to map a multitude of anatomical features into an individual beam score. An optimization scheme is then built to select and adjust the beam angles, considering the learned interbeam dependencies. The validity and quality of the automatically selected beams evaluated using the manually selected beams from the corresponding clinical plans as the ground truth. Results: The analysis included 149 clinically approved thoracic IMRT plans. For a randomly selected test subset of 27 plans, IMRT plans were generated using automatically selected beams and compared to the clinical plans. The comparison of the predicted and the clinical beam angles demonstrated a good average correspondence between the two (angular distance 16.8° ± 10°, correlation 0.75 ± 0.2). The dose distributions of the semiautomatic and clinical plans were equivalent in terms of primary target volume coverage and organ at risk sparing and were superior over plans produced with fixed sets of common beam angles. The great majority of the automatic plans (93%) were approved as clinically acceptable by three radiation therapy specialists. Conclusions: The results demonstrated the feasibility of utilizing a learning-based approach for automatic selection of beam angles in thoracic IMRT planning. The proposed method may assist in reducing the manual planning workload, while sustaining plan quality.« less

Practical utilization of recombinant AAV vector reference standards: focus on vector genomes titration by free ITR qPCR.

PubMed

D'Costa, Susan; Blouin, Veronique; Broucque, Frederic; Penaud-Budloo, Magalie; François, Achille; Perez, Irene C; Le Bec, Christine; Moullier, Philippe; Snyder, Richard O; Ayuso, Eduard

2016-01-01

Clinical trials using recombinant adeno-associated virus (rAAV) vectors have demonstrated efficacy and a good safety profile. Although the field is advancing quickly, vector analytics and harmonization of dosage units are still a limitation for commercialization. AAV reference standard materials (RSMs) can help ensure product safety by controlling the consistency of assays used to characterize rAAV stocks. The most widely utilized unit of vector dosing is based on the encapsidated vector genome. Quantitative polymerase chain reaction (qPCR) is now the most common method to titer vector genomes (vg); however, significant inter- and intralaboratory variations have been documented using this technique. Here, RSMs and rAAV stocks were titered on the basis of an inverted terminal repeats (ITRs) sequence-specific qPCR and we found an artificial increase in vg titers using a widely utilized approach. The PCR error was introduced by using single-cut linearized plasmid as the standard curve. This bias was eliminated using plasmid standards linearized just outside the ITR region on each end to facilitate the melting of the palindromic ITR sequences during PCR. This new "Free-ITR" qPCR delivers vg titers that are consistent with titers obtained with transgene-specific qPCR and could be used to normalize in-house product-specific AAV vector standards and controls to the rAAV RSMs. The free-ITR method, including well-characterized controls, will help to calibrate doses to compare preclinical and clinical data in the field.

Big data in sleep medicine: prospects and pitfalls in phenotyping

PubMed Central

Bianchi, Matt T; Russo, Kathryn; Gabbidon, Harriett; Smith, Tiaundra; Goparaju, Balaji; Westover, M Brandon

2017-01-01

Clinical polysomnography (PSG) databases are a rich resource in the era of “big data” analytics. We explore the uses and potential pitfalls of clinical data mining of PSG using statistical principles and analysis of clinical data from our sleep center. We performed retrospective analysis of self-reported and objective PSG data from adults who underwent overnight PSG (diagnostic tests, n=1835). Self-reported symptoms overlapped markedly between the two most common categories, insomnia and sleep apnea, with the majority reporting symptoms of both disorders. Standard clinical metrics routinely reported on objective data were analyzed for basic properties (missing values, distributions), pairwise correlations, and descriptive phenotyping. Of 41 continuous variables, including clinical and PSG derived, none passed testing for normality. Objective findings of sleep apnea and periodic limb movements were common, with 51% having an apnea–hypopnea index (AHI) >5 per hour and 25% having a leg movement index >15 per hour. Different visualization methods are shown for common variables to explore population distributions. Phenotyping methods based on clinical databases are discussed for sleep architecture, sleep apnea, and insomnia. Inferential pitfalls are discussed using the current dataset and case examples from the literature. The increasing availability of clinical databases for large-scale analytics holds important promise in sleep medicine, especially as it becomes increasingly important to demonstrate the utility of clinical testing methods in management of sleep disorders. Awareness of the strengths, as well as caution regarding the limitations, will maximize the productive use of big data analytics in sleep medicine. PMID:28243157

Development of a hospital-based patient-reported outcome framework for lung cancer patients: a study protocol.

PubMed

Moloczij, Natasha; Gough, Karla; Solomon, Benjamin; Ball, David; Mileshkin, Linda; Duffy, Mary; Krishnasamy, Mei

2018-01-11

Patient-reported outcome (PRO) data is central to the delivery of quality health care. Establishing sustainable, reliable and cost-efficient methods for routine collection and integration of PRO data into health information systems is challenging. This protocol paper describes the design and structure of a study to develop and pilot test a PRO framework to systematically and longitudinally collect PRO data from a cohort of lung cancer patients at a comprehensive cancer centre in Australia. Best-practice guidelines for developing registries aimed at collecting PROs informed the development of this PRO framework. Framework components included: achieving consensus on determining the purpose of the framework, the PRO measures to be included, the data collection time points and collection methods (electronic and paper), establishing processes to safeguard the quality of the data collected and to link the PRO framework to an existing hospital-based lung cancer clinical registry. Lung cancer patients will be invited to give feedback on the PRO measures (PROMs) chosen and the data collection time points and methods. Implementation of the framework will be piloted for 12 months. Then a mixed-methods approach used to explore patient and multidisciplinary perspectives on the feasibility of implementing the framework and linking it to the lung cancer clinical registry, its clinical utility, perceptions of data collection burden, and preliminary assessment of resource costs to integrate, implement and sustain the PRO framework. The PRO data set will include: a quality of life questionnaire (EORTC-QLQ-C30) and the EORTC lung cancer specific module (QLQC-LC-13). These will be collected pre-treatment (baseline), 2, 6 and 12 months post-baseline. Also, four social isolation questions (PROMIS) will be collected at baseline. Identifying and deciding on the overall purpose, clinical utility of data and which PROs to collect from patients requires careful consideration. Our study will explore how PRO data collection processes that link to a clinical data set can be developed and integrated; how PRO systems that are easy for patients to complete and professionals to use in practice can be achieved, and will provide indicative costs of developing and integrating a longitudinal PRO framework into routine hospital data collection systems. This study is not a clinical trial and is therefore not registered in any trial registry. However, it has received human research ethics approval (LNR/16/PMCC/45).

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).

Source-based neurofeedback methods using EEG recordings: training altered brain activity in a functional brain source derived from blind source separation

PubMed Central

White, David J.; Congedo, Marco; Ciorciari, Joseph

2014-01-01

A developing literature explores the use of neurofeedback in the treatment of a range of clinical conditions, particularly ADHD and epilepsy, whilst neurofeedback also provides an experimental tool for studying the functional significance of endogenous brain activity. A critical component of any neurofeedback method is the underlying physiological signal which forms the basis for the feedback. While the past decade has seen the emergence of fMRI-based protocols training spatially confined BOLD activity, traditional neurofeedback has utilized a small number of electrode sites on the scalp. As scalp EEG at a given electrode site reflects a linear mixture of activity from multiple brain sources and artifacts, efforts to successfully acquire some level of control over the signal may be confounded by these extraneous sources. Further, in the event of successful training, these traditional neurofeedback methods are likely influencing multiple brain regions and processes. The present work describes the use of source-based signal processing methods in EEG neurofeedback. The feasibility and potential utility of such methods were explored in an experiment training increased theta oscillatory activity in a source derived from Blind Source Separation (BSS) of EEG data obtained during completion of a complex cognitive task (spatial navigation). Learned increases in theta activity were observed in two of the four participants to complete 20 sessions of neurofeedback targeting this individually defined functional brain source. Source-based EEG neurofeedback methods using BSS may offer important advantages over traditional neurofeedback, by targeting the desired physiological signal in a more functionally and spatially specific manner. Having provided preliminary evidence of the feasibility of these methods, future work may study a range of clinically and experimentally relevant brain processes where individual brain sources may be targeted by source-based EEG neurofeedback. PMID:25374520

Utility of Liquid Biopsy by Improved PNA-LNA PCR Clamp Method for Detecting EGFR Mutation at Initial Diagnosis of Non-Small-Cell Lung Cancer: Observational Study of 190 Consecutive Cases in Clinical Practice.

PubMed

Ito, Kentaro; Suzuki, Yuta; Saiki, Haruko; Sakaguchi, Tadashi; Hayashi, Kosuke; Nishii, Yoichi; Watanabe, Fumiaki; Hataji, Osamu

2018-03-01

The clinical benefit of liquid biopsy for unselected patients at initial diagnosis has thus far been unclear. We aimed to evaluate the utility of liquid biopsy at initial diagnosis, as well as the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) based on liquid biopsy results in clinical practice, using the improved peptide nucleic acid-locked nucleic acid (PNA-LNA) PCR clamp method. We routinely performed liquid biopsy using the improved PNA-LNA PCR clamp method for all patients diagnosed with non-small-cell lung cancer (NSCLC) between June 2015 and October 2016. We retrospectively evaluated the reliability of liquid biopsy based either on clinical stage or between sensitizing EGFR mutation and T790M mutation, and the clinical benefit of EGFR-TKI based on the liquid biopsy results in practice. A total of 244 patients underwent liquid biopsies, with 168 patients tested at diagnosis and 22 tested for T790M after pretreatment of EGFR-TKI. For detecting a sensitizing EGFR mutation, the sensitivity, specificity, positive predictive value, and negative predictive value were 72.7%, 100%, 100%, and 93.7% in the group with advanced-stage NSCLC and 0, 100%, not evaluable, and 70.5% in the group with early-stage NSCLC. The positive predictive value and negative predictive value for T790M were 33.3% and 55.6%, respectively. Fourteen patients in the liquid-positive group and 16 patients in the tissue-positive group received EGFR-TKI. The objective response rates of first- and second-generation EGFR-TKI for the liquid-positive and tissue-positive groups were 90.0% and 90.9%, respectively. There was no significant difference in median progression-free survival between the liquid-positive and tissue-positive groups (P = .839). Patients with early-stage NSCLC should not be candidates for this liquid biopsy method. We recommend tissue biopsy as the preferred initial method of molecular analysis, with the exception of patients who are T790M positive or patients who are unable to tolerate invasive biopsy. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical scale rapid expansion of lymphocytes for adoptive cell transfer therapy in the WAVE® bioreactor

PubMed Central

2012-01-01

Background To simplify clinical scale lymphocyte expansions, we investigated the use of the WAVE®, a closed system bioreactor that utilizes active perfusion to generate high cell numbers in minimal volumes. Methods We have developed an optimized rapid expansion protocol for the WAVE bioreactor that produces clinically relevant numbers of cells for our adoptive cell transfer clinical protocols. Results TIL and genetically modified PBL were rapidly expanded to clinically relevant scales in both static bags and the WAVE bioreactor. Both bioreactors produced comparable numbers of cells; however the cultures generated in the WAVE bioreactor had a higher percentage of CD4+ cells and had a less activated phenotype. Conclusions The WAVE bioreactor simplifies the process of rapidly expanding tumor reactive lymphocytes under GMP conditions, and provides an alternate approach to cell generation for ACT protocols. PMID:22475724

Outcomes of a clinical partnership model for undergraduate nursing students.

PubMed

Newton, Jennifer M; Cross, Wendy M; White, Karin; Ockerby, Cherene; Billett, Stephen

2011-08-01

Over the last decade several innovative approaches to enhance students' transition to graduate nurse year have been implemented or piloted. This paper describes a study that investigated how the social practices of clinical partnership placement model underpin workplace learning for undergraduate students as they transitioned to graduate. A mixed method approach was utilized comprising individual interviews with students, observation of clinical workplaces across six different areas of nursing practice, student surveys of the clinical learning environment and participant workshops. Three themes were identified that influenced participants' preparedness for work and enhanced the transition into the workplace: 'organizational familiarity', 'continuity' and 'social participation'. A clinical partnership model offers a degree of work readiness for novices when commencing their professional practice role. It enables individuals to participate and engage in workplace activities which are a central component of their learning.

Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

PubMed

Takahashi, Fumihiro; Morita, Satoshi

2018-02-08

Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

Integration of biomimicry and nanotechnology for significantly improved detection of circulating tumor cells (CTCs).

PubMed

Myung, Ja Hye; Park, Sin-Jung; Wang, Andrew Z; Hong, Seungpyo

2017-12-13

Circulating tumor cells (CTCs) have received a great deal of scientific and clinical attention as a biomarker for diagnosis and prognosis of many types of cancer. Given their potential significance in clinics, a variety of detection methods, utilizing the recent advances in nanotechnology and microfluidics, have been introduced in an effort of achieving clinically significant detection of CTCs. However, effective detection and isolation of CTCs still remain a tremendous challenge due to their extreme rarity and phenotypic heterogeneity. Among many approaches that are currently under development, this review paper focuses on a unique, promising approach that takes advantages of naturally occurring processes achievable through application of nanotechnology to realize significant improvement in sensitivity and specificity of CTC capture. We provide an overview of successful outcome of this biomimetic CTC capture system in detection of tumor cells from in vitro, in vivo, and clinical pilot studies. We also emphasize the clinical impact of CTCs as biomarkers in cancer diagnosis and predictive prognosis, which provides a cost-effective, minimally invasive method that potentially replaces or supplements existing methods such as imaging technologies and solid tissue biopsy. In addition, their potential prognostic values as treatment guidelines and that ultimately help to realize personalized therapy are discussed. Copyright © 2017. Published by Elsevier B.V.

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).

Studying depression using imaging and machine learning methods.

PubMed

Patel, Meenal J; Khalaf, Alexander; Aizenstein, Howard J

2016-01-01

Depression is a complex clinical entity that can pose challenges for clinicians regarding both accurate diagnosis and effective timely treatment. These challenges have prompted the development of multiple machine learning methods to help improve the management of this disease. These methods utilize anatomical and physiological data acquired from neuroimaging to create models that can identify depressed patients vs. non-depressed patients and predict treatment outcomes. This article (1) presents a background on depression, imaging, and machine learning methodologies; (2) reviews methodologies of past studies that have used imaging and machine learning to study depression; and (3) suggests directions for future depression-related studies.

Retention in care, resource utilization, and costs for adults receiving antiretroviral therapy in Zambia: a retrospective cohort study

PubMed Central

2014-01-01

Background Of the estimated 800,000 adults living with HIV in Zambia in 2011, roughly half were receiving antiretroviral therapy (ART). As treatment scale up continues, information on the care provided to patients after initiating ART can help guide decision-making. We estimated retention in care, the quantity of resources utilized, and costs for a retrospective cohort of adults initiating ART under routine clinical conditions in Zambia. Methods Data on resource utilization (antiretroviral [ARV] and non-ARV drugs, laboratory tests, outpatient clinic visits, and fixed resources) and retention in care were extracted from medical records for 846 patients who initiated ART at ≥15 years of age at six treatment sites between July 2007 and October 2008. Unit costs were estimated from the provider’s perspective using site- and country-level data and are reported in 2011 USD. Results Patients initiated ART at a median CD4 cell count of 145 cells/μL. Fifty-nine percent of patients initiated on a tenofovir-containing regimen, ranging from 15% to 86% depending on site. One year after ART initiation, 75% of patients were retained in care. The average cost per patient retained in care one year after ART initiation was $243 (95% CI, $194-$293), ranging from $184 (95% CI, $172-$195) to $304 (95% CI, $290-$319) depending on site. Patients retained in care one year after ART initiation received, on average, 11.4 months’ worth of ARV drugs, 1.5 CD4 tests, 1.3 blood chemistry tests, 1.4 full blood count tests, and 6.5 clinic visits with a doctor or clinical officer. At all sites, ARV drugs were the largest cost component, ranging from 38% to 84% of total costs, depending on site. Conclusions Patients initiate ART late in the course of disease progression and a large proportion drop out of care after initiation. The quantity of resources utilized and costs vary widely by site, and patients utilize a different mix of resources under routine clinical conditions than if they were receiving fully guideline-concordant care. Improving retention in care and guideline concordance, including increasing the use of tenofovir in first-line ART regimens, may lead to increases in overall treatment costs. PMID:24684772

Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology.

PubMed

Clark, Andrew E; Kaleta, Erin J; Arora, Amit; Wolk, Donna M

2013-07-01

Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the "nuts and bolts" of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care.

Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology

PubMed Central

Clark, Andrew E.; Kaleta, Erin J.; Arora, Amit

2013-01-01

SUMMARY Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the “nuts and bolts” of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care. PMID:23824373

Utility of the Roche Cobas 4800 for detection of high-risk human papillomavirus in formalin-fixed paraffin-embedded oropharyngeal squamous cell carcinoma.

PubMed

Pettus, Jason R; Wilson, Terri L; Steinmetz, Heather B; Lefferts, Joel A; Tafe, Laura J

2017-02-01

Clinical laboratories are expected to reliably identify human papilloma virus (HPV) associated oropharyngeal squamous cell carcinoma (OPSCC) for prognostic and potential therapeutic applications. In addition to surrogate p16 immunohistochemistry (IHC) testing, DNA-based HPV-specific testing strategies are widely utilized. Recognizing the efficiency of the Roche Cobas 4800 platform for testing gynecological cytology specimens for high-risk HPV, we elected to evaluate the potential utility of this platform for testing formalin-fixed paraffin-embedded (FFPE) OPSCC tissue. Using the Roche Linear Array assay for comparison, we tested twenty-eight samples (16 primary OPSCC, 2 lymph node metastases from primary OPSCC, 1 oral tongue carcinoma, 3 benign squamous papillomas, and 3 non-oropharyngeal carcinoma tissues). Excluding two invalid results, the Roche Cobas 4800 testing resulted in excellent inter-assay concordance (25/26, 96.2%) and 100% concordance for HPV-16/HPV-18 positive samples. This data suggests that the Roche Cobas 4800 platform may be a cost-effective method for testing OPSCC FFPE tissues in a clinical molecular pathology laboratory setting. Copyright © 2016 Elsevier Inc. All rights reserved.

Open-source Software for Demand Forecasting of Clinical Laboratory Test Volumes Using Time-series Analysis

PubMed Central

Mohammed, Emad A.; Naugler, Christopher

2017-01-01

Background: Demand forecasting is the area of predictive analytics devoted to predicting future volumes of services or consumables. Fair understanding and estimation of how demand will vary facilitates the optimal utilization of resources. In a medical laboratory, accurate forecasting of future demand, that is, test volumes, can increase efficiency and facilitate long-term laboratory planning. Importantly, in an era of utilization management initiatives, accurately predicted volumes compared to the realized test volumes can form a precise way to evaluate utilization management initiatives. Laboratory test volumes are often highly amenable to forecasting by time-series models; however, the statistical software needed to do this is generally either expensive or highly technical. Method: In this paper, we describe an open-source web-based software tool for time-series forecasting and explain how to use it as a demand forecasting tool in clinical laboratories to estimate test volumes. Results: This tool has three different models, that is, Holt-Winters multiplicative, Holt-Winters additive, and simple linear regression. Moreover, these models are ranked and the best one is highlighted. Conclusion: This tool will allow anyone with historic test volume data to model future demand. PMID:28400996

Chemiluminescence of creatinine/H2O2/Co(2+) and its application for selective creatinine detection.

PubMed

Hanif, Saima; John, Peter; Gao, Wenyue; Saqib, Muhammad; Qi, Liming; Xu, Guobao

2016-01-15

Creatinine is an important biomarker in clinical diagnosis and biomonitoring programs as well as urinary metabolomic/metabonomics research. Current methods are either nonselective, time consuming or require heavy and expensive instruments. In this study, chemiluminescence of creatinine with hydrogen peroxide has been reported for the first time, and its chemiluminescence is remarkably enhanced in the presence of cobalt ions. By utilizing these phenomena, we have developed a sensitive and selective chemiluminescence method for creatinine determination by coupling with flow injection analysis. The calibration curve is linear in the range of 1×10(-7)-3×10(-5)mol/L with a limit of detection (S/N=3) of 7.2×10(-8)mol/L, which is adequate for detecting creatinine in the clinically accepted range. The relative standard deviation for seven measurements of 3×10(-5)mol/L creatinine is 1.2%. The chemiluminescence method was then utilized to detect creatinine in human urine samples after simple dilution with water. It takes less than 1min each measurement and the recoveries for spiked urine samples were 100-103%. The interference study demonstrates that some common species in urine, such as amino acids, ascorbic acid and creatine, have negligible effects on creatinine detection. The present method does not use expensive instruments, enzymes and separation technique. This method has the advantages of sensitivity, selectivity, simplicity, rapidity, and low cost. It holds great promise for basic or comprehensive metabolic panel, drug screening, anti-dopping, and urinary metabolomic/metabonomics research. Copyright © 2015 Elsevier B.V. All rights reserved.

From impedance theory to needle electrode guidance in tissue

NASA Astrophysics Data System (ADS)

Kalvøy, Håvard; Høyum, Per; Grimnes, Sverre; Martinsen, Ørjan G.

2010-04-01

Fast access to blood vessels or other tissues/organs can be crucial in clinical or acute medical treatment. We have developed a method for needle guidance for use in different types of applications. The feasibility of an automatic application for fast access to blood vessels during acute cardiac arrest, based on this method, has been evaluated. Suited electrode setups were found by development of needle electrode models used in simulation and sensitivity analyses. In vitro measurements were done both to determine the fundamental properties of the electrodes for use in the models and to confirm the simulation results. Development of algorithms for tissue characterization and differentiation was based on in vivo impedance measurement in porcine models and confirmed in human tissue in vivo. Feasibility was proven by application prototyping and impedance data presented as invasive Electrical Impedance Tomography (iEIT). Our conclusion is that this method can be utilized in a wide range of clinical applications.

Evaluating principal surrogate endpoints with time-to-event data accounting for time-varying treatment efficacy.

PubMed

Gabriel, Erin E; Gilbert, Peter B

2014-04-01

Principal surrogate (PS) endpoints are relatively inexpensive and easy to measure study outcomes that can be used to reliably predict treatment effects on clinical endpoints of interest. Few statistical methods for assessing the validity of potential PSs utilize time-to-event clinical endpoint information and to our knowledge none allow for the characterization of time-varying treatment effects. We introduce the time-dependent and surrogate-dependent treatment efficacy curve, ${\\mathrm {TE}}(t|s)$, and a new augmented trial design for assessing the quality of a biomarker as a PS. We propose a novel Weibull model and an estimated maximum likelihood method for estimation of the ${\\mathrm {TE}}(t|s)$ curve. We describe the operating characteristics of our methods via simulations. We analyze data from the Diabetes Control and Complications Trial, in which we find evidence of a biomarker with value as a PS.

Application of Raman spectroscopy for cervical dysplasia diagnosis

PubMed Central

Kanter, Elizabeth M.; Vargis, Elizabeth; Majumder, Shovan; Keller, Matthew D.; Woeste, Emily; Rao, Gautam G.; Mahadevan-Jansen, Anita

2014-01-01

Cervical cancer is the second most common malignancy among women worldwide, with over 490000 cases diagnosed and 274000 deaths each year. Although current screening methods have dramatically reduced cervical cancer incidence and mortality in developed countries, a “See and Treat” method would be preferred, especially in developing countries. Results from our previous work have suggested that Raman spectroscopy can be used to detect cervical precancers; however, with a classification accuracy of 88%, it was not clinically applicable. In this paper, we describe how incorporating a woman's hormonal status, particularly the point in menstrual cycle and menopausal state, into our previously developed classification algorithm improves the accuracy of our method to 94%. The results of this paper bring Raman spectroscopy one step closer to being utilized in a clinical setting to diagnose cervical dysplasia. Posterior probabilities of class membership, as determined by MRDF-SMLR, for patients regardless of menopausal status, and for pre-menopausal patients only PMID:19343687

Automatic corpus callosum segmentation for standardized MR brain scanning

NASA Astrophysics Data System (ADS)

Xu, Qing; Chen, Hong; Zhang, Li; Novak, Carol L.

2007-03-01

Magnetic Resonance (MR) brain scanning is often planned manually with the goal of aligning the imaging plane with key anatomic landmarks. The planning is time-consuming and subject to inter- and intra- operator variability. An automatic and standardized planning of brain scans is highly useful for clinical applications, and for maximum utility should work on patients of all ages. In this study, we propose a method for fully automatic planning that utilizes the landmarks from two orthogonal images to define the geometry of the third scanning plane. The corpus callosum (CC) is segmented in sagittal images by an active shape model (ASM), and the result is further improved by weighting the boundary movement with confidence scores and incorporating region based refinement. Based on the extracted contour of the CC, several important landmarks are located and then combined with landmarks from the coronal or transverse plane to define the geometry of the third plane. Our automatic method is tested on 54 MR images from 24 patients and 3 healthy volunteers, with ages ranging from 4 months to 70 years old. The average accuracy with respect to two manually labeled points on the CC is 3.54 mm and 4.19 mm, and differed by an average of 2.48 degrees from the orientation of the line connecting them, demonstrating that our method is sufficiently accurate for clinical use.

Reinforcement Learning Strategies for Clinical Trials in Non-small Cell Lung Cancer

PubMed Central

Zhao, Yufan; Zeng, Donglin; Socinski, Mark A.; Kosorok, Michael R.

2010-01-01

Summary Typical regimens for advanced metastatic stage IIIB/IV non-small cell lung cancer (NSCLC) consist of multiple lines of treatment. We present an adaptive reinforcement learning approach to discover optimal individualized treatment regimens from a specially designed clinical trial (a “clinical reinforcement trial”) of an experimental treatment for patients with advanced NSCLC who have not been treated previously with systemic therapy. In addition to the complexity of the problem of selecting optimal compounds for first and second-line treatments based on prognostic factors, another primary goal is to determine the optimal time to initiate second-line therapy, either immediately or delayed after induction therapy, yielding the longest overall survival time. A reinforcement learning method called Q-learning is utilized which involves learning an optimal regimen from patient data generated from the clinical reinforcement trial. Approximating the Q-function with time-indexed parameters can be achieved by using a modification of support vector regression which can utilize censored data. Within this framework, a simulation study shows that the procedure can extract optimal regimens for two lines of treatment directly from clinical data without prior knowledge of the treatment effect mechanism. In addition, we demonstrate that the design reliably selects the best initial time for second-line therapy while taking into account the heterogeneity of NSCLC across patients. PMID:21385164

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.

Perceptions and utilization of primary health care services in Iraq: findings from a national household survey

PubMed Central

2011-01-01

Background After many years of sanctions and conflict, Iraq is rebuilding its health system, with a strong emphasis on the traditional hospital-based services. A network exists of public sector hospitals and clinics, as well as private clinics and a few private hospitals. Little data are available about the approximately 1400 Primary Health Care clinics (PHCCs) staffed with doctors. How do Iraqis utilize primary health care services? What are their preferences and perceptions of public primary health care clinics and private primary care services in general? How does household wealth affect choice of services? Methods A 1256 household national survey was conducted in the catchment areas of randomly selected PHCCs in Iraq. A cluster of 10 households, beginning with a randomly selected start household, were interviewed in the service areas of seven public sector PHCC facilities in each of 17 of Iraq's 18 governorates. A questionnaire was developed using key informants. Teams of interviewers, including both males and females, were recruited and provided a week of training which included field practice. Teams then gathered data from households in the service areas of randomly selected clinics. Results Iraqi participants are generally satisfied with the quality of primary care services available both in the public and private sector. Private clinics are generally the most popular source of primary care, however the PHCCs are utilized more by poorer households. In spite of free services available at PHCCs many households expressed difficulty in affording health care, especially in the purchase of medications. There is no evidence of informal payments to secure health services in the public sector. Conclusions There is widespread satisfaction reported with primary health care services, and levels did not differ appreciably between public and private sectors. The public sector PHCCs are preferentially used by poorer populations where they are important providers. PHCC services are indeed free, with little evidence of informal payments to providers. PMID:22176866

Clinical Utility of an Automated Instrument for Gram Staining Single Slides ▿

PubMed Central

Baron, Ellen Jo; Mix, Samantha; Moradi, Wais

2010-01-01

Gram stains of 87 different clinical samples were prepared by the laboratory's conventional methods (automated or manual) and by a new single-slide-type automated staining instrument, GG&B AGS-1000. Gram stains from either heat- or methanol-fixed slides stained with the new instrument were easy to interpret, and results were essentially the same as those from the methanol-fixed slides prepared as a part of the routine workflow. This instrument is well suited to a rapid-response laboratory where Gram stain requests are commonly received on a stat basis. PMID:20410348

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.

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

Histotripsy Methods in Mechanical Disintegration of Tissue: Toward Clinical Applications

PubMed Central

Khokhlova, VA; Fowlkes, JB; Roberts, WW; Schade, GR; Xu, Z; Khokhlova, TD; Hall, TL; Maxwell, AD; Wang, YN; Cain, CA

2015-01-01

Purpose In high intensity focused ultrasound (HIFU) therapy, an ultrasound beam is focused within the body to locally affect the targeted site without damaging intervening tissues. The most common HIFU regime is thermal ablation. Recently, there has been increasing interest in generating purely mechanical lesions in tissue (histotripsy). This paper provides an overview of several studies on the development of histotripsy methods toward clinical applications. Material and Methods Two histotripsy approaches and examples of their applications are presented. In one approach, sequences of high-amplitude, short (microsecond-long), focused ultrasound pulses periodically produce dense, energetic bubble clouds that mechanically disintegrate tissue. In an alternative approach, longer (millisecond-long) pulses with shock fronts generate boiling bubbles and the interaction of shock fronts with the resulting vapor cavity causes tissue disintegration. Results Recent pre-clinical studies on histotripsy are reviewed for treating benign prostatic hyperplasia (BPH), liver and kidney tumors, kidney stone fragmentation, enhancing antitumor immune response, and tissue decellularization for regenerative medicine applications. Potential clinical advantages of the histotripsy methods are discussed. Conclusions Histotripsy methods can be used to mechanically ablate a wide variety of tissues, whilst selectivity sparing structures such as large vessels. Both ultrasound and MR imaging can be used for targeting and monitoring the treatment in real time. Although the two approaches utilize different mechanisms for tissue disintegration, both have many of the same advantages and offer a promising alternative method of noninvasive surgery. PMID:25707817

The Human Microbiome and Understanding the 16S rRNA Gene in Translational Nursing Science

PubMed Central

Ames, Nancy J.; Ranucci, Alexandra; Moriyama, Brad; Wallen, Gwenyth R.

2017-01-01

Background As more is understood regarding the human microbiome, it is increasingly important for nurse scientists and health care practitioners to analyze these microbial communities and their role in health and disease.16S rRNA sequencing is a key methodology in identifying these bacterial populations that has recently transitioned from use primarily in research to having increased utility in clinical settings. Objectives The objectives of this review are to: (a) describe 16S rRNA sequencing and its role in answering research questions important to nursing science; (b) provide an overview of the oral, lung and gut microbiomes and relevant research; and (c) identify future implications for microbiome research and 16S sequencing in translational nursing science. Discussion Sequencing using the 16S rRNA gene has revolutionized research and allowed scientists to easily and reliably characterize complex bacterial communities. This type of research has recently entered the clinical setting, one of the best examples involving the use of 16S sequencing to identify resistant pathogens, thereby improving the accuracy of bacterial identification in infection control. Clinical microbiota research and related requisite methods are of particular relevance to nurse scientists—individuals uniquely positioned to utilize these techniques in future studies in clinical settings. PMID:28252578

Clinical utility of FDG-PET in amyotrophic lateral sclerosis and Huntington's disease.

PubMed

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

2018-05-01

To evaluate the incremental value of FDG-PET over clinical tests in: (i) diagnosis of amyotrophic lateral sclerosis (ALS); (ii) picking early signs of neurodegeneration in patients with a genetic risk of Huntington's disease (HD); and detecting metabolic changes related to cognitive impairment in (iii) ALS and (iv) HD patients. Four comprehensive literature searches were conducted using the PICO model to extract evidence from relevant studies. An expert panel then voted using the Delphi method on these four diagnostic scenarios. The availability of evidence was good for FDG-PET utility to support the diagnosis of ALS, poor for identifying presymptomatic subjects carrying HD mutation who will convert to HD, and lacking for identifying cognitive-related metabolic changes in both ALS and HD. After the Delphi consensual procedure, the panel did not support the clinical use of FDG-PET for any of the four scenarios. Relative to other neurodegenerative diseases, the clinical use of FDG-PET in ALS and HD is still in its infancy. Once validated by disease-control studies, FDG-PET might represent a potentially useful biomarker for ALS diagnosis. FDG-PET is presently not justified as a routine investigation to predict conversion to HD, nor to detect evidence of brain dysfunction justifying cognitive decline in ALS and HD.

Peering beneath the surface: novel imaging techniques to noninvasively select gametes and embryos for ART.

PubMed

Jasensky, Joshua; Swain, Jason E

2013-10-01

Embryo imaging has long been a critical tool for in vitro fertilization laboratories, aiding in morphological assessment of embryos, which remains the primary tool for embryo selection. With the recent emergence of clinically applicable real-time imaging systems to assess embryo morphokinetics, a renewed interest has emerged regarding noninvasive methods to assess gamete and embryo development as a means of inferring quality. Several studies exist that utilize novel imaging techniques to visualize or quantify intracellular components of gametes and embryos with the intent of correlating localization of organelles or molecular constitution with quality or outcome. However, the safety of these approaches varies due to the potential detrimental impact of light exposure or other variables. Along with complexity of equipment and cost, these drawbacks currently limit clinical application of these novel microscopes and imaging techniques. However, as evidenced by clinical incorporation of some real-time imaging devices as well as use of polarized microscopy, some of these imaging approaches may prove to be useful. This review summarizes the existing literature on novel imaging approaches utilized to examine gametes and embryos. Refinement of some of these imaging systems may permit clinical application and serve as a means to offer new, noninvasive selection tools to improve outcomes for various assisted reproductive technology procedures.

Is the DLQI appropriate for medical decision-making in psoriasis patients?

PubMed

Poór, Adrienn Katalin; Brodszky, Valentin; Péntek, Márta; Gulácsi, László; Ruzsa, Gábor; Hidvégi, Bernadett; Holló, Péter; Kárpáti, Sarolta; Sárdy, Miklós; Rencz, Fanni

2018-01-01

Dermatology Life Quality Index (DLQI) is the most commonly applied measure of health-related quality of life (HRQoL) in psoriasis patients. It is among defining criteria of moderate-to-severe psoriasis and present in treatment guidelines. Our objective was to estimate preference-based HRQoL values (i.e., utilities) for hypothetical health states described by the 10 items of the DLQI in psoriasis patients. Moreover, we compare results to findings of a similar study previously conducted among the general public. A cross-sectional survey was carried out among 238 psoriasis patients. Seven hypothetical DLQI-defined health states with total scores of 6, 11, and 16 (3-3 and 1 states, respectively) were evaluated by time trade-off method. The difference in DLQI scores between hypothetical health states was set at 5 points, as it exceeds the minimal clinically important difference (MCID). Utility scores were found to be homogenous across the seven hypothetical health states (range of means for the 6-point states 0.85-0.91, range of means for the 11-point states 0.83-0.85, and mean of 0.84 for the 16-point state). Overall, mean utilities assessed by psoriasis patients were higher for all seven states compared with the general public (mean difference 0.16-0.28; p < 0.001). In 11 out of the 15 comparisons between health states with DLQI scores differing larger than the MCID, there was no statistically significant difference in utility. Thus, in clinical settings, patients with DLQI scores differing more than the MCID may have identical HRQoL. Improving the definition of moderate-to-severe disease and reconsideration of the DLQI in clinical assessment of psoriasis patients are suggested.

Acceptance of E-Learning Devices by Dental Students

PubMed Central

Sagheb, Keyvan; Affeldt, Harald; Klumpp, Hannah; Taylor, Kathy; Walter, Christian; Al-Nawas, Bilal

2013-01-01

Background E-Learning programs and their corresponding devices are increasingly employed to educate dental students during their clinical training. Objective Recent progress made in the development of e-learning software as well as in hardware (computers, tablet PCs, smartphones) caused us to more closely investigate into the habits of dental students in dealing with these learning techniques. Methods Dental students during their clinical training attended a survey compiled in cooperation with biostatisticians. The questionnaire probands were asked to complete based on previous surveys of similar subjects, allowing single as well as multiple answers. The data, which were obtained with respect to the learning devices students commonly employ, were compared with their internet learning activities. Results The e-learning devices utilized are of heterogeneous brands. Each student has access to at least one hardware type suitable for e-learning. All students held mobile devices, about 90 percent employed laptops, and about 60 percent possess smartphones. Unexceptional all participants of the survey acknowledged an unlimited internet access. In contrast, only 16 percent of students utilized tablet PCs. A detailed analysis of the survey outcome reveals that an increasing use of mobile devices (tablet PC, smartphone) facilitates internet learning activities while at the same time utilization of computers (desktop, laptop) declines. Conclusions Dental students overwhelmingly accept e-learning during their clinical training. Students report outstanding preconditions to conduct e-learning as both their access to hardware and to the internet is excellent. Less satisfying is the outcome of our survey regarding the utilization of e-learning programs. Depending of the hardware employed only one-third to barely one-half of students comprise learning programs. PMID:25075241

Luminol-Based Chemiluminescent Signals: Clinical and Non-clinical Application and Future Uses

PubMed Central

Khan, Parvez; Idrees, Danish; Moxley, Michael A.; Corbett, John A.; Ahmad, Faizan; von Figura, Guido; Sly, William S.; Waheed, Abdul

2015-01-01

Chemiluminescence (CL) is an important method for quantification and analysis of various macromolecules. A wide range of CL agents such as luminol, hydrogen peroxide, fluorescein, dioxetanes and derivatives of oxalate, and acridinium dyes are used according to their biological specificity and utility. This review describes the application of luminol chemiluminescence (LCL) in forensic, biomedical, and clinical sciences. LCL is a very useful detection method due to its selectivity, simplicity, low cost, and high sensitivity. LCL has a dynamic range of applications, including quantification and detection of macro and micromolecules such as proteins, carbohydrates, DNA, and RNA. Luminol-based methods are used in environmental monitoring as biosensors, in the pharmaceutical industry for cellular localization and as biological tracers, and in reporter gene-based assays and several other immunoassays. Here, we also provide information about different compounds that may enhance or inhibit the LCL along with the effect of pH and concentration on LCL. This review covers most of the significant information related to the applications of luminol in different fields. PMID:24752935

A new method for teaching physical examination to junior medical students

PubMed Central

Sayma, Meelad; Williams, Hywel Rhys

2016-01-01

Introduction Teaching effective physical examination is a key component in the education of medical students. Preclinical medical students often have insufficient clinical knowledge to apply to physical examination recall, which may hinder their learning when taught through certain understanding-based models. This pilot project aimed to develop a method to teach physical examination to preclinical medical students using “core clinical cases”, overcoming the need for “rote” learning. Methods This project was developed utilizing three cycles of planning, action, and reflection. Thematic analysis of feedback was used to improve this model, and ensure it met student expectations. Results and discussion A model core clinical case developed in this project is described, with gout as the basis for a “foot and ankle” examination. Key limitations and difficulties encountered on implementation of this pilot are discussed for future users, including the difficulty encountered in “content overload”. Conclusion This approach aims to teach junior medical students physical examination through understanding, using a simulated patient environment. Robust research is now required to demonstrate efficacy and repeatability in the physical examination of other systems. PMID:26937208

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.

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

A Novel Patient Recruitment Strategy: Patient Selection Directly from the Community through Linkage to Clinical Data.

PubMed

Zimmerman, Lindsay P; Goel, Satyender; Sathar, Shazia; Gladfelter, Charon E; Onate, Alejandra; Kane, Lindsey L; Sital, Shelly; Phua, Jasmin; Davis, Paris; Margellos-Anast, Helen; Meltzer, David O; Polonsky, Tamar S; Shah, Raj C; Trick, William E; Ahmad, Faraz S; Kho, Abel N

2018-01-01

This article presents and describes our methods in developing a novel strategy for recruitment of underrepresented, community-based participants, for pragmatic research studies leveraging routinely collected electronic health record (EHR) data. We designed a new approach for recruiting eligible patients from the community, while also leveraging affiliated health systems to extract clinical data for community participants. The strategy involves methods for data collection, linkage, and tracking. In this workflow, potential participants are identified in the community and surveyed regarding eligibility. These data are then encrypted and deidentified via a hashing algorithm for linkage of the community participant back to a record at a clinical site. The linkage allows for eligibility verification and automated follow-up. Longitudinal data are collected by querying the EHR data and surveying the community participant directly. We discuss this strategy within the context of two national research projects, a clinical trial and an observational cohort study. The community-based recruitment strategy is a novel, low-touch, clinical trial enrollment method to engage a diverse set of participants. Direct outreach to community participants, while utilizing EHR data for clinical information and follow-up, allows for efficient recruitment and follow-up strategies. This new strategy for recruitment links data reported from community participants to clinical data in the EHR and allows for eligibility verification and automated follow-up. The workflow has the potential to improve recruitment efficiency and engage traditionally underrepresented individuals in research. Schattauer GmbH Stuttgart.

Enhancing decision making about participation in cancer clinical trials: development of a question prompt list

PubMed Central

Brown, Richard F.; Shuk, Elyse; Leighl, Natasha; Butow, Phyllis; Ostroff, Jamie; Edgerson, Shawna; Tattersall, Martin

2016-01-01

Purpose Slow accrual to cancer clinical trials impedes the progress of effective new cancer treatments. Poor physician–patient communication has been identified as a key contributor to low trial accrual. Question prompt lists (QPLs) have demonstrated a significant promise in facilitating communication in general, surgical, and palliative oncology settings. These simple patient interventions have not been tested in the oncology clinical trial setting. We aimed to develop a targeted QPL for clinical trials (QPL-CT). Method Lung, breast, and prostate cancer patients who either had (trial experienced) or had not (trial naive) participated in a clinical trial were invited to join focus groups to help develop and explore the acceptability of a QPL-CT. Focus groups were audio-recorded and transcribed. A research team, including a qualitative data expert, analyzed these data to explore patients’ decision-making processes and views about the utility of the QPL-CT prompt to aid in trial decision making. Results Decision making was influenced by the outcome of patients’ comparative assessment of perceived risks versus benefits of a trial, and the level of trust patients had in their doctors’ recommendation about the trial. Severity of a patient’s disease influenced trial decision making only for trial-naive patients. Conclusion Although patients were likely to prefer a paternalistic decision-making style, they expressed valuation of the QPL as an aid to decision making. QPL-CT utility extended beyond the actual consultation to include roles both before and after the clinical trial discussion. PMID:20593202

An MRI-Compatible Robotic System With Hybrid Tracking for MRI-Guided Prostate Intervention

PubMed Central

Krieger, Axel; Iordachita, Iulian I.; Guion, Peter; Singh, Anurag K.; Kaushal, Aradhana; Ménard, Cynthia; Pinto, Peter A.; Camphausen, Kevin; Fichtinger, Gabor

2012-01-01

This paper reports the development, evaluation, and first clinical trials of the access to the prostate tissue (APT) II system—a scanner independent system for magnetic resonance imaging (MRI)-guided transrectal prostate interventions. The system utilizes novel manipulator mechanics employing a steerable needle channel and a novel six degree-of-freedom hybrid tracking method, comprising passive fiducial tracking for initial registration and subsequent incremental motion measurements. Targeting accuracy of the system in prostate phantom experiments and two clinical human-subject procedures is shown to compare favorably with existing systems using passive and active tracking methods. The portable design of the APT II system, using only standard MRI image sequences and minimal custom scanner interfacing, allows the system to be easily used on different MRI scanners. PMID:22009867

Utilizing Big Data and Twitter to Discover Emergent Online Communities of Cannabis Users

PubMed Central

Baumgartner, Peter; Peiper, Nicholas

2017-01-01

Large shifts in medical, recreational, and illicit cannabis consumption in the United States have implications for personalizing treatment and prevention programs to a wide variety of populations. As such, considerable research has investigated clinical presentations of cannabis users in clinical and population-based samples. Studies leveraging big data, social media, and social network analysis have emerged as a promising mechanism to generate timely insights that can inform treatment and prevention research. This study extends a novel method called stochastic block modeling to derive communities of cannabis consumers as part of a complex social network on Twitter. A set of examples illustrate how this method can ascertain candidate samples of medical, recreational, and illicit cannabis users. Implications for research planning, intervention design, and public health surveillance are discussed. PMID:28615950

3D-MICE: integration of cross-sectional and longitudinal imputation for multi-analyte longitudinal clinical data.

PubMed

Luo, Yuan; Szolovits, Peter; Dighe, Anand S; Baron, Jason M

2018-06-01

A key challenge in clinical data mining is that most clinical datasets contain missing data. Since many commonly used machine learning algorithms require complete datasets (no missing data), clinical analytic approaches often entail an imputation procedure to "fill in" missing data. However, although most clinical datasets contain a temporal component, most commonly used imputation methods do not adequately accommodate longitudinal time-based data. We sought to develop a new imputation algorithm, 3-dimensional multiple imputation with chained equations (3D-MICE), that can perform accurate imputation of missing clinical time series data. We extracted clinical laboratory test results for 13 commonly measured analytes (clinical laboratory tests). We imputed missing test results for the 13 analytes using 3 imputation methods: multiple imputation with chained equations (MICE), Gaussian process (GP), and 3D-MICE. 3D-MICE utilizes both MICE and GP imputation to integrate cross-sectional and longitudinal information. To evaluate imputation method performance, we randomly masked selected test results and imputed these masked results alongside results missing from our original data. We compared predicted results to measured results for masked data points. 3D-MICE performed significantly better than MICE and GP-based imputation in a composite of all 13 analytes, predicting missing results with a normalized root-mean-square error of 0.342, compared to 0.373 for MICE alone and 0.358 for GP alone. 3D-MICE offers a novel and practical approach to imputing clinical laboratory time series data. 3D-MICE may provide an additional tool for use as a foundation in clinical predictive analytics and intelligent clinical decision support.

Super-Resolution Image Reconstruction Applied to Medical Ultrasound

NASA Astrophysics Data System (ADS)

Ellis, Michael

Ultrasound is the preferred imaging modality for many diagnostic applications due to its real-time image reconstruction and low cost. Nonetheless, conventional ultrasound is not used in many applications because of limited spatial resolution and soft tissue contrast. Most commercial ultrasound systems reconstruct images using a simple delay-and-sum architecture on receive, which is fast and robust but does not utilize all information available in the raw data. Recently, more sophisticated image reconstruction methods have been developed that make use of far more information in the raw data to improve resolution and contrast. One such method is the Time-Domain Optimized Near-Field Estimator (TONE), which employs a maximum a priori estimation to solve a highly underdetermined problem, given a well-defined system model. TONE has been shown to significantly improve both the contrast and resolution of ultrasound images when compared to conventional methods. However, TONE's lack of robustness to variations from the system model and extremely high computational cost hinder it from being readily adopted in clinical scanners. This dissertation aims to reduce the impact of TONE's shortcomings, transforming it from an academic construct to a clinically viable image reconstruction algorithm. By altering the system model from a collection of individual hypothetical scatterers to a collection of weighted, diffuse regions, dTONE is able to achieve much greater robustness to modeling errors. A method for efficient parallelization of dTONE is presented that reduces reconstruction time by more than an order of magnitude with little loss in image fidelity. An alternative reconstruction algorithm, called qTONE, is also developed and is able to reduce reconstruction times by another two orders of magnitude while simultaneously improving image contrast. Each of these methods for improving TONE are presented, their limitations are explored, and all are used in concert to reconstruct in vivo images of a human testicle. In all instances, the methods presented here outperform conventional image reconstruction methods by a significant margin. As TONE and its variants are general image reconstruction techniques, the theories and research presented here have the potential to significantly improve not only ultrasound's clinical utility, but that of other imaging modalities as well.

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…

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…

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…

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.

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

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

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.

Stakeholder Assessment of the Evidence for Cancer Genomic Tests: Insights from Three Case Studies

PubMed Central

Deverka, Patricia A.; Schully, Sheri D.; Ishibe, Naoko; Carlson, Josh J.; Freedman, Andrew; Goddard, Katrina A.B.; Khoury, Muin J.; Ramsey, Scott D.

2015-01-01

Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Purpose Understanding stakeholders’ assessment of the current evidence base for clinical practice and coverage decisions should be a critical step to influence research, policy, and practice. Methods Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision-making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test. Results At baseline, the level of confidence on the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for EGFR mutation and Lynch Syndrome (LS) testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX and EGFR testing, but not LS. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach. Conclusion Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis. PMID:22481130

Comparing and combining biomarkers as principle surrogates for time-to-event clinical endpoints.

PubMed

Gabriel, Erin E; Sachs, Michael C; Gilbert, Peter B

2015-02-10

Principal surrogate endpoints are useful as targets for phase I and II trials. In many recent trials, multiple post-randomization biomarkers are measured. However, few statistical methods exist for comparison of or combination of biomarkers as principal surrogates, and none of these methods to our knowledge utilize time-to-event clinical endpoint information. We propose a Weibull model extension of the semi-parametric estimated maximum likelihood method that allows for the inclusion of multiple biomarkers in the same risk model as multivariate candidate principal surrogates. We propose several methods for comparing candidate principal surrogates and evaluating multivariate principal surrogates. These include the time-dependent and surrogate-dependent true and false positive fraction, the time-dependent and the integrated standardized total gain, and the cumulative distribution function of the risk difference. We illustrate the operating characteristics of our proposed methods in simulations and outline how these statistics can be used to evaluate and compare candidate principal surrogates. We use these methods to investigate candidate surrogates in the Diabetes Control and Complications Trial. Copyright © 2014 John Wiley & Sons, Ltd.

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

PubMed

Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

2017-05-01

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.

Effect of public-private partnership in treatment of sexually transmitted infections among female sex workers in Andhra Pradesh, India

PubMed Central

Kokku, Suresh Babu; Mahapatra, Bidhubhusan; Tucker, Saroj; Saggurti, Niranjan; Prabhakar, Parimi

2014-01-01

Background & objectives: Providing sexually transmitted infection (STI) services to female sex workers (FSWs) in rural and resource constrained settings is a challenge. This paper describes an approach to address this challenge through a partnership with government health facilities, and examines the effect of this partnership on the utilization of STI services by FSWs in Andhra Pradesh, India. Methods: Partnerships were formed with 46 government clinics located in rural areas for providing STI treatment to FSWs in 2007. Government health facilities were supported by local and State level non-government organizations (NGOs) through provision of medicines, training of medical staff, outreach in the communities, and other coordination activities. Data from programme monitoring and behaviour tracking survey were used to examine the accessibility and acceptability in utilization of STI services from partnership clinics. Results: The number of FSWs accessing services at the partnership clinics increased from 1627 in 2007 to over 15,000 in 2010. The average number of annual visits by FSWs to these clinics in 2010 was 3.4. In opinion surveys, the majority of FSWs accessing services at the partnership clinics expressed confidence that they would continue to receive effective services from the government facilities even if the programme terminates. The overall attitude of FSWs to visit government clinics was more positive among FSWs from partnership clinic areas compared to those from non-partnership clinic areas. Interpretation & conclusions: The partnership mechanism between the NGO-supported HIV prevention programme and government clinic facilities appeared to be a promising opportunity to provide timely and accessible STI services for FSWs living in rural and remote areas. PMID:24718405

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.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rodriguez, Jennifer N.; Hwang, Wonjun; Horn, John

We report that the rupture of an intracranial aneurysm, which can result in severe mental disabilities or death, affects approximately 30,000 people in the United States annually. The traditional surgical method of treating these arterial malformations involves a full craniotomy procedure, wherein a clip is placed around the aneurysm neck. In recent decades, research and device development have focused on new endovascular treatment methods to occlude the aneurysm void space. These methods, some of which are currently in clinical use, utilize metal, polymeric, or hybrid devices delivered via catheter to the aneurysm site. In this review, we present several suchmore » devices, including those that have been approved for clinical use, and some that are currently in development. We present several design requirements for a successful aneurysm filling device and discuss the success or failure of current and past technologies. Lastly, we also present novel polymeric based aneurysm filling methods that are currently being tested in animal models that could result in superior healing.« less

An Automatic Segmentation and Classification Framework Based on PCNN Model for Single Tooth in MicroCT Images.

PubMed

Wang, Liansheng; Li, Shusheng; Chen, Rongzhen; Liu, Sze-Yu; Chen, Jyh-Cheng

2016-01-01

Accurate segmentation and classification of different anatomical structures of teeth from medical images plays an essential role in many clinical applications. Usually, the anatomical structures of teeth are manually labelled by experienced clinical doctors, which is time consuming. However, automatic segmentation and classification is a challenging task because the anatomical structures and surroundings of the tooth in medical images are rather complex. Therefore, in this paper, we propose an effective framework which is designed to segment the tooth with a Selective Binary and Gaussian Filtering Regularized Level Set (GFRLS) method improved by fully utilizing three dimensional (3D) information, and classify the tooth by employing unsupervised learning Pulse Coupled Neural Networks (PCNN) model. In order to evaluate the proposed method, the experiments are conducted on the different datasets of mandibular molars and the experimental results show that our method can achieve better accuracy and robustness compared to other four state of the art clustering methods.

Quantitative body DW-MRI biomarkers uncertainty estimation using unscented wild-bootstrap.

PubMed

Freiman, M; Voss, S D; Mulkern, R V; Perez-Rossello, J M; Warfield, S K

2011-01-01

We present a new method for the uncertainty estimation of diffusion parameters for quantitative body DW-MRI assessment. Diffusion parameters uncertainty estimation from DW-MRI is necessary for clinical applications that use these parameters to assess pathology. However, uncertainty estimation using traditional techniques requires repeated acquisitions, which is undesirable in routine clinical use. Model-based bootstrap techniques, for example, assume an underlying linear model for residuals rescaling and cannot be utilized directly for body diffusion parameters uncertainty estimation due to the non-linearity of the body diffusion model. To offset this limitation, our method uses the Unscented transform to compute the residuals rescaling parameters from the non-linear body diffusion model, and then applies the wild-bootstrap method to infer the body diffusion parameters uncertainty. Validation through phantom and human subject experiments shows that our method identify the regions with higher uncertainty in body DWI-MRI model parameters correctly with realtive error of -36% in the uncertainty values.

Design and biocompatibility of endovascular aneurysm filling devices

DOE PAGES

Rodriguez, Jennifer N.; Hwang, Wonjun; Horn, John; ...

2014-08-04

We report that the rupture of an intracranial aneurysm, which can result in severe mental disabilities or death, affects approximately 30,000 people in the United States annually. The traditional surgical method of treating these arterial malformations involves a full craniotomy procedure, wherein a clip is placed around the aneurysm neck. In recent decades, research and device development have focused on new endovascular treatment methods to occlude the aneurysm void space. These methods, some of which are currently in clinical use, utilize metal, polymeric, or hybrid devices delivered via catheter to the aneurysm site. In this review, we present several suchmore » devices, including those that have been approved for clinical use, and some that are currently in development. We present several design requirements for a successful aneurysm filling device and discuss the success or failure of current and past technologies. Lastly, we also present novel polymeric based aneurysm filling methods that are currently being tested in animal models that could result in superior healing.« less

[Ways to improve measurement accuracy of blood glucose sensing by mid-infrared spectroscopy].

PubMed

Wang, Yan; Li, Ning; Xu, Kexin

2006-06-01

Mid-infrared (MIR) spectroscopy is applicable to blood glucose sensing without using any reagent, however, due to a result of inadequate accuracy, till now this method has not been used in clinical detection. The principle and key technologies of blood glucose sensing by MIR spectroscopy are presented in this paper. Along with our experimental results, the paper analyzes ways to enhance measurement accuracy and prediction accuracy by the following four methods: selection of optimized spectral region; application of spectra data processing method; elimination of the interference with other components in the blood, and promotion in system hardware. According to these four improving methods, we designed four experiments, i.e., strict determination of the region where glucose concentration changes most sensitively in MIR, application of genetic algorithm for wavelength selection, normalization of spectra for the purpose of enhancing measuring reproduction, and utilization of CO2 laser as light source. The results show that the measurement accuracy of blood glucose concentration is enhanced almost to a clinical detection level.

Design and biocompatibility of endovascular aneurysm filling devices

PubMed Central

Rodriguez, Jennifer N.; Hwang, Wonjun; Horn, John; Landsman, Todd L.; Boyle, Anthony; Wierzbicki, Mark A.; Hasan, Sayyeda M.; Follmer, Douglas; Bryant, Jesse; Small, Ward; Maitland, Duncan J.

2014-01-01

The rupture of an intracranial aneurysm, which can result in severe mental disabilities or death, affects approximately 30,000 people in the United States annually. The traditional surgical method of treating these arterial malformations involves a full craniotomy procedure, wherein a clip is placed around the aneurysm neck. In recent decades, research and device development have focused on new endovascular treatment methods to occlude the aneurysm void space. These methods, some of which are currently in clinical use, utilize metal, polymeric, or hybrid devices delivered via catheter to the aneurysm site. In this review, we present several such devices, including those that have been approved for clinical use, and some that are currently in development. We present several design requirements for a successful aneurysm filling device and discuss the success or failure of current and past technologies. We also present novel polymeric based aneurysm filling methods that are currently being tested in animal models that could result in superior healing. PMID:25044644

Benchmarking to Identify Practice Variation in Test Ordering: A Potential Tool for Utilization Management.

PubMed

Signorelli, Heather; Straseski, Joely A; Genzen, Jonathan R; Walker, Brandon S; Jackson, Brian R; Schmidt, Robert L

2015-01-01

Appropriate test utilization is usually evaluated by adherence to published guidelines. In many cases, medical guidelines are not available. Benchmarking has been proposed as a method to identify practice variations that may represent inappropriate testing. This study investigated the use of benchmarking to identify sites with inappropriate utilization of testing for a particular analyte. We used a Web-based survey to compare 2 measures of vitamin D utilization: overall testing intensity (ratio of total vitamin D orders to blood-count orders) and relative testing intensity (ratio of 1,25(OH)2D to 25(OH)D test orders). A total of 81 facilities contributed data. The average overall testing intensity index was 0.165, or approximately 1 vitamin D test for every 6 blood-count tests. The average relative testing intensity index was 0.055, or one 1,25(OH)2D test for every 18 of the 25(OH)D tests. Both indexes varied considerably. Benchmarking can be used as a screening tool to identify outliers that may be associated with inappropriate test utilization. Copyright© by the American Society for Clinical Pathology (ASCP).

DOE Office of Scientific and Technical Information (OSTI.GOV)

Villien, Marjorie; Wey, Hsiao-Ying; Mandeville, Joseph B.

We report that glucose is the principal source of energy for the brain and yet the dynamic response of glucose utilization to changes in brain activity is still not fully understood. Positron emission tomography (PET) allows quantitative measurement of glucose metabolism using 2-[18F]-fluorodeoxyglucose (FDG). However, FDG PET in its current form provides an integral (or average) of glucose consumption over tens of minutes and lacks the temporal information to capture physiological alterations associated with changes in brain activity induced by tasks or drug challenges. Traditionally, changes in glucose utilization are inferred by comparing two separate scans, which significantly limits themore » utility of the method. We report a novel method to track changes in FDG metabolism dynamically, with higher temporal resolution than exists to date and within a single session. Using a constant infusion of FDG, we demonstrate that our technique (termed fPET-FDG) can be used in an analysis pipeline similar to fMRI to define within-session differential metabolic responses. We use visual stimulation to demonstrate the feasibility of this method. Ultimately, this new method has a great potential to be used in research protocols and clinical settings since fPET-FDG imaging can be performed with most PET scanners and data acquisition and analysis are straightforward. fPET-FDG is a highly complementary technique to MRI and provides a rich new way to observe functional changes in brain metabolism.« less

Quantitative Fourier Domain Optical Coherence Tomography Imaging of the Ocular Anterior Segment

NASA Astrophysics Data System (ADS)

McNabb, Ryan Palmer

Clinical imaging within ophthalmology has had transformative effects on ocular health over the last century. Imaging has guided clinicians in their pharmaceutical and surgical treatments of macular degeneration, glaucoma, cataracts and numerous other pathologies. Many of the imaging techniques currently used are photography based and are limited to imaging the surface of ocular structures. This limitation forces clinicians to make assumptions about the underlying tissue which may reduce the efficacy of their diagnoses. Optical coherence tomography (OCT) is a non-invasive, non-ionizing imaging modality that has been widely adopted within the field of ophthalmology in the last 15 years. As an optical imaging technique, OCT utilizes low-coherence interferometry to produce micron-scale three-dimensional datasets of a tissue's structure. Much of the human body consists of tissues that significantly scatter and attenuate optical signals limiting the imaging depth of OCT in those tissues to only 1-2mm. However, the ocular anterior segment is unique among human tissue in that it is primarily transparent or translucent. This allows for relatively deep imaging of tissue structure with OCT and is no longer limited by the optical scattering properties of the tissue. This goal of this work is to develop methods utilizing OCT that offer the potential to reduce the assumptions made by clinicians in their evaluations of their patients' ocular anterior segments. We achieved this by first developing a method to reduce the effects of patient motion during OCT volume acquisitions allowing for accurate, three dimensional measurements of corneal shape. Having accurate corneal shape measurements then allowed us to determine corneal spherical and astigmatic refractive contribution in a given individual. This was then validated in a clinical study that showed OCT better measured refractive change due to surgery than other clinical devices. Additionally, a method was developed to combine the clinical evaluation of the iridocorneal angle through gonioscopy with OCT.

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.

The use of audio-visual methods in radiology and physics courses

NASA Astrophysics Data System (ADS)

Holmberg, Peter

1987-03-01

Today's medicine utilizes sophisticated equipment for radiological, biochemical and microbiological investigation procedures and analyses. Hence it is necessary that physicians have adequate scientific and technical knowledge of the apparatus they are using so that the equipment can be used in the most effective way. Partly this knowledge is obtained from science-orientated courses in the preclinical stage of the study program for medical students. To increase the motivation to study science-courses (medical physics) audio-visual methods are used to describe diagnostic and therapeutic procedures in the clinical routines.

Applying the trigger review method after a brief educational intervention: potential for teaching and improving safety in GP specialty training?

PubMed Central

2013-01-01

Background The Trigger Review Method (TRM) is a structured approach to screening clinical records for undetected patient safety incidents (PSIs) and identifying learning and improvement opportunities. In Scotland, TRM participation can inform GP appraisal and has been included as a core component of the national primary care patient safety programme that was launched in March 2013. However, the clinical workforce needs up-skilled and the potential of TRM in GP training has yet to be tested. Current TRM training utilizes a workplace face-to-face session by a GP expert, which is not feasible. A less costly, more sustainable educational intervention is necessary to build capability at scale. We aimed to determine the feasibility and impact of TRM and a related training intervention in GP training. Methods We recruited 25 west of Scotland GP trainees to attend a 2-hour TRM workshop. Trainees then applied TRM to 25 clinical records and returned findings within 4-weeks. A follow-up feedback workshop was held. Results 21/25 trainees (84%) completed the task. 520 records yielded 80 undetected PSIs (15.4%). 36/80 were judged potentially preventable (45%) with 35/80 classified as causing moderate to severe harm (44%). Trainees described a range of potential learning and improvement plans. Training was positively received and appeared to be successful given these findings. TRM was valued as a safety improvement tool by most participants. Conclusion This small study provides further evidence of TRM utility and how to teach it pragmatically. TRM is of potential value in GP patient safety curriculum delivery and preparing trainees for future safety improvement expectations. PMID:24000946

Assessing Tumor-infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method From the International Immunooncology Biomarkers Working Group: Part 1: Assessing the Host Immune Response, TILs in Invasive Breast Carcinoma and Ductal Carcinoma In Situ, Metastatic Tumor Deposits and Areas for Further Research.

PubMed

Hendry, Shona; Salgado, Roberto; Gevaert, Thomas; Russell, Prudence A; John, Tom; Thapa, Bibhusal; Christie, Michael; van de Vijver, Koen; Estrada, M V; Gonzalez-Ericsson, Paula I; Sanders, Melinda; Solomon, Benjamin; Solinas, Cinzia; Van den Eynden, Gert G G M; Allory, Yves; Preusser, Matthias; Hainfellner, Johannes; Pruneri, Giancarlo; Vingiani, Andrea; Demaria, Sandra; Symmans, Fraser; Nuciforo, Paolo; Comerma, Laura; Thompson, E A; Lakhani, Sunil; Kim, Seong-Rim; Schnitt, Stuart; Colpaert, Cecile; Sotiriou, Christos; Scherer, Stefan J; Ignatiadis, Michail; Badve, Sunil; Pierce, Robert H; Viale, Giuseppe; Sirtaine, Nicolas; Penault-Llorca, Frederique; Sugie, Tomohagu; Fineberg, Susan; Paik, Soonmyung; Srinivasan, Ashok; Richardson, Andrea; Wang, Yihong; Chmielik, Ewa; Brock, Jane; Johnson, Douglas B; Balko, Justin; Wienert, Stephan; Bossuyt, Veerle; Michiels, Stefan; Ternes, Nils; Burchardi, Nicole; Luen, Stephen J; Savas, Peter; Klauschen, Frederick; Watson, Peter H; Nelson, Brad H; Criscitiello, Carmen; O'Toole, Sandra; Larsimont, Denis; de Wind, Roland; Curigliano, Giuseppe; André, Fabrice; Lacroix-Triki, Magali; van de Vijver, Mark; Rojo, Federico; Floris, Giuseppe; Bedri, Shahinaz; Sparano, Joseph; Rimm, David; Nielsen, Torsten; Kos, Zuzana; Hewitt, Stephen; Singh, Baljit; Farshid, Gelareh; Loibl, Sibylle; Allison, Kimberly H; Tung, Nadine; Adams, Sylvia; Willard-Gallo, Karen; Horlings, Hugo M; Gandhi, Leena; Moreira, Andre; Hirsch, Fred; Dieci, Maria V; Urbanowicz, Maria; Brcic, Iva; Korski, Konstanty; Gaire, Fabien; Koeppen, Hartmut; Lo, Amy; Giltnane, Jennifer; Rebelatto, Marlon C; Steele, Keith E; Zha, Jiping; Emancipator, Kenneth; Juco, Jonathan W; Denkert, Carsten; Reis-Filho, Jorge; Loi, Sherene; Fox, Stephen B

2017-09-01

Assessment of tumor-infiltrating lymphocytes (TILs) in histopathologic specimens can provide important prognostic information in diverse solid tumor types, and may also be of value in predicting response to treatments. However, implementation as a routine clinical biomarker has not yet been achieved. As successful use of immune checkpoint inhibitors and other forms of immunotherapy become a clinical reality, the need for widely applicable, accessible, and reliable immunooncology biomarkers is clear. In part 1 of this review we briefly discuss the host immune response to tumors and different approaches to TIL assessment. We propose a standardized methodology to assess TILs in solid tumors on hematoxylin and eosin sections, in both primary and metastatic settings, based on the International Immuno-Oncology Biomarker Working Group guidelines for TIL assessment in invasive breast carcinoma. A review of the literature regarding the value of TIL assessment in different solid tumor types follows in part 2. The method we propose is reproducible, affordable, easily applied, and has demonstrated prognostic and predictive significance in invasive breast carcinoma. This standardized methodology may be used as a reference against which other methods are compared, and should be evaluated for clinical validity and utility. Standardization of TIL assessment will help to improve consistency and reproducibility in this field, enrich both the quality and quantity of comparable evidence, and help to thoroughly evaluate the utility of TILs assessment in this era of immunotherapy.

Medical student attitudes toward kidney physiology and nephrology: a qualitative study.

PubMed

Roberts, John K; Sparks, Matthew A; Lehrich, Ruediger W

2016-11-01

Interest in nephrology among trainees is waning in the USA. Early perceptions and attitudes to subject matter can be linked to the quality of pre-clinical curricula. We wanted to explore these attitudes in the setting of modern curriculum redesign. We utilized Q methodology to understand first-year medical student attitudes after an innovative kidney physiology curriculum redesign that focuses on blending multiple learning methods. First-year medical students were invited to take a Q sort survey at the conclusion of a kidney physiology course. Students prioritized statements related to their understanding of kidney physiology, learning preferences, preferred course characteristics, perceived clinical relevance of kidney physiology, and interest in nephrology as a career. Factor analysis was performed to identify different student viewpoints. At the conclusion of our modified course, all students (n = 108) were invited to take the survey and 44 (41%) Q sorts were returned. Two dominant viewpoints were defined according to interest in nephrology. The Potentials are students who understand kidney physiology, perceive kidney physiology as clinically relevant, attend class sessions, utilize videos, and are willing to shadow a nephrologist. The Uninterested are students who are less satisfied with their kidney physiology knowledge, prefer to study alone with a textbook, avoid lectures, and are not interested in learning about nephrology. In an updated renal physiology course, students that use multiple learning methods also have favorable attitudes toward learning kidney physiology. Thus, modern curriculum changes that accommodate a variety of learning styles may promote positive attitudes toward nephrology.

Multiple Intimate Partner Violence Experiences: Knowledge, Access, Utilization and Barriers to Utilization of Resources by Women of the African Diaspora

PubMed Central

Sabri, Bushra; Huerta, Julia; Alexander, Kamila A.; St.Vil, Noelle M.; Campbell, Jacquelyn C.; Callwood, Gloria B.

2016-01-01

Objective This study examined knowledge, access, utilization, and barriers to use of resources among Black women exposed to multiple types of intimate partner violence in Baltimore, Maryland and the U.S. Virgin Islands (USVI). Methods We analyzed quantitative survey data collected by 163 women recruited from primary care, prenatal or family planning clinics in Baltimore and the USVI. In addition we analyzed qualitative data from in-depth interviews with 11 women. Quantitative data were analyzed using descriptive statistics and qualitative data were analyzed using thematic analysis. Results A substantial proportion of Black women with multiple types of violence experiences lacked knowledge of, did not have access to, and did not use resources. Barriers to resource use were identified at the individual, relationship, and community levels. Conclusion There is need for programs to develop awareness, promote access and utilization of resources, and eliminate barriers to resource use among abused Black women. PMID:26548679

Life expectancy calculation in urology: Are we equitably treating older patients?

PubMed

Bhatt, Nikita R; Davis, Niall F; Breen, Kieran; Flood, Hugh D; Giri, Subhasis K

2017-01-01

The aim of our study was to determine the contemporary practice in the utilization of life expectancy (LE) calculations among urological clinicians. Members of the Irish Society of Urology (ISU) and the British Association of Urological Surgeons (BAUS) completed a questionnaire on LE utilization in urological practice. The survey was delivered to 1251 clinicians and the response rate was 17% (n = 208/1251). The majority (61%, n = 127) of urologists were aware of methods available for estimated LE calculation.Seventy-one percent (n = 148) had never utilized LE analysis in clinical practice and 81% (n = 170) routinely used 'eyeballing' (empiric prediction) for estimating LE. Life expectancy tables were utilized infrequently (12%, n = 25) in making the decision for treatment in the setting of multi-disciplinary meetings. LE is poorly integrated into treatment decision-making; not only for the management of urological patients but also in the multidisciplinary setting. Further education and awareness regarding the importance of LE is vital.

Interpretation of Blood Microbiology Results - Function of the Clinical Microbiologist.

PubMed

Kristóf, Katalin; Pongrácz, Júlia

2016-04-01

The proper use and interpretation of blood microbiology results may be one of the most challenging and one of the most important functions of clinical microbiology laboratories. Effective implementation of this function requires careful consideration of specimen collection and processing, pathogen detection techniques, and prompt and precise reporting of identification and susceptibility results. The responsibility of the treating physician is proper formulation of the analytical request and to provide the laboratory with complete and precise patient information, which are inevitable prerequisites of a proper testing and interpretation. The clinical microbiologist can offer advice concerning the differential diagnosis, sampling techniques and detection methods to facilitate diagnosis. Rapid detection methods are essential, since the sooner a pathogen is detected, the better chance the patient has of getting cured. Besides the gold-standard blood culture technique, microbiologic methods that decrease the time in obtaining a relevant result are more and more utilized today. In the case of certain pathogens, the pathogen can be identified directly from the blood culture bottle after propagation with serological or automated/semi-automated systems or molecular methods or with MALDI-TOF MS (matrix-assisted laser desorption-ionization time of flight mass spectrometry). Molecular biology methods are also suitable for the rapid detection and identification of pathogens from aseptically collected blood samples. Another important duty of the microbiology laboratory is to notify the treating physician immediately about all relevant information if a positive sample is detected. The clinical microbiologist may provide important guidance regarding the clinical significance of blood isolates, since one-third to one-half of blood culture isolates are contaminants or isolates of unknown clinical significance. To fully exploit the benefits of blood culture and other (non- culture based) diagnoses, the microbiologist and the clinician should interact directly.

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

Molecular typing of Sarcocystis neurona: current status and future trends.

PubMed

Elsheikha, Hany M; Mansfield, Linda S

2007-10-21

Sarcocystis neurona is an important protozoal pathogen because it causes the serious neurological disease equine protozoal myeloencephalitis (EPM). The capacity of this organism to cause a wide spectrum of neurological signs in horses and the broad geographic distribution of observed cases in the Americas drive the need for sensitive, reliable and rapid typing methods to characterize strains. Various molecular methods have been developed and used to diagnose EPM due to S. neurona, to identify S. neurona isolates and to determine the heterogeneity and evolutionary relatedness within this species and related Sarcocystis spp. These methods included sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), immuno-fluorescent assay (IFA), slide agglutination test (SAT), SnSAG-specific ELISA, random amplified polymorphic DNA (RAPD), PCR-based restriction fragment length polymorphism (RFLP), amplified fragment length polymorphism (AFLP) fingerprinting, and sequence analysis of surface protein genes, ribosomal genes, microsatellite alleles and other molecular markers. Here, the utility of these molecular methods is reviewed and evaluated with respect to the need for molecular approaches that utilize well-characterized polymorphic, simple, independent, and stable genetic markers. These tools have the potential to add to knowledge of the genetic population structure of S. neurona and to provide new insights into the pathogenesis of EPM and S. neurona epidemiology. In particular, these methods provide new tools to address the hypothesis that particular genetic variants are associated with adverse clinical outcomes (severe pathotypes). The ultimate goal is to utilize them in future studies to improve treatment and prevention strategies.

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.

The contribution of clinical assessments to the diagnostic algorithm of pulmonary embolism.

PubMed

Turan, Onur; Turgut, Deniz; Gunay, Turkan; Yilmaz, Erkan; Turan, Ayse; Akkoclu, Atila

2017-01-01

Pulmonary thromboembolism (PE) is a major disease in respiratory emergencies. Thoracic CT angiography (CTA) is an important method of visualizing PE. Because of the high radiation and contrast exposure, the method should be performed selectively in patients in whom PE is suspected. The aim of the study was to identify the role of clinical scoring systems utilizing CTA results to diagnose PE. The study investigated 196 patients referred to the hospital emergency service in whom PE was suspected and CTA performed. They were evaluated by empirical, Wells, Geneva and Miniati assessments and classified as low, intermediate and high clinical probability. They were also classified according to serum D-dimer levels. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated and evaluated according to CTA findings. Empirical scoring was found to have the highest sensitivity, while the Wells system had the highest specificity. When low D-dimer levels and "low probabilty" were evaluated together for each scoring system, the sensitivity was found to be 100% for all methods. Wells scoring with a cut-off score of 4 had the highest specificity (56.1%). Clinical scoring systems may be guides for patients in whom PE is suspected in the emergency department. The empirical and Wells scoring systems are effective methods for patient selection. Adding evaluation of D-dimer serum levels to the clinical scores could identify patients in whom CTA should be performed. Since CTA can only be used conservatively, the use of clinical scoring systems in conjunction with D-dimer levels can be a useful guide for patient selection.

Measurement properties of existing clinical assessment methods evaluating scapular positioning and function. A systematic review.

PubMed

Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans; Søgaard, Karen

2014-10-01

The aims were to compile a schematic overview of clinical scapular assessment methods and critically appraise the methodological quality of the involved studies. A systematic, computer-assisted literature search using Medline, CINAHL, SportDiscus and EMBASE was performed from inception to October 2013. Reference lists in articles were also screened for publications. From 50 articles, 54 method names were identified and categorized into three groups: (1) Static positioning assessment (n = 19); (2) Semi-dynamic (n = 13); and (3) Dynamic functional assessment (n = 22). Fifteen studies were excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57%) to "poor" (43%), with only one study rated as "good". The reliability domain was most often investigated. Few of the assessment methods in the included studies that had "fair" or "good" measurement property ratings demonstrated acceptable results for both reliability and validity. We found a substantially larger number of clinical scapular assessment methods than previously reported. Using the COSMIN checklist the methodological quality of the included measurement properties in the reliability and validity domains were in general "fair" to "poor". None were examined for all three domains: (1) reliability; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase utility for clinical practice.

Photoplethysmography: beyond the calculation of arterial oxygen saturation and heart rate.

PubMed

Shelley, Kirk H

2007-12-01

In this article, I examine the source of the photoplethysmograph (PPG), as well as methods of investigation, with an emphasize on amplitude, rhythm, and pulse analysis. The PPG waveform was first described in the 1930s. Although considered an interesting ancillary monitor, the "pulse waveform" never underwent intensive investigation. Its importance in clinical medicine was greatly increased with the introduction of the pulse oximeter into routine clinical care in the 1980s. Its waveform is now commonly displayed in the clinical setting. Active research efforts are beginning to demonstrate a utility beyond oxygen saturation and heart rate determination. Future trends are being heavily influenced by modern digital signal processing, which is allowing a re-examination of this ubiquitous waveform. Key to unlocking the potential of this waveform is an unfettered access to the raw signal, combined with standardization of its presentation, and methods of analysis. In the long run, we need to learn how to consistently quantify the characteristics of the PPG in such a way as to allow the results from research efforts be translated into clinically useful devices.

Color-coded visualization of magnetic resonance imaging multiparametric maps

NASA Astrophysics Data System (ADS)

Kather, Jakob Nikolas; Weidner, Anja; Attenberger, Ulrike; Bukschat, Yannick; Weis, Cleo-Aron; Weis, Meike; Schad, Lothar R.; Zöllner, Frank Gerrit

2017-01-01

Multiparametric magnetic resonance imaging (mpMRI) data are emergingly used in the clinic e.g. for the diagnosis of prostate cancer. In contrast to conventional MR imaging data, multiparametric data typically include functional measurements such as diffusion and perfusion imaging sequences. Conventionally, these measurements are visualized with a one-dimensional color scale, allowing only for one-dimensional information to be encoded. Yet, human perception places visual information in a three-dimensional color space. In theory, each dimension of this space can be utilized to encode visual information. We addressed this issue and developed a new method for tri-variate color-coded visualization of mpMRI data sets. We showed the usefulness of our method in a preclinical and in a clinical setting: In imaging data of a rat model of acute kidney injury, the method yielded characteristic visual patterns. In a clinical data set of N = 13 prostate cancer mpMRI data, we assessed diagnostic performance in a blinded study with N = 5 observers. Compared to conventional radiological evaluation, color-coded visualization was comparable in terms of positive and negative predictive values. Thus, we showed that human observers can successfully make use of the novel method. This method can be broadly applied to visualize different types of multivariate MRI data.

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

Overview of Experimental and Clinical Findings regarding the Neuroprotective Effects of Cerebral Ischemic Postconditioning.

PubMed

Ma, Di; Feng, Liangshu; Deng, Fang; Feng, Jia-Chun

2017-01-01

Research on attenuating the structural and functional deficits observed following ischemia-reperfusion has become increasingly focused on the therapeutic potential of ischemic postconditioning. In recent years, various methods and animal models of ischemic postconditioning have been utilized. The results of these numerous studies have indicated that the mechanisms underlying the neuroprotective effects of ischemic postconditioning may involve reductions in the generation of free radicals and inhibition of calcium overload, as well as the release of endogenous active substances, alterations in membrane channel function, and activation of protein kinases. Here we review the novel discovery, mechanism, key factors, and clinical application of ischemic postconditioning and discuss its implications for future research and problem of clinical practice.

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.

Functional connectivity change as shared signal dynamics

PubMed Central

Cole, Michael W.; Yang, Genevieve J.; Murray, John D.; Repovš, Grega; Anticevic, Alan

2015-01-01

Background An increasing number of neuroscientific studies gain insights by focusing on differences in functional connectivity – between groups, individuals, temporal windows, or task conditions. We found using simulations that additional insights into such differences can be gained by forgoing variance normalization, a procedure used by most functional connectivity measures. Simulations indicated that these functional connectivity measures are sensitive to increases in independent fluctuations (unshared signal) in time series, consistently reducing functional connectivity estimates (e.g., correlations) even though such changes are unrelated to corresponding fluctuations (shared signal) between those time series. This is inconsistent with the common notion of functional connectivity as the amount of inter-region interaction. New Method Simulations revealed that a version of correlation without variance normalization – covariance – was able to isolate differences in shared signal, increasing interpretability of observed functional connectivity change. Simulations also revealed cases problematic for non-normalized methods, leading to a “covariance conjunction” method combining the benefits of both normalized and non-normalized approaches. Results We found that covariance and covariance conjunction methods can detect functional connectivity changes across a variety of tasks and rest in both clinical and non-clinical functional MRI datasets. Comparison with Existing Method(s) We verified using a variety of tasks and rest in both clinical and non-clinical functional MRI datasets that it matters in practice whether correlation, covariance, or covariance conjunction methods are used. Conclusions These results demonstrate the practical and theoretical utility of isolating changes in shared signal, improving the ability to interpret observed functional connectivity change. PMID:26642966

HIV coreceptor phenotyping in the clinical setting.

PubMed

Low, Andrew J; Swenson, Luke C; Harrigan, P Richard

2008-01-01

The introduction of CCR5 antagonists increases the options available for constructing antiretroviral regimens. However, this option is coupled with the caveat that patients should be tested for HIV coreceptor tropism prior to initiating CCR5 antagonist-based therapy. Failure to screen for CXCR4 usage increases the risk of using an ineffective drug, thus reducing the likelihood of viral suppression and increasing their risk for developing antiretroviral resistance. This review discusses current and future methods of determining HIV tropism, with a focus on their utility in the clinical setting for screening purposes. Some of these methods include recombinant phenotypic tests, such as the Monogram Trofile assay, as well as genotype-based predictors, heteroduplex tracking assays, and flow cytometry based methods. Currently, the best evidence supports the use of phenotypic methods, although other methods of screening for HIV coreceptor usage prior to the administration of CCR5 antagonists may reduce costs and increase turnaround time over phenotypic methods. The presence of low levels of X4 virus is a challenge to all assay methods, resulting in reduced sensitivity in clinical, patient-derived samples when compared to clonally derived samples. Gaining a better understanding of the output of these assays and correlating them with clinical progression and therapy response will provide some indication on how both genotype-based, and phenotypic assays for determining HIV coreceptor usage can be improved. In addition, leveraging new technologies capable of detecting low-level minority species may provide the most significant advances in ensuring that individuals with low levels of dual/mixed tropic virus are not inadvertently prescribed CCR5 antagonists.

Hospital clinical pharmacy services in Vietnam.

PubMed

Trinh, Hieu T; Nguyen, Huong T L; Pham, Van T T; Ba, Hai L; Dong, Phuong T X; Cao, Thao T B; Nguyen, Hanh T H; Brien, Jo-Anne

2018-04-07

Background Clinical pharmacy is key to the quality use of medicines. While there are different approaches in different countries, international perspectives may inform health service development. The Vietnamese Ministry of Health introduced a legal regulation of clinical pharmacy services in December 2012. Objective To describe the services, and to explore reported barriers and facilitators in implementing clinical pharmacy activities in Vietnamese hospitals after the introduction of Vietnamese Ministry of Health legal regulation. Setting Thirty-nine hospitals in Hanoi, Vietnam, including 22 provincial and 17 district hospitals. Method A mixed methods study was utilized. An online questionnaire was sent to the hospitals. In-depth interviews were conducted with pairs of nominated pharmacists at ten of these hospitals. The questionnaire focused on four areas: facilities, workforce, policies and clinical pharmacy activities. Main outcome measure Proportion of clinical pharmacy activities in hospitals. Themes in clinical pharmacy practice. Results 34/39 (87%) hospitals had established clinical pharmacy teams. Most activities were non-patient-specific (87%) while the preliminary patient-specific clinical pharmacy services were available in only 8/39 hospitals (21%). The most common non-patient-specific activities were providing medicines information (97%), reporting adverse drug reactions (97%), monitoring medication usage (97%). The patient specific activities varied widely between hospitals and were ad hoc. The main challenges reported were: lack of workforce and qualified clinical pharmacists. Conclusion While most hospitals had hospital-based pharmacy activities, the direct patient care was limited. Training, education and an expanded work forces are needed to improve clinical pharmacy services.

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

A semi-automatic method for left ventricle volume estimate: an in vivo validation study

NASA Technical Reports Server (NTRS)

Corsi, C.; Lamberti, C.; Sarti, A.; Saracino, G.; Shiota, T.; Thomas, J. D.

2001-01-01

This study aims to the validation of the left ventricular (LV) volume estimates obtained by processing volumetric data utilizing a segmentation model based on level set technique. The validation has been performed by comparing real-time volumetric echo data (RT3DE) and magnetic resonance (MRI) data. A validation protocol has been defined. The validation protocol was applied to twenty-four estimates (range 61-467 ml) obtained from normal and pathologic subjects, which underwent both RT3DE and MRI. A statistical analysis was performed on each estimate and on clinical parameters as stroke volume (SV) and ejection fraction (EF). Assuming MRI estimates (x) as a reference, an excellent correlation was found with volume measured by utilizing the segmentation procedure (y) (y=0.89x + 13.78, r=0.98). The mean error on SV was 8 ml and the mean error on EF was 2%. This study demonstrated that the segmentation technique is reliably applicable on human hearts in clinical practice.

SPIRITUALITY AND RELIGION AMONG HIV-INFECTED INDIVIDUALS

PubMed Central

Szaflarski, Magdalena

2017-01-01

Spirituality and religion are important to many people living with HIV (PLWH). Recent research has focused on special populations (ethnic-minorities, women, and youth), spirituality/religion measurement, mediating/moderating mechanisms, and individual and community-level interventions. Spirituality/religion in PLWH has been refined as a multidimensional phenomenon which improves health/quality of life directly and through mediating factors (healthy behaviors, optimism, social support). Spirituality/religion helps people to cope with stressors, especially stigma/discrimination. Spiritual interventions utilizing the power of prayer and meditation and addressing spiritual struggle are under way. Faith-based community interventions have focused on stigma and could improve individual outcomes through access to spiritual/social support and care/treatment for PLWA. Community engagement is necessary to design/implement effective and sustainable programs. Future efforts should focus on vulnerable populations; utilize state-of the art methods (randomized clinical trials, community-based participatory research); and, address population-specific interventions at individual and community levels. Clinical and policy implications across geographic settings also need attention. PMID:23996649

Spirituality and religion among HIV-infected individuals.

PubMed

Szaflarski, Magdalena

2013-12-01

Spirituality and religion are important to many people living with HIV (PLWH). Recent research has focused on special populations (ethnic-minorities, women, and youth), spirituality/religion measurement, mediating/moderating mechanisms, and individual and community-level interventions. Spirituality/religion in PLWH has been refined as a multidimensional phenomenon, which improves health/quality of life directly and through mediating factors (healthy behaviors, optimism, social support). Spirituality/religion helps people to cope with stressors, especially stigma/discrimination. Spiritual interventions utilizing the power of prayer and meditation and addressing spiritual struggle are under way. Faith-based community interventions have focused on stigma and could improve individual outcomes through access to spiritual/social support and care/treatment for PLWA. Community engagement is necessary to design/implement effective and sustainable programs. Future efforts should focus on vulnerable populations; utilize state-of-the-art methods (randomized clinical trials, community-based participatory research); and, address population-specific interventions at individual and community levels. Clinical and policy implications across geographic settings also need attention.

Artificial intelligence-assisted occupational lung disease diagnosis.

PubMed

Harber, P; McCoy, J M; Howard, K; Greer, D; Luo, J

1991-08-01

An artificial intelligence expert-based system for facilitating the clinical recognition of occupational and environmental factors in lung disease has been developed in a pilot fashion. It utilizes a knowledge representation scheme to capture relevant clinical knowledge into structures about specific objects (jobs, diseases, etc) and pairwise relations between objects. Quantifiers describe both the closeness of association and risk, as well as the degree of belief in the validity of a fact. An independent inference engine utilizes the knowledge, combining likelihoods and uncertainties to achieve estimates of likelihood factors for specific paths from work to illness. The system creates a series of "paths," linking work activities to disease outcomes. One path links a single period of work to a single possible disease outcome. In a preliminary trial, the number of "paths" from job to possible disease averaged 18 per subject in a general population and averaged 25 per subject in an asthmatic population. Artificial intelligence methods hold promise in the future to facilitate diagnosis in pulmonary and occupational medicine.

External validation of a simple clinical tool used to predict falls in people with Parkinson disease

PubMed Central

Duncan, Ryan P.; Cavanaugh, James T.; Earhart, Gammon M.; Ellis, Terry D.; Ford, Matthew P.; Foreman, K. Bo; Leddy, Abigail L.; Paul, Serene S.; Canning, Colleen G.; Thackeray, Anne; Dibble, Leland E.

2015-01-01

Background Assessment of fall risk in an individual with Parkinson disease (PD) is a critical yet often time consuming component of patient care. Recently a simple clinical prediction tool based only on fall history in the previous year, freezing of gait in the past month, and gait velocity <1.1 m/s was developed and accurately predicted future falls in a sample of individuals with PD. METHODS We sought to externally validate the utility of the tool by administering it to a different cohort of 171 individuals with PD. Falls were monitored prospectively for 6 months following predictor assessment. RESULTS The tool accurately discriminated future fallers from non-fallers (area under the curve [AUC] = 0.83; 95% CI 0.76 –0.89), comparable to the developmental study. CONCLUSION The results validated the utility of the tool for allowing clinicians to quickly and accurately identify an individual’s risk of an impending fall. PMID:26003412

Utility of HLA Antibody Testing in Kidney Transplantation

PubMed Central

Konvalinka, Ana

2015-01-01

HLA antigens are polymorphic proteins expressed on donor kidney allograft endothelium and are critical targets for recipient immune recognition. HLA antibodies are risk factors for acute and chronic rejection and allograft loss. Solid-phase immunoassays for HLA antibody detection represent a major advance in sensitivity and specificity over cell-based methods and are widely used in organ allocation and pretransplant risk assessment. Post-transplant, development of de novo donor–specific HLA antibodies and/or increase in donor-specific antibodies from pretransplant levels are associated with adverse outcomes. Although single antigen bead assays have allowed sensitive detection of recipient HLA antibodies and their specificities, a number of interpretive considerations must be appreciated to understand test results in clinical and research contexts. This review, which is especially relevant for clinicians caring for transplant patients, discusses the technical aspects of single antigen bead assays, emphasizes their quantitative limitations, and explores the utility of HLA antibody testing in identifying and managing important pre- and post-transplant clinical outcomes. PMID:25804279

Clinical Utility of Noninvasive Method to Measure Specific Gravity in the Pediatric Population.

PubMed

Hall, Jeanine E; Huynh, Pauline P; Mody, Ameer P; Wang, Vincent J

2018-04-01

Clinicians rely on any combination of signs and symptoms, clinical scores, or invasive procedures to assess the hydration status in children. Noninvasive tests to evaluate for dehydration in the pediatric population are appealing. The objective of our study is to assess the utility of measuring specific gravity of tears compared to specific gravity of urine and the clinical assessment of dehydration. We conducted a prospective cohort convenience sample study, in a pediatric emergency department at a tertiary care children's hospital. We approached parents/guardians of children aged 6 months to 4 years undergoing transurethral catheterization for evaluation of urinary tract infection for enrollment. We collected tears and urine for measurement of tear specific gravity (TSG) and urine specific gravity (USG), respectively. Treating physicians completed dehydration assessment forms to assess for hydration status. Among the 60 participants included, the mean TSG was 1.0183 (SD = 0.007); the mean USG was 1.0186 (SD = 0.0083). TSG and USG were positively correlated with each other (Pearson Correlation = 0.423, p = 0.001). Clinical dehydration scores ranged from 0 to 3, with 87% assigned a score of 0, by physician assessment. Mean number of episodes of vomiting and diarrhea in a 24-hour period were 2.2 (SD = 3.9) and 1.5 (SD = 3.2), respectively. Sixty-two percent of parents reported decreased oral intake. TSG measurements yielded similar results compared with USG. Further studies are needed to determine if TSG can be used as a noninvasive method of dehydration assessment in children. Copyright © 2017 Elsevier Inc. All rights reserved.

Predicting health-related quality of life (EQ-5D-5 L) and capability wellbeing (ICECAP-A) in the context of opiate dependence using routine clinical outcome measures: CORE-OM, LDQ and TOP.

PubMed

Peak, Jasmine; Goranitis, Ilias; Day, Ed; Copello, Alex; Freemantle, Nick; Frew, Emma

2018-05-30

Economic evaluation normally requires information to be collected on outcome improvement using utility values. This is often not collected during the treatment of substance use disorders making cost-effectiveness evaluations of therapy difficult. One potential solution is the use of mapping to generate utility values from clinical measures. This study develops and evaluates mapping algorithms that could be used to predict the EuroQol-5D (EQ-5D-5 L) and the ICEpop CAPability measure for Adults (ICECAP-A) from the three commonly used clinical measures; the CORE-OM, the LDQ and the TOP measures. Models were estimated using pilot trial data of heroin users in opiate substitution treatment. In the trial the EQ-5D-5 L, ICECAP-A, CORE-OM, LDQ and TOP were administered at baseline, three and twelve month time intervals. Mapping was conducted using estimation and validation datasets. The normal estimation dataset, which comprised of baseline sample data, used ordinary least squares (OLS) and tobit regression methods. Data from the baseline and three month time periods were combined to create a pooled estimation dataset. Cluster and mixed regression methods were used to map from this dataset. Predictive accuracy of the models was assessed using the root mean square error (RMSE) and the mean absolute error (MAE). Algorithms were validated using sample data from the follow-up time periods. Mapping algorithms can be used to predict the ICECAP-A and the EQ-5D-5 L in the context of opiate dependence. Although both measures can be predicted, the ICECAP-A was better predicted by the clinical measures. There were no advantages of pooling the data. There were 6 chosen mapping algorithms, which had MAE scores ranging from 0.100 to 0.138 and RMSE scores ranging from 0.134 to 0.178. It is possible to predict the scores of the ICECAP-A and the EQ-5D-5 L with the use of mapping. In the context of opiate dependence, these algorithms provide the possibility of generating utility values from clinical measures and thus enabling economic evaluation of alternative therapy options. ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Value of information methods to design a clinical trial in a small population to optimise a health economic utility function.

PubMed

Pearce, Michael; Hee, Siew Wan; Madan, Jason; Posch, Martin; Day, Simon; Miller, Frank; Zohar, Sarah; Stallard, Nigel

2018-02-08

Most confirmatory randomised controlled clinical trials (RCTs) are designed with specified power, usually 80% or 90%, for a hypothesis test conducted at a given significance level, usually 2.5% for a one-sided test. Approval of the experimental treatment by regulatory agencies is then based on the result of such a significance test with other information to balance the risk of adverse events against the benefit of the treatment to future patients. In the setting of a rare disease, recruiting sufficient patients to achieve conventional error rates for clinically reasonable effect sizes may be infeasible, suggesting that the decision-making process should reflect the size of the target population. We considered the use of a decision-theoretic value of information (VOI) method to obtain the optimal sample size and significance level for confirmatory RCTs in a range of settings. We assume the decision maker represents society. For simplicity we assume the primary endpoint to be normally distributed with unknown mean following some normal prior distribution representing information on the anticipated effectiveness of the therapy available before the trial. The method is illustrated by an application in an RCT in haemophilia A. We explicitly specify the utility in terms of improvement in primary outcome and compare this with the costs of treating patients, both financial and in terms of potential harm, during the trial and in the future. The optimal sample size for the clinical trial decreases as the size of the population decreases. For non-zero cost of treating future patients, either monetary or in terms of potential harmful effects, stronger evidence is required for approval as the population size increases, though this is not the case if the costs of treating future patients are ignored. Decision-theoretic VOI methods offer a flexible approach with both type I error rate and power (or equivalently trial sample size) depending on the size of the future population for whom the treatment under investigation is intended. This might be particularly suitable for small populations when there is considerable information about the patient population.

TU-AB-BRB-02: Stochastic Programming Methods for Handling Uncertainty and Motion in IMRT Planning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Unkelbach, J.

The accepted clinical method to accommodate targeting uncertainties inherent in fractionated external beam radiation therapy is to utilize GTV-to-CTV and CTV-to-PTV margins during the planning process to design a PTV-conformal static dose distribution on the planning image set. Ideally, margins are selected to ensure a high (e.g. >95%) target coverage probability (CP) in spite of inherent inter- and intra-fractional positional variations, tissue motions, and initial contouring uncertainties. Robust optimization techniques, also known as probabilistic treatment planning techniques, explicitly incorporate the dosimetric consequences of targeting uncertainties by including CP evaluation into the planning optimization process along with coverage-based planning objectives. Themore » treatment planner no longer needs to use PTV and/or PRV margins; instead robust optimization utilizes probability distributions of the underlying uncertainties in conjunction with CP-evaluation for the underlying CTVs and OARs to design an optimal treated volume. This symposium will describe CP-evaluation methods as well as various robust planning techniques including use of probability-weighted dose distributions, probability-weighted objective functions, and coverage optimized planning. Methods to compute and display the effect of uncertainties on dose distributions will be presented. The use of robust planning to accommodate inter-fractional setup uncertainties, organ deformation, and contouring uncertainties will be examined as will its use to accommodate intra-fractional organ motion. Clinical examples will be used to inter-compare robust and margin-based planning, highlighting advantages of robust-plans in terms of target and normal tissue coverage. Robust-planning limitations as uncertainties approach zero and as the number of treatment fractions becomes small will be presented, as well as the factors limiting clinical implementation of robust planning. Learning Objectives: To understand robust-planning as a clinical alternative to using margin-based planning. To understand conceptual differences between uncertainty and predictable motion. To understand fundamental limitations of the PTV concept that probabilistic planning can overcome. To understand the major contributing factors to target and normal tissue coverage probability. To understand the similarities and differences of various robust planning techniques To understand the benefits and limitations of robust planning techniques.« less

TU-AB-BRB-00: New Methods to Ensure Target Coverage

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

The accepted clinical method to accommodate targeting uncertainties inherent in fractionated external beam radiation therapy is to utilize GTV-to-CTV and CTV-to-PTV margins during the planning process to design a PTV-conformal static dose distribution on the planning image set. Ideally, margins are selected to ensure a high (e.g. >95%) target coverage probability (CP) in spite of inherent inter- and intra-fractional positional variations, tissue motions, and initial contouring uncertainties. Robust optimization techniques, also known as probabilistic treatment planning techniques, explicitly incorporate the dosimetric consequences of targeting uncertainties by including CP evaluation into the planning optimization process along with coverage-based planning objectives. Themore » treatment planner no longer needs to use PTV and/or PRV margins; instead robust optimization utilizes probability distributions of the underlying uncertainties in conjunction with CP-evaluation for the underlying CTVs and OARs to design an optimal treated volume. This symposium will describe CP-evaluation methods as well as various robust planning techniques including use of probability-weighted dose distributions, probability-weighted objective functions, and coverage optimized planning. Methods to compute and display the effect of uncertainties on dose distributions will be presented. The use of robust planning to accommodate inter-fractional setup uncertainties, organ deformation, and contouring uncertainties will be examined as will its use to accommodate intra-fractional organ motion. Clinical examples will be used to inter-compare robust and margin-based planning, highlighting advantages of robust-plans in terms of target and normal tissue coverage. Robust-planning limitations as uncertainties approach zero and as the number of treatment fractions becomes small will be presented, as well as the factors limiting clinical implementation of robust planning. Learning Objectives: To understand robust-planning as a clinical alternative to using margin-based planning. To understand conceptual differences between uncertainty and predictable motion. To understand fundamental limitations of the PTV concept that probabilistic planning can overcome. To understand the major contributing factors to target and normal tissue coverage probability. To understand the similarities and differences of various robust planning techniques To understand the benefits and limitations of robust planning techniques.« less

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.

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.

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.

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

Utilization of lean management principles in the ambulatory clinic setting.

PubMed

Casey, Jessica T; Brinton, Thomas S; Gonzalez, Chris M

2009-03-01

The principles of 'lean management' have permeated many sectors of today's business world, secondary to the success of the Toyota Production System. This management method enables workers to eliminate mistakes, reduce delays, lower costs, and improve the overall quality of the product or service they deliver. These lean management principles can be applied to health care. Their implementation within the ambulatory care setting is predicated on the continuous identification and elimination of waste within the process. The key concepts of flow time, inventory and throughput are utilized to improve the flow of patients through the clinic, and to identify points that slow this process -- so-called bottlenecks. Nonessential activities are shifted away from bottlenecks (i.e. the physician), and extra work capacity is generated from existing resources, rather than being added. The additional work capacity facilitates a more efficient response to variability, which in turn results in cost savings, more time for the physician to interact with patients, and faster completion of patient visits. Finally, application of the lean management principle of 'just-in-time' management can eliminate excess clinic inventory, better synchronize office supply with patient demand, and reduce costs.

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

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.

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

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.

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.

Reliability of Chinese medicine diagnostic variables in the examination of patients with osteoarthritis of the knee.

PubMed

Hua, Bin; Abbas, Estelle; Hayes, Alan; Ryan, Peter; Nelson, Lisa; O'Brien, Kylie

2012-11-01

Chinese medicine (CM) has its own diagnostic indicators that are used as evidence of change in a patient's condition. The majority of studies investigating efficacy of Chinese herbal medicine (CHM) have utilized biomedical diagnostic endpoints. For CM clinical diagnostic variables to be incorporated into clinical trial designs, there would need to be evidence that these diagnostic variables are reliable. Previous studies have indicated that the reliability of CM syndrome diagnosis is variable. Little information is known about where the variability stems from--the basic data collection level or the synthesis of diagnostic data, or both. No previous studies have investigated systematically the reliability of all four diagnostic methods used in the CM diagnostic process (Inquiry, Inspection, Auscultation/Olfaction, and Palpation). The objective of this study was to assess the inter-rater reliability of data collected using the four diagnostic methods of CM in Australian patients with knee osteoarthritis (OA), in order to investigate if CM variables could be used with confidence as diagnostic endpoints in a clinical trial investigating the efficacy of a CHM in treating OA. An inter-rater reliability study was conducted as a substudy of a clinical trial investigating the treatment of knee OA with Chinese herbal medicine. Two (2) experienced CM practitioners conducted a CM examination separately, within 2 hours of each other, in 40 participants. A CM assessment form was utilized to record the diagnostic data. Cohen's κ coefficient was used as a measure of the level of agreement between 2 practitioners. There was a relatively good level of agreement for Inquiry and Auscultation variables, and, in general, a low level of agreement for (visual) Inspection and Palpation variables. There was variation in the level of agreement between 2 practitioners on clinical information collected using the Four Diagnostic Methods of a CM examination. Some aspects of CM diagnosis appear to be reliable, while others are not. Based on these results, it was inappropriate to use CM diagnostic variables as diagnostic endpoints in the main study, which was an investigation of efficacy of CHM treatment of knee OA.

An ex vivo approach to botanical-drug interactions: a proof of concept study.

PubMed

Wang, Xinwen; Zhu, Hao-Jie; Munoz, Juliana; Gurley, Bill J; Markowitz, John S

2015-04-02

Botanical medicines are frequently used in combination with therapeutic drugs, imposing a risk for harmful botanical-drug interactions (BDIs). Among the existing BDI evaluation methods, clinical studies are the most desirable, but due to their expense and protracted time-line for completion, conventional in vitro methodologies remain the most frequently used BDI assessment tools. However, many predictions generated from in vitro studies are inconsistent with clinical findings. Accordingly, the present study aimed to develop a novel ex vivo approach for BDI assessment and expand the safety evaluation methodology in applied ethnopharmacological research. This approach differs from conventional in vitro methods in that rather than botanical extracts or individual phytochemicals being prepared in artificial buffers, human plasma/serum collected from a limited number of subjects administered botanical supplements was utilized to assess BDIs. To validate the methodology, human plasma/serum samples collected from healthy subjects administered either milk thistle or goldenseal extracts were utilized in incubation studies to determine their potential inhibitory effects on CYP2C9 and CYP3A4/5, respectively. Silybin A and B, two principal milk thistle phytochemicals, and hydrastine and berberine, the purported active constituents in goldenseal, were evaluated in both phosphate buffer and human plasma based in vitro incubation systems. Ex vivo study results were consistent with formal clinical study findings for the effect of milk thistle on the disposition of tolbutamide, a CYP2C9 substrate, and for goldenseal׳s influence on the pharmacokinetics of midazolam, a widely accepted CYP3A4/5 substrate. Compared to conventional in vitro BDI methodologies of assessment, the introduction of human plasma into the in vitro study model changed the observed inhibitory effect of silybin A, silybin B and hydrastine and berberine on CYP2C9 and CYP3A4/5, respectively, results which more closely mirrored those generated in clinical study. Data from conventional buffer-based in vitro studies were less predictive than the ex vivo assessments. Thus, this novel ex vivo approach may be more effective at predicting clinically relevant BDIs than conventional in vitro methods. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD.

PubMed

Winhusen, Theresa; Winstanley, Erin L; Somoza, Eugene; Brigham, Gregory

2012-01-01

Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. In a multi-site trial evaluating Seeking Safety (SS), relative to Women's Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

A pyrosequencing assay for the quantitative methylation analysis of the PCDHB gene cluster, the major factor in neuroblastoma methylator phenotype.

PubMed

Banelli, Barbara; Brigati, Claudio; Di Vinci, Angela; Casciano, Ida; Forlani, Alessandra; Borzì, Luana; Allemanni, Giorgio; Romani, Massimo

2012-03-01

Epigenetic alterations are hallmarks of cancer and powerful biomarkers, whose clinical utilization is made difficult by the absence of standardization and of common methods of data interpretation. The coordinate methylation of many loci in cancer is defined as 'CpG island methylator phenotype' (CIMP) and identifies clinically distinct groups of patients. In neuroblastoma (NB), CIMP is defined by a methylation signature, which includes different loci, but its predictive power on outcome is entirely recapitulated by the PCDHB cluster only. We have developed a robust and cost-effective pyrosequencing-based assay that could facilitate the clinical application of CIMP in NB. This assay permits the unbiased simultaneous amplification and sequencing of 17 out of 19 genes of the PCDHB cluster for quantitative methylation analysis, taking into account all the sequence variations. As some of these variations were at CpG doublets, we bypassed the data interpretation conducted by the methylation analysis software to assign the corrected methylation value at these sites. The final result of the assay is the mean methylation level of 17 gene fragments in the protocadherin B cluster (PCDHB) cluster. We have utilized this assay to compare the methylation levels of the PCDHB cluster between high-risk and very low-risk NB patients, confirming the predictive value of CIMP. Our results demonstrate that the pyrosequencing-based assay herein described is a powerful instrument for the analysis of this gene cluster that may simplify the data comparison between different laboratories and, in perspective, could facilitate its clinical application. Furthermore, our results demonstrate that, in principle, pyrosequencing can be efficiently utilized for the methylation analysis of gene clusters with high internal homologies.

Need, Enabling, Predisposing, and Behavioral Determinants of Access to Preventative Care in Argentina: Analysis of the National Survey of Risk Factors

PubMed Central

Jahangir, Eiman; Irazola, Vilma; Rubinstein, Adolfo

2012-01-01

Introduction Health care utilization is an important step to disease management, providing opportunities for prevention and treatment. Anderson’s Health Behavior Model has defined utilization by need, predisposing, and enabling determinants. We hypothesize that need, predisposing, and enabling, highlighting behavioral factors are associated with utilization in Argentina. Methods We performed a logistic regression analysis of the 2005 and 2009 Argentinean Survey of Risk Factors, a cohort of 41,392 and 34,732 individuals, to explore the association between need, enabling, predisposing, and behavioral factors to blood pressure measurement in the last year. Results In the 2005 cohort, blood pressure measurement was associated with perception of health, insurance coverage, basic needs met, and income. Additionally, female sex, civil state, household type, older age groups, education, and alcohol use were associated with utilization. The 2009 cohort showed similar associations with only minor differences between the models. Conclusions We explored the association between utilization of clinical preventive services with need, enabling, predisposing, and behavioral factors. While predisposing and need determinants are associated with utilization, enabling factors such as insurance coverage provides an area for public intervention. These are important findings where policies should be focused to improve utilization of preventive services in Argentina. PMID:22984608

Beam focal spot position determination for an Elekta linac with the Agility® head; practical guide with a ready-to-go procedure.

PubMed

Chojnowski, Jacek M; Taylor, Lee M; Sykes, Jonathan R; Thwaites, David I

2018-05-14

A novel phantomless, EPID-based method of measuring the beam focal spot offset of a linear accelerator was proposed and validated for Varian machines. In this method, one set of jaws and the MLC were utilized to form a symmetric field and then a 180 o collimator rotation was utilized to determine the radiation isocenter defined by the jaws and the MLC, respectively. The difference between these two isocentres is directly correlated with the beam focal spot offset of the linear accelerator. In the current work, the method has been considered for Elekta linacs. An Elekta linac with the Agility ® head does not have two set of jaws, therefore, a modified method is presented making use of one set of diaphragms, the MLC and a full 360 o collimator rotation. The modified method has been tested on two Elekta Synergy ® linacs with Agility ® heads and independently validated. A practical guide with instructions and a MATLAB ® code is attached for easy implementation. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Combined pulse-oximeter-NIRS system for biotissue diagnostics

NASA Astrophysics Data System (ADS)

Hovhannisyan, Vladimir A.

2005-08-01

Multi-wavelength (670, 805, 848 and 905 nm), multi-detector device for non-invasive measurement of biochemical components concentration in human or animal tissues, combining the methods of conventional pulse-oximetry and near infrared spectroscopy, is developed. The portable and clinically applicable system allows to measure heart pulse rate, oxygen saturation of arterial hemoglobin (pulse-oximetry method) and local absolute concentration of oxyhemoglobin, deoxyhemoglobin and oxidized cytochrome aa3 or other IR absorbed compounds (NIRS method). The system can be applied in monitoring of oxygen availability and utilization by the brain in neonatal and adults, neuro- traumatology, intensive care medicine, transplantation and plastic surgery, in sport, high-altitude and aviation medicine.

The optical, photothermal, and facile surface chemical properties of gold and silver nanoparticles in biodiagnostics, therapy, and drug delivery

PubMed Central

Austin, Lauren A.; Mackey, Megan A.; Dreaden, Erik C.

2014-01-01

Nanotechnology is a rapidly growing area of research in part due to its integration into many biomedical applications. Within nanotechnology, gold and silver nanostructures are some of the most heavily utilized nanomaterial due to their unique optical, photothermal, and facile surface chemical properties. In this review, common colloid synthesis methods and biofunctionalization strategies of gold and silver nanostructures are highlighted. Their unique properties are also discussed in terms of their use in biodiagnostic, imaging, therapeutic, and drug delivery applications. Furthermore, relevant clinical applications utilizing gold and silver nanostructures are also presented. We also provide a table with reviews covering related topics. PMID:24894431

Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial.

PubMed

Zanaboni, Paolo; Landolina, Maurizio; Marzegalli, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Guenzati, Giuseppe; Curnis, Antonio; Valsecchi, Sergio; Borghetti, Francesca; Borghi, Gabriella; Masella, Cristina

2013-05-30

Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

Novel algorithmic approach predicts tumor mutation load and correlates with immunotherapy clinical outcomes using a defined gene mutation set.

PubMed

Roszik, Jason; Haydu, Lauren E; Hess, Kenneth R; Oba, Junna; Joon, Aron Y; Siroy, Alan E; Karpinets, Tatiana V; Stingo, Francesco C; Baladandayuthapani, Veera; Tetzlaff, Michael T; Wargo, Jennifer A; Chen, Ken; Forget, Marie-Andrée; Haymaker, Cara L; Chen, Jie Qing; Meric-Bernstam, Funda; Eterovic, Agda K; Shaw, Kenna R; Mills, Gordon B; Gershenwald, Jeffrey E; Radvanyi, Laszlo G; Hwu, Patrick; Futreal, P Andrew; Gibbons, Don L; Lazar, Alexander J; Bernatchez, Chantale; Davies, Michael A; Woodman, Scott E

2016-10-25

While clinical outcomes following immunotherapy have shown an association with tumor mutation load using whole exome sequencing (WES), its clinical applicability is currently limited by cost and bioinformatics requirements. We developed a method to accurately derive the predicted total mutation load (PTML) within individual tumors from a small set of genes that can be used in clinical next generation sequencing (NGS) panels. PTML was derived from the actual total mutation load (ATML) of 575 distinct melanoma and lung cancer samples and validated using independent melanoma (n = 312) and lung cancer (n = 217) cohorts. The correlation of PTML status with clinical outcome, following distinct immunotherapies, was assessed using the Kaplan-Meier method. PTML (derived from 170 genes) was highly correlated with ATML in cutaneous melanoma and lung adenocarcinoma validation cohorts (R 2  = 0.73 and R 2  = 0.82, respectively). PTML was strongly associated with clinical outcome to ipilimumab (anti-CTLA-4, three cohorts) and adoptive T-cell therapy (1 cohort) clinical outcome in melanoma. Clinical benefit from pembrolizumab (anti-PD-1) in lung cancer was also shown to significantly correlate with PTML status (log rank P value < 0.05 in all cohorts). The approach of using small NGS gene panels, already applied to guide employment of targeted therapies, may have utility in the personalized use of immunotherapy in cancer.

CDC-reported assisted reproductive technology live-birth rates may mislead the public.

PubMed

Kushnir, Vitaly A; Choi, Jennifer; Darmon, Sarah K; Albertini, David F; Barad, David H; Gleicher, Norbert

2017-08-01

The Centre for Disease Control and Prevention (CDC) publicly reports assisted reproductive technology live-birth rates (LBR) for each US fertility clinic under legal mandate. The 2014 CDC report excluded 35,406 of 184,527 (19.2%) autologous assisted reproductive technology cycles that involved embryo or oocyte banking from LBR calculations. This study calculated 2014 total clinic LBR for all patients utilizing autologous oocytes two ways: including all initiated assisted reproductive technology cycles or excluding banking cycles, as done by the CDC. The main limitation of this analysis is the CDC report did not differentiate between cycles involving long-term banking of embryos or oocytes for fertility preservation from cycles involving short-term embryo banking. Twenty-seven of 458 (6%) clinics reported over 40% of autologous cycles involved banking, collectively performing 12% of all US assisted reproductive technology cycles. LBR in these outlier clinics calculated by the CDC method, was higher than the other 94% of clinics (33.1% versus 31.1%). However, recalculated LBR including banking cycles in the outlier clinics was lower than the other 94% of clinics (15.5% versus 26.6%). LBR calculated by the two methods increasingly diverged based on proportion of banking cycles performed by each clinic reaching 4.5-fold, thereby, potentially misleading the public. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

A new method for teaching physical examination to junior medical students.

PubMed

Sayma, Meelad; Williams, Hywel Rhys

2016-01-01

Teaching effective physical examination is a key component in the education of medical students. Preclinical medical students often have insufficient clinical knowledge to apply to physical examination recall, which may hinder their learning when taught through certain understanding-based models. This pilot project aimed to develop a method to teach physical examination to preclinical medical students using "core clinical cases", overcoming the need for "rote" learning. This project was developed utilizing three cycles of planning, action, and reflection. Thematic analysis of feedback was used to improve this model, and ensure it met student expectations. A model core clinical case developed in this project is described, with gout as the basis for a "foot and ankle" examination. Key limitations and difficulties encountered on implementation of this pilot are discussed for future users, including the difficulty encountered in "content overload". This approach aims to teach junior medical students physical examination through understanding, using a simulated patient environment. Robust research is now required to demonstrate efficacy and repeatability in the physical examination of other systems.

Molecular Mechanisms Underlying Occult Hepatitis B Virus Infection

PubMed Central

Samal, Jasmine; Kandpal, Manish

2012-01-01

Summary: Chronic hepatitis B virus (HBV) infection is a complex clinical entity frequently associated with cirrhosis and hepatocellular carcinoma (HCC). The persistence of HBV genomes in the absence of detectable surface antigenemia is termed occult HBV infection. Mutations in the surface gene rendering HBsAg undetectable by commercial assays and inhibition of HBV by suppression of viral replication and viral proteins represent two fundamentally different mechanisms that lead to occult HBV infections. The molecular mechanisms underlying occult HBV infections, including recently identified mechanisms associated with the suppression of HBV replication and inhibition of HBV proteins, are reviewed in detail. The availability of highly sensitive molecular methods has led to increased detection of occult HBV infections in various clinical settings. The clinical relevance of occult HBV infection and the utility of appropriate diagnostic methods to detect occult HBV infection are discussed. The need for specific guidelines on the diagnosis and management of occult HBV infection is being increasingly recognized; the aspects of mechanistic studies that warrant further investigation are discussed in the final section. PMID:22232374

Application of machine learning algorithms for clinical predictive modeling: a data-mining approach in SCT.

PubMed

Shouval, R; Bondi, O; Mishan, H; Shimoni, A; Unger, R; Nagler, A

2014-03-01

Data collected from hematopoietic SCT (HSCT) centers are becoming more abundant and complex owing to the formation of organized registries and incorporation of biological data. Typically, conventional statistical methods are used for the development of outcome prediction models and risk scores. However, these analyses carry inherent properties limiting their ability to cope with large data sets with multiple variables and samples. Machine learning (ML), a field stemming from artificial intelligence, is part of a wider approach for data analysis termed data mining (DM). It enables prediction in complex data scenarios, familiar to practitioners and researchers. Technological and commercial applications are all around us, gradually entering clinical research. In the following review, we would like to expose hematologists and stem cell transplanters to the concepts, clinical applications, strengths and limitations of such methods and discuss current research in HSCT. The aim of this review is to encourage utilization of the ML and DM techniques in the field of HSCT, including prediction of transplantation outcome and donor selection.

A Novel Method to Generate and Expand Clinical-Grade, Genetically Modified, Tumor-Infiltrating Lymphocytes

PubMed Central

Forget, Marie-Andrée; Tavera, René J.; Haymaker, Cara; Ramachandran, Renjith; Malu, Shuti; Zhang, Minying; Wardell, Seth; Fulbright, Orenthial J.; Toth, Chistopher Leroy; Gonzalez, Audrey M.; Thorsen, Shawne T.; Flores, Esteban; Wahl, Arely; Peng, Weiyi; Amaria, Rodabe N.; Hwu, Patrick; Bernatchez, Chantale

2017-01-01

Following the clinical success achieved with the first generation of adoptive cell therapy (ACT) utilizing in vitro expanded tumor-infiltrating lymphocytes (TILs), the second and third generations of TIL ACT are evolving toward the use of genetically modified TIL. TIL therapy generally involves the transfer of a high number of TIL, ranging from 109 to 1011 cells. One of the technical difficulties in genetically modifying TIL, using a retroviral vector, is the ability to achieve large expansion of transduced TIL, while keeping the technique suitable to a Good Manufacturing Practices (GMP) environment. Consequently, we developed and optimized a novel method for the efficient production of large numbers of GMP-grade, gene-modified TIL for the treatment of patients with ACT. The chemokine receptor CXCR2 was used as the gene of interest for methodology development. The optimized procedure is currently used in the production of gene-modified TIL for two clinical trials for the treatment of metastatic melanoma at MD Anderson Cancer Center. PMID:28824634

An exploration of the biomedical optics course construction of undergraduate biomedical engineering program in medical colleges

NASA Astrophysics Data System (ADS)

Guo, Shijun; Lyu, Jie; Zhang, Peiming

2017-08-01

In this paper, the teaching goals, teaching contents and teaching methods in biomedical optics course construction are discussed. From the dimension of teaching goals, students should master the principle of optical inspection on the human body, diagnosis and treatment of methodology and instruments, through the study of the theory and practice of this course, and can utilize biomedical optics methods to solve practical problems in the clinical medical engineering practice. From the dimension of teaching contents, based on the characteristics of biomedical engineering in medical colleges, the organic integration of engineering aspects, medical optical instruments, and biomedical aspects dispersed in human anatomy, human physiology, clinical medicine fundamental related to the biomedical optics is build. Noninvasive measurement of the human body composition and noninvasive optical imaging of the human body were taken as actual problems in biomedical optics fields. Typical medical applications such as eye optics and laser medicine were also integrated into the theory and practice teaching. From the dimension of teaching methods, referencing to organ-system based medical teaching mode, optical principle and instrument principle were taught by teachers from school of medical instruments, and the histological characteristics and clinical actual need in areas such as digestive diseases and urinary surgery were taught by teachers from school of basic medicine or clinical medicine of medical colleges. Furthermore, clinical application guidance would be provided by physician and surgeons in hospitals.

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.

Cost-Utility Analysis of the EVOLVO Study on Remote Monitoring for Heart Failure Patients With Implantable Defibrillators: Randomized Controlled Trial

PubMed Central

Landolina, Maurizio; Marzegalli, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Guenzati, Giuseppe; Curnis, Antonio; Valsecchi, Sergio; Borghetti, Francesca; Borghi, Gabriella; Masella, Cristina

2013-01-01

Background Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. Objective We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Methods Two hundred patients implanted with a wireless transmission–enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Results Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Conclusions Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations. Trial Registration ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f). PMID:23722666

The cardiac muscle duplex as a method to study myocardial heterogeneity

PubMed Central

Solovyova, O.; Katsnelson, L.B.; Konovalov, P.V.; Kursanov, A.G.; Vikulova, N.A.; Kohl, P.; Markhasin, V.S.

2014-01-01

This paper reviews the development and application of paired muscle preparations, called duplex, for the investigation of mechanisms and consequences of intra-myocardial electro-mechanical heterogeneity. We illustrate the utility of the underlying combined experimental and computational approach for conceptual development and integration of basic science insight with clinically relevant settings, using previously published and new data. Directions for further study are identified. PMID:25106702

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.

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

An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder

PubMed Central

Algorta, Guillermo Perez; Youngstrom, Eric A.; Phelps, James; Jenkins, Melissa M.; Kogos, Jennifer L.; Findling, Robert L.

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient settings. Families (N=273) completed family history, rating scales, MINI and KSADS interviews about youths 5–18 (median=11) years presenting to an outpatient clinic. Primary caregivers completed a half page Family Index of Risk for Mood issues (FIRM). All families completed the FIRM quickly and easily. Most (78%) reported 1+ relatives having history of mood or substance issues, M=3.7 (SD=3.3). A simple sum of familial mood issues discriminated cases with PBD from all other cases, AUROC=.63, p=.006. FIRM scores were specific to youth mood disorder and not ADHD or disruptive behavior disorder. FIRM scores significantly improved the detection of PBD even controlling for rating scales. No subset of family risk items performed better than the total. Family history information showed clinically meaningful discrimination of PBD. Two different approaches to clinical interpretation showed validity in these clinically realistic data. Inexpensive and clinically practical methods of gathering family history can help to improve the detection of PBD. PMID:22800090

[Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

PubMed

Lázaro de Mercado, P

1997-06-01

Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative.

PubMed

Francis, Maureen D; Wieland, Mark L; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L

2015-03-01

Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model.

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

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

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.

Consumer sleep tracking devices: a review of mechanisms, validity and utility.

PubMed

Kolla, Bhanu Prakash; Mansukhani, Subir; Mansukhani, Meghna P

2016-05-01

Consumer sleep tracking devices such as fitness trackers and smartphone apps have become increasingly popular. These devices claim to measure the sleep duration of their users and in some cases purport to measure sleep quality and awaken users from light sleep, potentially improving overall sleep. Most of these devices appear to utilize data generated from in-built accelerometers to determine sleep parameters but the exact mechanisms and algorithms are proprietary. The growing literature comparing these devices against polysomnography/actigraphy shows that they tend to underestimate sleep disruptions and overestimate total sleep times and sleep efficiency in normal subjects. In this review, we evaluate the current literature comparing the accuracy of consumer sleep tracking devices against more conventional methods used to measure sleep duration and quality. We discuss the current technology that these devices utilize as well as summarize the value of these devices in clinical evaluations and their potential limitations.

Benefit-cost analysis of SBIRT interventions for substance using patients in emergency departments.

PubMed

Horn, Brady P; Crandall, Cameron; Forcehimes, Alyssa; French, Michael T; Bogenschutz, Michael

2017-08-01

Screening, brief intervention, and referral to treatment (SBIRT) has been widely implemented as a method to address substance use disorders in general medical settings, and some evidence suggests that its use is associated with decreased societal costs. In this paper, we investigated the economic impact of SBIRT using data from Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), a multisite, randomized controlled trial. Utilizing self-reported information on medical status, health services utilization, employment, and crime, we conduct a benefit-cost analysis. Findings indicate that neither of the SMART-ED interventions resulted in any significant changes to the main economic outcomes, nor had any significant impact on total economic benefit. Thus, while SBIRT interventions for substance abuse in Emergency Departments may be appealing from a clinical perspective, evidence from this economic study suggests resources could be better utilized supporting other health interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

Suitability of the molecular subtyping methods intergenic spacer region, direct genome restriction analysis, and pulsed-field gel electrophoresis for clinical and environmental Vibrio parahaemolyticus isolates.

PubMed

Lüdeke, Catharina H M; Fischer, Markus; LaFon, Patti; Cooper, Kara; Jones, Jessica L

2014-07-01

Vibrio parahaemolyticus is the leading cause of infectious illness associated with seafood consumption in the United States. Molecular fingerprinting of strains has become a valuable research tool for understanding this pathogen. However, there are many subtyping methods available and little information on how they compare to one another. For this study, a collection of 67 oyster and 77 clinical V. parahaemolyticus isolates were analyzed by three subtyping methods--intergenic spacer region (ISR-1), direct genome restriction analysis (DGREA), and pulsed-field gel electrophoresis (PFGE)--to determine the utility of these methods for discriminatory subtyping. ISR-1 analysis, run as previously described, provided the lowest discrimination of all the methods (discriminatory index [DI]=0.8665). However, using a broader analytical range than previously reported, ISR-1 clustered isolates based on origin (oyster versus clinical) and had a DI=0.9986. DGREA provided a DI=0.9993-0.9995, but did not consistently cluster the isolates by any identifiable characteristics (origin, serotype, or virulence genotype) and ∼ 15% of isolates were untypeable by this method. PFGE provided a DI=0.9998 when using the combined pattern analysis of both restriction enzymes, SfiI and NotI. This analysis was more discriminatory than using either enzyme pattern alone and primarily grouped isolates by serotype, regardless of strain origin (clinical or oyster) or presence of currently accepted virulence markers. These results indicate that PFGE and ISR-1 are more reliable methods for subtyping V. parahemolyticus, rather than DGREA. Additionally, ISR-1 may provide an indication of pathogenic potential; however, more detailed studies are needed. These data highlight the diversity within V. parahaemolyticus and the need for appropriate selection of subtyping methods depending on the study objectives.

Classification of bladder cancer cell lines using Raman spectroscopy: a comparison of excitation wavelength, sample substrate and statistical algorithms

NASA Astrophysics Data System (ADS)

Kerr, Laura T.; Adams, Aine; O'Dea, Shirley; Domijan, Katarina; Cullen, Ivor; Hennelly, Bryan M.

2014-05-01

Raman microspectroscopy can be applied to the urinary bladder for highly accurate classification and diagnosis of bladder cancer. This technique can be applied in vitro to bladder epithelial cells obtained from urine cytology or in vivo as an optical biopsy" to provide results in real-time with higher sensitivity and specificity than current clinical methods. However, there exists a high degree of variability across experimental parameters which need to be standardised before this technique can be utilized in an everyday clinical environment. In this study, we investigate different laser wavelengths (473 nm and 532 nm), sample substrates (glass, fused silica and calcium fluoride) and multivariate statistical methods in order to gain insight into how these various experimental parameters impact on the sensitivity and specificity of Raman cytology.

Application of person-centered analytic methodology in longitudinal research: exemplars from the Women's Health Initiative Clinical Trial data.

PubMed

Zaslavsky, Oleg; Cochrane, Barbara B; Herting, Jerald R; Thompson, Hilaire J; Woods, Nancy F; Lacroix, Andrea

2014-02-01

Despite the variety of available analytic methods, longitudinal research in nursing has been dominated by use of a variable-centered analytic approach. The purpose of this article is to present the utility of person-centered methodology using a large cohort of American women 65 and older enrolled in the Women's Health Initiative Clinical Trial (N = 19,891). Four distinct trajectories of energy/fatigue scores were identified. Levels of fatigue were closely linked to age, socio-demographic factors, comorbidities, health behaviors, and poor sleep quality. These findings were consistent regardless of the methodological framework. Finally, we demonstrated that energy/fatigue levels predicted future hospitalization in non-disabled elderly. Person-centered methods provide unique opportunities to explore and statistically model the effects of longitudinal heterogeneity within a population. © 2013 Wiley Periodicals, Inc.

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.

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.

Lost in translation: neuropsychiatric drug development.

PubMed

Becker, Robert E; Greig, Nigel H

2010-12-08

Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.

Discovering body site and severity modifiers in clinical texts

PubMed Central

Dligach, Dmitriy; Bethard, Steven; Becker, Lee; Miller, Timothy; Savova, Guergana K

2014-01-01

Objective To research computational methods for discovering body site and severity modifiers in clinical texts. Methods We cast the task of discovering body site and severity modifiers as a relation extraction problem in the context of a supervised machine learning framework. We utilize rich linguistic features to represent the pairs of relation arguments and delegate the decision about the nature of the relationship between them to a support vector machine model. We evaluate our models using two corpora that annotate body site and severity modifiers. We also compare the model performance to a number of rule-based baselines. We conduct cross-domain portability experiments. In addition, we carry out feature ablation experiments to determine the contribution of various feature groups. Finally, we perform error analysis and report the sources of errors. Results The performance of our method for discovering body site modifiers achieves F1 of 0.740–0.908 and our method for discovering severity modifiers achieves F1 of 0.905–0.929. Discussion Results indicate that both methods perform well on both in-domain and out-domain data, approaching the performance of human annotators. The most salient features are token and named entity features, although syntactic dependency features also contribute to the overall performance. The dominant sources of errors are infrequent patterns in the data and inability of the system to discern deeper semantic structures. Conclusions We investigated computational methods for discovering body site and severity modifiers in clinical texts. Our best system is released open source as part of the clinical Text Analysis and Knowledge Extraction System (cTAKES). PMID:24091648

Countertransference in Child and Adolescent Psychiatry-A Forgotten Concept?

PubMed Central

Rasic, Daniel

2010-01-01

Objectives: The purpose of this paper is to review the evolution of the concept of countertransference, its clinical utility and unique features in the child and adolescent psychiatry setting. Methods: This article employs a selective literature review of papers relevant to countertransference in general and in child and adolescent psychiatry. Results: Reviewed papers indicate that countertransference is a ubiquitous phenomenon in child and adolescent psychiatric practice and that it can have important clinical implications. Conclusions: Recognition and management of countertransference is a crucial skill in child and adolescent psychiatry. Recommendations are made regarding its incorporation in residency training and psychiatric practice. PMID:21037914

Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.

PubMed

Murphy, Michael F; Antonini, Paola; Lai, Zhihong Vicki

2011-01-01

Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into this environment mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally. To outline an example for clinical development programs that incorporate the perspective of multiple stakeholders into a portfolio of study designs to provide optimal data platforms that can resonate with diverse recipients. A contract research organization directly involved in the design, execution, and analysis of clinical trials for new drugs and devices across pharmaceutical and biotechnology companies provides a unique perspective regarding opportunities and challenges within the international clinical research environment. Drs Murphy, Antonini, and Lai, representing Worldwide Clinical Trials, utilize chronic obstructive pulmonary disease as a demonstration project exploiting its prevalence, direct and indirect costs, and the rapid infusion/diffusion of innovative therapy into practice as a rationale for focus, and illustrate methods of informing registration and technology assessments during a prototypical development process. By virtue of its chronicity, prevalence, and pattern of healthcare utilization, chronic obstructive pulmonary disease provides an ideal case for illustrating the application of clinical trial methodology that can facilitate data evaluation through the prism of multiple stakeholders. Adding an international dimension exacerbates system complexity and serves to illustrate the breadth of issues that can be addressed within this therapeutic area.

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

Citrate-based fluorescent materials for low-cost chloride sensing in the diagnosis of Cystic Fibrosis.

PubMed

Kim, Jimin P; Xie, Zhiwei; Creer, Michael; Liu, Zhiwen; Yang, Jian

2017-01-01

Chloride is an essential electrolyte that maintains homeostasis within the body, where abnormal chloride levels in biological fluids may indicate various diseases such as Cystic Fibrosis. However, current analytical solutions for chloride detection fail to meet the clinical needs of both high performance and low material or labor costs, hindering translation into clinical settings. Here we present a new class of fluorescence chloride sensors derived from a facile citrate -based synthesis platform that utilize dynamic quenching mechanisms. Based on this low-cost platform, we demonstrate for the first time a selective sensing strategy that uses a single fluorophore to detect multiple halides simultaneously, promising both selectivity and automation to improve performance and reduce labor costs. We also demonstrate the clinical utility of citrate-based sensors as a new sweat chloride test method for the diagnosis of Cystic Fibrosis by performing analytical validation with sweat controls and clinical validation with sweat from individuals with or without Cystic Fibrosis. Lastly, molecular modeling studies reveal the structural mechanism behind chloride sensing, serving to expand this class of fluorescence sensors with improved chloride sensitivities. Thus citrate-based fluorescent materials may enable low-cost, automated multi-analysis systems for simpler, yet accurate, point-of-care diagnostics that can be readily translated into clinical settings. More broadly, a wide range of medical, industrial, and environmental applications can be achieved with such a facile synthesis platform, demonstrated in our citrate-based biodegradable polymers with intrinsic fluorescence sensing.

A Qualitative Analysis Evaluating The Purposes And Practices Of Clinical Documentation

PubMed Central

Ho, Y.-X.; Gadd, C. S.; Kohorst, K.L.; Rosenbloom, S.T.

2014-01-01

Summary Objectives An important challenge for biomedical informatics researchers is determining the best approach for healthcare providers to use when generating clinical notes in settings where electronic health record (EHR) systems are used. The goal of this qualitative study was to explore healthcare providers’ and administrators’ perceptions about the purpose of clinical documentation and their own documentation practices. Methods We conducted seven focus groups with a total of 46 subjects composed of healthcare providers and administrators to collect knowledge, perceptions and beliefs about documentation from those who generate and review notes, respectively. Data were analyzed using inductive analysis to probe and classify impressions collected from focus group subjects. Results We observed that both healthcare providers and administrators believe that documentation serves five primary domains: clinical, administrative, legal, research, education. These purposes are tied closely to the nature of the clinical note as a document shared by multiple stakeholders, which can be a source of tension for all parties who must use the note. Most providers reported using a combination of methods to complete their notes in a timely fashion without compromising patient care. While all administrators reported relying on computer-based documentation tools to review notes, they expressed a desire for a more efficient method of extracting relevant data. Conclusions Although clinical documentation has utility, and is valued highly by its users, the development and successful adoption of a clinical documentation tool largely depends on its ability to be smoothly integrated into the provider’s busy workflow, while allowing the provider to generate a note that communicates effectively and efficiently with multiple stakeholders. PMID:24734130

Multiple Comorbidities and Interest in Research Participation Among Clients of a Nonprofit Food Distribution Site

PubMed Central

Higashi, Robin T.; Craddock Lee, Simon J.; Leonard, Tammy; Cuate, Erica L.; Cole, Jay

2015-01-01

Abstract Background Persons accessing food from nonprofit distribution sites face numerous challenges and typically have significant unmet health needs. However, given limited and intermittent healthcare system engagement, this vulnerable population is underrepresented in clinical research. We sought to better understand the health needs of a nonclinical population to inform future research and interventions. Methods : Focus groups were conducted in English (n = 4) and Spanish (n = 4) with clients of Crossroads Community Services (CCS), the largest distributor of North Texas Food Bank. Discussions probed participants’ health status, healthcare utilization, understanding and utilization of mammography, and attitudes toward participation in research. Results Participants included 42 CCS clients, primarily Hispanic or African American women. Participants reported multiple comorbid conditions among household members, yet utilization of health services was often limited by cost. The majority expressed interest in participating in research to communicate their health concerns and obtain emotional support. Conclusion CCS clients represent a high‐need, under‐reached population willing to engage in health‐related research that affords them opportunity to connect with peers in group settings and obtain information to improve management of daily life challenges. The Community Assistance Research (CARe) Initiative, a community–academic collaboration, establishes a much‐needed opportunity for ongoing clinical research and intervention among this underserved population. PMID:26277918

Clinical Utility of the Modified Segmental Boost Technique for Treatment of the Pelvis and Inguinal Nodes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Moran, M.S., E-mail: meena.moran@yale.ed; Yale New Haven Hospital, New Haven, Connecticut and William W. Backus Hospital, Norwich, Connecticut; Castrucci, W.A.

2010-03-15

Purpose: Low-lying pelvic malignancies often require simultaneous radiation to pelvis and inguinal nodes. We previously reported improved homogeneity with the modified segmental boost technique (MSBT) compared to that with traditional methods, using phantom models. Here we report our institutional clinical experience with MSBT. Methods and Materials: MSBT patients from May 2001 to March 2007 were evaluated. Parameters analyzed included isocenter/multileaf collimation shifts, time per fraction (four fields), monitor units (MU)/fraction, femoral doses, maximal dose relative to body mass index, and inguinal node depth. In addition, a dosimetric comparison of the MSBT versus intensity modulated radiation therapy (IMRT) was conducted. Results:more » Of the 37 MSBT patients identified, 32 were evaluable. Port film adjustments were required in 6% of films. Median values for each analyzed parameter were as follows: MU/fraction, 298 (range, 226-348); delivery time, 4 minutes; inguinal depth, 4.5 cm; volume receiving 45 Gy (V45), 7%; V27.5, 87%; body mass index, 25 (range, 16.0-33.8). Inguinal dose was 100% in all cases; in-field inhomogeneity ranged from 111% to 118%. IMRT resulted in significantly decreased dose to normal tissue but required more time for treatment planning and a higher number of MUs (1,184 vs. 313 MU). Conclusions: In our clinical experience, the mono-isocentric MSBT provides a high degree of accuracy, improved homogeneity compared with traditional techniques, ease of simulation, treatment planning, treatment delivery, and acceptable femoral doses for pelvic/inguinal radiation fields requiring 45 to 50.4 Gy. In addition, the MSBT delivers a relatively uniform dose distribution throughout the treatment volume, despite varying body habitus. Clinical scenarios for the use of MSBT vs. intensity-modulated radiation therapy are discussed. To our knowledge, this is the first study reporting the utility of MSBT in the clinical setting.« less

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.

Magnetic resonance imaging: A tool to monitor and optimize enzyme distribution during porcine pancreas distention for islet isolation

PubMed Central

Scott, WE; Weegman, BP; Balamurugan, AN; Ferrer-Fabrega, J; Anazawa, T; Karatzas, T; Jie, T; Hammer, BE; Matsumoto, S; Avgoustiniatos, ES; Maynard, KS; Sutherland, DER; Hering, BJ; Papas, KK

2014-01-01

Background Porcine islet xenotransplantation is emerging as a potential alternative for allogeneic clinical islet transplantation. Optimization of porcine islet isolation in terms of yield and quality is critical for the success and cost effectiveness of this approach. Incomplete pancreas distension and inhomogeneous enzyme distribution have been identified as key factors for limiting viable islet yield per porcine pancreas. The aim of this study was to explore the utility of Magnetic Resonance Imaging (MRI) as a tool to investigate the homogeneity of enzyme delivery in porcine pancreata. Traditional and novel methods for enzyme delivery aimed at optimizing enzyme distribution were examined. Methods Pancreata were procured from Landrace pigs via en bloc viscerectomy. The main pancreatic duct was then cannulated with an 18g winged catheter and MRI performed at 1.5 T. Images were collected before and after ductal infusion of chilled MRI contrast agent (gadolinium) in physiological saline. Results Regions of the distal aspect of the splenic lobe and portions of the connecting lobe and bridge exhibited reduced delivery of solution when traditional methods of distension were utilized. Use of alternative methods of delivery (such as selective re-cannulation and distension of identified problem regions) resolved these issues and MRI was successfully utilized as a guide and assessment tool for improved delivery. Conclusion Current methods of porcine pancreas distension do not consistently deliver enzyme uniformly or adequately to all regions of the pancreas. Novel methods of enzyme delivery should be investigated and implemented for improved enzyme distribution. MRI serves as a valuable tool to visualize and evaluate the efficacy of current and prospective methods of pancreas distension and enzyme delivery. PMID:24986758

Entropy-based consensus clustering for patient stratification.

PubMed

Liu, Hongfu; Zhao, Rui; Fang, Hongsheng; Cheng, Feixiong; Fu, Yun; Liu, Yang-Yu

2017-09-01

Patient stratification or disease subtyping is crucial for precision medicine and personalized treatment of complex diseases. The increasing availability of high-throughput molecular data provides a great opportunity for patient stratification. Many clustering methods have been employed to tackle this problem in a purely data-driven manner. Yet, existing methods leveraging high-throughput molecular data often suffers from various limitations, e.g. noise, data heterogeneity, high dimensionality or poor interpretability. Here we introduced an Entropy-based Consensus Clustering (ECC) method that overcomes those limitations all together. Our ECC method employs an entropy-based utility function to fuse many basic partitions to a consensus one that agrees with the basic ones as much as possible. Maximizing the utility function in ECC has a much more meaningful interpretation than any other consensus clustering methods. Moreover, we exactly map the complex utility maximization problem to the classic K -means clustering problem, which can then be efficiently solved with linear time and space complexity. Our ECC method can also naturally integrate multiple molecular data types measured from the same set of subjects, and easily handle missing values without any imputation. We applied ECC to 110 synthetic and 48 real datasets, including 35 cancer gene expression benchmark datasets and 13 cancer types with four molecular data types from The Cancer Genome Atlas. We found that ECC shows superior performance against existing clustering methods. Our results clearly demonstrate the power of ECC in clinically relevant patient stratification. The Matlab package is available at http://scholar.harvard.edu/yyl/ecc . yunfu@ece.neu.edu or yyl@channing.harvard.edu. Supplementary data are available at Bioinformatics online. © The Author (2017). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Barriers and facilitators to reducing frequent laboratory testing for patients who are stable on warfarin: a mixed methods study of de-implementation in five anticoagulation clinics.

PubMed

Barnes, Geoffrey D; Misirliyan, Sevan; Kaatz, Scott; Jackson, Elizabeth A; Haymart, Brian; Kline-Rogers, Eva; Kozlowski, Jay; Krol, Gregory; Froehlich, James B; Sales, Anne

2017-07-14

Patients on chronic warfarin therapy require regular laboratory monitoring to safely manage warfarin. Recent studies have challenged the need for routine monthly blood draws in the most stable warfarin-treated patients, suggesting the safety of less frequent laboratory testing (up to every 12 weeks). De-implementation efforts aim to reduce the use of low-value clinical practices. To explore barriers and facilitators of a de-implementation effort to reduce the use of frequent laboratory tests for patients with stable warfarin management in nurse/pharmacist-run anticoagulation clinics, we performed a mixed-methods study conducted within a state-wide collaborative quality improvement collaborative. Using a mixed-methods approach, we conducted post-implementation semi-structured interviews with a total of eight anticoagulation nurse or pharmacist staff members at five participating clinic sites to assess barriers and facilitators to de-implementing frequent international normalized ratio (INR) laboratory testing among patients with stable warfarin control. Interview guides were based on the Tailored Implementation for Chronic Disease (TICD) framework. Informed by interview themes, a survey was developed and administered to all anticoagulation clinical staff (n = 62) about their self-reported utilization of less frequent INR testing and specific barriers to de-implementing the standard (more frequent) INR testing practice. From the interviews, four themes emerged congruent with TICD domains: (1) staff overestimating their actual use of less frequent INR testing (individual health professional factors), (2) barriers to appropriate patient engagement (incentives and resources), (3) broad support for an electronic medical record flag to identify potentially eligible patients (incentives and resources), and (4) the importance of personalized nurse/pharmacist feedback (individual health professional factors). In the survey (65% response rate), staff report offering less frequent INR testing to 56% (46-66%) of eligible patients. Most survey responders (n = 24; 60%) agreed that an eligibility flag in the electronic medical record would be very helpful. Twenty-four (60%) respondents agreed that periodic, personalized feedback on use of less frequent INR testing would also be helpful. Leveraging information system notifications, reducing additional work load burden for participating patients and providers, and providing personalized feedback are strategies that may improve adoption and utilization new policies in anticoagulation clinics that focus on de-implementation.