Allogeneic tumor cell vaccines

PubMed Central

Srivatsan, Sanjay; Patel, Jaina M; Bozeman, Erica N; Imasuen, Imade E; He, Sara; Daniels, Danielle; Selvaraj, Periasamy

2014-01-01

The high mortality rate associated with cancer and its resistance to conventional treatments such as radiation and chemotherapy has led to the investigation of a variety of anti-cancer immunotherapies. The development of novel immunotherapies has been bolstered by the discovery of tumor-associated antigens (TAAs), through gene sequencing and proteomics. One such immunotherapy employs established allogeneic human cancer cell lines to induce antitumor immunity in patients through TAA presentation. Allogeneic cancer immunotherapies are desirable in a clinical setting due to their ease of production and availability. This review aims to summarize clinical trials of allogeneic tumor immunotherapies in various cancer types. To date, clinical trials have shown limited success due potentially to extensive degrees of inter- and intra-tumoral heterogeneity found among cancer patients. However, these clinical results provide guidance for the rational design and creation of more effective allogeneic tumor immunotherapies for use as monotherapies or in combination with other therapies. PMID:24064957

WJG sets an example of internationalization for other Chinese academic journals.

PubMed

Zu, Guang-An

2010-06-14

Supported by the "Special Fund for Key Academic Journals" of the National Natural Science Foundation of China, World Journal of Gastroenterology (WJG) has become a high-impact international clinical medical journal due to the great efforts of Professor Lian-Sheng Ma, Editor-in-Chief, and his team over several years. Now, WJG has successfully achieved a high degree of internationalization and sets a good example for other Chinese academic journals.

Reconciling the professional and student identities of clinical psychology trainees.

PubMed

McKenzie, Karen; Cossar, Jill A; Fawns, Tim; Murray, Aja L

2013-10-01

The study explored the ways in which qualified and trainee clinical psychologists perceived professional behaviour, as illustrated in a series of short vignettes, in student and clinical practice contexts. Comparisons were made to identify the extent to which ideas of professionalism differed across different learning contexts and between qualified and unqualified staff, with the aim of adding to the literature on which factors influence the development of professional identity in health professionals. An online questionnaire depicting a range of potentially unprofessional behaviours was completed by 265 clinical psychology trainees and 106 qualified clinical psychologists. The data were analysed using a general linear model with simultaneous entry in which rater (trainee vs qualified clinical psychologist), setting (student vs placement) and their interaction predicted acceptability ratings. We found that, in general, trainees and qualified staff agreed on those behaviours that were potentially unprofessional, although where significant differences were found, these were due to trainees rating the same behaviours as more professionally acceptable than qualified clinical psychologists. Despite trainees identifying a range of behaviours as professionally unacceptable, some percentage reported having engaged in a similar behaviour in the past. Irrespective of the status of the rater, the same behaviours tended to be viewed as more professionally unacceptable when in a placement (clinical) setting than in a student (university) setting. Generally, no support was found for a rater by setting interaction. The study suggests that trainee clinical psychologists are generally successful at identifying professional norms, although they do not always act in accordance with these. Conflicting student and professional norms may result in trainees viewing some potentially unprofessional behaviour as less severe than qualified staff. Health professional educators should be aware of this fact and take steps to shape trainee norms to be consistent with that of the professional group.

Sources of variation in baseline gene expression levels from toxicogenomics study control animals

EPA Science Inventory

The use of gene expression profiling in both clinical and laboratory settings would be enhanced by better characterization ofvariance due to individual, environmental, and technical factors. Meta-analysis ofmicroarray data from untreated or vehicle-treated animals within the con...

Healthcare costs associated with nephrology care in pre-dialysis chronic kidney disease patients.

PubMed

Vekeman, Francis; Yameogo, Nadege-Desiree; Lefebvre, Patrick; Bailey, Robert A; McKenzie, R Scott; Piech, Catherine Tak

2010-01-01

To compare the healthcare costs of pre-dialysis chronic kidney disease (CKD) patients cared for in a nephrology clinic setting versus other care settings. An analysis of health claims between 01/2002 and 09/2007 from the Ingenix Impact Database was conducted. Inclusion criteria were ≥ 18 years of age, ≥ 1 ICD-9 claim for CKD, and ≥ 1 estimated glomerular filtration rate (eGFR) value of < 60 mL/min/1.73 m(2). Patients were classified in the nephrology care cohort if they were treated in a nephrology clinic setting at least once during the study period. Univariate and multivariate analyses were conducted to compare average annualized healthcare costs of patients in nephrology care versus other care settings. Among the 20,135 patients identified for analysis, 1,547 patients were cared for in a nephrology clinic setting. Nephrology care was associated with lower healthcare costs with an unadjusted cost savings of $3,049 ($11,303 vs. $14,352, p = 0.0014) and a cost ratio of 0.8:1 relative to other care settings. After adjusting for covariates, nephrology care remained associated with lower costs (adjusted cost savings: $2,742, p = 0.006). Key limitations included potential inaccuracies of claims data, the lack of control for patients' ethnicity in the calculation of eGFR values, and the presence of potential biases due to the observational design of the study. The current study demonstrated that pre-dialysis CKD patients treated in nephrology clinics were associated with significantly lower healthcare costs compared with patients treated in other healthcare settings.

Transfusion Associated Microchimerism: The Hybrid Within

PubMed Central

Bloch, Evan M; Jackman, Rachael P; Lee, Tzong-Hae; Busch, Michael P

2012-01-01

Microchimerism, the coexistence of genetically disparate populations of cells in a receptive host, is well described in both clinical and physiological settings, including transplantation and pregnancy. Microchimerism can also occur following allogeneic blood transfusion in traumatically injured patients, where donor cells have been observed decades after transfusion. To date, transfusion-associated microchimerism (TA-MC) appears confined to this clinical subset, most likely due to the immune perturbations that occur following severe trauma that allow foreign donor cells to survive. TA-MC appears to be unaffected by leukoreduction and has been documented following transfusion with an array of blood products. The only significant predictor of TA-MC to date is the age of red cells, with fresher units associated with higher risk. Thus far, no adverse clinical effect has been observed in limited studies of TA-MC. There are, however, hypothesized links to transfusion-associated graft vs. host disease (TA-GvHD) that may be unrecognized and consequently under-reported. Microchimerism in other settings has gained increasing attention due to a plausible link to autoimmune diseases, as well as its diagnostic and therapeutic potential vis-a-vis ante-natal testing and adoptive immunotherapy, respectively. Furthermore, microchimerism provides a tool to further our understanding of immune tolerance and regulation. PMID:23102759

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.

Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

PubMed

Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

2017-08-01

Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

Genomic and metagenomic diversity of antibiotic resistance in dairy animals

USDA-ARS?s Scientific Manuscript database

Antibiotic resistance in food animals has received increased scrutiny in recent years due to the increased prevalence of antibiotic resistant infections in the human clinical setting. The extent to which antibiotic usage in food animals is responsible for the burden of antibiotic resistance in human...

WJG sets an example of internationalization for other Chinese academic journals

PubMed Central

Zu, Guang-An

2010-01-01

Supported by the “Special Fund for Key Academic Journals” of the National Natural Science Foundation of China, World Journal of Gastroenterology (WJG) has become a high-impact international clinical medical journal due to the great efforts of Professor Lian-Sheng Ma, Editor-in-Chief, and his team over several years. Now, WJG has successfully achieved a high degree of internationalization and sets a good example for other Chinese academic journals. PMID:20533589

Iterative integral parameter identification of a respiratory mechanics model.

PubMed

Schranz, Christoph; Docherty, Paul D; Chiew, Yeong Shiong; Möller, Knut; Chase, J Geoffrey

2012-07-18

Patient-specific respiratory mechanics models can support the evaluation of optimal lung protective ventilator settings during ventilation therapy. Clinical application requires that the individual's model parameter values must be identified with information available at the bedside. Multiple linear regression or gradient-based parameter identification methods are highly sensitive to noise and initial parameter estimates. Thus, they are difficult to apply at the bedside to support therapeutic decisions. An iterative integral parameter identification method is applied to a second order respiratory mechanics model. The method is compared to the commonly used regression methods and error-mapping approaches using simulated and clinical data. The clinical potential of the method was evaluated on data from 13 Acute Respiratory Distress Syndrome (ARDS) patients. The iterative integral method converged to error minima 350 times faster than the Simplex Search Method using simulation data sets and 50 times faster using clinical data sets. Established regression methods reported erroneous results due to sensitivity to noise. In contrast, the iterative integral method was effective independent of initial parameter estimations, and converged successfully in each case tested. These investigations reveal that the iterative integral method is beneficial with respect to computing time, operator independence and robustness, and thus applicable at the bedside for this clinical application.

Prevention of in-hospital falls: development of criteria for the conduct of a multi-site audit.

PubMed

Giles, Kristy; Stephenson, Matthew; McArthur, Alexa; Aromataris, Edoardo

2015-06-01

Patient falls are a significant issue for hospitals due to the high rates of morbidity and mortality associated with these events, as well as the financial costs for the healthcare system. To establish what constitutes best practice in terms of fall prevention in acute care facilities and use this to inform the development of best practice audit criteria. Criteria for clinical audit were developed from evidence derived from systematic reviews and guidelines. While these were drawn from the best available evidence, they were also developed in conjunction with clinicians undertaking a fall-prevention clinical audit and key stakeholders from the clinical settings to ensure their relevance and applicability to the acute care setting. Current literature recommends a comprehensive and multifactorial approach to fall prevention. Eight audit criteria were derived from the best available evidence including the domains of physical environment, hospital culture and care processes, use of technology and targeted interventions. Existing research evidence and consultation with stakeholders has allowed the development of applicable, evidence-based audit criteria for fall prevention in acute care settings. This model can promote engagement, impact clinical practice and lead to improved outcomes.

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea

PubMed Central

2013-01-01

Background In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Discussion Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Summary Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered. PMID:23885908

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea.

PubMed

Laman, Moses; Pomat, William; Siba, Peter; Betuela, Inoni

2013-07-26

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered.

State Variability and Psychopathological Attractors: the Behavioural Complexity as Discriminating Factor Between the Pathology and Normality Profiles

NASA Astrophysics Data System (ADS)

Marconi, Pier Luigi

369 patients, selected within a set of 1215 outpatients, were studied. The data were clustered into two set: the baseline set and the endpoint set. The clinical parameters had a higher variability at the baseline than at the endpoint. 4 to 5 factors were extracted in total group and 3 subgroups (190 "affective", 34 type-B personality, 166 without any of both disorders). In all subgroups there was a background pattern of 6 components: 3 components confirming the trifactorial temperamental model of Cloninger; 1 component related to the quality of social relationships; 2 components (that are the main components of factorial model about in all groups) relating to quality of life and adjustment self perceived by patients, and to pattern of dysfunctional behavior, inner feelings, and thought processes externally evaluated. These background components seem to aggregate differently in the subgroups in accordance to the clinical diagnosis. These patterns may be interpreted as expression of an increased "coherence" among parameters due to a lack of flexibility caused by the illness. The different class of illness can be further distinguished by intensity of maladjustment, that is related to the intensity of clinical signs just only at the baseline. These data suggest that the main interfering factors are clinical psychopathology at baseline and stable personality traits at endpoint. This persistent chronic maladjustment personality-driven is evidenced after the clinical disorder was cured by treatment. An interpretative model is presented by the author.

Treatment of acute burn blisters in unscheduled care settings.

PubMed

Payne, Sarah; Cole, Elaine

2012-09-01

Many patients with minor burns present at emergency departments and urgent care centres, where their management is often undertaken by experienced nurses rather than experts in treating burns. This article describes a small study of the clinical decision making that underpins nurses' management of minor burns in these non-specialist settings. The results suggest that, due to a lack of relevant research, nurses base their decisions on previous experience or expert colleagues' opinions and advice rather than on the evidence.

[Assessment of SUSARs. Clinical evaluation of single cases in terms of regulatory requirements].

PubMed

Wroblewski, H; Schmickler, M

2005-04-01

In the course of implementing the European directives on pharmaceutical law, focus is set on suspected unexpected serious adverse reactions (SUSARs). SUSARs are essential for expedited reporting to authorities and ethics committees. During on-line monitoring of the study, the investigator documents all adverse events. Serious adverse events are forwarded to the sponsor in due time. The sponsor identifies SUSARs for expedited reporting. Clinical causality assessment between the investigational product and the adverse event is substantial in this process. This requires a balanced clinical assessment of all case relevant aspects and information available reflecting the complexity of the specific case, which cannot be covered by algorithms in general. In the setting of on-line monitoring, SUSARs ensure the safety of the patient and the study. In addition, SUSARs are relevant for generation of the safety profile of the substance.

SIOP‐PODC adapted risk stratification and treatment guidelines: Recommendations for neuroblastoma in low‐ and middle‐income settings

PubMed Central

Howard, Scott C.; Chantada, Guillermo; Israels, Trijn; Khattab, Mohammed; Alcasabas, Patricia; Lam, Catherine G.; Faulkner, Lawrence; Park, Julie R.; London, Wendy B.; Matthay, Katherine K.

2015-01-01

Neuroblastoma is the most common extracranial solid tumor in childhood in high‐income countries (HIC), where consistent treatment approaches based on clinical and tumor biological risk stratification have steadily improved outcomes. However, in low‐ and middle‐ income countries (LMIC), suboptimal diagnosis, risk stratification, and treatment may occur due to limited resources and unavailable infrastructure. The clinical practice guidelines outlined in this manuscript are based on current published evidence and expert opinions. Standard risk stratification and treatment explicitly adapted to graduated resource settings can improve outcomes for children with neuroblastoma by reducing preventable toxic death and relapse. Pediatr Blood Cancer 2015;62:1305–1316. © 2015 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc. PMID:25810263

Development and testing of indicators to measure coordination of clinical information and management across levels of care.

PubMed

Aller, Marta-Beatriz; Vargas, Ingrid; Coderch, Jordi; Calero, Sebastià; Cots, Francesc; Abizanda, Mercè; Farré, Joan; Llopart, Josep Ramon; Colomés, Lluís; Vázquez, María Luisa

2015-08-13

Coordination across levels of care is becoming increasingly important due to rapid advances in technology, high specialisation and changes in the organization of healthcare services; to date, however, the development of indicators to evaluate coordination has been limited. The aim of this study is to develop and test a set of indicators to comprehensively evaluate clinical coordination across levels of care. A systematic review of literature was conducted to identify indicators of clinical coordination across levels of care. These indicators were analysed to identify attributes of coordination and classified accordingly. They were then discussed within an expert team and adapted or newly developed, and their relevance, scientific soundness and feasibility were examined. The indicators were tested in three healthcare areas of the Catalan health system. 52 indicators were identified addressing 11 attributes of clinical coordination across levels of care. The final set consisted of 21 output indicators. Clinical information transfer is evaluated based on information flow (4) and the adequacy of shared information (3). Clinical management coordination indicators evaluate care coherence through diagnostic testing (2) and medication (1), provision of care at the most appropriate level (2), completion of diagnostic process (1), follow-up after hospital discharge (4) and accessibility across levels of care (4). The application of indicators showed differences in the degree of clinical coordination depending on the attribute and area. A set of rigorous and scientifically sound measures of clinical coordination across levels of care were developed based on a literature review and discussion with experts. This set of indicators comprehensively address the different attributes of clinical coordination in main transitions across levels of care. It could be employed to identify areas in which health services can be improved, as well as to measure the effect of efforts to improve clinical coordination in healthcare organizations.

Utility of point of care test devices for infectious disease testing of blood and oral fluid and application to rapid testing in the field

NASA Astrophysics Data System (ADS)

Lee, Stephen R.; Kardos, Keith W.; Yearwood, Graham D.; Guillon, Geraldine B.; Kurtz, Lisa A.; Mokkapati, Vijaya K.

2008-04-01

Rapid, point of care (POC) testing has been increasingly deployed as an aid in the diagnosis of infectious disease, due to its ability to deliver rapid, actionable results. In the case of HIV, a number of rapid test devices have been FDA approved and CLIA-waived in order to enable diagnosis of HIV infection outside of traditional laboratory settings. These settings include STD clinics, community outreach centers and mobile testing units, as well as identifying HIV infection among pregnant women and managing occupational exposure to infection. The OraQuick ® rapid test platform has been widely used to identify HIV in POC settings, due to its simplicity, ease of use and the ability to utilize oral fluid as an alternative specimen to blood. More recently, a rapid test for antibodies to hepatitis C virus (HCV) has been developed on the same test platform which uses serum, plasma, finger-stick blood, venous blood and oral fluid. Clinical testing using this POC test device has shown that performance is equivalent to state of the art, laboratory based tests. These devices may be suitable for rapid field testing of blood and other body fluids for the presence of infectious agents.

Design of CT reconstruction kernel specifically for clinical lung imaging

NASA Astrophysics Data System (ADS)

Cody, Dianna D.; Hsieh, Jiang; Gladish, Gregory W.

2005-04-01

In this study we developed a new reconstruction kernel specifically for chest CT imaging. An experimental flat-panel CT scanner was used on large dogs to produce 'ground-truth" reference chest CT images. These dogs were also examined using a clinical 16-slice CT scanner. We concluded from the dog images acquired on the clinical scanner that the loss of subtle lung structures was due mostly to the presence of the background noise texture when using currently available reconstruction kernels. This qualitative evaluation of the dog CT images prompted the design of a new recon kernel. This new kernel consisted of the combination of a low-pass and a high-pass kernel to produce a new reconstruction kernel, called the 'Hybrid" kernel. The performance of this Hybrid kernel fell between the two kernels on which it was based, as expected. This Hybrid kernel was also applied to a set of 50 patient data sets; the analysis of these clinical images is underway. We are hopeful that this Hybrid kernel will produce clinical images with an acceptable tradeoff of lung detail, reliable HU, and image noise.

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

Sharing Patient-Generated Data in Clinical Practices: An Interview Study.

PubMed

Zhu, Haining; Colgan, Joanna; Reddy, Madhu; Choe, Eun Kyoung

2016-01-01

Patients are tracking and generating an increasingly large volume of personal health data outside the clinic due to an explosion of wearable sensing and mobile health (mHealth) apps. The potential usefulness of these data is enormous as they can provide good measures of everyday behavior and lifestyle. However, how we can fully leverage patient-generated data (PGD) and integrate them in clinical practice is less clear. In this interview study, we aim to understand how patients and clinicians currently share patient-generated data in clinical care practice. From the study, we identified technical, social, and organizational challenges in sharing and fully leveraging patient-generated data in clinical practices. Our findings can provide researchers potential avenues for enablers and barriers in sharing patient-generated data in clinical settings.

From Single Nucleotide Polymorphisms to Constant Immunosuppression: Mesenchymal Stem Cell Therapy for Autoimmune Diseases

PubMed Central

Galipeau, Jacques; Nooka, Ajay K.

2013-01-01

The regenerative abilities and the immunosuppressive properties of mesenchymal stromal cells (MSCs) make them potentially the ideal cellular product of choice for treatment of autoimmune and other immune mediated disorders. Although the usefulness of MSCs for therapeutic applications is in early phases, their potential clinical use remains of great interest. Current clinical evidence of use of MSCs from both autologous and allogeneic sources to treat autoimmune disorders confers conflicting clinical benefit outcomes. These varied results may possibly be due to MSC use across wide range of autoimmune disorders with clinical heterogeneity or due to variability of the cellular product. In the light of recent genome wide association studies (GWAS), linking predisposition of autoimmune diseases to single nucleotide polymorphisms (SNPs) in the susceptible genetic loci, the clinical relevance of MSCs possessing SNPs in the critical effector molecules of immunosuppression is largely undiscussed. It is of further interest in the allogeneic setting, where SNPs in the target pathway of MSC's intervention may also modulate clinical outcome. In the present review, we have discussed the known critical SNPs predisposing to disease susceptibility in various autoimmune diseases and their significance in the immunomodulatory properties of MSCs. PMID:24350294

Prospective treatment planning to improve locoregional hyperthermia for oesophageal cancer.

PubMed

Kok, H P; van Haaren, P M A; van de Kamer, J B; Zum Vörde Sive Vörding, P J; Wiersma, J; Hulshof, M C C M; Geijsen, E D; van Lanschot, J J B; Crezee, J

2006-08-01

In the Academic Medical Center (AMC) Amsterdam, locoregional hyperthermia for oesophageal tumours is applied using the 70 MHz AMC-4 phased array system. Due to the occurrence of treatment-limiting hot spots in normal tissue and systemic stress at high power, the thermal dose achieved in the tumour can be sub-optimal. The large number of degrees of freedom of the heating device, i.e. the amplitudes and phases of the antennae, makes it difficult to avoid treatment-limiting hot spots by intuitive amplitude/phase steering. Prospective hyperthermia treatment planning combined with high resolution temperature-based optimization was applied to improve hyperthermia treatment of patients with oesophageal cancer. All hyperthermia treatments were performed with 'standard' clinical settings. Temperatures were measured systemically, at the location of the tumour and near the spinal cord, which is an organ at risk. For 16 patients numerically optimized settings were obtained from treatment planning with temperature-based optimization. Steady state tumour temperatures were maximized, subject to constraints to normal tissue temperatures. At the start of 48 hyperthermia treatments in these 16 patients temperature rise (DeltaT) measurements were performed by applying a short power pulse with the numerically optimized amplitude/phase settings, with the clinical settings and with mixed settings, i.e. numerically optimized amplitudes combined with clinical phases. The heating efficiency of the three settings was determined by the measured DeltaT values and the DeltaT-ratio between the DeltaT in the tumour (DeltaToes) and near the spinal cord (DeltaTcord). For a single patient the steady state temperature distribution was computed retrospectively for all three settings, since the temperature distributions may be quite different. To illustrate that the choice of the optimization strategy is decisive for the obtained settings, a numerical optimization on DeltaT-ratio was performed for this patient and the steady state temperature distribution for the obtained settings was computed. A higher DeltaToes was measured with the mixed settings compared to the calculated and clinical settings; DeltaTcord was higher with the mixed settings compared to the clinical settings. The DeltaT-ratio was approximately 1.5 for all three settings. These results indicate that the most effective tumour heating can be achieved with the mixed settings. DeltaT is proportional to the Specific Absorption Rate (SAR) and a higher SAR results in a higher steady state temperature, which implies that mixed settings are likely to provide the most effective heating at steady state as well. The steady state temperature distributions for the clinical and mixed settings, computed for the single patient, showed some locations where temperatures exceeded the normal tissue constraints used in the optimization. This demonstrates that the numerical optimization did not prescribe the mixed settings, because it had to comply with the constraints set to the normal tissue temperatures. However, the predicted hot spots are not necessarily clinically relevant. Numerical optimization on DeltaT-ratio for this patient yielded a very high DeltaT-ratio ( approximately 380), albeit at the cost of excessive heating of normal tissue and lower steady state tumour temperatures compared to the conventional optimization. Treatment planning can be valuable to improve hyperthermia treatments. A thorough discussion on clinically relevant objectives and constraints is essential.

The pre-synaptic vesicle protein synaptotagmin is a novel biomarker for Alzheimer's disease.

PubMed

Öhrfelt, Annika; Brinkmalm, Ann; Dumurgier, Julien; Brinkmalm, Gunnar; Hansson, Oskar; Zetterberg, Henrik; Bouaziz-Amar, Elodie; Hugon, Jacques; Paquet, Claire; Blennow, Kaj

2016-10-03

Synaptic degeneration is a central pathogenic event in Alzheimer's disease that occurs early during the course of disease and correlates with cognitive symptoms. The pre-synaptic vesicle protein synaptotagmin-1 appears to be essential for the maintenance of an intact synaptic transmission and cognitive function. Synaptotagmin-1 in cerebrospinal fluid is a candidate Alzheimer biomarker for synaptic dysfunction that also may correlate with cognitive decline. In this study, a novel mass spectrometry-based assay for measurement of cerebrospinal fluid synaptotagmin-1 was developed, and was evaluated in two independent sample sets of patients and controls. Sample set I included cerebrospinal fluid samples from patients with dementia due to Alzheimer's disease (N = 17, age 52-86 years), patients with mild cognitive impairment due to Alzheimer's disease (N = 5, age 62-88 years), and controls (N = 17, age 41-82 years). Sample set II included cerebrospinal fluid samples from patients with dementia due to Alzheimer's disease (N = 24, age 52-84 years), patients with mild cognitive impairment due to Alzheimer's disease (N = 18, age 58-83 years), and controls (N = 36, age 43-80 years). The reproducibility of the novel method showed coefficients of variation of the measured synaptotagmin-1 peptide 215-223 (VPYSELGGK) and peptide 238-245 (HDIIGEFK) of 14 % or below. In both investigated sample sets, the CSF levels of synaptotagmin-1 were significantly increased in patients with dementia due to Alzheimer's disease (P ≤ 0.0001) and in patients with mild cognitive impairment due to Alzheimer's disease (P < 0.001). In addition, in sample set I the synaptotagmin-1 level was significantly higher in patients with mild cognitive impairment due to Alzheimer's disease compared with patients with dementia due to Alzheimer's disease (P ≤ 0.05). Cerebrospinal fluid synaptotagmin-1 is a promising biomarker to monitor synaptic dysfunction and degeneration in Alzheimer's disease that may be useful for clinical diagnosis, to monitor effect on synaptic integrity by novel drug candidates, and to explore pathophysiology directly in patients with Alzheimer's disease.

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

C6 Spinous Process Fracture in a Young Adult.

PubMed

Watson, Daniel J; Dolbeer, Jeffery A

2017-09-01

A 21-year-old male military academy cadet developed acute posterior neck pain after performing multiple sets of overhead shoulder presses and resting the bar on his lower neck and shoulders. He presented to a direct-access physical therapy clinic. Due to the acute onset and focal nature of pain in the setting of repetitive weightlifting, the physical therapist ordered radiographs of the cervical spine, which revealed a C6 spinous process fracture. J Orthop Sports Phys Ther 2017;47(8):578. doi:10.2519/jospt.2017.7277.

The Neuroanatomy of Autism Spectrum Disorder: An Overview of Structural Neuroimaging Findings and Their Translatability to the Clinical Setting

ERIC Educational Resources Information Center

Ecker, Christine

2017-01-01

Autism spectrum disorder is a complex neurodevelopmental disorder, which is accompanied by differences in brain anatomy, functioning and brain connectivity. Due to its neurodevelopmental character, and the large phenotypic heterogeneity among individuals on the autism spectrum, the neurobiology of autism spectrum disorder is inherently difficult…

Joint Probability Models of Radiology Images and Clinical Annotations

ERIC Educational Resources Information Center

Arnold, Corey Wells

2009-01-01

Radiology data, in the form of images and reports, is growing at a high rate due to the introduction of new imaging modalities, new uses of existing modalities, and the growing importance of objective image information in the diagnosis and treatment of patients. This increase has resulted in an enormous set of image data that is richly annotated…

Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management.

PubMed

Gottrup, F; Apelqvist, J; Price, P

2010-06-01

While there is a consensus that clinical practice should be evidence based, this can be difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group whose remit was to produce recommendations on clinical data collection in wound care. This document, produced by the group and disseminated by JWC, identifies criteria for producing rigorous outcomes in both randomised controlled trials and clinical studies, and describes how to ensure studies are consistent and reproducible.

Setting up of a cerebral visual impairment clinic for children: Challenges and future developments.

PubMed

Philip, Swetha Sara

2017-01-01

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. 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. 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. 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.

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

Potential oxidative stress biomarkers of mild cognitive impairment due to Alzheimer disease.

PubMed

García-Blanco, Ana; Baquero, Miguel; Vento, Máximo; Gil, Esperanza; Bataller, Luis; Cháfer-Pericás, Consuelo

2017-02-15

The high and increasing incidence of Alzheimer Disease (AD) worldwide is a major global concern. Classical diagnosis is carried out in the dementia phase, often in the moderate stages when treatment efficacy is limited. Nowadays, early diagnosis, even in pre-dementia stages, is possible in selected cases within an appropriate clinical setting, employing cerebral spinal fluid (CSF) sample analysis and neuroimaging procedures. In spite of the accurate diagnosis achieved by novel CSF biomarkers or positron emission tomography beta-amyloid tracers, these tests are invasive and expensive. Therefore, important work is being carried out to discover reliable biomarkers in peripheral biofluids (blood, plasma, urine) to be incorporated in clinical routine for early AD diagnosis. Although the nature of AD pathogenesis is complex, it is known that oxidative stress plays a key role, for which biomarkers are easily determined in peripheral biofluids. This review summarizes recent research on oxidative stress biomarkers in mild cognitive impairment due to AD. Among them, a promising research line is the study of the relationship between lipid peroxidation biomarkers and early AD clinical features. Results show a pronounced imbalance between scientific production and clinical reality due to the lack of clinical validation. We conclude that an important field in oxidative stress biomarkers could be developed with the aim to help clinicians in early disease diagnosis, effective treatment initiation and reliable disease monitoring. Copyright © 2017 Elsevier B.V. All rights reserved.

Metabolic vs. hedonic obesity: a conceptual distinction and its clinical implications

PubMed Central

Zhang, Y.; Mechanick, J. I.; Korner, J.; Peterli, R.

2015-01-01

Summary Body weight is determined via both metabolic and hedonic mechanisms. Metabolic regulation of body weight centres around the ‘body weight set point’, which is programmed by energy balance circuitry in the hypothalamus and other specific brain regions. The metabolic body weight set point has a genetic basis, but exposure to an obesogenic environment may elicit allostatic responses and upward drift of the set point, leading to a higher maintained body weight. However, an elevated steady‐state body weight may also be achieved without an alteration of the metabolic set point, via sustained hedonic over‐eating, which is governed by the reward system of the brain and can override homeostatic metabolic signals. While hedonic signals are potent influences in determining food intake, metabolic regulation involves the active control of both food intake and energy expenditure. When overweight is due to elevation of the metabolic set point (‘metabolic obesity’), energy expenditure theoretically falls onto the standard energy–mass regression line. In contrast, when a steady‐state weight is above the metabolic set point due to hedonic over‐eating (‘hedonic obesity’), a persistent compensatory increase in energy expenditure per unit metabolic mass may be demonstrable. Recognition of the two types of obesity may lead to more effective treatment and prevention of obesity. PMID:25588316

Genetic parameters for chronic progressive lymphedema in Belgian Draught Horses.

PubMed

De Keyser, K; Janssens, S; Peeters, L M; Foqué, N; Gasthuys, F; Oosterlinck, M; Buys, N

2014-12-01

Genetic parameters for chronic progressive lymphedema (CPL)-associated traits in Belgian Draught Horses were estimated, using a multitrait animal model. Clinical scores of CPL in the four limbs/horse (CPLclin ), skinfold thickness and hair samples (hair diameter) were studied. Due to CPLclin uncertainty in younger horses (progressive CPL character), a restricted data set (D_3+) was formed, excluding records from horses under 3 years from the complete data set (D_full). Age, gender, coat colour and limb hair pigmentation were included as fixed, permanent environment and date of recording as random effects. Higher CPLclin certainty (D_3+) increased heritability coefficients of, and genetic correlations between traits, with CPLclin heritabilities (SE) for the respective data sets: 0.11 (0.06) and 0.26 (0.05). A large proportion of the CPLclin variance was attributed to the permanent environmental effect in D_full, but less in D_3+. Date of recording explained a proportion of variance from 0.09 ± 0.03 to 0.61 ± 0.08. Additive genetic correlations between CPLclin and both skinfold thickness and hair diameter showed the latter two traits cannot be used as a direct diagnostic aid for CPL. Due to the relatively low heritability of CPLclin , selection should focus on estimated breeding values (from repeated clinical examinations) to reduce CPL occurrence in the Belgian Draught Horse. © 2014 Blackwell Verlag GmbH.

Evaluation of the pre-posterior distribution of optimized sampling times for the design of pharmacokinetic studies.

PubMed

Duffull, Stephen B; Graham, Gordon; Mengersen, Kerrie; Eccleston, John

2012-01-01

Information theoretic methods are often used to design studies that aim to learn about pharmacokinetic and linked pharmacokinetic-pharmacodynamic systems. These design techniques, such as D-optimality, provide the optimum experimental conditions. The performance of the optimum design will depend on the ability of the investigator to comply with the proposed study conditions. However, in clinical settings it is not possible to comply exactly with the optimum design and hence some degree of unplanned suboptimality occurs due to error in the execution of the study. In addition, due to the nonlinear relationship of the parameters of these models to the data, the designs are also locally dependent on an arbitrary choice of a nominal set of parameter values. A design that is robust to both study conditions and uncertainty in the nominal set of parameter values is likely to be of use clinically. We propose an adaptive design strategy to account for both execution error and uncertainty in the parameter values. In this study we investigate designs for a one-compartment first-order pharmacokinetic model. We do this in a Bayesian framework using Markov-chain Monte Carlo (MCMC) methods. We consider log-normal prior distributions on the parameters and investigate several prior distributions on the sampling times. An adaptive design was used to find the sampling window for the current sampling time conditional on the actual times of all previous samples.

A Prediction of Response of the Head and Neck of the U.S. Adult Military Population to Dynamic Impact Acceleration from Selected Dynamic Test Subjects.

DTIC Science & Technology

1976-05-01

to Review Grants for Clinical Research and Investigation Involving Human Beings, Medical School, The University of Michigan. 3 of biomechanical models...human volunteers in dynamic sled tests found no clinically observable effects. due to acceleration on a subject in which the peak mouth angular...minutes cf rest between trials , and the average fo-ce of each set computed. Figure 2.7 shows typi- cal forcc curves and the EMG signal resulting from

Type I allergic hypersensitivity reactions due to ethylene oxide sterilised leucocyte filters in patients with thalassaemia: report of four cases.

PubMed

Belen, Burcu; Polat, Meltem

2015-02-27

Ethylene oxide (EO) is a highly reactive gas used in sterilisation of heat sensitive medical devices, such as infusion sets, cannulae, intubation materials, ventriculoperitoneal shunts, dialysis catheters and stents. Allergic reactions due to EO have been reported in haemodialysis patients, patients undergoing extracorporeal photopheresis and donors of plasmapheresis. Clinical manifestations vary considerably and generally do not allow differentiation between IgE-mediated anaphylaxis and anaphylactoid reactions. We report four patients with thalassaemia who experienced anaphylaxis during transfusion due to ethylene oxide sterilised leucocyte filters. The aim of this report is to highlight the fact that frequently transfused patients can have allergic reactions due to EO particles left in leucocyte filters. 2015 BMJ Publishing Group Ltd.

Use of Smartphones for Clinical and Medical Education.

PubMed

Valle, Jazmine; Godby, Tyler; Paul, David P; Smith, Harlan; Coustasse, Alberto

Smartphone use in clinical settings and in medical education has been on the rise, benefiting both health care and health care providers. Studies have shown, however, that some health care facilities and providers are reluctant to switch to smartphones due to the threat of mixing personal apps with clinical care applications and the possibility that distraction created by smartphone use could lead to medication errors and errors linked to procedures, treatments, or tests. The purpose of this research was to examine the effects of smartphones in a clinical setting and for medical education, to determine their overall impact. The methodology for this qualitative study was a literature review, conducted over five electronic databases. The search was limited to articles published in English, between 2010 and 2016. Forty-one sources that focused on the implementation of and the barriers to use of smartphones in clinical and medical education environments were referenced. These studies revealed that smartphones have more positive than negative effects on the ability to enhance patient care and medical education. Smartphone use is clearly an effective and efficient method of enhancing patient care and medical education in the health care industry. Access to health care as well is enhanced by the use of this tool.

ASCOT: a text mining-based web-service for efficient search and assisted creation of clinical trials

PubMed Central

2012-01-01

Clinical trials are mandatory protocols describing medical research on humans and among the most valuable sources of medical practice evidence. Searching for trials relevant to some query is laborious due to the immense number of existing protocols. Apart from search, writing new trials includes composing detailed eligibility criteria, which might be time-consuming, especially for new researchers. In this paper we present ASCOT, an efficient search application customised for clinical trials. ASCOT uses text mining and data mining methods to enrich clinical trials with metadata, that in turn serve as effective tools to narrow down search. In addition, ASCOT integrates a component for recommending eligibility criteria based on a set of selected protocols. PMID:22595088

ASCOT: a text mining-based web-service for efficient search and assisted creation of clinical trials.

PubMed

Korkontzelos, Ioannis; Mu, Tingting; Ananiadou, Sophia

2012-04-30

Clinical trials are mandatory protocols describing medical research on humans and among the most valuable sources of medical practice evidence. Searching for trials relevant to some query is laborious due to the immense number of existing protocols. Apart from search, writing new trials includes composing detailed eligibility criteria, which might be time-consuming, especially for new researchers. In this paper we present ASCOT, an efficient search application customised for clinical trials. ASCOT uses text mining and data mining methods to enrich clinical trials with metadata, that in turn serve as effective tools to narrow down search. In addition, ASCOT integrates a component for recommending eligibility criteria based on a set of selected protocols.

Creating Clinical Fuzzy Automata with Fuzzy Arden Syntax.

PubMed

de Bruin, Jeroen S; Steltzer, Heinz; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2017-01-01

Formal constructs for fuzzy sets and fuzzy logic are incorporated into Arden Syntax version 2.9 (Fuzzy Arden Syntax). With fuzzy sets, the relationships between measured or observed data and linguistic terms are expressed as degrees of compatibility that model the unsharpness of the boundaries of linguistic terms. Propositional uncertainty due to incomplete knowledge of relationships between clinical linguistic concepts is modeled with fuzzy logic. Fuzzy Arden Syntax also supports the construction of fuzzy state monitors. The latter are defined as monitors that employ fuzzy automata to observe gradual transitions between different stages of disease. As a use case, we re-implemented FuzzyARDS, a previously published clinical monitoring system for patients suffering from acute respiratory distress syndrome (ARDS). Using the re-implementation as an example, we show how key concepts of fuzzy automata, i.e., fuzzy states and parallel fuzzy state transitions, can be implemented in Fuzzy Arden Syntax. The results showed that fuzzy state monitors can be implemented in a straightforward manner.

The Use and Abuse of Diagnostic/Classification Criteria

PubMed Central

June, Rayford R.; Aggarwal, Rohit

2015-01-01

In rheumatic diseases, classification criteria have been developed to identify well-defined homogenous cohorts for clinical research. Although, they are commonly used in clinical practice, their use may not be appropriate for routine diagnostic clinical care. Classification criteria are being revised with improved methodology and further understanding of disease pathophysiology, but still may not encompass all unique clinical situations to be applied for diagnosis of heterogeneous, rare, evolving rheumatic diseases. Diagnostic criteria development is challenging primarily due to difficulty for universal application given significant differences in prevalence of rheumatic diseases based on geographical area and clinic settings. Despite these shortcomings, the clinician can still use classification criteria for understanding the disease as well as a guide for diagnosis with a few caveats. We present the limits of current classification criteria, describe their use and abuse in clinical practice, and how they should be used with caution when applied in clinics. PMID:26096094

Examining the Reliability and Validity of Clinician Ratings on the Five-Factor Model Score Sheet

ERIC Educational Resources Information Center

Few, Lauren R.; Miller, Joshua D.; Morse, Jennifer Q.; Yaggi, Kirsten E.; Reynolds, Sarah K.; Pilkonis, Paul A.

2010-01-01

Despite substantial research use, measures of the five-factor model (FFM) are infrequently used in clinical settings due, in part, to issues related to administration time and a reluctance to use self-report instruments. The current study examines the reliability and validity of the Five-Factor Model Score Sheet (FFMSS), which is a 30-item…

Integrating a Parent-Implemented Blend of Developmental and Behavioral Intervention Strategies into Speech-Language Treatment for Toddlers at Risk for Autism Spectrum Disorder

ERIC Educational Resources Information Center

Rieth, Sarah R.; Haine-Schlagel, Rachel; Burgeson, Marilee; Searcy, Karyn; Dickson, Kelsey S.; Stahmer, Aubyn C.

2018-01-01

Naturalistic developmental behavioral interventions include an explicit focus on coaching parents to use therapy techniques in daily routines and are considered best practice for young children with autism. Unfortunately, these approaches are not widely used in community settings, possibly due to the clinical expertise and training required. This…

Update on the Medical Management of Crohn's Disease.

PubMed

Deepak, Parakkal; Bruining, David H

2015-11-01

The medical management of Crohn's disease is a rapidly evolving field with expanding therapeutic drug options and treatment strategies. In addition to corticosteroids, immunomodulators, and anti-tumor necrosis (anti-TNF) agents, a new anti-adhesion medication (vedolizumab) has been approved. Individualized patient-based dosing of immunomodulators and biologic agents is now possible with therapeutic drug monitoring (TDM). There is a changing paradigm in treatment goals to achieve deeper remission identified by composite clinical and endoscopic endpoints. More aggressive treatment strategies in the postoperative setting have been proposed due to emerging data on medication efficacy in this setting. Management algorithms that stratify CD patients into risk groups to balance treatment benefit against adverse events and costs are being developed to translate research into clinical practice. This review provides an update on these new developments for practicing gastroenterologists.

Perceptions of Support Networks During the Graduate-Assistant Athletic Trainer Experience.

PubMed

Mazerolle, Stephanie M; Clines, Stephanie; Eason, Christianne M; Pitney, William A

2015-12-01

The graduate-assistant position can be a highly influential experience because it is often the first time novice athletic trainers (ATs) are practicing autonomously. To gain an understanding of how graduate-assistant ATs (GAATs) perceive professional socialization and mentorship during their assistantships. Semistructured phone interviews. Graduate-assistant ATs in various clinical settings. Twenty-five GAATs (20 women, 5 men) studying in 1 of 3 academic tracks (postprofessional athletic training = 8, athletic training-based curriculum = 11, non-athletic training-based curriculum = 6). Median age was 24 years. Phone interviews were digitally recorded and transcribed verbatim. Data analysis used principles of the general inductive approach. Credibility was maintained using peer review, field notes, and intercoder reliability. Participants identified peer support throughout their experiences, in both academic and clinical settings. The GAATs frequently relied on other GAATs for support due to shared experiences and understanding of workloads. Participants described difficulty receiving supervisor support from full-time staff ATs due to the supervisors' workload and time constraints, limiting their availability for mentoring. Guidance from academic support personnel occurred only in athletic training-centered academic programs. Communication emerged as helpful for incoming GAATs; the previous GAATs provided formal mentorship via job descriptions highlighting role responsibilities and expectations. Differences between assistantship types were noted only in terms of receiving balanced mentorship between the academic and clinical staffs, such that students studying in postprofessional athletic training programs perceived more balanced support. Our results confirm the literature regarding the GAAT's pursuit of continued formal mentoring. The GAATs perceived less support from full-time AT staff members due to limited availability. Therefore, GAATs leaned on their peers for support during the graduate experience.

Creating an optical spectroscopy system for use in a primary care clinical setting (Conference Presentation)

NASA Astrophysics Data System (ADS)

Eshein, Adam; Nguyen, The-Quyen; Radosevich, Andrew J.; Gould, Bradley; Wu, Wenli; Konda, Vani; Yang, Leslie W.; Koons, Ann; Feder, Seth; Valuckaite, Vesta; Roy, Hemant K.; Backman, Vadim

2016-03-01

While there are a plethora of in-vivo spectroscopic techniques that have demonstrated the ability to detect a number of diseases in research trials, very few techniques have successfully become a fully realized clinical technology. This is primarily due to the stringent demands on a clinical device for widespread implementation. Some of these demands include: simple operation requiring minimal or no training, safe for in-vivo patient use, no disruption to normal clinic workflow, tracking of system performance, warning for measurement abnormality, and meeting all FDA guidelines for medical use. Previously, our group developed a fiber optic probe-based optical sensing technique known as low-coherence enhanced backscattering spectroscopy (LEBS) to quantify tissue ultrastructure in-vivo. Now we have developed this technique for the application of prescreening patients for colonoscopy in a primary care (PC) clinical setting. To meet the stringent requirements for a viable medical device used in a PC clinical setting, we developed several novel components including an automated calibration tool, optical contact sensor for signal acquisition, and a contamination sensor to identify measurements which have been affected by debris. The end result is a state-of-the-art medical device that can be realistically used by a PC physician to assess a person's risk for harboring colorectal precancerous lesions. The pilot study of this system shows great promise with excellent stability and accuracy in identifying high-risk patients. While this system has been designed and optimized for our specific application, the system and design concepts are universal to most in-vivo fiber optic based spectroscopic techniques.

Cost-effectiveness of point-of-care viral load monitoring of antiretroviral therapy in resource-limited settings: mathematical modelling study.

PubMed

Estill, Janne; Egger, Matthias; Blaser, Nello; Vizcaya, Luisa Salazar; Garone, Daniela; Wood, Robin; Campbell, Jennifer; Hallett, Timothy B; Keiser, Olivia

2013-06-01

Monitoring of HIV viral load in patients on combination antiretroviral therapy (ART) is not generally available in resource-limited settings. We examined the cost-effectiveness of qualitative point-of-care viral load tests (POC-VL) in sub-Saharan Africa. Mathematical model based on longitudinal data from the Gugulethu and Khayelitsha township ART programmes in Cape Town, South Africa. Cohorts of patients on ART monitored by POC-VL, CD4 cell count or clinically were simulated. Scenario A considered the more accurate detection of treatment failure with POC-VL only, and scenario B also considered the effect on HIV transmission. Scenario C further assumed that the risk of virologic failure is halved with POC-VL due to improved adherence. We estimated the change in costs per quality-adjusted life-year gained (incremental cost-effectiveness ratios, ICERs) of POC-VL compared with CD4 and clinical monitoring. POC-VL tests with detection limits less than 1000 copies/ml increased costs due to unnecessary switches to second-line ART, without improving survival. Assuming POC-VL unit costs between US$5 and US$20 and detection limits between 1000 and 10,000 copies/ml, the ICER of POC-VL was US$4010-US$9230 compared with clinical and US$5960-US$25540 compared with CD4 cell count monitoring. In Scenario B, the corresponding ICERs were US$2450-US$5830 and US$2230-US$10380. In Scenario C, the ICER ranged between US$960 and US$2500 compared with clinical monitoring and between cost-saving and US$2460 compared with CD4 monitoring. The cost-effectiveness of POC-VL for monitoring ART is improved by a higher detection limit, by taking the reduction in new HIV infections into account and assuming that failure of first-line ART is reduced due to targeted adherence counselling.

Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

PubMed

Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

2018-03-05

The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

Real-World Clinical Efficacy and Tolerability of Direct-Acting Antivirals in Hepatitis C Monoinfection Compared to Hepatitis C/HIV Coinfection in a Community Care Setting.

PubMed

Vijay, Gayam; Rajib, Hossain Muhammad; Mazin, Khalid; Sandipan, Chakaraborty; Osama, Mukhtar; Sumit, Dahal; Amrendra Kumar, Mandal; Arshpal, Gill; Pavani, Garlapati; Ramakrishnaiah, Sreedevi; Khalid, Mowyad; Jagannath, Sherigar; Mohammed, Mansour; Smruti, Mohanty

2018-06-22

Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR 12) after treatment, and adverse reactions were compared between the groups. A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR 12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. In a real-world setting, DAA regimens have lower SVR 12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response.

Development and implementation of sepsis alert systems

PubMed Central

Harrison, Andrew M.; Gajic, Ognjen; Pickering, Brian W.; Herasevich, Vitaly

2016-01-01

Synopsis/Summary Development and implementation of sepsis alert systems is challenging, particularly outside the monitored intensive care unit (ICU) setting. Important barriers to wider use of sepsis alerts include evolving clinical definitions of sepsis, information overload & alert fatigue, due to suboptimal alert performance. Outside the ICU, additional barriers include differences in health care delivery models, charting behaviors, and availability of electronic data. Currently available evidence does not support routine use of sepsis alert systems in clinical practice. However, continuous improvement in both the afferent (data availability and accuracy of detection algorithms) and efferent (evidence-based decision support and smoother integration into clinical workflow) limbs of sepsis alert systems will help translate theoretical advantages into measurable patient benefit. PMID:27229639

Looking beyond historical patient outcomes to improve clinical models.

PubMed

Chia, Chih-Chun; Rubinfeld, Ilan; Scirica, Benjamin M; McMillan, Sean; Gurm, Hitinder S; Syed, Zeeshan

2012-04-25

Conventional algorithms for modeling clinical events focus on characterizing the differences between patients with varying outcomes in historical data sets used for the model derivation. For many clinical conditions with low prevalence and where small data sets are available, this approach to developing models is challenging due to the limited number of positive (that is, event) examples available for model training. Here, we investigate how the approach of developing clinical models might be improved across three distinct patient populations (patients with acute coronary syndrome enrolled in the DISPERSE2-TIMI33 and MERLIN-TIMI36 trials, patients undergoing inpatient surgery in the National Surgical Quality Improvement Program registry, and patients undergoing percutaneous coronary intervention in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry). For each of these cases, we supplement an incomplete characterization of patient outcomes in the derivation data set (uncensored view of the data) with an additional characterization of the extent to which patients differ from the statistical support of their clinical characteristics (censored view of the data). Our approach exploits the same training data within the derivation cohort in multiple ways to improve the accuracy of prediction. We position this approach within the context of traditional supervised (2-class) and unsupervised (1-class) learning methods and present a 1.5-class approach for clinical decision-making. We describe a 1.5-class support vector machine (SVM) classification algorithm that implements this approach, and report on its performance relative to logistic regression and 2-class SVM classification with cost-sensitive weighting and oversampling. The 1.5-class SVM algorithm improved prediction accuracy relative to other approaches and may have value in predicting clinical events both at the bedside and for risk-adjusted quality of care assessment.

[Hypophosphatasia: Clinical manifestations, diagnostic recommendations and therapeutic options].

PubMed

Martos-Moreno, Gabriel A; Calzada, Joan; Couce, María L; Argente, Jesús

2018-06-01

Hypophosphatasia is a very rare bone metabolism disorder caused by a deficiency in alkaline phosphatase activity, due to mutations in the ALPL gene. Its clinical hallmark is the impairment of skeletal and teeth mineralisation, although extra-skeletal manifestations are frequent. Its phenotypic spectrum is widely variable from a subtype with exclusive odontological impairment (odontohypophosphatasia) to five subtypes with systemic involvement, classified according to the age at the onset of the first symptoms (four of them in the paediatric age range: perinatal lethal, perinatal benign, infant and childhood hypophosphatasia). Those subtypes of hypophosphatasia with an earliest onset usually involve a worse prognosis, due to the risk of developing potentially lethal complications, such as seizures or severe respiratory insufficiency, secondary to rib cage malformations. Due to the extremely low prevalence of the severe forms of hypophosphatasia, its clinical variability and overlapping phenotypic features with several more prevalent conditions, the diagnosis of hypophosphatasia in the clinical setting is challenging. However, its potential lethality and impact on the patient's quality of life, along with the recent availability of an enzyme replacement therapy, increases the relevance of the early and accurate identification of patients affected with hypophosphatasia. On the basis of published evidence and clinical experience, this article suggests an algorithm with practical recommendations for the differential diagnosis of childhood hypophosphatasia, as well as an updated review of current therapeutic options. Copyright © 2017 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

A Crowdsourcing Framework for Medical Data Sets.

PubMed

Ye, Cheng; Coco, Joseph; Epishova, Anna; Hajaj, Chen; Bogardus, Henry; Novak, Laurie; Denny, Joshua; Vorobeychik, Yevgeniy; Lasko, Thomas; Malin, Bradley; Fabbri, Daniel

2018-01-01

Crowdsourcing services like Amazon Mechanical Turk allow researchers to ask questions to crowds of workers and quickly receive high quality labeled responses. However, crowds drawn from the general public are not suitable for labeling sensitive and complex data sets, such as medical records, due to various concerns. Major challenges in building and deploying a crowdsourcing system for medical data include, but are not limited to: managing access rights to sensitive data and ensuring data privacy controls are enforced; identifying workers with the necessary expertise to analyze complex information; and efficiently retrieving relevant information in massive data sets. In this paper, we introduce a crowdsourcing framework to support the annotation of medical data sets. We further demonstrate a workflow for crowdsourcing clinical chart reviews including (1) the design and decomposition of research questions; (2) the architecture for storing and displaying sensitive data; and (3) the development of tools to support crowd workers in quickly analyzing information from complex data sets.

LexValueSets: An Approach for Context-Driven Value Sets Extraction

PubMed Central

Pathak, Jyotishman; Jiang, Guoqian; Dwarkanath, Sridhar O.; Buntrock, James D.; Chute, Christopher G.

2008-01-01

The ability to model, share and re-use value sets across multiple medical information systems is an important requirement. However, generating value sets semi-automatically from a terminology service is still an unresolved issue, in part due to the lack of linkage to clinical context patterns that provide the constraints in defining a concept domain and invocation of value sets extraction. Towards this goal, we develop and evaluate an approach for context-driven automatic value sets extraction based on a formal terminology model. The crux of the technique is to identify and define the context patterns from various domains of discourse and leverage them for value set extraction using two complementary ideas based on (i) local terms provided by the Subject Matter Experts (extensional) and (ii) semantic definition of the concepts in coding schemes (intensional). A prototype was implemented based on SNOMED CT rendered in the LexGrid terminology model and a preliminary evaluation is presented. PMID:18998955

[Perioperative onset of sarcoidosis : Rare differential diagnosis of a difficult airway].

PubMed

Jansen, G; Nowak, A

2018-05-01

Sarcoidosis is a rare multisystemic chronic inflammatory condition. Typically, there is a big discrepancy between the patient's subjectively perceived symptoms and the presence of clinical signs. Due to the high number of potential sites of onset (e. g. larynx, lungs, heart, liver, kidneys) the affected organs may show functional restrictions that are relevant for decisions related to anesthesia. Therefore, an anesthetists working in a clinical setting should be familiar with the special needs of this patient collective. This article describes the onset of sarcoidosis in a case of an unexpected difficult airway.

Image-guided surgery using near-infrared fluorescent light: from bench to bedside

NASA Astrophysics Data System (ADS)

Boogerd, Leonora S. F.; Handgraaf, Henricus J. M.; van de Velde, Cornelis J. H.; Vahrmeijer, Alexander L.

2015-03-01

Due to its relatively high tissue penetration, near-infrared (NIR; 700-900 nm) fluorescent light has the potential to visualize structures that need to be resected (e.g. tumors, lymph nodes) and structures that need to be spared (e.g. nerves, ureters, bile ducts). Until now, most clinical trials have focused on suboptimal, non-targeted dyes. Although successful, a new era in image-guided surgery has begun by the introduction of tumor-targeted agents. In this paper, we will describe how tumor-targeted NIR fluorescent imaging can be applied in a clinical setting.

Development and Implementation of Sepsis Alert Systems.

PubMed

Harrison, Andrew M; Gajic, Ognjen; Pickering, Brian W; Herasevich, Vitaly

2016-06-01

Development and implementation of sepsis alert systems is challenging, particularly outside the monitored intensive care unit (ICU) setting. Barriers to wider use of sepsis alerts include evolving clinical definitions of sepsis, information overload, and alert fatigue, due to suboptimal alert performance. Outside the ICU, barriers include differences in health care delivery models, charting behaviors, and availability of electronic data. Current evidence does not support routine use of sepsis alert systems in clinical practice. Continuous improvement in the afferent and efferent aspects will help translate theoretic advantages into measurable patient benefit. Copyright © 2016 Elsevier Inc. All rights reserved.

[Efficacy of high-frequency cinematography in diagnosis of dysphagia].

PubMed

Oelerich, M; Mai, R; Müller-Miny, H; Peters, P E

1995-10-01

Dysphagia is a common symptom in clinical practice. Due to the broad spectrum of underlying diseases many disciplines are involved in the therapy and diagnosis of dysphagia, where radiology plays a central role. The radiologist is confronted with different diagnostic problems and has to choose the most appropriate type of investigation. In many cases no organic disorder can be demonstrated by clinical examination, endoscopy or conventional radiological techniques. In this setting cineradiography is an outstanding tool for finding functional or structural changes in the swallowing chain. This study underlines the efficiency of cineradiography in the diagnosis of dysphagia.

Not the Usual Viral Suspects: Parvovirus B19, West Nile Virus, and Human T-Cell Lymphotrophic Virus Infections After Kidney Transplantation.

PubMed

Razonable, Raymund R

2016-09-01

Kidney transplant recipients are at increased risk of developing clinical disease due to uncommon opportunistic viral pathogens. Refractory anemia is classically associated with parvovirus B19 infection. West Nile virus has the propensity to cause fever and neurologic symptoms, while spastic paresis and lymphoma can be triggered by human T cell lymphotrophic virus. In this review article, the epidemiology, clinical manifestations, diagnosis and treatment of less common viruses are discussed in the setting of kidney transplantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of Children with Selective Mutism and Social Phobia: A Comparison of Psychological and Psychophysiological Arousal

ERIC Educational Resources Information Center

Young, Brennan J.; Bunnell, Brian E.; Beidel, Deborah C.

2012-01-01

Although children with social phobia (SP) and selective mutism (SM) present similarly in a clinical setting, it remains unclear whether children with SM are unable to speak due to overwhelming anxiety, or whether withholding speech functions as an avoidance mechanism. A total of 35 children (ages 5-12 years) with either SM (n = 10), SP (n = 11),…

Mindfulness Meditation for Adolescent Stress and Well-Being: A Systematic Review of the Literature with Implications for School Health Programs

ERIC Educational Resources Information Center

Erbe, Ryan; Lohrmann, David

2015-01-01

Stress poses one of the biggest threats to the health and well-being of young people. Adolescents are especially vulnerable to the negative effects of stress due to developmental factors. Recently, Mindfulness Meditation (MM) programs have been implemented into both clinical and school-based settings to reduce stress and promote the health of…

The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies.

PubMed

Poljak, Mario; Oštrbenk, Anja

2013-01-01

Human papillomavirus (HPV) testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. We reviewed the most important validation studies of a next-generation real-time polymerase chain reaction-based assay, the RealTime High Risk HPV test (RealTime)(Abbott Molecular, Des Plaines, IL, USA), for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older published in peer-reviewed journals from 2009 to 2013. RealTime is designed to detect 14 high-risk HPV genotypes with concurrent distinction of HPV-16 and HPV-18 from 12 other HPV genotypes. The test was launched on the European market in January 2009 and is currently used in many laboratories worldwide for routine detection of HPV. We concisely reviewed validation studies of a next-generation real-time polymerase chain reaction (PCR)-based assay: the Abbott RealTime High Risk HPV test. Eight validation studies of RealTime in referral settings showed its consistently high absolute clinical sensitivity for both CIN2+ (range 88.3-100%) and CIN3+ (range 93.0-100%), as well as comparative clinical sensitivity relative to the currently most widely used HPV test: the Qiagen/Digene Hybrid Capture 2 HPV DNA Test (HC2). Due to the significantly different composition of the referral populations, RealTime absolute clinical specificity for CIN2+ and CIN3+ varied greatly across studies, but was comparable relative to HC2. Four validation studies of RealTime performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, as well as comparative clinical sensitivity and specificity relative to HC2 and GP5+/6+ PCR. RealTime has been extensively evaluated in the last 4 years. RealTime can be considered clinically validated for triage in referral population settings and for use in primary cervical cancer screening in women 30 years and older.

Development of a brief instrument to measure smartphone addiction among nursing students.

PubMed

Cho, Sumi; Lee, Eunjoo

2015-05-01

Interruptions and distractions due to smartphone use in healthcare settings pose potential risks to patient safety. Therefore, it is important to assess smartphone use at work, to encourage nursing students to review their relevant behaviors, and to recognize these potential risks. This study's aim was to develop a scale to measure smartphone addiction and test its validity and reliability. We investigated nursing students' experiences of distractions caused by smartphones in the clinical setting and their opinions about smartphone use policies. Smartphone addiction and the need for a scale to measure it were identified through a literature review and in-depth interviews with nursing students. This scale showed reliability and validity with exploratory and confirmatory factor analysis. In testing the discriminant and convergent validity of the selected (18) items with four factors, the smartphone addiction model explained approximately 91% (goodness-of-fit index = 0.909) of the variance in the data. Pearson correlation coefficients among addiction level, distractions in the clinical setting, and attitude toward policies on smartphone use were calculated. Addiction level and attitude toward policies of smartphone use were negatively correlated. This study suggests that healthcare organizations in Korea should create practical guidelines and policies for the appropriate use of smartphones in clinical practice.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

PubMed

Jones, Christine E; Munoz, Flor M; Spiegel, Hans M L; Heininger, Ulrich; Zuber, Patrick L F; Edwards, Kathryn M; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T

2016-12-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. Copyright © 2016. Published by Elsevier Ltd.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

PubMed Central

Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

2017-01-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

Multi-resistant aspergillosis due to cryptic species.

PubMed

Howard, Susan Julie

2014-12-01

Reports of cryptic species causing aspergillosis in humans are increasing in the literature. Cryptic species are defined as those which are morphologically indistinguishable, although their identifications can be confirmed using molecular or other techniques which continue to become more widely available in the clinical setting. Antifungal resistance has often been noted in these cases, and indeed there does appear to be a higher prevalence of reduced susceptibility in cryptic species. Many of these observations are published as individual case reports or as a small component of larger data sets, making it challenging to review and compare the data fully. This review article seeks to describe the susceptibility trends and key learning outcomes of specific cases of infections caused by cryptic species, including Aspergillus alliaceus, Aspergillus calidoustus, Aspergillus felis, Aspergillus lentulus, Aspergillus tubingensis, Aspergillus viridinutans and Neosartorya pseudofischeri. These reports highlight the clinical need for full accurate identification and susceptibility testing to guide patient care.

Supportive relationship: Experiences of Iranian students and teachers concerning student-teacher relationship in clinical nursing education

PubMed Central

Heydari, Abbas; Yaghoubinia, Fariba; Roudsari, Robab Latifnejad

2013-01-01

Background: Student-teacher relationship is a salient issue in nursing education and has long-lasting implication in professional development of nursing students. Nowadays, this relationship in clinical settings is different from the past due to changing in nursing education paradigm. The purpose of this qualitative study was to explore the experiences of students and teachers about student-teacher relationship in the context of clinical nursing education in Iran. Materials and Methods: In this qualitative study that has been carried out adopting conventional qualitative content analysis approach, six bachelor nursing students and six clinical teachers in school of Nursing and Midwifery, were selected through purposive sampling. Semi-structured interview and participant observation were used for data collection. Interviews transcribed verbatim and analyzed using conventional content analysis through the process of data reduction and condensation, coding and also generating the categories and themes. Results: Results of the study showed the existence of a type of relationship in clinical education in which supportive actions of clinical teachers were prominent. These supportive actions appeared as three major categories including educational support, emotional support and social support which emerged from data. Conclusion: The results of this study explicit the ways that support could be provided for students in their relationship with clinical teachers. It also determines the teachers’ need to know more about the influence of their supportive relationship on students’ learning and the best possible outcomes of their education in clinical settings. PMID:24554945

Supportive relationship: Experiences of Iranian students and teachers concerning student-teacher relationship in clinical nursing education.

PubMed

Heydari, Abbas; Yaghoubinia, Fariba; Roudsari, Robab Latifnejad

2013-11-01

Student-teacher relationship is a salient issue in nursing education and has long-lasting implication in professional development of nursing students. Nowadays, this relationship in clinical settings is different from the past due to changing in nursing education paradigm. The purpose of this qualitative study was to explore the experiences of students and teachers about student-teacher relationship in the context of clinical nursing education in Iran. In this qualitative study that has been carried out adopting conventional qualitative content analysis approach, six bachelor nursing students and six clinical teachers in school of Nursing and Midwifery, were selected through purposive sampling. Semi-structured interview and participant observation were used for data collection. Interviews transcribed verbatim and analyzed using conventional content analysis through the process of data reduction and condensation, coding and also generating the categories and themes. Results of the study showed the existence of a type of relationship in clinical education in which supportive actions of clinical teachers were prominent. These supportive actions appeared as three major categories including educational support, emotional support and social support which emerged from data. The results of this study explicit the ways that support could be provided for students in their relationship with clinical teachers. It also determines the teachers' need to know more about the influence of their supportive relationship on students' learning and the best possible outcomes of their education in clinical settings.

Statin-Induced Cardioprotection Against Ischemia-Reperfusion Injury: Potential Drug-Drug Interactions. Lesson to be Learnt by Translating Results from Animal Models to the Clinical Settings.

PubMed

Birnbaum, Gilad D; Birnbaum, Itamar; Ye, Yumei; Birnbaum, Yochai

2015-01-01

Numerous interventions have been shown to limit myocardial infarct size in animal models; however, most of these interventions have failed to have a significant effect in clinical trials. One potential explanation for the lack of efficacy in the clinical setting is that in bench models, a single intervention is studied without the background of other interventions or modalities. This is in contrast to the clinical setting in which new medications are added to the "standard of care" treatment that by now includes a growing number of medications. Drug-drug interaction may lead to alteration, dampening, augmenting or masking the effects of the intended intervention. We use the well described model of statin-induced myocardial protection to demonstrate potential interactions with agents which are commonly concomitantly used in patients with stable coronary artery disease and/or acute coronary syndromes. These interactions could potentially explain the reduced efficacy of statins in the clinical trials compared to the animal models. In particular, caffeine and aspirin could attenuate the infarct size limiting effects of statins; morphine could delay the onset of protection or mask the protective effect in patients with ST elevation myocardial infarction, whereas other anti-platelet agents (dipyridamole, cilostazol and ticagrelor) may augment (or mask) the effect due to their favorable effects on adenosine cell reuptake and intracellular cAMP levels. We recommend that after characterizing the effects of new modalities in single intervention bench research, studies should be repeated in the background of standard-of-care medications to assure that the magnitude of the effect is not altered before proceeding with clinical trials.

Determination of Isavuconazole Susceptibility of Aspergillus and Candida Species by the EUCAST Method

PubMed Central

Howard, Susan J.; Lass-Flörl, Cornelia; Cuenca-Estrella, Manuel; Gomez-Lopez, Alicia

2013-01-01

Isavuconazole is a novel expanded-spectrum triazole, which has recently been approved by the FDA as an orphan drug to treat invasive aspergillosis and is currently being studied in phase III clinical trials for invasive candidiasis. The susceptibility of relatively few clinical isolates has been reported. In this study, the isavuconazole susceptibilities of 1,237 Aspergillus and 2,010 Candida geographically diverse clinical isolates were determined by EUCAST methodology at four European mycology laboratories, producing the largest multicenter data set thus far for this compound. In addition, a blinded collection of 30 cyp51A mutant Aspergillus fumigatus clinical isolates and 10 wild-type isolates was tested. From these two data sets, the following preliminary epidemiological cutoff (ECOFF) values were suggested: 2 mg/liter for Aspergillus fumigatus, Aspergillus terreus, and Aspergillus flavus; 4 mg/liter for Aspergillus niger; 0.25 mg/liter for Aspergillus nidulans; and 0.03 mg/liter for Candida albicans, Candida parapsilosis, and Candida tropicalis. Unfortunately, ECOFFs could not be determined for Candida glabrata or Candida krusei due to an unexplained interlaboratory MIC variation. For the blinded collection of A. fumigatus isolates, all MICs were ≤2 mg/liter for wild-type isolates. Differential isavuconazole MICs were observed for triazole-resistant A. fumigatus isolates with different cyp51A alterations: TR34/L98H mutants had elevated isavuconazole MICs, whereas isolates with G54 and M220 alterations had MICs in the wild-type range, suggesting that the efficacy of isavuconazole may not be affected by these alterations. This study will be an aid in interpreting isavuconazole MICs for clinical care and an important step in the future process of setting official clinical breakpoints. PMID:23959309

Strategies for Conducting Adolescent Health Research in the Clinical Setting: The Mount Sinai Adolescent Health Center HPV Experience

PubMed Central

Braun-Courville, Debra K.; Schlecht, Nicolas F.; Burk, Robert D.; Strickler, Howard D.; Rojas, Mary; Lorde-Rollins, Elizabeth; Nucci-Sack, Anne; Hollman, Dominic; Linares, L. Oriana; Diaz, Angela

2013-01-01

Background Clinical research with adolescents can be challenging due to issues of informed consent, parental involvement, institutional review board requirements, and adolescent psychosocial development. This presents a dilemma, particularly in the area of sexual health research, as adolescents are disproportionately affected by sexually transmitted infections such as human papillomavirus (HPV). To successfully conduct adolescent research in the clinical setting, one requires an awareness of state statutes regarding adolescent confidentiality and consent for medical care, and a close partnership with the IRB. Case Study In 2007, the Mount Sinai Adolescent Health Center (MSAHC) in collaboration with the Albert Einstein College of Medicine developed a longitudinal research study to examine the natural history of oral, cervical, and anal HPV in an adolescent female population engaged in high-risk sexual behaviors. We use this research project as a case study to explore the ethical, methodological, and clinical issues related to conducting adolescent health research. Summary and Conclusions Several strategies were identified to promote adolescent study participation, including: (1) building a research team that is motivated to work with adolescents; (2) combining research and patient care visits to avoid duplication of services; and (3) establishing a personalized communication network with participants. Using these methods, adolescent sexual health research can successfully be integrated into the clinical setting. While retaining a prospective cohort of adolescents has its challenges, a persistent and multi-disciplinary approach can help improve recruitment, sustain participation, and acquire critical data that will lead to improved healthcare knowledge applicable to understudied populations of adolescents. PMID:24332677

What do eye movements tell us about patients with neurological disorders? — An introduction to saccade recording in the clinical setting —

PubMed Central

TERAO, Yasuo; FUKUDA, Hideki; HIKOSAKA, Okihide

2017-01-01

Non-invasive and readily implemented in the clinical setting, eye movement studies have been conducted extensively not only in healthy human subjects but also in patients with neurological disorders. The purpose of saccade studies is to “read out” the pathophysiology underlying neurological disorders from the saccade records, referring to known primate physiology. In the current review, we provide an overview of studies in which we attempted to elucidate the patterns of saccade abnormalities in over 250 patients with neurological disorders, including cerebellar ataxia and brainstem pathology due to neurodegenerative disorders, and what they tell about the pathophysiology of patients with neurological disorders. We also discuss how interventions, such as deep brain stimulation, affect saccade performance and provide further insights into the workings of the oculomotor system in humans. Finally, we argue that it is important to understand the functional significance and behavioral correlate of saccade abnormalities in daily life, which could require eye tracking methodologies to be performed in settings similar to daily life. PMID:29225306

A quantitative assessment of alkaptonuria: testing the reliability of two disease severity scoring systems.

PubMed

Cox, Trevor F; Ranganath, Lakshminarayan

2011-12-01

Alkaptonuria (AKU) is due to excessive homogentisic acid accumulation in body fluids due to lack of enzyme homogentisate dioxygenase leading in turn to varied clinical manifestations mainly by a process of conversion of HGA to a polymeric melanin-like pigment known as ochronosis. A potential treatment, a drug called nitisinone, to decrease formation of HGA is available. However, successful demonstration of its efficacy in modifying the natural history of AKU requires an effective quantitative assessment tool. We have described two potential tools that could be used to quantitate disease burden in AKU. One tool describes scoring the clinical features that includes clinical assessments, investigations and questionnaires in 15 patients with AKU. The second tool describes a scoring system that only includes items obtained from questionnaires used in 44 people with AKU. Statistical analyses were carried out on the two patient datasets to assess the AKU tools; these included the calculation of Chronbach's alpha, multidimensional scaling and simple linear regression analysis. The conclusion was that there was good evidence that the tools could be adopted as AKU assessment tools, but perhaps with further refinement before being used in the practical setting of a clinical trial.

Experimental/clinical evaluation of EIT image reconstruction with l1 data and image norms

NASA Astrophysics Data System (ADS)

Mamatjan, Yasin; Borsic, Andrea; Gürsoy, Doga; Adler, Andy

2013-04-01

Electrical impedance tomography (EIT) image reconstruction is ill-posed, and the spatial resolution of reconstructed images is low due to the diffuse propagation of current and limited number of independent measurements. Generally, image reconstruction is formulated using a regularized scheme in which l2 norms are preferred for both the data misfit and image prior terms due to computational convenience which result in smooth solutions. However, recent work on a Primal Dual-Interior Point Method (PDIPM) framework showed its effectiveness in dealing with the minimization problem. l1 norms on data and regularization terms in EIT image reconstruction address both problems of reconstruction with sharp edges and dealing with measurement errors. We aim for a clinical and experimental evaluation of the PDIPM method by selecting scenarios (human lung and dog breathing) with known electrode errors, which require a rigorous regularization and cause the failure of reconstructions with l2 norm. Results demonstrate the applicability of PDIPM algorithms, especially l1 data and regularization norms for clinical applications of EIT showing that l1 solution is not only more robust to measurement errors in clinical setting, but also provides high contrast resolution on organ boundaries.

Blood Tests for People with Severe Learning Disabilities Receiving Dental Treatment under General Anaesthesia.

PubMed

Clough, Stacey; Shehabi, Zahra; Morgan, Claire; Sheppey, Claire

2016-11-01

People with learning disabilities (LDs) have poorer health than their non-disabled peers due to failures in reasonable adjustments. One hundred patients with severe LD and challenging behaviour attended for dental treatment under GA, during which routine blood testing was provided. Communication with general medical practitioners (GMPs) and blood test results were evaluated, showing poor communication with GMPs and significant undiagnosed disease among this group. Blood tests generate similar costs in primary and secondary care but a holistic approach to care under GA reduces expenses brought by lost clinical time and resources due to complex behaviours in an out-patient setting. Clinical relevance: This article discusses a holistic approach to healthcare for people with severe LD, including patient outcomes, financial and resource implications, and offers practical guidance on venepuncture technique, which is relevant to many aspects of both community and hospital dental practice.

Mild cognitive impairment: Profile of a cohort from a private sector memory clinic.

PubMed

Srinivasan, Srikanth

2014-07-01

Private hospital memory clinics might see a different clientele than university or academic institutes due to referral biases. To characterize the profile of patients with mild cognitive impairment (MCI) from a private sector memory clinic. MCI was diagnosed according to revised clinical criteria of Petersen et al. For a subset of patients with MCI medial temporal atrophy and cerebral small vessel disease (white matter lesions and lacunes) were rated on magnetic resonance imaging (MRI) scans and analyzed for their contribution towards cognitive impairment. Subjects with MCI formed one-third (113/371) of this memory clinic sample from a private hospital. MCI could be effectively diagnosed and subtyped using a brief cognitive scale (Concise Cognitive Test (CONCOG)). The amnestic MCI (single and multiple domains) subtype comprised the majority of cases with MCI. In a subsample of 33 patients, lacunar infarcts were more common than white matter lesions and hippocampal atrophy and were inversely associated with verbal fluency. MCI may be more commonly encountered in private hospital settings probably due to early referrals. It is possible to diagnose and subtype MCI using a brief cognitive instrument such as the CONCOG. In this sample, lacunar infarcts were more commonly encountered than medial temporal atrophy in such patients.

Case Study: Applying OpenEHR Archetypes to a Clinical Data Repository in a Chinese Hospital.

PubMed

Min, Lingtong; Wang, Li; Lu, Xudong; Duan, Huilong

2015-01-01

openEHR is a flexible and scalable modeling methodology for clinical information and has been widely adopted in Europe and Australia. Due to the reasons of differences in clinical process and management, there are few research projects involving openEHR in China. To investigate the feasibility of openEHR methodology for clinical information modelling in China, this paper carries out a case study to apply openEHR archetypes to Clinical Data Repository (CDR) in a Chinese hospital. The results show that a set of 26 archetypes are found to cover all the concepts used in the CDR. Of all these, 9 (34.6%) are reused without change, 10 are modified and/or extended, and 7 are newly defined. The reasons for modification, extension and newly definition have been discussed, including granularity of archetype, metadata-level versus data-level modelling, and the representation of relationships between archetypes.

Polyamidoamine Dendrimers for Enhanced Solubility of Small Molecules and Other Desirable Properties for Site Specific Delivery: Insights from Experimental and Computational Studies.

PubMed

Shadrack, Daniel M; Swai, Hulda S; Munissi, Joan J E; Mubofu, Egid B; Nyandoro, Stephen S

2018-06-12

Clinical applications of many small molecules are limited due to poor solubility and lack of controlled release besides lack of other desirable properties. Experimental and computational studies have reported on the therapeutic potential of polyamidoamine (PAMAM) dendrimers as solubility enhancers in pre-clinical and clinical settings. Besides formulation strategies, factors such as pH, PAMAM dendrimer generation, PAMAM dendrimer concentration, nature of the PAMAM core, special ligand and surface modifications of PAMAM dendrimer have an influence on drug solubility and other recommendable pharmacological properties. This review, therefore, compiles the recently reported applications of PAMAM dendrimers in pre-clinical and clinical uses as enhancers of solubility and other desirable properties such as sustained and controlled release, bioavailability, bio-distribution, toxicity reduction or enhancement, and targeted delivery of small molecules with emphasis on cancer treatment.

Sub-Optimal Treatment of Bacterial Biofilms

PubMed Central

Song, Tianyan; Duperthuy, Marylise; Wai, Sun Nyunt

2016-01-01

Bacterial biofilm is an emerging clinical problem recognized in the treatment of infectious diseases within the last two decades. The appearance of microbial biofilm in clinical settings is steadily increasing due to several reasons including the increased use of quality of life-improving artificial devices. In contrast to infections caused by planktonic bacteria that respond relatively well to standard antibiotic therapy, biofilm-forming bacteria tend to cause chronic infections whereby infections persist despite seemingly adequate antibiotic therapy. This review briefly describes the responses of biofilm matrix components and biofilm-associated bacteria towards sub-lethal concentrations of antimicrobial agents, which may include the generation of genetic and phenotypic variabilities. Clinical implications of bacterial biofilms in relation to antibiotic treatments are also discussed. PMID:27338489

ERP (enterprise resource planning) systems can streamline healthcare business functions.

PubMed

Jenkins, E K; Christenson, E

2001-05-01

Enterprise resource planning (ERP) software applications are designed to facilitate the systemwide integration of complex processes and functions across a large enterprise consisting of many internal and external constituents. Although most currently available ERP applications generally are tailored to the needs of the manufacturing industry, many large healthcare systems are investigating these applications. Due to the significant differences between manufacturing and patient care, ERP-based systems do not easily translate to the healthcare setting. In particular, the lack of clinical standardization impedes the use of ERP systems for clinical integration. Nonetheless, an ERP-based system can help a healthcare organization integrate many functions, including patient scheduling, human resources management, workload forecasting, and management of workflow, that are not directly dependent on clinical decision making.

Ureteric Embolization for Lower Urinary Tract Fistulae: Use of Two Amplatzer Vascular Plugs and N-Butyl Cyanoacrylate Employing the 'Sandwich' Technique

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

Saad, Wael E. A., E-mail: ws6r@virginia.edu; Kalagher, S.; Turba, U. C.

2013-08-01

PurposeThis study describes and evaluated the effectiveness of occluding distal ureters in the clinical setting of urinary vaginal (vesicovaginal or enterovesicovaginal) fistulae utilizing a new technique which combines Amplatzer vascular plugs and N-butyl cyanoacrylate.MaterialsThis is a retrospective study (January 2007-December 2010) of patients with urinary-vaginal fistulae undergoing distal ureter embolization utilizing an Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique. An 8-12-mm type-I or type-II Amplatzer vascular plug was delivered using the sheath and deployed in the ureter distal to the pelvic brim. Instillation of 0.8-1.5 cc of N-butyl cyanoacrylate into ureter proximal to the Amplatzer plug was performed. This was followed bymore » another set of 8-12-mm type-I or type-II Amplatzer vascular plugs in a technique referred to as the 'sandwich technique.'ResultsFive ureters in three patients were occluded utilizing the above-described technique during the 4-year study period. Mean maximum size Amplatzer used per ureter was 10.8 mm (range, 8-12). One ureter required three Amplatzer plugs and the rest required two. Two patients (3 ureters) were clinically successful with complete resolution of symptoms in 36-48 h. The third patient (2 ureters) was partly successful and required a second Amplatzer- N-butyl cyanoacrylate sandwich technique embolization. The mean clinical follow-up was 11.3 months (range, 1.7-29.2).ConclusionsThe Amplatzer- N-butyl cyanoacrylate-Amplatzer sandwich technique for occluding the distal ureter is safe and effective with a quick (probably due to the N-butyl cyanoacrylate) and durable (probably due to the Amplatzer plugs) clinical response.« less

CRC-113 gene expression signature for predicting prognosis in patients with colorectal cancer

PubMed Central

Nguyen, Dinh Truong; Kim, Jin-Hwan; Jo, Yong Hwa; Shahid, Muhammad; Akter, Salima; Aryal, Saurav Nath; Yoo, Ji Youn; Ahn, Yong-Joo; Cho, Kyoung Min; Lee, Ju-Seog; Choe, Wonchae; Kang, Insug; Ha, Joohun; Kim, Sung Soo

2015-01-01

Colorectal cancer (CRC) is the third leading cause of global cancer mortality. Recent studies have proposed several gene signatures to predict CRC prognosis, but none of those have proven reliable for predicting prognosis in clinical practice yet due to poor reproducibility and molecular heterogeneity. Here, we have established a prognostic signature of 113 probe sets (CRC-113) that include potential biomarkers and reflect the biological and clinical characteristics. Robustness and accuracy were significantly validated in external data sets from 19 centers in five countries. In multivariate analysis, CRC-113 gene signature showed a stronger prognostic value for survival and disease recurrence in CRC patients than current clinicopathological risk factors and molecular alterations. We also demonstrated that the CRC-113 gene signature reflected both genetic and epigenetic molecular heterogeneity in CRC patients. Furthermore, incorporation of the CRC-113 gene signature into a clinical context and molecular markers further refined the selection of the CRC patients who might benefit from postoperative chemotherapy. Conclusively, CRC-113 gene signature provides new possibilities for improving prognostic models and personalized therapeutic strategies. PMID:26397224

CRC-113 gene expression signature for predicting prognosis in patients with colorectal cancer.

PubMed

Nguyen, Minh Nam; Choi, Tae Gyu; Nguyen, Dinh Truong; Kim, Jin-Hwan; Jo, Yong Hwa; Shahid, Muhammad; Akter, Salima; Aryal, Saurav Nath; Yoo, Ji Youn; Ahn, Yong-Joo; Cho, Kyoung Min; Lee, Ju-Seog; Choe, Wonchae; Kang, Insug; Ha, Joohun; Kim, Sung Soo

2015-10-13

Colorectal cancer (CRC) is the third leading cause of global cancer mortality. Recent studies have proposed several gene signatures to predict CRC prognosis, but none of those have proven reliable for predicting prognosis in clinical practice yet due to poor reproducibility and molecular heterogeneity. Here, we have established a prognostic signature of 113 probe sets (CRC-113) that include potential biomarkers and reflect the biological and clinical characteristics. Robustness and accuracy were significantly validated in external data sets from 19 centers in five countries. In multivariate analysis, CRC-113 gene signature showed a stronger prognostic value for survival and disease recurrence in CRC patients than current clinicopathological risk factors and molecular alterations. We also demonstrated that the CRC-113 gene signature reflected both genetic and epigenetic molecular heterogeneity in CRC patients. Furthermore, incorporation of the CRC-113 gene signature into a clinical context and molecular markers further refined the selection of the CRC patients who might benefit from postoperative chemotherapy. Conclusively, CRC-113 gene signature provides new possibilities for improving prognostic models and personalized therapeutic strategies.

Report from the OMERACT Hand Osteoarthritis Special Interest Group: advances and future research priorities.

PubMed

Kloppenburg, Margreet; Bøyesen, Pernille; Smeets, Wilma; Haugen, Ida K; Haugen, Ida; Liu, Rani; Visser, Willemien; van der Heijde, Désirée M

2014-04-01

Osteoarthritis (OA) is one of the most common musculoskeletal disorders, frequently affecting the hands. In the last decade there has been increased awareness concerning this disorder because of its clinical burden. Unfortunately, only limited treatments for symptom alleviation are available, and no effective treatment for disease modification exists. The lack of treatment is due not only to a lack of understanding of the disease process, but also to poor outcome measures to assess the condition. The OMERACT Hand OA Special Interest Group (SIG) has started to develop a core set of outcome measures for hand OA clinical trials, observational studies, and clinical record keeping. At OMERACT 11, results from a Delphi exercise were presented, and a preliminary set of core domains was discussed. The group attempted to adopt the new OMERACT Filter 2.0 in the process, and literature overviews of conventional radiographs, ultrasonography, and magnetic resonance imaging as outcome measures in hand OA were presented. Discussions that followed highlighted further suggestions for core domains, the heterogeneity of hand OA, and future research priorities.

Assessment and intervention for dysphagia in infants and children: beyond the neonatal intensive care unit.

PubMed

Bell, Hannah R; Alper, Beth Sheckman

2007-08-01

Over the last 10 years, the assessment and intervention for feeding and swallowing problems in infants and children have attracted increased attention on a national and international level. Increases in the population of children with dysphagia are due, in large part, to advances in medical and surgical management of at-risk term infants, improved medical support for viability of younger and smaller preterm infants, and increases in the number of children on the autism spectrum. Because of legislative initiatives, settings in which children are seen for assessment and intervention have shifted, with services provided more often in the natural environments of homes, daycares, preschools, and schools, as well as in hospitals and outpatient clinics in the United States. Assessment of infants and children with dysphagia continues to include clinical and instrumental evaluations with clinical assessment including a specific focus on the feeding environment. Speech-language pathologists are increasingly assuming consultative roles to support the needs of children in all settings. Areas for further research in the era of evidence-based practice include efficacy of oral exercises and other intervention strategies.

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.

The differences in the assessments of side effects at an oncology outpatient clinic.

PubMed

Bayraktar-Ekincioglu, A; Kucuk, E

2018-04-01

Background There is a growing interest in the use of targeted and immunotherapies in oncology. However, the assessment of side effects can be different due to interpretation of patients' health status by healthcare professionals in oncology outpatient clinics. Objective To demonstrate the differences in the assessments of side effects conducted independently by a clinical pharmacist and nurses in patients who receive targeted therapies at an oncology outpatient clinic. Setting The study was conducted at the University Oncology Hospital in an outpatient clinic from October 2015 to March 2016. Method Patients receiving ipilimumab, nivolumab, pembrolizumab, bevacizumab, panitumumab or cetuximab during study period were included. The assessment of side effects was conducted by a pharmacist and nurse independently using the NCI-CTCAE version-2. Main outcome measure To compare the severity assessments of side effects between a clinical pharmacist and nurses in an outpatient clinic. Results During the study, 204 visits for 43 patients with a total of 5508 side effect assessments were recorded where 1137 (20.64%) assessments were graded differently. Out of 1137 assessments, 473 of them were graded higher by a clinical pharmacist whereas 664 were graded higher by nurses. Statistically significant differences were detected in the assessment of vomiting, taste changes, sense changes, alopecia, fatigue, mood changes, anxiety, hearing impairment, and allergic reactions. Conclusion An assessment of side effects by healthcare providers in patients with cancer may be challenging due to an increased workload in clinics and undistinguishable symptoms of side effects and cancer itself. Therefore, a new care model which increases an interprofessional communication may improve pharmaceutical care in oncology outpatient clinics.

Classification of Clinically Relevant Microorganisms in Non-Medical Environments

DTIC Science & Technology

2004-05-06

settings largely due to the rapidity of its evolutionary response to treatment. The first antibiotic-resistant strains of S . aureus were isolated only...studies have assigned isolates of the bacteria to known strains. The objectives of this study were to collect, isolate and characterize samples of S ...internal fragments of seven genes were obtained for 36 S . aureus isolates and assigned a unique allelic profile. These profiles, like fingerprints

Feasibility of Leadless Cardiac Pacing Using Injectable Magnetic Microparticles

PubMed Central

Rotenberg, Menahem Y.; Gabay, Hovav; Etzion, Yoram; Cohen, Smadar

2016-01-01

A noninvasive, effective approach for immediate and painless heart pacing would have invaluable implications in several clinical scenarios. Here we present a novel strategy that utilizes the well-known mechano-electric feedback of the heart to evoke cardiac pacing, while relying on magnetic microparticles as leadless mechanical stimulators. We demonstrate that after localizing intravenously-injected magnetic microparticles in the right ventricular cavity using an external electromagnet, the application of magnetic pulses generates mechanical stimulation that provokes ventricular overdrive pacing in the rat heart. This temporary pacing consistently managed to revert drug-induced bradycardia, but could only last up to several seconds in the rat model, most likely due to escape of the particles between the applied pulses using our current experimental setting. In a pig model with open chest, MEF-based pacing was induced by banging magnetic particles and has lasted for a longer time. Due to overheating of the electromagnet, we intentionally terminated the experiments after 2 min. Our results demonstrate for the first time the feasibility of external leadless temporary pacing, using injectable magnetic microparticles that are manipulated by an external electromagnet. This new approach can have important utilities in clinical settings in which immediate and painless control of cardiac rhythm is required. PMID:27091192

Judges' perception of candidates' organization and communication, in relation to oral certification examination ratings.

PubMed

Houston, James E; Myford, Carol M

2009-11-01

To determine (1) whether judges differed in the levels of severity they exercised when rating candidates' performance in an oral certification exam, (2) to what extent candidates' clinical competence ratings were related to their organization/communication ratings, and (3) to what extent clinical competence ratings could predict organization/communication ratings. Six hundred eighty-four physicians participated in a medical specialty board's 2002 oral examination. Ninety-nine senior members of the medical specialty served as judges, rating candidates' performances. Candidates' clinical competence ratings were analyzed using multifaceted Rasch measurement to investigate judge severity. A Pearson correlation was calculated to examine the relationship between ratings of clinical competence and organization/communication. Logistic regression was used to determine to what extent clinical competence ratings predicted organization/communication ratings. There were about three statistically distinct strata of judge severity; judges were not interchangeable. There was a moderately strong relationship between the two sets of candidate ratings. Higher clinical competence ratings were associated with an organization/communication rating of acceptable, whereas lower clinical competence ratings were associated with an organization/communication rating of unacceptable. The judges' clinical competence ratings correctly predicted 61.9% of the acceptable and 88.3% of the unacceptable organization/communication ratings. Overall, the clinical competence ratings correctly predicted 80% of the organization/communication ratings. The close association between the two sets of ratings was possibly due to a "halo" effect. Several explanations for this relationship were explored, and the authors considered the implications for their understanding of how judges carry out this complex rating task.

Doctors' and nurses' perceptions of a ward-based pharmacist in rural northern Sweden.

PubMed

Sjölander, Maria; Gustafsson, Maria; Gallego, Gisselle

2017-08-01

Background This project is part of the prospective quasi experimental proof-of-concept investigation of clinical pharmacist intervention study to reduce drug-related problems among people admitted to a ward in a rural hospital in northern Sweden. Objective To explore doctors' and nurses' perceptions and expectations of having a ward-based pharmacist providing clinical pharmacy services. Setting Medical ward in a rural hospital in northern Sweden. Method Eighteen face-to-face semi-structured interviews were conducted with a purposive sample of doctors and nurses working on the ward where the clinical pharmacy service was due to be implemented. Semi-structured interviews were digitally recorded, transcribed and analysed using thematic analysis. Main outcome measure Perceptions and expectations of nurses and doctors. Results Doctors and nurses had limited experience of working with pharmacists. Most had a vague idea of what pharmacists can contribute within a ward setting. Participants, mainly nurses, suggested inventory and drug distribution roles, but few were aware of the pharmacists' skills and clinical competence. Different views were expressed on whether the new clinical pharmacy service would have an impact on workload. However, most participants took a positive view of having a ward-based pharmacist. Conclusion This study provided an opportunity to explore doctors' and nurses' expectations of the role of clinical pharmacists before a clinical pharmacy service was implemented. To successfully implement a clinical pharmacy service, roles, clinical competence and responsibilities should be clearly described. Furthermore, it is important to focus on collaborative working relationships between doctors, nurses and pharmacists.

'Good ethics and moral standing': a qualitative study of aesthetic leadership in clinical nursing practice.

PubMed

Mannix, Judy; Wilkes, Lesley; Daly, John

2015-06-01

To explore how aesthetic leadership is embodied by clinical leaders in the nursing workplace. A number of different leadership styles have been developed, theorised and applied to the nursing workforce over the years. Many of these styles lack an explicit moral dimension in their identified leader attributes, due to a shift in theorising of leadership to focus on the impact of leader traits on followers. It is timely to look at aesthetic leadership, with its explicit moral dimension, as a way of improving outcomes for nurses, patients and health care organisations. Qualitative design, using conversation-style interviews with experienced registered nurses in designated clinical leadership roles. Twelve experienced registered nurses who worked in designated clinical leadership roles participated in an individual, digitally recorded, semi-structured conversation-style interview. Narrative data were transcribed and subject to thematic analysis. Three main themes emerged: 'True to their beliefs': embodying principled practice; 'Not all policies fit every patient': ethical leadership in ambiguous situations; and 'Being open to people's concerns': providing fair and just solutions. A strong moral compass shaped and guided participants' day-to-day clinical leadership activities. Participants provided a rich narrative on how aesthetic leadership is embodied in the clinical nursing setting. It was evident that their clinical leadership is shaped and guided by a strong moral compass. By incorporating into their practice an aesthetic world-view with its strong moral purpose, participants in this study have shown how aesthetic leadership can enhance the clinical nursing workplace. Nurses in the clinical setting value clinical leaders who embrace and operate with a strong moral compass. Aesthetic leadership, with its explicit strong moral purpose, offers a way of incorporating morality into clinical leadership in the nursing workplace. © 2015 John Wiley & Sons Ltd.

Evaluation of Interactive Visualization on Mobile Computing Platforms for Selection of Deep Brain Stimulation Parameters

PubMed Central

Butson, Christopher R.; Tamm, Georg; Jain, Sanket; Fogal, Thomas; Krüger, Jens

2012-01-01

In recent years there has been significant growth in the use of patient-specific models to predict the effects of neuromodulation therapies such as deep brain stimulation (DBS). However, translating these models from a research environment to the everyday clinical workflow has been a challenge, primarily due to the complexity of the models and the expertise required in specialized visualization software. In this paper, we deploy the interactive visualization system ImageVis3D Mobile, which has been designed for mobile computing devices such as the iPhone or iPad, in an evaluation environment to visualize models of Parkinson’s disease patients who received DBS therapy. Selection of DBS settings is a significant clinical challenge that requires repeated revisions to achieve optimal therapeutic response, and is often performed without any visual representation of the stimulation system in the patient. We used ImageVis3D Mobile to provide models to movement disorders clinicians and asked them to use the software to determine: 1) which of the four DBS electrode contacts they would select for therapy; and 2) what stimulation settings they would choose. We compared the stimulation protocol chosen from the software versus the stimulation protocol that was chosen via clinical practice (independently of the study). Lastly, we compared the amount of time required to reach these settings using the software versus the time required through standard practice. We found that the stimulation settings chosen using ImageVis3D Mobile were similar to those used in standard of care, but were selected in drastically less time. We show how our visualization system, available directly at the point of care on a device familiar to the clinician, can be used to guide clinical decision making for selection of DBS settings. In our view, the positive impact of the system could also translate to areas other than DBS. PMID:22450824

Rehabilitation of people with spinal cord damage due to tumor: literature review, international survey and practical recommendations for optimizing their rehabilitation

PubMed Central

Marshall, Ruth; Stubblefield, Michael D.; Scivoletto, Giorgio

2017-01-01

Background People with spinal cord dysfunction (SCDys) due to tumor (benign and malignant) pose enormous rehabilitation challenges. Objectives were: conduct literature search regarding epidemiology, clinical features and outcomes for SCDys due to tumor following rehabilitation, the ideal setting for rehabilitation and practical considerations for rehabilitation; and propose framework and practical considerations for managing people with SCDys due to tumor in spinal rehabilitation units (SRUs). Design Survey of rehabilitation health care professionals, consensus opinion from experts and literature search. Setting Workshop at International Spinal Cord Society and American Spinal Injury Association combined annual meeting, May 16, 2015, Montréal, Canada. Participants Workshop attendees and experts in the rehabilitation of people with SCDys due to tumor. Outcomes Measures Reports of services offered to people with SCDys due to tumor, including whether those with benign and malignant tumors are admitted into rehabilitation, any admission criteria used and the rational for declining admission. Results Most respondents (n = 33, 83%) reported that people with benign tumors were routinely admitted for rehabilitation but only 18 (45%) reported that people with malignant tumors were routinely admitted. A range of criteria and reasons for declining admission were given. Evidence from the literature and the opinion of experts support the admission of people with SCDys due to tumor into specialist SRUs. Conclusions A framework and practical considerations for managing people with SCDys due to tumor in SRUs are proposed. Patients with tumor causing SCDys should be given greater access to specialist SRU in order to achieve the best outcomes. PMID:27088581

The future of anticoagulation clinics.

PubMed

Macik, B Gail

2003-01-01

Anticoagulation therapy is the foundation of treatment for thromboembolic disorders; and coumarin derivatives (warfarin in the United States) are the only orally administered anticoagulant medications currently available. Due to the expense and relative difficulties associated with this route of administration, parenteral drugs are not used routinely for long-term therapy, leaving warfarin as the anticoagulant of choice in the outpatient setting. The management of warfarin is problematic, however, due the nuances of its pharmacodynamic and pharmacokinetic profile and the requirement for frequent monitoring of blood levels. Although management by anticoagulation clinics is considered the gold standard for warfarin therapy, management by an anticoagulation clinic may not be the optimal option from a clinician's view and, in many cases, may not be an option at all. Anticoagulation clinics may impinge on the doctor-patient relationship. Difficulties of communication and reimbursement are not ameliorated by a specialty clinic. Innovations in warfarin management, including patient self-management and computerized dosing programs, are alternatives for improved care that are available with or without input by an anticoagulation service. New oral drugs on the horizon do not require the same intensity of monitoring and do not present the same pharmacodynamic problems associated with warfarin. Warfarin will become obsolete in the foreseeable future. If anticoagulation clinics continue, they must re-define their role as the major part of the workload, warfarin management, disappears. To adapt, clinics must strengthen and enhance their role as coordinators and educators, and less so, managers of anticoagulation therapy.

Challenges in managing elderly people with diabetes in primary care settings in Norway

PubMed Central

2013-01-01

Abstract Objective To explore the experiences and clinical challenges that nurses and nursing assistants face when providing high-quality diabetes-specific management and care for elderly people with diabetes in primary care settings. Design Focus-group interviews. Subjects and setting Sixteen health care professionals: 12 registered nurses and four nursing assistants from nursing homes (10), district nursing service (5), and a service unit (1) were recruited by municipal managers who had local knowledge and knew the workforce. All the participants were women aged 32–59 years with clinical experience ranging from 1.5 to 38 years. Results Content analysis revealed a discrepancy between the level of expertise which the participants described as important to delivering high-quality care and their capacity to deliver such care. The discrepancy was due to lack of availability and access to current information, limited ongoing support, lack of cohesion among health care professionals, and limited confidence and autonomy. Challenges to delivering high-quality care included complex, difficult patient situations and lack of confidence to make decisions founded on evidence-based guidelines. Conclusion Participants lacked confidence and autonomy to manage elderly people with diabetes in municipal care settings. Lack of information, support, and professional cohesion made the role challenging. PMID:24205973

SU-E-J-262: Variability in Texture Analysis of Gynecological Tumors in the Context of An 18F-FDG PET Adaptive Protocol

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

Nawrocki, J; Chino, J; Das, S

Purpose: This study examines the effect on texture analysis due to variable reconstruction of PET images in the context of an adaptive FDG PET protocol for node positive gynecologic cancer patients. By measuring variability in texture features from baseline and intra-treatment PET-CT, we can isolate unreliable texture features due to large variation. Methods: A subset of seven patients with node positive gynecological cancers visible on PET was selected for this study. Prescribed dose varied between 45–50.4Gy, with a 55–70Gy boost to the PET positive nodes. A baseline and intratreatment (between 30–36Gy) PET-CT were obtained on a Siemens Biograph mCT. Eachmore » clinical PET image set was reconstructed 6 times using a TrueX+TOF algorithm with varying iterations and Gaussian filter. Baseline and intra-treatment primary GTVs were segmented using PET Edge (MIM Software Inc., Cleveland, OH), a semi-automatic gradient-based algorithm, on the clinical PET and transferred to the other reconstructed sets. Using an in-house MATLAB program, four 3D texture matrices describing relationships between voxel intensities in the GTV were generated: co-occurrence, run length, size zone, and neighborhood difference. From these, 39 textural features characterizing texture were calculated in addition to SUV histogram features. The percent variability among parameters was first calculated. Each reconstructed texture feature from baseline and intra-treatment per patient was normalized to the clinical baseline scan and compared using the Wilcoxon signed-rank test in order to isolate variations due to reconstruction parameters. Results: For the baseline scans, 13 texture features showed a mean range greater than 10%. For the intra scans, 28 texture features showed a mean range greater than 10%. Comparing baseline to intra scans, 25 texture features showed p <0.05. Conclusion: Variability due to different reconstruction parameters increased with treatment, however, the majority of texture features showed significant changes during treatment independent of reconstruction effects.« less

Quick screening tool for patients with severe negative emotional reactions to chronic illness: psychometric study of the negative emotions due to chronic illness screening test (NECIS).

PubMed

Huang, Yun-Hsin; Wu, Chih-Hsun; Chen, Hsiu-Jung; Cheng, Yih-Ru; Hung, Fu-Chien; Leung, Kai-Kuan; Lue, Bee-Horng; Chen, Ching-Yu; Chiu, Tai-Yuan; Wu, Yin-Chang

2018-01-16

Severe negative emotional reactions to chronic illness are maladaptive to patients and they need to be addressed in a primary care setting. The psychometric properties of a quick screening tool-the Negative Emotions due to Chronic Illness Screening Test (NECIS)-for general emotional problems among patients with chronic illness being treated in a primary care setting was investigated. Three studies including 375 of patients with chronic illness were used to assess and analyze internal consistency, test-retest reliability, criterion-related validity, a cut-off point for distinguishing maladaptive emotions and clinical application validity of NECIS. Self-report questionnaires were used. Internal consistency (Cronbach's α) ranged from 0.78 to 0.82, and the test-retest reliability was 0.71 (P < 0.001). Criterion-related validity was 0.51 (P < 0.001). Based on the 'severe maladaptation' and 'moderate maladaptation' groups defined by using the 'Worsening due to Chronic Illness' index as the analysis reference, the receiver-operating characteristic curve analysis revealed an area under the curve of 0.81 and 0.82 (ps < 0.001), and a cut-off point of 19/20 was the most satisfactory for distinguishing those with overly negative emotions, with a sensitivity and specificity of 83.3 and 69.0%, and 68.5 and 83.0%, respectively. The clinical application validity analysis revealed that low NECIS group showed significantly better adaptation to chronic illness on the scales of subjective health, general satisfaction with life, self-efficacy of self-care for disease, illness perception and stressors in everyday life. The NECIS has satisfactory psychometric properties for use in the primary care setting. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Multisite external validation of a risk prediction model for the diagnosis of blood stream infections in febrile pediatric oncology patients without severe neutropenia.

PubMed

Esbenshade, Adam J; Zhao, Zhiguo; Aftandilian, Catherine; Saab, Raya; Wattier, Rachel L; Beauchemin, Melissa; Miller, Tamara P; Wilkes, Jennifer J; Kelly, Michael J; Fernbach, Alison; Jeng, Michael; Schwartz, Cindy L; Dvorak, Christopher C; Shyr, Yu; Moons, Karl G M; Sulis, Maria-Luisa; Friedman, Debra L

2017-10-01

Pediatric oncology patients are at an increased risk of invasive bacterial infection due to immunosuppression. The risk of such infection in the absence of severe neutropenia (absolute neutrophil count ≥ 500/μL) is not well established and a validated prediction model for blood stream infection (BSI) risk offers clinical usefulness. A 6-site retrospective external validation was conducted using a previously published risk prediction model for BSI in febrile pediatric oncology patients without severe neutropenia: the Esbenshade/Vanderbilt (EsVan) model. A reduced model (EsVan2) excluding 2 less clinically reliable variables also was created using the initial EsVan model derivative cohort, and was validated using all 5 external validation cohorts. One data set was used only in sensitivity analyses due to missing some variables. From the 5 primary data sets, there were a total of 1197 febrile episodes and 76 episodes of bacteremia. The overall C statistic for predicting bacteremia was 0.695, with a calibration slope of 0.50 for the original model and a calibration slope of 1.0 when recalibration was applied to the model. The model performed better in predicting high-risk bacteremia (gram-negative or Staphylococcus aureus infection) versus BSI alone, with a C statistic of 0.801 and a calibration slope of 0.65. The EsVan2 model outperformed the EsVan model across data sets with a C statistic of 0.733 for predicting BSI and a C statistic of 0.841 for high-risk BSI. The results of this external validation demonstrated that the EsVan and EsVan2 models are able to predict BSI across multiple performance sites and, once validated and implemented prospectively, could assist in decision making in clinical practice. Cancer 2017;123:3781-3790. © 2017 American Cancer Society. © 2017 American Cancer Society.

A Crowdsourcing Framework for Medical Data Sets

PubMed Central

Ye, Cheng; Coco, Joseph; Epishova, Anna; Hajaj, Chen; Bogardus, Henry; Novak, Laurie; Denny, Joshua; Vorobeychik, Yevgeniy; Lasko, Thomas; Malin, Bradley; Fabbri, Daniel

2018-01-01

Crowdsourcing services like Amazon Mechanical Turk allow researchers to ask questions to crowds of workers and quickly receive high quality labeled responses. However, crowds drawn from the general public are not suitable for labeling sensitive and complex data sets, such as medical records, due to various concerns. Major challenges in building and deploying a crowdsourcing system for medical data include, but are not limited to: managing access rights to sensitive data and ensuring data privacy controls are enforced; identifying workers with the necessary expertise to analyze complex information; and efficiently retrieving relevant information in massive data sets. In this paper, we introduce a crowdsourcing framework to support the annotation of medical data sets. We further demonstrate a workflow for crowdsourcing clinical chart reviews including (1) the design and decomposition of research questions; (2) the architecture for storing and displaying sensitive data; and (3) the development of tools to support crowd workers in quickly analyzing information from complex data sets. PMID:29888085

Strategies for conducting adolescent health research in the clinical setting: the Mount Sinai Adolescent Health Center HPV experience.

PubMed

Braun-Courville, Debra K; Schlecht, Nicolas F; Burk, Robert D; Strickler, Howard D; Rojas, Mary; Lorde-Rollins, Elizabeth; Nucci-Sack, Anne; Hollman, Dominic; Linares, L Oriana; Diaz, Angela

2014-10-01

Clinical research with adolescents can be challenging due to issues of informed consent, parental involvement, institutional review board requirements, and adolescent psychosocial development. These requirements present a dilemma, particularly in the area of sexual health research, as adolescents are disproportionately affected by sexually transmitted infections such as human papillomavirus (HPV). To successfully conduct adolescent research in the clinical setting, one requires an awareness of state statutes regarding adolescent confidentiality and consent for medical care, and a close partnership with the IRB. In 2007, the Mount Sinai Adolescent Health Center in collaboration with the Albert Einstein College of Medicine developed a longitudinal research study to examine the natural history of oral, cervical, and anal HPV in an adolescent female population engaged in high-risk sexual behaviors. We use this research project as a case study to explore the ethical, methodological, and clinical issues related to conducting adolescent health research. Several strategies were identified to promote adolescent study participation, including: (1) building a research team that is motivated to work with adolescents; (2) combining research and patient care visits to avoid duplication of services; and (3) establishing a personalized communication network with participants. Using these methods, adolescent sexual health research can successfully be integrated into the clinical setting. While retaining a prospective cohort of adolescents has its challenges, a persistent and multi-disciplinary approach can help improve recruitment, sustain participation, and acquire critical data that will lead to improved healthcare knowledge applicable to understudied populations of adolescents. Copyright © 2014 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

A grid to facilitate physics staffing justification.

PubMed

Klein, Eric E

2009-12-03

Justification of clinical physics staffing levels is difficult due to the lack of direction as how to equate clinical needs with the staffing levels and competency required. When a physicist negotiates staffing requests to administration, she/he often refers to American College of Radiology staffing level suggestions, and resources such as the Abt studies. This approach is often met with questions as to how to fairly derive the time it takes to perform tasks. The result is often insufficient and/or inexperienced staff handling complex and cumbersome tasks. We undertook development of a staffing justification grid to equate the clinical needs to the quantity and quality of staffing required. The first step is using the Abt study, customized to the clinical setting, to derive time per task multiplied by the anticipated number of such tasks. Inclusion of vacation, meeting, and developmental time may be incorporated along with allocated time for education and administration. This is followed by mapping the tasks to the level of competency/experience needed. For example, in an academic setting the faculty appointment levels correlate with experience. Non-staff personnel, such as IMRT QA technicians or clerical staff, should also be part of the equation. By using the staffing justification grid, we derived strong documentation to justify a substantial budget increase. The grid also proved useful when our clinical demands changed. Justification for physics staffing can be significantly strengthened with a properly developed data-based time and work analysis. A staffing grid is presented, along with a development methodology that facilitated our justification. Though our grid is for a large academic facility, the methodology can be extended to a non-academic setting, and to a smaller scale. This grid method not only equates the clinical needs with the quantity of staffing, but can also help generate the personnel budget, based on the type of staff and personnel required. The grid is easily adaptable when changes to the clinical environment change, such as an increase in IMRT or IGRT applications.

An EAACI “European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)”: the methodology

PubMed Central

2014-01-01

At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a “harmonised terminology” according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective pilot survey to be conducted in three European countries (France, Germany and Spain). A designated “national coordinator” was responsible for following ethics requirements relative to each country and to select at least 30 doctors per country. Patients were recruited the same day they received their first dose of either SCIT or SLIT. Patient inclusion criteria were: adults and children, with IgE mediated pollen, house dust mite, Alternaria, and/or animal dander respiratory allergies who will initiate AIT. A list of 31 symptoms terms were extracted from the MedDRA (Medical Dictionary for Regulatory Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database. Three questionnaires were generated: i) the Doctor Questionnaire, ii) the Patient Questionnaire and iii) the Adverse Reaction Questionnaire. A handbook and a mistake report form were given to each doctor. In this paper, we describe the methodology followed. PMID:25075276

US-Cut: interactive algorithm for rapid detection and segmentation of liver tumors in ultrasound acquisitions

NASA Astrophysics Data System (ADS)

Egger, Jan; Voglreiter, Philip; Dokter, Mark; Hofmann, Michael; Chen, Xiaojun; Zoller, Wolfram G.; Schmalstieg, Dieter; Hann, Alexander

2016-04-01

Ultrasound (US) is the most commonly used liver imaging modality worldwide. It plays an important role in follow-up of cancer patients with liver metastases. We present an interactive segmentation approach for liver tumors in US acquisitions. Due to the low image quality and the low contrast between the tumors and the surrounding tissue in US images, the segmentation is very challenging. Thus, the clinical practice still relies on manual measurement and outlining of the tumors in the US images. We target this problem by applying an interactive segmentation algorithm to the US data, allowing the user to get real-time feedback of the segmentation results. The algorithm has been developed and tested hand-in-hand by physicians and computer scientists to make sure a future practical usage in a clinical setting is feasible. To cover typical acquisitions from the clinical routine, the approach has been evaluated with dozens of datasets where the tumors are hyperechoic (brighter), hypoechoic (darker) or isoechoic (similar) in comparison to the surrounding liver tissue. Due to the interactive real-time behavior of the approach, it was possible even in difficult cases to find satisfying segmentations of the tumors within seconds and without parameter settings, and the average tumor deviation was only 1.4mm compared with manual measurements. However, the long term goal is to ease the volumetric acquisition of liver tumors in order to evaluate for treatment response. Additional aim is the registration of intraoperative US images via the interactive segmentations to the patient's pre-interventional CT acquisitions.

Paediatric in-patient prescribing errors in Malaysia: a cross-sectional multicentre study.

PubMed

Khoo, Teik Beng; Tan, Jing Wen; Ng, Hoong Phak; Choo, Chong Ming; Bt Abdul Shukor, Intan Nor Chahaya; Teh, Siao Hean

2017-06-01

Background There is a lack of large comprehensive studies in developing countries on paediatric in-patient prescribing errors in different settings. Objectives To determine the characteristics of in-patient prescribing errors among paediatric patients. Setting General paediatric wards, neonatal intensive care units and paediatric intensive care units in government hospitals in Malaysia. Methods This is a cross-sectional multicentre study involving 17 participating hospitals. Drug charts were reviewed in each ward to identify the prescribing errors. All prescribing errors identified were further assessed for their potential clinical consequences, likely causes and contributing factors. Main outcome measures Incidence, types, potential clinical consequences, causes and contributing factors of the prescribing errors. Results The overall prescribing error rate was 9.2% out of 17,889 prescribed medications. There was no significant difference in the prescribing error rates between different types of hospitals or wards. The use of electronic prescribing had a higher prescribing error rate than manual prescribing (16.9 vs 8.2%, p < 0.05). Twenty eight (1.7%) prescribing errors were deemed to have serious potential clinical consequences and 2 (0.1%) were judged to be potentially fatal. Most of the errors were attributed to human factors, i.e. performance or knowledge deficit. The most common contributing factors were due to lack of supervision or of knowledge. Conclusions Although electronic prescribing may potentially improve safety, it may conversely cause prescribing errors due to suboptimal interfaces and cumbersome work processes. Junior doctors need specific training in paediatric prescribing and close supervision to reduce prescribing errors in paediatric in-patients.

Mild cognitive impairment due to Alzheimer disease in the community.

PubMed

Petersen, Ronald C; Aisen, Paul; Boeve, Bradley F; Geda, Yonas E; Ivnik, Robert J; Knopman, David S; Mielke, Michelle; Pankratz, Vernon S; Roberts, Rosebud; Rocca, Walter A; Weigand, Stephen; Weiner, Michael; Wiste, Heather; Jack, Clifford R

2013-08-01

The newly proposed National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer disease (AD) suggest a combination of clinical features and biomarker measures, but their performance in the community is not known. The Mayo Clinic Study of Aging (MCSA) is a population-based longitudinal study of nondemented subjects in Olmsted County, Minnesota. A sample of 154 MCI subjects from the MCSA was compared to a sample of 58 amnestic MCI subjects from the Alzheimer's Disease Neuroimaging Initiative 1 (ADNI-1) to assess the applicability of the criteria in both settings and to assess their outcomes. Fourteen percent of MCSA and 16% of ADNI-1 of subjects were biomarker negative. In addition, 14% of MCSA and 12% of ADNI-1 subjects had evidence for amyloid deposition only, whereas 43% of MCSA and 55% of ADNI-1 subjects had evidence for amyloid deposition plus neurodegeneration (magnetic resonance imaging atrophy, fluorodeoxyglucose positron emission tomography hypometabolism, or both). However, a considerable number of subjects had biomarkers inconsistent with the proposed AD model; for example, 29% of MCSA subjects and 17% of ADNI-1 subjects had evidence for neurodegeneration without amyloid deposition. These subjects may not be on an AD pathway. Neurodegeneration appears to be a key factor in predicting progression relative to amyloid deposition alone. The NIA-AA criteria apply to most MCI subjects in both the community and clinical trials settings; however, a sizeable proportion of subjects had conflicting biomarkers, which may be very important and need to be explored. © 2013 American Neurological Association.

Computed Tomography of the Abdomen in Eight Clinically Normal Common Marmosets (Callithrix jacchus).

PubMed

du Plessis, W M; Groenewald, H B; Elliott, D

2017-08-01

The aim of this study was to provide a detailed anatomical description of the abdomen in the clinically normal common marmoset by means of computed tomography (CT). Eight clinically healthy mature common marmosets ranging from 12 to 48 months and 235 to 365 g bodyweight were anesthetized and pre- and post-contrast CT examinations were performed using different CT settings in dorsal recumbency. Abdominal organs were identified and visibility noted. Diagnostic quality abdominal images could be obtained of the common marmoset despite its small size using a dual-slice CT scanner. Representative cross-sectional images were chosen from different animals illustrating the abdominal CT anatomy of clinically normal common marmosets. Identification or delineation of abdominal organs greatly improved with i.v. contrast. A modified high-frequency algorithm with edge enhancement added valuable information for identification of small structures such as the ureters. The Hounsfield unit (HU) of major abdominal organs differed from that of small animals (domestic dogs and cats). Due to their size and different anatomy, standard small animal CT protocols need to be critically assessed and adapted for exotics, such as the common marmoset. The established normal reference range of HU of major abdominal organs and adapted settings for a CT protocol will aid clinical assessment of the common marmoset. © 2017 Blackwell Verlag GmbH.

Heart-type fatty acid-binding protein in cardiovascular disease: A systemic review.

PubMed

Otaki, Yoichiro; Watanabe, Tetsu; Kubota, Isao

2017-11-01

Fatty acid-binding proteins, whose clinical applications have been studied, are a family of proteins that reflect tissue injury. Heart-type fatty acid-binding protein (H-FABP) is a marker of ongoing myocardial damage and useful for early diagnosis of acute myocardial infarction (AMI). In the past decade, compared to other cardiac enzymes, H-FABP has shown more promise as an early detection marker for AMI. However, the role of H-FABP is being re-examined due to recent refinement in the search for newer biomarkers, and greater understanding of the role of high-sensitivity troponin. We discuss the current role of H-FABP as an early marker for AMI in the era of high sensitive troponin. H-FABP is highlighted as a prognostic marker for a broad spectrum of fatal diseases, viz., AMI, heart failure, arrhythmia, and pulmonary embolism that could be associated with poor clinical outcomes. Because the cut-off value of what constitutes an abnormal H-FABP potentially differs for each cardiovascular event and depends on the clinical setting, an optimal cut-off value has not been clearly established. Of note, several factors such as age, gender, and cardiovascular risk factors, which affect H-FABP levels need to be considered in this context. In this review, we discuss the clinical applications of H-FABP as a prognostic marker in various clinical settings. Copyright © 2017 Elsevier B.V. All rights reserved.

Differences in vision between clinic and home and the effect of lighting in older adults with and without glaucoma

PubMed Central

Bhorade, Anjali M.; Perlmutter, Monica S.; Wilson, Brad; Kambarian, Jamie; Chang, Sidney; Pekmezci, Melike; Gordon, Mae

2015-01-01

Importance Patients often report greater visual difficulties at home than expected from vision testing in the clinic. Such discordance may be due to worse vision in the home than measured in clinic. Objective To compare vision measured between clinic and home and evaluate factors, including lighting, associated with these differences. Design Cross-sectional, between years 2005–2009. Setting Participants recruited from the Glaucoma and Comprehensive Eye Clinics at Washington University, St. Louis, MO underwent a clinic and home visit. Participants 126 glaucoma and 49 non-glaucoma patients, ages 55–90 years, consecutively recruited and met inclusion criteria for this report; 166 eligible patients refused participation. Exposure Participants underwent a clinic and home visit randomized to order of completion. At each visit, masked and certified examiners measured binocular distance visual acuity (DVA) with a non-backlit chart, near visual acuity (NVA), contrast sensitivity (CS), CS with glare, and lighting. Main Outcome Measure Differences in vision between clinic and home. Results Mean scores for all vision tests were significantly better in the clinic than home for glaucoma and non-glaucoma patients (p<0.05, matched pair t-tests). For DVA, 29% of glaucoma participants read ≥2 lines better in clinic than home and 39% with advanced glaucoma read ≥3 lines better. For the entire sample, 21% of participants read ≥2 lines better in clinic than home for NVA and 49% read ≥2 triplets better in clinic for CS with glare. Lighting was the most significant factor associated with differences in vision between clinic and home for DVA, NVA, and CS with glare testing (p<0.05 multiple regression model). Median home lighting was 4.3 times and 2.8 times lower than clinic lighting in areas tested for DVA and NVA, respectively. Home lighting was below that recommended in ≥ 85% of participants. Conclusions and Relevance Vision measured in the clinic is generally better than vision measured at home, with differences mainly due to poor home lighting. Knowledge that vision discrepancies between patient report and clinical testing may be due to home lighting may initiate clinician-patient discussions to increase home lighting and improve vision of older adults in their homes. PMID:24263699

The role of depression pharmacogenetic decision support tools in shared decision making.

PubMed

Arandjelovic, Katarina; Eyre, Harris A; Lenze, Eric; Singh, Ajeet B; Berk, Michael; Bousman, Chad

2017-10-29

Patients discontinue antidepressant medications due to lack of knowledge, unrealistic expectations, and/or unacceptable side effects. Shared decision making (SDM) invites patients to play an active role in their treatment and may indirectly improve outcomes through enhanced engagement in care, adherence to treatment, and positive expectancy of medication outcomes. We believe decisional aids, such as pharmacogenetic decision support tools (PDSTs), facilitate SDM in the clinical setting. PDSTs may likewise predict drug tolerance and efficacy, and therefore adherence and effectiveness on an individual-patient level. There are several important ethical considerations to be navigated when integrating PDSTs into clinical practice. The field requires greater empirical research to demonstrate clinical utility, and the mechanisms thereof, as well as exploration of the ethical use of these technologies.

MLBCD: a machine learning tool for big clinical data.

PubMed

Luo, Gang

2015-01-01

Predictive modeling is fundamental for extracting value from large clinical data sets, or "big clinical data," advancing clinical research, and improving healthcare. Machine learning is a powerful approach to predictive modeling. Two factors make machine learning challenging for healthcare researchers. First, before training a machine learning model, the values of one or more model parameters called hyper-parameters must typically be specified. Due to their inexperience with machine learning, it is hard for healthcare researchers to choose an appropriate algorithm and hyper-parameter values. Second, many clinical data are stored in a special format. These data must be iteratively transformed into the relational table format before conducting predictive modeling. This transformation is time-consuming and requires computing expertise. This paper presents our vision for and design of MLBCD (Machine Learning for Big Clinical Data), a new software system aiming to address these challenges and facilitate building machine learning predictive models using big clinical data. The paper describes MLBCD's design in detail. By making machine learning accessible to healthcare researchers, MLBCD will open the use of big clinical data and increase the ability to foster biomedical discovery and improve care.

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.

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.

Impact of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) on cancer treatment outcomes: An overview about well-established and recently emerging clinical data.

PubMed

Lalami, Yassine; Klastersky, Jean

2017-12-01

Despite the overwhelming evidence for the role of granulocyte colony stimulating factors (G-CSF) in managing febrile neutropenia (FN) risk, chemotherapy-induced neutropenia (CIN) and/or FN still remain the most common reasons for reducing relative dose intensity (RDI) and/or delaying chemotherapy schedule. The need to maintain RDI to ensure optimal clinical outcomes is one of the key rationales for utilizing G-CSF. There is a high incidence of reduced RDI in both curative and palliative settings, and this observation is especially evidenced in retrospective analyses. Reduced RDI leads to significantly decreased survival outcomes and quality of life in various malignancies at various clinical settings and stages. Beyond its role as a surrogate prognostic marker, high-grade CIN may have an unexpected predictive role in clinical practice, as illustrated by several data relating CIN occurrence with favorable survival outcomes; this may be due to the fact that body surface area (BSA) - based calculation of dose may not fully account for the pharmacokinetics (PK) of cytotoxic drugs and the fact that there may be variability in drug metabolism between patients treated with same chemotherapy regimens. Copyright © 2017 Elsevier B.V. All rights reserved.

Development of quality measures for monitoring and improving care in gastroenterology.

PubMed

Germansky, Katharine A; Leffler, Daniel A

2011-06-01

Over the past decade, most quality assurance (QA) efforts in gastroenterology have been aimed at endoscopy. Endoscopic quality improvement was the rational area to begin QA work in gastroenterology due to the relatively acute nature of complications and the high volume of procedures performed. While endoscopy is currently the focus of most quality assurance (QA) measures in gastroenterology, more recent efforts have begun to address clinical gastroenterology practices both in the outpatient and inpatient settings. Clinical outpatient and inpatient gastroenterology is laden with areas where standardization could benefit patient care. While data and experience in clinical gastroenterology QA is relatively limited, it is clear that inconsistent use of guidelines and practice variations in gastroenterology can lead to lower quality care. In this review, we review a variety of areas in clinical gastroenterology where existing guidelines and published data suggest both the need and practicality of active QA measures. Copyright © 2011 Elsevier Ltd. All rights reserved.

Bioresorbable Scaffolds: Current Evidences in the Treatment of Coronary Artery Disease

PubMed Central

2016-01-01

Percutaneous coronary revascularization strategies have gradually progressed over a period of last few decades. The advent of newer generation drug-eluting stents has significantly improved the outcomes of Percutaneous Coronary Intervention (PCI) by substantially reducing in-stent restenosis and stent thrombosis. However, vascular inflammation, restenosis, thrombosis, and neoatherosclerosis due to the permanent presence of a metallic foreign body within the artery limit their usage in complex Coronary Artery Disease (CAD). Bioresorbable Scaffolds (BRS) represent a novel approach in coronary stent technology. Complete resorption of the scaffold liberates the treated vessel from its cage and restores pulsatility, cyclical strain, physiological shear stress, and mechanotransduction. In this review article, we describe the advances in this rapidly evolving technology, present the evidence from the pre-clinical and clinical evaluation of these devices, and provide an overview of the ongoing clinical trials that were designed to examine the effectiveness of BRS in the clinical setting. PMID:27891384

Seeking a progressive relationship for learning: A theoretical scheme about the continuity of the student-educator relationship in clinical nursing education.

PubMed

Yaghoubinia, Fariba; Heydari, Abbas; Latifnejad Roudsari, Robab

2014-01-01

The student-educator relationship is an educational tool in nursing education and has long-lasting influence on the professional development of nursing students. Currently, this relationship in clinical settings is different from that in the past due to a paradigm shift in nursing education and its emphasis on the centrality of the relationship. The purpose of this grounded theory study was to explore the continuity of the student-educator relationship in the Iranian context of clinical nursing education. Ten bachelor nursing students and 10 clinical educators at Mashhad University of Medical Sciences, Iran, were selected through purposive and theoretical sampling. The data were collected through semi-structured interviews and participant observation. Interviews were transcribed verbatim, and data analysis was done through open, axial, and selective coding, using MAXQDA ver. 2007 qualitative data analysis software. The core category emerging from the data analysis was "seeking a progressive relationship for learning". Other major categories linked to and embraced within this core category were: "creating emotional connection", "trying to continue the relationship chain", and "adapting the behaviors". The findings indicated that in the Iranian sociocultural context, students and educators gain some action/interaction strategies for continuity of their relationship. It is obvious that the role of the nursing clinical educators and their relationship skills are critical in the relationship continuity of clinical settings. © 2013 The Authors. Japan Journal of Nursing Science © 2013 Japan Academy of Nursing Science.

Development and implementation of a psychotherapy tracking database in primary care.

PubMed

Craner, Julia R; Sawchuk, Craig N; Mack, John D; LeRoy, Michelle A

2017-06-01

Although there is a rapid increase in the integration of behavioral health services in primary care, few studies have evaluated the effectiveness of these services in real-world clinical settings, in part due to the difficulty of translating traditional mental health research designs to this setting. Accordingly, innovative approaches are needed to fit the unique challenges of conducting research in primary care. The development and implementation of one such approach is described in this article. A continuously populating database for psychotherapy services was implemented across 5 primary care clinics in a large health system to assess several levels of patient care, including service utilization, symptomatic outcomes, and session-by-session use of psychotherapy principles by providers. Each phase of implementation revealed challenges, including clinician time, dissemination to clinics with different resources, and fidelity of data collection strategy across providers, as well as benefits, including the generation of useful data to inform clinical care, program development, and empirical research. The feasible and sustainable implementation of data collection for routine clinical practice in primary care has the potential to fuel the evidence base around integrated care. The current project describes the development of an innovative approach that, with further empirical study and refinement, could enable health care professionals and systems to understand their population and clinical process in a way that addresses essential gaps in the integrated care literature. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Evaluation of the aspartate aminotransferase/platelet ratio index and enhanced liver fibrosis tests to detect significant fibrosis due to chronic hepatitis C.

PubMed

Petersen, John R; Stevenson, Heather L; Kasturi, Krishna S; Naniwadekar, Ashutosh; Parkes, Julie; Cross, Richard; Rosenberg, William M; Xiao, Shu-Yuan; Snyder, Ned

2014-04-01

The assessment of liver fibrosis in chronic hepatitis C patients is important for prognosis and making decisions regarding antiviral treatment. Although liver biopsy is considered the reference standard for assessing hepatic fibrosis in patients with chronic hepatitis C, it is invasive and associated with sampling and interobserver variability. Serum fibrosis markers have been utilized as surrogates for a liver biopsy. We completed a prospective study of 191 patients in which blood draws and liver biopsies were performed on the same visit. Using liver biopsies the sensitivity, specificity, and negative and positive predictive values for both aspartate aminotransferase/platelet ratio index (APRI) and enhanced liver fibrosis (ELF) were determined. The patients were divided into training and validation patient sets to develop and validate a clinically useful algorithm for differentiating mild and significant fibrosis. The area under the ROC curve for the APRI and ELF tests for the training set was 0.865 and 0.880, respectively. The clinical sensitivity in separating mild (F0-F1) from significant fibrosis (F2-F4) was 80% and 86.0% with a clinical specificity of 86.7% and 77.8%, respectively. For the validation sets the area under the ROC curve for the APRI and ELF tests was, 0.855 and 0.780, respectively. The clinical sensitivity of the APRI and ELF tests in separating mild (F0-F1) from significant (F2-F4) fibrosis for the validation set was 90.0% and 70.0% with a clinical specificity of 73.3% and 86.7%, respectively. There were no differences between the APRI and ELF tests in distinguishing mild from significant fibrosis for either the training or validation sets (P=0.61 and 0.20, respectively). Using APRI as the primary test followed by ELF for patients in the intermediate zone, would have decreased the number of liver biopsies needed by 40% for the validation set. Overall, use of our algorithm would have decreased the number of patients who needed a liver biopsy from 95 to 24-a 74.7% reduction. This study has shown that the APRI and ELF tests are equally accurate in distinguishing mild from significant liver fibrosis, and combining them into a validated algorithm improves their performance in distinguishing mild from significant fibrosis.

Improving Participants' Retention in a Smoking Cessation Intervention Using a Community-based Participatory Research Approach.

PubMed

Estreet, Anthony; Apata, Jummai; Kamangar, Farin; Schutzman, Christine; Buccheri, Jane; O'Keefe, Anne-Marie; Wagner, Fernando; Sheikhattari, Payam

2017-01-01

This study compares participant' sretention in three phases of smoking cessation interventions, one provided in a health clinic and the subsequent two in community-based settings. Smoking cessation interventions were conducted in three phases from 2008 to 2015 in two underserved urban communities with low socioeconomic profiles and high rates of smoking ( n = 951). Phase I was conducted in a clinic; Phases II and III were conducted in community venues. In Phases II and III, incremental changes were made based on lessons learned from the previous phases. Retention (attending six or more sessions) was the primary predictor of cessation and was analyzed while controlling for associated factors including age, gender, race, employment, education, and nicotine dependence. Retention increased substantially over the three phases, with rates for attending six or more sessions of 13.8%, 51.9%, and 67.9% in Phases I, II, and III, respectively. Retention was significantly higher in community settings than in the clinic setting (adjusted odds ratio [OR] = 6.7; 95% confidence intervals [CI] = 4.6, 9.8). In addition to the intervention in community venues, predictors of retention included age and unemployment. Higher retention was significantly associated with higher quit rates (adjusted OR = 2.4; 95% CI = 1.5, 3.8). Conducting the intervention in community settings using trained peer motivators rather than health-care providers resulted in significantly higher retention and smoking cessation rates. This was due in part to the ability to tailor cessation classes in the community for specific populations and improving the quality of the intervention based on feedback from participants and community partners.

Nationwide experience of treatment with protease inhibitors in chronic hepatitis C patients in Denmark: identification of viral resistance mutations.

PubMed

Sølund, Christina; Krarup, Henrik; Ramirez, Santseharay; Thielsen, Peter; Røge, Birgit T; Lunding, Suzanne; Barfod, Toke S; Madsen, Lone G; Tarp, Britta; Christensen, Peer B; Gerstoft, Jan; Laursen, Alex L; Bukh, Jens; Weis, Nina

2014-01-01

The first standard of care in treatment of chronic HCV genotype 1 infection involving directly acting antivirals was protease inhibitors telaprevir or boceprevir combined with pegylated-interferon and ribavirin (triple therapy). Phase III studies include highly selected patients. Thus, treatment response and development of viral resistance during triple therapy in a routine clinical setting needs to be determined. The aims of this study were to investigate treatment outcome and identify sequence variations after triple therapy in patients with chronic HCV genotype 1 infection in a routine clinical setting. 80 patients, who initiated and completed triple therapy in Denmark between May 2011 and November 2012, were included. Demographic data and treatment response were obtained from the Danish Database for Hepatitis B and C. Direct sequencing and clonal analysis of the RT-PCR amplified NS3 protease were performed in patients without cure following triple therapy. 38 (47%) of the patients achieved cure, 15 (19%) discontinued treatment due to adverse events and remained infected, and 27 (34%) experienced relapse or treatment failure of whom 15 of 21 analyzed patients had well-described protease inhibitor resistance variants detected. Most frequently detected protease variants were V36M and/or R155K, and V36M, in patients with genotype 1a and 1b infection, respectively. The cure rate after triple therapy in a routine clinical setting was 47%, which is substantially lower than in clinical trials. Resistance variants towards protease inhibitors were seen in 71% of patients failing therapy indicating that resistance could have an important role in treatment response.

Emergency medicine versus primary care: a case study of three prevalent, costly, and non-emergent diagnoses at a community teaching hospital.

PubMed

Martin, B C

2000-01-01

The high cost of emergency department (ED) care is often viewed as an area for achieving cost savings through reduced utilization for inappropriate conditions. The implementation of outpatient prospective payment for Medicare ED patients heightens scrutiny of costs and utilization in the ED versus primary care settings. Data from hospital clinical records, financial records, and a provider survey was used to develop a costing methodology and complete a comparative analysis of the cost of care for three diagnoses by setting. Total costs were significantly higher in the ED due primarily to differences in ancillary tests and prescription drugs ordered.

Transient hemolysis due to anti-D and anti-A1 produced by engrafted donor's lymphocytes after allogeneic unmanipulated haploidentical hematopoietic stem cell transplantation.

PubMed

Bailén, Rebeca; Kwon, Mi; Pérez-Corral, Ana María; Pascual, Cristina; Buño, Ismael; Balsalobre, Pascual; Serrano, David; Gayoso, Jorge; Díez-Martín, José Luis; Anguita, Javier

2017-10-01

Development of de novo alloantibodies against recipient's red blood cell (RBC) antigens by engrafted donor's lymphocytes is a known phenomenon in the setting of allogeneic hematopoietic stem cell transplantation (HSCT). This situation is usually clinically insignificant. We report a case of early clinically relevant hemolytic anemia in a blood group A 1 D+ patient, due to a limited production of anti-D and anti-A 1 produced by nonpreviously sensitized newly engrafted donor's immune system. A 31-year-old Caucasian woman, blood group A 1 , D+, with Hodgkin's lymphoma, received an unmanipulated haploidentical allogeneic peripheral blood HSCT after a nonmyeloablative conditioning regimen. Donor blood group was A 2 B, D-. The patient had an uneventful course until Day +34, when she developed clinically significant hemolytic anemia with a positive direct antiglobulin test. Anti-D and anti-A 1 produced by the donor-engrafted lymphocytes were detected both in serum and in eluate. The hemolysis produced an accelerated group change, turning the patient's ABO group into A 2 B 2 weeks after the detection of the alloantibodies. As the residual patient's RBCs progressively disappeared, anti-D and anti-A 1 production decreased and were not detected in serum by Day +41. This case illustrates that de novo alloantibody production against ABO and D antigens by the newly engrafted donor's lymphocytes can occasionally cause clinically significant anemia. To our knowledge, this is the first case reported of clinically significant hemolytic anemia due to a transient anti-D anti-A 1 alloimmunization after T-cell-repleted haploidentical HSCT. © 2017 AABB.

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 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.

Navigating highly homologous genes in a molecular diagnostic setting: a resource for clinical next-generation sequencing.

PubMed

Mandelker, Diana; Schmidt, Ryan J; Ankala, Arunkanth; McDonald Gibson, Kristin; Bowser, Mark; Sharma, Himanshu; Duffy, Elizabeth; Hegde, Madhuri; Santani, Avni; Lebo, Matthew; Funke, Birgit

2016-12-01

Next-generation sequencing (NGS) is now routinely used to interrogate large sets of genes in a diagnostic setting. Regions of high sequence homology continue to be a major challenge for short-read technologies and can lead to false-positive and false-negative diagnostic errors. At the scale of whole-exome sequencing (WES), laboratories may be limited in their knowledge of genes and regions that pose technical hurdles due to high homology. We have created an exome-wide resource that catalogs highly homologous regions that is tailored toward diagnostic applications. This resource was developed using a mappability-based approach tailored to current Sanger and NGS protocols. Gene-level and exon-level lists delineate regions that are difficult or impossible to analyze via standard NGS. These regions are ranked by degree of affectedness, annotated for medical relevance, and classified by the type of homology (within-gene, different functional gene, known pseudogene, uncharacterized noncoding region). Additionally, we provide a list of exons that cannot be analyzed by short-amplicon Sanger sequencing. This resource can help guide clinical test design, supplemental assay implementation, and results interpretation in the context of high homology.Genet Med 18 12, 1282-1289.

Neuropsychological Practice in the Oncology Setting.

PubMed

Noll, Kyle R; Bradshaw, Mariana E; Rexer, Jennie; Wefel, Jeffrey S

2018-05-01

Oncology has experienced positive shifts in survival curves for many cancers largely due to the development of earlier diagnostics and better therapeutics. This has increased the visibility and need for survivorship services, including clinical neuropsychology. Patients with cancer frequently experience cognitive dysfunction related to the presence of cancer itself and treatment neurotoxicity. These cognitive difficulties can profoundly impact patient functioning and autonomy with accompanying declines in quality of life. Clinical neuropsychologists are uniquely positioned to evaluate the cognitive and affective sequelae of cancer and treatment and provide interventions and recommendations that can benefit well-being and potentially alter the disease course. Despite increasing recognition of the importance of neuropsychological issues to cancer survivorship, many neuropsychologists have limited training and guidance regarding navigating and implementing services within the oncology setting. This article provides the basic rationale for neuropsychological practice and research activities in oncology, as well as the experience of the Section of Neuropsychology at The University of Texas MD Anderson Cancer Center.

Improving the Effectiveness of Electronic Health Record-Based Referral Processes

PubMed Central

2012-01-01

Electronic health records are increasingly being used to facilitate referral communication in the outpatient setting. However, despite support by technology, referral communication between primary care providers and specialists is often unsatisfactory and is unable to eliminate care delays. This may be in part due to lack of attention to how information and communication technology fits within the social environment of health care. Making electronic referral communication effective requires a multifaceted “socio-technical” approach. Using an 8-dimensional socio-technical model for health information technology as a framework, we describe ten recommendations that represent good clinical practices to design, develop, implement, improve, and monitor electronic referral communication in the outpatient setting. These recommendations were developed on the basis of our previous work, current literature, sound clinical practice, and a systems-based approach to understanding and implementing health information technology solutions. Recommendations are relevant to system designers, practicing clinicians, and other stakeholders considering use of electronic health records to support referral communication. PMID:22973874

Evidence based general practice: a retrospective study of interventions in one training practice.

PubMed Central

Gill, P.; Dowell, A. C.; Neal, R. D.; Smith, N.; Heywood, P.; Wilson, A. E.

1996-01-01

OBJECTIVES--To estimate the proportion of interventions in general practice that are based on evidence from clinical trials and to assess the appropriateness of such an evaluation. DESIGN--Retrospective review of case notes. SETTING--One suburban training general practice. SUBJECTS--122 consecutive doctor-patient consultations over two days. MAIN OUTCOME MEASURES--Proportions of interventions based on randomised controlled trials (from literature search with Medline, pharmaceutical databases, and standard textbooks), on convincing non-experimental evidence, and without substantial evidence. RESULTS--21 of the 122 consultations recorded were excluded due to insufficient data; 31 of the interventions were based on randomised controlled trial evidence and 51 based on convincing non-experimental evidence. Hence 82/101 (81%) of interventions were based on evidence meeting our criteria. CONCLUSIONS--Most interventions within general practice are based on evidence from clinical trials, but the methods used in such trials may not be the most appropriate to apply to this setting. PMID:8608291

Faster PET reconstruction with a stochastic primal-dual hybrid gradient method

NASA Astrophysics Data System (ADS)

Ehrhardt, Matthias J.; Markiewicz, Pawel; Chambolle, Antonin; Richtárik, Peter; Schott, Jonathan; Schönlieb, Carola-Bibiane

2017-08-01

Image reconstruction in positron emission tomography (PET) is computationally challenging due to Poisson noise, constraints and potentially non-smooth priors-let alone the sheer size of the problem. An algorithm that can cope well with the first three of the aforementioned challenges is the primal-dual hybrid gradient algorithm (PDHG) studied by Chambolle and Pock in 2011. However, PDHG updates all variables in parallel and is therefore computationally demanding on the large problem sizes encountered with modern PET scanners where the number of dual variables easily exceeds 100 million. In this work, we numerically study the usage of SPDHG-a stochastic extension of PDHG-but is still guaranteed to converge to a solution of the deterministic optimization problem with similar rates as PDHG. Numerical results on a clinical data set show that by introducing randomization into PDHG, similar results as the deterministic algorithm can be achieved using only around 10 % of operator evaluations. Thus, making significant progress towards the feasibility of sophisticated mathematical models in a clinical setting.

Thermo-cured glass ionomer cements in restorative dentistry.

PubMed

Gorseta, Kristina; Glavina, Domagoj

2017-01-01

Numerous positive properties of glass ionomer cements including biocompatibility, bioactivity, releasing of fluoride and good adhesion to hard dental tissue even under wet conditions and easy of handling are reasons for their wide use in paediatric and restorative dentistry. Their biggest drawbacks are the weaker mechanical properties. An important step forward in improving GIC's features is thermo-curing with the dental polymerization unit during setting of the material. Due to their slow setting characteristics the GIC is vulnerable to early exposure to moisture. After thermo curing, cements retain all the benefits of GIC with developed better mechanical properties, improved marginal adaptation, increased microhardness and shear bond strength. Adding external energy through thermocuring or ultrasound during the setting of conventional GIC is crucial to achieve faster and better initial mechanical properties. Further clinical studies are needed to confirm these findings.

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.

Clinical teaching with emotional intelligence: A teaching toolbox

PubMed Central

Omid, Athar; Haghani, Fariba; Adibi, Peyman

2016-01-01

Background: Emotional intelligence (EI) helps humans to perceive their own and others’ emotions. It helps to make better interpersonal communication that consequently leads to an increase in everyday performance and professional career. Teaching, particularly teaching in the clinical environment, is among the professions that need a high level of EI due to its relevance to human interactions. Materials and Methods: We adopted EI competencies with characteristics of a good clinical teacher. As a result, we extracted 12 strategies and then reviewed the literatures relevant to these strategies. Results: In the present article, 12 strategies that a clinical teacher should follow to use EI in her/his teaching were described. Conclusion: To apply EI in clinical settings, a teacher should consider all the factors that can bring about a more positive emotional environment and social interactions. These factors will increase students’ learning, improve patients’ care, and maintain her/his well-being. In addition, he/she will be able to evaluate her/his teaching to improve its effectiveness. PMID:27904573

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

PubMed

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

2018-01-01

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

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

PubMed Central

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

2018-01-01

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

British Orthodontic Society national audit of temporary anchorage devices (TADs): report of the first thousand TADs placed.

PubMed

Bearn, David R; Alharbi, Fahad

2015-09-01

To provide data from the British Orthodontic Society (BOS) national clinical audit on temporary anchorage device (TAD) use following the recommendations of the National Institute for Health and Clinical Excellence (NIHCE) Design and setting: The Audit commenced on 1 January 2008 and is still ongoing. This article reports the data for TADs placed from 1 January 2008 to 1 November 2013. Audit data was collected from participants using a system of both on-line data entry and hard copy forms. The criteria and standards for the audit were set following the NIHCE report in conjunction with the Development and Standards Committee of the BOS. Virtually all participants used the on-line data entry available on the BOS website. The data submitted was checked and entered manually into an Excel spreadsheet, and transferred to SPSS for analysis. Written information and documented discussion of risks were provided in over 90% of TADs placed, but 17.4% were placed without a specific signed consent form. Temporary anchorage device failure rate was 24.2% overall. Among failed TADs, 93.1% were lost or removed due to excess mobility. Infection or inflammation resulting in loss or removal was reported in 6% of TADs. The only audit standard that was met was failures due to infection of inflammation. The rest of the audit standards were not met. Recommendations are made to address these issues.

Concurrent hyperthyroidism and papillary thyroid cancer: a fortuitous and ambiguous case report from a resource-poor setting.

PubMed

Kadia, Benjamin Momo; Dimala, Christian Akem; Bechem, Ndemazie Nkafu; Aroke, Desmond

2016-07-26

Concurrent thyroid cancer (TC) and hyperthyroidism (HT) is rare though increasingly being reported. HT due to TC is much rarer and more challenging especially in Africa where TC and HT have significant case fatality rates. We present a 37-year-old Cameroonian female who had been on irregular regimens of propranolol and digoxin as treatment for worsening palpitations for 12 months. She came to our district hospital for her propranolol medication refill. We fortuitously identified features of HT and found a left uninodular goiter with no cervical lymphadenopathy. She was referred for thyroid assessment which suggested primary HT and an enlarged heterogeneous left lobe with a well-defined homogenous solid mass. We restarted her on propranolol and referred her for a course of methimazole. At the referral hospital, she also underwent a left thyroid lobectomy. The resected lobe was sent for histopathology which revealed a neoplastic nodule with features suggestive of a papillary thyroid cancer (PTC) causing HT. The patient's clinical progress postoperatively was good and there was regression of hyperthyroid symptoms. The historical, clinical, and laboratory findings were suggestive of HT due to PTC. A high index of suspicion, prompt referral and counter-referral lead to a positive outcome of such a rare case in a resource poor setting. We advocate for systematic and careful evaluation of all thyroid nodules.

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges.

PubMed

Angel, Juana; Steele, A Duncan; Franco, Manuel A

2014-01-01

Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

Arterial Spin Labeling: a one-stop-shop for measurement of brain perfusion in the clinical settings.

PubMed

Golay, Xavier; Petersen, Esben T; Zimine, Ivan; Lim, Tchoyoson C C

2007-01-01

Arterial Spin Labeling (ASL) has opened a unique window into the human brain function and perfusion physiology. Altogether fast and of intrinsic high spatial resolution, ASL is a technique very appealing not only for the diagnosis of vascular diseases, but also in basic neuroscience for the follow-up of small perfusion changes occurring during brain activation. However, due to limited signal-to-noise ratio and complex flow kinetics, ASL is one of the more challenging disciplines within magnetic resonance imaging. In this paper, the theoretical background and main implementations of ASL are revisited. In particular, the different uses of ASL, the pitfalls and possibilities are described and illustrated using clinical cases.

The impacts of a pharmacist-managed outpatient clinic and chemotherapy-directed electronic order sets for monitoring oral chemotherapy.

PubMed

Battis, Brandon; Clifford, Linda; Huq, Mostaqul; Pejoro, Edrick; Mambourg, Scott

2017-12-01

Objectives Patients treated with oral chemotherapy appear to have less contact with the treating providers. As a result, safety, adherence, medication therapy monitoring, and timely follow-up may be compromised. The trend of treating cancer with oral chemotherapy agents is on the rise. However, standard clinical guidance is still lacking for prescribing, monitoring, patient education, and follow-up of patients on oral chemotherapy across the healthcare settings. The purpose of this project is to establish an oral chemotherapy monitoring clinic, to create drug and lab specific provider order sets for prescribing and lab monitoring, and ultimately to ensure safe and effective treatment of the veterans we serve. Methods A collaborative agreement was reached among oncology pharmacists, a pharmacy resident, two oncologists, and a physician assistant to establish a pharmacist-managed oral chemotherapy monitoring clinic at the VA Sierra Nevada Healthcare System. Drug-specific electronic order sets for prescribing and lab monitoring were created for initiating new drug therapy and prescription renewal. The order sets were created to be provider-centric, minimizing clicks needed to order necessary medications and lab monitoring. A standard progress note template was developed for documenting interventions made by the clinic. Patients new to an oral chemotherapy regimen were first counseled by an oncology pharmacist. The patients were then enrolled into the oral chemotherapy monitoring clinic for subsequent follow up and pharmacist interventions. Further, patients lacking monitoring or missing provider appointments were captured through a Clinical Dashboard developed by the US Department of Veterans Affairs (VA) Regional Office (VISN21) using SQL Server Reporting Services. Between September 2014 and April 2015, a total of 68 patients on different oral chemotherapy agents were enrolled into the clinic. Results Out of the 68 patients enrolled into the oral chemotherapy monitoring clinic, 31 patients (45%) were identified as having a therapy-related problem with their oral chemotherapy regimen on a gross measure for safety and appropriateness of medication management during the course of eight months follow-up between September 2014 and April 2015. In addition, the clinic helped to reestablish care for three patients (4.4%) who were lost to follow-up. The clinic identified 12 patients (17.6%) non-adherent to their prescribed regimen in some degree, where patients were suspected to miss doses due to delay in refilling prescriptions at least three days later than the expected date. However, these patients denied non-adherence. Among them, six patients (8.8%) were truly non-adherent. These patients stated that they had missed at least one day of therapy or were not taking the medication as prescribed. Medication regimen errors were discovered for five patients, accounting for a 7.3% medication-related error rate. Finally, seven patients (10.3%) were found to have an adverse reaction attributed to their oral chemotherapy. Two of them (2.9%) developed severe adverse reactions (Grade 3 and 4), which required hospitalization or immediate dose de-escalation. Conclusions The pilot clinic was able to identify current deficiencies and gaps in our practice settings for managing oral chemotherapy in a Veterans population. The oral chemotherapy monitoring clinic played a proactive role to identify preventable medication errors, monitor medication therapy, improve adherence, manage adverse drug reactions and re-establish care for patients who were lost to follow-up. The results suggest that close monitoring and follow-up of patients on oral chemotherapy is crucial to achieve therapeutic goals, improve patient safety and adherence, and to reduce drug adverse events and health care cost.

Evaluation of a new 240-μm single-use holmium:YAG optical fiber for flexible ureteroscopy.

PubMed

Khemees, Tariq A; Shore, David M; Antiporda, Michael; Teichman, Joel M H; Knudsen, Bodo E

2013-04-01

Numerous holmium:yttrium-aluminum-garnet laser fibers are available for flexible ureteroscopy. Performance and durability of fibers can vary widely among different manufacturers and their product lines with differences within a single product line have been reported. We sought to evaluate a newly developed nontapered, single-use 240-μm fiber, Flexiva™ 200 (Boston Scientific, Natick, MA), during clinical use and in a bench-testing model. A total of 100 new fibers were tested after their use in 100 consecutive flexible ureteroscopic lithotripsy procedures by a single surgeon (B.K.). Prospectively recorded clinical parameters were laser pulse energy and frequency settings, total energy delivered and fibers failure. Subsequently, each fiber was bench-tested using an established protocol. Parameters evaluated for were fibers true diameter, flexibility, tip degradation, energy transmission in straight and 180° bend configuration and fibers failure threshold with stress testing. The mean total energy delivered was 2.20 kJ (range 0-18.24 kJ) and most common laser settings used were 0.8 J at 8 Hz, 0.2 J at 50 Hz, and 1.0 J at 10 Hz, respectively. No fiber fractured during clinical procedures. The true fiber diameter was 450 μm. Fiber tips burnt back an average of 1.664 mm, but were highly variable. With laser setting of 400 mJ at 5 Hz, the mean energy transmitted was 451 and 441 mJ in straight and 180° bend configuration, respectively. Thirteen percent of fibers fractured at the bend radius of 0.5 cm with a positive correlation to the total energy transmitted during clinical use identified. Fiber performance was consistent in terms of energy transmission and resistance to fracture when activated in bent configuration. Fiber failure during stress testing showed significant correlation with the total energy delivered during the clinical procedure. The lack of fiber fracture during clinical use may reduce the risk of flexible endoscope damage due to fiber failure.

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.

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

Appropriateness of tumor marker request: a case of study

PubMed Central

Trevisiol, Chiara; Fabricio, Aline S. C.

2017-01-01

Appropriateness is crucial to provide efficient and high-quality health services at affordable costs. Laboratory medicine is a sector of special interest for the investigation of inappropriateness, due to the high rate of technological innovation and its pivotal role in many diseases and clinical settings. Some subjective aspects related to either the patient or physician seem to have a major role on inappropriateness rates. Given the psychological impact of cancer on both patients and physicians, tumor markers represent a case of study for appropriateness. The assessment of inappropriateness of laboratory tests has been focused mainly on ordering patterns. Appropriateness can barely be appraised by matching the requested test with the clinical problem because clinical information on the test requisition form is usually inadequate. Monitoring inappropriateness through individual clinical information may be feasible in inpatient (clinical data are available), while an indirect approach should be used for outpatients. To estimate inappropriateness in outpatients our group developed innovative models based on comparison between the actually ordered and expected requests of tumor marker, calculated according to recommendations of clinical practice guidelines (CPGs) applied to figures of cancer prevalence. The implementation of the model at national scale in Italy led to recognize a very high rate of overordering of tumor markers. The model was further focused by a dedicated algorithm to be adapted to different clinical conditions or organizational settings by applying performance indicators to cohort-wide structured information in electronic health records (EHRs). With this novel approach, we showed that inappropriateness is multifaceted even within the specific category of tumour markers. The model was effective in identifying both over- and underordering. Implementation of evidence based information and monitoring their impact on the clinical practice are parts of the same, multistage, process aimed at the progressive improvement of health care. PMID:28758100

Cartilage defect repair in horses: Current strategies and recent developments in regenerative medicine of the equine joint with emphasis on the surgical approach.

PubMed

Cokelaere, Stefan; Malda, Jos; van Weeren, René

2016-08-01

Chondral and osteochondral lesions due to injury or other pathology are highly prevalent conditions in horses (and humans) and commonly result in the development of osteoarthritis and progression of joint deterioration. Regenerative medicine of articular cartilage is an emerging clinical treatment option for patients with articular cartilage injury or disease. Functional articular cartilage restoration, however, remains a major challenge, but the field is progressing rapidly and there is an increasing body of supportive clinical and scientific evidence. This review gives an overview of the established and emerging surgical techniques employed for cartilage repair in horses. Through a growing insight in surgical cartilage repair possibilities, surgeons might be more stimulated to explore novel techniques in a clinical setting. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry].

PubMed

Baumbauer, E

1996-01-01

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.

[Organising an investigation site: a national training reference document].

PubMed

Cornu, Catherine; David, Frédérique; Duchossoy, Luc; Hansel-Esteller, Sylvie; Bertoye, Pierre-Henri; Giacomino, Alain; Mouly, Stéphane; Diebolt, Vincent; Blazejewski, Sylvie

2014-01-01

Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation. This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation. The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Clinical analysis of aqueductal stenosis in patients with hydrocephalus in a Kenyan setting.

PubMed

Kaur, Loyal Poonamjeet; Munyiri, Nderitu Joseph; Dismus, Wekesa Vincent

2017-01-01

Aqueductal stenosis is the commonest cause of congenital hydrocephalus. The scope of this paper is to highlight the disease burden of hydrocephalus attributed to aqueductal stenosis which still remains unknown in our setting. In a descriptive cross-sectional study, 258 records of patients diagnosed with hydrocephalus were analyzed after ethical approval from Kenyatta National Hospital- University of Nairobi (KNH-UON) ethics and research committee from January 2010 to May 2016. Patients with a diagnosis of hydrocephalus due to aqueductal stenosis were included in this study. Patients age, sex, mode of delivery, associated comorbidities, presenting complaints, neurosurgical intervention performed, Kafarnosky score were recorded. Data were divided into 2 sets based on the patient's age i.e. whether < 1 year or > 12 years. Data were recorded on google data collection form and analyzed using Google spreadsheets. Out of 258 cases of hydrocephalus, 52 had aqueductal stenosis. Male to female sex ratio for this condition was 3:2. There were 25 cases < 1year and 27 cases > 12 years old who were diagnosed with hydrocephalus due to aqueductal stenosis. Associated conditions were bilateral congenital talipes equinovarus, spina bifida, Arnold Chairi malformations, meningitis and HIV. The presenting complaints differed according to the age groups. Neurosurgical interventions included Endoscopic Third Ventriculostomy (ETV) in 21 cases, insertion of Ventriculoperitoneal (VP) shunt and ETV were done in 3 cases while the rest had only insertion of VP shunt. The Kafanosky score improve from < 50 pre-op to 19 cases achieving a score of 100, six months post-op. Aqueductal stenosis contributes a significant burden of morbidity in patients with hydrocephalus. Clinical presentation differs according to patients age. Accurate diagnosis and treatment remain a cardinal to improving patient outcome.

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

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.

The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso.

PubMed

Tinto, Halidou; Valea, Innocent; Sorgho, Hermann; Tahita, Marc Christian; Traore, Maminata; Bihoun, Biébo; Guiraud, Issa; Kpoda, Hervé; Rouamba, Jérémi; Ouédraogo, Sayouba; Lompo, Palpouguini; Yara, Sandrine; Kabore, William; Ouédraogo, Jean-Bosco; Guiguemdé, Robert Tinga; Binka, Fred N; Ogutu, Bernhards

2014-03-22

The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population. Within five years (2008-2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community's quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment. Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in resource-poor settings, well beyond the task of generating expected study data.

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

PubMed

Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

2017-12-04

Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Rapid evaluation by lung-cardiac-inferior vena cava (LCI) integrated ultrasound for differentiating heart failure from pulmonary disease as the cause of acute dyspnea in the emergency setting

PubMed Central

2012-01-01

Background Rapid and accurate diagnosis and management can be lifesaving for patients with acute dyspnea. However, making a differential diagnosis and selecting early treatment for patients with acute dyspnea in the emergency setting is a clinical challenge that requires complex decision-making in order to achieve hemodynamic balance, improve functional capacity, and decrease mortality. In the present study, we examined the screening potential of rapid evaluation by lung-cardiac-inferior vena cava (LCI) integrated ultrasound for differentiating acute heart failure syndromes (AHFS) from primary pulmonary disease in patients with acute dyspnea in the emergency setting. Methods Between March 2011 and March 2012, 90 consecutive patients (45 women, 78.1 ± 9.9 years) admitted to the emergency room of our hospital for acute dyspnea were enrolled. Within 30 minutes of admission, all patients underwent conventional physical examination, rapid ultrasound (lung-cardiac-inferior vena cava [LCI] integrated ultrasound) examination with a hand-held device, routine laboratory tests, measurement of brain natriuretic peptide, and chest X-ray in the emergency room. Results The final diagnosis was acute dyspnea due to AHFS in 53 patients, acute dyspnea due to pulmonary disease despite a history of heart failure in 18 patients, and acute dyspnea due to pulmonary disease in 19 patients. Lung ultrasound alone showed a sensitivity, specificity, negative predictive value, and positive predictive value of 96.2, 54.0, 90.9, and 75.0%, respectively, for differentiating AHFS from pulmonary disease. On the other hand, LCI integrated ultrasound had a sensitivity, specificity, negative predictive value, and positive predictive value of 94.3, 91.9, 91.9, and 94.3%, respectively. Conclusions Our study demonstrated that rapid evaluation by LCI integrated ultrasound is extremely accurate for differentiating acute dyspnea due to AHFS from that caused by primary pulmonary disease in the emergency setting. PMID:23210515

Design of a surface plasmon resonance immunoassay for therapeutic drug monitoring of amikacin.

PubMed

Losoya-Leal, Adrian; Estevez, M-Carmen; Martínez-Chapa, Sergio O; Lechuga, Laura M

2015-08-15

The therapeutic drug monitoring (TDM) of pharmaceutical drugs with narrow therapeutic ranges is of great importance in the clinical setting. It provides useful information towards the enhancement of drug therapies, aiding in dosage control and toxicity risk management. Amikacin is an aminoglycoside antibiotic commonly used in neonatal therapies that is indicated for TDM due to the toxicity risks inherent in its use. Current techniques for TDM such as high performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS) are costly, time consuming, and cannot be performed at the site of action. Over the last decades, surface plasmon resonance (SPR) biosensors have become increasingly popular in clinical diagnostics due to their ability to detect biomolecular interactions in real-time. We present an SPR-based competitive immunoassay for the detection of the antibiotic amikacin, suitable for TDM in both adults and neonates. We have obtained high specificity and sensitivity levels with an IC50 value of 1.4ng/mL and a limit of detection of 0.13ng/mL, which comfortably comply with the drug's therapeutic range. Simple dilution of serum can therefore be sufficient to analyze low-volume real samples from neonates, increasing the potential of the methodology for TDM. Compared to current TDM conventional methods, this SPR-based immunoassay can provide advantages such as simplicity, potential portability, and label-free measurements with the possibility of high throughput. This work is the foundation towards the development of an integrated, simple use, highly sensitive, fast, and point-of-care sensing platform for the opportune TDM of antibiotics and other drugs in a clinical setting. Copyright © 2015 Elsevier B.V. All rights reserved.

Self-administered hearing loss screening using an interactive, tablet play audiometer with ear bud headphones.

PubMed

Yeung, Jeffrey C; Heley, Sophie; Beauregard, Yves; Champagne, Sandra; Bromwich, Matthew A

2015-08-01

The timely diagnosis and treatment of acquired hearing loss in the pediatric population has significant implications for a child's development. Audiological assessment in children, however, carries both technological and logistical challenges. Typically, specialized methods (such as play audiometry) are required to maintain the child's attention and can be resource intensive. These challenges were previously addressed by a novel, calibrated, interactive play audiometer for Apple(®) iOS(®) called "ShoeBOX Audiometry". This device has potential applications for deployment in environments where traditional clinical audiometry is either unavailable or impractical. The objective of this study was to assess the screening capability of the tablet audiometer in an uncontrolled environment using consumer ear-bud headphones. Consecutive patients presenting to the Audiology Clinic at the Children's Hospital of Eastern Ontario (ages 4 and older) were recruited. Participants' hearing was evaluted using the tablet audiometer calibrated to Apple(®) In-Ear headphones. The warble tone thresholds obtained were compared to gold standard measurements taken with a traditional clinical audiometer inside a soundbooth. 80 patients were enrolled. The majority of participants were capable of completing an audiologic assessment using the tablet computer. Due to ambient noise levels outside a soundbooth, thresholds obtained at 500Hz were not consistent with traditional audiometry. Excluding 500Hz threholds, the tablet audiometer demonstrated strong negative predictive value (89.7%) as well as strong sensitivity (91.2%) for hearing loss. Thresholds obtained in an uncontrolled setting are not reflective of diagnostic thresholds due to the uncalibrated nature of the headphones and variability of the setting without a booth. Nevertheless, the tablet audiometer proved to be both a valid and sensitive instrument for unsupervised screening of warble-tone thresholds in children. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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.

[Pharmacogenomics of the first-line treatment for gastric cancer: advances in the identification of genomic biomarkers for clinical response to chemotherapy].

PubMed

Castro-Rojas, Carlos; Ortiz-Lópezj, Rocío; Rojas-Martínez, Augusto

2014-06-01

Gastric cancer (GC) is often diagnosed at later stages due to the lack of specificity of symptoms associated with the neoplasm, causing high mortality rates worldwide. The first line of adjuvant and neoadjuvant treatment includes cytotoxic fluoropyrimidines and platin-containing compounds which cause the formation of DNA adducts. The clinical outcome with these antineoplastic agents depends mainly on tumor sensitivity, which is conditioned by the expression level of the drug targets and the DNA-repair system enzymes. In addition, some germ line polymorphisms, in genes linked to drug metabolism and response to chemotherapy, have been associated with poor responses and the development of adverse effects, even with fatal outcomes in GC patients. The identification of genomic biomarkers, such as individual gene polymorphisms or differential expression patterns of specific genes, in a patient-by-patient context with potential clinical application is the main focus of current pharmacogenomic research, which aims at developing a rational and personalized therapy (i.e., a therapy that ensures maximum efficacy with no predictable side effects). However, because of the future application of genomic technologies in the clinical setting, it is necessary to establish the prognostic value of these genomic biomarkers with genotype-phenotype association studies and to evaluate their prevalence in the population under treatment. These issues are important for their cost-effectiveness evaluation, which determines the feasibility of using these medical genomic research products for GC treatment in the clinical setting.

Using re-randomization to increase the recruitment rate in clinical trials - an assessment of three clinical areas.

PubMed

Kahan, Brennan C

2016-12-13

Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.

Acceptability and clinical outcomes of first- and second-trimester surgical abortion by suction aspiration in Colombia.

PubMed

DePiñeres, Teresa; Baum, Sarah; Grossman, Daniel

2014-09-01

Since partial decriminalization of abortion in Colombia, Oriéntame has provided legal abortion services through 15 weeks gestation in an outpatient primary care setting. We sought to document the safety and acceptability of the second trimester compared to the first-trimester surgical abortion in this setting. This was a prospective cohort study using a consecutive sample of 100 women undergoing surgical first-trimester abortion (11 weeks 6 days gestational age or less) and 200 women undergoing second-trimester abortion (12 weeks 0 days-15 weeks 0 days) over a 5-month period in 2012. After obtaining informed consent, a trained interviewer collected demographic and clinical information from direct observation and the patient's clinical chart. The interviewer asked questions after the procedure regarding satisfaction with the procedure, physical pain and emotional discomfort. Fifteen days later, the interviewer assessed satisfaction with the procedure and any delayed complications. There were no major complications and seven minor complications. Average measured blood loss was 37.87 mL in the first trimester and 109 mL in the second trimester (p<.001). Following the procedure, more second-trimester patients reported being very satisfied (81% vs. 94%, p=.006). Satisfaction was similar between groups at follow-up. There were no differences in reported emotional discomfort after the procedure or at follow-up, with the majority reporting no emotional discomfort. The majority of women (99%) stated that they would recommend the clinic to a friend or family member. Second-trimester surgical abortion in an outpatient primary care setting in Colombia can be provided safely, and satisfaction with these services is high. This is one of the first studies from Latin America, a region with a high proportion of maternal mortality due to unsafe abortion, which documents the safety and acceptability of surgical abortion in an outpatient primary care setting. Findings could support increased access to safe abortion services, particularly in the second trimester. Copyright © 2014 Elsevier Inc. All rights reserved.

Apatinib for metastatic breast cancer in non-clinical trial setting: Satisfying efficacy regardless of previous anti-angiogenic treatment.

PubMed

Lin, Ying; Wu, Zheng; Zhang, Jian; Hu, Xichun; Wang, Zhonghua; Wang, Biyun; Cao, Jun; Wang, Leiping

2017-06-01

Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2. This study aimed to evaluate the efficacy and safety of apatinib in metastatic breast cancer (MBC) under non-clinical trial setting, and to study the impact of previous antiangiogenic treatment to the efficacy of apatinib. 52 MBC patients treated with apatinib under non-clinical trial setting in Fudan University Shanghai Cancer Center between January 1st 2015 and October 1st 2016 were included. All patients were included in time-to-treatment failure (TTF) analysis, while 45 patients were enrolled for progression-free survival (PFS) and overall survival (OS) analysis because 7 of the patients with treatment discontinuation due to intolerable toxicities had too short time for efficacy assessment. Impact of previous exposure to antiangiogenic treatment and other factors to patients' survival were analyzed by Log-rank analysis and Cox multivariate analysis. The median PFS, median OS, and median TTF were 4.90 (95% confidence interval [CI] 3.44 - 6.36), 10.3 (unable to calculate 95% CI), and 3.93 (95% CI 1.96 - 5.90) months, respectively. Previous treatment of bevacizumab did not affect the efficacy of apatinib. Previous exposure to anthracycline, age of 60 years or older and palmar-plantar erythrodysesthesia syndrome were independent predictors for prolonged PFS. Discontinuation of treatment was more common in age group of 60 years or older than that in younger group, although the difference was not significant. Although toxicities were generally managable, a previously unrecorded grade 3~4 adverse event of dyspnea has been observed. This study confirmed the encouraging efficacy and manageable safety of apatinib on pretreated MBC patients in non-clinical trial setting. For the first time to our knowledge, this study found that previous treatment of bevacizumab did not affect the efficacy of apatinib, and reported an undocumented severe adverse effect of dyspnea.

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2012-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability, and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22382386

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2013-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22394228

Error mapping controller: a closed loop neuroprosthesis controlled by artificial neural networks.

PubMed

Pedrocchi, Alessandra; Ferrante, Simona; De Momi, Elena; Ferrigno, Giancarlo

2006-10-09

The design of an optimal neuroprostheses controller and its clinical use presents several challenges. First, the physiological system is characterized by highly inter-subjects varying properties and also by non stationary behaviour with time, due to conditioning level and fatigue. Secondly, the easiness to use in routine clinical practice requires experienced operators. Therefore, feedback controllers, avoiding long setting procedures, are required. The error mapping controller (EMC) here proposed uses artificial neural networks (ANNs) both for the design of an inverse model and of a feedback controller. A neuromuscular model is used to validate the performance of the controllers in simulations. The EMC performance is compared to a Proportional Integral Derivative (PID) included in an anti wind-up scheme (called PIDAW) and to a controller with an ANN as inverse model and a PID in the feedback loop (NEUROPID). In addition tests on the EMC robustness in response to variations of the Plant parameters and to mechanical disturbances are carried out. The EMC shows improvements with respect to the other controllers in tracking accuracy, capability to prolong exercise managing fatigue, robustness to parameter variations and resistance to mechanical disturbances. Different from the other controllers, the EMC is capable of balancing between tracking accuracy and mapping of fatigue during the exercise. In this way, it avoids overstressing muscles and allows a considerable prolongation of the movement. The collection of the training sets does not require any particular experimental setting and can be introduced in routine clinical practice.

Error mapping controller: a closed loop neuroprosthesis controlled by artificial neural networks

PubMed Central

Pedrocchi, Alessandra; Ferrante, Simona; De Momi, Elena; Ferrigno, Giancarlo

2006-01-01

Background The design of an optimal neuroprostheses controller and its clinical use presents several challenges. First, the physiological system is characterized by highly inter-subjects varying properties and also by non stationary behaviour with time, due to conditioning level and fatigue. Secondly, the easiness to use in routine clinical practice requires experienced operators. Therefore, feedback controllers, avoiding long setting procedures, are required. Methods The error mapping controller (EMC) here proposed uses artificial neural networks (ANNs) both for the design of an inverse model and of a feedback controller. A neuromuscular model is used to validate the performance of the controllers in simulations. The EMC performance is compared to a Proportional Integral Derivative (PID) included in an anti wind-up scheme (called PIDAW) and to a controller with an ANN as inverse model and a PID in the feedback loop (NEUROPID). In addition tests on the EMC robustness in response to variations of the Plant parameters and to mechanical disturbances are carried out. Results The EMC shows improvements with respect to the other controllers in tracking accuracy, capability to prolong exercise managing fatigue, robustness to parameter variations and resistance to mechanical disturbances. Conclusion Different from the other controllers, the EMC is capable of balancing between tracking accuracy and mapping of fatigue during the exercise. In this way, it avoids overstressing muscles and allows a considerable prolongation of the movement. The collection of the training sets does not require any particular experimental setting and can be introduced in routine clinical practice. PMID:17029636

Diagnostic criteria for CRPS I: differences between patient profiles using three different diagnostic sets.

PubMed

Perez, Roberto S G M; Collins, Susan; Marinus, Johan; Zuurmond, Wouter W A; de Lange, Jaap J

2007-11-01

Complex Regional Pain Syndrome type I (CRPS I) is an illness which usually occurs due to major or minor tissue injury to the extremities. Because a unique pathophysiological mechanism for CRPS I has not yet been established, the diagnosis is based on observation and measurement of clinical symptoms and signs. In this study, a comparison was made between three sets of diagnostic criteria (the IASP, Bruehl et al. and Veldman et al.) based on patient reports and physicians' assessments of signs and symptoms associated with CRPS I, in 372 outpatients suspected of having CRPS I. Agreement between CRPS I diagnosis among the three sets was poor (kappa-range: 0.29-0.42), leading to positive CRPS I diagnoses according to Veldman et al.'s criteria in 218 cases (59%), according to the IASP in 268 cases (72%), and according to Bruehl et al. in 129 cases (35%). Significant differences in patient profiles were found between the diagnostic sets for the number of patients reporting continuing disproportionate pain, larger area affected than the initial trauma (both p<0.001), increase of symptoms due to exercise (p=0.009), edema (p=0.015), temperature asymmetry (p=0.015), hyperesthesia, allodynia (both p<0.001) and hyperalgesia (p=0.036). Similarly, significant differences emerged for physicians' observations of hyperesthesia and allodynia (both p<0.001). Highest combined values of sensitivity (SE) and specificity (SP) for the strongest cases of presence (n=108) or absence (n=62) of CRPS I were found for reported hyperesthesia (SE+SP:165%), allodynia (160%), observed color asymmetry (162%), hyperesthesia (157%), temperature asymmetry (154%) and edema (152%). The lack of agreement between the different diagnostic sets for CRPS I and the different clinical profiles that result from it may lead to different therapeutic and study populations, hampering adequate treatment and scientific development for this illness. We propose explicit reference to diagnostic criteria used in studies, and registration in trials of a broad variety of CRPS I features, as used in this study, to make subgroup phenotyping and post hoc analyses based on different diagnostic criteria possible.

Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM).

PubMed

Sciagrà, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J; Slart, Riemer H J A; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Übleis, Christopher; Hacker, Marcus

2016-07-01

Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice.

Fully automated atlas-based hippocampal volumetry for detection of Alzheimer's disease in a memory clinic setting.

PubMed

Suppa, Per; Anker, Ulrich; Spies, Lothar; Bopp, Irene; Rüegger-Frey, Brigitte; Klaghofer, Richard; Gocke, Carola; Hampel, Harald; Beck, Sacha; Buchert, Ralph

2015-01-01

Hippocampal volume is a promising biomarker to enhance the accuracy of the diagnosis of dementia due to Alzheimer's disease (AD). However, whereas hippocampal volume is well studied in patient samples from clinical trials, its value in clinical routine patient care is still rather unclear. The aim of the present study, therefore, was to evaluate fully automated atlas-based hippocampal volumetry for detection of AD in the setting of a secondary care expert memory clinic for outpatients. One-hundred consecutive patients with memory complaints were clinically evaluated and categorized into three diagnostic groups: AD, intermediate AD, and non-AD. A software tool based on open source software (Statistical Parametric Mapping SPM8) was employed for fully automated tissue segmentation and stereotactical normalization of high-resolution three-dimensional T1-weighted magnetic resonance images. Predefined standard masks were used for computation of grey matter volume of the left and right hippocampus which then was scaled to the patient's total grey matter volume. The right hippocampal volume provided an area under the receiver operating characteristic curve of 84% for detection of AD patients in the whole sample. This indicates that fully automated MR-based hippocampal volumetry fulfills the requirements for a relevant core feasible biomarker for detection of AD in everyday patient care in a secondary care memory clinic for outpatients. The software used in the present study has been made freely available as an SPM8 toolbox. It is robust and fast so that it is easily integrated into routine workflow.

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.

Improving Participants’ Retention in a Smoking Cessation Intervention Using a Community-based Participatory Research Approach

PubMed Central

Estreet, Anthony; Apata, Jummai; Kamangar, Farin; Schutzman, Christine; Buccheri, Jane; O’Keefe, Anne-Marie; Wagner, Fernando; Sheikhattari, Payam

2017-01-01

Background: This study compares participant’ sretention in three phases of smoking cessation interventions, one provided in a health clinic and the subsequent two in community-based settings. Methods: Smoking cessation interventions were conducted in three phases from 2008 to 2015 in two underserved urban communities with low socioeconomic profiles and high rates of smoking (n = 951). Phase I was conducted in a clinic; Phases II and III were conducted in community venues. In Phases II and III, incremental changes were made based on lessons learned from the previous phases. Retention (attending six or more sessions) was the primary predictor of cessation and was analyzed while controlling for associated factors including age, gender, race, employment, education, and nicotine dependence. Results: Retention increased substantially over the three phases, with rates for attending six or more sessions of 13.8%, 51.9%, and 67.9% in Phases I, II, and III, respectively. Retention was significantly higher in community settings than in the clinic setting (adjusted odds ratio [OR] = 6.7; 95% confidence intervals [CI] = 4.6, 9.8). In addition to the intervention in community venues, predictors of retention included age and unemployment. Higher retention was significantly associated with higher quit rates (adjusted OR = 2.4; 95% CI = 1.5, 3.8). Conclusions: Conducting the intervention in community settings using trained peer motivators rather than health-care providers resulted in significantly higher retention and smoking cessation rates. This was due in part to the ability to tailor cessation classes in the community for specific populations and improving the quality of the intervention based on feedback from participants and community partners. PMID:29416835

Use of thermo‐coagulation as an alternative treatment modality in a ‘screen‐and‐treat’ programme of cervical screening in rural Malawi

PubMed Central

Kafwafwa, Savel; Brown, Hilary; Walker, Graeme; Madetsa, Belito; Deeny, Miriam; Kabota, Beatrice; Morton, David; Ter Haar, Reynier; Grant, Liz; Cubie, Heather A.

2016-01-01

The incidence of cervical cancer in Malawi is the highest in the world and projected to increase in the absence of interventions. Although government policy supports screening using visual inspection with acetic acid (VIA), screening provision is limited due to lack of infrastructure, trained personnel, and the cost and availability of gas for cryotherapy. Recently, thermo‐coagulation has been acknowledged as a safe and acceptable procedure suitable for low‐resource settings. We introduced thermo‐coagulation for treatment of VIA‐positive lesions as an alternative to cryotherapy within a cervical screening service based on VIA, coupled with appropriate, sustainable pathways of care for women with high‐grade lesions and cancers. Detailed planning was undertaken for VIA clinics, and approvals were obtained from the Ministry of Health, Regional and Village Chiefs. Educational resources were developed. Thermo‐coagulators were introduced into hospital and health centre settings, with theoretical and practical training in safe use and maintenance of equipment. A total of 7,088 previously unscreened women attended VIA clinics between October 2013 and March 2015. Screening clinics were held daily in the hospital and weekly in the health centres. Overall, VIA positivity was 6.1%. Almost 90% received same day treatment in the hospital setting, and 3‐ to 6‐month cure rates of more than 90% are observed. Thermo‐coagulation proved feasible and acceptable in this setting. Effective implementation requires comprehensive training and provider support, ongoing competency assessment, quality assurance and improvement audit. Thermo‐coagulation offers an effective alternative to cryotherapy and encouraged VIA screening of many more women. PMID:27006131

Use of thermo-coagulation as an alternative treatment modality in a 'screen-and-treat' programme of cervical screening in rural Malawi.

PubMed

Campbell, Christine; Kafwafwa, Savel; Brown, Hilary; Walker, Graeme; Madetsa, Belito; Deeny, Miriam; Kabota, Beatrice; Morton, David; Ter Haar, Reynier; Grant, Liz; Cubie, Heather A

2016-08-15

The incidence of cervical cancer in Malawi is the highest in the world and projected to increase in the absence of interventions. Although government policy supports screening using visual inspection with acetic acid (VIA), screening provision is limited due to lack of infrastructure, trained personnel, and the cost and availability of gas for cryotherapy. Recently, thermo-coagulation has been acknowledged as a safe and acceptable procedure suitable for low-resource settings. We introduced thermo-coagulation for treatment of VIA-positive lesions as an alternative to cryotherapy within a cervical screening service based on VIA, coupled with appropriate, sustainable pathways of care for women with high-grade lesions and cancers. Detailed planning was undertaken for VIA clinics, and approvals were obtained from the Ministry of Health, Regional and Village Chiefs. Educational resources were developed. Thermo-coagulators were introduced into hospital and health centre settings, with theoretical and practical training in safe use and maintenance of equipment. A total of 7,088 previously unscreened women attended VIA clinics between October 2013 and March 2015. Screening clinics were held daily in the hospital and weekly in the health centres. Overall, VIA positivity was 6.1%. Almost 90% received same day treatment in the hospital setting, and 3- to 6-month cure rates of more than 90% are observed. Thermo-coagulation proved feasible and acceptable in this setting. Effective implementation requires comprehensive training and provider support, ongoing competency assessment, quality assurance and improvement audit. Thermo-coagulation offers an effective alternative to cryotherapy and encouraged VIA screening of many more women. © 2016 The Authors International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

Improving efficiency and saving money in an otolaryngology urgent referral clinic.

PubMed

Ibrahim, Nader; Virk, Jagdeep; George, Jason; Elmiyeh, Behrad; Singh, Arvind

2015-06-16

A closed loop audit of the ear nose and throat (ENT) urgent referral clinic at a London hospital was conducted assessing the number of patients reviewed, referral source, appropriateness of referral, presenting complaint and assigned follow-up appointments. Data was sourced from clinic letters and the patient appointment system over a 3-mo period. The initial cycle analysed 490 patients and the subsequent cycle 396. The initial audit yielded clinically relevant and cost effective recommendations which were implemented, and the audit cycle was subsequently repeated. The re-audit demonstrated decreased clinic numbers from an average 9.8 to 7.2 patients per clinic, in keeping with ENT United Kingdom guidelines. A 21% decrease in patient follow-up and 13% decrease in inappropriate referrals was achieved. Direct bookings into outpatient clinics decreased by 8%, due to correct referral pathway utilisation. Comparisons of all data sets were found to show statistical significance P < 0.05. We reported a total financial saving of £32490 in a period of 3 mo (£590 per clinic). We demonstrated that simple guidelines, supervision and consultant-led education which are non-labour intensive can have a significant impact on service provision and cost.

Development and validation of an instrument to measure nurse educator perceived confidence in clinical teaching.

PubMed

Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

2017-12-01

Teaching nursing in clinical environments is considered complex and multi-faceted. Little is known about the role of the clinical nurse educator, specifically the challenges related to transition from clinician, or in some cases, from newly-graduated nurse to that of clinical nurse educator, as occurs in developing countries. Confidence in the clinical educator role has been associated with successful transition and the development of role competence. There is currently no valid and reliable instrument to measure clinical nurse educator confidence. This study was conducted to develop and psychometrically test an instrument to measure perceived confidence among clinical nurse educators. A multi-phase, multi-setting survey design was used. A total of 468 surveys were distributed, and 363 were returned. Data were analyzed using exploratory and confirmatory factor analyses. The instrument was successfully tested and modified in phase 1, and factorial validity was subsequently confirmed in phase 2. There was strong evidence of internal consistency, reliability, content, and convergent validity of the Clinical Nurse Educator Skill Acquisition Assessment instrument. The resulting instrument is applicable in similar contexts due to its rigorous development and validation process. © 2017 The Authors. Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.

Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.

PubMed

Takeshima, Fuminao; Yoshikawa, Daisuke; Higashi, Syuntaro; Morisaki, Tomohito; Oda, Hidetoshi; Ikeda, Maho; Machida, Haruhisa; Matsushima, Kayoko; Minami, Hitomi; Akazawa, Yuko; Yamaguchi, Naoyuki; Ohnita, Ken; Isomoto, Hajime; Ueno, Masato; Nakao, Kazuhiko

2016-07-29

There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study. We evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated. In 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months. ADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.

Clinically Identified Postpartum Depression in Asian American Mothers

PubMed Central

Goyal, Deepika; Wang, Elsie J.; Shen, Jeremy; Wong, Eric C.; Palaniappan, Latha P.

2015-01-01

Objective To identify the clinical diagnosis rate of postpartum depression (PPD) in Asian American subgroups (Asian Indian, Chinese, Filipino, Japanese, Korean, Vietnamese) compared to non-Hispanic Whites. Design Cross-sectional study using electronic health records (EHR). Setting A large, outpatient, multiservice clinic in Northern California. Participants A diverse clinical population of non-Hispanic White (N = 4582), Asian Indian (N = 1264), Chinese (N = 1160), Filipino (N = 347), Japanese (N = 124), Korean (N = 183), and Vietnamese (N = 147) mothers. Methods Cases of PPD were identified from EHRs using physician diagnosis codes, medication usage, and age standardized for comparison. The relationship between PPD and other demographic variables (race/ethnicity, maternal age, delivery type, marital status, and infant gender) were examined in a multivariate logistic regression model. Results The PPD diagnosis rate for all Asian American mothers in aggregate was significantly lower than the diagnosis rate in non-Hispanic White mothers. Moreover, of the six Asian American subgroups, PPD diagnosis rates for Asian Indian, Chinese, and Filipino mothers were significantly lower than non-Hispanic White mothers. In multivariate analyses, race/ethnicity, age, and cesarean were significant predictors of PPD. Conclusion In this insured population, PPD diagnosis rates were lower among Asian Americans, with variability in rates across the individual Asian American subgroups. It is unclear whether these lower rates are due to underreporting, underdiagnosis, or underutilization of mental health care in this setting. PMID:22536783

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

PubMed

Jason, Leonard A; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L; Strand, Elin Bolle

2017-01-01

The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch's F tests and Games-Howell post hoc tests were conducted. Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study.

Point-of-Care Diagnostics for Improving Maternal Health in South Africa

PubMed Central

Mashamba-Thompson, Tivani P.; Sartorius, Benn; Drain, Paul K.

2016-01-01

Improving maternal health is a global priority, particularly in high HIV-endemic, resource-limited settings. Failure to use health care facilities due to poor access is one of the main causes of maternal deaths in South Africa. “Point-of-care” (POC) diagnostics are an innovative healthcare approach to improve healthcare access and health outcomes in remote and resource-limited settings. In this review, POC testing is defined as a diagnostic test that is carried out near patients and leads to rapid clinical decisions. We review the current and emerging POC diagnostics for maternal health, with a specific focus on the World Health Organization (WHO) quality-ASSURED (Affordability, Sensitivity, Specificity, User friendly, Rapid and robust, Equipment free and Delivered) criteria for an ideal point-of-care test in resource-limited settings. The performance of POC diagnostics, barriers and challenges related to implementing POC diagnostics for maternal health in rural and resource-limited settings are reviewed. Innovative strategies for overcoming these barriers are recommended to achieve substantial progress on improving maternal health outcomes in these settings. PMID:27589808

Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography

PubMed Central

Byers, Robert A.; Maiti, Raman; Danby, Simon G.; Pang, Elaine J.; Mitchell, Bethany; Carré, Matt J.; Lewis, Roger; Cork, Michael J.; Matcher, Stephen J.

2018-01-01

Measurement of sub-clinical atopic dermatitis (AD) is important for determining how long therapies should be continued after clinical clearance of visible AD lesions. An important biomarker of sub-clinical AD is epidermal hypertrophy, the structural measures of which often make optical coherence tomography (OCT) challenging due to the lack of a clearly delineated dermal-epidermal junction in AD patients. Alternatively, angiographic OCT measurements of vascular depth and morphology may represent a robust biomarker for quantifying the severity of clinical and sub-clinical AD. To investigate this, angiographic data sets were acquired from 32 patients with a range of AD severities. Deeper vascular layers within skin were found to correlate with increasing clinical severity. Furthermore, for AD patients exhibiting no clinical symptoms, the superficial plexus depth was found to be significantly deeper than healthy patients at both the elbow (p = 0.04) and knee (p<0.001), suggesting that sub-clinical changes in severity can be detected. Furthermore, the morphology of vessels appeared altered in patients with severe AD, with significantly different vessel diameter, length, density and fractal dimension. These metrics provide valuable insight into the sub-clinical severity of the condition, allowing the effects of treatments to be monitored past the point of clinical remission. PMID:29675335

Nurse manager and student nurse perceptions of the use of personal smartphones or tablets and the adjunct applications, as an educational tool in clinical settings.

PubMed

McNally, George; Frey, Rosemary; Crossan, Michael

2017-03-01

Personally owned handheld referencing technology such as smartphones or tablets, and the adjunct applications (apps) that can be used on them, are becoming a part of everyday life for the New Zealand population. In common with the population at large, student nurses have embraced this technology since the advent of the Apple iPhone in 2010. Little is known internationally or in New Zealand about the way student nurses may apply personally owned handheld referencing technology to their education process. The perceptions of New Zealand nurse managers, toward personally owned handheld referencing technology, could not be located. Using a qualitative descriptive methodology, semi structured interviews were conducted with New Zealand student nurses (n = 13), and nurse managers (n = 5) about their perceptions of use of personally owned handheld referencing technology as an educational tool in clinical settings. A thematic analysis was conducted on the resulting text. Student nurses said they wanted to use their own handheld referencing technology to support clinical decisions. Nurse managers perceived the use of personally owned handheld referencing technology as unprofessional, and do not trust younger cohorts of student nurses to act ethically when using this technology. This research supports historical research findings from the student perspective about the usefulness of older hand held referencing devices to augment clinical decisions. However, due to perceptions held by nurse mangers regarding professional behaviour, safety and the perceived institutional costs of managing personally owned handheld referencing technology, the practice may remain problematic in the studied setting. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

An eight-year clinic experience with clozapine use in a Parkinson's disease clinic setting.

PubMed

Hack, Nawaz; Fayad, Sarah M; Monari, Erin H; Akbar, Umer; Hardwick, Angela; Rodriguez, Ramon L; Malaty, Irene A; Romrell, Janet; Shukla, Aparna A Wagle; McFarland, Nikolaus; Ward, Herbert E; Okun, Michael S

2014-01-01

To examine our eight year clinic-based experience in a Parkinson's disease expert clinical care center using clozapine as a treatment for refractory psychosis in Parkinson's disease (PD). The study was a retrospective chart review which covered eight years of clozapine registry use. Statistical T-tests, chi-square, correlations and regression analysis were used to analyze treatment response for potential associations of age, disease duration, and Hoehn & Yahr (H&Y) score, and degree of response to clozapine therapy. There were 36 participants included in the analysis (32 PD, 4 parkinsonism-plus). The characteristics included 30.6% female, age 45-87 years (mean 68.3±10.15), disease duration of 17-240 months (mean 108.14±51.13) and H&Y score of 2 to 4 (mean 2.51±0.51). The overall retention rate on clozapine was 41% and the most common reasons for discontinuation were frequent blood testing (28%), nursing home (NH) placement (11%) and leucopenia (8%). Responses to clozapine across the cohort were: complete (33%), partial (33%), absent (16%), and unknown (16%). Age (r = -0.36, p<0.01) and H&Y score (r = -0.41, p<0.01) were shown to be related to response to clozapine therapy, but disease duration was not an associated factor (r = 0.21, p>0.05). This single-center experience highlights the challenges associated with clozapine therapy in PD psychosis. Frequent blood testing remains a significant barrier for clozapine, even in patients with therapeutic benefit. Surprisingly, all patients admitted to a NH discontinued clozapine due to logistical issues of administration and monitoring within that setting. Consideration of the barriers to clozapine therapy will be important to its use and to its continued success in an outpatient setting.

A qualitative examination of women's self-presentation and social physique anxiety during injury rehabilitation.

PubMed

Driediger, Molly V; McKay, Carly D; Hall, Craig R; Echlin, Paul S

2016-12-01

To understand women's self-presentation experiences in the rehabilitation setting, and their attitudes and preferences toward the social and physical features of the rehabilitation environment. Qualitative study. Outpatient physiotherapy clinic. Ten women (age 18 to 64) with high social physique anxiety (Social Physique Anxiety Scale score ≥25) referred for physiotherapy following acute injury. Semi-structured interviews were conducted prior to commencement of treatment, and again after a third treatment session. Participants experienced extensive self-presentational concerns that were intensified due to the nature of the physiotherapy environment. The women reported that their self-presentational anxiety did not diminish over time, and was related to others' negative perceptions regarding their physical appearance and inability to perform exercises as well as expected. The presence of men or younger women in the clinic was identified as a barrier to appointment attendance, along with open concept clinic settings, which were associated with the most potential for evaluation. Mirrors and windows in the physiotherapy clinic were highlighted as anxiety provoking. The women suggested that they would feel apprehensive about advocating for themselves if they felt uncomfortable with the area in which they were receiving treatment, and instead used avoidance coping strategies (e.g., hiding behind equipment, preventing eye contact) to manage their anxiety. Physique-anxious women experience extensive self-presentational concerns in the rehabilitation environment, which could affect treatment adherence. Modifying the treatment setting, providing protective self-presentational strategies such as positive self-talk, and open patient-therapist communication could be implemented to help mitigate these concerns. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Exploring threats to generalisability in a large international rehabilitation trial (AVERT)

PubMed Central

Bernhardt, Julie; Raffelt, Audrey; Churilov, Leonid; Lindley, Richard I; Speare, Sally; Ancliffe, Jacqueline; Katijjahbe, Md Ali; Hameed, Shahul; Lennon, Sheila; McRae, Anna; Tan, Dawn; Quiney, Jan; Williamson, Hannah C; Collier, Janice; Dewey, Helen M; Donnan, Geoffrey A; Langhorne, Peter; Thrift, Amanda G

2015-01-01

Objective The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT). Design AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. Setting Acute stroke units at 44 hospitals in 8 countries. Participants The first 20 000 patients screened for AVERT, of whom 1158 were recruited and randomised. Model We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment. Results The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65). Conclusions A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247). PMID:26283667

Defining new guidelines for screening the 22q11.2 deletion based on a clinical and dysmorphologic evaluation of 194 individuals and review of the literature.

PubMed

Monteiro, Fabíola P; Vieira, Társis P; Sgardioli, Ilária C; Molck, Miriam C; Damiano, Ana Paula; Souza, Josiane; Monlleó, Isabella L; Fontes, Marshall I B; Fett-Conte, Agnes C; Félix, Têmis M; Leal, Gabriela F; Ribeiro, Erlane M; Banzato, Claudio E M; Dantas, Clarissa de R; Lopes-Cendes, Iscia; Gil-da-Silva-Lopes, Vera Lúcia

2013-07-01

The 22q11.2 deletion is the most frequent interstitial deletion in humans and presents a wide phenotypic spectrum, with over 180 clinical manifestations described. Distinct studies have detected frequencies of the deletion ranging from 0 % to 75 %, depending on the studied population and selection criteria adopted. Due to the lack of consensus in this matter, several studies have been conducted aiming to define which patients would be eligible for screening; however, the issue is still up for debate. In order to contribute to the delineation of possible clinical and dysmorphologic guidelines to optimize decision making in the clinical setting, 194 individuals with variable features of the 22q11.2 deletion syndromes (22q11.2DS) were evaluated. Group I, clinical suspicion of 22q11.2DS with palatal anomalies; Group II, clinical suspicion without palatal anomalies; Group III, cardiac malformations associated with the 22q11.2DS; and Group IV, juvenile-onset schizophrenia. Multiplex ligation-dependent probe amplification was used for screening the 22q11.2 deletion, which was detected in 45 patients (23.2 %), distributed as such: Group I, 35/101 (34.7 %); Group II, 4/18 (22.2 %); Group III, 6/52 (11.5 %); and Group IV, 0/23 (0 %). Clinical data were analyzed by frequency distribution and statistically. Based on the present results and on the review of the literature, we propose a set of guidelines for screening patients with distinct manifestations of the 22q11.2DS in order to maximize resources. In addition, we report the dysmorphic features which we found to be statistically correlated with the presence of the 22q11.2DS.

Excess cost burden of diabetes in Southern India: a clinic-based, comparative cost-of-illness study.

PubMed

Sharma, K M; Ranjani, H; Zabetian, A; Datta, M; Deepa, M; Moses, C R Anand; Narayan, K M V; Mohan, V; Ali, M K

2016-01-01

There are few data on excess direct and indirect costs of diabetes in India and limited data on rural costs of diabetes. We aimed to further explore these aspects of diabetes burdens using a clinic-based, comparative cost-of-illness study. Persons with diabetes ( n  = 606) were recruited from government, private, and rural clinics and compared to persons without diabetes matched for age, sex, and socioeconomic status ( n  = 356). We used interviewer-administered questionnaires to estimate direct costs (outpatient, inpatient, medication, laboratory, and procedures) and indirect costs [absence from (absenteeism) or low productivity at (presenteeism) work]. Excess costs were calculated as the difference between costs reported by persons with and without diabetes and compared across settings. Regression analyses were used to separately identify factors associated with total direct and indirect costs. Annual excess direct costs were highest amongst private clinic attendees (INR 19 552, US$425) and lowest amongst government clinic attendees (INR 1204, US$26.17). Private clinic attendees had the lowest excess absenteeism (2.36 work days/year) and highest presenteeism (0.06 work days/year) due to diabetes. Government clinic attendees reported the highest absenteeism (7.48 work days/year) and lowest presenteeism (-0.31 work days/year). Ten additional years of diabetes duration was associated with 11% higher direct costs ( p  < 0.001). Older age ( p  = 0.02) and longer duration of diabetes ( p  < 0.001) were associated with higher total lost work days. Excess health expenditures and lost productivity amongst individuals with diabetes are substantial and different across care settings. Innovative solutions are needed to cope with diabetes and its associated cost burdens in India.

Maximizing the probability of satisfying the clinical goals in radiation therapy treatment planning under setup uncertainty

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

Fredriksson, Albin, E-mail: albin.fredriksson@raysearchlabs.com; Hårdemark, Björn; Forsgren, Anders

2015-07-15

Purpose: This paper introduces a method that maximizes the probability of satisfying the clinical goals in intensity-modulated radiation therapy treatments subject to setup uncertainty. Methods: The authors perform robust optimization in which the clinical goals are constrained to be satisfied whenever the setup error falls within an uncertainty set. The shape of the uncertainty set is included as a variable in the optimization. The goal of the optimization is to modify the shape of the uncertainty set in order to maximize the probability that the setup error will fall within the modified set. Because the constraints enforce the clinical goalsmore » to be satisfied under all setup errors within the uncertainty set, this is equivalent to maximizing the probability of satisfying the clinical goals. This type of robust optimization is studied with respect to photon and proton therapy applied to a prostate case and compared to robust optimization using an a priori defined uncertainty set. Results: Slight reductions of the uncertainty sets resulted in plans that satisfied a larger number of clinical goals than optimization with respect to a priori defined uncertainty sets, both within the reduced uncertainty sets and within the a priori, nonreduced, uncertainty sets. For the prostate case, the plans taking reduced uncertainty sets into account satisfied 1.4 (photons) and 1.5 (protons) times as many clinical goals over the scenarios as the method taking a priori uncertainty sets into account. Conclusions: Reducing the uncertainty sets enabled the optimization to find better solutions with respect to the errors within the reduced as well as the nonreduced uncertainty sets and thereby achieve higher probability of satisfying the clinical goals. This shows that asking for a little less in the optimization sometimes leads to better overall plan quality.« less

Angelman syndrome with uniparental disomy due to paternal meiosis II nondisjunction.

PubMed

Gyftodimou, J; Karadima, G; Pandelia, E; Vassilopoulos, D; Petersen, M B

1999-06-01

We report a case of Angelman syndrome (AS) with paternal uniparental disomy (pUPD) of chromosome 15. This 6-year-old girl with overgrowth had frequent, but only provoked laughter, was mildly ataxic with limb hypertonia, and had no intelligible speech. She had deep-set eyes, protruding tongue, and prominent chin. The karyotype was normal. DNA analysis with microsatellites from chromosome 15 showed no inheritance of maternal alleles both within and outside the AS critical region. Proximal markers showed reduction to homozygosity of paternal alleles, intermediate markers showed nonreduction, and distal markers reduction, thus suggesting a meiosis II nondisjunction event in the father with two crossovers. This is, to our knowledge, the first reported case of AS due to meiosis II nondisjunction. We present detailed physical measurements in this patient, adding to the clinical description of the milder phenotype in AS due to pUPD.

Noncongenital central nervous system infections in children: radiology review.

PubMed

Acosta, Jorge Humberto Davila; Rantes, Claudia Isabel Lazarte; Arbelaez, Andres; Restrepo, Feliza; Castillo, Mauricio

2014-06-01

Infections of the central nervous system (CNS) are a very common worldwide health problem in childhood with significant morbidity and mortality. In children, viruses are the most common cause of CNS infections, followed by bacterial etiology, and less frequent due to mycosis and other causes. Noncomplicated meningitis is easier to recognize clinically; however, complications of meningitis such as abscesses, infarcts, venous thrombosis, or extra-axial empyemas are difficult to recognize clinically, and imaging plays a very important role on this setting. In addition, it is important to keep in mind that infectious process adjacent to the CNS such as mastoiditis can develop by contiguity in an infectious process within the CNS. We display the most common causes of meningitis and their complications.

International collaboration for pediatric oncology nursing leadership: Nicaragua and Canada.

PubMed

Orozco, A; Marin, V; Reyes, S; Challinor, J; Carpio, B

2009-01-01

In 2005, with financial support from the Pediatric Oncology Group of Ontario, a pilot nursing leadership project linked pediatric oncology nurses from Canada with nurses at the La Mascota Hospital in Managua, Nicaragua. Following consultation with the pediatric oncology team in Nicaragua, a program was developed to strengthen clinical nursing leadership in a clinical setting through continuing education. The nurses believed that care of the patient and family improved due to the increased leadership skills of nurses in the unit and as the profile and credibility of nurses as peers in the health care team became evident. Providing nurses with the autonomy and financing for a project related directly to nursing care represented an important development for leadership in the profession.

Prolonged delirium misdiagnosed as a mood disorder.

PubMed

Cao, Fei; Salem, Haitham; Nagpal, Caesa; Teixeira, Antonio L

2017-01-01

Delirium can be conceptualized as an acute decline in cognitive function that typically lasts from hours to a few days. Prolonged delirium can also affect patients with multiple predisposing and/or precipitating factors. In clinical practice, prolonged delirium is often unrecognized, and can be misdiagnosed as other psychiatric disorders. We describe a case of a 59-year-old male presenting with behavioral and cognitive symptoms that was first misdiagnosed as a mood disorder in a general hospital setting. After prolonged delirium due to multiple factors was confirmed, the patient was treated accordingly with symptomatic management. He evolved with progressive improvement of his clinical status. Early diagnosis and management of prolonged delirium are important to improve patient prognosis and avoid iatrogenic measures.

Reproducibility of radiomics for deciphering tumor phenotype with imaging

NASA Astrophysics Data System (ADS)

Zhao, Binsheng; Tan, Yongqiang; Tsai, Wei-Yann; Qi, Jing; Xie, Chuanmiao; Lu, Lin; Schwartz, Lawrence H.

2016-03-01

Radiomics (radiogenomics) characterizes tumor phenotypes based on quantitative image features derived from routine radiologic imaging to improve cancer diagnosis, prognosis, prediction and response to therapy. Although radiomic features must be reproducible to qualify as biomarkers for clinical care, little is known about how routine imaging acquisition techniques/parameters affect reproducibility. To begin to fill this knowledge gap, we assessed the reproducibility of a comprehensive, commonly-used set of radiomic features using a unique, same-day repeat computed tomography data set from lung cancer patients. Each scan was reconstructed at 6 imaging settings, varying slice thicknesses (1.25 mm, 2.5 mm and 5 mm) and reconstruction algorithms (sharp, smooth). Reproducibility was assessed using the repeat scans reconstructed at identical imaging setting (6 settings in total). In separate analyses, we explored differences in radiomic features due to different imaging parameters by assessing the agreement of these radiomic features extracted from the repeat scans reconstructed at the same slice thickness but different algorithms (3 settings in total). Our data suggest that radiomic features are reproducible over a wide range of imaging settings. However, smooth and sharp reconstruction algorithms should not be used interchangeably. These findings will raise awareness of the importance of properly setting imaging acquisition parameters in radiomics/radiogenomics research.

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

PubMed

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-08-01

A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.

[Clinical and neurologic characteristic and principles of therapy of late-onset Myasthenia gravis].

PubMed

Kosachev, V D; Alekseeva, T M; Khalmurzina, A N

2016-01-01

In the present work the results of the clinic-epidemiological analysis of 223 patients with the onset of the myasthenia at 60 y. o. and later, admitted and treated in the clinic of neurology for the passed 25years are represented. A dynamic growth of incidence of the late-onset myasthenia through the passed 10 years was administered. We administered a prevalence of the generalized form of the myasthenia gravis (61,5 %). The whole clinical table of the myasthenia was developed during an year in 76,7 % of the cases. A wide range of the concomitant somatic pathology in this group of the patients (especially, with a cardio-vascular pathology - 93,3 %) was found to worsen the course of the myasthenia itself. We found that the set of the therapeutic measures in myasthenia in the elderly is determined by the course of the myasthenia and the multiple organ failure due to the concomitant diseases. The scheme of complex corrective therapy of myasthenia gravis in elderly was developed.

Clinical impact of migraine for the management of glaucoma patients.

PubMed

Nguyen, Bao N; Lek, Jia Jia; Vingrys, Algis J; McKendrick, Allison M

2016-03-01

Migraine is a common and debilitating primary headache disorder that affects 10-15% of the general population, particularly people of working age. Migraine is relevant to providers of clinical eye-care because migraine attacks are associated with a range of visual sensory symptoms, and because of growing evidence that the results of standard tests of visual function necessary for the diagnosis and monitoring of glaucoma (visual fields, electrophysiology, ocular imaging) can be abnormal due to migraine. These abnormalities are measureable in-between migraine events (the interictal period), despite patients being asymptomatic and otherwise healthy. This picture is further complicated by epidemiological data that suggests an increased prevalence of migraine in patients with glaucoma, particularly in patients with normal tension glaucoma. We discuss how migraine, as a co-morbidity, can confound the results and interpretation of clinical tests that form part of contemporary glaucoma evaluation, and provide practical evidence-based recommendations for the clinical testing and management of patients with migraine who attend eye-care settings. Copyright © 2015 Elsevier Ltd. All rights reserved.

Current Evidence about Nutrition Support in Cardiac Surgery Patients-What Do We Know?

PubMed

Hill, Aileen; Nesterova, Ekaterina; Lomivorotov, Vladimir; Efremov, Sergey; Goetzenich, Andreas; Benstoem, Carina; Zamyatin, Mikhail; Chourdakis, Michael; Heyland, Daren; Stoppe, Christian

2018-05-11

Nutrition support is increasingly recognized as a clinically relevant aspect of the intensive care treatment of cardiac surgery patients. However, evidence from adequate large-scale studies evaluating its clinical significance for patients’ mid- to long-term outcome remains sparse. Considering nutrition support as a key component in the perioperative treatment of these critically ill patients led us to review and discuss our understanding of the metabolic response to the inflammatory burst induced by cardiac surgery. In addition, we discuss how to identify patients who may benefit from nutrition therapy, when to start nutritional interventions, present evidence about the use of enteral and parenteral nutrition and the potential role of pharmaconutrition in cardiac surgery patients. Although the clinical setting of cardiac surgery provides advantages due to its scheduled insult and predictable inflammatory response, researchers and clinicians face lack of evidence and several limitations in the clinical routine, which are critically considered and discussed in this paper.

Use of clinical prediction rules and D-dimer tests in the diagnostic management of pregnant patients with suspected acute pulmonary embolism.

PubMed

Van der Pol, L M; Mairuhu, A T A; Tromeur, C; Couturaud, F; Huisman, M V; Klok, F A

2017-03-01

Because pregnant women have an increased risk of venous thromboembolism (VTE) and at the same time normal pregnancy is associated with symptoms, mimicking those present in the setting of acute pulmonary embolism (PE), the latter diagnosis is frequently suspected in this patient category. Since imaging tests expose both mother and foetus to ionizing radiation, the ability to rule out PE based on non-radiological diagnostic tests is of paramount importance. However, clinical decision rules have only been scarcely evaluated in the pregnant population with suspected PE, while D-dimer levels lose diagnostic accuracy due to a physiological increase during normal pregnancy. Consequently, clinical guidelines provide contradicting and weak recommendations on this subject and the optimal diagnostic strategy remains highly debated. With this systematic review, we aimed to summarize current evidence on the safety and efficacy of clinical decision rules and biomarkers used in the diagnostic management of suspected acute PE in pregnant patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Immune-based strategies for mood disorders: facts and challenges.

PubMed

Colpo, Gabriela D; Leboyer, Marion; Dantzer, Robert; Trivedi, Mahdukar H; Teixeira, Antonio L

2018-02-01

Inflammation seems to play a role in the pathophysiology of mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). In the last years several studies have shown increased levels of inflammatory and/or immune markers in patients with mood disorders. Accordingly, the immune system has become a target of interest for the development of biomarkers and therapeutics for mood disorders. Areas covered: Here, we review the evidence showing low-grade inflammation in mood disorders and the studies evaluating immune-based strategies for the treatment of these conditions. Expert commentary: Clinical trials with non-steroidal anti-inflammatory drugs, polyunsaturated acids, N-acetylcysteine, anti-cytokines, physical activity and probiotics have provided promising results in terms of antidepressant efficacy in patients with MDD and BD. Regarding stem cells, only studies with animal models have been performed so far with interesting pre-clinical results. Due to the preliminary nature of the results, most of the clinical studies need to be replicated and/or confirmed in larger clinical settings, embracing the highly heterogeneous pathophysiology of mood disorders.

Linezolid in late-chronic prosthetic joint infection caused by gram-positive bacteria.

PubMed

Cobo, Javier; Lora-Tamayo, Jaime; Euba, Gorane; Jover-Sáenz, Alfredo; Palomino, Julián; del Toro, Ma Dolores; Rodríguez-Pardo, Dolors; Riera, Melchor; Ariza, Javier

2013-05-01

Linezolid may be an interesting alternative for prosthetic joint infection (PJI) due to its bioavailability and its antimicrobial spectrum. However, experience in this setting is scarce. The aim of the study was to assess linezolid's clinical and microbiological efficacy, and also its tolerance. This was a prospective, multicenter, open-label, non-comparative study of 25 patients with late-chronic PJI caused by Gram-positive bacteria managed with a two-step exchange procedure plus 6 weeks of linezolid. Twenty-two (88%) patients tolerated linezolid without major adverse effects, although a global decrease in the platelet count was observed. Three patients were withdrawn because of major toxicity, which reversed after linezolid stoppage. Among patients who completed treatment, 19 (86%) demonstrated clinical and microbiological cure. Two patients presented with clinical and microbiological failure, and one showed clinical cure and microbiological failure. In conclusion, linezolid showed good results in chronic PJI managed with a two-step exchange procedure. Tolerance seems acceptable, though close surveillance is required. Copyright © 2013 Elsevier Inc. All rights reserved.

A phase II study of pralatrexate with vitamin B12 and folic acid supplementation for previously treated recurrent and/or metastatic head and neck squamous cell cancer.

PubMed

Ho, Alan L; Lipson, Brynna L; Sherman, Eric J; Xiao, Han; Fury, Matthew G; Apollo, Arlyn; Seetharamu, Nagashree; Sima, Camelia S; Haque, Sofia; Lyo, John K; Sales, Roberta; Cox, Lisa; Pfister, David G

2014-06-01

Pralatrexate (Fotolyn(TM); Allos Therapeutics Inc.) is an antifolate dihydrofolate reductase (DHFR) inhibitor. We conducted a phase II study of pralatrexate with folic acid and B12 supplementation in patients with recurrent and/or metastatic head and neck squamous cell cancer (R/M HNSCC). This was a single-arm, Simon optimal two stage phase II study. Patients with R/M HNSCC previously treated with chemotherapy were eligible. The study was initiated with a dosing schedule of pralatrexate 190 mg/m(2) biweekly on a 4-week cycle with vitamin supplementation. Due to toxicity concerns, the dosing was modified to 30 mg/m(2) weekly for 3 weeks in a 4-week cycle with vitamin supplementation. Radiologic imaging was to be obtained about every 2 cycles. Thirteen subjects were enrolled; 12 were treated. Seven of the twelve patients had previously received ≥2 lines of chemotherapy. The most common grade 3 toxicity was mucositis (3 patients). Seven patients did not complete two cycles of therapy due to progression of disease (4), toxicity (1), death (1), and withdrawal of consent (1). Two deaths occurred: one due to disease progression and the other was an unwitnessed event that was possibly related to pralatrexate. No clinical activity was observed. The median overall survival was 3.1 months. The study was closed early due to lack of efficacy. Pralatrexate does not possess clinical activity against previously treated R/M HNSCC. Evaluation of pralatrexate in other clinical settings of HNSCC management with special considerations for drug toxicity may be warranted.

Performance of fast-setting impression materials in the reproduction of subgingival tooth surfaces without soft tissue retraction.

PubMed

Rudolph, Heike; Röhl, Andreas; Walter, Michael H; Luthardt, Ralph G; Quaas, Sebastian

2014-01-01

Fast-setting impression materials may be prone to inaccuracies due to accidental divergence from the recommended mixing protocol. This prospective randomized clinical trial aimed to assess three-dimensional (3D) deviations in the reproduction of subgingival tooth surfaces and to determine the effect of either following or purposely diverging from the recommended mixing procedure for a fast-setting addition-curing silicone (AS) and fast-setting polyether (PE). After three impressions each were taken from 96 participants, sawcut gypsum casts were fabricated with a standardized procedure and then optically digitized. Data were assessed with a computer-aided 3D analysis. For AS impressions, multivariate analysis of variance revealed a significant influence of the individual tooth and the degree to which the recommended mixing protocol was violated. For PE impressions, the ambient air temperature and individual tooth showed significant effects, while divergence from the recommended mixing protocol was not of significance. The fast-setting PE material was not affected by changes in the recommended mixing protocol. For the two fast-setting materials examined, no divergences from the recommended mixing protocol of less than 2 minutes led to failures in the reproduction of the subgingival tooth surfaces.

The presentation of rickets to orthopaedic clinics: return of the English disease.

PubMed

Naseem, Haris; Wall, Alun P; Sangster, Marshall; Paton, Robin W

2011-04-01

Rickets is a potentially treatable disease of the bone that is most commonly due to deficiency of vitamin D and is increasing in incidence in developed countries. Risk factors include dietary factors, the practice of covering up and darker skin pigmentation. This small retrospective case study set out to examine all cases of rickets presenting to the Paediatric Orthopaedic clinic over a 15-month period. Rickets presented in a bimodal fashion in the 6 cases identified: in males and females aged 3 or less and female adolescents aged 10 and above. This is in keeping with what is known regarding the rapid phases of growth during development. Five cases were from ethnic minority groups. Both female adolescents presented with genu valgum. Rickets can present primarily to Orthopaedic clinics with vague musculoskeletal symptoms. We recommend that biochemical screening be performed on patients from ethnic minorities who may be 'at risk'.

The utility of ultra-high performance supercritical fluid chromatography-tandem mass spectrometry (UHPSFC-MS/MS) for clinically relevant steroid analysis.

PubMed

Storbeck, Karl-Heinz; Gilligan, Lorna; Jenkinson, Carl; Baranowski, Elizabeth S; Quanson, Jonathan L; Arlt, Wiebke; Taylor, Angela E

2018-05-15

Liquid chromatography tandem mass spectrometry (LC-MS/MS) assays are considered the reference standard for serum steroid hormone analyses, while full urinary steroid profiles are only achievable by gas chromatography (GC-MS). Both LC-MS/MS and GC-MS have well documented strengths and limitations. Recently, commercial ultra-high performance supercritical fluid chromatography-tandem mass spectrometry (UHPSFC-MS/MS) systems have been developed. These systems combine the resolution of GC with the high-throughput capabilities of UHPLC. Uptake of this new technology into research and clinical labs has been slow, possibly due to the perceived increase in complexity. Here we therefore present fundamental principles of UHPSFC-MS/MS and the likely applications for this technology in the clinical research setting, while commenting on potential hurdles based on our experience to date. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Utilization of gene mapping and candidate gene mutation screening for diagnosing clinically equivocal conditions: a Norrie disease case study.

PubMed

Chini, Vasiliki; Stambouli, Danai; Nedelea, Florina Mihaela; Filipescu, George Alexandru; Mina, Diana; Kambouris, Marios; El-Shantil, Hatem

2014-06-01

Prenatal diagnosis was requested for an undiagnosed eye disease showing X-linked inheritance in a family. No medical records existed for the affected family members. Mapping of the X chromosome and candidate gene mutation screening identified a c.C267A[p.F89L] mutation in NPD previously described as possibly causing Norrie disease. The detection of the c.C267A[p.F89L] variant in another unrelated family confirms the pathogenic nature of the mutation for the Norrie disease phenotype. Gene mapping, haplotype analysis, and candidate gene screening have been previously utilized in research applications but were applied here in a diagnostic setting due to the scarcity of available clinical information. The clinical diagnosis and mutation identification were critical for providing proper genetic counseling and prenatal diagnosis for this family.

Placebo effect in clinical trial design for irritable bowel syndrome.

PubMed

Shah, Eric; Pimentel, Mark

2014-04-30

Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various ap-proaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.

Clinical Guidelines for the Diagnosis and Treatment of Cushing's Disease in Korea

PubMed Central

Hur, Kyu Yeon; Kim, Jung Hee; Kim, Byung Joon; Kim, Min-Seon; Lee, Eun Jig

2015-01-01

Cushing's disease (CD) is a rare disorder characterized by the overproduction of adrenocorticotropic hormone due to a pituitary adenoma that ultimately stimulates excessive cortisol secretion from the adrenal glands. Prior to the detection of pituitary adenomas, various clinical signs of CD such as central obesity, moon face, hirsutism, and facial plethora are usually already present. Uncontrolled hypercortisolism is associated with metabolic, cardiovascular, and psychological disorders that result in increased mortality. Hence, the early detection and treatment of CD are not only important but mandatory. Because its clinical manifestations vary from patient to patient and are common in other obesity-related conditions, the precise diagnosis of CD can be problematic. Thus, the present set of guidelines was compiled by Korean experts in this field to assist clinicians with the screening, diagnoses, and treatment of patients with CD using currently available tests and treatment modalities. PMID:25827452

Video-mosaicking of in vivo reflectance confocal microscopy images for noninvasive examination of skin lesion (Conference Presentation)

NASA Astrophysics Data System (ADS)

Kose, Kivanc; Gou, Mengran; Yelamos, Oriol; Cordova, Miguel A.; Rossi, Anthony; Nehal, Kishwer S.; Camps, Octavia I.; Dy, Jennifer G.; Brooks, Dana H.; Rajadhyaksha, Milind

2017-02-01

In this report we describe a computer vision based pipeline to convert in-vivo reflectance confocal microscopy (RCM) videos collected with a handheld system into large field of view (FOV) mosaics. For many applications such as imaging of hard to access lesions, intraoperative assessment of MOHS margins, or delineation of lesion margins beyond clinical borders, raster scan based mosaicing techniques have clinically significant limitations. In such cases, clinicians often capture RCM videos by freely moving a handheld microscope over the area of interest, but the resulting videos lose large-scale spatial relationships. Videomosaicking is a standard computational imaging technique to register, and stitch together consecutive frames of videos into large FOV high resolution mosaics. However, mosaicing RCM videos collected in-vivo has unique challenges: (i) tissue may deform or warp due to physical contact with the microscope objective lens, (ii) discontinuities or "jumps" between consecutive images and motion blur artifacts may occur, due to manual operation of the microscope, and (iii) optical sectioning and resolution may vary between consecutive images due to scattering and aberrations induced by changes in imaging depth and tissue morphology. We addressed these challenges by adapting or developing new algorithmic methods for videomosaicking, specifically by modeling non-rigid deformations, followed by automatically detecting discontinuities (cut locations) and, finally, applying a data-driven image stitching approach that fully preserves resolution and tissue morphologic detail without imposing arbitrary pre-defined boundaries. We will present example mosaics obtained by clinical imaging of both melanoma and non-melanoma skin cancers. The ability to combine freehand mosaicing for handheld microscopes with preserved cellular resolution will have high impact application in diverse clinical settings, including low-resource healthcare systems.

Clinical outcomes research in gynecologic oncology.

PubMed

Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

A SOA-Based Platform to Support Clinical Data Sharing.

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the "Interoperable" Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the "Interoperable" Tier, the current solution actually covers the "Connected" Tier, due to local hospital policy restrictions.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed

Gazzarata, R; Giannini, B; Giacomini, M

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. © 2017 R. Gazzarata et al.

A SOA-Based Platform to Support Clinical Data Sharing

PubMed Central

Gazzarata, R.; Giannini, B.

2017-01-01

The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes) vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions. PMID:29065576

Customizing anaphylaxis guidelines for emergency medicine.

PubMed

Nowak, Richard; Farrar, Judith Rosen; Brenner, Barry E; Lewis, Lawrence; Silverman, Robert A; Emerman, Charles; Hays, Daniel P; Russell, W Scott; Schmitz, Natalie; Miller, Judi; Singer, Ethan; Camargo, Carlos A; Wood, Joseph

2013-08-01

Most episodes of anaphylaxis are managed in emergency medical settings, where the cardinal signs and symptoms often differ from those observed in the allergy clinic. Data suggest that low recognition of anaphylaxis in the emergency setting may relate to inaccurate coding and lack of a standard, practical definition. Develop a simple, consistent definition of anaphylaxis for emergency medicine providers, supported by clinically relevant consensus statements. Definitions of anaphylaxis and criteria for diagnosis from current anaphylaxis guidelines were reviewed with regard to their utilization in emergency medical settings. The agreed-upon working definition is: Anaphylaxis is a serious reaction causing a combination of characteristic findings, and which is rapid in onset and may cause death. It is usually due to an allergic reaction but can be non-allergic. The definition is supported by Consensus Statements, each with referenced discussion. For a positive outcome, quick diagnosis and treatment of anaphylaxis are critical. However, even in the emergency setting, the patient may not present with life-threatening symptoms. Because mild initial symptoms can quickly progress to a severe, even fatal, reaction, the first-line treatment for any anaphylaxis episode--regardless of severity--is intramuscular injection of epinephrine into the anterolateral thigh; delaying its administration increases the potential for morbidity and mortality. When a reaction appears as "possible anaphylaxis," it is generally better to err on the side of caution and administer epinephrine. We believe that this working definition and the supporting Consensus Statements are a first step to better management of anaphylaxis in the emergency medical setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Symptomatic Acute-on-Chronic Subdural Hematoma: A Clinicopathological Study.

PubMed

Castellani, Rudy J; Mojica-Sanchez, Gruschenka; Schwartzbauer, Gary; Hersh, David S

2017-06-01

The pathophysiology of acute-on-chronic subdural hematoma (ACSDH) is complex and incompletely understood. Evidence to date indicates that the overall process is initiated by rotational force with movement of the brain inside the skull, which exerts tensile strain and rupture of bridging veins, leading in turn to acute hemorrhage in the subdural potential space. This is followed by the proliferation of mesenchymal elements with angiogenesis and inflammation, which in turn becomes a substrate for repeated hemorrhage and expansion of the lesion. Given the prevalence of traumatic subdural processes in the forensic setting and the importance of proper assessment of timing, etiology, risk factors, and clinicopathological correlation, we studied 47 patients presenting to the University of Maryland Shock Trauma Center, all of whom underwent craniotomy with resection of the outer membrane due to symptomatic ACSDH. The surgically resected tissue was examined for histopathologic features in all cases. Our findings highlight that ACSDH is a condition precipitated by trauma that affects middle-aged and older adults, is relatively indolent, is unilateral or asymmetric, and has a low in-hospital mortality rate. Pathological analysis demonstrates a substantial outer membrane in all cases with varying degrees of inflammation and organization that cannot be precisely dated as a function of clinical presentation. The extrapolation of adult ACSDH to mixed acute and chronic subdural hemorrhage in the pediatric setting is problematic due to substantial differences in clinical presentation, severity of underlying brain injury, gross and microscopic findings, and outcome.

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

Ethical violations in the clinical setting: the hidden curriculum learning experience of Pakistani nurses.

PubMed

Jafree, Sara Rizvi; Zakar, Rubeena; Fischer, Florian; Zakar, Muhammad Zakria

2015-03-19

The importance of the hidden curriculum is recognised as a practical training ground for the absorption of medical ethics by healthcare professionals. Pakistan's healthcare sector is hampered by the exclusion of ethics from medical and nursing education curricula and the absence of monitoring of ethical violations in the clinical setting. Nurses have significant knowledge of the hidden curriculum taught during clinical practice, due to long working hours in the clinic and front-line interaction with patients and other practitioners. The means of inquiry for this study was qualitative, with 20 interviews and four focus group discussions used to identify nurses' clinical experiences of ethical violations. Content analysis was used to discover sub-categories of ethical violations, as perceived by nurses, within four pre-defined categories of nursing codes of ethics: 1) professional guidelines and integrity, 2) patient informed consent, 3) patient rights, and 4) co-worker coordination for competency, learning and patient safety. Ten sub-categories of ethical violations were found: nursing students being used as adjunct staff, nurses having to face frequent violence in the hospital setting, patient reluctance to receive treatment from nurses, the near-absence of consent taken from patients for most non-surgical medical procedures, the absence of patient consent taking for receiving treatment from student nurses, the practice of patient discrimination on the basis of a patient's socio-demographic status, nurses withdrawing treatment out of fear for their safety, a non-learning culture and, finally, blame-shifting and non-reportage of errors. Immediate and urgent attention is required to reduce ethical violations in the healthcare sector in Pakistan through collaborative efforts by the government, the healthcare sector, and ethics regulatory bodies. Also, changes in socio-cultural values in hospital organisation, public awareness of how to conveniently report ethical violations by practitioners and public perceptions of nurse identity are needed.

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies.

PubMed

Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E

2017-03-01

Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

Quantitative Medical Image Analysis for Clinical Development of Therapeutics

NASA Astrophysics Data System (ADS)

Analoui, Mostafa

There has been significant progress in development of therapeutics for prevention and management of several disease areas in recent years, leading to increased average life expectancy, as well as of quality of life, globally. However, due to complexity of addressing a number of medical needs and financial burden of development of new class of therapeutics, there is a need for better tools for decision making and validation of efficacy and safety of new compounds. Numerous biological markers (biomarkers) have been proposed either as adjunct to current clinical endpoints or as surrogates. Imaging biomarkers are among rapidly increasing biomarkers, being examined to expedite effective and rational drug development. Clinical imaging often involves a complex set of multi-modality data sets that require rapid and objective analysis, independent of reviewer's bias and training. In this chapter, an overview of imaging biomarkers for drug development is offered, along with challenges that necessitate quantitative and objective image analysis. Examples of automated and semi-automated analysis approaches are provided, along with technical review of such methods. These examples include the use of 3D MRI for osteoarthritis, ultrasound vascular imaging, and dynamic contrast enhanced MRI for oncology. Additionally, a brief overview of regulatory requirements is discussed. In conclusion, this chapter highlights key challenges and future directions in this area.

Pharmaceutical intervention for myopia control

PubMed Central

Ganesan, Prema; Wildsoet, Christine F

2010-01-01

Myopia is the result of a mismatch between the optical power and the length of the eye, with the latter being too long. Driving the research in this field is the need to develop myopia treatments that can limit axial elongation. When axial elongation is excessive, as in high myopia, there is an increased risk of visual impairment and blindness due to ensuing pathologies such as retinal detachments. This article covers both clinical studies involving myopic children, and studies involving animal models for myopia. Atropine, a nonselective muscarinic antagonist, has been studied most extensively in both contexts. Because it remains the only drug used in a clinical setting, it is a major focus of the first part of this article, which also covers the many shortcomings of topical ophthalmic atropine. The second part of this article focuses on in vitro and animal-based drug studies, which encompass a range of drug targets including the retina, retinal pigment epithelium and sclera. While the latter studies have contributed to a better understanding of how eye growth is regulated, no new antimyopia drug treatments have reached the clinical setting. Less conservative approaches in research, and in particular, the exploration of new bioengineering approaches for drug delivery, are needed to advance this field. PMID:21258611

Role of platelet-rich plasma in articular cartilage injury and disease.

PubMed

Mascarenhas, Randy; Saltzman, Bryan M; Fortier, Lisa A; Cole, Brian J

2015-02-01

Clinical and laboratory research aimed at biological approaches to cartilage repair are currently in high demand due to the poor regenerative capacity of articular cartilage in the setting of a diseased articular environment. Platelet-rich plasma (PRP) takes advantage of supraphysiological concentrations of platelets and their growth factors harbored in α-granules, which together attempt to return the diseased articular cartilage to a preinjury state. The local use of PRP directly at the site of cartilage injury is thought to stimulate a natural healing cascade and accelerate the formation of cartilage repair tissue. This article provides an overview of the basic science behind the use of PRP in the treatment of cartilage injury and disease. Both initial and current examples of the use of intra-articular PRP in clinical human studies are provided. These include the use of PRP either alone or as an augmentation device with various other procedures, including arthroscopic microfracture and cell-free resorbable polyglycolic acid-hyaluronan implantation. Finally, the authors describe some of the potential future roles of PRP in clinical settings based on recent literature. These include Achilles tendon rupture, chronic tendinosis, chronic rotator cuff tendinopathy or tearing, muscle injury, and meniscal repair. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Obstacles to the implementation of the treat-to-target strategy for rheumatoid arthritis in clinical practice in Japan.

PubMed

Kaneko, Yuko; Koike, Takao; Oda, Hiromi; Yamamoto, Kazuhiko; Miyasaka, Nobuyuki; Harigai, Masayoshi; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Takeuchi, Tsutomu

2015-01-01

To clarify the obstacles preventing the implementation of the treat-to-target (T2T) strategy for rheumatoid arthritis (RA) in clinical practice. A total of 301 rheumatologists in Japan completed a questionnaire. In the first section, participants were indirectly questioned on the implementation of basic components of T2T, and in the second section, participants were directly questioned on their level of agreement and application. Although nearly all participants set treatment targets for the majority of RA patients with moderate to high disease activity, the proportion who set clinical remission as their target was 59%, with only 45% of these using composite measures. The proportion of participants who monitored X-rays and Health Assessment Questionnaires for all their patients was 44% and 14%, respectively. The proportion of participants who did not discuss treatment strategies was 44%, with approximately half of these reasoning that this was due to a proportion of patients having a lack of understanding of the treatment strategy or inability to make decisions. When participants were directly questioned, there was a high level of agreement with the T2T recommendations. Although there was a high level of agreement with the T2T recommendations, major obstacles preventing its full implementation still remain.

INVESTIGATING THE MANAGEMENT OF CARIOUS PRIMARY TEETH IN GENERAL DENTAL PRACTICE: AN OVERVIEW OF THE DEVELOPMENT AND CONDUCT OF THE FICTION TRIAL.

PubMed

Stewart, Matthew; Keightley, Alexander; Maguire, Anne; Chadwick, Barbara; Vale, Luke; Homer, Tara; Douglas, Gail; Deery, Chris; Marshman, Zoe; Ryan, Vicky; Innes, Nicola

2015-11-01

The management of carious primary teeth is a challenge for patients, parents and clinicians. Most evidence supporting different management strategies originates from a specialist setting and therefore its relevance to the primary care setting is questionable. The UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) has commissioned the FiCTION (Filling Children's Teeth: Indicated Or Not?) trial; a multi-centre primary dental care randomised controlled trial (RCT) to determine the most clinically and cost- effective approach to managing caries in the primary dentition in the UK. This large trial began in 2012, is due to be completed in late 2017 and involves 72 practices and 1,124 children initially aged three to seven years with dentine caries, following randomisation to one of three caries management strategies. Clinical, radiographic, quality of life, treatment acceptability and health economics data are collected during the three-year follow up period. This article provides an overview of the development and conduct of FiCTION and discusses some approaches adopted to manage challenges and achieve the patient recruitment target.

Hard x-ray micro-tomography of a human head post-mortem as a gold standard to compare x-ray modalities

NASA Astrophysics Data System (ADS)

Dalstra, M.; Schulz, G.; Dagassan-Berndt, D.; Verna, C.; Müller-Gerbl, M.; Müller, B.

2016-10-01

An entire human head obtained at autopsy was micro-CT scanned in a nano/micro-CT scanner in a 6-hour long session. Despite the size of the head, it could still be scanned with a pixel size of 70 μm. The aim of this study was to obtain an optimal quality 3D data-set to be used as baseline control in a larger study comparing the image quality of various cone beam CT systems currently used in dentistry. The image quality of the micro-CT scans was indeed better than the ones of the clinical imaging modalities, both with regard to noise and streak artifacts due to metal dental implants. Bony features in the jaws, like the trabecular architecture and the thin wall of the alveolar bone were clearly visible. Therefore, the 3D micro-CT data-set can be used as the gold standard for linear, angular, and volumetric measurements of anatomical features in and around the oral cavity when comparing clinical imaging modalities.

A Rare Presentation of Cyclitis Induced Myopia.

PubMed

Ijaz, Umar; Habib, Asad; Rathore, Hassan Sajjad

2018-03-01

Unilateral cyclitis leading to myopia is a rare and clinical relevant entity. In clinical settings, pseudomyopia is generally encountered in the form of accommodative spasm, which is always bilateral. Cyclitis due to inflammation, on the other hand, can cause pseudomyopia unilaterally and it is a very rare presentation. A young male with acute anterior uveitis, presented with acute episode of unilateral myopia. When patient was examined on first visit, there were no cells in anterior chamber; so he was started on cycloplegic eye drops, but his condition didn't improve. Examination on subsequent visit revealed cellular reaction in anterior chamber and narrowing of anterior chamber angles on anterior segment optical coherence tomography (OCT). Treatment for uveitis was started and patient's visual acuity and refractive error improved. Pseudomyopia is a known complication of several drugs and certain medical conditions. The possible mechanism is supraciliary exudation causing relaxation of zonular fibers and increased convexity of the crystalline lens. Myopia in the setting of a mild cellular reaction can easily be missed and has not been reported yet to the best of authors' literature search.

Effective Synchronization of EEG and EMG for Mobile Brain/Body Imaging in Clinical Settings.

PubMed

Artoni, Fiorenzo; Barsotti, Annalisa; Guanziroli, Eleonora; Micera, Silvestro; Landi, Alberto; Molteni, Franco

2017-01-01

Mobile Brain/Body Imaging (MoBI) is rapidly gaining traction as a new imaging modality to study how cognitive processes support locomotion. Electroencephalogram (EEG) and electromyogram (EMG), due to their time resolution, non-invasiveness and portability are the techniques of choice for MoBI, but synchronization requirements among others restrict its use to high-end research facilities. Here we test the effectiveness of a technique that enables us to achieve MoBI-grade synchronization of EEG and EMG, even when other strategies (such as Lab Streaming Layer (LSL)) cannot be used e.g., due to the unavailability of proprietary Application Programming Interfaces (APIs), which is often the case in clinical settings. The proposed strategy is that of aligning several spikes at the beginning and end of the session. We delivered a train of spikes to the EEG amplifier and EMG electrodes every 2 s over a 10-min time period. We selected a variable number of spikes (from 1 to 10) both at the beginning and end of the time series and linearly resampled the data so as to align them. We then compared the misalignment of the "middle" spikes over the whole recording to test for jitter and synchronization drifts, highlighting possible nonlinearities (due to hardware filters) and estimated the maximum length of the recording to achieve a [-5 to 5] ms misalignment range. We demonstrate that MoBI-grade synchronization can be achieved within 10-min recordings with a 1.7 ms jitter and [-5 5] ms misalignment range. We show that repeated spike delivery can be used to test online synchronization options and to troubleshoot synchronization issues over EEG and EMG. We also show that synchronization cannot rely only on the equipment sampling rate advertised by manufacturers. The synchronization strategy described can be used virtually in every clinical environment, and may increase the interest among a broader spectrum of clinicians and researchers in the MoBI framework, ultimately leading to a better understanding of the brain processes underlying locomotion control and the development of more effective rehabilitation approaches.

Is there an optimal preoperative management strategy for phaeochromocytoma/paraganglioma?

PubMed

Challis, B G; Casey, R T; Simpson, H L; Gurnell, M

2017-02-01

Phaeochromocytomas and paragangliomas (PPGLs) are catecholamine secreting neuroendocrine tumours that predispose to haemodynamic instability. Currently, surgery is the only available curative treatment, but carries potential risks including hypertensive and hypotensive crises, cardiac arrhythmias, myocardial infarction and stroke, due to tumoral release of catecholamines during anaesthetic induction and tumour manipulation. The mortality associated with surgical resection of PPGL has significantly improved from 20-45% in the early 20th century (Apgar & Papper, AMA Archives of Surgery, 1951, 62, 634) to 0-2·9% in the early 21st century (Kinney et al. Journal of Cardiothoracic and Vascular Anesthesia, 2002, 16, 359), largely due to availability of effective pharmacological agents and advances in surgical and anaesthetic practice. However, surgical resection of PPGL still poses significant clinical management challenges. Preoperatively, alpha-adrenoceptor blockade is the mainstay of management, although various pharmacological strategies have been proposed, based largely on reports derived from retrospective data sets. To date, no consensus has been reached regarding the 'ideal' preoperative strategy due, in part, to a paucity of data from high-quality evidence-based studies comparing different treatment regimens. Here, based on the available literature, we address the Clinical Question: Is there an optimal preoperative management strategy for PPGL? © 2016 John Wiley & Sons Ltd.

Validation of the Hospital Ethical Climate Survey for older people care.

PubMed

Suhonen, Riitta; Stolt, Minna; Katajisto, Jouko; Charalambous, Andreas; Olson, Linda L

2015-08-01

The exploration of the ethical climate in the care settings for older people is highlighted in the literature, and it has been associated with various aspects of clinical practice and nurses' jobs. However, ethical climate is seldom studied in the older people care context. Valid, reliable, feasible measures are needed for the measurement of ethical climate. This study aimed to test the reliability, validity, and sensitivity of the Hospital Ethical Climate Survey in healthcare settings for older people. A non-experimental cross-sectional study design was employed, and a survey using questionnaires, including the Hospital Ethical Climate Survey was used for data collection. Data were analyzed using descriptive statistics, inferential statistics, and multivariable methods. Survey data were collected from a sample of nurses working in the care settings for older people in Finland (N = 1513, n = 874, response rate = 58%) in 2011. This study was conducted according to good scientific inquiry guidelines, and ethical approval was obtained from the university ethics committee. The mean score for the Hospital Ethical Climate Survey total was 3.85 (standard deviation = 0.56). Cronbach's alpha was 0.92. Principal component analysis provided evidence for factorial validity. LISREL provided evidence for construct validity based on goodness-of-fit statistics. Pearson's correlations of 0.68-0.90 were found between the sub-scales and the Hospital Ethical Climate Survey. The Hospital Ethical Climate Survey was found able to reveal discrimination across care settings and proved to be a valid and reliable tool for measuring ethical climate in care settings for older people and sensitive enough to reveal variations across various clinical settings. The Finnish version of the Hospital Ethical Climate Survey, used mainly in the hospital settings previously, proved to be a valid instrument to be used in the care settings for older people. Further studies are due to analyze the factor structure and some items of the Hospital Ethical Climate Survey. © The Author(s) 2014.

Cytokine Reduction in the Setting of an ARDS-Associated Inflammatory Response with Multiple Organ Failure.

PubMed

Träger, Karl; Schütz, Christian; Fischer, Günther; Schröder, Janpeter; Skrabal, Christian; Liebold, Andreas; Reinelt, Helmut

2016-01-01

A 45-year-old male was admitted to our hospital with a small bowel obstruction due to torsion and was immediately scheduled for surgical intervention. At anesthesia induction, the patient aspirated and subsequently developed a severe SIRS with ARDS and multiple organ failure requiring the use of ECMO, CRRT, antibiotics, and low dose steroids. Due to a rapid deterioration in clinical status and a concurrent surge in inflammatory biomarkers, an extracorporeal cytokine adsorber (CytoSorb) was added to the CRRT blood circuit. The combined treatment resulted in a rapid and significant reduction in the levels of circulating inflammatory mediators. This decrease was paralleled by marked clinical stabilization of the patient including a significant improvement in hemodynamic stability and a reduced need for norepinephrine and improved respiratory function as measured by PaO2/FIO2, ventilator parameters, lung mechanics, and indirect measures of capillary leak syndrome. The patient could be discharged to a respiratory weaning unit where successful respiratory weaning could be achieved later on. We attribute the clinical improvement to the rapid control of the hyperinflammatory response and the reduction of inflammatory mediators using a combination of CytoSorb and these other therapies. CytoSorb treatment was safe and well tolerated, with no device-related adverse effects observed.

Cytokine Reduction in the Setting of an ARDS-Associated Inflammatory Response with Multiple Organ Failure

PubMed Central

Träger, Karl; Schütz, Christian; Fischer, Günther; Schröder, Janpeter; Skrabal, Christian; Liebold, Andreas; Reinelt, Helmut

2016-01-01

A 45-year-old male was admitted to our hospital with a small bowel obstruction due to torsion and was immediately scheduled for surgical intervention. At anesthesia induction, the patient aspirated and subsequently developed a severe SIRS with ARDS and multiple organ failure requiring the use of ECMO, CRRT, antibiotics, and low dose steroids. Due to a rapid deterioration in clinical status and a concurrent surge in inflammatory biomarkers, an extracorporeal cytokine adsorber (CytoSorb) was added to the CRRT blood circuit. The combined treatment resulted in a rapid and significant reduction in the levels of circulating inflammatory mediators. This decrease was paralleled by marked clinical stabilization of the patient including a significant improvement in hemodynamic stability and a reduced need for norepinephrine and improved respiratory function as measured by PaO2/FIO2, ventilator parameters, lung mechanics, and indirect measures of capillary leak syndrome. The patient could be discharged to a respiratory weaning unit where successful respiratory weaning could be achieved later on. We attribute the clinical improvement to the rapid control of the hyperinflammatory response and the reduction of inflammatory mediators using a combination of CytoSorb and these other therapies. CytoSorb treatment was safe and well tolerated, with no device-related adverse effects observed. PMID:26885411

[Differential diagnosis and therapy of acute abdomen in sickle cell crisis. A rare case in visceral surgery].

PubMed

Zülke, C; Graeb, C; Rüschhoff, J; Wagner, H; Jauch, K W

2000-01-01

Surgical therapy of the acute abdomen often allows only limited time for differential diagnosis to confirm the indication for surgery. Under consideration of clinical aspects and case history both common and rare causes of an acute abdomen should be investigated without undue loss of time. Differential diagnostic considerations and eventual therapy are presented in the following case of a 25-year-old Afro-american who developed multiorgan failure after an initial course of lower-back pain. In addition to the clinical setting of an acute abdomen the patient presented with acute respiratory failure and laboratory signs of severe hemolysis in combination with newly detected splenomegaly. The indication for splenectomy was made following CT-proven complete splenic infarction due to repeated acute squestration. Histologic examination of the spleen together with hemoglobin electrophoresis confirmed the clinical assumption of unusually late primary manifestation of a sickle cell crisis. In the underlying case, the hemoglobinopathy was in fact the less common form of combined sickle-cell-beta-thalassemia. A ten-day course of intensive care therapy was necessary to treat ongoing multiorgan failure due to persistent sickle cell crisis. Current diagnostic and therapeutic procedures in connection with sickle cell crisis as a rare cause of an acute abdomen with the necessity for surgical intervention are presented.

Trauma due to Self-aggression in Patient with Waardenburg Syndrome associated with Congenital Anomalies.

PubMed

Marta, Sara Nader; Kawakami, Roberto Yoshio; Sgavioli, Claudia Almeida Prado Piccino; Correa, Ana Eliza; D'Árk de Oliveira El Kadre, Guaniara; Carvalho, Ricardo Sandri

2016-08-01

Waardenburg syndrome (WS) is an inherited autosomal dominant genetic disorder presenting variable penetrance and expressivity, with an estimated prevalence of 1:42,000. Clinical characteristics of WS include lateral displacement of the internal eye canthus, hyperplasia of the medial portion of the eyebrows, prominent and broad nasal base, congenital deafness, pigmentation of the iris and skin, and white forelock. A 24-year-old male patient, previously diagnosed with WS, was referred to the Special Needs Dental Clinic of Sacred Heart University, Bauru, Brazil. Parents reported that the patient was experiencing self-mutilation, particularly in the oral region. He presented multiple congenital anomalies, including anophthalmia, mental retardation, low-set ears, and leg deformities. Clinical oral examination revealed hypodontia, abnormalities in dental morphology, extensive dental caries, periodontal disease, and fistulae. Extensive scars on the tongue, lips, and hands caused by self-mutilation were also observed. In accordance with his family and neurologist, full-mouth extraction under general anesthesia was performed, especially considering his severe self-aggressive behavior and the necessity to be fed with soft-food diet due to his inability to chew. After the surgical procedure, a significant reduction in the patient's irritability and gain of weight were reported in the follow-ups of 30, 60, and 180 days.

Outcomes of antiretroviral therapy in a northern Indian urban clinic

PubMed Central

Dhooria, Sahajal; Prasad, KT; George, Ninoo; Ranjan, Sanjay; Gupta, Deepak; Sreenivas, Vishnubhatla; Kadhiravan, Tamilarasu; Miglani, Sunita; Sinha, Sanjeev; Wig, Naveet; Biswas, Ashutosh; Vajpayee, Madhu

2010-01-01

Abstract Problem Antiretroviral therapy (ART) programmes have been successful in several countries. However, whether they would succeed as part of a national programme in a resource-constrained setting such as India is not clear. The outcomes and specific problems encountered in such a setting have not been adequately studied. Approach We assessed the efficacy and functioning of India’s national ART programme in a tertiary care centre in northern India. All ART-naive patients started on ART between May 2005 and October 2006 were included in the study and were followed until 31 April 2008. Periodic clinical and laboratory evaluations were carried out in accordance with national guidelines. Changes in CD4+ lymphocyte count, body weight and body mass index were assessed at follow-up, and the operational problems analysed. Local setting The setting was a tertiary care centre in northern India with a mixed population of patients, mostly of low socioeconomic status. The centre is reasonably well resourced but faces constraints in health-care delivery, such as lack of adequate human resources and a high patient load. Relevant changes The response to ART in the cohort studied was comparable to that reported from other countries. However, the programme had a high attrition rate, possibly due to patient-related factors and operational constraints. Lessons learnt A high rate of attrition can affect the overall efficacy and functioning of an ART programme. Addressing the issues causing attrition might improve patient outcomes in India and in other resource-constrained countries. PMID:20428391

Parents' views and experiences of childhood obesity management in primary care: a qualitative study.

PubMed

Turner, Katrina M; Salisbury, Chris; Shield, Julian P H

2012-08-01

Primary care has been viewed as an appropriate setting for childhood obesity management. Little is known about parents' views and experiences of obesity management within this clinical setting. These views and experiences need to be explored, as they could affect treatment success. To explore parents' views and experiences of primary care as a treatment setting for childhood obesity. In-depth interviews were held with 15 parents of obese children aged 5-10 years, to explore their views and experiences of primary care childhood obesity management. Parents were contacted via a hospital-based childhood obesity clinic, general practices and Mind, Exercise, Nutrition … Do it! (MEND) groups based in Bristol, England. The interviews were audio-taped transcribed verbatim and analysed thematically. Parents viewed primary care as an appropriate setting in which to treat childhood obesity but were reluctant to consult due to a fear of being blamed for their child's weight and a concern about their child's mental well-being. They also questioned whether practitioners had the knowledge, time and resources to effectively manage childhood obesity. Parents varied in the extent to which they had found consulting a practitioner helpful, and their accounts suggested that GPs and school nurses offer different types of support. Parents need to be reassured that practitioners will address their child's weight in a non-judgemental sensitive manner and are able to treat childhood obesity effectively. A multidisciplinary team approach might benefit a child, as different practitioners may vary in the type of care they provide.

Comprehensive viral enrichment enables sensitive respiratory virus genomic identification and analysis by next generation sequencing.

PubMed

O'Flaherty, Brigid M; Li, Yan; Tao, Ying; Paden, Clinton R; Queen, Krista; Zhang, Jing; Dinwiddie, Darrell L; Gross, Stephen M; Schroth, Gary P; Tong, Suxiang

2018-06-01

Next generation sequencing (NGS) technologies have revolutionized the genomics field and are becoming more commonplace for identification of human infectious diseases. However, due to the low abundance of viral nucleic acids (NAs) in relation to host, viral identification using direct NGS technologies often lacks sufficient sensitivity. Here, we describe an approach based on two complementary enrichment strategies that significantly improves the sensitivity of NGS-based virus identification. To start, we developed two sets of DNA probes to enrich virus NAs associated with respiratory diseases. The first set of probes spans the genomes, allowing for identification of known viruses and full genome sequencing, while the second set targets regions conserved among viral families or genera, providing the ability to detect both known and potentially novel members of those virus groups. Efficiency of enrichment was assessed by NGS testing reference virus and clinical samples with known infection. We show significant improvement in viral identification using enriched NGS compared to unenriched NGS. Without enrichment, we observed an average of 0.3% targeted viral reads per sample. However, after enrichment, 50%-99% of the reads per sample were the targeted viral reads for both the reference isolates and clinical specimens using both probe sets. Importantly, dramatic improvements on genome coverage were also observed following virus-specific probe enrichment. The methods described here provide improved sensitivity for virus identification by NGS, allowing for a more comprehensive analysis of disease etiology. © 2018 O'Flaherty et al.; Published by Cold Spring Harbor Laboratory Press.

Integrating Correctional and Community Health Care: An Innovative Approach for Clinical Learning in a Baccalaureate Nursing Program.

PubMed

Bouchaud, Mary T; Swan, Beth Ann

2017-01-01

With an evolving focus on primary, community-based, and patient-centered care rather than acute, hospital-centric, disease-focused care, and recognition of the importance of coordinating care and managing transitions across providers and settings of care, registered nurses need to be prepared from a different and broader knowledge base and skills set. A culture change among nurse educators and administrators and in nursing education is needed to prepare competent registered nurses capable of practicing from a health promotion, disease prevention, community- and population-focused construct in caring for a population of patients who are presenting health problems and conditions that persist across decades and/or lifetimes. While healthcare delivery is moving from the hospital to ambulatory and community settings, community-based educational opportunities for nursing students are shrinking due to a variety of reasons, including but not limited to increased regulatory requirements, the presence of competing numbers of nursing schools and their increased enrollment of students, and decreasing availability of community resources capable and willing to precept students in an all-day interactive learning environment. A detailed discussion of one college of nursings' journey to find an innovative solution and approach to the dilemma of limited and decreasing available community clinical sites to prepare senior level prelicensure baccalaureate nursing students for healthcare practice in the twenty-first century. This article demonstrated how medium/maximum prisons can provide an ideal learning experience for not only technical nursing skills but more importantly for reinforcing key learning goals for community-based care, raising population-based awareness, and promoting cultural awareness and sensitivity. In addition, this college of nursing overcame the challenges of initiating and maintaining clinical placement in a prison facility, collaboratively developed strategies to insure student and faculty safety satisfying legal and administrative concerns for both the college of nursing and the prison, and developed educational postclinical assignments that solidified clinical course and nursing program objectives. Lastly, this college of nursing quickly learned that not only did nursing students agree to clinical placement in an all-male medium- to maximum-security prison despite its accompanying restrictive regulations especially as it relates to their access to personal technology devices, but there was an unknown desire for a unique clinical experience. The initial pilot program of placing eight senior level prelicensure baccalaureate nursing students in a 4,000-person all male medium- to maximum-security prison for their community clinical rotation has expanded to include three state-run maximum all male prisons in two states, a 3,000-person male/female federal prison, and several juvenile detention centers. Clinical placement of students in these sites is by request only, resulting in lengthy student waiting lists. This innovative approach to clinical learning has piqued the interest of graduate nurse practitioner (NP) students as well. One MSN, NP student has been placed in the federal prison every semester for over a year. Due to increasing interest from graduate students to learn correctional health nursing, the college of nursing is now expanding NP placement to the other contracted maximum-security prisons. This entire experience has changed clinical policies within a well-established academic culture and promoted creative thinking regarding how and where to clinically educate and prepare registered baccalaureate nurses for the new culture of health and wellness. © 2016 Wiley Periodicals, Inc.

Charles Bonnet syndrome: a review.

PubMed

Schadlu, Anita P; Schadlu, Ramin; Shepherd, J Banks

2009-05-01

The aging of the population and the resultant increase in the number of patients with low vision due to age-related macular degeneration and other ocular diseases necessitate an increase in awareness of the Charles Bonnet syndrome among ophthalmic care providers. The clinical features of Charles Bonnet syndrome have been described by several different authors as formed visual hallucinations due to disturbances of the visual system in patients who are otherwise mentally normal. Theories regarding the causes underlying the Charles Bonnet syndrome are multifaceted and offer insight into the function of the visual system. The incidence of the Charles Bonnet syndrome varies among different population groups, but is underdiagnosed in most settings. Recent case reports of treatment options involve varied pharmacologic interventions, but visual improvement and patient reassurance remain the mainstays of treatment. As Charles Bonnet syndrome becomes more prevalent as the population ages, all physicians who care for low vision or elderly patients should be aware of its clinical characteristics and treatment options. Understanding of this syndrome by caregivers will lead to decreased anxiety among the patients who experience it. Further exploration of treatment options will be necessary in the future.

Regenerative and rehabilitative medicine: A necessary synergy for functional recovery from volumetric muscle loss injury

PubMed Central

Greising, Sarah M.; Dearth, Christopher L.; Corona, Benjamin T.

2017-01-01

Volumetric muscle loss (VML) is a complex and heterogeneous problem due to significant traumatic or surgical loss of skeletal muscle tissue. The consequences of VML are substantial functional deficits in joint range of motion and skeletal muscle strength, resulting in life long dysfunction and disability. Traditional physical medicine and rehabilitation paradigms do not address the magnitude of force loss due to VML and related musculoskeletal co-morbidities. Recent advancements in regenerative medicine have set forth encouraging and emerging therapeutic options for VML injuries. There is significant potential that combined rehabilitative and regenerative therapies can restore limb and muscle function following VML injury in a synergistic manner. This review presents the current state of the VML field, spanning clinical and preclinical literature, with particular focus on rehabilitation and regenerative medicine in addition to their synergy. Moving forward, multidisciplinary collaboration between clinical and research fields is encouraged in order to continue to improve the treatment of VML injuries and specifically address the encompassing physiology, pathology, and specific needs of this patient population. PMID:27825146

Is the Epworth Sleepiness Scale a useful tool for screening excessive daytime sleepiness in commercial drivers?

PubMed

Baiardi, Simone; La Morgia, Chiara; Sciamanna, Lucia; Gerosa, Alberto; Cirignotta, Fabio; Mondini, Susanna

2018-01-01

The significant social and economic impact of excessive daytime sleepiness makes sleep evaluation a primary medical need in commercial drivers. However, the best screening tool is still matter of debate. In our cohort of 221 commercial drivers, only ten (4.5%) had Epworth Sleepiness Scale scores indicative of excessive daytime sleepiness. These findings and the lack of concordance in estimating excessive daytime sleepiness among commercial drivers in previous studies using the same psychometric measure indicate that the Epworth Sleepiness Scale is not a reliable tool. This may be due to the low internal consistency of the scale in non-clinical samples and the possible intentional underscoring of sleepiness due to a perceived threat of driver's license suspension. Moreover, the reliability of the Epworth Sleepiness Scale results may be strongly influenced by the administration setting. The clinical application of inexpensive less time-consuming new tools like performance tests should be considered for the objective evaluation of excessive daytime sleepiness in commercial drivers. Copyright © 2017 Elsevier Ltd. All rights reserved.

General practitioners' perceptions of the current status and pharmacists' contribution to primary care in Iceland.

PubMed

Blondal, Anna Bryndis; Jonsson, Jon Steinar; Sporrong, Sofia Kälvemark; Almarsdottir, Anna Birna

2017-08-01

Background For the past several years pharmacists' responsibilities have expanded globally from traditional tasks of dispensing medications to collaborating with other health care professionals in patient care. Similar developments have not occurred in outpatient settings in Iceland. Objective The aim of this study was to explore Icelandic general practitioners' views on the current status of primary care, their perceptions of pharmacists as a health care profession, and their attitudes towards future GP-pharmacist collaboration in primary care in Iceland. Setting Twelve primary care clinics in Iceland. Methods Semi-structured in-depth interviews were conducted with general practitioners from different primary care clinics in Iceland. A purposive and snowball sampling technique was used to select participants. All interviews were recorded and transcribed verbatim. The transcripts were categorized by themes and then analyzed using conventional content analysis. Main outcome measure General practitioners' attitudes towards pharmacists. Results Twenty general practitioners from twelve different primary care clinics in Iceland were interviewed. There are several unmet needs regarding medicines and patient monitoring in the Icelandic health care system. General practitioners suggested ways in which these gaps may be addressed and pharmacist-led clinical service was one of the suggestions. Currently, their communication with pharmacists in the primary sector solely surrounds practical non-clinical issues. Due to increasing polypharmacy and multimorbidity, they suggested that pharmacists should be more involved in patient care. Conclusions General practitioners believe that pharmacist-led clinical service can increase the quality of patient therapy. To improve communication between these health care providers, pharmacists must also re-professionalize (strengthening the profession´s status through new responsibilities and tasks), not having a conflict of interest and showing that they have expertise in patient care.

Translating knowledge into best practice care bundles: a pragmatic strategy for EBP implementation via moving postprocedural pain management nursing guidelines into clinical practice.

PubMed

Saunders, Hannele

2015-07-01

To describe quantitative and qualitative best evidence as sources for practical interventions usable in daily care delivery in order to integrate best evidence into clinical decision-making at local practice settings. To illustrate the development, implementation and evaluation of a pain management nursing care bundle based on a clinical practice guideline via a real-world clinical exemplar. Successful implementation of evidence-based practice requires consistent integration of best evidence into daily clinical decision-making. Best evidence comprises high-quality knowledge summarised in systematic reviews and translated into guidelines. However, consistent integration of guidelines into care delivery remains challenging, partly due to guidelines not being in a usable form for daily practice or relevant for the local context. A position paper with a clinical exemplar of a nurse-led, evidence-based quality improvement project to design, implement and evaluate a pain management care bundle translated from a national nursing guideline. A pragmatic approach to integrating guidelines into daily practice is presented. Best evidence from a national nursing guideline was translated into a pain management care bundle and integrated into daily practice in 15 medical-surgical (med-surg) units of nine hospitals of a large university hospital system in Finland. Translation of best evidence from guidelines into usable form as care bundles adapted to the local setting may increase implementation and uptake of guidelines and improve quality and consistency of care delivery. A pragmatic approach to translating a nursing guideline into a pain management care bundle to incorporate best evidence into daily practice may help achieve more consistent and equitable integration of guidelines into care delivery, and better quality of pain management and patient outcomes. © 2015 John Wiley & Sons Ltd.

Application of machine learning classification for structural brain MRI in mood disorders: Critical review from a clinical perspective.

PubMed

Kim, Yong-Ku; Na, Kyoung-Sae

2018-01-03

Mood disorders are a highly prevalent group of mental disorders causing substantial socioeconomic burden. There are various methodological approaches for identifying the underlying mechanisms of the etiology, symptomatology, and therapeutics of mood disorders; however, neuroimaging studies have provided the most direct evidence for mood disorder neural substrates by visualizing the brains of living individuals. The prefrontal cortex, hippocampus, amygdala, thalamus, ventral striatum, and corpus callosum are associated with depression and bipolar disorder. Identifying the distinct and common contributions of these anatomical regions to depression and bipolar disorder have broadened and deepened our understanding of mood disorders. However, the extent to which neuroimaging research findings contribute to clinical practice in the real-world setting is unclear. As traditional or non-machine learning MRI studies have analyzed group-level differences, it is not possible to directly translate findings from research to clinical practice; the knowledge gained pertains to the disorder, but not to individuals. On the other hand, a machine learning approach makes it possible to provide individual-level classifications. For the past two decades, many studies have reported on the classification accuracy of machine learning-based neuroimaging studies from the perspective of diagnosis and treatment response. However, for the application of a machine learning-based brain MRI approach in real world clinical settings, several major issues should be considered. Secondary changes due to illness duration and medication, clinical subtypes and heterogeneity, comorbidities, and cost-effectiveness restrict the generalization of the current machine learning findings. Sophisticated classification of clinical and diagnostic subtypes is needed. Additionally, as the approach is inevitably limited by sample size, multi-site participation and data-sharing are needed in the future. Copyright © 2017 Elsevier Inc. All rights reserved.

Antimicrobial Resistance Profiles and Diversity in Salmonella from Humans and Cattle, 2004-2011.

PubMed

Afema, J A; Mather, A E; Sischo, W M

2015-11-01

Analysis of long-term anti-microbial resistance (AMR) data is useful to understand source and transmission dynamics of AMR. We analysed 5124 human clinical isolates from Washington State Department of Health, 391 cattle clinical isolates from the Washington Animal Disease Diagnostic Laboratory and 1864 non-clinical isolates from foodborne disease research on dairies in the Pacific Northwest. Isolates were assigned profiles based on phenotypic resistance to 11 anti-microbials belonging to eight classes. Salmonella Typhimurium (ST), Salmonella Newport (SN) and Salmonella Montevideo (SM) were the most common serovars in both humans and cattle. Multinomial logistic regression showed ST and SN from cattle had greater probability of resistance to multiple classes of anti-microbials than ST and SN from humans (P < 0.0001). While these findings could be consistent with the belief that cattle are a source of resistant ST and SN for people, occurrence of profiles unique to cattle and not observed in temporally related human isolates indicates these profiles are circulating in cattle only. We used various measures to assess AMR diversity, conditional on the weighting of rare versus abundant profiles. AMR profile richness was greater in the common serovars from humans, although both source data sets were dominated by relatively few profiles. The greater profile richness in human Salmonella may be due to greater diversity of sources entering the human population compared to cattle or due to continuous evolution in the human environment. Also, AMR diversity was greater in clinical compared to non-clinical cattle Salmonella, and this could be due to anti-microbial selection pressure in diseased cattle that received treatment. The use of bootstrapping techniques showed that although there were shared profiles between humans and cattle, the expected and observed number of profiles was different, suggesting Salmonella and associated resistance from humans and cattle may not be wholly derived from a common population. © 2014 The Authors. Zoonoses and Public Health Published by Blackwell Verlag GmbH.

Oral Ketamine in the Palliative Care Setting: A Review of the Literature and Case Report of a Patient With Neurofibromatosis Type 1 and Glomus Tumor-Associated Complex Regional Pain Syndrome

PubMed Central

Soto, Eliezer; Stewart, Douglas R.; Mannes, Andrew J.; Ruppert, Sarah L.; Baker, Karen; Zlott, Daniel; Handel, Daniel; Berger, Ann M.

2014-01-01

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been shown to be effective not only for its anesthetic properties but also for the analgesic and opiate-sparing effects. However, data on efficacy and safety of oral ketamine for the treatment of neuropathic or cancer pain syndromes is limited with most of the evidence based on small clinical trials and anecdotal experiences. In this review, we will analyze the clinical data on oral ketamine in the palliative care setting. After an extensive search using five major databases, a total of 19 relevant articles were included. No official clinical guidelines for the use of oral ketamine in this patient population were found. Studies on oral ketamine for cancer and neuropathic pain have shown mixed results which could be partially due to significant differences in hepatic metabolism. In addition, we will include a case report of a 38-year-old female with neurofibromatosis type 1 (NF1) with history of chronic, severe pain in her fingertips secondary to multiple glomus tumors which evolved into CRPS resistant to multiple therapies but responsive to oral ketamine. Based on our experience with oral ketamine, this drug should be administered after an intravenous trial to monitor response and side effects in patients with an adequate functional status. However, patients in the palliative care and hospice setting, especially the one at the end of their lives, may also benefit from oral ketamine even if an intravenous trial is not feasible. PMID:21803784

Promoting women's health in remote Aboriginal settings: Midwifery students' insights for practice.

PubMed

Thackrah, Rosalie D; Thompson, Sandra C; Durey, Angela

2015-12-01

To describe midwifery students' insights on promoting health to Aboriginal women in remote Australia following a supervised clinical placement. Semistructured, in-depth interviews were conducted with all midwifery students who undertook the placement between 2010 and 2013. Aboriginal communities on the Ngaanyatjarra Lands, Western Australia. Undergraduate and postgraduate midwifery students from a Western Australian university. Remote cultural immersion clinical placement. Student learning related to culturally respectful health care delivery and promotion of health. Students observed that, despite vast distances, high rates of participation in a breast screening program were achieved due to the informal provision of culturally relevant information and support. Opportunistic encounters in communities also enabled sexual health messages to be delivered more widely and in less formal settings. The role played by Aboriginal Health Workers and female family members was vital. The importance of culturally respectful approaches to sensitive women's business, including discretion, the use of local language and pictorial representations of information, was recognised as was the socio-cultural context and its impact on the health and well-being of the community. Although short in duration, the Ngaanyatjarra Lands clinical placement provided midwifery students with a rare opportunity to observe the importance of local contexts and cultural protocols in Aboriginal communities, and to adapt health promotion strategies to meet local needs and ways of doing things. These strategies embraced the strengths, assets and capacities of communities, yet students also witnessed challenges associated with access, delivery and acceptance of health care in remote settings. © 2015 National Rural Health Alliance Inc.

Extended-Spectrum β-Lactamase–Producing Enterobacteriaceae in Children: Old Foe, Emerging Threat

PubMed Central

Lukac, Paul J.; Bonomo, Robert A.; Logan, Latania K.

2015-01-01

Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae present an ever-growing burden in the hospital and community settings, across all ages and demographics. Infections due to ESBL-containing pathogens continue to be associated with significant morbidity and mortality worldwide. With widespread empiric broad-spectrum β-lactam use creating selective pressure, and the resultant emergence of stable, rapidly proliferating ESBL-producing clones with continued horizontal gene transfer across genera, addressing this issue remains imperative. Although well characterized in adults, the epidemiology, risk factors, outcomes, therapies, and control measures for ESBL-producing bacteria are less appreciated in children. This analysis provides a brief summary of ESBL-producing Enterobacteriaceae in children, with a focus on recent clinical and molecular data regarding colonization and infection in nonoutbreak settings. PMID:25595742

Reconsidering the H&E stain as the gold standard in assessing the depth of burn wounds.

PubMed

Rosenberg, Arlene S

2017-12-01

While histological examination is considered by most as the gold standard for burn depth assessment, it has no practical use in the clinical setting. It has, however, been used in the research setting, as a mean for evaluating emerging techniques of depth measurement. Due to the limitations of the H&E stain, other stains have also been explored, such as lactate dehydrogenase (LDH), as presented in this issue, in "Improving the Histologic Characterization of Burn Depth." As the determination of burn depth is not a typical subject in dermatopathology, a summary of selected techniques and the possible role for the LDH stain in future research, is described herein. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[The use of conscious sedation versus general anesthesia in modern dentistry: rising ethical dilemmas].

PubMed

Ayalon, S; Gozal, Y; Kaufman, E

2004-10-01

Conscious sedation and general anesthesia have been in the use of the dental profession since the first half of the 19th century. Although seemingly appealing to use due to alleviation of pain and anxiety induced by the dental treatment, the alteration of consciousness level of dental patients is not without risk. Morbidity and mortality due to dental treatment performed under general anesthesia were investigated at the last decades of the 20th century. The mortality rates found in these investigations were surprisingly high comparing to researches of morbidity and mortality due to other medical procedures, performed under general anesthesia. Therefore, although general anesthesia is sometimes the only way to treat certain patients, maintaining strict indications for dental treatment under general anesthesia is necessary. Conscious sedation was found as a safer alternative for achieving a level of consciousness enabling dental treatment in those patients who are unable to receive treatment in normal dental clinic settings. We therefore believe that conscious sedation should be the golden standard for the treatment of those patients. The practicing of dentistry in patients who have need of dental treatment under special settings such as general anesthesia and sedation raises ethical dilemmas to the caregiver. The following review will summarize the available data on morbidity and mortality due to dental treatment given under general anesthesia and conscious sedation. The ethical questions arising from their practicing will be discussed and some answers shall be proposed.

Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials.

PubMed

Lockley, Steven W; Dressman, Marlene A; Licamele, Louis; Xiao, Changfu; Fisher, Dennis M; Flynn-Evans, Erin E; Hull, Joseph T; Torres, Rosarelis; Lavedan, Christian; Polymeropoulos, Mihael H

2015-10-31

Most totally blind people have non-24-hour sleep-wake disorder (non-24), a rare circadian rhythm disorder caused by an inability of light to reset their circadian pacemaker. In two consecutive placebo-controlled trials (SET and RESET), we assessed safety and efficacy (in terms of circadian entrainment and maintenance) of once-daily tasimelteon, a novel dual-melatonin receptor agonist. We undertook the placebo-controlled, randomised, double-masked trials in 27 US and six German clinical research centres and sleep centres. We screened totally blind adults (18-75 years of age), who were eligible for the randomisation phase of SET if they had a non-24-hour circadian period (τ) of 24·25 h or longer (95% CI greater than 24·0 and up to 24·9 h), as calculated from measurements of urinary 6-sulphatoxymelatonin rhythms. For SET, we used block randomisation to assign patients (1:1) to receive tasimelteon (20 mg) or placebo every 24 h at a fixed clock time 1 h before target bedtime for 26 weeks. Patients who entered the open-label group receiving tasimelteon in SET or who did not meet the SET inclusion criteria but did meet the RESET inclusion criteria were screened for RESET. A subset of the patients who entered the open-label group before the RESET study and who had eligible τ values were screened for RESET after completing the open-label treatment. In RESET, we withdrew tasimelteon in a randomised manner (1:1) in patients who responded (ie, entrained) after a tasimelteon run-in period. Entrainment was defined as having τ of 24·1 h or less and a 95% CI that included 24·0 h. In SET, the primary endpoint was the proportion of entrained patients, assessed in the intention-to-treat population. The planned step-down primary endpoint assessed the proportion of patients who had a clinical response (entrainment at month 1 or month 7 plus clinical improvement, measured by the Non-24 Clinical Response Scale). In RESET, the primary endpoint was the proportion of non-entrained patients, assessed in the intention-to-treat population. Safety assessments included adverse events and clinical laboratory measures, assessed in all treated patients. These trials are registered with ClinicalTrials.gov, numbers NCT01163032 and NCT01430754. Between Aug 25, 2010, and July 5, 2012, we screened 391 totally blind patients for SET, of whom 84 (22%) were assigned to receive tasimelteon (n=42) or placebo (n=42). Two patients in the tasimelteon group and four in the placebo group discontinued the study before τ was measured, due to adverse events, withdrawal of consent, and a protocol deviation. Circadian entrainment occurred in eight (20%) of 40 patients in the tasimelteon group compared with one (3%) of 38 patients in the placebo group at month 1 (difference 17%, 95% CI 3·2-31·6; p=0·0171). Nine (24%) of 38 patients showed a clinical response, compared with none of 34 in the placebo group (difference 24%, 95% CI 8·4-39·0; p=0·0028). Between Sept 15, 2011, and Oct 4, 2012, we screened 58 patients for eligibility in RESET, 48 (83%) of whom had τ assessed and entered the open-label tasimelteon run-in phase. 24 (50%) patients entrained, and 20 (34%) were enrolled in the randomisation phase. Two (20%) of ten patients who were withdrawn to placebo remained entrained compared with nine (90%) of ten who continued to receive tasimelteon (difference 70%, 95% CI 26·4-100·0; p=0·0026). No deaths were reported in either study, and discontinuation rates due to adverse events were comparable between the tasimelteon (3 [6%] of 52 patients) and placebo (2 [4%] of 52 patients) treatment courses. The most common side-effects associated with tasimelteon in SET were headache (7 [17%] of 42 patients given tasimelteon vs 3 [7%] of 42 patients given placebo), elevated liver enzymes (4 [10%] vs 2 [5%]), nightmares or abnormal dreams (4 [10%] vs none), upper respiratory tract infection (3 [7%] vs none], and urinary tract infections (3 [7%] vs 1 [2%]). Once-daily tasimelteon can entrain totally blind people with non-24; however, continued tasimelteon treatment is necessary to maintain these improvements. Vanda Pharmaceuticals. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Obstructive sleep apnea syndrome in the setting of Gorlin-Goltz syndrome].

PubMed

Grundig, H; Sinikovic, B; Günther, J; Jungehülsing, M

2013-09-01

Goltz-Gorlin syndrome is a rare autosomal dominant hereditary disease associated with a high rate of spontaneous mutation. Diagnosis is based on clinically defined major and minor criteria. The disease is caused by a gene mutation locating to chromosome 9q22-31. We report on a young Goltz-Gorlin syndrome patient with obstructive sleep apnea syndrome. Due to intolerance to continuous positive airway pressure (CPAP) therapy and in order to avoid a tracheotomy, we opted for an alternative therapy comprising interdisciplinary multi-level surgery.

Herpes simplex virus following stab phlebectomy.

PubMed

Hicks, Caitlin W; Lum, Ying Wei; Heller, Jennifer A

2017-03-01

Herpes simplex virus infection following surgery is an unusual postoperative phenomenon. Many mechanisms have been suggested, with the most likely explanation related to latent virus reactivation due to a proinflammatory response in the setting of local trauma. Here, we present a case of herpes simplex virus reactivation in an immunocompetent female following a conventional right lower extremity stab phlebectomy. Salient clinical and physical examination findings are described, and management strategies for herpes simplex virus reactivation are outlined. This is the first known case report of herpes simplex virus reactivation following lower extremity phlebectomy.

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

PubMed Central

Jason, Leonard A.; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L.; Strand, Elin Bolle

2017-01-01

Background The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. Purpose The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Methods Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch’s F tests and Games-Howell post hoc tests were conducted. Results Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Conclusion Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study. PMID:29062593

Substance Abuse-Specific Knowledge Transfer or Loss? Treatment Program Turnover versus Professional Turnover among Substance Abuse Clinicians

PubMed Central

Eby, Lillian T.; Curtis, Sara L.

2014-01-01

This longitudinal study investigated the extent to which substance abuse (SA) clinician turnover is associated with SA-specific knowledge loss due to change in professions (professional turnover) versus SA-specific knowledge transfer due to movement from one SA clinical setting to another (treatment program turnover). For this study, clinicians had to voluntarily leave their current treatment program. Eligible clinicians completed a quantitative survey while employed and a qualitative post-employment exit interview 1 year later. Compared to those that exited the SA profession (N = 99), clinicians who changed treatment programs (N = 120) had greater SA-specific formal knowledge and were more likely to be personally in recovery. No differences were found between the two groups in terms of SA-specific practical knowledge. PMID:25115318

Effect of Shufeng Jiedu capsules as a broad-spectrum antibacterial.

PubMed

Bao, Yanyan; Gao, Yingjie; Cui, Xiaolan

2016-02-01

This study sought to investigate the broad-spectrum antibacterial action of an alternative medicine, Shufeng Jiedu capsules (SFJDC). Antibacterial testing was performed to determine whether SFJDC had broad-spectrum antibacterial action in vitro, and testing was performed to verify whether SFJDC prevented death due to a Streptococcus or Staphylococcus aureus infection in mice. Results of antibacterial testing suggested that SFJDC are a broad-spectrum antibacterial and that SFJDC are superior to Lianhua Qingwen capsules as a broad-spectrum antibacterial. Results of testing revealed that SFJDC lowered the mortality rate, it reduced mortality, it increased average survival time, and it increased the lifespan of mice dying due to a Staphylococcus aureus or Streptococcus infection. Thus, SFJDC could become a complement to broad-spectrum antimicrobials in clinical settings.

Directional atherectomy of a heavy calcified axillary artery stenosis inducing critical hand ischemia.

PubMed

Anzuini, Angelo; Palloshi, Altin; Aprigliano, Gianfranco; Ielasi, Alfonso

2013-07-01

The presence of a severe calcified peripheral artery lesion is responsible for a poor response to balloon dilation, due to significant acute vessel recoil and frequent flow-limiting dissections requiring stent implantation. This possibility could be associated with very high compression and/or fracture rates particularly in cases of lesion located at the mobile joints. In this setting directional atherectomy offers the theoretical advantages of eliminating stretch injury on arterial walls and reducing the restenosis rate by direct plaque excision. In this report, we present a case of critical hand ischemia due to a heavily calcified axillary artery lesion managed by directional atherectomy and balloon angioplasty followed by immediate angiographic success and sustained clinical benefit up to 3 years of follow-up.

Time-resolved singlet-oxygen luminescence detection with an efficient and practical semiconductor single-photon detector

PubMed Central

Boso, Gianluca; Ke, Damei; Korzh, Boris; Bouilloux, Jordan; Lange, Norbert; Zbinden, Hugo

2015-01-01

In clinical applications, such as PhotoDynamic Therapy, direct singlet-oxygen detection through its luminescence in the near-infrared range (1270 nm) has been a challenging task due to its low emission probability and the lack of suitable single-photon detectors. Here, we propose a practical setup based on a negative-feedback avalanche diode detector that is a viable alternative to the current state-of-the art for different clinical scenarios, especially where geometric collection efficiency is limited (e.g. fiber-based systems, confocal microscopy, scanning systems etc.). The proposed setup is characterized with Rose Bengal as a standard photosensitizer and it is used to measure the singlet-oxygen quantum yield of a new set of photosensitizers for site-selective photodynamic therapy. PMID:26819830

Multiple molecular mechanisms for multidrug resistance transporters.

PubMed

Higgins, Christopher F

2007-04-12

The acquisition of multidrug resistance is a serious impediment to improved healthcare. Multidrug resistance is most frequently due to active transporters that pump a broad spectrum of chemically distinct, cytotoxic molecules out of cells, including antibiotics, antimalarials, herbicides and cancer chemotherapeutics in humans. The paradigm multidrug transporter, mammalian P-glycoprotein, was identified 30 years ago. Nonetheless, success in overcoming or circumventing multidrug resistance in a clinical setting has been modest. Recent structural and biochemical data for several multidrug transporters now provide mechanistic insights into how they work. Organisms have evolved several elegant solutions to ridding the cell of such cytotoxic compounds. Answers are emerging to questions such as how multispecificity for different drugs is achieved, why multidrug resistance arises so readily, and what chance there is of devising a clinical solution.

Tethered capsule endomicroscopy: from bench to bedside at a primary care practice

NASA Astrophysics Data System (ADS)

Gora, Michalina J.; Simmons, Leigh H.; Quénéhervé, Lucille; Grant, Catriona N.; Carruth, Robert W.; Lu, Weina; Tiernan, Aubrey; Dong, Jing; Walker-Corkery, Beth; Soomro, Amna; Rosenberg, Mireille; Metlay, Joshua P.; Tearney, Guillermo J.

2016-10-01

Due to the relatively high cost and inconvenience of upper endoscopic biopsy and the rising incidence of esophageal adenocarcinoma, there is currently a need for an improved method for screening for Barrett's esophagus. Ideally, such a test would be applied in the primary care setting and patients referred to endoscopy if the result is suspicious for Barrett's. Tethered capsule endomicroscopy (TCE) is a recently developed technology that rapidly acquires microscopic images of the entire esophagus in unsedated subjects. Here, we present our first experience with clinical translation and feasibility of TCE in a primary care practice. The acceptance of the TCE device by the primary care clinical staff and patients shows the potential of this device to be useful as a screening tool for a broader population.

Using an embedded reality approach to improve test reliability for NHPT tasks.

PubMed

Bowler, M; Amirabdollahian, F; Dautenhahn, K

2011-01-01

Research into the use of haptic and virtual reality technologies has increased greatly over the past decade, in terms of both quality and quantity. Methods to utilise haptic and virtual technologies with currently existing techniques for assessing impairment are underway, and, due to the commercially available equipment, has found some success in the use of these methods for individuals who suffer upper limb impairment. This paper uses the clinically validated assessment technique for measuring motor impairment: the Nine Hole Peg Test and creates three tasks with different levels of realism. The efficacy of these tasks is discussed with particular attention paid to analysis in terms of removing factors that limit a virtual environment's use in a clinical setting, such as inter-subject variation. © 2011 IEEE

Massive Ischemic Stroke Due to Pulmonary Barotrauma and Cerebral Artery Air Embolism During Commercial Air Travel

PubMed Central

Zarabi, Sara Farshchi; Parotto, Matteo; Katznelson, Rita; Downar, James

2017-01-01

Patient: Male, 65 Final Diagnosis: Air emboli Symptoms: Short of breath Medication: — Clinical Procedure: — Specialty: Anesthesiology Objective: Unusual setting of medical care Background: Air embolism into the systemic arterial circulation secondary to pulmonary barotrauma has rarely been reported. Herein, we report the clinical course of an extremely rare presentation of cerebral air embolism likely due to ruptured pulmonary bullae during commercial air travel. Case Report: A 65-year-old man suddenly became unconscious during an airplane descent. Upon landing, he was immediately transferred to the nearest emergency department where he was intubated for airway protection. His head CT angiogram showed multiple air pockets in the right parietal lobe suspicious for multiple air emboli. His chest CT scan showed multiple large bullae in the left upper and lower lobes as well as diffusely emphysematous lung tissue. After initial stabilization, he underwent emergent hyperbaric oxygen treatment (HBOT) in the multiplace chamber at 2.8 atmospheres. The patient tolerated HBOT well with no complications. However, his neurologic status deteriorated in the following 24 hours due to progression of his cerebral edema and mass effects. The patient’s clinical status was discussed with his family and the decision was made to withdraw life-sustaining measures. He died shortly after withdrawal of life support. Post-mortem examination confirmed the presence of very large bullae in the lungs bilaterally. Conclusions: Spontaneous cerebral air embolism is a possible complication of ruptured pulmonary bullae during air travel. HBOT is well-tolerated and may be used with caution even in the presence of emphysematous bullae. PMID:28607332

The Value of History, Physical Examination, and Radiographic Findings in the Diagnosis of Symptomatic Meniscal Tear among Middle-Age Subjects with Knee Pain

PubMed Central

Katz, Jeffrey N.; Smith, Savannah R.; Yang, Heidi Y.; Martin, Scott D.; Wright, John; Donnell-Fink, Laurel A.; Losina, Elena

2016-01-01

Objective To evaluate the utility of clinical history, radiographic and physical exam findings in the diagnosis of symptomatic meniscal tear (SMT) in patients over age 45, in whom concomitant osteoarthritis is prevalent. Methods In a cross-sectional study of patients from two orthopedic surgeons’ clinics we assessed clinical history, physical examination and radiographic findings in patients over 45 with knee pain. The orthopedic surgeons rated their confidence that subjects’ symptoms were due to MT; we defined the diagnosis of SMT as at least 70% confidence. We used logistic regression to identify factors independently associated with diagnosis of SMT and we used the regression results to construct an index of the likelihood of SMT. Results In 174 participants, six findings were associated independently with the expert clinician having ≥70% confidence that symptoms were due to MT: localized pain, ability to fully bend the knee, pain duration <1 year, lack of varus alignment, lack of pes planus, and absence of joint space narrowing on radiographs. The index identified a low risk group with 3% likelihood of SMT. Conclusion While clinicians traditionally rely upon mechanical symptoms in this diagnostic setting, our findings did not support the conclusion that mechanical symptoms were associated with the expert’s confidence that symptoms were due to MT. An index that includes history of localized pain, full flexion, duration <1 year, pes planus, varus alignment, and joint space narrowing can be used to stratify patients according to their risk of SMT and it identifies a subgroup with very low risk. PMID:27390312

Retail clinic utilization associated with lower total cost of care.

PubMed

Sussman, Andrew; Dunham, Lisette; Snower, Kristen; Hu, Min; Matlin, Olga S; Shrank, William H; Choudhry, Niteesh K; Brennan, Troyen

2013-04-01

To better understand the impact of retail clinic use on a patient's annual total cost of care. A propensity score matched-pair, cohort design was used to analyze healthcare spending patterns among CVS Caremark employees in the year following a visit to a MinuteClinic, the retail clinics inside CVS pharmacies. De-identified medical and pharmacy claims for CVS Caremark employees and their dependents who received care at a retail clinic between June 1, 2009, and May 31, 2010, were matched to those of subjects who received care elsewhere. High-dimensional propensity score and greedy matching techniques were used to create a 1-to-1 matched cohort that was analyzed using generalized linear regression models. Individuals using a retail clinic had a lower total cost of care (-$262; 95% confidence interval, -$510 to -$31; P = .025) in the year following their clinic visit than individuals who received care in other settings. This savings was primarily due to lower medical expenses at physicians' offices ($77 savings, P = .008) and hospital inpatient care ($121 savings, P = .049). The 6022 retail clinic users also had 142 (12%) fewer emergency department visits (P = .01), though this was not related to significant cost savings. This study found that retail clinic use was associated with lower overall total cost of care compared with that at alternative sites. Savings may extend beyond the retail clinic visit itself to other types of medical utilization.

[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.

Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: qualitative study with trialists and other stakeholders.

PubMed

Briel, Matthias; Elger, Bernice; von Elm, Erik; Satalkar, Priya

2017-11-29

Premature discontinuation occurs in about 25% of randomised clinical trials in Switzerland; it mainly affects investigator-initiated trials and is mostly due to problems with recruitment of patients. The aim of this study was to qualitatively investigate reasons for trial discontinuation due to poor patient recruitment and suggestions to address those reasons in the Swiss context. We conducted semi-structured interviews with trialists whose trials were discontinued because of recruitment problems, other experienced trialists, and stakeholders in clinical research in Switzerland. Interviews were audio-recorded, transcribed verbatim, and anonymised. We analysed the transcripts using deductive coding and built up themes that were continuously discussed within the research team. Of 65 invited Swiss trialists and stakeholders, 39 (60%) agreed to be interviewed and contributed to this analysis. We identified four main themes of reasons for poor recruitment: (1) Switzerland has a decentralised healthcare system with many small hospitals and few patients per hospital, many research regulations, no standardisation of medical records across hospitals, and a heterogeneous ethics assessment of study protocols. There is little collaboration of different stakeholders in clinical research and a lack of prioritisation of projects. (2) Limited human and financial resources, especially in the academic setting, compromise research questions and size of clinical trials. When funding is used up this typically triggers discontinuation of already delayed clinical trials. (3) Investigators face underdeveloped research networks and a limited collaborative attitude among clinical researchers. They typically embark on clinical studies with a great deal of optimism but insufficient preparation. (4) Swiss patients have universal health coverage and many treatment options. Negative media coverage of clinical research and a lack of accessible information for patients about ongoing clinical studies frequently make participation in clinical trials less attractive. More interactive structures and collaboration across stakeholders were mentioned as potential solutions to tackle the problems. Recruitment of participants into clinical trials in Switzerland is challenging because of various, often interlinked factors related to the Swiss health system, available funding, investigators, and patients. Common goals and concerted efforts by involved stakeholders appear necessary to achieve improvement.

Interoperative efficiency in minimally invasive surgery suites.

PubMed

van Det, M J; Meijerink, W J H J; Hoff, C; Pierie, J P E N

2009-10-01

Performing minimally invasive surgery (MIS) in a conventional operating room (OR) requires additional specialized equipment otherwise stored outside the OR. Before the procedure, the OR team must collect, prepare, and connect the equipment, then take it away afterward. These extra tasks pose a thread to OR efficiency and may lengthen turnover times. The dedicated MIS suite has permanently installed laparoscopic equipment that is operational on demand. This study presents two experiments that quantify the superior efficiency of the MIS suite in the interoperative period. Preoperative setup and postoperative breakdown times in the conventional OR and the MIS suite in an experimental setting and in daily practice were analyzed. In the experimental setting, randomly chosen OR teams simulated the setup and breakdown for a standard laparoscopic cholecystectomy (LC) and a complex laparoscopic sigmoid resection (LS). In the clinical setting, the interoperative period for 66 LCs randomly assigned to the conventional OR or the MIS suite were analyzed. In the experimental setting, the setup and breakdown times were significantly shorter in the MIS suite. The difference between the two types of OR increased for the complex procedure: 2:41 min for the LC (p < 0.001) and 10:47 min for the LS (p < 0.001). In the clinical setting, the setup and breakdown times as a whole were not reduced in the MIS suite. Laparoscopic setup and breakdown times were significantly shorter in the MIS suite (mean difference, 5:39 min; p < 0.001). Efficiency during the interoperative period is significantly improved in the MIS suite. The OR nurses' tasks are relieved, which may reduce mental and physical workload and improve job satisfaction and patient safety. Due to simultaneous tasks of other disciplines, an overall turnover time reduction could not be achieved.

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.

Azithromycin-induced rash in a patient of infectious mononucleosis - a case report with review of literature.

PubMed

Banerjee, Indranil; Mondal, Somnath; Sen, Sukanta; Tripathi, Santanu Kumar; Banerjee, Gautam

2014-08-01

Antibiotic induced skin rash in setting of infectious mononucleosis is often encountered in clinical practice. However, macrolides like azithromycin are considered relatively safe and till date only two cases of azithromycin induced rash in setting of infectious mononucleosis have been reported. The following report illustrates the case of a 23-year-old man suffering from infectious mononucleosis who exhibited a generalized cutaneous rash following treatment with azithromycin. Using the Naranjo ADR probability scale, this case of acute onset rash following azithromycin administration was found to be in 'probable' category. The mechanism of antibiotic-induced rash in patients suffering from infectious mononucleosis is incompletely understood. It has been suggested that the rash could result from virus mediated immunomodulation or due to altered drug metabolism. The report calls for cautious use of antibiotics in the setting of suspected viral infections like infectious mononucleosis as injudicious use might increase the risk of deleterious skin reactions and increase the cost of healthcare.

Building a medical image processing algorithm verification database

NASA Astrophysics Data System (ADS)

Brown, C. Wayne

2000-06-01

The design of a database containing head Computed Tomography (CT) studies is presented, along with a justification for the database's composition. The database will be used to validate software algorithms that screen normal head CT studies from studies that contain pathology. The database is designed to have the following major properties: (1) a size sufficient for statistical viability, (2) inclusion of both normal (no pathology) and abnormal scans, (3) inclusion of scans due to equipment malfunction, technologist error, and uncooperative patients, (4) inclusion of data sets from multiple scanner manufacturers, (5) inclusion of data sets from different gender and age groups, and (6) three independent diagnosis of each data set. Designed correctly, the database will provide a partial basis for FDA (United States Food and Drug Administration) approval of image processing algorithms for clinical use. Our goal for the database is the proof of viability of screening head CT's for normal anatomy using computer algorithms. To put this work into context, a classification scheme for 'computer aided diagnosis' systems is proposed.

Costing behavioral interventions: a practical guide to enhance translation.

PubMed

Ritzwoller, Debra P; Sukhanova, Anna; Gaglio, Bridget; Glasgow, Russell E

2009-04-01

Cost and cost effectiveness of behavioral interventions are critical parts of dissemination and implementation into non-academic settings. Due to the lack of indicative data and policy makers' increasing demands for both program effectiveness and efficiency, cost analyses can serve as valuable tools in the evaluation process. To stimulate and promote broader use of practical techniques that can be used to efficiently estimate the implementation costs of behavioral interventions, we propose a set of analytic steps that can be employed across a broad range of interventions. Intervention costs must be distinguished from research, development, and recruitment costs. The inclusion of sensitivity analyses is recommended to understand the implications of implementation of the intervention into different settings using different intervention resources. To illustrate these procedures, we use data from a smoking reduction practical clinical trial to describe the techniques and methods used to estimate and evaluate the costs associated with the intervention. Estimated intervention costs per participant were $419, with a range of $276 to $703, depending on the number of participants.

Azithromycin-Induced Rash in a Patient of Infectious Mononucleosis – A Case Report with Review of Literature

PubMed Central

Mondal, Somnath; Sen, Sukanta; Tripathi, Santanu Kumar; Banerjee, Gautam

2014-01-01

Antibiotic induced skin rash in setting of infectious mononucleosis is often encountered in clinical practice. However, macrolides like azithromycin are considered relatively safe and till date only two cases of azithromycin induced rash in setting of infectious mononucleosis have been reported. The following report illustrates the case of a 23-year-old man suffering from infectious mononucleosis who exhibited a generalized cutaneous rash following treatment with azithromycin. Using the Naranjo ADR probability scale, this case of acute onset rash following azithromycin administration was found to be in ‘probable’ category. The mechanism of antibiotic-induced rash in patients suffering from infectious mononucleosis is incompletely understood. It has been suggested that the rash could result from virus mediated immunomodulation or due to altered drug metabolism. The report calls for cautious use of antibiotics in the setting of suspected viral infections like infectious mononucleosis as injudicious use might increase the risk of deleterious skin reactions and increase the cost of healthcare. PMID:25302218

Generation of silver standard concept annotations from biomedical texts with special relevance to phenotypes.

PubMed

Oellrich, Anika; Collier, Nigel; Smedley, Damian; Groza, Tudor

2015-01-01

Electronic health records and scientific articles possess differing linguistic characteristics that may impact the performance of natural language processing tools developed for one or the other. In this paper, we investigate the performance of four extant concept recognition tools: the clinical Text Analysis and Knowledge Extraction System (cTAKES), the National Center for Biomedical Ontology (NCBO) Annotator, the Biomedical Concept Annotation System (BeCAS) and MetaMap. Each of the four concept recognition systems is applied to four different corpora: the i2b2 corpus of clinical documents, a PubMed corpus of Medline abstracts, a clinical trails corpus and the ShARe/CLEF corpus. In addition, we assess the individual system performances with respect to one gold standard annotation set, available for the ShARe/CLEF corpus. Furthermore, we built a silver standard annotation set from the individual systems' output and assess the quality as well as the contribution of individual systems to the quality of the silver standard. Our results demonstrate that mainly the NCBO annotator and cTAKES contribute to the silver standard corpora (F1-measures in the range of 21% to 74%) and their quality (best F1-measure of 33%), independent from the type of text investigated. While BeCAS and MetaMap can contribute to the precision of silver standard annotations (precision of up to 42%), the F1-measure drops when combined with NCBO Annotator and cTAKES due to a low recall. In conclusion, the performances of individual systems need to be improved independently from the text types, and the leveraging strategies to best take advantage of individual systems' annotations need to be revised. The textual content of the PubMed corpus, accession numbers for the clinical trials corpus, and assigned annotations of the four concept recognition systems as well as the generated silver standard annotation sets are available from http://purl.org/phenotype/resources. The textual content of the ShARe/CLEF (https://sites.google.com/site/shareclefehealth/data) and i2b2 (https://i2b2.org/NLP/DataSets/) corpora needs to be requested with the individual corpus providers.

Inter-rater Reliability of Sustained Aberrant Movement Patterns as a Clinical Assessment of Muscular Fatigue

PubMed Central

Aerts, Frank; Carrier, Kathy; Alwood, Becky

2016-01-01

Background: The assessment of clinical manifestation of muscle fatigue is an effective procedure in establishing therapeutic exercise dose. Few studies have evaluated physical therapist reliability in establishing muscle fatigue through detection of changes in quality of movement patterns in a live setting. Objective: The purpose of this study is to evaluate the inter-rater reliability of physical therapists’ ability to detect altered movement patterns due to muscle fatigue. Design: A reliability study in a live setting with multiple raters. Participants: Forty-four healthy individuals (ages 19-35) were evaluated by six physical therapists in a live setting. Methods: Participants were evaluated by physical therapists for altered movement patterns during resisted shoulder rotation. Each participant completed a total of four tests: right shoulder internal rotation, right shoulder external rotation, left shoulder internal rotation and left shoulder external rotation. Results: For all tests combined, the inter-rater reliability for a single rater scoring ICC (2,1) was .65 (95%, .60, .71) This corresponds to moderate inter-rater reliability between physical therapists. Limitations: The results of this study apply only to healthy participants and therefore cannot be generalized to a symptomatic population. Conclusion: Moderate inter-rater reliability was found between physical therapists in establishing muscle fatigue through the observation of sustained altered movement patterns during dynamic resistive shoulder internal and external rotation. PMID:27347241

Uncovering the hidden risk architecture of the schizophrenias: confirmation in three independent genome-wide association studies.

PubMed

Arnedo, Javier; Svrakic, Dragan M; Del Val, Coral; Romero-Zaliz, Rocío; Hernández-Cuervo, Helena; Fanous, Ayman H; Pato, Michele T; Pato, Carlos N; de Erausquin, Gabriel A; Cloninger, C Robert; Zwir, Igor

2015-02-01

The authors sought to demonstrate that schizophrenia is a heterogeneous group of heritable disorders caused by different genotypic networks that cause distinct clinical syndromes. In a large genome-wide association study of cases with schizophrenia and controls, the authors first identified sets of interacting single-nucleotide polymorphisms (SNPs) that cluster within particular individuals (SNP sets) regardless of clinical status. Second, they examined the risk of schizophrenia for each SNP set and tested replicability in two independent samples. Third, they identified genotypic networks composed of SNP sets sharing SNPs or subjects. Fourth, they identified sets of distinct clinical features that cluster in particular cases (phenotypic sets or clinical syndromes) without regard for their genetic background. Fifth, they tested whether SNP sets were associated with distinct phenotypic sets in a replicable manner across the three studies. The authors identified 42 SNP sets associated with a 70% or greater risk of schizophrenia, and confirmed 34 (81%) or more with similar high risk of schizophrenia in two independent samples. Seventeen networks of SNP sets did not share any SNP or subject. These disjoint genotypic networks were associated with distinct gene products and clinical syndromes (i.e., the schizophrenias) varying in symptoms and severity. Associations between genotypic networks and clinical syndromes were complex, showing multifinality and equifinality. The interactive networks explained the risk of schizophrenia more than the average effects of all SNPs (24%). Schizophrenia is a group of heritable disorders caused by a moderate number of separate genotypic networks associated with several distinct clinical syndromes.

Plant food allergies: a suggested approach to allergen-resolved diagnosis in the clinical practice by identifying easily available sensitization markers.

PubMed

Asero, Riccardo

2005-09-01

Molecular biology techniques have led to the identification of a number of allergens in vegetable foods, but due to the lack of purified food proteins for routine diagnostic use, the detection of sensitizing allergens remains a nearly impossible task in most clinical settings. The allergen-resolved diagnosis of food allergy is essential because each plant-derived food may contain a number of different allergens showing different physical/chemical characteristics that strongly influence the clinical expression of allergy; moreover, many allergens may cross-react with homologue proteins present in botanically unrelated vegetable foods. Through a review of the available literature, this study aimed to detect "markers" of sensitization to specific plant food allergens that are easily accessible in the clinical practice. There are several "markers" of sensitization to different allergenic proteins in vegetable foods that can be helpful in the clinical practice. Specific algorithms for patients allergic to Rosaceae and to tree nuts were built. Clinical allergologists lacking the assistance of an advanced molecular biology lab may take advantage of some specific clinical data as well as of some "markers" in the difficult task of correctly diagnosing patients with plant food allergy and to provide them the best preventive advice. Copyright (c) 2005 S. Karger AG, Basel.

Rigor in electronic health record knowledge representation: Lessons learned from a SNOMED CT clinical content encoding exercise.

PubMed

Monsen, Karen A; Finn, Robert S; Fleming, Thea E; Garner, Erin J; LaValla, Amy J; Riemer, Judith G

2016-01-01

Rigor in clinical knowledge representation is necessary foundation for meaningful interoperability, exchange and reuse of electronic health record (EHR) data. It is critical for clinicians to understand principles and implications of using clinical standards for knowledge representation within EHRs. To educate clinicians and students about knowledge representation and to evaluate their success of applying the manual lookups method for assigning Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) concept identifiers using formally mapped concepts from the Omaha System interface terminology. Clinicians who were students in a doctoral nursing program conducted 21 lookups for Omaha System terms in publicly available SNOMED CT browsers. Lookups were deemed successful if results matched exactly with the corresponding code from the January 2013 SNOMED CT-Omaha System terminology cross-map. Of the 21 manual lookups attempted, 12 (57.1%) were successful. Errors were due to semantic gaps differences in granularity and synonymy or partial term matching. Achieving rigor in clinical knowledge representation across settings, vendors and health systems is a globally recognized challenge. Cross-maps have potential to improve rigor in SNOMED CT encoding of clinical data. Further research is needed to evaluate outcomes of using of terminology cross-maps to encode clinical terms with SNOMED CT concept identifiers based on interface terminologies.

THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN

PubMed Central

Snyder, Peter J; Ellenberg, Susan S; Cunningham, Glenn R; Matsumoto, Alvin M; Bhasin, Shalender; Barrett-Connor, Elizabeth; Gill, Thomas M; Farrar, John T; Cella, David; Rosen, Raymond C; Resnick, Susan M; Swerdloff, Ronald S; Cauley, Jane A; Cifelli, Denise; Fluharty, Laura; Pahor, Marco; Ensrud, Kristine E; Lewis, Cora E; Molitch, Mark E; Crandall, Jill P; Wang, Christina; Budoff, Matthew J; Wenger, Nanette K; Mohler, Emile R; Bild, Diane E; Cook, Nakela L; Keaveny, Tony M; Kopperdahl, David L; Lee, David; Schwartz, Ann V; Storer, Thomas W; Ershler, William B; Roy, Cindy N; Raffel, Leslie J; Romashkan, Sergei; Hadley, Evan

2014-01-01

Background The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results. Purpose To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and determine definitively if testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions. Methods We present the scientific and clinical rationale for the decisions made in the design of this trial. Results We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and also symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, treatment and monitoring and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data safety monitoring board (DSMB), the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in subject selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary end points for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation. Potential Limitations Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one subject. Conclusions The Testosterone Trials were designed to determine definitively if testosterone treatment of elderly men with low testosterone would have any clinical benefit. Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort. PMID:24686158

Advance Care Planning: Understanding Clinical Routines and Experiences of Interprofessional Team Members in Diverse Health Care Settings.

PubMed

Arnett, Kelly; Sudore, Rebecca L; Nowels, David; Feng, Cindy X; Levy, Cari R; Lum, Hillary D

2017-12-01

Interprofessional health care team members consider advance care planning (ACP) to be important, yet gaps remain in systematic clinical routines to support ACP. A clearer understanding of the interprofessional team members' perspectives on ACP clinical routines in diverse settings is needed. One hundred eighteen health care team members from community-based clinics, long-term care facilities, academic clinics, federally qualified health centers, and hospitals participated in a 35-question, cross-sectional online survey to assess clinical routines, workflow processes, and policies relating to ACP. Respondents were 53% physicians, 18% advanced practice nurses, 11% nurses, and 18% other interprofessional team members including administrators, chaplains, social workers, and others. Regarding clinical routines, respondents reported that several interprofessional team members play a role in facilitating ACP (ie, physician, social worker, nurse, others). Most (62%) settings did not have, or did not know of, policies related to ACP documentation. Only 14% of settings had a patient education program. Two-thirds of the respondents said that addressing ACP is a high priority and 85% felt that nonphysicians could have ACP conversations with appropriate training. The clinical resources needed to improve clinical routines included training for providers and staff, dedicated staff to facilitate ACP, and availability of patient/family educational materials. Although interprofessional health care team members consider ACP a priority and several team members may be involved, clinical settings lack systematic clinical routines to support ACP. Patient educational materials, interprofessional team training, and policies to support ACP clinical workflows that do not rely solely on physicians could improve ACP across diverse clinical settings.

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.

An evaluation of the infection control potential of a UV clinical podiatry unit.

PubMed

Humphreys, Paul N; Davies, Chris S; Rout, Simon

2014-02-28

Infection control is a key issue in podiatry as it is in all forms of clinical practice. Airborne contamination may be particularly important in podiatry due to the generation of particulates during treatment. Consequently, technologies that prevent contamination in podiatry settings may have a useful role. The aims of this investigation were twofold, firstly to determine the ability of a UV cabinet to protect instruments from airborne contamination and secondly to determine its ability to remove microbes from contaminated surfaces and instruments. A UV instrument cabinet was installed in a University podiatry suite. Impact samplers and standard microbiological techniques were used to determine the nature and extent of microbial airborne contamination. Sterile filters were used to determine the ability of the UV cabinet to protect exposed surfaces. Artificially contaminated instruments were used to determine the ability of the cabinet to remove microbial contamination. Airborne bacterial contamination was dominated by Gram positive cocci including Staphylococcus aureus. Airborne fungal levels were much lower than those observed for bacteria. The UV cabinet significantly reduced (p < 0.05) the observed levels of airborne contamination. When challenged with contaminated instruments the cabinet was able to reduce microbial levels by between 60% to 100% with more complex instruments e.g. clippers, remaining contaminated. Bacterial airborne contamination is a potential infection risk in podiatry settings due to the presence of S. aureus. The use of a UV instrument cabinet can reduce the risk of contamination by airborne microbes. The UV cabinet tested was unable to decontaminate instruments and as such could pose an infection risk if misused.

An evaluation of the infection control potential of a UV clinical podiatry unit

PubMed Central

2014-01-01

Background Infection control is a key issue in podiatry as it is in all forms of clinical practice. Airborne contamination may be particularly important in podiatry due to the generation of particulates during treatment. Consequently, technologies that prevent contamination in podiatry settings may have a useful role. The aims of this investigation were twofold, firstly to determine the ability of a UV cabinet to protect instruments from airborne contamination and secondly to determine its ability to remove microbes from contaminated surfaces and instruments. Method A UV instrument cabinet was installed in a University podiatry suite. Impact samplers and standard microbiological techniques were used to determine the nature and extent of microbial airborne contamination. Sterile filters were used to determine the ability of the UV cabinet to protect exposed surfaces. Artificially contaminated instruments were used to determine the ability of the cabinet to remove microbial contamination. Results Airborne bacterial contamination was dominated by Gram positive cocci including Staphylococcus aureus. Airborne fungal levels were much lower than those observed for bacteria. The UV cabinet significantly reduced (p < 0.05) the observed levels of airborne contamination. When challenged with contaminated instruments the cabinet was able to reduce microbial levels by between 60% to 100% with more complex instruments e.g. clippers, remaining contaminated. Conclusions Bacterial airborne contamination is a potential infection risk in podiatry settings due to the presence of S. aureus. The use of a UV instrument cabinet can reduce the risk of contamination by airborne microbes. The UV cabinet tested was unable to decontaminate instruments and as such could pose an infection risk if misused. PMID:24576315

FDA perspective on specifications for biotechnology products--from IND to PLA.

PubMed

Murano, G

1997-01-01

Quality standards are obligatory throughout development, approval and post-marketing phases of biotechnology-derived products, thus assuring product identity, purity, and potency/strength. The process of developing and setting specifications should be based on sound science and should represent a logical progression of actions based on the use of experiential data spanning manufacturing process validation, consistency in production, and characterization of relevant product properties/attributes, by multiple analytical means. This interactive process occurs in phases, varying in rigour. It is best described as encompassing a framework which starts with the implementation of realistic/practical operational quality limits, progressing to the establishment/adoption of more stringent specifications. The historical database is generated from preclinical, toxicology and early clinical lots. This supports the clinical development programme which, as it progresses, allows for further assay method validation/refinement, adoption/addition due to relevant or newly recognized product attributes or rejection due to irrelevance. In the next phase, (licensing/approval) specifications are set through extended experience and validation of both the preparative and analytical processes, to include availability of suitable reference standards and extensive product characterization throughout its proposed dating period. Subsequent to product approval, the incremental database of test results serves as a natural continuum for further evolving/refining specifications. While there is considerable latitude in the kinds of testing modalities finally adopted to establish product quality on a routine basis, for both drugs and drug products, it is important that the selection takes into consideration relevant (significant) product characteristics that appropriately reflect on identity, purity and potency.

Improvement in the stability of serum samples stored in an automated refrigerated module.

PubMed

Parra-Robert, Marina; Rico-Santana, Naira; Alcaraz-Quiles, José; Sandalinas, Silvia; Fernández, Esther; Falcón, Isabel; Pérez-Riedweg, Margarita; Bedini, Josep Lluís

2016-12-01

In clinical laboratories it is necessary to know for how long the analytes are stable in the samples with specific storage conditions. Our laboratory has implemented the new Aptio Automation System (AAS) (Siemens Healthcare Diagnostics) where the analyzed samples are stored in a refrigerated storage module (RSM) after being sealed. The aim of the study was to evaluate the stability of serum samples with the AAS and comparing the results with a previous study using a conventional refrigerated system. Serum samples from a total of 50 patients were collected and for each of them 27 biochemical analytes were analyzed. The samples were divided in 5 sets of 10 samples. Each set was re-analyzed at one of the following times: 24, 48, 72, 96 and 120h. Stability was evaluated according to the Total Limit of Change (TLC) criteria, which combine both analytical and biologic variation. A total of 26 out of 27 analytes were stable at the end of the study according to TLC criteria. Lactate dehydrogenase was not stable at 48h observing a decrease in its concentration until the end of the study. In the previous study (conventional storage system) 9 biochemical analytes were not stable with an increase of their levels due to the evaporation process. The RSM connected to the AAS improves the stability of serum samples. This system avoids the evaporation process due to the sealing of samples and allows better control of the samples during their storage. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Quality-control issues on high-resolution diagnostic monitors.

PubMed

Parr, L F; Anderson, A L; Glennon, B K; Fetherston, P

2001-06-01

Previous literature indicates a need for more data collection in the area of quality control of high-resolution diagnostic monitors. Throughout acceptance testing, which began in June 2000, stability of monitor calibration was analyzed. Although image quality on all monitors was found to be acceptable upon initial acceptance testing using VeriLUM software by Image Smiths, Inc (Germantown, MD), it was determined to be unacceptable during the clinical phase of acceptance testing. High-resolution monitors were evaluated for quality assurance on a weekly basis from installation through acceptance testing and beyond. During clinical utilization determination (CUD), monitor calibration was identified as a problem and the manufacturer returned and recalibrated all workstations. From that time through final acceptance testing, high-resolution monitor calibration and monitor failure rate remained a problem. The monitor vendor then returned to the site to address these areas. Monitor defocus was still noticeable and calibration checks were increased to three times per week. White and black level drift on medium-resolution monitors had been attributed to raster size settings. Measurements of white and black level at several different size settings were taken to determine the effect of size on white and black level settings. Black level remained steady with size change. White level appeared to increase by 2.0 cd/m2 for every 0.1 inches decrease in horizontal raster size. This was determined not to be the cause of the observed brightness drift. Frequency of calibration/testing is an issue in a clinical environment. The increased frequency required at our site cannot be sustained. The medical physics division cannot provide dedicated personnel to conduct the quality-assurance testing on all monitors at this interval due to other physics commitments throughout the hospital. Monitor access is also an issue due to radiologists' need to read images. Some workstations are in use 7 AM to 11 PM daily. An appropriate monitor calibration frequency must be established during acceptance testing to ensure unacceptable drift is not masked by excessive calibration frequency. Standards for acceptable black level and white level drift also need to be determined. The monitor vendor and hospital staff agree that currently, very small printed text is an acceptable method of determining monitor blur, however, a better method of determining monitor blur is being pursued. Although monitors may show acceptable quality during initial acceptance testing, they need to show sustained quality during the clinical acceptance-testing phase. Defocus, black level, and white level are image quality concerns, which need to be evaluated during the clinical phase of acceptance testing. Image quality deficiencies can have a negative impact on patient care and raise serious medical-legal concerns. The attention to quality control required of the hospital staff needs to be realistic and not have a significant impact on radiology workflow.

Reflecting the real value of health care resources in modelling and cost-effectiveness studies-The example of viral load informed differentiated care.

PubMed

Revill, Paul; Walker, Simon; Cambiano, Valentina; Phillips, Andrew; Sculpher, Mark J

2018-01-01

The WHO HIV Treatment Guidelines suggest routine viral-load monitoring can be used to differentiate antiretroviral therapy (ART) delivery and reduce the frequency of clinic visits for patients stable on ART. This recommendation was informed by economic analysis that showed the approach is very likely to be cost-effective, even in the most resource constrained of settings. The health benefits were shown to be modest but the costs of introducing and scaling up viral load monitoring can be offset by anticipated reductions in the costs of clinic visits, due to these being less frequent for many patients. The cost-effectiveness of introducing viral-load informed differentiated care depends upon whether cost reductions are possible if the number of clinic visits is reduced and/or how freed clinic capacity is used for alternative priorities. Where freed resources, either physical or financial, generate large health gains (e.g. if committed to patients failing ART or to other high value health care interventions), the benefits of differentiated care are expected to be high; if however these freed physical resources are already under-utilized or financial resources are used less efficiently and would not be put to as beneficial an alternative use, the policy may not be cost-effective. The implication is that the use of conventional unit costs to value resources may not well reflect the latter's value in contributing to health improvement. Analyses intended to inform resource allocated decisions in a number of settings may therefore have to be interpreted with due consideration to local context. In this paper we present methods of how economic analyses can reflect the real value of health care resources rather than simply applying their unit costs. The analyses informing the WHO Guidelines are re-estimated by implementing scenarios using this framework, informing how differentiated care can be prioritized to generate greatest gains in population health. The findings have important implications for how economic analyses should be undertaken and reported in HIV and other disease areas. Results provide guidance on conditions under which viral load informed differentiated care will more likely prove to be cost effective when implemented.

A proposal for funding and monitoring medical education supervision in expanded clinical settings--a 'meducation' card.

PubMed

DeWitt, D E; McColl, G J

2011-01-01

Entry to practice medical programs (graduate- and undergraduate-entry) in Australia are under considerable pressure to provide clinical training as a result of increased student numbers. At the same time modern medical curricula require the development of active placements in expanded settings to achieve graduate medical practitioners who are clinically able. These dual imperatives require a mechanism to fund and maintain the quality of clinical placements outside the traditional hospital setting. For teaching outside traditional teaching hospitals the Australian government's Practice Incentives Program (PIP) currently provides a student-related payment of AU$100 for each half-day teaching session in a general practice setting. This payment is not linked to the quality of the placement and does not support clinical placements in other settings, for example specialist consulting rooms or allied health practices. This short communication proposes a 'meducation' card as an efficient funding mechanism to facilitate an expansion of quality clinical placements in expanded settings including specialist and allied health practices. This student meducation card would use current Medicare Australia infrastructure to facilitate the payment of clinical teachers in expanded settings. Meducation payments would only be available to practitioners and practices that maintain quality teaching practices certified by medical or allied health schools.

The integration of behavioral health interventions in children's health care: services, science, and suggestions.

PubMed

Kolko, David J; Perrin, Ellen

2014-01-01

Because the integration of mental or behavioral health services in pediatric primary care is a national priority, a description and evaluation of the interventions applied in the healthcare setting is warranted. This article examines several intervention research studies based on alternative models for delivering behavioral health care in conjunction with comprehensive pediatric care. This review describes the diverse methods applied to different clinical problems, such as brief mental health skills, clinical guidelines, and evidence-based practices, and the empirical outcomes of this research literature. Next, several key treatment considerations are discussed to maximize the efficiency and effectiveness of these interventions. Some practical suggestions for overcoming key service barriers are provided to enhance the capacity of the practice to deliver behavioral health care. There is moderate empirical support for the feasibility, acceptability, and clinical utility of these interventions for treating internalizing and externalizing behavior problems. Practical strategies to extend this work and address methodological limitations are provided that draw upon recent frameworks designed to simplify the treatment enterprise (e.g., common elements). Pediatric primary care has become an important venue for providing mental health services to children and adolescents due, in part, to its many desirable features (e.g., no stigma, local setting, familiar providers). Further adaptation of existing delivery models may promote the delivery of effective integrated interventions with primary care providers as partners designed to address mental health problems in pediatric healthcare.

Cardiorenal Syndrome in Acute Heart Failure: Revisiting Paradigms.

PubMed

Núñez, Julio; Miñana, Gema; Santas, Enrique; Bertomeu-González, Vicente

2015-05-01

Cardiorenal syndrome has been defined as the simultaneous dysfunction of both the heart and the kidney. Worsening renal function that occurs in patients with acute heart failure has been classified as cardiorenal syndrome type 1. In this setting, worsening renal function is a common finding and is due to complex, multifactorial, and not fully understood processes involving hemodynamic (renal arterial hypoperfusion and renal venous congestion) and nonhemodynamic factors. Traditionally, worsening renal function has been associated with worse outcomes, but recent findings have revealed mixed and heterogeneous results, perhaps suggesting that the same phenotype represents a diversity of pathophysiological and clinical situations. Interpreting the magnitude and chronology of renal changes together with baseline renal function, fluid overload status, and clinical response to therapy might help clinicians to unravel the clinical meaning of renal function changes that occur during an episode of heart failure decompensation. In this article, we critically review the contemporary evidence on the pathophysiology and clinical aspects of worsening renal function in acute heart failure. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Advanced imaging technologies for mapping cadaveric lymphatic anatomy: magnetic resonance and computed tomography lymphangiography.

PubMed

Pan, W R; Rozen, W M; Stretch, J; Thierry, B; Ashton, M W; Corlett, R J

2008-09-01

Lymphatic anatomy has become increasingly clinically important as surgical techniques evolve for investigating and treating cancer metastases. However, due to limited anatomical techniques available, research in this field has been insufficient. The techniques of computed tomography (CT) and magnetic resonance (MR) lymphangiography have not been described previously in the imaging of cadaveric lymphatic anatomy. This preliminary work describes the feasibility of these advanced imaging technologies for imaging lymphatic anatomy. A single, fresh cadaveric lower limb underwent lymphatic dissection and cannulation utilizing microsurgical techniques. Contrast materials for both CT and MR studies were chosen based on their suitability for subsequent clinical use, and imaging was undertaken with a view to mapping lymphatic anatomy. Microdissection studies were compared with imaging findings in each case. Both MR-based and CT-based contrast media in current clinical use were found to be suitable for demonstrating cadaveric lymphatic anatomy upon direct intralymphatic injection. MR lymphangiography and CT lymphangiography are feasible modalities for cadaveric anatomical research for lymphatic anatomy. Future studies including refinements in scanning techniques may offer these technologies to the clinical setting.

Perspectives of HER2-targeting in gastric and esophageal cancer.

PubMed

Gerson, James N; Skariah, Sam; Denlinger, Crystal S; Astsaturov, Igor

2017-05-01

The blockade of HER2 signaling has significantly improved the outlook for esophagogastric cancer patients. However, targeting HER2 still remains challenging due to complex biology of this receptor in gastric and esophageal cancers. Areas covered: Here, we review complex HER2 biology, current methods of HER2 testing and tumor heterogeneity of gastroesophageal cancer. Ongoing and completed clinical research data are discussed. Expert opinion: HER2 overexpression is a validated target in gastroesophageal cancer, with therapeutic implications resulting in prolonged survival when inhibited in the front-line setting. With standardized HER2 testing in gastro-esophageal cancer, the ongoing trials are testing newer agents and combinations including combination of anti-HER2 antibodies with immunotherapy. Clonal heterogeneity and emergence of resistance will challenge our approach to treating these patients beyond the frontline settings.

Intermittent kangaroo mother care: a NICU protocol.

PubMed

Davanzo, Riccardo; Brovedani, Pierpaolo; Travan, Laura; Kennedy, Jacqueline; Crocetta, Anna; Sanesi, Cecilia; Strajn, Tamara; De Cunto, Angela

2013-08-01

The practice of kangaroo mother care (KMC) is steadily increasing in high-tech settings due to its proven benefits for both infants and parents. In spite of that, clear guidelines about how to implement this method of care are lacking, and as a consequence, some restrictions are applied in many neonatal intensive care units (NICUs), preventing its practice. Based on recommendations from the Expert Group of the International Network on Kangaroo Mother Care, we developed a hospital protocol in the neonatal unit of the Institute for Maternal and Child Health in Trieste, Italy, a level 3 unit, aimed to facilitate and promote KMC implementation in high-tech settings. Our guideline is therefore proposed, based both on current scientific literature and on practical considerations and experience. Future adjustments and improvements would be considered based on increasing clinical KMC use and further knowledge.

External closed-circuit cooling system for management of patients after device implantation: A feasibility study.

PubMed

Giofrè, Fabrizio; Ferrari, Paola; Leidi, Cristina; Foschi, Maria Laura; Senni, Michele; De Filippo, Paolo

2017-08-15

In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy. We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period. The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit. This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device. Copyright © 2017 Elsevier B.V. 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.

Matrix-assisted laser desorption ionization-time of flight mass spectrometry for fast and accurate identification of Pseudallescheria/Scedosporium species.

PubMed

Sitterlé, E; Giraud, S; Leto, J; Bouchara, J P; Rougeron, A; Morio, F; Dauphin, B; Angebault, C; Quesne, G; Beretti, J L; Hassouni, N; Nassif, X; Bougnoux, M E

2014-09-01

An increasing number of infections due to Pseudallescheria/Scedosporium species has been reported during the past decades, both in immunocompromised and immunocompetent patients. Additionally, these fungi are now recognized worldwide as common agents of fungal colonization of the airways in cystic fibrosis patients, which represents a risk factor for disseminated infections after lung transplantation. Currently six species are described within the Pseudallescheria/Scedosporium genus, including Scedosporium prolificans and species of the Pseudallescheria/Scedosporium apiospermum complex (i.e. S. apiospermum sensu stricto, Pseudallescheria boydii, Scedosporium aurantiacum, Pseudallescheria minutispora and Scedosporium dehoogii). Precise identification of clinical isolates at the species level is required because these species differ in their antifungal drug susceptibility patterns. Matrix-assisted laser desorption ionization (MALDI)-time of flight (TOF)/mass spectrometry (MS) is a powerful tool to rapidly identify moulds at the species level. We investigated the potential of this technology to discriminate Pseudallescheria/Scedosporium species. Forty-seven reference strains were used to build a reference database library. Profiles from 3-, 5- and 7-day-old cultures of each reference strain were analysed to identify species-specific discriminating profiles. The database was tested for accuracy using a set of 64 clinical or environmental isolates previously identified by multilocus sequencing. All isolates were unequivocally identified at the species level by MALDI-TOF/MS. Our results, obtained using a simple protocol, without prior protein extraction or standardization of the culture, demonstrate that MALDI-TOF/MS is a powerful tool for rapid identification of Pseudallescheria/Scedosporium species that cannot be currently identified by morphological examination in the clinical setting. © 2014 The Authors Clinical Microbiology and Infection © 2014 European Society of Clinical Microbiology and Infectious Diseases.

The detection of oral cancer using differential pathlength spectroscopy

NASA Astrophysics Data System (ADS)

Sterenborg, H. J. C. M.; Kanick, S.; de Visscher, S.; Witjes, M.; Amelink, A.

2010-02-01

The development of optical techniques for non-invasive diagnosis of cancer is an ongoing challenge to biomedical optics. For head and neck cancer we see two main fields of potential application 1) Screening for second primaries in patients with a history of oral cancer. This requires imaging techniques or an approach where a larger area can be scanned quickly. 2) Distinguishing potentially malignant visible primary lesions from benign ones. Here fiberoptic point measurements can be used as the location of the lesion is known. This presentation will focus on point measurement techniques. Various techniques for point measurements have been developed and investigated clinically for different applications. Differential Pathlength Spectroscopy is a recently developed fiberoptic point measurement technique that measures scattered light in a broad spectrum. Due to the specific fiberoptic geometry we measure only scattered photons that have travelled a predetermined pathlength. This allows us to analyse the spectrum mathematically and translate the measured curve into a set of parameters that are related to the microvasculature and to the intracellular morphology. DPS has been extensively evaluated on optical phantoms and tested clinically in various clinical applications. The first measurements in biopsy proven squamous cell carcinoma showed significant changes in both vascular and morphological parameters. Measurements on thick keratinized lesions however failed to generate any vascular signatures. This is related to the sampling depth of the standard optical fibers used. Recently we developed a fiberoptic probe with a ~1 mm sampling depth. Measurements on several leukoplakias showed that with this new probe we sample just below the keratin layer and can obtain vascular signatures. The results of a first set of clinical measurements will be presented and the significance for clinical diagnostics will be discussed.

Caught you: threats to confidentiality due to the public release of large-scale genetic data sets

PubMed Central

2010-01-01

Background Large-scale genetic data sets are frequently shared with other research groups and even released on the Internet to allow for secondary analysis. Study participants are usually not informed about such data sharing because data sets are assumed to be anonymous after stripping off personal identifiers. Discussion The assumption of anonymity of genetic data sets, however, is tenuous because genetic data are intrinsically self-identifying. Two types of re-identification are possible: the "Netflix" type and the "profiling" type. The "Netflix" type needs another small genetic data set, usually with less than 100 SNPs but including a personal identifier. This second data set might originate from another clinical examination, a study of leftover samples or forensic testing. When merged to the primary, unidentified set it will re-identify all samples of that individual. Even with no second data set at hand, a "profiling" strategy can be developed to extract as much information as possible from a sample collection. Starting with the identification of ethnic subgroups along with predictions of body characteristics and diseases, the asthma kids case as a real-life example is used to illustrate that approach. Summary Depending on the degree of supplemental information, there is a good chance that at least a few individuals can be identified from an anonymized data set. Any re-identification, however, may potentially harm study participants because it will release individual genetic disease risks to the public. PMID:21190545

Caught you: threats to confidentiality due to the public release of large-scale genetic data sets.

PubMed

Wjst, Matthias

2010-12-29

Large-scale genetic data sets are frequently shared with other research groups and even released on the Internet to allow for secondary analysis. Study participants are usually not informed about such data sharing because data sets are assumed to be anonymous after stripping off personal identifiers. The assumption of anonymity of genetic data sets, however, is tenuous because genetic data are intrinsically self-identifying. Two types of re-identification are possible: the "Netflix" type and the "profiling" type. The "Netflix" type needs another small genetic data set, usually with less than 100 SNPs but including a personal identifier. This second data set might originate from another clinical examination, a study of leftover samples or forensic testing. When merged to the primary, unidentified set it will re-identify all samples of that individual. Even with no second data set at hand, a "profiling" strategy can be developed to extract as much information as possible from a sample collection. Starting with the identification of ethnic subgroups along with predictions of body characteristics and diseases, the asthma kids case as a real-life example is used to illustrate that approach. Depending on the degree of supplemental information, there is a good chance that at least a few individuals can be identified from an anonymized data set. Any re-identification, however, may potentially harm study participants because it will release individual genetic disease risks to the public.

Home-based Computer Assisted Arm Rehabilitation (hCAAR) robotic device for upper limb exercise after stroke: results of a feasibility study in home setting.

PubMed

Sivan, Manoj; Gallagher, Justin; Makower, Sophie; Keeling, David; Bhakta, Bipin; O'Connor, Rory J; Levesley, Martin

2014-12-12

Home-based robotic technologies may offer the possibility of self-directed upper limb exercise after stroke as a means of increasing the intensity of rehabilitation treatment. The current literature has a paucity of robotic devices that have been tested in a home environment. The aim of this research project was to evaluate a robotic device Home-based Computer Assisted Arm Rehabilitation (hCAAR) that can be used independently at home by stroke survivors with upper limb weakness. hCAAR device comprises of a joystick handle moved by the weak upper limb to perform tasks on the computer screen. The device provides assistance to the movements depending on users ability. Nineteen participants (stroke survivors with upper limb weakness) were recruited. Outcome measures performed at baseline (A0), at end of 8-weeks of hCAAR use (A1) and 1 month after end of hCAAR use (A2) were: Optotrak kinematic variables, Fugl Meyer Upper Extremity motor subscale (FM-UE), Action Research Arm Test (ARAT), Medical Research Council (MRC) and Modified Ashworth Scale (MAS), Chedoke Arm and Hand Activity Inventory (CAHAI) and ABILHAND. Two participants were unable to use hCAAR: one due to severe paresis and the other due to personal problems. The remaining 17 participants were able to use the device independently in their home setting. No serious adverse events were reported. The median usage time was 433 minutes (IQR 250 - 791 min). A statistically significant improvement was observed in the kinematic and clinical outcomes at A1. The median gain in the scores at A1 were by: movement time 19%, path length 15% and jerk 19%, FM-UE 1 point, total MAS 1.5 point, total MRC 2 points, ARAT 3 points, CAHAI 5.5 points and ABILHAND 3 points. Three participants showed clinically significant improvement in all the clinical outcomes. The hCAAR feasibility study is the first clinical study of its kind reported in the current literature; in this study, 17 participants used the robotic device independently for eight weeks in their own homes with minimal supervision from healthcare professionals. Statistically significant improvements were observed in the kinematic and clinical outcomes in the study.

Feasibility of noninvasive fetal electrocardiographic monitoring in a clinical setting.

PubMed

Arya, Bhawna; Govindan, Rathinaswamy; Krishnan, Anita; Duplessis, Adre; Donofrio, Mary T

2015-06-01

Cardiac rhythm is an essential component of fetal cardiac evaluation. The Monica AN24 is a fetal heart rate monitor that may provide a quick, inexpensive modality for obtaining a noninvasive fetal electrocardiogram (fECG) in a clinical setting. The fECG device has the ability to acquire fECG signals and allow calculation of fetal cardiac time intervals between 16- and 42-week gestational age (GA). We aimed to demonstrate the feasibility of fECG acquisition in a busy fetal cardiology clinic using the Monica fetal heart rate monitor. This is a prospective observational pilot study of fECG acquired from fetuses referred for fetal echocardiography. Recordings were performed for 5-15 min. Maternal signals were attenuated and fECG averaged. fECG and fetal cardiac time intervals (PR, QRS, RR, and QT) were evaluated by two cardiologists independently and inter-observer reliability was assessed using intraclass coefficient (ICC). Sixty fECGs were collected from 50 mothers (mean GA 28.1 ± 6.1). Adequate signal-averaged waveforms were obtained in 20 studies with 259 cardiac cycles. Waveforms could not be obtained between 26 and 30 weeks. Fetal cardiac time intervals were measured and were reproducible for PR (ICC = 0.89; CI 0.77-0.94), QRS (ICC = 0.79; CI 0.51-0.91), and RR (ICC = 0.77; CI 0.53-0.88). QT ICC was poor due to suboptimal T-wave tracings. Acquisition of fECG and measurement of fetal cardiac time intervals is feasible in a clinical setting between 19- and 42-week GA, though tracings are difficult to obtain, especially between 26 and 30 weeks. There was high reliability in fetal cardiac time intervals measurements, except for QT. The device may be useful for assessing atrioventricular/intraventricular conduction in fetuses from 20 to 26 and >30 weeks. Techniques to improve signal acquisition, namely T-wave amplification, are ongoing.

An Eight-Year Clinic Experience with Clozapine Use in a Parkinson’s Disease Clinic Setting

PubMed Central

Hack, Nawaz; Fayad, Sarah M.; Monari, Erin H.; Akbar, Umer; Hardwick, Angela; Rodriguez, Ramon L.; Malaty, Irene A.; Romrell, Janet; Shukla, Aparna A. Wagle.; McFarland, Nikolaus; Ward, Herbert E.; Okun, Michael S.

2014-01-01

Background To examine our eight year clinic-based experience in a Parkinson’s disease expert clinical care center using clozapine as a treatment for refractory psychosis in Parkinson's disease (PD). Methods The study was a retrospective chart review which covered eight years of clozapine registry use. Statistical T-tests, chi-square, correlations and regression analysis were used to analyze treatment response for potential associations of age, disease duration, and Hoehn & Yahr (H&Y) score, and degree of response to clozapine therapy. Results There were 36 participants included in the analysis (32 PD, 4 parkinsonism-plus). The characteristics included 30.6% female, age 45–87 years (mean 68.3±10.15), disease duration of 17–240 months (mean 108.14±51.13) and H&Y score of 2 to 4 (mean 2.51±0.51). The overall retention rate on clozapine was 41% and the most common reasons for discontinuation were frequent blood testing (28%), nursing home (NH) placement (11%) and leucopenia (8%). Responses to clozapine across the cohort were: complete (33%), partial (33%), absent (16%), and unknown (16%). Age (r = −0.36, p<0.01) and H&Y score (r = −0.41, p<0.01) were shown to be related to response to clozapine therapy, but disease duration was not an associated factor (r = 0.21, p>0.05). Conclusions This single-center experience highlights the challenges associated with clozapine therapy in PD psychosis. Frequent blood testing remains a significant barrier for clozapine, even in patients with therapeutic benefit. Surprisingly, all patients admitted to a NH discontinued clozapine due to logistical issues of administration and monitoring within that setting. Consideration of the barriers to clozapine therapy will be important to its use and to its continued success in an outpatient setting. PMID:24646688

The Professional Socialization of Collegiate Female Athletic Trainers: Navigating Experiences of Gender Bias

PubMed Central

Mazerolle, Stephanie M.; Borland, John F.; Burton, Laura J.

2012-01-01

Context Female athletic trainers (ATs) experience gender discrimination in the workplace due to stereotypical gender roles, but limited information is available regarding the topic. Objective To understand the challenges and obstacles faced by young female ATs working in National Collegiate Athletic Association Division I athletics. Design Exploratory study using semistructured interviews. Setting Division I clinical setting. Patients or Other Participants A total of 14 female ATs were included in the study, using both criterion and snowball- sampling techniques. Their mean age was 27 ± 2 years, with 5 ± 2 years of overall clinical experience. Criteria included employment at the Division I clinical setting, being a full-time assistant AT, and at least 3 years of working experience but no more than 9 years to avoid role continuance. Data Collection and Analysis Analysis of the interview data followed inductive procedures as outlined by a grounded theory approach. Credibility was established by member checks, multiple-analyst triangulation, and peer review. Results Clear communication with both coaches and players about expectations and philosophies regarding medical care, a supportive head AT in terms of clinical competence, and having and serving as a role model were cited as critical tools to alleviate gender bias in the workplace. Conclusions The female ATs in this study stressed the importance of being assertive with coaches early in the season with regard to the AT's role on the team. They reasoned that these actions brought forth a greater perception of congruity between their roles as ATs and their gender and age. We suggest that female athletic training students seek mentors in their field while they complete their coursework and practicums. The ATs in the current study indicated that a mentor, regardless of sex, helped them feel empowered to navigate the male-centric terrain of athletic departments by encouraging them to be assertive and not second-guess their decisions. PMID:23182018

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

[Thrombotic microangiopathy in pregnancy complicated by acute hemorrhagic-necrotic pancreatitis during early puerperium].

PubMed

Redechová, S; Féderová, L; Hammerová, L; Filkászová, A; Horváthová, D; Redecha, M

2014-06-01

Authors in the article describe a case of a patient with thrombotic thrombocytopenic purpurain 37 weeks gestation complicated by acute severe hemorrhagic-necrotic pancreatitis during the early puerperium. Case report. Ist Department of gynaecology and obstetrics of the Comenius University Bratislava. 33-years-old patient in the 37 weeks gestation was admitted to our department with the signs of HELLP syndrome (hemolysis, elevated liver enzymes, low platelets). Due to the worsening clinical status, we have performed caesarean section. After the transient stabilization of the patient's clinical status, the hemolysis with severe thrombocytopenia reappeared. Based on the clinical signs of abdominal pain and computer tomography, the diagnosis of acute hemorrhagic-necrotic pancreatitis was set. The primary diagnosis was thrombotic thrombocytopenic purpura. Therefore, therapeutic plasma exchange was performed with consequent improvement of the patients clinical state. Normalization of the platelet count was achieved after 4.plasma exchanges. Consequently 5 plasma exchanges were performed. However, one month later, the disease relapsed. Therapeutic plasma exchanges were needed again (4x), with anti CD 20 administration. This therapy had good clinical outcome, without the need for further plasma exchanges. Thrombotic thrombocytopenic purpura is highly lethal disease. Early diagnosis, treatment, and multidisciplinary approach are essential.

Rivaroxaban in patients with atrial fibrillation: from ROCKET AF to everyday practice.

PubMed

Barón-Esquivias, Gonzalo; Marín, Francisco; Sanmartín Fernandez, Marcelo

2017-05-01

Registries and non-interventional studies offer relevant and complementary information to clinical trials, since they have a high external validity. Areas covered: The information regarding the efficacy and safety of rivaroxaban compared with warfarin, or rivaroxaban alone in clinical practice was reviewed in this manuscript. For this purpose, a search on MEDLINE and EMBASE databases was performed. The MEDLINE and EMBASE search included both medical subject headings (MeSH) and keywords including: atrial fibrillation (AF) OR warfarin OR clinical practice OR ROCKET AF AND rivaroxaban. Case reports were not considered. Expert commentary: In ROCKET AF, rivaroxaban was at least as effective as warfarin for the prevention of stroke in patients with nonvalvular AF at high risk of stroke, but, importantly, with a lesser risk of intracranial, critical and fatal bleedings. A number of observational comparative and non-comparative studies, with more than 60,000 patients included treated with rivaroxaban, have analyzed the efficacy and safety of rivaroxaban in real-life patients with AF in different clinical settings. These studies have shown that in clinical practice, rates of stroke and major bleeding were consistently lower than those reported in ROCKET AF, likely due to the lower thromboembolic and bleeding risk observed in these patients.

Educational needs and preferred methods of learning among Florida practitioners who order genetic testing for hereditary breast and ovarian cancer.

PubMed

Cragun, Deborah; Besharat, Andrea Doty; Lewis, Courtney; Vadaparampil, Susan T; Pal, Tuya

2013-12-01

With the expansion of genetic testing options due to tremendous advances in sequencing technologies, testing will increasingly be offered by a variety of healthcare providers in diverse settings, as has been observed with BRCA1 and BRCA2 (BRCA) gene testing over the last decade. In an effort to assess the educational needs and preferences of healthcare providers primarily in a community-based setting, we mailed a survey to healthcare providers across Florida who order BRCA testing. Within the packet, a supplemental card was included to give participants the opportunity to request free clinical educational resources from the investigative team. Of 81 eligible providers who completed the survey, most were physicians or nurse practitioners; and over 90 % worked in a community or private practice setting. Respondents provided BRCA testing services for a median of 5 years, but the majority (56 %) reported no formal training in clinical cancer genetics. Most respondents (95 %) expressed interest in formal training opportunities, with 3-day in-person weekend training representing the most highly preferred format. The most widely selected facilitators to participation were minimal requirement to take time off work and continuing education credits. Overall, 64 % of respondents requested free clinical educational resources. Preferences for informal education included written materials and in-person presentations; whereas accessing a DVD or website were less popular. Findings from our study highlight both the need for and interest in ongoing educational opportunities and resources among community providers who order BRCA testing. These results can be used to enhance participation of community-based providers in educational training programs by targeting educational resources to the most preferred format.

Diagnosis and Management of Patients with Paroxysmal Sympathetic Hyperactivity following Acute Brain Injuries Using a Consensus-Based Diagnostic Tool: A Single Institutional Case Series.

PubMed

Godo, Shigeo; Irino, Shigemi; Nakagawa, Atsuhiro; Kawazoe, Yu; Fujita, Motoo; Kudo, Daisuke; Nomura, Ryosuke; Shimokawa, Hiroaki; Kushimoto, Shigeki

2017-09-01

Paroxysmal sympathetic hyperactivity (PSH) is a distinct syndrome of episodic sympathetic hyperactivities following severe acquired brain injury, characterized by paroxysmal transient fever, tachycardia, hypertension, tachypnea, excessive diaphoresis and specific posturing. PSH remains to be an under-recognized condition with a diagnostic pitfall especially in the intensive care unit (ICU) settings due to the high prevalence of concomitant diseases that mimic PSH. A consensus set of diagnostic criteria named PSH-Assessment Measure (PSH-AM) has been developed recently, which is consisted of two components: a diagnosis likelihood tool derived from clinical characteristics of PSH, and a clinical feature scale assigned to the severity of each sympathetic hyperactivity. We herein present a case series of patients with PSH who were diagnosed and followed by using PSH-AM in our tertiary institutional medical and surgical ICU between April 2015 and March 2017 in order to evaluate the clinical efficacy of PSH-AM. Among 394 survivors of 521 patients admitted with acquired brain injury defined as acute brain injury at all levels of severity regardless of the presence of altered consciousness, including traumatic brain injury, stroke, infectious disease, and encephalopathy, 6 patients (1.5%) were diagnosed as PSH by using PSH-AM. PSH-AM served as a useful scoring system for early objective diagnosis, assessment of severity, and serial evaluation of treatment efficacy in the management of PSH in the ICU settings. In conclusion, critical care clinicians should consider the possibility of PSH and can use PSH-AM as a useful diagnostic and guiding tool in the management of PSH.

Neutrophil-inspired propulsion in a combined acoustic and magnetic field.

PubMed

Ahmed, Daniel; Baasch, Thierry; Blondel, Nicolas; Läubli, Nino; Dual, Jürg; Nelson, Bradley J

2017-10-03

Systems capable of precise motion in the vasculature can offer exciting possibilities for applications in targeted therapeutics and non-invasive surgery. So far, the majority of the work analysed propulsion in a two-dimensional setting with limited controllability near boundaries. Here we show bio-inspired rolling motion by introducing superparamagnetic particles in magnetic and acoustic fields, inspired by a neutrophil rolling on a wall. The particles self-assemble due to dipole-dipole interaction in the presence of a rotating magnetic field. The aggregate migrates towards the wall of the channel due to the radiation force of an acoustic field. By combining both fields, we achieved a rolling-type motion along the boundaries. The use of both acoustic and magnetic fields has matured in clinical settings. The combination of both fields is capable of overcoming the limitations encountered by single actuation techniques. We believe our method will have far-reaching implications in targeted therapeutics.Devising effective swimming and propulsion strategies in microenvironments is attractive for drug delivery applications. Here Ahmed et al. demonstrate a micropropulsion strategy in which a combination of magnetic and acoustic fields is used to assemble and propel colloidal particles along channel walls.

Artifact correction in diffusion MRI of non-human primate brains on a clinical 3T scanner.

PubMed

Zhang, Xiaodong; Kirsch, John E; Zhong, Xiaodong

2016-02-01

Smearing artifacts were observed and investigated in diffusion tensor imaging (DTI) studies of macaque monkeys on a clinical whole-body 3T scanner. Four adult macaques were utilized to evaluate DTI artifacts. DTI images were acquired with a single-shot echo-planar imaging (EPI) sequence using a parallel imaging technique. The smearing artifacts observed on the diffusion-weighted images and fractional anisotropy maps were caused by the incomplete fat suppression due to the irregular macaque frontal skull geometry and anatomy. The artifact can be reduced substantially using a novel three-dimensional (3D) shimming procedure. The smearing artifacts observed on diffusion weighted images and fractional anisotropy (FA) maps of macaque brains can be reduced substantially using a robust 3D shimming approach. The DTI protocol combined with the shimming procedure could be a robust approach to examine brain connectivity and white matter integrity of non-human primates using a conventional clinical setting. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Evaluating Candidate Principal Surrogate Endpoints

PubMed Central

Gilbert, Peter B.; Hudgens, Michael G.

2009-01-01

Summary Frangakis and Rubin (2002, Biometrics 58, 21–29) proposed a new definition of a surrogate endpoint (a “principal” surrogate) based on causal effects. We introduce an estimand for evaluating a principal surrogate, the causal effect predictiveness (CEP) surface, which quantifies how well causal treatment effects on the biomarker predict causal treatment effects on the clinical endpoint. Although the CEP surface is not identifiable due to missing potential outcomes, it can be identified by incorporating a baseline covariate(s) that predicts the biomarker. Given case–cohort sampling of such a baseline predictor and the biomarker in a large blinded randomized clinical trial, we develop an estimated likelihood method for estimating the CEP surface. This estimation assesses the “surrogate value” of the biomarker for reliably predicting clinical treatment effects for the same or similar setting as the trial. A CEP surface plot provides a way to compare the surrogate value of multiple biomarkers. The approach is illustrated by the problem of assessing an immune response to a vaccine as a surrogate endpoint for infection. PMID:18363776

Clinical Manifestations and Case Management of Ebola Haemorrhagic Fever Caused by a Newly Identified Virus Strain, Bundibugyo, Uganda, 2007–2008

PubMed Central

Roddy, Paul; Howard, Natasha; Van Kerkhove, Maria D.; Lutwama, Julius; Wamala, Joseph; Yoti, Zabulon; Colebunders, Robert; Palma, Pedro Pablo; Sterk, Esther; Jeffs, Benjamin; Van Herp, Michel; Borchert, Matthias

2012-01-01

A confirmed Ebola haemorrhagic fever (EHF) outbreak in Bundibugyo, Uganda, November 2007–February 2008, was caused by a putative new species (Bundibugyo ebolavirus). It included 93 putative cases, 56 laboratory-confirmed cases, and 37 deaths (CFR = 25%). Study objectives are to describe clinical manifestations and case management for 26 hospitalised laboratory-confirmed EHF patients. Clinical findings are congruous with previously reported EHF infections. The most frequently experienced symptoms were non-bloody diarrhoea (81%), severe headache (81%), and asthenia (77%). Seven patients reported or were observed with haemorrhagic symptoms, six of whom died. Ebola care remains difficult due to the resource-poor setting of outbreaks and the infection-control procedures required. However, quality data collection is essential to evaluate case definitions and therapeutic interventions, and needs improvement in future epidemics. Organizations usually involved in EHF case management have a particular responsibility in this respect. PMID:23285243

Enhancing nursing informatics competencies and critical thinking skills using wireless clinical simulation laboratories.

PubMed

Cholewka, Patricia A; Mohr, Bernard

2009-01-01

Nursing students at New York City College of Technology are assigned client care experiences that focus on common alterations in health status. However, due to the unpredictability of client census within any healthcare facility, it is not possible for all students to have the same opportunity to care for clients with specific medical conditions. But with the use of patient simulators in a dedicated Clinical Simulation Laboratory setting, students can be universally, consistently, and repeatedly exposed to programmed scenarios that connect theory with the clinical environment. Outcomes from using patient simulators include improved nursing knowledge base, enhanced critical thinking, reflective learning, and increased understanding of information technology for using a Personal Digital Assistant and documenting care by means of an electronic Patient Record System. An innovative nursing education model using a wireless, inter-connective data network was developed by this college in response to the need for increasing nursing informatics competencies and critical thinking skills by students in preparation for client care.

[Clinical guidelines for the prevention of infective endocarditis].

PubMed

Pérez-Lescure Picarzo, J; Crespo Marcos, D; Centeno Malfaz, F

2014-03-01

This article sets out the recommendations for the prevention of infective endocarditis (IE), contained in the guidelines developed by the American Heart Association (AHA) and the European Society of Cardiology (ESC), from which the recommendations of the Spanish Society of Paediatric Cardiology and Congenital Heart Disease have been agreed. In recent years, there has been a considerable change in the recommendations for the prevention of IE, mainly due to the lack of evidence on the effectiveness of antibiotic prophylaxis in prevention, and the risk of the development of antibiotic resistance. The main change is a reduction of the indications for antibiotic prophylaxis, both in terms of patients and procedures considered at risk. Clinical practice guidelines and recommendations should assist health professionals in making clinical decisions in their daily practice. However, the ultimate judgment regarding the care of a particular patient must be taken by the physician responsible. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Breech presentation: an audit project as means of pursuing clinical excellence.

PubMed

Siassakos, D; Anderson, H; Panter, K

2005-10-01

Clinical audit is an effective quality improvement process to evaluate important clinical issues. Breech presentation is such an issue due to its contribution to the rising caesarean section (CS) rate. We set out to assess the management of breech presentation using, as standards, the delivery suite protocol and national guidelines. Our first audit revealed a low success rate of external cephalic version (ECV) and deficient documentation of written consent for ECV, other aspects of care being satisfactory. The results were presented to a multidisciplinary meeting and disseminated to relevant stakeholders. A re-audit was then performed. It confirmed significant improvement in the documentation of consent for ECV. It also revealed a good detection rate of breech, optimal offer rate of ECV and good neonatal outcome. However, uptake of ECV as well as the success rate could both be improved so as to reduce the CS rate for breech presentation. We discuss options for improving the uptake and success rate for ECV.

Fast interactive real-time volume rendering of real-time three-dimensional echocardiography: an implementation for low-end computers

NASA Technical Reports Server (NTRS)

Saracino, G.; Greenberg, N. L.; Shiota, T.; Corsi, C.; Lamberti, C.; Thomas, J. D.

2002-01-01

Real-time three-dimensional echocardiography (RT3DE) is an innovative cardiac imaging modality. However, partly due to lack of user-friendly software, RT3DE has not been widely accepted as a clinical tool. The object of this study was to develop and implement a fast and interactive volume renderer of RT3DE datasets designed for a clinical environment where speed and simplicity are not secondary to accuracy. Thirty-six patients (20 regurgitation, 8 normal, 8 cardiomyopathy) were imaged using RT3DE. Using our newly developed software, all 3D data sets were rendered in real-time throughout the cardiac cycle and assessment of cardiac function and pathology was performed for each case. The real-time interactive volume visualization system is user friendly and instantly provides consistent and reliable 3D images without expensive workstations or dedicated hardware. We believe that this novel tool can be used clinically for dynamic visualization of cardiac anatomy.

Adverse events associated with apremilast use and withdrawal for psoriasis in a real-world setting.

PubMed

Lee, Erica B; Amin, Mina; Egeberg, Alexander; Wu, Jashin J

2018-05-06

Apremilast, a phosphodiesterase-4 inhibitor, is an oral therapy for treatment of psoriasis. Its safety profile is favorable, with side effects including diarrhea, nausea, vomiting, depression, and weight decrease, primarily based on clinical trial data. However, limited research exists on the side effect frequency and subsequent adverse events (AEs) in real-world practice. This retrospective chart review included patients who presented to the dermatology clinic at Kaiser Permanente Los Angeles Medical Center and were treated with apremilast at any time between January 1, 2015 and January 11, 2018. Patients were not included if they did not have at least one follow-up by clinic visit, telephone, or email correspondence after being prescribed apremilast. A total of 77 patients were included. AEs and withdrawal due to AEs were assessed throughout the treatment period from each patient's respective medical record. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Peer Assisted Learning in the Clinical Setting: An Activity Systems Analysis

ERIC Educational Resources Information Center

Bennett, Deirdre; O'Flynn, Siun; Kelly, Martina

2015-01-01

Peer assisted learning (PAL) is a common feature of medical education. Understanding of PAL has been based on processes and outcomes in controlled settings, such as clinical skills labs. PAL in the clinical setting, a complex learning environment, requires fresh evaluation. Socio-cultural theory is proposed as a means to understand educational…

Educational Preparation for the Clinic Job Setting: Clinical Athletic Trainers' Perspectives

ERIC Educational Resources Information Center

Schilling, Jim; Combs, Martha

2011-01-01

Context: Acquiring input from all stakeholders on the importance of existing competencies and suggestions for new ones is essential to competency-based pedagogical design quality. Objective: To survey athletic trainers (ATs) employed in clinical settings to assess their perceptions of the competencies most pertinent to their settings and whether…

Dermatology facing autoinflammatory syndrome.

PubMed

Alecu, Mihail; Coman, Gabriela; Muşetescu, Alina; Cojoacă, Marian Emanuel; Coman, Oana Andreia

2015-01-01

Cutaneous symptoms are characteristic for the autoinflammatory disorders (AIDs), both in the classical autoinflammatory phenotype and in most disorders included in this syndrome, but they are not specific and inconstant. Several skin disorders (pyoderma gangrenosum and pustular acne) may be encountered either isolate or associated with autoinflammatory symptoms, forming well-defined clinical entities within the autoinflammatory syndrome. The high prevalence of cutaneous manifestations is an important characteristic of AIDs. The presence of cutaneous symptoms in AIDs opens the perspective of understanding the contribution of innate immunity mechanisms involved in skin pathology. It is possible that many diseases present the alteration, in various degrees, of the innate immune mechanisms. Recently, dermatology faced two challenges connected to AIDs. The first involves the diagnosis of skin symptoms in a clinical autoinflammatory setting and the investigative approach to identify a disorder classified as AID. The second is to identify the altered mechanisms of inborn immunity among the pathogenetic mechanisms of known dermatological diseases (e.g., neutrophilic dermatoses). On the other hand, cutaneous symptoms are in certain cases regarded as a criterion to asses the efficacy of specific or non-specific therapies with monoclonal antibodies in disorders included in AIDs. Dermatology mostly benefits from the identification and knowledge of AIDs due to the role of innate immunity in skin pathogeny and also due to the large extent of clinical forms resulting from the association of skin symptoms with other disorders included in this group.

Clinical bacteriology in low-resource settings: today's solutions.

PubMed

Ombelet, Sien; Ronat, Jean-Baptiste; Walsh, Timothy; Yansouni, Cedric P; Cox, Janneke; Vlieghe, Erika; Martiny, Delphine; Semret, Makeda; Vandenberg, Olivier; Jacobs, Jan

2018-03-05

Low-resource settings are disproportionately burdened by infectious diseases and antimicrobial resistance. Good quality clinical bacteriology through a well functioning reference laboratory network is necessary for effective resistance control, but low-resource settings face infrastructural, technical, and behavioural challenges in the implementation of clinical bacteriology. In this Personal View, we explore what constitutes successful implementation of clinical bacteriology in low-resource settings and describe a framework for implementation that is suitable for general referral hospitals in low-income and middle-income countries with a moderate infrastructure. Most microbiological techniques and equipment are not developed for the specific needs of such settings. Pending the arrival of a new generation diagnostics for these settings, we suggest focus on improving, adapting, and implementing conventional, culture-based techniques. Priorities in low-resource settings include harmonised, quality assured, and tropicalised equipment, consumables, and techniques, and rationalised bacterial identification and testing for antimicrobial resistance. Diagnostics should be integrated into clinical care and patient management; clinically relevant specimens must be appropriately selected and prioritised. Open-access training materials and information management tools should be developed. Also important is the need for onsite validation and field adoption of diagnostics in low-resource settings, with considerable shortening of the time between development and implementation of diagnostics. We argue that the implementation of clinical bacteriology in low-resource settings improves patient management, provides valuable surveillance for local antibiotic treatment guidelines and national policies, and supports containment of antimicrobial resistance and the prevention and control of hospital-acquired infections. Copyright © 2018 Elsevier Ltd. All rights reserved.

Intercultural Competency in Public Health: A Call for Action to Incorporate Training into Public Health Education

PubMed Central

Fleckman, Julia M.; Dal Corso, Mark; Ramirez, Shokufeh; Begalieva, Maya; Johnson, Carolyn C.

2015-01-01

Due to increasing national diversity, programs addressing cultural competence have multiplied in U.S. medical training institutions. Although these programs share common goals for improving clinical care for patients and reducing health disparities, there is little standardization across programs. Furthermore, little progress has been made to translate cultural competency training from the clinical setting into the public health setting where the focus is on population-based health, preventative programming, and epidemiological and behavioral research. The need for culturally relevant public health programming and culturally sensitive public health research is more critical than ever. Awareness of differing cultures needs to be included in all processes of planning, implementation and evaluation. By focusing on community-based health program planning and research, cultural competence implies that it is possible for public health professionals to completely know another culture, whereas intercultural competence implies it is a dual-sided process. Public health professionals need a commitment toward intercultural competence and skills that demonstrate flexibility, openness, and self-reflection so that cultural learning is possible. In this article, the authors recommend a number of elements to develop, adapt, and strengthen intercultural competence education in public health educational institutions. PMID:26389109

New systemic strategies for overcoming resistance to targeted therapies in non-small cell lung cancer.

PubMed

Genova, Carlo; Rijavec, Erika; Biello, Federica; Rossi, Giovanni; Barletta, Giulia; Dal Bello, Maria Giovanna; Vanni, Irene; Coco, Simona; Alama, Angela; Grossi, Francesco

2017-01-01

Although the achievements in the treatment of advanced non-small cell lung cancer (NSCLC) have been translated in improved disease control, response rate and survival, especially in the case of patients with targetable oncogenic drivers, acquired resistance is common after initial benefit; furthermore, primary resistance can occasionally be observed. Due to its clinical implications, the management of treatment-resistant NSCLC is a top topic of the current research, and many efforts are being put in the study of the mechanisms at the base of resistance and in the development of effective therapeutic countermeasures. Areas covered: This review aims at identifying the most relevant novel chemical therapies designed to overcome resistance in NSCLC, including recently approved agents, as well as compounds in clinical development. Expert opinion: An improved knowledge of the mechanisms causing resistance to treatments in NSCLC translates into effective innovative chemical therapies able to overcome such occurrence, and the paradigms of this progress are represented by novel inhibitors of the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK); however, the study of novel systemic therapies in this setting is challenging, and further efforts in this setting are highly needed.

Intercultural Competency in Public Health: A Call for Action to Incorporate Training into Public Health Education.

PubMed

Fleckman, Julia M; Dal Corso, Mark; Ramirez, Shokufeh; Begalieva, Maya; Johnson, Carolyn C

2015-01-01

Due to increasing national diversity, programs addressing cultural competence have multiplied in U.S. medical training institutions. Although these programs share common goals for improving clinical care for patients and reducing health disparities, there is little standardization across programs. Furthermore, little progress has been made to translate cultural competency training from the clinical setting into the public health setting where the focus is on population-based health, preventative programming, and epidemiological and behavioral research. The need for culturally relevant public health programming and culturally sensitive public health research is more critical than ever. Awareness of differing cultures needs to be included in all processes of planning, implementation and evaluation. By focusing on community-based health program planning and research, cultural competence implies that it is possible for public health professionals to completely know another culture, whereas intercultural competence implies it is a dual-sided process. Public health professionals need a commitment toward intercultural competence and skills that demonstrate flexibility, openness, and self-reflection so that cultural learning is possible. In this article, the authors recommend a number of elements to develop, adapt, and strengthen intercultural competence education in public health educational institutions.

Computer-aided detection of basal cell carcinoma through blood content analysis in dermoscopy images

NASA Astrophysics Data System (ADS)

Kharazmi, Pegah; Kalia, Sunil; Lui, Harvey; Wang, Z. Jane; Lee, Tim K.

2018-02-01

Basal cell carcinoma (BCC) is the most common type of skin cancer, which is highly damaging to the skin at its advanced stages and causes huge costs on the healthcare system. However, most types of BCC are easily curable if detected at early stage. Due to limited access to dermatologists and expert physicians, non-invasive computer-aided diagnosis is a viable option for skin cancer screening. A clinical biomarker of cancerous tumors is increased vascularization and excess blood flow. In this paper, we present a computer-aided technique to differentiate cancerous skin tumors from benign lesions based on vascular characteristics of the lesions. Dermoscopy image of the lesion is first decomposed using independent component analysis of the RGB channels to derive melanin and hemoglobin maps. A novel set of clinically inspired features and ratiometric measurements are then extracted from each map to characterize the vascular properties and blood content of the lesion. The feature set is then fed into a random forest classifier. Over a dataset of 664 skin lesions, the proposed method achieved an area under ROC curve of 0.832 in a 10-fold cross validation for differentiating basal cell carcinomas from benign lesions.

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

PubMed

Parrino, Thomas A

2005-02-01

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

Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations.

PubMed

Yoshinaga, Keiichiro; Naya, Masanao; Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara

2014-02-01

"Ischaemic memory" is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[(123)I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of (123)I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with (18)F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations.

Clinical utility of multiplex ligation-dependent probe amplification technique in identification of aetiology of unexplained mental retardation: a study in 203 Indian patients.

PubMed

Boggula, Vijay R; Shukla, Anju; Danda, Sumita; Hariharan, Sankar V; Nampoothiri, Sheela; Kumar, Rashmi; Phadke, Shubha R

2014-01-01

Developmental delay (DD)/mental retardation also described as intellectual disability (ID), is seen in 1-3 per cent of general population. Diagnosis continues to be a challenge at clinical level. With the advancement of new molecular cytogenetic techniques such as cytogenetic microarray (CMA), multiplex ligation-dependent probe amplification (MLPA) techniques, many microdeletion/microduplication syndromes with DD/ID are now delineated. MLPA technique can probe 40-50 genomic regions in a single reaction and is being used for evaluation of cases with DD/ID. In this study we evaluated the clinical utility of MLPA techniques with different probe sets to identify the aetiology of unexplained mental retardation in patients with ID/DD. A total of 203 randomly selected DD/ID cases with/without malformations were studied. MLPA probe sets for subtelomeric regions (P070/P036) and common microdeletions/microduplications (P245-A2) and X-chromosome (P106) were used. Positive cases with MLPA technique were confirmed using either fluorescence in situ hybridization (FISH) or follow up confirmatory MLPA probe sets. The overall detection rate was found to be 9.3 per cent (19 out of 203). The detection rates were 6.9 and 7.4 per cent for common microdeletion/microduplication and subtelomeric probe sets, respectively. No abnormality was detected with probe set for X-linked ID. The subtelomeric abnormalities detected included deletions of 1p36.33, 4p, 5p, 9p, 9q, 13q telomeric regions and duplication of 9pter. The deletions/duplications detected in non telomeric regions include regions for Prader Willi/Angelman regions, Williams syndrome, Smith Magenis syndrome and Velocardiofacial syndrome. Our results show that the use of P245-A2 and P070/P036-E1 probes gives good diagnostic yield. Though MLPA cannot probe the whole genome like cytogenetic microarray, due to its ease and relative low cost it is an important technique for evaluation of cases with DD/ID.

Financial and clinical governance implications of clinical coding accuracy in neurosurgery: a multidisciplinary audit.

PubMed

Haliasos, N; Rezajooi, K; O'neill, K S; Van Dellen, J; Hudovsky, Anita; Nouraei, Sar

2010-04-01

Clinical coding is the translation of documented clinical activities during an admission to a codified language. Healthcare Resource Groupings (HRGs) are derived from coding data and are used to calculate payment to hospitals in England, Wales and Scotland and to conduct national audit and benchmarking exercises. Coding is an error-prone process and an understanding of its accuracy within neurosurgery is critical for financial, organizational and clinical governance purposes. We undertook a multidisciplinary audit of neurosurgical clinical coding accuracy. Neurosurgeons trained in coding assessed the accuracy of 386 patient episodes. Where clinicians felt a coding error was present, the case was discussed with an experienced clinical coder. Concordance between the initial coder-only clinical coding and the final clinician-coder multidisciplinary coding was assessed. At least one coding error occurred in 71/386 patients (18.4%). There were 36 diagnosis and 93 procedure errors and in 40 cases, the initial HRG changed (10.4%). Financially, this translated to pound111 revenue-loss per patient episode and projected to pound171,452 of annual loss to the department. 85% of all coding errors were due to accumulation of coding changes that occurred only once in the whole data set. Neurosurgical clinical coding is error-prone. This is financially disadvantageous and with the coding data being the source of comparisons within and between departments, coding inaccuracies paint a distorted picture of departmental activity and subspecialism in audit and benchmarking. Clinical engagement improves accuracy and is encouraged within a clinical governance framework.

Stochastic Estimation of Arm Mechanical Impedance During Robotic Stroke Rehabilitation

PubMed Central

Palazzolo, Jerome J.; Ferraro, Mark; Krebs, Hermano Igo; Lynch, Daniel; Volpe, Bruce T.; Hogan, Neville

2009-01-01

This paper presents a stochastic method to estimate the multijoint mechanical impedance of the human arm suitable for use in a clinical setting, e.g., with persons with stroke undergoing robotic rehabilitation for a paralyzed arm. In this context, special circumstances such as hypertonicity and tissue atrophy due to disuse of the hemiplegic limb must be considered. A low-impedance robot was used to bring the upper limb of a stroke patient to a test location, generate force perturbations, and measure the resulting motion. Methods were developed to compensate for input signal coupling at low frequencies apparently due to human–machine interaction dynamics. Data was analyzed by spectral procedures that make no assumption about model structure. The method was validated by measuring simple mechanical hardware and results from a patient's hemiplegic arm are presented. PMID:17436881

Evaluation of Polyuria: The Roles of Solute Loading and Water Diuresis.

PubMed

Bhasin, Bhavna; Velez, Juan Carlos Q

2016-03-01

Polyuria, defined as daily urine output in excess of 3.0 to 3.5L/d, can occur due to solute or water diuresis. Solute-induced polyuria can be seen in hospitalized patients after a high solute load from exogenous protein administration or following relief of urinary obstruction. Similar clinical scenarios are rarely encountered in the outpatient setting. We describe a case of polyuria due to high solute ingestion and excessive water intake leading to a mixed picture of solute and water diuresis. Restriction of the daily solute load and water intake resulted in complete resolution of polyuria. Determination of the daily excreted urinary osmoles may yield important clues to the cause of polyuria and should be included in the routine workup of polyuria. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Demographic and clinical features of patients with fibromyalgia syndrome of different settings: a gender comparison.

PubMed

Häuser, Winfried; Kühn-Becker, Hedi; von Wilmoswky, Hubertus; Settan, Margit; Brähler, Elmar; Petzke, Frank

2011-04-01

Well-established gender differences in the clinical picture of fibromyalgia syndrome (FMS) have been suggested. However, studies on gender differences in demographic and clinical features of FMS have contradictory results. Their significance is limited by the small number of patients included and selection bias of single settings. The purpose of this study was to compare demographic characteristics (age, family status) and clinical variables (duration of chronic pain and FMS diagnosis, tender point count, number of pain sites, and somatic and depressive symptoms) of male and female patients in different settings (general population, FMS self-help organization, and different clinical settings). FMS was diagnosed according to survey criteria in the general population and in the self-help organization setting and by 1990 criteria of the American College of Rheumatology in the clinical settings. Tender point examination was performed according to the manual tender point survey protocol in clinical settings. Somatic and depressive symptoms were assessed by validated questionnaires. A total of 1023 patients (885 female, 138 male) were included in the analysis. Compared with male participants, female participants reported a longer duration of chronic widespread pain (P = 0.009) and time since FMS diagnosis (P = 0.05), and they had a higher tender point count (P = 0.04). There were no gender differences in age, family status, number of pain sites, or somatic and depressive symptoms. We found no relevant gender differences in the clinical picture of FMS. The assumption of well-established gender differences in the clinical picture of FMS could not be supported. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

phMRI: methodological considerations for mitigating potential confounding factors

PubMed Central

Bourke, Julius H.; Wall, Matthew B.

2015-01-01

Pharmacological Magnetic Resonance Imaging (phMRI) is a variant of conventional MRI that adds pharmacological manipulations in order to study the effects of drugs, or uses pharmacological probes to investigate basic or applied (e.g., clinical) neuroscience questions. Issues that may confound the interpretation of results from various types of phMRI studies are briefly discussed, and a set of methodological strategies that can mitigate these problems are described. These include strategies that can be employed at every stage of investigation, from study design to interpretation of resulting data, and additional techniques suited for use with clinical populations are also featured. Pharmacological MRI is a challenging area of research that has both significant advantages and formidable difficulties, however with due consideration and use of these strategies many of the key obstacles can be overcome. PMID:25999812

Clinical use of Heliox in asthma and COPD.

PubMed

Valli, G; Paoletti, P; Savi, D; Martolini, D; Palange, P

2007-09-01

Heliox is a low density gas mixture of helium and oxygen commonly used in deep diving (> 6 ATM). This mixture has been also used for clinical purposes, particularly in the critical care setting. Due to of its physical proprieties, Heliox breathing reduces air flow resistances within the bronchial tree; in patients with obstructive lung diseases Heliox may also reduce the work of breathing and improve pulmonary gas exchange efficiency. Beneficial effects have been documented in severe asthma attacks and in patients with chronic obstructive pulmonary disease. A reduction in WOB during mechanical ventilation and an increase in exercise endurance capacity have also been described in COPD. Heliox has been also used in the treatment of upper airways obstruction, bronchiolitis and bronchopulmonary dysplasia. Despite the encouraging results, Heliox use in routine practice remains controversial because of technical implications and high costs.

Multidisciplinary care of craniosynostosis

PubMed Central

Buchanan, Edward P; Xue, Yunfeng; Xue, Amy S; Olshinka, Asaf; Lam, Sandi

2017-01-01

The management of craniosynostosis, especially in the setting of craniofacial syndromes, is ideally done in a multidisciplinary clinic with a team focused toward comprehensive care. Craniosynostosis is a congenital disorder of the cranium, caused by the premature fusion of one or more cranial sutures. This fusion results in abnormal cranial growth due to the inability of the involved sutures to accommodate the growing brain. Skull growth occurs only at the patent sutures, resulting in an abnormal head shape. If cranial growth is severely restricted, as seen in multisuture craniosynostosis, elevation in intracranial pressure can occur. Whereas most patients treated in a multidisciplinary craniofacial clinic have non-syndromic or isolated craniosynostosis, the most challenging patients are those with syndromic craniosynostosis. The purpose of this article was to discuss the multidisciplinary team care required to treat both syndromic and non-syndromic craniosynostosis. PMID:28740400

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.

Validating archetypes for the Multiple Sclerosis Functional Composite.

PubMed

Braun, Michael; Brandt, Alexander Ulrich; Schulz, Stefan; Boeker, Martin

2014-08-03

Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions.This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model.

Validating archetypes for the Multiple Sclerosis Functional Composite

PubMed Central

2014-01-01

Background Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. Methods A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Results Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. Conclusions The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions. This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model. PMID:25087081

Association of health literacy with type 2 diabetes mellitus self-management and clinical outcomes within the primary care setting of Iran.

PubMed

Niknami, Marzieh; Mirbalouchzehi, Ali; Zareban, Iraj; Kalkalinia, Elahibakhsh; Rikhtgarha, Gasem; Hosseinzadeh, Hassan

2018-04-06

This study explores the potential association of health literacy with type 2 diabetes mellitus (T2DM) self-management and clinical outcomes in the primary care setting of Iran. A total of 347 T2DM patients, mostly female (52.4%), 50 years old or younger (63.1%), unemployed (53.6%) and rural residents (55.6%) participated in this study. Most of the respondents had type 2 diabetes mellitus (T2DM) for 2-5 years (63.1%) and did not receive any T2DM education (52.2%). Approximately 19.0% were hospitalised due to uncontrolled T2DM. Participants mainly found managing T2DM self-management behaviours difficult. Approximately half of the participants had poor fasting blood sugar (FBS) (47.0%) and haemoglobin A1c (HbA1c) (59.4%) control and were overweight or obese (77.6%). The level of health literacy was poor and most of the participants had difficulties reading hospital materials (66.0%), understanding medical materials (62.5%) and engaging in medical conversations (63.7%). Health literacy could predict 22.5% variance in difficulty of T2DM self-management and 3.8-23.3% variance in T2DM clinical outcomes after controlling for sociodemographic factors. Participants with higher health literacy were more likely to find managing T2DM less challenging and their clinical outcomes were within the normal range. This implies that interventions targeting patient's health literacy can be a promising tool for addressing the burden of T2DM.

Projecting future drug expenditures--2012.

PubMed

Hoffman, James M; Li, Edward; Doloresco, Fred; Matusiak, Linda; Hunkler, Robert J; Shah, Nilay D; Vermeulen, Lee C; Schumock, Glen T

2012-03-01

Factors likely to influence drug expenditures, drug expenditure trends in 2010 and 2011, and projected drug expenditures for 2012 are discussed. Data were analyzed to provide drug expenditure trends for total drug expenditures and the hospital and clinic sectors. Data were obtained from the IMS Health National Sales Perspectives database. From 2009 to 2010, total U.S. drug expenditures increased by 2.7%, with total spending rising from $299.2 billion to $307.5 billion. Drug expenditures in clinics grew by 6.0% from 2009 to 2010. Hospital drug expenditures increased at the moderate rate of 1.5% from 2009 to 2010; through the first nine months of 2011, hospital drug expenditures increased by only 0.3% compared with the same period in 2010. The dominant trend over the past several years is substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction and wide use of generic versions of high-cost, frequently used medications. At the end of 2010, generic drugs accounted for 78% of all retail prescriptions dispensed. Another pattern is substantial increases in expenditures for specialized medications, particularly in the outpatient setting as growth in prescription drug expenditures for clinic-administered drugs consistently outpaces growth in total expenditures. Various factors are likely to influence drug expenditures in 2012, including drugs in development, the diffusion of new drugs, generic drugs, drug shortages, and biosimilars. For 2012, we project a 3-5% increase in total drug expenditures across all settings, a 5-7% increase in expenditures for clinic-administered drugs, and a 0-2% increase in hospital drug expenditures.

Reliability and validity assessment of administrative databases in measuring the quality of rectal cancer management.

PubMed

Corbellini, Carlo; Andreoni, Bruno; Ansaloni, Luca; Sgroi, Giovanni; Martinotti, Mario; Scandroglio, Ildo; Carzaniga, Pierluigi; Longoni, Mauro; Foschi, Diego; Dionigi, Paolo; Morandi, Eugenio; Agnello, Mauro

2018-01-01

Measurement and monitoring of the quality of care using a core set of quality measures are increasing in health service research. Although administrative databases include limited clinical data, they offer an attractive source for quality measurement. The purpose of this study, therefore, was to evaluate the completeness of different administrative data sources compared to a clinical survey in evaluating rectal cancer cases. Between May 2012 and November 2014, a clinical survey was done on 498 Lombardy patients who had rectal cancer and underwent surgical resection. These collected data were compared with the information extracted from administrative sources including Hospital Discharge Dataset, drug database, daycare activity data, fee-exemption database, and regional screening program database. The agreement evaluation was performed using a set of 12 quality indicators. Patient complexity was a difficult indicator to measure for lack of clinical data. Preoperative staging was another suboptimal indicator due to the frequent missing administrative registration of tests performed. The agreement between the 2 data sources regarding chemoradiotherapy treatments was high. Screening detection, minimally invasive techniques, length of stay, and unpreventable readmissions were detected as reliable quality indicators. Postoperative morbidity could be a useful indicator but its agreement was lower, as expected. Healthcare administrative databases are large and real-time collected repositories of data useful in measuring quality in a healthcare system. Our investigation reveals that the reliability of indicators varies between them. Ideally, a combination of data from both sources could be used in order to improve usefulness of less reliable indicators.

Management of the elderly patient with AL amyloidosis.

PubMed

Nuvolone, Mario; Milani, Paolo; Palladini, Giovanni; Merlini, Giampaolo

2018-05-22

Systemic immunoglobulin light chain (AL) amyloidosis is an aging-associated protein misfolding and deposition disease. This condition is caused by a small and otherwise indolent plasma cell (or B cell) clone secreting an unstable circulating light chain, which misfolds and deposits as amyloid fibrils possibly leading to progressive dysfunction of affected organs. AL amyloidosis can occur in the typical setting of other, rarer forms of systemic amyloidosis and can mimic other more prevalent conditions of the elderly. Therefore, its diagnosis requires a high degree of clinical suspicion and reliable diagnostic tools for accurate amyloid typing, available at specialized referral centers. In AL amyloidosis, frailty is dictated by the type and severity of organ involvement, with heart involvement being the main determinant of morbidity and mortality. Still, given a similar disease stage, elderly patients with AL amyloidosis are often an even frailer group, due to significant comorbidities, associated disability and polypharmacotherapy, socioeconomic restrictions, and limited access to clinical trials. Recent improvements in the use of biomarkers for early diagnosis, risk stratification and response monitoring, the flourishing of novel, effective anti-plasma cell therapies developed against multiple myeloma and adapted to treat AL amyloidosis, and possibly the introduction of anti-amyloid therapies are rapidly changing the clinical management of this disease and are reflected by improved outcomes. Of note, hematologic and organ responses in elderly patients with AL amyloidosis do translate in better outcome, advocating the importance of treating these patients and striving for a rapid response to therapy also in this challenging clinical setting. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Accuracy of dengue clinical diagnosis with and without NS1 antigen rapid test: Comparison between human and Bayesian network model decision.

PubMed

Sa-Ngamuang, Chaitawat; Haddawy, Peter; Luvira, Viravarn; Piyaphanee, Watcharapong; Iamsirithaworn, Sopon; Lawpoolsri, Saranath

2018-06-18

Differentiating dengue patients from other acute febrile illness patients is a great challenge among physicians. Several dengue diagnosis methods are recommended by WHO. The application of specific laboratory tests is still limited due to high cost, lack of equipment, and uncertain validity. Therefore, clinical diagnosis remains a common practice especially in resource limited settings. Bayesian networks have been shown to be a useful tool for diagnostic decision support. This study aimed to construct Bayesian network models using basic demographic, clinical, and laboratory profiles of acute febrile illness patients to diagnose dengue. Data of 397 acute undifferentiated febrile illness patients who visited the fever clinic of the Bangkok Hospital for Tropical Diseases, Thailand, were used for model construction and validation. The two best final models were selected: one with and one without NS1 rapid test result. The diagnostic accuracy of the models was compared with that of physicians on the same set of patients. The Bayesian network models provided good diagnostic accuracy of dengue infection, with ROC AUC of 0.80 and 0.75 for models with and without NS1 rapid test result, respectively. The models had approximately 80% specificity and 70% sensitivity, similar to the diagnostic accuracy of the hospital's fellows in infectious disease. Including information on NS1 rapid test improved the specificity, but reduced the sensitivity, both in model and physician diagnoses. The Bayesian network model developed in this study could be useful to assist physicians in diagnosing dengue, particularly in regions where experienced physicians and laboratory confirmation tests are limited.

Swedish nursing students' experience of stress during clinical practice in relation to clinical setting characteristics and the organisation of the clinical education.

PubMed

Blomberg, Karin; Bisholt, Birgitta; Kullén Engström, Agneta; Ohlsson, Ulla; Sundler Johansson, Annelie; Gustafsson, Margareta

2014-08-01

To describe nursing students' experience of stress during clinical practice and evaluate the risk of stress in relation to the clinical setting characteristics and the organisation of the clinical education. Stress during clinical practice is well documented, but there is a lack of knowledge concerning whether the clinical setting characteristics and the organisation of the education make a difference. A cross-sectional study with evaluative design. Data were collected by means of a numerical rating scale for the assessment of stress and questions about the clinical setting characteristics and the organisation of the education. One hundred and eighty-four students who had completed their final year on the nursing programme at three universities in Sweden were included. Nearly half of the students (43%) experienced high level of stress during clinical practice. Measured by decision in the tree analysis, the absolute risk of stress was 57% in students with placements in hospital departments, as compared to 13% in students with placements in other clinical settings. The risk of stress increased to 71% if the students with placement in a hospital took the national clinical final examination. Performance of practice in a hospital department overcrowded with patients was also associated with increased risk of stress. The organisation of supervision and number of students at the clinical placement had an effect on the experience of stress, but did not prove to be risk factors in the analysis. The risk of stress in nursing students during their clinical practice differs depending on clinical setting characteristics. The taking of the national clinical final examination could be a source of stress, but this requires further investigation. It is important that supervisors are aware that students in hospital departments overcrowded with patients are at risk of stress and may have increased need of support. © 2014 John Wiley & Sons Ltd.

Periodic limb movements and insomnia, a common but under-recognized association

PubMed Central

Varadharajulu, Saravanan; Chandrasekaran, Baskaran

2015-01-01

Periodic limb movements unlike restless leg syndrome is under diagnosed and unrecognized in medical arena. While robust Western trials have elucidated the association between periodic limb movements and sleep disturbances, it is not well received and recognized in India even in well sophisticated tertiary care hospital. We report a chronic insomnia patient who had sleep disturbances for past 30 years due to periodic limb movements alone. This was diagnosed through polysomnography. This case emphasizes monitoring leg movements during sleep study. This report may open new horizons in improving monitoring in sleep study in clinical setting. PMID:26124530

Lung cancer biology: a genetic and genomic perspective.

PubMed

Sánchez-Céspedes, M

2009-05-01

Lung cancer is the leading cause of death due to cancer in most western countries and, as tobacco consumption is not significantly decreasing worldwide, will remain so in the coming decades. Thus, in addition to preventing uptake and encouraging cessation of the smoking habit, it is important to invest in understanding the biology of this type of cancer. Of particular interest are the recent efforts directed towards characterising the entire set of gene alterations in lung cancer. The present review describes the catalogue of known genetic alterations in lung cancer, their biological role and their use in clinical management.

Factors influencing parental consent in a hypothetical pediatric vaccine trial in a developing country setting: a questionnaire study.

PubMed

Serce, Ozge; Gonen, Ismail; Bakir, Mustafa

2015-01-01

Clinical vaccine trials have been lacking in the pediatric population due to lower consent rate of the parents. We assessed characteristics of the parents, and motives and barriers underlying the decision process. The results of the questionnaire were evaluated by multivariate analysis. Parents who opted in were younger and more often employed than the parents who opted out. The most important motives were receiving detailed information about trial and benefits to human health. The qualified education of medical community and public about the rationale and benefits of trials is essential for opt-in.

Overlapping bio-absorbable scaffolds: Aim for D2D technique?

PubMed

Khan, Asaad A; Dangas, George D

2018-06-01

The results of overlapping metallic stents have been concerning but this practice is often unavoidable in the setting of long or tortuous lesions, diameter discrepancy of proximal and distal vessel, and for residual dissections. Theoretically, bio-absorbable scaffolds may carry an advantage over metallic stents due to the progressive resorption of the scaffold theoretically rendering the overlap a non-issue; this has not been clinically evident. Since stent/scaffold overlap cannot be entirely avoided, improved stent delivery/deployment and scaffold design modification may reduce complications in this complex patient subset. © 2018 Wiley Periodicals, Inc.

[Amiodarone and thyroid].

PubMed

Capraro, Joël; Thalmann, Sébastien

2011-06-01

Amiodarone is a widely used antiarrythmic drug and can lead either to hypothyroidism or hyperthyroidism due to its molecular structure which is similar to levothyroxin. Amiodarone induced hypothyroidism can be treated easely with hormonal subsitution. Hyperthyroidism is more challenging. There exist two forms of amiodarone-induced Hyperthyroidism (AIT): AIT type 1 is directly related to the iodine compound of amiodarone and responds to thyreostatic therapy. Type 2 is a consequence of the direct toxicity of amiodarone to the thyroid gland and is treated primarily with glucocorticoids. However, this differentiation often is impossible in clinical settings and a pragmatic approach is needed.

Tri-phasic fever in dengue fever.

PubMed

D, Pradeepa H; Rao, Sathish B; B, Ganaraj; Bhat, Gopalakrishna; M, Chakrapani

2018-04-01

Dengue fever is an acute febrile illness with a duration of 2-12 days. Our observational study observed the 24-h continuous tympanic temperature pattern of 15 patients with dengue fever and compared this with 26 others with fever due to a non-dengue aetiology. A tri-phasic fever pattern was seen among two-thirds of dengue fever patients, but in only one with an inflammatory disease. One-third of dengue fever patients exhibited a single peak temperature. Continuous temperature monitoring and temperature pattern analysis in clinical settings can aid in the early differentiation of dengue fever from non-dengue aetiology.

Innovative partnerships: the clinical nurse leader role in diverse clinical settings.

PubMed

Lammon, Carol Ann Barnett; Stanton, Marietta P; Blakney, John L

2010-01-01

The American Association of Colleges of Nursing in collaboration with leaders in the health care arena has developed a new role in nursing, the clinical nurse leader (CNL). The CNL is a master's-prepared advanced nurse generalist, accountable for providing high-quality, cost-effective care for a cohort of patients in a specific microsystem. Although initial implementation of the CNL has been predominantly in urban acute care settings, the skill set of the CNL role is equally applicable to diverse clinical settings, such as smaller rural hospitals, home-based home care providers, long-term care facilities, schools, Veteran's Administration facilities, and public health settings. This article reports the strategies used and the progress made at The University of Alabama Capstone College of Nursing in the development of innovative partnerships to develop the role of the CNL in diverse clinical settings. With academia and practice working in partnership, the goal of transforming health care and improving patient outcomes can be achieved. Copyright © 2010 Elsevier Inc. All rights reserved.

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

Dallas, Michael J

2008-01-01

Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

Regenerative and Rehabilitative Medicine: A Necessary Synergy for Functional Recovery from Volumetric Muscle Loss Injury.

PubMed

Greising, Sarah M; Dearth, Christopher L; Corona, Benjamin T

2016-01-01

Volumetric muscle loss (VML) is a complex and heterogeneous problem due to significant traumatic or surgical loss of skeletal muscle tissue. The consequences of VML are substantial functional deficits in joint range of motion and skeletal muscle strength, resulting in life-long dysfunction and disability. Traditional physical medicine and rehabilitation paradigms do not address the magnitude of force loss due to VML and related musculoskeletal comorbidities. Recent advancements in regenerative medicine have set forth encouraging and emerging therapeutic options for VML injuries. There is significant potential that combined rehabilitative and regenerative therapies can restore limb and muscle function following VML injury in a synergistic manner. This review presents the current state of the VML field, spanning clinical and preclinical literature, with particular focus on rehabilitation and regenerative medicine in addition to their synergy. Moving forward, multidisciplinary collaboration between clinical and research fields is encouraged in order to continue to improve the treatment of VML injuries and specifically address the encompassing physiology, pathology, and specific needs of this patient population. This is a work of the US Government and is not subject to copyright protection in the USA. Foreign copyrights may apply. Published by S. Karger AG, Basel.

Understanding and Managing Atrial Fibrillation in Patients with Kidney Disease.

PubMed

Khouri, Yazan; Stephens, Tiona; Ayuba, Gloria; AlAmeri, Hazim; Juratli, Nour; McCullough, Peter A

2015-01-01

Chronic kidney disease (CKD) is on the rise due to the increased rate of related comorbidities such as diabetes and hypertension. Patients with CKD are at higher risk of cardiovascular events and atrial fibrillation is more common in this patient population. It is estimated that the prevalence of chronic atrial fibrillation in patients with CKD is two to three times higher than general population. Furthermore, patients with CKD are less likely to stay in sinus rhythm. Atrial fibrillation presents a major burden in this population due to difficult treatment decisions in the setting of a lack of evidence from randomized clinical trials. Patients with CKD have higher risk of stroke with more than half having a CHADS2 score ≥ 2. Anticoagulation have been shown to significantly decrease embolic stroke risk, however bleeding complications such as hemorrhagic stroke is twofold higher with warfarin. Although newer novel anticoagulation drugs have shown promise with lower intracranial hemorrhage risk in comparison to warfarin, lack clinical trial data in CKD and the unavailability of an antidote remains an issue. In this review, we discuss the treatment options available including anticoagulation and the evidence behind them in patients with chronic kidney disease suffering from atrial fibrillation.

X linked mental retardation: a clinical guide.

PubMed

Raymond, F L

2006-03-01

Mental retardation is more common in males than females in the population, assumed to be due to mutations on the X chromosome. The prevalence of the 24 genes identified to date is low and less common than expansions in FMR1, which cause Fragile X syndrome. Systematic screening of all other X linked genes in X linked families with mental retardation is currently not feasible in a clinical setting. The phenotypes of genes causing syndromic and non-syndromic mental retardation (NLGN3, NLGN4, RPS6KA3(RSK2), OPHN1, ATRX, SLC6A8, ARX, SYN1, AGTR2, MECP2, PQBP1, SMCX, and SLC16A2) are first discussed, as these may be the focus of more targeted mutation analysis. Secondly, the relative prevalence of genes causing only non-syndromic mental retardation (IL1RAPL1, TM4SF2, ZNF41, FTSJ1, DLG3, FACL4, PAK3, ARHGEF6, FMR2, and GDI) is summarised. Thirdly, the problem of recurrence risk where a molecular genetics diagnosis has not been made and what proportion of the male excess of mental retardation is due to monogenic disorders of the X chromosome are discussed.

EUCAST breakpoints for antifungals.

PubMed

Rodríguez-Tudela, Juan L; Arendrup, Maiken C; Cuenca-Estrella, Manuel; Donnelly, J Peter; Lass-Flörl, Cornelia

2010-03-01

Susceptibility testing of fungi and development of interpretative breakpoints has become increasingly important due to the growing incidence of invasive fungal infections, the number and classes of antifungals, and the emerging reports of acquired resistance. The subcommittee on antifungal susceptibility testing of the European Committee on Antibiotic Susceptibility Testing (EUCAST) has developed standards for susceptibility testing of fermentative yeasts and molds as well as proposing breakpoints for fluconazole and voriconazole against Candida. The aim of this work is to describe the EUCAST process of setting breakpoints for antifungals. Five aspects are evaluated during the process of developing breakpoints: 1) the most common dosage used in each European country, 2) the definition of the wild-type population for each target microorganism at the species level and the determination of epidemiological cutoffs, 3) the drug's pharmacokinetics and 4) pharmacodynamics, including Monte Carlo simulations, and 5) the correlation of MICs with clinical outcome of patients treated with the compound. When insufficient data are available (e.g., due to lack of information on the clinical outcome of infections caused by isolates with an elevated MIC), epidemiological cutoff values, rather than breakpoints, are recommended until the necessary information becomes available. Copyright 2010 Prous Science, S.A.U. or its licensors. All rights reserved.

[Time consumption and quality of an automated fusion tool for SPECT and MRI images of the brain].

PubMed

Fiedler, E; Platsch, G; Schwarz, A; Schmiedehausen, K; Tomandl, B; Huk, W; Rupprecht, Th; Rahn, N; Kuwert, T

2003-10-01

Although the fusion of images from different modalities may improve diagnostic accuracy, it is rarely used in clinical routine work due to logistic problems. Therefore we evaluated performance and time needed for fusing MRI and SPECT images using a semiautomated dedicated software. PATIENTS, MATERIAL AND METHOD: In 32 patients regional cerebral blood flow was measured using (99m)Tc ethylcystein dimer (ECD) and the three-headed SPECT camera MultiSPECT 3. MRI scans of the brain were performed using either a 0,2 T Open or a 1,5 T Sonata. Twelve of the MRI data sets were acquired using a 3D-T1w MPRAGE sequence, 20 with a 2D acquisition technique and different echo sequences. Image fusion was performed on a Syngo workstation using an entropy minimizing algorithm by an experienced user of the software. The fusion results were classified. We measured the time needed for the automated fusion procedure and in case of need that for manual realignment after automated, but insufficient fusion. The mean time of the automated fusion procedure was 123 s. It was for the 2D significantly shorter than for the 3D MRI datasets. For four of the 2D data sets and two of the 3D data sets an optimal fit was reached using the automated approach. The remaining 26 data sets required manual correction. The sum of the time required for automated fusion and that needed for manual correction averaged 320 s (50-886 s). The fusion of 3D MRI data sets lasted significantly longer than that of the 2D MRI data. The automated fusion tool delivered in 20% an optimal fit, in 80% manual correction was necessary. Nevertheless, each of the 32 SPECT data sets could be merged in less than 15 min with the corresponding MRI data, which seems acceptable for clinical routine use.

Assessing patients' attitudes to opt-out HIV rapid screening in community dental clinics: a cross-sectional Canadian experience.

PubMed

Brondani, Mario; Chang, Steve; Donnelly, Leeann

2016-05-10

As a public health initiative, provided-initiated HIV screening test in dental settings has long been available in the U.S.; it was only in 2011 that such setting was used in Canada. The objective of this paper was to assess patients' response to, and attitudes towards, an opt-out rapid HIV screening test in a dental setting in Vancouver, Canada. A cross-sectional evaluation design using a self-complete survey questionnaire on self-perceived values and benefits of an opt-out rapid HIV screening was employed. An anonymous 10-item questionnaire was developed to explore reasons for accepting or declining the HIV rapid screening test, and barriers and facilitators for the HIV screening in dental settings. Eligible participants were male and female older than 19 years attending community dental clinics and who were offered the HIV screening test between June 2010 and February 2015. From the 1552 age-eligible patients, 519 completed the survey and 155 (10 %) accepted the HIV screening due to its convenience, and/or free cost, and/or instant results. From the 458 respondents who did not accept the screening, 362 (79 %) were between the ages of 25 and 45 years; 246 (53.7 %) had identifiable risk factors for contracting HIV; and 189 (41.3 %) reported having been tested within the last 3 months. Those tested in less than 3 months had 3.5 times higher odds to decline the HIV screening compared to those who have been tested between 3 months and 1 year. Convenience, cost-free and readily available results are factors influencing rapid HIV screening uptake. Although dental settings remain an alternative venue for HIV screening from the patients' perspectives, dental hygiene settings might offer a better option.

Clinical and no-clinical setting specificities in first session short-term psychotherapy psychodrama group.

PubMed

Drakulić, Aleksandra Mindoljević

2011-03-01

Modern history of short-term group psychotherapy dates back to the late 1950-ies. From then to present day, this psychotherapeutic method has been used in various forms, from dynamic-oriented to cognitive behavioural psychotherapies. Although it has always been considered rather controversial, due its cost-effectiveness, it has been capturing more and more popularity. This paper presents the specificities of first session short-term psychotherapy psychodrama group through session work with two examined groups: a group of 20 adult women who suffer from mild or moderate forms of unipolar depression and a group of 20 students of the School of Medicine in Zagreb without any psychiatric symptomatology. The results indicate the high importance of having structure in first psychodrama session, of relating it with the previously thoroughly conducted, initial, clinical, interviews, and of the clarity and focus in terms of determining the goals of therapy, especially in a clinical context. This study also confirmed assumptions regarding the need for different approaches of warming-up in psychodrama, both in the clinical and in non-clinical samples. A psychodrama psychotherapist should have good time managing skills and capability to convert the time available into an opportunity for directly boosting the group energy and work on therapeutic alliance.

Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006–2015

PubMed Central

Baldi, Ileana; Lanera, Corrado; Berchialla, Paola; Gregori, Dario

2017-01-01

Objectives To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual. Setting The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016. Design The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015. Results Thirteen thousand and seven hundred twenty-nine cardiovascular trials were identified. Of these, 8900 (65%) were classified as closed studies. Globally, 11% of closed trials were terminated. This proportion varied from 9.6% to 14% for trials recruiting from Europe and Americas, respectively, with a slightly decreasing trend (p=0.02) over the study period. The most common reason for trials failing to complete was poor accrual (41%). Intercontinental trials exhibited lower figures of poor accrual as the reason for their early stopping, as compared with trials recruiting in a single continent (28% vs 44%, p=0.002). Conclusions Poor accrual significantly challenges the successful completion of cardiovascular clinical trials. Findings are suggestive of a positive effect of globalisation of cardiovascular clinical research on the achievement of enrolment goals within a reasonable time frame. PMID:28619765

Attitudes of Staff Nurse Preceptors Related to the Education of Nurses with Learning Disabilities in Clinical Settings

ERIC Educational Resources Information Center

L'Ecuyer, Kristine Marie

2014-01-01

This dissertation presents a quantitative study of the attitudes of staff nurse preceptors toward nursing students with learning disabilities. There are an increased number of nursing students with learning disabilities. These students may have additional challenges in clinical settings, particularly if clinical settings do not understand or…

Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial.

PubMed

Wadhwa, Nitya; Basnet, Sudha; Natchu, Uma Chandra Mouli; Shrestha, Laxman P; Bhatnagar, Shinjini; Sommerfelt, Halvor; Strand, Tor A; Ramji, Siddarth; Aggarwal, K C; Chellani, Harish; Govil, Anuradha; Jajoo, Mamta; Mathur, N B; Bhatt, Meenakshi; Mohta, Anup; Ansari, Imran; Basnet, Srijana; Chapagain, Ram H; Shah, Ganesh P; Shrestha, Binod M

2017-07-10

An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.

Value of History, Physical Examination, and Radiographic Findings in the Diagnosis of Symptomatic Meniscal Tear Among Middle-Aged Subjects With Knee Pain.

PubMed

Katz, Jeffrey N; Smith, Savannah R; Yang, Heidi Y; Martin, Scott D; Wright, John; Donnell-Fink, Laurel A; Losina, Elena

2017-04-01

To evaluate the utility of clinical history, radiographic findings, and physical examination findings in the diagnosis of symptomatic meniscal tear (SMT) in patients over age 45 years, in whom concomitant osteoarthritis is prevalent. In a cross-sectional study of patients from 2 orthopedic surgeons' clinics, we assessed clinical history, physical examination findings, and radiographic findings in patients age >45 years with knee pain. The orthopedic surgeons rated their confidence that subjects' symptoms were due to meniscal tear; we defined the diagnosis of SMT as at least 70% confidence. We used logistic regression to identify factors independently associated with diagnosis of SMT, and we used the regression results to construct an index of the likelihood of SMT. In 174 participants, 6 findings were associated independently with the expert clinician having ≥70% confidence that symptoms were due to meniscal tear: localized pain, ability to fully bend the knee, pain duration <1 year, lack of varus alignment, lack of pes planus, and absence of joint space narrowing on radiographs. The index identified a low-risk group with 3% likelihood of SMT. While clinicians traditionally rely upon mechanical symptoms in this diagnostic setting, our findings did not support the conclusion that mechanical symptoms were associated with the expert's confidence that symptoms were due to meniscal tear. An index that includes history of localized pain, full flexion, duration <1 year, pes planus, varus alignment, and joint space narrowing can be used to stratify patients according to their risk of SMT, and it identifies a subgroup with very low risk. © 2016, American College of Rheumatology.

Clinical SAS programming in India: A study of industry needs versus wants.

PubMed

Ananthakrishnan, Nithiyanandhan

2014-07-01

The clinical SAS (www.sas.com) programming industry, in India, has seen a rapid growth in the last decade and the trend seems set to continue, for the next couple of years, due to cost advantage and the availability of skilled labor. On one side the industry needs are focused on less execution time, high margins, segmented tasks and the delivery of high quality output with minimal oversight. On the other side, due to the increased demand for skilled resources, the wants of the programmers have taken a different shift toward diversifying exposure, unsustainable wage inflation due to multiple opportunities and generally high expectations around career progression. If the industry needs are not going to match with programmers want, or vice versa, then there is the possibility that the current year on year growth may start to slow or even go into decline. This paper is intended to identify the gap between wants and need and puts forwards some suggestions, for both sides, in ways to change the equation to benefit all. Questionnaire on similar themes created to survey managers and programmers working in clinical SAS programming industry and was surveyed online to collect their perspectives. Their views are compared for each theme and presented as results. Two surveys were created in www.surveymonkey.com. https://www.surveymonkey.com/s/SAS_India_managment_needvswant_survey. Programmer: https://www.surveymonkey.com/s/SAS_India_programmer_needvswant_survey. Bar chart and pie chart used on data collect to show segmentation of data. In conclusion, it seeks to highlight the future industry direction and the skillset that existing programmers need to have, in order to sustain the momentum and remain competitive, to contribute to the future pipeline and the development of the profession in India.

Integration of physical abuse clinical decision support into the electronic health record at a Tertiary Care Children's Hospital.

PubMed

Suresh, Srinivasan; Saladino, Richard A; Fromkin, Janet; Heineman, Emily; McGinn, Tom; Richichi, Rudolph; Berger, Rachel P

2018-04-12

To evaluate the effect of a previously validated electronic health record-based child abuse trigger system on physician compliance with clinical guidelines for evaluation of physical abuse. A randomized controlled trial (RCT) with comparison to a preintervention group was performed. RCT-experimental subjects' providers received alerts with a direct link to a physical abuse-specific order set. RCT-control subjects' providers had no alerts, but could manually search for the order set. Preintervention subjects' providers had neither alerts nor access to the order set. Compliance with clinical guidelines was calculated. Ninety-nine preintervention subjects and 130 RCT subjects (73 RCT-experimental and 57 RCT-control) met criteria to undergo a physical abuse evaluation. Full compliance with clinical guidelines was 84% pre-intervention, 86% in RCT-control group, and 89% in RCT-experimental group. The physical abuse order set was used 43 times during the 7-month RCT. When the abuse order set was used, full compliance was 100%. The proportion of cases in which there was partial compliance decreased from 10% to 3% once the order set became available (P = .04). Male gender, having >10 years of experience and completion of a pediatric emergency medicine fellowship were associated with increased compliance. A child abuse clinical decision support system comprised of a trigger system, alerts and a physical abuse order set was quickly accepted into clinical practice. Use of the physical abuse order set always resulted in full compliance with clinical guidelines. Given the high baseline compliance at our site, evaluation of this alert system in hospitals with lower baseline compliance rates will be more valuable in assessing the efficacy in adherence to clinical guidelines for the evaluation of suspected child abuse.

Clinical reasoning: concept analysis.

PubMed

Simmons, Barbara

2010-05-01

This paper is a report of a concept analysis of clinical reasoning in nursing. Clinical reasoning is an ambiguous term that is often used synonymously with decision-making and clinical judgment. Clinical reasoning has not been clearly defined in the literature. Healthcare settings are increasingly filled with uncertainty, risk and complexity due to increased patient acuity, multiple comorbidities, and enhanced use of technology, all of which require clinical reasoning. Data sources. Literature for this concept analysis was retrieved from several databases, including CINAHL, PubMed, PsycINFO, ERIC and OvidMEDLINE, for the years 1980 to 2008. Rodgers's evolutionary method of concept analysis was used because of its applicability to concepts that are still evolving. Multiple terms have been used synonymously to describe the thinking skills that nurses use. Research in the past 20 years has elucidated differences among these terms and identified the cognitive processes that precede judgment and decision-making. Our concept analysis defines one of these terms, 'clinical reasoning,' as a complex process that uses cognition, metacognition, and discipline-specific knowledge to gather and analyse patient information, evaluate its significance, and weigh alternative actions. This concept analysis provides a middle-range descriptive theory of clinical reasoning in nursing that helps clarify meaning and gives direction for future research. Appropriate instruments to operationalize the concept need to be developed. Research is needed to identify additional variables that have an impact on clinical reasoning and what are the consequences of clinical reasoning in specific situations.

Identifying Opportunities for Vertical Integration of Biochemistry and Clinical Medicine.

PubMed

Wendelberger, Karen J.; Burke, Rebecca; Haas, Arthur L.; Harenwattananon, Marisa; Simpson, Deborah

1998-01-01

Objectives: Retention of basic science knowledge, as judged by National Board of Medical Examiners' (NBME) data, suffers due to lack of apparent relevance and isolation of instruction from clinical application, especially in biochemistry. However, the literature reveals no systematic process for identifying key biochemical concepts and associated clinical conditions. This study systematically identified difficult biochemical concepts and their common clinical conditions as a critical step towards enhancing relevance and retention of biochemistry.Methods: A multi-step/ multiple stakeholder process was used to: (1) identify important biochemistry concepts; (2) determine students' perceptions of concept difficulty; (3) assess biochemistry faculty, student, and clinical teaching scholars' perceived relevance of identified concepts; and (4) identify associated common clinical conditions for relevant and difficult concepts. Surveys and a modified Delphi process were used to gather data, subsequently analyzed using SPSS for Windows.Results: Sixteen key biochemical concepts were identified. Second year medical students rated 14/16 concepts as extremely difficult while fourth year students rated nine concepts as moderately to extremely difficult. On average, each teaching scholar generated common clinical conditions for 6.2 of the 16 concepts, yielding a set of seven critical concepts and associated clinical conditions.Conclusions: Key stakeholders in the instructional process struggle to identify biochemistry concepts that are critical, difficult to learn and associated with common clinical conditions. However, through a systematic process beginning with identification of concepts and associated clinical conditions, relevance of basic science instruction can be enhanced.

Occult Hepatitis B (OBH) in Clinical Settings

PubMed Central

Alavian, Seyed Moayed; Miri, Seyed Mohammad; Hollinger, F. Blaine; Jazayeri, Seyed Mohammad

2012-01-01

Context Occult hepatitis B (OHB), or persistent HBV DNA in patients who are hepatitis B surface antigen (HBsAg) negative, is a recently recognized entity. In an attempt to summarize the issues, this review presents an overview of the current proposed hypothesis on the clinical relevance and also updates the knowledge on the classification of OHB in different clinical settings. Evidence Acquisition OHB could be found in different population and clinical backgrounds including: viral co-infections (with either human immunodeficiency or hepatitis C viruses), HBV chronic carriers, dialysis patients, transplantation settings and certain clinical situations (named in here: special clinical settings) with no apparent distinguishable clinical parameters. Results The exact magnitude, pathogenesis, and clinical relevance of OHB are unclear. Even the possible role exerted by this cryptic infection on liver disease outcome, and hepatocellular carcinoma development remains unknown. Conclusions Monitoring of Individuals with positive anti-HBc, mass immunization programs and improvement in diagnostic tools seem to be important to control the probability of transmission of HBV through cryptic HBV infection. PMID:23087749

Challenges in pediatric chronic inflammatory demyelinating polyneuropathy.

PubMed

Haliloğlu, Göknur; Yüksel, Deniz; Temoçin, Cağri Mesut; Topaloğlu, Haluk

2016-12-01

Chronic inflammatory demyelinating neuropathy, a treatable immune-mediated disease of the peripheral nervous system is less common in childhood compared to adults. Despite different sets of diagnostic criteria, lack of a reliable biologic marker leads to challenges in diagnosis, follow-up and treatment. Our first aim was to review clinical presentation, course, response to treatment, and prognosis in our childhood patients. We also aimed to document diagnostic and therapeutic pitfalls and challenges at the bedside. Our original cohort consisted of 23 pediatric patients who were referred to us with a clinical diagnosis of chronic inflammatory demyelinating neuropathy. Seven patients reaching to an alternative diagnosis were excluded. In the remaining patients, diagnostic, treatment and follow-up data were compared in typical patients who satisfied both clinical and electrodiagnostic criteria and atypical patients who failed to meet minimal research chronic inflammatory demyelinating neuropathy electrodiagnostic requirements. Eight of 16 patients (50%) met the minimal chronic inflammatory demyelinating neuropathy research diagnostic requirements. There was only a statistically significant difference (p = 0.010) in terms of European Neuromuscular Centre childhood chronic inflammatory diagnostic mandatory clinical criteria between the two groups. Misdiagnosis due to errors in electrophysiological interpretation (100%, n = 8), cerebrospinal fluid cytoalbuminologic dissociation (100%, n = 4 and/or subjective improvement on any immunotherapy modality (80 ± 19.27%)) was frequent. Pediatric CIDP is challenging in terms of diagnostic and therapeutic pitfalls at the bedside. Diagnostic errors due to electrophysiological interpretation, cerebrospinal fluid cytoalbuminologic dissociation, and/or subjective improvement on immunotherapy should be considered. Copyright © 2016 Elsevier B.V. All rights reserved.

In vivo two-dimensional NMR correlation spectroscopy

NASA Astrophysics Data System (ADS)

Kraft, Robert A.

1999-10-01

The poor resolution of in-vivo one- dimensional nuclear magnetic resonance spectroscopy (NMR) has limited its clinical potential. Currently, only the large singlet methyl resonances arising from N-acetyl aspartate (NAA), choline, and creatine are quantitated in a clinical setting. Other metabolites such as myo- inositol, glutamine, glutamate, lactate, and γ- amino butyric acid (GABA) are of clinical interest but quantitation is difficult due to the overlapping resonances and limited spectral resolution. To improve the spectral resolution and distinguish between overlapping resonances, a series of two- dimensional chemical shift correlation spectroscopy experiments were developed for a 1.5 Tesla clinical imaging magnet. Two-dimensional methods are attractive for in vivo spectroscopy due to their ability to unravel overlapping resonances with the second dimension, simplifying the interpretation and quantitation of low field NMR spectra. Two-dimensional experiments acquired with mix-mode line shape negate the advantages of the second dimension. For this reason, a new experiment, REVOLT, was developed to achieve absorptive mode line shape in both dimensions. Absorptive mode experiments were compared to mixed mode experiments with respect to sensitivity, resolution, and water suppression. Detailed theoretical and experimental calculations of the optimum spin lock and radio frequency power deposition were performed. Two-dimensional spectra were acquired from human bone marrow and human brain tissue. The human brain tissue spectra clearly reveal correlations among the coupled spins of NAA, glutamine, glutamate, lactate, GABA, aspartate and myo-inositol obtained from a single experiment of 23 minutes from a volume of 59 mL. (Copies available exclusively from MIT Libraries, Rm. 14-0551, Cambridge, MA 02139-4307. Ph. 617-253-5668; Fax 617-253-1690.)

Working with women experiencing mid-trimester termination of pregnancy: the integration of nursing and feminist knowledge in the gynaecological setting.

PubMed

Huntington, Annette D

2002-03-01

1. Working with women experiencing a mid-trimester termination of pregnancy is part of clinical practice in many gynaecological services. In this paper recent research with nurses working in the gynaecological area is drawn on to explore the issues for nurses working with women experiencing mid-trimester termination. Mid-trimester terminations are those carried out between approximately 12 and 20 weeks. 2. Mid-trimester termination results in the delivery of a fetus and this event requires sensitive management as it is has the potential to cause distress for the women due to the psychological and physical impact of the procedure. However, health professionals involved can also find this a distressing clinical event due to the complex nature of the management and care required. 3. Consideration of this clinical event from a feminist perspective led to my exploring the way in which feminist theory could be applied in the situation of mid-trimester termination. Using notions from feminist theory can assist in the management of this process, and feminist concepts related to the centrality of women's experience can be integrated into actual practice. 4. A series of recommendations are provided in this paper to show the way in which feminist concepts can be integrated into clinical practice. Integrating feminist principles into practice can support both the woman experiencing the abortion and the nurse whose role in the event is sustained and intimate, and result in positive outcomes for both women. This can result in an environment that is safe and supportive for all women involved in mid-trimester terminations.

Bias due to Preanalytical Dilution of Rodent Serum for Biochemical Analysis on the Siemens Dimension Xpand Plus

PubMed Central

Johns, Jennifer L.; Moorhead, Kaitlin A.; Hu, Jing; Moorhead, Roberta C.

2018-01-01

Clinical pathology testing of rodents is often challenging due to insufficient sample volume. One solution in clinical veterinary and exploratory research environments is dilution of samples prior to analysis. However, published information on the impact of preanalytical sample dilution on rodent biochemical data is incomplete. The objective of this study was to evaluate the effects of preanalytical sample dilution on biochemical analysis of mouse and rat serum samples utilizing the Siemens Dimension Xpand Plus. Rats were obtained from end of study research projects. Mice were obtained from sentinel testing programs. For both, whole blood was collected via terminal cardiocentesis into empty tubes and serum was harvested. Biochemical parameters were measured on fresh and thawed frozen samples run straight and at dilution factors 2–10. Dilutions were performed manually, utilizing either ultrapure water or enzyme diluent per manufacturer recommendations. All diluted samples were generated directly from the undiluted sample. Preanalytical dilution caused clinically unacceptable bias in most analytes at dilution factors four and above. Dilution-induced bias in total calcium, creatinine, total bilirubin, and uric acid was considered unacceptable with any degree of dilution, based on the more conservative of two definitions of acceptability. Dilution often caused electrolyte values to fall below assay range precluding evaluation of bias. Dilution-induced bias occurred in most biochemical parameters to varying degrees and may render dilution unacceptable in the exploratory research and clinical veterinary environments. Additionally, differences between results obtained at different dilution factors may confound statistical comparisons in research settings. Comparison of data obtained at a single dilution factor is highly recommended. PMID:29497614

The interprofessional learning experience: Findings from a qualitative study based in an outpatient setting.

PubMed

Jakobsen, Flemming; Mørcke, Anne Mette; Hansen, Torben Bæk

2017-09-01

Clinical interprofessional education has traditionally taken place in hospital wards, but much diagnosis and treatment have shifted to the outpatient setting. The logical consequence is to shift more students' clinical placements from the "bedside" to outpatient settings. However, it is unclear how we ensure that this shift maximises learning. The purpose of this article is to understand the authentic learning experience in an interprofessional outpatient clinic setting. We performed an exploratory case study with interviews of four nursing students, 13 medical students, and six staff members who worked in an interprofessional outpatient orthopaedic clinic from March 2015 to January 2016. The interviews were transcribed and analysed using systematic text condensation. The students' self-reported learning experience in this outpatient clinic was characterised by direct patient contact and by authentic, interprofessional, task-based learning, and a preference for indirect supervision when conducting uncomplicated patient consultations. The supervisors intended to create this interprofessional outpatient clinic experience by having a clear teaching approach based on adult learning principles in a safe and challenging learning environment. The shift to the outpatient setting was strongly and practically supported by the management. This study indicates that student learning can be shifted to the outpatient clinic setting if there is supportive management and dedicated supervisors who establish a challenging yet safe interprofessional learning environment.

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.

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.

Identifying and applying psychological theory to setting and achieving rehabilitation goals.

PubMed

Scobbie, Lesley; Wyke, Sally; Dixon, Diane

2009-04-01

Goal setting is considered to be a fundamental part of rehabilitation; however, theories of behaviour change relevant to goal-setting practice have not been comprehensively reviewed. (i) To identify and discuss specific theories of behaviour change relevant to goal-setting practice in the rehabilitation setting. (ii) To identify 'candidate' theories that that offer most potential to inform clinical practice. The rehabilitation and self-management literature was systematically searched to identify review papers or empirical studies that proposed a specific theory of behaviour change relevant to setting and/or achieving goals in a clinical context. Data from included papers were extracted under the headings of: key constructs, clinical application and empirical support. Twenty-four papers were included in the review which proposed a total of five theories: (i) social cognitive theory, (ii) goal setting theory, (iii) health action process approach, (iv) proactive coping theory, and (v) the self-regulatory model of illness behaviour. The first three of these theories demonstrated most potential to inform clinical practice, on the basis of their capacity to inform interventions that resulted in improved patient outcomes. Social cognitive theory, goal setting theory and the health action process approach are theories of behaviour change that can inform clinicians in the process of setting and achieving goals in the rehabilitation setting. Overlapping constructs within these theories have been identified, and can be applied in clinical practice through the development and evaluation of a goal-setting practice framework.

Teachers' Perceptions of Their Mentoring Role in Three Different Clinical Settings: Student Teaching, Early Field Experiences, and Entry Year Teaching

ERIC Educational Resources Information Center

Gut, Dianne M.; Beam, Pamela C.; Henning, John E.; Cochran, Deborah C.; Knight, Rhonda Talford

2014-01-01

The purpose of this study was to determine the differences in mentoring across three different clinical settings: student teaching, early field experiences, and entry year teachers. Eighteen teachers with mentoring experience in all three clinical settings were selected and interviewed. The teachers' expectations for teacher development,…

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

PubMed

Turley, Ryan S; Mi, Xiaojuan; Qualls, Laura G; Vemulapalli, Sreekanth; Peterson, Eric D; Patel, Manesh R; Curtis, Lesley H; Jones, W Schuyler

2017-06-12

Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p < 0.001), major lower extremity amputation (10.1% vs. 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs. 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs. 26.9% vs. 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Setting times for endodontic sealers under clinical usage and in vitro conditions.

PubMed

Allan, N A; Walton, R C; Schaeffer, M A; Schaffer, A

2001-06-01

The object of this study was to determine the set of sealers under simulated clinical versus bench-top conditions. One hundred twenty extracted teeth were divided into four groups (Roth's, Tubuliseal, Sealapex, AH26). Canal preparation and lateral condensation were performed with the four sealers (30 teeth each). Teeth were placed into 100% humidity at 37 degrees C. The same mix of sealer on a glass slab was stored within the same environment. After 1 to 8 wk the teeth were fractured longitudinally to expose the gutta-percha-sealer interface. Evaluation, both clinical and in vitro, was qualitative under a microscope with a needle tip. The degree of set was categorized as: (a) unset (smearable), (b) partially set (indented easily, but not smearable), or (3) set (not easily indentable). There were inconsistencies in setting times within and between groups. In canals most of three (AH26, Sealapex, and Tubuliseal) were partially set after 1 wk; set was complete after 4 wk. Roth's was very slow; most were unset after 8 wk. Sealers on the glass slab set much more rapidly. In conclusion, under clinical conditions, sealers set slowly (particularly Roth's) and were more delayed than when tested in vitro.

[Microbiological diagnosis of viral respiratory infections].

PubMed

Eiros, José M; Ortiz de Lejarazu, Raúl; Tenorio, Alberto; Casas, Inmaculada; Pozo, Francisco; Ruiz, Guillermo; Pérez-Breña, Pilar

2009-03-01

Acute respiratory infection is the most common disease occurring over a person's lifetime, with etiological variations determined mainly by age, environmental circumstances, the healthcare setting, and the underlying pathology. More than 200 different viruses distributed in six viral families have been implicated in the pathogenesis of respiratory tract infection. These facts are generating an increasing diagnostic demand that should be incorporated into the healthcare setting without delay. To meet this demand, the Spanish Society of Infectious Diseases and Clinical Microbiology has updated its Standard Procedure for the microbiological diagnosis of viral respiratory infection. This document contains an update primarily of infections caused by influenza viruses, and secondarily, infections due to other conventional and emerging respiratory viruses. In all cases, the methods for direct virological diagnosis (cell culture, and detection of antigens and nucleic acid) are reviewed, with special reference to techniques for molecular detection and genetic characterization.

The Importance of Rockall Scoring System for Upper Gastrointestinal Bleeding in Long-Term Follow-Up.

PubMed

Bozkurt, Mehmet Abdussamet; Peker, Kıvanç Derya; Unsal, Mustafa Gökhan; Yırgın, Hakan; Kahraman, İzzettin; Alış, Halil

2017-06-01

The aim of the study is to examine the importance of Rockall scoring system in long-term setting to estimate re-bleeding and mortality rate due to upper gastrointestinal bleeding. A total of 321 patients who had been treated for upper gastrointestinal bleeding were recruited to the study. Patients' demographic and clinical data, the amount of blood transfusion, endoscopy results, and Rockall scores were retrieved from patients' charts. The re-bleeding, morbidity, and mortality rates were noted after 3 years of follow-up with telephone. Re-bleeding rate was statistically significantly higher in Rockall 4 group compared to Rockall 0 group. Mortality rate was also statistically significantly higher in Rockall 4 group. Rockall risk scoring system is a valuable tool to predict re-bleeding and mortality rates for patients with upper gastrointestinal bleeding in long-term setting.

Merkel cell carcinoma in the community setting: a case report.

PubMed

Callaghan, Cameron M; Amornmarn, Rumpa

2018-04-12

Merkel cell carcinoma (MCC) is a rare neuroendocrine tumor of the skin initially believed to arise from the Merkel cells. In the community setting a general radiation oncologist may only encounter this pathology in a handful of cases over the course of their career. Due to the low incidence of this malignancy, few prospective randomized controlled trials have ever been conducted and therefore guidelines are based on relatively lower levels of evidence upon which the clinical recommendations are made. We discuss the case of a female in her 90s presenting with a classic MCC primary lesion, as well as satellite lesions proximal to both the primary and the draining regional lymph nodes with no evidence of nodal involvement. Here we discuss the presentation, management, treatment planning, underlying pathology, results and sequelae of treatment. We also review new treatment modalities, and the most current staging systems and guidelines.

Target therapy: new drugs or new combinations of drugs in malignant pleural mesothelioma.

PubMed

Zucali, Paolo A

2018-01-01

Malignant pleural mesothelioma (MPM) is a disease with a poor prognosis due to its aggressive nature. The management of patients with MPM is controversial. Considering that the contribution of surgery and radiation therapy in the management of this disease is not yet established, systemic treatments are predominantly considered during the course of MPM. Unfortunately, the currently therapeutic armamentarium is scarce and its outcomes still appear modest. New treatment strategies are needed. In preclinical setting, cell cycle regulation, apoptosis, growth factor pathways, and angiogenesis pathways involved in the development of MPM have been identified. However, in clinical setting, several drugs targeting these pathways resulted without a significant activity. A deeper knowledge of the biology and pathogenesis of this disease is required to develop more effective tools for diagnosis, therapy and prevention. This paper reviews therapeutic advances in MPM, with a particular focus on new drugs and new association of drugs of target therapy.

Safe and effective administration of T-VEC in a patient with heart transplantation and recurrent locally advanced melanoma.

PubMed

Schvartsman, Gustavo; Perez, Kristen; Flynn, Jill E; Myers, Jeffrey N; Tawbi, Hussein

2017-01-01

Immunotherapy plays a key role in the treatment of metastatic melanoma. Patients with autoimmune conditions and/or on immunosuppressive therapy due to orthotropic transplants, however, are systematically excluded from clinical trials. Talimogene laherparepvec (T-VEC) is the first oncolytic virus to be approved by the FDA for cancer therapy. To our knowledge, this is the first report of T-VEC being administered in the setting of an organ transplant recipient. Here we present the case of a patient with recurrent locally advanced cutaneous melanoma receiving salvage T-VEC therapy in the setting of orthotropic heart transplantation. After 5 cycles of therapy, no evidence of graft rejection has been observed to date, and the patient achieved a complete remission, and is currently off therapy. This case advocates for further investigation on the safety and efficacy of immunotherapeutic approaches, such as T-VEC, in solid organ transplant recipients.

Machine Learning for Treatment Assignment: Improving Individualized Risk Attribution

PubMed Central

Weiss, Jeremy; Kuusisto, Finn; Boyd, Kendrick; Liu, Jie; Page, David

2015-01-01

Clinical studies model the average treatment effect (ATE), but apply this population-level effect to future individuals. Due to recent developments of machine learning algorithms with useful statistical guarantees, we argue instead for modeling the individualized treatment effect (ITE), which has better applicability to new patients. We compare ATE-estimation using randomized and observational analysis methods against ITE-estimation using machine learning, and describe how the ITE theoretically generalizes to new population distributions, whereas the ATE may not. On a synthetic data set of statin use and myocardial infarction (MI), we show that a learned ITE model improves true ITE estimation and outperforms the ATE. We additionally argue that ITE models should be learned with a consistent, nonparametric algorithm from unweighted examples and show experiments in favor of our argument using our synthetic data model and a real data set of D-penicillamine use for primary biliary cirrhosis. PMID:26958271

Machine Learning for Treatment Assignment: Improving Individualized Risk Attribution.

PubMed

Weiss, Jeremy; Kuusisto, Finn; Boyd, Kendrick; Liu, Jie; Page, David

2015-01-01

Clinical studies model the average treatment effect (ATE), but apply this population-level effect to future individuals. Due to recent developments of machine learning algorithms with useful statistical guarantees, we argue instead for modeling the individualized treatment effect (ITE), which has better applicability to new patients. We compare ATE-estimation using randomized and observational analysis methods against ITE-estimation using machine learning, and describe how the ITE theoretically generalizes to new population distributions, whereas the ATE may not. On a synthetic data set of statin use and myocardial infarction (MI), we show that a learned ITE model improves true ITE estimation and outperforms the ATE. We additionally argue that ITE models should be learned with a consistent, nonparametric algorithm from unweighted examples and show experiments in favor of our argument using our synthetic data model and a real data set of D-penicillamine use for primary biliary cirrhosis.

Assessing the risk of pH-dependent absorption for new molecular entities: a novel in vitro dissolution test, physicochemical analysis, and risk assessment strategy.

PubMed

Mathias, Neil R; Xu, Yan; Patel, Dhaval; Grass, Michael; Caldwell, Brett; Jager, Casey; Mullin, Jim; Hansen, Luke; Crison, John; Saari, Amy; Gesenberg, Christoph; Morrison, John; Vig, Balvinder; Raghavan, Krishnaswamy

2013-11-04

Weak base therapeutic agents can show reduced absorption or large pharmacokinetic variability when coadministered with pH-modifying agents, or in achlorhydria disease states, due to reduced dissolution rate and/or solubility at high gastric pH. This is often referred to as pH-effect. The goal of this study was to understand why some drugs exhibit a stronger pH-effect than others. To study this, an API-sparing, two-stage, in vitro microdissolution test was developed to generate drug dissolution, supersaturation, and precipitation kinetic data under conditions that mimic the dynamic pH changes in the gastrointestinal tract. In vitro dissolution was assessed for a chemically diverse set of compounds under high pH and low pH, analogous to elevated and normal gastric pH conditions observed in pH-modifier cotreated and untreated subjects, respectively. Represented as a ratio between the conditions, the in vitro pH-effect correlated linearly with clinical pH-effect based on the Cmax ratio and in a non-linear relationship based on AUC ratio. Additionally, several in silico approaches that use the in vitro dissolution data were found to be reasonably predictive of the clinical pH-effect. To explore the hypothesis that physicochemical properties are predictors of clinical pH-effect, statistical correlation analyses were conducted using linear sequential feature selection and partial least-squares regression. Physicochemical parameters did not show statistically significant linear correlations to clinical pH-effect for this data set, which highlights the complexity and poorly understood nature of the interplay between parameters. Finally, a strategy is proposed for implementation early in clinical development, to systematically assess the risk of clinical pH-effect for new molecular entities that integrates physicochemical analysis and in vitro, in vivo and in silico methods.

Clinical chemistry reference values for 75-year-old apparently healthy persons.

PubMed

Huber, Klaus Roland; Mostafaie, Nazanin; Stangl, Gerhard; Worofka, Brigitte; Kittl, Eva; Hofmann, Jörg; Hejtman, Milos; Michael, Rainer; Weissgram, Silvia; Leitha, Thomas; Jungwirth, Susanne; Fischer, Peter; Tragl, Karl-Heinz; Bauer, Kurt

2006-01-01

Clinical chemistry reference values for elderly persons are sparse and mostly intermixed with those for younger subjects. To understand the links between metabolism and aging, it is paramount to differentiate between "normal" physiological processes in apparently healthy elderly subjects and metabolic changes due to long-lasting diseases. The Vienna Transdanube Aging (VITA) study, which began in 2000 and is continuing, will allow us to do just that, because more than 600 male and female volunteers aged exactly 75 years (to exclude any influence of the "aging" factor in this cohort) are participating in this study. Extensive clinical, neurological, biochemical, psychological, genetic, and radiological analyses, with a special emphasis on consumption of medication and abuse of drugs, were performed on each of the probands. The multitude of data and questionnaires obtained made possible an a posteriori approach to select individuals fulfilling criteria for a reference sample group of apparently healthy 75-year-old subjects for our study. Specific analytes were quantified on automated clinical analyzers, while manual methods were used for hormonal analytes. All clinical chemistry analytes were evaluated using in-depth statistical analyses with SPSS for Windows. In all, reference intervals for 45 analytes could be established. These include routine parameters for the assessment of organ functions, as well as hormone concentrations and hematological appraisals. Because all patients were reevaluated after exactly 30 months in the course of this study, we had the opportunity to reassess their health status at the age of 77.5 years. This was very useful for validation of the first round data set. Data of the second round evaluation corroborate the reference limits of the baseline analysis and further confirm our inclusion and exclusion criteria. In summary, we have established a reliable set of reference data for hormonal, hematological, and clinical chemistry analytes for elderly subjects. These values will be very useful for our future attempts to correlate disease states and aging processes with metabolic factors.

Birth Control in Clinical Trials

PubMed Central

Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

2015-01-01

The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

Early clinics of the cardiac forms of Chagas' disease: Discovery and study of original medical files (1909-1915).

PubMed

Gachelin, Gabriel; Bestetti, Reinaldo B

2017-10-01

We have uncovered 80 medical files corresponding to original cases of Chagas' disease used for the classical description of the acute and cardiac forms of the disease. Sixty of them were diagnosed cardiac forms of the disease. The detailed clinical description of these 60 files is in excellent agreement with the nosography of progressive heart disease given by Chagas in his original 1922 paper. The reports we had access to, characterize a novel form of cardiac disease, dominated by progressive AV block, enlargement and displacement of the heart and sudden death, in relatively young adults including juveniles. In contrast to that remarkable clinical description, the assertion made by Chagas that this set of clinical signs was the consequence of an earlier infection by Trypanosoma cruzi rests on weak evidence, due to the difficulty to identify the parasite in most patients. Moreover, the association of thyroid dysfunction with cardiac disease emphasized by Chagas cannot be deduced from the files we have examined. Finally, the main reason why the disease had not been recognized for long as a defined clinical entity, is likely the absence of markedly distinctive clinical signs compared to most other parasitic diseases, poor sanitary conditions and the probable lack of clinical skills of the rare doctors working in the area where the disease was described. Copyright © 2017 Elsevier B.V. All rights reserved.

Ubiquitous information for ubiquitous computing: expressing clinical data sets with openEHR archetypes.

PubMed

Garde, Sebastian; Hovenga, Evelyn; Buck, Jasmin; Knaup, Petra

2006-01-01

Ubiquitous computing requires ubiquitous access to information and knowledge. With the release of openEHR Version 1.0 there is a common model available to solve some of the problems related to accessing information and knowledge by improving semantic interoperability between clinical systems. Considerable work has been undertaken by various bodies to standardise Clinical Data Sets. Notwithstanding their value, several problems remain unsolved with Clinical Data Sets without the use of a common model underpinning them. This paper outlines these problems like incompatible basic data types and overlapping and incompatible definitions of clinical content. A solution to this based on openEHR archetypes is motivated and an approach to transform existing Clinical Data Sets into archetypes is presented. To avoid significant overlaps and unnecessary effort during archetype development, archetype development needs to be coordinated nationwide and beyond and also across the various health professions in a formalized process.

Preceptors' Perceptions of Interprofessional Practice, Student Interactions, and Strategies for Interprofessional Education in Clinical Settings.

PubMed

Hudak, Nicholas M; Melcher, Betsy; Strand de Oliveira, Justine

2017-12-01

This study describes clinical preceptors' perceptions of interprofessional practice, the nature and variety of physician assistant (PA) students' interprofessional interactions during clinical training, and factors that facilitate or hinder interprofessional education (IPE) in clinical settings. This qualitative study involved interviews with preceptors that were audio-recorded, transcribed, and then analyzed through an iterative process to identify key conceptual themes. Fourteen preceptors from a variety of clinical settings participated. Four themes were identified: (1) preceptors define interprofessional practice differently; (2) students learn about teams by being a part of teams; (3) preceptors separate students to avoid diluting learning experiences; and (4) preceptors can facilitate IPE by introducing students to members of the team and role modeling team skills. The themes may inform PA educators' efforts to increase IPE in clinical settings through educational interventions with both preceptors and students.

Does sensitivity measured from screening test-sets predict clinical performance?

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick B.; Mello-Thoms, Claudia R.; Tapia, Kriscia A.; Ryan, John; Hung, Wai Tak; Thompson, Graham J.; Heard, Rob; Brennan, Patrick C.

2014-03-01

Aim: To examine the relationship between sensitivity measured from the BREAST test-set and clinical performance. Background: Although the UK and Australia national breast screening programs have regarded PERFORMS and BREAST test-set strategies as possible methods of estimating readers' clinical efficacy, the relationship between test-set and real life performance results has never been satisfactorily understood. Methods: Forty-one radiologists from BreastScreen New South Wales participated in this study. Each reader interpreted a BREAST test-set which comprised sixty de-identified mammographic examinations sourced from the BreastScreen Digital Imaging Library. Spearman's rank correlation coefficient was used to compare the sensitivity measured from the BREAST test-set with screen readers' clinical audit data. Results: Results shown statistically significant positive moderate correlations between test-set sensitivity and each of the following metrics: rate of invasive cancer per 10 000 reads (r=0.495; p < 0.01); rate of small invasive cancer per 10 000 reads (r=0.546; p < 0.001); detection rate of all invasive cancers and DCIS per 10 000 reads (r=0.444; p < 0.01). Conclusion: Comparison between sensitivity measured from the BREAST test-set and real life detection rate demonstrated statistically significant positive moderate correlations which validated that such test-set strategies can reflect readers' clinical performance and be used as a quality assurance tool. The strength of correlation demonstrated in this study was higher than previously found by others.

Experimental platform utilising melting curve technology for detection of mutations in Mycobacterium tuberculosis isolates.

PubMed

Broda, Agnieszka; Nikolayevskyy, Vlad; Casali, Nicki; Khan, Huma; Bowker, Richard; Blackwell, Gemma; Patel, Bhakti; Hume, James; Hussain, Waqar; Drobniewski, Francis

2018-04-20

Tuberculosis (TB) remains one of the most deadly infections with approximately a quarter of cases not being identified and/or treated mainly due to a lack of resources. Rapid detection of TB or drug-resistant TB enables timely adequate treatment and is a cornerstone of effective TB management. We evaluated the analytical performance of a single-tube assay for multidrug-resistant TB (MDR-TB) on an experimental platform utilising RT-PCR and melting curve analysis that could potentially be operated as a point-of-care (PoC) test in resource-constrained settings with a high burden of TB. Firstly, we developed and evaluated the prototype MDR-TB assay using specimens extracted from well-characterised TB isolates with a variety of distinct rifampicin and isoniazid resistance conferring mutations and nontuberculous Mycobacteria (NTM) strains. Secondly, we validated the experimental platform using 98 clinical sputum samples from pulmonary TB patients collected in high MDR-TB settings. The sensitivity of the platform for TB detection in clinical specimens was 75% for smear-negative and 92.6% for smear-positive sputum samples. The sensitivity of detection for rifampicin and isoniazid resistance was 88.9 and 96.0% and specificity was 87.5 and 100%, respectively. Observed limitations in sensitivity and specificity could be resolved by adjusting the sample preparation methodology and melting curve recognition algorithm. Overall technology could be considered a promising PoC methodology especially in resource-constrained settings based on its combined accuracy, convenience, simplicity, speed, and cost characteristics.

Outcomes of antiretroviral therapy in a northern Indian urban clinic.

PubMed

Sharma, Surendra K; Dhooria, Sahajal; Prasad, K T; George, Ninoo; Ranjan, Sanjay; Gupta, Deepak; Sreenivas, Vishnubhatla; Kadhiravan, Tamilarasu; Miglani, Sunita; Sinha, Sanjeev; Wig, Naveet; Biswas, Ashutosh; Vajpayee, Madhu

2010-03-01

Antiretroviral therapy (ART) programmes have been successful in several countries. However, whether they would succeed as part of a national programme in a resource-constrained setting such as India is not clear. The outcomes and specific problems encountered in such a setting have not been adequately studied. We assessed the efficacy and functioning of India's national ART programme in a tertiary care centre in northern India. All ART-naive patients started on ART between May 2005 and October 2006 were included in the study and were followed until 31 April 2008. Periodic clinical and laboratory evaluations were carried out in accordance with national guidelines. Changes in CD4+ lymphocyte count, body weight and body mass index were assessed at follow-up, and the operational problems analysed. The setting was a tertiary care centre in northern India with a mixed population of patients, mostly of low socioeconomic status. The centre is reasonably well resourced but faces constraints in health-care delivery, such as lack of adequate human resources and a high patient load. The response to ART in the cohort studied was comparable to that reported from other countries. However, the programme had a high attrition rate, possibly due to patient-related factors and operational constraints. A high rate of attrition can affect the overall efficacy and functioning of an ART programme. Addressing the issues causing attrition might improve patient outcomes in India and in other resource-constrained countries.

Management of trauma pain in the emergency setting: low-dose methoxyflurane or nitrous oxide? A systematic review and indirect treatment comparison.

PubMed

Porter, Keith M; Siddiqui, Mohd Kashif; Sharma, Ikksheta; Dickerson, Sara; Eberhardt, Alice

2018-01-01

Low-dose methoxyflurane and nitrous oxide (N 2 O; 50:50 with oxygen) are both self-administered, self-titrated, rapid-acting, nonnarcotic, and noninvasive inhalational agents with similar onset times of pain relief. The aim of this review was to compare the clinical efficacy, safety, and tolerability of these analgesics in emergency care. A systematic literature search and review according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were performed using Embase, Medline, the Cochrane Library, several clinical trial registers, and emergency-medicine conference material. Although both compounds have been used for many years in emergency care, the search found only a few controlled studies and no head-to-head trials performed in this setting. Two double-blind, randomized studies comparing their respective study medication (low-dose methoxyflurane or N 2 O) to placebo were identified that could be compared in an indirect approach by using placebo as a bridging comparator. Both agents provided rapid pain relief to trauma patients, with no significant differences between them; both treatments were generally well tolerated. Both low-dose methoxyflurane and N 2 O are suitable options for the pain treatment of trauma patients in the emergency setting. Due to the ease of administration and portability, inhaled low-dose methoxyflurane, however, may not only offer advantages in emergency situations in remote or difficult-to-reach locations and mass-casualty situations but also be of significant value in urban and rural environments.

Mental models of audit and feedback in primary care settings.

PubMed

Hysong, Sylvia J; Smitham, Kristen; SoRelle, Richard; Amspoker, Amber; Hughes, Ashley M; Haidet, Paul

2018-05-30

Audit and feedback has been shown to be instrumental in improving quality of care, particularly in outpatient settings. The mental model individuals and organizations hold regarding audit and feedback can moderate its effectiveness, yet this has received limited study in the quality improvement literature. In this study we sought to uncover patterns in mental models of current feedback practices within high- and low-performing healthcare facilities. We purposively sampled 16 geographically dispersed VA hospitals based on high and low performance on a set of chronic and preventive care measures. We interviewed up to 4 personnel from each location (n = 48) to determine the facility's receptivity to audit and feedback practices. Interview transcripts were analyzed via content and framework analysis to identify emergent themes. We found high variability in the mental models of audit and feedback, which we organized into positive and negative themes. We were unable to associate mental models of audit and feedback with clinical performance due to high variance in facility performance over time. Positive mental models exhibit perceived utility of audit and feedback practices in improving performance; whereas, negative mental models did not. Results speak to the variability of mental models of feedback, highlighting how facilities perceive current audit and feedback practices. Findings are consistent with prior research  in that variability in feedback mental models is associated with lower performance.; Future research should seek to empirically link mental models revealed in this paper to high and low levels of clinical performance.

Solution Focused Empathy Training Groups for Students with Fire-Setting Behaviors

ERIC Educational Resources Information Center

Froeschle, Janet G.

2006-01-01

Fire-setting students are those who intentionally or unintentionally set one or more fires due to curiosity, stress, a need for attention, or due to criminal delinquency. This article describes the nature of fire-setting behaviors, discusses the profile and risk factors associated with the behavior, and outlines a group program using empathy…

Streak Imaging Flow Cytometer for Rare Cell Analysis.

PubMed

Balsam, Joshua; Bruck, Hugh Alan; Ossandon, Miguel; Prickril, Ben; Rasooly, Avraham

2017-01-01

There is a need for simple and affordable techniques for cytology for clinical applications, especially for point-of-care (POC) medical diagnostics in resource-poor settings. However, this often requires adapting expensive and complex laboratory-based techniques that often require significant power and are too massive to transport easily. One such technique is flow cytometry, which has great potential for modification due to the simplicity of the principle of optical tracking of cells. However, it is limited in that regard due to the flow focusing technique used to isolate cells for optical detection. This technique inherently reduces the flow rate and is therefore unsuitable for rapid detection of rare cells which require large volume for analysis.To address these limitations, we developed a low-cost, mobile flow cytometer based on streak imaging. In our new configuration we utilize a simple webcam for optical detection over a large area associated with a wide-field flow cell. The new flow cell is capable of larger volume and higher throughput fluorescence detection of rare cells than the flow cells with hydrodynamic focusing used in conventional flow cytometry. The webcam is an inexpensive, commercially available system, and for fluorescence analysis we use a 1 W 450 nm blue laser to excite Syto-9 stained cells with emission at 535 nm. We were able to detect low concentrations of stained cells at high flow rates of 10 mL/min, which is suitable for rapidly analyzing larger specimen volumes to detect rare cells at appropriate concentration levels. The new rapid detection capabilities, combined with the simplicity and low cost of this device, suggest a potential for clinical POC flow cytometry in resource-poor settings associated with global health.

Aspirin for acute stroke of unknown etiology in resource-limited settings: a decision analysis.

PubMed

Berkowitz, Aaron L; Westover, M Brandon; Bianchi, Matt T; Chou, Sherry H-Y

2014-08-26

To analyze the potential impact of aspirin on outcome at hospital discharge after acute stroke in resource-limited settings without access to neuroimaging to distinguish ischemic stroke from intracerebral hemorrhage (ICH). A decision analysis was conducted to evaluate aspirin use in all patients with acute stroke of unknown type for the duration of initial hospitalization. Data were obtained from the International Stroke Trial and Chinese Acute Stroke Trial. Predicted in-hospital mortality and stroke recurrence risk were determined across the worldwide reported range of the proportion of strokes caused by ICH. Sensitivity analyses were performed on aspirin-associated relative risks in patients with ICH. At the highest reported proportion of strokes due to ICH from a large epidemiologic study (34% in sub-Saharan Africa), aspirin initiation after acute stroke of undetermined etiology is predicted to reduce in-hospital mortality (from 85/1,000 without treatment to 81/1,000 with treatment), in-hospital stroke recurrence (58/1,000 to 50/1,000), and combined risk of in-hospital mortality or stroke recurrence (127/1,000 to 114/1,000). Benefits of aspirin therapy remained in sensitivity analyses across a range of plausible parameter estimates for relative risks associated with aspirin initiation after ICH. Aspirin treatment for the period of initial hospitalization after acute stroke of undetermined etiology is predicted to decrease acute stroke-related mortality and in-hospital stroke recurrence even at the highest reported proportion of acute strokes due to ICH. In the absence of clinical trials to test this approach empirically, clinical decisions require patient-specific evaluation of risks and benefits of aspirin in this context. © 2014 American Academy of Neurology.

[Consensus statement: Management of oral anticoagulation for stroke prevention in patients with nonvalvular atrial fibrillation].

PubMed

Helms, Thomas Maria; Silber, Sigmund; Schäfer, Andreas; Masuhr, Florian; Palm, Frederick; Darius, Harald; Schrör, Karsten; Bänsch, Dietmar; Bramlage, Peter; Hankowitz, Johannes; Karle, Christoph A; Stargardt, Tom; Weil, Joachim; Geller, Johann Christoph

2016-09-01

With the introduction of edoxaban last year in Germany, four nonvitamin K antagonist oral anticoagulants are now available for stroke prevention in patients with nonvalvular atrial fibrillation. These novel oral anticoagulants (NOAC) represent an attractive new option compared to vitamin K antagonists (e.g., warfarin or phenprocoumon) due to simple use and fewer interactions with other drugs or food. Therefore, no INR monitoring and dosage adjustments are required for NOAC. The compelling clinical advantage of NOAC is the dramatic risk reduction of hemorhagic stroke and intracranial bleeding compared to current standard. In addition, total mortality is significantly reduced by 10 %. These effects are demonstrated for all four NOAC (dabigatran, rivaroxaban, apixaban and edoxaban). Therefore, current national and international guidelines recommend NOAC as the preferred option or at least as an attractive alternative compared to the former standard of vitamin K antagonists. The economic impact and reimbursement by Statutory Health Insurance (GKV) is of major importance for treatment in an outpatient setting. For apixaban and edoxaban, an additional benefit was granted by the institution of G‑BA and IQWiG in this clinical setting, whereas dabigatran and rivaroxaban were not assessed due to market entrance prior to 2011 before the AMNOG procedure was initiated. The members of this consensus paper recommend NOAC as the preferred option for patients with nonvalvular atrial fibrillation who are currently not treated with anticoagulant drugs in spite of clear indication for anticoagulation. For new patients with nonvalvular fibrillation, it should be decided on an individual basis which treatment option is adequate for the patient with their respective comorbidities.

Prevalence, incidence, and epidemiological features of poliomyelitis in the Yemen Arab Republic.

PubMed

Hajar, M M; Zeid, A S; Saif, M A; Parvez, M A; Steinglass, R C; Crain, S

1983-01-01

There is a lack of reliable information on the extent of the poliomyelitis problem in developing countries, although the disease is thought to be more of a threat in urban than in rural areas. The Expanded Programme on Immunization (EPI) began operations in Yemen in 1977, and it was considered appropriate to try to establish the prevalence of residual paralysis due to poliomyelitis in children aged 5-13 years, in order to estimate the annual incidence of clinical cases of the disease, and to determine the epidemiological features of poliomyelitis in the country. The data thus obtained would provide a basis for assessing the impact of the immunization programme on the incidence of poliomyelitis.The results of the survey showed a prevalence of lameness due to poliomyelitis of 4.0 per 1000 children. The estimated annual incidence of the disease is thus 18.6 per 100 000 of the general population, or approximately 1088 cases each year, with an estimated 163 deaths. An estimated 5000 children aged 5-13 years are lame as a result of poliomyelitis. There was no significant difference in the incidence of the disease in rural and urban areas. The median age of onset was 1.92 years in the urban setting and 1.29 years in the rural setting, with more than half of all cases occurring before the age of 2 years. Immunization efforts should therefore be directed towards infants aged under 2 years. Although a national disease notification system was established in 1976, 95% of the clinical cases discovered during the survey had not been reported. This underlines the importance of special surveys in gathering the data necessary to evaluate the effectiveness of the immunization programme.

Epidemiological and economic burden of Clostridium difficile in the United States: estimates from a modeling approach.

PubMed

Desai, Kamal; Gupta, Swati B; Dubberke, Erik R; Prabhu, Vimalanand S; Browne, Chantelle; Mast, T Christopher

2016-06-18

Despite a large increase in Clostridium difficile infection (CDI) severity, morbidity and mortality in the US since the early 2000s, CDI burden estimates have had limited generalizability and comparability due to widely varying clinical settings, populations, or study designs. A decision-analytic model incorporating key input parameters important in CDI epidemiology was developed to estimate the annual number of initial and recurrent CDI cases, attributable and all-cause deaths, economic burden in the general population, and specific number of high-risk patients in different healthcare settings and the community in the US. Economic burden was calculated adopting a societal perspective using a bottom-up approach that identified healthcare resources consumed in the management of CDI. Annually, a total of 606,058 (439,237 initial and 166,821 recurrent) episodes of CDI were predicted in 2014: 34.3 % arose from community exposure. Over 44,500 CDI-attributable deaths in 2014 were estimated to occur. High-risk susceptible individuals representing 5 % of the total hospital population accounted for 23 % of hospitalized CDI patients. The economic cost of CDI was $5.4 billion ($4.7 billion (86.7 %) in healthcare settings; $725 million (13.3 %) in the community), mostly due to hospitalization. A modeling framework provides more comprehensive and detailed national-level estimates of CDI cases, recurrences, deaths and cost in different patient groups than currently available from separate individual studies. As new treatments for CDI are developed, this model can provide reliable estimates to better focus healthcare resources to those specific age-groups, risk-groups, and care settings in the US where they are most needed. (Trial Identifier ClinicaTrials.gov: NCT01241552).

The Context Dependency of the Self-Report Version of the Strength and Difficulties Questionnaire (SDQ): A Cross-Sectional Study between Two Administration Settings

PubMed Central

Hoofs, H.; Jansen, N. W. H.; Mohren, D. C. L.; Jansen, M. W. J.; Kant, I. J.

2015-01-01

Background The Strength and Difficulties Questionnaire (SDQ) is a screening instrument for psychosocial problems in children and adolescents, which is applied in “individual” and “collective” settings. Assessment in the individual setting is confidential for clinical applications, such as preventive child healthcare, while assessment in the collective setting is anonymous and applied in (epidemiological) research. Due to administration differences between the settings it remains unclear whether results and conclusions actually can be used interchangeably. This study therefore aims to investigate whether the SDQ is invariant across settings. Methods Two independent samples were retrieved (mean age = 14.07 years), one from an individual setting (N = 6,594) and one from a collective setting (N = 4,613). The SDQ was administered in the second year of secondary school in both settings. Samples come from the same socio-geographic population in the Netherlands. Results Confirmatory factor analysis showed that the SDQ was measurement invariant/equivalent across settings and gender. On average, children in the individual setting scored lower on total difficulties (mean difference = 2.05) and the psychosocial problems subscales compared to those in the collective setting. This was also reflected in the cut-off points for caseness, defined by the 90th percentiles, which were lower in the individual setting. Using cut-off points from the collective in the individual setting therefore resulted in a small number of cases, 2 to 3%, while ∼10% is expected. Conclusion The SDQ has the same connotation across the individual and collective setting. The observed structural differences regarding the mean scores, however, undermine the validity of the cross-use of absolute SDQ-scores between these settings. Applying cut-off scores from the collective setting in the individual setting could, therefore, result in invalid conclusions and potential misuse of the instrument. To correctly apply cut-off scores these should be retrieved from the applied setting. PMID:25886464

Neurophysiological criteria in the diagnosis of different clinical types of Guillain-Barre syndrome.

PubMed

Kalita, J; Misra, U K; Das, M

2008-03-01

The diagnostic yield of various neurophysiological criteria may vary in different subforms of Guillain-Barre syndrome (GBS), whose prevalence varies in different geographical areas. To evaluate the sensitivity of various neurophysiological criteria in different clinical subtypes of GBS, and their relationship with severity, duration and outcome. Consecutive patients with GBS underwent detailed clinical evaluation. Severity was graded on a scale from 0 to 10. Motor and sensory nerve conductions and F wave studies were performed. The diagnostic sensitivity of Albers et al (set 1), Cornblath (set 2), Ho et al (set 3), Dutch GBS study group (set 4), Italian GBS study group (set 5) and Albers and Kelly (set 6) criteria were evaluated and correlated with clinical subtypes of GBS, duration, severity and outcome. There were 51 patients. Mean disability was 6.8; 34 patients were bedridden and five needed a ventilator. Clinical presentation was pure motor in 31, motorsensory in 18 and pure sensory in two patients. The sensitivity of nerve conduction study in the diagnosis of GBS was highest in set 1 (88.2%) followed by set 3 (86.3%) and set 4 (82.4%) and lowest in set 2 (39.2%). The diagnostic yield of sets 1, 3 and 4 were also higher than sets 2, 5 and 6 in different clinical subtypes of GBS. As per Ho et al, patients could be categorised into acute inflammatory demyelinating polyradiculoneuropathy (44 (86.3%)), acute motor axonal neuropathy (4 (7.8%)) and acute motor sensory axonal neuropathy (3 (5.9%)). One (2%) patient died, 22.4% had complete, 57.1% partial and 18.4% poor recovery at 3 months. Outcome was related to severity of illness and compound muscle action potential (CMAP) amplitude. The sensitivity of different neurophysiological criteria in the diagnosis of Indian GBS patients varied from 39.2% to 88.2%. The outcome was related to severity of illness and CMAP amplitude.

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

PubMed

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

2017-05-01

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. 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. 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"). 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. 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. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.

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

Supporting clinical rules engine in the adjustment of medication (SCREAM): protocol of a multicentre, prospective, randomised study.

PubMed

Mestres Gonzalvo, Carlota; de Wit, Hugo A J M; van Oijen, Brigit P C; Hurkens, Kim P G M; Janknegt, Rob; Schols, Jos M G A; Mulder, Wubbo J; Verhey, Frans R; Winkens, Bjorn; van der Kuy, Paul-Hugo M

2017-01-26

In the nursing home population, it is estimated that 1 in every 3 patients is polymedicated and given their considerable frailty, these patients are especially prone to adverse drug reactions. Clinical pharmacist-led medication reviews are considered successful interventions to improve medication safety in the inpatient setting. Due to the limited available evidence concerning the benefits of medication reviews performed in the nursing home setting, we propose a study aiming to demonstrate a positive effect that a clinical decision support system, as a health care intervention, may have on the target population. The primary objective of this study is to reduce the number of patients with at least one event when using the clinical decision support system compared to the regular care. These events consist of hospital referrals, delirium, falls, and/or deaths. This study is a multicentre, prospective, randomised study with a cluster group design. The randomisation will be per main nursing home physician and stratified per ward (somatic and psychogeriatric). In the intervention group the clinical decision support system will be used to screen medication list, laboratory values and medical history in order to obtain potential clinical relevant remarks. The remarks will be sent to the main physician and feedback will be provided whether the advice was followed or not. In the control group regular care will be applied. We strongly believe that by using a clinical decision support system, medication reviews are performed in a standardised way which leads to comparable results between patients. In addition, using a clinical decision support system eliminates the time factor to perform medication reviews as the major problems related to medication, laboratory values, indications and/or established patient characteristics will be directly available. In this way, and in order to make the medication review process complete, consultation within healthcare professionals and/or the patient itself will be time effective and the medication surveillance could be performed around the clock. The Netherlands National Trial Register NTR5165 . Registered 2nd April 2015.

(99m)Tc-MDP SPECT/CT as the one-stop imaging modality for the diagnosis of early setting of Kienbock's disease.

PubMed

Arora, S; Singh Dhull, V; Karunanithi, S; Kumar Parida, G; Sharma, A; Shamim, S A

2015-01-01

(99m)Tc-Methylene diphosphonate (MDP) triple phase bone scintigraphy (BS) has a role in early diagnosis of Kienbock's disease, especially when the X-ray is negative. Early diagnosis can result in prompt management of the patient since wrist pain in older individuals due to aging may go unnoticed or be due to other diagnoses with the production of greater damage and eventually a worse prognosis. Herein, we present a case report of a 29-year-old female with Kienbock's disease in whom the X-ray was negative and MRI incorrect. The (99m)Tc-MDP SPECT/CT BS helped the diagnosis of the disease in an early stage (stage 1) and had a clinical impact on the patient's management. Copyright © 2014 Elsevier España, S.L.U. and SEMNIM. All rights reserved.

Evaluating the impact of new anticoagulants in the hospital setting

PubMed Central

Braidy, Nady; Bui, Khai; Bajorek, Beata

2010-01-01

The short-comings of current anticoagulants have led to the development of newer, albeit more expensive, oral alternatives. Objective To explore the potential impact the new anticoagulants dabigatran and rivaroxaban in the local hospital setting, in terms of utilisation and subsequent costing. Method A preliminary costing analysis was performed based on a prospective 2-week clinical audit (29th June - 13th July 2009). Data regarding current anticoagulation management were extracted from the medical files of patients admitted to Ryde Hospital. To model potential costing implications of using the newer agents, the reported incidence of VTE/stroke and bleeding events were obtained from key clinical trials. Results Data were collected for 67 patients treated with either warfarin (n=46) or enoxaparin (n=21) for prophylaxis of VTE/stroke. At least two-thirds of all patients were deemed suitable candidates for the use of newer oral anticoagulants (by current therapy: warfarin: 65.2% (AF), 34.8% (VTE); enoxaparin: 100%, (VTE)). The use of dabigatran in VTE/stroke prevention was found to be more cost- effective than warfarin and enoxaparin due to significantly lower costs of therapeutic monitoring and reduced administration costs. Rivaroxaban was more cost-effective than warfarin and enoxaparin for VTE/stroke prevention when supplier-rebates (33%) were factored into costing. Conclusion This study highlights the potential cost- effectiveness of newer anticoagulants, dabigatran and rivaroxaban, compared to warfarin and enoxaparin. These agents may offer economic advantages, as well as clinical benefits, in the hospital-based management of anticoagulated patients. PMID:25132883

Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer.

PubMed

Watanabe, Toshiaki; Muro, Kei; Ajioka, Yoichi; Hashiguchi, Yojiro; Ito, Yoshinori; Saito, Yutaka; Hamaguchi, Tetsuya; Ishida, Hideyuki; Ishiguro, Megumi; Ishihara, Soichiro; Kanemitsu, Yukihide; Kawano, Hiroshi; Kinugasa, Yusuke; Kokudo, Norihiro; Murofushi, Keiko; Nakajima, Takako; Oka, Shiro; Sakai, Yoshiharu; Tsuji, Akihito; Uehara, Keisuke; Ueno, Hideki; Yamazaki, Kentaro; Yoshida, Masahiro; Yoshino, Takayuki; Boku, Narikazu; Fujimori, Takahiro; Itabashi, Michio; Koinuma, Nobuo; Morita, Takayuki; Nishimura, Genichi; Sakata, Yuh; Shimada, Yasuhiro; Takahashi, Keiichi; Tanaka, Shinji; Tsuruta, Osamu; Yamaguchi, Toshiharu; Yamaguchi, Naohiko; Tanaka, Toshiaki; Kotake, Kenjiro; Sugihara, Kenichi

2018-02-01

Japanese mortality due to colorectal cancer is on the rise, surpassing 49,000 in 2015. Many new treatment methods have been developed during recent decades. The Japanese Society for Cancer of the Colon and Rectum Guidelines 2016 for the treatment of colorectal cancer (JSCCR Guidelines 2016) were prepared to show standard treatment strategies for colorectal cancer, to eliminate disparities among institutions in terms of treatment, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding between health-care professionals and patients by making these Guidelines available to the general public. These Guidelines were prepared by consensus reached by the JSCCR Guideline Committee, based on a careful review of the evidence retrieved by literature searches, and in view of the medical health insurance system and actual clinical practice settings in Japan. Therefore, these Guidelines can be used as a tool for treating colorectal cancer in actual clinical practice settings. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions held by the Guideline Committee, controversial issues were selected as Clinical Questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2016.

The Child Adolescent Bullying Scale (CABS): Psychometric evaluation of a new measure.

PubMed

Strout, Tania D; Vessey, Judith A; DiFazio, Rachel L; Ludlow, Larry H

2018-06-01

While youth bullying is a significant public health problem, healthcare providers have been limited in their ability to identify bullied youths due to the lack of a reliable, and valid instrument appropriate for use in clinical settings. We conducted a multisite study to evaluate the psychometric properties of a new 22-item instrument for assessing youths' experiences of being bullied, the Child Adolescent Bullying Scale (CABS). The 20 items summed to produce the measure's score were evaluated here. Diagnostic performance was assessed through evaluation of sensitivity, specificity, predictive values, and area under receiver operating characteristic (AUROC) curve. A sample of 352 youths from diverse racial, ethnic, and geographic backgrounds (188 female, 159 male, 5 transgender, sample mean age 13.5 years) were recruited from two clinical sites. Participants completed the CABS and existing youth bullying measures. Analyses grounded in classical test theory, including assessments of reliability and validity, item analyses, and principal components analysis, were conducted. The diagnostic performance and test characteristics of the CABS were also evaluated. The CABS is comprised of one component, accounting for 67% of observed variance. Analyses established evidence of internal consistency reliability (Cronbach's α = 0.97), construct and convergent validity. Sensitivity was 84%, specificity was 65%, and the AUROC curve was 0.74 (95% CI: 0.69-0.80). Findings suggest that the CABS holds promise as a reliable, valid tool for healthcare provider use in screening for bullying exposure in the clinical setting. © 2018 Wiley Periodicals, Inc.

A Review of the Effectiveness of Neuroimaging Modalities for the Detection of Traumatic Brain Injury.

PubMed

Amyot, Franck; Arciniegas, David B; Brazaitis, Michael P; Curley, Kenneth C; Diaz-Arrastia, Ramon; Gandjbakhche, Amir; Herscovitch, Peter; Hinds, Sidney R; Manley, Geoffrey T; Pacifico, Anthony; Razumovsky, Alexander; Riley, Jason; Salzer, Wanda; Shih, Robert; Smirniotopoulos, James G; Stocker, Derek

2015-11-15

The incidence of traumatic brain injury (TBI) in the United States was 3.5 million cases in 2009, according to the Centers for Disease Control and Prevention. It is a contributing factor in 30.5% of injury-related deaths among civilians. Additionally, since 2000, more than 260,000 service members were diagnosed with TBI, with the vast majority classified as mild or concussive (76%). The objective assessment of TBI via imaging is a critical research gap, both in the military and civilian communities. In 2011, the Department of Defense (DoD) prepared a congressional report summarizing the effectiveness of seven neuroimaging modalities (computed tomography [CT], magnetic resonance imaging [MRI], transcranial Doppler [TCD], positron emission tomography, single photon emission computed tomography, electrophysiologic techniques [magnetoencephalography and electroencephalography], and functional near-infrared spectroscopy) to assess the spectrum of TBI from concussion to coma. For this report, neuroimaging experts identified the most relevant peer-reviewed publications and assessed the quality of the literature for each of these imaging technique in the clinical and research settings. Although CT, MRI, and TCD were determined to be the most useful modalities in the clinical setting, no single imaging modality proved sufficient for all patients due to the heterogeneity of TBI. All imaging modalities reviewed demonstrated the potential to emerge as part of future clinical care. This paper describes and updates the results of the DoD report and also expands on the use of angiography in patients with TBI.

Modifications in Glass Ionomer Cements: Nano-Sized Fillers and Bioactive Nanoceramics

PubMed Central

Najeeb, Shariq; Khurshid, Zohaib; Zafar, Muhammad Sohail; Khan, Abdul Samad; Zohaib, Sana; Martí, Juan Manuel Nuñez; Sauro, Salvatore; Matinlinna, Jukka Pekka; Rehman, Ihtesham Ur

2016-01-01

Glass ionomer cements (GICs) are being used for a wide range of applications in dentistry. In order to overcome the poor mechanical properties of glass ionomers, several modifications have been introduced to the conventional GICs. Nanotechnology involves the use of systems, modifications or materials the size of which is in the range of 1–100 nm. Nano-modification of conventional GICs and resin modified GICs (RMGICs) can be achieved by incorporation of nano-sized fillers to RMGICs, reducing the size of the glass particles, and introducing nano-sized bioceramics to the glass powder. Studies suggest that the commercially available nano-filled RMGIC does not hold any significant advantage over conventional RMGICs as far as the mechanical and bonding properties are concerned. Conversely, incorporation of nano-sized apatite crystals not only increases the mechanical properties of conventional GICs, but also can enhance fluoride release and bioactivity. By increasing the crystallinity of the set matrix, apatites can make the set cement chemically more stable, insoluble, and improve the bond strength with tooth structure. Increased fluoride release can also reduce and arrest secondary caries. However, due to a lack of long-term clinical studies, the use of nano-modified glass ionomers is still limited in daily clinical dentistry. In addition to the in vitro and in vivo studies, more randomized clinical trials are required to justify the use of these promising materials. The aim of this paper is to review the modification performed in GIC-based materials to improve their physicochemical properties. PMID:27428956

A Review of the Effectiveness of Neuroimaging Modalities for the Detection of Traumatic Brain Injury

PubMed Central

Amyot, Franck; Arciniegas, David B.; Brazaitis, Michael P.; Curley, Kenneth C.; Diaz-Arrastia, Ramon; Gandjbakhche, Amir; Herscovitch, Peter; Hinds, Sidney R.; Manley, Geoffrey T.; Razumovsky, Alexander; Riley, Jason; Salzer, Wanda; Shih, Robert; Smirniotopoulos, James G.; Stocker, Derek

2015-01-01

Abstract The incidence of traumatic brain injury (TBI) in the United States was 3.5 million cases in 2009, according to the Centers for Disease Control and Prevention. It is a contributing factor in 30.5% of injury-related deaths among civilians. Additionally, since 2000, more than 260,000 service members were diagnosed with TBI, with the vast majority classified as mild or concussive (76%). The objective assessment of TBI via imaging is a critical research gap, both in the military and civilian communities. In 2011, the Department of Defense (DoD) prepared a congressional report summarizing the effectiveness of seven neuroimaging modalities (computed tomography [CT], magnetic resonance imaging [MRI], transcranial Doppler [TCD], positron emission tomography, single photon emission computed tomography, electrophysiologic techniques [magnetoencephalography and electroencephalography], and functional near-infrared spectroscopy) to assess the spectrum of TBI from concussion to coma. For this report, neuroimaging experts identified the most relevant peer-reviewed publications and assessed the quality of the literature for each of these imaging technique in the clinical and research settings. Although CT, MRI, and TCD were determined to be the most useful modalities in the clinical setting, no single imaging modality proved sufficient for all patients due to the heterogeneity of TBI. All imaging modalities reviewed demonstrated the potential to emerge as part of future clinical care. This paper describes and updates the results of the DoD report and also expands on the use of angiography in patients with TBI. PMID:26176603

Demoralization in mental health organizations: leadership and social support help.

PubMed

Gabel, Stewart

2012-12-01

Demoralization is a commonly observed feeling state that is characterized by a sense of loss of or threat to one's personal values or goals and a perceived inability to overcome obstacles toward achieving these goals. Demoralization has features in common with burnout and may precede or accompany it. Psychiatrists working in many mental health care organizational settings, be they in the public or private sectors, may be at particular risk for demoralization. This is due partly to stressors that threaten their own professional values because of factors such as programmatic cut backs, budgetary reductions and changing social emphases on the value of mental health treatments. They also may be at risk for demoralization because of the effects on them of the governance styles of the agencies in which they are employed. The leadership or governance style in large organizational settings often is authoritarian, hierarchical and bureaucratic, approaches that are antithetical to the more participative leadership styles favored by many mental health professionals in their clinical activities. Clinical leaders in mental health organizations must exhibit various competencies to successfully address demoralization in clinical staff and to provide a counterbalance to the effects of the governance style of many agencies in which they are employed. Appropriate leadership skills, sometimes too simplistically termed "social support", have been found to reduce burnout in various populations and are likely to lessen demoralization as well. This paper reviews these important leadership issues and the relationship of social support to recognized leadership competencies.

The diagnostic value of troponin T testing in the community setting.

PubMed

Planer, David; Leibowitz, David; Paltiel, Ora; Boukhobza, Rina; Lotan, Chaim; Weiss, Teddy A

2006-03-08

Many patients presenting with chest pain to their family physician are referred to the emergency room, in part, due to lack of accurate objective diagnostic tools. This study aimed to assess the diagnostic value of bedside troponin T kit testing in patients presenting with chest pain to their family physician. Prospective, multi-center study. Consecutive subjects with chest pain were recruited from 44 community clinics in Jerusalem. Following clinical assessment by the family physician, qualitative troponin kit testing was performed. Patients with a negative clinical assessment and negative troponin kit were sent home and all others were referred to the emergency room. The final diagnosis at the time of hospital discharge was recorded and telephone follow up was performed after 60 days. Positive predictive value, negative predictive value, sensitivity and specificity of troponin kit for myocardial infarction diagnosis and of family physician for hospitalization, were assessed. Of 392 patients enrolled, 349 (89%) were included in the final analysis. The prevalence of myocardial infarction was 1.7%. The positive and negative predictive values of the troponin kit for myocardial infarction diagnosis were 100% and 99.7%, respectively. The positive and negative predictive values of the family physician's assessment to predict hospitalization were 41.4% and 94.1%, respectively. Troponin kit testing is an important tool to assist the family physician in the assessment of patients with chest pain in the community setting. Troponin kit testing may identify otherwise undiagnosed cases of myocardial infarctions, and reduce unnecessary referrals to the emergency room.

Evaluation of the chemiluminescent enzyme immunoassay system for the measurement of testosterone in the serum and whole blood of stallions

PubMed Central

TOISHI, Yuko; TSUNODA, Nobuo; NAGATA, Shun-ichi; KIRISAWA, Rikio; NAGAOKA, Kentaro; WATANABE, Gen; YANAGAWA, Yojiro; KATAGIRI, Seiji; TAYA, Kazuyoshi

2017-01-01

Testosterone (T) concentration is a useful indicator of reproductive function in male animals. However, T concentration is not usually measured in veterinary clinics, partly due to the unavailability of reliable and rapid assays for animal samples. In this study, a rapid chemiluminescent enzyme immunoassay system (CLEIA system) that was developed for the measurement of T concentration in humans use was validated for stallion blood samples. First, serum T concentrations were measured using the CLEIA system and compared with those measured by a fluoroimmunoassay that has been validated for use in stallions. The serum T concentrations measured by the two methods were highly correlated (r = 0.9865, n = 56). Second, to validate the use of whole blood as assay samples, T concentrations in whole blood and in the serum were measured by the CLEIA system. T concentrations in both samples were highly correlated (r = 0.9665, n = 64). Finally, to evaluate the practical value of the CLEIA system in clinical settings, T concentrations were measured in three stallions with reproductive abnormalities after the administration of human chorionic gonadotropin (hCG). Two stallions with small or absent testes in the scrotum showed an increase in T production in response to hCG administration and one stallion with seminoma did not. In conclusion, the CLEIA system was found to be a rapid and reliable tool for measuring T concentrations in stallions and may improve reproductive management in clinical settings and in breeding studs. PMID:29129877

A traditionally administered short course failed to improve medical students' diagnostic performance. A quantitative evaluation of diagnostic thinking.

PubMed

Noguchi, Yoshinori; Matsui, Kunihiko; Imura, Hiroshi; Kiyota, Masatomo; Fukui, Tsuguya

2004-05-01

Quite often medical students or novice residents have difficulty in ruling out diseases even though they are quite unlikely and, due to this difficulty, such students and novice residents unnecessarily repeat laboratory or imaging tests. To explore whether or not a carefully designed short training course teaching Bayesian probabilistic thinking improves the diagnostic ability of medical students. Ninety students at 2 medical schools were presented with clinical scenarios of coronary artery disease corresponding to high, low, and intermediate pretest probabilities. The students' estimates of test characteristics of exercise stress test, and pretest and posttest probability for each scenario were evaluated before and after the short course. The pretest probability estimates by the students, as well as their proficiency in applying Bayes's theorem, were improved in the high pretest probability scenario after the short course. However, estimates of pretest probability in the low pretest probability scenario, and their proficiency in applying Bayes's theorem in the intermediate and low pretest probability scenarios, showed essentially no improvement. A carefully designed, but traditionally administered, short course could not improve the students' abilities in estimating pretest probability in a low pretest probability setting, and subsequently students remained incompetent in ruling out disease. We need to develop educational methods that cultivate a well-balanced clinical sense to enable students to choose a suitable diagnostic strategy as needed in a clinical setting without being one-sided to the "rule-in conscious paradigm."

INFECTION CONTROL IN ALTERNATIVE HEALTHCARE SETTINGS

PubMed Central

Flanagan, Elaine; Chopra, Teena; Mody, Lona

2011-01-01

SYNOPSIS With the changing healthcare delivery, patients receive care at various settings including acute care hospitals, skilled nursing facilities, outpatient primary care and specialty clinics, as well as at home, exposing them to pathogens in various settings. Various healthcare settings face unique challenges requiring individualized infection control programs. Infection control programs in skilled nursing facilities should address: surveillance for infections and antimicrobial resistance, outbreak investigation and control plan for epidemics, isolation precautions, hand hygiene, staff education, and employee and resident health programs. Infection control programs in ambulatory clinics should address: Triage and standard – transmission based precautions, cleaning, disinfection and sterilization principles, surveillance in surgical clinics, safe injection practices, and bioterrorism and disaster planning for ambulatory clinics. PMID:21316005

"Perpetual Problem-Solving": An Ethnographic Study of Clinical Reasoning in a Therapeutic Recreation Setting.

ERIC Educational Resources Information Center

Hutchinson, Susan L.; LeBlanc, Adrienne; Booth, Rhonda

2002-01-01

Reviews literature on the concept and practice of clinical reasoning, presenting evidence of clinical reasoning in a therapeutic recreation setting. Data from observations of and interviews with recreation therapists and clients in a Canadian rehabilitation hospital provided evidence of therapists' clinical reasoning practices which supported the…

Clinical Instructor Characteristics, Behaviors and Skills in Allied Health Care Settings: A Literature Review

ERIC Educational Resources Information Center

Levy, Linda S.; Sexton, Patrick; Willeford, K. Sean; Barnum, Mary G.; Guyer, M. Susan; Gardner, Greg; Fincher, A. Louise

2009-01-01

The purpose of this literature review is to compare both clinical instructor and student perceptions of helpful and hindering clinical instructor characteristics, behaviors and skills in athletic training and allied health care settings. Clinical education in athletic training is similar to that of other allied health care professions. Clinical…

Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases

PubMed Central

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O.; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-01-01

Background: A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. Methods: NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. Results: The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit[1]website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. Limitations: The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static but require frequent revisions. Conclusions: Standard protocol templates that meet applicable regulations can be important tools to assist investigators in the effective conduct of clinical research, but they require dedicated resources and ongoing input from key stakeholders. PMID:19625326

Varieties of clinical reasoning.

PubMed

Bolton, Jonathan W

2015-06-01

Clinical reasoning comprises a variety of different modes of inference. The modes that are practiced will be influenced by the sociological characteristics of the clinical settings and the tasks to be performed by the clinician. This article presents C.S. Peirce's typology of modes of inference: deduction, induction and abduction. It describes their differences and their roles as stages in scientific argument. The article applies the typology to reasoning in clinical settings. The article describes their differences, and their roles as stages in scientific argument. It then applies the typology to reasoning in typical clinical settings. Abduction is less commonly taught or discussed than induction and deduction. However, it is a common mode of inference in clinical settings, especially when the clinician must try to make sense of a surprising phenomenon. Whether abduction is followed up with deductive and inductive verification is strongly influenced by situational constraints and the cognitive and psychological stamina of the clinician. Recognizing the inevitability of abduction in clinical practice and its value to discovery is important to an accurate understanding of clinical reasoning. © 2015 John Wiley & Sons, Ltd.

Physiotherapy students' perceptions and experiences of clinical prediction rules.

PubMed

Knox, Grahame M; Snodgrass, Suzanne J; Stanton, Tasha R; Kelly, David H; Vicenzino, Bill; Wand, Benedict M; Rivett, Darren A

2017-09-01

Clinical reasoning can be difficult to teach to pre-professional physiotherapy students due to their lack of clinical experience. It may be that tools such as clinical prediction rules (CPRs) could aid the process, but there has been little investigation into their use in physiotherapy clinical education. This study aimed to determine the perceptions and experiences of physiotherapy students regarding CPRs, and whether they are learning about CPRs on clinical placement. Cross-sectional survey using a paper-based questionnaire. Final year pre-professional physiotherapy students (n=371, response rate 77%) from five universities across five states of Australia. Sixty percent of respondents had not heard of CPRs, and a further 19% had not clinically used CPRs. Only 21% reported using CPRs, and of these nearly three-quarters were rarely, if ever, learning about CPRs in the clinical setting. However most of those who used CPRs (78%) believed CPRs assisted in the development of clinical reasoning skills and none (0%) was opposed to the teaching of CPRs to students. The CPRs most commonly recognised and used by students were those for determining the need for an X-ray following injuries to the ankle and foot (67%), and for identifying deep venous thrombosis (63%). The large majority of students in this sample knew little, if anything, about CPRs and few had learned about, experienced or practiced them on clinical placement. However, students who were aware of CPRs found them helpful for their clinical reasoning and were in favour of learning more about them. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Healthcare professionals' agreement on clinical relevance of drug-related problems among elderly patients.

PubMed

Bech, Christine Flagstad; Frederiksen, Tine; Villesen, Christine Tilsted; Højsted, Jette; Nielsen, Per Rotbøll; Kjeldsen, Lene Juel; Nørgaard, Lotte Stig; Christrup, Lona Louring

2018-02-01

Background Disagreement among healthcare professionals on the clinical relevance of drug-related problems can lead to suboptimal treatment and increased healthcare costs. Elderly patients with chronic non-cancer pain and comorbidity are at increased risk of drug related problems compared to other patient groups due to complex medication regimes and transition of care. Objective To investigate the agreement among healthcare professionals on their classification of clinical relevance of drug-related problems in elderly patients with chronic non-cancer pain and comorbidity. Setting Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark. Method A pharmacist performed medication review on elderly patients with chronic non-cancer pain and comorbidity, identified their drug-related problems and classified these problems in accordance with an existing categorization system. A five-member clinical panel rated the drug-related problems' clinical relevance in accordance with a five-level rating scale, and their agreement was compared using Fleiss' κ. Main outcome measure Healthcare professionals' agreement on clinical relevance of drug related problems, using Fleiss' κ. Results Thirty patients were included in the study. A total of 162 drug related problems were identified, out of which 54% were of lower clinical relevance (level 0-2) and 46% of higher clinical relevance (level 3-4). Only slight agreement (κ = 0.12) was found between the panellists' classifications of clinical relevance using a five-level rating scale. Conclusion The clinical pharmacist identified drug related problems of lower and higher clinical relevance. Poor overall agreement on the severity of the drug related problems was found among the panelists.

Transition of care for patients with type 1 diabetes mellitus from pediatric to adult health care systems

PubMed Central

Glick, Bethany; Kamboj, Manmohan K.

2017-01-01

Planning for the transition from pediatric to adult healthcare is broadly understood to be beneficial to the quality of care of patients with chronic illness. Due to the level of self-care that is necessary in the maintenance of most chronic diseases, it is important that pediatric settings can offer support during a time when adolescents are beginning to take more responsibility in all areas of their lives. Lack of supportive resources for adolescents with chronic conditions often results in both decreased access to care and impaired health and function likely leading to increased medical costs later. Additionally, fundamental differences in health care delivery exist between pediatric and adult care settings. There is limited empiric data and information on best practices in transition care. In this article we address the importance of bridging pediatric and adult care settings and highlight the challenges and successes of the implementation of the young adult transition clinic program for patients with type 1 diabetes at our facility. We provide recommendations for further research and program implementation with the transition population. PMID:29184818

3D brain tumor segmentation in multimodal MR images based on learning population- and patient-specific feature sets.

PubMed

Jiang, Jun; Wu, Yao; Huang, Meiyan; Yang, Wei; Chen, Wufan; Feng, Qianjin

2013-01-01

Brain tumor segmentation is a clinical requirement for brain tumor diagnosis and radiotherapy planning. Automating this process is a challenging task due to the high diversity in appearance of tumor tissue among different patients and the ambiguous boundaries of lesions. In this paper, we propose a method to construct a graph by learning the population- and patient-specific feature sets of multimodal magnetic resonance (MR) images and by utilizing the graph-cut to achieve a final segmentation. The probabilities of each pixel that belongs to the foreground (tumor) and the background are estimated by global and custom classifiers that are trained through learning population- and patient-specific feature sets, respectively. The proposed method is evaluated using 23 glioma image sequences, and the segmentation results are compared with other approaches. The encouraging evaluation results obtained, i.e., DSC (84.5%), Jaccard (74.1%), sensitivity (87.2%), and specificity (83.1%), show that the proposed method can effectively make use of both population- and patient-specific information. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

[Neuroanesthetic management for surgical clipping of a ruptured cerebral aneurysm: clinical practice guidelines].

PubMed

Ingelmo Ingelmo, I; Carmona Aurioles, J; Rama-Maceiras, P; Fàbregas Julià, N; Hernández-Palazón, J

2010-12-01

Subarachnoid hemorrhage due to spontaneous rupture of a cerebral aneurysm is associated with high rates of morbidity and mortality and requires multidisciplinary treatment. The debate on surgical vs endovascular treatment continues, although short-term clinical outcomes and survival rates are better after endovascular treatment. In Spain, a strong trend toward reduced use of clipping has been noted, and neuroanesthetists are less often called on to provide anesthesia in this setting. Our intervention, however, can be decisive. The neuroscience working group of the Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor has developed guidelines for managing anesthesia in these procedures. Based on a national survey and a systematic review of the literature, the recommendations emphasize the importance of ensuring appropriate intracranial conditions, treating complications, and taking steps to protect against cerebral hemorrhage.

Obstructive sleep apnea syndrome: An important piece in the puzzle of cardiovascular risk factors.

PubMed

Costa, Cátia; Santos, Beatriz; Severino, Davide; Cabanelas, Nuno; Peres, Marisa; Monteiro, Isabel; Leal, Margarida

2015-01-01

The obstructive sleep apnea syndrome (OSA) is a clinical entity characterized by recurring episodes of apnea and/or hypopnea during sleep, due to a total or partial collapse, respectively, of the upper airway. This collapse originates a set of pathophysiological changes that determine the appearance of several cardiovascular complications. OSA contributes for the development of hypertension, heart failure, arrhythmias and coronary heart disease. Nowadays it is recognized to be an important public health problem, taking into account not just its repercussions but also its prevalence, since the main risk factor for the disease is obesity, a growing problem worldwide, both in developed and developing countries. The present review summarizes the current knowledge about OSA, as regards its definition, pathophysiology, clinical manifestations, diagnosis, cardiovascular effects and treatment. Copyright © 2014 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

The Length of Child Anxiety Treatment in a Regional Health System.

PubMed

Whiteside, Stephen P H; Ale, Chelsea M; Young, Brennan; Olsen, Mark W; Biggs, Bridget K; Gregg, Melissa S; Geske, Jennifer R; Homan, Kendra

2016-12-01

Anxiety disorders are often undertreated due to unsuccessful dissemination of evidence-based treatments (EBTs). Lack of empirical data regarding the typical length of treatment in clinical settings may hamper the development of clinically relevant protocols. The current study examined billing records for 335 children ages 7-17 years to quantify the treatment received for newly diagnosed anxiety disorders within a regional health system. The vast majority of patients did not receive a sufficient number of appointments to complete the typical cognitive behavioral therapy protocol or reach the sessions introducing exposure. Although half of the sample received pharmacotherapy, the vast majority received fewer follow-up appointments than participants in pharmacotherapy research studies. Further, the type of treatment (i.e., number of sessions and medication) differed depending on utilization of specialty care. These results underscore the need to develop brief and flexible EBT protocols that can be standardized and implemented in community practice.

Central Venous Catheter-Related Bloodstream Infection with Kocuria kristinae in a Patient with Propionic Acidemia

PubMed Central

Kawai, Eichiro; Yaoita, Hisao; Ichinoi, Natsuko; Sakamoto, Osamu; Kure, Shigeo

2017-01-01

Kocuria kristinae is a catalase-positive, coagulase-negative, Gram-positive coccus found in the environment and in normal skin and mucosa in humans; however, it is rarely isolated from clinical specimens and is considered a nonpathogenic bacterium. We describe a case of catheter-related bacteremia due to K. kristinae in a young adult with propionic acidemia undergoing periodic hemodialysis. The patient had a central venous catheter implanted for total parenteral nutrition approximately 6 months prior to the onset of symptoms because of repeated acute pancreatitis. K. kristinae was isolated from two sets of blood cultures collected from the catheter. Vancomycin followed by cefazolin for 16 days and 5-day ethanol lock therapy successfully eradicated the K. kristinae bacteremia. Although human infections with this organism appear to be rare and are sometimes considered to result from contamination, physicians should not underestimate its significance when it is isolated in clinical specimens. PMID:28194286

Central Venous Catheter-Related Bloodstream Infection with Kocuria kristinae in a Patient with Propionic Acidemia.

PubMed

Kimura, Masato; Kawai, Eichiro; Yaoita, Hisao; Ichinoi, Natsuko; Sakamoto, Osamu; Kure, Shigeo

2017-01-01

Kocuria kristinae is a catalase-positive, coagulase-negative, Gram-positive coccus found in the environment and in normal skin and mucosa in humans; however, it is rarely isolated from clinical specimens and is considered a nonpathogenic bacterium. We describe a case of catheter-related bacteremia due to K. kristinae in a young adult with propionic acidemia undergoing periodic hemodialysis. The patient had a central venous catheter implanted for total parenteral nutrition approximately 6 months prior to the onset of symptoms because of repeated acute pancreatitis. K. kristinae was isolated from two sets of blood cultures collected from the catheter. Vancomycin followed by cefazolin for 16 days and 5-day ethanol lock therapy successfully eradicated the K. kristinae bacteremia. Although human infections with this organism appear to be rare and are sometimes considered to result from contamination, physicians should not underestimate its significance when it is isolated in clinical specimens.

Low-Dimensional Statistics of Anatomical Variability via Compact Representation of Image Deformations.

PubMed

Zhang, Miaomiao; Wells, William M; Golland, Polina

2016-10-01

Using image-based descriptors to investigate clinical hypotheses and therapeutic implications is challenging due to the notorious "curse of dimensionality" coupled with a small sample size. In this paper, we present a low-dimensional analysis of anatomical shape variability in the space of diffeomorphisms and demonstrate its benefits for clinical studies. To combat the high dimensionality of the deformation descriptors, we develop a probabilistic model of principal geodesic analysis in a bandlimited low-dimensional space that still captures the underlying variability of image data. We demonstrate the performance of our model on a set of 3D brain MRI scans from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database. Our model yields a more compact representation of group variation at substantially lower computational cost than models based on the high-dimensional state-of-the-art approaches such as tangent space PCA (TPCA) and probabilistic principal geodesic analysis (PPGA).

Polymeric Micelles and Alternative Nanonized Delivery Vehicles for Poorly Soluble Drugs

PubMed Central

Lu, Ying; Park, Kinam

2013-01-01

Poorly soluble drugs often encounter low bioavailability and erratic absorption patterns in the clinical setting. Due to the rising number of compounds having solubility issues, finding ways to enhance the solubility of drugs is one of the major challenges in the pharmaceutical industry today. Polymeric micelles, which form upon self-assembly of amphiphilic macromolecules, can act as solubilizing agents for delivery of poorly soluble drugs. This manuscript examines the fundamentals of polymeric micelles through reviews of representative literature and demonstrates possible applications through recent examples of clinical trial developments. In particular, the potential of polymeric micelles for delivery of poorly water-soluble drugs, especially in the areas of oral delivery and in cancer therapy, is discussed. Key considerations in utilizing polymeric micelles’ advantages and overcoming potential disadvantages have been highlighted. Lastly, other possible strategies related to particle size reduction for enhancing solubilization of poorly water-soluble drugs are introduced. PMID:22944304

A complete heart block in a young male: a case report and review of literature of cardiac sarcoidosis.

PubMed

Patel, Brijesh; Shah, Mahek; Gelaye, Alehegn; Dusaj, Raman

2017-01-01

Cardiac sarcoidosis is one of the uncommon causes of heart failure. Generally, it presents in the form of varying clinical manifestations ranging from asymptomatic to fatal arrhythmias such as ventricular tachycardia and complete heart block. It is difficult to make a diagnosis strictly based on clinical grounds. However, in the setting of extracardiac sarcoidosis and patients presenting with advanced heart block or ventricular arrhythmia, direct cardiac involvement should be suspected. The definitive diagnosis of cardiac sarcoidosis can be made from endomyocardial biopsy, but it is falling out of favor due to patchy myocardial involvement, considerable procedure-related risks, and advancement in additional imaging modalities. Once cardiac sarcoidosis has been diagnosed, management of the disease remains challenging. Steroids are considered the mainstay of therapy, and implantable cardioverter defibrillator therapy can be considered in a selected group of patients at greater risk for malignant ventricular arrhythmias.

Lower Genital Tract Trauma in A Tertiary Care Centre in Mid-Western Nepal.

PubMed

Adhikari, A K; Dutta, M; Das, C R

2017-01-01

The study of lower genital tract trauma has become important in gynaecological practice. There is paucity of reports on this clinical entity from our settings. The main aim of this study is to document injuries in female lower genital tract in Mid-Western Nepal. Sixty female patients admitted to the hospital with genital tract injuries caused by coitus or accidents were included in the study. Details of the causes of trauma clinical presentations and management were recorded. These injuries were grouped according to etiological factors. This study included 33 (55%) coital injuries and 27 (45%) non- coital injuries. Out of coital injury, 12 cases were criminal assault (rape) in age group of 4 to 18 years. Four unmarried girls had consensual sex. Non-coital injuries were due to fall from height, cattle horn injuries, straddle type of trauma, vulvar haematoma and anorectal injuries. Appropriate surgical intervention can avert morbidity and mortality.

Non-invasive lightweight integration engine for building EHR from autonomous distributed systems.

PubMed

Angulo, Carlos; Crespo, Pere; Maldonado, José A; Moner, David; Pérez, Daniel; Abad, Irene; Mandingorra, Jesús; Robles, Montserrat

2007-12-01

In this paper we describe Pangea-LE, a message-oriented lightweight data integration engine that allows homogeneous and concurrent access to clinical information from disperse and heterogeneous data sources. The engine extracts the information and passes it to the requesting client applications in a flexible XML format. The XML response message can be formatted on demand by appropriate Extensible Stylesheet Language (XSL) transformations in order to meet the needs of client applications. We also present a real deployment in a hospital where Pangea-LE collects and generates an XML view of all the available patient clinical information. The information is presented to healthcare professionals in an Electronic Health Record (EHR) viewer Web application with patient search and EHR browsing capabilities. Implantation in a real setting has been a success due to the non-invasive nature of Pangea-LE which respects the existing information systems.

Specimen Identification Errors in Breast Biopsies: Age Matters. Report of Two Near-Miss Events and Review of the Literature.

PubMed

Tozbikian, Gary; Gemignani, Mary L; Brogi, Edi

2017-09-01

The consequences of patient identification errors due to specimen mislabeling can be deleterious. We describe two near-miss events involving mislabeled breast specimens from two patients who sought treatment at our institution. In both cases, microscopic review of the slides identified inconsistencies between the histologic findings and patient age, unveiling specimen identification errors. By correlating the clinical information with the microscopic findings, we identified mistakes that had occurred at the time of specimen accessioning at the original laboratories. In both cases, thanks to a timely reassignment of the specimens, the patients suffered no harm. These cases highlight the importance of routine clinical and pathologic correlation as a critical component of quality assurance and patient safety. A review of possible specimen identification errors in the anatomic pathology setting is presented. © 2017 Wiley Periodicals, Inc.

A Literature Review of Research Quality and Effective Practices in Alternative Education Settings

ERIC Educational Resources Information Center

Flower, Andrea; McDaniel, Sara C.; Jolivette, Kristine

2011-01-01

Effective behavioral practices for students with emotional/behavioral disorders (E/BD) are critical. Students with E/BD are often served in alternative education (AE) settings due to behavior that cannot be supported in a typical school setting or due to court adjudication based on delinquent activity. Like other settings for students with E/BD,…

Influence on general practitioners of teaching undergraduates: qualitative study of London general practitioner teachers

PubMed Central

Hartley, Sarah; Macfarlane, Fraser; Gantley, Madeleine; Murray, Elizabeth

1999-01-01

Objective To examine the perceived effect of teaching clinical skills and associated teacher training programmes on general practitioners' morale and clinical practice. Design Qualitative semistructured interview study. Setting General practices throughout north London. Subjects 30 general practitioners who taught clinical skills were asked about the effect of teaching and teacher training on their morale, confidence in clinical and teaching skills, and clinical practice. Results The main theme was a positive effect on morale. Within teacher training this was attributed to developing peer and professional support; improved teaching skills; and revision of clinical knowledge and skills. Within teaching this was attributed to a broadening of horizons; contact with enthusiastic students; increased time with patients; improved clinical practice; improved teaching skills; and an improved image of the practice. Problems with teaching were due to external factors such as lack of time and space and anxieties about adequacy of clinical cover while teaching. Conclusions Teaching clinical skills can have a positive effect on the morale of general practitioner teachers as a result of contact with students and peers, as long as logistic and funding issues are adequately dealt with. Key messagesThe increase in community based teaching of clinical skills requires an increase in the number of general practitioner teachersLittle evidence is available about the effect of teaching of clinical skills and teacher training on general practitioner teachers and practicesGeneral practitioner teachers reported an increase in morale, improvements in clinical skills, and changes in clinical practice and in practice infrastructure as a result of teaching and trainingGeneral practitioner teachers reported problems because of pressure on time, lack of space, problems recruiting patients, and unsupportive practice partnersPositive effects on morale and clinical practice may be important for sustainable teaching and continuing medical education PMID:10541508

Development of Clinically Relevant Implantable Pressure Sensors: Perspectives and Challenges

PubMed Central

Clausen, Ingelin; Glott, Thomas

2014-01-01

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported. PMID:25248071

[Reorganization of the interdisciplinary emergency unit at the university clinic of Göttingen].

PubMed

Blaschke, Sabine; Müller, Gerhard A; Bergmann, Günther

2008-04-01

Configuration of the interdisciplinary emergency unit within the university clinic of Göttingen was successfully reorganized during the past two years. All emergencies except traumatologic, gynecologic and pediatric emergencies are treated within this functional unit which is guided by the center of internal medicine. It is organized in a three shift operation manner over a period of 24 hours. Due to a close interdisciplinary collaboration between different departments patients receive optimal diagnostic and therapeutic treatment within a short period of time. To improve processes within the emergency department a series of measures were taken including the -establishment of an intermediate care unit for unstable patients, setting up of special diagnostic and therapeutic units for the acute coronary syndrome as well as stroke, implementation of standardized clinical pathways, establishment of an electronic data processing network in close communication with all diagnostic entities, introduction of a quality assurance system and reduction of medical costs. Reorganization measures lead to a substantial optimization and acceleration of emergency proceedings and thus, provides optimal patient care around the clock. In addition, medical costs could clearly be reduced at the interface between preclinical and clinical emergency medicine.

Necrotizing fasciitis: case series and review of the literature on clinical and medico-legal diagnostic challenges.

PubMed

Fais, Paolo; Viero, Alessia; Viel, Guido; Giordano, Renzo; Raniero, Dario; Kusstatscher, Stefano; Giraudo, Chiara; Cecchetto, Giovanni; Montisci, Massimo

2018-04-07

Necrotizing fasciitis (NF) is a life-threatening infection of soft tissues spreading along the fasciae to the surrounding musculature, subcutaneous fat and overlying skin areas that can rapidly lead to septic shock and death. Due to the pandemic increase of medical malpractice lawsuits, above all in Western countries, the forensic pathologist is frequently asked to investigate post-mortem cases of NF in order to determine the cause of death and to identify any related negligence and/or medical error. Herein, we review the medical literature dealing with cases of NF in a post-mortem setting, present a case series of seven NF fatalities and discuss the main ante-mortem and post-mortem diagnostic challenges of both clinical and forensic interests. In particular, we address the following issues: (1) origin of soft tissue infections, (2) micro-organisms involved, (3) time of progression of the infection to NF, (4) clinical and histological staging of NF and (5) pros and cons of clinical and laboratory scores, specific forensic issues related to the reconstruction of the ideal medical conduct and the evaluation of the causal value/link of any eventual medical error.

Development of clinically relevant implantable pressure sensors: perspectives and challenges.

PubMed

Clausen, Ingelin; Glott, Thomas

2014-09-22

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians.  Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.

Cell based advanced therapeutic medicinal products for bone repair: Keep it simple?

PubMed

Leijten, J; Chai, Y C; Papantoniou, I; Geris, L; Schrooten, J; Luyten, F P

2015-04-01

The development of cell based advanced therapeutic medicinal products (ATMPs) for bone repair has been expected to revolutionize the health care system for the clinical treatment of bone defects. Despite this great promise, the clinical outcomes of the few cell based ATMPs that have been translated into clinical treatments have been far from impressive. In part, the clinical outcomes have been hampered because of the simplicity of the first wave of products. In response the field has set-out and amassed a plethora of complexities to alleviate the simplicity induced limitations. Many of these potential second wave products have remained "stuck" in the development pipeline. This is due to a number of reasons including the lack of a regulatory framework that has been evolving in the last years and the shortage of enabling technologies for industrial manufacturing to deal with these novel complexities. In this review, we reflect on the current ATMPs and give special attention to novel approaches that are able to provide complexity to ATMPs in a straightforward manner. Moreover, we discuss the potential tools able to produce or predict 'goldilocks' ATMPs, which are neither too simple nor too complex. Copyright © 2014 Elsevier B.V. All rights reserved.

Implementation of quality management for clinical bacteriology in low-resource settings.

PubMed

Barbé, B; Yansouni, C P; Affolabi, D; Jacobs, J

2017-07-01

The declining trend of malaria and the recent prioritization of containment of antimicrobial resistance have created a momentum to implement clinical bacteriology in low-resource settings. Successful implementation relies on guidance by a quality management system (QMS). Over the past decade international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and malaria. To describe the progress towards accreditation of medical laboratories and to identify the challenges and best practices for implementation of QMS in clinical bacteriology in low-resource settings. Published literature, online reports and websites related to the implementation of laboratory QMS, accreditation of medical laboratories and initiatives for containment of antimicrobial resistance. Apart from the limitations of infrastructure, equipment, consumables and staff, QMS are challenged with the complexity of clinical bacteriology and the healthcare context in low-resource settings (small-scale laboratories, attitudes and perception of staff, absence of laboratory information systems). Likewise, most international initiatives addressing laboratory health strengthening have focused on public health and outbreak management rather than on hospital based patient care. Best practices to implement quality-assured clinical bacteriology in low-resource settings include alignment with national regulations and public health reference laboratories, participating in external quality assurance programmes, support from the hospital's management, starting with attainable projects, conducting error review and daily bench-side supervision, looking for locally adapted solutions, stimulating ownership and extending existing training programmes to clinical bacteriology. The implementation of QMS in clinical bacteriology in hospital settings will ultimately boost a culture of quality to all sectors of healthcare in low-resource settings. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Third year nursing students' viewpoints about circumstances which threaten safety in the clinical setting.

PubMed

Montgomery, Phyllis; Killam, Laura; Mossey, Sharolyn; Heerschap, Corey

2014-02-01

Evidence emphasizes that learners, educators, clinicians, programs, and organizations share the responsibility for establishing and maintaining safety throughout undergraduate nursing education. Increased knowledge about students' perceptions of threats to safety in the clinical setting may guide educators' efforts to promote the development of safe novice practitioners while preserving patient safety. The purpose of this study was to describe third year nursing students' viewpoints of the circumstances which threaten safety in the clinical setting. Using Q methodology, 34 third year Bachelor of Science in Nursing students sorted 43 theoretical statement cards. Each card identified a statement describing a threat to safety in the clinical setting. These statements were generated through a review of nursing literature and consultation with experts in nursing education. Centroid factor analysis and varimax rotation identified viewpoints regarding circumstances that most threaten safety. Three discrete viewpoints and one consensus perspective constituted students' description of threatened safety. The discrete viewpoints were labeled lack of readiness, misdirected practices, and negation of professional boundaries. There was consensus that it is most unsafe in the clinical setting when novices fail to consolidate an integrated cognitive, behavioral, and ethical identity. This unifying perspective was labeled non-integration. Third year nursing students and their educators are encouraged to be mindful of the need to ensure readiness prior to entry into the clinical setting. In the clinical setting, the learning of prepared students must be guided by competent educators. Finally, both students and their educators must respect professional boundaries to promote safety for students and patients. © 2013.

Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT.

PubMed

Chidini, Giovanna; Piastra, Marco; Marchesi, Tiziana; De Luca, Daniele; Napolitano, Luisa; Salvo, Ida; Wolfler, Andrea; Pelosi, Paolo; Damasco, Mirco; Conti, Giorgio; Calderini, Edoardo

2015-04-01

Noninvasive continuous positive airway pressure (CPAP) is usually applied with a nasal or facial mask to treat mild acute respiratory failure (ARF) in infants. A pediatric helmet has now been introduced in clinical practice to deliver CPAP. This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF. In this multicenter randomized controlled trial, 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet (n = 17) or facial mask (n = 13). The primary endpoint was treatment failure rate (defined as due to intolerance or need for intubation). Secondary outcomes were CPAP application time, number of patients requiring sedation, and complications with each interface. Compared with the facial mask, CPAP by helmet had a lower treatment failure rate due to intolerance (3/17 [17%] vs 7/13 [54%], P = .009), and fewer infants required sedation (6/17 [35%] vs 13/13 [100%], P = .023); the intubation rates were similar. In successfully treated patients, CPAP resulted in better gas exchange and breathing pattern with both interfaces. No major complications due to the interfaces occurred, but CPAP by mask had higher rates of cutaneous sores and leaks. These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation. In addition, it is safe to use and free from adverse events, even in a prolonged clinical setting. Copyright © 2015 by the American Academy of Pediatrics.

The Importance of Clinical Phenotype in Understanding and Preventing Spontaneous Preterm Birth.

PubMed

Esplin, M Sean

2016-02-01

Spontaneous preterm birth (SPTB) is a well-known cause of maternal and neonatal morbidity. The search for the underlying pathways, documentation of the genetic causes, and identification of markers of spontaneous PTB have been marginally successful due to the fact that it is highly complex, with numerous processes that lead to a final common pathway. There is a great need for a comprehensive, consistent, and uniform classification system, which will be useful in identifying mechanisms, assigning prognosis, aiding in clinical management, and can identify areas of interest for intervention and future study. Effective classification systems must overcome obstacles including the lack of widely accepted definitions and uncertainty about inclusion of classifying features (e.g., presentation at delivery and multiple gestations) and levels of detail of these features. The optimal classification system should be based on the clinical phenotype, including characteristics of the mother, fetus, placenta, and the presentation for delivery. We present a proposed phenotyping system for spontaneous PTB. Future classification systems must establish a universally accepted set of definitions and a standardized clinical workup for all PTBs including the minimum clinical data to be collected and the laboratory and pathologic evaluation that should be completed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Clinical impact of reducing routine blood culture incubation time from 7 to 5 days.

PubMed

Marginson, Michael J; Daveson, Kathryn L; Kennedy, Karina J

2014-12-01

The aim of this study was to determine the clinical impact of reducing the blood culture incubation protocol from 7 to 5 days.A laboratory data extraction identified positive blood cultures occurring after 5 or more days of incubation at Canberra Hospital, Australia between 1 January 2001 and 31 August 2011. Isolates were identified as clinically significant using a pre-existing prospective bacteraemia database. Medical records review determined whether the positive result affected clinical management.Positive blood cultures after 5 or more days of incubation accounted for 2.65% (423/15979) of all positive blood cultures, although the majority were false positives or contaminants. Eighty-five were significant/indeterminate, representing an average of eight cases per year or 0.47% (85/15979) of all positive blood cultures sets. Forty-three were isolated for the first time, representing 1.1% of all significant/indeterminate blood culture episodes. Fungi and anaerobic bacteria compromised over 50% of isolates. In 26 cases (2.4 cases per year), the culture result led to a change in patient management.A 7 day incubation protocol is preferable due to late isolation of organisms; however, if space is required to accommodate increasing blood culture numbers, reducing to a 5 or 6 day protocol would miss only a small percentage of clinically significant isolates.

Development of criteria for evaluating clinical response in thyroid eye disease (CRI-TED) using a modified Delphi technique

PubMed Central

Douglas, Raymond S.; Tsirbas, Angelo; Gordon, Mark; Lee, Diana; Khadavi, Nicole; Garneau, Helene Chokron; Goldberg, Robert A.; Cahill, Kenneth; Dolman, Peter J.; Elner, Victor; Feldon, Steve; Lucarelli, Mark; Uddin, Jimmy; Kazim, Michael; Smith, Terry J.; Khanna, Dinesh

2014-01-01

To identify components of a provisional clinical response index for thyroid eye disease (CRI-TED) using a modified Delphi technique. The International Thyroid Eye Disease Society (ITEDS) conducted a structured, 3-round Delphi exercise establishing consensus for a core set of measures for clinical trials in TED. The steering committee discussed the results in a face-to-face meeting (nominal group technique) and evaluated each criterion with respect to its feasibility, reliability, redundancy, and validity. Redundant measures were consolidated or excluded. Criteria were parsed into 11 domains for the Delphi surveys. Eighty four respondents participated in the Delphi-1 survey, providing 220 unique items. Ninety- two members (100% of the respondents from Delphi 1 plus eight new participants) responded in Delphi-2 and rated the same 220 items. Sixty-four members (76% of participants) rated 153 criteria in Delphi-3 (67 criteria were excluded due to redundancy). Criteria with a mean greater than 6 (1 least appropriate to 9 most appropriate) were further evaluated by the nominal group technique and provisional core measures were chosen. Using a Delphi exercise, we developed provisional core measures for assessing disease activity and severity in clinical trials of therapies for TED. These measures will be iteratively refined for use in multicenter clinical trials. PMID:19752424

Perceived Frequency of Peer-Assisted Learning in the Laboratory and Collegiate Clinical Settings

PubMed Central

Henning, Jolene M.; Weidner, Thomas G.; Snyder, Melissa; Dudley, William N.

2012-01-01

Context: Peer-assisted learning (PAL) has been recommended as an educational strategy to improve students' skill acquisition and supplement the role of the clinical instructor (CI). How frequently students actually engage in PAL in different settings is unknown. Objective: To determine the perceived frequency of planned and unplanned PAL (peer modeling, peer feedback and assessment, peer mentoring) in different settings. Design: Cross-sectional study. Setting: Laboratory and collegiate clinical settings. Patients or Other Participants: A total of 933 students, 84 administrators, and 208 CIs representing 52 (15%) accredited athletic training education programs. Intervention(s): Three versions (student, CI, administrator) of the Athletic Training Peer Assisted Learning Survey (AT-PALS) were administered. Cronbach α values ranged from .80 to .90. Main Outcome Measure(s): Administrators' and CIs' perceived frequency of 3 PAL categories under 2 conditions (planned, unplanned) and in 2 settings (instructional laboratory, collegiate clinical). Self-reported frequency of students' engagement in 3 categories of PAL in 2 settings. Results: Administrators and CIs perceived that unplanned PAL (0.39 ± 0.22) occurred more frequently than planned PAL (0.29 ± 0.19) regardless of category or setting (F1,282 = 83.48, P < .001). They perceived that PAL occurred more frequently in the collegiate clinical (0.46 ± 0.22) than laboratory (0.21 ± 0.24) setting regardless of condition or category (F1,282 = 217.17, P < .001). Students reported engaging in PAL more frequently in the collegiate clinical (3.31 ± 0.56) than laboratory (3.26 ± 0.62) setting regardless of category (F1,860 = 13.40, P < .001). We found a main effect for category (F2,859 = 1318.02, P < .001), with students reporting they engaged in peer modeling (4.01 ± 0.60) more frequently than peer mentoring (2.99 ± 0.88) (P < .001) and peer assessment and feedback (2.86 ± 0.64) (P < .001). Conclusions: Participants perceived that students engage in unplanned PAL in the collegiate clinical setting with a stronger inclination toward engagement in peer modeling. Educators should develop planned PAL activities to capitalize on the inherent desire of the students to collaborate with their peers. PMID:22488288

Knowledge boosting: a graph-based integration approach with multi-omics data and genomic knowledge for cancer clinical outcome prediction

PubMed Central

Kim, Dokyoon; Joung, Je-Gun; Sohn, Kyung-Ah; Shin, Hyunjung; Park, Yu Rang; Ritchie, Marylyn D; Kim, Ju Han

2015-01-01

Objective Cancer can involve gene dysregulation via multiple mechanisms, so no single level of genomic data fully elucidates tumor behavior due to the presence of numerous genomic variations within or between levels in a biological system. We have previously proposed a graph-based integration approach that combines multi-omics data including copy number alteration, methylation, miRNA, and gene expression data for predicting clinical outcome in cancer. However, genomic features likely interact with other genomic features in complex signaling or regulatory networks, since cancer is caused by alterations in pathways or complete processes. Methods Here we propose a new graph-based framework for integrating multi-omics data and genomic knowledge to improve power in predicting clinical outcomes and elucidate interplay between different levels. To highlight the validity of our proposed framework, we used an ovarian cancer dataset from The Cancer Genome Atlas for predicting stage, grade, and survival outcomes. Results Integrating multi-omics data with genomic knowledge to construct pre-defined features resulted in higher performance in clinical outcome prediction and higher stability. For the grade outcome, the model with gene expression data produced an area under the receiver operating characteristic curve (AUC) of 0.7866. However, models of the integration with pathway, Gene Ontology, chromosomal gene set, and motif gene set consistently outperformed the model with genomic data only, attaining AUCs of 0.7873, 0.8433, 0.8254, and 0.8179, respectively. Conclusions Integrating multi-omics data and genomic knowledge to improve understanding of molecular pathogenesis and underlying biology in cancer should improve diagnostic and prognostic indicators and the effectiveness of therapies. PMID:25002459

Knowledge boosting: a graph-based integration approach with multi-omics data and genomic knowledge for cancer clinical outcome prediction.

PubMed

Kim, Dokyoon; Joung, Je-Gun; Sohn, Kyung-Ah; Shin, Hyunjung; Park, Yu Rang; Ritchie, Marylyn D; Kim, Ju Han

2015-01-01

Cancer can involve gene dysregulation via multiple mechanisms, so no single level of genomic data fully elucidates tumor behavior due to the presence of numerous genomic variations within or between levels in a biological system. We have previously proposed a graph-based integration approach that combines multi-omics data including copy number alteration, methylation, miRNA, and gene expression data for predicting clinical outcome in cancer. However, genomic features likely interact with other genomic features in complex signaling or regulatory networks, since cancer is caused by alterations in pathways or complete processes. Here we propose a new graph-based framework for integrating multi-omics data and genomic knowledge to improve power in predicting clinical outcomes and elucidate interplay between different levels. To highlight the validity of our proposed framework, we used an ovarian cancer dataset from The Cancer Genome Atlas for predicting stage, grade, and survival outcomes. Integrating multi-omics data with genomic knowledge to construct pre-defined features resulted in higher performance in clinical outcome prediction and higher stability. For the grade outcome, the model with gene expression data produced an area under the receiver operating characteristic curve (AUC) of 0.7866. However, models of the integration with pathway, Gene Ontology, chromosomal gene set, and motif gene set consistently outperformed the model with genomic data only, attaining AUCs of 0.7873, 0.8433, 0.8254, and 0.8179, respectively. Integrating multi-omics data and genomic knowledge to improve understanding of molecular pathogenesis and underlying biology in cancer should improve diagnostic and prognostic indicators and the effectiveness of therapies. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Cardiac troponins--Translational biomarkers in cardiology: Theory and practice of cardiac troponin high-sensitivity assays.

PubMed

Adamcova, Michaela; Popelova-Lencova, Olga; Jirkovsky, Eduard; Simko, Fedor; Gersl, Vladimir; Sterba, Martin

2016-01-01

Tn is a unique translational biomarker in cardiology whose potential has not been diminished in the new era of high sensitive assays. cTns can be valuable markers in cardiac diseases as well as in infectious diseases and respiratory diseases. Furthermore, the role of cTns is growing in the routine evaluation of cardioxicity and in determining the efficacy/safety ratio of novel cardioprotective strategies in clinical settings. cTns can detect myocardial injury not only in a wide spectrum of laboratory animals in experimental studies in vivo, but also in isolated heart models or cardiomyocytes in vitro. The crucial issue regarding the cross-species usage of cardiac troponin investigation remains the choice of cardiac troponin testing. This review summarizes the recent proteomic data on aminoacid sequences of cTnT and cTnI in various species, as well as selected analytical characteristics of human cardiac troponin high-sensitivity assays. Due to the highly phylogenetically conserved structure of troponins, the same bioindicator can be investigated using the same method in both clinical and experimental cardiology, thus contributing to a better understanding of the pathogenesis of cardiac diseases as well as to increased effectiveness of troponin use in clinical practice. Measuring cardiac troponins using commercially available human high-sensitivity cardiac troponin tests with convenient antibodies selected on the basis of adequate proteomic knowledge can solve many issues which would otherwise be difficult to address in clinical settings for various ethical and practical reasons. Our survey could help elaborate the practical guidelines for optimizing the choice of cTns assay in cardiology. © 2016 International Union of Biochemistry and Molecular Biology.

A meta-model for computer executable dynamic clinical safety checklists.

PubMed

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

Use of multiplex PCR based molecular diagnostics in diagnosis of suspected CNS infections in tertiary care setting-A retrospective study.

PubMed

Javali, Mahendra; Acharya, Purushottam; Mehta, Aneesh; John, Aju Abraham; Mahale, Rohan; Srinivasa, R

2017-10-01

CNS infections like meningitis and encephalitis pose enormous healthcare challenges due to mortality, sequelae and socioeconomic burden. In tertiary setting, clinical, microbiological, cytological and radiological investigations are not distinctive enough for diagnosing microbial etiology. Molecular diagnostics is filling this gap. We evaluated the clinical impact of a commercially available multiplex molecular diagnostic system - SES for diagnosing suspected CNS infections. This study was conducted in our tertiary level Neurology ICU. 110 patients admitted during Nov-2010 to April-2014 were included. CSF samples of patients clinically suspected of having CNS infections were subjected to routine investigation in our laboratory and SES test at XCyton Diagnostics. We studied the impact of SES in diagnosis of CNS infections and its efficacy in helping therapeutic management. SES showed detection rate of 42.18% and clinical specificity of 100%. It had 10 times higher detection rate than conventional tests. Streptococcus pneumoniae and Mycobacterium tuberculosis were two top bacterial pathogens. VZV was most detected viral pathogen. SES results elicited changes in therapy in both positive and negative cases. We observed superior patient outcomes as measured by GCS scale. 75% and 82.14% of the patients positive and negative on SES respectively, recovered fully. Detecting causative organism and ruling out infectious etiology remain the most critical aspect for management and prognosis of patients with suspected CNS infections. In this study, we observed higher detection rate of pathogens, target specific escalation and evidence based de-escalation of antimicrobials using SES. Institution of appropriate therapy helped reduce unnecessary use of antimicrobials. Copyright © 2017 Elsevier B.V. All rights reserved.

The professional socialization of collegiate female athletic trainers: navigating experiences of gender bias.

PubMed

Mazerolle, Stephanie M; Borland, John F; Burton, Laura J

2012-01-01

Female athletic trainers (ATs) experience gender discrimination in the workplace due to stereotypical gender roles, but limited information is available regarding the topic. To understand the challenges and obstacles faced by young female ATs working in National Collegiate Athletic Association Division I athletics. Exploratory study using semistructured interviews. Division I clinical setting. A total of 14 female ATs were included in the study, using both criterion and snowball-sampling techniques. Their mean age was 27 ± 2 years, with 5 ± 2 years of overall clinical experience. Criteria included employment at the Division I clinical setting, being a full-time assistant AT, and at least 3 years of working experience but no more than 9 years to avoid role continuance. Analysis of the interview data followed inductive procedures as outlined by a grounded theory approach. Credibility was established by member checks, multiple-analyst triangulation, and peer review. Clear communication with both coaches and players about expectations and philosophies regarding medical care, a supportive head AT in terms of clinical competence, and having and serving as a role model were cited as critical tools to alleviate gender bias in the workplace. The female ATs in this study stressed the importance of being assertive with coaches early in the season with regard to the AT's role on the team. They reasoned that these actions brought forth a greater perception of congruity between their roles as ATs and their gender and age. We suggest that female athletic training students seek mentors in their field while they complete their coursework and practicums. The ATs in the current study indicated that a mentor, regardless of sex, helped them feel empowered to navigate the male-centric terrain of athletic departments by encouraging them to be assertive and not second-guess their decisions.

Exploring threats to generalisability in a large international rehabilitation trial (AVERT).

PubMed

Bernhardt, Julie; Raffelt, Audrey; Churilov, Leonid; Lindley, Richard I; Speare, Sally; Ancliffe, Jacqueline; Katijjahbe, Md Ali; Hameed, Shahul; Lennon, Sheila; McRae, Anna; Tan, Dawn; Quiney, Jan; Williamson, Hannah C; Collier, Janice; Dewey, Helen M; Donnan, Geoffrey A; Langhorne, Peter; Thrift, Amanda G

2015-08-17

The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT). AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. Acute stroke units at 44 hospitals in 8 countries. The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised. We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment. The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65). A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials. Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247). 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.

Treatment patterns and clinical outcomes with pazopanib in patients with advanced soft tissue sarcomas in a compassionate use setting: results of the SPIRE study.

PubMed

Gelderblom, Hans; Judson, Ian R; Benson, Charlotte; Merimsky, Ofer; Grignani, Giovanni; Katz, Daniela; Freivogel, Klaus W; Stein, Dara; Jobanputra, Minesh; Mungul, Arron; Manson, Stephanie C; Sanfilippo, Roberta

2017-12-01

A named patient program (NPP) was designed to provide patients with advanced soft-tissue sarcoma (aSTS) access to pazopanib, a multitargeted tyrosine kinase inhibitor. The SPIRE study was a retrospective chart review of participating patients. Eligibility criteria for the NPP and SPIRE mirrored those of the pivotal phase-III study, PALETTE, which compared pazopanib with placebo in patients ≥18 years with aSTS and whose disease had progressed during or following prior chemotherapy or were otherwise unsuitable for chemotherapy. Outcomes of interest included treatment patterns, treatment duration, relative dose intensity, progression-free survival (PFS), overall survival (OS), clinical benefit rate, adverse events (AEs) and reasons for treatment discontinuation. A total of 211 patients were enrolled (median age 56 years; 60% female). Most patients received pazopanib in second- and third-line therapy (28.0% and 28.4%, respectively), followed by fourth line (19.0%) and ≥ fifth line (18.5%). The median duration of pazopanib treatment was 3.1 months (95% CI: 2.8-3.8), with a mean daily dose of 715 mg equating to 92% of recommended dose. Median OS was 11.1 months and clinical benefit rate was 46%. There was evidence of some clinical benefit across most histological subtypes. At study end, 40% of patients were alive and of these, 18% remained on pazopanib. Thirteen percent (13%) of patients discontinued pazopanib due to AEs. The SPIRE study demonstrated activity of pazopanib in heavily pretreated aSTS patients in a compassionate use setting. No new safety concerns were noted. Reassuringly, the relative dose intensity of pazopanib was 92%.

A 3D-printed anatomical pancreas and kidney phantom for optimizing SPECT/CT reconstruction settings in beta cell imaging using 111In-exendin.

PubMed

Woliner-van der Weg, Wietske; Deden, Laura N; Meeuwis, Antoi P W; Koenrades, Maaike; Peeters, Laura H C; Kuipers, Henny; Laanstra, Geert Jan; Gotthardt, Martin; Slump, Cornelis H; Visser, Eric P

2016-12-01

Quantitative single photon emission computed tomography (SPECT) is challenging, especially for pancreatic beta cell imaging with 111 In-exendin due to high uptake in the kidneys versus much lower uptake in the nearby pancreas. Therefore, we designed a three-dimensionally (3D) printed phantom representing the pancreas and kidneys to mimic the human situation in beta cell imaging. The phantom was used to assess the effect of different reconstruction settings on the quantification of the pancreas uptake for two different, commercially available software packages. 3D-printed, hollow pancreas and kidney compartments were inserted into the National Electrical Manufacturers Association (NEMA) NU2 image quality phantom casing. These organs and the background compartment were filled with activities simulating relatively high and low pancreatic 111 In-exendin uptake for, respectively, healthy humans and type 1 diabetes patients. Images were reconstructed using Siemens Flash 3D and Hermes Hybrid Recon, with varying numbers of iterations and subsets and corrections. Images were visually assessed on homogeneity and artefacts, and quantitatively by the pancreas-to-kidney activity concentration ratio. Phantom images were similar to clinical images and showed comparable artefacts. All corrections were required to clearly visualize the pancreas. Increased numbers of subsets and iterations improved the quantitative performance but decreased homogeneity both in the pancreas and the background. Based on the phantom analyses, the Hybrid Recon reconstruction with 6 iterations and 16 subsets was found to be most suitable for clinical use. This work strongly contributed to quantification of pancreatic 111 In-exendin uptake. It showed how clinical images of 111 In-exendin can be interpreted and enabled selection of the most appropriate protocol for clinical use.

A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

PubMed

Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

2018-06-01

Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

Superior Diagnostic Performance of Malaria Rapid Diagnostic Tests as compared to Blood Smears in U.S. Clinical Practice

PubMed Central

Stauffer, William M.; Cartwright, Charles P.; Olson, Douglas; Juni, Billie Anne; Taylor, Charlotte M; Bowers, Susan H.; Hanson, Kevan L.; Rosenblatt, Jon E.; Boulware, David R.

2010-01-01

Background Approximately 4 million U.S. travelers to developing countries are ill enough to seek healthcare with 1,500 malaria cases reported in the U.S. annually. The diagnosis of malaria is frequently delayed due to the time to prepare malaria blood films and lack of technical expertise. An easy, reliable rapid diagnostic test (RDT) with high sensitivity and negative predictive value (NPV), particularly for Plasmodium falciparum, would be clinically useful. The study objective was to determine the diagnostic performance of the FDA-approved NOW® Malaria Test in comparison to traditional thick and thin blood smears for malaria diagnosis. Methods This prospective study tested 852 consecutive blood samples sent for thick and thin smears with blinded, malaria rapid tests at three hospital laboratories during 2003–2006. Polymerase chain reaction (PCR) verified positive tests and discordant results. Results Malaria occurred in 11% (95/852). The rapid test had superior performance than the standard Giemsa thick blood smear (P=.003). The rapid test’s sensitivity for all malaria was 97% (92/95) vs. 85% (81/95) by blood smear, and the RDT had superior NPV of 99.6% vs. 98.2% (P=.001). The P. falciparum performance was excellent with 100% rapid test sensitivity versus only 88% (65/74) by blood smear (P=.003). Conclusions This operational study demonstrates the FDA-approved rapid malaria test is superior to a single set of blood smears performed under routine U.S. clinical laboratory conditions. The most valuable clinical role of the RDT is in the rapid diagnosis or the exclusion of P. falciparum malaria, which is particularly useful in outpatient settings when evaluating febrile travelers. PMID:19686072

Data capture by digital pen in clinical trials: a qualitative and quantitative study.

PubMed

Estellat, Candice; Tubach, Florence; Costa, Yolande; Hoffmann, Isabelle; Mantz, Jean; Ravaud, Philippe

2008-05-01

To investigate the use of the digital pen (DP) system to collect data in a clinical trial. To assess the accuracy of the system in this setting. Qualitative study based on semistructured interviews and a focus group. Quantitative study comparing the DP system and a double manual data-entry system in accuracy of acquiring data by variable type (tick boxes, dates, numbers, letters). An ongoing randomised multicentric clinical trial in tertiary care in France. 27 investigators involved in the trial (anaesthetists) who did or did not include patients, 4 study monitors and the study coordinator. Six key findings emerged: 1) the DP system was easy to use; its utilisation was intuitive, even for investigators inexperienced in informatics; 2) despite its portability, the DP was not always used in front of patients; 3) the DP system did not affect patient recruitment; 4) most of the technical problems of the system occurred during setup (compatibility, password access, antivirus software); 5) the main advantage was quickness of data availability for the study coordination staff and the main hindrance was the extra time required for online verification; and 6) all investigators were ready to use the system again. The investigators had to check 16% of data obtained by the DP system during the verification step. There is no relevant difference between the number of errors for the DP and the double manual data-entry systems: 8/5022 versus 6/5022 data entries. 5 out of 8 DP-system failures were due to the intelligent character recognition system. The DP system has a good acceptability among all investigators in a clinical setting, whether they are experienced with computers or not, and a good accuracy, as compared with double manual data entry.

Influence of multiple clinical use on fatigue resistance of ProTaper rotary nickel-titanium instruments.

PubMed

Vieira, E P; França, E C; Martins, R C; Buono, V T L; Bahia, M G A

2008-02-01

To examine the influence of clinical use on the occurrence of deformation and fracture and on the fatigue resistance of ProTaper rotary instruments. Root canal treatments were performed on patients using the ProTaper rotary system. Ten sets of instruments were used by an experienced endodontist, each set in five molars. Another 10 sets of instruments were used by the same operator, each set in eight molars. In addition, 10 sets of instruments were used, each set in five molars, by undergraduate students with no clinical experience with the system. After clinical use, S1, S2, F1 and F2 instruments were analysed for damage by optical and scanning electron microscopy. The used sets, along with a control group of 12 sets of new instruments, were then tested in a bench device for fatigue resistance. The use of the ProTaper rotary instruments by an experienced endodontist allowed for the cleaning and shaping of the root canal system of up to eight molars without fracture. During the students work, six instruments fractured. Fatigue resistance decreased upon clinical use for all instruments analysed. Fatigue resistance of used instruments was reduced, but no significant change was observed amongst the instruments used for shaping the canals of five and eight molars. Operator experience affected the occurrence of fracture and plastic deformation during shaping.

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.

Clinical Profile of Children and Adolescents Attending the Behavioural Paediatrics Unit OPD in a Tertiary Care Set up

ERIC Educational Resources Information Center

Jayaprakash, R.

2012-01-01

Background: There are limited studies on the clinical profile of children attending child guidance clinic under Paediatric background. Aims: To study clinical profile of Children & adolescents attending the Behavioural Paediatrics Unit (BPU) OPD under department of Paediatrics in a tertiary care set up. Methods: Monthly average turnover in the…

The pathophysiology of transfusional iron overload.

PubMed

Porter, John B; Garbowski, Maciej

2014-08-01

The pathophysiologic consequences of transfusional iron overload (TIO) as well as the benefits of iron chelation therapy are best described in thalassemia major, although TIO is increasingly seen in other clinical settings. These consequences broadly reflect the levels and distribution of excess storage iron in the heart, endocrine tissues, and liver. TIO also increases the risk of infection, due to increased availability of labile iron to microorganisms. The authors suggest that extrahepatic iron distribution, and hence toxicity, is influenced by balance between generation of nontransferrin-bound iron from red cell catabolism and the utilization of transferrin iron by the erythron. Copyright © 2014 Elsevier Inc. All rights reserved.

Sporadic Jakob-Creutzfeldt Disease Presenting as Primary Progressive Aphasia

PubMed Central

Johnson, David Y.; Dunkelberger, Diana L.; Henry, Maya; Haman, Aissatou; Greicius, Michael D.; Wong, Katherine; DeArmond, Stephen J.; Miller, Bruce L.; Gorno-Tempini, Maria Luisa; Geschwind, Michael D.

2015-01-01

Objective To report the clinical, neuropsychological, linguistic, imaging, and neuropathological features of a unique case of sporadic Jakob-Creutzfeldt disease in which the patient presented with a logopenic variant of primary progressive aphasia. Design Case report. Setting Large referral center for atypical memory and aging disorders, particularly Jakob-Creutzfeldt disease. Patient Patient presenting with logopenic variant primary progressive aphasia initially thought to be due to Alzheimer disease. Results Despite the long, slow 3.5-year course, the patient was shown to have pathology-proven sporadic Jakob-Creutzfeldt disease. Conclusions These findings expand the differential of primary progressive aphasia to include prion disease. PMID:23400721

Optical measurements of microvascular circulatory function in the foot for detection of peripheral neuropathy

NASA Astrophysics Data System (ADS)

Zamora, G.; Chekh, V.; Burge, M.; Barriga, E. S.; Luan, S.; Heintz, P.; Edwards, A.; McGrew, E.; Soliz, P.

2012-03-01

The purpose of this research is to quantify functional signals in the microvascular circulation of the plantar. Our device is based on thermal and spectral technologies that can be easily adopted in clinical and tele-screening settings. Eightytwo thousand amputations are performed annually on diabetics in the US. The cost of foot disorder diagnosis and management are estimated at $10.9 billion dollars annually. Our experiments on normal controls and diabetics assess the temperature recovery time characteristics due to cold provocation to the bottom of the foot (plantar). A difference in the nature of the recovery time between normal controls and diabetics was observed.

Serious gaming: A tool to educate health care providers about domestic violence.

PubMed

Mason, Robin; Turner, Linda

2018-05-10

Due to many adverse health effects, victims of domestic violence are frequently seen in the health care system. Yet, health care providers may lack the training to assist them. Online curricula can be an effective instructional tool. Our competency-based, serious video game, Responding to Domestic Violence in Clinical Settings, was designed to address health care providers' knowledge gaps through 17 modules, each a half hour in length. Nearly 9,000 participants completed at least one module; nursing students completed the most modules, approximately five hours of instruction. This serious video game-based curriculum is useful in helping health providers and students learn about Domestic Violence.

Acute respiraotry diseases in students at the University of the Philippines, 1964-69.

PubMed

Evans, A S; Espiritu-Campos, L

1971-01-01

Acute respiratory infections have been found to be a common cause of morbidity in young adults in the tropical setting of the Philippines, with incidence rates equalling those of colder northern countries. Influenza outbreaks have occurred as part of a worldwide pattern and parainfluenza infections are common, as revealed by serological tests on such students. About half of the respiratory infections could be identified etiologically. In contrast, clinical infections from group A haemolytic streptococci, Mycoplasma pneumoniae, adenoviruses, and infections due to Epstein-Barr virus (infectious mononucleosis) were rare in this population. The role of prior immunity is discussed in relation to these patterns.

Potentially ineffective care: time for earnest reexamination.

PubMed

Jackson, William L; Sales, Joseph F

2014-01-01

The rising costs and suboptimal quality throughout the American health care system continue to invite critical inquiry, and practice in the intensive care unit setting is no exception. Due to their relatively large impact, outcomes and costs in critical care are of significant interest to policymakers and health care administrators. Measurement of potentially ineffective care has been proposed as an outcome measure to evaluate critical care delivery, and the Patient Protection and Affordable Care Act affords the opportunity to reshape the care of the critically ill. Given the impetus of the PPACA, systematic formal measurement of potentially ineffective care and its clinical, economic, and societal impact merits timely reconsideration.

Inappropriate ICD discharges due to "triple counting" during normal sinus rhythm.

PubMed

Khan, Ejaz; Voudouris, Apostolos; Shorofsky, Stephen R; Peters, Robert W

2006-11-01

To describe the clinical course of a patient with multiple ICD shocks in the setting of advanced renal failure and hyperkalemia. The patient was brought to the Electrophysiology Laboratory where the ICD was interrogated. The patient was found to be hyperkalemic (serum potassium 7.6 mg/dl). Analysis of stored intracardiac electrograms from the ICD revealed "triple counting" (twice during his QRS complex and once during the T wave) and multiple inappropriate shocks. Correction of his electrolyte abnormality normalized his electrogram and no further ICD activations were observed. Electrolyte abnormalities can distort the intracardiac electrogram in patients with ICD's and these changes can lead to multiple inappropriate shocks.

Cattle Uterus: A Novel Animal Laboratory Model for Advanced Hysteroscopic Surgery Training

PubMed Central

Ewies, Ayman A. A.; Khan, Zahid R.

2015-01-01

In recent years, due to reduced training opportunities, the major shift in surgical training is towards the use of simulation and animal laboratories. Despite the merits of Virtual Reality Simulators, they are far from representing the real challenges encountered in theatres. We introduce the “Cattle Uterus Model” in the hope that it will be adopted in training courses as a low cost and easy-to-set-up tool. It adds new dimensions to the advanced hysteroscopic surgery training experience by providing tactile sensation and simulating intraoperative difficulties. It complements conventional surgical training, aiming to maximise clinical exposure and minimise patients' harm. PMID:26265918

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

PubMed

Edelbring, Samuel; Parodis, Ioannis; Lundberg, Ingrid E

2018-02-27

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. The objective of this study was to thoroughly investigate interactions during medical students' clinical reasoning in two-party VP settings. 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. 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. 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. ©Samuel Edelbring, Ioannis Parodis, Ingrid E Lundberg. Originally published in JMIR Medical Education (http://mededu.jmir.org), 27.02.2018.

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

A Survey on Turkish nursing students' perception of clinical learning environment and its association with academic motivation and clinical decision making.

PubMed

Aktaş, Yeşim Yaman; Karabulut, Neziha

2016-01-01

Nursing education is a process that includes theoretical and practical learning and requires the acquisition of theoretical knowledge and skill. Nursing students need a good clinical practice environment in order to apply their knowledge and skills due to the fact that the clinical practice settings play an important role in the nursing profession. This study was carried out in an effort to explore nursing students' perception of the clinical learning environment and its association with academic motivation and clinical decision making. A descriptive survey design was used. This study was conducted in Giresun University in Turkey. Participants were second-, third- and fourth-year undergraduate students (n=222) in the Bachelor of Nursing Science Degree in the academic spring term of 2014-2015. The data was collected using the 'Clinical Learning Environment Scale', the 'Academic Motivation, and the 'The Clinical Decision Making in Nursing Scale'. Of the respondents in this study, 45% of the students were second class, 30.6% of the students were third class and 24.3% of the students were fourth class. There was a statistically significant positive correlation found between the clinical learning environment and the nursing students' academic motivation (r=0.182, p<.05). However, there was no correlation between the clinical learning environment and clinical decision making (r=0.082, p>.05). One of the prerequisites for the training of qualified students is to provide nursing students with a qualified clinical environment. It was found that nursing students' academic motivation increased as the quality of their clinical learning environment improved. Copyright © 2015 Elsevier Ltd. All rights reserved.

Issues in Developing a Surveillance Case Definition for Nonfatal Suicide Attempt and Intentional Self-harm Using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Coded Data.

PubMed

Hedegaard, Holly; Schoenbaum, Michael; Claassen, Cynthia; Crosby, Alex; Holland, Kristin; Proescholdbell, Scott

2018-02-01

Suicide and intentional self-harm are among the leading causes of death in the United States. To study this public health issue, epidemiologists and researchers often analyze data coded using the International Classification of Diseases (ICD). Prior to October 1, 2015, health care organizations and providers used the clinical modification of the Ninth Revision of ICD (ICD-9-CM) to report medical information in electronic claims data. The transition in October 2015 to use of the clinical modification of the Tenth Revision of ICD (ICD-10-CM) resulted in the need to update methods and selection criteria previously developed for ICD-9-CM coded data. This report provides guidance on the use of ICD-10-CM codes to identify cases of nonfatal suicide attempts and intentional self-harm in ICD-10-CM coded data sets. ICD-10-CM codes for nonfatal suicide attempts and intentional self-harm include: X71-X83, intentional self-harm due to drowning and submersion, firearms, explosive or thermal material, sharp or blunt objects, jumping from a high place, jumping or lying in front of a moving object, crashing of motor vehicle, and other specified means; T36-T50 with a 6th character of 2 (except for T36.9, T37.9, T39.9, T41.4, T42.7, T43.9, T45.9, T47.9, and T49.9, which are included if the 5th character is 2), intentional self-harm due to drug poisoning (overdose); T51-T65 with a 6th character of 2 (except for T51.9, T52.9, T53.9, T54.9, T56.9, T57.9, T58.0, T58.1, T58.9, T59.9, T60.9, T61.0, T61.1, T61.9, T62.9, T63.9, T64.0, T64.8, and T65.9, which are included if the 5th character is 2), intentional self-harm due to toxic effects of nonmedicinal substances; T71 with a 6th character of 2, intentional self-harm due to asphyxiation, suffocation, strangulation; and T14.91, Suicide attempt. Issues to consider when selecting records for nonfatal suicide attempts and intentional self-harm from ICD-10-CM coded administrative data sets are also discussed. All material appearing in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.

HapMap scanning of novel human minor histocompatibility antigens.

PubMed

Kamei, Michi; Nannya, Yasuhito; Torikai, Hiroki; Kawase, Takakazu; Taura, Kenjiro; Inamoto, Yoshihiro; Takahashi, Taro; Yazaki, Makoto; Morishima, Satoko; Tsujimura, Kunio; Miyamura, Koichi; Ito, Tetsuya; Togari, Hajime; Riddell, Stanley R; Kodera, Yoshihisa; Morishima, Yasuo; Takahashi, Toshitada; Kuzushima, Kiyotaka; Ogawa, Seishi; Akatsuka, Yoshiki

2009-05-21

Minor histocompatibility antigens (mHags) are molecular targets of allo-immunity associated with hematopoietic stem cell transplantation (HSCT) and involved in graft-versus-host disease, but they also have beneficial antitumor activity. mHags are typically defined by host SNPs that are not shared by the donor and are immunologically recognized by cytotoxic T cells isolated from post-HSCT patients. However, the number of molecularly identified mHags is still too small to allow prospective studies of their clinical importance in transplantation medicine, mostly due to the lack of an efficient method for isolation. Here we show that when combined with conventional immunologic assays, the large data set from the International HapMap Project can be directly used for genetic mapping of novel mHags. Based on the immunologically determined mHag status in HapMap panels, a target mHag locus can be uniquely mapped through whole genome association scanning taking advantage of the unprecedented resolution and power obtained with more than 3 000 000 markers. The feasibility of our approach could be supported by extensive simulations and further confirmed by actually isolating 2 novel mHags as well as 1 previously identified example. The HapMap data set represents an invaluable resource for investigating human variation, with obvious applications in genetic mapping of clinically relevant human traits.