Test set readings predict clinical performance to a limited extent: preliminary findings

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick M.; Kench, Peter L.; Reed, Warren M.; McEntee, Mark F.; Brennan, Patrick C.

2013-03-01

Aim: To investigate the level of agreement between test sets and actual clinical reading Background: The performance of screen readers in detecting breast cancer is being assessed in some countries by using mammographic test sets. However, previous studies have provided little evidence that performance assessed by test sets strongly correlate to performance in clinical reading. Methods: Five clinicians from BreastScreen New South Wales participated in this study. Each clinician was asked to read 200 de-identified mammographic examinations gathered from their own case history within the BreastScreen NSW Digital Imaging Library. All test sets were designed with specific proportions of true positive, true negative, false positive and false negative examinations from the previous actual clinical reads of each reader. A prior mammogram examination for comparison (when available) was also provided for each case. Results: Preliminary analyses have shown that there is a moderate level of agreement (Kappa 0.42-0.56, p < 0.001) between laboratory test sets and actual clinical reading. In addition, a mean increase of 38% in sensitivity in the laboratory test sets as compared to their actual clinical readings was demonstrated. Specificity is similar between the laboratory test sets and actual clinical reading. Conclusion: This study demonstrated a moderate level of agreement between actual clinical reading and test set reading, which suggests that test sets have a role in reflecting clinical performance.

Gram stain method shows better sensitivity than clinical criteria for detection of bacterial vaginosis in surveillance of pregnant, low-income women in a clinical setting.

PubMed Central

Tam, M T; Yungbluth, M; Myles, T

1998-01-01

OBJECTIVE: The purpose of the study is to determine whether the Gram stain method is superior to the clinical criteria for the diagnosis of bacterial vaginosis in low-income pregnant women seen in a resident clinic setting. The clinical criteria is the current diagnostic method employed to diagnose bacterial vaginosis. STUDY DESIGN: In this study, 51 pregnant women with vaginal discharge were prospectively evaluated. All were screened using the clinical criteria, Gram stain method, and culture of the discharge. The modified scoring system instituted by Nugent et al. (J Clin Microbiol 29:297-301, 1991) was employed in reading the Gram stain smears. The clinical criteria were then compared with the Gram stain method. Isolation of moderate to many Gardnerella vaginalis growth by culture was used as the confirmatory finding. RESULTS: Sensitivity of the Gram stain method (91%) was significantly higher than that of the clinical criteria (46%), (sign test P = 0.0023, < 0.01). The Gram stain method also has both a low false-negative (4%) and high negative predictive value (96%), making it an ideal diagnostic test. CONCLUSION: The Gram stain method is a rapid and cost-effective test that is also highly reproducible and readily available in many laboratories. These features make the Gram stain method a more desirable screening procedure for bacterial vaginosis in a clinic population. PMID:9894174

Implementation of an anonymisation tool for clinical trials using a clinical trial processor integrated with an existing trial patient data information system.

PubMed

Aryanto, Kadek Y E; Broekema, André; Oudkerk, Matthijs; van Ooijen, Peter M A

2012-01-01

To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two methods are presented for an adapted CTP test set-up. In the first method, images are pushed from the Picture Archiving and Communication System (PACS) using the DICOM protocol through a local network. In the second method, images are transferred through the internet using the HTTPS protocol. In total 25,000 images from 50 patients were moved from the PACS, anonymised and stored within roughly 2 h using the first method. In the second method, an average of 10 images per minute were transferred and processed over a residential connection. In both methods, no duplicated images were stored when previous images were retransferred. The anonymised images are stored in appropriate directories. The CTP can transfer and process DICOM images correctly in a very easy set-up providing a fast, secure and stable environment. The adapted CTP allows easy integration into an environment in which patient data are already included in an existing information system.

Nursing students' perceptions of their clinical learning environment in placements outside traditional hospital settings

PubMed Central

Bjørk, Ida T; Berntsen, Karin; Brynildsen, Grethe; Hestetun, Margrete

2014-01-01

Aims and objectives To explore students' opinions of the learning environment during clinical placement in settings outside traditional hospital settings. Background Clinical placement experiences may influence positively on nursing students attitudes towards the clinical setting in question. Most studies exploring the quality of clinical placements have targeted students' experience in hospital settings. The number of studies exploring students' experiences of the learning environment in healthcare settings outside of the hospital venue does not match the growing importance of such settings in the delivery of health care, nor the growing number of nurses needed in these venues. Design A survey design was used. Method The Clinical Learning Environment Inventory was administered to two cohorts of undergraduate nursing students (n = 184) after clinical placement in mental health care, home care and nursing home care. Results Nursing students' overall contentment with the learning environment was quite similar across all three placement areas. Students in mental health care had significantly higher scores on the subscale individualisation, and older students had significantly higher scores on the total scale. Compared with other studies where the Clinical Learning Environment Inventory has been used, the students' total scores in this study are similar or higher than scores in studies including students from hospital settings. Conclusion Results from this study negate the negative views on clinical placements outside the hospital setting, especially those related to placements in nursing homes and mental healthcare settings. Relevance to clinical practice Students' experience of the learning environment during placements in mental health care, home care and nursing homes indicates the relevance of clinical education in settings outside the hospital setting. PMID:24460862

Mining functionally relevant gene sets for analyzing physiologically novel clinical expression data.

PubMed

Turcan, Sevin; Vetter, Douglas E; Maron, Jill L; Wei, Xintao; Slonim, Donna K

2011-01-01

Gene set analyses have become a standard approach for increasing the sensitivity of transcriptomic studies. However, analytical methods incorporating gene sets require the availability of pre-defined gene sets relevant to the underlying physiology being studied. For novel physiological problems, relevant gene sets may be unavailable or existing gene set databases may bias the results towards only the best-studied of the relevant biological processes. We describe a successful attempt to mine novel functional gene sets for translational projects where the underlying physiology is not necessarily well characterized in existing annotation databases. We choose targeted training data from public expression data repositories and define new criteria for selecting biclusters to serve as candidate gene sets. Many of the discovered gene sets show little or no enrichment for informative Gene Ontology terms or other functional annotation. However, we observe that such gene sets show coherent differential expression in new clinical test data sets, even if derived from different species, tissues, and disease states. We demonstrate the efficacy of this method on a human metabolic data set, where we discover novel, uncharacterized gene sets that are diagnostic of diabetes, and on additional data sets related to neuronal processes and human development. Our results suggest that our approach may be an efficient way to generate a collection of gene sets relevant to the analysis of data for novel clinical applications where existing functional annotation is relatively incomplete.

Development, implementation and evaluation of a clinical research engagement and leadership capacity building program in a large Australian health care service.

PubMed

Misso, Marie L; Ilic, Dragan; Haines, Terry P; Hutchinson, Alison M; East, Christine E; Teede, Helena J

2016-01-14

Health professionals need to be integrated more effectively in clinical research to ensure that research addresses clinical needs and provides practical solutions at the coal face of care. In light of limited evidence on how best to achieve this, evaluation of strategies to introduce, adapt and sustain evidence-based practices across different populations and settings is required. This project aims to address this gap through the co-design, development, implementation, evaluation, refinement and ultimately scale-up of a clinical research engagement and leadership capacity building program in a clinical setting with little to no co-ordinated approach to clinical research engagement and education. The protocol is based on principles of research capacity building and on a six-step framework, which have previously led to successful implementation and long-term sustainability. A mixed methods study design will be used. Methods will include: (1) a review of the literature about strategies that engage health professionals in research through capacity building and/or education in research methods; (2) a review of existing local research education and support elements; (3) a needs assessment in the local clinical setting, including an online cross-sectional survey and semi-structured interviews; (4) co-design and development of an educational and support program; (5) implementation of the program in the clinical environment; and (6) pre- and post-implementation evaluation and ultimately program scale-up. The evaluation focuses on research activity and knowledge, attitudes and preferences about clinical research, evidence-based practice and leadership and post implementation, about their satisfaction with the program. The investigators will evaluate the feasibility and effect of the program according to capacity building measures and will revise where appropriate prior to scale-up. It is anticipated that this clinical research engagement and leadership capacity building program will enable and enhance clinically relevant research to be led and conducted by health professionals in the health setting. This approach will also encourage identification of areas of clinical uncertainty and need that can be addressed through clinical research within the health setting.

[Screening of sexually transmitted diseases in clinical and non-clinical settings in Salvador, Bahia, Brazil].

PubMed

de Codes, José Santiago; Cohen, Deborah Ann; de Melo, Neli Almeida; Teixeira, Guilherme Gonzaga; Leal, Alexandre dos Santos; Silva, Tiago de Jesus; de Oliveira, Miucha Pereira Rios

2006-02-01

The objectives were to study: (1) acceptance of STD screening in non-clinical settings for asymptomatic individuals; (2) risk factors and STD prevalence among individuals in non-clinical and clinical settings; and (3) non-clinical screening of asymptomatic populations as a feasible method for STD control. We recruited 139 males and 486 females between 18 and 30 years of age from a family planning clinic, schools, and community centers in low-income neighborhoods. We asked about STD symptoms and STD/HIV risk behaviors and tested the individuals for gonorrhea, Chlamydia, syphilis, and HIV. Except for HIV, women recruited directly from the community had higher STD rates than those who came in for care at the clinic. Screening in non-clinical settings in Brazil is feasible and has a high yield among young adults in low-income communities. Infected participants would likely never have otherwise sought care or been tested or treated. STD control efforts could be implemented in any site that can reach populations at risk and become a routine procedure in health care settings where people report for problems unrelated to STDs.

Role Models and Teachers: medical students perception of teaching-learning methods in clinical settings, a qualitative study from Sri Lanka.

PubMed

Jayasuriya-Illesinghe, Vathsala; Nazeer, Ishra; Athauda, Lathika; Perera, Jennifer

2016-02-09

Medical education research in general, and those focusing on clinical settings in particular, have been a low priority in South Asia. This explorative study from 3 medical schools in Sri Lanka, a South Asian country, describes undergraduate medical students' experiences during their final year clinical training with the aim of understanding the teaching-learning experiences. Using qualitative methods we conducted an exploratory study. Twenty eight graduates from 3 medical schools participated in individual interviews. Interview recordings were transcribed verbatim and analyzed using qualitative content analysis method. Emergent themes reveled 2 types of teaching-learning experiences, role modeling, and purposive teaching. In role modelling, students were expected to observe teachers while they conduct their clinical work, however, this method failed to create positive learning experiences. The clinical teachers who predominantly used this method appeared to be 'figurative' role models and were not perceived as modelling professional behaviors. In contrast, purposeful teaching allowed dedicated time for teacher-student interactions and teachers who created these learning experiences were more likely to be seen as 'true' role models. Students' responses and reciprocations to these interactions were influenced by their perception of teachers' behaviors, attitudes, and the type of teaching-learning situations created for them. Making a distinction between role modeling and purposeful teaching is important for students in clinical training settings. Clinical teachers' awareness of their own manifest professional characterizes, attitudes, and behaviors, could help create better teaching-learning experiences. Moreover, broader systemic reforms are needed to address the prevailing culture of teaching by humiliation and subordination.

Standard Setting for Clinical Competence at Graduation from Medical School: A Comparison of Passing Scores across Five Medical Schools

ERIC Educational Resources Information Center

Boursicot, Katharine A. M.; Roberts, Trudie E.; Pell, Godfrey

2006-01-01

While Objective Structured Clinical Examinations (OSCEs) have become widely used to assess clinical competence at the end of undergraduate medical courses, the method of setting the passing score varies greatly, and there is no agreed best methodology. While there is an assumption that the passing standard at graduation is the same at all medical…

Forensic Luminol Blood Test for Preventing Cross-contamination in Dentistry: An Evaluation of a Dental School Clinic

PubMed Central

Bortoluzzi, Marcelo Carlos; Cadore, Peterson; Gallon, Andrea; Imanishi, Soraia Almeida Watanabe

2014-01-01

Background: More than 200 different diseases may be transmitted from exposure to blood in the dental setting. The aim of this study is to identify possible faults in the crosscontamination chain control in a dental school clinic searching for traces of blood in the clinical contact surfaces (CCS) through forensic luminol blood test. Methods: Traces of invisible blood where randomly searched in CCS of one dental school clinic. Results: Forty eight surfaces areas in the CCS were tested and the presence of invisible and remnant blood was identified in 28 (58.3%) items. Conclusions: We suggest that the luminol method is suitable for identifying contamination with invisible blood traces and this method may be a useful tool to prevent cross-contamination in the dental care setting. PMID:25400895

A hybrid approach of gene sets and single genes for the prediction of survival risks with gene expression data.

PubMed

Seok, Junhee; Davis, Ronald W; Xiao, Wenzhong

2015-01-01

Accumulated biological knowledge is often encoded as gene sets, collections of genes associated with similar biological functions or pathways. The use of gene sets in the analyses of high-throughput gene expression data has been intensively studied and applied in clinical research. However, the main interest remains in finding modules of biological knowledge, or corresponding gene sets, significantly associated with disease conditions. Risk prediction from censored survival times using gene sets hasn't been well studied. In this work, we propose a hybrid method that uses both single gene and gene set information together to predict patient survival risks from gene expression profiles. In the proposed method, gene sets provide context-level information that is poorly reflected by single genes. Complementarily, single genes help to supplement incomplete information of gene sets due to our imperfect biomedical knowledge. Through the tests over multiple data sets of cancer and trauma injury, the proposed method showed robust and improved performance compared with the conventional approaches with only single genes or gene sets solely. Additionally, we examined the prediction result in the trauma injury data, and showed that the modules of biological knowledge used in the prediction by the proposed method were highly interpretable in biology. A wide range of survival prediction problems in clinical genomics is expected to benefit from the use of biological knowledge.

A Hybrid Approach of Gene Sets and Single Genes for the Prediction of Survival Risks with Gene Expression Data

PubMed Central

Seok, Junhee; Davis, Ronald W.; Xiao, Wenzhong

2015-01-01

Accumulated biological knowledge is often encoded as gene sets, collections of genes associated with similar biological functions or pathways. The use of gene sets in the analyses of high-throughput gene expression data has been intensively studied and applied in clinical research. However, the main interest remains in finding modules of biological knowledge, or corresponding gene sets, significantly associated with disease conditions. Risk prediction from censored survival times using gene sets hasn’t been well studied. In this work, we propose a hybrid method that uses both single gene and gene set information together to predict patient survival risks from gene expression profiles. In the proposed method, gene sets provide context-level information that is poorly reflected by single genes. Complementarily, single genes help to supplement incomplete information of gene sets due to our imperfect biomedical knowledge. Through the tests over multiple data sets of cancer and trauma injury, the proposed method showed robust and improved performance compared with the conventional approaches with only single genes or gene sets solely. Additionally, we examined the prediction result in the trauma injury data, and showed that the modules of biological knowledge used in the prediction by the proposed method were highly interpretable in biology. A wide range of survival prediction problems in clinical genomics is expected to benefit from the use of biological knowledge. PMID:25933378

Using digital photography in a clinical setting: a valid, accurate, and applicable method to assess food intake.

PubMed

Winzer, Eva; Luger, Maria; Schindler, Karin

2018-06-01

Regular monitoring of food intake is hardly integrated in clinical routine. Therefore, the aim was to examine the validity, accuracy, and applicability of an appropriate and also quick and easy-to-use tool for recording food intake in a clinical setting. Two digital photography methods, the postMeal method with a picture after the meal, the pre-postMeal method with a picture before and after the meal, and the visual estimation method (plate diagram; PD) were compared against the reference method (weighed food records; WFR). A total of 420 dishes from lunch (7 weeks) were estimated with both photography methods and the visual method. Validity, applicability, accuracy, and precision of the estimation methods, and additionally food waste, macronutrient composition, and energy content were examined. Tests of validity revealed stronger correlations for photography methods (postMeal: r = 0.971, p < 0.001; pre-postMeal: r = 0.995, p < 0.001) compared to the visual estimation method (r = 0.810; p < 0.001). The pre-postMeal method showed smaller variability (bias < 1 g) and also smaller overestimation and underestimation. This method accurately and precisely estimated portion sizes in all food items. Furthermore, the total food waste was 22% for lunch over the study period. The highest food waste was observed in salads and the lowest in desserts. The pre-postMeal digital photography method is valid, accurate, and applicable in monitoring food intake in clinical setting, which enables a quantitative and qualitative dietary assessment. Thus, nutritional care might be initiated earlier. This method might be also advantageous for quantitative and qualitative evaluation of food waste, with a resultantly reduction in costs.

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Child Emotional Aggression and Abuse: Definitions and Prevalence

ERIC Educational Resources Information Center

Slep, Amy M. Smith; Heyman, Richard E.; Snarr, Jeffery D.

2011-01-01

Objective: Research on and intervention for child emotional abuse and emotional aggression toward children have been severely hampered because there have been no agreed-upon, clinically usable definitions. Methods: We have (a) proposed and field-tested a set of criteria to operationally define child emotional abuse for clinical settings and (b)…

A Clinical Librarian-Nursing Partnership to Bridge Clinical Practice and Research in an Oncology Setting.

PubMed

Ginex, Pamela K; Hernandez, Marisol; Vrabel, Mark

2016-09-01

Nurses in clinical settings in which evidence-based, individualized care is expected are often the best resource to identify important clinical questions and gaps in practice. These nurses are frequently challenged by a lack of resources to fully develop their questions and identify the most appropriate methods to answer them. A strategic and ongoing partnership between medical library services and nursing can support nurses as they embark on the process of answering these questions and, ultimately, improving patient care and clinical outcomes

Detecting clinically relevant new information in clinical notes across specialties and settings.

PubMed

Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

2017-07-05

Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol.

PubMed

Beuscart, Jean-Baptiste; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne

2017-01-01

Medication review has been advocated to address the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. Heterogeneity of outcomes reported in clinical trials can hinder the comparison of clinical trial findings in systematic reviews. Moreover, the outcomes that matter most to older patients might be under-reported or disregarded altogether. A core outcome set can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials in any particular field of research. As part of the European Commission-funded project, called OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly, this paper describes the methods used to develop a core outcome set for clinical trials of medication review in older patients with multimorbidity. The study was designed in several steps. First, a systematic review established which outcomes were measured in published and ongoing clinical trials of medication review in older patients. Second, we undertook semistructured interviews with older patients and carers aimed at identifying additional relevant outcomes. Then, a multilanguage European Delphi survey adapted to older patients was designed. The international Delphi survey was conducted with older patients, health care professionals, researchers, and clinical experts in geriatric pharmacotherapy to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. We present the method for developing a core outcome set for medication review in older patients with multimorbidity. This study protocol could be used as a basis to develop core outcome sets in other fields of geriatric research.

Measuring impedance in congestive heart failure: Current options and clinical applications

PubMed Central

Tang, W. H. Wilson; Tong, Wilson

2011-01-01

Measurement of impedance is becoming increasingly available in the clinical setting as a tool for assessing hemodynamics and volume status in patients with heart failure. The 2 major categories of impedance assessment are the band electrode method and the implanted device lead method. The exact sources of the impedance signal are complex and can be influenced by physiologic effects such as blood volume, fluid, and positioning. This article provides a critical review of our current understanding and promises of impedance measurements, the techniques that have evolved, as well as the evidence and limitations regarding their clinical applications in the setting of heart failure management. PMID:19249408

The STAR Data Reporting Guidelines for Clinical High Altitude Research.

PubMed

Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

2018-03-01

Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

Evaluation of a Serum Lung Cancer Biomarker Panel

PubMed Central

Mazzone, Peter J; Wang, Xiao-Feng; Han, Xiaozhen; Choi, Humberto; Seeley, Meredith; Scherer, Richard; Doseeva, Victoria

2018-01-01

Background: A panel of 3 serum proteins and 1 autoantibody has been developed to assist with the detection of lung cancer. We aimed to validate the accuracy of the biomarker panel in an independent test set and explore the impact of adding a fourth serum protein to the panel, as well as the impact of combining molecular and clinical variables. Methods: The training set of serum samples was purchased from commercially available biorepositories. The testing set was from a biorepository at the Cleveland Clinic. All lung cancer and control subjects were >50 years old and had smoked a minimum of 20 pack-years. A panel of biomarkers including CEA (carcinoembryonic antigen), CYFRA21-1 (cytokeratin-19 fragment 21-1), CA125 (carbohydrate antigen 125), HGF (hepatocyte growth factor), and NY-ESO-1 (New York esophageal cancer-1 antibody) was measured using immunoassay techniques. The multiple of the median method, multivariate logistic regression, and random forest modeling was used to analyze the results. Results: The training set consisted of 604 patient samples (268 with lung cancer and 336 controls) and the testing set of 400 patient samples (155 with lung cancer and 245 controls). With a threshold established from the training set, the sensitivity and specificity of both the 4- and 5-biomarker panels on the testing set was 49% and 96%, respectively. Models built on the testing set using only clinical variables had an area under the receiver operating characteristic curve of 0.68, using the biomarker panel 0.81 and by combining clinical and biomarker variables 0.86. Conclusions: This study validates the accuracy of a panel of proteins and an autoantibody in a population relevant to lung cancer detection and suggests a benefit to combining clinical features with the biomarker results. PMID:29371783

Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

ERIC Educational Resources Information Center

Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

2017-01-01

Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

Integrated Analysis of Pharmacologic, Clinical, and SNP Microarray Data using Projection onto the Most Interesting Statistical Evidence with Adaptive Permutation Testing

PubMed Central

Pounds, Stan; Cao, Xueyuan; Cheng, Cheng; Yang, Jun; Campana, Dario; Evans, William E.; Pui, Ching-Hon; Relling, Mary V.

2010-01-01

Powerful methods for integrated analysis of multiple biological data sets are needed to maximize interpretation capacity and acquire meaningful knowledge. We recently developed Projection Onto the Most Interesting Statistical Evidence (PROMISE). PROMISE is a statistical procedure that incorporates prior knowledge about the biological relationships among endpoint variables into an integrated analysis of microarray gene expression data with multiple biological and clinical endpoints. Here, PROMISE is adapted to the integrated analysis of pharmacologic, clinical, and genome-wide genotype data that incorporating knowledge about the biological relationships among pharmacologic and clinical response data. An efficient permutation-testing algorithm is introduced so that statistical calculations are computationally feasible in this higher-dimension setting. The new method is applied to a pediatric leukemia data set. The results clearly indicate that PROMISE is a powerful statistical tool for identifying genomic features that exhibit a biologically meaningful pattern of association with multiple endpoint variables. PMID:21516175

Estimates of Dietary Sodium Consumption in Patients With Chronic Heart Failure.

PubMed

Colin-Ramirez, Eloisa; Arcand, JoAnne; Ezekowitz, Justin A

2015-12-01

Estimating dietary sodium intake is a key component of dietary assessment in the clinical setting of HF to effectively implement appropriate dietary interventions for sodium reduction and monitor adherence to the dietary treatment. In a research setting, assessment of sodium intake is crucial to an essential methodology to evaluate outcomes after a dietary or behavioral intervention. Current available sodium intake assessment methods include 24-hour urine collection, spot urine collections, multiple day food records, food recalls, and food frequency questionnaires. However, these methods have inherent limitations that make assessment of sodium intake challenging, and the utility of traditional methods may be questionable for estimating sodium intake in patients with HF. Thus, there are remaining questions about how to best assess dietary sodium intake in this patient population, and there is a need to identify a reliable method to assess and monitor sodium intake in the research and clinical setting of HF. This paper provides a comprehensive review of the current methods for sodium intake assessment, addresses the challenges for its accurate evaluation, and highlights the relevance of applying the highest-quality measurement methods in the research setting to minimize the risk of biased data. Copyright © 2015 Elsevier Inc. All rights reserved.

Forensic Luminol Blood Test for Preventing Cross-contamination in Dentistry: An Evaluation of a Dental School Clinic.

PubMed

Bortoluzzi, Marcelo Carlos; Cadore, Peterson; Gallon, Andrea; Imanishi, Soraia Almeida Watanabe

2014-10-01

More than 200 different diseases may be transmitted from exposure to blood in the dental setting. The aim of this study is to identify possible faults in the crosscontamination chain control in a dental school clinic searching for traces of blood in the clinical contact surfaces (CCS) through forensic luminol blood test. Traces of invisible blood where randomly searched in CCS of one dental school clinic. Forty eight surfaces areas in the CCS were tested and the presence of invisible and remnant blood was identified in 28 (58.3%) items. We suggest that the luminol method is suitable for identifying contamination with invisible blood traces and this method may be a useful tool to prevent cross-contamination in the dental care setting.

"Theory Becoming Alive": The Learning Transition Process of Newly Graduated Nurses in Canada.

PubMed

Nour, Violet; Williams, Anne M

2018-01-01

Background Newly graduated nurses often encounter a gap between theory and practice in clinical settings. Although this has been the focus of considerable research, little is known about the learning transition process. Purpose The purpose of this study was to explore the experiences of newly graduated nurses in acute healthcare settings within Canada. This study was conducted to gain a greater understanding of the experiences and challenges faced by graduates. Methods Grounded theory method was utilized with a sample of 14 registered nurses who were employed in acute-care settings. Data were collected using in-depth interviews. Constant comparative analysis was used to analyze data. Results Findings revealed a core category, "Theory Becoming Alive," and four supporting categories: Entry into Practice, Immersion, Committing, and Evolving. Theory Becoming Alive described the process of new graduate nurses' clinical learning experiences as well as the challenges that they encountered in clinical settings after graduating. Conclusions This research provides a greater understanding of learning process of new graduate nurses in Canada. It highlights the importance of providing supportive environments to assist new graduate nurses to develop confidence as independent registered nurses in clinical areas. Future research directions as well as supportive educational strategies are described.

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.

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project

PubMed Central

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Rengerink, Katrien Oude; Gee, Harry; Mol, Ben WJ; Khan, Khalid S

2009-01-01

Background Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. Methods We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. Results The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. Conclusion This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education. PMID:19744327

Establishing the feasibility of direct observation in the assessment of tics in children with chronic tic disorders.

PubMed

Himle, Michael B; Chang, Susanna; Woods, Douglas W; Pearlman, Amanda; Buzzella, Brian; Bunaciu, Liviu; Piacentini, John C

2006-01-01

Behavior analysis has been at the forefront in establishing effective treatments for children and adults with chronic tic disorders. As is customary in behavior analysis, the efficacy of these treatments has been established using direct-observation assessment methods. Although behavior-analytic treatments have enjoyed acceptance and integration into mainstream health care practices for tic disorders (e.g., psychiatry and neurology), the use of direct observation as a primary assessment tool has been neglected in favor of less objective methods. Hesitation to use direct observation appears to stem largely from concerns about the generalizability of clinic observations to other settings (e.g., home) and a lack of consensus regarding the most appropriate and feasible techniques for conducting and scoring direct observation. The purpose of the current study was to evaluate and establish a reliable, valid, and feasible direct-observation protocol capable of being transported to research and clinical settings. A total of 43 children with tic disorders, collected from two outpatient specialty clinics, were assessed using direct (videotape samples) and indirect (Yale Global Tic Severity Scale; YGTSS) methods. Videotaped observation samples were collected across 3 consecutive weeks and two different settings (clinic and home), were scored using both exact frequency counts and partial-interval coding, and were compared to data from a common indirect measure of tic severity (the YGTSS). In addition, various lengths of videotaped segments were scored to determine the optimal observation length. Results show that (a) clinic-based observations correspond well to home-based observations, (b) brief direct-observation segments scored with time-sampling methods reliably quantified tics, and (c) indirect methods did not consistently correspond with the direct methods.

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

PubMed

McMahon, Michelle A; Christopher, Kimberly A

2011-08-19

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

Standard Setting Methods for Pass/Fail Decisions on High-Stakes Objective Structured Clinical Examinations: A Validity Study.

PubMed

Yousuf, Naveed; Violato, Claudio; Zuberi, Rukhsana W

2015-01-01

CONSTRUCT: Authentic standard setting methods will demonstrate high convergent validity evidence of their outcomes, that is, cutoff scores and pass/fail decisions, with most other methods when compared with each other. The objective structured clinical examination (OSCE) was established for valid, reliable, and objective assessment of clinical skills in health professions education. Various standard setting methods have been proposed to identify objective, reliable, and valid cutoff scores on OSCEs. These methods may identify different cutoff scores for the same examinations. Identification of valid and reliable cutoff scores for OSCEs remains an important issue and a challenge. Thirty OSCE stations administered at least twice in the years 2010-2012 to 393 medical students in Years 2 and 3 at Aga Khan University are included. Psychometric properties of the scores are determined. Cutoff scores and pass/fail decisions of Wijnen, Cohen, Mean-1.5SD, Mean-1SD, Angoff, borderline group and borderline regression (BL-R) methods are compared with each other and with three variants of cluster analysis using repeated measures analysis of variance and Cohen's kappa. The mean psychometric indices on the 30 OSCE stations are reliability coefficient = 0.76 (SD = 0.12); standard error of measurement = 5.66 (SD = 1.38); coefficient of determination = 0.47 (SD = 0.19), and intergrade discrimination = 7.19 (SD = 1.89). BL-R and Wijnen methods show the highest convergent validity evidence among other methods on the defined criteria. Angoff and Mean-1.5SD demonstrated least convergent validity evidence. The three cluster variants showed substantial convergent validity with borderline methods. Although there was a high level of convergent validity of Wijnen method, it lacks the theoretical strength to be used for competency-based assessments. The BL-R method is found to show the highest convergent validity evidences for OSCEs with other standard setting methods used in the present study. We also found that cluster analysis using mean method can be used for quality assurance of borderline methods. These findings should be further confirmed by studies in other settings.

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

Clinical code set engineering for reusing EHR data for research: A review.

PubMed

Williams, Richard; Kontopantelis, Evangelos; Buchan, Iain; Peek, Niels

2017-06-01

The construction of reliable, reusable clinical code sets is essential when re-using Electronic Health Record (EHR) data for research. Yet code set definitions are rarely transparent and their sharing is almost non-existent. There is a lack of methodological standards for the management (construction, sharing, revision and reuse) of clinical code sets which needs to be addressed to ensure the reliability and credibility of studies which use code sets. To review methodological literature on the management of sets of clinical codes used in research on clinical databases and to provide a list of best practice recommendations for future studies and software tools. We performed an exhaustive search for methodological papers about clinical code set engineering for re-using EHR data in research. This was supplemented with papers identified by snowball sampling. In addition, a list of e-phenotyping systems was constructed by merging references from several systematic reviews on this topic, and the processes adopted by those systems for code set management was reviewed. Thirty methodological papers were reviewed. Common approaches included: creating an initial list of synonyms for the condition of interest (n=20); making use of the hierarchical nature of coding terminologies during searching (n=23); reviewing sets with clinician input (n=20); and reusing and updating an existing code set (n=20). Several open source software tools (n=3) were discovered. There is a need for software tools that enable users to easily and quickly create, revise, extend, review and share code sets and we provide a list of recommendations for their design and implementation. Research re-using EHR data could be improved through the further development, more widespread use and routine reporting of the methods by which clinical codes were selected. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

A study of active learning methods for named entity recognition in clinical text.

PubMed

Chen, Yukun; Lasko, Thomas A; Mei, Qiaozhu; Denny, Joshua C; Xu, Hua

2015-12-01

Named entity recognition (NER), a sequential labeling task, is one of the fundamental tasks for building clinical natural language processing (NLP) systems. Machine learning (ML) based approaches can achieve good performance, but they often require large amounts of annotated samples, which are expensive to build due to the requirement of domain experts in annotation. Active learning (AL), a sample selection approach integrated with supervised ML, aims to minimize the annotation cost while maximizing the performance of ML-based models. In this study, our goal was to develop and evaluate both existing and new AL methods for a clinical NER task to identify concepts of medical problems, treatments, and lab tests from the clinical notes. Using the annotated NER corpus from the 2010 i2b2/VA NLP challenge that contained 349 clinical documents with 20,423 unique sentences, we simulated AL experiments using a number of existing and novel algorithms in three different categories including uncertainty-based, diversity-based, and baseline sampling strategies. They were compared with the passive learning that uses random sampling. Learning curves that plot performance of the NER model against the estimated annotation cost (based on number of sentences or words in the training set) were generated to evaluate different active learning and the passive learning methods and the area under the learning curve (ALC) score was computed. Based on the learning curves of F-measure vs. number of sentences, uncertainty sampling algorithms outperformed all other methods in ALC. Most diversity-based methods also performed better than random sampling in ALC. To achieve an F-measure of 0.80, the best method based on uncertainty sampling could save 66% annotations in sentences, as compared to random sampling. For the learning curves of F-measure vs. number of words, uncertainty sampling methods again outperformed all other methods in ALC. To achieve 0.80 in F-measure, in comparison to random sampling, the best uncertainty based method saved 42% annotations in words. But the best diversity based method reduced only 7% annotation effort. In the simulated setting, AL methods, particularly uncertainty-sampling based approaches, seemed to significantly save annotation cost for the clinical NER task. The actual benefit of active learning in clinical NER should be further evaluated in a real-time setting. Copyright © 2015 Elsevier Inc. All rights reserved.

Discerning trends in multiplex immunoassay technology with potential for resource-limited settings.

PubMed

Gordon, Julian; Michel, Gerd

2012-04-01

In the search for more powerful tools for diagnoses of endemic diseases in resource-limited settings, we have been analyzing technologies with potential applicability. Increasingly, the process focuses on readily accessible bodily fluids combined with increasingly powerful multiplex capabilities to unambiguously diagnose a condition without resorting to reliance on a sophisticated reference laboratory. Although these technological advances may well have important implications for the sensitive and specific detection of disease, to date their clinical utility has not been demonstrated, especially in resource-limited settings. Furthermore, many emerging technological developments are in fields of physics or engineering, which are not readily available to or intelligible to clinicians or clinical laboratory scientists. This review provides a look at technology trends that could have applicability to high-sensitivity multiplexed immunoassays in resource-limited settings. Various technologies are explained and assessed according to potential for reaching relevant limits of cost, sensitivity, and multiplex capability. Frequently, such work is reported in technical journals not normally read by clinical scientists, and the authors make enthusiastic claims for the potential of their technology while ignoring potential pitfalls. Thus it is important to draw attention to technical hurdles that authors may not be publicizing. Immunochromatographic assays, optical methods including those involving waveguides, electrochemical methods, magnetorestrictive methods, and field-effect transistor methods based on nanotubes, nanowires, and nanoribbons reveal possibilities as next-generation technologies.

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.

Optimal Methods to Screen Men and Women for Intimate Partner Violence: Results from an Internal Medicine Residency Continuity Clinic

ERIC Educational Resources Information Center

Kapur, Nitin A.; Windish, Donna M.

2011-01-01

Contradictory data exist regarding optimal methods and instruments for intimate partner violence (IPV) screening in primary care settings. The purpose of this study was to determine the optimal method and screening instrument for IPV among men and women in a primary-care resident clinic. We conducted a cross-sectional study at an urban, academic,…

Video observation in HIT development: lessons learned on benefits and challenges.

PubMed

Høstgaard, Anna Marie; Bertelsen, Pernille

2012-08-22

Experience shows that the precondition for the development of successful health information technologies is a thorough insight into clinical work practice. In contemporary clinical work practice, clinical work and health information technology are integrated, and part of the practice is tacit. When work practice becomes routine, it slips to the background of the conscious awareness and becomes difficult to recognize without the context to support recall. This means that it is difficult to capture with traditional ethnographic research methods or in usability laboratories or clinical set ups. Observation by the use of the video technique within healthcare settings has proven to be capable of providing a thorough insight into the complex clinical work practice and its context - including parts of the tacit practice. The objective of this paper is 1) to argue for the video observation technique to inform and improve health-information-technology development and 2) to share insights and lessons learned on benefits and challenges when using the video observation technique within healthcare settings. A multiple case study including nine case studies conducted by DaCHI researchers 2004-2011 using audio-visual, non-participant video observation for data collection within different healthcare settings. In HIT development, video observation is beneficial for 1) informing and improving system design 2) studying changes in work practice 3) identifying new potentials and 4) documenting current work practices. The video observation technique used within healthcare settings is superior to other ethnographic research methods when it comes to disclosing the complexity in clinical work practice. The insights gained are far more realistic compared to traditional ethnographic studies or usability studies and studies in clinical set ups. Besides, the data generated through video recordings provide a solid basis for dialog between the health care professionals involved. The most important lessons learned are that a well considered methodology and clear formulated objectives are imperative, in order to stay focused during the data rich analysis phase. Additionally, the video observation technique is primarily recommended for studies of specific clinical work practices within delimited clinical settings. Overall, the video observation technique has proven to be capable of improving our understanding of the interwoven relation between clinical work practice and HIT and to inform us about user requirements and needs for HIT, which is a precondition for the development of more successful HIT systems in the future.

The Challenges of Nursing Students in the Clinical Learning Environment: A Qualitative Study

PubMed Central

Jamshidi, Nahid; Molazem, Zahra; Sharif, Farkhondeh; Torabizadeh, Camellia; Najafi Kalyani, Majid

2016-01-01

Background/Aim. Clinical learning is a main part of nursing education. Students' exposure to clinical learning environment is one of the most important factors affecting the teaching-learning process in clinical settings. Identifying challenges of nursing students in the clinical learning environment could improve training and enhance the quality of its planning and promotion of the students. We aimed to explore Iranian nursing students' challenges in the clinical learning environment. Materials and Methods. This is a qualitative study using the content analysis approach. The participants consisted of seventeen nursing students and three nursing instructors. The participants were selected through purposive sampling method and attended semistructured interviews and focus groups. Results. Three themes emerged after data analysis, including ineffective communications, inadequate readiness, and emotional reactions. Conclusion. Nursing students in Iran are faced with many challenges in the clinical learning environment. All challenges identified in this study affected the students' learning in clinical setting. Therefore, we recommend that the instructors prepare students with a specific focus on their communication and psychological needs. PMID:27366787

A collaborative comparison of objective structured clinical examination (OSCE) standard setting methods at Australian medical schools.

PubMed

Malau-Aduli, Bunmi Sherifat; Teague, Peta-Ann; D'Souza, Karen; Heal, Clare; Turner, Richard; Garne, David L; van der Vleuten, Cees

2017-12-01

A key issue underpinning the usefulness of the OSCE assessment to medical education is standard setting, but the majority of standard-setting methods remain challenging for performance assessment because they produce varying passing marks. Several studies have compared standard-setting methods; however, most of these studies are limited by their experimental scope, or use data on examinee performance at a single OSCE station or from a single medical school. This collaborative study between 10 Australian medical schools investigated the effect of standard-setting methods on OSCE cut scores and failure rates. This research used 5256 examinee scores from seven shared OSCE stations to calculate cut scores and failure rates using two different compromise standard-setting methods, namely the Borderline Regression and Cohen's methods. The results of this study indicate that Cohen's method yields similar outcomes to the Borderline Regression method, particularly for large examinee cohort sizes. However, with lower examinee numbers on a station, the Borderline Regression method resulted in higher cut scores and larger difference margins in the failure rates. Cohen's method yields similar outcomes as the Borderline Regression method and its application for benchmarking purposes and in resource-limited settings is justifiable, particularly with large examinee numbers.

3D motion and strain estimation of the heart: initial clinical findings

NASA Astrophysics Data System (ADS)

Barbosa, Daniel; Hristova, Krassimira; Loeckx, Dirk; Rademakers, Frank; Claus, Piet; D'hooge, Jan

2010-03-01

The quantitative assessment of regional myocardial function remains an important goal in clinical cardiology. As such, tissue Doppler imaging and speckle tracking based methods have been introduced to estimate local myocardial strain. Recently, volumetric ultrasound has become more readily available, allowing therefore the 3D estimation of motion and myocardial deformation. Our lab has previously presented a method based on spatio-temporal elastic registration of ultrasound volumes to estimate myocardial motion and deformation in 3D, overcoming the spatial limitations of the existing methods. This method was optimized on simulated data sets in previous work and is currently tested in a clinical setting. In this manuscript, 10 healthy volunteers, 10 patient with myocardial infarction and 10 patients with arterial hypertension were included. The cardiac strain values extracted with the proposed method were compared with the ones estimated with 1D tissue Doppler imaging and 2D speckle tracking in all patient groups. Although the absolute values of the 3D strain components assessed by this new methodology were not identical to the reference methods, the relationship between the different patient groups was similar.

Progressive sampling-based Bayesian optimization for efficient and automatic machine learning model selection.

PubMed

Zeng, Xueqiang; Luo, Gang

2017-12-01

Machine learning is broadly used for clinical data analysis. Before training a model, a machine learning algorithm must be selected. Also, the values of one or more model parameters termed hyper-parameters must be set. Selecting algorithms and hyper-parameter values requires advanced machine learning knowledge and many labor-intensive manual iterations. To lower the bar to machine learning, miscellaneous automatic selection methods for algorithms and/or hyper-parameter values have been proposed. Existing automatic selection methods are inefficient on large data sets. This poses a challenge for using machine learning in the clinical big data era. To address the challenge, this paper presents progressive sampling-based Bayesian optimization, an efficient and automatic selection method for both algorithms and hyper-parameter values. We report an implementation of the method. We show that compared to a state of the art automatic selection method, our method can significantly reduce search time, classification error rate, and standard deviation of error rate due to randomization. This is major progress towards enabling fast turnaround in identifying high-quality solutions required by many machine learning-based clinical data analysis tasks.

Longitudinal Reliability of Self-Reported Age at Menarche in Adolescent Girls: Variability across Time and Setting

ERIC Educational Resources Information Center

Dorn, Lorah D.; Sontag-Padilla, Lisa M.; Pabst, Stephanie; Tissot, Abbigail; Susman, Elizabeth J.

2013-01-01

Age at menarche is critical in research and clinical settings, yet there is a dearth of studies examining its reliability in adolescents. We examined age at menarche during adolescence, specifically, (a) average method reliability across 3 years, (b) test-retest reliability between time points and methods, (c) intraindividual variability of…

A summative, Objective, Structured, Clinical Examination in ENT used to assess postgraduate doctors after one year of ENT training, as part of the Diploma of Otorhinolaryngology, Head and Neck Surgery.

PubMed

Drake-Lee, A B; Skinner, D; Hawthorne, M; Clarke, R

2009-10-01

'High stakes' postgraduate medical examinations should conform to current educational standards. In the UK and Ireland, national assessments in surgery are devised and managed through the examination structure of the Royal Colleges of Surgeons. Their efforts are not reported in the medical education literature. In the current paper, we aim to clarify this process. To replace the clinical section of the Diploma of Otorhinolaryngology with an Objective, Structured, Clinical Examination, and to set the level of the assessment at one year of postgraduate training in the specialty. After 'blueprinting' against the whole curriculum, an Objective, Structured, Clinical Examination comprising 25 stations was divided into six clinical stations and 19 other stations exploring written case histories, instruments, test results, written communication skills and interpretation skills. The pass mark was set using a modified borderline method and other methods, and statistical analysis of the results was performed. The results of nine examinations between May 2004 and May 2008 are presented. The pass mark varied between 68 and 82 per cent. Internal consistency was good, with a Cronbach's alpha value of 0.99 for all examinations and split-half statistics varying from 0.96 to 0.99. Different standard settings gave similar pass marks. We have developed a summative, Objective, Structured, Clinical Examination for doctors training in otorhinolaryngology, reported herein. The objectives and standards of setting a high quality assessment were met.

Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.

PubMed

Kukafka, Rita; Allegrante, John P; Khan, Sharib; Bigger, J Thomas; Johnson, Stephen B

2013-09-01

Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings. © 2013.

Feasibility of a shorter Goal Attainment Scaling method for a pediatric spasticity clinic - The 3-milestones GAS.

PubMed

Krasny-Pacini, A; Pauly, F; Hiebel, J; Godon, S; Isner-Horobeti, M-E; Chevignard, M

2017-07-01

Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales to quantify progress toward defined goals. It is useful in rehabilitation but is hampered by the experience required to adequately "predict" the possible outcomes relating to a particular goal before treatment and the time needed to describe all 5 levels of the scale. Here we aimed to investigate the feasibility of using GAS in a clinical setting of a pediatric spasticity clinic with a shorter method, the "3-milestones" GAS (goal setting with 3 levels and goal rating with the classical 5 levels). Secondary aims were to (1) analyze the types of goals children's therapists set for botulinum toxin treatment and (2) compare the score distribution (and therefore the ability to predict outcome) by goal type. Therapists were trained in GAS writing and prepared GAS scales in the regional spasticity-management clinic they attended with their patients and families. The study included all GAS scales written during a 2-year period. GAS score distribution across the 5 GAS levels was examined to assess whether the therapist could reliably predict outcome and whether the 3-milestones GAS yielded similar distributions as the original GAS method. In total, 541 GAS scales were written and showed the expected score distribution. Most scales (55%) referred to movement quality goals and fewer (29%) to family goals and activity domains. The 3-milestones GAS method was feasible within the time constraints of the spasticity clinic and could be used by local therapists in cooperation with the hospital team. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Syndrome diagnosis: human intuition or machine intelligence?

PubMed

Braaten, Oivind; Friestad, Johannes

2008-01-01

The aim of this study was to investigate whether artificial intelligence methods can represent objective methods that are essential in syndrome diagnosis. Most syndromes have no external criterion standard of diagnosis. The predictive value of a clinical sign used in diagnosis is dependent on the prior probability of the syndrome diagnosis. Clinicians often misjudge the probabilities involved. Syndromology needs objective methods to ensure diagnostic consistency, and take prior probabilities into account. We applied two basic artificial intelligence methods to a database of machine-generated patients - a 'vector method' and a set method. As reference methods we ran an ID3 algorithm, a cluster analysis and a naive Bayes' calculation on the same patient series. The overall diagnostic error rate for the the vector algorithm was 0.93%, and for the ID3 0.97%. For the clinical signs found by the set method, the predictive values varied between 0.71 and 1.0. The artificial intelligence methods that we used, proved simple, robust and powerful, and represent objective diagnostic methods.

Methods and means of diagnostics of oncological diseases on the basis of pattern recognition: intelligent morphological systems - problems and solutions

NASA Astrophysics Data System (ADS)

Nikitaev, V. G.

2017-01-01

The development of methods of pattern recognition in modern intelligent systems of clinical cancer diagnosis are discussed. The histological (morphological) diagnosis - primary diagnosis for medical setting with cancer are investigated. There are proposed: interactive methods of recognition and structure of intellectual morphological complexes based on expert training-diagnostic and telemedicine systems. The proposed approach successfully implemented in clinical practice.

Data Acquisition for a Patient-directed Intervention Protocol in the Dynamic Intensive Care Unit Setting

PubMed Central

Chlan, Linda; Patterson, Robert P.; Heiderscheit, Annie

2011-01-01

Methods to easily, accurately, and efficiently obtain data in an ICU-based clinical trial can be challenging in this high-tech setting. Patient medical status and the dynamic nature of this clinical setting further complicates data collection. The purpose of this paper is to describe the modifications of commercially available headphones and the application of a data logging device to capture frequency and length of protocol use (music listening or headphones only for noise cancellation) without burdening participants or busy ICU nurses. With the automatic capture of protocol use by research participants, there have been no instances of lost data for this clinical trial. PMID:21382515

Data acquisition for a patient-directed intervention protocol in the dynamic intensive care unit setting.

PubMed

Chlan, Linda; Patterson, Robert P; Heiderscheit, Annie

2011-07-01

Methods to easily, accurately, and efficiently obtain data in an ICU-based clinical trial can be challenging in this high-tech setting. Patient medical status and the dynamic nature of this clinical setting further complicate data collection. The purpose of this paper is to describe the modifications of commercially available headphones and the application of a data logging device to capture frequency and length of protocol use (music listening or headphones only for noise cancellation) without burdening participants or busy ICU nurses. With the automatic capture of protocol use by research participants, there have been no instances of lost data for this clinical trial. Copyright © 2011 Elsevier Inc. All rights reserved.

Interpersonal relationships between registered nurses and student nurses in the clinical setting--A systematic integrative review.

PubMed

Rebeiro, Geraldine; Edward, Karen-leigh; Chapman, Rose; Evans, Alicia

2015-12-01

A significant proportion of undergraduate nursing education occurs in the clinical setting in the form of practising skills and competencies, and is a requirement of all nursing curriculum for registration to practice. Education in the clinical setting is facilitated by registered nurses, yet this interpersonal relationship has not been examined well. To investigate the experience of interpersonal relationships between registered nurses and student nurses in the clinical setting from the point of view of the registered nurse. Integrative review Review methods: The databases of MEDLINE, CINAHL and OVID were searched. Key words used included: Registered Nurse, Preceptor, Buddy Nurse, Clinical Teacher, Mentor, Student Nurse, Nursing Student, Interpersonal Relationships, Attitudes and Perceptions. Additional review of the literature was manually undertaken through university library textbooks. 632 abstracts were returned after duplicates were removed. Twenty one articles were identified for full text read (quantitative n=2, mixed n=6, qualitative n=14); of these, seven articles addressed the experience of interpersonal relationships between registered nurses and student nurses in the clinical setting from the point of view of the registered nurse and these were reviewed. Providing education for registered nurses to enable them to lead student education in the clinical setting communicates the organizational value of the role. Registered nurses identified being supported in having the time-to-teach were considered important in facilitation of the clinical teaching role. The integrative review did not provide evidence related to the impact diverse clinical settings can have on the relationships between registered nurses and student nurses revealing an area for further examination. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Diet and Colorectal Cancer Risk: Baseline Dietary Knowledge of Colorectal Patients

ERIC Educational Resources Information Center

Dyer, K. J.; Fearon, K. C. H.; Buckner, K.; Richardson, R. A.

2004-01-01

Objective: To establish the dietary knowledge, attitudes and potential barriers to change of patients attending a colorectal outpatient clinic. Design: Use of a semistructured interview to generate qualitative and quantitative data. Setting: A regional colorectal outpatient clinic within Edinburgh. Method: Patients attending clinic with colorectal…

A simple method for plasma total vitamin C analysis suitable for routine clinical laboratory use.

PubMed

Robitaille, Line; Hoffer, L John

2016-04-21

In-hospital hypovitaminosis C is highly prevalent but almost completely unrecognized. Medical awareness of this potentially important disorder is hindered by the inability of most hospital laboratories to determine plasma vitamin C concentrations. The availability of a simple, reliable method for analyzing plasma vitamin C could increase opportunities for routine plasma vitamin C analysis in clinical medicine. Plasma vitamin C can be analyzed by high performance liquid chromatography (HPLC) with electrochemical (EC) or ultraviolet (UV) light detection. We modified existing UV-HPLC methods for plasma total vitamin C analysis (the sum of ascorbic and dehydroascorbic acid) to develop a simple, constant-low-pH sample reduction procedure followed by isocratic reverse-phase HPLC separation using a purely aqueous low-pH non-buffered mobile phase. Although EC-HPLC is widely recommended over UV-HPLC for plasma total vitamin C analysis, the two methods have never been directly compared. We formally compared the simplified UV-HPLC method with EC-HPLC in 80 consecutive clinical samples. The simplified UV-HPLC method was less expensive, easier to set up, required fewer reagents and no pH adjustments, and demonstrated greater sample stability than many existing methods for plasma vitamin C analysis. When compared with the gold-standard EC-HPLC method in 80 consecutive clinical samples exhibiting a wide range of plasma vitamin C concentrations, it performed equivalently. The easy set up, simplicity and sensitivity of the plasma vitamin C analysis method described here could make it practical in a normally equipped hospital laboratory. Unlike any prior UV-HPLC method for plasma total vitamin C analysis, it was rigorously compared with the gold-standard EC-HPLC method and performed equivalently. Adoption of this method could increase the availability of plasma vitamin C analysis in clinical medicine.

Correcting for Optimistic Prediction in Small Data Sets

PubMed Central

Smith, Gordon C. S.; Seaman, Shaun R.; Wood, Angela M.; Royston, Patrick; White, Ian R.

2014-01-01

The C statistic is a commonly reported measure of screening test performance. Optimistic estimation of the C statistic is a frequent problem because of overfitting of statistical models in small data sets, and methods exist to correct for this issue. However, many studies do not use such methods, and those that do correct for optimism use diverse methods, some of which are known to be biased. We used clinical data sets (United Kingdom Down syndrome screening data from Glasgow (1991–2003), Edinburgh (1999–2003), and Cambridge (1990–2006), as well as Scottish national pregnancy discharge data (2004–2007)) to evaluate different approaches to adjustment for optimism. We found that sample splitting, cross-validation without replication, and leave-1-out cross-validation produced optimism-adjusted estimates of the C statistic that were biased and/or associated with greater absolute error than other available methods. Cross-validation with replication, bootstrapping, and a new method (leave-pair-out cross-validation) all generated unbiased optimism-adjusted estimates of the C statistic and had similar absolute errors in the clinical data set. Larger simulation studies confirmed that all 3 methods performed similarly with 10 or more events per variable, or when the C statistic was 0.9 or greater. However, with lower events per variable or lower C statistics, bootstrapping tended to be optimistic but with lower absolute and mean squared errors than both methods of cross-validation. PMID:24966219

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

A new acoustic method to determine the setting time of calcium sulfate bone cement mixed with antibiotics.

PubMed

Cooper, J J; Brayford, M J; Laycock, P A

2014-08-01

A new method is described which can be used to determine the setting times of small amounts of high value bone cements. The test was developed to measure how the setting times of a commercially available synthetic calcium sulfate cement (Stimulan, Biocomposites, UK) in two forms (standard and Rapid Cure) varies with the addition of clinically relevant antibiotics. The importance of being able to accurately quantify these setting times is discussed. The results demonstrate that this new method, which is shown to correlate to the Vicat needle, gives reliable and repeatable data with additional benefits expressed in the article. The majority of antibiotics mixed were found to retard the setting reaction of the calcium sulfate cement.

Syndrome Diagnosis: Human Intuition or Machine Intelligence?

PubMed Central

Braaten, Øivind; Friestad, Johannes

2008-01-01

The aim of this study was to investigate whether artificial intelligence methods can represent objective methods that are essential in syndrome diagnosis. Most syndromes have no external criterion standard of diagnosis. The predictive value of a clinical sign used in diagnosis is dependent on the prior probability of the syndrome diagnosis. Clinicians often misjudge the probabilities involved. Syndromology needs objective methods to ensure diagnostic consistency, and take prior probabilities into account. We applied two basic artificial intelligence methods to a database of machine-generated patients - a ‘vector method’ and a set method. As reference methods we ran an ID3 algorithm, a cluster analysis and a naive Bayes’ calculation on the same patient series. The overall diagnostic error rate for the the vector algorithm was 0.93%, and for the ID3 0.97%. For the clinical signs found by the set method, the predictive values varied between 0.71 and 1.0. The artificial intelligence methods that we used, proved simple, robust and powerful, and represent objective diagnostic methods. PMID:19415142

Support in Clinical Settings as Perceived by Nursing Students in Iran: A Qualitative Study

PubMed Central

Joolaee, Soodabeh; Ashghali Farahani, Mansoureh; Jafarian Amiri, Seyedeh Roghayeh; Varaei, Shokoh

2016-01-01

Background Although support is one of the most substantial needs of nursing students during clinical education, it is not clearly defined in the literature. Objectives The current study aimed to explore the concept of support in clinical settings as perceived by nursing students. Materials and Methods A qualitative content analysis was used to explore the meaning of student support in clinical settings. A purposive sampling with maximum variation was used to select the participants among bachelor nursing students in the nursing school of Babol University of Medical Sciences in the north of Iran. Semi-structured interviews were conducted to gather the perceptions and experiences of seventeen nursing students. Conventional content analysis was applied to analyze the data. Results In the current study, the main theme, nurturance, was emerged with seven subthemes of humanistic behavior with the student, respectful communication with students, accepting the student in the clinical setting, sustaining confidence, need based supervision, accepting the profession in the society and empowerment. Conclusions Nursing students support in the clinical education requires a nurturing care; a care that leads to the sense of worthiness and respectability in students and contributes to the improvement of their clinical abilities. PMID:27331057

Rapid diagnostic tests apply for pediatric infections at outpatient clinic setting.

PubMed

Ushijima, Hiroshi; Thongprachum, Aksara; Tran, Dinh Nguyen; Fujimoto, Tsuguto; Hanaoka, Nozomu; Okitsu, Shoko; Takanashi, Sayaka; Mizuguchi, Masashi; Hayakawa, Satoshi

2015-01-01

Early identification of the etiology of infection is beneficial. Most infections are treated as outpatients. However, facilities for rapid diagnosis are not available in clinic settings. We applied Immunochromatography (IC) and Loop-mediated Isothermal Amplification (LAMP) methods to rapidly diagnose pathogens among 31 children with respiratory infection and 12 with gastroenteritis at a clinic in Saitama prefecture, Japan. Pathogens were then screened by multiplex conventional and real-time PCRs and bacterial culture. Respiratory pathogens were found in 64.5%. Despite the narrow spectrum, rapid tests identified pathogens in 28.6% of cases with a high agreement rate of 89.3% with PCR. Gastroenteritis pathogens were found in 66.7%. E. coli was positive in 3 cases and all were negative for verotoxin by LAMP. The agreement rate of IC and PCR assay was high, 100%. IC and LAMP are reliable and suitable methods in limited-resource settings for early pathogenic identification, which will help appropriate management, avoid unnecessary intervention, and cost saving.

Nurse educators' critical thinking: A mixed methods exploration.

PubMed

Raymond, Christy; Profetto-McGrath, Joanne; Myrick, Florence; Strean, William B

2018-07-01

Nurse educator's critical thinking remains unexamined as a key factor in the development of students' critical thinking. The objective of this study is to understand how nurse educators reveal their critical thinking in the clinical setting while supervising students. This study uses a single-phase triangulation mixed methods design with multiple data gathering techniques. Participants for this study are clinical nurse educators from a large Western Canadian baccalaureate nursing program who teach 2nd or 3rd year students in medical-surgical settings. Participants for this study completed a demographic survey, the California Critical Thinking Skills Test (CCTST), the California Critical Thinking Disposition Inventory (CCTDI), participant observation in a clinical practice setting, and semi-structured interviews. The results from the California Critical Thinking assessments (CCTST and CCTDI) show that participants are positively inclined and have a moderate to strong ability to think critically, similar to other studies. Participants find it difficult to describe how they reveal their critical thinking in the clinical setting, yet all participants use role modeling and questioning to share their critical thinking with students. When the quantitative and qualitative results are compared, it is apparent that the confidence in reasoning subscale of the California Critical Thinking Skills Test is higher in those educators who more frequently demonstrate and voice engagement in reflective activities. Dispositions associated with critical thinking, as measured by the California Critical Thinking Disposition Inventory, are more easily observed compared to critical thinking skills. This study is a beginning exploration of nurse educators' critical thinking-in-action. Our mixed methods approach uncovers a valuable approach to understanding the complexity of nurse educators' critical thinking. Further study is needed to uncover how nurse educators' can specifically enact their thinking abilities to support student learning in the clinical setting. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Accuracy of a radiofrequency identification (RFID) badge system to monitor hand hygiene behavior during routine clinical activities.

PubMed

Pineles, Lisa L; Morgan, Daniel J; Limper, Heather M; Weber, Stephen G; Thom, Kerri A; Perencevich, Eli N; Harris, Anthony D; Landon, Emily

2014-02-01

Hand hygiene (HH) is a critical part of infection prevention in health care settings. Hospitals around the world continuously struggle to improve health care personnel (HCP) HH compliance. The current gold standard for monitoring compliance is direct observation; however, this method is time-consuming and costly. One emerging area of interest involves automated systems for monitoring HH behavior such as radiofrequency identification (RFID) tracking systems. To assess the accuracy of a commercially available RFID system in detecting HCP HH behavior, we compared direct observation with data collected by the RFID system in a simulated validation setting and to a real-life clinical setting over 2 hospitals. A total of 1,554 HH events was observed. Accuracy for identifying HH events was high in the simulated validation setting (88.5%) but relatively low in the real-life clinical setting (52.4%). This difference was significant (P < .01). Accuracy for detecting HCP movement into and out of patient rooms was also high in the simulated setting but not in the real-life clinical setting (100% on entry and exit in simulated setting vs 54.3% entry and 49.5% exit in real-life clinical setting, P < .01). In this validation study of an RFID system, almost half of the HH events were missed. More research is necessary to further develop these systems and improve accuracy prior to widespread adoption. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Benchmarking Distance Control and Virtual Drilling for Lateral Skull Base Surgery.

PubMed

Voormolen, Eduard H J; Diederen, Sander; van Stralen, Marijn; Woerdeman, Peter A; Noordmans, Herke Jan; Viergever, Max A; Regli, Luca; Robe, Pierre A; Berkelbach van der Sprenkel, Jan Willem

2018-01-01

Novel audiovisual feedback methods were developed to improve image guidance during skull base surgery by providing audiovisual warnings when the drill tip enters a protective perimeter set at a distance around anatomic structures ("distance control") and visualizing bone drilling ("virtual drilling"). To benchmark the drill damage risk reduction provided by distance control, to quantify the accuracy of virtual drilling, and to investigate whether the proposed feedback methods are clinically feasible. In a simulated surgical scenario using human cadavers, 12 unexperienced users (medical students) drilled 12 mastoidectomies. Users were divided into a control group using standard image guidance and 3 groups using distance control with protective perimeters of 1, 2, or 3 mm. Damage to critical structures (sigmoid sinus, semicircular canals, facial nerve) was assessed. Neurosurgeons performed another 6 mastoidectomy/trans-labyrinthine and retro-labyrinthine approaches. Virtual errors as compared with real postoperative drill cavities were calculated. In a clinical setting, 3 patients received lateral skull base surgery with the proposed feedback methods. Users drilling with distance control protective perimeters of 3 mm did not damage structures, whereas the groups using smaller protective perimeters and the control group injured structures. Virtual drilling maximum cavity underestimations and overestimations were 2.8 ± 0.1 and 3.3 ± 0.4 mm, respectively. Feedback methods functioned properly in the clinical setting. Distance control reduced the risks of drill damage proportional to the protective perimeter distance. Errors in virtual drilling reflect spatial errors of the image guidance system. These feedback methods are clinically feasible. Copyright © 2017 Elsevier Inc. All rights reserved.

Rapid phenotypic antimicrobial susceptibility testing using nanoliter arrays.

PubMed

Avesar, Jonathan; Rosenfeld, Dekel; Truman-Rosentsvit, Marianna; Ben-Arye, Tom; Geffen, Yuval; Bercovici, Moran; Levenberg, Shulamit

2017-07-18

Antibiotic resistance is a major global health concern that requires action across all sectors of society. In particular, to allow conservative and effective use of antibiotics clinical settings require better diagnostic tools that provide rapid determination of antimicrobial susceptibility. We present a method for rapid and scalable antimicrobial susceptibility testing using stationary nanoliter droplet arrays that is capable of delivering results in approximately half the time of conventional methods, allowing its results to be used the same working day. In addition, we present an algorithm for automated data analysis and a multiplexing system promoting practicality and translatability for clinical settings. We test the efficacy of our approach on numerous clinical isolates and demonstrate a 2-d reduction in diagnostic time when testing bacteria isolated directly from urine samples.

Collaborative learning in gerontological clinical settings: The students' perspective.

PubMed

Suikkala, Arja; Kivelä, Eeva; Käyhkö, Pirjo

2016-03-01

This study deals with student nurses' experiences of collaborative learning in gerontological clinical settings where aged people are involved as age-experts in students' learning processes. The data were collected in 2012 using the contents of students' reflective writing assignments concerning elderly persons' life history interviews and the students' own assessments of their learning experiences in authentic elder care settings. The results, analyzed using qualitative content analysis, revealed mostly positive learning experiences. Interaction and collaborative learning activities in genuine gerontological clinical settings contributed to the students' understanding of the multiple age-related and disease-specific challenges as well as the issues of functional decline that aged patients face. Three types of factors influenced the students' collaborative learning experiences in gerontological clinical settings: student-related, patient-related and learning environment-related factors. According to the results, theoretical studies in combination with collaboration, in an authentic clinical environment, by student nurses, elderly patients, representatives of the elder care staff and nurse educators provide a feasible method for helping students transform their experiences with patients into actual skills. Their awareness of and sensitivity to the needs of the elderly increase as they learn. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Teaching of Hypnosis: Outline and Method.

ERIC Educational Resources Information Center

Taub-Bynum, Edward Bruce; House, Joseph J.

1983-01-01

A training seminar in clinical hypnosis was given to eight health professionals and paraprofessionals. The seminar involved lectures, clinical induction, and the use of hypnosis in supervised settings. A session-by-session account of seminar activities is provided. (Author/PP)

Predicting inpatient clinical order patterns with probabilistic topic models vs conventional order sets

PubMed Central

Goldstein, Mary K; Asch, Steven M; Mackey, Lester; Altman, Russ B

2017-01-01

Objective: Build probabilistic topic model representations of hospital admissions processes and compare the ability of such models to predict clinical order patterns as compared to preconstructed order sets. Materials and Methods: The authors evaluated the first 24 hours of structured electronic health record data for > 10 K inpatients. Drawing an analogy between structured items (e.g., clinical orders) to words in a text document, the authors performed latent Dirichlet allocation probabilistic topic modeling. These topic models use initial clinical information to predict clinical orders for a separate validation set of > 4 K patients. The authors evaluated these topic model-based predictions vs existing human-authored order sets by area under the receiver operating characteristic curve, precision, and recall for subsequent clinical orders. Results: Existing order sets predict clinical orders used within 24 hours with area under the receiver operating characteristic curve 0.81, precision 16%, and recall 35%. This can be improved to 0.90, 24%, and 47% (P < 10−20) by using probabilistic topic models to summarize clinical data into up to 32 topics. Many of these latent topics yield natural clinical interpretations (e.g., “critical care,” “pneumonia,” “neurologic evaluation”). Discussion: Existing order sets tend to provide nonspecific, process-oriented aid, with usability limitations impairing more precise, patient-focused support. Algorithmic summarization has the potential to breach this usability barrier by automatically inferring patient context, but with potential tradeoffs in interpretability. Conclusion: Probabilistic topic modeling provides an automated approach to detect thematic trends in patient care and generate decision support content. A potential use case finds related clinical orders for decision support. PMID:27655861

Seeing Students Squirm: Nursing Students’ Experiences of Bullying Behaviors During Clinical Rotations

PubMed Central

Smith, Carolyn R.; Gillespie, Gordon Lee; Brown, Kathryn C.; Grubb, Paula L.

2016-01-01

Background Bullying remains a troubling problem in the nursing profession. Nursing students may encounter bullying behavior in clinical settings. However nursing students may not be adequately prepared to recognize and handle bullying behavior when it occurs. The purpose of this study was to gain greater understanding of nursing students’ experiences of bullying behaviors in the clinical setting. Method Using a descriptive qualitative approach, eight focus groups were held with 56 undergraduate baccalaureate nursing students from four college campuses. Focus group data were coded and analyzed for themes. Results Four categories of themes were identified: bullying behaviors, rationale for bullying, response to bullying, and recommendations to address bullying. Each category and its corresponding themes are presented. Conclusion Interventions for nurse educators to address bullying of nursing students in clinical settings are presented. PMID:27560118

Paving the COWpath: data-driven design of pediatric order sets

PubMed Central

Zhang, Yiye; Padman, Rema; Levin, James E

2014-01-01

Objective Evidence indicates that users incur significant physical and cognitive costs in the use of order sets, a core feature of computerized provider order entry systems. This paper develops data-driven approaches for automating the construction of order sets that match closely with user preferences and workflow while minimizing physical and cognitive workload. Materials and methods We developed and tested optimization-based models embedded with clustering techniques using physical and cognitive click cost criteria. By judiciously learning from users’ actual actions, our methods identify items for constituting order sets that are relevant according to historical ordering data and grouped on the basis of order similarity and ordering time. We evaluated performance of the methods using 47 099 orders from the year 2011 for asthma, appendectomy and pneumonia management in a pediatric inpatient setting. Results In comparison with existing order sets, those developed using the new approach significantly reduce the physical and cognitive workload associated with usage by 14–52%. This approach is also capable of accommodating variations in clinical conditions that affect order set usage and development. Discussion There is a critical need to investigate the cognitive complexity imposed on users by complex clinical information systems, and to design their features according to ‘human factors’ best practices. Optimizing order set generation using cognitive cost criteria introduces a new approach that can potentially improve ordering efficiency, reduce unintended variations in order placement, and enhance patient safety. Conclusions We demonstrate that data-driven methods offer a promising approach for designing order sets that are generalizable, data-driven, condition-based, and up to date with current best practices. PMID:24674844

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes.

PubMed

Keltie, Kim; Cole, Helen; Arber, Mick; Patrick, Hannah; Powell, John; Campbell, Bruce; Sims, Andrew

2014-11-28

Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

PubMed

Kirkham, Jamie J; Clarke, Mike; Williamson, Paula R

2017-05-17

Objective  To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries. Design  Review of randomised trials. Setting  ClinicalTrials.gov. Subjects  273 randomised trials of drug interventions for the treatment of rheumatoid arthritis and registered in ClinicalTrials.gov between 2002 and 2016. Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science. Main outcome measure  The percentage of trials reporting or planning to measure the rheumatoid arthritis core outcome set calculated from the information presented in the trial registry and compared with the percentage reporting the rheumatoid arthritis core outcome set in the resulting trial publications. Results  The full rheumatoid arthritis core outcome set was reported in 81% (116/143) of trials identified on the registry as completed (or terminated) for which results were found in either the published literature or the registry. For trials identified on the registry as completed (or terminated), using information only available in the registry gives an estimate for uptake of 77% (145/189). Conclusions  The uptake of the rheumatoid arthritis core outcome set in clinical trials has continued to increase over time. Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. The method proposed may provide an efficient approach for an up-to-date assessment of the uptake of the 300 core outcome sets already published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Evidence-based Practices Addressed in Community-based Children’s Mental Health Clinical Supervision

PubMed Central

Accurso, Erin C.; Taylor, Robin M.; Garland, Ann F.

2013-01-01

Context Clinical supervision is the principal method of training for psychotherapeutic practice, however there is virtually no research on supervision practice in community settings. Of particular interest is the role supervision might play in facilitating implementation of evidence-based (EB) care in routine care settings. Objective This study examines the format and functions of clinical supervision sessions in routine care, as well as the extent to which supervision addresses psychotherapeutic practice elements common to EB care for children with disruptive behavior problems, who represent the majority of patients served in publicly-funded routine care settings. Methods Supervisors (n=7) and supervisees (n=12) from four publicly-funded community-based child mental health clinics reported on 130 supervision sessions. Results Supervision sessions were primarily individual in-person meetings lasting one hour. The most common functions included case conceptualization and therapy interventions. Coverage of practice elements common to EB treatments was brief. Discussion Despite the fact that most children presenting to public mental health services are referred for disruptive behavior problems, supervision sessions are infrequently focused on practice elements consistent with EB treatments for this population. Supervision is a promising avenue through which training in EB practices could be supported to improve the quality of care for children in community-based “usual care” clinics. PMID:24761163

Identifying the educational needs of nursing staff: the role of the clinical nurse specialist in perinatal nursing.

PubMed

Millhaem, Toni Brown; Timm, Kathleen

2007-01-01

One of the priorities of the perinatal clinical nurse specialist is the identification of educational needs. This article describes the experience of 2 perinatal clinical nurse specialists and presents various methods for identifying the educational needs of perinatal nursing staff in the hospital setting.

Exploring e-readers to support clinical medical education: two case studies*†

PubMed Central

von Isenburg, Megan

2011-01-01

Question: Can e-readers loaded with medical textbooks and other relevant material benefit medical students, residents, and preceptors in clinical settings? Settings: The settings are North Carolina community clinics served by Duke University Medical Center and St. Joseph's Hospital in Bryan, Texas, and Scott and White Memorial Hospital in Temple, Texas. Methods: Duke University: Twenty second-year medical students and fourteen family medicine clerkship preceptors used Kindle e-readers in clinics during eight months of rotations. Students and preceptors provided feedback through an anonymous online survey. Texas A&M University: Nine fourth-year medical students in an elective compared medical textbooks in print, online, and on a Kindle. Six residents at a local hospital completed an anonymous online survey after a three-week loan of a Kindle loaded with medical textbooks. Results: The e-reader's major advantages in clinical settings are portability and searchability. The selected e-reader's limitations include connection speed, navigation, and display. User preferences varied, but online resources were preferred. Participants suggested additional uses for Kindles in medical education. Conclusions: The selected e-reader's limitations may be resolved with further development of the device. Investigation of other e-readers is needed. Criteria for evaluating e-readers in clinical settings should include portability, searchability, speed, navigation, and display. Research comparing e-readers and mobile devices in clinical education is also warranted. PMID:21464848

Biasogram: Visualization of Confounding Technical Bias in Gene Expression Data

PubMed Central

Krzystanek, Marcin; Szallasi, Zoltan; Eklund, Aron C.

2013-01-01

Gene expression profiles of clinical cohorts can be used to identify genes that are correlated with a clinical variable of interest such as patient outcome or response to a particular drug. However, expression measurements are susceptible to technical bias caused by variation in extraneous factors such as RNA quality and array hybridization conditions. If such technical bias is correlated with the clinical variable of interest, the likelihood of identifying false positive genes is increased. Here we describe a method to visualize an expression matrix as a projection of all genes onto a plane defined by a clinical variable and a technical nuisance variable. The resulting plot indicates the extent to which each gene is correlated with the clinical variable or the technical variable. We demonstrate this method by applying it to three clinical trial microarray data sets, one of which identified genes that may have been driven by a confounding technical variable. This approach can be used as a quality control step to identify data sets that are likely to yield false positive results. PMID:23613961

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.

Multiprimer PCR system for differential identification of mycobacteria in clinical samples.

PubMed Central

Del Portillo, P; Thomas, M C; Martínez, E; Marañón, C; Valladares, B; Patarroyo, M E; Carlos López, M

1996-01-01

A novel multiprimer PCR method with the potential to identify mycobacteria in clinical samples is presented. The assay relies on the simultaneous amplification of three bacterial DNA genomic fragments by using different sets of oligonucleotide primers. The first set of primers amplifies a 506-bp fragment from the gene for the 32-kDa antigen of Mycobacterium tuberculosis, which is present in most of the species belonging to the genus Mycobacterium. The second set of primers amplifies a 984-bp fragment from the IS6110 insertion sequence of the bacteria belonging to the M. tuberculosis complex. The third set of primers, derived from an M. tuberculosis species-specific sequence named MTP40, amplifies a 396-bp genomic fragment. Thus, while the multiprimer system would render three amplification fragments from the M. tuberculosis genome and two fragments from the Mycobacterium bovis genome, a unique amplification fragment would be obtained from nontuberculous mycobacteria. The results obtained, using reference mycobacterial strains and typed clinical isolates, show that the multiprimer PCR method may be a rapid, sensitive, and specific tool for the differential identification of various mycobacterial strains in a single-step assay. PMID:8789008

Development of a method for measuring femoral torsion using real-time ultrasound.

PubMed

Hafiz, Eliza; Hiller, Claire E; Nicholson, Leslie L; Nightingale, E Jean; Clarke, Jillian L; Grimaldi, Alison; Eisenhuth, John P; Refshauge, Kathryn M

2014-07-01

Excessive femoral torsion has been associated with various musculoskeletal and neurological problems. To explore this relationship, it is essential to be able to measure femoral torsion in the clinic accurately. Computerized tomography (CT) and magnetic resonance imaging (MRI) are thought to provide the most accurate measurements but CT involves significant radiation exposure and MRI is expensive. The aim of this study was to design a method for measuring femoral torsion in the clinic, and to determine the reliability of this method. Details of design process, including construction of a jig, the protocol developed and the reliability of the method are presented. The protocol developed used ultrasound to image a ridge on the greater trochanter, and a customized jig placed on the femoral condyles as reference points. An inclinometer attached to the customized jig allowed quantification of the degree of femoral torsion. Measurements taken with this protocol had excellent intra- and inter-rater reliability (ICC2,1 = 0.98 and 0.97, respectively). This method of measuring femoral torsion also permitted measurement of femoral torsion with a high degree of accuracy. This method is applicable to the research setting and, with minor adjustments, will be applicable to the clinical setting.

Algorithmic tools for interpreting vital signs.

PubMed

Rathbun, Melina C; Ruth-Sahd, Lisa A

2009-07-01

Today's complex world of nursing practice challenges nurse educators to develop teaching methods that promote critical thinking skills and foster quick problem solving in the novice nurse. Traditional pedagogies previously used in the classroom and clinical setting are no longer adequate to prepare nursing students for entry into practice. In addition, educators have expressed frustration when encouraging students to apply newly learned theoretical content to direct the care of assigned patients in the clinical setting. This article presents algorithms as an innovative teaching strategy to guide novice student nurses in the interpretation and decision making related to vital sign assessment in an acute care setting.

A novel approach to generating CER hypotheses based on mining clinical data.

PubMed

Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

2013-01-01

Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

Multiple Levels of Suffering

PubMed Central

Kiley, Kasey B.; Haywood, Carlton; Bediako, Shawn M.; Lanzkron, Sophie; Carroll, C. Patrick; Buenaver, Luis F.; Pejsa, Megan; Edwards, Robert R.; Haythornthwaite, Jennifer A.; Campbell, Claudia M.

2016-01-01

Objective: People living with sickle cell disease (SCD) experience severe episodic and chronic pain and frequently report poor interpersonal treatment within health-care settings. In this particularly relevant context, we examined the relationship between perceived discrimination and both clinical and laboratory pain. Methods: Seventy-one individuals with SCD provided self-reports of experiences with discrimination in health-care settings and clinical pain severity, and completed a psychophysical pain testing battery in the laboratory. Results: Discrimination in health-care settings was correlated with greater clinical pain severity and enhanced sensitivity to multiple laboratory-induced pain measures, as well as stress, depression, and sleep. After controlling for relevant covariates, discrimination remained a significant predictor of mechanical temporal summation (a marker of central pain facilitation), but not clinical pain severity or suprathreshold heat pain response. Furthermore, a significant interaction between experience with discrimination and clinical pain severity was associated with mechanical temporal summation; increased experience with discrimination was associated with an increased correlation between clinical pain severity and temporal summation of pain. Discussion: Perceived discrimination within health-care settings was associated with pain facilitation. These findings suggest that discrimination may be related to increased central sensitization among SCD patients, and more broadly that health-care social environments may interact with pain pathophysiology. PMID:26889615

Assessing Suturing Skills in a Self-Guided Learning Setting: Absolute Symmetry Error

ERIC Educational Resources Information Center

Brydges, Ryan; Carnahan, Heather; Dubrowski, Adam

2009-01-01

Directed self-guidance, whereby trainees independently practice a skill-set in a structured setting, may be an effective technique for novice training. Currently, however, most evaluation methods require an expert to be present during practice. The study aim was to determine if absolute symmetry error, a clinically important measure that can be…

Increasing Reasoning Awareness: Video Analysis of Students’ Two-Party Virtual Patient Interactions

PubMed Central

Parodis, Ioannis; Lundberg, Ingrid E

2018-01-01

Background Collaborative reasoning occurs in clinical practice but is rarely developed during education. The computerized virtual patient (VP) cases allow for a stepwise exploration of cases and thus stimulate active learning. Peer settings during VP sessions are believed to have benefits in terms of reasoning but have received scant attention in the literature. Objective The objective of this study was to thoroughly investigate interactions during medical students’ clinical reasoning in two-party VP settings. Methods An in-depth exploration of students’ interactions in dyad settings of VP sessions was performed. For this purpose, two prerecorded VP sessions lasting 1 hour each were observed, transcribed in full, and analyzed. The transcriptions were analyzed using thematic analysis, and short clips from the videos were selected for subsequent analysis in relation to clinical reasoning and clinical aspects. Results Four categories of interactions were identified: (1) task-related dialogue, in which students negotiated a shared understanding of the task and strategies for information gathering; (2) case-related insights and perspectives were gained, and the students consolidated and applied preexisting biomedical knowledge into a clinical setting; (3) clinical reasoning interactions were made explicit. In these, hypotheses were followed up and clinical examples were used. The researchers observed interactions not only between students and the VP but also (4) interactions with other resources, such as textbooks. The interactions are discussed in relation to theories of clinical reasoning and peer learning. Conclusions The dyad VP setting is conducive to activities that promote analytic clinical reasoning. In this setting, components such as peer interaction, access to different resources, and reduced time constraints provided a productive situation in which the students pursued different lines of reasoning. PMID:29487043

Estimating clinical chemistry reference values based on an existing data set of unselected animals.

PubMed

Dimauro, Corrado; Bonelli, Piero; Nicolussi, Paola; Rassu, Salvatore P G; Cappio-Borlino, Aldo; Pulina, Giuseppe

2008-11-01

In an attempt to standardise the determination of biological reference values, the International Federation of Clinical Chemistry (IFCC) has published a series of recommendations on developing reference intervals. The IFCC recommends the use of an a priori sampling of at least 120 healthy individuals. However, such a high number of samples and laboratory analysis is expensive, time-consuming and not always feasible, especially in veterinary medicine. In this paper, an alternative (a posteriori) method is described and is used to determine reference intervals for biochemical parameters of farm animals using an existing laboratory data set. The method used was based on the detection and removal of outliers to obtain a large sample of animals likely to be healthy from the existing data set. This allowed the estimation of reliable reference intervals for biochemical parameters in Sarda dairy sheep. This method may also be useful for the determination of reference intervals for different species, ages and gender.

Experiences of clinical teaching for dental core trainees working in hospital.

PubMed

Mannion, C J; Brotherton, P

2014-07-11

There is recognition that the provision of excellence in education and training results in a skilled and competent workforce. However, the educational experiences of dental core trainees (DCT's) working in the hospital oral and maxillofacial surgery (OMFS) setting have not been previously investigated. In this paper, we examine DCT's learning experiences both 'formal' and 'non-formal' within the hospital setting of ward and clinic-based teaching. Are hospital dental core trainees receiving a meaningful educational experience? To conclude this paper, the authors recommend methods, based upon sound educational principles, to maximise the value of clinical sessions for teaching.

Clinical Trials With Large Numbers of Variables: Important Advantages of Canonical Analysis.

PubMed

Cleophas, Ton J

2016-01-01

Canonical analysis assesses the combined effects of a set of predictor variables on a set of outcome variables, but it is little used in clinical trials despite the omnipresence of multiple variables. The aim of this study was to assess the performance of canonical analysis as compared with traditional multivariate methods using multivariate analysis of covariance (MANCOVA). As an example, a simulated data file with 12 gene expression levels and 4 drug efficacy scores was used. The correlation coefficient between the 12 predictor and 4 outcome variables was 0.87 (P = 0.0001) meaning that 76% of the variability in the outcome variables was explained by the 12 covariates. Repeated testing after the removal of 5 unimportant predictor and 1 outcome variable produced virtually the same overall result. The MANCOVA identified identical unimportant variables, but it was unable to provide overall statistics. (1) Canonical analysis is remarkable, because it can handle many more variables than traditional multivariate methods such as MANCOVA can. (2) At the same time, it accounts for the relative importance of the separate variables, their interactions and differences in units. (3) Canonical analysis provides overall statistics of the effects of sets of variables, whereas traditional multivariate methods only provide the statistics of the separate variables. (4) Unlike other methods for combining the effects of multiple variables such as factor analysis/partial least squares, canonical analysis is scientifically entirely rigorous. (5) Limitations include that it is less flexible than factor analysis/partial least squares, because only 2 sets of variables are used and because multiple solutions instead of one is offered. We do hope that this article will stimulate clinical investigators to start using this remarkable method.

Natural language processing and the representation of clinical data.

PubMed Central

Sager, N; Lyman, M; Bucknall, C; Nhan, N; Tick, L J

1994-01-01

OBJECTIVE: Develop a representation of clinical observations and actions and a method of processing free-text patient documents to facilitate applications such as quality assurance. DESIGN: The Linguistic String Project (LSP) system of New York University utilizes syntactic analysis, augmented by a sublanguage grammar and an information structure that are specific to the clinical narrative, to map free-text documents into a database for querying. MEASUREMENTS: Information precision (I-P) and information recall (I-R) were measured for queries for the presence of 13 asthma-health-care quality assurance criteria in a database generated from 59 discharge letters. RESULTS: I-P, using counts of major errors only, was 95.7% for the 28-letter training set and 98.6% for the 31-letter test set. I-R, using counts of major omissions only, was 93.9% for the training set and 92.5% for the test set. PMID:7719796

Making the Most of Five Minutes: The Clinical Teaching Moment.

PubMed

Smith, Jo R; Lane, India F

2015-01-01

Clinical educators face the challenge of simultaneously caring for patients and teaching learners, often with an unpredictable caseload and learners of varied abilities. They also often have little control over the organization of their time. Effective clinical teaching must encourage student participation, problem solving, integration of basic and clinical knowledge, and deliberate practice. Close supervision and timely feedback are also essential. Just as one develops an effective lecture through training and practice, clinical teaching effectiveness may also be improved by using specific skills to teach in small increments. The purpose of this paper is to identify potential teachable moments and to describe efficient instructional methods to use in the clinical setting under time constraints. These techniques include asking better questions, performing focused observations, thinking aloud, and modeling reflection. Different frameworks for teaching encounters during case presentations can be selected according to learner ability and available time. These methods include modeling and deconstructing the concrete experience; guiding the thinking and reflecting process; and providing the setting and opportunity for active practice. Use of these educational strategies encourages the learner to acquire knowledge, clinical reasoning, and technical skills, and also values, attitudes, and professional judgment.

Alarm characterization for continuous glucose monitors used as adjuncts to self-monitoring of blood glucose.

PubMed

McGarraugh, Geoffrey

2010-01-01

Continuous glucose monitoring (CGM) devices available in the United States are approved for use as adjuncts to self-monitoring of blood glucose (SMBG). Alarm evaluation in the Clinical and Laboratory Standards Institute (CLSI) guideline for CGM does not specifically address devices that employ both CGM and SMBG. In this report, an alarm evaluation method is proposed for these devices. The proposed method builds on the CLSI method using data from an in-clinic study of subjects with type 1 diabetes. CGM was used to detect glycemic events, and SMBG was used to determine treatment. To optimize detection of a single glucose level, such as 70 mg/dl, a range of alarm threshold settings was evaluated. The alarm characterization provides a choice of alarm settings that trade off detection and false alarms. Detection of a range of high glucose levels was similarly evaluated. Using low glucose alarms, detection of 70 mg/dl within 30 minutes increased from 64 to 97% as alarm settings increased from 70 to 100 mg/dl, and alarms that did not require treatment (SMBG >85 mg/dl) increased from 18 to 52%. Using high glucose alarms, detection of 180 mg/dl within 30 minutes increased from 87 to 96% as alarm settings decreased from 180 to 165 mg/dl, and alarms that did not require treatment (SMBG <180 mg/dl) increased from 24 to 42%. The proposed alarm evaluation method provides information for choosing appropriate alarm thresholds and reflects the clinical utility of CGM alarms. 2010 Diabetes Technology Society.

Group‐Based Trajectory Models: Assessing Adherence to Antihypertensive Medication in Older Adults in a Community Pharmacy Setting

PubMed Central

Stewart, Derek; Smith, Susan M.; Gallagher, Paul; Cousins, Gráinne

2017-01-01

Antihypertensive medication nonadherence is highly prevalent, leading to uncontrolled blood pressure. Methods that facilitate the targeting and tailoring of adherence interventions in clinical settings are required. Group‐Based Trajectory Modeling (GBTM) is a newer method to evaluate adherence using pharmacy dispensing (refill) data that has advantages over traditional refill adherence metrics (e.g. Proportion of Days Covered) by identifying groups of patients who may benefit from adherence interventions, and identifying patterns of adherence behavior over time that may facilitate tailoring of an adherence intervention. We evaluated adherence to antihypertensive medication in 905 patients over a 12‐month period in a community pharmacy setting using GBTM, identifying three subgroups of adherence patterns: 52.8%, 40.7%, and 6.5% had very high, high, and low adherence, respectively. However, GBTM failed to demonstrate predictive validity with blood pressure at 12 months. Further research on the validity of adherence measures that facilitate interventions in clinical settings is required. PMID:28875569

Candidate-based proteomics in the search for biomarkers of cardiovascular disease

PubMed Central

Anderson, Leigh

2005-01-01

The key concept of proteomics (looking at many proteins at once) opens new avenues in the search for clinically useful biomarkers of disease, treatment response and ageing. As the number of proteins that can be detected in plasma or serum (the primary clinical diagnostic samples) increases towards 1000, a paradoxical decline has occurred in the number of new protein markers approved for diagnostic use in clinical laboratories. This review explores the limitations of current proteomics protein discovery platforms, and proposes an alternative approach, applicable to a range of biological/physiological problems, in which quantitative mass spectrometric methods developed for analytical chemistry are employed to measure limited sets of candidate markers in large sets of clinical samples. A set of 177 candidate biomarker proteins with reported associations to cardiovascular disease and stroke are presented as a starting point for such a ‘directed proteomics’ approach. PMID:15611012

The effectiveness of clinical problem-based learning model of medico-jurisprudence education on general law knowledge for Obstetrics/Gynecological interns.

PubMed

Chang, Hui-Chin; Wang, Ning-Yen; Ko, Wen-Ru; Yu, You-Tsz; Lin, Long-Yau; Tsai, Hui-Fang

2017-06-01

The effective education method of medico-jurisprudence for medical students is unclear. The study was designed to evaluate the effectiveness of problem-based learning (PBL) model teaching medico-jurisprudence in clinical setting on General Law Knowledge (GLK) for medical students. Senior medical students attending either campus-based law curriculum or Obstetrics/Gynecology (Ob/Gyn) clinical setting morning meeting from February to July in 2015 were enrolled. A validated questionnaire comprising 45 questions were completed before and after the law education. The interns attending clinical setting small group improvisation medico-jurisprudence problem-based learning education had significantly better GLK scores than the GLK of students attending campus-based medical law education course after the period studied. PBL teaching model of medico-jurisprudence is an ideal alternative pedagogy model in medical law education curriculum. Copyright © 2017. Published by Elsevier B.V.

Gaming as an Educational Strategy to Enhance Clinical Judgment and Knowledge Retention

ERIC Educational Resources Information Center

Lane, Jodie

2011-01-01

Classroom lecture methods in nursing education are falling short of providing long-term retention of knowledge and do not enhance problem solving skills or clinical judgment at the bedside. This problem impacts the health care recipients because applied knowledge and an enhanced skill set can provide nurses with confident clinical judgment to…

An Active Contour Model Based on Adaptive Threshold for Extraction of Cerebral Vascular Structures.

PubMed

Wang, Jiaxin; Zhao, Shifeng; Liu, Zifeng; Tian, Yun; Duan, Fuqing; Pan, Yutong

2016-01-01

Cerebral vessel segmentation is essential and helpful for the clinical diagnosis and the related research. However, automatic segmentation of brain vessels remains challenging because of the variable vessel shape and high complex of vessel geometry. This study proposes a new active contour model (ACM) implemented by the level-set method for segmenting vessels from TOF-MRA data. The energy function of the new model, combining both region intensity and boundary information, is composed of two region terms, one boundary term and one penalty term. The global threshold representing the lower gray boundary of the target object by maximum intensity projection (MIP) is defined in the first-region term, and it is used to guide the segmentation of the thick vessels. In the second term, a dynamic intensity threshold is employed to extract the tiny vessels. The boundary term is used to drive the contours to evolve towards the boundaries with high gradients. The penalty term is used to avoid reinitialization of the level-set function. Experimental results on 10 clinical brain data sets demonstrate that our method is not only able to achieve better Dice Similarity Coefficient than the global threshold based method and localized hybrid level-set method but also able to extract whole cerebral vessel trees, including the thin vessels.

The Development of Clinical Document Standards for Semantic Interoperability in China

PubMed Central

Yang, Peng; Pan, Feng; Wan, Yi; Tu, Haibo; Tang, Xuejun; Hu, Jianping

2011-01-01

Objectives This study is aimed at developing a set of data groups (DGs) to be employed as reusable building blocks for the construction of the eight most common clinical documents used in China's general hospitals in order to achieve their structural and semantic standardization. Methods The Diagnostics knowledge framework, the related approaches taken from the Health Level Seven (HL7), the Integrating the Healthcare Enterprise (IHE), and the Healthcare Information Technology Standards Panel (HITSP) and 1,487 original clinical records were considered together to form the DG architecture and data sets. The internal structure, content, and semantics of each DG were then defined by mapping each DG data set to a corresponding Clinical Document Architecture data element and matching each DG data set to the metadata in the Chinese National Health Data Dictionary. By using the DGs as reusable building blocks, standardized structures and semantics regarding the clinical documents for semantic interoperability were able to be constructed. Results Altogether, 5 header DGs, 48 section DGs, and 17 entry DGs were developed. Several issues regarding the DGs, including their internal structure, identifiers, data set names, definitions, length and format, data types, and value sets, were further defined. Standardized structures and semantics regarding the eight clinical documents were structured by the DGs. Conclusions This approach of constructing clinical document standards using DGs is a feasible standard-driven solution useful in preparing documents possessing semantic interoperability among the disparate information systems in China. These standards need to be validated and refined through further study. PMID:22259722

The need to approximate the use-case in clinical machine learning

PubMed Central

Saeb, Sohrab; Jayaraman, Arun; Mohr, David C.; Kording, Konrad P.

2017-01-01

Abstract The availability of smartphone and wearable sensor technology is leading to a rapid accumulation of human subject data, and machine learning is emerging as a technique to map those data into clinical predictions. As machine learning algorithms are increasingly used to support clinical decision making, it is vital to reliably quantify their prediction accuracy. Cross-validation (CV) is the standard approach where the accuracy of such algorithms is evaluated on part of the data the algorithm has not seen during training. However, for this procedure to be meaningful, the relationship between the training and the validation set should mimic the relationship between the training set and the dataset expected for the clinical use. Here we compared two popular CV methods: record-wise and subject-wise. While the subject-wise method mirrors the clinically relevant use-case scenario of diagnosis in newly recruited subjects, the record-wise strategy has no such interpretation. Using both a publicly available dataset and a simulation, we found that record-wise CV often massively overestimates the prediction accuracy of the algorithms. We also conducted a systematic review of the relevant literature, and found that this overly optimistic method was used by almost half of the retrieved studies that used accelerometers, wearable sensors, or smartphones to predict clinical outcomes. As we move towards an era of machine learning-based diagnosis and treatment, using proper methods to evaluate their accuracy is crucial, as inaccurate results can mislead both clinicians and data scientists. PMID:28327985

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project.

PubMed

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Oude Rengerink, Katrien; Gee, Harry; Mol, Ben W J; Khan, Khalid S

2009-09-10

Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.

shinyGISPA: A web application for characterizing phenotype by gene sets using multiple omics data combinations.

PubMed

Dwivedi, Bhakti; Kowalski, Jeanne

2018-01-01

While many methods exist for integrating multi-omics data or defining gene sets, there is no one single tool that defines gene sets based on merging of multiple omics data sets. We present shinyGISPA, an open-source application with a user-friendly web-based interface to define genes according to their similarity in several molecular changes that are driving a disease phenotype. This tool was developed to help facilitate the usability of a previously published method, Gene Integrated Set Profile Analysis (GISPA), among researchers with limited computer-programming skills. The GISPA method allows the identification of multiple gene sets that may play a role in the characterization, clinical application, or functional relevance of a disease phenotype. The tool provides an automated workflow that is highly scalable and adaptable to applications that go beyond genomic data merging analysis. It is available at http://shinygispa.winship.emory.edu/shinyGISPA/.

shinyGISPA: A web application for characterizing phenotype by gene sets using multiple omics data combinations

PubMed Central

Dwivedi, Bhakti

2018-01-01

While many methods exist for integrating multi-omics data or defining gene sets, there is no one single tool that defines gene sets based on merging of multiple omics data sets. We present shinyGISPA, an open-source application with a user-friendly web-based interface to define genes according to their similarity in several molecular changes that are driving a disease phenotype. This tool was developed to help facilitate the usability of a previously published method, Gene Integrated Set Profile Analysis (GISPA), among researchers with limited computer-programming skills. The GISPA method allows the identification of multiple gene sets that may play a role in the characterization, clinical application, or functional relevance of a disease phenotype. The tool provides an automated workflow that is highly scalable and adaptable to applications that go beyond genomic data merging analysis. It is available at http://shinygispa.winship.emory.edu/shinyGISPA/. PMID:29415010

Artificial intelligence in medicine.

PubMed Central

Ramesh, A. N.; Kambhampati, C.; Monson, J. R. T.; Drew, P. J.

2004-01-01

INTRODUCTION: Artificial intelligence is a branch of computer science capable of analysing complex medical data. Their potential to exploit meaningful relationship with in a data set can be used in the diagnosis, treatment and predicting outcome in many clinical scenarios. METHODS: Medline and internet searches were carried out using the keywords 'artificial intelligence' and 'neural networks (computer)'. Further references were obtained by cross-referencing from key articles. An overview of different artificial intelligent techniques is presented in this paper along with the review of important clinical applications. RESULTS: The proficiency of artificial intelligent techniques has been explored in almost every field of medicine. Artificial neural network was the most commonly used analytical tool whilst other artificial intelligent techniques such as fuzzy expert systems, evolutionary computation and hybrid intelligent systems have all been used in different clinical settings. DISCUSSION: Artificial intelligence techniques have the potential to be applied in almost every field of medicine. There is need for further clinical trials which are appropriately designed before these emergent techniques find application in the real clinical setting. PMID:15333167

Clinical learning environment at Shiraz Medical School.

PubMed

Rezaee, Rita; Ebrahimi, Sedigheh

2013-01-01

Clinical learning occurs in the context of a dynamic environment. Learning environment found to be one of the most important factors in determining the success of an effective teaching program. To investigate, from the attending and resident's perspective, factors that may affect student leaning in the educational hospital setting at Shiraz University of Medical Sciences (SUMS). This study combined qualitative and quantitative methods to determine factors affecting effective learning in clinical setting. Residents evaluated the perceived effectiveness of the university hospital learning environment. Fifty two faculty members and 132 residents participated in this study. Key determinants that contribute to an effective clinical teaching were autonomy, supervision, social support, workload, role clarity, learning opportunity, work diversity and physical facilities. In a good clinical setting, residents should be appreciated and given appropriate opportunities to study in order to meet their objectives. They require a supportive environment to consolidate their knowledge, skills and judgment. © 2013 Tehran University of Medical Sciences. All rights reserved.

Nano-flow vs standard-flow: Which is the more suitable LC/MS method for quantifying hepcidin-25 in human serum in routine clinical settings?

PubMed

Vialaret, Jérôme; Picas, Alexia; Delaby, Constance; Bros, Pauline; Lehmann, Sylvain; Hirtz, Christophe

2018-06-01

Hepcidin-25 peptide is a biomarker which is known to have considerable clinical potential for diagnosing iron-related diseases. Developing analytical methods for the absolute quantification of hepcidin is still a real challenge, however, due to the sensitivity, specificity and reproducibility issues involved. In this study, we compare and discuss two MS-based assays for quantifying hepcidin, which differ only in terms of the type of liquid chromatography (nano LC/MS versus standard LC/MS) involved. The same sample preparation, the same internal standards and the same MS analyzer were used with both approaches. In the field of proteomics, nano LC chromatography is generally known to be more sensitive and less robust than standard LC methods. In this study, we established that the performances of the standard LC method are equivalent to those of our previously developed nano LC method. Although the analytical performances were very similar in both cases. The standard-flow platform therefore provides the more suitable alternative for accurately determining hepcidin in clinical settings. Copyright © 2018 Elsevier B.V. All rights reserved.

Configurations of leadership practices in hospital units.

PubMed

Meier, Ninna

2015-01-01

The purpose of this paper is to explore how leadership is practiced across four different hospital units. The study is a comparative case study of four hospital units, based on detailed observations of the everyday work practices, interactions and interviews with ten interdisciplinary clinical managers. Comparing leadership as configurations of practices across four different clinical settings, the author shows how flexible and often shared leadership practices were embedded in and central to the core clinical work in all units studied here, especially in more unpredictable work settings. Practices of symbolic work and emotional support to staff were particularly important when patients were severely ill. Based on a study conducted with qualitative methods, these results cannot be expected to apply in all clinical settings. Future research is invited to extend the findings presented here by exploring leadership practices from a micro-level perspective in additional health care contexts: particularly the embedded and emergent nature of such practices. This paper shows leadership practices to be primarily embedded in the clinical work and often shared across organizational or professional boundaries. This paper demonstrated how leadership practices are embedded in the everyday work in hospital units. Moreover, the analysis shows how configurations of leadership practices varied in four different clinical settings, thus contributing with contextual accounts of leadership as practice, and suggested "configurations of practice" as a way to carve out similarities and differences in leadership practices across settings.

Advanced imaging techniques in brain tumors

PubMed Central

2009-01-01

Abstract Perfusion, permeability and magnetic resonance spectroscopy (MRS) are now widely used in the research and clinical settings. In the clinical setting, qualitative, semi-quantitative and quantitative approaches such as review of color-coded maps to region of interest analysis and analysis of signal intensity curves are being applied in practice. There are several pitfalls with all of these approaches. Some of these shortcomings are reviewed, such as the relative low sensitivity of metabolite ratios from MRS and the effect of leakage on the appearance of color-coded maps from dynamic susceptibility contrast (DSC) magnetic resonance (MR) perfusion imaging and what correction and normalization methods can be applied. Combining and applying these different imaging techniques in a multi-parametric algorithmic fashion in the clinical setting can be shown to increase diagnostic specificity and confidence. PMID:19965287

Instructional Development for Clinical Settings.

ERIC Educational Resources Information Center

Cranton, P. A.

Clinical teaching involves instruction in a natural health-related environment which allows students to observe and participate in the actual practice of the profession. The use of objectives, the sequence of instruction, the instructional methods and materials, and the evaluation of student performance constitute the components studied in…

Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

PubMed

Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

2014-05-01

The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product. This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.

Criteria for quantitative and qualitative data integration: mixed-methods research methodology.

PubMed

Lee, Seonah; Smith, Carrol A M

2012-05-01

Many studies have emphasized the need and importance of a mixed-methods approach for evaluation of clinical information systems. However, those studies had no criteria to guide integration of multiple data sets. Integrating different data sets serves to actualize the paradigm that a mixed-methods approach argues; thus, we require criteria that provide the right direction to integrate quantitative and qualitative data. The first author used a set of criteria organized from a literature search for integration of multiple data sets from mixed-methods research. The purpose of this article was to reorganize the identified criteria. Through critical appraisal of the reasons for designing mixed-methods research, three criteria resulted: validation, complementarity, and discrepancy. In applying the criteria to empirical data of a previous mixed methods study, integration of quantitative and qualitative data was achieved in a systematic manner. It helped us obtain a better organized understanding of the results. The criteria of this article offer the potential to produce insightful analyses of mixed-methods evaluations of health information systems.

A method and knowledge base for automated inference of patient problems from structured data in an electronic medical record

PubMed Central

Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; Ramelson, Harley Z; Schneider, Louise I; Bates, David W

2011-01-01

Background Accurate knowledge of a patient's medical problems is critical for clinical decision making, quality measurement, research, billing and clinical decision support. Common structured sources of problem information include the patient problem list and billing data; however, these sources are often inaccurate or incomplete. Objective To develop and validate methods of automatically inferring patient problems from clinical and billing data, and to provide a knowledge base for inferring problems. Study design and methods We identified 17 target conditions and designed and validated a set of rules for identifying patient problems based on medications, laboratory results, billing codes, and vital signs. A panel of physicians provided input on a preliminary set of rules. Based on this input, we tested candidate rules on a sample of 100 000 patient records to assess their performance compared to gold standard manual chart review. The physician panel selected a final rule for each condition, which was validated on an independent sample of 100 000 records to assess its accuracy. Results Seventeen rules were developed for inferring patient problems. Analysis using a validation set of 100 000 randomly selected patients showed high sensitivity (range: 62.8–100.0%) and positive predictive value (range: 79.8–99.6%) for most rules. Overall, the inference rules performed better than using either the problem list or billing data alone. Conclusion We developed and validated a set of rules for inferring patient problems. These rules have a variety of applications, including clinical decision support, care improvement, augmentation of the problem list, and identification of patients for research cohorts. PMID:21613643

Management of intrathecal baclofen therapy for severe acquired brain injury: consensus and recommendations for good clinical practice.

PubMed

De Tanti, Antonio; Scarponi, Federico; Bertoni, Michele; Gasperini, Giulio; Lanzillo, Bernardo; Molteni, Franco; Posteraro, Federico; Vitale, Dino Francesco; Zanpolini, Mauro

2017-08-01

Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.

Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana.

PubMed

Ansah, Evelyn K; Narh-Bana, Solomon; Epokor, Michael; Akanpigbiam, Samson; Quartey, Alberta Amu; Gyapong, John; Whitty, Christopher J M

2010-03-05

To test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis. Randomised, controlled, open label clinical trial. Four clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria ("microscopy setting") and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms ("clinical setting"). Patients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients. The primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years. Of the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm. Where microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.

Clinical Resting-state fMRI in the Preoperative Setting

PubMed Central

Lee, Megan H.; Miller-Thomas, Michelle M.; Benzinger, Tammie L.; Marcus, Daniel S.; Hacker, Carl D.; Leuthardt, Eric C.; Shimony, Joshua S.

2017-01-01

The purpose of this manuscript is to provide an introduction to resting-state functional magnetic resonance imaging (RS-fMRI) and to review the current application of this new and powerful technique in the preoperative setting using our institute’s extensive experience. RS-fMRI has provided important insights into brain physiology and is an increasingly important tool in the clinical setting. As opposed to task-based functional MRI wherein the subject performs a task while being scanned, RS-fMRI evaluates low-frequency fluctuations in the blood oxygen level dependent (BOLD) signal while the subject is at rest. Multiple resting state networks (RSNs) have been identified, including the somatosensory, language, and visual networks, which are of primary importance for presurgical planning. Over the past 4 years, we have performed over 300 RS-fMRI examinations in the clinical setting and these have been used to localize eloquent somatosensory and language cortices before brain tumor resection. RS-fMRI is particularly useful in this setting for patients who are unable to cooperate with the task-based paradigm, such as young children or those who are sedated, paretic, or aphasic. Although RS-fMRI is still investigational, our experience indicates that this method is ready for clinical application in the presurgical setting. PMID:26848556

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review

PubMed Central

2014-01-01

Background Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. Objectives This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Data sources Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Study selection Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methods Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Results Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. Conclusion While many studies support ABT’s potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice. PMID:24625308

Enhancing predictive accuracy and reproducibility in clinical evaluation research: Commentary on the special section of the Journal of Evaluation in Clinical Practice.

PubMed

Bryant, Fred B

2016-12-01

This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine-learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods-advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data. © 2016 John Wiley & Sons, Ltd.

Morphological embryo selection: an elective single embryo transfer proposal

PubMed Central

Déniz, Francisco Parera; Encinas, Carlos; Fuente, Jorge La

2018-01-01

Objective To describe a patient selection method for elective single embryo transfer (eSET), emphasizing inclusion criteria and results. Methods This retrospective study included all cases seen in a private clinic between June 2011 and December 2016, in La Paz, Bolivia (3600 meters above sea level). Elective single embryo transfer was the method of choice in 34 IVF/ICSI cycles, all in the blastocyst stage. Gardner's blastocyst classification criteria were used. Between the two stages of the study (July 2015), each embryo grade implantation rate was recalculated, which led to the expansion of the inclusion criteria. Results The clinical pregnancy rate of the 34 cases in the first transfer group was 55.9% (19/34). Twin or multiple pregnancies did not occur. The cumulative pregnancy rate to date is 64% [(19+3)/34]. The first stage comprised 2.56% (12/468) of the patients offered elective single embryo transfers; the implantation rate was 58.3% (7/12). In the second stage, 14.29% (22/154) of the patients were eligible, and the implantation rate was 54.55% (12/22). Conclusion The implementation of an eSET program based on in-depth morphological embryo assessment combined with the calculation of the implantation potential of each embryo grade led to acceptable clinical outcomes and fewer multiple pregnancies in patients transferred two embryos. Each clinic should be aware of the implantation rates of each embryo grade in its own setting. PMID:29338137

Construction of a Clinical Decision Support System for Undergoing Surgery Based on Domain Ontology and Rules Reasoning

PubMed Central

Bau, Cho-Tsan; Huang, Chung-Yi

2014-01-01

Abstract Objective: To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. Materials and Methods: The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé–Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. Results: The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. Conclusions: The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia. PMID:24730353

Structured assessment of microsurgery skills in the clinical setting.

PubMed

Chan, WoanYi; Niranjan, Niri; Ramakrishnan, Venkat

2010-08-01

Microsurgery is an essential component in plastic surgery training. Competence has become an important issue in current surgical practice and training. The complexity of microsurgery requires detailed assessment and feedback on skills components. This article proposes a method of Structured Assessment of Microsurgery Skills (SAMS) in a clinical setting. Three types of assessment (i.e., modified Global Rating Score, errors list and summative rating) were incorporated to develop the SAMS method. Clinical anastomoses were recorded on videos using a digital microscope system and were rated by three consultants independently and in a blinded fashion. Fifteen clinical cases of microvascular anastomoses performed by trainees and a consultant microsurgeon were assessed using SAMS. The consultant had consistently the highest scores. Construct validity was also demonstrated by improvement of SAMS scores of microsurgery trainees. The overall inter-rater reliability was strong (alpha=0.78). The SAMS method provides both formative and summative assessment of microsurgery skills. It is demonstrated to be a valid, reliable and feasible assessment tool of operating room performance to provide systematic and comprehensive feedback as part of the learning cycle. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

The Effectiveness of Peer Taught Group Sessions of Physiotherapy Students within the Clinical Setting: A Quasi-Experimental Study

ERIC Educational Resources Information Center

Scott, Dee; Jelsma, Jennifer

2014-01-01

The study aimed to investigate whether learning from peers, learning from a clinical educator, or being the peer teacher during clinical group sessions was more effective at enhancing student learning outcomes for different health conditions. A secondary aim was to determine which method students found more satisfactory. Physiotherapy students at…

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Teacher Candidates' Experiences with Clinical Teaching in Reading Instruction: A Comparison between the Professional Development School Environment and the Non-Professional Development School Environment

ERIC Educational Resources Information Center

Hopper, Cynthia J.

2016-01-01

Teacher candidates experience a variety of school settings when enrolled in teacher education methods courses. Candidates report varied experiences when in public school classrooms. This dissertation investigated clinical experiences of teacher candidates when placed in two different environments for clinical teaching. The two environments were a…

Noise detection in heart sound recordings.

PubMed

Zia, Mohammad K; Griffel, Benjamin; Fridman, Vladimir; Saponieri, Cesare; Semmlow, John L

2011-01-01

Coronary artery disease (CAD) is the leading cause of death in the United States. Although progression of CAD can be controlled using drugs and diet, it is usually detected in advanced stages when invasive treatment is required. Current methods to detect CAD are invasive and/or costly, hence not suitable as a regular screening tool to detect CAD in early stages. Currently, we are developing a noninvasive and cost-effective system to detect CAD using the acoustic approach. This method identifies sounds generated by turbulent flow through partially narrowed coronary arteries to detect CAD. The limiting factor of this method is sensitivity to noises commonly encountered in the clinical setting. Because the CAD sounds are faint, these noises can easily obscure the CAD sounds and make detection impossible. In this paper, we propose a method to detect and eliminate noise encountered in the clinical setting using a reference channel. We show that our method is effective in detecting noise, which is essential to the success of the acoustic approach.

Indicators to assess the functionality of clubfoot clinics in low-resource settings: a Delphi consensus approach and pilot study.

PubMed

Smythe, Tracey; Mudariki, Debra; Foster, Allen; Lavy, Christopher

2018-05-19

This study aims to determine the indicators for assessing the functionality of clubfoot clinics in a low-resource setting. The Delphi method was employed with experienced clubfoot practitioners in Africa to rate the importance of indicators of a good clubfoot clinic. The consistency among the participants was determined with the intraclass correlation coefficient. Indicators that achieved strong agreement (mean≥9 [SD <1.5]) were included in the final consensus definition. Based on the final consensus definition, a set of questions was developed to form the Functionality Assessment Clubfoot Clinic Tool (FACT). The FACT was used between February and July 2017 to assess the functionality of clinics in the Zimbabwe clubfoot programme. A set of 10 indicators that includes components of five of the six building blocks of a health system-leadership, human resources, essential medical equipment, health information systems and service delivery-was produced. The most common needs identified in Zimbabwe clubfoot clinics were a standard treatment protocol, a process for surgical referrals and a process to monitor dropout of patients. Practitioners had good consistency in rating indicators. The consensus definition includes components of the World Health Organization building blocks of health systems. Useful information was obtained on how to improve the services in the Zimbabwe clubfoot programme.

[Assessment of competence in pediatric postgraduate education: implementation of a pediatric version of the Mini-Cex].

PubMed

Urman, Gabriela; Folgueral, Silvana; Gasparri, Mercedes; López, Diana; Urman, Jorge; Grosman, Arnoldo; Alves de Lima, Alberto

2011-12-01

Faced with the increased challenge of assessing competences in young doctors, the purpose of the study was to evaluate the implementation of a pediatric version of the Mini-Cex in pediatric trainees as well as the level of satisfaction of teachers and students with the new assessment tool. From July 2007 to August 2009, 54 pediatric trainees were periodically monitored in a variety of clinical settings by 50 teachers. The competences evaluated included medical interviewing, physical examination and counseling skills, humanistic qualities/ professionalism, clinical judgment, organization and overall clinical competence. The feasibility of this study was defined as an average 4 observations per participant, and observations in all clinical rotations. During the study, 388 observations were carried over 54 students (average of 7.18 observations per student); 57% took place in ambulatory settings, 60% were of low complexity and 85% involved healthy children programmed consultations. The ratings for specific competences had little variation; the focus related to the setting. Used in a variety of settings, with different patient problems, the method was well accepted by both students and teachers.

A framework for improving access and customer service times in health care: application and analysis at the UCLA Medical Center.

PubMed

Duda, Catherine; Rajaram, Kumar; Barz, Christiane; Rosenthal, J Thomas

2013-01-01

There has been an increasing emphasis on health care efficiency and costs and on improving quality in health care settings such as hospitals or clinics. However, there has not been sufficient work on methods of improving access and customer service times in health care settings. The study develops a framework for improving access and customer service time for health care settings. In the framework, the operational concept of the bottleneck is synthesized with queuing theory to improve access and reduce customer service times without reduction in clinical quality. The framework is applied at the Ronald Reagan UCLA Medical Center to determine the drivers for access and customer service times and then provides guidelines on how to improve these drivers. Validation using simulation techniques shows significant potential for reducing customer service times and increasing access at this institution. Finally, the study provides several practice implications that could be used to improve access and customer service times without reduction in clinical quality across a range of health care settings from large hospitals to small community clinics.

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Examining organizational change in primary care practices: experiences from using ethnographic methods.

PubMed

Russell, Grant; Advocat, Jenny; Geneau, Robert; Farrell, Barbara; Thille, Patricia; Ward, Natalie; Evans, Samantha

2012-08-01

Qualitative methods are an important part of the primary care researcher's toolkit providing a nuanced view of the complexity in primary care reform and delivery. Ethnographic research is a comprehensive approach to qualitative data collection, including observation, in-depth interviews and document analysis. Few studies have been published outlining methodological issues related to ethnography in this setting. This paper examines some of the challenges of conducting an ethnographic study in primary care setting in Canada, where there recently have been major reforms to traditional methods of organizing primary care services. This paper is based on an ethnographic study set in primary care practices in Ontario, Canada, designed to investigate changes to organizational and clinical routines in practices undergoing transition to new, interdisciplinary Family Health Teams (FHTs). The study was set in six new FHTs in Ontario. This paper is a reflexive examination of some of the challenges encountered while conducting an ethnographic study in a primary care setting. Our experiences in this study highlight some potential benefits of and difficulties in conducting an ethnographic study in family practice. Our study design gave us an opportunity to highlight the changes in routines within an organization in transition. A study with a clinical perspective requires training, support, a mixture of backgrounds and perspectives and ongoing communication. Despite some of the difficulties, the richness of this method has allowed the exploration of a number of additional research questions that emerged during data analysis.

Geodesic denoising for optical coherence tomography images

NASA Astrophysics Data System (ADS)

Shahrian Varnousfaderani, Ehsan; Vogl, Wolf-Dieter; Wu, Jing; Gerendas, Bianca S.; Simader, Christian; Langs, Georg; Waldstein, Sebastian M.; Schmidt-Erfurth, Ursula

2016-03-01

Optical coherence tomography (OCT) is an optical signal acquisition method capturing micrometer resolution, cross-sectional three-dimensional images. OCT images are used widely in ophthalmology to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD) and Glaucoma. While OCT allows the visualization of retinal structures such as vessels and retinal layers, image quality and contrast is reduced by speckle noise, obfuscating small, low intensity structures and structural boundaries. Existing denoising methods for OCT images may remove clinically significant image features such as texture and boundaries of anomalies. In this paper, we propose a novel patch based denoising method, Geodesic Denoising. The method reduces noise in OCT images while preserving clinically significant, although small, pathological structures, such as fluid-filled cysts in diseased retinas. Our method selects optimal image patch distribution representations based on geodesic patch similarity to noisy samples. Patch distributions are then randomly sampled to build a set of best matching candidates for every noisy sample, and the denoised value is computed based on a geodesic weighted average of the best candidate samples. Our method is evaluated qualitatively on real pathological OCT scans and quantitatively on a proposed set of ground truth, noise free synthetic OCT scans with artificially added noise and pathologies. Experimental results show that performance of our method is comparable with state of the art denoising methods while outperforming them in preserving the critical clinically relevant structures.

Kaplan-Meier survival analysis overestimates cumulative incidence of health-related events in competing risk settings: a meta-analysis.

PubMed

Lacny, Sarah; Wilson, Todd; Clement, Fiona; Roberts, Derek J; Faris, Peter; Ghali, William A; Marshall, Deborah A

2018-01-01

Kaplan-Meier survival analysis overestimates cumulative incidence in competing risks (CRs) settings. The extent of overestimation (or its clinical significance) has been questioned, and CRs methods are infrequently used. This meta-analysis compares the Kaplan-Meier method to the cumulative incidence function (CIF), a CRs method. We searched MEDLINE, EMBASE, BIOSIS Previews, Web of Science (1992-2016), and article bibliographies for studies estimating cumulative incidence using the Kaplan-Meier method and CIF. For studies with sufficient data, we calculated pooled risk ratios (RRs) comparing Kaplan-Meier and CIF estimates using DerSimonian and Laird random effects models. We performed stratified meta-analyses by clinical area, rate of CRs (CRs/events of interest), and follow-up time. Of 2,192 identified abstracts, we included 77 studies in the systematic review and meta-analyzed 55. The pooled RR demonstrated the Kaplan-Meier estimate was 1.41 [95% confidence interval (CI): 1.36, 1.47] times higher than the CIF. Overestimation was highest among studies with high rates of CRs [RR = 2.36 (95% CI: 1.79, 3.12)], studies related to hepatology [RR = 2.60 (95% CI: 2.12, 3.19)], and obstetrics and gynecology [RR = 1.84 (95% CI: 1.52, 2.23)]. The Kaplan-Meier method overestimated the cumulative incidence across 10 clinical areas. Using CRs methods will ensure accurate results inform clinical and policy decisions. Copyright © 2017 Elsevier Inc. All rights reserved.

A computational approach to compare regression modelling strategies in prediction research.

PubMed

Pajouheshnia, Romin; Pestman, Wiebe R; Teerenstra, Steven; Groenwold, Rolf H H

2016-08-25

It is often unclear which approach to fit, assess and adjust a model will yield the most accurate prediction model. We present an extension of an approach for comparing modelling strategies in linear regression to the setting of logistic regression and demonstrate its application in clinical prediction research. A framework for comparing logistic regression modelling strategies by their likelihoods was formulated using a wrapper approach. Five different strategies for modelling, including simple shrinkage methods, were compared in four empirical data sets to illustrate the concept of a priori strategy comparison. Simulations were performed in both randomly generated data and empirical data to investigate the influence of data characteristics on strategy performance. We applied the comparison framework in a case study setting. Optimal strategies were selected based on the results of a priori comparisons in a clinical data set and the performance of models built according to each strategy was assessed using the Brier score and calibration plots. The performance of modelling strategies was highly dependent on the characteristics of the development data in both linear and logistic regression settings. A priori comparisons in four empirical data sets found that no strategy consistently outperformed the others. The percentage of times that a model adjustment strategy outperformed a logistic model ranged from 3.9 to 94.9 %, depending on the strategy and data set. However, in our case study setting the a priori selection of optimal methods did not result in detectable improvement in model performance when assessed in an external data set. The performance of prediction modelling strategies is a data-dependent process and can be highly variable between data sets within the same clinical domain. A priori strategy comparison can be used to determine an optimal logistic regression modelling strategy for a given data set before selecting a final modelling approach.

Student nurse dyads create a community of learning: proposing a holistic clinical education theory.

PubMed

Ruth-Sahd, Lisa A

2011-11-01

This paper is a report of a qualitative study of students' experiences of cooperative learning in the clinical setting. Although cooperative learning is often used successfully in the classroom, it has not been documented in the clinical setting with sophomore nursing students being paired with other sophomore nursing students. Using a grounded theory methodology a sample of 64 participants (32 student nurse dyads, eight clinical groups, in two different acute care institutions) were observed on their first day in the clinical setting while working as cooperative partners. Interviews were also conducted with students, patients and staff preceptors. Data were collected in the fall of 2008, spring and fall of 2009 and the spring of 2010 using semi-structured interviews and reflective surveys. Data were analysed using the constant comparative method. A holistic clinical education theory for student nurses was identified from the data. This theory includes a reciprocal relationship among five categories relevant to a community of learning: supportive clinical experience; improved transition into practice; enhanced socialization into the profession; increased accountability and responsibility; and emergence of self-confidence as a beginning student nurse. The use of student dyads creates a supportive learning environment while students were able to meet the clinical learning objectives. Cooperative learning in the clinical setting creates a community of learning while instilling very early in the education process the importance of teamwork. This approach to clinical instruction eases the transition from the classroom to the clinical learning environment, and improves patient outcomes. © 2011 Blackwell Publishing Ltd.

Barriers and Solutions to Fieldwork Education in Hand Therapy.

PubMed

Short, Nathan; Sample, Shelby; Murphy, Malachi; Austin, Brittany; Glass, Jillian

2017-08-09

Survey. Fieldwork education is a vital component of training the next generation of CHTs. Barriers and solutions to fieldwork rotations in hand therapy are examined, as well as proposed solutions, including recommendations for student preparation. This descriptive study examined barriers for certified hand therapist clinicians to accept students for clinical rotations and clinicians' preferences for student preparation before a rotation in a hand setting. A survey was developed, peer reviewed, and distributed using the electronic mailing list of the Hand Therapy Certification Commission via SurveyMonkey. Aggregate responses were analyzed to identify trends including barriers to student clinical rotations and recommendations for students to prepare for hand rotations. A total of 2080 participants responded to the survey, representing a 37% response rate. Common logistical barriers were identified for accepting students such as limited clinical time and space. Many clinicians (32% agree and 8% strongly agree) also felt that the students lack the clinical knowledge to be successful. Areas of knowledge, skill set, and experience were surveyed for development before a clinical rotation in a hand setting. Most respondents (74%) reported increased likelihood of accepting a student with the recommended preparation. Novel qualitative responses to improve clinical experiences are presented as well. Student preparation before a clinical rotation in a hand setting appears to be a significant barrier based on the survey results. Areas of recommended knowledge, skill set, and experience may serve to guide both formal and informal methods of student preparation before a hand-specific clinical rotation to facilitate knowledge translation from experienced certified hand therapists to the next generation. Although logistical barriers may be difficult to overcome, hand-specific preparation based on clinician' recommendations may facilitate student acceptance and success in hand specialty clinical rotations. N/A. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Spectral gene set enrichment (SGSE).

PubMed

Frost, H Robert; Li, Zhigang; Moore, Jason H

2015-03-03

Gene set testing is typically performed in a supervised context to quantify the association between groups of genes and a clinical phenotype. In many cases, however, a gene set-based interpretation of genomic data is desired in the absence of a phenotype variable. Although methods exist for unsupervised gene set testing, they predominantly compute enrichment relative to clusters of the genomic variables with performance strongly dependent on the clustering algorithm and number of clusters. We propose a novel method, spectral gene set enrichment (SGSE), for unsupervised competitive testing of the association between gene sets and empirical data sources. SGSE first computes the statistical association between gene sets and principal components (PCs) using our principal component gene set enrichment (PCGSE) method. The overall statistical association between each gene set and the spectral structure of the data is then computed by combining the PC-level p-values using the weighted Z-method with weights set to the PC variance scaled by Tracy-Widom test p-values. Using simulated data, we show that the SGSE algorithm can accurately recover spectral features from noisy data. To illustrate the utility of our method on real data, we demonstrate the superior performance of the SGSE method relative to standard cluster-based techniques for testing the association between MSigDB gene sets and the variance structure of microarray gene expression data. Unsupervised gene set testing can provide important information about the biological signal held in high-dimensional genomic data sets. Because it uses the association between gene sets and samples PCs to generate a measure of unsupervised enrichment, the SGSE method is independent of cluster or network creation algorithms and, most importantly, is able to utilize the statistical significance of PC eigenvalues to ignore elements of the data most likely to represent noise.

Content Validation of Athletic Therapy Clinical Presentations in Canada

ERIC Educational Resources Information Center

Lafave, Mark R.; Yeo, Michelle; Westbrook, Khatija; Valdez, Dennis; Eubank, Breda; McAllister, Jenelle

2016-01-01

Context: Competency-based education requires strong planning and a vehicle to deliver and track students' progress across their undergraduate programs. Clinical presentations (CPs) are proposed as 1 method to deliver a competency-based curriculum in a Canadian undergraduate athletic therapy program. Objective: Validation of 253 CPs. Setting:…

Decaying Relevance of Clinical Data Towards Future Decisions in Data-Driven Inpatient Clinical Order Sets

PubMed Central

Chen, Jonathan H; Alagappan, Muthuraman; Goldstein, Mary K; Asch, Steven M; Altman, Russ B

2017-01-01

Objective Determine how varying longitudinal historical training data can impact prediction of future clinical decisions. Estimate the “decay rate” of clinical data source relevance. Materials and Methods We trained a clinical order recommender system, analogous to Netflix or Amazon’s “Customers who bought A also bought B…” product recommenders, based on a tertiary academic hospital’s structured electronic health record data. We used this system to predict future (2013) admission orders based on different subsets of historical training data (2009 through 2012), relative to existing human-authored order sets. Results Predicting future (2013) inpatient orders is more accurate with models trained on just one month of recent (2012) data than with 12 months of older (2009) data (ROC AUC 0.91 vs. 0.88, precision 27% vs. 22%, recall 52% vs. 43%, all P<10−10). Algorithmically learned models from even the older (2009) data was still more effective than existing human-authored order sets (ROC AUC 0.81, precision 16% recall 35%). Training with more longitudinal data (2009–2012) was no better than using only the most recent (2012) data, unless applying a decaying weighting scheme with a “half-life” of data relevance about 4 months. Discussion Clinical practice patterns (automatically) learned from electronic health record data can vary substantially across years. Gold standards for clinical decision support are elusive moving targets, reinforcing the need for automated methods that can adapt to evolving information. Conclusions and Relevance Prioritizing small amounts of recent data is more effective than using larger amounts of older data towards future clinical predictions. PMID:28495350

Preserving temporal relations in clinical data while maintaining privacy

PubMed Central

Mirhaji, Parsa; Low, Alexander FH; Malin, Bradley A

2016-01-01

Objective Maintaining patient privacy is a challenge in large-scale observational research. To assist in reducing the risk of identifying study subjects through publicly available data, we introduce a method for obscuring date information for clinical events and patient characteristics. Methods The method, which we call Shift and Truncate (SANT), obscures date information to any desired granularity. Shift and Truncate first assigns each patient a random shift value, such that all dates in that patient’s record are shifted by that amount. Data are then truncated from the beginning and end of the data set. Results The data set can be proven to not disclose temporal information finer than the chosen granularity. Unlike previous strategies such as a simple shift, it remains robust to frequent – even daily – updates and robust to inferring dates at the beginning and end of date-shifted data sets. Time-of-day may be retained or obscured, depending on the goal and anticipated knowledge of the data recipient. Conclusions The method can be useful as a scientific approach for reducing re-identification risk under the Privacy Rule of the Health Insurance Portability and Accountability Act and may contribute to qualification for the Safe Harbor implementation. PMID:27013522

Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial.

PubMed

Paul, Mandira; Iyengar, Sharad D; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Kirti; Bring, Johan; Klingberg-Allvin, Marie

2016-10-17

Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion. A randomized controlled, non-inferiority, trial (RCT) compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n = 731). Women with known contraindications to medical abortions, Hb < 85 mg/l and aged below 18 were excluded. Data were collected between April 2013 and August 2014 in six primary health-care clinics in Rajasthan. A computerised random number generator created the randomisation sequence (1:1) in blocks of six. Contraceptive use was measured at 2 weeks among women successfully followed-up (n = 623) and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n = 114). There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment), however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62 ± 12 %), while women in the home-assessment group were most likely to adopt a method after next menstruation (60 ± 13 %). Fifty-two per cent of women who initiated a method at 2 weeks chose the 3-month injection or the copper intrauterine device. Only 4 % of women preferred sterilization. Caste, educational attainment, or type of residence did not influence contraceptive use. Simplified follow-up after early medical abortion will not change women's opportunities to access contraception in a low-resource setting, if contraceptive services are provided as intra-abortion services as early as on day one. Women's postabortion contraceptive use at 3 months is unlikely to be affected by mode of followup after medical abortion, also in a low-resource setting. Clinical guidelines need to encourage intra-abortion contraception, offering the full spectrum of evidence-based methods, especially long-acting reversible methods. Clinicaltrials.gov NCT01827995.

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

The need to approximate the use-case in clinical machine learning.

PubMed

Saeb, Sohrab; Lonini, Luca; Jayaraman, Arun; Mohr, David C; Kording, Konrad P

2017-05-01

The availability of smartphone and wearable sensor technology is leading to a rapid accumulation of human subject data, and machine learning is emerging as a technique to map those data into clinical predictions. As machine learning algorithms are increasingly used to support clinical decision making, it is vital to reliably quantify their prediction accuracy. Cross-validation (CV) is the standard approach where the accuracy of such algorithms is evaluated on part of the data the algorithm has not seen during training. However, for this procedure to be meaningful, the relationship between the training and the validation set should mimic the relationship between the training set and the dataset expected for the clinical use. Here we compared two popular CV methods: record-wise and subject-wise. While the subject-wise method mirrors the clinically relevant use-case scenario of diagnosis in newly recruited subjects, the record-wise strategy has no such interpretation. Using both a publicly available dataset and a simulation, we found that record-wise CV often massively overestimates the prediction accuracy of the algorithms. We also conducted a systematic review of the relevant literature, and found that this overly optimistic method was used by almost half of the retrieved studies that used accelerometers, wearable sensors, or smartphones to predict clinical outcomes. As we move towards an era of machine learning-based diagnosis and treatment, using proper methods to evaluate their accuracy is crucial, as inaccurate results can mislead both clinicians and data scientists. © The Author 2017. Published by Oxford University Press.

Catatonia in Resource Limited Settings: A Case Series and Treatment Protocol

PubMed Central

Smith, Stephanie L.; Grelotti, David J.; Fils-Aime, Reginald; Uwimana, Eugenie; Ndikubwimana, Jean-Sauveur; Therosme, Tatiana; Severe, Jennifer; Dushimiyimana, Dominique; Uwamariya, Clemence; Bienvenu, Robert; Alcindor, Yoldie; Eustache, Eddy; Raviola, Giuseppe J.; Fricchione, Gregory L.

2014-01-01

Objective The Catatonic Syndrome (“catatonia”) is characterized by motor and motivation dysregulation and is associated with a number of neuropsychiatric and medical disorders. It is recognizable in a variety of clinical settings. We present observations from the treatment of four individuals with catatonia in Haiti and Rwanda, and introduce a treatment protocol for use in resource limited settings Methods Four patients from rural Haiti and Rwanda with clinical signs of catatonia and a positive screen using the Bush-Francis-Catatonia Rating Scale were treated collaboratively by general physicians and mental health clinicians with either lorazepam or diazepam. Success in treatment was clinically assessed by complete remittance of catatonia symptoms. Results The four patients in this report exhibited a range of characteristic and recognizable signs of catatonia, including immobility/stupor, stereotypic movements, echophenomena, posturing, odd mannerisms, mutism, and refusal to eat or drink. All four cases presented initially to rural outpatient general health services in low resource settings. In some cases, diagnostic uncertainty initially led to treatment with typical antipsychotics. In each case, proper identification and treatment of catatonia with benzodiazepines led to significant clinical improvement. Conclusion Catatonia can be effectively and inexpensively treated in resource limited settings. Identification and management of catatonia is critical for the health and safety of patients with this syndrome. Familiarity with the clinical features of catatonia is essential for health professionals working in low resource settings. To facilitate early recognition of this treatable disorder, catatonia should feature more prominently in global mental health discourse. PMID:25467078

[Quality of health care for diabetic and hypertensive patients in primary care settings servicing Mexican Seguro Popular].

PubMed

Ortiz-Domínguez, Maki E; Garrido-Latorre, Francisco; Orozco, Ricardo; Pineda-Pérez, Dayana; Rodríguez-Salgado, Marlenne

2011-01-01

To assess health care quality provided to type-2 diabetic and hypertensive patients in primary care settings from the Mexican Ministry of Health and to evaluate whether accredited clinics providing services to the Mexican Seguro Popular performed better in terms of metabolic control of those patients compared to the non-accredited. Cross-sectional study performed on 2008. Previous year clinical measures were obtained from 5 444 diabetic and 5 827 hypertensive patient's clinical records. Adequate metabolic control (glucose <110 mg/dl for diabetes and blood pressure <140/90 mmHg for hypertension) associated factors were assessed by multiple-multilevel logistic regression methods. Patients attending accredited clinics were more likely to be controlled, however, metabolic control was not constant over time of accreditation. Additional efforts are required to monitor accredited clinics' performance in order to maintain both metabolic control and clinical assessment of patients.

Targeted Therapy Database (TTD): A Model to Match Patient's Molecular Profile with Current Knowledge on Cancer Biology

PubMed Central

Mocellin, Simone; Shrager, Jeff; Scolyer, Richard; Pasquali, Sandro; Verdi, Daunia; Marincola, Francesco M.; Briarava, Marta; Gobbel, Randy; Rossi, Carlo; Nitti, Donato

2010-01-01

Background The efficacy of current anticancer treatments is far from satisfactory and many patients still die of their disease. A general agreement exists on the urgency of developing molecularly targeted therapies, although their implementation in the clinical setting is in its infancy. In fact, despite the wealth of preclinical studies addressing these issues, the difficulty of testing each targeted therapy hypothesis in the clinical arena represents an intrinsic obstacle. As a consequence, we are witnessing a paradoxical situation where most hypotheses about the molecular and cellular biology of cancer remain clinically untested and therefore do not translate into a therapeutic benefit for patients. Objective To present a computational method aimed to comprehensively exploit the scientific knowledge in order to foster the development of personalized cancer treatment by matching the patient's molecular profile with the available evidence on targeted therapy. Methods To this aim we focused on melanoma, an increasingly diagnosed malignancy for which the need for novel therapeutic approaches is paradigmatic since no effective treatment is available in the advanced setting. Relevant data were manually extracted from peer-reviewed full-text original articles describing any type of anti-melanoma targeted therapy tested in any type of experimental or clinical model. To this purpose, Medline, Embase, Cancerlit and the Cochrane databases were searched. Results and Conclusions We created a manually annotated database (Targeted Therapy Database, TTD) where the relevant data are gathered in a formal representation that can be computationally analyzed. Dedicated algorithms were set up for the identification of the prevalent therapeutic hypotheses based on the available evidence and for ranking treatments based on the molecular profile of individual patients. In this essay we describe the principles and computational algorithms of an original method developed to fully exploit the available knowledge on cancer biology with the ultimate goal of fruitfully driving both preclinical and clinical research on anticancer targeted therapy. In the light of its theoretical nature, the prediction performance of this model must be validated before it can be implemented in the clinical setting. PMID:20706624

Complementary nonparametric analysis of covariance for logistic regression in a randomized clinical trial setting.

PubMed

Tangen, C M; Koch, G G

1999-03-01

In the randomized clinical trial setting, controlling for covariates is expected to produce variance reduction for the treatment parameter estimate and to adjust for random imbalances of covariates between the treatment groups. However, for the logistic regression model, variance reduction is not obviously obtained. This can lead to concerns about the assumptions of the logistic model. We introduce a complementary nonparametric method for covariate adjustment. It provides results that are usually compatible with expectations for analysis of covariance. The only assumptions required are based on randomization and sampling arguments. The resulting treatment parameter is a (unconditional) population average log-odds ratio that has been adjusted for random imbalance of covariates. Data from a randomized clinical trial are used to compare results from the traditional maximum likelihood logistic method with those from the nonparametric logistic method. We examine treatment parameter estimates, corresponding standard errors, and significance levels in models with and without covariate adjustment. In addition, we discuss differences between unconditional population average treatment parameters and conditional subpopulation average treatment parameters. Additional features of the nonparametric method, including stratified (multicenter) and multivariate (multivisit) analyses, are illustrated. Extensions of this methodology to the proportional odds model are also made.

Quantitative Imaging Biomarkers: A Review of Statistical Methods for Technical Performance Assessment

PubMed Central

2017-01-01

Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers (QIBs) to measure changes in these features. Critical to the performance of a QIB in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method and metrics used to assess a QIB for clinical use. It is therefore, difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America (RSNA) and the Quantitative Imaging Biomarker Alliance (QIBA) with technical, radiological and statistical experts developed a set of technical performance analysis methods, metrics and study designs that provide terminology, metrics and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of QIB performance studies so that results from multiple studies can be compared, contrasted or combined. PMID:24919831

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.

Assessing Hospital Performance After Percutaneous Coronary Intervention Using Big Data.

PubMed

Spertus, Jacob V; T Normand, Sharon-Lise; Wolf, Robert; Cioffi, Matt; Lovett, Ann; Rose, Sherri

2016-11-01

Although risk adjustment remains a cornerstone for comparing outcomes across hospitals, optimal strategies continue to evolve in the presence of many confounders. We compared conventional regression-based model to approaches particularly suited to leveraging big data. We assessed hospital all-cause 30-day excess mortality risk among 8952 adults undergoing percutaneous coronary intervention between October 1, 2011, and September 30, 2012, in 24 Massachusetts hospitals using clinical registry data linked with billing data. We compared conventional logistic regression models with augmented inverse probability weighted estimators and targeted maximum likelihood estimators to generate more efficient and unbiased estimates of hospital effects. We also compared a clinically informed and a machine-learning approach to confounder selection, using elastic net penalized regression in the latter case. Hospital excess risk estimates range from -1.4% to 2.0% across methods and confounder sets. Some hospitals were consistently classified as low or as high excess mortality outliers; others changed classification depending on the method and confounder set used. Switching from the clinically selected list of 11 confounders to a full set of 225 confounders increased the estimation uncertainty by an average of 62% across methods as measured by confidence interval length. Agreement among methods ranged from fair, with a κ statistic of 0.39 (SE: 0.16), to perfect, with a κ of 1 (SE: 0.0). Modern causal inference techniques should be more frequently adopted to leverage big data while minimizing bias in hospital performance assessments. © 2016 American Heart Association, Inc.

A Mixed Methods Approach to Evaluate Partnerships and Implementation of the Massachusetts Prevention and Wellness Trust Fund.

PubMed

Lee, Rebekka M; Ramanadhan, Shoba; Kruse, Gina R; Deutsch, Charles

2018-01-01

Background: Strong partnerships are critical to integrate evidence-based prevention interventions within clinical and community-based settings, offering multilevel and sustainable solutions to complex health issues. As part of Massachusetts' 2012 health reform, The Prevention and Wellness Trust Fund (PWTF) funded nine local partnerships throughout the state to address hypertension, pediatric asthma, falls among older adults, and tobacco use. The initiative was designed to improve health outcomes through prevention and disease management strategies and reduce healthcare costs. Purpose: Describe the mixed-methods study design for investigating PWTF implementation. Methods: The Consolidated Framework for Implementation Research guided the development of this evaluation. First, the study team conducted semi-structured qualitative interviews with leaders from each of nine partnerships to document partnership development and function, intervention adaptation and delivery, and the influence of contextual factors on implementation. The interview findings were used to develop a quantitative survey to assess the implementation experiences of 172 staff from clinical and community-based settings and a social network analysis to assess changes in the relationships among 72 PWTF partner organizations. The quantitative survey data on ratings of perceived implementation success were used to purposively select 24 staff for interviews to explore the most successful experiences of implementing evidence-based interventions for each of the four conditions. Conclusions: This mixed-methods approach for evaluation of implementation of evidence-based prevention interventions by PWTF partnerships can help decision-makers set future priorities for implementing and assessing clinical-community partnerships focused on prevention.

Toward the International Classification of Functioning, Disability and Health (ICF) Rehabilitation Set: A Minimal Generic Set of Domains for Rehabilitation as a Health Strategy.

PubMed

Prodinger, Birgit; Cieza, Alarcos; Oberhauser, Cornelia; Bickenbach, Jerome; Üstün, Tevfik Bedirhan; Chatterji, Somnath; Stucki, Gerold

2016-06-01

To develop a comprehensive set of the International Classification of Functioning, Disability and Health (ICF) categories as a minimal standard for reporting and assessing functioning and disability in clinical populations along the continuum of care. The specific aims were to specify the domains of functioning recommended for an ICF Rehabilitation Set and to identify a minimal set of environmental factors (EFs) to be used alongside the ICF Rehabilitation Set when describing disability across individuals and populations with various health conditions. Secondary analysis of existing data sets using regression methods (Random Forests and Group Lasso regression) and expert consultations. Along the continuum of care, including acute, early postacute, and long-term and community rehabilitation settings. Persons (N=9863) with various health conditions participated in primary studies. The number of respondents for whom the dependent variable data were available and used in this analysis was 9264. Not applicable. For regression analyses, self-reported general health was used as a dependent variable. The ICF categories from the functioning component and the EF component were used as independent variables for the development of the ICF Rehabilitation Set and the minimal set of EFs, respectively. Thirty ICF categories to be complemented with 12 EFs were identified as relevant to the identified ICF sets. The ICF Rehabilitation Set constitutes of 9 ICF categories from the component body functions and 21 from the component activities and participation. The minimal set of EFs contains 12 categories spanning all chapters of the EF component of the ICF. The identified sets proposed serve as minimal generic sets of aspects of functioning in clinical populations for reporting data within and across heath conditions, time, clinical settings including rehabilitation, and countries. These sets present a reference framework for harmonizing existing information on disability across general and clinical populations. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Study design and data analysis considerations for the discovery of prognostic molecular biomarkers: a case study of progression free survival in advanced serous ovarian cancer.

PubMed

Qin, Li-Xuan; Levine, Douglas A

2016-06-10

Accurate discovery of molecular biomarkers that are prognostic of a clinical outcome is an important yet challenging task, partly due to the combination of the typically weak genomic signal for a clinical outcome and the frequently strong noise due to microarray handling effects. Effective strategies to resolve this challenge are in dire need. We set out to assess the use of careful study design and data normalization for the discovery of prognostic molecular biomarkers. Taking progression free survival in advanced serous ovarian cancer as an example, we conducted empirical analysis on two sets of microRNA arrays for the same set of tumor samples: arrays in one set were collected using careful study design (that is, uniform handling and randomized array-to-sample assignment) and arrays in the other set were not. We found that (1) handling effects can confound the clinical outcome under study as a result of chance even with randomization, (2) the level of confounding handling effects can be reduced by data normalization, and (3) good study design cannot be replaced by post-hoc normalization. In addition, we provided a practical approach to define positive and negative control markers for detecting handling effects and assessing the performance of a normalization method. Our work showcased the difficulty of finding prognostic biomarkers for a clinical outcome of weak genomic signals, illustrated the benefits of careful study design and data normalization, and provided a practical approach to identify handling effects and select a beneficial normalization method. Our work calls for careful study design and data analysis for the discovery of robust and translatable molecular biomarkers.

Evaluation of a Serum Lung Cancer Biomarker Panel.

PubMed

Mazzone, Peter J; Wang, Xiao-Feng; Han, Xiaozhen; Choi, Humberto; Seeley, Meredith; Scherer, Richard; Doseeva, Victoria

2018-01-01

A panel of 3 serum proteins and 1 autoantibody has been developed to assist with the detection of lung cancer. We aimed to validate the accuracy of the biomarker panel in an independent test set and explore the impact of adding a fourth serum protein to the panel, as well as the impact of combining molecular and clinical variables. The training set of serum samples was purchased from commercially available biorepositories. The testing set was from a biorepository at the Cleveland Clinic. All lung cancer and control subjects were >50 years old and had smoked a minimum of 20 pack-years. A panel of biomarkers including CEA (carcinoembryonic antigen), CYFRA21-1 (cytokeratin-19 fragment 21-1), CA125 (carbohydrate antigen 125), HGF (hepatocyte growth factor), and NY-ESO-1 (New York esophageal cancer-1 antibody) was measured using immunoassay techniques. The multiple of the median method, multivariate logistic regression, and random forest modeling was used to analyze the results. The training set consisted of 604 patient samples (268 with lung cancer and 336 controls) and the testing set of 400 patient samples (155 with lung cancer and 245 controls). With a threshold established from the training set, the sensitivity and specificity of both the 4- and 5-biomarker panels on the testing set was 49% and 96%, respectively. Models built on the testing set using only clinical variables had an area under the receiver operating characteristic curve of 0.68, using the biomarker panel 0.81 and by combining clinical and biomarker variables 0.86. This study validates the accuracy of a panel of proteins and an autoantibody in a population relevant to lung cancer detection and suggests a benefit to combining clinical features with the biomarker results.

Provider, Patient, and Family Perspectives of Adolescent Alcohol Use and Treatment in Rural Settings

ERIC Educational Resources Information Center

Gordon, Adam J.; Ettaro, Lorraine; Rodriguez, Keri L.; Mocik, John; Clark, Duncan B.

2011-01-01

Purpose: We examined rural primary care providers' (PCPs) self-reported practices of screening, brief interventions, and referral to treatment (SBIRT) on adolescent alcohol use and examined PCPs', adolescents', and parents' attitudes regarding SBIRT on adolescent alcohol use in rural clinic settings. Methods: In 2007, we mailed surveys that…

Container-Based Clinical Solutions for Portable and Reproducible Image Analysis.

PubMed

Matelsky, Jordan; Kiar, Gregory; Johnson, Erik; Rivera, Corban; Toma, Michael; Gray-Roncal, William

2018-05-08

Medical imaging analysis depends on the reproducibility of complex computation. Linux containers enable the abstraction, installation, and configuration of environments so that software can be both distributed in self-contained images and used repeatably by tool consumers. While several initiatives in neuroimaging have adopted approaches for creating and sharing more reliable scientific methods and findings, Linux containers are not yet mainstream in clinical settings. We explore related technologies and their efficacy in this setting, highlight important shortcomings, demonstrate a simple use-case, and endorse the use of Linux containers for medical image analysis.

Utility of qualitative methods in a clinical setting: perinatal care in the Western Province.

PubMed

Jayasuriya, V

2012-03-01

A peculiar paradox that has been observed in previous studies of antenatal care is where patients are satisfied with the services despite obvious lack of basic facilities. Qualitative methods were used to describe the experience of perinatal care in the Western province with the objective of demonstrating application of this method in a clinical setting. This paper used a 'naturalistic' approach of qualitative methods. In-depth interviews conducted with 20 postnatal mothers delivering in tertiary care institutions in the Western province was tape recorded, transcribed and content analysed. To ensure objectivity and validity of results, the principle investigator received only the anonymised data to prevent any prejudices or pre-conceptions affecting the results. The main themes emerging from the text demonstrated 'naïve trust' in the carer and a state of 'hero worship' where patients were distanced and therefore unable and unwilling to query the decisions made by the carers. This is similar to a state of patient-carer relationship described in a published model known as guarded alliance, where the relationship develops though four phases based on the level of trust and confidence in the relationship. This state explains not only why patients fail to recognise and report any deficiencies in the services but also the need for them to justify the behaviour of caregivers even when it amounts to incompetence and negligence. Qualitative methods allow the researcher to capture experiences in its 'natural' form rather than based on pre-determined protocols or plans, which may be limited to our own understanding and expectations and therefore unable to explain many idiosyncrasies of the programmes. This paper argues favourably for the use of qualitative methods in other clinical settings.

A geometrically based method for automated radiosurgery planning.

PubMed

Wagner, T H; Yi, T; Meeks, S L; Bova, F J; Brechner, B L; Chen, Y; Buatti, J M; Friedman, W A; Foote, K D; Bouchet, L G

2000-12-01

A geometrically based method of multiple isocenter linear accelerator radiosurgery treatment planning optimization was developed, based on a target's solid shape. Our method uses an edge detection process to determine the optimal sphere packing arrangement with which to cover the planning target. The sphere packing arrangement is converted into a radiosurgery treatment plan by substituting the isocenter locations and collimator sizes for the spheres. This method is demonstrated on a set of 5 irregularly shaped phantom targets, as well as a set of 10 clinical example cases ranging from simple to very complex in planning difficulty. Using a prototype implementation of the method and standard dosimetric radiosurgery treatment planning tools, feasible treatment plans were developed for each target. The treatment plans generated for the phantom targets showed excellent dose conformity and acceptable dose homogeneity within the target volume. The algorithm was able to generate a radiosurgery plan conforming to the Radiation Therapy Oncology Group (RTOG) guidelines on radiosurgery for every clinical and phantom target examined. This automated planning method can serve as a valuable tool to assist treatment planners in rapidly and consistently designing conformal multiple isocenter radiosurgery treatment plans.

A surrogate-based metaheuristic global search method for beam angle selection in radiation treatment planning.

PubMed

Zhang, H H; Gao, S; Chen, W; Shi, L; D'Souza, W D; Meyer, R R

2013-03-21

An important element of radiation treatment planning for cancer therapy is the selection of beam angles (out of all possible coplanar and non-coplanar angles in relation to the patient) in order to maximize the delivery of radiation to the tumor site and minimize radiation damage to nearby organs-at-risk. This category of combinatorial optimization problem is particularly difficult because direct evaluation of the quality of treatment corresponding to any proposed selection of beams requires the solution of a large-scale dose optimization problem involving many thousands of variables that represent doses delivered to volume elements (voxels) in the patient. However, if the quality of angle sets can be accurately estimated without expensive computation, a large number of angle sets can be considered, increasing the likelihood of identifying a very high quality set. Using a computationally efficient surrogate beam set evaluation procedure based on single-beam data extracted from plans employing equallyspaced beams (eplans), we have developed a global search metaheuristic process based on the nested partitions framework for this combinatorial optimization problem. The surrogate scoring mechanism allows us to assess thousands of beam set samples within a clinically acceptable time frame. Tests on difficult clinical cases demonstrate that the beam sets obtained via our method are of superior quality.

A surrogate-based metaheuristic global search method for beam angle selection in radiation treatment planning

PubMed Central

Zhang, H H; Gao, S; Chen, W; Shi, L; D’Souza, W D; Meyer, R R

2013-01-01

An important element of radiation treatment planning for cancer therapy is the selection of beam angles (out of all possible coplanar and non-coplanar angles in relation to the patient) in order to maximize the delivery of radiation to the tumor site and minimize radiation damage to nearby organs-at-risk. This category of combinatorial optimization problem is particularly difficult because direct evaluation of the quality of treatment corresponding to any proposed selection of beams requires the solution of a large-scale dose optimization problem involving many thousands of variables that represent doses delivered to volume elements (voxels) in the patient. However, if the quality of angle sets can be accurately estimated without expensive computation, a large number of angle sets can be considered, increasing the likelihood of identifying a very high quality set. Using a computationally efficient surrogate beam set evaluation procedure based on single-beam data extracted from plans employing equally-spaced beams (eplans), we have developed a global search metaheuristic process based on the Nested Partitions framework for this combinatorial optimization problem. The surrogate scoring mechanism allows us to assess thousands of beam set samples within a clinically acceptable time frame. Tests on difficult clinical cases demonstrate that the beam sets obtained via our method are superior quality. PMID:23459411

Core outcome sets for research and clinical practice.

PubMed

Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Evaluation of RSA set-up from a clinical biplane fluoroscopy system for 3D joint kinematic analysis.

PubMed

Bonanzinga, Tommaso; Signorelli, Cecilia; Bontempi, Marco; Russo, Alessandro; Zaffagnini, Stefano; Marcacci, Maurilio; Bragonzoni, Laura

2016-01-01

dinamic roentgen stereophotogrammetric analysis (RSA), a technique currently based only on customized radiographic equipment, has been shown to be a very accurate method for detecting three-dimensional (3D) joint motion. The aim of the present work was to evaluate the applicability of an innovative RSA set-up for in vivo knee kinematic analysis, using a biplane fluoroscopic image system. To this end, the Authors describe the set-up as well as a possible protocol for clinical knee joint evaluation. The accuracy of the kinematic measurements is assessed. the Authors evaluated the accuracy of 3D kinematic analysis of the knee in a new RSA set-up, based on a commercial biplane fluoroscopy system integrated into the clinical environment. The study was organized in three main phases: an in vitro test under static conditions, an in vitro test under dynamic conditions reproducing a flexion-extension range of motion (ROM), and an in vivo analysis of the flexion-extension ROM. For each test, the following were calculated, as an indication of the tracking accuracy: mean, minimum, maximum values and standard deviation of the error of rigid body fitting. in terms of rigid body fitting, in vivo test errors were found to be 0.10±0.05 mm. Phantom tests in static and kinematic conditions showed precision levels, for translations and rotations, of below 0.1 mm/0.2° and below 0.5 mm/0.3° respectively for all directions. the results of this study suggest that kinematic RSA can be successfully performed using a standard clinical biplane fluoroscopy system for the acquisition of slow movements of the lower limb. a kinematic RSA set-up using a clinical biplane fluoroscopy system is potentially applicable and provides a useful method for obtaining better characterization of joint biomechanics.

An application of actuarial methods in psychiatric diagnosis.

PubMed

Overall, J E; Higgins, C W

1977-10-01

An actuarial program for psychiatric diagnosis is evaluated for agreement with final clinical diagnosis in a series of 288 patients. The acturial program provides a probability differential diagnosis based on an analysis of history and background data, symptom rating profiles, and MMPI clinical scale profiles. The observed agreement with final clinical diagnosis is approximately 50% higher than previously reported for psychological testing in this same setting. The results emphasize the importance for psychologists of clinical interview and observation skills.

Initial experience with non-invasive prenatal testing of cell-free DNA for major chromosomal anomalies in a clinical setting.

PubMed

Comas, Carmina; Echevarria, Mónica; Rodríguez, M Angeles; Prats, Pilar; Rodríguez, Ignacio; Serra, Bernat

2015-07-01

To evaluate non-invasive prenatal testing (NIPT) of cell-free DNA (cfDNA) as a screening method for major chromosomal anomalies (CA) in a clinical setting. From January to December 2013, Panorama™ test or Harmony™ prenatal test were offered as advanced NIPT, in addition to first-trimester combined screening in singleton pregnancies. The cohort included 333 pregnant women with a mean maternal age (MA) of 37 years who underwent testing at a mean gestational age of 14.6 weeks. Eighty-four percent were low-risk pregnancies. Results were provided in 97.3% of patients at a mean reporting time of 12.9 calendar days. Repeat sampling was performed in six cases and results were obtained in five of them. No results were provided in four cases. Four cases of Down syndrome were detected and there was one discordant result of Turner syndrome. We found no statistical differences between commercial tests except in reporting time, fetal fraction and MA. The cfDNA fraction was statistically associated with test type, maternal weight, BMI and log βhCG levels. NIPT has the potential to be a highly effective screening method for major CA in a clinical setting.

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.

A Doubly Stochastic Change Point Detection Algorithm for Noisy Biological Signals.

PubMed

Gold, Nathan; Frasch, Martin G; Herry, Christophe L; Richardson, Bryan S; Wang, Xiaogang

2017-01-01

Experimentally and clinically collected time series data are often contaminated with significant confounding noise, creating short, noisy time series. This noise, due to natural variability and measurement error, poses a challenge to conventional change point detection methods. We propose a novel and robust statistical method for change point detection for noisy biological time sequences. Our method is a significant improvement over traditional change point detection methods, which only examine a potential anomaly at a single time point. In contrast, our method considers all suspected anomaly points and considers the joint probability distribution of the number of change points and the elapsed time between two consecutive anomalies. We validate our method with three simulated time series, a widely accepted benchmark data set, two geological time series, a data set of ECG recordings, and a physiological data set of heart rate variability measurements of fetal sheep model of human labor, comparing it to three existing methods. Our method demonstrates significantly improved performance over the existing point-wise detection methods.

A Systematic Evaluation of Field-Based Screening Methods for the Assessment of Anterior Cruciate Ligament (ACL) Injury Risk.

PubMed

Fox, Aaron S; Bonacci, Jason; McLean, Scott G; Spittle, Michael; Saunders, Natalie

2016-05-01

Laboratory-based measures provide an accurate method to identify risk factors for anterior cruciate ligament (ACL) injury; however, these methods are generally prohibitive to the wider community. Screening methods that can be completed in a field or clinical setting may be more applicable for wider community use. Examination of field-based screening methods for ACL injury risk can aid in identifying the most applicable method(s) for use in these settings. The objective of this systematic review was to evaluate and compare field-based screening methods for ACL injury risk to determine their efficacy of use in wider community settings. An electronic database search was conducted on the SPORTDiscus™, MEDLINE, AMED and CINAHL databases (January 1990-July 2015) using a combination of relevant keywords. A secondary search of the same databases, using relevant keywords from identified screening methods, was also undertaken. Studies identified as potentially relevant were independently examined by two reviewers for inclusion. Where consensus could not be reached, a third reviewer was consulted. Original research articles that examined screening methods for ACL injury risk that could be undertaken outside of a laboratory setting were included for review. Two reviewers independently assessed the quality of included studies. Included studies were categorized according to the screening method they examined. A description of each screening method, and data pertaining to the ability to prospectively identify ACL injuries, validity and reliability, recommendations for identifying 'at-risk' athletes, equipment and training required to complete screening, time taken to screen athletes, and applicability of the screening method across sports and athletes were extracted from relevant studies. Of 1077 citations from the initial search, a total of 25 articles were identified as potentially relevant, with 12 meeting all inclusion/exclusion criteria. From the secondary search, eight further studies met all criteria, resulting in 20 studies being included for review. Five ACL-screening methods-the Landing Error Scoring System (LESS), Clinic-Based Algorithm, Observational Screening of Dynamic Knee Valgus (OSDKV), 2D-Cam Method, and Tuck Jump Assessment-were identified. There was limited evidence supporting the use of field-based screening methods in predicting ACL injuries across a range of populations. Differences relating to the equipment and time required to complete screening methods were identified. Only screening methods for ACL injury risk were included for review. Field-based screening methods developed for lower-limb injury risk in general may also incorporate, and be useful in, screening for ACL injury risk. Limited studies were available relating to the OSDKV and 2D-Cam Method. The LESS showed predictive validity in identifying ACL injuries, however only in a youth athlete population. The LESS also appears practical for community-wide use due to the minimal equipment and set-up/analysis time required. The Clinic-Based Algorithm may have predictive value for ACL injury risk as it identifies athletes who exhibit high frontal plane knee loads during a landing task, but requires extensive additional equipment and time, which may limit its application to wider community settings.

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

Introducing First-Year Medical Students to Early Diagnostic Hypotheses

ERIC Educational Resources Information Center

Taylor, P. J.; And Others

1978-01-01

A method of instruction in gynecology is described that encouraged the formulation of early diagnostic hypotheses, an important part of clinical problem-solving. Students were given a set of clinical clues to help them make broad diagnostic hypotheses. Student ability, results, and student perceptions of the course are provided. (Author/LBH)

The Preceptorship Experience of Associate Degree Nursing Students

ERIC Educational Resources Information Center

Chapman, Pamela J.

2017-01-01

Preceptorship in nursing education, pairing a student with an experienced nurse in a clinical setting, is a popular method of clinical instruction that may be used throughout the nursing curriculum or as a culminating experience in the last semester of the nursing program. Although many studies have been conducted regarding the preceptor,…

Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

ERIC Educational Resources Information Center

Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

2012-01-01

Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

The 1999 ICSI/IHI colloquium on clinical quality improvement--"quality: settling the frontier".

PubMed

Palmersheim, T M

1999-12-01

A Colloquium on Clinical Quality Improvement, "Quality: Setting the Frontier," held in May 1999, covered methods and programs in clinical quality improvement. Leadership and organizational behavior were the main themes of the breakout sessions; specific topics included implementing guidelines, applying continuous quality improvement (CQI) methods in preventive services and primary care, and using systems thinking to improve clinical outcomes. Three keynote addresses were presented. James L. Reinertsen, MD (CareGroup, Boston), characterized the financial challenges faced by many health care organizations as a "clarion call" for leadership on quality. "The leadership imperative is to establish an environment in which quality can thrive, despite unprecedented, severe economic pressures on our health systems." How do we make improvement more effective? G. Ross Baker, PhD (University of Toronto), reviewed what organizational literature says about making teams more effective, understanding the organizational context to enable improvement work, and augmenting existing methods for creating sustainable improvement. For example, he noted the increasing interest among may organizations in rapid-cycle improvement but cautioned that such efforts may work best where problems can be addressed by existing clinical teams (not cross-functional work groups) and where there are available solutions that have worked in other settings. Mark Chassin, MD (Mount Sinai School of Medicine, New York), stated that critical tasks for improving quality include increasing public awareness, engaging clinicians in improvement, increasing the investment in producing measures and improvement tools, and reinventing health care delivery, clinical education and training, and QI.

Prediction of arterial oxygen partial pressure after changes in FIO₂: validation and clinical application of a novel formula.

PubMed

Al-Otaibi, H M; Hardman, J G

2011-11-01

Existing methods allow prediction of Pa(O₂) during adjustment of Fi(O₂). However, these are cumbersome and lack sufficient accuracy for use in the clinical setting. The present studies aim to extend the validity of a novel formula designed to predict Pa(O₂) during adjustment of Fi(O₂) and to compare it with the current methods. Sixty-seven new data sets were collected from 46 randomly selected, mechanically ventilated patients. Each data set consisted of two subsets (before and 20 min after Fi(O₂) adjustment) and contained ventilator settings, pH, and arterial blood gas values. We compared the accuracy of Pa(O₂) prediction using a new formula (which utilizes only the pre-adjustment Pa(O₂) and pre- and post-adjustment Fi(O₂) with prediction using assumptions of constant Pa(O₂)/Fi(O₂) or constant Pa(O₂)/Pa(O₂). Subsequently, 20 clinicians predicted Pa(O₂) using the new formula and using Nunn's isoshunt diagram. The accuracy of the clinician's predictions was examined. The 95% limits of agreement (LA(95%)) between predicted and measured Pa(O₂) in the patient group were: new formula 0.11 (2.0) kPa, Pa(O₂)/Fi(O₂) -1.9 (4.4) kPa, and Pa(O₂)/Pa(O₂) -1.0 (3.6) kPa. The LA(95%) of clinicians' predictions of Pa(O₂) were 0.56 (3.6) kPa (new formula) and -2.7 (6.4) kPa (isoshunt diagram). The new formula's prediction of changes in Pa(O₂) is acceptably accurate and reliable and better than any other existing method. Its use by clinicians appears to improve accuracy over the most popular existing method. The simplicity of the new method may allow its regular use in the critical care setting.

A unified procedure for meta-analytic evaluation of surrogate end points in randomized clinical trials

PubMed Central

Dai, James Y.; Hughes, James P.

2012-01-01

The meta-analytic approach to evaluating surrogate end points assesses the predictiveness of treatment effect on the surrogate toward treatment effect on the clinical end point based on multiple clinical trials. Definition and estimation of the correlation of treatment effects were developed in linear mixed models and later extended to binary or failure time outcomes on a case-by-case basis. In a general regression setting that covers nonnormal outcomes, we discuss in this paper several metrics that are useful in the meta-analytic evaluation of surrogacy. We propose a unified 3-step procedure to assess these metrics in settings with binary end points, time-to-event outcomes, or repeated measures. First, the joint distribution of estimated treatment effects is ascertained by an estimating equation approach; second, the restricted maximum likelihood method is used to estimate the means and the variance components of the random treatment effects; finally, confidence intervals are constructed by a parametric bootstrap procedure. The proposed method is evaluated by simulations and applications to 2 clinical trials. PMID:22394448

Interprofessional education in the clinical setting: A qualitative look at the preceptor's perspective in training advanced practice nursing students.

PubMed

Chen, Angel K; Rivera, Josette; Rotter, Nicole; Green, Emily; Kools, Susan

2016-11-01

With the shift towards interprofessional education to promote collaborative practice, clinical preceptors are increasingly working with trainees from various professions to provide patient care. It is unclear whether and how preceptors modify their existing precepting approach when working with trainees from other professions. There is little information on strategies for this type of precepting, and how preceptors may foster or impede interprofessional collaboration. The purpose of this qualitative description pilot study was to identify current methods preceptors use to teach trainees from other professions in the clinical setting, particularly advanced practice nursing and medical trainees, and to identify factors that support or impede this type of precepting. Data collected through observations and interviews were analyzed by the research team using thematic analysis procedures. Three major themes were identified: 1) a variety of teaching approaches and levels of engagement with trainees of different professions, 2) preceptor knowledge gaps related to curricula, goals, and scope of practice of trainees from other professions, and 3) administrative, structural and logistical elements that impact the success of precepting trainees from different professions in the clinical setting. This study has implications for faculty development and evaluation of current precepting practices in clinical settings. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Fostering interprofessional learning in a rehabilitation setting: development of an interprofessional clinical learning unit.

PubMed

Vanderzalm, Jeanne; Hall, Mark D; McFarlane, Lu-Anne; Rutherford, Laurie; Patterson, Steven K

2013-01-01

The development and implementation of interprofessional (IP) clinical learning units as a method to enhance IP clinical education and improve patient care in a rehabilitation setting are described. Using a community-based participatory research approach, academia and healthcare delivery agencies formed a partnership to create an IP clinical learning unit in a rehabilitation setting. Preimplementation data from surveys and focus group data identified areas for improvement to enhance IP understanding and collaboration. A working group developed and implemented initiatives to enhance IP practice. Preimplementation, eight themes emerged from which the working group identified goals and implemented strategies to strengthen IP learning. Goals included Creation of an IP Learning Environment, Increased Awareness of IP Practice, Role Clarification, Enhanced IP Communication, and Reflection and Evaluation. Postimplementation data revealed six themes: Communication, Informal IP Learning, Role Awareness, Positive Learning Environment, Logistics, and Challenges. The development of the IP clinical learning unit was successful and rewarding, but not without its challenges. Formal IP education was necessary to enhance collaborative practice, even in a multidisciplinary environment. Commitment and support from all participants, particularly managers and administrators from the healthcare agency, were critical to success. The focus of this unit was on a stroke rehabilitation unit; however, the development and implementation principles identified may be applicable to any team-based clinical setting. © 2013 Association of Rehabilitation Nurses.

Role of Ambulatory and Home Blood Pressure Monitoring in Clinical Practice: A Narrative Review

PubMed Central

Shimbo, Daichi; Abdalla, Marwah; Falzon, Louise; Townsend, Raymond R.; Muntner, Paul

2015-01-01

Hypertension, a common cardiovascular disease (CVD) risk factor, is usually diagnosed and treated based on blood pressure readings obtained in the clinic setting. Blood pressure may differ considerably when measured in the clinic versus outside of the clinic setting. Over the past several decades, evidence has accumulated on two approaches for measuring out-of-clinic blood pressure: ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). Blood pressure measures on ABPM and HBPM each have a stronger association with CVD outcomes than clinic blood pressure. Controversy exists whether ABPM or HBPM is superior for estimating CVD risk, and under what circumstances these methods should be used in clinical practice for assessing out-of-clinic blood pressure. This review describes ABPM and HBPM procedures, the blood pressure phenotypic measures that can be ascertained, and the evidence that supports the use of each approach to measure out-of-clinic blood pressure. This review also describes barriers to the successful implementation of ABPM and HBPM in clinical practice, proposes core competencies for the conduct of these procedures, and highlights important areas for future research. PMID:26457954

Research methods to change clinical practice for patients with rare cancers.

PubMed

Billingham, Lucinda; Malottki, Kinga; Steven, Neil

2016-02-01

Rare cancers are a growing group as a result of reclassification of common cancers by molecular markers. There is therefore an increasing need to identify methods to assess interventions that are sufficiently robust to potentially affect clinical practice in this setting. Methods advocated for clinical trials in rare diseases are not necessarily applicable in rare cancers. This Series paper describes research methods that are relevant for rare cancers in relation to the range of incidence levels. Strategies that maximise recruitment, minimise sample size, or maximise the usefulness of the evidence could enable the application of conventional clinical trial design to rare cancer populations. Alternative designs that address specific challenges for rare cancers with the aim of potentially changing clinical practice include Bayesian designs, uncontrolled n-of-1 trials, and umbrella and basket trials. Pragmatic solutions must be sought to enable some level of evidence-based health care for patients with rare cancers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Chiren, Sarah G; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Cartee, Todd V; Maher, Ian A; Alam, Murad; Sobanko, Joseph F

2017-07-12

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

A Microsoft Kinect-Based Point-of-Care Gait Assessment Framework for Multiple Sclerosis Patients.

PubMed

Gholami, Farnood; Trojan, Daria A; Kovecses, Jozsef; Haddad, Wassim M; Gholami, Behnood

2017-09-01

Gait impairment is a prevalent and important difficulty for patients with multiple sclerosis (MS), a common neurological disorder. An easy to use tool to objectively evaluate gait in MS patients in a clinical setting can assist clinicians to perform an objective assessment. The overall objective of this study is to develop a framework to quantify gait abnormalities in MS patients using the Microsoft Kinect for the Windows sensor; an inexpensive, easy to use, portable camera. Specifically, we aim to evaluate its feasibility for utilization in a clinical setting, assess its reliability, evaluate the validity of gait indices obtained, and evaluate a novel set of gait indices based on the concept of dynamic time warping. In this study, ten ambulatory MS patients, and ten age and sex-matched normal controls were studied at one session in a clinical setting with gait assessment using a Kinect camera. The expanded disability status scale (EDSS) clinical ambulation score was calculated for the MS subjects, and patients completed the Multiple Sclerosis walking scale (MSWS). Based on this study, we established the potential feasibility of using a Microsoft Kinect camera in a clinical setting. Seven out of the eight gait indices obtained using the proposed method were reliable with intraclass correlation coefficients ranging from 0.61 to 0.99. All eight MS gait indices were significantly different from those of the controls (p-values less than 0.05). Finally, seven out of the eight MS gait indices were correlated with the objective and subjective gait measures (Pearson's correlation coefficients greater than 0.40). This study shows that the Kinect camera is an easy to use tool to assess gait in MS patients in a clinical setting.

"A golden opportunity": Exploring interprofessional learning and practice in rural clinical settings.

PubMed

Spencer, Judy; Woodroffe, Jessica; Cross, Merylin; Allen, Penny

2015-01-01

Little is known about interprofessional practice (IPP) and interprofessional learning (IPL) in rural health services, despite national funding and continuing emphasis on increasing students' clinical placements in rural areas. This short paper outlines a study in Tasmania, Australia, which investigated how and under what contexts and conditions IPP and IPL occur in rural clinical settings, and the enabling factors and strategies that promote this learning and practice. This study employed a mixed method design comprising focus group discussions and a survey involving health professionals from two rural health services. The findings demonstrate that formal and informal arrangements, the collaborative nature of small, close-knit healthcare teams and patient-centred models of care employed in rural practice settings, provide ideal contexts for IPP and IPL. The study has implications for promoting organisational readiness for IPP and IPL and harnessing the potential of rural services to promote and develop students' interprofessional capability.

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

Applications of mid-infrared spectroscopy in the clinical laboratory setting.

PubMed

De Bruyne, Sander; Speeckaert, Marijn M; Delanghe, Joris R

2018-01-01

Fourier transform mid-infrared (MIR-FTIR) spectroscopy is a nondestructive, label-free, highly sensitive and specific technique that provides complete information on the chemical composition of biological samples. The technique both can offer fundamental structural information and serve as a quantitative analysis tool. Therefore, it has many potential applications in different fields of clinical laboratory science. Although considerable technological progress has been made to promote biomedical applications of this powerful analytical technique, most clinical laboratory analyses are based on spectroscopic measurements in the visible or ultraviolet (UV) spectrum and the potential role of FTIR spectroscopy still remains unexplored. In this review, we present some general principles of FTIR spectroscopy as a useful method to study molecules in specimens by MIR radiation together with a short overview of methods to interpret spectral data. We aim at illustrating the wide range of potential applications of the proposed technique in the clinical laboratory setting with a focus on its advantages and limitations and discussing the future directions. The reviewed applications of MIR spectroscopy include (1) quantification of clinical parameters in body fluids, (2) diagnosis and monitoring of cancer and other diseases by analysis of body fluids, cells, and tissues, (3) classification of clinically relevant microorganisms, and (4) analysis of kidney stones, nails, and faecal fat.

A method and knowledge base for automated inference of patient problems from structured data in an electronic medical record.

PubMed

Wright, Adam; Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; Ramelson, Harley Z; Schneider, Louise I; Bates, David W

2011-01-01

Accurate knowledge of a patient's medical problems is critical for clinical decision making, quality measurement, research, billing and clinical decision support. Common structured sources of problem information include the patient problem list and billing data; however, these sources are often inaccurate or incomplete. To develop and validate methods of automatically inferring patient problems from clinical and billing data, and to provide a knowledge base for inferring problems. We identified 17 target conditions and designed and validated a set of rules for identifying patient problems based on medications, laboratory results, billing codes, and vital signs. A panel of physicians provided input on a preliminary set of rules. Based on this input, we tested candidate rules on a sample of 100,000 patient records to assess their performance compared to gold standard manual chart review. The physician panel selected a final rule for each condition, which was validated on an independent sample of 100,000 records to assess its accuracy. Seventeen rules were developed for inferring patient problems. Analysis using a validation set of 100,000 randomly selected patients showed high sensitivity (range: 62.8-100.0%) and positive predictive value (range: 79.8-99.6%) for most rules. Overall, the inference rules performed better than using either the problem list or billing data alone. We developed and validated a set of rules for inferring patient problems. These rules have a variety of applications, including clinical decision support, care improvement, augmentation of the problem list, and identification of patients for research cohorts.

Use of standardised patients to assess quality of healthcare in Nairobi, Kenya: a pilot, cross-sectional study with international comparisons

PubMed Central

Daniels, Benjamin; Dolinger, Amy; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Coarasa, Jorge; Wafula, Francis; Mwaura, Njeri; Kimeu, Redemptar

2017-01-01

Introduction The quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics. Methods We deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China. Results Across 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case. Conclusions The SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered. PMID:29225937

Psychiatric education in the correctional setting: challenges and opportunities.

PubMed

Holoyda, Brian J; Scott, Charles L

2017-02-01

As the need for mental healthcare services within correctional settings in the US increases, so does the need for a mental health workforce that is motivated to work within such systems. One potentially effective method by which to increase the number of psychiatrists working in jails, prisons, and parole clinics is to provide exposure to these environments during their training. Correctional settings can serve as unique training sites for medical students and psychiatric residents and fellows. Such training experiences can provide a host of benefits to both trainees and staff within the correctional mental health system. Alongside many potential benefits exist substantial potential barriers to coordinating correctional training experiences, including both programme directors' and residents' concerns regarding safety and enjoyment and negative perceptions of inmate and prisoner patients. The establishment of academic affiliations with correctional institutions and didactic instruction on commonly encountered clinical issues with inmate populations may be methods of diffusing these concerns. Improving residents' and fellows' training experiences offers a hope for increasing the attractiveness of a career in correctional psychiatry.

Assessement of serum amyloid A levels in the rehabilitation setting in the Florida manatee (Trichechus manatus latirostris).

PubMed

Cray, Carolyn; Dickey, Meranda; Brewer, Leah Brinson; Arheart, Kristopher L

2013-12-01

The acute phase protein serum amyloid A (SAA) has been previously shown to have value as a biomarker of inflammation and infection in many species, including manatees (Trichechus manatus latirostris). In the current study, results from an automated assay for SAA were used in a rehabilitation setting. Reference intervals were established from clinically normal manatees using the robust method: 0-46 mg/L. More than 30-fold higher mean SAA levels were observed in manatees suffering from cold stress and boat-related trauma. Poor correlations were observed between SAA and total white blood count, percentage of neutrophils, albumin, and albumin/globulin ratio. A moderate correlation was observed between SAA and the presence of nucleated red blood cells. The sensitivity of SAA testing was 93% and the specificity was 98%, representing the highest combined values of all the analytes. The results indicate that the automated method for SAA quantitation can provide important clinical data for manatees in a rehabilitation setting.

Morphological embryo selection: an elective single embryo transfer proposal.

PubMed

Déniz, Francisco Parera; Encinas, Carlos; Fuente, Jorge La

2018-03-01

To describe a patient selection method for elective single embryo transfer (eSET), emphasizing inclusion criteria and results. This retrospective study included all cases seen in a private clinic between June 2011 and December 2016, in La Paz, Bolivia (3600 meters above sea level). Elective single embryo transfer was the method of choice in 34 IVF/ICSI cycles, all in the blastocyst stage. Gardner's blastocyst classification criteria were used. Between the two stages of the study (July 2015), each embryo grade implantation rate was recalculated, which led to the expansion of the inclusion criteria. The clinical pregnancy rate of the 34 cases in the first transfer group was 55.9% (19/34). Twin or multiple pregnancies did not occur. The cumulative pregnancy rate to date is 64% [(19+3)/34]. The first stage comprised 2.56% (12/468) of the patients offered elective single embryo transfers; the implantation rate was 58.3% (7/12). In the second stage, 14.29% (22/154) of the patients were eligible, and the implantation rate was 54.55% (12/22). The implementation of an eSET program based on in-depth morphological embryo assessment combined with the calculation of the implantation potential of each embryo grade led to acceptable clinical outcomes and fewer multiple pregnancies in patients transferred two embryos. Each clinic should be aware of the implantation rates of each embryo grade in its own setting.

Treatment of Childhood and Adolescent Obesity: An Integrative Review of Recent Recommendations from Five Expert Groups

ERIC Educational Resources Information Center

Kirschenbaum, Daniel S.; Gierut, Kristen

2013-01-01

Objective: To compare and contrast 5 sets of expert recommendations about the treatment of childhood and adolescent obesity. Method: We reviewed 5 sets of recent expert recommendations: 2007 health care organizations' four stage model, 2007 Canadian clinical practice guidelines, 2008 Endocrine Society recommendations, 2009 seven step model, and…

Concordance of Patient-Physician Obesity Diagnosis and Treatment Beliefs in Rural Practice Settings

ERIC Educational Resources Information Center

Ely, Andrea Charbonneau; Greiner, K. Allen; Born, Wendi; Hall, Sandra; Rhode, Paula C.; James, Aimee S.; Nollen, Nicole; Ahluwalia, Jasjit S.

2006-01-01

Context: Although clinical guidelines recommend routine screening and treatment for obesity in primary care, lack of agreement between physicians and patients about the need for obesity treatment in the primary care setting may be an unexplored factor contributing to the obesity epidemic. Purpose and Methods: To better understand this dynamic, we…

Recent Advances in Resting-State Electroencephalography Biomarkers for Autism Spectrum Disorder-A Review of Methodological and Clinical Challenges.

PubMed

Heunis, Tosca-Marie; Aldrich, Chris; de Vries, Petrus J

2016-08-01

Electroencephalography (EEG) has been used for almost a century to identify seizure-related disorders in humans, typically through expert interpretation of multichannel recordings. Attempts have been made to quantify EEG through frequency analyses and graphic representations. These "traditional" quantitative EEG analysis methods were limited in their ability to analyze complex and multivariate data and have not been generally accepted in clinical settings. There has been growing interest in identification of novel EEG biomarkers to detect early risk of autism spectrum disorder, to identify clinically meaningful subgroups, and to monitor targeted intervention strategies. Most studies to date have, however, used quantitative EEG approaches, and little is known about the emerging multivariate analytical methods or the robustness of candidate biomarkers in the context of the variability of autism spectrum disorder. Here, we present a targeted review of methodological and clinical challenges in the search for novel resting-state EEG biomarkers for autism spectrum disorder. Three primary novel methodologies are discussed: (1) modified multiscale entropy, (2) coherence analysis, and (3) recurrence quantification analysis. Results suggest that these methods may be able to classify resting-state EEG as "autism spectrum disorder" or "typically developing", but many signal processing questions remain unanswered. We suggest that the move to novel EEG analysis methods is akin to the progress in neuroimaging from visual inspection, through region-of-interest analysis, to whole-brain computational analysis. Novel resting-state EEG biomarkers will have to evaluate a range of potential demographic, clinical, and technical confounders including age, gender, intellectual ability, comorbidity, and medication, before these approaches can be translated into the clinical setting. Copyright © 2016 Elsevier Inc. All rights reserved.

Using Audit Information to Adjust Parameter Estimates for Data Errors in Clinical Trials

PubMed Central

Shepherd, Bryan E.; Shaw, Pamela A.; Dodd, Lori E.

2013-01-01

Background Audits are often performed to assess the quality of clinical trial data, but beyond detecting fraud or sloppiness, the audit data is generally ignored. In earlier work using data from a non-randomized study, Shepherd and Yu (2011) developed statistical methods to incorporate audit results into study estimates, and demonstrated that audit data could be used to eliminate bias. Purpose In this manuscript we examine the usefulness of audit-based error-correction methods in clinical trial settings where a continuous outcome is of primary interest. Methods We demonstrate the bias of multiple linear regression estimates in general settings with an outcome that may have errors and a set of covariates for which some may have errors and others, including treatment assignment, are recorded correctly for all subjects. We study this bias under different assumptions including independence between treatment assignment, covariates, and data errors (conceivable in a double-blinded randomized trial) and independence between treatment assignment and covariates but not data errors (possible in an unblinded randomized trial). We review moment-based estimators to incorporate the audit data and propose new multiple imputation estimators. The performance of estimators is studied in simulations. Results When treatment is randomized and unrelated to data errors, estimates of the treatment effect using the original error-prone data (i.e., ignoring the audit results) are unbiased. In this setting, both moment and multiple imputation estimators incorporating audit data are more variable than standard analyses using the original data. In contrast, in settings where treatment is randomized but correlated with data errors and in settings where treatment is not randomized, standard treatment effect estimates will be biased. And in all settings, parameter estimates for the original, error-prone covariates will be biased. Treatment and covariate effect estimates can be corrected by incorporating audit data using either the multiple imputation or moment-based approaches. Bias, precision, and coverage of confidence intervals improve as the audit size increases. Limitations The extent of bias and the performance of methods depend on the extent and nature of the error as well as the size of the audit. This work only considers methods for the linear model. Settings much different than those considered here need further study. Conclusions In randomized trials with continuous outcomes and treatment assignment independent of data errors, standard analyses of treatment effects will be unbiased and are recommended. However, if treatment assignment is correlated with data errors or other covariates, naive analyses may be biased. In these settings, and when covariate effects are of interest, approaches for incorporating audit results should be considered. PMID:22848072

In-situ medical simulation for pre-implementation testing of clinical service in a regional hospital in Hong Kong.

PubMed

Chen, P P; Tsui, N Tk; Fung, A Sw; Chiu, A Hf; Wong, W Cw; Leong, H T; Lee, P Sf; Lau, J Yw

2017-08-01

The implementation of a new clinical service is associated with anxiety and challenges that may prevent smooth and safe execution of the service. Unexpected issues may not be apparent until the actual clinical service commences. We present a novel approach to test the new clinical setting before actual implementation of our endovascular aortic repair service. In-situ simulation at the new clinical location would enable identification of potential process and system issues prior to implementation of the service. After preliminary planning, a simulation test utilising a case scenario with actual simulation of the entire care process was carried out to identify any logistic, equipment, settings or clinical workflow issues, and to trial a contingency plan for a surgical complication. All patient care including anaesthetic, surgical, and nursing procedures and processes were simulated and tested. Overall, 17 vital process and system issues were identified during the simulation as potential clinical concerns. They included difficult patient positioning, draping pattern, unsatisfactory equipment setup, inadequate critical surgical instruments, blood products logistics, and inadequate nursing support during crisis. In-situ simulation provides an innovative method to identify critical deficiencies and unexpected issues before implementation of a new clinical service. Life-threatening and serious practical issues can be identified and corrected before formal service commences. This article describes our experience with the use of simulation in pre-implementation testing of a clinical process or service. We found the method useful and would recommend it to others.

Platelet Aggregometry Testing: Molecular Mechanisms, Techniques and Clinical Implications

PubMed Central

Koltai, Katalin; Kesmarky, Gabor; Feher, Gergely; Tibold, Antal

2017-01-01

Platelets play a fundamental role in normal hemostasis, while their inherited or acquired dysfunctions are involved in a variety of bleeding disorders or thrombotic events. Several laboratory methodologies or point-of-care testing methods are currently available for clinical and experimental settings. These methods describe different aspects of platelet function based on platelet aggregation, platelet adhesion, the viscoelastic properties during clot formation, the evaluation of thromboxane metabolism or certain flow cytometry techniques. Platelet aggregometry is applied in different clinical settings as monitoring response to antiplatelet therapies, the assessment of perioperative bleeding risk, the diagnosis of inherited bleeding disorders or in transfusion medicine. The rationale for platelet function-driven antiplatelet therapy was based on the result of several studies on patients undergoing percutaneous coronary intervention (PCI), where an association between high platelet reactivity despite P2Y12 inhibition and ischemic events as stent thrombosis or cardiovascular death was found. However, recent large scale randomized, controlled trials have consistently failed to demonstrate a benefit of personalised antiplatelet therapy based on platelet function testing. PMID:28820484

Fast and robust brain tumor segmentation using level set method with multiple image information.

PubMed

Lok, Ka Hei; Shi, Lin; Zhu, Xianlun; Wang, Defeng

2017-01-01

Brain tumor segmentation is a challenging task for its variation in intensity. The phenomenon is caused by the inhomogeneous content of tumor tissue and the choice of imaging modality. In 2010 Zhang developed the Selective Binary Gaussian Filtering Regularizing Level Set (SBGFRLS) model that combined the merits of edge-based and region-based segmentation. To improve the SBGFRLS method by modifying the singed pressure force (SPF) term with multiple image information and demonstrate effectiveness of proposed method on clinical images. In original SBGFRLS model, the contour evolution direction mainly depends on the SPF. By introducing a directional term in SPF, the metric could control the evolution direction. The SPF is altered by statistic values enclosed by the contour. This concept can be extended to jointly incorporate multiple image information. The new SPF term is expected to bring a solution for blur edge problem in brain tumor segmentation. The proposed method is validated with clinical images including pre- and post-contrast magnetic resonance images. The accuracy and robustness is compared with sensitivity, specificity, DICE similarity coefficient and Jaccard similarity index. Experimental results show improvement, in particular the increase of sensitivity at the same specificity, in segmenting all types of tumors except for the diffused tumor. The novel brain tumor segmentation method is clinical-oriented with fast, robust and accurate implementation and a minimal user interaction. The method effectively segmented homogeneously enhanced, non-enhanced, heterogeneously-enhanced, and ring-enhanced tumor under MR imaging. Though the method is limited by identifying edema and diffuse tumor, several possible solutions are suggested to turn the curve evolution into a fully functional clinical diagnosis tool.

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review.

PubMed

Steins, Dax; Dawes, Helen; Esser, Patrick; Collett, Johnny

2014-03-13

Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. While many studies support ABT's potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice.

Quantitative Analysis Tools and Digital Phantoms for Deformable Image Registration Quality Assurance.

PubMed

Kim, Haksoo; Park, Samuel B; Monroe, James I; Traughber, Bryan J; Zheng, Yiran; Lo, Simon S; Yao, Min; Mansur, David; Ellis, Rodney; Machtay, Mitchell; Sohn, Jason W

2015-08-01

This article proposes quantitative analysis tools and digital phantoms to quantify intrinsic errors of deformable image registration (DIR) systems and establish quality assurance (QA) procedures for clinical use of DIR systems utilizing local and global error analysis methods with clinically realistic digital image phantoms. Landmark-based image registration verifications are suitable only for images with significant feature points. To address this shortfall, we adapted a deformation vector field (DVF) comparison approach with new analysis techniques to quantify the results. Digital image phantoms are derived from data sets of actual patient images (a reference image set, R, a test image set, T). Image sets from the same patient taken at different times are registered with deformable methods producing a reference DVFref. Applying DVFref to the original reference image deforms T into a new image R'. The data set, R', T, and DVFref, is from a realistic truth set and therefore can be used to analyze any DIR system and expose intrinsic errors by comparing DVFref and DVFtest. For quantitative error analysis, calculating and delineating differences between DVFs, 2 methods were used, (1) a local error analysis tool that displays deformation error magnitudes with color mapping on each image slice and (2) a global error analysis tool that calculates a deformation error histogram, which describes a cumulative probability function of errors for each anatomical structure. Three digital image phantoms were generated from three patients with a head and neck, a lung and a liver cancer. The DIR QA was evaluated using the case with head and neck. © The Author(s) 2014.

National audit of continence care: laying the foundation.

PubMed

Mian, Sarah; Wagg, Adrian; Irwin, Penny; Lowe, Derek; Potter, Jonathan; Pearson, Michael

2005-12-01

National audit provides a basis for establishing performance against national standards, benchmarking against other service providers and improving standards of care. For effective audit, clinical indicators are required that are valid, feasible to apply and reliable. This study describes the methods used to develop clinical indicators of continence care in preparation for a national audit. To describe the methods used to develop and test clinical indicators of continence care with regard to validity, feasibility and reliability. A multidisciplinary working group developed clinical indicators that measured the structure, process and outcome of care as well as case-mix variables. Literature searching, consensus workshops and a Delphi process were used to develop the indicators. The indicators were tested in 15 secondary care sites, 15 primary care sites and 15 long-term care settings. The process of development produced indicators that received a high degree of consensus within the Delphi process. Testing of the indicators demonstrated an internal reliability of 0.7 and an external reliability of 0.6. Data collection required significant investment in terms of staff time and training. The method used produced indicators that achieved a high degree of acceptance from health care professionals. The reliability of data collection was high for this audit and was similar to the level seen in other successful national audits. Data collection for the indicators was feasible to collect, however, issues of time and staffing were identified as limitations to such data collection. The study has described a systematic method for developing clinical indicators for national audit. The indicators proved robust and reliable in primary and secondary care as well as long-term care settings.

Exploration of the affordances of mobile devices in integrating theory and clinical practice in an undergraduate nursing programme.

PubMed

Willemse, Juliana J; Bozalek, Vivienne

2015-01-01

Promoting the quality and effectiveness of nursing education is an important factor, given the increased demand for nursing professionals. It is important to establish learning environments that provide personalised guidance and feedback to students about their practical skills and application of their theoretical knowledge. To explore and describe the knowledge and points of view of students and educators about introduction of new technologies into an undergraduate nursing programme. The qualitative design used Tesch's (1990) steps of descriptive data analysis to complete thematic analysis of the data collected in focus group discussions (FGDs) and individual interviews to identify themes. Themes identified from the students’ FGDs and individual interviews included: mobile devices as a communication tool; email, WhatsApp and Facebook as methods of communication; WhatsApp as a method of communication; nurses as role-models in the clinical setting; setting personal boundaries; and impact of mobile devices in clinical practice on professionalism. Themes identified from the FGD, individual interviews and a discussion session held with educators included: peer learning via mobile devices; email, WhatsApp and Facebook as methods of communication; the mobile device as a positive learning method; students need practical guidance; and ethical concerns in clinical facilities about Internet access and use of mobile devices. The research project established an understanding of the knowledge and points of view of students and educators regarding introduction of new technologies into an undergraduate nursing programme with the aim of enhancing integration of theory and clinical practice through use of mobile devices.

Comparing Two Processing Pipelines to Measure Subcortical and Cortical Volumes in Patients with and without Mild Traumatic Brain Injury.

PubMed

Reid, Matthew W; Hannemann, Nathan P; York, Gerald E; Ritter, John L; Kini, Jonathan A; Lewis, Jeffrey D; Sherman, Paul M; Velez, Carmen S; Drennon, Ann Marie; Bolzenius, Jacob D; Tate, David F

2017-07-01

To compare volumetric results from NeuroQuant® and FreeSurfer in a service member setting. Since the advent of medical imaging, quantification of brain anatomy has been a major research and clinical effort. Rapid advancement of methods to automate quantification and to deploy this information into clinical practice has surfaced in recent years. NeuroQuant® is one such tool that has recently been used in clinical settings. Accurate volumetric data are useful in many clinical indications; therefore, it is important to assess the intermethod reliability and concurrent validity of similar volume quantifying tools. Volumetric data from 148 U.S. service members across three different experimental groups participating in a study of mild traumatic brain injury (mTBI) were examined. Groups included mTBI (n = 71), posttraumatic stress disorder (n = 22), or a noncranial orthopedic injury (n = 55). Correlation coefficients and nonparametric group mean comparisons were used to assess reliability and concurrent validity, respectively. Comparison of these methods across our entire sample demonstrates generally fair to excellent reliability as evidenced by large intraclass correlation coefficients (ICC = .4 to .99), but little concurrent validity as evidenced by significantly different Mann-Whitney U comparisons for 26 of 30 brain structures measured. While reliability between the two segmenting tools is fair to excellent, volumetric outcomes are statistically different between the two methods. As suggested by both developers, structure segmentation should be visually verified prior to clinical use and rigor should be used when interpreting results generated by either method. Copyright © 2017 by the American Society of Neuroimaging.

Nonparametric Subgroup Identification by PRIM and CART: A Simulation and Application Study

PubMed Central

2017-01-01

Two nonparametric methods for the identification of subgroups with outstanding outcome values are described and compared to each other in a simulation study and an application to clinical data. The Patient Rule Induction Method (PRIM) searches for box-shaped areas in the given data which exceed a minimal size and average outcome. This is achieved via a combination of iterative peeling and pasting steps, where small fractions of the data are removed or added to the current box. As an alternative, Classification and Regression Trees (CART) prediction models perform sequential binary splits of the data to produce subsets which can be interpreted as subgroups of heterogeneous outcome. PRIM and CART were compared in a simulation study to investigate their strengths and weaknesses under various data settings, taking different performance measures into account. PRIM was shown to be superior in rather complex settings such as those with few observations, a smaller signal-to-noise ratio, and more than one subgroup. CART showed the best performance in simpler situations. A practical application of the two methods was illustrated using a clinical data set. For this application, both methods produced similar results but the higher amount of user involvement of PRIM became apparent. PRIM can be flexibly tuned by the user, whereas CART, although simpler to implement, is rather static. PMID:28611849

A Mass Spectrometric Analysis Method Based on PPCA and SVM for Early Detection of Ovarian Cancer.

PubMed

Wu, Jiang; Ji, Yanju; Zhao, Ling; Ji, Mengying; Ye, Zhuang; Li, Suyi

2016-01-01

Background. Surfaced-enhanced laser desorption-ionization-time of flight mass spectrometry (SELDI-TOF-MS) technology plays an important role in the early diagnosis of ovarian cancer. However, the raw MS data is highly dimensional and redundant. Therefore, it is necessary to study rapid and accurate detection methods from the massive MS data. Methods. The clinical data set used in the experiments for early cancer detection consisted of 216 SELDI-TOF-MS samples. An MS analysis method based on probabilistic principal components analysis (PPCA) and support vector machine (SVM) was proposed and applied to the ovarian cancer early classification in the data set. Additionally, by the same data set, we also established a traditional PCA-SVM model. Finally we compared the two models in detection accuracy, specificity, and sensitivity. Results. Using independent training and testing experiments 10 times to evaluate the ovarian cancer detection models, the average prediction accuracy, sensitivity, and specificity of the PCA-SVM model were 83.34%, 82.70%, and 83.88%, respectively. In contrast, those of the PPCA-SVM model were 90.80%, 92.98%, and 88.97%, respectively. Conclusions. The PPCA-SVM model had better detection performance. And the model combined with the SELDI-TOF-MS technology had a prospect in early clinical detection and diagnosis of ovarian cancer.

Nonparametric Subgroup Identification by PRIM and CART: A Simulation and Application Study.

PubMed

Ott, Armin; Hapfelmeier, Alexander

2017-01-01

Two nonparametric methods for the identification of subgroups with outstanding outcome values are described and compared to each other in a simulation study and an application to clinical data. The Patient Rule Induction Method (PRIM) searches for box-shaped areas in the given data which exceed a minimal size and average outcome. This is achieved via a combination of iterative peeling and pasting steps, where small fractions of the data are removed or added to the current box. As an alternative, Classification and Regression Trees (CART) prediction models perform sequential binary splits of the data to produce subsets which can be interpreted as subgroups of heterogeneous outcome. PRIM and CART were compared in a simulation study to investigate their strengths and weaknesses under various data settings, taking different performance measures into account. PRIM was shown to be superior in rather complex settings such as those with few observations, a smaller signal-to-noise ratio, and more than one subgroup. CART showed the best performance in simpler situations. A practical application of the two methods was illustrated using a clinical data set. For this application, both methods produced similar results but the higher amount of user involvement of PRIM became apparent. PRIM can be flexibly tuned by the user, whereas CART, although simpler to implement, is rather static.

Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

PubMed

Kottner, J; Jacobi, L; Hahnel, E; Alam, M; Balzer, K; Beeckman, D; Busard, C; Chalmers, J; Deckert, S; Eleftheriadou, V; Furlan, K; Horbach, S E R; Kirkham, J; Nast, A; Spuls, P; Thiboutot, D; Thorlacius, L; Weller, K; Williams, H C; Schmitt, J

2018-04-01

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. © 2018 British Association of Dermatologists.

Recognition of medication information from discharge summaries using ensembles of classifiers.

PubMed

Doan, Son; Collier, Nigel; Xu, Hua; Pham, Hoang Duy; Tu, Minh Phuong

2012-05-07

Extraction of clinical information such as medications or problems from clinical text is an important task of clinical natural language processing (NLP). Rule-based methods are often used in clinical NLP systems because they are easy to adapt and customize. Recently, supervised machine learning methods have proven to be effective in clinical NLP as well. However, combining different classifiers to further improve the performance of clinical entity recognition systems has not been investigated extensively. Combining classifiers into an ensemble classifier presents both challenges and opportunities to improve performance in such NLP tasks. We investigated ensemble classifiers that used different voting strategies to combine outputs from three individual classifiers: a rule-based system, a support vector machine (SVM) based system, and a conditional random field (CRF) based system. Three voting methods were proposed and evaluated using the annotated data sets from the 2009 i2b2 NLP challenge: simple majority, local SVM-based voting, and local CRF-based voting. Evaluation on 268 manually annotated discharge summaries from the i2b2 challenge showed that the local CRF-based voting method achieved the best F-score of 90.84% (94.11% Precision, 87.81% Recall) for 10-fold cross-validation. We then compared our systems with the first-ranked system in the challenge by using the same training and test sets. Our system based on majority voting achieved a better F-score of 89.65% (93.91% Precision, 85.76% Recall) than the previously reported F-score of 89.19% (93.78% Precision, 85.03% Recall) by the first-ranked system in the challenge. Our experimental results using the 2009 i2b2 challenge datasets showed that ensemble classifiers that combine individual classifiers into a voting system could achieve better performance than a single classifier in recognizing medication information from clinical text. It suggests that simple strategies that can be easily implemented such as majority voting could have the potential to significantly improve clinical entity recognition.

Counseling in the clinical setting to prevent unintended pregnancy: an evidence-based research agenda.

PubMed

Moos, Merry K; Bartholomew, Neva E; Lohr, Kathleen N

2003-02-01

Unintended pregnancies account for about half of all pregnancies in the United States and, in 1995, numbered nearly 3 million pregnancies. They pose appreciable medical, emotional, social and financial costs on women, their families and society. The US is not attaining national goals to decrease unintended pregnancies, and little is known about effective means for reducing unintended pregnancy rates in adults or adolescents.To examine the evidence about the effectiveness, benefits and harms of counseling in a clinical setting to prevent unintended pregnancy in adults and adolescents and to use the evidence to propose a research agenda.We identified English-language articles from comprehensive searches of the MEDLINE, CINAHL, PsychLit and other databases from 1985 through May 2000; the main clinical search terms included pregnancy (mistimed, unintended, unplanned, unwanted), family planning, contraceptive behavior, counseling, sex counseling, and knowledge, attitudes and behavior. We also used published systematic reviews, hand searching of relevant articles, the second Guide to Clinical Preventive Services and extensive peer review to identify important articles not otherwise found and to assure completeness. Of 673 abstracts examined, we retained 354 for full article review; of these, we used 74 for the systematic evidence review and abstracted data from 13 articles for evidence tables. Four studies addressed the effectiveness of counseling in a clinical setting in changing knowledge, skills and attitudes about contraception and pregnancy; all had poor internal validity and generalizability and collectively did not provide definitive guidance about effective counseling strategies. Nine studies (three in teenage populations) addressed the relationship of knowledge on contraceptive use and adherence. Knowledge of correct contraceptive methods may be positively associated with appropriate use, but reservations about the method itself, partner support of the method, and women's beliefs about their own fertility are important determinants of method adherence that may attenuate the knowledge effect. Many factors influence contraceptive use and adherence; among them are age, marital status, ambivalence about becoming pregnant, attitudes of partner, side effects, satisfaction with provider and costs; however, the impact of such factors may not be consistent across populations defined by cultural, age or other factors. The studies themselves differed materially in outcome variables, populations and methodologies and did not yield a body of work that can reliably identify specific influences on contraceptive use and adherence. No literature reports on harms of counseling or on the costs or cost-effectiveness of different approaches to counseling about unintended conceptions in the primary care setting. Virtually no experimental or observational literature reliably answers questions about the effectiveness of counseling in the clinical setting to reduce rates of unintended (unwanted, mistimed) pregnancies in this country. Existing studies suffer from appreciable threats to internal validity and loss to follow-up and are extremely heterogeneous in terms of populations studied and outcomes measured. The quality of the existing research does not provide strong guidance for recommendations about clinical practice but does suggest directions for future investigations. Numerous issues warrant rigorous investigation.

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

PubMed Central

2010-01-01

Background High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; Methods/Design This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; Discussion The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; Trial registration The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov]. PMID:20673325

Clinical applications of breath testing

PubMed Central

Paschke, Kelly M; Mashir, Alquam

2010-01-01

Breath testing has the potential to benefit the medical field as a cost-effective, non-invasive diagnostic tool for diseases of the lung and beyond. With growing evidence of clinical worth, standardization of methods, and new sensor and detection technologies the stage is set for breath testing to gain considerable attention and wider application in upcoming years. PMID:21173863

Considered Evaluation of Clinical Placements in a New Medical School

ERIC Educational Resources Information Center

Booth, Jerry; Collins, Sarah; Hammond, Anna

2009-01-01

This article suggests that quality assessment in the UK has been largely set apart from learning and teaching and reports on a pilot project at the Hull York Medical School which attempted to integrate students' evaluation of their clinical placements into the curriculum. It outlines the operational demands of this integrated method and compares…

Detecting Motor Impairment in Early Parkinson’s Disease via Natural Typing Interaction With Keyboards: Validation of the neuroQWERTY Approach in an Uncontrolled At-Home Setting

PubMed Central

Ledesma-Carbayo, María J; Butterworth, Ian; Matarazzo, Michele; Montero-Escribano, Paloma; Puertas-Martín, Verónica; Gray, Martha L

2018-01-01

Background Parkinson’s disease (PD) is the second most prevalent neurodegenerative disease and one of the most common forms of movement disorder. Although there is no known cure for PD, existing therapies can provide effective symptomatic relief. However, optimal titration is crucial to avoid adverse effects. Today, decision making for PD management is challenging because it relies on subjective clinical evaluations that require a visit to the clinic. This challenge has motivated recent research initiatives to develop tools that can be used by nonspecialists to assess psychomotor impairment. Among these emerging solutions, we recently reported the neuroQWERTY index, a new digital marker able to detect motor impairment in an early PD cohort through the analysis of the key press and release timing data collected during a controlled in-clinic typing task. Objective The aim of this study was to extend the in-clinic implementation to an at-home implementation by validating the applicability of the neuroQWERTY approach in an uncontrolled at-home setting, using the typing data from subjects’ natural interaction with their laptop to enable remote and unobtrusive assessment of PD signs. Methods We implemented the data-collection platform and software to enable access and storage of the typing data generated by users while using their computer at home. We recruited a total of 60 participants; of these participants 52 (25 people with Parkinson’s and 27 healthy controls) provided enough data to complete the analysis. Finally, to evaluate whether our in-clinic-built algorithm could be used in an uncontrolled at-home setting, we compared its performance on the data collected during the controlled typing task in the clinic and the results of our method using the data passively collected at home. Results Despite the randomness and sparsity introduced by the uncontrolled setting, our algorithm performed nearly as well in the at-home data (area under the receiver operating characteristic curve [AUC] of 0.76 and sensitivity/specificity of 0.73/0.69) as it did when used to evaluate the in-clinic data (AUC 0.83 and sensitivity/specificity of 0.77/0.72). Moreover, the keystroke metrics presented a strong correlation between the 2 typing settings, which suggests a minimal influence of the in-clinic typing task in users’ normal typing. Conclusions The finding that an algorithm trained on data from an in-clinic setting has comparable performance with that tested on data collected through naturalistic at-home computer use reinforces the hypothesis that subtle differences in motor function can be detected from typing behavior. This work represents another step toward an objective, user-convenient, and quasi-continuous monitoring tool for PD. PMID:29581092

Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence.

PubMed

Whitebird, Robin R; Bliss, Donna Zimmaro; Savik, Kay; Lowry, Ann; Jung, Hans-Joachim G

2010-12-01

Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). In the Fiber Study, a randomized controlled trial on symptom management for FI, we successfully enrolled 189 community-living adults through collaborations with specialty-based and community-based settings, each employing methods tailored to the organizational characteristics of their site. Results show that using the two settings increased racial and ethnic diversity of the sample and inclusion of informal caregivers. There were no differential effects on enrollment, final eligibility, or completion of protocol by site. Strategic collaborations with complementary sites can achieve sample recruitment goals for clinical trials on topics that are sensitive or known to be underreported. Copyright © 2010 Wiley Periodicals, Inc.

Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.

PubMed

Raunig, David L; McShane, Lisa M; Pennello, Gene; Gatsonis, Constantine; Carson, Paul L; Voyvodic, James T; Wahl, Richard L; Kurland, Brenda F; Schwarz, Adam J; Gönen, Mithat; Zahlmann, Gudrun; Kondratovich, Marina V; O'Donnell, Kevin; Petrick, Nicholas; Cole, Patricia E; Garra, Brian; Sullivan, Daniel C

2015-02-01

Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers to measure changes in these features. Critical to the performance of a quantitative imaging biomarker in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method, and metrics used to assess a quantitative imaging biomarker for clinical use. It is therefore difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America and the Quantitative Imaging Biomarker Alliance with technical, radiological, and statistical experts developed a set of technical performance analysis methods, metrics, and study designs that provide terminology, metrics, and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of quantitative imaging biomarker performance studies so that results from multiple studies can be compared, contrasted, or combined. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

A similarity based learning framework for interim analysis of outcome prediction of acupuncture for neck pain.

PubMed

Zhang, Gang; Liang, Zhaohui; Yin, Jian; Fu, Wenbin; Li, Guo-Zheng

2013-01-01

Chronic neck pain is a common morbid disorder in modern society. Acupuncture has been administered for treating chronic pain as an alternative therapy for a long time, with its effectiveness supported by the latest clinical evidence. However, the potential effective difference in different syndrome types is questioned due to the limits of sample size and statistical methods. We applied machine learning methods in an attempt to solve this problem. Through a multi-objective sorting of subjective measurements, outstanding samples are selected to form the base of our kernel-oriented model. With calculation of similarities between the concerned sample and base samples, we are able to make full use of information contained in the known samples, which is especially effective in the case of a small sample set. To tackle the parameters selection problem in similarity learning, we propose an ensemble version of slightly different parameter setting to obtain stronger learning. The experimental result on a real data set shows that compared to some previous well-known methods, the proposed algorithm is capable of discovering the underlying difference among different syndrome types and is feasible for predicting the effective tendency in clinical trials of large samples.

Brain imaging in the study of Alzheimer's disease.

PubMed

Reiman, Eric M; Jagust, William J

2012-06-01

Over the last 20 years, there has been extraordinary progress in brain imaging research and its application to the study of Alzheimer's disease (AD). Brain imaging researchers have contributed to the scientific understanding, early detection and tracking of AD. They have set the stage for imaging techniques to play growing roles in the clinical setting, the evaluation of disease-modifying treatments, and the identification of demonstrably effective prevention therapies. They have developed ground-breaking methods, including positron emission tomography (PET) ligands to measure fibrillar amyloid-β (Aβ) deposition, new magnetic resonance imaging (MRI) pulse sequences, and powerful image analysis techniques, to help in these endeavors. Additional work is needed to develop even more powerful imaging methods, to further clarify the relationship and time course of Aβ and other disease processes in the predisposition to AD, to establish the role of brain imaging methods in the clinical setting, and to provide the scientific means and regulatory approval pathway needed to evaluate the range of promising disease-modifying and prevention therapies as quickly as possible. Twenty years from now, AD may not yet be a distant memory, but the best is yet to come. Copyright © 2011 Elsevier Inc. All rights reserved.

BRAIN IMAGING IN THE STUDY OF ALZHEIMER'S DISEASE

PubMed Central

Reiman, Eric M.; Jagust, William J.

2012-01-01

Over the last 20 years, there has been extraordinary progress in brain imaging research and its application to the study of Alzheimer's disease (AD). Brain imaging researchers have contributed to the scientific understanding, early detection and tracking of AD. They have set the stage for imaging techniques to play growing roles in the clinical setting, the evaluation of disease-modifying treatments, and the identification of demonstrably effective prevention therapies. They have developed ground-breaking methods, including positron emission tomography (PET) ligands to measure fibrillar amyloid-β (Aβ) deposition, new magnetic resonance imaging (MRI) pulse sequences, and powerful image analysis techniques, to help in these endeavors. Additional work is needed to develop even more powerful imaging methods, to further clarify the relationship and time course of Aβ and other disease processes in the predisposition to AD, to establish the role of brain imaging methods in the clinical setting, and to provide the scientific means and regulatory approval pathway needed to evaluate the range of promising disease-modifying and prevention therapies as quickly as possible. Twenty years from now, AD may not yet be a distant memory, but the best is yet to come. PMID:22173295

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

PubMed Central

Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

2015-01-01

Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

Scaled Anatomical Model Creation of Biomedical Tomographic Imaging Data and Associated Labels for Subsequent Sub-surface Laser Engraving (SSLE) of Glass Crystals.

PubMed

Betts, Aislinn M; McGoldrick, Matthew T; Dethlefs, Christopher R; Piotrowicz, Justin; Van Avermaete, Tony; Maki, Jeff; Gerstler, Steve; Leevy, W M

2017-04-25

Biomedical imaging modalities like computed tomography (CT) and magnetic resonance (MR) provide excellent platforms for collecting three-dimensional data sets of patient or specimen anatomy in clinical or preclinical settings. However, the use of a virtual, on-screen display limits the ability of these tomographic images to fully convey the anatomical information embedded within. One solution is to interface a biomedical imaging data set with 3D printing technology to generate a physical replica. Here we detail a complementary method to visualize tomographic imaging data with a hand-held model: Sub Surface Laser Engraving (SSLE) of crystal glass. SSLE offers several unique benefits including: the facile ability to include anatomical labels, as well as a scale bar; streamlined multipart assembly of complex structures in one medium; high resolution in the X, Y, and Z planes; and semi-transparent shells for visualization of internal anatomical substructures. Here we demonstrate the process of SSLE with CT data sets derived from pre-clinical and clinical sources. This protocol will serve as a powerful and inexpensive new tool with which to visualize complex anatomical structures for scientists and students in a number of educational and research settings.

The diversity of Iranian nursing students' clinical learning styles: a qualitative study.

PubMed

Baraz, Shahram; Memarian, Robabeh; Vanaki, Zohreh

2014-09-01

Numerous factors, including learning styles, affect the learning process of nursing students. Having insights about students' learning styles helps promoting the quality of education. The aim of this study was to explore the Iranian baccalaureate nursing students' learning styles in clinical settings. A qualitative design using a content analysis approach was used to collect and analyze data. Semi-structured interviews were conducted with fifteen Iranian baccalaureate nursing students selected using a purposive sample method. During data analysis, it was found that nursing students employed different clinical learning styles such as 'thoughtful observation,' 'learning by thinking,' and 'learning by doing'. Students adopt different learning strategies in clinical practice. Designing teaching strategies based on students' learning styles can promote students' learning and maximize their academic and clinical practice success. Nursing educators, curriculum designers, and students can use the findings of this study to improve the quality of nursing education in both the classroom and clinical settings. Copyright © 2014 Elsevier Ltd. All rights reserved.

Patient costs in anticoagulation management: a comparison of primary and secondary care.

PubMed Central

Parry, D; Bryan, S; Gee, K; Murray, E; Fitzmaurice, D

2001-01-01

BACKGROUND: The demand for anticoagulation management is increasing. This has led to care being provided in non-hospital settings. While clinical studies have similarly demonstrated good clinical care in these settings, it is still unclear as to which alternative is the most efficient. AIM: To determine the costs borne by patients when attending an anticoagulation management clinic in either primary or secondary care and to use this information to consider the cost-effectiveness of anticoagulation management in primary and secondary care, both from the National Health Service and patient perspectives. DESIGN OF STUDY: Observational study comparing two cohorts of patients currently attending anticoagulation management clinics. SETTING: Four primary care clinics in Birmingham and one in Warwickshire, and the haematology clinics at the University of Birmingham Hospitals Trust and the City Hospital NHS Trust. METHOD: The survey of patients attending the clinics was used to ascertain patient costs. This information was then used in conjunction with the findings of a recent randomised controlled trial to establish cost-effectiveness. RESULTS: Patient costs were lower in primary care than in secondary care settings; the mean (standard deviation) costs per visit were Pound Sterling6.78 (Pound Sterling5.04) versus Pound Sterling14.58 (Pound Sterling9.08). While a previous cost-effectiveness analysis from a health sector perspective alone found a higher cost for primary care, the adoption of the societal perspective lead to a marked change in the result: a similar total cost per patient in both sectors. CONCLUSION: There are significantly higher costs borne by patients attending secondary care anticoagulation management clinics than similar patients attending primary care clinics. This study also demonstrates that the perspective adopted in an economic evaluation can influence the final result. PMID:11766869

Integration of Evidence into a Detailed Clinical Model-based Electronic Nursing Record System

PubMed Central

Park, Hyeoun-Ae; Jeon, Eunjoo; Chung, Eunja

2012-01-01

Objectives The purpose of this study was to test the feasibility of an electronic nursing record system for perinatal care that is based on detailed clinical models and clinical practice guidelines in perinatal care. Methods This study was carried out in five phases: 1) generating nursing statements using detailed clinical models; 2) identifying the relevant evidence; 3) linking nursing statements with the evidence; 4) developing a prototype electronic nursing record system based on detailed clinical models and clinical practice guidelines; and 5) evaluating the prototype system. Results We first generated 799 nursing statements describing nursing assessments, diagnoses, interventions, and outcomes using entities, attributes, and value sets of detailed clinical models for perinatal care which we developed in a previous study. We then extracted 506 recommendations from nine clinical practice guidelines and created sets of nursing statements to be used for nursing documentation by grouping nursing statements according to these recommendations. Finally, we developed and evaluated a prototype electronic nursing record system that can provide nurses with recommendations for nursing practice and sets of nursing statements based on the recommendations for guiding nursing documentation. Conclusions The prototype system was found to be sufficiently complete, relevant, useful, and applicable in terms of content, and easy to use and useful in terms of system user interface. This study has revealed the feasibility of developing such an ENR system. PMID:22844649

Questionnaires for assessment of female sexual dysfunction: a review and proposal for a standardized screener.

PubMed

Giraldi, Annamaria; Rellini, Alessandra; Pfaus, James G; Bitzer, Johannes; Laan, Ellen; Jannini, Emmanuele A; Fugl-Meyer, Axel R

2011-10-01

There are many methods to evaluate female sexual function and dysfunction (FSD) in clinical and research settings, including questionnaires, structured interviews, and detailed case histories. Of these, questionnaires have become an easy first choice to screen individuals into different categories of FSD. The aim of this study was to review the strengths and weaknesses of different questionnaires currently available to assess different dimensions of women's sexual function and dysfunction, and to suggest a simple screener for FSD. A literature search of relevant databases, books, and articles in journals was used to identify questionnaires that have been used in basic or epidemiological research, clinical trials, or in clinical settings. Measures were grouped in four levels based on their purposes and degree of development, and were reviewed for their psychometric properties and utility in clinical or research settings. A Sexual Complaints Screener for Women (SCS-W) was then proposed based on epidemiological methods. Although many questionnaires are adequate for their own purposes, our review revealed a serious lack of standardized, internationally (culturally) acceptable questionnaires that are truly epidemiologically validated in general populations and that can be used to assess FSD in women with or without a partner and independent of the partner's gender. The SCS-W is proposed as a 10-item screener to aid clinicians in making a preliminary assessment of FSD. The definition of FSD continues to change and basic screening tools are essential to help advance clinical diagnosis and treatment, or to slate patients adequately into the right diagnostic categories for basic and epidemiological research or clinical trials. © 2011 International Society for Sexual Medicine.

Infants' social withdrawal symptoms assessed with a direct infant observation method in primary health care.

PubMed

Puura, Kaija; Mäntymaa, Mirjami; Luoma, Ilona; Kaukonen, Pälvi; Guedeney, Antoine; Salmelin, Raili; Tamminen, Tuula

2010-12-01

Distressed infants may withdraw from social interaction, but recognising infants' social withdrawal is difficult. The aims of the study were to see whether an infant observation method can be reliably used by front line workers, and to examine the prevalence of infants' social withdrawal symptoms. A random sample of 363 families with four, eight or 18-month-old infants participated in the study. The infants were examined by general practitioners (GPs) in well-baby clinics with the Alarm Distress BaBy Scale (ADBB), an observation method developed for clinical settings. A score of five or more on the ADBB Scale in two subsequent assessments at a two-week interval was regarded as a sign of clinically significant infant social withdrawal. Kappas were calculated for the GPs' correct rating of withdrawn/not withdrawn against a set of videotapes rated by developer of the method, Professor Guedeney and his research group. The kappas for their ratings ranged from 0.5 to 1. The frequency of infants scoring above the cut off in two subsequent assessments was 3%. The ADBB Scale is a promising method for detecting infant social withdrawal in front line services. Three percents of infants were showing sustained social withdrawal as a sign of distress in this normal population sample. Copyright © 2010 Elsevier Inc. All rights reserved.

Potential Impact of Rapid Blood Culture Testing for Gram-Positive Bacteremia in Japan with the Verigene Gram-Positive Blood Culture Test

PubMed Central

Matsuda, Mari; Iguchi, Shigekazu; Mizutani, Tomonori; Hiramatsu, Keiichi; Tega-Ishii, Michiru; Sansaka, Kaori; Negishi, Kenta; Shimada, Kimie; Umemura, Jun; Notake, Shigeyuki; Yanagisawa, Hideji; Yabusaki, Reiko; Araoka, Hideki; Yoneyama, Akiko

2017-01-01

Background. Early detection of Gram-positive bacteremia and timely appropriate antimicrobial therapy are required for decreasing patient mortality. The purpose of our study was to evaluate the performance of the Verigene Gram-positive blood culture assay (BC-GP) in two special healthcare settings and determine the potential impact of rapid blood culture testing for Gram-positive bacteremia within the Japanese healthcare delivery system. Furthermore, the study included simulated blood cultures, which included a library of well-characterized methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) isolates reflecting different geographical regions in Japan. Methods. A total 347 BC-GP assays were performed on clinical and simulated blood cultures. BC-GP results were compared to results obtained by reference methods for genus/species identification and detection of resistance genes using molecular and MALDI-TOF MS methodologies. Results. For identification and detection of resistance genes at two clinical sites and simulated blood cultures, overall concordance of BC-GP with reference methods was 327/347 (94%). The time for identification and antimicrobial resistance detection by BC-GP was significantly shorter compared to routine testing especially at the cardiology hospital, which does not offer clinical microbiology services on weekends and holidays. Conclusion. BC-GP generated accurate identification and detection of resistance markers compared with routine laboratory methods for Gram-positive organisms in specialized clinical settings providing more rapid results than current routine testing. PMID:28316631

Finding consensus on frailty assessment in acute care through Delphi method

PubMed Central

2016-01-01

Objective We seek to address gaps in knowledge and agreement around optimal frailty assessment in the acute medical care setting. Frailty is a common term describing older persons who are at increased risk of developing multimorbidity, disability, institutionalisation and death. Consensus has not been reached on the practical implementation of this concept to assess clinically and manage older persons in the acute care setting. Design Modified Delphi, via electronic questionnaire. Questions included ranking items that best recognise frailty, optimal timing, location and contextual elements of a successful tool. Intraclass correlation coefficients for overall levels of agreement, with consensus and stability tested by 2-way ANOVA with absolute agreement and Fisher's exact test. Participants A panel of national experts (academics, front-line clinicians and specialist charities) were invited to electronic correspondence. Results Variables reflecting accumulated deficit and high resource usage were perceived by participants as the most useful indicators of frailty in the acute care setting. The Acute Medical Unit and Care of the older Persons Ward were perceived as optimum settings for frailty assessment. ‘Clinically meaningful and relevant’, ‘simple (easy to use)’ and ‘accessible by multidisciplinary team’ were perceived as characteristics of a successful frailty assessment tool in the acute care setting. No agreement was reached on optimal timing, number of variables and organisational structures. Conclusions This study is a first step in developing consensus for a clinically relevant frailty assessment model for the acute care setting, providing content validation and illuminating contextual requirements. Testing on clinical data sets is a research priority. PMID:27742633

Comparison Study of Judged Clinical Skills Competence from Standard Setting Ratings Generated under Different Administration Conditions

ERIC Educational Resources Information Center

Roberts, William L.; Boulet, John; Sandella, Jeanne

2017-01-01

When the safety of the public is at stake, it is particularly relevant for licensing and credentialing exam agencies to use defensible standard setting methods to categorize candidates into competence categories (e.g., pass/fail). The aim of this study was to gather evidence to support change to the Comprehensive Osteopathic Medical Licensing-USA…

CUILESS2016: a clinical corpus applying compositional normalization of text mentions.

PubMed

Osborne, John D; Neu, Matthew B; Danila, Maria I; Solorio, Thamar; Bethard, Steven J

2018-01-10

Traditionally text mention normalization corpora have normalized concepts to single ontology identifiers ("pre-coordinated concepts"). Less frequently, normalization corpora have used concepts with multiple identifiers ("post-coordinated concepts") but the additional identifiers have been restricted to a defined set of relationships to the core concept. This approach limits the ability of the normalization process to express semantic meaning. We generated a freely available corpus using post-coordinated concepts without a defined set of relationships that we term "compositional concepts" to evaluate their use in clinical text. We annotated 5397 disorder mentions from the ShARe corpus to SNOMED CT that were previously normalized as "CUI-less" in the "SemEval-2015 Task 14" shared task because they lacked a pre-coordinated mapping. Unlike the previous normalization method, we do not restrict concept mappings to a particular set of the Unified Medical Language System (UMLS) semantic types and allow normalization to occur to multiple UMLS Concept Unique Identifiers (CUIs). We computed annotator agreement and assessed semantic coverage with this method. We generated the largest clinical text normalization corpus to date with mappings to multiple identifiers and made it freely available. All but 8 of the 5397 disorder mentions were normalized using this methodology. Annotator agreement ranged from 52.4% using the strictest metric (exact matching) to 78.2% using a hierarchical agreement that measures the overlap of shared ancestral nodes. Our results provide evidence that compositional concepts can increase semantic coverage in clinical text. To our knowledge we provide the first freely available corpus of compositional concept annotation in clinical text.

High-throughput label-free detection of aggregate platelets with optofluidic time-stretch microscopy (Conference Presentation)

NASA Astrophysics Data System (ADS)

Jiang, Yiyue; Lei, Cheng; Yasumoto, Atsushi; Ito, Takuro; Guo, Baoshan; Kobayashi, Hirofumi; Ozeki, Yasuyuki; Yatomi, Yutaka; Goda, Keisuke

2017-02-01

According to WHO, approximately 10 million new cases of thrombotic disorders are diagnosed worldwide every year. In the U.S. and Europe, their related diseases kill more people than those from AIDS, prostate cancer, breast cancer and motor vehicle accidents combined. Although thrombotic disorders, especially arterial ones, mainly result from enhanced platelet aggregability in the vascular system, visual detection of platelet aggregates in vivo is not employed in clinical settings. Here we present a high-throughput label-free platelet aggregate detection method, aiming at the diagnosis and monitoring of thrombotic disorders in clinical settings. With optofluidic time-stretch microscopy with a spatial resolution of 780 nm and an ultrahigh linear scanning rate of 75 MHz, it is capable of detecting aggregated platelets in lysed blood which flows through a hydrodynamic-focusing microfluidic device at a high throughput of 10,000 particles/s. With digital image processing and statistical analysis, we are able to distinguish them from single platelets and other blood cells via morphological features. The detection results are compared with results of fluorescence-based detection (which is slow and inaccurate, but established). Our results indicate that the method holds promise for real-time, low-cost, label-free, and minimally invasive detection of platelet aggregates, which is potentially applicable to detection of platelet aggregates in vivo and to the diagnosis and monitoring of thrombotic disorders in clinical settings. This technique, if introduced clinically, may provide important clinical information in addition to that obtained by conventional techniques for thrombotic disorder diagnosis, including ex vivo platelet aggregation tests.

Robust optimization methods for cardiac sparing in tangential breast IMRT

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

Mahmoudzadeh, Houra, E-mail: houra@mie.utoronto.ca; Lee, Jenny; Chan, Timothy C. Y.

Purpose: In left-sided tangential breast intensity modulated radiation therapy (IMRT), the heart may enter the radiation field and receive excessive radiation while the patient is breathing. The patient’s breathing pattern is often irregular and unpredictable. We verify the clinical applicability of a heart-sparing robust optimization approach for breast IMRT. We compare robust optimized plans with clinical plans at free-breathing and clinical plans at deep inspiration breath-hold (DIBH) using active breathing control (ABC). Methods: Eight patients were included in the study with each patient simulated using 4D-CT. The 4D-CT image acquisition generated ten breathing phase datasets. An average scan was constructedmore » using all the phase datasets. Two of the eight patients were also imaged at breath-hold using ABC. The 4D-CT datasets were used to calculate the accumulated dose for robust optimized and clinical plans based on deformable registration. We generated a set of simulated breathing probability mass functions, which represent the fraction of time patients spend in different breathing phases. The robust optimization method was applied to each patient using a set of dose-influence matrices extracted from the 4D-CT data and a model of the breathing motion uncertainty. The goal of the optimization models was to minimize the dose to the heart while ensuring dose constraints on the target were achieved under breathing motion uncertainty. Results: Robust optimized plans were improved or equivalent to the clinical plans in terms of heart sparing for all patients studied. The robust method reduced the accumulated heart dose (D10cc) by up to 801 cGy compared to the clinical method while also improving the coverage of the accumulated whole breast target volume. On average, the robust method reduced the heart dose (D10cc) by 364 cGy and improved the optBreast dose (D99%) by 477 cGy. In addition, the robust method had smaller deviations from the planned dose to the accumulated dose. The deviation of the accumulated dose from the planned dose for the optBreast (D99%) was 12 cGy for robust versus 445 cGy for clinical. The deviation for the heart (D10cc) was 41 cGy for robust and 320 cGy for clinical. Conclusions: The robust optimization approach can reduce heart dose compared to the clinical method at free-breathing and can potentially reduce the need for breath-hold techniques.« less

A Bayesian estimate of the concordance correlation coefficient with skewed data.

PubMed

Feng, Dai; Baumgartner, Richard; Svetnik, Vladimir

2015-01-01

Concordance correlation coefficient (CCC) is one of the most popular scaled indices used to evaluate agreement. Most commonly, it is used under the assumption that data is normally distributed. This assumption, however, does not apply to skewed data sets. While methods for the estimation of the CCC of skewed data sets have been introduced and studied, the Bayesian approach and its comparison with the previous methods has been lacking. In this study, we propose a Bayesian method for the estimation of the CCC of skewed data sets and compare it with the best method previously investigated. The proposed method has certain advantages. It tends to outperform the best method studied before when the variation of the data is mainly from the random subject effect instead of error. Furthermore, it allows for greater flexibility in application by enabling incorporation of missing data, confounding covariates, and replications, which was not considered previously. The superiority of this new approach is demonstrated using simulation as well as real-life biomarker data sets used in an electroencephalography clinical study. The implementation of the Bayesian method is accessible through the Comprehensive R Archive Network. Copyright © 2015 John Wiley & Sons, Ltd.

Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care

PubMed Central

Bush, Shirley H.; Bruera, Eduardo; Lawlor, Peter G.; Kanji, Salmaan; Davis, Daniel H.J.; Agar, Meera; Wright, David; Hartwick, Michael; Currow, David C.; Gagnon, Bruno; Simon, Jessica; Pereira, José L.

2014-01-01

Context Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. Objectives This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. Methods We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. Results There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Conclusion Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. PMID:24766743

A group matrix representation relevant to scales of measurement of clinical disease states via stratified vectors.

PubMed

Sawamura, Jitsuki; Morishita, Shigeru; Ishigooka, Jun

2016-02-09

Previously, we applied basic group theory and related concepts to scales of measurement of clinical disease states and clinical findings (including laboratory data). To gain a more concrete comprehension, we here apply the concept of matrix representation, which was not explicitly exploited in our previous work. Starting with a set of orthonormal vectors, called the basis, an operator Rj (an N-tuple patient disease state at the j-th session) was expressed as a set of stratified vectors representing plural operations on individual components, so as to satisfy the group matrix representation. The stratified vectors containing individual unit operations were combined into one-dimensional square matrices [Rj]s. The [Rj]s meet the matrix representation of a group (ring) as a K-algebra. Using the same-sized matrix of stratified vectors, we can also express changes in the plural set of [Rj]s. The method is demonstrated on simple examples. Despite the incompleteness of our model, the group matrix representation of stratified vectors offers a formal mathematical approach to clinical medicine, aligning it with other branches of natural science.

Optimized diffusion gradient orientation schemes for corrupted clinical DTI data sets.

PubMed

Dubois, J; Poupon, C; Lethimonnier, F; Le Bihan, D

2006-08-01

A method is proposed for generating schemes of diffusion gradient orientations which allow the diffusion tensor to be reconstructed from partial data sets in clinical DT-MRI, should the acquisition be corrupted or terminated before completion because of patient motion. A general energy-minimization electrostatic model was developed in which the interactions between orientations are weighted according to their temporal order during acquisition. In this report, two corruption scenarios were specifically considered for generating relatively uniform schemes of 18 and 60 orientations, with useful subsets of 6 and 15 orientations. The sets and subsets were compared to conventional sets through their energy, condition number and rotational invariance. Schemes of 18 orientations were tested on a volunteer. The optimized sets were similar to uniform sets in terms of energy, condition number and rotational invariance, whether the complete set or only a subset was considered. Diffusion maps obtained in vivo were close to those for uniform sets whatever the acquisition time was. This was not the case with conventional schemes, whose subset uniformity was insufficient. With the proposed approach, sets of orientations responding to several corruption scenarios can be generated, which is potentially useful for imaging uncooperative patients or infants.

Basic investigation of the laminated alginate impression technique: Setting time, permanent deformation, elastic deformation, consistency, and tensile bond strength tests.

PubMed

Kitamura, Aya; Kawai, Yasuhiko

2015-01-01

Laminated alginate impression for edentulous is simple and time efficient compared to border molding technique. The purpose of this study was to examine clinical applicability of the laminated alginate impression, by measuring the effects of different Water/Powder (W/P) and mixing methods, and different bonding methods in the secondary impression of alginate impression. Three W/P: manufacturer-designated mixing water amount (standard), 1.5-fold (1.5×) and 1.75-fold (1.75×) water amount were mixed by manual and automatic mixing methods. Initial and complete setting time, permanent and elastic deformation, and consistency of the secondary impression were investigated (n=10). Additionally, tensile bond strength between the primary and secondary impression were measured in the following surface treatment; air blow only (A), surface baking (B), and alginate impression material bonding agent (ALGI-BOND: AB) (n=12). Initial setting times significantly shortened with automatic mixing for all W/P (p<0.05). The permanent deformation decreased and elastic deformation increased as high W/P, regardless of the mixing method. Elastic deformation significantly reduced in 1.5× and 1.75× with automatic mixing (p<0.05). All of these properties resulted within JIS standards. For all W/P, AB showed a significantly high bonding strength as compared to A and B (p<0.01). The increase of mixing water, 1.5× and 1.75×, resulted within JIS standards in setting time, suggesting its applicability in clinical setting. The use of automatic mixing device decreased elastic strain and shortening of the curing time. For the secondary impression application of adhesives on the primary impression gives secure adhesion. Copyright © 2014 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing.

PubMed

Dimech, Wayne; Karakaltsas, Marina; Vincini, Giuseppe A

2018-05-25

A general trend towards conducting infectious disease serology testing in centralized laboratories means that quality control (QC) principles used for clinical chemistry testing are applied to infectious disease testing. However, no systematic assessment of methods used to establish QC limits has been applied to infectious disease serology testing. A total of 103 QC data sets, obtained from six different infectious disease serology analytes, were parsed through standard methods for establishing statistical control limits, including guidelines from Public Health England, USA Clinical and Laboratory Standards Institute (CLSI), German Richtlinien der Bundesärztekammer (RiliBÄK) and Australian QConnect. The percentage of QC results failing each method was compared. The percentage of data sets having more than 20% of QC results failing Westgard rules when the first 20 results were used to calculate the mean±2 standard deviation (SD) ranged from 3 (2.9%) for R4S to 66 (64.1%) for 10X rule, whereas the percentage ranged from 0 (0%) for R4S to 32 (40.5%) for 10X when the first 100 results were used to calculate the mean±2 SD. By contrast, the percentage of data sets with >20% failing the RiliBÄK control limits was 25 (24.3%). Only two data sets (1.9%) had more than 20% of results outside the QConnect Limits. The rate of failure of QCs using QConnect Limits was more applicable for monitoring infectious disease serology testing compared with UK Public Health, CLSI and RiliBÄK, as the alternatives to QConnect Limits reported an unacceptably high percentage of failures across the 103 data sets.

Genome-Level Determination of Plasmodium falciparum Blood-Stage Targets of Malarial Clinical Immunity in the Peruvian Amazon

PubMed Central

Torres, Katherine J.; Castrillon, Carlos E.; Moss, Eli L.; Saito, Mayuko; Tenorio, Roy; Molina, Douglas M.; Davies, Huw; Neafsey, Daniel E.; Felgner, Philip; Vinetz, Joseph M.; Gamboa, Dionicia

2015-01-01

Background. Persons with blood-stage Plasmodium falciparum parasitemia in the absence of symptoms are considered to be clinically immune. We hypothesized that asymptomatic subjects with P. falciparum parasitemia would differentially recognize a subset of P. falciparum proteins on a genomic scale. Methods and Findings. Compared with symptomatic subjects, sera from clinically immune, asymptomatically infected individuals differentially recognized 51 P. falciparum proteins, including the established vaccine candidate PfMSP1. Novel, hitherto unstudied hypothetical proteins and other proteins not previously recognized as potential vaccine candidates were also differentially recognized. Genes encoding the proteins differentially recognized by the Peruvian clinically immune individuals exhibited a significant enrichment of nonsynonymous nucleotide variation, an observation consistent with these genes undergoing immune selection. Conclusions. A limited set of P. falciparum protein antigens was associated with the development of naturally acquired clinical immunity in the low-transmission setting of the Peruvian Amazon. These results imply that, even in a low-transmission setting, an asexual blood-stage vaccine designed to reduce clinical malaria symptoms will likely need to contain large numbers of often-polymorphic proteins, a finding at odds with many current efforts in the design of vaccines against asexual blood-stage P. falciparum. PMID:25381370

An Intimate Partner Violence informational program in a hospital fracture clinic: a pre-test post-test intervention study

PubMed Central

PREVAIL, Investigators

2017-01-01

Abstract: Background: Many organizations have conducted Intimate Partner Violence (IPV) informational campaigns, but the extent to which such cost-effective, simple changes to the clinic environment can improve patient perceptions about IPV is largely unknown. Our primary objective was to determine how an IPV informational program affects patients’ perceptions about discussing IPV in a fracture clinic setting. Methods: We conducted a pre-post intervention study to evaluate the impacts of an IPV informational program on patients’ perceptions and willingness to discuss IPV in an orthopaedic fracture clinic setting. During the intervention phase, there were posters and brochures in each bed area and several places in the waiting area, and the surgeons received a button to wear on their lab coat stating their openness to discuss IPV and a set of instructions on how to ask patients about IPV and refer them to resources. Results: A total of 160 patients (80 pre-intervention and 80 post-intervention) have participated in this study. Overall perception of the clinic as an open place in which to discuss IPV did not change as a result of the informational program compared to the control setting. However, more patients exposed to posters and information about IPV believed the clinic staff possessed resources to help IPV victims compared to the control group; however, this difference did not reach statistical significance (62% vs. 53%, respectively, p=0.29). Conclusions: Passive interventions may serve an adjunctive role in facilitating active interventions in a clinic environment, but should not be considered in isolation as an effective approach. PMID:28039685

A comparison of cosegregation analysis methods for the clinical setting.

PubMed

Rañola, John Michael O; Liu, Quanhui; Rosenthal, Elisabeth A; Shirts, Brian H

2018-04-01

Quantitative cosegregation analysis can help evaluate the pathogenicity of genetic variants. However, genetics professionals without statistical training often use simple methods, reporting only qualitative findings. We evaluate the potential utility of quantitative cosegregation in the clinical setting by comparing three methods. One thousand pedigrees each were simulated for benign and pathogenic variants in BRCA1 and MLH1 using United States historical demographic data to produce pedigrees similar to those seen in the clinic. These pedigrees were analyzed using two robust methods, full likelihood Bayes factors (FLB) and cosegregation likelihood ratios (CSLR), and a simpler method, counting meioses. Both FLB and CSLR outperform counting meioses when dealing with pathogenic variants, though counting meioses is not far behind. For benign variants, FLB and CSLR greatly outperform as counting meioses is unable to generate evidence for benign variants. Comparing FLB and CSLR, we find that the two methods perform similarly, indicating that quantitative results from either of these methods could be combined in multifactorial calculations. Combining quantitative information will be important as isolated use of cosegregation in single families will yield classification for less than 1% of variants. To encourage wider use of robust cosegregation analysis, we present a website ( http://www.analyze.myvariant.org ) which implements the CSLR, FLB, and Counting Meioses methods for ATM, BRCA1, BRCA2, CHEK2, MEN1, MLH1, MSH2, MSH6, and PMS2. We also present an R package, CoSeg, which performs the CSLR analysis on any gene with user supplied parameters. Future variant classification guidelines should allow nuanced inclusion of cosegregation evidence against pathogenicity.

Sharing clinical information across care settings: the birth of an integrated assessment system

PubMed Central

Gray, Leonard C; Berg, Katherine; Fries, Brant E; Henrard, Jean-Claude; Hirdes, John P; Steel, Knight; Morris, John N

2009-01-01

Background Population ageing, the emergence of chronic illness, and the shift away from institutional care challenge conventional approaches to assessment systems which traditionally are problem and setting specific. Methods From 2002, the interRAI research collaborative undertook development of a suite of assessment tools to support assessment and care planning of persons with chronic illness, frailty, disability, or mental health problems across care settings. The suite constitutes an early example of a "third generation" assessment system. Results The rationale and development strategy for the suite is described, together with a description of potential applications. To date, ten instruments comprise the suite, each comprising "core" items shared among the majority of instruments and "optional" items that are specific to particular care settings or situations. Conclusion This comprehensive suite offers the opportunity for integrated multi-domain assessment, enabling electronic clinical records, data transfer, ease of interpretation and streamlined training. PMID:19402891

Rapid real-time diagnostic PCR for Trichophyton rubrum and Trichophyton mentagrophytes in patients with tinea unguium and tinea pedis using specific fluorescent probes.

PubMed

Miyajima, Yoshiharu; Satoh, Kazuo; Uchida, Takao; Yamada, Tsuyoshi; Abe, Michiko; Watanabe, Shin-ichi; Makimura, Miho; Makimura, Koichi

2013-03-01

Trichophyton rubrum and Trichophyton mentagrophytes human-type (synonym, Trichophyton interdigitale (anthropophilic)) are major causative pathogens of tinea unguium. For suitable diagnosis and treatment, rapid and accurate identification of etiologic agents in clinical samples using reliable molecular based method is required. For identification of organisms causing tinea unguium, we developed a new real-time polymerase chain reaction (PCR) with a pan-fungal primer set and probe, as well as specific primer sets and probes for T. rubrum and T. mentagrophytes human-type. We designed two sets of primers from the internal transcribed spacer 1 (ITS1) region of fungal ribosomal DNA (rDNA) and three quadruple fluorescent probes, one for detection wide range pathogenic fungi and two for classification of T. rubrum and T. mentagrophytes by specific binding to different sites in the ITS1 region. We investigated the specificity of these primer sets and probes using fungal genomic DNA, and also examined 42 clinical specimens with our real-time PCR. The primers and probes specifically detected T. rubrum, T. mentagrophytes, and a wide range of pathogenic fungi. The causative pathogens were identified in 42 nail and skin samples from 32 patients. The total time required for identification of fungal species in each clinical specimen was about 3h. The copy number of each fungal DNA in the clinical specimens was estimated from the intensity of fluorescence simultaneously. This PCR system is one of the most rapid and sensitive methods available for diagnosing dermatophytosis, including tinea unguium and tinea pedis. Copyright © 2012 Japanese Society for Investigative Dermatology. Published by Elsevier Ireland Ltd. All rights reserved.

EG-09EPIGENETIC PROFILING REVEALS A CpG HYPERMETHYLATION PHENOTYPE (CIMP) ASSOCIATED WITH WORSE PROGRESSION-FREE SURVIVAL IN MENINGIOMA

PubMed Central

Olar, Adriana; Wani, Khalida; Mansouri, Alireza; Zadeh, Gelareh; Wilson, Charmaine; DeMonte, Franco; Fuller, Gregory; Jones, David; Pfister, Stefan; von Deimling, Andreas; Sulman, Erik; Aldape, Kenneth

2014-01-01

BACKGROUND: Methylation profiling of solid tumors has revealed biologic subtypes, often with clinical implications. Methylation profiles of meningioma and their clinical implications are not well understood. METHODS: Ninety-two meningioma samples (n = 44 test set and n = 48 validation set) were profiled using the Illumina HumanMethylation450 BeadChip. Unsupervised clustering and analyses for recurrence-free survival (RFS) were performed. RESULTS: Unsupervised clustering of the test set using approximately 900 highly variable markers identified two clearly defined methylation subgroups. One of the groups (n = 19) showed global hypermethylation of a set of markers, analogous to CpG island methylator phenotype (CIMP). These findings were reproducible in the validation set, with 18/48 samples showing the CIMP-positive phenotype. Importantly, of 347 highly variable markers common to both the test and validation set analyses, 107 defined CIMP in the test set and 94 defined CIMP in the validation set, with an overlap of 83 markers between the two datasets. This number is much greater than expected by chance indicating reproducibly of the hypermethylated markers that define CIMP in meningioma. With respect to clinical correlation, the 37 CIMP-positive cases displayed significantly shorter RFS compared to the 55 non-CIMP cases (hazard ratio 2.9, p = 0.013). In an effort to develop a preliminary outcome predictor, a 155-marker subset correlated with RFS was identified in the test dataset. When interrogated in the validation dataset, this 155-marker subset showed a statistical trend (p < 0.1) towards distinguishing survival groups. CONCLUSIONS: This study defines the existence of a CIMP phenotype in meningioma, which involves a substantial proportion (37/92, 40%) of samples with clinical implications. Ongoing work will expand this cohort and examine identification of additional biologic differences (mutational and DNA copy number analysis) to further characterize the aberrant methylation subtype in meningioma. CIMP-positivity with aberrant methylation in recurrent/malignant meningioma suggests a potential therapeutic target for clinically aggressive cases.

Student-Directed Video Validation of Psychomotor Skills Performance: A Strategy to Facilitate Deliberate Practice, Peer Review, and Team Skill Sets.

PubMed

DeBourgh, Gregory A; Prion, Susan K

2017-03-22

Background Essential nursing skills for safe practice are not limited to technical skills, but include abilities for determining salience among clinical data within dynamic practice environments, demonstrating clinical judgment and reasoning, problem-solving abilities, and teamwork competence. Effective instructional methods are needed to prepare new nurses for entry-to-practice in contemporary healthcare settings. Method This mixed-methods descriptive study explored self-reported perceptions of a process to self-record videos for psychomotor skill performance evaluation in a convenience sample of 102 pre-licensure students. Results Students reported gains in confidence and skill acquisition using team skills to record individual videos of skill performance, and described the importance of teamwork, peer support, and deliberate practice. Conclusion Although time consuming, the production of student-directed video validations of psychomotor skill performance is an authentic task with meaningful accountabilities that is well-received by students as an effective, satisfying learner experience to increase confidence and competence in performing psychomotor skills.

Nursing Education Interventions for Managing Acute Pain in Hospital Settings: A Systematic Review of Clinical Outcomes and Teaching Methods.

PubMed

Drake, Gareth; de C Williams, Amanda C

2017-02-01

The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Alternatives to current flow cytometry data analysis for clinical and research studies.

PubMed

Gondhalekar, Carmen; Rajwa, Bartek; Patsekin, Valery; Ragheb, Kathy; Sturgis, Jennifer; Robinson, J Paul

2018-02-01

Flow cytometry has well-established methods for data analysis based on traditional data collection techniques. These techniques typically involved manual insertion of tube samples into an instrument that, historically, could only measure 1-3 colors. The field has since evolved to incorporate new technologies for faster and highly automated sample preparation and data collection. For example, the use of microwell plates on benchtop instruments is now a standard on virtually every new instrument, and so users can easily accumulate multiple data sets quickly. Further, because the user must carefully define the layout of the plate, this information is already defined when considering the analytical process, expanding the opportunities for automated analysis. Advances in multi-parametric data collection, as demonstrated by the development of hyperspectral flow-cytometry, 20-40 color polychromatic flow cytometry, and mass cytometry (CyTOF), are game-changing. As data and assay complexity increase, so too does the complexity of data analysis. Complex data analysis is already a challenge to traditional flow cytometry software. New methods for reviewing large and complex data sets can provide rapid insight into processes difficult to define without more advanced analytical tools. In settings such as clinical labs where rapid and accurate data analysis is a priority, rapid, efficient and intuitive software is needed. This paper outlines opportunities for analysis of complex data sets using examples of multiplexed bead-based assays, drug screens and cell cycle analysis - any of which could become integrated into the clinical environment. Copyright © 2017. Published by Elsevier Inc.

Information Seeking Behaviour of Parents of Paediatric Patients for Clinical Decision Making: The Central Role of Information Literacy in a Participatory Setting

ERIC Educational Resources Information Center

Kostagiolas, Petros; Martzoukou, Konstantina; Georgantzi, Georgia; Niakas, Dimitris

2013-01-01

Introduction: This study investigated the information seeking behaviour and needs of parents of paediatric patients and their motives for seeking Internet-based information. Method: A questionnaire survey of 121 parents was conducted in a paediatric clinic of a Greek university hospital. Analysis: The data were analysed using SPSS; descriptive…

Acute kidney injury—an overview of diagnostic methods and clinical management

PubMed Central

Hertzberg, Daniel; Rydén, Linda; Pickering, John W.; Sartipy, Ulrik

2017-01-01

Abstract Acute kidney injury (AKI) is a common condition in multiple clinical settings. Patients with AKI are at an increased risk of death, over both the short and long term, and of accelerated renal impairment. As the condition has become more recognized and definitions more unified, there has been a rapid increase in studies examining AKI across many different clinical settings. This review focuses on the classification, diagnostic methods and clinical management that are available, or promising, for patients with AKI. Furthermore, preventive measures with fluids, acetylcysteine, statins and remote ischemic preconditioning, as well as when dialysis should be initiated in AKI patients are discussed. The classification of AKI includes both changes in serum creatinine concentrations and urine output. Currently, no kidney injury biomarkers are included in the classification of AKI, but proposals have been made to include them as independent diagnostic markers. Treatment of AKI is aimed at addressing the underlying causes of AKI, and at limiting damage and preventing progression. The key principles are: to treat the underlying disease, to optimize fluid balance and optimize hemodynamics, to treat electrolyte disturbances, to discontinue or dose-adjust nephrotoxic drugs and to dose-adjust drugs with renal elimination. PMID:28616210

Construction of a clinical decision support system for undergoing surgery based on domain ontology and rules reasoning.

PubMed

Bau, Cho-Tsan; Chen, Rung-Ching; Huang, Chung-Yi

2014-05-01

To construct a clinical decision support system (CDSS) for undergoing surgery based on domain ontology and rules reasoning in the setting of hospitalized diabetic patients. The ontology was created with a modified ontology development method, including specification and conceptualization, formalization, implementation, and evaluation and maintenance. The Protégé-Web Ontology Language editor was used to implement the ontology. Embedded clinical knowledge was elicited to complement the domain ontology with formal concept analysis. The decision rules were translated into JENA format, which JENA can use to infer recommendations based on patient clinical situations. The ontology includes 31 classes and 13 properties, plus 38 JENA rules that were built to generate recommendations. The evaluation studies confirmed the correctness of the ontology, acceptance of recommendations, satisfaction with the system, and usefulness of the ontology for glycemic management of diabetic patients undergoing surgery, especially for domain experts. The contribution of this research is to set up an evidence-based hybrid ontology and an evaluation method for CDSS. The system can help clinicians to achieve inpatient glycemic control in diabetic patients undergoing surgery while avoiding hypoglycemia.

Use of CHROMagar Candida for the presumptive identification of Candida species directly from clinical specimens in resource-limited settings.

PubMed

Nadeem, Sayyada Ghufrana; Hakim, Shazia Tabassum; Kazmi, Shahana Urooj

2010-02-09

Identification of yeast isolated from clinical specimens to the species level has become increasingly important. Ever-increasing numbers of immuno-suppressed patients, a widening range of recognized pathogens, and the discovery of resistance to antifungal drugs are contributing factors to this necessity. A total of 487 yeast strains were studied for the primary isolation and presumptive identification, directly from clinical specimen. Efficacy of CHROMagar Candida has been evaluated with conventional methods including morphology on Corn meal-tween 80 agar and biochemical methods by using API 20 C AUX. The result of this study shows that CHROMagar Candida can easily identify three species of Candida on the basis of colonial color and morphology, and accurately differentiate between them i.e. Candida albicans, Candida tropicalis, and Candida krusei. The specificity and sensitivity of CHROMagar Candida for C. albicans calculated as 99%, for C. tropicalis calculated as 98%, and C. krusei it is 100%. The data presented supports the use of CHROMagar Candida for the rapid identification of Candida species directly from clinical specimens in resource-limited settings, which could be very helpful in developing appropriate therapeutic strategy and management of patients.

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.

Initiating Self-Assessment Strategies in Novice Physiotherapy Students: A Method Case Study

ERIC Educational Resources Information Center

Young, Catherine

2013-01-01

Student self- and peer-assessment strategies ideally are instigated early in programmes for health professionals. This study presents an innovative method of stimulating critical evaluation of clinical skills learned in the practical class setting for first year physiotherapy students. Twice in the semester (beginning and end) students assessed…

Comparison of computer systems and ranking criteria for automatic melanoma detection in dermoscopic images.

PubMed

Møllersen, Kajsa; Zortea, Maciel; Schopf, Thomas R; Kirchesch, Herbert; Godtliebsen, Fred

2017-01-01

Melanoma is the deadliest form of skin cancer, and early detection is crucial for patient survival. Computer systems can assist in melanoma detection, but are not widespread in clinical practice. In 2016, an open challenge in classification of dermoscopic images of skin lesions was announced. A training set of 900 images with corresponding class labels and semi-automatic/manual segmentation masks was released for the challenge. An independent test set of 379 images, of which 75 were of melanomas, was used to rank the participants. This article demonstrates the impact of ranking criteria, segmentation method and classifier, and highlights the clinical perspective. We compare five different measures for diagnostic accuracy by analysing the resulting ranking of the computer systems in the challenge. Choice of performance measure had great impact on the ranking. Systems that were ranked among the top three for one measure, dropped to the bottom half when changing performance measure. Nevus Doctor, a computer system previously developed by the authors, was used to participate in the challenge, and investigate the impact of segmentation and classifier. The diagnostic accuracy when using an automatic versus the semi-automatic/manual segmentation is investigated. The unexpected small impact of segmentation method suggests that improvements of the automatic segmentation method w.r.t. resemblance to semi-automatic/manual segmentation will not improve diagnostic accuracy substantially. A small set of similar classification algorithms are used to investigate the impact of classifier on the diagnostic accuracy. The variability in diagnostic accuracy for different classifier algorithms was larger than the variability for segmentation methods, and suggests a focus for future investigations. From a clinical perspective, the misclassification of a melanoma as benign has far greater cost than the misclassification of a benign lesion. For computer systems to have clinical impact, their performance should be ranked by a high-sensitivity measure.

A Semantic Parsing Method for Mapping Clinical Questions to Logical Forms

PubMed Central

Roberts, Kirk; Patra, Braja Gopal

2017-01-01

This paper presents a method for converting natural language questions about structured data in the electronic health record (EHR) into logical forms. The logical forms can then subsequently be converted to EHR-dependent structured queries. The natural language processing task, known as semantic parsing, has the potential to convert questions to logical forms with extremely high precision, resulting in a system that is usable and trusted by clinicians for real-time use in clinical settings. We propose a hybrid semantic parsing method, combining rule-based methods with a machine learning-based classifier. The overall semantic parsing precision on a set of 212 questions is 95.6%. The parser’s rules furthermore allow it to “know what it does not know”, enabling the system to indicate when unknown terms prevent it from understanding the question’s full logical structure. When combined with a module for converting a logical form into an EHR-dependent query, this high-precision approach allows for a question answering system to provide a user with a single, verifiably correct answer. PMID:29854217

Rapid antibiotic-resistance predictions from genome sequence data for Staphylococcus aureus and Mycobacterium tuberculosis

PubMed Central

Bradley, Phelim; Gordon, N. Claire; Walker, Timothy M.; Dunn, Laura; Heys, Simon; Huang, Bill; Earle, Sarah; Pankhurst, Louise J.; Anson, Luke; de Cesare, Mariateresa; Piazza, Paolo; Votintseva, Antonina A.; Golubchik, Tanya; Wilson, Daniel J.; Wyllie, David H.; Diel, Roland; Niemann, Stefan; Feuerriegel, Silke; Kohl, Thomas A.; Ismail, Nazir; Omar, Shaheed V.; Smith, E. Grace; Buck, David; McVean, Gil; Walker, A. Sarah; Peto, Tim E. A.; Crook, Derrick W.; Iqbal, Zamin

2015-01-01

The rise of antibiotic-resistant bacteria has led to an urgent need for rapid detection of drug resistance in clinical samples, and improvements in global surveillance. Here we show how de Bruijn graph representation of bacterial diversity can be used to identify species and resistance profiles of clinical isolates. We implement this method for Staphylococcus aureus and Mycobacterium tuberculosis in a software package (‘Mykrobe predictor') that takes raw sequence data as input, and generates a clinician-friendly report within 3 minutes on a laptop. For S. aureus, the error rates of our method are comparable to gold-standard phenotypic methods, with sensitivity/specificity of 99.1%/99.6% across 12 antibiotics (using an independent validation set, n=470). For M. tuberculosis, our method predicts resistance with sensitivity/specificity of 82.6%/98.5% (independent validation set, n=1,609); sensitivity is lower here, probably because of limited understanding of the underlying genetic mechanisms. We give evidence that minor alleles improve detection of extremely drug-resistant strains, and demonstrate feasibility of the use of emerging single-molecule nanopore sequencing techniques for these purposes. PMID:26686880

Exploring the perception of nursing students about consequences of reflection in clinical settings

PubMed Central

Karimi, Shahnaz; Haghani, Fariba; Yamani, Nikoo; Kalyani, Majid Najafi

2017-01-01

Background Reflection on practical experiences is a key element that enables students to recognize their own strengths and weaknesses and develop nursing skills. Whilst reflection may enhance students’ learning in practice, there is little evidence about nursing students’ perception of the consequences of reflection in clinical settings. Objective This study aimed to explore Iranian nursing students’ perception regarding the consequences of reflection during clinical practices. Methods This qualitative study was conducted by a conventional content analysis approach in two nursing schools at Shiraz and Fasa Universities of Medical Sciences in Iran. Data were collected through in-depth semi-structured interviews during 2015–2016, from 20 students selected by purposive sampling. All the interviews were tape-recorded, transcribed verbatim, and analyzed by content analysis method. Rigor of this study was approved by member check and external audit. Results Two categories emerged from the data analysis, including movement toward professionalism and self-actualization of emotions. The former consisted of three subcategories of function modification, sharing experiences and generalizing experiences. The latter consisted of two subcategories of inner satisfaction and peace of mind. Conclusion The results indicated that nursing students’ reflection in clinical settings is effective in personal and professional levels. Reflection in a personal level led to positive emotions that increased the quality of care in patients. Accordingly, nursing educators need to create a nurturing climate as well as supporting reflective behaviors of nursing students. PMID:29038696

An innovative system for 3D clinical photography in the resource-limited settings

PubMed Central

2014-01-01

Background Kaposi’s sarcoma (KS) is the most frequently occurring cancer in Mozambique among men and the second most frequently occurring cancer among women. Effective therapeutic treatments for KS are poorly understood in this area. There is an unmet need to develop a simple but accurate tool for improved monitoring and diagnosis in a resource-limited setting. Standardized clinical photographs have been considered to be an essential part of the evaluation. Methods When a therapeutic response is achieved, nodular KS often exhibits a reduction of the thickness without a change in the base area of the lesion. To evaluate the vertical space along with other characters of a KS lesion, we have created an innovative imaging system with a consumer light-field camera attached to a miniature “photography studio” adaptor. The image file can be further processed by computational methods for quantification. Results With this novel imaging system, each high-quality 3D image was consistently obtained with a single camera shot at bedside by minimally trained personnel. After computational processing, all-focused photos and measurable 3D parameters were obtained. More than 80 KS image sets were processed in a semi-automated fashion. Conclusions In this proof-of-concept study, the feasibility to use a simple, low-cost and user-friendly system has been established for future clinical study to monitor KS therapeutic response. This 3D imaging system can be also applied to obtain standardized clinical photographs for other diseases. PMID:24929434

Recommendations for Selecting Drug-Drug Interactions for Clinical Decision Support

PubMed Central

Tilson, Hugh; Hines, Lisa E.; McEvoy, Gerald; Weinstein, David M.; Hansten, Philip D.; Matuszewski, Karl; le Comte, Marianne; Higby-Baker, Stefanie; Hanlon, Joseph T.; Pezzullo, Lynn; Vieson, Kathleen; Helwig, Amy L.; Huang, Shiew-Mei; Perre, Anthony; Bates, David W.; Poikonen, John; Wittie, Michael A.; Grizzle, Amy J.; Brown, Mary; Malone, Daniel C.

2016-01-01

Purpose To recommend principles for including drug-drug interactions (DDIs) in clinical decision support. Methods A conference series was conducted to improve clinical decision support (CDS) for DDIs. The Content Workgroup met monthly by webinar from January 2013 to February 2014, with two in-person meetings to reach consensus. The workgroup consisted of 20 experts in pharmacology, drug information, and CDS from academia, government agencies, health information (IT) vendors, and healthcare organizations. Workgroup members addressed four key questions: (1) What process should be used to develop and maintain a standard set of DDIs?; (2) What information should be included in a knowledgebase of standard DDIs?; (3) Can/should a list of contraindicated drug pairs be established?; and (4) How can DDI alerts be more intelligently filtered? Results To develop and maintain a standard set of DDIs for CDS in the United States, we recommend a transparent, systematic, and evidence-driven process with graded recommendations by a consensus panel of experts and oversight by a national organization. We outline key DDI information needed to help guide clinician decision-making. We recommend judicious classification of DDIs as contraindicated, as only a small set of drug combinations are truly contraindicated. Finally, we recommend more research to identify methods to safely reduce repetitive and less relevant alerts. Conclusion A systematic ongoing process is necessary to select DDIs for alerting clinicians. We anticipate that our recommendations can lead to consistent and clinically relevant content for interruptive DDIs, and thus reduce alert fatigue and improve patient safety. PMID:27045070

Detecting borderline infection in an automated monitoring system for healthcare-associated infection using fuzzy logic.

PubMed

de Bruin, Jeroen S; Adlassnig, Klaus-Peter; Blacky, Alexander; Koller, Walter

2016-05-01

Many electronic infection detection systems employ dichotomous classification methods, classifying patient data as pathological or normal with respect to one or several types of infection. An electronic monitoring and surveillance system for healthcare-associated infections (HAIs) known as Moni-ICU is being operated at the intensive care units (ICUs) of the Vienna General Hospital (VGH) in Austria. Instead of classifying patient data as pathological or normal, Moni-ICU introduces a third borderline class. Patient data classified as borderline with respect to an infection-related clinical concept or HAI surveillance definition signify that the data nearly or partly fulfill the definition for the respective concept or HAI, and are therefore neither fully pathological nor fully normal. Using fuzzy sets and propositional fuzzy rules, we calculated how frequently patient data are classified as normal, borderline, or pathological with respect to infection-related clinical concepts and HAI definitions. In dichotomous classification methods, borderline classification results would be confounded by normal. Therefore, we also assessed whether the constructed fuzzy sets and rules employed by Moni-ICU classified patient data too often or too infrequently as borderline instead of normal. Electronic surveillance data were collected from adult patients (aged 18 years or older) at ten ICUs of the VGH. All adult patients admitted to these ICUs over a two-year period were reviewed. In all 5099 patient stays (4120 patients) comprising 49,394 patient days were evaluated. For classification, a part of Moni-ICU's knowledge base comprising fuzzy sets and rules for ten infection-related clinical concepts and four top-level HAI definitions was employed. Fuzzy sets were used for the classification of concepts directly related to patient data; fuzzy rules were employed for the classification of more abstract clinical concepts, and for top-level HAI surveillance definitions. Data for each clinical concept and HAI definition were classified as either normal, borderline, or pathological. For the assessment of fuzzy sets and rules, we compared how often a borderline value for a fuzzy set or rule would result in a borderline value versus a normal value for its associated HAI definition(s). The statistical significance of these comparisons was expressed in p-values calculated with Fisher's exact test. The results showed that, for clinical concepts represented by fuzzy sets, 1-17% of the data were classified as borderline. The number was substantially higher (20-81%) for fuzzy rules representing more abstract clinical concepts. A small body of data were found to be in the borderline range for the four top-level HAI definitions (0.02-2.35%). Seven of ten fuzzy sets and rules were associated significantly more often with borderline values than with normal values for their respective HAI definition(s) (p<0.001). The study showed that Moni-ICU was effective in classifying patient data as borderline for infection-related concepts and top-level HAI surveillance definitions. Copyright © 2016 Elsevier B.V. All rights reserved.

Achilles tenotomy as an office procedure and current practising trends among New Zealand orthopaedic surgeons.

PubMed

Agius, Lewis; Wickham, Angus; Walker, Cameron; Knudsen, Joshua

2018-05-18

Percutaneous Achilles tenotomy (PAT) is performed during the final phase of casting with Ponseti method. Several settings have been proposed as venues for this procedure, however it is increasingly being performed in theatre under a general anaesthetic (GA). General anaesthesia, however, is expensive and not without risks. The purpose of the present study was to compare results of outpatient releases to theatre releases, and assess current practising trends among orthopaedic surgeons. Retrospective comparison of patients with idiopathic clubfoot managed by Ponseti method who had Achilles tenotomy performed in outpatient clinic and in theatre. Surveys were sent to all POSNZ members to determine current practising trends in New Zealand. Parental satisfaction surveys were performed. Comparative cost analysis was performed using hospital billing information. The current study includes 64 idiopathic congenital clubfeet (19 bilateral cases). PAT was performed on 26 clubfeet under local anaesthetic in an outpatient setting, and 33 clubfeet under GA in a theatre setting. There was no significant difference for post-operative complications, or recurrence (p=0.67). Those in theatre group were exposed to a greater number of general anaesthetics before the age of four. Among practising New Zealand paediatric orthopaedic surgeons, 77.78% perform this in theatre under general anaesthesia, while only 22.22% perform PAT in outpatient clinic. The main barriers included concerns regarding pain control, concerns regarding incomplete release, concerns regarding distress to family and concerns regarding sterility. Parental satisfaction surveys found pain management to be excellent. Financial data was analysed and indicative costs were $6,061 NZD per procedure in theatre, compared to $378 NZD per procedure in clinic. PAT performed in a clinic setting is both safe and efficacious with results comparative to that performed in theatre. There was no difference in post-operative complications or recurrence. Parental satisfaction to this procedure is excellent. There are significant financial advantages. Based on this data, our institution now performs all releases in an outpatient setting.

Application of A Mobile Platform-based System for the Management of Fundus Diease in Outpatient Settings.

PubMed

Dend, Xun; Li, Hong-Yan; Yin, Hong; Liang, Jian-Hong; Chen, Yi; Li, Xiao-Xin; Zhao, Ming-Wei

2016-08-01

Objective To evaluate the application of a mobile platform-based system in the management of fundus disease in outpatient settings. Methods In the outpatient departments of fundus disease,premature babies requiring eye examination under general anesthesia and adults requiring intraocular surgery were enrolled as the subjects. According to the existing clinical practices,we developed a system that met the requirements of clinical practices and optimized the clinical management. Based on the FileMaker database,the tablet computers were used as the mobile platform and the system could also be run in iPad and PC terminals.Results Since 2013,the system recorded 7500 cases of special examinations. Since July 2015,4100 cases of intravitreal drug injection were also recored in the system. Multiple-point and real-time reservation pattern increased the efficiency and opimize the clinical management. All the clinical data were digitalized. Conclusion The mobile platform-based system can increase the efficacy of examination and other clinical processes and standardize data collection;thus,it is feasible for the clinical practices in outpatient departments of ophthalmology.

Postgraduate general dentistry residency: a clinical model.

PubMed

Gowan, J

1995-01-01

Dental graduates today are expected to be knowledgeable in many more areas than their predecessors. Changing technology and increased competition require entering the dental profession with more experience and skills. One approach to achieving this skill level is a postgraduate general dentistry residency in a clinical setting during the year following dental school graduation (PGY1). The clinical residency provides new dentists with additional hands-on training and reinforces classroom learning. HealthPartners was selected as a clinical rotation for residents in the advanced general dentistry program at the University of Minnesota Dental School. The program provides dental graduates in PGY1 training in all areas of practice. The HealthPartners rotation is highly unique. It is a staff model HMO with a clinical, multi-specialty setting. Today, HealthPartners--a Minnesota-based healthcare organization--has 116,000 members with prepaid dental benefits. Residents trained in the program develop increased skills in all areas of dental practice. In addition, they develop a good working knowledge in the basic sciences. Methods of instruction include didactic training in the form of seminars, lectures, and clinical training in HealthPartners' dental clinics.

Precise determination of time to reach viral load set point after acute HIV-1 infection.

PubMed

Huang, Xiaojie; Chen, Hui; Li, Wei; Li, Haiying; Jin, Xia; Perelson, Alan S; Fox, Zoe; Zhang, Tong; Xu, Xiaoning; Wu, Hao

2012-12-01

The HIV viral load set point has long been used as a prognostic marker of disease progression and more recently as an end-point parameter in HIV vaccine clinical trials. The definition of set point, however, is variable. Moreover, the earliest time at which the set point is reached after the onset of infection has never been clearly defined. In this study, we obtained sequential plasma viral load data from 60 acutely HIV-infected Chinese patients among a cohort of men who have sex with men, mathematically determined viral load set point levels, and estimated time to attain set point after infection. We also compared the results derived from our models and that obtained from an empirical method. With novel uncomplicated mathematic model, we discovered that set points may vary from 21 to 119 days dependent on the patients' initial viral load trajectory. The viral load set points were 4.28 ± 0.86 and 4.25 ± 0.87 log10 copies per milliliter (P = 0.08), respectively, as determined by our model and an empirical method, suggesting an excellent agreement between the old and new methods. We provide a novel method to estimate viral load set point at the very early stage of HIV infection. Application of this model can accurately and reliably determine the set point, thus providing a new tool for physicians to better monitor early intervention strategies in acutely infected patients and scientists to rationally design preventative vaccine studies.

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.

Machine Learning Approaches for Clinical Psychology and Psychiatry.

PubMed

Dwyer, Dominic B; Falkai, Peter; Koutsouleris, Nikolaos

2018-05-07

Machine learning approaches for clinical psychology and psychiatry explicitly focus on learning statistical functions from multidimensional data sets to make generalizable predictions about individuals. The goal of this review is to provide an accessible understanding of why this approach is important for future practice given its potential to augment decisions associated with the diagnosis, prognosis, and treatment of people suffering from mental illness using clinical and biological data. To this end, the limitations of current statistical paradigms in mental health research are critiqued, and an introduction is provided to critical machine learning methods used in clinical studies. A selective literature review is then presented aiming to reinforce the usefulness of machine learning methods and provide evidence of their potential. In the context of promising initial results, the current limitations of machine learning approaches are addressed, and considerations for future clinical translation are outlined.

Clinical governance—watchword or buzzword?

PubMed Central

Campbell, A.

2001-01-01

In the latest reform of the National Health Service great emphasis has been placed on the achievement and maintenance of quality. Mechanisms for ensuring this are being set up under the general title of "clinical governance". What is the meaning of this term? The metaphor behind the phrase is of navigation through stormy seas, but who guides the helmsman? Clinical ethics committees could have a part to play in these changes, provided their role is properly understood. Clinical governance is concerned with management according to an agreed set of aims. The task of ethics committees is Socratic rather than managerial. They should ask fundamental questions about the ethical norms of the services provided and give critical appraisal of the moral character of institutional policies. If these tasks are carried out then governance may become a watchword rather than just another buzzword. Key Words: Governance • quality • National Health Service (NHS) • ethics committees • Socratic method NHS PMID:11314615

Clinical interdisciplinary health team care: an educational experiment.

PubMed

Mazur, H; Beeston, J J; Yerxa, E J

1979-09-01

With increasing concern for teamwork in clinical practice in health care settings, the need to identify the concepts, methods, and learning processes for improving interdisciplinary team skills is apparent. This paper describes patient-centered, clinical-research-demonstration programs for teams of students, preceptors, and faculty members from six disciplines who provided patient care in a long-term rehabilitation setting. The teams were involved in the theory and practice of team-building, including weekly sessions on leadership styles, communication, group decision-making, and team effectiveness assessment. Objective and subjective measurements were administered throughout the program. The results indicate that task-oriented patient care favors the learning of team skills, especially when all levels of administration support and participate in the processes. Question are raised concerning the effect of clinical teams on the quality of patient care, their cost-effectiveness, and the low priority given to teaching interdisciplinary team skills in professional education.

Method for Automatic Selection of Parameters in Normal Tissue Complication Probability Modeling.

PubMed

Christophides, Damianos; Appelt, Ane L; Gusnanto, Arief; Lilley, John; Sebag-Montefiore, David

2018-07-01

To present a fully automatic method to generate multiparameter normal tissue complication probability (NTCP) models and compare its results with those of a published model, using the same patient cohort. Data were analyzed from 345 rectal cancer patients treated with external radiation therapy to predict the risk of patients developing grade 1 or ≥2 cystitis. In total, 23 clinical factors were included in the analysis as candidate predictors of cystitis. Principal component analysis was used to decompose the bladder dose-volume histogram into 8 principal components, explaining more than 95% of the variance. The data set of clinical factors and principal components was divided into training (70%) and test (30%) data sets, with the training data set used by the algorithm to compute an NTCP model. The first step of the algorithm was to obtain a bootstrap sample, followed by multicollinearity reduction using the variance inflation factor and genetic algorithm optimization to determine an ordinal logistic regression model that minimizes the Bayesian information criterion. The process was repeated 100 times, and the model with the minimum Bayesian information criterion was recorded on each iteration. The most frequent model was selected as the final "automatically generated model" (AGM). The published model and AGM were fitted on the training data sets, and the risk of cystitis was calculated. The 2 models had no significant differences in predictive performance, both for the training and test data sets (P value > .05) and found similar clinical and dosimetric factors as predictors. Both models exhibited good explanatory performance on the training data set (P values > .44), which was reduced on the test data sets (P values < .05). The predictive value of the AGM is equivalent to that of the expert-derived published model. It demonstrates potential in saving time, tackling problems with a large number of parameters, and standardizing variable selection in NTCP modeling. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Effect of postmortem sampling technique on the clinical significance of autopsy blood cultures.

PubMed

Hove, M; Pencil, S D

1998-02-01

Our objective was to investigate the value of postmortem autopsy blood cultures performed with an iodine-subclavian technique relative to the classical method of atrial heat searing and antemortem blood cultures. The study consisted of a prospective autopsy series with each case serving as its own control relative to subsequent testing, and a retrospective survey of patients coming to autopsy who had both autopsy blood cultures and premortem blood cultures. A busy academic autopsy service (600 cases per year) at University of Texas Medical Branch Hospitals, Galveston, Texas, served as the setting for this work. The incidence of non-clinically relevant (false-positive) culture results were compared using different methods for collecting blood samples in a prospective series of 38 adult autopsy specimens. One hundred eleven adult autopsy specimens in which both postmortem and antemortem blood cultures were obtained were studied retrospectively. For both studies, positive culture results were scored as either clinically relevant or false positives based on analysis of the autopsy findings and the clinical summary. The rate of false-positive culture results obtained by an iodine-subclavian technique from blood drawn soon after death were statistically significantly lower (13%) than using the classical method of obtaining blood through the atrium after heat searing at the time of the autopsy (34%) in the same set of autopsy subjects. When autopsy results were compared with subjects' antemortem blood culture results, there was no significant difference in the rate of non-clinically relevant culture results in a paired retrospective series of antemortem blood cultures and postmortem blood cultures using the iodine-subclavian postmortem method (11.7% v 13.5%). The results indicate that autopsy blood cultures obtained using the iodine-subclavian technique have reliability equivalent to that of antemortem blood cultures.

Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

PubMed Central

Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins

2014-01-01

Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191

Barriers of physical assessment skills among nursing students in Arab Peninsula

PubMed Central

Alamri, Majed Sulaiman; Almazan, Joseph U.

2018-01-01

Objective: There is a growing demand for health-care nursing services in several health care institutions. Understanding barriers to physical assessment among nursing students create a more detailed assessment in the development of quality patient’s care in nursing practice. This study examined the barriers to physical assessment skills among nursing students in a government university in Arab Peninsula. Methods: A cross-sectional research survey design of 206 nursing students using a standardized questionnaire was used. The questionnaire is composed of 7 subscales in evaluating the barriers to physical assessment skills between the classroom and clinical setting. Independent Samples t-test was used in comparing the gender mean of the nursing students about the barriers to physical assessment. Paired t-test was also used in determining the differences between perceived barriers to physical assessment in the classroom and clinical setting. Results: Subscale “reliance on others and technology,” ward culture, “lack of influence on patient care” have significant differences between perceived barriers in physical assessment among classroom settings and clinical setting. Conclusion: Although nursing students were oriented and educated about physical assessment in the nursing curriculum, this is not often practiced in clinical settings. The point that is if nursing students are incorrectly performing the patient assessment, then no amount of critical thinking could lead to better clinical decisions. Continuous exposure and enhancing the quality of planning and promotion of the nursing students could develop necessary skills. In addition, increasing self-confidence is vital to assess the patient’s health status effectively and minimize the barriers to performing the physical assessment. PMID:29896073

Transportation cost of anticoagulation clinic visits in an urban setting.

PubMed

Hwang, Jamie M; Clemente, Jennifer; Sharma, Krishna P; Taylor, Thomas N; Garwood, Candice L

2011-10-01

Patients being managed on warfarin make frequent or regular visits to anticoagulation monitoring appointments. International studies have evaluated transportation cost and associated time related to anticoagulation clinic visits. To our knowledge, no studies have evaluated the cost of transportation to such clinic visits in the United States. To describe the methods of transportation and estimate the average total cost of transportation to and from an anticoagulation clinic in an urban setting. We prospectively conducted a survey of patients treated at the Harper Anticoagulation Clinic located in Detroit, Michigan, during November 2010. The survey was given to patients while waiting at their regularly scheduled clinic appointments and included questions regarding mode of transportation, distance traveled in miles, parking payment, and time missed from work for clinic appointments. The mean distance traveled was translated into cost assuming 50 cents per mile based on 2010 estimates by the Internal Revenue Service. Sixty patients responded to the 11-item survey; response rates for individual items varied because participants were instructed to skip questions that did not pertain to them. Of the 47 participants responding to demographic questions, 70.2% were female, and 46.8% were older than 60 years. Transportation by private vehicle (80.0%), either driven by patients (41.7%) or someone else (38.3%), was the most common method reported. Use of private automobile translated into a cost of $11.19 per round trip. Other means of transportation identified include a ride from a medical transportation service (10.0%), bus (5.0%), walking (3.3%), and taxi (1.7%). The mean (SD) distance traveled to the clinic for all methods of transportation was 8.34 (7.7) miles. We estimated the average cost of round-trip transportation to be $10.78 weighted for all transportation modes. This is a direct nonmedical cost that is paid for by most patients out of pocket. However, 9 of 44 (20.5%) responded that their insurance plans provided at least some coverage for their rides to the anticoagulation clinic. Most participants stated that they did not take any time off work for clinic visits (88%) primarily because a large proportion of the study population was unemployed or retired. The round-trip cost of transportation to an anticoagulation clinic in an urban setting in the United States may translate into a substantial expense, ranging from weekly appointments ($560 annually) to once monthly appointments ($130 annually).

Progress on core outcome sets for critical care research.

PubMed

Blackwood, Bronagh; Marshall, John; Rose, Louise

2015-10-01

Appropriate selection and definition of outcome measures are essential for clinical trials to be maximally informative. Core outcome sets (an agreed, standardized collection of outcomes measured and reported in all trials for a specific clinical area) were developed due to established inconsistencies in trial outcome selection. This review discusses the rationale for, and methods of, core outcome set development, as well as current initiatives in critical care. Recent systematic reviews of reported outcomes and measurement instruments relevant to the critically ill highlight inconsistencies in outcome selection, definition, and measurement, thus establishing the need for core outcome sets. Current critical care initiatives include development of core outcome sets for trials aimed at reducing mechanical ventilation duration; rehabilitation following critical illness; long-term outcomes in acute respiratory failure; and epidemic and pandemic studies of severe acute respiratory infection. Development and utilization of core outcome sets for studies relevant to the critically ill is in its infancy compared to other specialties. Notwithstanding, core outcome set development frameworks and guidelines are available, several sets are in various stages of development, and there is strong support from international investigator-led collaborations including the International Forum for Acute Care Trialists.

Community-based field implementation scenarios of a short message service reporting tool for lymphatic filariasis case estimates in Africa and Asia.

PubMed

Mableson, Hayley E; Martindale, Sarah; Stanton, Michelle C; Mackenzie, Charles; Kelly-Hope, Louise A

2017-01-01

Lymphatic filariasis (LF) is a neglected tropical disease (NTD) targeted for global elimination by 2020. Currently there is considerable international effort to scale-up morbidity management activities in endemic countries, however there remains a need for rapid, cost-effective methods and adaptable tools for obtaining estimates of people presenting with clinical manifestations of LF, namely lymphoedema and hydrocele. The mHealth tool ' MeasureSMS-Morbidity ' allows health workers in endemic areas to use their own mobile phones to send clinical information in a simple format using short message service (SMS). The experience gained through programmatic use of the tool in five endemic countries across a diversity of settings in Africa and Asia is used here to present implementation scenarios that are suitable for adapting the tool for use in a range of different programmatic, endemic, demographic and health system settings. A checklist of five key factors and sub-questions was used to determine and define specific community-based field implementation scenarios for using the MeasureSMS-Morbidity tool in a range of settings. These factors included: (I) tool feasibility (acceptability; community access and ownership); (II) LF endemicity (high; low prevalence); (III) population demography (urban; rural); (IV) health system structure (human resources; community access); and (V) integration with other diseases (co-endemicity). Based on experiences in Bangladesh, Ethiopia, Malawi, Nepal and Tanzania, four implementation scenarios were identified as suitable for using the MeasureSMS-Morbidity tool for searching and reporting LF clinical case data across a range of programmatic, endemic, demographic and health system settings. These include: (I) urban, high endemic setting with two-tier reporting; (II) rural, high endemic setting with one-tier reporting; (III) rural, high endemic setting with two-tier reporting; and (IV) low-endemic, urban and rural setting with one-tier reporting. A decision-making framework built from the key factors and questions, and the resulting four implementation scenarios is proposed as a means of using the MeasureSMS-Morbidity tool. This framework will help national LF programmes consider appropriate methods to implement a survey using this tool to improve estimates of the clinical burden of LF. Obtaining LF case estimates is a vital step towards the elimination of LF as a public health problem in endemic countries.

Automatic analysis of nuclear-magnetic-resonance-spectroscopy clinical research data

NASA Astrophysics Data System (ADS)

Scott, Katherine N.; Wilson, David C.; Bruner, Angela P.; Lyles, Teresa A.; Underhill, Brandon; Geiser, Edward A.; Ballinger, J. Ray; Scott, James D.; Stopka, Christine B.

1998-03-01

A major problem of P-31 nuclear magnetic spectroscopy (MRS) in vivo applications is that when large data sets are acquired, the time invested in data reduction and analysis with currently available technologies may totally overshadow the time required for data acquisition. An example is out MRS monitoring of exercise therapy for patients with peripheral vascular disease. In these, the spectral acquisition requires 90 minutes per patient study, whereas data analysis and reduction requires 6-8 hours. Our laboratory currently uses the proprietary software SA/GE developed by General Electric. However, other software packages have similar limitations. When data analysis takes this long, the researcher does not have the rapid feedback required to ascertain the quality of data acquired nor the result of the study. This highly undesirable even in a research environment, but becomes intolerable in the clinical setting. The purpose of this report is to outline progress towards the development of an automated method for eliminating the spectral analysis burden on the researcher working in the clinical setting.

Reference-free ground truth metric for metal artifact evaluation in CT images.

PubMed

Kratz, Bärbel; Ens, Svitlana; Müller, Jan; Buzug, Thorsten M

2011-07-01

In computed tomography (CT), metal objects in the region of interest introduce data inconsistencies during acquisition. Reconstructing these data results in an image with star shaped artifacts induced by the metal inconsistencies. To enhance image quality, the influence of the metal objects can be reduced by different metal artifact reduction (MAR) strategies. For an adequate evaluation of new MAR approaches a ground truth reference data set is needed. In technical evaluations, where phantoms can be measured with and without metal inserts, ground truth data can easily be obtained by a second reference data acquisition. Obviously, this is not possible for clinical data. Here, an alternative evaluation method is presented without the need of an additionally acquired reference data set. The proposed metric is based on an inherent ground truth for metal artifacts as well as MAR methods comparison, where no reference information in terms of a second acquisition is needed. The method is based on the forward projection of a reconstructed image, which is compared to the actually measured projection data. The new evaluation technique is performed on phantom and on clinical CT data with and without MAR. The metric results are then compared with methods using a reference data set as well as an expert-based classification. It is shown that the new approach is an adequate quantification technique for artifact strength in reconstructed metal or MAR CT images. The presented method works solely on the original projection data itself, which yields some advantages compared to distance measures in image domain using two data sets. Beside this, no parameters have to be manually chosen. The new metric is a useful evaluation alternative when no reference data are available.

Linking metabolic network features to phenotypes using sparse group lasso.

PubMed

Samal, Satya Swarup; Radulescu, Ovidiu; Weber, Andreas; Fröhlich, Holger

2017-11-01

Integration of metabolic networks with '-omics' data has been a subject of recent research in order to better understand the behaviour of such networks with respect to differences between biological and clinical phenotypes. Under the conditions of steady state of the reaction network and the non-negativity of fluxes, metabolic networks can be algebraically decomposed into a set of sub-pathways often referred to as extreme currents (ECs). Our objective is to find the statistical association of such sub-pathways with given clinical outcomes, resulting in a particular instance of a self-contained gene set analysis method. In this direction, we propose a method based on sparse group lasso (SGL) to identify phenotype associated ECs based on gene expression data. SGL selects a sparse set of feature groups and also introduces sparsity within each group. Features in our model are clusters of ECs, and feature groups are defined based on correlations among these features. We apply our method to metabolic networks from KEGG database and study the association of network features to prostate cancer (where the outcome is tumor and normal, respectively) as well as glioblastoma multiforme (where the outcome is survival time). In addition, simulations show the superior performance of our method compared to global test, which is an existing self-contained gene set analysis method. R code (compatible with version 3.2.5) is available from http://www.abi.bit.uni-bonn.de/index.php?id=17. samal@combine.rwth-aachen.de or frohlich@bit.uni-bonn.de. Supplementary data are available at Bioinformatics online. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

'CHEATS': a generic information communication technology (ICT) evaluation framework.

PubMed

Shaw, Nicola T

2002-05-01

This paper describes a generic framework for the evaluation of information communication technologies. This framework, CHEATS, utilises both qualitative and quantitative research methods and has proved appropriate in multiple clinical settings including telepsychiatry, teledermatology and teleeducation. The paper demonstrates how a multidisciplinary approach is essential when evaluating new and emerging technologies, particularly when such systems are implemented in real service as opposed to a research setting.

Significance testing of clinical data using virus dynamics models with a Markov chain Monte Carlo method: application to emergence of lamivudine-resistant hepatitis B virus.

PubMed Central

Burroughs, N J; Pillay, D; Mutimer, D

1999-01-01

Bayesian analysis using a virus dynamics model is demonstrated to facilitate hypothesis testing of patterns in clinical time-series. Our Markov chain Monte Carlo implementation demonstrates that the viraemia time-series observed in two sets of hepatitis B patients on antiviral (lamivudine) therapy, chronic carriers and liver transplant patients, are significantly different, overcoming clinical trial design differences that question the validity of non-parametric tests. We show that lamivudine-resistant mutants grow faster in transplant patients than in chronic carriers, which probably explains the differences in emergence times and failure rates between these two sets of patients. Incorporation of dynamic models into Bayesian parameter analysis is of general applicability in medical statistics. PMID:10643081

Automated encoding of clinical documents based on natural language processing.

PubMed

Friedman, Carol; Shagina, Lyudmila; Lussier, Yves; Hripcsak, George

2004-01-01

The aim of this study was to develop a method based on natural language processing (NLP) that automatically maps an entire clinical document to codes with modifiers and to quantitatively evaluate the method. An existing NLP system, MedLEE, was adapted to automatically generate codes. The method involves matching of structured output generated by MedLEE consisting of findings and modifiers to obtain the most specific code. Recall and precision applied to Unified Medical Language System (UMLS) coding were evaluated in two separate studies. Recall was measured using a test set of 150 randomly selected sentences, which were processed using MedLEE. Results were compared with a reference standard determined manually by seven experts. Precision was measured using a second test set of 150 randomly selected sentences from which UMLS codes were automatically generated by the method and then validated by experts. Recall of the system for UMLS coding of all terms was .77 (95% CI.72-.81), and for coding terms that had corresponding UMLS codes recall was .83 (.79-.87). Recall of the system for extracting all terms was .84 (.81-.88). Recall of the experts ranged from .69 to .91 for extracting terms. The precision of the system was .89 (.87-.91), and precision of the experts ranged from .61 to .91. Extraction of relevant clinical information and UMLS coding were accomplished using a method based on NLP. The method appeared to be comparable to or better than six experts. The advantage of the method is that it maps text to codes along with other related information, rendering the coded output suitable for effective retrieval.

Some strategies to address the challenges of collecting observational data in a busy clinical environment.

PubMed

Jackson, Debra; McDonald, Glenda; Luck, Lauretta; Waine, Melissa; Wilkes, Lesley

2016-01-01

Studies drawing on observational methods can provide vital data to enhance healthcare. However, collecting observational data in clinical settings is replete with challenges, particularly where multiple data-collecting observers are used. Observers collecting data require shared understanding and training to ensure data quality, and particularly, to confirm accurate and consistent identification, discrimination and recording of data. The aim of this paper is to describe strategies for preparing and supporting multiple researchers tasked with collecting observational data in a busy, and often unpredictable, hospital environment. We hope our insights might assist future researchers undertaking research in similar settings.

Meta-analysis in clinical trials revisited.

PubMed

DerSimonian, Rebecca; Laird, Nan

2015-11-01

In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. Published by Elsevier Inc.

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials

PubMed Central

Connor, Jason T.; Ayers, Gregory D; Alvarez, JoAnn

2014-01-01

Background Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. Purpose We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods. Results For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. Limitations Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval. Conclusions The use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision making process. PMID:24872363

Simultaneous use of multiplex ligation-dependent probe amplification assay and flow cytometric DNA ploidy analysis in patients with acute leukemia.

PubMed

Reyes-Núñez, Virginia; Galo-Hooker, Evelyn; Pérez-Romano, Beatriz; Duque, Ricardo E; Ruiz-Arguelles, Alejandro; Garcés-Eisele, Javier

2018-01-01

The aim of this work was to simultaneously use multiplex ligation-dependent probe amplification (MLPA) assay and flow cytometric DNA ploidy analysis (FPA) to detect aneuploidy in patients with newly diagnosed acute leukemia. MLPA assay and propidium iodide FPA were used to test samples from 53 consecutive patients with newly diagnosed acute leukemia referred to our laboratory for immunophenotyping. Results were compared by nonparametric statistics. The combined use of both methods significantly increased the rate of detection of aneuploidy as compared to that obtained by each method alone. The limitations of one method are somehow countervailed by the other and vice versa. MPLA and FPA yield different yet complementary information concerning aneuploidy in acute leukemia. The simultaneous use of both methods might be recommended in the clinical setting. © 2017 International Clinical Cytometry Society. © 2017 International Clinical Cytometry Society.

The usefulness of mobile insulator sheets for the optimisation of deep heating area for regional hyperthermia using a capacitively coupled heating method: phantom, simulation and clinical prospective studies.

PubMed

Tomura, Kyosuke; Ohguri, Takayuki; Mulder, Hendrik Thijmen; Murakami, Motohiro; Nakahara, Sota; Yahara, Katsuya; Korogi, Yukunori

2017-11-20

To evaluate the feasibility and efficacy of deep regional hyperthermia with the use of mobile insulator sheets in a capacitively coupled heating device. The heat was applied using an 8-MHz radiofrequency-capacitive device. The insulator sheet was inserted between the regular bolus and cooled overlay bolus in each of upper and lower side of the electrode. Several settings using the insulator sheets were investigated in an experimental study using an agar phantom to evaluate the temperature distributions. The specific absorption rate (SAR) distributions in several organs were also computed for the three-dimensional patient model. In a clinical prospective study, a total of five heating sessions were scheduled for the pelvic tumours, to assess the thermal parameters. The conventional setting was used during the first, third and fifth treatment sessions, and insulator sheets were used during the second and fourth treatment sessions. In the phantom study, the higher heating area improved towards the centre when the mobile insulator sheets were used. The subcutaneous fat/target ratios for the averaged SARs in the setting with the mobile insulator (median, 2.5) were significantly improved compared with those in the conventional setting (median, 3.4). In the clinical study, the thermal dose parameters of CEM43°CT90 in the sessions with the mobile insulator sheets (median, 1.9 min) were significantly better than those in the sessions using a conventional setting (median, 1.0 min). Our novel heating method using mobile insulator sheets was thus found to improve the thermal dose parameters. Further investigations are expected.

Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps

PubMed Central

Hedlund, Nancy; Sarangpur, Shishir; Kayler, Shannon; O'Brien, Kathy

2017-01-01

This retrospective study of 6426 hip replacement, coronary artery bypass graft, and colectomy surgeries across 23 US hospitals found that intravenous (IV) set designs that can be interchanged for use both in gravity-fed and automated pump delivery systems are replaced less frequently than IV sets designed for use primarily by one delivery method. Semistructured interviews with nurses highlighted the impact of set design on nursing workflow when moving between gravity-fed and pump-based administration. Use of interchangeable, single-design IV sets across gravity and automated infusions minimizes disruptions to closed systems, may reduce nurses being distracted from patients' clinical needs when replacing sets, and may yield supply cost savings. PMID:28682999

Predicting breast cancer using an expression values weighted clinical classifier.

PubMed

Thomas, Minta; De Brabanter, Kris; Suykens, Johan A K; De Moor, Bart

2014-12-31

Clinical data, such as patient history, laboratory analysis, ultrasound parameters-which are the basis of day-to-day clinical decision support-are often used to guide the clinical management of cancer in the presence of microarray data. Several data fusion techniques are available to integrate genomics or proteomics data, but only a few studies have created a single prediction model using both gene expression and clinical data. These studies often remain inconclusive regarding an obtained improvement in prediction performance. To improve clinical management, these data should be fully exploited. This requires efficient algorithms to integrate these data sets and design a final classifier. LS-SVM classifiers and generalized eigenvalue/singular value decompositions are successfully used in many bioinformatics applications for prediction tasks. While bringing up the benefits of these two techniques, we propose a machine learning approach, a weighted LS-SVM classifier to integrate two data sources: microarray and clinical parameters. We compared and evaluated the proposed methods on five breast cancer case studies. Compared to LS-SVM classifier on individual data sets, generalized eigenvalue decomposition (GEVD) and kernel GEVD, the proposed weighted LS-SVM classifier offers good prediction performance, in terms of test area under ROC Curve (AUC), on all breast cancer case studies. Thus a clinical classifier weighted with microarray data set results in significantly improved diagnosis, prognosis and prediction responses to therapy. The proposed model has been shown as a promising mathematical framework in both data fusion and non-linear classification problems.

Systems-based biological concordance and predictive reproducibility of gene set discovery methods in cardiovascular disease.

PubMed

Azuaje, Francisco; Zheng, Huiru; Camargo, Anyela; Wang, Haiying

2011-08-01

The discovery of novel disease biomarkers is a crucial challenge for translational bioinformatics. Demonstration of both their classification power and reproducibility across independent datasets are essential requirements to assess their potential clinical relevance. Small datasets and multiplicity of putative biomarker sets may explain lack of predictive reproducibility. Studies based on pathway-driven discovery approaches have suggested that, despite such discrepancies, the resulting putative biomarkers tend to be implicated in common biological processes. Investigations of this problem have been mainly focused on datasets derived from cancer research. We investigated the predictive and functional concordance of five methods for discovering putative biomarkers in four independently-generated datasets from the cardiovascular disease domain. A diversity of biosignatures was identified by the different methods. However, we found strong biological process concordance between them, especially in the case of methods based on gene set analysis. With a few exceptions, we observed lack of classification reproducibility using independent datasets. Partial overlaps between our putative sets of biomarkers and the primary studies exist. Despite the observed limitations, pathway-driven or gene set analysis can predict potentially novel biomarkers and can jointly point to biomedically-relevant underlying molecular mechanisms. Copyright © 2011 Elsevier Inc. All rights reserved.

Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set.

PubMed

Khalil, Asma; Perry, Helen; Duffy, James; Reed, Keith; Baschat, Ahmet; Deprest, Jan; Hecher, Kurt; Lewi, Liesbeth; Lopriore, Enrico; Oepkes, Dick

2017-07-14

Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS. An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context. The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care, maternal, short-term perinatal outcomes and long-term neurodevelopmental outcomes. Core Outcome Measures in Effectiveness Trials (COMET), 921 Registered on July 2016. International Prospective Register of Systematic Reviews (PROSPERO), CRD42016043999 . Registered on 2 August 2016.

An ontology-based method for secondary use of electronic dental record data.

PubMed

Schleyer, Titus Kl; Ruttenberg, Alan; Duncan, William; Haendel, Melissa; Torniai, Carlo; Acharya, Amit; Song, Mei; Thyvalikakath, Thankam P; Liu, Kaihong; Hernandez, Pedro

2013-01-01

A key question for healthcare is how to operationalize the vision of the Learning Healthcare System, in which electronic health record data become a continuous information source for quality assurance and research. This project presents an initial, ontology-based, method for secondary use of electronic dental record (EDR) data. We defined a set of dental clinical research questions; constructed the Oral Health and Disease Ontology (OHD); analyzed data from a commercial EDR database; and created a knowledge base, with the OHD used to represent clinical data about 4,500 patients from a single dental practice. Currently, the OHD includes 213 classes and reuses 1,658 classes from other ontologies. We have developed an initial set of SPARQL queries to allow extraction of data about patients, teeth, surfaces, restorations and findings. Further work will establish a complete, open and reproducible workflow for extracting and aggregating data from a variety of EDRs for research and quality assurance.

An integrated methods study of the experiences of youth with severe disabilities in leisure activity settings: the importance of belonging, fun, and control and choice.

PubMed

King, Gillian; Gibson, Barbara E; Mistry, Bhavnita; Pinto, Madhu; Goh, Freda; Teachman, Gail; Thompson, Laura

2014-01-01

The aim was to examine the leisure activity setting experiences of two groups of youth with severe disabilities - those with complex continuing care (CCC) needs and those who have little functional speech and communicate using augmentative and alternative communication (AAC). Twelve youth took part in a mixed methods study, in which their experiences were ascertained using qualitative methods (observations, photo elicitation and interviews) and the measure of Self-Reported Experiences of Activity Settings (SEAS). Data integration occurred using a "following a thread" technique and case-by-case analysis. The analysis revealed several highly valued aspects of leisure activity setting experiences for youth, including engagement with others, enjoying the moment, and control and choice in selection and participation in activity settings. The findings provide preliminary insights into the nature of optimal activity settings for youth with severe disabilities, and the mediators of these experiences. Compared to other youth, the data illustrate both the commonalities of experiences and differences in the ways in which these experiences are attained. Implications for research concern the utility of mixed methods approaches in understanding the complex nature of participation experiences. Implications for clinical practice concern the importance of not assuming the nature of youths' experiences.

Modeling Eye Gaze Patterns in Clinician-Patient Interaction with Lag Sequential Analysis

PubMed Central

Montague, E; Xu, J; Asan, O; Chen, P; Chewning, B; Barrett, B

2011-01-01

Objective The aim of this study was to examine whether lag-sequential analysis could be used to describe eye gaze orientation between clinicians and patients in the medical encounter. This topic is particularly important as new technologies are implemented into multi-user health care settings where trust is critical and nonverbal cues are integral to achieving trust. This analysis method could lead to design guidelines for technologies and more effective assessments of interventions. Background Nonverbal communication patterns are important aspects of clinician-patient interactions and may impact patient outcomes. Method Eye gaze behaviors of clinicians and patients in 110-videotaped medical encounters were analyzed using the lag-sequential method to identify significant behavior sequences. Lag-sequential analysis included both event-based lag and time-based lag. Results Results from event-based lag analysis showed that the patients’ gaze followed that of clinicians, while clinicians did not follow patients. Time-based sequential analysis showed that responses from the patient usually occurred within two seconds after the initial behavior of the clinician. Conclusion Our data suggest that the clinician’s gaze significantly affects the medical encounter but not the converse. Application Findings from this research have implications for the design of clinical work systems and modeling interactions. Similar research methods could be used to identify different behavior patterns in clinical settings (physical layout, technology, etc.) to facilitate and evaluate clinical work system designs. PMID:22046723

3D Modelling and Printing Technology to Produce Patient-Specific 3D Models.

PubMed

Birbara, Nicolette S; Otton, James M; Pather, Nalini

2017-11-10

A comprehensive knowledge of mitral valve (MV) anatomy is crucial in the assessment of MV disease. While the use of three-dimensional (3D) modelling and printing in MV assessment has undergone early clinical evaluation, the precision and usefulness of this technology requires further investigation. This study aimed to assess and validate 3D modelling and printing technology to produce patient-specific 3D MV models. A prototype method for MV 3D modelling and printing was developed from computed tomography (CT) scans of a plastinated human heart. Mitral valve models were printed using four 3D printing methods and validated to assess precision. Cardiac CT and 3D echocardiography imaging data of four MV disease patients was used to produce patient-specific 3D printed models, and 40 cardiac health professionals (CHPs) were surveyed on the perceived value and potential uses of 3D models in a clinical setting. The prototype method demonstrated submillimetre precision for all four 3D printing methods used, and statistical analysis showed a significant difference (p<0.05) in precision between these methods. Patient-specific 3D printed models, particularly using multiple print materials, were considered useful by CHPs for preoperative planning, as well as other applications such as teaching and training. This study suggests that, with further advances in 3D modelling and printing technology, patient-specific 3D MV models could serve as a useful clinical tool. The findings also highlight the potential of this technology to be applied in a variety of medical areas within both clinical and educational settings. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Methodological considerations for implementation of lymphocyte subset analysis in a clinical reference laboratory.

PubMed

Muirhead, K A; Wallace, P K; Schmitt, T C; Frescatore, R L; Franco, J A; Horan, P K

1986-01-01

As the diagnostic utility of lymphocyte subset analysis has been recognized in the clinical research laboratory, a wide variety of reagents and cell preparation, staining and analysis methods have also been described. Methods that are perfectly suitable for analysis of smaller sample numbers in the biological or clinical research setting are not always appropriate and/or applicable in the setting of a high volume clinical reference laboratory. We describe here some of the specific considerations involved in choosing a method for flow cytometric analysis which minimizes sample preparation and data analysis time while maximizing sample stability, viability, and reproducibility. Monoclonal T- and B-cell reagents from three manufacturers were found to give equivalent results for a reference population of healthy individuals. This was true whether direct or indirect immunofluorescence staining was used and whether cells were prepared by Ficoll-Hypaque fractionation (FH) or by lysis of whole blood. When B cells were enumerated using a polyclonal anti-immunoglobulin reagent, less cytophilic immunoglobulin staining was present after lysis than after FH preparation. However, both preparation methods required additional incubation at 37 degrees C to obtain results concordant with monoclonal B-cell reagents. Standard reagents were chosen on the basis of maximum positive/negative separation and the availability of appropriate negative controls. The effects of collection medium and storage conditions on sample stability and reproducibility of subset analysis were also assessed. Specimens collected in heparin and stored at room temperature in buffered medium gave reproducible results for 3 days after specimen collection, using either FH or lysis as the preparation method. General strategies for instrument optimization, quality control, and biohazard containment are also discussed.

Scaled Anatomical Model Creation of Biomedical Tomographic Imaging Data and Associated Labels for Subsequent Sub-surface Laser Engraving (SSLE) of Glass Crystals

PubMed Central

Dethlefs, Christopher R.; Piotrowicz, Justin; Van Avermaete, Tony; Maki, Jeff; Gerstler, Steve; Leevy, W. M.

2017-01-01

Biomedical imaging modalities like computed tomography (CT) and magnetic resonance (MR) provide excellent platforms for collecting three-dimensional data sets of patient or specimen anatomy in clinical or preclinical settings. However, the use of a virtual, on-screen display limits the ability of these tomographic images to fully convey the anatomical information embedded within. One solution is to interface a biomedical imaging data set with 3D printing technology to generate a physical replica. Here we detail a complementary method to visualize tomographic imaging data with a hand-held model: Sub Surface Laser Engraving (SSLE) of crystal glass. SSLE offers several unique benefits including: the facile ability to include anatomical labels, as well as a scale bar; streamlined multipart assembly of complex structures in one medium; high resolution in the X, Y, and Z planes; and semi-transparent shells for visualization of internal anatomical substructures. Here we demonstrate the process of SSLE with CT data sets derived from pre-clinical and clinical sources. This protocol will serve as a powerful and inexpensive new tool with which to visualize complex anatomical structures for scientists and students in a number of educational and research settings. PMID:28518066

Implementation of customized health information technology in diabetes self management programs.

PubMed

Alexander, Susan; Frith, Karen H; O'Keefe, Louise; Hennigan, Michael A

2011-01-01

The project was a nurse-led implementation of a software application, designed to combine clinical and demographic records for a diabetes education program, which would result in secure, long-term record storage. Clinical information systems may be prohibitively expensive for small practices and require extensive training for implementation. A review of the literature suggests that the use of simple, practice-based registries offer an economical method of monitoring the outcomes of diabetic patients. The database was designed using a common software application, Microsoft Access. The theory used to guide implementation and staff training was Rogers' Diffusion of Innovations theory (1995). Outcomes after a 3-month period included incorporation of 100% of new clinical and demographic patient records into the database and positive changes in staff attitudes regarding software applications used in diabetes self-management training. These objectives were met while keeping project costs under budgeted amounts. As a function of the clinical nurse specialist (CNS) researcher role, there is a need for CNSs to identify innovative and economical methods of data collection. The success of this nurse-led project reinforces suggestions in the literature for less costly methods of data maintenance in small practice settings. Ongoing utilization and enhancement have resulted in the creation of a robust database that could aid in the research of multiple clinical issues. Clinical nurse specialists can use existing evidence to guide and improve both their own practice and outcomes for patients and organizations. Further research regarding specific factors that predict efficient transition of informatics applications, how these factors vary according to practice settings, and the role of the CNS in implementation of such applications is needed.

Mobile Medical Education (MoMEd) - how mobile information resources contribute to learning for undergraduate clinical students - a mixed methods study

PubMed Central

2012-01-01

Background Mobile technology is increasingly being used by clinicians to access up-to-date information for patient care. These offer learning opportunities in the clinical setting for medical students but the underlying pedagogic theories are not clear. A conceptual framework is needed to understand these further. Our initial questions were how the medical students used the technology, how it enabled them to learn and what theoretical underpinning supported the learning. Methods 387 medical students were provided with a personal digital assistant (PDA) loaded with medical resources for the duration of their clinical studies. Outcomes were assessed by a mixed-methods triangulation approach using qualitative and quantitative analysis of surveys, focus groups and usage tracking data. Results Learning occurred in context with timely access to key facts and through consolidation of knowledge via repetition. The PDA was an important addition to the learning ecology rather than a replacement. Contextual factors impacted on use both positively and negatively. Barriers included concerns of interrupting the clinical interaction and of negative responses from teachers and patients. Students preferred a future involving smartphone platforms. Conclusions This is the first study to describe the learning ecology and pedagogic basis behind the use of mobile learning technologies in a large cohort of undergraduate medical students in the clinical environment. We have developed a model for mobile learning in the clinical setting that shows how different theories contribute to its use taking into account positive and negative contextual factors. The lessons from this study are transferable internationally, to other health care professions and to the development of similar initiatives with newer technology such as smartphones or tablet computers. PMID:22240206

Using the modified Delphi method to establish clinical consensus for the diagnosis and treatment of patients with rotator cuff pathology.

PubMed

Eubank, Breda H; Mohtadi, Nicholas G; Lafave, Mark R; Wiley, J Preston; Bois, Aaron J; Boorman, Richard S; Sheps, David M

2016-05-20

Patients presenting to the healthcare system with rotator cuff pathology do not always receive high quality care. High quality care occurs when a patient receives care that is accessible, appropriate, acceptable, effective, efficient, and safe. The aim of this study was twofold: 1) to develop a clinical pathway algorithm that sets forth a stepwise process for making decisions about the diagnosis and treatment of rotator cuff pathology presenting to primary, secondary, and tertiary healthcare settings; and 2) to establish clinical practice guidelines for the diagnosis and treatment of rotator cuff pathology to inform decision-making processes within the algorithm. A three-step modified Delphi method was used to establish consensus. Fourteen experts representing athletic therapy, physiotherapy, sport medicine, and orthopaedic surgery were invited to participate as the expert panel. In round 1, 123 best practice statements were distributed to the panel. Panel members were asked to mark "agree" or "disagree" beside each statement, and provide comments. The same voting method was again used for round 2. Round 3 consisted of a final face-to-face meeting. In round 1, statements were grouped and reduced to 44 statements that met consensus. In round 2, five statements reached consensus. In round 3, ten statements reached consensus. Consensus was reached for 59 statements representing five domains: screening, diagnosis, physical examination, investigations, and treatment. The final face-to-face meeting was also used to develop clinical pathway algorithms (i.e., clinical care pathways) for three types of rotator cuff pathology: acute, chronic, and acute-on-chronic. This consensus guideline will help to standardize care, provide guidance on the diagnosis and treatment of rotator cuff pathology, and assist in clinical decision-making for all healthcare professionals.

A day in the life of third-year medical students: using an ethnographic method to understand information seeking and use*

PubMed Central

Twiss-Brooks, Andrea B.; Andrade, Ricardo; Bass, Michelle B.; Kern, Barbara; Peterson, Jonna; Werner, Debra A.

2017-01-01

Objective The authors undertook this project to learn how third-year medical students seek and use information in the course of daily activities, especially activities conducted in clinical settings in a variety of institutions. Methods We recruited sixty-eight third-year undergraduate medical school students to create a mapping diary of a day that included clinical activities. We conducted semi-structured interviews based on the mapping diaries. Using content and thematic analyses of the resulting interview transcripts, we developed an ethnographic case study for each participant. Results In the studied sample, we identified a broad range of information resources used for personal, clinical, and educational use. Participants relied heavily on technology throughout their day, including desktop computers, smart phones, handheld tablets, and laptops. Time management was a pervasive theme in the interviews, with participants squeezing in time to study for exams wherever and whenever they could. Selection of a particular information resource or technology to use was governed largely by the convenience of using that resource or technology. When obstacles were encountered, workarounds might be sought, but in many cases, the resource or technology would be abandoned in favor of a more convenient solution. Convenience was also a consideration in choosing spaces to use for clinical duties or for study, with specific considerations of available technology, proximity to clinical areas, and security for belongings contributing to choices made. Conclusions Some of our results align with those of other recent studies of information use among medical students, residents, and practicing physicians. In particular, the fast-paced clinical setting favors use of information resources that are fast and easy to use. We demonstrated that the methods used are suitable to better understand clinicians’ discovery and use of information. PMID:28096741

A pilot study evaluating alternative approaches of academic detailing in rural family practice clinics

PubMed Central

2012-01-01

Background Academic detailing is an interactive, convenient, and user-friendly approach to delivering non-commercial education to healthcare clinicians. While evidence suggests academic detailing is associated with improvements in prescribing behavior, uncertainty exists about generalizability and scalability in diverse settings. Our study evaluates different models of delivering academic detailing in a rural family medicine setting. Methods We conducted a pilot project to assess the feasibility, effectiveness, and satisfaction with academic detailing delivered face-to-face as compared to a modified approach using distance-learning technology. The recipients were four family medicine clinics within the Oregon Rural Practice-based Research Network (ORPRN). Two clinics were allocated to receive face-to-face detailing and two received outreach through video conferencing or asynchronous web-based outreach. Surveys at midpoint and completion were used to assess effectiveness and satisfaction. Results Each clinic received four outreach visits over an eight month period. Topics included treatment-resistant depression, management of atypical antipsychotics, drugs for insomnia, and benzodiazepine tapering. Overall, 90% of participating clinicians were satisfied with the program. Respondents who received in person detailing reported a higher likelihood of changing their behavior compared to respondents in the distance detailing group for five of seven content areas. While 90%-100% of respondents indicated they would continue to participate if the program were continued, the likelihood of participation declined if only distance approaches were offered. Conclusions We found strong support and satisfaction for the program among participating clinicians. Participants favored in-person approaches to distance interactions. Future efforts will be directed at quantitative methods for evaluating the economic and clinical effectiveness of detailing in rural family practice settings. PMID:23276303

An update on 'dose calibrator' settings for nuclides used in nuclear medicine.

PubMed

Bergeron, Denis E; Cessna, Jeffrey T

2018-06-01

Most clinical measurements of radioactivity, whether for therapeutic or imaging nuclides, rely on commercial re-entrant ionization chambers ('dose calibrators'). The National Institute of Standards and Technology (NIST) maintains a battery of representative calibrators and works to link calibration settings ('dial settings') to primary radioactivity standards. Here, we provide a summary of NIST-determined dial settings for 22 radionuclides. We collected previously published dial settings and determined some new ones using either the calibration curve method or the dialing-in approach. The dial settings with their uncertainties are collected in a comprehensive table. In general, current manufacturer-provided calibration settings give activities that agree with National Institute of Standards and Technology standards to within a few percent.

An Exploratory Mixed Method Assessment of Low Income, Pregnant Hispanic Women's Understanding of Gestational Diabetes and Dietary Change

ERIC Educational Resources Information Center

Rhoads-Baeza, Maria Elena; Reis, Janet

2012-01-01

Objective: To describe and assess low income, healthy, pregnant Hispanic women's understanding of gestational diabetes (GDM) and willingness to change aspects of their diet. Design: One-on-one, in-person interviews conducted in Spanish with 94 women (primarily Mexican). Setting: Federal Qualified Community Health Center's prenatal clinic. Method:…

Empirical and Clinical Methods in the Assessment of Personality and Psychopathology: An Integrative Approach for Training

ERIC Educational Resources Information Center

Flanagan, Rosemary; Esquivel, Giselle B.

2006-01-01

School psychologists have a critical role in identifying social-emotional problems and psychopathology in youth based on a set of personality-assessment competencies. The development of competencies in assessing personality and psychopathology is complex, requiring a variety of integrated methods and approaches. Given the limited extent and scope…

Plasma protein absolute quantification by nano-LC Q-TOF UDMSE for clinical biomarker verification

PubMed Central

ILIES, MARIA; IUGA, CRISTINA ADELA; LOGHIN, FELICIA; DHOPLE, VISHNU MUKUND; HAMMER, ELKE

2017-01-01

Background and aims Proteome-based biomarker studies are targeting proteins that could serve as diagnostic, prognosis, and prediction molecules. In the clinical routine, immunoassays are currently used for the absolute quantification of such biomarkers, with the major limitation that only one molecule can be targeted per assay. The aim of our study was to test a mass spectrometry based absolute quantification method for the verification of plasma protein sets which might serve as reliable biomarker panels for the clinical practice. Methods Six EDTA plasma samples were analyzed after tryptic digestion using a high throughput data independent acquisition nano-LC Q-TOF UDMSE proteomics approach. Synthetic Escherichia coli standard peptides were spiked in each sample for the absolute quantification. Data analysis was performed using ProgenesisQI v2.0 software (Waters Corporation). Results Our method ensured absolute quantification of 242 non redundant plasma proteins in a single run analysis. The dynamic range covered was 105. 86% were represented by classical plasma proteins. The overall median coefficient of variation was 0.36, while a set of 63 proteins was found to be highly stable. Absolute protein concentrations strongly correlated with values reviewed in the literature. Conclusions Nano-LC Q-TOF UDMSE proteomic analysis can be used for a simple and rapid determination of absolute amounts of plasma proteins. A large number of plasma proteins could be analyzed, while a wide dynamic range was covered with low coefficient of variation at protein level. The method proved to be a reliable tool for the quantification of protein panel for biomarker verification in the clinical practice. PMID:29151793

Wear measurement of dental tissues and materials in clinical studies: A systematic review.

PubMed

Wulfman, C; Koenig, V; Mainjot, A K

2018-06-01

This study aims to systematically review the different methods used for wear measurement of dental tissues and materials in clinical studies, their relevance and reliability in terms of accuracy and precision, and the performance of the different steps of the workflow taken independently. An exhaustive search of clinical studies related to wear of dental tissues and materials reporting a quantitative measurement method was conducted. MedLine, Embase, Scopus, Cochrane Library and Web of Science databases were used. Prospective studies, pilot studies and case series (>10 patients), as long as they contained a description of wear measurement methodology. Only studies published after 1995 were considered. After duplicates' removal, 495 studies were identified, and 41 remained for quantitative analysis. Thirty-four described wear-measurement protocols, using digital profilometry and superimposition, whereas 7 used alternative protocols. A specific form was designed to analyze the risk of bias. The methods were described in terms of material analyzed; study design; device used for surface acquisition; matching software details and settings; type of analysis (vertical height-loss measurement vs volume loss measurement); type of area investigated (entire occlusal area or selective areas); and results. There is a need of standardization of clinical wear measurement. Current methods exhibit accuracy, which is not sufficient to monitor wear of restorative materials and tooth tissues. Their performance could be improved, notably limiting the use of replicas, using standardized calibration procedures and positive controls, optimizing the settings of scanners and matching softwares, and taking into account unusable data. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Self-reported patient safety competence among new graduates in medicine, nursing and pharmacy

PubMed Central

Ginsburg, Liane R; Tregunno, Deborah; Norton, Peter G

2013-01-01

Background As efforts to address patient safety (PS) in health professional (HP) education increase, it is important to understand new HPs’ perspectives on their own PS competence at entry to practice. This study examines the self-reported PS competence of newly registered nurses, pharmacists and physicians. Methods A cross-sectional survey of 4496 new graduates in medicine (1779), nursing (2196) and pharmacy (521) using the HP Education in PS Survey (H-PEPSS). The H-PEPSS measures HPs’ self-reported PS competence on six socio-cultural dimensions of PS, including culture, teamwork, communication, managing risk, responding to risk and understanding human factors. The H-PEPSS asks about confidence in PS learning in classroom and clinical settings. Results All HP groups reported feeling more confident in the dimension of PS learning related to effective communication with patients and other providers. Greater confidence in PS learning was reported for learning experiences in the clinical setting compared with the class setting with one exception—nurses’ confidence in learning about working in teams with other HPs deteriorated as they moved from thinking about learning in the classroom setting to thinking about learning in the clinical setting. Conclusions Large-scale efforts are required to more deeply and consistently embed PS learning into HP education. However, efforts to embed PS learning in HP education seem to be hampered by deficiencies that persist in the culture of the clinical training environments in which we educate and acculturate new HPs. PMID:23178859

Targeted Therapy Database (TTD): a model to match patient's molecular profile with current knowledge on cancer biology.

PubMed

Mocellin, Simone; Shrager, Jeff; Scolyer, Richard; Pasquali, Sandro; Verdi, Daunia; Marincola, Francesco M; Briarava, Marta; Gobbel, Randy; Rossi, Carlo; Nitti, Donato

2010-08-10

The efficacy of current anticancer treatments is far from satisfactory and many patients still die of their disease. A general agreement exists on the urgency of developing molecularly targeted therapies, although their implementation in the clinical setting is in its infancy. In fact, despite the wealth of preclinical studies addressing these issues, the difficulty of testing each targeted therapy hypothesis in the clinical arena represents an intrinsic obstacle. As a consequence, we are witnessing a paradoxical situation where most hypotheses about the molecular and cellular biology of cancer remain clinically untested and therefore do not translate into a therapeutic benefit for patients. To present a computational method aimed to comprehensively exploit the scientific knowledge in order to foster the development of personalized cancer treatment by matching the patient's molecular profile with the available evidence on targeted therapy. To this aim we focused on melanoma, an increasingly diagnosed malignancy for which the need for novel therapeutic approaches is paradigmatic since no effective treatment is available in the advanced setting. Relevant data were manually extracted from peer-reviewed full-text original articles describing any type of anti-melanoma targeted therapy tested in any type of experimental or clinical model. To this purpose, Medline, Embase, Cancerlit and the Cochrane databases were searched. We created a manually annotated database (Targeted Therapy Database, TTD) where the relevant data are gathered in a formal representation that can be computationally analyzed. Dedicated algorithms were set up for the identification of the prevalent therapeutic hypotheses based on the available evidence and for ranking treatments based on the molecular profile of individual patients. In this essay we describe the principles and computational algorithms of an original method developed to fully exploit the available knowledge on cancer biology with the ultimate goal of fruitfully driving both preclinical and clinical research on anticancer targeted therapy. In the light of its theoretical nature, the prediction performance of this model must be validated before it can be implemented in the clinical setting.

How Stable are Temperaments in the Clinical Setting: A Pilot Study

PubMed Central

Karam, Elie G.; El Khoury, Elaine; Itani, Lynn

2016-01-01

Background An essential point in evaluating the utility of measuring temperaments is the stability of the instrument used especially in the presence of mental disorders. One of the most commonly used instruments in the clinical setting is the Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire (TEMPS-A). To our knowledge, the TEMPS-A’s stability in an outpatient adult clinical setting has not been evaluated. Objective: To assess the stability of the effect of temperament, time and clinical intervention. Methods: A sample of 89 adult outpatients was assessed at baseline and follow-up on their TEMPS-A scores. Diagnoses of mental disorders were reached through clinical interviews, and the severity of the conditions was clinically assessed at baseline and follow-up on a Likert scale. Changes in scores were examined in terms of z-scores, and possible predictors of the change in scores were assessed. Results: Eighty-nine percent of all subjects’ temperaments scores did not change or changed less than one z-score, and specifically: 84.2% in the case of depressive, 89.9% for cyclothymic, 92.1% for hyperthymic, 92.2% for irritable, and 86.5% for anxious temperaments. For all of the five temperaments, age, gender, time difference between baseline and follow up, number of diagnoses, and percent improvement were not significantly associated with the change in temperament scores. Limitations: Well-established severity measures would add to the validity of any future findings. Conclusion: Shifts in temperament scores between baseline and follow-up were minor, thus proving the stability of temperaments and the TEMPS-A scale in a clinical setting. PMID:27733865

Improved artificial neural networks in prediction of malignancy of lesions in contrast-enhanced MR-mammography.

PubMed

Vomweg, T W; Buscema, M; Kauczor, H U; Teifke, A; Intraligi, M; Terzi, S; Heussel, C P; Achenbach, T; Rieker, O; Mayer, D; Thelen, M

2003-09-01

The aim of this study was to evaluate the capability of improved artificial neural networks (ANN) and additional novel training methods in distinguishing between benign and malignant breast lesions in contrast-enhanced magnetic resonance-mammography (MRM). A total of 604 histologically proven cases of contrast-enhanced lesions of the female breast at MRI were analyzed. Morphological, dynamic and clinical parameters were collected and stored in a database. The data set was divided into several groups using random or experimental methods [Training & Testing (T&T) algorithm] to train and test different ANNs. An additional novel computer program for input variable selection was applied. Sensitivity and specificity were calculated and compared with a statistical method and an expert radiologist. After optimization of the distribution of cases among the training and testing sets by the T & T algorithm and the reduction of input variables by the Input Selection procedure a highly sophisticated ANN achieved a sensitivity of 93.6% and a specificity of 91.9% in predicting malignancy of lesions within an independent prediction sample set. The best statistical method reached a sensitivity of 90.5% and a specificity of 68.9%. An expert radiologist performed better than the statistical method but worse than the ANN (sensitivity 92.1%, specificity 85.6%). Features extracted out of dynamic contrast-enhanced MRM and additional clinical data can be successfully analyzed by advanced ANNs. The quality of the resulting network strongly depends on the training methods, which are improved by the use of novel training tools. The best results of an improved ANN outperform expert radiologists.

Quantifying Data Quality for Clinical Trials Using Electronic Data Capture

PubMed Central

Nahm, Meredith L.; Pieper, Carl F.; Cunningham, Maureen M.

2008-01-01

Background Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. Methods and Principal Findings The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. Conclusions Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks. PMID:18725958

Correction of stain variations in nuclear refractive index of clinical histology specimens

PubMed Central

Uttam, Shikhar; Bista, Rajan K.; Hartman, Douglas J.; Brand, Randall E.; Liu, Yang

2011-01-01

For any technique to be adopted into a clinical setting, it is imperative that it seamlessly integrates with well-established clinical diagnostic workflow. We recently developed an optical microscopy technique—spatial-domain low-coherence quantitative phase microscopy (SL-QPM) that can extract the refractive index of the cell nucleus from the standard histology specimens on glass slides prepared via standard clinical protocols. This technique has shown great potential in detecting cancer with a better sensitivity than conventional pathology. A major hurdle in the clinical translation of this technique is the intrinsic variation among staining agents used in histology specimens, which limits the accuracy of refractive index measurements of clinical samples. In this paper, we present a simple and easily generalizable method to remove the effect of variations in staining levels on nuclear refractive index obtained with SL-QPM. We illustrate the efficacy of our correction method by applying it to variously stained histology samples from animal model and clinical specimens. PMID:22112118

International guidelines for the in vivo assessment of skin properties in non-clinical settings: part 1. pH

PubMed Central

Stefaniak, Aleksandr B; du Plessis, Johan; John, Swen M; Eloff, Fritz; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus F C; Kudla, Irena; Holness, D Linn

2013-01-01

Background Skin surface pH is known to influence the dissolution and partitioning of chemicals and may influence exposures that lead to skin diseases. Non-clinical environments (e.g. workplaces) are highly variable, thereby presenting unique measurement challenges that are not typically encountered in clinical settings. Hence, guidelines are needed for consistent measurement of skin surface pH in environments that are difficult to control. Methods An expert workshop was convened at the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals to review available data on factors that could influence the determination of skin surface pH in non-clinical settings with emphasis on the workplace as a worst case scenario. Results The key elements of the guidelines are: (i) minimize, to the extent feasible, the influences of relevant endogenous (anatomical position, skin health, time of day), exogenous (hand washing, barrier creams, soaps and detergents, occlusion), environmental (seasonality), and measurement (atmospheric conditions) factors; (ii) report pH measurements results as a difference or percent change (not absolute values) using a measure of central tendency and variability; and (iii) report notable deviations from these guidelines and other relevant factors that may influence measurements. Conclusion Guidelines on the measurement and reporting of skin surface pH in non-clinical settings should promote consistency in data reporting, facilitate inter-comparison of study results, and aid in understanding and preventing occupational skin diseases. PMID:23279097

Reference Value Advisor: a new freeware set of macroinstructions to calculate reference intervals with Microsoft Excel.

PubMed

Geffré, Anne; Concordet, Didier; Braun, Jean-Pierre; Trumel, Catherine

2011-03-01

International recommendations for determination of reference intervals have been recently updated, especially for small reference sample groups, and use of the robust method and Box-Cox transformation is now recommended. Unfortunately, these methods are not included in most software programs used for data analysis by clinical laboratories. We have created a set of macroinstructions, named Reference Value Advisor, for use in Microsoft Excel to calculate reference limits applying different methods. For any series of data, Reference Value Advisor calculates reference limits (with 90% confidence intervals [CI]) using a nonparametric method when n≥40 and by parametric and robust methods from native and Box-Cox transformed values; tests normality of distributions using the Anderson-Darling test and outliers using Tukey and Dixon-Reed tests; displays the distribution of values in dot plots and histograms and constructs Q-Q plots for visual inspection of normality; and provides minimal guidelines in the form of comments based on international recommendations. The critical steps in determination of reference intervals are correct selection of as many reference individuals as possible and analysis of specimens in controlled preanalytical and analytical conditions. Computing tools cannot compensate for flaws in selection and size of the reference sample group and handling and analysis of samples. However, if those steps are performed properly, Reference Value Advisor, available as freeware at http://www.biostat.envt.fr/spip/spip.php?article63, permits rapid assessment and comparison of results calculated using different methods, including currently unavailable methods. This allows for selection of the most appropriate method, especially as the program provides the CI of limits. It should be useful in veterinary clinical pathology when only small reference sample groups are available. ©2011 American Society for Veterinary Clinical Pathology.

Bipolar Disorder Center for Pennsylvanians: Implementing an Effectiveness Trial to Improve Treatment for At-Risk Patients

PubMed Central

Kupfer, David J.; Friedman, Edward S.; Reynolds, Charles F.; Axelson, David A.; Grochocinski, Victoria J.; Stofko, Mary G.; Birmaher, Boris; Houck, Patricia R.; Swartz, Holly A.; Brown, Charlotte; Kilbourne, Amy M.; Thase, Michael E.; Curet, David E.; Mulsant, Benoit H.; Turkin, Scott R.; Fagiolini, Andrea; Pollock, Bruce G.; Whyte, Ellen M.; Frank, Ellen

2012-01-01

Objective Adolescents, elderly persons, African Americans, and rural residents with bipolar disorder are less likely than their middle-aged, white, urban counterparts to be diagnosed, receive adequate treatment, remain in treatment once identified, and have positive outcomes. The Bipolar Disorder Center for Pennsylvanians (BDCP) study was designed to address these disparities. This report highlights the methods used to recruit, screen, and enroll a cohort of difficult-to-recruit individuals with bipolar disorder. Methods Study sites included three specialty clinics for bipolar disorder in a university setting and a rural behavioral health clinic. Study operations were standardized, and all study personnel were trained in study procedures. Several strategies were used for recruitment. Results It was possible to introduce the identical assessment and screening protocol in settings regardless of whether they had a history of implementing research protocols. This protocol was also able to be used across the age spectrum, in urban and rural areas, and in a racially diverse cohort of participants. Across the four sites 515 individuals with bipolar disorder were enrolled as a result of these methods (69 African Americans and 446 non–African Americans). Although clinical characteristics at study entry did not differ appreciably between African Americans and non–African Americans, the pathways into treatment differed significantly. Conclusions Rigorous recruitment and assessment procedures can be successfully introduced in different settings and with different patient cohorts, thus facilitating access to high-quality treatment for individuals who frequently do not receive appropriate care for bipolar disorder. PMID:19564218

Rapid detection of D-Dimers with mLabs® whole blood method for venous thromboembolism exclusion. Comparison with Vidas® D-Dimers assay.

PubMed

Gerotziafas, Grigoris T; Ray, Patrick; Gkalea, Vasiliki; Benzarti, Ahlem; Khaterchi, Amir; Cast, Claire; Pernet, Julie; Lefkou, Eleftheria; Elalamy, Ismail

2016-12-01

Easy to use point of care assays for D-Dimers measurement in whole blood from patients with clinical suspicion of venous thromboembolism (VTE) will facilitate the diagnostic strategy in the Emergency Department (ED) setting. We prospectively evaluated the diagnostic performance of the point-of-care mLabs® Whole Blood D-Dimers test and we compared it with the Vidas® D-Dimers assay. As part of the diagnostic algorithm applied in patients with clinical suspicion of VTE, the VIDAS® D-Dimers Test was prescribed by the emergency physician in charge. The mLabs® Whole Blood D-Dimers Test was used on the same samples. All patients had undergone exploration with the recommended imaging techniques for VTE diagnosis. Both assays were performed, on 99 emergency patients (mean age was 65 years) with clinical suspicion of VTE. In 3% of patients, VTE was documented with a reference imaging technique. The Bland and Altman test showed significant agreement between the two methods. Both assays showed equal sensitivity and negative predictive value for VTE. The mLabs whole blood assay is a promising point of care method for measurement of D-Dimers and exclusion of VTE diagnosis in the emergency setting which should be validated in a larger prospective study.

Bioelectrical impedance methods in clinical research: a follow-up to the NIH Technology Assessment Conference.

PubMed

Ellis, K J; Bell, S J; Chertow, G M; Chumlea, W C; Knox, T A; Kotler, D P; Lukaski, H C; Schoeller, D A

1999-01-01

In 1994, the National Institutes of Health (NIH) convened a Technology Assessment Conference "to provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement." In 1997, Serono Symposia USA, Inc., organized an invited panel of scientists and clinicians, with extensive research and clinical experience with BIA, to provide an update. Panel members presented reviews based on their own work and published studies for the intervening years. Updates were provided on the single and multifrequency BIA methods and models; continued clinical research experiences; efforts toward establishing population reference norms; and the feasibility of establishing guidelines for potential diagnostic use of BIA in a clinical setting. This report provides a summary of the panel's findings including a consensus on several technical and clinical issues related to the research use of BIA, and those areas that are still in need of additional study.

Motivational journey of Iranian bachelor of nursing students during clinical education: a grounded theory study.

PubMed

Hanifi, Nasrin; Parvizy, Soroor; Joolaee, Soodabeh

2013-09-01

This study explored how nursing students can be kept motivated throughout their clinical education. Motivation is a key issue in nursing clinical education for student retention. The study was conducted using grounded theory methods, which are appropriate when studying process in a social context. Sixteen students and four instructors, who were purposefully selected, participated in semistructured interviews. Data were analyzed using the constant comparative method. Students' motivational journey occurred in three steps: (i) social condition; (ii) encountering the clinical education challenges; and (iii) looking for an escape from nursing, or simply tolerating nursing. Struggling with professional identity emerged as the core variable. Iran's social context and many other conditions in the clinical education setting affect students' motivation. Identifying motivational process might assist educational authorities in offering solutions to promote motivation among students. © 2013 Wiley Publishing Asia Pty Ltd.

Linked symptom monitoring and depression treatment programmes for specialist cancer services: protocol for a mixed-methods implementation study

PubMed Central

Walker, Jane; Burke, Katy; Sevdalis, Nick; Richardson, Alison; Mulick, Amy; Frost, Chris; Sharpe, Michael

2017-01-01

Introduction There is growing awareness that cancer services need to address patients’ well-being as well as treating their cancer. We developed systematic approaches to (1) monitoring patients’ symptoms including depression using a ‘Symptom Monitoring Service’ and (2) providing treatment for those with major depression using a programme called ‘Depression Care for People with Cancer’. Used together, these two programmes were found to be highly effective and cost-effective in clinical trials. The overall aims of this project are to: (1) study the process of introducing these programmes into routine clinical care in a large cancer service, (2) identify the challenges associated with implementation and how these are overcome, (3) determine their effectiveness in a routine non-research setting and (4) describe patients’ and clinicians’ experience of the programmes. Methods and analysis This is a mixed-methods longitudinal implementation study. We will study the process of implementation in three phases (April 2016–December 2018): ‘Pre-implementation’ (setting up of the new programmes), ‘Early Implementation’ (implementation of the programmes in a small number of clinics) and ‘Implementation and Maintenance’ (implementation in the majority of clinics). We will use the following methods of data collection: (1) contemporaneous logs of the implementation process, (2) interviews with healthcare professionals and managers, (3) interviews with patients and (4) routinely collected clinical data. Ethics and dissemination The study has been reviewed by a joint committee of Oxford University Hospitals National Health Service Foundation Trust Research and Development Department and the University of Oxford’s Clinical Trials and Research Governance Department and judged to be service evaluation, not requiring ethics committee approval. The findings of this study will guide the scaling up implementation of the programmes across the UK and will enable us to construct an implementation toolkit. We will disseminate our findings in publications and at relevant national and international conferences. PMID:28674143

Single Anisotropic 3-D MR Image Upsampling via Overcomplete Dictionary Trained From In-Plane High Resolution Slices.

PubMed

Jia, Yuanyuan; He, Zhongshi; Gholipour, Ali; Warfield, Simon K

2016-11-01

In magnetic resonance (MR), hardware limitation, scanning time, and patient comfort often result in the acquisition of anisotropic 3-D MR images. Enhancing image resolution is desired but has been very challenging in medical image processing. Super resolution reconstruction based on sparse representation and overcomplete dictionary has been lately employed to address this problem; however, these methods require extra training sets, which may not be always available. This paper proposes a novel single anisotropic 3-D MR image upsampling method via sparse representation and overcomplete dictionary that is trained from in-plane high resolution slices to upsample in the out-of-plane dimensions. The proposed method, therefore, does not require extra training sets. Abundant experiments, conducted on simulated and clinical brain MR images, show that the proposed method is more accurate than classical interpolation. When compared to a recent upsampling method based on the nonlocal means approach, the proposed method did not show improved results at low upsampling factors with simulated images, but generated comparable results with much better computational efficiency in clinical cases. Therefore, the proposed approach can be efficiently implemented and routinely used to upsample MR images in the out-of-planes views for radiologic assessment and postacquisition processing.

A comparison of the cooperative learning and traditional learning methods in theory classes on nursing students' communication skill with patients at clinical settings.

PubMed

Baghcheghi, Nayereh; Koohestani, Hamid Reza; Rezaei, Koresh

2011-11-01

The purpose of this study was to compare the effect of traditional learning and cooperative learning methods on nursing students' communication skill with patients. This was an experimental study in which 34 nursing students in their 2nd semester of program participated. They were divided randomly into two groups, a control group who were taught their medical/surgical nursing course by traditional learning method and an experimental group, who were taught the same material using cooperative learning method. Before and after the teaching intervention, the students' communication skills with patients at clinical settings were examined. The results showed that no significant difference between the two groups in students' communication skills scores before the teaching intervention, but did show a significant difference between the two groups in the interaction skills and problem follow up sub-scales scores after the teaching intervention. This study provides evidence that cooperative learning is an effective method for improving and increasing communication skills of nursing students especially in interactive skills and follow up the problems sub-scale, thereby it is recommended to increase nursing students' participation in arguments by applying active teaching methods which can provide the opportunity for increased communication skills. Copyright © 2011 Elsevier Ltd. All rights reserved.

The HIV care cascade: a systematic review of data sources, methodology and comparability.

PubMed

Medland, Nicholas A; McMahon, James H; Chow, Eric P F; Elliott, Julian H; Hoy, Jennifer F; Fairley, Christopher K

2015-01-01

The cascade of HIV diagnosis, care and treatment (HIV care cascade) is increasingly used to direct and evaluate interventions to increase population antiretroviral therapy (ART) coverage, a key component of treatment as prevention. The ability to compare cascades over time, sub-population, jurisdiction or country is important. However, differences in data sources and methodology used to construct the HIV care cascade might limit its comparability and ultimately its utility. Our aim was to review systematically the different methods used to estimate and report the HIV care cascade and their comparability. A search of published and unpublished literature through March 2015 was conducted. Cascades that reported the continuum of care from diagnosis to virological suppression in a demographically definable population were included. Data sources and methods of measurement or estimation were extracted. We defined the most comparable cascade elements as those that directly measured diagnosis or care from a population-based data set. Thirteen reports were included after screening 1631 records. The undiagnosed HIV-infected population was reported in seven cascades, each of which used different data sets and methods and could not be considered to be comparable. All 13 used mandatory HIV diagnosis notification systems to measure the diagnosed population. Population-based data sets, derived from clinical data or mandatory reporting of CD4 cell counts and viral load tests from all individuals, were used in 6 of 12 cascades reporting linkage, 6 of 13 reporting retention, 3 of 11 reporting ART and 6 of 13 cascades reporting virological suppression. Cascades with access to population-based data sets were able to directly measure cascade elements and are therefore comparable over time, place and sub-population. Other data sources and methods are less comparable. To ensure comparability, countries wishing to accurately measure the cascade should utilize complete population-based data sets from clinical data from elements of a centralized healthcare setting, where available, or mandatory CD4 cell count and viral load test result reporting. Additionally, virological suppression should be presented both as percentage of diagnosed and percentage of estimated total HIV-infected population, until methods to calculate the latter have been standardized.

Vascular Plug Assisted Retrograde Transvenous Obliteration (PARTO) for Gastric Varix Bleeding Patients in the Emergent Clinical Setting

PubMed Central

Yang, Heechul; Lee, Chun Kyon; Kim, Gun Bea

2016-01-01

Purpose To evaluate the technical feasibility and safety of vascular plug assisted retrograde transvenous obliteration (PARTO) for bleeding gastric varix performed in the emergent clinical setting and describe the mid-term clinical results. Materials and Methods From April 2012 to January 2015, emergent PARTO was tried in total 9 patients presented with active gastric varix bleeding. After initial insufficient or failure of endoscopic approach, they underwent PARTO in the emergent clinical setting. Gelatin sponge embolization of both gastrorenal (GR) shunt and gastric varix was performed after retrograde transvenous placement of a vascular plug in GR shunt. Coil assisted RTO (CARTO) was performed in one patient who had challenging GR shunt anatomy for vascular plug placement. Additional embolic materials, such as microcoils and NBCA glue-lipiodol mixture, were required in three patients to enhance complete occlusion of GR shunt or obliteration of competitive collateral vessels. Clinical success was defined as no variceal rebleeding and disappearance of gastric varix. Results All technical and clinical success–i.e., complete GR shunt occlusion and offending gastric varix embolization with immediate bleeding control–was achieved in all 9 patients. There was no procedure-related complication. All cases showed successful clinical outcome during mean follow up of 17 months (12–32 months), evidenced by imaging studies, endoscopy and clinical data. In 4 patients, mild worsening of esophageal varices or transient ascites was noted as portal hypertensive related change. Conclusion Emergent PARTO is technically feasible and safe, with acceptable mid-term clinical results, in treating active gastric varix bleeding. PMID:27189294

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

In search of memory tests equivalent for experiments on animals and humans.

PubMed

Brodziak, Andrzej; Kołat, Estera; Różyk-Myrta, Alicja

2014-12-19

Older people often exhibit memory impairments. Contemporary demographic trends cause aging of the society. In this situation, it is important to conduct clinical trials of drugs and use training methods to improve memory capacity. Development of new memory tests requires experiments on animals and then clinical trials in humans. Therefore, we decided to review the assessment methods and search for tests that evaluate analogous cognitive processes in animals and humans. This review has enabled us to propose 2 pairs of tests of the efficiency of working memory capacity in animals and humans. We propose a basic set of methods for complex clinical trials of drugs and training methods to improve memory, consisting of 2 pairs of tests: 1) the Novel Object Recognition Test - Sternberg Item Recognition Test and 2) the Object-Location Test - Visuospatial Memory Test. We postulate that further investigations of methods that are equivalent in animals experiments and observations performed on humans are necessary.

Microcomputer Calculated Diagnostic X-Ray Exposure Factors: Clinical Evaluation

PubMed Central

Markivee, C. R.; Edwards, F. Marc; Leonard, Patricia

1981-01-01

Calculation of correct settings for the controls of a diagnostic x-ray machine was established as feasible in a microcomputer with 4K memory. The cost effectiveness and other findings in the application of this method are discussed.

Clinical evaluation of a loop-mediated isothermal amplification (LAMP) assay for rapid detection of Neisseria meningitidis in cerebrospinal fluid.

PubMed

Lee, DoKyung; Kim, Eun Jin; Kilgore, Paul E; Kim, Soon Ae; Takahashi, Hideyuki; Ohnishi, Makoto; Anh, Dang Duc; Dong, Bai Qing; Kim, Jung Soo; Tomono, Jun; Miyamoto, Shigehiko; Notomi, Tsugunori; Kim, Dong Wook; Seki, Mitsuko

2015-01-01

Neisseria meningitidis (Nm) is a leading causative agent of bacterial meningitis in humans. Traditionally, meningococcal meningitis has been diagnosed by bacterial culture. However, isolation of bacteria from patients' cerebrospinal fluid (CSF) is time consuming and sometimes yields negative results. Recently, polymerase chain reaction (PCR)-based diagnostic methods of detecting Nm have been considered the gold standard because of their superior sensitivity and specificity compared with culture. In this study, we developed a loop-mediated isothermal amplification (LAMP) method and evaluated its ability to detect Nm in cerebrospinal fluid (CSF). We developed a meningococcal LAMP assay (Nm LAMP) that targets the ctrA gene. The primer specificity was validated using 16 strains of N. meningitidis (serogroup A, B, C, D, 29-E, W-135, X, Y, and Z) and 19 non-N. meningitidis species. Within 60 min, the Nm LAMP detected down to ten copies per reaction with sensitivity 1000-fold more than that of conventional PCR. The LAMP assays were evaluated using a set of 1574 randomly selected CSF specimens from children with suspected meningitis collected between 1998 and 2002 in Vietnam, China, and Korea. The LAMP method was shown to be more sensitive than PCR methods for CSF samples (31 CSF samples were positive by LAMP vs. 25 by PCR). The detection rate of the LAMP method was substantially higher than that of the PCR method. In a comparative analysis of the PCR and LAMP assays, the clinical sensitivity, specificity, positive predictive value, and negative predictive value of the LAMP assay were 100%, 99.6%, 80.6%, and 100%, respectively. Compared to PCR, LAMP detected Nm with higher analytical and clinical sensitivity. This sensitive and specific LAMP method offers significant advantages for screening patients on a population basis and for diagnosis in clinical settings.

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.

Measuring Data Quality Through a Source Data Verification Audit in a Clinical Research Setting.

PubMed

Houston, Lauren; Probst, Yasmine; Humphries, Allison

2015-01-01

Health data has long been scrutinised in relation to data quality and integrity problems. Currently, no internationally accepted or "gold standard" method exists measuring data quality and error rates within datasets. We conducted a source data verification (SDV) audit on a prospective clinical trial dataset. An audit plan was applied to conduct 100% manual verification checks on a 10% random sample of participant files. A quality assurance rule was developed, whereby if >5% of data variables were incorrect a second 10% random sample would be extracted from the trial data set. Error was coded: correct, incorrect (valid or invalid), not recorded or not entered. Audit-1 had a total error of 33% and audit-2 36%. The physiological section was the only audit section to have <5% error. Data not recorded to case report forms had the greatest impact on error calculations. A significant association (p=0.00) was found between audit-1 and audit-2 and whether or not data was deemed correct or incorrect. Our study developed a straightforward method to perform a SDV audit. An audit rule was identified and error coding was implemented. Findings demonstrate that monitoring data quality by a SDV audit can identify data quality and integrity issues within clinical research settings allowing quality improvement to be made. The authors suggest this approach be implemented for future research.

Nurses’ experiences of humour in clinical settings

PubMed Central

Ghaffari, Fatemeh; Dehghan-Nayeri, Nahid; Shali, Mahboubeh

2015-01-01

Background: Providing holistic nursing care when there is a shortage of personnel and equipment exposes nurses to stress and a higher risk of occupational burnout. Humour can promote nurses’ health and influence nursing care. The aim of this study was to describe nurses’ experiences of humour in clinical settings and factors affecting it. Methods: This qualitative study investigated nurses’ experiences of humour. Five hospitals affiliated to Tehran University of Medical Sciences provided the setting for this study. The participants comprised of 17 nurses with master’s and Baccalaureate degrees (BSN) in nursing. These nurses worked at educational hospitals affiliated to Tehran University of Medical Sciences and had minimum work experience of 12 months in various clinical wards. Nurses from all wards were invited to participate in this study. The data were collected through semi structure interviews using guides comprising probing questions. Telephonic interviews were used to further supplement the data. The data were analysed using conventional content analysis. Results: The data were classified into five themes including the dynamics of humour, condition enforcement, Risk making probability, Instrumental use and Change: opportunities and threats. Conclusion: Understanding nurses’ perceptions and experiences of humour helps identify its contributing factors and provides valuable guidelines for enhancing nurses and patients’ mental, emotional and physical health. Spreading a culture of humour through teaching methods can improve workplace cheerfulness and highlights the importance of humour in patient care in nurses and nursing students. PMID:26034735

Random forests-based differential analysis of gene sets for gene expression data.

PubMed

Hsueh, Huey-Miin; Zhou, Da-Wei; Tsai, Chen-An

2013-04-10

In DNA microarray studies, gene-set analysis (GSA) has become the focus of gene expression data analysis. GSA utilizes the gene expression profiles of functionally related gene sets in Gene Ontology (GO) categories or priori-defined biological classes to assess the significance of gene sets associated with clinical outcomes or phenotypes. Many statistical approaches have been proposed to determine whether such functionally related gene sets express differentially (enrichment and/or deletion) in variations of phenotypes. However, little attention has been given to the discriminatory power of gene sets and classification of patients. In this study, we propose a method of gene set analysis, in which gene sets are used to develop classifications of patients based on the Random Forest (RF) algorithm. The corresponding empirical p-value of an observed out-of-bag (OOB) error rate of the classifier is introduced to identify differentially expressed gene sets using an adequate resampling method. In addition, we discuss the impacts and correlations of genes within each gene set based on the measures of variable importance in the RF algorithm. Significant classifications are reported and visualized together with the underlying gene sets and their contribution to the phenotypes of interest. Numerical studies using both synthesized data and a series of publicly available gene expression data sets are conducted to evaluate the performance of the proposed methods. Compared with other hypothesis testing approaches, our proposed methods are reliable and successful in identifying enriched gene sets and in discovering the contributions of genes within a gene set. The classification results of identified gene sets can provide an valuable alternative to gene set testing to reveal the unknown, biologically relevant classes of samples or patients. In summary, our proposed method allows one to simultaneously assess the discriminatory ability of gene sets and the importance of genes for interpretation of data in complex biological systems. The classifications of biologically defined gene sets can reveal the underlying interactions of gene sets associated with the phenotypes, and provide an insightful complement to conventional gene set analyses. Copyright © 2012 Elsevier B.V. All rights reserved.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

PubMed Central

Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

2016-01-01

Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

Connecting the Dots and Merging Meaning: Using Mixed Methods to Study Primary Care Delivery Transformation

PubMed Central

Scammon, Debra L; Tomoaia-Cotisel, Andrada; Day, Rachel L; Day, Julie; Kim, Jaewhan; Waitzman, Norman J; Farrell, Timothy W; Magill, Michael K

2013-01-01

Objective. To demonstrate the value of mixed methods in the study of practice transformation and illustrate procedures for connecting methods and for merging findings to enhance the meaning derived. Data Source/Study Setting. An integrated network of university-owned, primary care practices at the University of Utah (Community Clinics or CCs). CC has adopted Care by Design, its version of the Patient Centered Medical Home. Study Design. Convergent case study mixed methods design. Data Collection/Extraction Methods. Analysis of archival documents, internal operational reports, in-clinic observations, chart audits, surveys, semistructured interviews, focus groups, Centers for Medicare and Medicaid Services database, and the Utah All Payer Claims Database. Principal Findings. Each data source enriched our understanding of the change process and understanding of reasons that certain changes were more difficult than others both in general and for particular clinics. Mixed methods enabled generation and testing of hypotheses about change and led to a comprehensive understanding of practice change. Conclusions. Mixed methods are useful in studying practice transformation. Challenges exist but can be overcome with careful planning and persistence. PMID:24279836

On the Edge of Life, II: House Officer Struggles Recorded in an Intensive Care Unit Journal

PubMed Central

Sekeres, Mikkael A.; Stern, Theodore A.

2002-01-01

Background: In a general hospital, few clinical settings match the intensity of the intensive care unit (ICU) experience. Clinical rotations in ICUs elicit and emphasize the struggles house officers face on a daily basis throughout their training. Method: These struggles were recorded by hundreds of residents in a journal maintained in one Medical ICU for the past 20 years. We systematically reviewed these unsolicited entries to develop categories that define and illustrate common stressors. Results: Stressors for house officers include isolation, insecurity, care for the terminally ill, sleep deprivation, and long work weeks. Conclusion: By placing the struggles of house staff in context, trainees and their residency training programs can be prepared for the intensity of the experience and for work in clinical practice settings that follows completion of training. PMID:15014706

Supervisory needs of research doctoral students in a university teaching hospital setting.

PubMed

Caldwell, Patrina Hy; Oldmeadow, Wendy; Jones, Cheryl A

2012-10-01

Teaching hospitals affiliated with universities are now common sites for research higher degree supervision. We hypothesised that the hospital environment poses unique challenges to supervision compared with the traditional university research institute setting. This study aimed to identify and rank important supervision issues in a clinical setting from the students' perspective. Using the Delphi method to explore issues and facilitate consensus, small group discussions were conducted with 10 research doctoral students from a tertiary teaching hospital. We identified supervision issues that are unique to the hospital-based context. These include the demands placed on supervisors combining clinical and supervisory roles, the challenges of academic medical/scientific writing and career issues for students who are already established in their professions. Other issues identified, common to all doctoral students, include differing expectations between students and supervisors (with students wanting support for their career plans, training in research skills and increasing autonomy and responsibility), supervisor access, quality and frequency of meetings, lack of training in writing and dealing with conflicts. Our research identified that postgraduate students of supervisors who combine clinical and supervisory roles report significant issues with supervision, some of which are unique to the clinical setting. Clinician researchers who supervise postgraduate students need to balance clinical and supervisory responsibilities, identify and negotiate student expectations early in candidature and provide career counselling to students who are already highly experienced. Furthermore, clinician supervisors should undertake postgraduate supervisor training programme tailored to the hospital setting to better support their students. © 2012 The Authors. Journal of Paediatrics and Child Health © 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Patients' Willingness to Participate in Rapid HIV Testing: A pilot study in three New York City dental hygiene clinics.

PubMed

Davide, Susan H; Santella, Anthony J; Furnari, Winnie; Leuwaisee, Petal; Cortell, Marilyn; Krishnamachari, Bhuma

2017-12-01

Purpose: One in eight people living with an HIV infection in the United States is unaware of their status. Rapid HIV testing (RHT) is an easily used and accepted screening tool that has been introduced in a limited number of clinical settings. The purpose of this study was to investigate patient acceptability, certainty of their decision, and willingness to pay for screening if RHT was offered in university-based dental hygiene clinics. Methods: A cross-sectional survey was administered to 426 patients at three dental hygiene clinics in New York City over a period of four months. The survey questionnaire was based on the decisional conflict scale measuring personal perceptions; with zero indicating extremely high conflict to four indicating no conflict. Patients were assessed for their acceptance of RHT, provider preference for administration of the test and their willingness to pay for RHT. Results: Over half (72.2%) indicated acceptance of HIV testing in a dental hygiene clinic setting; with 85.3% choosing oral RHT, 4.9% fingerstick RHT, and 8.8% venipuncture. Respondents were amenable to testing when offered by dental hygienists (71.7%) and dentists (72.4%). Over 30% indicated their willingness to receive HIV testing in the dental setting when offered at no additional cost. The mean decisional conflict score was 3.42/4.0 indicating no decisional conflict. Conclusions: Patients are willing to undergo oral RHT when offered as a service and provided by dental hygienists in the dental setting. Patients appear to be aware of the benefits and risks associated with RHT. Further research is needed to evaluate the public health benefits and logistical challenges facing the delivery of RHT within in the dental setting. Copyright © 2017 The American Dental Hygienists’ Association.

Development of an automated analysis system for data from flow cytometric intracellular cytokine staining assays from clinical vaccine trials

PubMed Central

Shulman, Nick; Bellew, Matthew; Snelling, George; Carter, Donald; Huang, Yunda; Li, Hongli; Self, Steven G.; McElrath, M. Juliana; De Rosa, Stephen C.

2008-01-01

Background Intracellular cytokine staining (ICS) by multiparameter flow cytometry is one of the primary methods for determining T cell immunogenicity in HIV-1 clinical vaccine trials. Data analysis requires considerable expertise and time. The amount of data is quickly increasing as more and larger trials are performed, and thus there is a critical need for high throughput methods of data analysis. Methods A web based flow cytometric analysis system, LabKey Flow, was developed for analyses of data from standardized ICS assays. A gating template was created manually in commercially-available flow cytometric analysis software. Using this template, the system automatically compensated and analyzed all data sets. Quality control queries were designed to identify potentially incorrect sample collections. Results Comparison of the semi-automated analysis performed by LabKey Flow and the manual analysis performed using FlowJo software demonstrated excellent concordance (concordance correlation coefficient >0.990). Manual inspection of the analyses performed by LabKey Flow for 8-color ICS data files from several clinical vaccine trials indicates that template gates can appropriately be used for most data sets. Conclusions The semi-automated LabKey Flow analysis system can analyze accurately large ICS data files. Routine use of the system does not require specialized expertise. This high-throughput analysis will provide great utility for rapid evaluation of complex multiparameter flow cytometric measurements collected from large clinical trials. PMID:18615598

Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research.

PubMed

Ortiz-Osorno, Alberto Betto; Ehler, Linda A; Brooks, Judith

2015-01-01

Determining what constitutes an anticipatable incidental finding (IF) from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the "actionability" of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of "Actionability at the Participant's Research Setting Level" (APRSL) for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. © 2015 American Society of Law, Medicine & Ethics, Inc.

Glycated albumin: from biochemistry and laboratory medicine to clinical practice.

PubMed

Dozio, Elena; Di Gaetano, Nicola; Findeisen, Peter; Corsi Romanelli, Massimiliano Marco

2017-03-01

This review summarizes current knowledge about glycated albumin. We review the changes induced by glycation on the properties of albumin, the pathological implications of high glycated albumin levels, glycated albumin quantification methods, and the use of glycated albumin as a complementary biomarker for diabetes mellitus diagnosis and monitoring and for dealing with long-term complications. The advantages and limits of this biomarker in different clinical settings are also discussed.

Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

PubMed

Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

2013-02-01

Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

Simulated settings; powerful arenas for learning patient safety practices and facilitating transference to clinical practice. A mixed method study.

PubMed

Reime, Marit Hegg; Johnsgaard, Tone; Kvam, Fred Ivan; Aarflot, Morten; Breivik, Marit; Engeberg, Janecke Merethe; Brattebø, Guttorm

2016-11-01

Poor teamwork is an important factor in the occurrence of critical incidents because of a lack of non-technical skills. Team training can be a key to prevent these incidents. The purpose of this study was to explore the experience of nursing and medical students after a simulation-based interprofessional team training (SBITT) course and its impact on professional and patient safety practices, using a concurrent mixed-method design. The participants (n = 262) were organized into 44 interprofessional teams. The results showed that two training sequences the same day improved overall team performance. Making mistakes during SBITT appeared to improve the quality of patient care once the students returned to clinical practice as it made the students more vigilant. Furthermore, the video-assisted oral debriefing provided an opportunity to strengthen interprofessional teamwork and share situational awareness. SBITT gave the students an opportunity to practice clinical reasoning skills and to share professional knowledge. The students conveyed the importance of learning to speak up to ensure safe patient practices. Simulated settings seem to be powerful arenas for learning patient safety practices and facilitating transference of this awareness to clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

A Novel Approach to Study Medical Decision Making in the Clinical Setting: The "Own-point-of-view" Perspective.

PubMed

Pelaccia, Thierry; Tardif, Jacques; Triby, Emmanuel; Charlin, Bernard

2017-07-01

Making diagnostic and therapeutic decisions is a critical activity among physicians. It relies on the ability of physicians to use cognitive processes and specific knowledge in the context of a clinical reasoning. This ability is a core competency in physicians, especially in the field of emergency medicine where the rate of diagnostic errors is high. Studies that explore medical decision making in an authentic setting are increasing significantly. They are based on the use of qualitative methods that are applied at two separate times: 1) a video recording of the subject's actual activity in an authentic setting and 2) an interview with the subject, supported by the video recording. Traditionally, activity is recorded from an "external perspective"; i.e., a camera is positioned in the room in which the consultation takes place. This approach has many limits, both technical and with respect to the validity of the data collected. The article aims at 1) describing how decision making is currently being studied, especially from a qualitative standpoint, and the reasons why new methods are needed, and 2) reporting how we used an original, innovative approach to study decision making in the field of emergency medicine and findings from these studies to guide further the use of this method. The method consists in recording the subject's activity from his own point of view, by fixing a microcamera on his temple or the branch of his glasses. An interview is then held on the basis of this recording, so that the subject being interviewed can relive the situation, to facilitate the explanation of his reasoning with respect to his decisions and actions. We describe how this method has been used successfully in investigating medical decision making in emergency medicine. We provide details on how to use it optimally, taking into account the constraints associated with the practice of emergency medicine and the benefits in the study of clinical reasoning. The "own-point-of-view" video technique is a promising method to study clinical decision making in emergency medicine. It is a powerful tool to stimulate recall and help physicians make their reasoning explicit, thanks to a greater psychological immersion. © 2017 by the Society for Academic Emergency Medicine.

Meta-Analysis in Clinical Trials Revisited

PubMed Central

Laird, Nan

2015-01-01

In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effect model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the “DerSimonian and Laird method” is now often referred to as the ‘standard approach’ or a ‘popular’ method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. PMID:26343745

Extracting important information from Chinese Operation Notes with natural language processing methods.

PubMed

Wang, Hui; Zhang, Weide; Zeng, Qiang; Li, Zuofeng; Feng, Kaiyan; Liu, Lei

2014-04-01

Extracting information from unstructured clinical narratives is valuable for many clinical applications. Although natural Language Processing (NLP) methods have been profoundly studied in electronic medical records (EMR), few studies have explored NLP in extracting information from Chinese clinical narratives. In this study, we report the development and evaluation of extracting tumor-related information from operation notes of hepatic carcinomas which were written in Chinese. Using 86 operation notes manually annotated by physicians as the training set, we explored both rule-based and supervised machine-learning approaches. Evaluating on unseen 29 operation notes, our best approach yielded 69.6% in precision, 58.3% in recall and 63.5% F-score. Copyright © 2014 Elsevier Inc. All rights reserved.

Service impact of a national clinical leadership development programme: findings from a qualitative study.

PubMed

Fealy, Gerard M; McNamara, Martin S; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2015-04-01

The study reported here was part of a larger study, which evaluated a national clinical leadership development programme with reference to resources, participant experiences, participant outcomes and service impact. The aim of the present study was to evaluate the programme's service impact. Clinical leadership development develops competencies that are expressed in context. The outcomes of clinical leadership development occur at individual, departmental and organisational levels. The methods used to evaluate the service impact were focus groups, group interviews and individual interviews. Seventy participants provided data in 18 separate qualitative data collection events. The data contained numerous accounts of service development activities, initiated by programme participants, which improved service and/or improved the culture of the work setting. Clinical leadership development programmes that incorporate a deliberate service impact element can result in identifiable positive service outcomes. The nuanced relationship between leader development and service development warrants further investigation. This study demonstrates that clinical leadership development can impact on service in distinct and identifiable ways. Clinical leadership development programmes should focus on the setting in which the leadership competencies will be demonstrated. © 2013 John Wiley & Sons Ltd.

Disinfection of transvaginal ultrasound probes in a clinical setting: comparative performance of automated and manual reprocessing methods.

PubMed

Buescher, D L; Möllers, M; Falkenberg, M K; Amler, S; Kipp, F; Burdach, J; Klockenbusch, W; Schmitz, R

2016-05-01

Transvaginal and intracavitary ultrasound probes are a possible source of cross-contamination with microorganisms and thus a risk to patients' health. Therefore appropriate methods for reprocessing are needed. This study was designed to compare the standard disinfection method for transvaginal ultrasound probes in Germany with an automated disinfection method in a clinical setting. This was a prospective randomized controlled clinical study of two groups. In each group, 120 microbial samples were collected from ultrasound transducers before and after disinfection with either an automated method (Trophon EPR®) or a manual method (Mikrozid Sensitive® wipes). Samples were then analyzed for microbial growth and isolates were identified to species level. Automated disinfection had a statistically significantly higher success rate of 91.4% (106/116) compared with 78.8% (89/113) for manual disinfection (P = 0.009). The risk of contamination was increased by 2.9-fold when disinfection was performed manually (odds ratio, 2.9 (95% CI, 1.3-6.3)). Before disinfection, bacterial contamination was observed on 98.8% of probes. Microbial analysis revealed 36 different species of bacteria, including skin and environmental bacteria as well as pathogenic bacteria such as Staphylococcus aureus, enterobacteriaceae and Pseudomonas spp. Considering the high number of contaminated probes and bacterial species found, disinfection of the ultrasound probe's body and handle should be performed after each use to decrease the risk of cross-contamination. This study favored automated disinfection owing to its significantly higher efficacy compared with a manual method. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Decision tree-based method for integrating gene expression, demographic, and clinical data to determine disease endotypes

PubMed Central

2013-01-01

Background Complex diseases are often difficult to diagnose, treat and study due to the multi-factorial nature of the underlying etiology. Large data sets are now widely available that can be used to define novel, mechanistically distinct disease subtypes (endotypes) in a completely data-driven manner. However, significant challenges exist with regard to how to segregate individuals into suitable subtypes of the disease and understand the distinct biological mechanisms of each when the goal is to maximize the discovery potential of these data sets. Results A multi-step decision tree-based method is described for defining endotypes based on gene expression, clinical covariates, and disease indicators using childhood asthma as a case study. We attempted to use alternative approaches such as the Student’s t-test, single data domain clustering and the Modk-prototypes algorithm, which incorporates multiple data domains into a single analysis and none performed as well as the novel multi-step decision tree method. This new method gave the best segregation of asthmatics and non-asthmatics, and it provides easy access to all genes and clinical covariates that distinguish the groups. Conclusions The multi-step decision tree method described here will lead to better understanding of complex disease in general by allowing purely data-driven disease endotypes to facilitate the discovery of new mechanisms underlying these diseases. This application should be considered a complement to ongoing efforts to better define and diagnose known endotypes. When coupled with existing methods developed to determine the genetics of gene expression, these methods provide a mechanism for linking genetics and exposomics data and thereby accounting for both major determinants of disease. PMID:24188919

Dynamic Knee Alignment and Collateral Knee Laxity and Its Variations in Normal Humans

PubMed Central

Deep, Kamal; Picard, Frederic; Clarke, Jon V.

2015-01-01

Alignment of normal, arthritic, and replaced human knees is a much debated subject as is the collateral ligamentous laxity. Traditional quantitative values have been challenged. Methods used to measure these are also not without flaws. Authors review the recent literature and a novel method of measurement of these values has been included. This method includes use of computer navigation technique in clinic setting for assessment of the normal or affected knee before the surgery. Computer navigation has been known for achievement of alignment accuracy during knee surgery. Now its use in clinic setting has added to the inventory of measurement methods. Authors dispel the common myth of straight mechanical axis in normal knees and also look at quantification of amount of collateral knee laxity. Based on the scientific studies, it has been shown that the mean alignment is in varus in normal knees. It changes from lying non-weight-bearing position to standing weight-bearing position in both coronal and the sagittal planes. It also varies with gender and race. The collateral laxity is also different for males and females. Further studies are needed to define the ideal alignment and collateral laxity which the surgeon should aim for individual knees. PMID:26636090

Shared decision-making – transferring research into practice: the Analytic Hierarchy Process (AHP)

PubMed Central

Dolan, James G.

2008-01-01

Objective To illustrate how the Analytic Hierarchy Process (AHP) can be used to promote shared decision-making and enhance clinician-patient communication. Methods Tutorial review. Results The AHP promotes shared decision making by creating a framework that is used to define the decision, summarize the information available, prioritize information needs, elicit preferences and values, and foster meaningful communication among decision stakeholders. Conclusions The AHP and related multi-criteria methods have the potential for improving the quality of clinical decisions and overcoming current barriers to implementing shared decision making in busy clinical settings. Further research is needed to determine the best way to implement these tools and to determine their effectiveness. Practice Implications Many clinical decisions involve preference-based trade-offs between competing risks and benefits. The AHP is a well-developed method that provides a practical approach for improving patient-provider communication, clinical decision-making, and the quality of patient care in these situations. PMID:18760559

Suitability of the PROMIS Alcohol Use Short Form for Screening in a HIV Clinical Care Setting*

PubMed Central

Gibbons, Laura E.; Fredericksen, Rob; Merrill, Joseph O.; McCaul, Mary E.; Chander, Geetanjali; Hutton, Heidi; Lober, William B.; Mathews, W. Chris; Mayer, Kenneth; Burkholder, Greer; Willig, James H.; Mugavero, Michael J.; Saag, Michael S.; Kitahata, Mari M.; Edwards, Todd C.; Patrick, Donald L; Crane, Heidi M.; Crane, Paul K.

2016-01-01

Background At-risk alcohol use is important to identify in clinical settings to facilitate interventions. The Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Use Short Form was developed through an item response theory process, but its utility as a screening instrument in clinical care has not been reported. Objective To determine the ability of the PROMIS Alcohol Use Short Form to identify people with current or future at-risk alcohol use defined by the Alcohol Use Disorders Identification Test consumption (AUDIT-C) instrument. Methods Observational study of people living with HIV (PLWH) in clinical care at four sites across the US. Patients completed a tablet-based clinical assessment prior to seeing their providers at clinic appointments. We used 3 definitions of clinically-relevant at-risk alcohol use and determined the proportion of PLWH with current or future at-risk drinking identified by the PROMIS instrument. Results Of 2,497 PLWH who endorsed ≥1 drink in the prior 12 months, 1,500 PLWH (60%) endorsed “never” for all PROMIS items. In that group, 26% had clinically-relevant at-risk alcohol use defined by one or more AUDIT-C definitions. At follow-up (N=1,608), high baseline PROMIS scores had 55% sensitivity for at-risk drinking among those with at-risk drinking at baseline, and 22% sensitivity among those without baseline risk. Conclusions The PROMIS Alcohol Use Short Form cannot be used alone to identify PLWH with clinically-relevant at-risk alcohol use. Optimal assessment of problem drinking behavior is not clear, but there does not seem to be an important role for the PROMIS instrument in this clinical setting. PMID:27209223

Comparative study of joint analysis of microarray gene expression data in survival prediction and risk assessment of breast cancer patients

PubMed Central

2016-01-01

Abstract Microarray gene expression data sets are jointly analyzed to increase statistical power. They could either be merged together or analyzed by meta-analysis. For a given ensemble of data sets, it cannot be foreseen which of these paradigms, merging or meta-analysis, works better. In this article, three joint analysis methods, Z -score normalization, ComBat and the inverse normal method (meta-analysis) were selected for survival prognosis and risk assessment of breast cancer patients. The methods were applied to eight microarray gene expression data sets, totaling 1324 patients with two clinical endpoints, overall survival and relapse-free survival. The performance derived from the joint analysis methods was evaluated using Cox regression for survival analysis and independent validation used as bias estimation. Overall, Z -score normalization had a better performance than ComBat and meta-analysis. Higher Area Under the Receiver Operating Characteristic curve and hazard ratio were also obtained when independent validation was used as bias estimation. With a lower time and memory complexity, Z -score normalization is a simple method for joint analysis of microarray gene expression data sets. The derived findings suggest further assessment of this method in future survival prediction and cancer classification applications. PMID:26504096

A CTSA Agenda to Advance Methods for Comparative Effectiveness Research

PubMed Central

Helfand, Mark; Tunis, Sean; Whitlock, Evelyn P.; Pauker, Stephen G.; Basu, Anirban; Chilingerian, Jon; Harrell Jr., Frank E.; Meltzer, David O.; Montori, Victor M.; Shepard, Donald S.; Kent, David M.

2011-01-01

Abstract Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient‐centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient‐centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies. In this paper, we describe 10 priority areas that address 3 critical needs for research on patient‐centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient‐centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER. Clin Trans Sci 2011; Volume 4: 188–198 PMID:21707950

Use of standardised patients to assess quality of healthcare in Nairobi, Kenya: a pilot, cross-sectional study with international comparisons.

PubMed

Daniels, Benjamin; Dolinger, Amy; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Coarasa, Jorge; Wafula, Francis; Mwaura, Njeri; Kimeu, Redemptar; Das, Jishnu

2017-01-01

The quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics. We deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China. Across 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case. The SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered.

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

Bench Test Evaluation of Adaptive Servoventilation Devices for Sleep Apnea Treatment

PubMed Central

Zhu, Kaixian; Kharboutly, Haissam; Ma, Jianting; Bouzit, Mourad; Escourrou, Pierre

2013-01-01

Rationale: Adaptive servoventilation devices are marketed to overcome sleep disordered breathing with apneas and hypopneas of both central and obstructive mechanisms often experienced by patients with chronic heart failure. The clinical efficacy of these devices is still questioned. Study Objectives: This study challenged the detection and treatment capabilities of the three commercially available adaptive servoventilation devices in response to sleep disordered breathing events reproduced on an innovative bench test. Methods: The bench test consisted of a computer-controlled piston and a Starling resistor. The three devices were subjected to a flow sequence composed of central and obstructive apneas and hypopneas including Cheyne-Stokes respiration derived from a patient. The responses of the devices were separately evaluated with the maximum and the clinical settings (titrated expiratory positive airway pressure), and the detected events were compared to the bench-scored values. Results: The three devices responded similarly to central events, by increasing pressure support to raise airflow. All central apneas were eliminated, whereas hypopneas remained. The three devices responded differently to the obstructive events with the maximum settings. These obstructive events could be normalized with clinical settings. The residual events of all the devices were scored lower than bench test values with the maximum settings, but were in agreement with the clinical settings. However, their mechanisms were misclassified. Conclusion: The tested devices reacted as expected to the disordered breathing events, but not sufficiently to normalize the breathing flow. The device-scored results should be used with caution to judge efficacy, as their validity depends upon the initial settings. Citation: Zhu K; Kharboutly H; Ma J; Bouzit M; Escourrou P. Bench test evaluation of adaptive servoventilation devices for sleep apnea treatment. J Clin Sleep Med 2013;9(9):861-871. PMID:23997698

Decaying relevance of clinical data towards future decisions in data-driven inpatient clinical order sets.

PubMed

Chen, Jonathan H; Alagappan, Muthuraman; Goldstein, Mary K; Asch, Steven M; Altman, Russ B

2017-06-01

Determine how varying longitudinal historical training data can impact prediction of future clinical decisions. Estimate the "decay rate" of clinical data source relevance. We trained a clinical order recommender system, analogous to Netflix or Amazon's "Customers who bought A also bought B..." product recommenders, based on a tertiary academic hospital's structured electronic health record data. We used this system to predict future (2013) admission orders based on different subsets of historical training data (2009 through 2012), relative to existing human-authored order sets. Predicting future (2013) inpatient orders is more accurate with models trained on just one month of recent (2012) data than with 12 months of older (2009) data (ROC AUC 0.91 vs. 0.88, precision 27% vs. 22%, recall 52% vs. 43%, all P<10 -10 ). Algorithmically learned models from even the older (2009) data was still more effective than existing human-authored order sets (ROC AUC 0.81, precision 16% recall 35%). Training with more longitudinal data (2009-2012) was no better than using only the most recent (2012) data, unless applying a decaying weighting scheme with a "half-life" of data relevance about 4 months. Clinical practice patterns (automatically) learned from electronic health record data can vary substantially across years. Gold standards for clinical decision support are elusive moving targets, reinforcing the need for automated methods that can adapt to evolving information. Prioritizing small amounts of recent data is more effective than using larger amounts of older data towards future clinical predictions. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Fatigue as a Driver of Overall Quality of Life in Cancer Patients

PubMed Central

McCabe, Ryan M.; Grutsch, James F.; Braun, Donald P.; Nutakki, Swetha B.

2015-01-01

Background This manuscript describes an approach for analyzing large amounts of disparate clinical data to elucidate the most impactful factor(s) that relate to a meaningful clinical outcome, in this case, the quality of life of cancer patients. The relationships between clinical and quality of life variables were evaluated using the EORTC QLQ-C30 global health domain—a validated surrogate variable for overall cancer patient well-being. Methods A cross-sectional study design was used to evaluate the determinants of global health in cancer patients who initiated treatment at two regional medical centers between January 2001 and December 2009. Variables analyzed included 15 EORTC QLQ-C30 scales, age at diagnosis, gender, newly diagnosed/ recurrent disease status, and stage. The decision tree algorithm, perhaps unfamiliar to practicing clinicians, evaluates the relative contribution of individual parameters in classifying a clinically meaningful functional endpoint, such as the global health of a patient. Findings Multiple patient characteristics were identified as important contributors. Fatigue, in particular, emerged as the most prevalent indicator of cancer patients’ quality of life in 16/23 clinically relevant subsets. This analysis allowed results to be stated in a clinically-intuitive, rule set format using the language and quantities of the Quality of Life (QoL) tool itself. Interpretation By applying the classification algorithms to a large data set, identification of fatigue as a root factor in driving global health and overall QoL was revealed. The ability to practice mining of clinical data sets to uncover critical clinical insights that are immediately applicable to patient care practices is illustrated. PMID:26070133

Volumetric modulated arc therapy for treatment of solid tumors: current insights

PubMed Central

Macchia, Gabriella; Deodato, Francesco; Cilla, Savino; Cammelli, Silvia; Guido, Alessandra; Ferioli, Martina; Siepe, Giambattista; Valentini, Vincenzo; Morganti, Alessio Giuseppe; Ferrandina, Gabriella

2017-01-01

Aim This article discusses the current use of volumetric modulated arc therapy (VMAT) techniques in clinical practice and reviews the available data from clinical outcome studies in different clinical settings. An overview of available literature about clinical outcomes with VMAT stereotactic/radiosurgical treatment is also reported. Materials and methods All published manuscripts reporting the use of VMAT in a clinical setting from 2009 to November 2016 were identified. The search was carried out in December 2016 using the National Library of Medicine (PubMed/Medline). The following words were searched: “volumetric arc therapy”[All Fields] OR “vmat”[All Fields] OR “rapidarc”[All Fields], AND “radiotherapy”[All Fields] AND “Clinical Trial”[All Fields]. Results Overall, 37 studies (21 prospective and 16 retrospective) fulfilling inclusion criteria and thus included in the review evaluated 2,029 patients treated with VMAT; of these patients, ~30.8% had genitourinary (GU) tumors (81% prostate, 19% endometrial), 26.2% head-and-neck cancer (H&NC), 13.9% oligometastases, 11.2% had anorectal cancer, 10.6% thoracic neoplasms (81% breast, 19% lung), and 7.0% brain metastases (BMs). Six different clinical scenarios for VMAT use were identified: 1) BMs, 2) H&NC, 3) thoracic neoplasms, 4) GU cancer, 5) anorectal tumor, and 6) stereotactic body radiation therapy (SBRT) performed by VMAT technique in the oligometastatic patient setting. Conclusion The literature addressing the clinical appropriateness of VMAT is scarce. Current literature suggests that VMAT, especially when used as simultaneous integrated boost or SBRT strategy, is an effective safe modality for all cancer types. PMID:28794640

Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?

PubMed

Leidl, Reiner; Schweikert, Bernd; Hahmann, Harry; Steinacker, Juergen M; Reitmeir, Peter

2016-03-22

Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.

Improved modeling of clinical data with kernel methods.

PubMed

Daemen, Anneleen; Timmerman, Dirk; Van den Bosch, Thierry; Bottomley, Cecilia; Kirk, Emma; Van Holsbeke, Caroline; Valentin, Lil; Bourne, Tom; De Moor, Bart

2012-02-01

Despite the rise of high-throughput technologies, clinical data such as age, gender and medical history guide clinical management for most diseases and examinations. To improve clinical management, available patient information should be fully exploited. This requires appropriate modeling of relevant parameters. When kernel methods are used, traditional kernel functions such as the linear kernel are often applied to the set of clinical parameters. These kernel functions, however, have their disadvantages due to the specific characteristics of clinical data, being a mix of variable types with each variable its own range. We propose a new kernel function specifically adapted to the characteristics of clinical data. The clinical kernel function provides a better representation of patients' similarity by equalizing the influence of all variables and taking into account the range r of the variables. Moreover, it is robust with respect to changes in r. Incorporated in a least squares support vector machine, the new kernel function results in significantly improved diagnosis, prognosis and prediction of therapy response. This is illustrated on four clinical data sets within gynecology, with an average increase in test area under the ROC curve (AUC) of 0.023, 0.021, 0.122 and 0.019, respectively. Moreover, when combining clinical parameters and expression data in three case studies on breast cancer, results improved overall with use of the new kernel function and when considering both data types in a weighted fashion, with a larger weight assigned to the clinical parameters. The increase in AUC with respect to a standard kernel function and/or unweighted data combination was maximum 0.127, 0.042 and 0.118 for the three case studies. For clinical data consisting of variables of different types, the proposed kernel function--which takes into account the type and range of each variable--has shown to be a better alternative for linear and non-linear classification problems. Copyright © 2011 Elsevier B.V. All rights reserved.

Family-based treatment of a 17-year-old twin presenting with emerging anorexia nervosa: a case study using the "Maudsley method".

PubMed

Loeb, Katharine L; Hirsch, Alicia M; Greif, Rebecca; Hildebrandt, Thomas B

2009-01-01

This article describes the successful application of family-based treatment (FBT) for a 17-year-old identical twin presenting with a 4-month history of clinically significant symptoms of anorexia nervosa (AN). FBT is a manualized treatment that has been studied in randomized controlled trials for adolescents with AN. This case study illustrates the administration of this evidence-based intervention in a clinical setting, highlighting how the best available research was used to make clinical decisions at each stage of treatment delivery.

Systematic computation with functional gene-sets among leukemic and hematopoietic stem cells reveals a favorable prognostic signature for acute myeloid leukemia.

PubMed

Yang, Xinan Holly; Li, Meiyi; Wang, Bin; Zhu, Wanqi; Desgardin, Aurelie; Onel, Kenan; de Jong, Jill; Chen, Jianjun; Chen, Luonan; Cunningham, John M

2015-03-24

Genes that regulate stem cell function are suspected to exert adverse effects on prognosis in malignancy. However, diverse cancer stem cell signatures are difficult for physicians to interpret and apply clinically. To connect the transcriptome and stem cell biology, with potential clinical applications, we propose a novel computational "gene-to-function, snapshot-to-dynamics, and biology-to-clinic" framework to uncover core functional gene-sets signatures. This framework incorporates three function-centric gene-set analysis strategies: a meta-analysis of both microarray and RNA-seq data, novel dynamic network mechanism (DNM) identification, and a personalized prognostic indicator analysis. This work uses complex disease acute myeloid leukemia (AML) as a research platform. We introduced an adjustable "soft threshold" to a functional gene-set algorithm and found that two different analysis methods identified distinct gene-set signatures from the same samples. We identified a 30-gene cluster that characterizes leukemic stem cell (LSC)-depleted cells and a 25-gene cluster that characterizes LSC-enriched cells in parallel; both mark favorable-prognosis in AML. Genes within each signature significantly share common biological processes and/or molecular functions (empirical p = 6e-5 and 0.03 respectively). The 25-gene signature reflects the abnormal development of stem cells in AML, such as AURKA over-expression. We subsequently determined that the clinical relevance of both signatures is independent of known clinical risk classifications in 214 patients with cytogenetically normal AML. We successfully validated the prognosis of both signatures in two independent cohorts of 91 and 242 patients respectively (log-rank p < 0.0015 and 0.05; empirical p < 0.015 and 0.08). The proposed algorithms and computational framework will harness systems biology research because they efficiently translate gene-sets (rather than single genes) into biological discoveries about AML and other complex diseases.

Cost-Effectiveness of HIV Screening in STD Clinics, Emergency Departments, and Inpatient Units: A Model-Based Analysis

PubMed Central

Prabhu, Vimalanand S.; Farnham, Paul G.; Hutchinson, Angela B.; Soorapanth, Sada; Heffelfinger, James D.; Golden, Matthew R.; Brooks, John T.; Rimland, David; Sansom, Stephanie L.

2011-01-01

Background Identifying and treating persons with human immunodeficiency virus (HIV) infection early in their disease stage is considered an effective means of reducing the impact of the disease. We compared the cost-effectiveness of HIV screening in three settings, sexually transmitted disease (STD) clinics serving men who have sex with men, hospital emergency departments (EDs), settings where patients are likely to be diagnosed early, and inpatient diagnosis based on clinical manifestations. Methods and Findings We developed the Progression and Transmission of HIV/AIDS model, a health state transition model that tracks index patients and their infected partners from HIV infection to death. We used program characteristics for each setting to compare the incremental cost per quality-adjusted life year gained from early versus late diagnosis and treatment. We ran the model for 10,000 index patients for each setting, examining alternative scenarios, excluding and including transmission to partners, and assuming HAART was initiated at a CD4 count of either 350 or 500 cells/µL. Screening in STD clinics and EDs was cost-effective compared with diagnosing inpatients, even when including only the benefits to the index patients. Screening patients in STD clinics, who have less-advanced disease, was cost-effective compared with ED screening when treatment with HAART was initiated at a CD4 count of 500 cells/µL. When the benefits of reduced transmission to partners from early diagnosis were included, screening in settings with less-advanced disease stages was cost-saving compared with screening later in the course of infection. The study was limited by a small number of observations on CD4 count at diagnosis and by including transmission only to first generation partners of the index patients. Conclusions HIV prevention efforts can be advanced by screening in settings where patients present with less-advanced stages of HIV infection and by initiating treatment with HAART earlier in the course of infection. PMID:21625489

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

PubMed

Hartzler, Bryan; Peavy, K Michelle; Jackson, T Ron; Carney, Molly

2016-01-22

Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures. It is hoped this discussion offers ideas for how to impact local clinical and policy decisions via effective behavior therapy dissemination.

Enhancing pediatric clinical competency with high-fidelity simulation.

PubMed

Birkhoff, Susan D; Donner, Carol

2010-09-01

In today's tertiary pediatric hospital setting, the increased complexity of patient care demands seamless coordination and collaboration among multidisciplinary team members. In an effort to enhance patient safety, clinical competence, and teamwork, simulation-based learning has become increasingly integrated into pediatric clinical practice as an innovative educational strategy. The simulated setting provides a risk-free environment where learners can incorporate cognitive, psychomotor, and affective skill acquisition without fear of harming patients. One pediatric university hospital in Southeastern Pennsylvania has enhanced the traditional American Heart Association (AHA) Pediatric Advanced Life Support (PALS) course by integrating high-fidelity simulation into skill acquisition, while still functioning within the guidelines and framework of the AHA educational standards. However, very little research with reliable standardized testing methods has been done to measure the effect of simulation-based learning. This article discusses the AHA guidelines for PALS, evaluation of PALS and nursing clinical competencies, communication among a multidisciplinary team, advantages and disadvantages of simulation, incorporation of high-fidelity simulation into pediatric practice, and suggestions for future practice. Copyright 2010, SLACK Incorporated.

A practical material decomposition method for x-ray dual spectral computed tomography.

PubMed

Hu, Jingjing; Zhao, Xing

2016-03-17

X-ray dual spectral CT (DSCT) scans the measured object with two different x-ray spectra, and the acquired rawdata can be used to perform the material decomposition of the object. Direct calibration methods allow a faster material decomposition for DSCT and can be separated in two groups: image-based and rawdata-based. The image-based method is an approximative method, and beam hardening artifacts remain in the resulting material-selective images. The rawdata-based method generally obtains better image quality than the image-based method, but this method requires geometrically consistent rawdata. However, today's clinical dual energy CT scanners usually measure different rays for different energy spectra and acquire geometrically inconsistent rawdata sets, and thus cannot meet the requirement. This paper proposes a practical material decomposition method to perform rawdata-based material decomposition in the case of inconsistent measurement. This method first yields the desired consistent rawdata sets from the measured inconsistent rawdata sets, and then employs rawdata-based technique to perform material decomposition and reconstruct material-selective images. The proposed method was evaluated by use of simulated FORBILD thorax phantom rawdata and dental CT rawdata, and simulation results indicate that this method can produce highly quantitative DSCT images in the case of inconsistent DSCT measurements.

Abortion experiences among Zanzibari women: a chain-referral sampling study.

PubMed

Norris, Alison; Harrington, Bryna J; Grossman, Daniel; Hemed, Maryam; Hindin, Michelle J

2016-03-11

In Zanzibar, a semi-autonomous region of Tanzania, induced abortion is illegal but common, and fewer than 12% of married reproductive-aged women use modern contraception. As part of a multi-method study about contraception and consequences of unwanted pregnancies, the objective of this study was to understand the experiences of Zanzibari women who terminated pregnancies. The cross-sectional study was set in Zanzibar, Tanzania. Participants were a community-based sample of women who had terminated pregnancies. We carried out semi-structured interviews with 45 women recruited via chain-referral sampling. We report the characteristics of women who have had abortions, the reasons they had abortions, and the methods used to terminate their pregnancies. Women in Zanzibar terminate pregnancies that are unwanted for a range of reasons, at various points in their reproductive lives, and using multiple methods. While clinical methods were most effective, nearly half of our participants successfully terminated a pregnancy using non-clinical methods and very few had complications requiring post abortion care (PAC). Even in settings where abortion is illegal, some women experience illegal abortions without adverse health consequences, what we might call 'safer' unsafe abortions; these kinds of abortion experiences can be missed in studies about abortion conducted among women seeking PAC in hospitals.

The trials methodological research agenda: results from a priority setting exercise

PubMed Central

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance. PMID:24456928

Rural Doctors’ Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study

PubMed Central

Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

2016-01-01

Background Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. Aim This study aimed to explore the views and experiences of rural doctors’ about evidence-based medicine in their daily clinical practice in a rural primary care setting. Methods Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Results Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. Conclusion The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers. PMID:27031700

Template based rotation: A method for functional connectivity analysis with a priori templates☆

PubMed Central

Schultz, Aaron P.; Chhatwal, Jasmeer P.; Huijbers, Willem; Hedden, Trey; van Dijk, Koene R.A.; McLaren, Donald G.; Ward, Andrew M.; Wigman, Sarah; Sperling, Reisa A.

2014-01-01

Functional connectivity magnetic resonance imaging (fcMRI) is a powerful tool for understanding the network level organization of the brain in research settings and is increasingly being used to study large-scale neuronal network degeneration in clinical trial settings. Presently, a variety of techniques, including seed-based correlation analysis and group independent components analysis (with either dual regression or back projection) are commonly employed to compute functional connectivity metrics. In the present report, we introduce template based rotation,1 a novel analytic approach optimized for use with a priori network parcellations, which may be particularly useful in clinical trial settings. Template based rotation was designed to leverage the stable spatial patterns of intrinsic connectivity derived from out-of-sample datasets by mapping data from novel sessions onto the previously defined a priori templates. We first demonstrate the feasibility of using previously defined a priori templates in connectivity analyses, and then compare the performance of template based rotation to seed based and dual regression methods by applying these analytic approaches to an fMRI dataset of normal young and elderly subjects. We observed that template based rotation and dual regression are approximately equivalent in detecting fcMRI differences between young and old subjects, demonstrating similar effect sizes for group differences and similar reliability metrics across 12 cortical networks. Both template based rotation and dual-regression demonstrated larger effect sizes and comparable reliabilities as compared to seed based correlation analysis, though all three methods yielded similar patterns of network differences. When performing inter-network and sub-network connectivity analyses, we observed that template based rotation offered greater flexibility, larger group differences, and more stable connectivity estimates as compared to dual regression and seed based analyses. This flexibility owes to the reduced spatial and temporal orthogonality constraints of template based rotation as compared to dual regression. These results suggest that template based rotation can provide a useful alternative to existing fcMRI analytic methods, particularly in clinical trial settings where predefined outcome measures and conserved network descriptions across groups are at a premium. PMID:25150630

Bridging technology and clinical practice: innovating inpatient hyperglycaemia management in non-critical care settings.

PubMed

Thabit, H; Hovorka, R

2018-04-01

Emerging evidence shows that suboptimal glycaemic control is associated with increased morbidity and length of stay in hospital. Various guidelines for safe and effective inpatient glycaemic control in the non-critical care setting have been published. In spite of this, implementation in practice remains limited because of the increasing number of people with diabetes admitted to hospital and staff work burden. The use of technology in the outpatient setting has led to improved glycaemic outcomes and quality of life for people with diabetes. There remains an unmet need for technology utilisation in inpatient hyperglycaemia management in the non-critical care setting. Novel technologies have the potential to provide benefits in diabetes care in hospital by improving efficacy, safety and efficiency. Rapid analysis of glucose measurements by point-of-care devices help facilitate clinical decision-making and therapy adjustment in the hospital setting. Glucose treatment data integration with computerized glucose management systems underpins the effective use of decision support systems and may streamline clinical staff workflow. Continuous glucose monitoring and automation of insulin delivery through closed-loop systems may provide a safe and efficacious tool for hospital staff to manage inpatient hyperglycaemia whilst reducing staff workload. This review summarizes the evidence with regard to technological methods to manage inpatient glycaemic control, their limitations and the future outlook, as well as potential strategies by healthcare organizations such as the National Health Service to mediate the adoption, procurement and use of diabetes technologies in the hospital setting. © 2017 Diabetes UK.

geneCommittee: a web-based tool for extensively testing the discriminatory power of biologically relevant gene sets in microarray data classification.

PubMed

Reboiro-Jato, Miguel; Arrais, Joel P; Oliveira, José Luis; Fdez-Riverola, Florentino

2014-01-30

The diagnosis and prognosis of several diseases can be shortened through the use of different large-scale genome experiments. In this context, microarrays can generate expression data for a huge set of genes. However, to obtain solid statistical evidence from the resulting data, it is necessary to train and to validate many classification techniques in order to find the best discriminative method. This is a time-consuming process that normally depends on intricate statistical tools. geneCommittee is a web-based interactive tool for routinely evaluating the discriminative classification power of custom hypothesis in the form of biologically relevant gene sets. While the user can work with different gene set collections and several microarray data files to configure specific classification experiments, the tool is able to run several tests in parallel. Provided with a straightforward and intuitive interface, geneCommittee is able to render valuable information for diagnostic analyses and clinical management decisions based on systematically evaluating custom hypothesis over different data sets using complementary classifiers, a key aspect in clinical research. geneCommittee allows the enrichment of microarrays raw data with gene functional annotations, producing integrated datasets that simplify the construction of better discriminative hypothesis, and allows the creation of a set of complementary classifiers. The trained committees can then be used for clinical research and diagnosis. Full documentation including common use cases and guided analysis workflows is freely available at http://sing.ei.uvigo.es/GC/.

Nurses' Lived Experience of Working with Nursing Students in Clinical Wards: a Phenomenological Study

PubMed Central

Parvan, Kobra; Shahbazi, Shahla; Ebrahimi, Hossein; Valizadeh, Susan; Rahmani, Azad; Jabbarzadeh Tabrizi, Faranak; Esmaili, Fariba

2018-01-01

Introduction: Despite being aware of the importance of nurses’ role in providing clinical training to nursing students, studies show that sufficient research has not yet been conducted on the experience of clinical nurses who are engaged in training nursing students outside their normal working hours. The present study aim to describe the experience of these nurses who are training outside their routine working hours. Methods: This study was conducted using descriptive-phenomenology method. Twelve nurses was participated in this research. Data were collected using purposive sampling method and face to face interviews based on nurses’ real life experience of students’ learning in clinical settings through answering open-ended questions. Spiegel burg analysis method was used to analyze the data. Results: The result of data analysis was the derivation of four themes and eight sub-themes. Themes included "nurses as teaching sources", "changes in the balance of doing routine tasks", "professional enthusiasm", and "nurses as students' professional socialization source of inspiration". Sub-themes included "efficient education", "poor education", "support", "interference in the role," "self-efficacy development", "inner satisfaction", "positive imaging" and "being a model". Conclusion: It is necessary that academic centers plan for teaching nurses working on a contractual basis in the field of the evaluation method and various methods of teaching. The findings also suggested the development of individual self-efficacy in clinical nurses who train students. PMID:29637056

Goal-setting to Promote a Healthier Lifestyle in Later Life: Qualitative Evaluation of the AgeWell Trial

PubMed Central

Nelis, Sharon M.; Thom, Jeanette M.; Jones, Ian Rees; Hindle, John V.

2018-01-01

ABSTRACT Objective: We report a mixed method evaluation of the feasibility and implementation of the AgeWell goal-setting intervention to promote healthy ageing later life. Method: Researcher field notes, goal-setting interview content, and semi-structured interviews with participants were content analysed to review trial implementation and participants’ perspective on the goal-setting and mentoring intervention. Results: 75 people were recruited: 21 in the goal-setting and 22 in the goal-setting with mentoring arms of the intervention. Goal-setting was feasible in the main domains of interest. Adherence to the protocol was good and the mentoring schedule was adhered to. Participants reported satisfaction with their goal attainment, but barriers for non-achievement were also identified. Recommendations for small changes to the intervention included reducing the number of goals. Conclusions: Participants understood the goal-setting process, and were able to set realistic and achievable lifestyle goals. The intervention and the procedures were acceptable but changes in how goal-setting is both introduced and monitored are needed for wider implementation. Clinical Implications: Goal-setting can be a useful process to help people alter their lifestyle to allow them to age more successfully and reduce risk factors associated with dementia. PMID:29308992

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.

A compact clinical instrument for quantifying suppression.

PubMed

Black, Joanne M; Thompson, Benjamin; Maehara, Goro; Hess, Robert F

2011-02-01

We describe a compact and convenient clinical apparatus for the measurement of suppression based on a previously reported laboratory-based approach. In addition, we report and validate a novel, rapid psychophysical method for measuring suppression using this apparatus, which makes the technique more applicable to clinical practice. By using a Z800 dual pro head-mounted display driven by a MAC laptop, we provide dichoptic stimulation. Global motion stimuli composed of arrays of moving dots are presented to each eye. One set of dots move in a coherent direction (termed signal) whereas another set of dots move in a random direction (termed noise). To quantify performance, we measure the signal/noise ratio corresponding to a direction-discrimination threshold. Suppression is quantified by assessing the extent to which it matters which eye sees the signal and which eye sees the noise. A space-saving, head-mounted display using current video technology offers an ideal solution for clinical practice. In addition, our optimized psychophysical method provided results that were in agreement with those produced using the original technique. We made measures of suppression on a group of nine adult amblyopic participants using this apparatus with both the original and new psychophysical paradigms. All participants had measurable suppression ranging from mild to severe. The two different psychophysical methods gave a strong correlation for the strength of suppression (rho = -0.83, p = 0.006). Combining the new apparatus and new psychophysical method creates a convenient and rapid technique for parametric measurement of interocular suppression. In addition, this apparatus constitutes the ideal platform for suppressors to combine information between their eyes in a similar way to binocularly normal people. This provides a convenient way for clinicians to implement the newly proposed binocular treatment of amblyopia that is based on antisuppression training.

A biological network-based regularized artificial neural network model for robust phenotype prediction from gene expression data.

PubMed

Kang, Tianyu; Ding, Wei; Zhang, Luoyan; Ziemek, Daniel; Zarringhalam, Kourosh

2017-12-19

Stratification of patient subpopulations that respond favorably to treatment or experience and adverse reaction is an essential step toward development of new personalized therapies and diagnostics. It is currently feasible to generate omic-scale biological measurements for all patients in a study, providing an opportunity for machine learning models to identify molecular markers for disease diagnosis and progression. However, the high variability of genetic background in human populations hampers the reproducibility of omic-scale markers. In this paper, we develop a biological network-based regularized artificial neural network model for prediction of phenotype from transcriptomic measurements in clinical trials. To improve model sparsity and the overall reproducibility of the model, we incorporate regularization for simultaneous shrinkage of gene sets based on active upstream regulatory mechanisms into the model. We benchmark our method against various regression, support vector machines and artificial neural network models and demonstrate the ability of our method in predicting the clinical outcomes using clinical trial data on acute rejection in kidney transplantation and response to Infliximab in ulcerative colitis. We show that integration of prior biological knowledge into the classification as developed in this paper, significantly improves the robustness and generalizability of predictions to independent datasets. We provide a Java code of our algorithm along with a parsed version of the STRING DB database. In summary, we present a method for prediction of clinical phenotypes using baseline genome-wide expression data that makes use of prior biological knowledge on gene-regulatory interactions in order to increase robustness and reproducibility of omic-scale markers. The integrated group-wise regularization methods increases the interpretability of biological signatures and gives stable performance estimates across independent test sets.

Verification of respiratory-gated radiotherapy with new real-time tumour-tracking radiotherapy system using cine EPID images and a log file

NASA Astrophysics Data System (ADS)

Shiinoki, Takehiro; Hanazawa, Hideki; Yuasa, Yuki; Fujimoto, Koya; Uehara, Takuya; Shibuya, Keiko

2017-02-01

A combined system comprising the TrueBeam linear accelerator and a new real-time tumour-tracking radiotherapy system, SyncTraX, was installed at our institution. The objectives of this study are to develop a method for the verification of respiratory-gated radiotherapy with SyncTraX using cine electronic portal image device (EPID) images and a log file and to verify this treatment in clinical cases. Respiratory-gated radiotherapy was performed using TrueBeam and the SyncTraX system. Cine EPID images and a log file were acquired for a phantom and three patients during the course of the treatment. Digitally reconstructed radiographs (DRRs) were created for each treatment beam using a planning CT set. The cine EPID images, log file, and DRRs were analysed using a developed software. For the phantom case, the accuracy of the proposed method was evaluated to verify the respiratory-gated radiotherapy. For the clinical cases, the intra- and inter-fractional variations of the fiducial marker used as an internal surrogate were calculated to evaluate the gating accuracy and set-up uncertainty in the superior-inferior (SI), anterior-posterior (AP), and left-right (LR) directions. The proposed method achieved high accuracy for the phantom verification. For the clinical cases, the intra- and inter-fractional variations of the fiducial marker were  ⩽3 mm and  ±3 mm in the SI, AP, and LR directions. We proposed a method for the verification of respiratory-gated radiotherapy with SyncTraX using cine EPID images and a log file and showed that this treatment is performed with high accuracy in clinical cases. This work was partly presented at the 58th Annual meeting of American Association of Physicists in Medicine.

Verification of respiratory-gated radiotherapy with new real-time tumour-tracking radiotherapy system using cine EPID images and a log file.

PubMed

Shiinoki, Takehiro; Hanazawa, Hideki; Yuasa, Yuki; Fujimoto, Koya; Uehara, Takuya; Shibuya, Keiko

2017-02-21

A combined system comprising the TrueBeam linear accelerator and a new real-time tumour-tracking radiotherapy system, SyncTraX, was installed at our institution. The objectives of this study are to develop a method for the verification of respiratory-gated radiotherapy with SyncTraX using cine electronic portal image device (EPID) images and a log file and to verify this treatment in clinical cases. Respiratory-gated radiotherapy was performed using TrueBeam and the SyncTraX system. Cine EPID images and a log file were acquired for a phantom and three patients during the course of the treatment. Digitally reconstructed radiographs (DRRs) were created for each treatment beam using a planning CT set. The cine EPID images, log file, and DRRs were analysed using a developed software. For the phantom case, the accuracy of the proposed method was evaluated to verify the respiratory-gated radiotherapy. For the clinical cases, the intra- and inter-fractional variations of the fiducial marker used as an internal surrogate were calculated to evaluate the gating accuracy and set-up uncertainty in the superior-inferior (SI), anterior-posterior (AP), and left-right (LR) directions. The proposed method achieved high accuracy for the phantom verification. For the clinical cases, the intra- and inter-fractional variations of the fiducial marker were  ⩽3 mm and  ±3 mm in the SI, AP, and LR directions. We proposed a method for the verification of respiratory-gated radiotherapy with SyncTraX using cine EPID images and a log file and showed that this treatment is performed with high accuracy in clinical cases.

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

PubMed

Thompson, David A; Marsteller, Jill A; Pronovost, Peter J; Gurses, Ayse; Lubomski, Lisa H; Goeschel, Christine A; Gosbee, John W; Wahr, Joyce; Martinez, Elizabeth A

2015-09-01

The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Subject-specific cardiovascular system model-based identification and diagnosis of septic shock with a minimally invasive data set: animal experiments and proof of concept.

PubMed

Chase, J Geoffrey; Lambermont, Bernard; Starfinger, Christina; Hann, Christopher E; Shaw, Geoffrey M; Ghuysen, Alexandre; Kolh, Philippe; Dauby, Pierre C; Desaive, Thomas

2011-01-01

A cardiovascular system (CVS) model and parameter identification method have previously been validated for identifying different cardiac and circulatory dysfunctions in simulation and using porcine models of pulmonary embolism, hypovolemia with PEEP titrations and induced endotoxic shock. However, these studies required both left and right heart catheters to collect the data required for subject-specific monitoring and diagnosis-a maximally invasive data set in a critical care setting although it does occur in practice. Hence, use of this model-based diagnostic would require significant additional invasive sensors for some subjects, which is unacceptable in some, if not all, cases. The main goal of this study is to prove the concept of using only measurements from one side of the heart (right) in a 'minimal' data set to identify an effective patient-specific model that can capture key clinical trends in endotoxic shock. This research extends existing methods to a reduced and minimal data set requiring only a single catheter and reducing the risk of infection and other complications-a very common, typical situation in critical care patients, particularly after cardiac surgery. The extended methods and assumptions that found it are developed and presented in a case study for the patient-specific parameter identification of pig-specific parameters in an animal model of induced endotoxic shock. This case study is used to define the impact of this minimal data set on the quality and accuracy of the model application for monitoring, detecting and diagnosing septic shock. Six anesthetized healthy pigs weighing 20-30 kg received a 0.5 mg kg(-1) endotoxin infusion over a period of 30 min from T0 to T30. For this research, only right heart measurements were obtained. Errors for the identified model are within 8% when the model is identified from data, re-simulated and then compared to the experimentally measured data, including measurements not used in the identification process for validation. Importantly, all identified parameter trends match physiologically and clinically and experimentally expected changes, indicating that no diagnostic power is lost. This work represents a further with human subjects validation for this model-based approach to cardiovascular diagnosis and therapy guidance in monitoring endotoxic disease states. The results and methods obtained can be readily extended from this case study to the other animal model results presented previously. Overall, these results provide further support for prospective, proof of concept clinical testing with humans.

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

PubMed Central

2012-01-01

Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

Discovery and Validation of Novel Expression Signature for Postcystectomy Recurrence in High-Risk Bladder Cancer

PubMed Central

Lam, Lucia L.; Ghadessi, Mercedeh; Erho, Nicholas; Vergara, Ismael A.; Alshalalfa, Mohammed; Buerki, Christine; Haddad, Zaid; Sierocinski, Thomas; Triche, Timothy J.; Skinner, Eila C.; Davicioni, Elai; Daneshmand, Siamak; Black, Peter C.

2014-01-01

Background Nearly half of muscle-invasive bladder cancer patients succumb to their disease following cystectomy. Selecting candidates for adjuvant therapy is currently based on clinical parameters with limited predictive power. This study aimed to develop and validate genomic-based signatures that can better identify patients at risk for recurrence than clinical models alone. Methods Transcriptome-wide expression profiles were generated using 1.4 million feature-arrays on archival tumors from 225 patients who underwent radical cystectomy and had muscle-invasive and/or node-positive bladder cancer. Genomic (GC) and clinical (CC) classifiers for predicting recurrence were developed on a discovery set (n = 133). Performances of GC, CC, an independent clinical nomogram (IBCNC), and genomic-clinicopathologic classifiers (G-CC, G-IBCNC) were assessed in the discovery and independent validation (n = 66) sets. GC was further validated on four external datasets (n = 341). Discrimination and prognostic abilities of classifiers were compared using area under receiver-operating characteristic curves (AUCs). All statistical tests were two-sided. Results A 15-feature GC was developed on the discovery set with area under curve (AUC) of 0.77 in the validation set. This was higher than individual clinical variables, IBCNC (AUC = 0.73), and comparable to CC (AUC = 0.78). Performance was improved upon combining GC with clinical nomograms (G-IBCNC, AUC = 0.82; G-CC, AUC = 0.86). G-CC high-risk patients had elevated recurrence probabilities (P < .001), with GC being the best predictor by multivariable analysis (P = .005). Genomic-clinicopathologic classifiers outperformed clinical nomograms by decision curve and reclassification analyses. GC performed the best in validation compared with seven prior signatures. GC markers remained prognostic across four independent datasets. Conclusions The validated genomic-based classifiers outperform clinical models for predicting postcystectomy bladder cancer recurrence. This may be used to better identify patients who need more aggressive management. PMID:25344601

The Gap Between Clinical Research and Standard of Care: A Review of Frailty Assessment Scales in Perioperative Surgical Settings.

PubMed

Stoicea, Nicoleta; Baddigam, Ramya; Wajahn, Jennifer; Sipes, Angela C; Arias-Morales, Carlos E; Gastaldo, Nicholas; Bergese, Sergio D

2016-01-01

The elderly population in the United States is increasing exponentially in tandem with risk for frailty. Frailty is described by a clinically significant state where a patient is at risk for developing complications requiring increased assistance in daily activities. Frailty syndrome studied in geriatric patients is responsible for an increased risk for falls, and increased mortality. In efforts to prepare for and to intervene in perioperative complications and general frailty, a universal scale to measure frailty is necessary. Many methods for determining frailty have been developed, yet there remains a need to define clinical frailty and, therefore, the most effective way to measure it. This article reviews six popular scales for measuring frailty and evaluates their clinical effectiveness demonstrated in previous studies. By identifying the most time-efficient, criteria comprehensive, and clinically effective scale, a universal scale can be implemented into standard of care and reduce complications from frailty in both non-surgical and surgical settings, especially applied to the perioperative surgical home model. We suggest further evaluation of the Edmonton Frailty Scale for inclusion in patient care.

The Gap Between Clinical Research and Standard of Care: A Review of Frailty Assessment Scales in Perioperative Surgical Settings

PubMed Central

Stoicea, Nicoleta; Baddigam, Ramya; Wajahn, Jennifer; Sipes, Angela C.; Arias-Morales, Carlos E.; Gastaldo, Nicholas; Bergese, Sergio D.

2016-01-01

The elderly population in the United States is increasing exponentially in tandem with risk for frailty. Frailty is described by a clinically significant state where a patient is at risk for developing complications requiring increased assistance in daily activities. Frailty syndrome studied in geriatric patients is responsible for an increased risk for falls, and increased mortality. In efforts to prepare for and to intervene in perioperative complications and general frailty, a universal scale to measure frailty is necessary. Many methods for determining frailty have been developed, yet there remains a need to define clinical frailty and, therefore, the most effective way to measure it. This article reviews six popular scales for measuring frailty and evaluates their clinical effectiveness demonstrated in previous studies. By identifying the most time-efficient, criteria comprehensive, and clinically effective scale, a universal scale can be implemented into standard of care and reduce complications from frailty in both non-surgical and surgical settings, especially applied to the perioperative surgical home model. We suggest further evaluation of the Edmonton Frailty Scale for inclusion in patient care. PMID:27493935

Effective and cost-effective clinical trial recruitment strategies for postmenopausal women in a community-based, primary care setting.

PubMed

Butt, Debra A; Lock, Michael; Harvey, Bart J

2010-09-01

Little evidence exists to guide investigators on the effectiveness and cost-effectiveness of various recruitment strategies in primary care research. The purpose of this study is to describe the effectiveness and cost-effectiveness of eight clinical trial recruitment methods for postmenopausal women in a community-based setting. A retrospective analysis of the yield and cost of eight different recruitment methods: 1) family physician (FP) recruiters, 2) FP referrals, 3) community presentations, 4) community events, 5) newsletters, 6) direct mailings, 7) posters, and 8) newspaper advertisements that were used to recruit postmenopausal women to a randomized clinical trial (RCT) evaluating the effectiveness of gabapentin in treating hot flashes. We recruited 197 postmenopausal women from a total of 904 screened, with 291 of the remainder being ineligible and 416 declining to participate. Of the 904 women screened, 34 (3.8%) were from FP recruiters and 35 (3.9%) were from other FP referrals while 612 (67.7%) resulted from newspaper advertisements. Of the 197 women enrolled, 141 (72%) were from newspaper advertisements, with 26 (13%) following next from posters. Word of mouth was identified as an additional unanticipated study recruitment strategy. Metropolitan newspaper advertising at $112.73 (Canadian) per enrolled participant and posters at $119.98 were found to be cost-effective recruitment methods. Newspaper advertisements were the most successful method to recruit postmenopausal women into a community-based, primary care RCT. Copyright 2010 Elsevier Inc. All rights reserved.

Lessons from pediatrics residency program directors' experiences with work hour limitations in New York State.

PubMed

Samuels, Ronald C; Chi, Grace W; Rauch, Daniel A; Palfrey, Judith S; Shelov, Steven P

2005-05-01

To evaluate the impact of residency work hour limitations on pediatrics residency programs in New York State, and to learn lessons that can be used nationally with the implementation of the Accreditation Council of Graduate Medical Education's similar rules. A three-page questionnaire was mailed to all pediatrics residency program directors in New York. The questionnaire assessed methods used to accommodate the work hour limitations and perceptions of the limitations' effects. Twenty-one program directors responded (68%). Only large programs used night floats and night teams to meet work hour requirements. Programs of all sizes and in all settings used cross coverage and sent residents home immediately post call. About half of the programs hired additional nonresident staff, usually nurse practitioners, physician assistants, and/or attendings. The most frequently reported effects were decreases in the amount of time residents spent in inpatient settings, patient continuity in inpatient settings, flexibility of residents' scheduling, and increased logistical work needed to maintain continuity clinic. A summary of advice to other program directors was "be creative" and "be flexible." New York's pediatrics residency programs used a variety of mechanisms to meet work hour restrictions. Smaller programs had fewer methods available to them to meet such restrictions. Although the logistical work needed to maintain continuity clinic increased greatly, continuity and outpatient settings themselves were not greatly affected by work hour limitations. Inpatient settings were more affected and experienced much more in the way of change.

PCR method for the rapid detection and discrimination of Legionella spp. based on the amplification of pcs, pmtA, and 16S rRNA genes.

PubMed

Janczarek, Monika; Palusińska-Szysz, Marta

2016-05-01

Legionella bacteria are organisms of public health interest due to their ability to cause pneumonia (Legionnaires' disease) in susceptible humans and their ubiquitous presence in water supply systems. Rapid diagnosis of Legionnaires' disease allows the use of therapy specific for the disease. L. pneumophila serogroup 1 is the most common cause of infection acquired in community and hospital environments. The non-L. pneumophila infections are likely under-detected because of a lack of effective diagnosis. In this work, simplex and duplex PCR assays with the use of new molecular markers pcs and pmtA involved in phosphatidylcholine synthesis were specified for rapid and cost-efficient identification and distinguishing Legionella species. The sets of primers developed were found to be sensitive and specific for reliable detection of Legionella belonging to the eight most clinically relevant species. Among these, four primer sets I, II, VI, and VII used for duplex-PCRs proved to have the highest identification power and reliability in the detection of the bacteria. Application of this PCR-based method should improve detection of Legionella spp. in both clinical and environmental settings and facilitate molecular typing of these organisms.

A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement

PubMed Central

de Roos, Paul; Bloem, Bastiaan R.; Kelley, Thomas A.; Antonini, Angelo; Dodel, Richard; Hagell, Peter; Marras, Connie; Martinez-Martin, Pablo; Mehta, Shyamal H.; Odin, Per; Chaudhuri, Kallol Ray; Weintraub, Daniel; Wilson, Bil; Uitti, Ryan J.

2017-01-01

Background Parkinson’s disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential. Objective Propose a global consensus standard set of outcome measures for PD. Methods Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected. Results The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment. Conclusions The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of ‘best practices’, ultimately leading to better informed treatment decisions. PMID:28671140

Missed Opportunities: Screening and Brief Intervention for Risky Alcohol Use in Women's Health Settings

PubMed Central

Cockrell, Stephanie; Russo, Jennifer; Corder-Mabe, Joan; Yowell-Many, Alycia; Chisholm, Christian; Ingersoll, Karen

2015-01-01

Abstract Background: Although women's health settings could provide access to women for screening, brief intervention, and referral to treatment (SBIRT) for risky alcohol use, little is known about rates of alcohol use or associated risk for alcohol-exposed pregnancy (AEP) among women's health patients, receipt of SBIRT services in these settings, or patient attitudes towards SBIRT services. Methods: This study reports the results of a self-administered survey to a convenience sample of women's health patients attending public clinics for family planning or sexually transmitted infection visits. Results: Surveys were analyzed for 199 reproductive-aged women who had visited the clinic within the past year. The rate of risky drinking among the sample was (44%) and risk for AEP was (17%). Despite this, many patients did not receive SBIRT services, with more than half of risky drinking patients reporting that they were not advised about safe drinking limits (59%) and similar rates of patients at risk for AEP reporting that their medical provider did not discuss risk factors of AEP (53%). Patient attitudes towards receipt of SBIRT services were favorable; more than 90% of women agreed or strongly agreed that if their drinking was affecting their health, their women's health provider should advise them to cut down. Conclusions: Women's health clinics may be an ideal setting to implement SBIRT and future research should address treatment efficacy in these settings. PMID:26230758

Pervasive healthcare as a scientific discipline.

PubMed

Bardram, J E

2008-01-01

The OECD countries are facing a set of core challenges; an increasing elderly population; increasing number of chronic and lifestyle-related diseases; expanding scope of what medicine can do; and increasing lack of medical professionals. Pervasive healthcare asks how pervasive computing technology can be designed to meet these challenges. The objective of this paper is to discuss 'pervasive healthcare' as a research field and tries to establish how novel and distinct it is, compared to related work within biomedical engineering, medical informatics, and ubiquitous computing. The paper presents the research questions, approach, technologies, and methods of pervasive healthcare and discusses these in comparison to those of other related scientific disciplines. A set of central research themes are presented; monitoring and body sensor networks; pervasive assistive technologies; pervasive computing for hospitals; and preventive and persuasive technologies. Two projects illustrate the kind of research being done in pervasive healthcare. The first project is targeted at home-based monitoring of hypertension; the second project is designing context-aware technologies for hospitals. Both projects approach the healthcare challenges in a new way, apply a new type of research method, and come up with new kinds of technological solutions. 'Clinical proof-of-concept' is recommended as a new method for pervasive healthcare research; the method helps design and test pervasive healthcare technologies, and in ascertaining their clinical potential before large-scale clinical tests are needed. The paper concludes that pervasive healthcare as a research field and agenda is novel; it is addressing new emerging research questions, represents a novel approach, designs new types of technologies, and applies a new kind of research method.

Efficient Detection of Copy Number Mutations in PMS2 Exons with a Close Homolog.

PubMed

Herman, Daniel S; Smith, Christina; Liu, Chang; Vaughn, Cecily P; Palaniappan, Selvi; Pritchard, Colin C; Shirts, Brian H

2018-07-01

Detection of 3' PMS2 copy-number mutations that cause Lynch syndrome is difficult because of highly homologous pseudogenes. To improve the accuracy and efficiency of clinical screening for these mutations, we developed a new method to analyze standard capture-based, next-generation sequencing data to identify deletions and duplications in PMS2 exons 9 to 15. The approach captures sequences using PMS2 targets, maps sequences randomly among regions with equal mapping quality, counts reads aligned to homologous exons and introns, and flags read count ratios outside of empirically derived reference ranges. The method was trained on 1352 samples, including 8 known positives, and tested on 719 samples, including 17 known positives. Clinical implementation of the first version of this method detected new mutations in the training (N = 7) and test (N = 2) sets that had not been identified by our initial clinical testing pipeline. The described final method showed complete sensitivity in both sample sets and false-positive rates of 5% (training) and 7% (test), dramatically decreasing the number of cases needing additional mutation evaluation. This approach leveraged the differences between gene and pseudogene to distinguish between PMS2 and PMS2CL copy-number mutations. These methods enable efficient and sensitive Lynch syndrome screening for 3' PMS2 copy-number mutations and may be applied similarly to other genomic regions with highly homologous pseudogenes. Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

A new framework for the documentation and interpretation of oral food challenges in population-based and clinical research.

PubMed

Grabenhenrich, L B; Reich, A; Bellach, J; Trendelenburg, V; Sprikkelman, A B; Roberts, G; Grimshaw, K E C; Sigurdardottir, S; Kowalski, M L; Papadopoulos, N G; Quirce, S; Dubakiene, R; Niggemann, B; Fernández-Rivas, M; Ballmer-Weber, B; van Ree, R; Schnadt, S; Mills, E N C; Keil, T; Beyer, K

2017-03-01

The conduct of oral food challenges as the preferred diagnostic standard for food allergy (FA) was harmonized over the last years. However, documentation and interpretation of challenge results, particularly in research settings, are not sufficiently standardized to allow valid comparisons between studies. Our aim was to develop a diagnostic toolbox to capture and report clinical observations in double-blind placebo-controlled food challenges (DBPCFC). A group of experienced allergists, paediatricians, dieticians, epidemiologists and data managers developed generic case report forms and standard operating procedures for DBPCFCs and piloted them in three clinical centres. The follow-up of the EuroPrevall/iFAAM birth cohort and other iFAAM work packages applied these methods. A set of newly developed questionnaire or interview items capture the history of FA. Together with sensitization status, this forms the basis for the decision to perform a DBPCFC, following a standardized decision algorithm. A generic form including details about severity and timing captures signs and symptoms observed during or after the procedures. In contrast to the commonly used dichotomous outcome FA vs no FA, the allergy status is interpreted in multiple categories to reflect the complexity of clinical decision-making. The proposed toolbox sets a standard for improved documentation and harmonized interpretation of DBPCFCs. By a detailed documentation and common terminology for communicating outcomes, these tools hope to reduce the influence of subjective judgment of supervising physicians. All forms are publicly available for further evolution and free use in clinical and research settings. © 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.

Clinical risk assessment of patients with chronic kidney disease by using clinical data and multivariate models.

PubMed

Chen, Zewei; Zhang, Xin; Zhang, Zhuoyong

2016-12-01

Timely risk assessment of chronic kidney disease (CKD) and proper community-based CKD monitoring are important to prevent patients with potential risk from further kidney injuries. As many symptoms are associated with the progressive development of CKD, evaluating risk of CKD through a set of clinical data of symptoms coupled with multivariate models can be considered as an available method for prevention of CKD and would be useful for community-based CKD monitoring. Three common used multivariate models, i.e., K-nearest neighbor (KNN), support vector machine (SVM), and soft independent modeling of class analogy (SIMCA), were used to evaluate risk of 386 patients based on a series of clinical data taken from UCI machine learning repository. Different types of composite data, in which proportional disturbances were added to simulate measurement deviations caused by environment and instrument noises, were also utilized to evaluate the feasibility and robustness of these models in risk assessment of CKD. For the original data set, three mentioned multivariate models can differentiate patients with CKD and non-CKD with the overall accuracies over 93 %. KNN and SVM have better performances than SIMCA has in this study. For the composite data set, SVM model has the best ability to tolerate noise disturbance and thus are more robust than the other two models. Using clinical data set on symptoms coupled with multivariate models has been proved to be feasible approach for assessment of patient with potential CKD risk. SVM model can be used as useful and robust tool in this study.

Combining large number of weak biomarkers based on AUC.

PubMed

Yan, Li; Tian, Lili; Liu, Song

2015-12-20

Combining multiple biomarkers to improve diagnosis and/or prognosis accuracy is a common practice in clinical medicine. Both parametric and non-parametric methods have been developed for finding the optimal linear combination of biomarkers to maximize the area under the receiver operating characteristic curve (AUC), primarily focusing on the setting with a small number of well-defined biomarkers. This problem becomes more challenging when the number of observations is not order of magnitude greater than the number of variables, especially when the involved biomarkers are relatively weak. Such settings are not uncommon in certain applied fields. The first aim of this paper is to empirically evaluate the performance of existing linear combination methods under such settings. The second aim is to propose a new combination method, namely, the pairwise approach, to maximize AUC. Our simulation studies demonstrated that the performance of several existing methods can become unsatisfactory as the number of markers becomes large, while the newly proposed pairwise method performs reasonably well. Furthermore, we apply all the combination methods to real datasets used for the development and validation of MammaPrint. The implication of our study for the design of optimal linear combination methods is discussed. Copyright © 2015 John Wiley & Sons, Ltd.

Combining large number of weak biomarkers based on AUC

PubMed Central

Yan, Li; Tian, Lili; Liu, Song

2018-01-01

Combining multiple biomarkers to improve diagnosis and/or prognosis accuracy is a common practice in clinical medicine. Both parametric and non-parametric methods have been developed for finding the optimal linear combination of biomarkers to maximize the area under the receiver operating characteristic curve (AUC), primarily focusing on the setting with a small number of well-defined biomarkers. This problem becomes more challenging when the number of observations is not order of magnitude greater than the number of variables, especially when the involved biomarkers are relatively weak. Such settings are not uncommon in certain applied fields. The first aim of this paper is to empirically evaluate the performance of existing linear combination methods under such settings. The second aim is to propose a new combination method, namely, the pairwise approach, to maximize AUC. Our simulation studies demonstrated that the performance of several existing methods can become unsatisfactory as the number of markers becomes large, while the newly proposed pairwise method performs reasonably well. Furthermore, we apply all the combination methods to real datasets used for the development and validation of MammaPrint. The implication of our study for the design of optimal linear combination methods is discussed. PMID:26227901

Modifications to ART service delivery models by health facilities in Uganda in promotion of intervention sustainability: a mixed methods study.

PubMed

Zakumumpa, Henry; Bennett, Sara; Ssengooba, Freddie

2017-04-04

In November 2015, WHO released new treatment guidelines recommending that all diagnosed as HIV positive be enrolled on antiretroviral therapy (ART). Sustaining and expanding ART scale-up programs in resource-limited settings will require adaptations and modifications to traditional ART delivery models to meet the rapid increase in demand. We identify modifications to ART service delivery models by health facilities in Uganda to sustain ART interventions over a 10-year period (2004-2014). A mixed methods approach involving two study phases was adopted. In the first phase, a survey of a nationally representative sample of health facilities (n = 195) in Uganda which were accredited to provide ART between 2004 and 2009 was conducted. The second phase involved semi-structured interviews (n = 18) with ART clinic managers of 6 of the 195 health facilities purposively selected from the first study phase. We adopted a thematic framework consisting of four categories of modifications (format, setting, personnel, and population). The majority of health facilities 185 (95%) reported making modifications to ART interventions between 2004 and 2014. Of the 195 health facilities, 157 (81%) rated the modifications made to ART as "major." Modifications to ART were reported under all the four themes. The quantitative and qualitative findings are integrated and presented under four themes. Format: Reducing the frequency of clinic appointments and pharmacy-only refill programs was identified as important strategies for decongesting ART clinics. Home-based care programs were introduced to reduce provider ART delivery costs. Personnel: Task shifting to non-physician cadre was reported in 181 (93%) of the health facilities. Visits to the ART clinic were rationalized in favor of the sub-population deemed to have more clinical need. Two health facilities focused on patients living nearer the health facilities to align with targets set by external donors. Over the study period, health facilities made several modifications ART interventions to improve fit with their resource-constrained settings thereby promoting long-term sustainability. Further research evaluating the effect of these modifications on patient outcomes and ART delivery costs is recommended. Our findings have implications for the sustainability of ART scale-up programs in Uganda and other resource-limited settings.

SU-F-BRD-10: Lung IMRT Planning Using Standardized Beam Bouquet Templates

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

Yuan, L; Wu, Q J.; Yin, F

2014-06-15

Purpose: We investigate the feasibility of choosing from a small set of standardized templates of beam bouquets (i.e., entire beam configuration settings) for lung IMRT planning to improve planning efficiency and quality consistency, and also to facilitate automated planning. Methods: A set of beam bouquet templates is determined by learning from the beam angle settings in 60 clinical lung IMRT plans. A k-medoids cluster analysis method is used to classify the beam angle configuration into clusters. The value of the average silhouette width is used to determine the ideal number of clusters. The beam arrangements in each medoid of themore » resulting clusters are taken as the standardized beam bouquet for the cluster, with the corresponding case taken as the reference case. The resulting set of beam bouquet templates was used to re-plan 20 cases randomly selected from the database and the dosimetric quality of the plans was evaluated against the corresponding clinical plans by a paired t-test. The template for each test case was manually selected by a planner based on the match between the test and reference cases. Results: The dosimetric parameters (mean±S.D. in percentage of prescription dose) of the plans using 6 beam bouquet templates and those of the clinical plans, respectively, and the p-values (in parenthesis) are: lung Dmean: 18.8±7.0, 19.2±7.0 (0.28), esophagus Dmean: 32.0±16.3, 34.4±17.9 (0.01), heart Dmean: 19.2±16.5, 19.4±16.6 (0.74), spinal cord D2%: 47.7±18.8, 52.0±20.3 (0.01), PTV dose homogeneity (D2%-D99%): 17.1±15.4, 20.7±12.2 (0.03).The esophagus Dmean, cord D02 and PTV dose homogeneity are statistically better in the plans using the standardized templates, but the improvements (<5%) may not be clinically significant. The other dosimetric parameters are not statistically different. Conclusion: It's feasible to use a small number of standardized beam bouquet templates (e.g. 6) to generate plans with quality comparable to that of clinical plans. Partially supported by NIH/NCI under grant #R21CA161389 and a master research grant by Varian Medical System.« less

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.

PubMed

Minozzi, Silvia; Ruggiero, Francesca; Capobussi, Matteo; González-Lorenzo, Marien; La Regina, Micaela; Squizzato, Alessandro; Moja, Lorenzo; Orlandini, Francesco

2018-05-01

The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

Clinical implementation of integrated whole-genome copy number and mutation profiling for glioblastoma

PubMed Central

Ramkissoon, Shakti H.; Bi, Wenya Linda; Schumacher, Steven E.; Ramkissoon, Lori A.; Haidar, Sam; Knoff, David; Dubuc, Adrian; Brown, Loreal; Burns, Margot; Cryan, Jane B.; Abedalthagafi, Malak; Kang, Yun Jee; Schultz, Nikolaus; Reardon, David A.; Lee, Eudocia Q.; Rinne, Mikael L.; Norden, Andrew D.; Nayak, Lakshmi; Ruland, Sandra; Doherty, Lisa M.; LaFrankie, Debra C.; Horvath, Margaret; Aizer, Ayal A.; Russo, Andrea; Arvold, Nils D.; Claus, Elizabeth B.; Al-Mefty, Ossama; Johnson, Mark D.; Golby, Alexandra J.; Dunn, Ian F.; Chiocca, E. Antonio; Trippa, Lorenzo; Santagata, Sandro; Folkerth, Rebecca D.; Kantoff, Philip; Rollins, Barrett J.; Lindeman, Neal I.; Wen, Patrick Y.; Ligon, Azra H.; Beroukhim, Rameen; Alexander, Brian M.; Ligon, Keith L.

2015-01-01

Background Multidimensional genotyping of formalin-fixed paraffin-embedded (FFPE) samples has the potential to improve diagnostics and clinical trials for brain tumors, but prospective use in the clinical setting is not yet routine. We report our experience with implementing a multiplexed copy number and mutation-testing program in a diagnostic laboratory certified by the Clinical Laboratory Improvement Amendments. Methods We collected and analyzed clinical testing results from whole-genome array comparative genomic hybridization (OncoCopy) of 420 brain tumors, including 148 glioblastomas. Mass spectrometry–based mutation genotyping (OncoMap, 471 mutations) was performed on 86 glioblastomas. Results OncoCopy was successful in 99% of samples for which sufficient DNA was obtained (n = 415). All clinically relevant loci for glioblastomas were detected, including amplifications (EGFR, PDGFRA, MET) and deletions (EGFRvIII, PTEN, 1p/19q). Glioblastoma patients ≤40 years old had distinct profiles compared with patients >40 years. OncoMap testing reliably identified mutations in IDH1, TP53, and PTEN. Seventy-seven glioblastoma patients enrolled on trials, of whom 51% participated in targeted therapeutic trials where multiplex data informed eligibility or outcomes. Data integration identified patients with complete tumor suppressor inactivation, albeit rarely (5% of patients) due to lack of whole-gene coverage in OncoMap. Conclusions Combined use of multiplexed copy number and mutation detection from FFPE samples in the clinical setting can efficiently replace singleton tests for clinical diagnosis and prognosis in most settings. Our results support incorporation of these assays into clinical trials as integral biomarkers and their potential to impact interpretation of results. Limited tumor suppressor variant capture by targeted genotyping highlights the need for whole-gene sequencing in glioblastoma. PMID:25754088

Destruction of giant cluster-like vesicles by an ultrasonically activated device

NASA Astrophysics Data System (ADS)

Yahagi, Ryosuke; Yoshida, Kenji; Zhang, Yiting; Ebata, Masahiko; Toyota, Taro; Yamaguchi, Tadashi; Hayashi, Hideki

2016-07-01

In this paper, we propose a technically simple method of destroying a tissue marker composed of giant cluster-like vesicles (GCVs) to facilitate laparoscopic surgeries; the method releases various biological tracers contained in GCVs. An ultrasonically activated device (USAD) emitting 55.5 kHz ultrasound was employed for this purpose. Optical microscopy and fluorospectrophotometry revealed the destruction of GCVs after ultrasound irradiation when the blade tip was set 1.0 mm or closer to, but not directly in contact with, a GCV-containing cell. This means that USAD could be safely used for destroying this GCV tissue marker in clinical settings.

Registered nurses' clinical reasoning skills and reasoning process: A think-aloud study.

PubMed

Lee, JuHee; Lee, Young Joo; Bae, JuYeon; Seo, Minjeong

2016-11-01

As complex chronic diseases are increasing, nurses' prompt and accurate clinical reasoning skills are essential. However, little is known about the reasoning skills of registered nurses. This study aimed to determine how registered nurses use their clinical reasoning skills and to identify how the reasoning process proceeds in the complex clinical situation of hospital setting. A qualitative exploratory design was used with a think-aloud method. A total of 13 registered nurses (mean years of experience=11.4) participated in the study, solving an ill-structured clinical problem based on complex chronic patients cases in a hospital setting. Data were analyzed using deductive content analysis. Findings showed that the registered nurses used a variety of clinical reasoning skills. The most commonly used skill was 'checking accuracy and reliability.' The reasoning process of registered nurses covered assessment, analysis, diagnosis, planning/implementation, and evaluation phase. It is critical that registered nurses apply appropriate clinical reasoning skills in complex clinical practice. The main focus of registered nurses' reasoning in this study was assessing a patient's health problem, and their reasoning process was cyclic, rather than linear. There is a need for educational strategy development to enhance registered nurses' competency in determining appropriate interventions in a timely and accurate fashion. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Group Objective Structured Clinical Experience: building communication skills in the clinical reasoning context.

PubMed

Konopasek, Lyuba; Kelly, Kevin V; Bylund, Carma L; Wenderoth, Suzanne; Storey-Johnson, Carol

2014-07-01

Students are rarely taught communication skills in the context of clinical reasoning training. The purpose of this project was to combine the teaching of communication skills using SPs with clinical reasoning exercises in a Group Objective Structured Clinical Experience (GOSCE) to study feasibility of the approach, the effect on learners' self-efficacy and attitude toward learning communication skills, and the effect of providing multiple sources of immediate, collaborative feedback. GOSCE sessions were piloted in Pediatrics and Medicine clerkships with students assessing their own performance and receiving formative feedback on communication skills from peers, standardized patients (SPs), and faculty. The sessions were evaluated using a retrospective pre/post-training questionnaire rating changes in self-efficacy and attitudes, and the value of the feedback. Results indicate a positive impact on attitudes toward learning communication skills and self-efficacy regarding communication in the clinical setting. Also, learners considered feedback by peers, SPs, and faculty valuable in each GOSCE. The GOSCE is an efficient and learner-centered method to attend to multiple goals of teaching communication skills, clinical reasoning, self-assessment, and giving feedback in a formative setting. The GOSCE is a low-resource, feasible strategy for experiential learning in communication skills and clinical reasoning. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Performance comparison of first-order conditional estimation with interaction and Bayesian estimation methods for estimating the population parameters and its distribution from data sets with a low number of subjects.

PubMed

Pradhan, Sudeep; Song, Byungjeong; Lee, Jaeyeon; Chae, Jung-Woo; Kim, Kyung Im; Back, Hyun-Moon; Han, Nayoung; Kwon, Kwang-Il; Yun, Hwi-Yeol

2017-12-01

Exploratory preclinical, as well as clinical trials, may involve a small number of patients, making it difficult to calculate and analyze the pharmacokinetic (PK) parameters, especially if the PK parameters show very high inter-individual variability (IIV). In this study, the performance of a classical first-order conditional estimation with interaction (FOCE-I) and expectation maximization (EM)-based Markov chain Monte Carlo Bayesian (BAYES) estimation methods were compared for estimating the population parameters and its distribution from data sets having a low number of subjects. In this study, 100 data sets were simulated with eight sampling points for each subject and with six different levels of IIV (5%, 10%, 20%, 30%, 50%, and 80%) in their PK parameter distribution. A stochastic simulation and estimation (SSE) study was performed to simultaneously simulate data sets and estimate the parameters using four different methods: FOCE-I only, BAYES(C) (FOCE-I and BAYES composite method), BAYES(F) (BAYES with all true initial parameters and fixed ω 2 ), and BAYES only. Relative root mean squared error (rRMSE) and relative estimation error (REE) were used to analyze the differences between true and estimated values. A case study was performed with a clinical data of theophylline available in NONMEM distribution media. NONMEM software assisted by Pirana, PsN, and Xpose was used to estimate population PK parameters, and R program was used to analyze and plot the results. The rRMSE and REE values of all parameter (fixed effect and random effect) estimates showed that all four methods performed equally at the lower IIV levels, while the FOCE-I method performed better than other EM-based methods at higher IIV levels (greater than 30%). In general, estimates of random-effect parameters showed significant bias and imprecision, irrespective of the estimation method used and the level of IIV. Similar performance of the estimation methods was observed with theophylline dataset. The classical FOCE-I method appeared to estimate the PK parameters more reliably than the BAYES method when using a simple model and data containing only a few subjects. EM-based estimation methods can be considered for adapting to the specific needs of a modeling project at later steps of modeling.

Clinical Pharmacy Consultations Provided by American and Kenyan Pharmacy Students During an Acute Care Advanced Pharmacy Practice Experience

PubMed Central

Pastakia, Sonak D.; Manji, Imran; Kamau, Evelyn; Schellhase, Ellen M.

2011-01-01

Objective To compare the clinical consultations provided by American and Kenyan pharmacy students in an acute care setting in a developing country. Methods The documented pharmacy consultation recommendations made by American and Kenyan pharmacy students during patient care rounds on an advanced pharmacy practice experience at a referral hospital in Kenya were reviewed and classified according to type of intervention and therapeutic area. Results The Kenyan students documented more interventions than American students (16.7 vs. 12.0 interventions/day) and provided significantly more consultations regarding human immunodeficiency virus (HIV) and antibiotics. The top area of consultations provided by American students was cardiovascular diseases. Conclusions American and Kenyan pharmacy students successfully providing clinical pharmacy consultations in a resource-constrained, acute-care practice setting suggests an important role for pharmacy students in the reconciliation of prescriber orders with medication administration records and in providing drug information. PMID:21655396

Performance evaluation and clinical applications of 3D plenoptic cameras

NASA Astrophysics Data System (ADS)

Decker, Ryan; Shademan, Azad; Opfermann, Justin; Leonard, Simon; Kim, Peter C. W.; Krieger, Axel

2015-06-01

The observation and 3D quantification of arbitrary scenes using optical imaging systems is challenging, but increasingly necessary in many fields. This paper provides a technical basis for the application of plenoptic cameras in medical and medical robotics applications, and rigorously evaluates camera integration and performance in the clinical setting. It discusses plenoptic camera calibration and setup, assesses plenoptic imaging in a clinically relevant context, and in the context of other quantitative imaging technologies. We report the methods used for camera calibration, precision and accuracy results in an ideal and simulated surgical setting. Afterwards, we report performance during a surgical task. Test results showed the average precision of the plenoptic camera to be 0.90mm, increasing to 1.37mm for tissue across the calibrated FOV. The ideal accuracy was 1.14mm. The camera showed submillimeter error during a simulated surgical task.

Current Options for Determining Fracture Union

PubMed Central

2014-01-01

Determining whether a bone fracture is healed is one of the most important and fundamental clinical determinations made in orthopaedics. However, there are currently no standardized methods of assessing fracture union, which in turn has created significant disagreement among orthopaedic surgeons in both clinical and research settings. An extensive amount of research has been dedicated to finding novel and reliable ways of determining healing with some promising results. Recent advancements in imaging techniques and introduction of new radiographic scores have helped decrease the amount of disagreement on this topic among physicians. The knowledge gained from biomechanical studies of bone healing has helped us refine our tools and create more efficient and practical research instruments. Additionally, a deeper understanding of the molecular pathways involved in the bone healing process has led to emergence of serologic markers as possible candidates in assessment of fracture union. In addition to our current physician centered methods, patient-centered approaches assessing quality of life and function are gaining popularity in assessment of fracture union. Despite these advances, assessment of union remains an imperfect practice in the clinical setting. Therefore, clinicians need to draw on multiple modalities that directly and indirectly measure or correlate with bone healing when counseling patients. PMID:26556422

Experiences of using the Theoretical Domains Framework across diverse clinical environments: a qualitative study

PubMed Central

Phillips, Cameron J; Marshall, Andrea P; Chaves, Nadia J; Jankelowitz, Stacey K; Lin, Ivan B; Loy, Clement T; Rees, Gwyneth; Sakzewski, Leanne; Thomas, Susie; To, The-Phung; Wilkinson, Shelley A; Michie, Susan

2015-01-01

Background The Theoretical Domains Framework (TDF) is an integrative framework developed from a synthesis of psychological theories as a vehicle to help apply theoretical approaches to interventions aimed at behavior change. Purpose This study explores experiences of TDF use by professionals from multiple disciplines across diverse clinical settings. Methods Mixed methods were used to examine experiences, attitudes, and perspectives of health professionals in using the TDF in health care implementation projects. Individual interviews were conducted with ten health care professionals from six disciplines who used the TDF in implementation projects. Deductive content and thematic analysis were used. Results Three main themes and associated subthemes were identified including: 1) reasons for use of the TDF (increased confidence, broader perspective, and theoretical underpinnings); 2) challenges using the TDF (time and resources, operationalization of the TDF) and; 3) future use of the TDF. Conclusion The TDF provided a useful, flexible framework for a diverse group of health professionals working across different clinical settings for the assessment of barriers and targeting resources to influence behavior change for implementation projects. The development of practical tools and training or support is likely to aid the utility of TDF. PMID:25834455

Managing and Communicating Operational Workflow

PubMed Central

Weinberg, Stuart T.; Danciu, Ioana; Unertl, Kim M.

2016-01-01

Summary Background Healthcare team members in emergency department contexts have used electronic whiteboard solutions to help manage operational workflow for many years. Ambulatory clinic settings have highly complex operational workflow, but are still limited in electronic assistance to communicate and coordinate work activities. Objective To describe and discuss the design, implementation, use, and ongoing evolution of a coordination and collaboration tool supporting ambulatory clinic operational workflow at Vanderbilt University Medical Center (VUMC). Methods The outpatient whiteboard tool was initially designed to support healthcare work related to an electronic chemotherapy order-entry application. After a highly successful initial implementation in an oncology context, a high demand emerged across the organization for the outpatient whiteboard implementation. Over the past 10 years, developers have followed an iterative user-centered design process to evolve the tool. Results The electronic outpatient whiteboard system supports 194 separate whiteboards and is accessed by over 2800 distinct users on a typical day. Clinics can configure their whiteboards to support unique workflow elements. Since initial release, features such as immunization clinical decision support have been integrated into the system, based on requests from end users. Conclusions The success of the electronic outpatient whiteboard demonstrates the usefulness of an operational workflow tool within the ambulatory clinic setting. Operational workflow tools can play a significant role in supporting coordination, collaboration, and teamwork in ambulatory healthcare settings. PMID:27081407

Improving record linkage performance in the presence of missing linkage data.

PubMed

Ong, Toan C; Mannino, Michael V; Schilling, Lisa M; Kahn, Michael G

2014-12-01

Existing record linkage methods do not handle missing linking field values in an efficient and effective manner. The objective of this study is to investigate three novel methods for improving the accuracy and efficiency of record linkage when record linkage fields have missing values. By extending the Fellegi-Sunter scoring implementations available in the open-source Fine-grained Record Linkage (FRIL) software system we developed three novel methods to solve the missing data problem in record linkage, which we refer to as: Weight Redistribution, Distance Imputation, and Linkage Expansion. Weight Redistribution removes fields with missing data from the set of quasi-identifiers and redistributes the weight from the missing attribute based on relative proportions across the remaining available linkage fields. Distance Imputation imputes the distance between the missing data fields rather than imputing the missing data value. Linkage Expansion adds previously considered non-linkage fields to the linkage field set to compensate for the missing information in a linkage field. We tested the linkage methods using simulated data sets with varying field value corruption rates. The methods developed had sensitivity ranging from .895 to .992 and positive predictive values (PPV) ranging from .865 to 1 in data sets with low corruption rates. Increased corruption rates lead to decreased sensitivity for all methods. These new record linkage algorithms show promise in terms of accuracy and efficiency and may be valuable for combining large data sets at the patient level to support biomedical and clinical research. Copyright © 2014 Elsevier Inc. All rights reserved.

The 5C Concept and 5S Principles in Inflammatory Bowel Disease Management

PubMed Central

Hibi, Toshifumi; Panaccione, Remo; Katafuchi, Miiko; Yokoyama, Kaoru; Watanabe, Kenji; Matsui, Toshiyuki; Matsumoto, Takayuki; Travis, Simon; Suzuki, Yasuo

2017-01-01

Abstract Background and Aims The international Inflammatory Bowel Disease [IBD] Expert Alliance initiative [2012–2015] served as a platform to define and support areas of best practice in IBD management to help improve outcomes for all patients with IBD. Methods During the programme, IBD specialists from around the world established by consensus two best practice charters: the 5S Principles and the 5C Concept. Results The 5S Principles were conceived to provide health care providers with key guidance for improving clinical practice based on best management approaches. They comprise the following categories: Stage the disease; Stratify patients; Set treatment goals; Select appropriate treatment; and Supervise therapy. Optimised management of patients with IBD based on the 5S Principles can be achieved most effectively within an optimised clinical care environment. Guidance on optimising the clinical care setting in IBD management is provided through the 5C Concept, which encompasses: Comprehensive IBD care; Collaboration; Communication; Clinical nurse specialists; and Care pathways. Together, the 5C Concept and 5S Principles provide structured recommendations on organising the clinical care setting and developing best-practice approaches in IBD management. Conclusions Consideration and application of these two dimensions could help health care providers optimise their IBD centres and collaborate more effectively with their multidisciplinary team colleagues and patients, to provide improved IBD care in daily clinical practice. Ultimately, this could lead to improved outcomes for patients with IBD. PMID:28981622

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.

Highly sensitive fluorescence detection of metastatic lymph nodes of gastric cancer with photo-oxidation of protoporphyrin IX.

PubMed

Koizumi, N; Harada, Y; Beika, M; Minamikawa, T; Yamaoka, Y; Dai, P; Murayama, Y; Yanagisawa, A; Otsuji, E; Tanaka, H; Takamatsu, T

2016-08-01

The establishment of a precise and rapid method to detect metastatic lymph nodes (LNs) is essential to perform less invasive surgery with reduced gastrectomy along with reduced lymph node dissection. We herein describe a novel imaging strategy to detect 5-aminolevulinic acid (5-ALA)-induced protoporphyrin IX (PpIX) fluorescence in excised LNs specifically with reduced effects of tissue autofluorescence based on photo-oxidation of PpIX. We applied the method in a clinical setting, and evaluated its feasibility. To reduce the unfavorable effect of autofluorescence, we focused on photo-oxidation of PpIX: Following light irradiation, PpIX changes into another substance, photo-protoporphyrin, via an oxidative process, which has a different spectral peak, at 675 nm, whereas PpIX has its spectral peak at 635 nm. Based on the unique spectral alteration, fluorescence spectral imaging before and after light irradiation and subsequent originally-developed image processing was performed. Following in vitro study, we applied this method to a total of 662 excised LNs obtained from 30 gastric cancer patients administered 5-ALA preoperatively. Specific visualization of PpIX was achieved in in vitro study. The method allowed highly sensitive detection of metastatic LNs, with sensitivity of 91.9% and specificity of 90.8% in the in vivo clinical trial. Receiver operating characteristic analysis indicated high diagnostic accuracy, with the area under the curve of 0.926. We established a highly sensitive and specific 5-ALA-induced fluorescence imaging method applicable in clinical settings. The novel method has a potential to become a useful tool for intraoperative rapid diagnosis of LN metastasis. Copyright © 2016 Elsevier Ltd. All rights reserved.

Models of clinical reasoning with a focus on general practice: A critical review

PubMed Central

YAZDANI, SHAHRAM; HOSSEINZADEH, MOHAMMAD; HOSSEINI, FAKHROLSADAT

2017-01-01

Introduction: Diagnosis lies at the heart of general practice. Every day general practitioners (GPs) visit patients with a wide variety of complaints and concerns, with often minor but sometimes serious symptoms. General practice has many features which differentiate it from specialty care setting, but during the last four decades little attention was paid to clinical reasoning in general practice. Therefore, we aimed to critically review the clinical reasoning models with a focus on the clinical reasoning in general practice or clinical reasoning of general practitioners to find out to what extent the existing models explain the clinical reasoning specially in primary care and also identity the gaps of the model for use in primary care settings. Methods: A systematic search to find models of clinical reasoning were performed. To have more precision, we excluded the studies that focused on neurobiological aspects of reasoning, reasoning in disciplines other than medicine decision making or decision analysis on treatment or management plan. All the articles and documents were first scanned to see whether they include important relevant contents or any models. The selected studies which described a model of clinical reasoning in general practitioners or with a focus on general practice were then reviewed and appraisal or critics of other authors on these models were included. The reviewed documents on the model were synthesized. Results: Six models of clinical reasoning were identified including hypothetic-deductive model, pattern recognition, a dual process diagnostic reasoning model, pathway for clinical reasoning, an integrative model of clinical reasoning, and model of diagnostic reasoning strategies in primary care. Only one model had specifically focused on general practitioners reasoning. Conclusion: A Model of clinical reasoning that included specific features of general practice to better help the general practitioners with the difficulties of clinical reasoning in this setting is needed. PMID:28979912

Validation of a clinical assessment of spectral-ripple resolution for cochlear implant users.

PubMed

Drennan, Ward R; Anderson, Elizabeth S; Won, Jong Ho; Rubinstein, Jay T

2014-01-01

Nonspeech psychophysical tests of spectral resolution, such as the spectral-ripple discrimination task, have been shown to correlate with speech-recognition performance in cochlear implant (CI) users. However, these tests are best suited for use in the research laboratory setting and are impractical for clinical use. A test of spectral resolution that is quicker and could more easily be implemented in the clinical setting has been developed. The objectives of this study were (1) To determine whether this new clinical ripple test would yield individual results equivalent to the longer, adaptive version of the ripple-discrimination test; (2) To evaluate test-retest reliability for the clinical ripple measure; and (3) To examine the relationship between clinical ripple performance and monosyllabic word recognition in quiet for a group of CI listeners. Twenty-eight CI recipients participated in the study. Each subject was tested on both the adaptive and the clinical versions of spectral ripple discrimination, as well as consonant-nucleus-consonant word recognition in quiet. The adaptive version of spectral ripple used a two-up, one-down procedure for determining spectral ripple discrimination threshold. The clinical ripple test used a method of constant stimuli, with trials for each of 12 fixed ripple densities occurring six times in random order. Results from the clinical ripple test (proportion correct) were then compared with ripple-discrimination thresholds (in ripples per octave) from the adaptive test. The clinical ripple test showed strong concurrent validity, evidenced by a good correlation between clinical ripple and adaptive ripple results (r = 0.79), as well as a correlation with word recognition (r = 0.7). Excellent test-retest reliability was also demonstrated with a high test-retest correlation (r = 0.9). The clinical ripple test is a reliable nonlinguistic measure of spectral resolution, optimized for use with CI users in a clinical setting. The test might be useful as a diagnostic tool or as a possible surrogate outcome measure for evaluating treatment effects in hearing.

Rapid Identification of Methicillin-Resistant Staphylococcus aureus (MRSA) by the Vitek MS Saramis system.

PubMed

Shan, Weiguang; Li, Jiaping; Fang, Ying; Wang, Xuan; Gu, Danxia; Zhang, Rong

2016-01-01

A rapid, sensitive, and accurate Vitek MS assay was developed to distinguish clinical isolates of methicillin-resistant Staphylococcus aureus (MRSA) from clinical isolates of methicillin-sensitive Staphylococcus aureus (MSSA) by developing an in-house knowledgebase of SuperSpectra. Three unique peaks, including peaks at 2305.6 and 3007.3 Da specific to MRSA, and 6816.7 Da specific to MSSA, were selected for differentiating MRSA and MSSA. This assay accurately identified 84 and 91% of clinical MRSA and MSSA strains out of the total 142 clinically acquired S. aureus strains that were tested. This method will greatly improve the efficiency of single clinical sample identification of MRSA, thereby facilitating a reduction in the transmission of MRSA in clinical settings.

Clinical care costing method for the Clinical Care Classification System.

PubMed

Saba, Virginia K; Arnold, Jean M

2004-01-01

To provide a means for calculating the cost of nursing care using the Clinical Care Classification System (CCCS). Three CCCS indicators of care components, actions, and outcomes in conjunction with Clinical Care Pathways (CCPs). The cost of patient care is based on the type of action time multiplied by care components and nursing costs. The CCCM for the CCCS makes it possible to measure and cost out clinical practice. The CCCM may be used with CCPs in the electronic patient medical record. The CCPs make it easy to track the clinical nursing care across time, settings, population groups, and geographical locations. Collected data may be used many times, allowing for improved documentation, analysis, and costing out of care.

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.

The diversity issue revisited: international students in clinical environment.

PubMed

Pitkäjärvi, Marianne; Eriksson, Elina; Pitkälä, Kaisu

2012-01-01

Background. Globalization within higher education leads to an increase in cultural and linguistic diversity in student populations. The purpose of this study was to explore culturally diverse health care students' experiences in clinical environment in Finland, and to compare them with those of native Finnish students' participating in the same program. Method. A cross-sectional survey was performed at 10 polytechnic faculties of health care in Finland. 283 respondents (148 international and 95 Finnish students) responded to items concerning clinical rotation. The survey included items grouped as dimensions: (1) welcoming clinical environment, (2) unsupportive clinical environment, (3) approach to cultural diversity, (4) communication, and (5) structural arrangements. Results. International students felt as welcome on their placements as Finnish students. Concerning structural arrangements set up to facilitate preceptorship and approach to cultural diversity in the learning environment, the two groups' opinions were similar. However, international students were more likely than Finnish students to experience their clinical learning environment as unsupportive (P < 0.001). In addition, their experiences of communication with the staff was poorer than that of their Finnish peers' (P = 0.04). Conclusions. Awareness of strategies that enhance understanding, acceptance, and appreciation of cultural and linguistic diversity in any health care setting are needed.

Increasing patient safety and efficiency in transfusion therapy using formal process definitions.

PubMed

Henneman, Elizabeth A; Avrunin, George S; Clarke, Lori A; Osterweil, Leon J; Andrzejewski, Chester; Merrigan, Karen; Cobleigh, Rachel; Frederick, Kimberly; Katz-Bassett, Ethan; Henneman, Philip L

2007-01-01

The administration of blood products is a common, resource-intensive, and potentially problem-prone area that may place patients at elevated risk in the clinical setting. Much of the emphasis in transfusion safety has been targeted toward quality control measures in laboratory settings where blood products are prepared for administration as well as in automation of certain laboratory processes. In contrast, the process of transfusing blood in the clinical setting (ie, at the point of care) has essentially remained unchanged over the past several decades. Many of the currently available methods for improving the quality and safety of blood transfusions in the clinical setting rely on informal process descriptions, such as flow charts and medical algorithms, to describe medical processes. These informal descriptions, although useful in presenting an overview of standard processes, can be ambiguous or incomplete. For example, they often describe only the standard process and leave out how to handle possible failures or exceptions. One alternative to these informal descriptions is to use formal process definitions, which can serve as the basis for a variety of analyses because these formal definitions offer precision in the representation of all possible ways that a process can be carried out in both standard and exceptional situations. Formal process definitions have not previously been used to describe and improve medical processes. The use of such formal definitions to prospectively identify potential error and improve the transfusion process has not previously been reported. The purpose of this article is to introduce the concept of formally defining processes and to describe how formal definitions of blood transfusion processes can be used to detect and correct transfusion process errors in ways not currently possible using existing quality improvement methods.

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

PubMed

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

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.

Intracranial Pressure Monitoring—Review and Avenues for Development

PubMed Central

Dolmans, Rianne G. F.

2018-01-01

Intracranial pressure (ICP) monitoring is a staple of neurocritical care. The most commonly used current methods of monitoring in the acute setting include fluid-based systems, implantable transducers and Doppler ultrasonography. It is well established that management of elevated ICP is critical for clinical outcomes. However, numerous studies show that current methods of ICP monitoring cannot reliably define the limit of the brain’s intrinsic compensatory capacity to manage increases in pressure, which would allow for proactive ICP management. Current work in the field hopes to address this gap by harnessing live-streaming ICP pressure-wave data and a multimodal integration with other physiologic measures. Additionally, there is continued development of non-invasive ICP monitoring methods for use in specific clinical scenarios. PMID:29401746

Modeling eye gaze patterns in clinician-patient interaction with lag sequential analysis.

PubMed

Montague, Enid; Xu, Jie; Chen, Ping-Yu; Asan, Onur; Barrett, Bruce P; Chewning, Betty

2011-10-01

The aim of this study was to examine whether lag sequential analysis could be used to describe eye gaze orientation between clinicians and patients in the medical encounter. This topic is particularly important as new technologies are implemented into multiuser health care settings in which trust is critical and nonverbal cues are integral to achieving trust. This analysis method could lead to design guidelines for technologies and more effective assessments of interventions. Nonverbal communication patterns are important aspects of clinician-patient interactions and may affect patient outcomes. The eye gaze behaviors of clinicians and patients in 110 videotaped medical encounters were analyzed using the lag sequential method to identify significant behavior sequences. Lag sequential analysis included both event-based lag and time-based lag. Results from event-based lag analysis showed that the patient's gaze followed that of the clinician, whereas the clinician's gaze did not follow the patient's. Time-based sequential analysis showed that responses from the patient usually occurred within 2 s after the initial behavior of the clinician. Our data suggest that the clinician's gaze significantly affects the medical encounter but that the converse is not true. Findings from this research have implications for the design of clinical work systems and modeling interactions. Similar research methods could be used to identify different behavior patterns in clinical settings (physical layout, technology, etc.) to facilitate and evaluate clinical work system designs.

A Feature-based Approach to Big Data Analysis of Medical Images

PubMed Central

Toews, Matthew; Wachinger, Christian; Estepar, Raul San Jose; Wells, William M.

2015-01-01

This paper proposes an inference method well-suited to large sets of medical images. The method is based upon a framework where distinctive 3D scale-invariant features are indexed efficiently to identify approximate nearest-neighbor (NN) feature matches in O(log N) computational complexity in the number of images N. It thus scales well to large data sets, in contrast to methods based on pair-wise image registration or feature matching requiring O(N) complexity. Our theoretical contribution is a density estimator based on a generative model that generalizes kernel density estimation and K-nearest neighbor (KNN) methods. The estimator can be used for on-the-fly queries, without requiring explicit parametric models or an off-line training phase. The method is validated on a large multi-site data set of 95,000,000 features extracted from 19,000 lung CT scans. Subject-level classification identifies all images of the same subjects across the entire data set despite deformation due to breathing state, including unintentional duplicate scans. State-of-the-art performance is achieved in predicting chronic pulmonary obstructive disorder (COPD) severity across the 5-category GOLD clinical rating, with an accuracy of 89% if both exact and one-off predictions are considered correct. PMID:26221685

A Feature-Based Approach to Big Data Analysis of Medical Images.

PubMed

Toews, Matthew; Wachinger, Christian; Estepar, Raul San Jose; Wells, William M

2015-01-01

This paper proposes an inference method well-suited to large sets of medical images. The method is based upon a framework where distinctive 3D scale-invariant features are indexed efficiently to identify approximate nearest-neighbor (NN) feature matches-in O (log N) computational complexity in the number of images N. It thus scales well to large data sets, in contrast to methods based on pair-wise image registration or feature matching requiring O(N) complexity. Our theoretical contribution is a density estimator based on a generative model that generalizes kernel density estimation and K-nearest neighbor (KNN) methods.. The estimator can be used for on-the-fly queries, without requiring explicit parametric models or an off-line training phase. The method is validated on a large multi-site data set of 95,000,000 features extracted from 19,000 lung CT scans. Subject-level classification identifies all images of the same subjects across the entire data set despite deformation due to breathing state, including unintentional duplicate scans. State-of-the-art performance is achieved in predicting chronic pulmonary obstructive disorder (COPD) severity across the 5-category GOLD clinical rating, with an accuracy of 89% if both exact and one-off predictions are considered correct.

Developing adaptive interventions for adolescent substance use treatment settings: protocol of an observational, mixed-methods project.

PubMed

Grant, Sean; Agniel, Denis; Almirall, Daniel; Burkhart, Q; Hunter, Sarah B; McCaffrey, Daniel F; Pedersen, Eric R; Ramchand, Rajeev; Griffin, Beth Ann

2017-12-19

Over 1.6 million adolescents in the United States meet criteria for substance use disorders (SUDs). While there are promising treatments for SUDs, adolescents respond to these treatments differentially in part based on the setting in which treatments are delivered. One way to address such individualized response to treatment is through the development of adaptive interventions (AIs): sequences of decision rules for altering treatment based on an individual's needs. This protocol describes a project with the overarching goal of beginning the development of AIs that provide recommendations for altering the setting of an adolescent's substance use treatment. This project has three discrete aims: (1) explore the views of various stakeholders (parents, providers, policymakers, and researchers) on deciding the setting of substance use treatment for an adolescent based on individualized need, (2) generate hypotheses concerning candidate AIs, and (3) compare the relative effectiveness among candidate AIs and non-adaptive interventions commonly used in everyday practice. This project uses a mixed-methods approach. First, we will conduct an iterative stakeholder engagement process, using RAND's ExpertLens online system, to assess the importance of considering specific individual needs and clinical outcomes when deciding the setting for an adolescent's substance use treatment. Second, we will use results from the stakeholder engagement process to analyze an observational longitudinal data set of 15,656 adolescents in substance use treatment, supported by the Substance Abuse and Mental Health Services Administration, using the Global Appraisal of Individual Needs questionnaire. We will utilize methods based on Q-learning regression to generate hypotheses about candidate AIs. Third, we will use robust statistical methods that aim to appropriately handle casemix adjustment on a large number of covariates (marginal structural modeling and inverse probability of treatment weights) to compare the relative effectiveness among candidate AIs and non-adaptive decision rules that are commonly used in everyday practice. This project begins filling a major gap in clinical and research efforts for adolescents in substance use treatment. Findings could be used to inform the further development and revision of influential multi-dimensional assessment and treatment planning tools, or lay the foundation for subsequent experiments to further develop or test AIs for treatment planning.

Setting up of a cerebral visual impairment clinic for children: Challenges and future developments

PubMed Central

Philip, Swetha Sara

2017-01-01

Aim: The aim of this study is to describe the setting up of a cerebral visual impairment (CVI) clinic in a tertiary care hospital in South India and to describe the spectrum of cases seen. Materials and Methods: The CVI clinic, set up in February 2011, receives interdisciplinary input from a core team involving a pediatrician, neurologist, psychiatrist, occupational therapist, pediatric ophthalmologist, and an optometrist. All children, <18 years of age, with cerebral palsy (CP), learning disability, autism, neurodegenerative diseases, and brain trauma are referred to the clinic for functional vision assessment and opinion for further management. Results: One thousand four hundred and seventy-eight patients were seen in the CVI clinic from February 2011 to September 2015. Eighty-five percent of the patients were from different parts of India. In the clinic, 61% had CP, 28% had seizure disorders, autism was seen in 9.5%, and learning disability, neurodegenerative conditions, and brain injury together constituted 1.5%. Most of the children (45%) had moderate CP. Forty percent of CVI was due to birth asphyxia, but about 20% did not have any known cause for CVI. Seventy percent of patients, who came back for follow-up, were carrying out the habilitation strategies suggested. Conclusions: Average attendance of over 300 new patients a year suggests a definite need for CVI clinics in the country. These children need specialized care to handle their complex needs. Although difficult to coordinate, an interdisciplinary team including the support groups and voluntary organizations is needed to facilitate the successful implementation of such specialized service. PMID:28300737

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

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.

Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

PubMed

Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

2016-06-05

Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

An ontology-based method for secondary use of electronic dental record data

PubMed Central

Schleyer, Titus KL; Ruttenberg, Alan; Duncan, William; Haendel, Melissa; Torniai, Carlo; Acharya, Amit; Song, Mei; Thyvalikakath, Thankam P.; Liu, Kaihong; Hernandez, Pedro

A key question for healthcare is how to operationalize the vision of the Learning Healthcare System, in which electronic health record data become a continuous information source for quality assurance and research. This project presents an initial, ontology-based, method for secondary use of electronic dental record (EDR) data. We defined a set of dental clinical research questions; constructed the Oral Health and Disease Ontology (OHD); analyzed data from a commercial EDR database; and created a knowledge base, with the OHD used to represent clinical data about 4,500 patients from a single dental practice. Currently, the OHD includes 213 classes and reuses 1,658 classes from other ontologies. We have developed an initial set of SPARQL queries to allow extraction of data about patients, teeth, surfaces, restorations and findings. Further work will establish a complete, open and reproducible workflow for extracting and aggregating data from a variety of EDRs for research and quality assurance. PMID:24303273

Learning Semantic Tags from Big Data for Clinical Text Representation.

PubMed

Li, Yanpeng; Liu, Hongfang

2015-01-01

In clinical text mining, it is one of the biggest challenges to represent medical terminologies and n-gram terms in sparse medical reports using either supervised or unsupervised methods. Addressing this issue, we propose a novel method for word and n-gram representation at semantic level. We first represent each word by its distance with a set of reference features calculated by reference distance estimator (RDE) learned from labeled and unlabeled data, and then generate new features using simple techniques of discretization, random sampling and merging. The new features are a set of binary rules that can be interpreted as semantic tags derived from word and n-grams. We show that the new features significantly outperform classical bag-of-words and n-grams in the task of heart disease risk factor extraction in i2b2 2014 challenge. It is promising to see that semantics tags can be used to replace the original text entirely with even better prediction performance as well as derive new rules beyond lexical level.

Melanoma Diagnosis

NASA Astrophysics Data System (ADS)

Horsch, Alexander

The chapter deals with the diagnosis of the malignant melanoma of the skin. This aggressive type of cancer with steadily growing incidence in white populations can hundred percent be cured if it is detected in an early stage. Imaging techniques, in particular dermoscopy, have contributed significantly to improvement of diagnostic accuracy in clinical settings, achieving sensitivities for melanoma experts of beyond 95% at specificities of 90% and more. Automatic computer analysis of dermoscopy images has, in preliminary studies, achieved classification rates comparable to those of experts. However, the diagnosis of melanoma requires a lot of training and experience, and at the time being, average numbers of lesions excised per histology-proven melanoma are around 30, a number which clearly is too high. Further improvements in computer dermoscopy systems and their competent use in clinical settings certainly have the potential to support efforts of improving this situation. In the chapter, medical basics, current state of melanoma diagnosis, image analysis methods, commercial dermoscopy systems, evaluation of systems, and methods and future directions are presented.

Hydra: A web-based system for cardiovascular analysis, diagnosis and treatment.

PubMed

Novo, J; Hermida, A; Ortega, M; Barreira, N; Penedo, M G; López, J E; Calvo, C

2017-02-01

Cardiovascular (CV) risk stratification is a highly complex process involving an extensive set of clinical trials to support the clinical decision-making process. There are many clinical conditions (e.g. diabetes, obesity, stress, etc.) that can lead to the early diagnosis or establishment of cardiovascular disease. In order to determine all these clinical conditions, a complete set of clinical patient analyses is typically performed, including a physical examination, blood analysis, electrocardiogram, blood pressure (BP) analysis, etc. This article presents a web-based system, called Hydra, which integrates a full and detailed set of services and functionalities for clinical decision support in order to help and improve the work of clinicians in cardiovascular patient diagnosis, risk assessment, treatment and monitoring over time. Hydra integrates a number of different services: a service for inputting all the information gathered by specialists (physical examination, habits, BP, blood analysis, electrocardiogram, etc.); a tool to automatically determine the CV risk stratification, including well-known standard risk stratification tables; and, finally, various tools to incorporate, analyze and graphically present the records of the ambulatory BP monitoring that provides BP analysis over a given period of time (24 or 48 hours). In addition, the platform presents a set of reports derived from all the information gathered from the patient in order to support physicians in their clinical decisions. Hydra was tested and validated in a real domain. In particular, internal medicine specialists at the Hypertension Unit of the Santiago de Compostela University Hospital (CHUS) validated the platform and used it in different clinical studies to demonstrate its utility. It was observed that the platform increased productivity and accuracy in the assessment of patient data yielding a cost reduction in clinical practice. This paper proposes a complete platform that includes different services for cardiovascular clinical decision support. It was also run as a web-based application to facilitate its use by clinicians, who can access the platform from any remote computer with Internet access. Hydra also includes different automated methods to facilitate the physicians' work and avoid potential errors in the analysis of patient data. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Nursing students' perceptions of their clinical learning environment in placements outside traditional hospital settings.

PubMed

Bjørk, Ida T; Berntsen, Karin; Brynildsen, Grethe; Hestetun, Margrete

2014-10-01

To explore students' opinions of the learning environment during clinical placement in settings outside traditional hospital settings. Clinical placement experiences may influence positively on nursing students attitudes towards the clinical setting in question. Most studies exploring the quality of clinical placements have targeted students' experience in hospital settings. The number of studies exploring students' experiences of the learning environment in healthcare settings outside of the hospital venue does not match the growing importance of such settings in the delivery of health care, nor the growing number of nurses needed in these venues. A survey design was used. The Clinical Learning Environment Inventory was administered to two cohorts of undergraduate nursing students (n = 184) after clinical placement in mental health care, home care and nursing home care. Nursing students' overall contentment with the learning environment was quite similar across all three placement areas. Students in mental health care had significantly higher scores on the subscale individualisation, and older students had significantly higher scores on the total scale. Compared with other studies where the Clinical Learning Environment Inventory has been used, the students' total scores in this study are similar or higher than scores in studies including students from hospital settings. Results from this study negate the negative views on clinical placements outside the hospital setting, especially those related to placements in nursing homes and mental healthcare settings. Students' experience of the learning environment during placements in mental health care, home care and nursing homes indicates the relevance of clinical education in settings outside the hospital setting. © 2014 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.

A mixed methods pilot study to investigate the impact of a hospital-specific iPhone application (iTreat) within a British junior doctor cohort.

PubMed

Payne, Karl Fb; Weeks, Lucy; Dunning, Paul

2014-03-01

We present a pilot study to investigate the impact of introducing a hospital-specific smartphone application into a cohort of British junior doctors. We created the iPhone application 'iTreat' that contained disease management and antibiotic dosing guidelines specific to our hospital, together with a postgraduate education department really simple syndication feed, a contact number phonebook and a favourites section. This intervention was trialled in a group of 39 foundation grade junior doctors, in a UK hospital, for a time period of 4 months. Mixed methods data capture, utilising survey and semi-structured interviews, was used to evaluate application usage patterns and potential barriers to endorsement of smartphone technology in the hospital setting. Sixty eight per cent of participants felt the application saved them time during clinical activities, with a decrease in the frequency of participants not referring to hospital clinical guidelines. The findings from this pilot study point towards the internal hospital environment as having a major impact upon smartphone usage. Participants viewed smartphone use as unprofessional in the ward-based setting, with a perceived negative attitude from other healthcare staff. An understanding of how healthcare staff choose to utilise smartphones in the clinical environment is crucial to enable the successful assimilation of smartphone technology into the hospital setting. This pilot study provides experience and parameters for future substantive studies being carried out by this group.

Resources of learning through hidden curriculum: Iranian nursing students’ perspective

PubMed Central

Karimi, Zohreh; Ashktorab, Tahereh; Mohammadi, Eesa; Abedi, Heidarali; Zarea, Kourosh

2015-01-01

Background: Students tend to internalize and perpetuate the patterns of behavior and the values surrounding them. Review of literature showed that there are several student learning sources through the hidden curriculum, but they have not been identified in nursing yet. Hence, the purpose of this study is explanation of learning resources in the hidden curriculum in the view of baccalaureate nursing students. Materials and Methods: This qualitative study was carried out in 2012 with the participation of 32 baccalaureate nursing students in Nursing and Midwifery College of Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran by purposeful sampling strategies. Data were collected by semi-structured interviews and continued to the level of data saturation and themes’ emergence. Data analysis was performed through inductive content analysis method. Result: “Instructor as the unique learning element,” “various learning resources in the clinical setting,” and “instructive nature of the education environment” were extracted as the main themes, each of which incorporated some categories. Conclusion: Baccalaureate undergraduate nursing students learnt the hidden curriculum by the resources such as instructors, resources existing in the clinical setting, and the university campus. Therefore, more research is recommended for the identification of other resources. In order to promote positive messages and reduce the negative messages of the hidden curricula running at academic and clinical settings, nursing educators and nurses need to learn more about this issue in the nursing profession. PMID:26430684

A modern optical character recognition system in a real world clinical setting: some accuracy and feasibility observations.

PubMed

Biondich, Paul G; Overhage, J Marc; Dexter, Paul R; Downs, Stephen M; Lemmon, Larry; McDonald, Clement J

2002-01-01

Advances in optical character recognition (OCR) software and computer hardware have stimulated a reevaluation of the technology and its ability to capture structured clinical data from preexisting paper forms. In our pilot evaluation, we measured the accuracy and feasibility of capturing vitals data from a pediatric encounter form that has been in use for over twenty years. We found that the software had a digit recognition rate of 92.4% (95% confidence interval: 91.6 to 93.2) overall. More importantly, this system was approximately three times as fast as our existing method of data entry. These preliminary results suggest that with further refinements in the approach and additional development, we may be able to incorporate OCR as another method for capturing structured clinical data.

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.

A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.

PubMed

Duffy, James M N; van 't Hooft, Janneke; Gale, Chris; Brown, Mark; Grobman, William; Fitzpatrick, Ray; Karumanchi, S Ananth; Lucas, Nuala; Magee, Laura; Mol, Ben; Stark, Michael; Thangaratinam, Shakila; Wilson, Mathew; von Dadelszen, Peter; Williamson, Paula; Khan, Khalid S; Ziebland, Sue; McManus, Richard J

2016-10-01

Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529. Copyright © 2016 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.

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

Gilchrist, Kristin H., E-mail: kgilchrist@rti.org; Lewis, Gregory F.; Gay, Elaine A.

Microelectrode arrays (MEAs) recording extracellular field potentials of human-induced pluripotent stem cell-derived cardiomyocytes (hiPS-CM) provide a rich data set for functional assessment of drug response. The aim of this work is the development of a method for a systematic analysis of arrhythmia using MEAs, with emphasis on the development of six parameters accounting for different types of cardiomyocyte signal irregularities. We describe a software approach to carry out such analysis automatically including generation of a heat map that enables quick visualization of arrhythmic liability of compounds. We also implemented signal processing techniques for reliable extraction of the repolarization peak formore » field potential duration (FPD) measurement even from recordings with low signal to noise ratios. We measured hiPS-CM's on a 48 well MEA system with 5 minute recordings at multiple time points (0.5, 1, 2 and 4 h) after drug exposure. We evaluated concentration responses for seven compounds with a combination of hERG, QT and clinical proarrhythmia properties: Verapamil, Ranolazine, Flecainide, Amiodarone, Ouabain, Cisapride, and Terfenadine. The predictive utility of MEA parameters as surrogates of these clinical effects were examined. The beat rate and FPD results exhibited good correlations with previous MEA studies in stem cell derived cardiomyocytes and clinical data. The six-parameter arrhythmia assessment exhibited excellent predictive agreement with the known arrhythmogenic potential of the tested compounds, and holds promise as a new method to predict arrhythmic liability. - Highlights: • Six parameters describing arrhythmia were defined and measured for known compounds. • Software for efficient parameter extraction from large MEA data sets was developed. • The proposed cellular parameter set is predictive of clinical drug proarrhythmia.« less

Rural Doctors' Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study.

PubMed

Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

2016-01-01

Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. This study aimed to explore the views and experiences of rural doctors' about evidence-based medicine in their daily clinical practice in a rural primary care setting. Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers.

Promotion of anagen, increased hair density and reduction of hair fall in a clinical setting following identification of FGF5-inhibiting compounds via a novel 2-stage process

PubMed Central

Burg, Dominic; Yamamoto, Masakuni; Namekata, Masato; Haklani, Joseph; Koike, Koichiro; Halasz, Maria

2017-01-01

Background There are very few effective, scientifically validated treatments with known mechanisms of action for treatment of hair loss in both men and women. Fibroblast growth factor 5 (FGF5) is an important factor in the irreversible transition from anagen to catagen, and inhibition of FGF5 prolongs anagen phase and reduces hair loss. Objective We aimed to screen botanically derived molecules for FGF5 inhibitory activity in vitro and assess efficacy in a clinical setting. Methods We screened for FGF5 inhibitory efficacy via a novel 2-step in vitro pipeline consisting of an engineered FGF5 responsive cell line, followed by an activated dermal papillae (DP) cell method. Efficacy in a clinical setting was assessed in a randomized, single-blind, placebo-controlled trial against early- to mid-stage pattern hair loss in men and women. Results We observed FGF5 inhibitory activity for a number of compounds from the monoterpenoid family, many showing greater inhibitory efficacy than our previously reported crude plant extracts. Evaluation of a lead candidate in a clinical study over 112 days showed a significant improvement in anagen:telogen (AT) ratio (p = 0.002), reduced hair fall (p = 0.007) and improved visual grading (p = 0.004). Scientifically matched photography on a subgroup of randomly chosen participants highlighted significant improvement in hair density, with increases evident in all tested participants compared to baseline. Conclusion Isolates from the monoterpenoid family displayed efficacy in FGF5 inhibition in vitro. A topical formulation containing a leading isolate significantly improved AT ratio, reduced hair fall and increased apparent hair density in the tested population of men and women. PMID:28280377

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

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

Supporting research sites in resource-limited settings: Challenges in implementing IT infrastructure

PubMed Central

Whalen, Christopher; Donnell, Deborah; Tartakovsky, Michael

2014-01-01

As Information and Communication Technology infrastructure becomes more reliable, new methods of Electronic Data Capture (EDC), datamarts/Data warehouses, and mobile computing provide platforms for rapid coordination of international research projects and multisite studies. However, despite the increasing availability of internet connectivity and communication systems in remote regions of the world, there are still significant obstacles. Sites with poor infrastructure face serious challenges participating in modern clinical and basic research, particularly that relying on EDC and internet communication technologies. This report discusses our experiences in supporting research in resource-limited settings (RLS). We describe examples of the practical and ethical/regulatory challenges raised by use of these newer technologies for data collection in multisite clinical studies. PMID:24321986

Supporting research sites in resource-limited settings: challenges in implementing information technology infrastructure.

PubMed

Whalen, Christopher J; Donnell, Deborah; Tartakovsky, Michael

2014-01-01

As information and communication technology infrastructure becomes more reliable, new methods of electronic data capture, data marts/data warehouses, and mobile computing provide platforms for rapid coordination of international research projects and multisite studies. However, despite the increasing availability of Internet connectivity and communication systems in remote regions of the world, there are still significant obstacles. Sites with poor infrastructure face serious challenges participating in modern clinical and basic research, particularly that relying on electronic data capture and Internet communication technologies. This report discusses our experiences in supporting research in resource-limited settings. We describe examples of the practical and ethical/regulatory challenges raised by the use of these newer technologies for data collection in multisite clinical studies.

2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

PubMed

Aggarwal, Rohit; Rider, Lisa G; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Oddis, Chester V; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R; Lundberg, Ingrid E; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri

2017-05-01

To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute percent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (P < 0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement. © 2017, American College of Rheumatology.

Design and validation of a real-time RT-PCR for the simultaneous detection of enteroviruses and parechoviruses in clinical samples.

PubMed

Cabrerizo, María; Calvo, Cristina; Rabella, Nuria; Muñoz-Almagro, Carmen; del Amo, Eva; Pérez-Ruiz, Mercedes; Sanbonmatsu-Gámez, Sara; Moreno-Docón, Antonio; Otero, Almudena; Trallero, Gloria

2014-11-01

Human enteroviruses (EVs) and parechoviruses (HPeVs) are important etiological agents causing infections such as meningitis, encephalitis and sepsis-like disease in neonates and young children. We have developed a real-time RT-PCR for simultaneous detection of EV and HPeV in clinical samples. Primers and probe sets were designed from the conserved 5'-noncoding region of the genomes. The sensitivity, specificity and reproducibility of the technique were measured using a set of 25 EV and 6 HPeV types. All EVs but no HPeVs were detected with the EV primers-probe set. The HPeV primers-probe set detected only the 6 HPeV types. The lower detection limit was found to be 4 and 40CCID50/ml for HPeV and EV respectively, demonstrating high sensitivity of the technique for both viruses. The threshold cycle values were highly reproducible on repeat testing of positive controls among assay runs. The assay was evaluated in 53 clinical samples of suspected meningitis, sepsis or febrile syndromes from children under 3 years. In 11 of these (21%) EVs were detected, while 4, i.e. 7.5%, were HPeV positive. Molecular typing was carried out for 73% of the viruses. In summary, the RT-PCR method developed demonstrated effectively both EV and HPeV detection, which can cause similar clinical symptoms in infants. Copyright © 2014 Elsevier B.V. All rights reserved.

Patience, Persistence and Pragmatism: Experiences and Lessons Learnt from the Implementation of Clinically Integrated Teaching and Learning of Evidence-Based Health Care – A Qualitative Study

PubMed Central

Young, Taryn; Rohwer, Anke; van Schalkwyk, Susan; Volmink, Jimmy; Clarke, Mike

2015-01-01

Background Clinically integrated teaching and learning are regarded as the best options for improving evidence-based healthcare (EBHC) knowledge, skills and attitudes. To inform implementation of such strategies, we assessed experiences and opinions on lessons learnt of those involved in such programmes. Methods and Findings We conducted semi-structured interviews with 24 EBHC programme coordinators from around the world, selected through purposive sampling. Following data transcription, a multidisciplinary group of investigators carried out analysis and data interpretation, using thematic content analysis. Successful implementation of clinically integrated teaching and learning of EBHC takes much time. Student learning needs to start in pre-clinical years with consolidation, application and assessment following in clinical years. Learning is supported through partnerships between various types of staff including the core EBHC team, clinical lecturers and clinicians working in the clinical setting. While full integration of EBHC learning into all clinical rotations is considered necessary, this was not always achieved. Critical success factors were pragmatism and readiness to use opportunities for engagement and including EBHC learning in the curriculum; patience; and a critical mass of the right teachers who have EBHC knowledge and skills and are confident in facilitating learning. Role modelling of EBHC within the clinical setting emerged as an important facilitator. The institutional context exerts an important influence; with faculty buy-in, endorsement by institutional leaders, and an EBHC-friendly culture, together with a supportive community of practice, all acting as key enablers. The most common challenges identified were lack of teaching time within the clinical curriculum, misconceptions about EBHC, resistance of staff, lack of confidence of tutors, lack of time, and negative role modelling. Conclusions Implementing clinically integrated EBHC curricula requires institutional support, a critical mass of the right teachers and role models in the clinical setting combined with patience, persistence and pragmatism on the part of teachers. PMID:26110641

Patient and provider perspectives on Bedsider.org, an online contraceptive information tool, in a low income, racially diverse clinic population.

PubMed

Gressel, Gregory M; Lundsberg, Lisbet S; Illuzzi, Jessica L; Danton, Cheryl M; Sheth, Sangini S; Xu, Xiao; Gariepy, Aileen

2014-12-01

To explore patient and provider perspectives regarding a new Web-based contraceptive support tool. We conducted a qualitative study at an urban Medicaid-based clinic among sexually active women interested in starting a new contraceptive method, clinic providers and staff. All participants were given the opportunity to explore Bedsider, an online contraceptive support tool developed for sexually active women ages 18-29 by the National Campaign to Prevent Teen and Unplanned Pregnancy and endorsed by the American Congress of Obstetricians and Gynecologists. Focus groups were conducted separately among patient participants and clinic providers/staff using open-ended structured interview guides to identify specific themes and key concepts related to use of this tool in an urban clinic setting. Patient participants were very receptive to this online contraceptive support tool, describing it as trustworthy, accessible and empowering. In contrast, clinic providers and staff had concerns regarding the Website's legitimacy, accessibility, ability to empower patients and applicability, which limited their willingness to recommend its use to patients. Contrasting opinions regarding Bedsider may point to a potential disconnect between how providers and patients view contraception information tools. Further qualitative and quantitative studies are needed to explore women's perspectives on contraceptive education and counseling and providers' understanding of these perspectives. This study identifies a contrast between how patients and providers in an urban clinic setting perceive a Web-based contraceptive tool. Given a potential patient-provider discrepancy in preferred methods and approaches to contraceptive counseling, additional research is needed to enhance this important arena of women's health care. Copyright © 2014 Elsevier Inc. All rights reserved.

Priority setting for health technology assessments: a systematic review of current practical approaches.

PubMed

Noorani, Hussein Z; Husereau, Donald R; Boudreau, Rhonda; Skidmore, Becky

2007-01-01

This study sought to identify and compare various practical and current approaches of health technology assessment (HTA) priority setting. A literature search was performed across PubMed, MEDLINE, EMBASE, BIOSIS, and Cochrane. Given an earlier review conducted by European agencies (EUR-ASSESS project), the search was limited to literature indexed from 1996 onward. We also searched Web sites of HTA agencies as well as HTAi and ISTAHC conference abstracts. Agency representatives were contacted for information about their priority-setting processes. Reports on practical approaches selected through these sources were identified independently by two reviewers. A total of twelve current priority-setting frameworks from eleven agencies were identified. Ten countries were represented: Canada, Denmark, England, Hungary, Israel, Scotland, Spain, Sweden, The Netherlands, and United States. Fifty-nine unique HTA priority-setting criteria were divided into eleven categories (alternatives; budget impact; clinical impact; controversial nature of proposed technology; disease burden; economic impact; ethical, legal, or psychosocial implications; evidence; interest; timeliness of review; variation in rates of use). Differences across HTA agencies were found regarding procedures for categorizing, scoring, and weighing of policy criteria. Variability exists in the methods for priority setting of health technology assessment across HTA agencies. Quantitative rating methods and consideration of cost benefit for priority setting were seldom used. These study results will assist HTA agencies that are re-visiting or developing their prioritization methods.

Fracture healing: A review of clinical, imaging and laboratory diagnostic options.

PubMed

Cunningham, Brian P; Brazina, Sloane; Morshed, Saam; Miclau, Theodore

2017-06-01

A fundamental issue in clinical orthopaedics is the determination of when a fracture is united. However, there are no established "gold standards," nor standardized methods for assessing union, which has resulted in significant disagreement among orthopaedic surgeons in both clinical practice and research. A great deal of investigative work has been directed to addressing this problem, with a number of exciting new techniques described. This review provides a brief summary of the burden of nonunion fractures and addresses some of the challenges related to the assessment of fracture healing. The tools currently available to determine union are discussed, including various imaging modalities, biomechanical testing methods, and laboratory and clinical assessments. The evaluation of fracture healing in the setting of both patient care and clinical research is integral to the orthopaedic practice. Weighted integration of several available metrics must be considered to create a composite outcome measure of patient prognosis. Copyright © 2017 Elsevier Ltd. All rights reserved.

Health level 7 development framework for medication administration.

PubMed

Kim, Hwa Sun; Cho, Hune

2009-01-01

We propose the creation of a standard data model for medication administration activities through the development of a clinical document architecture using the Health Level 7 Development Framework process based on an object-oriented analysis and the development method of Health Level 7 Version 3. Medication administration is the most common activity performed by clinical professionals in healthcare settings. A standardized information model and structured hospital information system are necessary to achieve evidence-based clinical activities. A virtual scenario is used to demonstrate the proposed method of administering medication. We used the Health Level 7 Development Framework and other tools to create the clinical document architecture, which allowed us to illustrate each step of the Health Level 7 Development Framework in the administration of medication. We generated an information model of the medication administration process as one clinical activity. It should become a fundamental conceptual model for understanding international-standard methodology by healthcare professionals and nursing practitioners with the objective of modeling healthcare information systems.

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.

Comparative analysis of Pareto surfaces in multi-criteria IMRT planning

NASA Astrophysics Data System (ADS)

Teichert, K.; Süss, P.; Serna, J. I.; Monz, M.; Küfer, K. H.; Thieke, C.

2011-06-01

In the multi-criteria optimization approach to IMRT planning, a given dose distribution is evaluated by a number of convex objective functions that measure tumor coverage and sparing of the different organs at risk. Within this context optimizing the intensity profiles for any fixed set of beams yields a convex Pareto set in the objective space. However, if the number of beam directions and irradiation angles are included as free parameters in the formulation of the optimization problem, the resulting Pareto set becomes more intricate. In this work, a method is presented that allows for the comparison of two convex Pareto sets emerging from two distinct beam configuration choices. For the two competing beam settings, the non-dominated and the dominated points of the corresponding Pareto sets are identified and the distance between the two sets in the objective space is calculated and subsequently plotted. The obtained information enables the planner to decide if, for a given compromise, the current beam setup is optimal. He may then re-adjust his choice accordingly during navigation. The method is applied to an artificial case and two clinical head neck cases. In all cases no configuration is dominating its competitor over the whole Pareto set. For example, in one of the head neck cases a seven-beam configuration turns out to be superior to a nine-beam configuration if the highest priority is the sparing of the spinal cord. The presented method of comparing Pareto sets is not restricted to comparing different beam angle configurations, but will allow for more comprehensive comparisons of competing treatment techniques (e.g. photons versus protons) than with the classical method of comparing single treatment plans.

Approved Clinical Instructors' Perspectives on Implementation Strategies in Evidence-Based Practice for Athletic Training Students

PubMed Central

Hankemeier, Dorice A.; Van Lunen, Bonnie L.

2011-01-01

Context: Understanding implementation strategies of Approved Clinical Instructors (ACIs) who use evidence-based practice (EBP) in clinical instruction will help promote the use of EBP in clinical practice. Objective: To examine the perspectives and experiences of ACIs using EBP concepts in undergraduate athletic training education programs to determine the importance of using these concepts in clinical practice, clinical EBP implementation strategies for students, and challenges of implementing EBP into clinical practice while mentoring and teaching their students. Design: Qualitative study. Setting: Telephone interviews. Patients or Other Participants: Sixteen ACIs (11 men, 5 women; experience as a certified athletic trainer = 10 ± 4.7 years, experience as an ACI = 6.8 ± 3.9 years) were interviewed. Data Collection and Analysis: We interviewed each participant by telephone. Interview transcripts were analyzed and coded for common themes and subthemes regarding implementation strategies. Established themes were triangulated through peer review and member checking to verify the data. Results: The ACIs identified EBP implementation as important for validation of the profession, changing paradigm shift, improving patient care, and improving student educational experiences. They promoted 3 methods of implementing EBP concepts with their students: self-discovery, promoting critical thinking, and sharing information. They assisted students with the steps of EBP and often faced challenges in implementation of the first 3 steps of EBP: defining a clinical question, literature searching, and literature appraisal. Finally, ACIs indicated that modeling the behavior of making clinical decisions based on evidence was the best way to encourage students to continue using EBP. Conclusions: Athletic training education program directors should encourage and recommend specific techniques for EBP implementation in the clinical setting. The ACIs believed that role modeling is a strategy that can be used to promote the use of EBP with students. Training of ACIs should include methods by which to address the steps of the EBP process while still promoting critical thinking. PMID:22488192

SU-E-E-05: Improving Contouring Precision and Consistency for Physicians-In-Training with Simple Lab Experiments

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

Ma, L; Larson, D A

2015-06-15

Purpose: Target contouring for high-dose treatments such as radiosurgery of brain metastases is highly critical in eliminating marginal failure and reducing complications as shown by recent clinical studies. In order to improve contouring accuracy and practice consistency for the procedure, we introduced a self-assessed physics lab practice for the physicians-in-training. Methods: A set of commercially acquired high-precision PMMA plastic spheres were randomly embedded in a Styrofoam block and then scanned with the CT/MR via the clinical procedural imaging protocol. A group of first-year physicians-in-training (n=6) from either neurosurgery or radiation oncology department were asked to contour the scanned objects (diametermore » ranged from 0.4 cm to 3.8 cm). These user-defined contours were then compared with the ideal contour sets of object shape for self assessments to determine the maximum areas of the observed discrepancies and method of improvements. Results: The largest discrepancies from initial practice were consistently found to be located near the extreme longitudinal portions of the target for all the residents. Discrepancy was especially prominent when contouring small objects < 1.0 cm in diameters. For example, the mean volumes rendered from the initial contour data set differed from the ideal data set by 7.7%±6.6% for the participants (p> 0.23 suggesting agreement cannot be established). However, when incorporating a secondary imaging scan such as reconstructed coronal or sagittal images in a repeat practice, the agreement was dramatically improved yielding p<0.02 in agreement with the reference data set for all the participants. Conclusion: A simple physics lab revealed a common pitfall in contouring small metastatic brain tumors for radiosurgical procedures and provided a systematic tool for physicians-in-training in improving their clinical contouring skills. Dr Ma is current a board member of international stereotactic radiosurgical society.« less

Discovering Potential Pathogens among Fungi Identified as Nonsporulating Molds▿

PubMed Central

Pounder, June I.; Simmon, Keith E.; Barton, Claudia A.; Hohmann, Sheri L.; Brandt, Mary E.; Petti, Cathy A.

2007-01-01

Fungal infections are increasing, particularly among immunocompromised hosts, and a rapid diagnosis is essential to initiate antifungal therapy. Often fungi cannot be identified by conventional methods and are classified as nonsporulating molds (NSM).We sequenced internal transcribed spacer regions from 50 cultures of NSM and found 16 potential pathogens that can be associated with clinical disease. In selected clinical settings, identification of NSM could prove valuable and have an immediate impact on patient management. PMID:17135442

Opinions of sports clinical practice chiropractors, with sports specialty training and those without, about chiropractic research priorities in sports health care: a centering resonance analysis

PubMed Central

Lee, Alexander D; Szabo, Kaitlyn; McDowell, Kirstie; Granger, Sydney

2016-01-01

Introduction: A Canadian sports chiropractic research agenda has yet to be defined. The Delphi method can be utilized to achieve this purpose; however, the sample of experts who participate can influence the results. To better inform sample selection for future research agenda development, we set out to determine if differences in opinions about research priorities exist between chiropractors who have their sports specialty designation and those who do not. Methods: Fifteen sports clinical practice chiropractors who have their sports fellowship designation and fifteen without, were interviewed with a set of standardized questions about sports chiropractic research priorities. A centering resonance analysis and cluster analysis were conducted on the interview responses. Results: The two practitioner groups differed in their opinions about the type of research that they would like to see conducted, the research that would impact their clinical practice the most, and where they believed research was lacking. However, both groups were similar in their opinions about research collaborations. Conclusion: Sports clinical practice chiropractors, with their sports specialty designation and those without, differed in their opinions about sports chiropractic research priorities; however, they had similar opinions about research collaborations. These results suggest that it may be important to sample from both practitioner groups in future studies aimed at developing research agendas for chiropractic research in sport. PMID:28065995

Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

PubMed Central

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V.

2013-01-01

Background The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. Methods and Results We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. Conclusion This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries. PMID:23936257

Barriers to using eHealth data for clinical performance feedback in Malawi: A case study

PubMed Central

Landis-Lewis, Zach; Manjomo, Ronald; Gadabu, Oliver J; Kam, Matthew; Simwaka, Bertha N; Zickmund, Susan L; Chimbwandira, Frank; Douglas, Gerald P; Jacobson, Rebecca S

2016-01-01

Introduction Sub-optimal performance of healthcare providers in low-income countries is a critical and persistent global problem. The use of electronic health information technology (eHealth) in these settings is creating large-scale opportunities to automate performance measurement and provision of feedback to individual healthcare providers, to support clinical learning and behavior change. An electronic medical record system (EMR) deployed in 66 antiretroviral therapy clinics in Malawi collects data that supervisors use to provide quarterly, clinic-level performance feedback. Understanding barriers to provision of eHealth-based performance feedback for individual healthcare providers in this setting could present a relatively low-cost opportunity to significantly improve the quality of care. Objective The aims of this study were to identify and describe barriers to using EMR data for individualized audit and feedback for healthcare providers in Malawi and to consider how to design technology to overcome these barriers. Methods We conducted a qualitative study using interviews, observations, and informant feedback in eight public hospitals in Malawi where an EMR is used. We interviewed 32 healthcare providers and conducted seven hours of observation of system use. Results We identified four key barriers to the use of EMR data for clinical performance feedback: provider rotations, disruptions to care processes, user acceptance of eHealth, and performance indicator lifespan. Each of these factors varied across sites and affected the quality of EMR data that could be used for the purpose of generating performance feedback for individual healthcare providers. Conclusion Using routinely collected eHealth data to generate individualized performance feedback shows potential at large-scale for improving clinical performance in low-resource settings. However, technology used for this purpose must accommodate ongoing changes in barriers to eHealth data use. Understanding the clinical setting as a complex adaptive system (CAS) may enable designers of technology to effectively model change processes to mitigate these barriers. PMID:26238704

Revitalization of clinical skills training at the University of the Western Cape.

PubMed

Jeggels, J D; Traut, A; Kwast, M

2010-06-01

Most educational institutions that offer health related qualifications make use of clinical skills laboratories. These spaces are generally used for the demonstration and assessment of clinical skills. The purpose of this paper is to share our experiences related to the revitalization of skills training by introducing the skills lab method at the School of Nursing (SoN), University of the Western Cape (UWC). To accommodate the contextual changes as a result of the restructuring of the higher education landscape in 2003, the clinical skills training programme at UWC had to be reviewed. With a dramatic increase in the student numbers and a reduction in hospital beds, the skills lab method provided students with an opportunity to develop clinical skills prior to their placement in real service settings. The design phase centred on adopting a skills training methodology that articulates with the case-based approach used by the SoN. Kolb's, experiential learning cycle provided the theoretical underpinning for the methodology. The planning phase was spent on the development of resources. Eight staff members were trained by our international higher education collaborators who also facilitated the training of clinical supervisors and simulated patients. The physical space had to be redesigned to accommodate audio visual and information technology to support the phases of the skills lab method. The implementation of the skills lab method was phased in from the first-year level. An interactive seminar held after the first year of implementation provided feedback from all the role players and was mostly positive. The results of introducing the skills lab method include: a move by students towards self-directed clinical skills development, clinical supervisors adopting the role of facilitators of learning and experiential clinical learning being based on, amongst others, the students' engagement with simulated patients. Finally, the recommendations relate to tailor-making clinical skills training by using various aspects of teaching and learning principles, i.e. case-based teaching, experiential learning and the skills lab method.

A Little Effort Can Withstand the Hardship: Fielding an Internet-Based Intervention to Prevent Depression among Urban Racial/Ethnic Minority Adolescents in a Primary Care Setting.

PubMed

Bansa, Melishia; Brown, Darryl; DeFrino, Daniela; Mahoney, Nicholas; Saulsberry, Alexandria; Marko-Holguin, Monika; Fogel, Joshua; Gladstone, Tracy R G; Van Voorhees, Benjamin W

2018-04-01

This study explored the implementation of Chicago Urban Resiliency Building (CURB), a randomized clinical trial designed as an Internet-based primary care depression prevention intervention for urban African American and Latino adolescents. We utilized a mixed methods analysis to explore four aims. First, we estimated the percent of at-risk adolescents that were successfully screened. Second, we examined clinic site factors and performance. Third, primary care providers (n = 10) and clinic staff (n = 18) were surveyed to assess their knowledge and attitudes about the intervention. Fourth, clinic staff (nursing and medical assistant) interviews were analyzed using thematic analysis to gather perspectives of the implementation process. We found that the estimated percent of at-risk adolescents who were successfully screened in each clinic varied widely between clinics with a mean of 14.48%. Daily clinic communication was suggestive of greater successful screening. Feasibility of screening was high for both primary care providers and clinic staff. Clinic staff exit interviews indicated the presence of community barriers that inhibited successful implementation of the intervention. This study shares the challenges and successes for depression screening and implementing Internet-based mental health interventions for urban racial/ethnic minority adolescents in primary care settings. Published by Elsevier Inc.

Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

PubMed Central

Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

2015-01-01

Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

The trials methodological research agenda: results from a priority setting exercise.

PubMed

Tudur Smith, Catrin; Hickey, Helen; Clarke, Mike; Blazeby, Jane; Williamson, Paula

2014-01-23

Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group's average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were 'Research into methods to boost recruitment in trials' (considered the highest priority), 'Methods to minimise attrition' and 'Choosing appropriate outcomes to measure'. Fifty other topics were included in the list of priorities and consensus was reached that two topics, 'Radiotherapy study designs' and 'Low carbon trials', were not priorities. This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance.

Effect of clothing weight on body weight

USDA-ARS?s Scientific Manuscript database

Background: In clinical settings, it is common to measure weight of clothed patients and estimate a correction for the weight of clothing, but we can find no papers in the medical literature regarding the variability in clothing weight with weather, season, and gender. Methods: Fifty adults (35 wom...

An acuity cards cookbook.

PubMed

Vital-Durand, F

1996-01-01

Acuity cards are being more commonly used in clinical and screening practice. The author describes his experience from over 6000 infants tested with the method, using two commercially available sets of cards to provide users with comprehensive guidelines to allow them to get the most out of this useful test.

Enrollees Choose Priorities for Medicare

ERIC Educational Resources Information Center

Danis, Marion; Biddle, Andrea K.; Goold, Susan Dorr

2004-01-01

Purpose: The purpose of this study was to demonstrate the feasibility and results of ascertaining Medicare enrollees' priorities for insured medical benefits. Design and Methods: Structured group exercises were conducted with Medicare enrollees from clinical and community settings in central North Carolina. By participating in a decision exercise,…

Proposal of quality indicators for cardiac rehabilitation after acute coronary syndrome in Japan: a modified Delphi method and practice test.

PubMed

Ohtera, Shosuke; Kanazawa, Natsuko; Ozasa, Neiko; Ueshima, Kenji; Nakayama, Takeo

2017-01-27

Cardiac rehabilitation is underused and its quality in practice is unclear. A quality indicator is a measurable element of clinical practice performance. This study aimed to propose a set of quality indicators for cardiac rehabilitation following an acute coronary event in the Japanese population and conduct a small-size practice test to confirm feasibility and applicability of the indicators in real-world clinical practice. This study used a modified Delphi technique (the RAND/UCLA appropriateness method), a consensus method which involves an evidence review, a face-to-face multidisciplinary panel meeting and repeated anonymous rating. Evidence to be reviewed included clinical practice guidelines available in English or Japanese and existing quality indicators. Performance of each indicator was assessed retrospectively using medical records at a university hospital in Japan. 10 professionals in cardiac rehabilitation for the consensus panel. In the literature review, 23 clinical practice guidelines and 16 existing indicators were identified to generate potential indicators. Through the consensus-building process, a total of 30 indicators were assessed and finally 13 indicators were accepted. The practice test (n=39) revealed that 74% of patients underwent cardiac rehabilitation. Median performance of process measures was 93% (IQR 46-100%). 'Communication with the doctor who referred the patient to cardiac rehabilitation' and 'continuous participation in cardiac rehabilitation' had low performance (32% and 38%, respectively). A modified Delphi technique identified a comprehensive set of quality indicators for cardiac rehabilitation. The single-site, small-size practice test confirmed that most of the proposed indicators were measurable in real-world clinical practice. However, some clinical processes which are not covered by national health insurance in Japan had low performance. Further studies will be needed to clarify and improve the quality of care in cardiac rehabilitation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Cost analysis of Periodontitis management in public sector specialist dental clinics

PubMed Central

2014-01-01

Background The objective of this paper is to quantify the cost of periodontitis management at public sector specialist periodontal clinic settings and analyse the distribution of cost components. Methods Five specialist periodontal clinics in the Ministry of Health represented the public sector in providing clinical and cost data for this study. Newly-diagnosed periodontitis patients (N = 165) were recruited and followed up for one year of specialist periodontal care. Direct and indirect costs from the societal viewpoint were included in the cost analysis. They were measured in 2012 Ringgit Malaysia (MYR) and estimated from the societal perspective using activity-based and step-down costing methods, and substantiated by clinical pathways. Cost of dental equipment, consumables and labour (average treatment time) for each procedure was measured using activity-based costing method. Meanwhile, unit cost calculations for clinic administration, utilities and maintenance used step-down approach. Patient expenditures and absence from work were recorded via diary entries. The conversion from MYR to Euro was based on the 2012 rate (1€ = MYR4). Results A total of 2900 procedures were provided, with an average cost of MYR 2820 (€705) per patient for the study year, and MYR 376 (€94) per outpatient visit. Out of this, 90% was contributed by provider cost and 10% by patient cost; 94% for direct cost and 4% for lost productivity. Treatment of aggressive periodontitis was significantly higher than for chronic periodontitis (t-test, P = 0.003). Higher costs were expended as disease severity increased (ANOVA, P = 0.022) and for patients requiring surgeries (ANOVA, P < 0.001). Providers generally spent most on consumables while patients spent most on transportation. Conclusions Cost of providing dental treatment for periodontitis patients at public sector specialist settings were substantial and comparable with some non-communicable diseases. These findings provide basis for identifying potential cost-reducing strategies, estimating economic burden of periodontitis management and performing economic evaluation of the specialist periodontal programme. PMID:24884465

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

[Quality standards for ultrasound assessment of the superficial venous system of the lower limbs. Report of the French Society for Vascular Medicine].

PubMed

Auvert, J-F; Chleir, F; Coppé, G; Hamel-Desnos, C; Moraglia, L; Pichot, O

2014-02-01

The quality standards of the French Society for Vascular Medicine for the ultrasound assessment of the superficial venous system of the lower limbs are based on the two following requirements: technical know-how (mastering the use of ultrasound devices and the method of examination); medical know-how (ability to adapt the methods and scope of the examination to its clinical indications and purpose and to rationally analyze and interpret its results). To describe an optimal method of examination in relation to the clinical question and hypothesis; to achieve consistent practice, methods, glossary terminologies and reporting; to provide good practice reference points and to promote a high quality process. The three levels of examination. Their clinical indications and goals. The reference standard examination (level 2) and its variants according to clinical needs. The minimal content of the examination report, the letter to the referring physician (synthesis, conclusion and management suggestions) and iconography. Commented glossary (anatomy, hemodynamics, semiology). Technical basis. Ultrasound devices settings. We discuss of use of Duplex ultrasound for the assessment of the superficial veins of the lower limbs in vascular medicine practice. Copyright © 2014. Published by Elsevier Masson SAS.

New insights in non-small-cell lung cancer: circulating tumor cells and cell-free DNA

PubMed Central

Duréndez-Sáez, Elena; Azkárate, Aitor; Meri, Marina; Calabuig-Fariñas, Silvia; Aguilar-Gallardo, Cristóbal; Blasco, Ana

2017-01-01

Lung cancer is the second most frequent tumor and the leading cause of death by cancer in both men and women. Increasing knowledge about the cancer genome and tumor environment has led to a new setting in which morphological and molecular characterization is needed to treat patients in the most personalized way in order to achieve better outcomes. Since tumor products can be detected in body fluids, the liquid biopsy, particularly, peripheral blood, has emerged as a new source for lung cancer biomarker’s analysis. A variety of tumor components can be used for this purpose. Among them, circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) should be especially considered. Different detection methods for both CTCs and ctDNA have been and are being developed to improve the sensitivity and specificity of these tests. This would lead to better characterization and would solve some clinical doubts at different disease evolution times, e.g., intratumoral or temporal heterogeneity, difficulty in the obtaining a tumor sample, etc., and would also avoid the side effects of very expensive and complicated tumor obtaining interventions. CTCs and ctDNA are useful in different lung cancer settings. Their value has been shown for the early diagnosis, prognosis, prediction of treatment efficacy, monitoring responses and early detection of lung cancer relapse. CTCs have still not been validated for use in clinical settings in non-small-cell lung cancer (NSCLC), while ctDNA has been approved by the Food and Drug Administration (FDA) and European Medical Association (EMA), and the main clinical guidelines used for detect different epidermal growth factor receptor (EGFR) mutations and the monitoring and treatment choice of mutated patients with tyrosine kinase inhibitors (TKIs). This review, describes how ctDNA seem to be winning the race against CTCs from the laboratory bench to clinical practice due to easier obtaining methods, manipulation and its implementation into clinical practice. PMID:29184672

Tumor Control Probability Modeling for Stereotactic Body Radiation Therapy of Early-Stage Lung Cancer Using Multiple Bio-physical Models

PubMed Central

Liu, Feng; Tai, An; Lee, Percy; Biswas, Tithi; Ding, George X.; El Naqa, Isaam; Grimm, Jimm; Jackson, Andrew; Kong, Feng-Ming (Spring); LaCouture, Tamara; Loo, Billy; Miften, Moyed; Solberg, Timothy; Li, X Allen

2017-01-01

Purpose To analyze pooled clinical data using different radiobiological models and to understand the relationship between biologically effective dose (BED) and tumor control probability (TCP) for stereotactic body radiotherapy (SBRT) of early-stage non-small cell lung cancer (NSCLC). Method and Materials The clinical data of 1-, 2-, 3-, and 5-year actuarial or Kaplan-Meier TCP from 46 selected studies were collected for SBRT of NSCLC in the literature. The TCP data were separated for Stage T1 and T2 tumors if possible, otherwise collected for combined stages. BED was calculated at isocenters using six radiobiological models. For each model, the independent model parameters were determined from a fit to the TCP data using the least chi-square (χ2) method with either one set of parameters regardless of tumor stages or two sets for T1 and T2 tumors separately. Results The fits to the clinic data yield consistent results of large α/β ratios of about 20 Gy for all models investigated. The regrowth model that accounts for the tumor repopulation and heterogeneity leads to a better fit to the data, compared to other 5 models where the fits were indistinguishable between the models. The models based on the fitting parameters predict that the T2 tumors require about additional 1 Gy physical dose at isocenters per fraction (≤5 fractions) to achieve the optimal TCP when compared to the T1 tumors. Conclusion This systematic analysis of a large set of published clinical data using different radiobiological models shows that local TCP for SBRT of early-stage NSCLC has strong dependence on BED with large α/β ratios of about 20 Gy. The six models predict that a BED (calculated with α/β of 20) of 90 Gy is sufficient to achieve TCP ≥ 95%. Among the models considered, the regrowth model leads to a better fit to the clinical data. PMID:27871671

WE-G-204-07: Automated Characterization of Perceptual Quality of Clinical Chest Radiographs: Improvements in Lung, Spine, and Hardware Detection

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

Wells, J; Zhang, L; Samei, E

Purpose: To develop and validate more robust methods for automated lung, spine, and hardware detection in AP/PA chest images. This work is part of a continuing effort to automatically characterize the perceptual image quality of clinical radiographs. [Y. Lin et al. Med. Phys. 39, 7019–7031 (2012)] Methods: Our previous implementation of lung/spine identification was applicable to only one vendor. A more generalized routine was devised based on three primary components: lung boundary detection, fuzzy c-means (FCM) clustering, and a clinically-derived lung pixel probability map. Boundary detection was used to constrain the lung segmentations. FCM clustering produced grayscale- and neighborhood-based pixelmore » classification probabilities which are weighted by the clinically-derived probability maps to generate a final lung segmentation. Lung centerlines were set along the left-right lung midpoints. Spine centerlines were estimated as a weighted average of body contour, lateral lung contour, and intensity-based centerline estimates. Centerline estimation was tested on 900 clinical AP/PA chest radiographs which included inpatient/outpatient, upright/bedside, men/women, and adult/pediatric images from multiple imaging systems. Our previous implementation further did not account for the presence of medical hardware (pacemakers, wires, implants, staples, stents, etc.) potentially biasing image quality analysis. A hardware detection algorithm was developed using a gradient-based thresholding method. The training and testing paradigm used a set of 48 images from which 1920 51×51 pixel{sup 2} ROIs with and 1920 ROIs without hardware were manually selected. Results: Acceptable lung centerlines were generated in 98.7% of radiographs while spine centerlines were acceptable in 99.1% of radiographs. Following threshold optimization, the hardware detection software yielded average true positive and true negative rates of 92.7% and 96.9%, respectively. Conclusion: Updated segmentation and centerline estimation methods in addition to new gradient-based hardware detection software provide improved data integrity control and error-checking for automated clinical chest image quality characterization across multiple radiography systems.« less

Nursing students' assessment of the learning environment in different clinical settings.

PubMed

Bisholt, Birgitta; Ohlsson, Ulla; Engström, Agneta Kullén; Johansson, Annelie Sundler; Gustafsson, Margareta

2014-05-01

Nursing students perform their clinical practice in different types of clinical settings. The clinical learning environment is important for students to be able to achieve desired learning outcomes. Knowledge is lacking about the learning environment in different clinical settings. The aim was to compare the learning environment in different clinical settings from the perspective of the nursing students. A cross-sectional study with comparative design was conducted. Data was collected from 185 nursing students at three universities by means of a questionnaire involving the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) evaluation scale. An open-ended question was added in order to ascertain reasons for dissatisfaction with the clinical placement. The nursing students' satisfaction with the placement did not differ between clinical settings. However, those with clinical placement in hospital departments agreed more strongly that sufficient meaningful learning situations occurred and that learning situations were multi-dimensional. Some students reported that the character of the clinical setting made it difficult to achieve the learning objectives. In the planning of the clinical placement, attention must be paid to whether the setting offers the student a meaningful learning situation where the appropriate learning outcome may be achieved. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical Supervision of Athletic Training Students at Colleges and Universities Needs Improvement

PubMed Central

Weidner, Thomas G.; Pipkin, Jennifer

2002-01-01

Objectives: To assess the type and amount of clinical supervision athletic training students received during clinical education. Design and Setting: An online survey was conducted with a questionnaire developed specifically for this study. Subjects: Head athletic trainers from National Collegiate Athletic Association Division I (28), Division II (34), and Division III institutions (30). Thirty-four represented Commission on the Accreditation of Allied Health Education Programs-accredited athletic training education programs, 20 represented athletic training programs in Joint Review Commission on Athletic Training candidacy, and 35 offered the internship route. Measurements: Descriptive statistics were computed. Three sets of chi-square analyses were completed to assess associations among athletic training students with first-responder qualifications, program and institution characteristics, certified athletic trainer medical coverage of moderate- and increased-risk sports, and clinical supervision. A trend analysis of students' class standing and time spent in different types of clinical supervision was also completed. The alpha level was set at < .05. Results: Most of the athletic training students (83.7%), particularly in accredited programs, had first-responder qualifications. More than half of the head athletic trainers (59.8%) indicated that athletic training students were authorized to provide medical care coverage without supervision. A minimal amount of medical care coverage of moderate- and increased-risk sports was unsupervised. No significant difference between the size of the education or athletic program and type and amount of clinical supervision was noted. Freshman athletic training students spent more time in direct clinical supervision and less time in unsupervised experience, but the opposite was true for senior students. Conclusions: Athletic training students are being utilized beyond appropriate clinical supervision and the scope of clinical education. Future research should employ methods using nonparticipant observation of clinical instructors' supervision of students as well as students' own perceptions of their clinical supervision. PMID:12937552

Standardized methods for photography in procedural dermatology using simple equipment.

PubMed

Hexsel, Doris; Hexsel, Camile L; Dal'Forno, Taciana; Schilling de Souza, Juliana; Silva, Aline F; Siega, Carolina

2017-04-01

Photography is an important tool in dermatology. Reproducing the settings of before photos after interventions allows more accurate evaluation of treatment outcomes. In this article, we describe standardized methods and tips to obtain photographs, both for clinical practice and research procedural dermatology, using common equipment. Standards for the studio, cameras, photographer, patients, and framing are presented in this article. © 2017 The International Society of Dermatology.

[The importance of using the computer in treating children with strabismus and amblyopia].

PubMed

Tatarinov, S A; Amel'ianova, S G; Kashchenko, T P; Lakomkin, V I; Avuchenkova, T N; Galich, V I

1993-01-01

A method for therapy of strabismus and amblyopia with the use of IBM PC AT type computer is suggested. It consists in active interaction of a patient with various test objects on the monitor and is realized via a special set of programs. Clinical indications for the use of a new method are defined. Its use yielded good results in 82 of 97 children.

A method to optimize the processing algorithm of a computed radiography system for chest radiography.

PubMed

Moore, C S; Liney, G P; Beavis, A W; Saunderson, J R

2007-09-01

A test methodology using an anthropomorphic-equivalent chest phantom is described for the optimization of the Agfa computed radiography "MUSICA" processing algorithm for chest radiography. The contrast-to-noise ratio (CNR) in the lung, heart and diaphragm regions of the phantom, and the "system modulation transfer function" (sMTF) in the lung region, were measured using test tools embedded in the phantom. Using these parameters the MUSICA processing algorithm was optimized with respect to low-contrast detectability and spatial resolution. Two optimum "MUSICA parameter sets" were derived respectively for maximizing the CNR and sMTF in each region of the phantom. Further work is required to find the relative importance of low-contrast detectability and spatial resolution in chest images, from which the definitive optimum MUSICA parameter set can then be derived. Prior to this further work, a compromised optimum MUSICA parameter set was applied to a range of clinical images. A group of experienced image evaluators scored these images alongside images produced from the same radiographs using the MUSICA parameter set in clinical use at the time. The compromised optimum MUSICA parameter set was shown to produce measurably better images.

Metabolomics biomarkers to predict acamprosate treatment response in alcohol-dependent subjects.

PubMed

Hinton, David J; Vázquez, Marely Santiago; Geske, Jennifer R; Hitschfeld, Mario J; Ho, Ada M C; Karpyak, Victor M; Biernacka, Joanna M; Choi, Doo-Sup

2017-05-31

Precision medicine for alcohol use disorder (AUD) allows optimal treatment of the right patient with the right drug at the right time. Here, we generated multivariable models incorporating clinical information and serum metabolite levels to predict acamprosate treatment response. The sample of 120 patients was randomly split into a training set (n = 80) and test set (n = 40) five independent times. Treatment response was defined as complete abstinence (no alcohol consumption during 3 months of acamprosate treatment) while nonresponse was defined as any alcohol consumption during this period. In each of the five training sets, we built a predictive model using a least absolute shrinkage and section operator (LASSO) penalized selection method and then evaluated the predictive performance of each model in the corresponding test set. The models predicted acamprosate treatment response with a mean sensitivity and specificity in the test sets of 0.83 and 0.31, respectively, suggesting our model performed well at predicting responders, but not non-responders (i.e. many non-responders were predicted to respond). Studies with larger sample sizes and additional biomarkers will expand the clinical utility of predictive algorithms for pharmaceutical response in AUD.

Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes

PubMed Central

Trevitt, Sara; Simpson, Sue; Wood, Annette

2015-01-01

Background: Closed-loop artificial pancreas device (APD) systems are externally worn medical devices that are being developed to enable people with type 1 diabetes to regulate their blood glucose levels in a more automated way. The innovative concept of this emerging technology is that hands-free, continuous, glycemic control can be achieved by using digital communication technology and advanced computer algorithms. Methods: A horizon scanning review of this field was conducted using online sources of intelligence to identify systems in development. The systems were classified into subtypes according to their level of automation, the hormonal and glycemic control approaches used, and their research setting. Results: Eighteen closed-loop APD systems were identified. All were being tested in clinical trials prior to potential commercialization. Six were being studied in the home setting, 5 in outpatient settings, and 7 in inpatient settings. It is estimated that 2 systems may become commercially available in the EU by the end of 2016, 1 during 2017, and 2 more in 2018. Conclusions: There are around 18 closed-loop APD systems progressing through early stages of clinical development. Only a few of these are currently in phase 3 trials and in settings that replicate real life. PMID:26589628

Precision assessment of model-based RSA for a total knee prosthesis in a biplanar set-up.

PubMed

Trozzi, C; Kaptein, B L; Garling, E H; Shelyakova, T; Russo, A; Bragonzoni, L; Martelli, S

2008-10-01

Model-based Roentgen Stereophotogrammetric Analysis (RSA) was recently developed for the measurement of prosthesis micromotion. Its main advantage is that markers do not need to be attached to the implants as traditional marker-based RSA requires. Model-based RSA has only been tested in uniplanar radiographic set-ups. A biplanar set-up would theoretically facilitate the pose estimation algorithm, since radiographic projections would show more different shape features of the implants than in uniplanar images. We tested the precision of model-based RSA and compared it with that of the traditional marker-based method in a biplanar set-up. Micromotions of both tibial and femoral components were measured with both the techniques from double examinations of patients participating in a clinical study. The results showed that in the biplanar set-up model-based RSA presents a homogeneous distribution of precision for all the translation directions, but an inhomogeneous error for rotations, especially internal-external rotation presented higher errors than rotations about the transverse and sagittal axes. Model-based RSA was less precise than the marker-based method, although the differences were not significant for the translations and rotations of the tibial component, with the exception of the internal-external rotations. For both prosthesis components the precisions of model-based RSA were below 0.2 mm for all the translations, and below 0.3 degrees for rotations about transverse and sagittal axes. These values are still acceptable for clinical studies aimed at evaluating total knee prosthesis micromotion. In a biplanar set-up model-based RSA is a valid alternative to traditional marker-based RSA where marking of the prosthesis is an enormous disadvantage.

Quantitative characterization of metastatic disease in the spine. Part I. Semiautomated segmentation using atlas-based deformable registration and the level set method

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

Hardisty, M.; Gordon, L.; Agarwal, P.

2007-08-15

Quantitative assessment of metastatic disease in bone is often considered immeasurable and, as such, patients with skeletal metastases are often excluded from clinical trials. In order to effectively quantify the impact of metastatic tumor involvement in the spine, accurate segmentation of the vertebra is required. Manual segmentation can be accurate but involves extensive and time-consuming user interaction. Potential solutions to automating segmentation of metastatically involved vertebrae are demons deformable image registration and level set methods. The purpose of this study was to develop a semiautomated method to accurately segment tumor-bearing vertebrae using the aforementioned techniques. By maintaining morphology of anmore » atlas, the demons-level set composite algorithm was able to accurately differentiate between trans-cortical tumors and surrounding soft tissue of identical intensity. The algorithm successfully segmented both the vertebral body and trabecular centrum of tumor-involved and healthy vertebrae. This work validates our approach as equivalent in accuracy to an experienced user.« less