Sample records for additional clinical studies

  1. Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

    PubMed

    Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

    2017-07-14

    In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

  2. Design, methodology, and baseline data of the Personalized Addition Lenses Clinical Trial (PACT)

    PubMed Central

    Yu, Xinping; Zhang, Binjun; Bao, Jinhua; Zhang, Junxiao; Wu, Ge; Xu, Jinling; Zheng, Jingwei; Drobe, Björn; Chen, Hao

    2017-01-01

    Abstract Background: The aim of this study was to describe the design, methods, and baseline characteristics of children enrolled in the Personalized Addition lenses Clinical Trial (PACT). PACT aims to test the myopia control efficacy of progressive addition lenses (PALs) with personalized addition values compared with standard (+2.00 D) addition PALs and single vision lenses (SVLs). Methods: PACT is a randomized, controlled, double-masked clinical trial. Two hundred eleven myopic Chinese children (7–12 years) were enrolled and randomized into 1 of the 3 following groups: personalized addition PALs; +2.00 addition PALs; and SVLs. Personalized addition values were determined based on the highest addition that satisfied Sheard criterion. Axial length and other biometric data were also recorded. Results: At baseline, no differences were found between the right and left eyes for any of the main parameters. The enrolled children were 9.7 ± 1.1 years’ old with cycloplegic autorefraction (right eye [OD]: −2.36 ± 0.64 D), near phoria (1.0 ± 5.0 prism diopter esophoria), lag of accommodation (1.40 ± 0.50 D) and axial length (OD: 24.58 ± 0.74 mm). The personalized addition values ranged from +0.75 to +3.00 (average ± SD: 2.19 ± 0.73 D). Conclusion: PACT is a clinical trial evaluating whether myopia progression in children can be slowed by wearing personalized addition PALs compared with fixed addition PALs and SVLs as measured by cycloplegic autorefraction and axial length. Baseline data were comparable with those of previous myopia control studies in children. Subjects will be followed up every 6 months for 2 years. PMID:28296722

  3. Additive scales in degenerative disease--calculation of effect sizes and clinical judgment.

    PubMed

    Riepe, Matthias W; Wilkinson, David; Förstl, Hans; Brieden, Andreas

    2011-12-16

    The therapeutic efficacy of an intervention is often assessed in clinical trials by scales measuring multiple diverse activities that are added to produce a cumulative global score. Medical communities and health care systems subsequently use these data to calculate pooled effect sizes to compare treatments. This is done because major doubt has been cast over the clinical relevance of statistically significant findings relying on p values with the potential to report chance findings. Hence in an aim to overcome this pooling the results of clinical studies into a meta-analyses with a statistical calculus has been assumed to be a more definitive way of deciding of efficacy. We simulate the therapeutic effects as measured with additive scales in patient cohorts with different disease severity and assess the limitations of an effect size calculation of additive scales which are proven mathematically. We demonstrate that the major problem, which cannot be overcome by current numerical methods, is the complex nature and neurobiological foundation of clinical psychiatric endpoints in particular and additive scales in general. This is particularly relevant for endpoints used in dementia research. 'Cognition' is composed of functions such as memory, attention, orientation and many more. These individual functions decline in varied and non-linear ways. Here we demonstrate that with progressive diseases cumulative values from multidimensional scales are subject to distortion by the limitations of the additive scale. The non-linearity of the decline of function impedes the calculation of effect sizes based on cumulative values from these multidimensional scales. Statistical analysis needs to be guided by boundaries of the biological condition. Alternatively, we suggest a different approach avoiding the error imposed by over-analysis of cumulative global scores from additive scales.

  4. Lessons learned from additional research analyses of unsolved clinical exome cases.

    PubMed

    Eldomery, Mohammad K; Coban-Akdemir, Zeynep; Harel, Tamar; Rosenfeld, Jill A; Gambin, Tomasz; Stray-Pedersen, Asbjørg; Küry, Sébastien; Mercier, Sandra; Lessel, Davor; Denecke, Jonas; Wiszniewski, Wojciech; Penney, Samantha; Liu, Pengfei; Bi, Weimin; Lalani, Seema R; Schaaf, Christian P; Wangler, Michael F; Bacino, Carlos A; Lewis, Richard Alan; Potocki, Lorraine; Graham, Brett H; Belmont, John W; Scaglia, Fernando; Orange, Jordan S; Jhangiani, Shalini N; Chiang, Theodore; Doddapaneni, Harsha; Hu, Jianhong; Muzny, Donna M; Xia, Fan; Beaudet, Arthur L; Boerwinkle, Eric; Eng, Christine M; Plon, Sharon E; Sutton, V Reid; Gibbs, Richard A; Posey, Jennifer E; Yang, Yaping; Lupski, James R

    2017-03-21

    Given the rarity of most single-gene Mendelian disorders, concerted efforts of data exchange between clinical and scientific communities are critical to optimize molecular diagnosis and novel disease gene discovery. We designed and implemented protocols for the study of cases for which a plausible molecular diagnosis was not achieved in a clinical genomics diagnostic laboratory (i.e. unsolved clinical exomes). Such cases were recruited to a research laboratory for further analyses, in order to potentially: (1) accelerate novel disease gene discovery; (2) increase the molecular diagnostic yield of whole exome sequencing (WES); and (3) gain insight into the genetic mechanisms of disease. Pilot project data included 74 families, consisting mostly of parent-offspring trios. Analyses performed on a research basis employed both WES from additional family members and complementary bioinformatics approaches and protocols. Analysis of all possible modes of Mendelian inheritance, focusing on both single nucleotide variants (SNV) and copy number variant (CNV) alleles, yielded a likely contributory variant in 36% (27/74) of cases. If one includes candidate genes with variants identified within a single family, a potential contributory variant was identified in a total of ~51% (38/74) of cases enrolled in this pilot study. The molecular diagnosis was achieved in 30/63 trios (47.6%). Besides this, the analysis workflow yielded evidence for pathogenic variants in disease-associated genes in 4/6 singleton cases (66.6%), 1/1 multiplex family involving three affected siblings, and 3/4 (75%) quartet families. Both the analytical pipeline and the collaborative efforts between the diagnostic and research laboratories provided insights that allowed recent disease gene discoveries (PURA, TANGO2, EMC1, GNB5, ATAD3A, and MIPEP) and increased the number of novel genes, defined in this study as genes identified in more than one family (DHX30 and EBF3). An efficient genomics pipeline in which

  5. Replacing Phosphorus-Containing Food Additives With Foods Without Additives Reduces Phosphatemia in End-Stage Renal Disease Patients: A Randomized Clinical Trial.

    PubMed

    de Fornasari, Margareth Lage Leite; Dos Santos Sens, Yvoty Alves

    2017-03-01

    The purpose of the study was to verify the effects of replacing phosphorus-containing food additives with foods without additives on phosphatemia in end-stage renal disease (ESRD) patients. Randomized clinical trial. Adult patients on hemodialysis for ≥6 months at a single center. A total of 134 patients with phosphorus levels of >5.5 mg/dL were included and were randomized into an intervention group (n = 67) and a control group (n = 67). The IG received individual orientation to replace processed foods that have phosphorus additives with foods of similar nutritional value without these additives. The CG received only the nutritional orientation given before the study. Clinical laboratory data, nutritional status, energy and protein intake, and normalized protein nitrogen appearance (nPNA) were evaluated at the beginning of the study and after 90 days. There was no initial difference between the groups in terms of serum phosphorus levels, nutritional status, and energy intake. After 3 months, there was a decline in phosphorus levels in the IG (from 7.2 ± 1.4 to 5.0 ± 1.3 mg/dL, P < .001), but there was no significant difference in the CG (from 7.1 ± 1.2 to 6.7 ± 1.2 mg/dL, P = .65). In the IG, 69.7% of the patients reached the serum phosphorus target of ≤5.5 mg/dL; however, only 18.5% of the CG subjects reached this level (P < .001). At the end, there was no difference between the two groups in terms of nutritional status, energy intake, protein intake, and nPNA. The replacing phosphorus-containing food additives with foods without additives reduced serum phosphorus without interfering in the nutritional status of ESRD patients. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  6. [Elastography as an additional tool in breast sonography. Technical principles and clinical applications].

    PubMed

    Rjosk-Dendorfer, D; Reichelt, A; Clevert, D-A

    2014-03-01

    In recent years the use of elastography in addition to sonography has become a routine clinical tool for the characterization of breast masses. Whereas free hand compression elastography results in qualitative imaging of tissue stiffness due to induced compression, shear wave elastography displays quantitative information of tissue displacement. Recent studies have investigated the use of elastography in addition to sonography and improvement of specificity in differentiating benign from malignant breast masses could be shown. Therefore, additional use of elastography could help to reduce the number of unnecessary biopsies in benign breast lesions especially in category IV lesions of the ultrasound breast imaging reporting data system (US-BI-RADS).

  7. Utility of additional tissue sections in dermatopathology: diagnostic, clinical and financial implications.

    PubMed

    Stuart, Lauren N; Rodriguez, Adrianna S; Gardner, Jerad M; Foster, Toby E; MacKelfresh, Jamie; Parker, Douglas C; Chen, Suephy C; Stoff, Benjamin K

    2014-02-01

    As histopathologic assessment is subject to sampling error, some institutions 'preorder' deeper sections on some or all cases (hereafter referred to as prospective deeper sections), while others order additional sections only when needed (hereafter referred to as retrospective deeper sections). We investigated how often additional sections changed a diagnosis and/or clinical management. Given the recent decrease in reimbursement for CPT-code 88305, we also considered the financial implications of ordering additional sections. Cases (n = 204) were assigned a preliminary diagnosis, based on review of the initial slide, and a final diagnosis, after reviewing additional sections. Cases with discordant diagnoses were assessed by two dermatologists, who indicated whether the change in diagnosis altered clinical management. Expenses were estimated for three scenarios: (a) no additional sections, (b) prospective deeper sections and (c) retrospective deeper sections. Diagnoses were modified in 9% of cases, which changed clinical management in 56% of these cases. Lesions obtained by punch-biopsy and inflammatory lesions were disproportionately overrepresented amongst cases with changed diagnoses (p < 0.001, p = 0.12, respectively). The cost of prospective deeper sections and retrospective deeper sections represented a 56% and 115% increase over base costs, respectively. Labor costs, particularly the cost of dermatopathologist evaluation, were the most significant cost-drivers. While additional sections improve diagnostic accuracy, they delay turn-around-time and increase expenditures. In our practice, prospective deeper sections are cost effective, however, this may vary by institution. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

    PubMed

    Turner, Leigh

    2017-09-01

    Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

  9. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children.

    PubMed

    Nibhanipudi, Kumara V

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher's exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  10. The evidence for clinically significant bias in plasma glucose between liquid and lyophilized citrate buffer additive.

    PubMed

    Juricic, Gordana; Saracevic, Andrea; Kopcinovic, Lara Milevoj; Bakliza, Ana; Simundic, Ana-Maria

    2016-12-01

    Citrate buffer additive has been suggested to be of supreme performance in inhibiting glycolysis. However, there is little evidence in the literature regarding the comparability of glucose concentrations in liquid and lyophilized citrate buffer containing tubes. The aim of this study was to compare glucose concentrations in tubes containing liquid (Glucomedics) and lyophilized citrate buffer (Terumo VENOSAFE™ Glycemia) additive, measured immediately after centrifugation. Blood was collected from forty volunteers into both Glucomedics and Venosafe Glycemia tubes. Blood was centrifuged within 15min from venipuncture and glucose concentration was measured immediately after centrifugation, on the Abbott Architect analyzer. Differences between glucose concentrations in Glucomedics and Terumo tubes were tested using the paired t-test. Mean bias was calculated and compared to recommended quality specification for glucose (i.e. 2.2%). Glucose concentration in Terumo tubes was 3.4% lower than in Glucomedics tubes (P<0.001). The mean bias was clinically significant. There is a clinically significant difference between glucose concentrations in liquid and lyophilized citrate buffer additive tubes (Glucomedics vs. Terumo tubes) measured immediately after centrifugation. This difference may affect the patient outcome due to the misclassification of diabetes. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  11. Clinical outcomes of double staining and additional ILM peeling during ERM surgery.

    PubMed

    Oh, Ha Na; Lee, Joo Eun; Kim, Hyun Woong; Yun, Il Han

    2013-08-01

    To assess the clinical outcomes in idiopathic epiretinal membrane (ERM) patients after vitrectomy and ERM removal with or without additional indocyanine green (ICG)-assisted internal limiting membrane (ILM) peeling. The medical records of 43 patients with an idiopathic ERM that underwent vitrectomy and ERM removal between July 2007 and April 2010 were reviewed. The patients were divided into two groups: triamcinolone-assisted simple ERM peeling only (group A, n = 23) and triamcinolone-assisted ERM peeling followed by ICG staining and peeling of the remaining internal ILM (group B, n = 20). No difference was found between the two groups in terms of visual acuity, macular thickness, P1 amplitude or implicit time on multifocal-electroretinogram (mfERG) at six and 12 months postoperatively. In group B, ICG staining after ERM peeling demonstrated that the ILM had been removed together with the ERM in 12 eyes (60%), and all 12 eyes showed punctate retinal hemorrhages during ERM peeling. There was no recurrence of an ERM in either group. Additional procedures involving ICG staining and ILM peeling during ERM surgery do not appear to have an additive effect on the clinical outcomes in terms of visual acuity, retinal function based on mfERG, or recurrence rate.

  12. Sustained impact of a short small group course with systematic feedback in addition to regular clinical clerkship activities on musculoskeletal examination skills--a controlled study.

    PubMed

    Perrig, Martin; Berendonk, Christoph; Rogausch, Anja; Beyeler, Christine

    2016-01-28

    The discrepancy between the extensive impact of musculoskeletal complaints and the common deficiencies in musculoskeletal examination skills lead to increased emphasis on structured teaching and assessment. However, studies of single interventions are scarce and little is known about the time-dependent effect of assisted learning in addition to a standard curriculum. We therefore evaluated the immediate and long-term impact of a small group course on musculoskeletal examination skills. All 48 Year 4 medical students of a 6 year curriculum, attending their 8 week clerkship of internal medicine at one University department in Berne, participated in this controlled study. Twenty-seven students were assigned to the intervention of a 6×1 h practical course (4-7 students, interactive hands-on examination of real patients; systematic, detailed feedback to each student by teacher, peers and patients). Twenty-one students took part in the regular clerkship activities only and served as controls. In all students clinical skills (CS, 9 items) were assessed in an Objective Structured Clinical Examination (OSCE) station, including specific musculoskeletal examination skills (MSES, 7 items) and interpersonal skills (IPS, 2 items). Two raters assessed the skills on a 4-point Likert scale at the beginning (T0), the end (T1) and 4-12 months after (T2) the clerkship. Statistical analyses included Friedman test, Wilcoxon rank sum test and Mann-Whitney U test. At T0 there were no significant differences between the intervention and control group. At T1 and T2 the control group showed no significant changes of CS, MSES and IPS compared to T0. In contrast, the intervention group significantly improved CS, MSES and IPS at T1 (p < 0.001). This enhancement was sustained for CS and MSES (p < 0.05), but not for IPS at T2. Year 4 medical students were incapable of improving their musculoskeletal examination skills during regular clinical clerkship activities. However, an additional

  13. Conducting clinical post-conference in clinical teaching: a qualitative study.

    PubMed

    Hsu, Li-Ling

    2007-08-01

    The aim of this study was to explore nurse educators' perceptions regarding clinical postconferences. Additional aims included the exploration of interaction characteristics between students and faculty in clinical postconferences. Nursing students are challenged to think and learn in ways that will prepare them for practice in a complex health care environment. Clinical postconferences give students the opportunity to share knowledge gained through transformative learning and provide a forum for discussion and critical thinking. Faculty members must guide students as the latter participate in discussions, develop problem-solving skills and express feedings and attitudes in clinical conferences. The study used qualitative research methods, including participant observation and an open-ended questionnaire. Participant observers watched interaction activities between teachers and students in clinical postconferences. A total of 20 clinical postconferences, two conferences per teacher, were observed. The Non-Numerical Unstructured Data Indexing Searching and Theory-building qualitative software program was used in data analysis. Research findings indicated that, of the six taxonomy questions, lower-level questions (knowledge and comprehensive questions) were mostly asked by faculty members' postclinical conferences. The most frequently used guideline was task orientation, which is related to practice goals and was found in discussions of assignments, reading reports, discussions of clinical experiences, role plays, psychomotor skill practice, quizzes and student evaluations. It is an essential responsibility of nurse educators to employ postconferences to assist students in applying their knowledge in practical situations, in developing professional values and in enhancing their problem solving abilities.

  14. Clinical laboratory studies of disinfection with Sporicidin.

    PubMed Central

    Isenberg, H D

    1985-01-01

    The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

  15. Clinical Studies with Epothilones

    NASA Astrophysics Data System (ADS)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  16. Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

    PubMed

    Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

    2016-01-01

    Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

  17. Wise Additions Bridge the Gap between Social Psychology and Clinical Practice: Cognitive-Behavioral Therapy as an Exemplar

    PubMed Central

    Folk, Johanna B.; Disabato, David J.; Goodman, Fallon R.; Carter, Sarah P.; DiMauro, Jennifer C.; Riskind, John H.

    2017-01-01

    Progress in clinical science, theory, and practice requires the integration of advances from multiple fields of psychology, but much integration remains to be done. The current article seeks to address the specific gap that exists between basic social psychological theories and the implementation of related therapeutic techniques. We propose several “wise additions,” based upon the principles outlined by Walton (2014), intended to bridge current social psychological research with clinical psychological therapeutic practice using cognitive behavioral therapy as an example. We consider how recent advances in social psychological theories can inform the development and implementation of wise additions in clinical case conceptualization and interventions. We specifically focus on self and identity, self-affirmation, transference, social identity, and embodied cognition, five dominant areas of interest in the field that have clear clinical applications. PMID:28919701

  18. Best practices for clinical pathology testing in carcinogenicity studies.

    PubMed

    Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

    2011-02-01

    The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

  19. Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

    PubMed

    Baumrind, S

    1998-11-01

    A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

  20. Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

    PubMed

    Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

    2016-09-01

    Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd. CBT treatments for insomnia can be enhanced using recent developments in cognitive therapy. CBT treatments for insomnia can be enhanced using mindfulness-based treatments. Both cognitive therapy and mindfulness produce additional clinically significant change. Copyright © 2015 John Wiley & Sons, Ltd.

  1. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  2. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  3. Analyzing global trends of biomarker use in drug interventional clinical studies.

    PubMed

    Hayashi, K; Masuda, S; Kimura, H

    2012-04-01

    The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.

  4. [Application of SAS macro to evaluated multiplicative and additive interaction in logistic and Cox regression in clinical practices].

    PubMed

    Nie, Z Q; Ou, Y Q; Zhuang, J; Qu, Y J; Mai, J Z; Chen, J M; Liu, X Q

    2016-05-01

    Conditional logistic regression analysis and unconditional logistic regression analysis are commonly used in case control study, but Cox proportional hazard model is often used in survival data analysis. Most literature only refer to main effect model, however, generalized linear model differs from general linear model, and the interaction was composed of multiplicative interaction and additive interaction. The former is only statistical significant, but the latter has biological significance. In this paper, macros was written by using SAS 9.4 and the contrast ratio, attributable proportion due to interaction and synergy index were calculated while calculating the items of logistic and Cox regression interactions, and the confidence intervals of Wald, delta and profile likelihood were used to evaluate additive interaction for the reference in big data analysis in clinical epidemiology and in analysis of genetic multiplicative and additive interactions.

  5. [Etiological, clinical and neuroradiological investigation of deaf children with additional neuropsychiatric disabilities].

    PubMed

    Chilosi, A M; Scusa, M F; Comparini, A; Genovese, E; Forli, F; Berrettini, S; Cipriani, P

    2012-04-01

    Sensorineural hearing loss (SNHL) is complicated by additional disabilities in about 30% of cases, but the epidemiology of associated disorders, in terms of type, frequency and aetiology is still not clearly defined. Additional disabilities in a deaf child have important consequences in assessing and choosing a therapeutic treatment, in particular when considering cochlear implantation (CI) or hearing aids (HA). The aim of this paper was to evaluate frequency, type and severity of additional neurodevelopmental disabilities in children with profound bilateral sensorineural hearing loss and to investigate the relationship between disability and the etiology of deafness. Eighty children with profound bilateral sensorineural hearing loss (mean age 5.4 years) were investigated by means of a diagnostic protocol including clinical, neurodevelopmental, and audiological procedures together with genetic and neurometabolic tests and neuroradiological investigation by brain MRI. Fifty-five percent of the sample exhibited one or more disabilities in addition to deafness, with cognitive, behavioural-emotional and motor disorders being the most frequent. The risk of additional disabilities varied according to aetiology, with a higher incidence in hereditary syndromic deafness, in cases due to pre-perinatal pathology (in comparison to unknown and hereditary non syndromic forms) and in the presence of major brain abnormalities at MRI. Our results suggest that the aetiology of deafness may be a significant risk indicator for the presence of neuropsychiatric disorders. A multidimensional evaluation, including aetiological, neurodevelopmental and MRI investigation is needed for formulating prognosis and for planning therapeutic intervention, especially in those children candidated to cochlear implant.

  6. Comparison of risk assessment based on clinical judgement and Cariogram in addition to patient perceived treatment need.

    PubMed

    Hänsel Petersson, Gunnel; Åkerman, Sigvard; Isberg, Per-Erik; Ericson, Dan

    2016-07-07

    Predicting future risk for oral diseases, treatment need and prognosis are tasks performed daily in clinical practice. A large variety of methods have been reported, ranging from clinical judgement or "gut feeling" or even patient interviewing, to complex assessments of combinations of known risk factors. In clinical practice, there is an ongoing continuous search for less complicated and more valid tools for risk assessment. There is also a lack of knowledge how different common methods relates to one another. The aim of this study was to investigate if caries risk assessment (CRA) based on clinical judgement and the Cariogram model give similar results. In addition, to assess which factors from clinical status and history agree best with the CRA based on clinical judgement and how the patient's own perception of future oral treatment need correspond with the sum of examiners risk score. Clinical examinations were performed on randomly selected individuals 20-89 years old living in Skåne, Sweden. In total, 451 individuals were examined, 51 % women. The clinical examination included caries detection, saliva samples and radiographic examination together with history and a questionnaire. The examiners made a risk classification and the authors made a second risk calculation according to the Cariogram. For those assessed as low risk using the Cariogram 69 % also were assessed as low risk based on clinical judgement. For the other risk groups the agreement was lower. Clinical variables that significantly related to CRA based on clinical judgement were DS (decayed surfaces) and combining DS and incipient lesions, DMFT (decayed, missed, filled teeth), plaque amount, history and soft drink intake. Patients' perception of future oral treatment need correlated to some extent with the sum of examiners risk score. The main finding was that CRA based on clinical judgement and the Cariogram model gave similar results for the groups that were predicted at low level of future

  7. Mutations in RIT1 cause Noonan syndrome - additional functional evidence and expanding the clinical phenotype.

    PubMed

    Koenighofer, M; Hung, C Y; McCauley, J L; Dallman, J; Back, E J; Mihalek, I; Gripp, K W; Sol-Church, K; Rusconi, P; Zhang, Z; Shi, G-X; Andres, D A; Bodamer, O A

    2016-03-01

    RASopathies are a clinically heterogeneous group of conditions caused by mutations in 1 of 16 proteins in the RAS-mitogen activated protein kinase (RAS-MAPK) pathway. Recently, mutations in RIT1 were identified as a novel cause for Noonan syndrome. Here we provide additional functional evidence for a causal role of RIT1 mutations and expand the associated phenotypic spectrum. We identified two de novo missense variants p.Met90Ile and p.Ala57Gly. Both variants resulted in increased MEK-ERK signaling compared to wild-type, underscoring gain-of-function as the primary functional mechanism. Introduction of p.Met90Ile and p.Ala57Gly into zebrafish embryos reproduced not only aspects of the human phenotype but also revealed abnormalities of eye development, emphasizing the importance of RIT1 for spatial and temporal organization of the growing organism. In addition, we observed severe lymphedema of the lower extremity and genitalia in one patient. We provide additional evidence for a causal relationship between pathogenic mutations in RIT1, increased RAS-MAPK/MEK-ERK signaling and the clinical phenotype. The mutant RIT1 protein may possess reduced GTPase activity or a diminished ability to interact with cellular GTPase activating proteins; however the precise mechanism remains unknown. The phenotypic spectrum is likely to expand and includes lymphedema of the lower extremities in addition to nuchal hygroma. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups.

  9. [A Critical Condition of Clinical Studies in Japan -- A Battle of Clinical Study Groups].

    PubMed

    Furukawa, Hiroshi

    2016-04-01

    The post-marketing clinical study groups have been losing their activity due to stop of financial support. As the result, clinical study groups cannot achieve any EBM for treatment guidelines. Financial supports should be restarted immediately not to extinguish the post-marketing clinical studies and study groups.

  10. The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies.

    PubMed

    Pinder, Margaret; Conteh, Lesong; Jeffries, David; Jones, Caroline; Knudsen, Jakob; Kandeh, Balla; Jawara, Musa; Sicuri, Elisa; D'Alessandro, Umberto; Lindsay, Steve W

    2016-06-03

    In malaria-endemic areas, residents of modern houses have less malaria than those living in traditional houses. This study will determine if modern housing provides incremental protection against clinical malaria over the current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in The Gambia, determine the incremental cost-effectiveness of the interventions, and analyze the housing market in The Gambia. A two-armed, household, cluster-randomized, controlled study will be conducted to assess whether improved housing and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in The Gambia. The unit of randomization will be the household, defined as a house and its occupants. A total of 800 households will be enrolled and will receive LLINs, and 400 will receive improved housing before clinical follow-up. One child aged 6 months to 13 years will be enrolled from each household and followed for clinical malaria using active case detection to estimate malaria incidence for two malaria transmission seasons. Episodes of clinical malaria will be the primary endpoint. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection, parasite density, and the prevalence of anemia. Exposure to malaria parasites will be assessed using light traps, followed by detection of Anopheles gambiae species and sporozoite infection. Ancillary economic and social science studies will undertake a cost-effectiveness analysis and use qualitative and participatory methods to explore the acceptability of the housing modifications and to design strategies for scaling-up housing interventions. The study is the first of its kind to measure the efficacy of housing on reducing clinical malaria, assess the incremental cost-effectiveness of improved housing, and identify mechanisms for scaling up housing interventions. Trial findings will help inform policy

  11. Therapists' Use of DBT: A Survey Study of Clinical Practice

    ERIC Educational Resources Information Center

    DiGiorgio, Kimberly E.; Glass, Carol R.; Arnkoff, Diane B.

    2010-01-01

    The purpose of this study was to examine how therapists conduct Dialectical Behavior Therapy (DBT) individual psychotherapy with clients, focusing on clinical factors that could account for decisions regarding modifications of DBT (e.g., client diagnosis, therapist theoretical orientation, and intensity of DBT training). Additionally, the study…

  12. Barriers and facilitators for the implementation of an online clinical health community in addition to usual fertility care: a cross-sectional study.

    PubMed

    Aarts, Johanna W M; Faber, Marjan J; den Boogert, Anne G; Cohlen, Ben J; van der Linden, Paul J Q; Kremer, Jan A M; Nelen, Willianne L D M

    2013-08-30

    Online health communities are becoming more popular in health care. Patients and professionals can communicate with one another online, patients can find peer support, and professionals can use it as an additional information channel to their patients. However, the implementation of online health communities into daily practice is challenging. These challenges relate to the fact that patients need to be activated to (1) become a member (ie, subscription) and (2) participate actively within the community before any effect can be expected. Therefore, we aimed at answering 2 research questions: (1) what factors are associated with subscription to an online health community, and (2) which are associated with becoming an active participant within an online health community. To identify barriers and facilitators as perceived by patients for the implementation of an online health community. We performed a cross-sectional study. Three Dutch fertility clinics (2 IVF-licensed) offered their patients a secure online clinical health community through which clinicians can provide online information and patients can ask questions to the medical team or share experiences and find support from peers. We randomly selected and invited 278 men and women suffering from infertility and attending 1 of the participating clinics. Participants filled out a questionnaire about their background characteristics and current use of the online community. Possible barriers and facilitators were divided into 2 parts: (1) those for subscription to the community, and (2) those for active participation in the community. We performed 2 multivariate logistic regression analyses to calculate determinants for both subscription and active participation. Subscription appeared to be associated with patients' background characteristics (eg, gender, treatment phase), intervention-related facilitators (odds ratio [OR] 2.45, 95% CI 1.14-5.27), and patient-related barriers (OR 0.20, 95% CI 0.08-0.54), such as

  13. Skew-t partially linear mixed-effects models for AIDS clinical studies.

    PubMed

    Lu, Tao

    2016-01-01

    We propose partially linear mixed-effects models with asymmetry and missingness to investigate the relationship between two biomarkers in clinical studies. The proposed models take into account irregular time effects commonly observed in clinical studies under a semiparametric model framework. In addition, commonly assumed symmetric distributions for model errors are substituted by asymmetric distribution to account for skewness. Further, informative missing data mechanism is accounted for. A Bayesian approach is developed to perform parameter estimation simultaneously. The proposed model and method are applied to an AIDS dataset and comparisons with alternative models are performed.

  14. Evaluation of additive effects of hydrolyzed jojoba (Simmondsia chinensis) esters and glycerol: a preliminary study.

    PubMed

    Meyer, Jaimi; Marshall, Brooke; Gacula, Maximo; Rheins, Lawrence

    2008-12-01

    Glycerol has long served the topical prescriptive and personal care industry as a versatile and functional active and inactive ingredient. In skin care products, it acts primarily as an emollient, softening the skin through robust humectant hydration action. Hydrolyzed Jojoba Esters K-20W (K-20W) have been shown to increase skin hydration and improve sensory skin "feel" when included in a variety of skin, hair, and nail care cosmetic/personal care formulations. The addition of glycerol and hydrolyzed jojoba esters provides a substantial long-acting 24 h (moisturizing) skin hydration effect for topical products. A small pilot study was conducted to support the "proof of concept" that an enhanced, additive role exists between these two ingredients resulting in a long-term (24 h) skin moisturization effect. Topical treatments were applied to the skin (lower leg) of subjects, and evaluations were made at baseline and 8- to 24-h post-application. Skin hydration data were obtained via bio-instrumental transepidermal water loss (TEWL) measurements and expert clinical skin grading, including standardized digital clinical photography. Clinical skin grading evaluations and TEWL measurements found that significantly lower evaporative (P < 0.05) TEWL values occurred in the topical formulations containing 3.75% glycerol and 1.25% K-20W (hydrolyzed jojoba esters) than with glycerol alone in a standard base skin care lotion at 8 and 24 h posttreatment. This preliminary data "proof of concept" supports the position that glycerol and hydrolyzed jojoba esters work in tandem to enhance skin moisturization for at least 24 h. This unique moisturizing potential may prove valuable in the future development of cosmetic and over-the-counter/prescriptive topical products, including new medicaments containing botanicals. This fact is further reinforced with the recent greater commercial use and demand for defined safe botanicals in cosmetic as well as pharmaceutical topical formulations

  15. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. © 2013 Published by Elsevier Ltd.

  16. Resveratrol and diabetes: A critical review of clinical studies.

    PubMed

    Öztürk, Ebru; Arslan, Ayşe Kübra Karaboğa; Yerer, Mükerrem Betül; Bishayee, Anupam

    2017-11-01

    Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia. The disease results from the defects of insulin secretion and/or action. Resveratrol is a non-flavonoid polyphenol that naturally occurs as phytoalexin. The shell and stem of Vitis vinifera L. (Vitaceae) are the richest source of this compound. In addition to various in vitro and in vivo studies revealing the effectiveness of resveratrol in DM, there are many clinical trials indicating that resveratrol has the potential to benefit in DM patients. The therapeutic action of this compound in relation to diabetes is complex and involves in several beneficial roles. In view of this, clinical studies are necessary to elucidate these roles. In the near future, the use of resveratrol, alone or in combination with current anti-diabetic therapies, might be a conventional approach to effectively manage DM or its complications. This mini-review provides a critical overview of currently available clinical studies examining the effects of resveratrol in DM last decade. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  17. A comparative study of additive and subtractive manufacturing for dental restorations.

    PubMed

    Bae, Eun-Jeong; Jeong, Il-Do; Kim, Woong-Chul; Kim, Ji-Hwan

    2017-08-01

    Digital systems have recently found widespread application in the fabrication of dental restorations. For the clinical assessment of dental restorations fabricated digitally, it is necessary to evaluate their accuracy. However, studies of the accuracy of inlay restorations fabricated with additive manufacturing are lacking. The purpose of this in vitro study was to evaluate and compare the accuracy of inlay restorations fabricated by using recently introduced additive manufacturing with the accuracy of subtractive methods. The inlay (distal occlusal cavity) shape was fabricated using 3-dimensional image (reference data) software. Specimens were fabricated using 4 different methods (each n=10, total N=40), including 2 additive manufacturing methods, stereolithography apparatus and selective laser sintering; and 2 subtractive methods, wax and zirconia milling. Fabricated specimens were scanned using a dental scanner and then compared by overlapping reference data. The results were statistically analyzed using a 1-way analysis of variance (α=.05). Additionally, the surface morphology of 1 randomly (the first of each specimen) selected specimen from each group was evaluated using a digital microscope. The results of the overlap analysis of the dental restorations indicated that the root mean square (RMS) deviation observed in the restorations fabricated using the additive manufacturing methods were significantly different from those fabricated using the subtractive methods (P<.05). However, no significant differences were found between restorations fabricated using stereolithography apparatus and selective laser sintering, the additive manufacturing methods (P=.466). Similarly, no significant differences were found between wax and zirconia, the subtractive methods (P=.986). The observed RMS values were 106 μm for stereolithography apparatus, 113 μm for selective laser sintering, 116 μm for wax, and 119 μm for zirconia. Microscopic evaluation of the surface

  18. Study on thermal effects & sulfurized additives, in lubricating greases

    NASA Astrophysics Data System (ADS)

    Shah, Ami Atul

    Lithium Base grease constitutes about 50% of market. The greases are developed to be able to work in multiple working conditions and have longer working life. Greases with extreme pressure additives and anti-wear additives have been developed as a solution to many of the applications. These developed greases are tested under ASTM D2266 testing conditions to meet the requirements. The actual working conditions, although, differ than the real testing conditions. The loading, speed and temperature conditions can be more harsh, or fluctuating in nature. The cyclic nature of the parameters cannot be directly related to the test performance. For this purpose studies on the performance under spectrum loading, variable speed and fluctuating temperature must be performed. This study includes tests to understand the effect of thermal variation on some of the most commonly used grease additives that perform well under ASTM D2266 testing conditions. The studied additives include most widely used industrial extreme pressure additive MoS2. Performance of ZDDP which is trying to replace MoS2 in its industrial applications has also been studied. The tests cover study of extreme pressure, anti-wear and friction modifier additives to get a general idea on the effects of thermal variation in three areas. Sulphur is the most common extreme pressure additive. Sulphur based MoS 2 is extensively used grease additive. Study to understand the tribological performance of this additive through wear testing and SEM/EDX studies has been done. This performance is also studied for other metallic sulfides like WS2 and sulphur based organic compound. The aim is to study the importance of the type of bond that sulphur shares in its additive's structure on its performance. The MoS2 film formation is found to be on the basis of the FeS formation on the substrate and protection through sacrificial monolayer deposition of the MoS2 sheared structure. The free Mo then tends to oxidise. An attempt to

  19. The UK Clinical Aptitude Test and clinical course performance at Nottingham: a prospective cohort study.

    PubMed

    Yates, Janet; James, David

    2013-02-26

    The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course.The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools.

  20. Clinical evaluation of a new pupil independent diffractive multifocal intraocular lens with a +2.75 D near addition: a European multicentre study.

    PubMed

    Kretz, Florian T A; Gerl, Matthias; Gerl, Ralf; Müller, Matthias; Auffarth, Gerd U

    2015-12-01

    To evaluate the clinical outcomes after cataract surgery with implantation of a new diffractive multifocal intraocular lens (IOL) with a lower near addition (+2.75 D.). 143 eyes of 85 patients aged between 40 years and 83 years that underwent cataract surgery with implantation of the multifocal IOL (MIOL) Tecnis ZKB00 (Abbott Medical Optics,Santa Ana, California, USA) were evaluated. Changes in uncorrected (uncorrected distance visual acuity, uncorrected intermediate visual acuity, uncorrected near visual acuity) and corrected (corrected distance visual acuity, corrected near visual acuity) logMAR distance, intermediate visual acuity and near visual acuity, as well as manifest refraction were evaluated during a 3-month follow-up. Additionally, patients were asked about photic phenomena and spectacle dependence. Postoperative spherical equivalent was within ±0.50 D and ±1.00 D of emmetropia in 78.1% and 98.4% of eyes, respectively. Postoperative mean monocular uncorrected distance visual acuity, uncorrected near visual acuity and uncorrected intermediate visual acuity was 0.20 LogMAR or better in 73.7%, 81.1% and 83.9% of eyes, respectively. All eyes achieved monocular corrected distance visual acuity of 0.30 LogMAR or better. A total of 100% of patients referred to be at least moderately happy with the outcomes of the surgery. Only 15.3% of patients required the use of spectacles for some daily activities postoperatively. The introduction of low add MIOLs follows a trend to increase intermediate visual acuity. In this study a near add of +2.75 D still reaches satisfying near results and leads to high patient satisfaction for intermediate visual acuity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  1. Self-Esteem, Oral Health Behaviours, and Clinical Oral Health Status in Chinese Adults: An Exploratory Study

    ERIC Educational Resources Information Center

    Chin, Luzy Siu-Hei; Chan, Joanne Chung-Yan

    2013-01-01

    Objectives: This is an exploratory study to examine the relations among self-esteem, oral health behaviours and clinical oral health status in Chinese adults. In addition, gender differences in clinical oral health status and oral health behaviours were explored. Methods: Participants were 192 patients from a private dental clinic in Hong Kong…

  2. Registered nurses' clinical reasoning in home healthcare clinical practice: A think-aloud study with protocol analysis.

    PubMed

    Johnsen, Hege Mari; Slettebø, Åshild; Fossum, Mariann

    2016-05-01

    The home healthcare context can be unpredictable and complex, and requires registered nurses with a high level of clinical reasoning skills and professional autonomy. Thus, additional knowledge about registered nurses' clinical reasoning performance during patient home care is required. The aim of this study is to describe the cognitive processes and thinking strategies used by recently graduated registered nurses while caring for patients in home healthcare clinical practice. An exploratory qualitative think-aloud design with protocol analysis was used. Home healthcare visits to patients with stroke, diabetes, and chronic obstructive pulmonary disease in seven healthcare districts in southern Norway. A purposeful sample of eight registered nurses with one year of experience. Each nurse was interviewed using the concurrent think-aloud technique in three different patient home healthcare clinical practice visits. A total of 24 home healthcare visits occurred. Follow-up interviews were conducted with each participant. The think-aloud sessions were transcribed and analysed using three-step protocol analysis. Recently graduated registered nurses focused on both general nursing concepts and concepts specific to the domains required and tasks provided in home healthcare services as well as for different patient groups. Additionally, participants used several assertion types, cognitive processes, and thinking strategies. Our results showed that recently graduated registered nurses used both simple and complex cognitive processes involving both inductive and deductive reasoning. However, their reasoning was more reactive than proactive. The results may contribute to nursing practice in terms of developing effective nursing education programmes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

    PubMed

    Royle, P; Waugh, N

    2003-01-01

    To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. A sample of 20 recent TARs. All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known

  4. Randomized clinical trials and observational studies in the assessment of drug safety.

    PubMed

    Sawchik, J; Hamdani, J; Vanhaeverbeek, M

    2018-05-01

    Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  5. Disc displacement without reduction: a retrospective study of a clinical diagnostic sign.

    PubMed

    Giraudeau, Anne; Jeany, Marion; Ehrmann, Elodie; Déjou, Jacques; Ouni, Imed; Orthlieb, Jean-Daniel

    2017-03-01

    The purpose of this retrospective study is to evaluate a clinical diagnostic sign for disc displacement without reduction (DDWR), the absence of additional condylar translation during opening compared with protrusion. Thirty-eight electronic axiographic and magnetic resonance imaging (MRI) examinations of the TMJ were analyzed in order to compare the opening/protrusion ratio of condylar translation between non-painful DDWR and non-DDWR. According to the Mann-Whitney U test, the opening/protrusion ratio in non-painful DDWR differs significantly from non-DDWR (p < 0.0001). Among non-painful DDWR, there is no additional condylar translation during opening in comparison with protrusion, and this is probably also the case for DDWR without limited opening, which is a subtype that has not been validated by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Comparative condylar palpation can analyze this sign, and therefore, further comparative investigations between MRI and clinical examination are needed to validate the corresponding clinical test.

  6. New-onset asthma after exposure to the steam system additive 2-diethylaminoethanol. A descriptive study.

    PubMed

    Gadon, M E; Melius, J M; McDonald, G J; Orgel, D

    1994-06-01

    Through a leak in the steam heating system, the anticorrosive agent 2-diethylaminoethanol was released into the air of a large office building. Irritative symptoms were experienced by most of the 2500 employees, and 14 workers developed asthma within 3 months of exposure. This study was undertaken to review clinical characteristics of these asthmatics. Environmental exposure monitoring data and medical records were reviewed. Seven of 14 cases were defined as "confirmed" and 7 of 14 as "suspect," using the National Institute for Occupational Safety and Health surveillance case definition of occupational asthma. Spirometry was positive in 4 of 14 of the cases and peak flow testing in 10 of 14. Three cases were diagnosed on the basis of work-related symptoms and physical examination alone. The study suggests that acute exposure to the irritating steam additive 2-diethylaminoethanol was a contributing factor in the development of clinical asthma in this population.

  7. Interprofessional student clinics: an economic evaluation of collaborative clinical placement education.

    PubMed

    Haines, Terry P; Kent, Fiona; Keating, Jennifer L

    2014-07-01

    Interprofessional student clinics can be used to create clinical education placements for health professional students in addition to traditional hospital-based placements and present an opportunity to provide interprofessional learning experiences in a clinical context. To date, little consideration has been given in research literature as to whether such clinics are economically viable for a university to run. We conducted an economic evaluation based upon data generated during a pilot of an interprofessional student clinic based in Australia. Cost-minimization analyses of the student clinic as opposed to traditional profession-specific clinical education in hospitals were conducted from university, Commonwealth Government, state government and societal perspectives. Cost data gathered during the pilot study and market prices were used where available, while $AUD currency at 2011 values were used. Per student day of clinical education, the student clinic cost an additional $289, whereas the state government saved $49 and the Commonwealth Government saved $66. Overall, society paid an additional $175 per student day of clinical education using the student clinic as opposed to conventional hospital-based placements, indicating that traditional hospital-based placements are a cost-minimizing approach overall for providing clinical education. Although interprofessional student clinics have reported positive patient and student learning outcomes, further research is required to determine if these benefits can justify the additional cost of this model of education. Considerations for clinic sustainability are proposed.

  8. Quality assurance study of caries risk assessment performance by clinical faculty members in a school of dentistry.

    PubMed

    Rechmann, Peter; Featherstone, John D B

    2014-09-01

    The goal of this quality assurance study was to explore the decision making of clinical faculty members at the University of California, San Francisco School of Dentistry predoctoral dental clinic in terms of caries risk level assignment using the caries risk assessment (CRA) as part of the Caries Management by Risk Assessment (CAMBRA) concept. This research was done in part to determine if additional training and calibration were needed for these faculty members. The study tested the reliability and reproducibility of the caries risk levels assigned by different clinical teachers who completed CRA forms for simulated patients. In the first step, five clinical teachers assigned caries risk levels for thirteen simulated patients. Six months later, the same five plus an additional nine faculty members assigned caries risk levels to the same thirteen simulated and nine additional cases. While the intra-examiner reliability with weighted kappa strength of agreement was very high, the inter-examiner agreements with a gold standard were on average only moderate. In total, 20 percent of the presented high caries risk cases were underestimated at caries levels too low, even when obvious caries disease indicators were present. This study suggests that more consistent training and calibration of clinical faculty members as well as students are needed.

  9. Production tolerance of additive manufactured polymeric objects for clinical applications.

    PubMed

    Braian, Michael; Jimbo, Ryo; Wennerberg, Ann

    2016-07-01

    To determine the production tolerance of four commercially available additive manufacturing systems. By reverse engineering annex A and B from the ISO_12836;2012, two geometrical figures relevant to dentistry was obtained. Object A specifies the measurement of an inlay-shaped object and B a multi-unit specimen to simulate a four-unit bridge model. The objects were divided into x, y and z measurements, object A was divided into a total of 16 parameters and object B was tested for 12 parameters. The objects were designed digitally and manufactured by professionals in four different additive manufacturing systems; each system produced 10 samples of each objects. For object A, three manufacturers presented an accuracy of <100μm and one system showed an accuracy of <20μm. For object B, all systems presented an accuracy of <100μm, and most parameters were <40μm. The standard deviation for most parameters were <40μm. The growing interest and use of intra-oral digitizing systems stresses the use of computer aided manufacturing of working models. The additive manufacturing techniques has the potential to help us in the digital workflow. Thus, it is important to have knowledge about production accuracy and tolerances. This study presents a method to test additive manufacturing units for accuracy and repeatability. Copyright © 2016 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  10. A study of patients who go to a psychology clinic seeking treatment.

    PubMed

    Estupiñá, Francisco José; Labrador, Francisco Javier; García-Vera, María Paz

    2012-03-01

    In order to characterize a typical clinical context, as opposed to an academic or research context, this article will analyze the sociodemographic and clinical characteristics of patients who turn to a psychology clinic in need of professional help. This study was conducted using an initial sample of 1,305 patients at the Universidad Complutense de Madrid (UCM) Clínica Universitaria de Psicología. Of the sociodemographic characteristics studied, it is noteworthy that the majority of patients were women (65%) and relatively young (the average age is 29.7 years-old). The disorders for which psychological help was most often needed were anxiety and mood disorders and relationship problems, which together made up 50% of cases. In 17.70% of cases, patients had at least one comorbid disorder in addition to the one that brought them to the clinic. The generalizability and implications of the results are discussed.

  11. Evaluation of increased milking frequency as an additional treatment for cows with clinical mastitis.

    PubMed

    Krömker, Volker; Zinke, Claudia; Paduch, Jan-Hendrik; Klocke, Doris; Reimann, Anette; Eller, Georg

    2010-02-01

    This field study focused on the possible effects of increased milking frequency (milking four times a day in comparison with milking twice a day) on clinical and bacteriological cure rates of clinical, antibiotically treated mastitis cases. Parameters tested were clinical, microbiological and full (cytomicrobiological) cure as well as the development of milk yield after the clinical mastitis episode. Cows from a large dairy herd meeting the study criteria (n=93) were assigned to two treatment groups by a systematic randomization scheme (blocked by body temperature <=or >39.5 degrees C). Both groups were randomly divided by experimental treatments: a) antibiotic intramammary treatment and milking 2-times a day; b) antibiotic intramammary treatment and milking 4-times a day. Treatments were initiated before the culture results were known. Cows were surveyed and evaluated on days 1-6, 24 and 31. No significant differences between treatment and control groups regarding clinical cure, microbiological cure, full cure and milk production could be established. Applying a 4-times a day milking regime did not lead to any significant effect, either positive or negative. Therefore, the results suggest that milking 4-times a day as a supporting therapy for mild, moderate and severe antimicrobially treated mastitis cases cannot be recommended.

  12. Studies of biochemistry and clinical biochemistry. Studies at sample medical schools in 13 EU countries regarding biochemistry and clinical biochemistry teaching.

    PubMed

    Stern, Petr; Sebesta, Ivan; Trnkova, Bohuslava; Zima, Tomas

    2008-07-01

    The study summarizes the results obtained during personal visits to 53 medical schools in the 13 original EU countries during 2004--2006. Data from the Czech Republic is shown for comparison. The possibilities of acquiring information from the websites of the medical schools in the local language and English are assessed. The admission process to medical schools and the organization of studies of medicine, dentistry, and non-medical healthcare fields are briefly characterized. Significant attention is paid to the forms of education in biochemistry and clinical (bio)chemistry in the medical study field. The position of these subjects in the studies of dentistry and non-medical healthcare fields is also noted. In addition, the course of subject exams is described. The methods of funding and postgraduate studies at the medical schools are also briefly addressed.

  13. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

  14. Clinical and imaging evaluation of the response to intravenous steroids in patients with Graves' orbitopathy and analysis on who requires additional therapy.

    PubMed

    Tsirouki, Theodora; Bargiota, Alexandra; Tigas, Stelios; Vasileiou, Agathi; Kapsalaki, Eftichia; Giotaki, Zoe; Asproudis, Ioannis; Tsatsoulis, Agathokles; Koukoulis, Georgios; Tsironi, Evangelia E

    2016-01-01

    The aim of this study was to evaluate the safety and efficacy of an individualized steroid regimen in patients with moderate-to-severe Graves' orbitopathy (GO) by monitoring clinical and imaging parameters. In total, 47 patients with active, moderate-to-severe GO were enrolled in this study. All the patients received the proposed treatment regimen by European Group on GO of 4.5 g of intravenous (IV) methylprednisolone for 12 weeks. At the end of the IV treatment, patients with persistent active GO (Group 1) who were assessed by clinical examination and orbital imaging with short tau inversion recovery-sequence magnetic resonance imaging (STIR MRI) received additional treatment with oral prednisolone, and those with inactive GO (Group 2) received no further treatment. Of the 42 patients who completed the study, 22 (52.4%) patients formed Group 1 and 20 (47.6%) patients Group 2. At the 12th week, the overall response to IV treatment was 76.2%, and clinical activity score (CAS) improvement was 69%. At the 24th week, the overall response was 92.8%, and CAS improvement was 97.6%, without statistically significant difference in CAS and total eye score between these two groups ( P =0.157 and P =0.856, respectively). Ophthalmic manifestations were improved, being absent or minimal in 78.6% of patients at the 24th week follow-up. Recurrence of disease activity occurred in 9.5% of patients up to 24 weeks after the completion of treatment, and major adverse events occurred in 6.4% of patients. In patients with moderate-to-severe GO, IV steroid treatment, followed by oral treatment, when needed, is an effective regimen with low rates of adverse events and recurrences. STIR MRI is a significant tool for recognizing patients who need additional steroid treatment.

  15. Clinical and imaging evaluation of the response to intravenous steroids in patients with Graves’ orbitopathy and analysis on who requires additional therapy

    PubMed Central

    Tsirouki, Theodora; Bargiota, Alexandra; Tigas, Stelios; Vasileiou, Agathi; Kapsalaki, Eftichia; Giotaki, Zoe; Asproudis, Ioannis; Tsatsoulis, Agathokles; Koukoulis, Georgios; Tsironi, Evangelia E

    2016-01-01

    Objective The aim of this study was to evaluate the safety and efficacy of an individualized steroid regimen in patients with moderate-to-severe Graves’ orbitopathy (GO) by monitoring clinical and imaging parameters. Methods In total, 47 patients with active, moderate-to-severe GO were enrolled in this study. All the patients received the proposed treatment regimen by European Group on GO of 4.5 g of intravenous (IV) methylprednisolone for 12 weeks. At the end of the IV treatment, patients with persistent active GO (Group 1) who were assessed by clinical examination and orbital imaging with short tau inversion recovery-sequence magnetic resonance imaging (STIR MRI) received additional treatment with oral prednisolone, and those with inactive GO (Group 2) received no further treatment. Results Of the 42 patients who completed the study, 22 (52.4%) patients formed Group 1 and 20 (47.6%) patients Group 2. At the 12th week, the overall response to IV treatment was 76.2%, and clinical activity score (CAS) improvement was 69%. At the 24th week, the overall response was 92.8%, and CAS improvement was 97.6%, without statistically significant difference in CAS and total eye score between these two groups (P=0.157 and P=0.856, respectively). Ophthalmic manifestations were improved, being absent or minimal in 78.6% of patients at the 24th week follow-up. Recurrence of disease activity occurred in 9.5% of patients up to 24 weeks after the completion of treatment, and major adverse events occurred in 6.4% of patients. Conclusion In patients with moderate-to-severe GO, IV steroid treatment, followed by oral treatment, when needed, is an effective regimen with low rates of adverse events and recurrences. STIR MRI is a significant tool for recognizing patients who need additional steroid treatment. PMID:27895458

  16. Adsorption of molecular additive onto lead halide perovskite surfaces: A computational study on Lewis base thiophene additive passivation

    NASA Astrophysics Data System (ADS)

    Zhang, Lei; Yu, Fengxi; Chen, Lihong; Li, Jingfa

    2018-06-01

    Organic additives, such as the Lewis base thiophene, have been successfully applied to passivate halide perovskite surfaces, improving the stability and properties of perovskite devices based on CH3NH3PbI3. Yet, the detailed nanostructure of the perovskite surface passivated by additives and the mechanisms of such passivation are not well understood. This study presents a nanoscopic view on the interfacial structure of an additive/perovskite interface, consisting of a Lewis base thiophene molecular additive and a lead halide perovskite surface substrate, providing insights on the mechanisms that molecular additives can passivate the halide perovskite surfaces and enhance the perovskite-based device performance. Molecular dynamics study on the interactions between water molecules and the perovskite surfaces passivated by the investigated additive reveal the effectiveness of employing the molecular additives to improve the stability of the halide perovskite materials. The additive/perovskite surface system is further probed via molecular engineering the perovskite surfaces. This study reveals the nanoscopic structure-property relationships of the halide perovskite surface passivated by molecular additives, which helps the fundamental understanding of the surface/interface engineering strategies for the development of halide perovskite based devices.

  17. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    PubMed

    Logvinov, Ilana

    2014-03-01

    Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

    PubMed

    Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

    2017-09-01

    To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

  19. Optimal design in pediatric pharmacokinetic and pharmacodynamic clinical studies.

    PubMed

    Roberts, Jessica K; Stockmann, Chris; Balch, Alfred; Yu, Tian; Ward, Robert M; Spigarelli, Michael G; Sherwin, Catherine M T

    2015-03-01

    It is not trivial to conduct clinical trials with pediatric participants. Ethical, logistical, and financial considerations add to the complexity of pediatric studies. Optimal design theory allows investigators the opportunity to apply mathematical optimization algorithms to define how to structure their data collection to answer focused research questions. These techniques can be used to determine an optimal sample size, optimal sample times, and the number of samples required for pharmacokinetic and pharmacodynamic studies. The aim of this review is to demonstrate how to determine optimal sample size, optimal sample times, and the number of samples required from each patient by presenting specific examples using optimal design tools. Additionally, this review aims to discuss the relative usefulness of sparse vs rich data. This review is intended to educate the clinician, as well as the basic research scientist, whom plan on conducting a pharmacokinetic/pharmacodynamic clinical trial in pediatric patients. © 2015 John Wiley & Sons Ltd.

  20. Posttraumatic stress disorder and physical illness: results from clinical and epidemiologic studies.

    PubMed

    Boscarino, Joseph A

    2004-12-01

    Research indicates that exposure to traumatic stressors and psychological trauma is widespread. The association of such exposures with posttraumatic stress disorder (PTSD) and other mental health conditions is well known. However, epidemiologic research increasingly suggests that exposure to these events is related to increased health care utilization, adverse health outcomes, the onset of specific diseases, and premature death. To date, studies have linked traumatic stress exposures and PTSD to such conditions as cardiovascular disease, diabetes, gastrointestinal disease, fibromyalgia, chronic fatigue syndrome, musculoskeletal disorders, and other diseases. Evidence linking cardiovascular disease and exposure to psychological trauma is particularly strong and has been found consistently across different populations and stressor events. In addition, clinical studies have suggested the biological pathways through which stressor-induced diseases may be pathologically expressed. In particular, recent studies have implicated the hypothalamic-pituitary-adrenal (HPA) and the sympathetic-adrenal-medullary (SAM) stress axes as key in this pathogenic process, although genetic and behavioral/psychological risk factors cannot be ruled out. Recent findings, indicating that victims of PTSD have higher circulating T-cell lymphocytes and lower cortisol levels, are intriguing and suggest that chronic sufferers of PTSD may be at risk for autoimmune diseases. To test this hypothesis, we assessed the association between chronic PTSD in a national sample of 2,490 Vietnam veterans and the prevalence of common autoimmune diseases, including rheumatoid arthritis, psoriasis, insulin-dependent diabetes, and thyroid disease. Our analyses suggest that chronic PTSD, particularly comorbid PTSD or complex PTSD, is associated with all of these conditions. In addition, veterans with comorbid PTSD were more likely to have clinically higher T-cell counts, hyperreactive immune responses on

  1. Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

    PubMed

    Takahashi, K; Sengoku, S; Kimura, H

    2011-02-01

    A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

  2. Anxiety in Parkinson's disease: a critical review of experimental and clinical studies.

    PubMed

    Prediger, Rui D S; Matheus, Filipe C; Schwarzbold, Marcelo L; Lima, Marcelo M S; Vital, Maria A B F

    2012-01-01

    Parkinson's disease (PD) is the second most common neurodegenerative disorder affecting about 1% of the population older than 60 years. Classically, PD is considered as a movement disorder, and its diagnosis is based on the presence of a set of cardinal motor signs that are the consequence of a pronounced death of dopaminergic neurons in the substantia nigra pars compacta. There is now considerable evidence showing that the neurodegenerative processes leading to sporadic PD begin many years before the appearance of the characteristic motor symptoms, and that additional neuronal fields and neurotransmitter systems are also involved in PD, including olfactory structures, amygdala, caudal raphe nuclei, locus coeruleus, and hippocampus. Accordingly, adrenergic and serotonergic neurons are also lost, which seems to contribute to the anxiety in PD. Non-motor features of PD usually do not respond to dopaminergic medication and probably form the major current challenge in the clinical management of PD. Additionally, most studies performed with animal models of PD have investigated their ability to induce motor alterations associated with advanced phases of PD, and some studies begin to assess non-motor behavioral features of the disease. The present review attempts to examine results obtained from clinical and experimental studies to provide a comprehensive picture of the neurobiology and current and potential treatments for anxiety in PD. The data reviewed here indicate that, despite their high prevalence and impact on the quality of life, anxiety disorders are often under-diagnosed and under-treated in PD patients. Moreover, there are currently few clinical and pre-clinical studies underway to investigate new pharmacological agents for relieving these symptoms, and we hope that this article may inspire clinicians and researchers devote to the studies on anxiety in PD to change this scenario. This article is part of a Special Issue entitled 'Anxiety and Depression

  3. A qualitative study on acceptable levels of risk for pregnant women in clinical research.

    PubMed

    van der Zande, Indira S E; van der Graaf, Rieke; Oudijk, Martijn A; van Delden, Johannes J M

    2017-05-15

    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient

  4. Clinical Research Methodology 2: Observational Clinical Research.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

  5. Microfinance investments in quality at private clinics in Uganda: a case-control study.

    PubMed

    Seiber, Eric E; Robinson, Amara L

    2007-10-18

    Small private-sector health care providers can play an important role in meeting the developing country health care needs, but a lack of credit can prove major constraint to small-provider expansion. This study examines the potential of small, microfinance loans to strengthen the private health sector and improve access to quality preventive and curative health services in Uganda. This study estimates logistic regressions using 2,387 client exit interviews to assess the impact of microfinance loans on perceived quality and the viability and sustainability of small, private clinics. The study finds perceived quality improved with loan recipients' clients being more likely to choose clinics on the basis of drug availability, fair charges, cleanliness, and confidentiality. In addition, the assessment found evidence of increased client flows, but the changes produced mixed results for sustainability with respondents being only half as likely to "always" visit a particular clinic. The results indicate that the microfinance program improved perceived quality at loan recipient clinics, especially as reliable drug outlets.

  6. Studying the effect of clinical uncertainty on physicians' decision-making using ILIAD.

    PubMed

    Anderson, J D; Jay, S J; Weng, H C; Anderson, M M

    1995-01-01

    The influence of uncertainty on physicians' practice behavior is not well understood. In this research, ILIAD, a diagnostic expert system, has been used to study physicians' responses to uncertainty and how their responses affected clinical performance. The simulation mode of ILIAD was used to standardize the presentation and scoring of two cases to 46 residents in emergency medicine, internal medicine, family practice and transitional medicine at Methodist Hospital of Indiana. A questionnaire was used to collect additional data on how physicians respond to clinical uncertainty. A structural equation model was developed, estimated, and tested. The results indicate that stress that physicians experience in dealing with clinical uncertainty has a negative effect on their clinical performance. Moreover, the way that physicians respond to uncertainty has positive and negative effects on their performance. Open discussions with patients about clinical decisions and the use of practice guidelines improves performance. However, when the physician's clinical decisions are influenced by patient demands or their peers, their performance scores decline.

  7. Use of FEV1 in Cystic Fibrosis Epidemiologic Studies and Clinical Trials: A Statistical Perspective for the Clinical Researcher

    PubMed Central

    Szczesniak, Rhonda; Heltshe, Sonya L.; Stanojevic, Sanja; Mayer-Hamblett, Nicole

    2017-01-01

    Background Forced expiratory volume in 1 second (FEV1) is an established marker of cystic fibrosis (CF) disease progression that is used to capture clinical course and evaluate therapeutic efficacy. The research community has established FEV1 surveillance data through a variety of observational data sources such as patient registries, and there is a growing pipeline of new CF therapies demonstrated to be efficacious in clinical trials by establishing improvements in FEV1. Results In this review, we summarize from a statistical perspective the clinical relevance of FEV1 based on its association with morbidity and mortality in CF, its role in epidemiologic studies of disease progression and comparative effectiveness, and its utility in clinical trials. In addition, we identify opportunities to advance epidemiologic research and the clinical development pipeline through further statistical considerations. Conclusions Our understanding of CF disease course, therapeutics, and clinical care has evolved immensely in the past decades, in large part due to the thoughtful application of rigorous research methods and meaningful clinical endpoints such as FEV1. A continued commitment to conduct research that minimizes the potential for bias, maximizes the limited patient population, and harmonizes approaches to FEV1 analysis while maintaining clinical relevance, will facilitate further opportunities to advance CF care. PMID:28117136

  8. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  9. Are Mammographically Occult Additional Tumors Identified More Than 2 Cm Away From the Primary Breast Cancer on MRI Clinically Significant?

    PubMed

    Goodman, Sarah; Mango, Victoria; Friedlander, Lauren; Desperito, Elise; Wynn, Ralph; Ha, Richard

    2018-06-08

    To evaluate the clinical significance of mammographically occult additional tumors identified more than 2cm away from the primary breast cancer on preoperative magnetic resonance imaging (MRI). An Institutional Review Board approved review of consecutive preoperative breast MRIs performed from 1/1/08 to 12/31/14, yielded 667 patients with breast cancer. These patients underwent further assessment to identify biopsy proven mammographically occult breast tumors located more than 2cm away from the edge of the primary tumor. Additional MRI characteristics of the primary and secondary tumors and pathology were reviewed. Statistical analysis was performed using SPSS (v. 24). Of 667 patients with breast cancer, 129 patients had 150 additional ipsilateral mammographically occult tumors that were more than 2cm away from the edge of the primary tumor. One hundred twelve of 129 (86.8%) patients had one additional tumor and 17/129 (13.2%) had two or more additional tumors. In 71/129 (55.0%), additional tumors were located in a different quadrant and in 58/129 (45.0%) additional tumors were in the same quadrant but ≥2cm away. Overall, primary tumor size was significantly larger (mean 1.87± 1.25 cm) than the additional tumors (mean 0.79 ± 0.61cm, p < 0.001). However, in 20/129 (15.5%) the additional tumor was larger and in 26/129 (20.2%) the additional tumor was ≥1cm. The primary tumor was significantly more likely to be invasive (81.4%, 105/129) compared to additional tumors (70%, 105/150, p = 0.03). In 9/129 (7.0%) patients, additional tumors yielded unsuspected invasive cancer orhigher tumor grade. The additional tumor was more likely to be nonmass lesion type (37.3% vs 24% p = 0.02) and focus lesion type (10% vs 0.08%, p < 0.001) compared to primary tumor. Mammographically occult additional tumors identified more than 2cm away from the primary breast tumor on MRI are unlikely to be surgically treated if undiagnosed and may be clinically significant. Copyright

  10. Does Additional Biceps Augmentation Improve Rotator Cuff Healing and Clinical Outcomes in Anterior L-Shaped Rotator Cuff Tears? Clinical Comparisons With Arthroscopic Partial Repair.

    PubMed

    Jeon, Yoon Sang; Lee, Juyeob; Kim, Rag Gyu; Ko, Young-Won; Shin, Sang-Jin

    2017-11-01

    The repair of anterior L-shaped tears is usually difficult because of the lack of anterior rotator cuff tendon to cover the footprint. The biceps tendon is usually exposed from the retracted anterolateral corner of the torn tendon and can be easily used to augment rotator cuff repair. Hypothesis/Purpose: This study compared the clinical outcomes of the biceps augmentation technique with those of partial tendon repair for the arthroscopic treatment of large anterior L-shaped rotator cuff tears to evaluate the role of additional biceps augmentation in tendon healing. We hypothesized that the biceps augmentation technique would lead to a lower rotator cuff tendon retear rate and provide satisfactory functional outcomes. Cohort study; Level of evidence, 3. This study included 64 patients with anterior L-shaped rotator cuff tears who underwent arthroscopic repair. Patients were divided into 2 groups: group A (31 patients) underwent repair of an anterior L-shaped tear combined with biceps augmentation, and group B (33 patients) had a partially repaired tendon whose footprint was exposed after repair without undue tension on the retracted tendon. Clinical evaluations were performed using the American Shoulder and Elbow Surgeons (ASES) score, Constant score, muscle strength, visual analog scale for pain, and patient satisfaction. Magnetic resonance imaging (MRI) was performed for tendon integrity at 6 months postoperatively. The mean period of follow-up was 29.1 ± 3.5 months (range, 24-40 months). The mean ASES and Constant scores significantly improved from 52.8 ± 10.6 and 43.2 ± 9.9 preoperatively to 88.2 ± 6.9 and 86.8 ± 6.2 at final follow-up in group A ( P < .001) and from 53.0 ± 11.8 and 44.3 ± 11.3 preoperatively to 87.4 ± 7.2 and 87.9 ± 7.3 at final follow-up in group B ( P < .001). Overall muscle strength (given as % of the other side's strength) significantly increased from preoperatively to final follow-up in group A (forward flexion [FF]: 62.0 ± 8

  11. Microfinance investments in quality at private clinics in Uganda: a case-control study

    PubMed Central

    Seiber, Eric E; Robinson, Amara L

    2007-01-01

    Background Small private-sector health care providers can play an important role in meeting the developing country health care needs, but a lack of credit can prove major constraint to small-provider expansion. This study examines the potential of small, microfinance loans to strengthen the private health sector and improve access to quality preventive and curative health services in Uganda. Methods This study estimates logistic regressions using 2,387 client exit interviews to assess the impact of microfinance loans on perceived quality and the viability and sustainability of small, private clinics. Results The study finds perceived quality improved with loan recipients' clients being more likely to choose clinics on the basis of drug availability, fair charges, cleanliness, and confidentiality. In addition, the assessment found evidence of increased client flows, but the changes produced mixed results for sustainability with respondents being only half as likely to "always" visit a particular clinic. Conclusion The results indicate that the microfinance program improved perceived quality at loan recipient clinics, especially as reliable drug outlets. PMID:17945024

  12. Laser doppler imaging as additional monitoring after digital replanting: A prospective study.

    PubMed

    Schmid, Marc; Seyed Jafari, S Morteza; Haug, Luzian; Surke, Carsten; Hunger, Robert E; Van De Ville, Dimitri; Juon Personeni, Bettina; Shafighi, Maziar; Voegelin, Esther

    2018-03-14

    Despite various exisiting monitoring methods, there is still a need for new technologies to improve the quality of post-operative evaluation of digital replantation. The purpose of the study is using a laser Doppler imaging device (Easy-LDI) as an additional tool to assess perfusion. In this method, the changes in the frequency of the laser ligth provide information regarding perfusion of the monitored tissue. This study included seven patients (10 fingers; age of patients: 21-57 years) who suffered from a total (n = 6) or subtotal amputation (n = 4) due to accidents. In addition to hourly standard monitoring with clinical evaluation and skin thermometry, revascularized fingers were hourly monitored with Easy LDI for 48 h. LDI measurement values ranged between 0.8 and 223 (mean 90.62 ± 21.42) arbitrary perfusion units (APU). The mean LDI values before and after revascularization were 7.1 ± 2.85 and 65.30 ± 30.83 APU, respectively. For the successful revascularized fingers (8 of 10 fingers) values from 19 to 223 APU (mean 98.52 ± 15.48) were demonstrated. All of the replants survived, but due to venous occlusion two digits required revision 12 and 35 h after revascularization, respectively. In the two cases, Easy-LDI also showed a constant and slow decline of the perfusion values. Furthermore, Pearson normalized correlation coefficient showed a positive significant correlation between temperatures of the replants and LDI-values (P < .001, r = +0.392) and a negative significant correlation between Δtemperature and LDI-values (P < .001, r = -0.474). The LDI-device might be a promising additional monitoring technique in detection of perfusion disturbance in monitoring digital replantations. © 2018 Wiley Periodicals, Inc.

  13. Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

    PubMed Central

    Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

    2011-01-01

    Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project

  14. Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

    PubMed

    Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

    Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

  15. Updates on clinical studies of selenium supplementation in radiotherapy

    PubMed Central

    2014-01-01

    To establish guidelines for the selenium supplementation in radiotherapy we assessed the benefits and risks of selenium supplementation in radiotherapy. Clinical studies on the use of selenium in radiotherapy were searched in the PubMed electronic database in January 2013. Sixteen clinical studies were identified among the 167 articles selected in the initial search. Ten articles were observational studies, and the other 6 articles reported studies on the effects of selenium supplementation in patients with cancer who underwent radiotherapy. The studies were conducted worldwide including European, American and Asian countries between 1987 and 2012. Plasma, serum or whole blood selenium levels were common parameters used to assess the effects of radiotherapy and the selenium supplementation status. Selenium supplementation improved the general conditions of the patients, improved their quality of life and reduced the side effects of radiotherapy. At the dose of selenium used in these studies (200–500 μg/day), selenium supplementation did not reduce the effectiveness of radiotherapy, and no toxicities were reported. Selenium supplementation may offer specific benefits for several types of cancer patients who undergo radiotherapy. Because high-dose selenium and long-term supplementation may be unsafe due to selenium toxicity, more evidence-based information and additional research are needed to ensure the therapeutic benefits of selenium supplementation. PMID:24885670

  16. Clinical Laboratory Automation: A Case Study

    PubMed Central

    Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

    2017-01-01

    Background This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. Materials and Methods The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. Results The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. Conclusions The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs. Significance for public health Automation is an emerging trend in modern clinical laboratories with a positive impact on service level to patients and on staff safety as shown by different studies. In fact, it allows process standardization which, in turn, decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff safety. In this study, we analyse a further potential benefit of automation, that is economic convenience. We study the case of the automated laboratory of one of the biggest hospital in Italy and compare the cost related to the pre and post automation situation. Introducing automation lead to a cost decrease without affecting the service level to patients

  17. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness

    PubMed Central

    Ridd, Matthew J; Francis, Nick A; Stuart, Beth; Rumsby, Kate; Chorozoglou, Maria; Becque, Taeko; Roberts, Amanda; Liddiard, Lyn; Nollett, Claire; Hooper, Julie; Prude, Martina; Wood, Wendy; Thomas, Kim S; Thomas-Jones, Emma; Williams, Hywel C; Little, Paul

    2018-01-01

    Abstract Objectives To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children. Design Pragmatic randomised open label superiority trial with two parallel groups. Setting 96 general practices in Wales and western and southern England. Participants 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded. Interventions Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants. Main outcome measures The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed. Results 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the

  18. Service provider perceptions of telerehabilitation as an additional service delivery option within an Australian neurosurgical and orthopaedic physiotherapy screening clinic: A qualitative study.

    PubMed

    Cottrell, Michelle A; Hill, Anne J; O'Leary, Shaun P; Raymer, Maree E; Russell, Trevor G

    2017-12-01

    The Neurosurgical & Orthopaedic Physiotherapy Screening Clinic and Multidisciplinary Service (N/OPSC&MDS) originated as a complementary, non-surgical pathway for patients referred to public neurosurgical and orthopaedic specialist services. Patient access to the N/OPSC&MDS could potentially be improved with the implementation of telerehabilitation as an additional method of service delivery. To evaluate service provider's views on (1) current barriers to patients' accessing N/OPSC & MD services, and (2) the implementation of telerehabilitation within the N/OPSC&MDS. Qualitative descriptive study design. Healthcare providers (n = 26) were recruited from six N/OPSC&MD services located throughout Queensland, Australia. Semi-structured interviews were conducted to explore service providers' views with respect to existing barriers to patients accessing the N/OPSC&MDS, and if telerehabilitation could be feasibly adopted to address current barriers. Template analysis resulted in six themes: (1) barriers to some patients' accessing current N/OPSC&MD services are complex & multifaceted; (2) telerehabilitation could improve patient access to appropriate management for their musculoskeletal condition; (3) telerehabilitation may have limitations when compared to face-to-face healthcare; (4) the delivery of telerehabilitation needs to be flexible; (5) perceived barriers, and (6) facilitators to the successful implementation of telerehabilitation within the N/OPSC&MDS. This study represents a critical step in determining the readiness of service providers for the implementation of telerehabilitation within the N/OPSC&MDS. Although cautious, service providers are overall accepting of the implementation of telerehabilitation, acknowledging that it could eliminate several current barriers, subsequently achieving more equitable access to the service. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  19. Additivity vs Synergism: Investigation of the Additive Interaction of Cinnamon Bark Oil and Meropenem in Combinatory Therapy.

    PubMed

    Yang, Shun-Kai; Yusoff, Khatijah; Mai, Chun-Wai; Lim, Wei-Meng; Yap, Wai-Sum; Lim, Swee-Hua Erin; Lai, Kok-Song

    2017-11-04

    Combinatory therapies have been commonly applied in the clinical setting to tackle multi-drug resistant bacterial infections and these have frequently proven to be effective. Specifically, combinatory therapies resulting in synergistic interactions between antibiotics and adjuvant have been the main focus due to their effectiveness, sidelining the effects of additivity, which also lowers the minimal effective dosage of either antimicrobial agent. Thus, this study was undertaken to look at the effects of additivity between essential oils and antibiotic, via the use of cinnamon bark essential oil (CBO) and meropenem as a model for additivity. Comparisons between synergistic and additive interaction of CBO were performed in terms of the ability of CBO to disrupt bacterial membrane, via zeta potential measurement, outer membrane permeability assay and scanning electron microscopy. It has been found that the additivity interaction between CBO and meropenem showed similar membrane disruption ability when compared to those synergistic combinations which was previously reported. Hence, results based on our studies strongly suggest that additive interaction acts on a par with synergistic interaction. Therefore, further investigation in additive interaction between antibiotics and adjuvant should be performed for a more in depth understanding of the mechanism and the impacts of such interaction.

  20. Manual therapy in addition to physiotherapy does not improve clinical or economic outcomes after ankle fracture.

    PubMed

    Lin, Chung-Wei Christine; Moseley, Anne M; Haas, Marion; Refshauge, Kathryn M; Herbert, Robert D

    2008-06-01

    The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture. Assessor-blinded randomized controlled trial. Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture. Inclusion criteria were: they were able to weight-bear as tolerated or partial weight-bear, were referred for physiotherapy, and experienced pain. Ninety-one participants completed the study. Participants were randomly allocated to receive manual therapy (anterior-posterior joint mobilization over the talus) plus a standard physiotherapy programme (experimental), or the standard physiotherapy programme only (control). They were assessed by a blinded assessor at baseline, and at 4, 12 and 24 weeks. The main outcomes were activity limitation and quality of life. Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks. There were no clinically worthwhile differences in activity limitation or quality of life between groups at any time-point. There was also no between-group difference in quality-adjusted life-years, but the experimental group incurred higher out-of-pocket costs (mean between-group difference = AU$200, 95% confidence interval 26-432). When provided in addition to a physiotherapy programme, manual therapy did not enhance outcome in adults after ankle fracture.

  1. Electrostatic Levitation for Studies of Additive Manufactured Materials

    NASA Technical Reports Server (NTRS)

    SanSoucie, Michael P.; Rogers, Jan R.; Tramel, Terri

    2014-01-01

    The electrostatic levitation (ESL) laboratory at NASA's Marshall Space Flight Center is a unique facility for investigators studying high temperature materials. The laboratory boasts two levitators in which samples can be levitated, heated, melted, undercooled, and resolidified. Electrostatic levitation minimizes gravitational effects and allows materials to be studied without contact with a container or instrumentation. The lab also has a high temperature emissivity measurement system, which provides normal spectral and normal total emissivity measurements at use temperature. The ESL lab has been instrumental in many pioneering materials investigations of thermophysical properties, e.g., creep measurements, solidification, triggered nucleation, and emissivity at high temperatures. Research in the ESL lab has already led to the development of advanced high temperature materials for aerospace applications, coatings for rocket nozzles, improved medical and industrial optics, metallic glasses, ablatives for reentry vehicles, and materials with memory. Modeling of additive manufacturing materials processing is necessary for the study of their resulting materials properties. In addition, the modeling of the selective laser melting processes and its materials property predictions are also underway. Unfortunately, there is very little data for the properties of these materials, especially of the materials in the liquid state. Some method to measure thermophysical properties of additive manufacturing materials is necessary. The ESL lab is ideal for these studies. The lab can provide surface tension and viscosity of molten materials, density measurements, emissivity measurements, and even creep strength measurements. The ESL lab can also determine melting temperature, surface temperatures, and phase transition temperatures of additive manufactured materials. This presentation will provide background on the ESL lab and its capabilities, provide an approach to using the ESL

  2. Exploring Organizational Barriers to Strengthening Clinical Supervision of Psychiatric Nursing Staff: A Longitudinal Controlled Intervention Study.

    PubMed

    Gonge, Henrik; Buus, Niels

    2016-05-01

    This article reports findings from a longitudinal controlled intervention study of 115 psychiatric nursing staff. The twofold objective of the study was: (a) To test whether the intervention could increase clinical supervision participation and effectiveness of existing supervision practices, and (b) To explore organizational constraints to implementation of these strengthened practices. Questionnaire responses and registration of participation in clinical supervision were registered prior and subsequent to the intervention consisting of an action learning oriented reflection on staff's existing clinical supervision practices. Major organizational changes in the intervention group during the study period obstructed the implementation of strengthened clinical supervision practices, but offered an opportunity for studying the influences of organizational constraints. The main findings were that a) diminishing experience of social support from colleagues was associated with reduced participation in clinical supervision, while b) additional quantitative demands were associated with staff reporting difficulties finding time for supervision. This probably explained a negative development in the experienced effectiveness of supervision. It is concluded that organizational support is an imperative for implementation of clinical supervision.

  3. HIS-Based Support of Follow-Up Documentation – Concept and Implementation for Clinical Studies

    PubMed Central

    Herzberg, S.; Fritz, F.; Rahbar, K.; Stegger, L.; Schäfers, M.; Dugas, M.

    2011-01-01

    Objective Follow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation. Methods We have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively. Results A HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week). Conclusion HIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols. PMID:23616857

  4. Embedding clinical interventions into observational studies

    PubMed Central

    Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

    2017-01-01

    Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

  5. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies

    PubMed Central

    O’Donnell, Lauren A.; Perry, Michael W.; Doup, Dane’t R.

    2015-01-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course. PMID:26753029

  6. Clinical Benefits of Rivastigmine in the Real World Dementia Clinics of the Okayama Rivastigmine Study (ORS).

    PubMed

    Matsuzono, Kosuke; Sato, Kota; Kono, Syoichiro; Hishikawa, Nozomi; Ohta, Yasuyuki; Yamashita, Toru; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

    2015-01-01

    Alzheimer's disease (AD) is one of the most important diseases in an aging society, but the clinical effects of rivastigmine have not been fully examined in real world domestic clinics. We performed the "Okayama Rivastigmine Study (ORS)" to retrospectively analyze the clinical effects of rivastigmine (n = 75) or donepezil (n = 71) on AD patients with seven dementia assessment batteries at the baseline, 3, 6, and 12 months. In addition, we divided the rivastigmine group into two subgroups at the baseline: the mild behavioral and psychological symptoms of dementia (BPSD) group (Abe's BPSD score (ABS) <6) and the severe BPSD group (6≤ABS). In these two subgroups, baseline scores and changes were also retrospectively analyzed until 12 months. Rivastigmine significantly improved the Mini-Mental State Examination score at 3 months (*p <  0.05 versus baseline) and at 6 months (*p <  0.05), the Frontal Assessment Battery (FAB) at 6 months (*p <  0.05), and ABS at 3 months (**p <  0.01) while donepezil only stabilized the three cognitive scores. On the other hand, the Geriatric Depression Scale and the Apathy Scale were stable until 12 months in both groups. Baseline BPSD severity-dependent analysis showed a small improvement of FAB at 6 months in the mild BPSD subgroup (*p <  0.05) and a great improvement of ABS at 3 months in the severe BPSD subgroup (**p <  0.01) in the rivastigmine group. Our present study showed that rivastigmine improved both cognitive and affective functions at 3 and 6 months, and suggested an advantage at 3 and 6 months compared to donepezil in real world dementia clinics.

  7. A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

    PubMed

    El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

    2016-10-27

    Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

  8. Engagement and practical wisdom in clinical practice: a phenomenological study.

    PubMed

    Saraga, Michael; Boudreau, Donald; Fuks, Abraham

    2018-05-08

    In order to understand the lived experiences of physicians in clinical practice, we interviewed eleven expert, respected clinicians using a phenomenological interpretative methodology. We identified the essence of clinical practice as engagement. Engagement accounts for the daily routine of clinical work, as well as the necessity for the clinician to sometimes trespass common boundaries or limits. Personally engaged in the clinical situation, the clinician is able to create a space/time bubble within which the clinical encounter can unfold. Engagement provides an account of clinical practice as a unitary lived experience. This stands in stark contrast to the prevailing notion, referred to as a dual discourse, that describes medicine as the addition of humanism to science. Drawing on Aristotle's notion of phronesis and Sartre's definition of the situation, we illustrate how this novel perspective entwines clinical practice, the person of the clinician, and the clinician's situation.

  9. Kidney volume measurement methods for clinical studies on autosomal dominant polycystic kidney disease

    PubMed Central

    Sharma, Kanishka; Caroli, Anna; Quach, Le Van; Petzold, Katja; Bozzetto, Michela; Serra, Andreas L.; Remuzzi, Giuseppe; Remuzzi, Andrea

    2017-01-01

    Background In autosomal dominant polycystic kidney disease (ADPKD), total kidney volume (TKV) is regarded as an important biomarker of disease progression and different methods are available to assess kidney volume. The purpose of this study was to identify the most efficient kidney volume computation method to be used in clinical studies evaluating the effectiveness of treatments on ADPKD progression. Methods and findings We measured single kidney volume (SKV) on two series of MR and CT images from clinical studies on ADPKD (experimental dataset) by two independent operators (expert and beginner), twice, using all of the available methods: polyline manual tracing (reference method), free-hand manual tracing, semi-automatic tracing, Stereology, Mid-slice and Ellipsoid method. Additionally, the expert operator also measured the kidney length. We compared different methods for reproducibility, accuracy, precision, and time required. In addition, we performed a validation study to evaluate the sensitivity of these methods to detect the between-treatment group difference in TKV change over one year, using MR images from a previous clinical study. Reproducibility was higher on CT than MR for all methods, being highest for manual and semiautomatic contouring methods (planimetry). On MR, planimetry showed highest accuracy and precision, while on CT accuracy and precision of both planimetry and Stereology methods were comparable. Mid-slice and Ellipsoid method, as well as kidney length were fast but provided only a rough estimate of kidney volume. The results of the validation study indicated that planimetry and Stereology allow using an importantly lower number of patients to detect changes in kidney volume induced by drug treatment as compared to other methods. Conclusions Planimetry should be preferred over fast and simplified methods for accurately monitoring ADPKD progression and assessing drug treatment effects. Expert operators, especially on MR images, are required

  10. Antiobesity Effects of Anthocyanins in Preclinical and Clinical Studies

    PubMed Central

    Giacometti, Jasminka

    2017-01-01

    The natural phytochemicals present in foods, including anthocyanins, might play a role in attenuating obesity by producing a decrease in weight and adipose tissue. This review focused on current knowledge about anthocyanins' role in obesity and its related comorbidities reported in animal models and humans. We summarized their target identification and mechanism of action through several pathways and their final effects on health and well-being. Into consideration of ongoing researches, we highlighted the following key points: a healthy relationship between anthocyanin supplementation and antiobesity effects suffers of the same pros and cons evidenced when the beneficial responses to other phytochemical treatments towards different degenerative diseases have been considered; the different dosage applied in animal versus clinical studies; the complex metabolism and biotransformation to which anthocyanins and phytochemicals are subjected in the intestine and tissues; the possibility that different components present in the supplemented mixtures can interact generating antagonistic, synergistic, or additive effects difficult to predict, and the difference between prevention and therapy. The evolution of the field must seriously consider the need to establish new and adequate cellular and animal models which may, in turn, allow the design of more efficient and prevention-targeted clinical studies. PMID:28785373

  11. Antiobesity Effects of Anthocyanins in Preclinical and Clinical Studies.

    PubMed

    Azzini, Elena; Giacometti, Jasminka; Russo, Gian Luigi

    2017-01-01

    The natural phytochemicals present in foods, including anthocyanins, might play a role in attenuating obesity by producing a decrease in weight and adipose tissue. This review focused on current knowledge about anthocyanins' role in obesity and its related comorbidities reported in animal models and humans. We summarized their target identification and mechanism of action through several pathways and their final effects on health and well-being. Into consideration of ongoing researches, we highlighted the following key points: a healthy relationship between anthocyanin supplementation and antiobesity effects suffers of the same pros and cons evidenced when the beneficial responses to other phytochemical treatments towards different degenerative diseases have been considered; the different dosage applied in animal versus clinical studies; the complex metabolism and biotransformation to which anthocyanins and phytochemicals are subjected in the intestine and tissues; the possibility that different components present in the supplemented mixtures can interact generating antagonistic, synergistic, or additive effects difficult to predict, and the difference between prevention and therapy. The evolution of the field must seriously consider the need to establish new and adequate cellular and animal models which may, in turn, allow the design of more efficient and prevention-targeted clinical studies.

  12. [Teaching of clinical reasoning to medical students using prototypical clinical cases].

    PubMed

    Montaldo L, Gustavo; Herskovic L, Pedro

    2013-07-01

    Clinical reasoning is the most important competente in the training process of a physician. To develop a method for teaching clinical reasoning based on prototypes of clinical cases. The study was conducted on sixty-four third year medical students. The study and control groups attended lectures and tutorial sessions with patients. The study group attended additionally discussion seminars of prototypical clinical cases. A clinical reasoning test was applied at the start and end of the learning period to both groups. At the end of the study, the opinions of students of the study group were collected in a focus group. After the learning period, both groups significantly increased their clinical reasoning skills. However, the improvement in the study group was more than double than that of the control group. The absolute improvement in the study group was 30.9%. Students interviewed in the focus group were unanimous in expressing their satisfaction in each and every aspect discussed. The teaching of clinical reasoning to third year medical students by means of pattern recognition in seminars with clinical cases improved significantly their skills.

  13. Clinical, Morphological, and Molecular Evaluations of Bone Regeneration With an Additive Manufactured Osteosynthesis Plate.

    PubMed

    Thor, Andreas; Palmquist, Anders; Hirsch, Jan-Michaél; Rännar, Lars-Erik; Dérand, Per; Omar, Omar

    2016-10-01

    There is limited information on the biological status of bone regenerated with microvascular fibula flap combined with biomaterials. This paper describes the clinical, histological, ultrastructural, and molecular picture of bone regenerated with patient-customized plate, used for mandibular reconstruction in combination with microvascular osteomyocutaneous fibula flap. The plate was virtually planned and additively manufactured using electron beam melting. This plate was retrieved from the patient after 33 months. Microcomputed tomography, backscattered-scanning electron microscopy, histology, and quantitative-polymerase chain reaction were employed to evaluate the regenerated bone and the flap bone associated with the retrieved plate. At retrieval, the posterior two-thirds of the plate were in close adaptation with the underlying flap, whereas soft tissue was observed between the native mandible and the anterior one-third. The histological and structural analyses showed new bone regeneration, ingrowth, and osseointegration of the posterior two-thirds. The histological observations were supported by the gene expression analysis showing higher expression of bone formation and remodeling genes under the posterior two-thirds compared with the anterior one-third of the plate. The observation of osteocytes in the flap indicated its viability. The present data endorse the suitability of the customized, additively manufactured plate for the vascularized fibula mandibular reconstruction. Furthermore, the combination of the analytical techniques provides possibilities to deduce the structural and molecular characteristics of bone regenerated using this procedure.

  14. Non-invasive prenatal testing (NIPT): Europe's first multicenter post-market clinical follow-up study validating the quality in clinical routine.

    PubMed

    Flöck, Anne; Tu, Ngoc-Chi; Rüland, Anna; Holzgreve, Wolfgang; Gembruch, Ulrich; Geipel, Annegret

    2017-11-01

    Non-invasive prenatal tests (NIPT) for the determination of fetal aneuploidies from maternal blood are firmly established in clinical routine. For the first time, the accuracy of an NIPT for the determination of trisomies 21, 18 and 13 in singleton pregnancies was assessed by means of a prospective German-wide multicenter post-market clinical follow-up study, to reliably evaluate the quality in clinical routine. The study covered the indications for testing, the test results, the rate of invasive diagnostics and the pregnancy outcome. 2232 cases were tested for trisomy 21. Of these, 1946 cases were additionally examined for trisomy 18 and 13. Sensitivity and specificity for trisomy 21 (43/43) and for trisomy 13 (2/2) were 100%, for trisomy 18 the sensitivity was 80% (4/5) with a specificity of 99.8%. Three false-positive results for trisomy 18 were observed (FPR 0.15%). The no-call rate was 0.5%. In this subgroup, 27.3% (3/11) aneuploidies were diagnosed. The rate of invasive procedures was 2.6%. NIPT provides a very high quality for the fetal trisomies 21, 13 and 18 in clinical routine. The results support the recommendation that NIPT should be offered after genetic counseling and only in conjunction with a qualified ultrasound examination.

  15. Embedding clinical interventions into observational studies.

    PubMed

    Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

    2016-01-01

    Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

  16. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    PubMed

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  17. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness.

    PubMed

    Santer, Miriam; Ridd, Matthew J; Francis, Nick A; Stuart, Beth; Rumsby, Kate; Chorozoglou, Maria; Becque, Taeko; Roberts, Amanda; Liddiard, Lyn; Nollett, Claire; Hooper, Julie; Prude, Martina; Wood, Wendy; Thomas, Kim S; Thomas-Jones, Emma; Williams, Hywel C; Little, Paul

    2018-05-03

    To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children. Pragmatic randomised open label superiority trial with two parallel groups. 96 general practices in Wales and western and southern England. 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded. Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants. The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed. 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score

  18. Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

    PubMed Central

    Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

    2009-01-01

    Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

  19. Clinical Research Informatics: Supporting the Research Study Lifecycle.

    PubMed

    Johnson, S B

    2017-08-01

    Objectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years 2015-2016. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions. Georg Thieme Verlag KG Stuttgart.

  20. [Clinical studies on SM-4300].

    PubMed

    Sawae, Y; Nagafuchi, S

    1985-09-01

    Use of SM-4300, which is a newly developed human immunoglobulin preparation for intravenous administration, has clinically been evaluated in the patients with severe or intractable bacterial infections. Of total 13 cases of the admitted patients at the 1st department of internal medicine, faculty of medicine, Kyushu university, 10-pneumonia case were associated with blood diseases like acute myelocytic leukemia (AML) and multiple myeloma (MM), and in addition, with other underlying diseases like lung cancer and bronchiectasis, 1 was prosthetic valve endocarditis, 1 cholecystitis associated with pericarditis and 1 fever of undetermined origin (FUO). SM-4300 of 5 g single bolus or 3 daily doses of 2.5 g per day were infused with chemotherapy drugs preceedingly administered for more than 3 days and the results were evaluated; good in 4, fair 4, poor 2 and unknown 3, and the efficacy rate was 40%. Bacteriologically, the results were decreased in 1, persisted 1 and the majority was unknown. Observed were no side reactions nor the changes in clinical examination variables incurred by this drug. It is therefore considered that SM-4300 is of use for the treatment of intractable bacterial infections when used with antibiotics.

  1. Effect of study partner on the conduct of Alzheimer disease clinical trials

    PubMed Central

    Raman, Rema; Ernstrom, Karin; Aisen, Paul; Karlawish, Jason

    2013-01-01

    Objective: Alzheimer disease (AD) dementia clinical trials require 2 participants: a patient and a study partner. We assessed the prevalence of study partner types and how these types associate with patient-related outcome measures. Methods: Retrospective analyses of 6 Alzheimer’s Disease Cooperative Study (ADCS) randomized clinical trials were conducted. Study partners were categorized as spouse, adult child, or other. Prevalence of study partner type and associations between study partner type and trial outcomes including study completion and placebo decline on the Mini-Mental State Examination, the Alzheimer’s Disease Assessment Scale–cognitive subscale, the Clinical Dementia Rating scale Sum of the Boxes score, and the ADCS–Activities of Daily Living were examined. Results: More participants (67%) enrolled with spouses than adult children (26%) or other study partners (7%). Participants with spouse partners had a lower dropout rate (25%) than those with adult child (32%) or other study partners (34%); only the difference vs others was statistically significant. Participants with adult child and other partners randomized to placebo performed worse at baseline than those with spouse partners on the ADCS–Activities of Daily Living (p = 0.04), but were not different at 18 months. There were no differences at baseline for the Mini-Mental State Examination, Clinical Dementia Rating scale Sum of the Boxes score, or Alzheimer’s Disease Assessment Scale–cognitive subscale. In multivariate models of the rates of change over time among placebo participants, no differences among study partner groups reached statistical significance. Conclusions: Patients with nonspouse caregivers less frequently participate in AD dementia trials. Increased enrollment of AD patients with nonspouse caregivers may require additional recruitment and retention strategies. PMID:23255824

  2. Influence of an alloy addition on the physical and clinical behaviour of glass ionomer cement

    NASA Astrophysics Data System (ADS)

    Abour, Mohamed Abour Bashir

    These in vitro studies compared the various properties of an experimental high powder liquid content glass ionomer cement (EXPT) with those of a metal addition GIC (Hi-Dense) and disperse phase amalgam (Dispersalloy). Bi-axial, four point flexural and compressive tests were used to evaluate strength. Six groups of ten specimens were constructed for each test for each material and allowed to set in an oven at 37°C for 60 minutes. Specimens were stored in distilled water at 37°C until testing at one day, one week, one, three, six months and year. It was found that the strength of Hi-Dense increased and then maintained over extended time, whereas the strength of EXPT showed a declined at 3 months. The bond strengths of the materials to both enamel and dentine were also evaluated. Ten groups of ten teeth, five for each surface for each glass ionomer materials, were prepared. Teeth were aligned leaving the enamel and dentine surfaces exposed. The mixed material was condensed into a cylinder placed on the appropriate surface. These specimens were also stored in distilled water at 37°C. It was found that Hi-Dense had a higher bond strength to enamel that increased with time. The bond strength to dentine was maintained over the test period. The erosion rate of the materials was evaluated using the lactic acid erosion test. Three groups of six specimens for each material were constructed and tested after one hour, one day and at six months. Each specimen was subjected to an impinging jet of lactic acid solution. The erosion rate was determined by weight loss and dimensional change. It was found that Hi-Dense had a high erosion resistance which was slightly better than the experimental material. The microleakage, around restorations prepared, using the glass ionomer materials, was evaluated after cyclical loading the restoration-tooth complex. It was found that there was less leakage around Hi-Dense than EXPT at both the cervical and occlusal margins. In a clinical

  3. Depression and Physical Frailty Have Additive Effect on the Nutritional Status and Clinical Outcome of Chinese Peritoneal Dialysis.

    PubMed

    Szeto, Cheuk-Chun; Chan, Gordon Chun-Kau; Ng, Jack Kit-Chung; Chow, Kai-Ming; Kwan, Bonnie Ching-Ha; Cheng, Phyllis Mei-Shan; Kwong, Vickie Wai-Ki; Law, Man-Ching; Leung, Chi-Bon; Li, Philip Kam-Tao

    2018-06-07

    Frailty and depression both contribute to malnutrition and adverse clinical outcome of peritoneal dialysis (PD) patients. However, their interaction is incompletely defined. We studied 178 adult Chinese PD patients. Physical frailty was assessed by a validated in-house questionnaire; depressive symptoms was screened by the Geriatric Depression Scale; nutritional status was determined by subjective global assessment (SGA) and malnutrition inflammation score (MIS). All patients were followed for up to 24 months for survival and hospitalization analysis. There were 111 patients (62.4%) physically frail, amongst those 48 (43.2%) had depressive symptoms. Only 1 patient had depressive symptoms without frailty. There was an additive effect of depressive symptoms and physical frailty on nutritional status. For the groups with no frailty, frail but no depressive symptoms, and frail with depressive symptoms, serum albumin decreased in a stepwise manner (35.8 ± 5.6, 34.9 ± 4.4, and 32.9 ± 5.3 g/L, respectively, p=0.025); overall SGA score was 5.75 ± 0.61, 5.41 ± 0.59, and 5.04 ± 0.77, respectively (p< 0.0001), and MIS was 5.12 ± 2.30, 7.13 ± 3.22, and 9.48 ± 3.97, respectively (p< 0.0001). At 24 months, patient survival was 86.6%, 71.4%, and 62.5% for patients with no frailty, frail but no depressive symptoms, and frail with depressive symptoms, respective (p=0.001). The median number of hospital stay was 8.04 (inter-quartile range [IQR] 0.91 - 19.42), 14.05 (IQR 3.57 - 37.27), and 26.62 (IQR 10.65 - 61.18) days per year of follow up, respectively (p< 0.0001). Physical frailty and depressive symptoms are both common in Chinese PD patients, and they have additive adverse effect on the nutritional status and clinical outcome. © 2018 The Author(s). Published by S. Karger AG, Basel.

  4. Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

    PubMed Central

    Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

    2016-01-01

    Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Results Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10−8), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10−12; OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10−23; OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10−9; OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case–control ORs for two distinct types of gout (r=0.96 [p=4.8×10−4] for urate clearance and r=0.96 [p=5.0×10−4] for urinary urate excretion). Conclusions Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. PMID:25646370

  5. Clinical waste incinerators in Cameroon--a case study.

    PubMed

    Mochungong, Peter Ikome Kuwoh; Gulis, Gabriel; Sodemann, Morten

    2012-01-01

    Incinerators are widely used to treat clinical waste in Cameroon's Northwest Region. These incinerators cause public apprehension owing to purported risks to operators, communities and the environment. This article aims to summarize findings from an April 2008 case study. Three incinerators were randomly selected and investigated for site, design and operating standards. Empirical field observation was adopted and data collected through inventory and informal interviews. Bottom ash samples collected from the incinerators were prepared according to standard procedures and analyzed for heavy metals using Inductively Coupled Plasma (ICP) Emission Spectroscopy. Shortcomings associated with site selection, design and operation standards were identified. Chemical analysis revealed that Cr, Cu, Fe, Mn, Ni, Pb, Zn, Mg and Ca were present in the bottom ash with mean concentration ranging from 10 mg/kg for Pb to 178080 mg/kg for Ca. For logistic reasons, feedstock quantity and quality into the incinerators were not investigated. Neither were soil samples around and away from the incinerators. Although highly favored, clinical waste incineration methods in this region have to be reconsidered. A thorough health and environmental impact assessment is suggested before subsequent decisions on choice and disposal site is made. This will curb potential negative impacts to the environment and public health. This article adds a different perspective and sheds additional information to the debate on unsatisfactory clinical waste incinerators in resources-poor countries. Alternative methods to incineration are presented that will be helpful to practitioners.

  6. Anatomically ordered tapping interferes more with one-digit addition than two-digit addition: a dual-task fMRI study.

    PubMed

    Soylu, Firat; Newman, Sharlene D

    2016-02-01

    Fingers are used as canonical representations for numbers across cultures. In previous imaging studies, it was shown that arithmetic processing activates neural resources that are known to participate in finger movements. Additionally, in one dual-task study, it was shown that anatomically ordered finger tapping disrupts addition and subtraction more than multiplication, possibly due to a long-lasting effect of early finger counting experiences on the neural correlates and organization of addition and subtraction processes. How arithmetic task difficulty and tapping complexity affect the concurrent performance is still unclear. If early finger counting experiences have bearing on the neural correlates of arithmetic in adults, then one would expect anatomically and non-anatomically ordered tapping to have different interference effects, given that finger counting is usually anatomically ordered. To unravel these issues, we studied how (1) arithmetic task difficulty and (2) the complexity of the finger tapping sequence (anatomical vs. non-anatomical ordering) affect concurrent performance and use of key neural circuits using a mixed block/event-related dual-task fMRI design with adult participants. The results suggest that complexity of the tapping sequence modulates interference on addition, and that one-digit addition (fact retrieval), compared to two-digit addition (calculation), is more affected from anatomically ordered tapping. The region-of-interest analysis showed higher left angular gyrus BOLD response for one-digit compared to two-digit addition, and in no-tapping conditions than dual tapping conditions. The results support a specific association between addition fact retrieval and anatomically ordered finger movements in adults, possibly due to finger counting strategies that deploy anatomically ordered finger movements early in the development.

  7. Kinetic studies of retinol addition radicals.

    PubMed

    El-Agamey, Ali; Fukuzumi, Shunichi; Naqvi, K Razi; McGarvey, David J

    2011-03-07

    Retinol neutral radicals (RS-retinol˙), generated from the reaction of retinol with 4-pyridylthiyl and 2-pyridylthiyl radicals in argon-saturated methanol, undergo β-elimination, which can be monitored via the slow secondary absorption rise at 380 nm attributed to the rearrangement of the unstable retinol neutral addition radicals to the more stable addition radicals. Rate constants for the β-elimination reactions (k(β)) of 4-PyrS-retinol˙ were measured at different temperatures and the Arrhenius equation for the reaction is described by log (k(β)/s(-1)) = (12.7 ± 0.2) - (54.3 ± 1.3)/θ, where θ = 2.3RT kJ mol(-1). The reactivities of retinol addition radicals (RS-retinol˙), generated from the reaction of retinol with various thiyl radicals, towards oxygen have also been investigated in methanol. In the presence of oxygen, the decay of RS-retinol˙ fits to biexponential kinetics and both observed rate constants for the RS-retinol˙ decay are oxygen-concentration dependent. This suggests that at least two thiyl addition radicals, formed from the reaction of RS˙ with retinol, undergo oxygen addition reactions. In light of the estimated rate constants for oxygen addition to RS-retinol˙ and RS-CAR˙ (CAR: carotenoid), the antioxidant-prooxidant properties of retinol are discussed.

  8. Communicating their individual results to participants in an environmental exposure study: Insights from clinical ethics

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

    Deck, W.; Kosatsky, T.

    1999-02-01

    A study measuring the uptake of chemical contaminants among sport fishers who consume fish caught in the St. Lawrence river is currently being conducted in Montreal, Canada. In this study, blood, hair, and urine collected from local sport fishers is being tested for heavy metals and persistent organochlorine chemicals. The objective of this study was to formulate a framework for determining what information to communicate to individual subjects of a study measuring biomarkers of exposure, consistent with the principles of ethical clinical and research practice. Methods consisted of review of the scope of environmental exposure studies, including the use ofmore » biomarker measurement in clinical medicine and environmental research and the relevant principles of clinical ethics and research practice. An exposure biomarker study is designed to elucidate constitutional, behavioral, and environmental determinants of tissue concentrations of exogenous substances. Ethical clinical and research practice, aiming to maximize autonomy and beneficence and to minimize harm, requires that study findings concerning the determinants of exposure be communicated to study participants. In addition, investigators should reference clinical action levels beyond which individual biomarker results are routinely communicated to participants. When biomarkers have no known relation to risk, or when levels fall below action levels, it may be preferable not co communicate individual results, if this arrangement has been formalized at the time of informed consent.« less

  9. Additive mixed effect model for recurrent gap time data.

    PubMed

    Ding, Jieli; Sun, Liuquan

    2017-04-01

    Gap times between recurrent events are often of primary interest in medical and observational studies. The additive hazards model, focusing on risk differences rather than risk ratios, has been widely used in practice. However, the marginal additive hazards model does not take the dependence among gap times into account. In this paper, we propose an additive mixed effect model to analyze gap time data, and the proposed model includes a subject-specific random effect to account for the dependence among the gap times. Estimating equation approaches are developed for parameter estimation, and the asymptotic properties of the resulting estimators are established. In addition, some graphical and numerical procedures are presented for model checking. The finite sample behavior of the proposed methods is evaluated through simulation studies, and an application to a data set from a clinic study on chronic granulomatous disease is provided.

  10. Displaced Neer Type IIB distal-third clavicle fractures-Long-term clinical outcome after plate fixation and additional screw augmentation for coracoclavicular instability.

    PubMed

    Tiefenboeck, Thomas M; Boesmueller, Sandra; Binder, Harald; Bukaty, Adam; Tiefenboeck, Michael M; Joestl, Julian; Hofbauer, Marcus; Ostermann, Roman C

    2017-01-23

    Unstable Neer Type IIB fractures require meticulous surgical treatment. Thus, the aim of this study was to present long-term outcomes after plate fixation and minimally invasive coracoclavicular (CC) stabilization using screw fixation. A consecutive series of patients with unstable Neer Type IIB displaced clavicle fractures, treated by open reduction and internal fixation (ORIF) with a plate and additional screw fixation for coracoclavicular ligament instability, was reviewed in order to determine long-term clinical and radiological outcome. Seven patients, six males and one female, with a mean age of 37 ± 8 years (median: 36 years; range, 28-51 years), were evaluated. At latest follow-up, after a mean of 67 months (range, 11-117 months), patients presented with the following mean scores: DASH: 0.57, ASES: 98.81, UCLA: 34.29, VAS: 0.43, Simple Shoulder Test: 11.57. However, two complications were observed: one case of implant loosening and one non-union. There were no differences observed between the CC distances comparing postoperative X-rays to those in final follow-up. In 25% of our patients early postoperative complications occurred. In all patients reoperation was necessary to remove the implanted screw. The results of the present study indicate that the treatment of Neer Type IIB lateral clavicle fractures with ORIF using a plate and additional CC screw fixation, leads to satisfying clinical and radiological outcomes in the long-term. However, considering an early postoperative complication rate of 25% and a 100% rate of secondary surgery due to removal of the CC screw does not seem to justify this technique anymore.

  11. Comparison between different thickness umbrella-shaped expandable radiofrequency electrodes (SuperSlim and CoAccess): Experimental and clinical study

    PubMed Central

    KODA, MASAHIKO; TOKUNAGA, SHIHO; MATONO, TOMOMITSU; SUGIHARA, TAKAAKI; NAGAHARA, TAKAKAZU; MURAWAKI, YOSHIKAZU

    2011-01-01

    The purpose of the present study was to compare the size and configuration of the ablation zones created by SuperSlim and CoAccess electrodes, using various ablation algorithms in ex vivo bovine liver and in clinical cases. In the experimental study, we ablated explanted bovine liver using 2 types of electrodes and 4 ablation algorithms (combinations of incremental power supply, stepwise expansion and additional low-power ablation) and evaluated the ablation area and time. In the clinical study, we compared the ablation volume and the shape of the ablation zone between both electrodes in 23 hepatocellular carcinoma (HCC) cases with the best algorithm (incremental power supply, stepwise expansion and additional low-power ablation) as derived from the experimental study. In the experimental study, the ablation area and time by the CoAccess electrode were significantly greater compared to those by the SuperSlim electrode for the single-step (algorithm 1, p=0.0209 and 0.0325, respectively) and stepwise expansion algorithms (algorithm 2, p=0.0002 and <0.0001, respectively; algorithm 3, p= 0.006 and 0.0407, respectively). However, differences were not significant for the additional low-power ablation algorithm. In the clinical study, the ablation volume and time in the CoAccess group were significantly larger and longer, respectively, compared to those in the SuperSlim group (p=0.0242 and 0.009, respectively). Round ablation zones were acquired in 91.7% of the CoAccess group, while irregular ablation zones were obtained in 45.5% of the SuperSlim group (p=0.0428). In conclusion, the CoAccess electrode achieves larger and more uniform ablation zones compared with the SuperSlim electrode, though it requires longer ablation times in experimental and clinical studies. PMID:22977647

  12. In vitro properties of concentrated canine platelets stored in two additive solutions: a comparative study.

    PubMed

    Hlavac, N; Lasta, C S; Dalmolin, M L; Lacerda, L A; de Korte, D; Marcondes, N A; Terra, S R; Fernandes, F B; González, F H D

    2017-11-15

    Platelet transfusion therapy poses many challenges in veterinary clinical practice. Lack of readily available blood donors, short shelf-life, and inability to administer a sufficient number of platelets to meet a dog's transfusion need are the major difficulties encountered. Platelet additive solutions are already in use at American and European human blood banks, showing to be a realistic alternative. This study compares the in vitro platelet function in plasma, Composol, or SSP+ during storage for 13 days. Platelet rich plasma-platelet concentrate with 35% plasma and 65% platelet additive solutions (Composol or SSP+) and a control group (100% plasma) were prepared. Swirling, platelet count, blood gases, metabolic variables, platelet activation markers, and apoptosis markers were analyzed on days 1, 5, 9 and 13. Swirling was well preserved and pH was acceptable (> 6.2) during storage for all platelet additive solutions units until day 9. SSP + units showed more stable pH and metabolic variables until day 13. Platelets in plasma showed higher glucose consumption than in Composol or in SSP+. The platelet additive solutions units showed better platelet metabolism maintenance, reduced glucose consumption and lactate production. The apoptotic markers were still low for 9 days in platelet concentrates with platelet additive solutions, suggesting the possibility to extend the shelf life with the use of SSP+ or Composol. Our findings suggest that the uses of Composol and SSP+ in canine platelet concentrates are potential alternatives in veterinary blood banks.

  13. Clinical decision-making described by Swedish prehospital emergency care nurse students - An exploratory study.

    PubMed

    Nilsson, Tomas; Lindström, Veronica

    2016-07-01

    The purpose of this study was to explore the PECN students' clinical decision-making during a seven-week clinical rotation in the ambulance services. Developing expertise in prehospital emergency care practices requires both theoretical and empirical learning. A prehospital emergency care nurse (PECN) is a Registered Nurse (RN) with one year of additional training in emergency care. There has been little investigation of how PECN students describe their decision-making during a clinical rotation. A qualitative study design was used, and 12 logbooks written by the Swedish PECN students were analysed using content analysis. The students wrote about 997 patient encounters - ambulance assignments during their clinical rotation. Four themes emerged as crucial for the students' decision-making: knowing the patient, the context-situation awareness in the ambulance service, collaboration, and evaluation. Based on the themes, students made decisions on how to respond to patients' illnesses. The PECN students used several variables in their decision-making. The decision- making was an on-going process during the whole ambulance assignment. The university has the responsibility to guide the students during their transition from an RN to a PECN. The findings of the study can support the educators and clinical supervisors in developing the programme of study for becoming a PECN. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    PubMed

    Ohnmeiss, Donna D

    2015-03-01

    invitation, 13 not yet recruiting, 18 terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%) have been published. The mean time to publish was 27.9 months from the date of completion. Among unpublished studies, the mean length of time from study completion to the preparation of this article was 62.0 months. There was no difference in the likelihood of publication based on the geographic region of study origin or whether the study was registered before or after initiation. There were statistically significant relationships between the publication rate and the funding type as well as the research type (p<.05) with industrial-funded studies and those evaluating devices having a lower publication rate and those that were funded by a federal agency and comparing surgery to nonoperative care had the highest publication rates. Although the 38.9% publication rate for spine-related studies found in this study appears low, it is in line with other studies reporting a 22.8% publication rate for arthroplasty trials and 43.2% for orthopedic trauma trials. In addition to ClinicalTrials.gov Web site fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, and others and raise queries concerning the reasons for not publishing what appear to be well-designed studies. The posting of spine studies before initiation can increase transparency and ability to evaluate clinical trials in spine. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. [Exploratory study of clinical reasoning in nursing students with concept mapping].

    PubMed

    Paucard-Dupont, Sylvie; Marchand, Claire

    2014-06-01

    The training reference leading to the state nursing diploma places the learning of clinical reasoning at the center of the training. We have been wondering about the possibilities of making visible the student nurse's mental processes when they provide nursing care in order to identify their strategies and reasoning difficulties. It turns out that concept mapping is a research tool capable of showing these two aspects. The aim of this study is to verify a concept mapping made during an interview and built from the speech of a nursing student when analyzing a simulated clinical situation, is able to make visible its strategies clinical reasoning and reasoning difficulties. In a second phase of it, is to explore how the concept map once elaborated allows students to identify their own intellectual reasoning. 12 nursing second year students have participated in the study. Concept maps were constructed by the trainer/researcher as the students analyzed aloud a simulated clinical situation written. Concept maps were analyzed from a reference grid. Interviews were conducted following the elaboration of concept maps and student's comments were analyzed. Students reasoning strategies were either mixed inductive dominant (5/12) or hypothetical-deductive dominant (5/12). Reasoning difficulties identified are related to the lack of identification of important information, the lack of analysis of data, lack of connection or the existence of faulty links. Analysis of the comments highlights that concept mapping contributed to the development of metacognitive skills. The concept mapping has shown benefits in contributing to a diagnostic assessment of clinical reasoning learning. It is an additional resource tool to facilitate the development of metacognitive skills for students. This tool can be useful to implement support learning strategies in clinical reasoning.

  16. An evaluative study of clinical preceptorship.

    PubMed

    Kaviani, N; Stillwell, Y

    2000-04-01

    Clinical preceptorships, in collaboration between clinical agencies and educational institutions have been documented as an effective and innovative means of facilitating student learning, providing advantages for both the clinical and educational settings. A preceptorship programme of 100 hours duration was developed and delivered by the nurse education institute, in consultation with a health care organization. The objectives of the preceptorship programme were to help registered nurses, in partnership with clinical nurse educators, to effectively integrate, support and assist the development of clinical competence in the undergraduate nursing student. Following the implementation of the preceptorship programme a research study was conducted to evaluate programme effectiveness. The purpose of the study was to examine preceptors, preceptees, and nurse managers' preceptions of the preceptor role and factors which influenced the performance of preceptors. The methods used in this study included those commonly found in evaluation research. That is, participants were drawn from those who were involved, either directly or indirectly, in the preceptorship programme, namely preceptors, preceptees and nurse managers. Using focus groups, they were each asked to identify the outcomes of the programme in practice. Study findings highlighted the importance of formal preceptor preparation, which was shown to enhance teaching and learning opportunities for student preceptees, personal and professional development of the preceptors, and the promotion of positive partnerships between nurse educators and nurse practitioners. The need for formal recognition of the preceptor role in practice, particularly in relation to the provision of adequate time and resources, emerged from the study. The research findings enabled the development of an evaluative model of preceptorship, which highlights the intrinsic and extrinsic factors impacting on the preceptor role.

  17. Governance for clinical decision support: case studies and recommended practices from leading institutions

    PubMed Central

    Sittig, Dean F; Ash, Joan S; Bates, David W; Feblowitz, Joshua; Fraser, Greg; Maviglia, Saverio M; McMullen, Carmit; Nichol, W Paul; Pang, Justine E; Starmer, Jack; Middleton, Blackford

    2011-01-01

    Objective Clinical decision support (CDS) is a powerful tool for improving healthcare quality and ensuring patient safety; however, effective implementation of CDS requires effective clinical and technical governance structures. The authors sought to determine the range and variety of these governance structures and identify a set of recommended practices through observational study. Design Three site visits were conducted at institutions across the USA to learn about CDS capabilities and processes from clinical, technical, and organizational perspectives. Based on the results of these visits, written questionnaires were sent to the three institutions visited and two additional sites. Together, these five organizations encompass a variety of academic and community hospitals as well as small and large ambulatory practices. These organizations use both commercially available and internally developed clinical information systems. Measurements Characteristics of clinical information systems and CDS systems used at each site as well as governance structures and content management approaches were identified through extensive field interviews and follow-up surveys. Results Six recommended practices were identified in the area of governance, and four were identified in the area of content management. Key similarities and differences between the organizations studied were also highlighted. Conclusion Each of the five sites studied contributed to the recommended practices presented in this paper for CDS governance. Since these strategies appear to be useful at a diverse range of institutions, they should be considered by any future implementers of decision support. PMID:21252052

  18. Culturally and linguistically diverse healthcare students' experiences of learning in a clinical environment: A systematic review of qualitative studies.

    PubMed

    Mikkonen, Kristina; Elo, Satu; Kuivila, Heli-Maria; Tuomikoski, Anna-Maria; Kääriäinen, Maria

    2016-02-01

    Learning in the clinical environment of healthcare students plays a significant part in higher education. The greatest challenges for culturally and linguistically diverse healthcare students were found in clinical placements, where differences in language and culture have been shown to cause learning obstacles for students. There has been no systematic review conducted to examine culturally and linguistically diverse healthcare students' experiences of their learning in the clinical environment. This systematic review aims to identify culturally and linguistically diverse healthcare students' experiences of learning in a clinical environment. The search strategy followed the guidelines of the Centre of Reviews and Dissemination. The original studies were identified from seven databases (CINAHL, Medline Ovid, Scopus, Web of Science, Academic Search Premiere, Eric and Cochrane Library) for the period 2000-2014. Two researchers selected studies based on titles, abstracts and full texts using inclusion criteria and assessed the quality of studies independently. Twelve original studies were chosen for the review. The culturally and linguistically diverse healthcare students' learning experiences were divided into three influential aspects of learning in a clinical environment: experiences with implementation processes and provision; experiences with peers and mentors; and experiences with university support and instructions. The main findings indicate that culturally and linguistically diverse healthcare students embarking on clinical placements initially find integration stressful. Implementing the process of learning in a clinical environment requires additional time, well prepared pedagogical orientation, prior cultural and language education, and support for students and clinical staff. Barriers to learning by culturally and linguistically diverse healthcare students were not being recognized and individuals were not considered motivated; learners experienced the

  19. Basophil activation test with food additives in chronic urticaria patients.

    PubMed

    Kang, Min-Gyu; Song, Woo-Jung; Park, Han-Ki; Lim, Kyung-Hwan; Kim, Su-Jung; Lee, Suh-Young; Kim, Sae-Hoon; Cho, Sang-Heon; Min, Kyung-Up; Chang, Yoon-Seok

    2014-01-01

    The role of food additives in chronic urticaria (CU) is still under investigation. In this study, we aimed to explore the association between food additives and CU by using the basophil activation test (BAT). The BAT using 15 common food additives was performed for 15 patients with CU who had a history of recurrent urticarial aggravation following intake of various foods without a definite food-specific IgE. Of the 15 patients studied, two (13.3%) showed positive BAT results for one of the tested food additives. One patient responded to monosodium glutamate, showing 18.7% of CD203c-positive basophils. Another patient showed a positive BAT result to sodium benzoate. Both patients had clinical correlations with the agents, which were partly determined by elimination diets. The present study suggested that at least a small proportion of patients with CU had symptoms associated with food additives. The results may suggest the potential utility of the BAT to identity the role of food additives in CU.

  20. Clinical Impact of Additional Cytogenetic Aberrations, cKIT and RAS Mutations, and Treatment Elements in Pediatric t(8;21)-AML: Results From an International Retrospective Study by the International Berlin-Frankfurt-Münster Study Group

    PubMed Central

    Klein, Kim; Kaspers, Gertjan; Harrison, Christine J.; Beverloo, H. Berna; Reedijk, Ardine; Bongers, Mathilda; Cloos, Jacqueline; Pession, Andrea; Reinhardt, Dirk; Zimmerman, Martin; Creutzig, Ursula; Dworzak, Michael; Alonzo, Todd; Johnston, Donna; Hirsch, Betsy; Zapotocky, Michal; De Moerloose, Barbara; Fynn, Alcira; Lee, Vincent; Taga, Takashi; Tawa, Akio; Auvrignon, Anne; Zeller, Bernward; Forestier, Erik; Salgado, Carmen; Balwierz, Walentyna; Popa, Alexander; Rubnitz, Jeffrey; Raimondi, Susana; Gibson, Brenda

    2015-01-01

    Purpose This retrospective cohort study aimed to determine the predictive relevance of clinical characteristics, additional cytogenetic aberrations, and cKIT and RAS mutations, as well as to evaluate whether specific treatment elements were associated with outcomes in pediatric t(8;21)-positive patients with acute myeloid leukemia (AML). Patients and Methods Karyotypes of 916 pediatric patients with t(8;21)-AML were reviewed for the presence of additional cytogenetic aberrations, and 228 samples were screened for presence of cKIT and RAS mutations. Multivariable regression models were used to assess the relevance of anthracyclines, cytarabine, and etoposide during induction and overall treatment. End points were the probability of achieving complete remission, cumulative incidence of relapse (CIR), probability of event-free survival, and probability of overall survival. Results Of 838 patients included in final analyses, 92% achieved complete remission. The 5-year overall survival, event-free survival, and CIR were 74%, 58%, and 26%, respectively. cKIT mutations and RAS mutations were not significantly associated with outcome. Patients with deletions of chromosome arm 9q [del(9q); n = 104] had a lower probability of complete remission (P = .01). Gain of chromosome 4 (+4; n = 21) was associated with inferior CIR and survival (P < .01). Anthracycline doses greater than 150 mg/m2 and etoposide doses greater than 500 mg/m2 in the first induction course and high-dose cytarabine 3 g/m2 during induction were associated with better outcomes on various end points. Cumulative doses of cytarabine greater than 30 g/m2 and etoposide greater than 1,500 mg/m2 were associated with lower CIR rates and better probability of event-free survival. Conclusion Pediatric patients with t(8;21)-AML and additional del(9q) or additional +4 might not be considered at good risk. Patients with t(8;21)-AML likely benefit from protocols that have high doses of anthracyclines, etoposide, and

  1. Adverse reactions to the sulphite additives

    PubMed Central

    Misso, Neil LA

    2012-01-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. Most studies report a prevalence of sulphite sensitivity of 3 to 10% among asthmatic subjects who ingest these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. Although a number of potential mechanisms have been proposed, the precise mechanisms underlying sulphite sensitivity remain unclear. PMID:24834193

  2. Clinical learning environment and supervision of international nursing students: A cross-sectional study.

    PubMed

    Mikkonen, Kristina; Elo, Satu; Miettunen, Jouko; Saarikoski, Mikko; Kääriäinen, Maria

    2017-05-01

    Previously, it has been shown that the clinical learning environment causes challenges for international nursing students, but there is a lack of empirical evidence relating to the background factors explaining and influencing the outcomes. To describe international and national students' perceptions of their clinical learning environment and supervision, and explain the related background factors. An explorative cross-sectional design was used in a study conducted in eight universities of applied sciences in Finland during September 2015-May 2016. All nursing students studying English language degree programs were invited to answer a self-administered questionnaire based on both the clinical learning environment, supervision and nurse teacher scale and Cultural and Linguistic Diversity scale with additional background questions. Participants (n=329) included international (n=231) and Finnish (n=98) nursing students. Binary logistic regression was used to identify background factors relating to the clinical learning environment and supervision. International students at a beginner level in Finnish perceived the pedagogical atmosphere as worse than native speakers. In comparison to native speakers, these international students generally needed greater support from the nurse teacher at their university. Students at an intermediate level in Finnish reported two times fewer negative encounters in cultural diversity at their clinical placement than the beginners. To facilitate a successful learning experience, international nursing students require a sufficient level of competence in the native language when conducting clinical placements. Educational interventions in language education are required to test causal effects on students' success in the clinical learning environment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients.

    PubMed

    Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

    2016-05-01

    Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05).

  4. Towards Data Value-Level Metadata for Clinical Studies.

    PubMed

    Zozus, Meredith Nahm; Bonner, Joseph

    2017-01-01

    While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

  5. Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes.

    PubMed

    Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

    2016-04-01

    Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10(-8)), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10(-12); OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10(-23); OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10(-9); OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case-control ORs for two distinct types of gout (r=0.96 [p=4.8×10(-4)] for urate clearance and r=0.96 [p=5.0×10(-4)] for urinary urate excretion). Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. A functional neuroimaging study of the clinical reasoning of medical students.

    PubMed

    Chang, Hyung-Joo; Kang, June; Ham, Byung-Joo; Lee, Young-Mee

    2016-12-01

    As clinical reasoning is a fundamental competence of physicians for good clinical practices, medical academics have endeavored to teach reasoning skills to undergraduate students. However, our current understanding of student-level clinical reasoning is limited, mainly because of the lack of evaluation tools for this internal cognitive process. This functional magnetic resonance imaging (fMRI) study aimed to examine the clinical reasoning processes of medical students in response to problem-solving questions. We recruited 24 2nd-year medical students who had completed their preclinical curriculum. They answered 40 clinical vignette-based multiple-choice questions during fMRI scanning. We compared the imaging data for 20 problem-solving questions (reasoning task) and 20 recall questions (recall task). Compared to the recall task, the reasoning task resulted in significantly greater activation in nine brain regions, including the dorsolateral prefrontal cortex and inferior parietal cortex, which are known to be associated with executive function and deductive reasoning. During the recall task, significant activation was observed in the brain regions that are related to memory and emotions, including the amygdala and ventromedial prefrontal cortex. Our results support that medical students mainly solve clinical questions with deductive reasoning involving prior knowledge structures and executive functions. The problem-solving questions induced the students to utilize higher cognitive functions compared with the recall questions. Interestingly, the results suggested that the students experienced some emotional distress while they were solving the recall questions. In addition, these results suggest that fMRI is a promising research tool for investigating students' cognitive processes.

  7. Relearning To Teach Arithmetic Addition and Subtraction: A Teacher's Study Guide.

    ERIC Educational Resources Information Center

    Russell, Susan Jo

    This package features videotapes and a study guide that are designed to help teachers revisit the operations of addition and subtraction and consider how students can develop meaningful approaches to these operations. The study guides' sessions are on addition, subtraction, the teacher's role, and goals for students and teachers. The readings in…

  8. Screening for Addictive Disorders Within a Workers’ Compensation Clinic: An Exploratory Study

    PubMed Central

    Parhami, Iman; Hyman, Mark; Siani, Aaron; Lin, Stephanie; Collard, Michael; Garcia, Johnny; Casaus, Laurie; Tsuang, John; Fong, Timothy W.

    2012-01-01

    We conducted a cross-sectional study investigating the extent of addictive disorders within a workers’ compensation (WC) clinic. We also examined the feasibility of substance abuse screening within the same clinic. In 2009, 100 patients were asked to complete the World Health Organization’s Alcohol, Smoking, Substance Involvement Screening Test (WHO-ASSIST) and the Current Opioid Misuse Measure (COMM). According to the WHO-ASSIST, we found that 46% of WC patients required intervention for at least one substance-related disorder (25% tobacco, 23% sedatives, 8% opioids), and according to the COMM, 46% screened positive for prescription opioid misuse. Importantly, the addition of this screening was brief, economical, and well accepted by patients. Further research should analyze the costs and benefits of detection and intervention of substance-related disorders in this setting. PMID:22066751

  9. Advances in clinical study of curcumin.

    PubMed

    Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

    2013-01-01

    Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

  10. A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

    PubMed

    Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

    2017-06-01

    The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug

  11. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes.

    PubMed

    Cook, Andrea J; Wellman, Robert D; Cherkin, Daniel C; Kahn, Janet R; Sherman, Karen J

    2015-10-01

    This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. The aim was to determine the optimal dose of massage for neck pain. Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain

  12. Clinically unrecognized miliary tuberculosis: an autopsy study.

    PubMed

    Savic, Ivana; Trifunovic-Skodric, Vesna; Mitrovic, Dragan

    2016-01-01

    Miliary tuberculosis (TB) usually presents with atypical clinical manifestations; thus it is often recognized only at autopsy. Our objectives were to study the frequency of MT diagnosed at autopsy and determine clinical diagnoses that masked TB, as well as causes of death and comorbidities. Retrospective study of all autopsies performed between 2008 and 2014. Institute of Pathology, Belgrade, Serbia. in subjects where autopsy showed the presence of MT that was not recognized clinically, we recorded the clinical diagnoses (presumed causes of death) as reported in autopsy request forms, as well as actual cause of death and comorbidities as determined at autopsy. Clinically unrecognized MT. The total number of autopsies in this period was 6206. thirty-five individuals showed clinically unrecognized MT (0.56% of all autopsies, age: 62.2 [17.2] years, M:F=2:3). Common clinical diagnoses masking pulmonary MT were exacerbation of COPD (25%) and pulmonary thromboembolism (25%), with common radiological presentation of diffuse pulmonary infiltrates (56.3%). Dominant clinical diagnoses in patients with generalized MT were adult respiratory distress syndrome, sepsis, gastrointestinal bleeding and meningoencephalitis. Disseminated MT was often associated with secondary anemia or thrombocytopenia (15.8%) and recent surgery (15.8%). Frequent comorbidities included chronic renal failure and malignancies, whereas MT was a dominant cause of death. Greater awareness of MT is needed to improve recognition in clinical settings. In particular, MT should be considered in patients with atypical clinical presentation and diffuse pulmonary infiltrates on chest X-ray, particularly if they have chronic renal failure, malignancy, hematological disorders or a history of recent surgery. None.

  13. Angiogenic factors combined with clinical risk factors to predict preterm pre-eclampsia in nulliparous women: a predictive test accuracy study.

    PubMed

    Myers, J E; Kenny, L C; McCowan, L M E; Chan, E H Y; Dekker, G A; Poston, L; Simpson, N A B; North, R A

    2013-09-01

    To assess the performance of clinical risk factors, uterine artery Doppler and angiogenic markers to predict preterm pre-eclampsia in nulliparous women. Predictive test accuracy study. Prospective multicentre cohort study Screening for Pregnancy Endpoints (SCOPE). Low-risk nulliparous women with a singleton pregnancy were recruited. Clinical risk factor data were obtained and plasma placental growth factor (PlGF), soluble endoglin and soluble fms-like tyrosine kinase-1 (sFlt-1) were measured at 14-16 weeks of gestation. Prediction models were developed using multivariable stepwise logistic regression. Preterm pre-eclampsia (delivered before 37(+0)  weeks of gestation). Of the 3529 women recruited, 187 (5.3%) developed pre-eclampsia of whom 47 (1.3%) delivered preterm. Controls (n = 188) were randomly selected from women without preterm pre-eclampsia and included women who developed other pregnancy complications. An area under a receiver operating characteristic curve (AUC) of 0.76 (95% CI 0.67-0.84) was observed using previously reported clinical risk variables. The AUC improved following the addition of PlGF measured at 14-16 weeks (0.84; 95% CI 0.77-0.91), but no further improvement was observed with the addition of uterine artery Doppler or the other angiogenic markers. A sensitivity of 45% (95% CI 0.31-0.59) (5% false-positive rate) and post-test probability of 11% (95% CI 9-13) were observed using clinical risk variables and PlGF measurement. Addition of plasma PlGF at 14-16 weeks of gestation to clinical risk assessment improved the identification of nulliparous women at increased risk of developing preterm pre-eclampsia, but the performance is not sufficient to warrant introduction as a clinical screening test. These findings are marker dependent, not assay dependent; additional markers are needed to achieve clinical utility. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

  14. The dilemma of allergy to food additives.

    PubMed

    Bahna, Sami L; Burkhardt, Joshua G

    2018-01-01

    To provide a brief summary on food additives and to outline a practical approach for evaluating subjects suspected of having reactions to food additives. Information was derived from selected reviews and original articles published in peer-reviewed journals, supplemented by the clinical experience of the authors. Priority was given to studies that used blinded, placebo controlled, oral challenges to confirm adverse reactions to food additives. In addition, selected, appropriately evaluated case reports were included. A large number of food additives are widely used in the food industry. Allergic reactions to additives seem to be rare but are very likely underdiagnosed, primarily due to a low index of suspicion. A wide variety of symptoms to food additives have been reported, but a cause-and-effect relationship has not been well documented in the majority of cases. Reactions to food additives should be suspected in patients who report symptoms related to multiple foods or to a certain food when commercially prepared but not when home made. It is also prudent to investigate food additives in subjects considered to have "idiopathic" reactions. Except for a limited number of natural additives, there is a small role for skin tests or in vitro testing. Oral challenge, in stages, with commonly used additives is the definitive procedure for detecting the offending agent. Once the specific additive is identified, management is strict avoidance, which can be difficult.

  15. Study of mandible reconstruction using a fibula flap with application of additive manufacturing technology.

    PubMed

    Tsai, Ming-June; Wu, Ching-Tsai

    2014-05-06

    This study aimed to establish surgical guiding techniques for completing mandible lesion resection and reconstruction of the mandible defect area with fibula sections in one surgery by applying additive manufacturing technology, which can reduce the surgical duration and enhance the surgical accuracy and success rate. A computer assisted mandible reconstruction planning (CAMRP) program was used to calculate the optimal cutting length and number of fibula pieces and design the fixtures for mandible cutting, registration, and arrangement of the fibula segments. The mandible cutting and registering fixtures were then generated using an additive manufacturing system. The CAMRP calculated the optimal fibula cutting length and number of segments based on the location and length of the defective portion of the mandible. The mandible cutting jig was generated according to the boundary surface of the lesion resection on the mandible STL model. The fibular cutting fixture was based on the length of each segment, and the registered fixture was used to quickly arrange the fibula pieces into the shape of the defect area. In this study, the mandibular lesion was reconstructed using registered fibular sections in one step, and the method is very easy to perform. The application of additive manufacturing technology provided customized models and the cutting fixtures and registered fixtures, which can improve the efficiency of clinical application. This study showed that the cutting fixture helped to rapidly complete lesion resection and fibula cutting, and the registered fixture enabled arrangement of the fibula pieces and allowed completion of the mandible reconstruction in a timely manner. Our method can overcome the disadvantages of traditional surgery, which requires a long and different course of treatment and is liable to cause error. With the help of optimal cutting planning by the CAMRP and the 3D printed mandible resection jig and fibula cutting fixture, this all

  16. Facilitating Case Studies in Massage Therapy Clinical Education

    PubMed Central

    Baskwill, Amanda

    2013-01-01

    The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

  17. The database for aggregate analysis of ClinicalTrials.gov (AACT) and subsequent regrouping by clinical specialty.

    PubMed

    Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J; Pietrobon, Ricardo

    2012-01-01

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

  18. A Study of Clinically Related Open Source Software Projects

    PubMed Central

    Hogarth, Michael A.; Turner, Stuart

    2005-01-01

    Open source software development has recently gained significant interest due to several successful mainstream open source projects. This methodology has been proposed as being similarly viable and beneficial in the clinical application domain as well. However, the clinical software development venue differs significantly from the mainstream software venue. Existing clinical open source projects have not been well characterized nor formally studied so the ‘fit’ of open source in this domain is largely unknown. In order to better understand the open source movement in the clinical application domain, we undertook a study of existing open source clinical projects. In this study we sought to characterize and classify existing clinical open source projects and to determine metrics for their viability. This study revealed several findings which we believe could guide the healthcare community in its quest for successful open source clinical software projects. PMID:16779056

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

    PubMed

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

    2017-01-01

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

  20. Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System.

    PubMed

    Gutmann, Anja; Kaier, Klaus; Sorg, Stefan; von Zur Mühlen, Constantin; Siepe, Matthias; Moser, Martin; Geibel, Annette; Zirlik, Andreas; Ahrens, Ingo; Baumbach, Hardy; Beyersdorf, Friedhelm; Vach, Werner; Zehender, Manfred; Bode, Christoph; Reinöhl, Jochen

    2015-01-20

    This study aims at analyzing complication-induced additional costs of patients undergoing transcatheter aortic valve replacement (TAVR). In a prospective observational study, a total of 163 consecutive patients received either transfemoral (TF-, n=97) or transapical (TA-) TAVR (n=66) between February 2009 and December 2012. Clinical endpoints were categorized according to VARC-2 definitions and in-hospital costs were determined from the hospital perspective. Finally, the additional costs of complications were estimated using multiple linear regression models. TF-TAVR patients experienced significantly more minor access site bleeding, major non-access site bleeding, minor vascular complications, stage 2 acute kidney injury (AKI) and permanent pacemaker implantation. Total in-hospital costs did not differ between groups and were on average €40,348 (SD 15,851) per patient. The average incremental cost component of a single complication was €3438 (p<0.01) and the estimated cost of a TF-TAVR without complications was €34,351. The complications associated with the highest additional costs were life-threatening non-access site bleeding (€47,494; p<0.05), stage 3 AKI (€20,468; p<0.01), implantation of a second valve (€16,767; p<0.01) and other severe cardiac dysrhythmia (€10,611 p<0.05). Overall, the presence of complication-related in-hospital mortality increased costs. Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers in our TAVR patients. Strategies and advances in device design aimed at reducing these complications have the potential to generate significant in-hospital cost reductions for the German Health Care System. Copyright © 2014. Published by Elsevier Ireland Ltd.

  1. Nursing Students' Opinion on the Use of Smartphone Applications (Apps) in Clinical Education and Training: A Study Protocol.

    PubMed

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Nurse educators are exploring different mobile technologies to provide additional support to nursing students in clinical practice. However, the view of nursing students on the use of smartphone applications (apps) to enhance clinical education has not been explored. This proposed study will use a self-reported questionnaire to examine the opinions of nursing students on the current and potential use of smartphone apps when training in clinical settings. Descriptive and inferential statistics will be performed on the quantitative data. Qualitative data from open ended questions will be thematically analysed using the framework approach. This will be the first study to examine the use of smartphone apps as a support in clinical teaching from a students' perspective. Their opinion is vital if the right mobile technology is to be designed and implemented.

  2. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

    PubMed

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses

  3. Autism and genetics: Clinical approach and association study with two markers of HRAS gene

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

    Herault, J.; Petit, E.; Cherpi, C.

    Twin studies and familial aggregation studies indicate that genetic factors could play a role in infantile autism. In an earlier study, we identified a possible positive association between autism and a c-Harvey-ras (HRAS) oncogene marker at the 3{prime} end of the coding region. In an attempt to confirm this finding, we studied a larger population, well-characterized clinically and genetically. We report a positive association between autism and two HRAS markers, the 3{prime} marker used in the initial study and an additional marker in exon 1. 46 refs., 1 fig., 2 tabs.

  4. Basophil Activation Test with Food Additives in Chronic Urticaria Patients

    PubMed Central

    Kang, Min-Gyu; Song, Woo-Jung; Park, Han-Ki; Lim, Kyung-Hwan; Kim, Su-Jung; Lee, Suh-Young; Kim, Sae-Hoon; Cho, Sang-Heon; Min, Kyung-Up

    2014-01-01

    The role of food additives in chronic urticaria (CU) is still under investigation. In this study, we aimed to explore the association between food additives and CU by using the basophil activation test (BAT). The BAT using 15 common food additives was performed for 15 patients with CU who had a history of recurrent urticarial aggravation following intake of various foods without a definite food-specific IgE. Of the 15 patients studied, two (13.3%) showed positive BAT results for one of the tested food additives. One patient responded to monosodium glutamate, showing 18.7% of CD203c-positive basophils. Another patient showed a positive BAT result to sodium benzoate. Both patients had clinical correlations with the agents, which were partly determined by elimination diets. The present study suggested that at least a small proportion of patients with CU had symptoms associated with food additives. The results may suggest the potential utility of the BAT to identity the role of food additives in CU. PMID:24527415

  5. Expanding the clinical and molecular spectrum of PRMT7 mutations: 3 additional patients and review.

    PubMed

    Agolini, E; Dentici, M L; Bellacchio, E; Alesi, V; Radio, F C; Torella, A; Musacchia, F; Tartaglia, M; Dallapiccola, B; Nigro, V; Digilio, M C; Novelli, A

    2018-03-01

    Protein arginine methyltransferase 7 (PRMT7) is a member of a family of enzymes that catalyze the transfer of methyl groups from S-adenosyl-l-methionine to nitrogen atoms on arginine residues. Arginine methylation is involved in multiple biological processes, such as signal transduction, mRNA splicing, transcriptional control, DNA repair, and protein translocation. Currently, 7 patients have been described harboring compound heterozygous or homozygous variants in the PRMT7 gene, causing a novel intellectual disability syndrome, known as SBIDDS syndrome (Short Stature, Brachydactyly, Intellectual Developmental Disability, and Seizures). We report on 3 additional patients from 2 consanguineous families with severe/moderate intellectual disability, short stature, brachydactyly and dysmorphisms. Exome sequencing revealed 2 novel homozygous mutations in PRMT7. Our findings expand the clinical and molecular spectrum of homozygous PRMT7 mutations, associated to the SBIDDS syndrome, showing a possible correlation between the type of mutation and the severity of the phenotype. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. Evaluation systems for clinical governance development: a comparative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  7. Physicians' perception of alternative displays of clinical research evidence for clinical decision support - A study with case vignettes.

    PubMed

    Slager, Stacey L; Weir, Charlene R; Kim, Heejun; Mostafa, Javed; Del Fiol, Guilherme

    2017-07-01

    To design alternate information displays that present summaries of clinical trial results to clinicians to support decision-making; and to compare the displays according to efficacy and acceptability. A 6-between (information display presentation order) by 3-within (display type) factorial design. Two alternate displays were designed based on Information Foraging theory: a narrative summary that reduces the content to a few sentences; and a table format that structures the display according to the PICO (Population, Intervention, Comparison, Outcome) framework. The designs were compared with the summary display format available in PubMed. Physicians were asked to review five clinical studies retrieved for a case vignette; and were presented with the three display formats. Participants were asked to rate their experience with each of the information displays according to a Likert scale questionnaire. Twenty physicians completed the study. Overall, participants rated the table display more highly than either the text summary or PubMed's summary format (5.9vs. 5.4vs. 3.9 on a scale between 1 [strongly disagree] and 7 [strongly agree]). Usefulness ratings of seven pieces of information, i.e. patient population, patient age range, sample size, study arm, primary outcome, results of primary outcome, and conclusion, were high (average across all items=4.71 on a 1 to 5 scale, with 1=not at all useful and 5=very useful). Study arm, primary outcome, and conclusion scored the highest (4.9, 4.85, and 4.85 respectively). Participants suggested additional details such as rate of adverse effects. The table format reduced physicians' perceived cognitive effort when quickly reviewing clinical trial information and was more favorably received by physicians than the narrative summary or PubMed's summary format display. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

    PubMed Central

    2014-01-01

    Background Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Methods Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). Results 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). Conclusions The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design. PMID:24607083

  9. Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

    PubMed

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

    High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

  10. Autologous Myoblast Transplantation for Oculopharyngeal Muscular Dystrophy: a Phase I/Iia Clinical Study

    PubMed Central

    Périé, Sophie; Trollet, Capucine; Mouly, Vincent; Vanneaux, Valérie; Mamchaoui, Kamel; Bouazza, Belaïd; Marolleau, Jean Pierre; Laforêt, Pascal; Chapon, Françoise; Eymard, Bruno; Butler-Browne, Gillian; Larghero, Jérome; St Guily, Jean Lacau

    2014-01-01

    Oculopharyngeal muscular dystrophy (OPMD) is a late-onset autosomal dominant genetic disease mainly characterized by ptosis and dysphagia. We conducted a phase I/IIa clinical study (ClinicalTrials.gov NCT00773227) using autologous myoblast transplantation following myotomy in adult OPMD patients. This study included 12 patients with clinical diagnosis of OPMD, indication for cricopharyngeal myotomy, and confirmed genetic diagnosis. The feasibility and safety end points of both autologous myoblast transplantation and the surgical procedure were assessed by videoendoscopy in addition to physical examinations. Potential therapeutic benefit was also assessed through videoendoscopy and videofluoroscopy of swallowing, quality of life score, dysphagia grade, and a drink test. Patients were injected with a median of 178 million myoblasts following myotomy. Short and long-term (2 years) safety and tolerability were observed in all the patients, with no adverse effects. There was an improvement in the quality of life score for all 12 patients, and no functional degradation in swallowing was observed for 10 patients. A cell dose-dependant improvement in swallowing was even observed in this study. This trial supports the hypothesis that a local injection of autologous myoblasts in the pharyngeal muscles is a safe and efficient procedure for OPMD patients. PMID:23831596

  11. First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

    2016-02-01

    Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

  12. Job strain as a risk factor for clinical depression: systematic review and meta-analysis with additional individual participant data.

    PubMed

    Madsen, I E H; Nyberg, S T; Magnusson Hanson, L L; Ferrie, J E; Ahola, K; Alfredsson, L; Batty, G D; Bjorner, J B; Borritz, M; Burr, H; Chastang, J-F; de Graaf, R; Dragano, N; Hamer, M; Jokela, M; Knutsson, A; Koskenvuo, M; Koskinen, A; Leineweber, C; Niedhammer, I; Nielsen, M L; Nordin, M; Oksanen, T; Pejtersen, J H; Pentti, J; Plaisier, I; Salo, P; Singh-Manoux, A; Suominen, S; Ten Have, M; Theorell, T; Toppinen-Tanner, S; Vahtera, J; Väänänen, A; Westerholm, P J M; Westerlund, H; Fransson, E I; Heikkilä, K; Virtanen, M; Rugulies, R; Kivimäki, M

    2017-06-01

    Adverse psychosocial working environments characterized by job strain (the combination of high demands and low control at work) are associated with an increased risk of depressive symptoms among employees, but evidence on clinically diagnosed depression is scarce. We examined job strain as a risk factor for clinical depression. We identified published cohort studies from a systematic literature search in PubMed and PsycNET and obtained 14 cohort studies with unpublished individual-level data from the Individual-Participant-Data Meta-analysis in Working Populations (IPD-Work) Consortium. Summary estimates of the association were obtained using random-effects models. Individual-level data analyses were based on a pre-published study protocol. We included six published studies with a total of 27 461 individuals and 914 incident cases of clinical depression. From unpublished datasets we included 120 221 individuals and 982 first episodes of hospital-treated clinical depression. Job strain was associated with an increased risk of clinical depression in both published [relative risk (RR) = 1.77, 95% confidence interval (CI) 1.47-2.13] and unpublished datasets (RR = 1.27, 95% CI 1.04-1.55). Further individual participant analyses showed a similar association across sociodemographic subgroups and after excluding individuals with baseline somatic disease. The association was unchanged when excluding individuals with baseline depressive symptoms (RR = 1.25, 95% CI 0.94-1.65), but attenuated on adjustment for a continuous depressive symptoms score (RR = 1.03, 95% CI 0.81-1.32). Job strain may precipitate clinical depression among employees. Future intervention studies should test whether job strain is a modifiable risk factor for depression.

  13. Clinical insomnia and associated factors in failed back surgery syndrome: a retrospective cross-sectional study.

    PubMed

    Yun, Soon Young; Kim, Do Heon; Do, Hae Yoon; Kim, Shin Hyung

    2017-01-01

    Background Insomnia frequently occurs to patients with persistent back pain. By worsening pain, mood, and physical functioning, insomnia could lead to the negative clinical consequences of patients with failed back surgery syndrome (FBSS). This retrospective and cross-sectional study aims to identify the risk factors associated with clinical insomnia in FBSS patients. Methods A total of 194 patients with FBSS, who met the study inclusion criteria, were included in this analysis. The Insomnia Severity Index (ISI) was utilized to ascertain the presence of clinical insomnia (ISI score ≥ 15). Logistic regression analysis evaluates patient demographic factors, clinical factors including prior surgical factors, and psychological factors to identify the risk factors of clinical insomnia in FBSS patients. Results After the persistent pain following lumbar spine surgery worsened, 63.4% of patients reported a change from mild to severe insomnia. In addition, 26.2% of patients met the criteria for clinically significant insomnia. In a multivariate logistic regression analysis, high pain intensity (odds ratio (OR) =2.742, 95% confidence interval (CI): 1.022 - 7.353, P =0.045), high pain catastrophizing (OR=4.185, 95% CI: 1.697 - 10.324, P =0.002), greater level of depression (OR =3.330, 95% CI: 1.127 - 9.837, P =0.030) were significantly associated with clinical insomnia. However, patient demographic factors and clinical factors including prior surgical factors were not significantly associated with clinical insomnia. Conclusions Insomnia should be addressed as a critical part of pain management in FBSS patients with these risk factors, especially in patients with high pain catastrophizing.

  14. Geometrical accuracy of metallic objects produced with additive or subtractive manufacturing: A comparative in vitro study.

    PubMed

    Braian, Michael; Jönsson, David; Kevci, Mir; Wennerberg, Ann

    2018-07-01

    To evaluate the accuracy and precision of objects produced by additive manufacturing systems (AM) for use in dentistry and to compare with subtractive manufacturing systems (SM). Ten specimens of two geometrical objects were produced by five different AM machines and one SM machine. Object A mimics an inlay-shaped object, while object B imitates a four-unit bridge model. All the objects were sorted into different measurement dimensions (x, y, z), linear distances, angles and corner radius. None of the additive manufacturing or subtractive manufacturing groups presented a perfect match to the CAD file with regard to all parameters included in the present study. Considering linear measurements, the precision for subtractive manufacturing group was consistent in all axes for object A, presenting results of <0.050mm. The additive manufacturing groups had consistent precision in the x-axis and y-axis but not in the z-axis. With regard to corner radius measurements, the SM group had the best overall accuracy and precision for both objects A and B when compared to the AM groups. Within the limitations of this in vitro study, the conclusion can be made that subtractive manufacturing presented overall precision on all measurements below 0.050mm. The AM machines also presented fairly good precision, <0.150mm, on all axes except for the z-axis. Knowledge regarding accuracy and precision for different production techniques utilized in dentistry is of great clinical importance. The dental community has moved from casting to milling and additive techniques are now being implemented. Thus all these production techniques need to be tested, compared and validated. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

  15. Doctors' experience with handheld computers in clinical practice: qualitative study.

    PubMed

    McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

    2004-05-15

    To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. 54 doctors who did or did not use handheld computers. Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care.

  16. A case study on topology optimized design for additive manufacturing

    NASA Astrophysics Data System (ADS)

    Gebisa, A. W.; Lemu, H. G.

    2017-12-01

    Topology optimization is an optimization method that employs mathematical tools to optimize material distribution in a part to be designed. Earlier developments of topology optimization considered conventional manufacturing techniques that have limitations in producing complex geometries. This has hindered the topology optimization efforts not to fully be realized. With the emergence of additive manufacturing (AM) technologies, the technology that builds a part layer upon a layer directly from three dimensional (3D) model data of the part, however, producing complex shape geometry is no longer an issue. Realization of topology optimization through AM provides full design freedom for the design engineers. The article focuses on topologically optimized design approach for additive manufacturing with a case study on lightweight design of jet engine bracket. The study result shows that topology optimization is a powerful design technique to reduce the weight of a product while maintaining the design requirements if additive manufacturing is considered.

  17. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

    PubMed

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-06-04

    To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives

  18. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the

  19. A Cross‐Study Analysis Evaluating the Effects of Food on the Pharmacokinetics of Rivaroxaban in Clinical Studies

    PubMed Central

    Peters, Gary; Haskell, Lloyd; Patel, Purve; Nandy, Partha; Moore, Kenneth Todd

    2017-01-01

    Abstract US prescribing guidelines recommend that 15‐ and 20‐mg doses of rivaroxaban be administered with food for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for reduction in the risk of recurrence of DVT and PE. In addition, the US prescribing guidelines recommend these doses be administered with an evening meal to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The purpose of this model‐based cross‐study comparison was to examine the impact of food, with regard to both meal timing and content, on the pharmacokinetics (PK) of rivaroxaban, using data collected during its clinical development. Results of this analysis showed that a PK model built from pooled data in the AF population (for whom rivaroxaban was administered with an evening meal) and in the DVT population (for whom rivaroxaban was administered with a morning meal) can describe both data sets well. Furthermore, the PK model built from data in the AF population alone can adequately predict the PK profile of the DVT population and vice versa. This cross‐study analysis also confirmed the findings from previous clinical pharmacology studies, which showed that meal content does not have a clinically relevant impact on the PK of rivaroxaban at 20 mg. Therefore, although the administration of rivaroxaban with food is necessary for maintaining high bioavailability, neither meal timing nor meal content appears to affect the PK of rivaroxaban. PMID:28679020

  20. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

    PubMed Central

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

  1. How redesigning AD clinical trials might increase study partners' willingness to participate.

    PubMed

    Karlawish, Jason; Cary, Mark S; Rubright, Jonathan; Tenhave, Tom

    2008-12-02

    Timely recruiting and retaining participants into Alzheimer disease (AD) clinical trials is a challenge. We used conjoint analysis to identify how alterations in attributes of clinical trial design improve willingness to participate: risk, home visits, car service, or increased chance of receiving intervention. A total of 108 study partners of patients with very mild to severe stage AD rated willingness to allow their relative to participate in eight clinical trials that varied combinations of the four attributes. The highest utility was for home visits (0.89) which essentially compensated for the disutility of high risk (-0.85). The combination of home visits and car service was redundant, with almost no increase in utility over home visits alone. Seventeen percent were willing to participate in a trial with no amenities; the addition of home visits increased predicted willingness to participate to 27%; low risk, home visits, and higher chance of active treatment increased predicted willingness to 60%. The value of reducing the hassles of travel correlated well with measures of AD severity (activities of daily living r = 0.41, p < 0.001; basic activities of daily living r = 0.38, p < 0.001; Neuropsychiatric Inventory severity p = 0.24, p = 0.01; Neuropsychiatric Inventory distress r = 0.23, p < 0.02). No association was found between degree of study partner burden and willingness to tolerate risk of an intervention. Clinical trials that reduce travel inconvenience may offset the disincentive of study features such as the risk of intervention and may also increase willingness to participate. Redesigning trials may also help recruit patients with more severe Alzheimer disease. Shorter recruitment periods and increased retention rates may offset costs of these changes.

  2. SES, Ethnic, and Gender Differences in Young Children's Informal Addition and Subtraction: A Clinical Interview Investigation

    ERIC Educational Resources Information Center

    Ginsburg, Herbert P.; Pappas, Sandra

    2004-01-01

    The main goal of this study was to examine possible socioeconomic status (SES) differences in 4- and 5-year-old children's informal mathematical knowledge. One hundred and two children, 32 from lower, 39 from middle, and 31 from upper SES families participated in the study. Each participant was given a clinical interview involving several addition…

  3. What factors facilitate good learning experiences in clinical studies in nursing: bachelor students' perceptions.

    PubMed

    Dale, Bjørg; Leland, Arne; Dale, Jan Gunnar

    2013-12-17

    Clinical studies constitute 50% of the bachelor program in nursing education in Norway, and the quality of these studies may be decisive for the students' opportunities to learn and develop their professional competences. The aim of this study was to explore what bachelor students' in nursing perceived to be important for having good learning experiences in clinical studies. Data was collected in a focus group interview with eight nursing students who were in the last year of the educational program. The interview was transcribed verbatim, and qualitative content analysis was used for exploring and interpreting the content of the interview text. One main theme emerged from the analysis: "being in a vulnerable and exposed position characterized by conflicting needs." Four categories were found: "aspects related to the clinical setting", "aspects related to the nurse supervisor," "aspects related to the student," and "aspects related to the student-supervisor relationship". The findings revealed that the students' learning experiences and motivation were related to individual, relational, and organizational aspects. The students highlighted their own as well as their supervisors' attitudes and competences and the importance of positive relationships. In addition, feeling welcomed, included, and valued in the ward improved their motivation, self-confidence, and self-respect.

  4. Etiology of Cellulitis and Clinical Prediction of Streptococcal Disease: A Prospective Study

    PubMed Central

    Bruun, Trond; Oppegaard, Oddvar; Kittang, Bård R.; Mylvaganam, Haima; Langeland, Nina; Skrede, Steinar

    2016-01-01

    Background. The importance of bacteria other than group A streptococci (GAS) in different clinical presentations of cellulitis is unclear, commonly leading to treatment with broad-spectrum antibiotics. The aim of this study was to describe the etiological and clinical spectrum of cellulitis and identify clinical features predicting streptococcal etiology. Methods. We prospectively enrolled 216 patients hospitalized with cellulitis. Clinical details were registered. Bacterial culture was performed from blood, cutaneous or subcutaneous tissue, and/or swabs from skin lesions. Paired serum samples were analyzed for anti-streptolysin O and anti-deoxyribonuclease B antibodies. Results. Serology or blood or tissue culture confirmed β-hemolytic streptococcal (BHS) etiology in 72% (146 of 203) of cases. An additional 13% (27 of 203) of cases had probable BHS infection, indicated by penicillin response or BHS cultured from skin swabs. β-hemolytic streptococcal etiology was predominant in all clinical subgroups, including patients without sharply demarcated erythema. β-hemolytic group C or G streptococci (GCS/GGS) were more commonly isolated than GAS (36 vs 22 cases). This predominance was found in the lower extremity infections. Group C or G streptococci in swabs were associated with seropositivity just as often as GAS. Staphylococcus aureus was cultured from swabs as a single pathogen in 24 cases, 14 (64%) of which had confirmed BHS etiology. Individual BHS-associated clinical characteristics increased the likelihood of confirmed BHS disease only slightly; positive likelihood ratios did not exceed 2.1. Conclusions. β-hemolytic streptococci were the dominating cause of cellulitis in all clinical subgroups and among cases with S aureus in cutaneous swabs. Group C or G streptococci were more frequently detected than GAS. No single clinical feature substantially increased the probability of confirmed BHS etiology. PMID:26734653

  5. Clinical characteristics of patients with treated epilepsy in Korea: a nationwide epidemiologic study.

    PubMed

    Kim, Dong Wook; Lee, Seo-Young; Chung, Soo-Eun; Cheong, Hae-Kwan; Jung, Ki-Young

    2014-01-01

    Although a number of epidemiologic studies have been conducted on the prevalence and incidence of epilepsy around the world, only a few studies have investigated the clinical characteristics of patients with epilepsy in a population-based sample. The purpose of the present study was to describe the clinical characteristics of treated patients with epilepsy in Korea via a nationwide medical records survey. The study population was obtained through a nationwide database registered to the Health Insurance Review and Assessment service. Patients were recruited from clinics and hospitals in each cluster according to region and referral level by random selection from a preallocated sample of patients. All patients were being treated with antiepileptic drug medication with or without a diagnosis code for epilepsy or seizure between January 2009 and December 2009. Among the 6,436 selected patients, 2,150 met the diagnostic criteria for epilepsy and were included in our survey on the clinical characteristics of patients who were with treated epilepsy. The proportion of male patients with epilepsy in this study was higher (1,226; 57.0%) than that of female patients. In addition, 10.6% of patients were first diagnosed with epilepsy in 2009, and 53.6% of patients experienced at least one seizure over the course of 2009; 78.1% were classified as having localization-related epilepsy, whereas 7.3% were considered to have generalized epilepsy. Thirty-five percent of patients were thus classified as idiopathic or cryptogenic cases. The most common cause of symptomatic epilepsy was trauma (10.0%), followed by stroke (9.6%), central nervous system (CNS) infection (5.7%), and hippocampal sclerosis (4.9%). This is the first nationwide study of the clinical characteristics of treated epilepsy in Korea using a national database validated by medical records survey. The etiologies of epilepsy and epilepsy syndrome classifications were comparable to those previously reported in other

  6. Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

    PubMed

    Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

    2017-11-01

    Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study.

    PubMed

    Nakamura, Mio; Altshuler, David; Chadwell, Margit; Binienda, Juliann

    2014-12-12

    At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical skills, including self-confidence, self-reflection, and professionalism. Scores of the Year 1 Objective Structured Clinical Exam (OSCE) were compared between SRFC volunteers and non-volunteers. There were a total of 206 (68.2%) and 80 (26.5%) survey responses at the beginning and end of Year 1, respectively. Of the 80 students, 31 (38.7%) volunteered at SRFC during Year 1. Statistically significant differences were found between time points in self-confidence (p < 0.001) in both groups. When looking at self-confidence in skills pertaining to SRFC, the difference between groups was statistically significant (p = 0.032) at both time points. A total of 302 students participated in the Year 1 OSCE, 27 (9%) of which were SRFC volunteers. No statistically significant differences were found between groups for mean score (p = 0.888) and established level of rapport (p = 0.394). While this study indicated no significant differences in clinical skills in students who volunteer at the SRFC, it is a first step in attempting to measure clinical skill development outside of the structured medical school setting. The findings lend themselves to development of research designs, clinical surveys, and future studies to measure the impact of clinical volunteer opportunities on clinical skills development in future physicians.

  8. The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

    PubMed Central

    Tasneem, Asba; Aberle, Laura; Ananth, Hari; Chakraborty, Swati; Chiswell, Karen; McCourt, Brian J.; Pietrobon, Ricardo

    2012-01-01

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

  9. “Entering a Clinical Trial: Is it Right For You?"-- A Randomized Study of The Clinical Trials Video and Its Impact on the Informed Consent Process

    PubMed Central

    Hoffner, Brianna; Bauer-Wu, Susan; Hitchcock-Bryan, Suzanne; Powell, Mark; Wolanski, Andrew; Joffe, Steven

    2011-01-01

    PURPOSE This randomized study was designed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation. The study assessed the effect of the video on patients’ understanding and perceptions of clinical trials, its impact on decision making and patient-provider communication, and patients’ satisfaction with the video. METHODS Ninety adults considering cancer clinical trials were randomized to receive (n=45) or not receive (n=45) the video. Using the validated Quality of Informed Consent (QuIC), respondents’ knowledge about clinical trial participation was assessed. All subjects completed additional questions about satisfaction with the video, decision making, and patient-provider communication. Data were analyzed using the Wilcoxon rank-sum test, regression model and descriptive statistics. RESULTS Although intent-to-treat analysis found no significant group differences in objective understanding between those randomized to view or not view the video, the majority of participants reported favorable experiences with regard to watching the video: 85% found the video was an important source of information about clinical trials; 81% felt better prepared to discuss the trial with their physician; 89% of those who watched the video with family indicated that it helped family better understand clinical trials; and 73% indicated it helped family accept their decision about participation. CONCLUSIONS Although the video did not measurably improve patients’ knowledge about clinical trials, it was an important source of information, helped educate families, and enhanced patient communication with their oncology providers. PMID:22009665

  10. A survey on clinical governance awareness among clinical staff: a cross-sectional study.

    PubMed

    Ravaghi, Hamid; Zarnaq, Rahim Khodayari; Adel, Amin; Badpa, Mahnaz; Adel, Moein; Abolhassani, Nazanin

    2014-06-25

    Clinical Governance (CG) program has been raised in Iran in order to improve the quality of clinical care. The purpose of this study is to investigate the awareness of clinical governance program among clinical staff working in selected teaching hospitals in Tehran, Iran. To investigate the CG awareness, a cross-sectional survey was conducted among 345 clinical staff working in 20 selected public hospitals in Tehran. Data were gathered using the standardized clinical governance awareness questionnaire. Descriptive statistics were used to analyze the data. The results showed that the level of staff awareness about the concept of CG was low. They perceived continuous quality improvement, responsibility, medical errors reduction and patient safety as the main concepts of the CG framework. Reaching agreement of standards concepts among staff and positive changes in attitudes were considered as two most observed changes. The main perceived barriers to the implementation of clinical governance included lack of proper management and leadership, lack of full support, inappropriate organizational culture, lack of knowledge, poor communication system and insufficient training. The concepts and goals of clinical governance have not been effectively conveyed to the staff and despite its implementation in the hospitals, there has been low clinical governance awareness among the staff. Clinical Governance must be implemented through comprehensive management support and participation of all staff and health professionals at both hospital and policy making level.

  11. PPB | What is a Clinical Study

    Cancer.gov

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  12. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    PubMed Central

    2011-01-01

    Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT) will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE) PMID:21663656

  13. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to any...

  14. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to any...

  15. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to any...

  16. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to any...

  17. 42 CFR 52d.9 - Additional conditions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Additional conditions. 52d.9 Section 52d.9 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM § 52d.9 Additional conditions. The Director, NCI, may with respect to any...

  18. National questionnaire study on clinical ICT systems proofs: physicians suffer from poor usability.

    PubMed

    Viitanen, Johanna; Hyppönen, Hannele; Lääveri, Tinja; Vänskä, Jukka; Reponen, Jarmo; Winblad, Ilkka

    2011-10-01

    problems and deficiencies which considerably hindered the efficiency of clinical ICT use and physician's routine work. Systems lacked the appropriate features to support typical clinical tasks, such as decision making, prevention of medical errors, and review of a patient's treatment chart. The systems also required physicians to perform fixed sequences of steps and tasks, and poorly supported the documentation and retrieval of patient data. The findings on ICT support for collaboration showed mainly negative results, aside from collaboration between co-located physicians. In addition, the study results pointed out physicians suffering from system failures and a lack of integration between the systems. The described study and related results are unique in several ways. A national usability study with nearly 4000 respondents had not been conducted in other countries in which healthcare technologies are widely adopted. The questionnaire study provided a generalized picture about the usability problems, however, it should be noted that there were significant differences between legacy systems in use. Previously, researchers had not approached contextual aspects of usability the context of clinical work, where numerous systems are in use. The described usability dimensions and the presented study results can be considered as the first step towards conceptualizing ICT usability in the unique setting of clinical work. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  19. Additional follow-up telephone counselling and initial smoking relapse: a longitudinal, controlled study.

    PubMed

    Wu, Lei; He, Yao; Jiang, Bin; Zuo, Fang; Liu, Qinghui; Zhang, Li; Zhou, Changxi

    2016-04-20

    Smoking cessation services can help smokers to quit; however, many smoking relapse cases occur over time. Initial relapse prevention should play an important role in achieving the goal of long-term smoking cessation. Several studies have focused on the effect of extended telephone support in relapse prevention, but the conclusions remain conflicting. From October 2008 to August 2013, a longitudinal, controlled study was performed in a large general hospital of Beijing. The smokers who sought treatment at our smoking cessation clinic were non-randomised and divided into 2 groups: face-to-face individual counselling group (FC group), and face-to-face individual counselling plus telephone follow-up counselling group (FCF group). No pharmacotherapy was offered. The timing of initial smoking relapse was compared between FC and FCF groups. Predictors of initial relapse were investigated during the first 180 days, using the Cox proportional hazards model. Of 547 eligible male smokers who volunteered to participate, 457 participants (117 in FC group and 340 in FCF group) achieved at least 24 h abstinence. The majority of the lapse episodes occurred during the first 2 weeks after the quit date. Smokers who did not receive the follow-up telephone counselling (FC group) tended to relapse to smoking earlier than those smokers who received the additional follow-up telephone counselling (FCF group), and the log-rank test was statistically significant (p=0.003). A Cox regression model showed that, in the FCF group, being married, and having a lower Fagerström test score, normal body mass index and doctor-diagnosed tobacco-related chronic diseases, were significantly independent protective predictors of smoking relapse. Within the limitations of this study, it can be concluded that additional follow-up telephone counselling might be an effective strategy in preventing relapse. Further research is still needed to confirm our findings. Published by the BMJ Publishing Group

  20. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    PubMed

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  1. Poststroke Seizures and Epilepsy: Clinical Studies and Animal Models

    PubMed Central

    Kelly, Kevin M.

    2002-01-01

    Poststroke seizures and epilepsy have been described in numerous clinical studies for many years. Most studies are retrospective in design, include relatively small numbers of patients, have limited periods of follow-up, and report a diversity of findings. Well-designed clinical trials and population studies in the recent past addressed several critical clinical issues and generated important findings regarding the occurrence of poststroke seizures and epilepsy. In contrast, the pathophysiologic events of injured brain that establish poststroke epileptogenesis are not well understood, and animal modeling has had limited development. Reviews of several important clinical studies and animal models that hold promise for a better understanding of poststroke epileptogenesis are presented. PMID:15309107

  2. Study of mandible reconstruction using a fibula flap with application of additive manufacturing technology

    PubMed Central

    2014-01-01

    Background This study aimed to establish surgical guiding techniques for completing mandible lesion resection and reconstruction of the mandible defect area with fibula sections in one surgery by applying additive manufacturing technology, which can reduce the surgical duration and enhance the surgical accuracy and success rate. Methods A computer assisted mandible reconstruction planning (CAMRP) program was used to calculate the optimal cutting length and number of fibula pieces and design the fixtures for mandible cutting, registration, and arrangement of the fibula segments. The mandible cutting and registering fixtures were then generated using an additive manufacturing system. The CAMRP calculated the optimal fibula cutting length and number of segments based on the location and length of the defective portion of the mandible. The mandible cutting jig was generated according to the boundary surface of the lesion resection on the mandible STL model. The fibular cutting fixture was based on the length of each segment, and the registered fixture was used to quickly arrange the fibula pieces into the shape of the defect area. In this study, the mandibular lesion was reconstructed using registered fibular sections in one step, and the method is very easy to perform. Results and conclusion The application of additive manufacturing technology provided customized models and the cutting fixtures and registered fixtures, which can improve the efficiency of clinical application. This study showed that the cutting fixture helped to rapidly complete lesion resection and fibula cutting, and the registered fixture enabled arrangement of the fibula pieces and allowed completion of the mandible reconstruction in a timely manner. Our method can overcome the disadvantages of traditional surgery, which requires a long and different course of treatment and is liable to cause error. With the help of optimal cutting planning by the CAMRP and the 3D printed mandible resection jig and

  3. Clinical history for diagnosis of dementia in men: Caerphilly Prospective Study

    PubMed Central

    Creavin, Sam; Fish, Mark; Gallacher, John; Bayer, Antony; Ben-Shlomo, Yoav

    2015-01-01

    Background Diagnosis of dementia often requires specialist referral and detailed, time-consuming assessments. Aim To investigate the utility of simple clinical items that non-specialist clinicians could use, in addition to routine practice, to diagnose all-cause dementia syndrome. Design and setting Cross-sectional diagnostic test accuracy study. Participants were identified from the electoral roll and general practice lists in Caerphilly and adjoining villages in South Wales, UK. Method Participants (1225 men aged 45–59 years) were screened for cognitive impairment using the Cambridge Cognitive Examination, CAMCOG, at phase 5 of the Caerphilly Prospective Study (CaPS). Index tests were a standardised clinical evaluation, neurological examination, and individual items on the Informant Questionnaire for Cognitive Disorders in the Elderly (IQCODE). Results Two-hundred and five men who screened positive (68%) and 45 (4.8%) who screened negative were seen, with 59 diagnosed with dementia. The model comprising problems with personal finance and planning had an area under the curve (AUC) of 0.92 (95% confidence interval [CI] = 0.86 to 0.97), positive likelihood ratio (LR+) of 23.7 (95% CI = 5.88 to 95.6), negative likelihood ratio (LR−) of 0.41 (95% CI = 0.27 to 0.62). The best single item for ruling out was no problems learning to use new gadgets (LR− of 0.22, 95% CI = 0.11 to 0.43). Conclusion This study found that three simple questions have high utility for diagnosing dementia in men who are cognitively screened. If confirmed, this could lead to less burdensome assessment where clinical assessment suggests possible dementia. PMID:26212844

  4. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

    PubMed

    Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

    2015-02-01

    )-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

  5. An overview of clinical studies on fiber post systems.

    PubMed

    Dikbas, Idil; Tanalp, Jale

    2013-01-01

    Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

  6. An Overview of Clinical Studies on Fiber Post Systems

    PubMed Central

    Dikbas, Idil; Tanalp, Jale

    2013-01-01

    Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis. PMID:24250255

  7. Can clinical CT data improve forensic reconstruction?

    PubMed

    Schuh, P; Scheurer, E; Fritz, K; Pavlic, M; Hassler, E; Rienmüller, R; Yen, K

    2013-05-01

    In accidents resulting in severe injuries, a clinical forensic examination is generally abandoned in the initial phase due to high-priority clinical needs. However, in many cases, data from clinical computed tomography (CT) examinations are available. The goals of this prospective study were (a) to evaluate clinical CT data as a basis for forensic reconstruction of the sequence of events, (b) to assess if forensic radiological follow-up reading improves the forensic diagnostic benefit compared to the written clinical radiological reports, and (c) to evaluate if full data storage including additional reconstructed 0.6-mm slices enhances forensic analysis. Clinical CT data of 15 living individuals with imaging of at least the head, thorax, and abdomen following polytrauma were examined regarding the forensic evaluation of the sequence of events. Additionally, 0.6-mm slices and 3D images were reconstructed for forensic purposes and used for the evaluation. At the forensic radiological readings, additional traumatic findings were observed in ten of the 15 patients. The main weakness of the clinical reports was that they were not detailed enough, particularly regarding the localization of injuries and description of wound morphology. In seven cases, however, forensic conclusions were possible on the basis of the written clinical reports, whereas in five cases forensic reconstruction required specific follow-up reading. The additional 0.6-mm slices were easily available and with improved 3D image quality and forensic diagnostics. In conclusion, the use of clinical CT data can considerably support forensic expertise regarding reconstruction issues. Forensic follow-up reading as well as the use of additional thin slices for 3D analysis can further improve its benefit for forensic reconstruction purposes.

  8. To belong or not to belong: nursing students' interactions with clinical learning environments - an observational study.

    PubMed

    Liljedahl, Matilda; Björck, Erik; Kalén, Susanne; Ponzer, Sari; Bolander Laksov, Klara

    2016-08-05

    Belongingness has been argued to be a prerequisite for students' learning in the clinical setting but making students feel like they belong to the workplace is a challenge. From a sociocultural perspective, workplace participatory practices is a framework that views clinical learning environments to be created in interaction between students and the workplace and hence, are dependent on them both. The aim of this study was to explore the interdependence between affordances and engagement in clinical learning environments. The research question was: How are nursing students influenced in their interactions with clinical learning environments? An observational study with field observations and follow-up interviews was performed. The study setting comprised three academic teaching hospitals. Field observations included shadowing undergraduate nursing students during entire shifts. Fifty-five hours of field observations and ten follow-up interviews with students, supervisors and clinical managers formed the study data. A thematic approach to the analysis was taken and performed iteratively with the data collection. The results revealed that students strived to fill out the role they were offered in an aspirational way but that they became overwhelmed when given the responsibility of care. When students' basic values did not align with those enacted by the workplace, they were not willing to compromise their own values. Workplaces succeeded in inviting students into the community of nurses and the practice of care. Students demonstrated hesitance regarding their desire to belong to the workplace community. The results imply that the challenge for clinical education is not to increase the experience of belongingness but to maintain students' critical and reflective approach to health care practice. Additionally, results suggest students to be included as an important stakeholder in creating clinical learning environments rather than being viewed as consumer of clinical

  9. A study of the additional costs of dispensing workers' compensation prescriptions.

    PubMed

    Schafermeyer, Kenneth W

    2007-03-01

    Although there is a significant amount of additional work involved in dispensing workers' compensation prescriptions, these costs have not been quantified. A study of the additional costs to dispense a workers' compensation prescription is needed to measure actual costs and to help determine the reasonableness of reimbursement for prescriptions dispensed under workers' compensation programs. The purpose of this study was to determine the minimum additional time and costs required to dispense workers' compensation prescriptions in Texas. A convenience sample of 30 store-level pharmacy staff members involved in submitting and processing prescription claims for the Texas Mutual workers' compensation program were interviewed by telephone. Data collected to determine the additional costs of dispensing a workers' compensation prescription included (1) the amount of additional time and personnel costs required to dispense and process an average workers' compensation prescription claim, (2) the difference in time required for a new versus a refilled prescription, (3) overhead costs for processing workers' compensation prescription claims by experienced experts at a central processing facility, (4) carrying costs for workers' compensation accounts receivable, and (5) bad debts due to uncollectible workers' compensation claims. The median of the sample pharmacies' additional costs for dispensing a workers' compensation prescription was estimated to be at least $9.86 greater than for a cash prescription. This study shows that the estimated costs for workers' compensation prescriptions were significantly higher than for cash prescriptions. These costs are probably much more than most employers, workers' compensation payers, and pharmacy managers would expect. It is recommended that pharmacy managers should estimate their own costs and compare these costs to actual reimbursement when considering the reasonableness of workers' compensation prescriptions and whether to accept

  10. Emerging technologies in arthroplasty: additive manufacturing.

    PubMed

    Banerjee, Samik; Kulesha, Gene; Kester, Mark; Mont, Michael A

    2014-06-01

    Additive manufacturing is an industrial technology whereby three-dimensional visual computer models are fabricated into physical components by selectively curing, depositing, or consolidating various materials in consecutive layers. Although initially developed for production of simulated models, the technology has undergone vast improvements and is currently increasingly being used for the production of end-use components in various aerospace, automotive, and biomedical specialties. The ability of this technology to be used for the manufacture of solid-mesh-foam monolithic and coated components of complex geometries previously considered unmanufacturable has attracted the attention of implant manufacturers, bioengineers, and orthopedic surgeons. Currently, there is a paucity of reports describing this fabrication method in the orthopedic literature. Therefore, we aimed to briefly describe this technology, some of the applications in other orthopedic subspecialties, its present use in hip and knee arthroplasty, and concerns with the present form of the technology. As there are few reports of clinical trials presently available, the true benefits of this technology can only be realized when studies evaluating the clinical and radiographic outcomes of cementless implants manufactured with additive manufacturing report durable fixation, less stress shielding, and better implant survivorship. Nevertheless, the authors believe that this technology holds great promise and may potentially change the conventional methods of casting, machining, and tooling for implant manufacturing in the future. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  11. [Failure of a study in forensic psychiatric hospitals : Clinical trial to investigate the additive effect of triptorelin on the efficacy of psychotherapy].

    PubMed

    Briken, Peer; Müller, Jürgen L; Berner, Wolfgang; Bödeker, Rolf-Hasso; Vollmann, Jochen; Kasperk, Christian; Koller, Matthias

    2017-05-01

    A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medication, is still lacking. This article describes the process from the planning to the rejection of a clinical trial over the period from 2009 to 2015. Despite the careful planning with an interdisciplinary team and giving special consideration to the complex legal situation, the Federal Institute for Drugs and Medical Devices (BfArM) rejected the proposed trial in a brief formal letter with reference to the German Drug Law (§ 40 para. 1 p. 3 nr. 4 AMG). The ethics committee of the Hamburg Medical Association considered that clinical research is basically not possible with patients detained in a forensic psychiatric hospital. In the opinion of the authors, the described facts illustrate how legal regulations that should protect vulnerable groups in medical research, in a specific case can lead to the fact that a therapy form relevant to the corresponding patient group cannot be scientifically investigated.

  12. Doctors' experience with handheld computers in clinical practice: qualitative study

    PubMed Central

    McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

    2004-01-01

    Objective To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Design Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Setting Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. Participants 54 doctors who did or did not use handheld computers. Results Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Conclusions Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care. PMID:15142920

  13. How redesigning AD clinical trials might increase study partners’ willingness to participate

    PubMed Central

    Karlawish, Jason; Cary, Mark S.; Rubright, Jonathan; TenHave, Tom

    2008-01-01

    Background: Timely recruiting and retaining participants into Alzheimer disease (AD) clinical trials is a challenge. We used conjoint analysis to identify how alterations in attributes of clinical trial design improve willingness to participate: risk, home visits, car service, or increased chance of receiving intervention. Method: A total of 108 study partners of patients with very mild to severe stage AD rated willingness to allow their relative to participate in eight clinical trials that varied combinations of the four attributes. Results: The highest utility was for home visits (0.89) which essentially compensated for the disutility of high risk (−0.85). The combination of home visits and car service was redundant, with almost no increase in utility over home visits alone. Seventeen percent were willing to participate in a trial with no amenities; the addition of home visits increased predicted willingness to participate to 27%; low risk, home visits, and higher chance of active treatment increased predicted willingness to 60%. The value of reducing the hassles of travel correlated well with measures of AD severity (activities of daily living r = 0.41, p < 0.001; basic activities of daily living r = 0.38, p < 0.001; Neuropsychiatric Inventory severity p = 0.24, p = 0.01; Neuropsychiatric Inventory distress r = 0.23, p < 0.02). No association was found between degree of study partner burden and willingness to tolerate risk of an intervention. Conclusion: Clinical trials that reduce travel inconvenience may offset the disincentive of study features such as the risk of intervention and may also increase willingness to participate. Redesigning trials may also help recruit patients with more severe Alzheimer disease. Shorter recruitment periods and increased retention rates may offset costs of these changes. GLOSSARY AD = Alzheimer disease; BLUP = best linear unbiased prediction; RAQ = Research Attitude Questionnaire. PMID:19047560

  14. A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study.

    PubMed

    Chan, Kevin

    2007-12-04

    The randomized controlled trial is the "gold standard" for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.

  15. Educating for health service reform: clinical learning, governance and capability - a case study protocol.

    PubMed

    Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

    2016-01-01

    The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. A case study design will be used to investigate educational governance and capability theory in nurse practitioner education. Nurse practitioner students, their clinical mentors and university academic staff, from an Australian university that offers an accredited nurse practitioner Master's degree, will be invited to participate in the study. Semi-structured interviews will be conducted with students and their respective clinical mentors and university academic staff to investigate learning objectives related to educational governance and attributes of capability learning. Limited demographic data on age, gender, specialty, education level and nature of the clinical healthcare learning site will also be collected. Episodes of nurse practitioner student specialty clinical learning will be observed and documentation from the students' healthcare learning sites will be collected. Descriptive statistics will be used to report age groups, areas of specialty and types of facilities where clinical learning and teaching is observed. Qualitative data from interviews, observations and student documents will be coded, aggregated and explored to inform a framework of educational governance, to confirm the existing capability framework and describe any additional characteristics of capability and capability learning. This research has widespread significance and will contribute to ongoing development of the Australian health workforce. Stakeholders from industry and academic bodies will be involved in shaping the framework that

  16. Additional EIPC Study Analysis. Final Report

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

    Hadley, Stanton W; Gotham, Douglas J.; Luciani, Ralph L.

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a Stakeholder Steering Committee (SSC) that included representatives from the Eastern Interconnection States Planning Council (EISPC) among others, the project was conducted in two phases. Phase 1 involved a long-term capacity expansion analysis that involved creation of eight major futures plus 72 sensitivities. Three scenarios were selected for more extensive transmission- focused evaluation in Phase 2. Five power flow analyses, nine production cost model runs (including six sensitivities), and three capital cost estimations weremore » developed during this second phase. The results from Phase 1 and 2 provided a wealth of data that could be examined further to address energy-related questions. A list of 14 topics was developed for further analysis. This paper brings together the earlier interim reports of the first 13 topics plus one additional topic into a single final report.« less

  17. Mental additions and verbal-domain interference in children with developmental dyscalculia.

    PubMed

    Mammarella, Irene C; Caviola, Sara; Cornoldi, Cesare; Lucangeli, Daniela

    2013-09-01

    This study examined the involvement of verbal and visuo-spatial domains in solving addition problems with carrying in a sample of children diagnosed with developmental dyscalculia (DD) divided into two groups: (i) those with DD alone and (ii) those with DD and dyslexia. Age and stage matched typically developing (TD) children were also studied. The addition problems were presented horizontally or vertically and associated with verbal or visuo-spatial information. Study results showed that DD children's performance on mental calculation tasks was more impaired when they tackled horizontally presented addition problems compared to vertically presented ones that are associated to verbal domain involvement. The performance pattern in the two DD groups was found to be similar. The theoretical, clinical and educational implications of these findings are discussed. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. Marketing and clinical trials: a case study

    PubMed Central

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-01-01

    Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

  19. Marketing and clinical trials: a case study.

    PubMed

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  20. The role of the nurse teacher in clinical practice: an empirical study of Finnish student nurse experiences.

    PubMed

    Saarikoski, Mikko; Warne, Tony; Kaila, Päivi; Leino-Kilpi, Helena

    2009-08-01

    This paper focuses on the role of the nurse teacher (NT) in supporting student nurse education in clinical practice. The paper draws on the outcomes of a study aimed at exploring student nurse experiences of the pedagogical relationship with NTs during their clinical placements. The participants (N=549) were student nurses studying on pre-registration nursing programmes in Finland. Data were analysed using descriptive statistics, cross-tabulation and ANOVA. The study showed that the core aspect of NTs work in clinical practice revolved around the relationship between student, mentor and NT. Higher levels of satisfaction were experienced in direct proportion to the number of meetings held between the student and NT. However, whilst the importance of this relationship has been reported elsewhere, an additional aspect of this relationship emerged in the data analysis. Those NT who facilitated good face to face contact also used other methods to enhance the relationship, particularly e-mail, virtual learning environment and texting. This outcome suggests that NT's interpersonal and communicative skills are as important as their clinical knowledge and skills in promoting effective learning in the clinical practice area. The paper argues for such approaches to be utilised within the emergent opportunities afforded by new communication and educational technologies.

  1. Using Big Data in oncology to prospectively impact clinical patient care: A proof of concept study.

    PubMed

    Dougoud-Chauvin, Vérène; Lee, Jae Jin; Santos, Edgardo; Williams, Vonetta L; Battisti, Nicolò M L; Ghia, Kavita; Sehovic, Marina; Croft, Cortlin; Kim, Jongphil; Balducci, Lodovico; Kish, Julie A; Extermann, Martine

    2018-04-17

    Big Data is widely seen as a major opportunity for progress in the practice of personalized medicine, attracting the attention from medical societies and presidential teams alike as it offers a unique opportunity to enlarge the base of evidence, especially for older patients underrepresented in clinical trials. This study prospectively assessed the real-time availability of clinical cases in the Health & Research Informatics Total Cancer Care™ (TCC) database matching community patients with cancer, and the impact of such a consultation on treatment. Patients aged 70 and older seen at the Lynn Cancer Institute (LCI) with a documented malignancy were eligible. Geriatric screening information and the oncologist's pre-consultation treatment plan were sent to Moffitt. A search for similar patients was done in TCC and additional information retrieved from Electronic Medical Records. A report summarizing the data was sent and the utility of such a consultation was assessed per email after the treatment decision. Thirty one patients were included. The geriatric screening was positive in 87.1% (27) of them. The oncogeriatric consultation took on average 2.2 working days. It influenced treatment in 38.7% (12), and modified it in 19.4% (6). The consultation was perceived as "somewhat" to "very useful" in 83.9% (26). This study establishes a proof of concept of the feasibility of real time use of Big Data for clinical practice. The geriatric screening and the consultation report influenced treatment in 38.7% of cases and modified it in 19.4%, which compares very well with oncogeriatric literature. Additional steps are needed to render it financially and clinically viable. Copyright © 2018 Elsevier Inc. All rights reserved.

  2. Diagnostic potential of optical coherence tomography in non-melanoma skin cancer: a clinical study

    NASA Astrophysics Data System (ADS)

    Mogensen, Mette; Thrane, Lars; Jørgensen, Thomas Martini; Jemec, Gregor B. E.

    2007-07-01

    Introduction: Non-melanoma skin cancer (NMSC) is the most prevalent cancer in the Western World. OCT has proved potential in assisting clinical diagnosis and perhaps reducing the need for biopsies in NMSC. As non-invasive treatment is increasingly used for NMSC patients with superficial lesions, the development of non-invasive diagnostic technologies is highly relevant. Methods: The aim of this cross-sectional clinical study, enrolling 100 NMSC patients and 20 healthy volunteers, is to investigate the diagnostic accuracy and applicability of OCT in NMSC diagnosis. Our OCT-system has been developed at Risoe National Laboratory, Denmark and offers ppolarization sensitive-OCT (PS-OCT) that may have additional advantaged as NMSC differ in content of birefringent collagens from normal skin. Results: Basal cell carcinomas (BCC) can in some cases be distinguished from normal skin in OCT-images, as normal skin exhibits a layered structure this layering is not present in BCC and sometimes not in actinic keratosis (AK). BCC lesions seem to be clearly less reflective than normal tissue. The predictive value of OCT in NMSC will be presented from a clinical point of view. Discussion: The earlier a skin cancer is diagnosed, the better the prognosis. Estimation of diagnostic accuracy and abilities of OCT in clinical studies of skin cancer patients is essential to establish the role and future set-ups for diagnostic OCT-systems.

  3. Making intelligent systems team players: Additional case studies

    NASA Technical Reports Server (NTRS)

    Malin, Jane T.; Schreckenghost, Debra L.; Rhoads, Ron W.

    1993-01-01

    Observations from a case study of intelligent systems are reported as part of a multi-year interdisciplinary effort to provide guidance and assistance for designers of intelligent systems and their user interfaces. A series of studies were conducted to investigate issues in designing intelligent fault management systems in aerospace applications for effective human-computer interaction. The results of the initial study are documented in two NASA technical memoranda: TM 104738 Making Intelligent Systems Team Players: Case Studies and Design Issues, Volumes 1 and 2; and TM 104751, Making Intelligent Systems Team Players: Overview for Designers. The objective of this additional study was to broaden the investigation of human-computer interaction design issues beyond the focus on monitoring and fault detection in the initial study. The results of this second study are documented which is intended as a supplement to the original design guidance documents. These results should be of interest to designers of intelligent systems for use in real-time operations, and to researchers in the areas of human-computer interaction and artificial intelligence.

  4. Second Mesiobuccal Canal Treatment in a Predoctoral Dental Clinic: A Retrospective Clinical Study.

    PubMed

    Coelho, Marcelo Santos; Parker, Jeffrey M; Tawil, Peter Z

    2016-06-01

    The aim of this retrospective clinical study was to evaluate the location and treatment of second canals in mesiobuccal roots (MB2) of first and second maxillary molars in a predoctoral endodontic clinic by the graduating classes of 2008 to 2015. These results were compared to similar clinical studies. Included in the study were 368 root canal treatments performed by 310 third- and fourth-year dental students at one U.S. dental school. All cases were done under faculty supervision, and the students were instructed to use dental loupe magnification. Students' evaluation sheets were used to deteremine the total MB2 canals treated in first and second maxillary molars. The results showed that, overall, 72.55% of the teeth had an MB2 canal treated. The frequency was higher in first molars (75.91%) than in second molars (56.92%) (p<0.05). Third-year students were able to detect 39 MB2 canals in 57 maxillary molars (68.42%), while fourth-year students detected 228 MB2 canals in 311 teeth (73.31%) (p>0.05). Under proper supervision by experienced endodontists, these dental students were capable of treating MB2 canals in maxillary molars. The frequency of MB2 canals located and treated by dental students with the assistance of experienced professionals was higher in first than in second molars. No significant difference was found between third- and fourth-year students. The incidence of MB2 canals located and treated in this study was found to be similar to that in other clinical studies.

  5. The transfer of theoretical knowledge to clinical practice by nursing students and the difficulties they experience: A qualitative study.

    PubMed

    Günay, Ulviye; Kılınç, Gülsen

    2018-06-01

    Nursing education contains both theoretical and practical training processes. Clinical training is the basis of nursing education. The quality of clinical training is closely related to the quality of the clinical learning environment. This study aimed to determine the transfer of theoretical knowledge into clinical practice by nursing students and the difficulties they experience during this process. A qualitative research design was used in the study. The study was conducted in 2015 with 30 nursing students in a university located in the east of Turkey, constituting three focus groups. The questions directed to the students during the focus group interviews were as follows: What do you think about your clinical training? How do you evaluate yourself in the process of putting your theoretical knowledge into clinical practice? What kind of difficulties are you experiencing in clinical practices? The data were interpreted using the method of content analysis. Most of the students reported that theoretical information they received was excessive, their ability to put most of this information into practice was weak, and they lacked courage to touch patients for fear of implementing procedures incorrectly. As a result of the analysis of the data, five main themes were determined: clinical training, guidance and communication, hospital environment and expectations. The results of this study showed that nursing students found their clinical knowledge and skills insufficient and usually failed to transfer their theoretical knowledge into clinical practices. The study observed that nursing students experienced various issues in clinical practices. In order to fix these issues and achieve an effective clinical training environment, collaboration should be achieved among nursing instructors, nurses, nursing school and hospital managements. Additionally, the number of nursing educators should be increased and training programs should be provided regarding effective clinical

  6. Clinical, Dopaminergic, and Metabolic Correlations in Parkinson Disease: A Dual-Tracer PET Study.

    PubMed

    Liu, Feng-Tao; Ge, Jing-Jie; Wu, Jian-Jun; Wu, Ping; Ma, Yilong; Zuo, Chuan-Tao; Wang, Jian

    2018-05-31

    Neuroimaging indicators of Parkinson disease have been developed and applied in clinical practices. Dopaminergic imaging reflects nigrostriatal dopaminergic dysfunction, and metabolic network imaging offers disease-related metabolic changes at a system level. We aimed to elucidate the association between Parkinsonian symptoms and neuroimaging, and interactions between different imaging techniques. We conducted a dual-tracer PET study for the combined assessments of dopaminergic binding (C-CFT) and glucose metabolism (F-FDG) in 103 participants with Parkinson disease (65 male and 38 female subjects). The detailed clinical rating scores were systematically collected in all members. The interactions among dopaminergic bindings, metabolic changes, and clinical manifestations were evaluated at voxel, regional, and network levels. Striatal DAT binding correlated with akinesia-rigidity (P < 0.001) but not with tremor; the metabolic PET imaging, nonspecific to the dopaminergic dysfunction, disclosed a set of brain regions correlating with the cardinal symptoms, including tremor. In addition, the unilateral symptom correlated with the contralateral nigrostriatal dopamine loss, but with bilateral metabolic changes, suggesting their differences in the application of disease-related mechanistic studies. Further imaging-imaging correlation study revealed that dopaminergic dysfunction correlated with widely distributed metabolic changes in Parkinson disease, and the modest correlations supported the findings on the clinical-imaging correlation. In this dual-tracer PET study, we demonstrated the robust interactions among dopaminergic dysfunction, metabolic brain changes and clinical manifestations at voxel, regional, and network levels. Our findings might promote the understanding in the proper application of dopaminergic and metabolic PET imaging in Parkinson disease and offer more evidence in support of Parkinsonian pathophysiological mechanisms.This is an open-access article

  7. SEMIPARAMETRIC ADDITIVE RISKS REGRESSION FOR TWO-STAGE DESIGN SURVIVAL STUDIES

    PubMed Central

    Li, Gang; Wu, Tong Tong

    2011-01-01

    In this article we study a semiparametric additive risks model (McKeague and Sasieni (1994)) for two-stage design survival data where accurate information is available only on second stage subjects, a subset of the first stage study. We derive two-stage estimators by combining data from both stages. Large sample inferences are developed. As a by-product, we also obtain asymptotic properties of the single stage estimators of McKeague and Sasieni (1994) when the semiparametric additive risks model is misspecified. The proposed two-stage estimators are shown to be asymptotically more efficient than the second stage estimators. They also demonstrate smaller bias and variance for finite samples. The developed methods are illustrated using small intestine cancer data from the SEER (Surveillance, Epidemiology, and End Results) Program. PMID:21931467

  8. Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

    PubMed

    Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

    2015-07-01

    Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these

  9. The treatment of missing data in a large cardiovascular clinical outcomes study.

    PubMed

    Little, Roderick J; Wang, Julia; Sun, Xiang; Tian, Hong; Suh, Eun-Young; Lee, Michael; Sarich, Troy; Oppenheimer, Leonard; Plotnikov, Alexei; Wittes, Janet; Cook-Bruns, Nancy; Burton, Paul; Gibson, C Michael; Mohanty, Surya

    2016-06-01

    The potential impact of missing data on the results of clinical trials has received heightened attention recently. A National Research Council study provides recommendations for limiting missing data in clinical trial design and conduct, and principles for analysis, including the need for sensitivity analyses to assess robustness of findings to alternative assumptions about the missing data. A Food and Drug Administration advisory committee raised missing data as a serious concern in their review of results from the ATLAS ACS 2 TIMI 51 study, a large clinical trial that assessed rivaroxaban for its ability to reduce the risk of cardiovascular death, myocardial infarction or stroke in patients with acute coronary syndrome. This case study describes a variety of measures that were taken to address concerns about the missing data. A range of analyses are described to assess the potential impact of missing data on conclusions. In particular, measures of the amount of missing data are discussed, and the fraction of missing information from multiple imputation is proposed as an alternative measure. The sensitivity analysis in the National Research Council study is modified in the context of survival analysis where some individuals are lost to follow-up. The impact of deviations from ignorable censoring is assessed by differentially increasing the hazard of the primary outcome in the treatment groups and multiply imputing events between dropout and the end of the study. Tipping-point analyses are described, where the deviation from ignorable censoring that results in a reversal of significance of the treatment effect is determined. A study to determine the vital status of participants lost to follow-up was also conducted, and the results of including this additional information are assessed. Sensitivity analyses suggest that findings of the ATLAS ACS 2 TIMI 51 study are robust to missing data; this robustness is reinforced by the follow-up study, since inclusion of data

  10. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    PubMed

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  11. A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study

    PubMed Central

    Chan, Kevin

    2007-01-01

    The randomized controlled trial is the “gold standard” for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial. PMID:18056618

  12. Comparison of prosthetic models produced by traditional and additive manufacturing methods.

    PubMed

    Park, Jin-Young; Kim, Hae-Young; Kim, Ji-Hwan; Kim, Jae-Hong; Kim, Woong-Chul

    2015-08-01

    The purpose of this study was to verify the clinical-feasibility of additive manufacturing by comparing the accuracy of four different manufacturing methods for metal coping: the conventional lost wax technique (CLWT); subtractive methods with wax blank milling (WBM); and two additive methods, multi jet modeling (MJM), and micro-stereolithography (Micro-SLA). Thirty study models were created using an acrylic model with the maxillary upper right canine, first premolar, and first molar teeth. Based on the scan files from a non-contact blue light scanner (Identica; Medit Co. Ltd., Seoul, Korea), thirty cores were produced using the WBM, MJM, and Micro-SLA methods, respectively, and another thirty frameworks were produced using the CLWT method. To measure the marginal and internal gap, the silicone replica method was adopted, and the silicone images obtained were evaluated using a digital microscope (KH-7700; Hirox, Tokyo, Japan) at 140X magnification. Analyses were performed using two-way analysis of variance (ANOVA) and Tukey post hoc test (α=.05). The mean marginal gaps and internal gaps showed significant differences according to tooth type (P<.001 and P<.001, respectively) and manufacturing method (P<.037 and P<.001, respectively). Micro-SLA did not show any significant difference from CLWT regarding mean marginal gap compared to the WBM and MJM methods. The mean values of gaps resulting from the four different manufacturing methods were within a clinically allowable range, and, thus, the clinical use of additive manufacturing methods is acceptable as an alternative to the traditional lost wax-technique and subtractive manufacturing.

  13. Efficacy of thrust and nonthrust manipulation and exercise with or without the addition of myofascial therapy for the management of acute inversion ankle sprain: a randomized clinical trial.

    PubMed

    Truyols-Domí Nguez, Sebastián; Salom-Moreno, Jaime; Abian-Vicen, Javier; Cleland, Joshua A; Fernández-de-Las-Peñas, César

    2013-05-01

    Randomized clinical trial. To compare the effects of thrust and nonthrust manipulation and exercises with and without the addition of myofascial therapy for the treatment of acute inversion ankle sprain. Studies have reported that thrust and nonthrust manipulations of the ankle joint are effective for the management of patients post-ankle sprain. However, it is not known whether the inclusion of soft tissue myofascial therapy could further improve clinical and functional outcomes. Fifty patients (37 men and 13 women; mean ± SD age, 33 ± 10 years) post-acute inversion ankle sprain were randomly assigned to 2 groups: a comparison group that received a thrust and nonthrust manipulation and exercise intervention, and an experimental group that received the same protocol and myofascial therapy. The primary outcomes were ankle pain at rest and functional ability. Additionally, ankle mobility and pressure pain threshold over the ankle were assessed by a clinician who was blinded to the treatment allocation. Outcomes of interest were captured at baseline, immediately after the treatment period, and at a 1-month follow-up. The primary analysis was the group-by-time interaction. The 2-by-3 mixed-model analyses of variance revealed a significant group-by-time interaction for ankle pain (P<.001) and functional score (P = .002), with the patients who received the combination of nonthrust and thrust manipulation and myofascial intervention experiencing a greater improvement in pain and function than those who received the nonthrust and thrust manipulation intervention alone. Significant group-by-time interactions were also observed for ankle mobility (P<.001) and pressure pain thresholds (all, P<.01), with those in the experimental group experiencing greater increases in ankle mobility and pressure pain thresholds. Between-group effect sizes were large (d>0.85) for all outcomes. This study provides evidence that, in the treatment of individuals post-inversion ankle sprain, the

  14. New clinical trial to study long-term progression of brain and spine cancers | Center for Cancer Research

    Cancer.gov

    Dr. Mark Gilbert, Chief, Neuro-Oncology Branch, describes an ambitious new clinical trial that, for the first time, will study the long-term progression of brain and spine cancers. The 10,000 patient trial is the largest of its kind and will follow patients throughout the course of their disease. In addition to identifying optimal treatments for common brain and spine cancers, the study focuses on treatment discovery for rare, overlooked cancers.

  15. PMMA denture base material enhancement: a review of fiber, filler, and nanofiller addition

    PubMed Central

    Gad, Mohammed M; Fouda, Shaimaa M; Al-Harbi, Fahad A; Näpänkangas, Ritva; Raustia, Aune

    2017-01-01

    This paper reviews acrylic denture base resin enhancement during the past few decades. Specific attention is given to the effect of fiber, filler, and nanofiller addition on poly(methyl methacrylate) (PMMA) properties. The review is based on scientific reviews, papers, and abstracts, as well as studies concerning the effect of additives, fibers, fillers, and reinforcement materials on PMMA, published between 1974 and 2016. Many studies have reported improvement of PMMA denture base material with the addition of fillers, fibers, nanofiller, and hybrid reinforcement. However, most of the studies were limited to in vitro investigations without bioactivity and clinical implications. Considering the findings of the review, there is no ideal denture base material, but the properties of PMMA could be improved with some modifications, especially with silanized nanoparticle addition and a hybrid reinforcement system. PMID:28553115

  16. Competence of novice nurses: role of clinical work during studying

    PubMed Central

    Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

    2015-01-01

    Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

  17. [Creation and Evaluation of Educational Programs for Additional Delayed Scan of FDG-PET/CT].

    PubMed

    Wada, Ryota; Kamiya, Takashi; Fujino, Kouichi; Ueda, Junpei; Isohashi, Kayako; Tatsumi, Mitsuaki; Hatazawa, Jun

    Generally, FDG-PET/CT image is acquired at the 60th minute after tracer administration. Depending on the clinical case, additional delayed scans may be useful. However, it is difficult to judge whether additional delayed scan is useful or not. The purposes of this study were creation and evaluation of educational programs to help radiological technologists to decide the usefulness of additional delayed scan of FDG-PET/CT. Educational programs consisted of the instructional materials and the judgment test of clinical cases. The instructional materials provided the valuable findings for differentiation between uptake in the wall of the colon and colon content, distinction between uptake in the lymph node and urinary tract, and evaluation of malignancy. The judgment test of clinical cases consisted of 10 cases selected by a nuclear medicine physician (for 5 of that cases additional delayed scan was decided to be useful). Five experienced technologists and five inexperienced technologists scored the volubility of additional delayed scan pre- and post-training using the instructional materials (the full marks of score is 5). After the educational programs using the instructional materials, the score was improved with the significant difference in both experienced (pre: 3.6±1.4, post: 4.0±1.2) and inexperienced (pre: 2.8±1.5, post: 3.7±1.5) groups (p<0.05). According to the educational programs, technologist might be able to decide whether the additional delayed scan is useful or not. The successful results of this study may improve the interpretation or reduce the total exposure dose of the PET/CT scan.

  18. Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large Clinical Follow-up Study.

    PubMed

    Kaspar, Mathias; Ertl, Maximilian; Fette, Georg; Dietrich, Georg; Toepfer, Martin; Angermann, Christiane; Störk, Stefan; Puppe, Frank

    2016-08-05

    Data that needs to be documented for clinical studies has often been acquired and documented in clinical routine. Usually this data is manually transferred to Case Report Forms (CRF) and/or directly into an electronic data capture (EDC) system. To enhance the documentation process of a large clinical follow-up study targeting patients admitted for acutely decompensated heart failure by accessing the data created during routine and study visits from a hospital information system (HIS) and by transferring it via a data warehouse (DWH) into the study's EDC system. This project is based on the clinical DWH developed at the University of Würzburg. The DWH was extended by several new data domains including data created by the study team itself. An R user interface was developed for the DWH that allows to access its source data in all its detail, to transform data as comprehensively as possible by R into study-specific variables and to support the creation of data and catalog tables. A data flow was established that starts with labeling patients as study patients within the HIS and proceeds with updating the DWH with this label and further data domains at a daily rate. Several study-specific variables were defined using the implemented R user interface of the DWH. This system was then used to export these variables as data tables ready for import into our EDC system. The data tables were then used to initialize the first 296 patients within the EDC system by pseudonym, visit and data values. Afterwards, these records were filled with clinical data on heart failure, vital parameters and time spent on selected wards. This solution focuses on the comprehensive access and transformation of data for a DWH-EDC system linkage. Using this system in a large clinical study has demonstrated the feasibility of this approach for a study with a complex visit schedule.

  19. Cervicitis: limited clinical utility for the detection of Mycoplasma genitalium in a cross-sectional study of women attending a New Zealand sexual health clinic.

    PubMed

    Oliphant, Jeannie; Azariah, Sunita

    2013-07-01

    Although multiple studies have confirmed Mycoplasma genitalium as a cause of nongonococcal urethritis in men, there is less evidence of its pathogenicity in women. Our aims were to determine the prevalence of M. genitalium in a sample of women attending a sexual health clinic and to assess whether there was any association between the detection of M. genitalium and a diagnosis of cervicitis in this population. A cross-sectional study recruited women who required screening for sexually transmissible infections. Endocervical swabs to detect the presence of M. genitalium were taken in addition to routine testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Data were collected on demographics, sexual behaviour, clinical symptoms and the presence of clinical or microscopic cervicitis. The prevalence of M. genitalium was 8.4% (n=22, 95% confidence interval (CI): 5.4-12.5%) in the study sample of 261 women. There was an association between the finding of cervical contact bleeding (odds ratio OR): 5.45; 95% CI: 1.93-15.42, P=0.001) and microscopic cervicitis (OR: 2.64; 95% CI: 0.95-7.34, P=0.06) and the presence of M. genitalium when compared with women with no diagnosed infection; however, the latter finding was not statistically significant. Although the prevalence of M. genitalium was high at 8.4%, the overall lack of any association between the findings of cervicitis and the detection of M. genitalium support the conclusion that cervicitis has poor clinical utility as an indicator for the presence of M. genitalium infection.

  20. Clinical cardiac regenerative studies in children.

    PubMed

    Pavo, Imre J; Michel-Behnke, Ina

    2017-02-26

    Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients.

  1. Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

    PubMed

    Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

    2017-12-01

    The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

  2. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    PubMed

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2015-11-09

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  3. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    ERIC Educational Resources Information Center

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  4. Timely Digital Patient-Clinician Communication in Specialist Clinical Services for Young People: A Mixed-Methods Study (The LYNC Study)

    PubMed Central

    Bryce, Carol; Cave, Jonathan; Dritsaki, Melina; Fraser, Joseph; Hamilton, Kathryn; Huxley, Caroline; Ignatowicz, Agnieszka; Kim, Sung Wook; Kimani, Peter K; Madan, Jason; Slowther, Anne-Marie; Sujan, Mark; Sturt, Jackie

    2017-01-01

    Background Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. Objective Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. Methods We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. Results Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of

  5. New clinical trial to study long-term progression of brain and spine cancers | Center for Cancer Research

    Cancer.gov

    Dr. Mark Gilbert, Chief, Neuro-Oncology Branch, describes an ambitious new clinical trial that, for the first time, will study the long-term progression of brain and spine cancers. The 10,000 patient trial is the largest of its kind and will follow patients throughout the course of their disease. In addition to identifying optimal treatments for common brain and spine cancers,

  6. Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

    PubMed Central

    Bank, Alan J; Obetz, Christopher; Konrardy, Ann; Khan, Akbar; Pillai, Kamalesh M; McKinley, Benjamin J; Gage, Ryan M; Turnbull, Mark A; Kenney, William O

    2013-01-01

    Objective Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient) to a scribe system (15 minute follow-up and 30 minute new patient) in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001) from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase) and work relative value units (wRVU) per hour increased (P < 0.001) from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase). Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01) for scribe visits, but time of patient interaction (without computer) was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01). Subjective assessment of physician–patient interaction (1–10) was higher (P < 0.01) on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1). Direct and indirect (downstream) revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. PMID:23966799

  7. Establishing a Multicenter Longitudinal Clinical Cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project.

    PubMed

    Teklu, Alula M; Tsegaye, Eyuel; Fekade, Daniel; Hailemelak, Abraham; Weiss, William; Hassen, Elham; Simmons, Nicole; Zewdu, Solomon; Berhan, Yifru; Getachew, Assefa; Hagos, Tesfalem; Alebachew, Achamyeleh; Damena, Melake; Sitotaw, Yohannes; Assefa, Yibeltal; Medhin, Girmay; Ruff, Andrea

    2017-02-01

    The purpose of this paper is to describe the establishment of the Advanced Clinical Monitoring of ART Project in Ethiopia for monitoring and evaluation of the longitudinal effectiveness of the ART program and to show the opportunities it presents. This cohort was established in response to the 2005 call by WHO for establishing additional mechanisms for stronger monitoring of ART and the need for creating the platform to generate evidence to guide the care given for the ever increasing number of patients on ART in Ethiopia. A participatory and multi-stage process which started from a consensus building workshop and steered by a mother protocol as well as guiding documents which dictated the degree of engagement and expectations was followed. The primary and secondary aims of the study were agreed upon. A multi-site longitudinal observational clinical cohort was established by a consortium of stakeholders including seven Ethiopian medical schools and their affiliated referral hospitals, John Hopkins University, Ethiopian Public Health Institute, Ministry of Science and Technology, US Centers for Disease Prevention and Control - CDC-Ethiopia, and the Federal Ministry of Health. Adult and adolescent cohorts covering the age range of 14+ years) and pediatric cohorts covering those below age 14 years were the two main cohorts. During the initial recruitment of these cohorts information was extracted from existing documents for a total of 2,100 adult participants. In parallel, a prospective cohort of 1,400 adult and adolescent patients were enrolled for ART initiation and follow-up. Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective and prospective cohorts. Replacement of participants were made in subsequent years based on lost follow up and death rates to maintain adequacy of the sample to be followed-up. Between January 2005 and August 2013 a total of 4,339 patients were followed for a median of 41.6 months and data on

  8. RAMSEYS DRAFT WILDERNESS STUDY AREA AND ADDITION, VIRGINIA.

    USGS Publications Warehouse

    Lesure, Frank G.; Mory, Peter C.

    1984-01-01

    Mineral-resource surveys of the Ramseys Draft Wilderness Study Area and adjoining roadless area addition in George Washington National Forest in the western valley and ridge province, Augusta and Highland Counties, Virginia, were done. The surveys outlined three small areas containing anomalous amounts of copper, lead, and zinc related to stratabound red-bed copper mineralization, but these occurrences are not large and are not considered as having mineral-resource potential. The area contains abundant sandstone suitable for construction materials and shale suitable for making brick, tile, and other low-grade ceramic products, but these commodities occur in abundance outside the wilderness study area. Structural conditions are probably favorable for the accumulation of natural gas, but exploratory drilling has not been done sufficiently near the area to evaluate the gas potential.

  9. Mentoring in Clinical-Translational Research: A Study of Participants in Master's Degree Programs.

    PubMed

    McGinn, Aileen P; Lee, Linda S; Baez, Adriana; Zwanziger, Jack; Anderson, Karl E; Seely, Ellen W; Schoenbaum, Ellie

    2015-12-01

    Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of master's-level trainees in clinical-translational research training programs. A cross-sectional online survey of recent graduates of clinical research master's program was conducted. Of 73 surveys distributed, 56.2% (n = 41) complete responses were analyzed. Trainees were overwhelmingly positive about participation in their master's programs and the impact it had on their professional development. Overall the majority (≥75%) of trainees perceived they had effective mentoring in terms of developing skills needed for conducting clinical-translational research. Fewer trainees perceived effective mentoring in career development and work-life balance. In all 15 areas of mentoring effectiveness assessed, higher rates of perceived mentor effectiveness was seen among trainees with ≥2 mentors compared to those with solo mentoring (SM). In addition, trainees with ≥2 mentors perceived having effective mentoring in more mentoring aspects (median: 14.0; IQR: 12.0-15.0) than trainees with SM (median: 10.5; IQR: 8.0-14.5). Results from this survey suggest having ≥2 mentors may be beneficial in fulfilling trainee expectations for mentoring in clinical-translational training. © 2015 Wiley Periodicals, Inc.

  10. [The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research].

    PubMed

    Ohmann, Christian; Bruns, Insa; Wolff, Stephanie

    2010-01-01

    The Network of the Coordination Centers for Clinical Trials (CTCs; Koordinierungszentren für Klinische Studien(KKS)) comprises 17 institutions working as scientific service provider for universities, study groups, the pharmaceutical and medical devices industry as well as additional clients associated with clinical research. The CTCs have established planning and conduct of clinical trials according to Good Clinical Practice (GCP) guidelines,with a wide range of study support in academia. One focus according to indications is cancer. Expertise in hematological/oncological research can be requested nationwide and cross-institutional. The KKS network currently cooperates with medical societies and other, even European networks in 20 countries and has been established as a strong platform for oncological trials. Copyright © 2010 S. Karger AG, Basel.

  11. Malaria Diagnostics in Clinical Trials

    PubMed Central

    Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests. PMID:24062484

  12. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

    PubMed

    Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

    2014-01-01

    An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

  13. Using EHR audit trail logs to analyze clinical workflow: A case study from community-based ambulatory clinics.

    PubMed

    Wu, Danny T Y; Smart, Nikolas; Ciemins, Elizabeth L; Lanham, Holly J; Lindberg, Curt; Zheng, Kai

    2017-01-01

    To develop a workflow-supported clinical documentation system, it is a critical first step to understand clinical workflow. While Time and Motion studies has been regarded as the gold standard of workflow analysis, this method can be resource consuming and its data may be biased due to the cognitive limitation of human observers. In this study, we aimed to evaluate the feasibility and validity of using EHR audit trail logs to analyze clinical workflow. Specifically, we compared three known workflow changes from our previous study with the corresponding EHR audit trail logs of the study participants. The results showed that EHR audit trail logs can be a valid source for clinical workflow analysis, and can provide an objective view of clinicians' behaviors, multi-dimensional comparisons, and a highly extensible analysis framework.

  14. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK

    PubMed Central

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane

    2016-01-01

    Background While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. Methods A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. Results A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8–15 years. Ninety‐seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy‐four percent of parents participated in research studies in order to “do something important”, while 74% of patients participated “to help medical staff”. Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety‐six percent of parents and 87% of patients would participate in future studies. Conclusions The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. PMID:26928983

  15. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK.

    PubMed

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane; Veal, Gareth J

    2016-07-01

    While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8-15 years. Ninety-seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy-four percent of parents participated in research studies in order to "do something important", while 74% of patients participated "to help medical staff". Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety-six percent of parents and 87% of patients would participate in future studies. The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. © 2016 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc.

  16. Clinical studies of fiber posts: a literature review.

    PubMed

    Cagidiaco, Maria C; Goracci, Cecilia; Garcia-Godoy, Franklin; Ferrari, Marco

    2008-01-01

    This literature review aimed to find answers to relevant questions regarding the clinical outcome of endontically treated teeth restored with fiber posts. All clinical studies published since 1990 in journals indexed in MEDLINE were retrieved by searching PubMed with the query terms "fiber posts and clinical studies." The reference list of the collected articles was also screened for further relevant citations. The strength of the evidence provided by the reviewed papers was assessed according to the criteria of evidence-based dentistry. Five randomized controlled trials (RCTs) on fiber posts have been published in peer-reviewed journals. A meta-analysis is not applicable to these studies since they do not address the same specific clinical question. Retrospective and prospective trials without controls are also available. Two RCTs indicate that fiber-reinforced composite posts outperform metal posts in the restoration of endontically treated teeth. However, this evidence cannot be considered as conclusive. Longer-term RCTs would be desirable. The placement of a fiber-reinforced composite post protects against failure, especially under conditions of extensive coronal destruction. The most common type of failure with fiber-reinforced composite posts is debonding.

  17. Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review.

    PubMed

    Verrest, Luka; Dorlo, Thomas P C

    2017-06-01

    Neglected tropical diseases (NTDs) affect more than one billion people, mainly living in developing countries. For most of these NTDs, treatment is suboptimal. To optimize treatment regimens, clinical pharmacokinetic studies are required where they have not been previously conducted to enable the use of pharmacometric modeling and simulation techniques in their application, which can provide substantial advantages. Our aim was to provide a systematic overview and summary of all clinical pharmacokinetic studies in NTDs and to assess the use of pharmacometrics in these studies, as well as to identify which of the NTDs or which treatments have not been sufficiently studied. PubMed was systematically searched for all clinical trials and case reports until the end of 2015 that described the pharmacokinetics of a drug in the context of treating any of the NTDs in patients or healthy volunteers. Eighty-two pharmacokinetic studies were identified. Most studies included small patient numbers (only five studies included >50 subjects) and only nine (11 %) studies included pediatric patients. A large part of the studies was not very recent; 56 % of studies were published before 2000. Most studies applied non-compartmental analysis methods for pharmacokinetic analysis (62 %). Twelve studies used population-based compartmental analysis (15 %) and eight (10 %) additionally performed simulations or extrapolation. For ten out of the 17 NTDs, none or only very few pharmacokinetic studies could be identified. For most NTDs, adequate pharmacokinetic studies are lacking and population-based modeling and simulation techniques have not generally been applied. Pharmacokinetic clinical trials that enable population pharmacokinetic modeling are needed to make better use of the available data. Simulation-based studies should be employed to enable the design of improved dosing regimens and more optimally use the limited resources to effectively provide therapy in this neglected area.

  18. Prevalence of xerostomia in an adolescent inpatient psychiatric clinic: a preliminary study.

    PubMed

    Kaur, Manvir; Himadi, Elaine; Chi, Donald L

    2016-01-01

    Adolescents with psychiatric conditions may be at risk for xerostomia. In this preliminary study, we estimated xerostomia prevalence in adolescents ages 9 to 17 years from an inpatient psychiatric clinic (N = 25) and examined whether: (1) gender and age were associated with xerostomia and (2) xerostomia was associated with self-reported cavities. We used a modified 11-item Xerostomia Index to identify xerostomia (no/yes) and asked if adolescents ever had or currently have cavities (no/yes). The mean age was 14 years (SD = 2.3) and 72% were male. Sixty percent reported xerostomia (SD = 50). There were no significant associations between xerostomia and gender (p = 0.99) or age (p = 0.66), or between xerostomia and past (p = 0.26) or current cavities (p = 0.11). Larger proportions of adolescents with xerostomia reported previous and current cavities. Sixty percent of adolescents from an inpatient psychiatric clinic reported having xerostomia, which may lead to increased caries risk over time. Additional research should examine the prevalence and consequences of xerostomia in high-risk adolescents. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

  19. The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

    PubMed

    Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

    2018-05-01

    When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

  20. Biosimilars for psoriasis: clinical studies to determine similarity.

    PubMed

    Blauvelt, A; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; Skov, L; Zachariae, C; Young, H; Prens, E; Cohen, A; van der Walt, J; Wu, J J

    2017-07-01

    Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design. © 2016 British Association of Dermatologists.

  1. Recommendations for conducting controlled clinical studies of dental restorative materials.

    PubMed

    Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

    2007-03-01

    designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the "Journal of Adhesive Dentistry" and the "Clinical Oral Investigations." Additionally an extended abstract will be published in the "International Dental Journal" giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.

  2. Use of Statins to Augment Progenitor Cell Function in Preclinical and Clinical Studies of Regenerative Therapy: a Systematic Review.

    PubMed

    Park, Angela; Barrera-Ramirez, Juliana; Ranasinghe, Indee; Pilon, Sophie; Sy, Richmond; Fergusson, Dean; Allan, David S

    2016-06-01

    Mesenchymal stromal cells (MSCs) and endothelial progenitor cells (EPCs) are used in cell-based regenerative therapy. HMG CoA reductase inhibitors (statins) appear promising in blocking apoptosis, prolonging progenitor cell survival and improving their capacity to repair organ function. We performed a systematic review of preclinical and clinical studies to clarify whether statins can improve cell-based repair of organ injury. MEDLINE, EMBASE, and PUBMED databases were searched (1947 to June 25, 2013). Controlled clinical and pre-clinical studies were included that evaluated statin therapy used alone or in combination with MSCs or EPCs in patients or animals with organ injury. After screening 771 citations, 100 records underwent full eligibility screening of which 38 studies met eligibility and were included in the review: Studies were grouped into pre-clinical studies that involved statin treatment in combination with cell therapy (18 studies), preclinical studies of statin therapy alone (13 studies) and clinical studies of statin therapy (7 studies). Studies addressed cardiac injury (14 studies), vascular disorders (15 studies), neurologic conditions (8 studies) and bone fractures (1 study). Pre-clinical studies of statins in combination with MSC infusion (15 studies) or EPC therapy (3 studies) were described and despite marked heterogeneity in reporting outcomes of cellular analysis and organ function, all of these cell-based pre-clinical studies reported improved organ recovery with the addition of statin therapy. Moreover, 13 pre-clinical studies involved the administration of a statin drug alone to animals. An increase in EPC number and/or function (no studies of MSCs) was reported in 11 of these studies (85 %) and improved organ function in 12 studies (92 %). We also identified 7 clinical studies and none involved the administration of cells but described an increased number and/or function of EPCs (no studies of MSCs) and improved organ function with

  3. Application of ion chromatography in clinical studies and pharmaceutical industry.

    PubMed

    Michalski, Rajmund

    2014-01-01

    Ion chromatography is a well-established regulatory method for analyzing anions and cations in environmental, food and many other samples. It offers an enormous range of possibilities for selecting stationary and mobile phases. Additionally, it usually helps to solve various separation problems, particularly when it is combined with different detection techniques. Ion chromatography can also be used to determine many ions and substances in clinical and pharmaceutical samples. It provides: availability of high capacity stationary phases and sensitive detectors; simple sample preparation; avoidance of hazardous chemicals; decreased sample volumes; flexible reaction options on a changing sample matrix to be analyzed; or the option to operate a fully-automated system. This paper provides a short review of the ion chromatography applications for determining different inorganic and organic substances in clinical and pharmaceutical samples.

  4. Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study.

    PubMed

    Turnbull, Alison E; Sepulveda, Kristin A; Dinglas, Victor D; Chessare, Caroline M; Bingham, Clifton O; Needham, Dale M

    2017-06-01

    To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge. A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers that rated the importance of 19 preliminary outcome domains and 2) results from a qualitative study of acute respiratory failure survivors' outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey. Web-based surveys of participants representing four stakeholder groups relevant to clinical research evaluating postdischarge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations. None. None. Survey response rates were 97% and 99% in round 1 and round 2, respectively. There were seven domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function. This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

  5. Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis.

    PubMed

    Enden, T; Resch, S; White, C; Wik, H S; Kløw, N E; Sandset, P M

    2013-06-01

    Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS). To estimate the cost effectiveness of additional CDT compared with standard treatment alone. Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY). In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64,709 for additional CDT and $51,866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20,429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55,000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50,000/QALY gained. Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding. © 2013 International Society on Thrombosis and Haemostasis.

  6. Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis

    PubMed Central

    ENDEN, T.; RESCH, S.; WHITE, C.; WIK, H. S.; KLØW, N. E.; SANDSET, P. M.

    2013-01-01

    Summary Background Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS). Objectives To estimate the cost effectiveness of additional CDT compared with standard treatment alone. Methods Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY). Results In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64 709 for additional CDT and $51 866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20 429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55 000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50 000/QALY gained. Conclusions Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding. PMID:23452204

  7. Case Study: Learner Physiotherapists' Perceptions of Clinical Education.

    ERIC Educational Resources Information Center

    Harris, Duncan; Naylor, Sandra

    1992-01-01

    Describes a study conducted in the United Kingdom to discover what processes learner physiotherapists experience in clinical education and whether their experience is comparable to that of other students in medical professions. The need for feedback is addressed, and the role of the clinical educator is discussed. A form for student assessment is…

  8. Clinical supervision for nurses in administrative and leadership positions: a systematic literature review of the studies focusing on administrative clinical supervision.

    PubMed

    Sirola-Karvinen, Pirjo; Hyrkäs, Kristiina

    2006-11-01

    The aim of this systematic literature review was to describe administrative clinical supervision from the nursing leaders', directors' and administrators' perspective. Administrative clinical supervision is a timely and important topic as organizational structures in health care and nursing leadership are changing in addition to the increasing number of complex challenges present in health care. The material in this review was drawn from national and international databases including doctoral dissertations, distinguished thesis and peer-reviewed articles. The material was analysed by means of content analysis. The theoretical framework for the analysis was based on the three main functions of clinical supervision: administrative, educational and supportive. The findings demonstrated that the experiences of the administrative clinical supervision and its supportiveness were varying. The intervention was seen to provide versatility of learning experiences and support in challenging work experiences. Administrative clinical supervision effects and assures the quality of care. The effects as a means of development were explained through its resemblance to a leading specialist community. The findings support earlier perceptions concerning the importance and significance of administrative clinical supervision for nursing managers and administrators. However, more research is needed to develop administrative clinical supervision and to increase understanding of theoretical assumptions and relationships of the concepts on the background.

  9. Clinical validity of new genetic biomarkers of irinotecan neutropenia: an independent replication study.

    PubMed

    Crona, D J; Ramirez, J; Qiao, W; de Graan, A-J; Ratain, M J; van Schaik, R H N; Mathijssen, R H J; Rosner, G L; Innocenti, F

    2016-02-01

    The overall goal of this study was to provide evidence for the clinical validity of nine genetic variants in five genes previously associated with irinotecan neutropenia and pharmacokinetics. Variants associated with absolute neutrophil count (ANC) nadir and/or irinotecan pharmacokinetics in a discovery cohort of cancer patients were genotyped in an independent replication cohort of 108 cancer patients. Patients received single-agent irinotecan every 3 weeks. For ANC nadir, we replicated UGT1A1*28, UGT1A1*93 and SLCO1B1*1b in univariate analyses. For irinotecan area under the concentration-time curve (AUC0-24), we replicated ABCC2 -24C>T; however, ABCC2 -24C>T only predicted a small fraction of the variance. For SN-38 AUC0-24 and the glucuronidation ratio, we replicated UGT1A1*28 and UGT1A1*93. In addition to UGT1A1*28, this study independently validated UGT1A1*93 and SLCO1B1*1b as new predictors of irinotecan neutropenia. Further demonstration of their clinical utility will optimize irinotecan therapy in cancer patients.

  10. Nanoparticles in the clinic

    PubMed Central

    Anselmo, Aaron C.

    2016-01-01

    Abstract Nanoparticle/microparticle‐based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems. PMID:29313004

  11. Contrast-enhanced postmortem computed tomography in clinical pathology: enhanced value of 20 clinical autopsies.

    PubMed

    Westphal, Saskia E; Apitzsch, Jonas C; Penzkofer, Tobias; Kuhl, Christiane K; Mahnken, Andreas H; Knüchel, Ruth

    2014-09-01

    Postmortem computed tomography (PMCT) is a modern tool that complements autopsy diagnostics. In clinical autopsies, a major cause of death is cardiovascular disease. To improve the performance of PMCT in cardiovascular disease, full body angiography was developed (PMCT angiography [PMCTA]). Twenty PMCTA scans generated before autopsy were compared with native PMCT and clinical autopsy. The objective of the study was to quantify the additional diagnostic value of adding angiography to native imaging and to compare PMCT and PMCTA findings to autopsy findings. The diagnosis of the cause of death was identical or overlapped in 80% of the cases that used PMCTA and 70% that used PMCT. The additional diagnostic yield given by PMCT and PMCTA in combination with autopsy was 55%. PMCT yielded additional diagnoses in the musculoskeletal system. The greatest additional diagnostic value of PMCTA was in association with cardiovascular diagnoses. The accuracy of PMCTA for cardiac causes of death was 80%, and the positive predictive value was 90%. The findings indicate that native PMCT cannot display the cardiovascular system sufficiently clearly for high-quality diagnostic assessment. However, PMCTA is a powerful tool in autopsy cases with a history of cardiovascular disease and/or a suspected cardiovascular cause of death. The combination of PMCTA and clinical autopsy enhances diagnostic quality and completeness of the autopsy report. Furthermore, in cases without consent or with a restricted consent for clinical autopsy, PMCTA has the potential to provide information on cardiovascular causes of death. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Exploitation of prisoners in clinical research: perceptions of study participants

    PubMed Central

    Christopher, Paul P.; Stein, Michael D.; Johnson, Jennifer E.; Rich, Josiah D.; Friedmann, Peter D.; Clarke, Jennifer G.; Lidz, Charles W.

    2015-01-01

    This paper discusses findings of a study examining whether prisoners view their participation in clinical research studies as exploitative. Perspectives of seventy prisoners who were enrolled in one of six different clinical studies were analyzed. A minority of participants agreed with statements suggestive of potential exploitation. All but one participant believed that prisoners should have greater access to research. On balance, these data provide reassurance that prisoners in this sample do not view their involvement in clinical research as inappropriately exploitative. PMID:26964404

  13. Timely Digital Patient-Clinician Communication in Specialist Clinical Services for Young People: A Mixed-Methods Study (The LYNC Study).

    PubMed

    Griffiths, Frances; Bryce, Carol; Cave, Jonathan; Dritsaki, Melina; Fraser, Joseph; Hamilton, Kathryn; Huxley, Caroline; Ignatowicz, Agnieszka; Kim, Sung Wook; Kimani, Peter K; Madan, Jason; Slowther, Anne-Marie; Sujan, Mark; Sturt, Jackie

    2017-04-10

    Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can

  14. The SAPHO syndrome: a clinical and imaging study.

    PubMed

    Sallés, Meritxell; Olivé, Alejandro; Perez-Andres, Ricard; Holgado, Susana; Mateo, Lourdes; Riera, Elena; Tena, Xavier

    2011-02-01

    The purpose of this study is to describe the clinical and radiological manifestations of patients with the synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome. Retrospective study (1984-2007) was performed in a single center. All patients with the SAPHO syndrome were included. Fifty-two patients were included: 26 male, mean age at diagnosis is 42±12 years. Ostearticular involvement was present before cutaneous involvement in 59.6% of patients and concomitantly in 23.5%. Anterior chest pain was the commonest clinical manifestation, it was present in 38 patients (73%), followed by peripheral arthritis in 17 patients (32%), and sacroliliac pain in 14 patients (26.9%). Cutaneous involvement was present in 33 patients (63.5%). HLA B27 antigen was present in eight patients (17.7%). Bone scintigraphy showed an increased uptake in 42 patients (93.3%). The location of the uptake was mainly in sternoclavicular and manubriosternal joints. CT scan was performed in all "hot joints" showing sclerosis, erosions, hyperostosis, and soft tissue involvement. Refractory patients were treated mainly with pamidronate. Although SAPHO syndrome is an entity that share features that fit into a variety of established disease categories, the present study has a homogenous clinical and radiological pattern that gives support to believe that the SAPHO syndrome is an isolated clinical entity.

  15. JAK2 inhibitor therapy in myeloproliferative disorders: rationale, preclinical studies and ongoing clinical trials.

    PubMed

    Pardanani, A

    2008-01-01

    The recent identification of somatic mutations such as JAK2V617F that deregulate Janus kinase (JAK)-signal transducer and activator of transcription signaling has spurred development of orally bioavailable small-molecule inhibitors that selectively target JAK2 kinase as an approach to pathogenesis-directed therapy of myeloproliferative disorders (MPD). In pre-clinical studies, these compounds inhibit JAK2V617F-mediated cell growth at nanomolar concentrations, and in vivo therapeutic efficacy has been demonstrated in mouse models of JAK2V617F-induced disease. In addition, ex vivo growth of progenitor cells from MPD patients harboring JAK2V617F or MPLW515L/K mutations is also potently inhibited. JAK2 inhibitors currently in clinical trials can be grouped into those designed to primarily target JAK2 kinase (JAK2-selective) and those originally developed for non-MPD indications, but that nevertheless have significant JAK2-inhibitory activity (non-JAK2 selective). This article discusses the rationale for using JAK2 inhibitors for the treatment of MPD, as well as relevant aspects of clinical trial development for these patients. For instance, which group of MPD patients is appropriate for initial Phase I studies? Should JAK2V617F-negative MPD patients be included in the initial studies? What are the likely consequences of 'off-target' JAK3 and wild-type JAK2 inhibition? How should treatment responses be monitored?

  16. The role and potential contribution of clinical research nurses to clinical trials.

    PubMed

    Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

    2008-02-01

    This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

  17. A multicenter study: how do medical students perceive clinical learning climate?

    PubMed

    Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

    2016-01-01

    The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

  18. A multicenter study: how do medical students perceive clinical learning climate?

    PubMed Central

    Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

    2016-01-01

    Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students’ perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students’ interactions in clinical settings, self-realization, mood, students’ intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve

  19. A multicenter study: how do medical students perceive clinical learning climate?

    PubMed

    Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

    2016-01-01

    Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve

  20. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.

    PubMed

    Prayle, Andrew P; Hurley, Matthew N; Smyth, Alan R

    2012-01-03

    To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Registry based study of clinical trial summaries. ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year. Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009. Proportion of trials for which results had been reported. The ClinicalTrials.gov registry contained 83,579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ(2) test, P = 2.6 × 10(-9)). Later phase trials were more likely to report results (P = 4.4 × 10(-11)), as were industry funded trials (P = 2.2 × 10(-16)). Most trials subject to mandatory reporting did not report results within a year of completion.

  1. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    PubMed Central

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  2. Recommended Protocol for Round Robin Studies in Additive Manufacturing.

    PubMed

    Moylan, Shawn; Brown, Christopher U; Slotwinski, John

    2016-03-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST's experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed.

  3. A study of vibrating nanotubes with additional adsorbed masses

    NASA Astrophysics Data System (ADS)

    Adler, Joan; Adler, Omri

    2017-11-01

    We describe calculations of the electronic density surrounding strained nanotubes. These are then used to estimate the nanotube wall width. This width is an essential parameter for the analysis of the nanotube vibrations. By studying the effect of additional adsorbed molecules on the nanotubes’ vibrations and their frequency changes we can deduce the molecules’ mass. Our calculations show that the strain does not greatly affect the nanotube width, but the vibrations change sufficiently for the mass to be detected.

  4. Team dynamics, clinical work satisfaction, and patient care coordination between primary care providers: A mixed methods study.

    PubMed

    Song, Hummy; Ryan, Molly; Tendulkar, Shalini; Fisher, Josephine; Martin, Julia; Peters, Antoinette S; Frolkis, Joseph P; Rosenthal, Meredith B; Chien, Alyna T; Singer, Sara J

    Team-based care is essential for delivering high-quality, comprehensive, and coordinated care. Despite considerable research about the effects of team-based care on patient outcomes, few studies have examined how team dynamics relate to provider outcomes. The aim of this study was to examine relationships among team dynamics, primary care provider (PCP) clinical work satisfaction, and patient care coordination between PCPs in 18 Harvard-affiliated primary care practices participating in Harvard's Academic Innovations Collaborative. First, we administered a cross-sectional survey to all 548 PCPs (267 attending clinicians, 281 resident physicians) working at participating practices; 65% responded. We assessed the relationship of team dynamics with PCPs' clinical work satisfaction and perception of patient care coordination between PCPs, respectively, and the potential mediating effect of patient care coordination on the relationship between team dynamics and work satisfaction. In addition, we embedded a qualitative evaluation within the quantitative evaluation to achieve a convergent mixed methods design to help us better understand our findings and illuminate relationships among key variables. Better team dynamics were positively associated with clinical work satisfaction and quality of patient care coordination between PCPs. Coordination partially mediated the relationship between team dynamics and satisfaction for attending clinicians, suggesting that higher satisfaction depends, in part, on better teamwork, yielding more coordinated patient care. We found no mediating effects for resident physicians. Qualitative results suggest that sources of satisfaction from positive team dynamics for PCPs may be most relevant to attending clinicians. Improving primary care team dynamics could improve clinical work satisfaction among PCPs and patient care coordination between PCPs. In addition to improving outcomes that directly concern health care providers, efforts to

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

    PubMed

    Ream, Margie A; Mikati, Mohamad A

    2014-08-01

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

  6. The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

    PubMed

    Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

    2013-12-11

    A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

  7. Pilot study: assessing the clinical diagnosis of allergy in atopic children using a microarray assay in addition to skin prick testing and serum specific IgE.

    PubMed

    Foong, Ru-Xin; Roberts, Graham; Fox, Adam Tobias; du Toit, George

    2016-01-01

    Children with atopic dermatitis (AD) are at risk of developing allergy. Alongside clinical history, testing modalities include skin prick tests (SPT), specific immunoglobulin-E (sp-IgE) and recently, microarray assays. The aim of this pilot study was to assess current tests and the ISAC sIgE-112 system in the diagnosis of food and aeroallergen allergy. Children aged 0-11 years with moderate to severe AD were included. An initial allergy assessment including clinical history, SPT and sp-IgE was performed to determine food and aeroallergen sensitization. A second independent clinical assessment using the same information given to the first assessor and ISAC test results for food and aeroallergen sensitization was also made for each participant. The results from both were compared. 30 children [mean age 3.91 years (SD 3.3)] were included; 53.3 and 46.7 % had moderate and severe AD, respectively. Sp-IgE tests had a higher percentage of positive results compared to SPT and ISAC tests for common allergens. There was a significant difference between the three tests in detecting aeroallergen sensitization (p = 0.038), especially between sp-IgE and ISAC tests, but no significant difference between the tests for food allergen sensitization. There was good agreement between the two assessors; 70 % of the children had a change in diagnosis, with 60 % having at least one diagnosis added and 40 % having at least one diagnosis removed. There is a role for the use of ISAC testing in diagnosing sensitization and allergy in children with AD as it leads to a change in diagnosis for many patients. Further work is required to assess its clinical and cost effectiveness.

  8. Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study.

    PubMed

    Levac, Danielle; McCormick, Anna; Levin, Mindy F; Brien, Marie; Mills, Richard; Miller, Elka; Sveistrup, Heidi

    2018-02-01

    To compare changes in gross motor skills and functional mobility between ambulatory children with cerebral palsy who underwent a 1-week clinic-based virtual reality intervention (VR) followed by a 6-week, therapist-monitored home active video gaming (AVG) program and children who completed only the 6-week home AVG program. Pilot non-randomized controlled trial. Five children received 1 hour of VR training for 5 days followed by a 6-week home AVG program, supervised online by a physical therapist. Six children completed only the 6-week home AVG program. The Gross Motor Function Measure Challenge Module (GMFM-CM) and Six Minute Walk Test (6MWT) evaluated change. There were no significant differences between groups. The home AVG-only group demonstrated a statistically and clinically significant improvement in GMFM-CM scores following the 6-week AVG intervention (median difference 4.5 points, interquartile range [IQR] 4.75, p = 0.042). The VR + AVG group demonstrated a statistically and clinically significant decrease in 6MWT distance following the intervention (median decrease 68.2 m, IQR 39.7 m, p = 0.043). All 6MWT scores returned to baseline at 2 months post-intervention. Neither intervention improved outcomes in this small sample. Online mechanisms to support therapist-child communication for exercise progression were insufficient to individualize exercise challenge.

  9. Smoking cessation in primary care clinics.

    PubMed

    Sippel, J M; Osborne, M L; Bjornson, W; Goldberg, B; Buist, A S

    1999-11-01

    To document smoking cessation rates achieved by applying the 1996 Agency for Health Care Policy and Research (AHCPR) smoking cessation guidelines for primary care clinics, compare these quit rates with historical results, and determine if quit rates improve with an additional motivational intervention that includes education as well as spirometry and carbon monoxide measurements. Randomized clinical trial. Two university-affiliated community primary care clinics. Two hundred five smokers with routinely scheduled appointments. All smokers were given advice and support according to AHCPR guidelines. Half of the subjects received additional education with spirometry and carbon monoxide measurements. Quit rate was evaluated at 9-month follow-up. Eleven percent of smokers were sustained quitters at follow-up. Sustained quit rate was no different for intervention and control groups (9% vs 14%; [OR] 0.6; 95% [CI] 0.2, 1.4). Nicotine replacement therapy was strongly associated with sustained cessation (OR 6.7; 95% CI 2.3, 19.6). Subjects without insurance were the least likely to use nicotine replacement therapy ( p =.05). Historical data from previously published studies showed that 2% of smokers quit following physician advice, and additional support similar to AHCPR guidelines increased the quit rate to 5%. The sustained smoking cessation rate achieved by following AHCPR guidelines was 11% at 9 months, which compares favorably with historical results. Additional education with spirometry did not improve the quit rate. Nicotine replacement therapy was the strongest predictor of cessation, yet was used infrequently owing to cost. These findings support the use of AHCPR guidelines in primary care clinics, but do not support routine spirometry for motivating patients similar to those studied here.

  10. Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

    PubMed

    Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

    2014-01-01

    In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

  11. Development of an arthroscopically compatible polymer additive layer manufacture technique.

    PubMed

    Partridge, Simon W; Benning, Matthew J; German, Matthew J; Dalgarno, Kenneth W

    2017-06-01

    This article describes a proof of concept study designed to evaluate the potential of an in vivo three-dimensional printing route to support minimally invasive repair of the musculoskeletal system. The study uses a photocurable material to additively manufacture in situ a model implant and demonstrates that this can be achieved effectively within a clinically relevant timescale. The approach has the potential to be applied with a wide range of light-curable materials and with development could be applied to create functionally gradient structures in vivo.

  12. Update on Abdominal Aortic Aneurysm Research: From Clinical to Genetic Studies

    PubMed Central

    Kuivaniemi, Helena; Ryer, Evan J.; Elmore, James R.; Hinterseher, Irene; Smelser, Diane T.; Tromp, Gerard

    2014-01-01

    An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta with a diameter of at least 3.0 cm. AAAs are often asymptomatic and are discovered as incidental findings in imaging studies or when the AAA ruptures leading to a medical emergency. AAAs are more common in males than females, in individuals of European ancestry, and in those over 65 years of age. Smoking is the most important environmental risk factor. In addition, a positive family history of AAA increases the person's risk for AAA. Interestingly, diabetes has been shown to be a protective factor for AAA in many large studies. Hallmarks of AAA pathogenesis include inflammation, vascular smooth muscle cell apoptosis, extracellular matrix degradation, and oxidative stress. Autoimmunity may also play a role in AAA development and progression. In this Outlook paper, we summarize our recent studies on AAA including clinical studies related to surgical repair of AAA and genetic risk factor and large-scale gene expression studies. We conclude with a discussion on our research projects using large data sets available through electronic medical records and biobanks. PMID:24834361

  13. Pedagogical strategies used in clinical medical education: an observational study

    PubMed Central

    2010-01-01

    Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

  14. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of the...

  15. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 11 2012-01-01 2012-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of the...

  16. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of the...

  17. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of the...

  18. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of the...

  19. Re-emergent tremor in Parkinson's disease: A clinical and electromyographic study.

    PubMed

    Mailankody, Pooja; Thennarasu, K; Nagaraju, B C; Yadav, Ravi; Pal, Pramod Kumar

    2016-07-15

    Re-emergent tremor (ReT) in Parkinson's disease (PD) is the tremor that re-emerges after a variable period of latency while maintaining posture. The phenomenology and electrophysiological aspects of ReT have not been well characterized. The aims of this study were to characterize ReT clinically and electrophysiologically. Sixty three patients with tremor dominant PD were recruited and subjected to clinical and electrophysiological evaluations. Group 1 consisted of 26 patients with rest tremor (RT) and ReT and group 2 consisted of 37 patients with RT and postural tremor (PT). The presence of silent period of ReT was determined clinically and confirmed electrophysiologically. The duration of illness was significantly shorter in patients with ReT as compared to patients without ReT (5.2±4.4years vs 7.4±4.5years, p=0.03). ReT was similar to RT in terms of both frequency (4.8±0.7Hz vs 4.7±0.6Hz, p=0.1) and pattern of contraction. The frequency of RT was not significantly different in the 2 groups (p=0.5). The mean duration of silent period was 8.1±8.7s. A significantly shorter duration of illness was found in patients with ReT as compared to patients without ReT. ReT is similar to RT in terms of frequency and pattern of contraction. However, the presence of silent period may imply additional pathophysiological mechanisms. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

    PubMed

    Sheth, Neha

    2009-01-01

    Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.

  1. Impact of clinical history on chest radiograph interpretation.

    PubMed

    Test, Matthew; Shah, Samir S; Monuteaux, Michael; Ambroggio, Lilliam; Lee, Edward Y; Markowitz, Richard I; Bixby, Sarah; Diperna, Stephanie; Servaes, Sabah; Hellinger, Jeffrey C; Neuman, Mark I

    2013-07-01

    The inclusion of clinical information may have unrecognized influence in the interpretation of diagnostic testing. The objective of the study was to determine the impact of clinical history on chest radiograph interpretation in the diagnosis of pneumonia. Prospective case-based study. Radiologists interpreted 110 radiographs of children evaluated for suspicion of pneumonia. Clinical information was withheld during the first interpretation. After 6 months the radiographs were reviewed with clinical information. Radiologists reported on pneumonia indicators described by the World Health Organization (ie, any infiltrate, alveolar infiltrate, interstitial infiltrate, air bronchograms, hilar adenopathy, pleural effusion). Children's Hospital of Philadelphia and Boston Children's Hospital. Six board-certified radiologists. Inter- and inter-rater reliability were assessed using the kappa statistic. The addition of clinical history did not have a substantial impact on the inter-rater reliability in the identification of any infiltrate, alveolar infiltrate, interstitial infiltrate, pleural effusion, or hilar adenopathy. Inter-rater reliability in the identification of air bronchograms improved from fair (k = 0.32) to moderate (k = 0.53). Intra-rater reliability for the identification of alveolar infiltrate remained substantial to almost perfect for all 6 raters with and without clinical information. One rater had a decrease in inter-rater reliability from almost perfect (k = 1.0) to fair (k = 0.21) in the identification of interstitial infiltrate with the addition of clinical history. Alveolar infiltrate and pleural effusion are findings with high intra- and inter-rater reliability in the diagnosis of bacterial pneumonia. The addition of clinical information did not have a substantial impact on the reliability of these findings. © 2012 Society of Hospital Medicine.

  2. Comparative study of sickle cell anemia and hemoglobin SC disease: clinical characterization, laboratory biomarkers and genetic profiles.

    PubMed

    Aleluia, Milena Magalhães; Fonseca, Teresa Cristina Cardoso; Souza, Regiana Quinto; Neves, Fábia Idalina; da Guarda, Caroline Conceição; Santiago, Rayra Pereira; Cunha, Bruna Laís Almeida; Figueiredo, Camylla Villas Boas; Santana, Sânzio Silva; da Paz, Silvana Sousa; Ferreira, Júnia Raquel Dutra; Cerqueira, Bruno Antônio Veloso; Gonçalves, Marilda de Souza

    2017-01-01

    In this study, we evaluate the association of different clinical profiles, laboratory and genetic biomarkers in patients with sickle cell anemia (SCA) and hemoglobin SC disease (HbSC) in attempt to characterize the sickle cell disease (SCD) genotypes. We conducted a cross-sectional study from 2013 to 2014 in 200 SCD individuals (141 with SCA; 59 with HbSC) and analyzed demographic data to characterize the study population. In addition, we determined the association of hematological, biochemical and genetic markers including the β S -globin gene haplotypes and the 3.7 Kb deletion of α-thalassemia (-α 3.7Kb -thal), as well as the occurrence of clinical events in both SCD genotypes. Laboratory parameters showed a hemolytic profile associated with endothelial dysfunction in SCA individuals; however, the HbSC genotype was more associated with increased blood viscosity and inflammatory conditions. The BEN haplotype was the most frequently observed and was associated with elevated fetal hemoglobin (HbF) and low S hemoglobin (HbS). The -α 3.7Kb -thal prevalence was 0.09 (9%), and it was associated with elevated hemoglobin and hematocrit concentrations. Clinical events were more frequent in SCA patients. Our data emphasize the differences between SCA and HbSC patients based on laboratory parameters and the clinical and genetic profile of both genotypes.

  3. Sequential neural processes in abacus mental addition: an EEG and FMRI case study.

    PubMed

    Ku, Yixuan; Hong, Bo; Zhou, Wenjing; Bodner, Mark; Zhou, Yong-Di

    2012-01-01

    Abacus experts are able to mentally calculate multi-digit numbers rapidly. Some behavioral and neuroimaging studies have suggested a visuospatial and visuomotor strategy during abacus mental calculation. However, no study up to now has attempted to dissociate temporally the visuospatial neural process from the visuomotor neural process during abacus mental calculation. In the present study, an abacus expert performed the mental addition tasks (8-digit and 4-digit addends presented in visual or auditory modes) swiftly and accurately. The 100% correct rates in this expert's task performance were significantly higher than those of ordinary subjects performing 1-digit and 2-digit addition tasks. ERPs, EEG source localizations, and fMRI results taken together suggested visuospatial and visuomotor processes were sequentially arranged during the abacus mental addition with visual addends and could be dissociated from each other temporally. The visuospatial transformation of the numbers, in which the superior parietal lobule was most likely involved, might occur first (around 380 ms) after the onset of the stimuli. The visuomotor processing, in which the superior/middle frontal gyri were most likely involved, might occur later (around 440 ms). Meanwhile, fMRI results suggested that neural networks involved in the abacus mental addition with auditory stimuli were similar to those in the visual abacus mental addition. The most prominently activated brain areas in both conditions included the bilateral superior parietal lobules (BA 7) and bilateral middle frontal gyri (BA 6). These results suggest a supra-modal brain network in abacus mental addition, which may develop from normal mental calculation networks.

  4. Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

    PubMed Central

    Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Manson, JoAnn E.; Langer, Robert D.; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F. Allan; Kooperberg, Charles; Kuller, Lewis H.; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E.; Anderson, Garnet L.

    2009-01-01

    The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical trial and observational study toward understanding this apparent discrepancy and refining hazard ratio estimates. After control for prior use of postmenopausal hormone therapy and for confounding factors, CEE hazard ratio estimates were higher from the observational study compared with the clinical trial by 43% (p = 0.12). However, after additional control for time from menopause to first use of postmenopausal hormone therapy, the hazard ratios agreed closely between the two cohorts (p = 0.82). For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index. PMID:18448442

  5. Asking good clinical research questions and choosing the right study design.

    PubMed

    Bragge, P

    2010-07-01

    Clinicians and researchers seek answers to clinical research questions, primarily by accessing the results of clinical research studies. This paper moves the focus of research enquiry from getting answers to developing good clinical research questions. Using worked examples, the steps involved in refining questions drawn from various sources to create 'answerable' clinical research questions using the 'PICO' principle are described. Issues to consider in prioritising clinical research questions are also identified. Theoretical and practical considerations involved in choosing the right study design for a clinical research question are then discussed using the worked examples. These include: Copyright (c) 2010 Elsevier Ltd. All rights reserved.

  6. Adolescent health--a descriptive study of a school doctor clinic.

    PubMed

    Chavasse, M; North, D; McAvoy, B

    1995-07-14

    To describe a school doctor clinic at a New Zealand secondary school. A three phase study was designed and conducted at a coeducational secondary school in Auckland. Firstly, a health questionnaire was developed to assess adolescents' perceptions of their health status and use of primary health care services. The second phase was descriptive study of a newly established school doctor clinic. The doctor clinic was run twice weekly over a 3 month period in 1993. The third phase of the study was a clinic-based satisfaction survey. A 75% response rate was achieved, with a total of 221 health questionnaires completed from 292. Although the majority of students (n = 184, 84%) considered themselves healthy, 16% (n = 36) described their health as only 'fair' or 'poor'. Seventy one percent (n = 157) of students had seen their general practitioner in the preceeding twelve months. Thirteen percent (n = 142) of the school population consulted the school doctor clinic. Significantly more female, Maori and European students attended the school doctor clinic compared with the school demography. The commonest diagnoses for the doctor clinic were respiratory, skin and musculoskeletal problems. Thirty one percent of the diagnoses related to recognised adolescent health needs such as contraception, sexual health, nutrition, and psychosocial problems. Over two thirds of students at the first consultation had not seen another health provider. Students perceived that the doctor clinic overcame barriers such as access, cost and confidentiality. The school doctor clinic was well utilised, overcame some barriers to access and addressed many recognised adolescent health needs.

  7. A clinical study of the LiVac laparoscopic liver retractor system.

    PubMed

    Gan, Philip; Bingham, Judy

    2016-02-01

    All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients. The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound. The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported. The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.

  8. The impact of tobacco additives on cigarette smoke toxicity: a critical appraisal of tobacco industry studies.

    PubMed

    Paumgartten, Francisco José Roma; Gomes-Carneiro, Maria Regina; Oliveira, Ana Cecilia Amado Xavier de

    2017-09-21

    Cigarette production involves a number of substances and materials other than just tobacco, paper and a filter. Tobacco additives include flavorings, enhancers, humectants, sugars, and ammonium compounds. Although companies maintain that tobacco additives do not enhance smoke toxicity and do not make cigarettes more attractive or addictive, these claims are questioned by independent researchers. This study reviewed the studies on the effects of tobacco additives on smoke chemistry and toxicity. Tobacco additives lead to higher levels of formaldehyde and minor changes in other smoke analytes. Toxicological studies (bacterial mutagenicity and mammalian cytoxicity tests, rat 90 days inhalation studies and bone-marrow cell micronucleus assays) found that tobacco additives did not enhance smoke toxicity. Rodent assays, however, poorly predicted carcinogenicity of tobacco smoke, and were clearly underpowered to disclose small albeit toxicologically relevant differences between test (with tobacco additives) and control (without tobacco additives) cigarettes. This literature review led to the conclusion that the impact of tobacco additives on tobacco smoke harmfulness remains unclear.

  9. Heuristic errors in clinical reasoning.

    PubMed

    Rylander, Melanie; Guerrasio, Jeannette

    2016-08-01

    Errors in clinical reasoning contribute to patient morbidity and mortality. The purpose of this study was to determine the types of heuristic errors made by third-year medical students and first-year residents. This study surveyed approximately 150 clinical educators inquiring about the types of heuristic errors they observed in third-year medical students and first-year residents. Anchoring and premature closure were the two most common errors observed amongst third-year medical students and first-year residents. There was no difference in the types of errors observed in the two groups. Errors in clinical reasoning contribute to patient morbidity and mortality Clinical educators perceived that both third-year medical students and first-year residents committed similar heuristic errors, implying that additional medical knowledge and clinical experience do not affect the types of heuristic errors made. Further work is needed to help identify methods that can be used to reduce heuristic errors early in a clinician's education. © 2015 John Wiley & Sons Ltd.

  10. [Clinical status and outcome biomarkers in schizophrenia: a review for near-infrared spectroscopy studies].

    PubMed

    Koike, Shinsuke

    2013-01-01

    Neuroimaging technologies have seen enormous progress during the past two decades, and are now able to provide detailed illustrations of brain structure and activity. As a result, our understanding of the pathophysiology of mental illnesses such as schizophrenia has expanded, and potential clinical applications are becoming apparent. Unlike most physical illnesses, mental illnesses often lack objective markers, and this is one of the reasons why some patients and their family members experience difficulty in understanding symptoms and disabilities. In some cases, this leads to delays in patients seeking treatment, discontinuation of treatment, and relapse. If biological markers can be utilized as aids in differential diagnosis, selection of treatment options, and assessment of severity and treatment response in clinical settings, they may lead to improved treatment quality and clinical outcomes. Near-infrared spectroscopy (NIRS) is a functional neuroimaging technique that may be a candidate for clinical application in psychiatry. Advantages of NIRS include: 1) its non-invasive nature, with no harmful impact resulting from repeated measurement, even in infants; 2) high temporal resolution (> 10 Hz); 3) compact size, enabling easy movement; and 4) no required restraint position: people undergoing testing may take a natural position, such as sitting or standing, and may converse and perform manual tasks during measurement. Previous NIRS studies have revealed different characteristic waveform patterns during verbal fluency tasks among patients with major depression, bipolar disorder, and schizophrenia, which led to government approval in 2009 as an "advanced medical technology to aid in the differential diagnosis of depressive symptoms." This was the first approval in the field of psychiatry in Japan. Future NIRS studies will focus more on clinical applications, and multi-site studies are needed to assess the impact of non-illness factors such as age, sex, and head

  11. Validity and Reliability of the Clinical Competency Evaluation Instrument for Use among Physiotherapy Students: Pilot study.

    PubMed

    Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

    2015-05-01

    The aim of this study was to determine the content validity, internal consistency, test-retest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI) in assessing the clinical performance of physiotherapy students. This study was carried out between June and September 2013 at University Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia. A panel of 10 experts were identified to establish content validity by evaluating and rating each of the items used in the CCEVI with regards to their relevance in measuring students' clinical competency. A total of 50 UKM undergraduate physiotherapy students were assessed throughout their clinical placement to determine the construct validity of these items. The instrument's reliability was determined through a cross-sectional study involving a clinical performance assessment of 14 final-year undergraduate physiotherapy students. The content validity index of the entire CCEVI was 0.91, while the proportion of agreement on the content validity indices ranged from 0.83-1.00. The CCEVI construct validity was established with factor loading of ≥0.6, while internal consistency (Cronbach's alpha) overall was 0.97. Test-retest reliability of the CCEVI was confirmed with a Pearson's correlation range of 0.91-0.97 and an intraclass coefficient correlation range of 0.95-0.98. Inter-rater reliability of the CCEVI domains ranged from 0.59 to 0.97 on initial and subsequent assessments. This pilot study confirmed the content validity of the CCEVI. It showed high internal consistency, thereby providing evidence that the CCEVI has moderate to excellent inter-rater reliability. However, additional refinement in the wording of the CCEVI items, particularly in the domains of safety and documentation, is recommended to further improve the validity and reliability of the instrument.

  12. Clinical nurse leaders' and academics' perspectives in clinical assessment of final-year nursing students: A qualitative study.

    PubMed

    Wu, Xi Vivien; Enskär, Karin; Pua, Lay Hoon; Heng, Doreen Gek Noi; Wang, Wenru

    2017-09-01

    The nature of nursing practice is diverse; therefore, clinical assessment is a complex process. This study explores the perceptions of clinical nurse leaders and academics on clinical assessment for undergraduate nursing education during transition to practice. An explorative qualitative approach was applied. Eight nurse managers, six clinical nurse educators, and eight academics from two tertiary hospitals and a university in Singapore participated in four focus group discussions. Thematic analysis was conducted. Four overriding themes were revealed: the need for a valid and reliable clinical assessment tool, preceptors' competency in clinical assessment, challenges encountered by the students in clinical assessment, and the need for close academic and clinical collaboration to support preceptors and students. Closer academic-clinical partnership is recommended to review the clinical education curriculum. Clinical and educational institutions need to work closely to design a learning program to enhance preceptors' competence in clinical pedagogy and assessment. Furthermore, a stress management program could build students' resiliency in coping with unfamiliar clinical environments. Ongoing support needs to be provided for both preceptors and students to enrich the preceptorship and learning experiences. © 2017 John Wiley & Sons Australia, Ltd.

  13. The history of the Gynecologic Cancer Study Group (GCSG) of the Japan Clinical Oncology Group (JCOG).

    PubMed

    Onda, Takashi; Konishi, Ikuo; Yoshikawa, Hiroyuki; Kamura, Toshiharu

    2011-10-01

    The Gynecologic Cancer Study Group (GCSG) of the Japan Clinical Oncology Group (JCOG) was organized in 1994. The GCSG has developed under the leadership of three successive group representatives, five principal study investigators, the cooperation of group members and the support of several public research funds. At present, 38 institutions are participating as active members of the GCSG of the JCOG. In addition to gynecologic oncologists, medical oncologists, pathologists and radiotherapists are participating in our group. Our group manages female genital malignancies including uterine cervical, endometrial, ovarian, tubal and vulvar cancers. Because the incidences of uterine cervical (in younger women), endometrial and ovarian cancer have increased in Japan in recent years, we are developing new standard treatments especially for these malignancies. As of 31 May 2011, our group has conducted six JCOG clinical trials (three completed and three ongoing) and completed one JCOG accompanying study, which is now in preparation for publication. Our group has also conducted several retrospective studies, and Phase I and II trials independent of the JCOG Data Center. Our aim is to conduct unique and high-quality clinical trials which we can appeal to the world. In this review, we present the organization and achievements of our group, along with a list of participating institutions, as the history of the GCSG of the JCOG.

  14. Computational intelligence for the Balanced Scorecard: studying performance trends of hemodialysis clinics.

    PubMed

    Cattinelli, Isabella; Bolzoni, Elena; Chermisi, Milena; Bellocchio, Francesco; Barbieri, Carlo; Mari, Flavio; Amato, Claudia; Menzer, Marcus; Stopper, Andrea; Gatti, Emanuele

    2013-07-01

    The Balanced Scorecard (BSC) is a general, widely employed instrument for enterprise performance monitoring based on the periodic assessment of strategic Key Performance Indicators that are scored against preset targets. The BSC is currently employed as an effective management support tool within Fresenius Medical Care (FME) and is routinely analyzed via standard statistical methods. More recently, the application of computational intelligence techniques (namely, self-organizing maps) to BSC data has been proposed as a way to enhance the quantity and quality of information that can be extracted from it. In this work, additional methods are presented to analyze the evolution of clinic performance over time. Performance evolution is studied at the single-clinic level by computing two complementary indexes that measure the proportion of time spent within performance clusters and improving/worsening trends. Self-organizing maps are used in conjunction with these indexes to identify the specific drivers of the observed performance. The performance evolution for groups of clinics is modeled under a probabilistic framework by resorting to Markov chain properties. These allow a study of the probability of transitioning between performance clusters as time progresses for the identification of the performance level that is expected to become dominant over time. We show the potential of the proposed methods through illustrative results derived from the analysis of BSC data of 109 FME clinics in three countries. We were able to identify the performance drivers for specific groups of clinics and to distinguish between countries whose performances are likely to improve from those where a decline in performance might be expected. According to the stationary distribution of the Markov chain, the expected trend is best in Turkey (where the highest performance cluster has the highest probability, P=0.46), followed by Portugal (where the second best performance cluster dominates

  15. Retrieval of diagnostic and treatment studies for clinical use through PubMed and PubMed's Clinical Queries filters.

    PubMed

    Lokker, Cynthia; Haynes, R Brian; Wilczynski, Nancy L; McKibbon, K Ann; Walter, Stephen D

    2011-01-01

    Clinical Queries filters were developed to improve the retrieval of high-quality studies in searches on clinical matters. The study objective was to determine the yield of relevant citations and physician satisfaction while searching for diagnostic and treatment studies using the Clinical Queries page of PubMed compared with searching PubMed without these filters. Forty practicing physicians, presented with standardized treatment and diagnosis questions and one question of their choosing, entered search terms which were processed in a random, blinded fashion through PubMed alone and PubMed Clinical Queries. Participants rated search retrievals for applicability to the question at hand and satisfaction. For treatment, the primary outcome of retrieval of relevant articles was not significantly different between the groups, but a higher proportion of articles from the Clinical Queries searches met methodologic criteria (p=0.049), and more articles were published in core internal medicine journals (p=0.056). For diagnosis, the filtered results returned more relevant articles (p=0.031) and fewer irrelevant articles (overall retrieval less, p=0.023); participants needed to screen fewer articles before arriving at the first relevant citation (p<0.05). Relevance was also influenced by content terms used by participants in searching. Participants varied greatly in their search performance. Clinical Queries filtered searches returned more high-quality studies, though the retrieval of relevant articles was only statistically different between the groups for diagnosis questions. Retrieving clinically important research studies from Medline is a challenging task for physicians. Methodological search filters can improve search retrieval.

  16. 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.

  17. Hypoalbuminemia and acute kidney injury: a meta-analysis of observational clinical studies.

    PubMed

    Wiedermann, Christian J; Wiedermann, Wolfgang; Joannidis, Michael

    2010-10-01

    To test the hypothesis that hypoalbuminemia is independently associated with increased risk of acute kidney injury (AKI). A meta-analysis was performed of observational clinical studies evaluating the relationship between serum albumin level and the occurrence of AKI by multivariate methods. Additionally, the impact was assessed of lower serum albumin on mortality in patients who developed AKI. Eligible studies were sought by multiple methods, and adjusted odds ratios (OR) were quantitatively combined using a random effects model. Seventeen clinical studies with 3,917 total patients were included: 11 studies (6 in surgical or intensive care unit patients and 5 in other hospital settings) evaluating the influence of serum albumin on AKI incidence and 6 studies describing the relationship between serum albumin and mortality among patients who had developed AKI. Lower serum albumin was an independent predictor both of AKI and of death after AKI development. With each 10 g L(-1) serum albumin decrement, the odds of AKI increased by 134%. The pooled OR for AKI was 2.34 with a 95% confidence interval (CI) of 1.74-3.14. Among patients who had developed AKI, the odds of death rose 147% (pooled OR 2.47, 95% CI 1.51-4.05) with each 10 g L(-1) serum albumin decrement. This meta-analysis provides evidence that hypoalbuminemia is a significant independent predictor both of AKI and of death following AKI development. Serum albumin determinations may be of utility in identifying patients at increased risk for AKI or for death after AKI. Controlled studies are warranted to assess interventions aimed at correcting hypoalbuminemia.

  18. Preliminary clinical nursing leadership competency model: a qualitative study from Thailand.

    PubMed

    Supamanee, Treeyaphan; Krairiksh, Marisa; Singhakhumfu, Laddawan; Turale, Sue

    2011-12-01

    This qualitative study explored the clinical nursing leadership competency perspectives of Thai nurses working in a university hospital. To collect data, in-depth interviews were undertaken with 23 nurse administrators, and focus groups were used with 31 registered nurses. Data were analyzed using content analysis, and theory development was guided by the Iceberg model. Nurses' clinical leadership competencies emerged, comprising hidden characteristics and surface characteristics. The hidden characteristics composed three elements: motive (respect from the nursing and healthcare team and being secure in life), self-concept (representing positive attitudes and values), and traits (personal qualities necessary for leadership). The surface characteristics comprised specific knowledge of nurse leaders about clinical leadership, management and nursing informatics, and clinical skills, such as coordination, effective communication, problem solving, and clinical decision-making. The study findings help nursing to gain greater knowledge of the essence of clinical nursing leadership competencies, a matter critical for theory development in leadership. This study's results later led to the instigation of a training program for registered nurse leaders at the study site, and the formation of a preliminary clinical nursing leadership competency model. © 2011 Blackwell Publishing Asia Pty Ltd.

  19. Comparing the clinical outcomes in patients with atrial fibrillation receiving dual antiplatelet therapy and patients receiving an addition of an anticoagulant after coronary stent implantation: A systematic review and meta-analysis of observational studies.

    PubMed

    Chaudhary, Nabin; Bundhun, Pravesh Kumar; Yan, He

    2016-12-01

    Data regarding the clinical outcomes in patients with atrial fibrillation (AF) receiving dual antiplatelet therapy (DAPT) and an anticoagulant in addition to DAPT (DAPT + vitamin K antagonist [VKA]) after coronary stent implantation are still controversial. Therefore, in order to solve this issue, we aim to compare the adverse clinical outcomes in AF patients receiving DAPT and DAPT + VKA after percutaneous coronary intervention and stenting (PCI-S). Observational studies comparing the adverse clinical outcomes such as major bleeding, major adverse cardiovascular events, stroke, myocardial infarction, all-cause mortality, and stent thrombosis (ST) in AF patients receiving DAPT + VKA therapy, and DAPT after PCI-S have been searched from Medline, EMBASE, and PubMed databases. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to express the pooled effect on discontinuous variables, and the pooled analyses were performed with RevMan 5.3. Eighteen studies consisting of a total of 20,456 patients with AF (7203 patients received DAPT + VKA and 13,253 patients received DAPT after PCI-S) were included in this meta-analysis. At a mean follow-up period of 15 months, the risk of major bleeding was significantly higher in DAPT + VKA group, with OR 0.62 (95% CI 0.50-0.77, P < 0.0001). There was no significant differences in myocardial infarction and major adverse cardiovascular event between DAPT + VKA and DAPT, with OR 1.27 (95% CI 0.92-1.77, P = 0.15) and OR 1.17 (95% CI 0.99-1.39, P = 0.07), respectively. However, the ST, stroke, and all-cause mortality were significantly lower in the DAPT + VKA group, with OR 1.98 (95% CI 1.03-3.81, P = 0.04), 1.59 (95% CI 1.08-2.34, P = 0.02), and 1.41 (95% CI 1.03-1.94, P = 0.03), respectively. At a mean follow-up period of 15 months, DAPT + VKA was associated with significantly lower risk of stroke, ST, and all-cause mortality in AF patients after PCI-S compared with

  20. Exploring Factors Affecting Undergraduate Medical Students' Study Strategies in the Clinical Years: A Qualitative Study

    ERIC Educational Resources Information Center

    Al Kadri, Hanan M. F.; Al-Moamary, Mohamed S.; Elzubair, Margaret; Magzoub, Mohi Eldien; AlMutairi, Abdulrahman; Roberts, Christopher; van der Vleuten, Cees

    2011-01-01

    The aim of this study is to explore the effects of clinical supervision, and assessment characteristics on the study strategies used by undergraduate medical students during their clinical rotations. We conducted a qualitative phenomenological study at King Saud Bin Abdulaziz University for Health Sciences, College of Medicine, Riyadh, Saudi…

  1. Longitudinal Study of Left Ventricular Mass Growth: Comparative Study of Clinic and Ambulatory Systolic Blood Pressure in Chronic Kidney Disease.

    PubMed

    Agarwal, Rajiv

    2016-04-01

    Left ventricular (LV) hypertrophy is an established cardiovascular risk factor, yet little is known about its trajectory in people with chronic kidney disease. The goal of this prospective research study was to describe the trajectory of LV mass index, its relationship with blood pressure (BP), and specifically to compare the relationship of BP measured in the clinic and 24-hour ambulatory BP monitoring with LV mass index. Among 274 veterans with chronic kidney disease followed for over ≤ 4 years, the rate of growth of log LV mass index was inversely related to baseline LV mass index; it was rapid in the first 2 years, and plateaued subsequently. Systolic BP also significantly increased, but linearly, 1.7 mm Hg/y by clinic measurements and 1.8 mm Hg/y by 24-hour ambulatory BP. Cross-sectional and longitudinal associations of both clinic BP and 24-hour ambulatory BP with LV mass index were similar; both BP recording methods were associated with LV mass index and its growth over time. Controlled hypertension, masked uncontrolled hypertension, and uncontrolled hypertension categories had increasing LV mass index when diagnosed by 24-hour ambulatory and awake BP (P<0.05 for linear trend) but not sleep BP. After accounting for clinic BP both at baseline and longitudinally, LV mass index among individuals was additionally predicted by the difference in sleep systolic BP and clinic systolic BP (P=0.032). In conclusion, among people with chronic kidney disease, the growth of LV mass index is rapid. Research-grade clinic BP is useful to assess LV mass index and its growth over time. © 2016 American Heart Association, Inc.

  2. Investigation of the practical aspects of an additional 0.1 mm copper x-ray spectral filter for cine acquisition mode imaging in a clinical care setting.

    PubMed

    Fetterly, Kenneth A

    2010-11-01

    Minimizing the x-ray radiation dose is an important aspect of patient safety during interventional fluoroscopy procedures. This work investigates the practical aspects of an additional 0.1 mm Cu x-ray beam spectral filter applied to cine acquisition mode imaging on patient dose and image quality. Measurements were acquired using clinical interventional imaging systems. Acquisition images of Solid Water phantoms (15-40 cm) were acquired using x-ray beams with the x-ray tube inherent filtration and using an additional 0.1 mm Cu x-ray beam spectral filter. The skin entrance air kerma (dose) rate was measured and the signal difference to noise ratio (SDNR) of an iodine target embedded into the phantom was calculated to assess image quality. X-ray beam parameters were recorded and analyzed and a primary x-ray beam simulation was performed to assess additional x-ray tube burden attributable to the Cu filter. For all phantom thicknesses, the 0.1 mm Cu filter resulted in a 40% reduction in the entrance air kerma rate to the phantoms and a 9% reduction in the SDNR of the iodine phantom. The expected additional tube load required by the 0.1 mm Cu filter ranged from 11% for a 120 kVp x-ray beam to 43% for a 60 kVp beam. For these clinical systems, use of the 0.1 mm Cu filter resulted in a favorable compromise between reduced skin dose rate and image quality and increased x-ray tube burden.

  3. Informatics tools to improve clinical research study implementation.

    PubMed

    Brandt, Cynthia A; Argraves, Stephanie; Money, Roy; Ananth, Gowri; Trocky, Nina M; Nadkarni, Prakash M

    2006-04-01

    There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. We describe an approach that emphasizes the use of a variety of informatics tools that can facilitate study coordination, training, data checks and early identification and correction of faulty procedures and data problems. The paper focuses on informatics tools that can help in case report form design, procedures and training and data management. Informatics tools can be used to facilitate study coordination and implementation of clinical research trials.

  4. Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions.

    PubMed

    Kuchinke, W; Wiegelmann, S; Verplancke, P; Ohmann, C

    2006-01-01

    Our objectives were to analyze the possibility of an exchange of an entire clinical study between two different and independent study software solutions. The question addressed was whether a software-independent transfer of study metadata can be performed without programming efforts and with software routinely used for clinical research. Study metadata was transferred with ODM standard (CDISC). Study software systems employed were MACRO (InferMed) and XTrial (XClinical). For the Proof of Concept, a test study was created with MACRO and exported as ODM. For modification and validation of the ODM export file XML-Spy (Altova) and ODM-Checker (XML4Pharma) were used. Through exchange of a complete clinical study between two different study software solutions, a Proof of Concept of the technical feasibility of a system-independent metadata exchange was conducted successfully. The interchange of study metadata between two different systems at different centers was performed with minimal expenditure. A small number of mistakes had to be corrected in order to generate a syntactically correct ODM file and a "vendor extension" had to be inserted. After these modifications, XTrial exhibited the study, including all data fields, correctly. However, the optical appearance of both CRFs (case report forms) was different. ODM can be used as an exchange format for clinical studies between different study software. Thus, new forms of cooperation through exchange of metadata seem possible, for example the joint creation of electronic study protocols or CRFs at different research centers. Although the ODM standard represents a clinical study completely, it contains no information about the representation of data fields in CRFs.

  5. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    PubMed

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  6. Phytosomal curcumin: A review of pharmacokinetic, experimental and clinical studies.

    PubMed

    Mirzaei, Hamed; Shakeri, Abolfazl; Rashidi, Bahman; Jalili, Amin; Banikazemi, Zarrin; Sahebkar, Amirhossein

    2017-01-01

    Curcumin, a hydrophobic polyphenol, is the principal constituent extracted from dried rhizomes of Curcuma longa L. (turmeric). Curcumin is known as a strong anti-oxidant and anti-inflammatory agent that has different pharmacological effects. In addition, several studies have demonstrated that curcumin is safe even at dosages as high as 8g per day; however, instability at physiological pH, low solubility in water and rapid metabolism results in a low oral bioavailability of curcumin. The phytosomal formulation of curcumin (a complex of curcumin with phosphatidylcholine) has been shown to improve curcumin bioavailability. Existence of phospholipids in phytosomes leads to specific physicochemical properties such as amphiphilic nature that allows dispersion in both hydrophilic and lipophilic media. The efficacy and safety of curcumin phytosomes have been shown against several human diseases including cancer, osteoarthritis, diabetic microangiopathy and retinopathy, and inflammatory diseases. This review focuses on the pharmacokinetics as well as pharmacological and clinical effects of phytosomal curcumin. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  7. Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies.

    PubMed

    Fermaglich, Lewis J; Chen, Ru; Kim, Carol Y; Chuh, Eunjung Esther; Thomas, Teena; Shetty, Daiva; Lee, Julia; Young, Johnny; Fan, Ying

    2018-01-01

    The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays. Multiple internal FDA databases were searched to evaluate and summarize common deficiencies identified in ANDA submissions containing clinical endpoint studies and skin I/S/A studies that required review by the Division of Clinical Review. A total of 275 ANDA submissions with filing reviews from January 2007 to June 2017 were analyzed in this report. Two hundred eighteen (79.3%) filing reviews contained one or more deficiencies. Seventy-nine (28.7%) ANDAs were issued RTR letters because of major clinical deficiencies, specifically bioequivalence and clinical deficiencies, accounting for 9% of overall identified deficiencies. Twenty-two other categories of deficiencies are summarized into 4 main categories: missing information related to the clinical studies other than data sets (38%), missing data sets (35%), formulation issues (12%), and organization/format issues (6%). The most common deficiency in the "missing information related to the clinical studies other than data sets" category was "missing clarification of information" (22%). We also noted that the Division of Filing Review has identified these same types of deficiencies since assuming responsibility of the filing assessment for ANDAs with clinical endpoint BE studies and skin I/S/A studies. In conclusion, to minimize "refuse-to-receive" actions, "information requests," and approval of ANDA delays for generic drug products, applicants should submit full clinical study reports, including all data sets for drug products recommending clinical

  8. The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study.

    PubMed

    Macaluso, Fabio Salvatore; Sapienza, Chiara; Ventimiglia, Marco; Renna, Sara; Rizzuto, Giulia; Orlando, Rosalba; Di Pisa, Marta; Affronti, Marco; Orlando, Emanuele; Cottone, Mario; Orlando, Ambrogio

    2018-01-18

    The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficacy and safety of this selective combination therapy in patients with IBD. All consecutive patients with loss of response to anti-TNFα monotherapy despite an intensive dose optimization who added an IM from October 2014 to October 2016 were entered into a prospective database. Among 630 patients treated with anti-TNFα agents during the study period, 46 (7.3%) added an IM. A total of 31 patients (67.4%) were treated with an intravenous anti-TNFα (infliximab, as originator or biosimilar), while 15 (32.6%) were treated with a subcutaneous anti-TNFα agent (10 adalimumab and 5 golimumab). The mean duration of follow-up was 12.8 ± 7.3 months. Twenty-one patients (45.7%) remained on combination therapy at the end of follow-up: 15 (32.6%) maintained a steroid-free remission, and 6 (13.0%) achieved a clinical response. In patients who experienced treatment success, the median value of C-reactive protein decreased from baseline to the end of follow-up (13.2 vs 3.0, P = 0.01; normal values <5 mg/L). Adverse events leading to treatment discontinuation were reported in 8 out of 46 patients (17.4%). In the largest cohort on this argument reported to date, the addition of an IM was an effective and safe optimization strategy after loss of response to anti-TNFα monotherapy. Low doses of IM were sufficient to achieve a clinical response. © 2018 Crohn’s & Colitis Foundation of America. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  9. Improving Translation from Preclinical Studies to Clinical Trials in Acute Kidney Injury.

    PubMed

    Fiorentino, Marco; Kellum, John A

    2018-05-23

    Several cellular and molecular targets and mechanisms have been investigated in preclinical studies of acute kidney injury (AKI), but translation in successful clinical studies has failed to date. This article reviews many issues that have limited this and the potential future perspectives in AKI prevention and treatment. Preclinical models of AKI should closely mimic the complexity of human AKI, considering the importance of several comorbidities in determining the clinical course and outcomes in the human disease. Moreover, studies should test novel interventions in models where AKI is already established, instead of focusing only at primary prevention. AKI definitions and endpoints in animal studies should be similar to those applied in clinical studies; in particular, AKI biomarkers should be implemented to guide patient selection for clinical trials and monitor intervention efficacy. In this scenario, cell-cycle arrest biomarkers have been widely investigated as AKI predictors in both preclinical and clinical studies and they serve as useful tools for future interventional studies. A better understanding of human AKI through a large collection of biological samples and kidney biopsies and omics applications, and an iterative relationship between preclinical and clinical studies are critical steps to improve future preclinical models and clinical trials. Finally, given the great variability in clinical manifestation of AKI, a strong collaboration between research centers and industry is recommended. Key messages: Several methodological issues have hampered the translation of basic research findings in clinical studies, and overcoming these obstacles is necessary to achieve success. © 2018 S. Karger AG, Basel.

  10. World Workshop on Oral Medicine VI: an international validation study of clinical competencies for advanced training in oral medicine.

    PubMed

    Steele, John C; Clark, Hadleigh J; Hong, Catherine H L; Jurge, Sabine; Muthukrishnan, Arvind; Kerr, A Ross; Wray, David; Prescott-Clements, Linda; Felix, David H; Sollecito, Thomas P

    2015-08-01

    To explore international consensus for the validation of clinical competencies for advanced training in Oral Medicine. An electronic survey of clinical competencies was designed. The survey was sent to and completed by identified international stakeholders during a 10-week period. To be validated, an individual competency had to achieve 90% or greater consensus to keep it in its current format. Stakeholders from 31 countries responded. High consensus agreement was achieved with 93 of 101 (92%) competencies exceeding the benchmark for agreement. Only 8 warranted further attention and were reviewed by a focus group. No additional competencies were suggested. This is the first international validated study of clinical competencies for advanced training in Oral Medicine. These validated clinical competencies could provide a model for countries developing an advanced training curriculum for Oral Medicine and also inform review of existing curricula. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Additive-induced aggregate changes of two structurally similar dyes in aqueous solutions: A comparative photophysical study

    NASA Astrophysics Data System (ADS)

    Ghanadzadeh Gilani, A.; Poormohammadi-Ahandani, Z.; Kian, R.

    2018-01-01

    Absorption and emission spectral characteristics of the two structurally similar phenothiazine dyes, azure B and toluidine blue, in aqueous solutions of the two sets of molecular additives (ureas and monosaccharides) were studied as a function of the dye and additive concentrations. The absorption spectra of the dyes were also studied in pure tetramethylurea with an aprotic nature. The spectral data were analyzed using DECOM Program. The dimer structure of the interacting molecules in these dyes was discussed using the exciton model. The urea class of additives was found to act as water structure-breakers over the range of studied concentration. The carbohydrate additives were found to act as water structure-breakers at low concentrations. However, the water structure breaking process may be disfavored by the additive-additive interactions at higher concentrations. It can be concluded that at low additive concentrations, the main driving force for breaking the dye association is water-additive interaction, which disrupts the water hydrogen bonds induced by the additives. However, at the high additive concentrations, the different phenomena including additive-additive and additive-dye interactions can change the structure, strength, and aggregative properties of the dyes. Finally, the urea in water induces noticeably fluorescence quenching in emission spectra of both the dyes.

  12. Additive-induced aggregate changes of two structurally similar dyes in aqueous solutions: A comparative photophysical study.

    PubMed

    Ghanadzadeh Gilani, A; Poormohammadi-Ahandani, Z; Kian, R

    2018-01-15

    Absorption and emission spectral characteristics of the two structurally similar phenothiazine dyes, azure B and toluidine blue, in aqueous solutions of the two sets of molecular additives (ureas and monosaccharides) were studied as a function of the dye and additive concentrations. The absorption spectra of the dyes were also studied in pure tetramethylurea with an aprotic nature. The spectral data were analyzed using DECOM Program. The dimer structure of the interacting molecules in these dyes was discussed using the exciton model. The urea class of additives was found to act as water structure-breakers over the range of studied concentration. The carbohydrate additives were found to act as water structure-breakers at low concentrations. However, the water structure breaking process may be disfavored by the additive-additive interactions at higher concentrations. It can be concluded that at low additive concentrations, the main driving force for breaking the dye association is water-additive interaction, which disrupts the water hydrogen bonds induced by the additives. However, at the high additive concentrations, the different phenomena including additive-additive and additive-dye interactions can change the structure, strength, and aggregative properties of the dyes. Finally, the urea in water induces noticeably fluorescence quenching in emission spectra of both the dyes. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

    PubMed

    Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of

  14. Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

    PubMed Central

    Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of

  15. Personality Factors and Depressive Configurations. An Exploratory Study in an Italian Clinical Sample

    PubMed Central

    Straccamore, Francesca; Ruggi, Simona; Lingiardi, Vittorio; Zanardi, Raffaella; Vecchi, Sara; Oasi, Osmano

    2017-01-01

    Introduction: This study focuses on the relationship between personality configurations and depressive experiences. More specifically, the aim of this study is to investigate the relationship between self-criticism and dependency and personality styles or disorders, exploring the association between personality features and depressive symptoms. The two-configurations model of personality developed by Blatt (2004, 2008) is adopted as a reference point in sharing a valid framework and in understanding the results. Methods: Five instruments are administered to 51 participants with a diagnosis of depressive disorder, in accordance with DSM-IV-TR (American Psychiatric Association, 2000): Self-criticism and dependency dimensions of depression are measured with the Depressive Experiences Questionnaire (DEQ); self-reported depression is assessed with the Beck Depression Inventory-II (BDI-II); observer-rated depression is assessed with the Hamilton Depression Rating Scale (HDRS); personality is assessed with the Clinical Diagnostic Interview (CDI) and the Shedler Westen Assessment Procedure-200 (SWAP-200). Results: Only self-criticism, and not dependency, is associated with depressive symptoms. In addition, the SWAP Borderline PD Scale and the Dysphoric: Emotionally dysregulated Q-factor emerge as significant in predicting depression. Conclusions: Findings support the assumption that depressive personality configurations can enhance the vulnerability to developing depression. Theoretical and clinical implications of these results are discussed. PMID:28316575

  16. 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

  17. Spectra-temporal patterns underlying mental addition: an ERP and ERD/ERS study.

    PubMed

    Ku, Yixuan; Hong, Bo; Gao, Xiaorong; Gao, Shangkai

    2010-03-12

    Functional neuroimaging data have shown that mental calculation involves fronto-parietal areas that are composed of different subsystems shared with other cognitive functions such as working memory and language. Event-related potential (ERP) analysis has also indicated sequential information changes during the calculation process. However, little is known about the dynamic properties of oscillatory networks in this process. In the present study, we applied both ERP and event-related (de-)synchronization (ERS/ERD) analyses to EEG data recorded from normal human subjects performing tasks for sequential visual/auditory mental addition. Results in the study indicate that the late positive components (LPCs) can be decomposed into two separate parts. The earlier element LPC1 (around 360ms) reflects the computing attribute and is more prominent in calculation tasks. The later element LPC2 (around 590ms) indicates an effect of number size and appears larger only in a more complex 2-digit addition task. The theta ERS and alpha ERD show modality-independent frontal and parietal differential patterns between the mental addition and control groups, and discrepancies are noted in the beta ERD between the 2-digit and 1-digit mental addition groups. The 2-digit addition (both visual and auditory) results in similar beta ERD patterns to the auditory control, which may indicate a reliance on auditory-related resources in mental arithmetic, especially with increasing task difficulty. These results coincide with the theory of simple calculation relying on the visuospatial process and complex calculation depending on the phonological process. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  18. Would a student midwife run postnatal clinic make a valuable addition to midwifery education in the UK?--a systematic review.

    PubMed

    Marsh, Wendy; Colbourne, Dana M; Way, Susan; Hundley, Vanora A

    2015-03-01

    There is growing evidence in the UK that some National Health Service improvements, particularly in the postnatal period, are having an impact on the quality and variety of student midwives' clinical experiences, making it challenging for them to meet the standards set by the regulatory body for midwives and receive a licence to practice. A possible solution to this may be the introduction of a Student Midwife integrated Learning Environment (SMiLE) focusing upon the delivery of postnatal care (PN) through a student run clinic. To identify the current state of knowledge, regarding the educational outcomes of students who engage with student run clinics (SRC) and the satisfaction of clients who attend them. Search strategy--BNI, CINAHL, EMBASE, and MEDLINE were searched for articles published until April 2014. Studies, nationally and internationally, were carried out on healthcare students running their own clinics. Outcome measures were the evaluation of educational outcomes of students and client satisfaction were included. Data were extracted, analysed and synthesised to produce a summary of knowledge, regarding the effectiveness of SRCs. 6 studies were selected for this review. The findings that SRC can offer advantages in improving educational outcomes of students and provide an effective service to clients are encouraging. However, given the limited number of high-quality studies included in this review, further research is required to investigate the effectiveness of SRC. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Brief review of published alprazolam clinical studies

    PubMed Central

    Straw, R. N.

    1985-01-01

    1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879

  20. 42 CFR 68a.15 - Additional conditions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Additional conditions. 68a.15 Section 68a.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES FELLOWSHIPS, INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM...

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

    PubMed Central

    von Isenburg, Megan

    2011-01-01

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

  2. The administration of music therapy training clinics: a descriptive study.

    PubMed

    Abbott, Elaine A

    2006-01-01

    A two-part study was conducted to describe issues and administrative practices related to university and college affiliated music therapy training clinics. First, all 72 AMTA academic directors were surveyed in order to discover (a) which programs had a clinic, and (b) the reasons why other directors did not operate a clinic. Second, 12 survey respondents, who reported that they were involved with a training clinic, participated in in-depth interviews discussing: (a) their motivations for establishing a clinic, (b) the possible effects of a clinic on the community, (c) the individuals and groups involved in clinic operations, d) clinic space and equipment, (e) policy and procedure topics, (f) specific administrative practices related to clients and students, (g) finances, (h) research (i) quality assurance, (j) dual roles, and (k) liability issues. The administrative practices described by the interviewees varied greatly across clinics and provided a wealth of information that could be considered both useful and thought provoking for those interested in operating a music therapy clinic.

  3. In search for genetic determinants of clinically meaningful differential cardiovascular event reduction by pravastatin in the PHArmacogenetic study of Statins in the Elderly at risk (PHASE)/PROSPER study.

    PubMed

    Postmus, Iris; Johnson, Paul C D; Trompet, Stella; de Craen, Anton J M; Slagboom, P Eline; Devlin, James J; Shiffman, Dov; Sacks, Frank M; Kearney, Patricia M; Stott, David J; Buckley, Brendan M; Sattar, Naveed; Ford, Ian; Westendorp, Rudi G J; Jukema, J Wouter

    2014-07-01

    Statin therapy is widely used in the prevention and treatment of cardiovascular events and is associated with significant risk reductions. However, there is considerable variation in response to statin therapy both in terms of LDL cholesterol reduction and clinical outcomes. It has been hypothesized that genetic variation contributes importantly to this individual drug response. We investigated the interaction between genetic variants and pravastatin or placebo therapy on the incidence of cardiovascular events by performing a genome-wide association study in the participants of the PROspective Study of Pravastatin in the Elderly at Risk for vascular disease--PHArmacogenetic study of Statins in the Elderly at risk (PROSPER/PHASE) study (n = 5244). We did not observe genome-wide significant associations with a clinically meaningful differential cardiovascular event reduction by pravastatin therapy. In addition, SNPs with p-values lower than 1 × 10(-4) were assessed for replication in a case-only analysis within two randomized placebo controlled pravastatin trials, CARE (n = 711) and WOSCOPS (n = 522). rs7102569, on chromosome 11 near the ODZ4 gene, was replicated in the CARE study (p = 0.008), however the direction of effect was opposite. This SNP was not associated in WOSCOPS. In addition, none of the SNPs replicated significantly after correcting for multiple testing. We could not identify genetic variation that was significantly associated at genome-wide level with a clinically meaningful differential event reduction by pravastatin treatment in a large prospective study. We therefore assume that in daily practice the use of genetic characteristics to personalize pravastatin treatment to improve prevention of cardiovascular disease will be limited. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  4. Clinical and subclinical leaks after low colorectal anastomosis: a clinical and radiologic study.

    PubMed

    Lim, Michael; Akhtar, Saleem; Sasapu, Kishore; Harris, Keith; Burke, Dermot; Sagar, Peter; Finan, Paul

    2006-10-01

    This study was designed to examine the natural history of subclinical leaks and their effect on bowel function and quality of life and to evaluate water-soluble contrast enema features that predict anastomotic healing after leaks. Consecutive patients who underwent low rectal anastomosis were followed up postoperatively for leaks. All leaks were confirmed radiologically with CT scanning and water-soluble contrast enema imaging. Water-soluble contrast enemas were serially repeated to identify healing. Characteristics on initial water-soluble contrast enema were correlated with observed healing. Postoperatively, patients were required to fill in a quality of life and a bowel function questionnaire. A total of 138 patients underwent low rectal anastomosis procedures with a median follow-up period of 26 (interquartile range, 19-37) months. There were 23 documented leaks of which 13 (9 percent) presented clinically and 10 (8 percent) presented subclinically. Ileostomy closure was possible in 4 of 13 (30 percent) patients with a clinical leak and all 10 (100 percent) patients with a subclinical leak. Median quality of life scores were lower for patients with clinical leaks and no ileostomy closure (P = 0.03). Bowel function for subclinical leak patients and clinical leak patients with ileostomy closure were similarly impaired. The presence of a cavity (P = 0.01) and a stricture (P = 0.01) at the anastomotic site were unfavorable radiologic features associated with nonhealing. Subclinical leaks are more benign in their natural history compared with clinical leaks. Quality of life and bowel function is no better in patients with a subclinical leak compared with patients with a clinical leak who have ileostomy closure. Anastomotic leaks may resolve if favorable radiologic features are present.

  5. Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

    PubMed

    Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

    2016-01-01

    An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Concerns of nursing students beginning clinical courses: A descriptive study.

    PubMed

    Cowen, Kay J; Hubbard, Lori J; Hancock, Debbie Croome

    2016-08-01

    Students harbor fears related to the clinical environment that influence their participation and learning. Some studies have addressed general anxieties in undergraduate nursing students, but few have asked students to report their fears and concerns prior to entering the clinical environment. Therefore, this study examined the fears and concerns of undergraduate nursing students beginning clinical courses as well as their continued concerns upon completion of the first year of instruction. The study also assessed their confidence in physical assessment skills. Ninety-six junior nursing students enrolled in a generic baccalaureate nursing program completed a survey, two items of which asked about their fears and concerns related to beginning clinical experiences and their confidence in physical assessment. A follow up survey was completed at the end of the junior year by 72 students. Making a mistake, lack of course success, and not knowing how to do something were students' major concerns prior to the start of clinical experiences. Bad experiences with a nurse or instructor, freezing up, and uncomfortable patient/family experiences were also concerns. Not knowing how to do something persisted as a concern at the completion of the first year. Fears about being/feeling left alone in a clinical setting as well as concern about the senior year also emerged on the post survey. Confidence in physical assessment was a mean of 60.46 on a scale of 0-100 at the beginning of clinical instruction and 71.28 at the end of the junior year. Faculty should structure learning activities that decrease anxiety and enhance students' confidence prior to initial clinical experiences. Opportunities might include in-depth orientation to clinical settings and various simulations that allow practice of skills and communication. Awareness of predominant student fears and concerns can also guide staff nurses to provide a welcoming environment and enhance learning. Copyright © 2016 Elsevier

  7. The UK clinical research network--has it been a success for dermatology clinical trials?

    PubMed

    Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

    2011-06-16

    Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  8. Clinical Significance of the Number of Depressive Symptoms in Major Depressive Disorder: Results from the CRESCEND Study.

    PubMed

    Park, Seon-Cheol; Sakong, Jeongkyu; Koo, Bon Hoon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

    2016-04-01

    Our study aimed to establish the relationship between the number of depressive symptoms and the clinical characteristics of major depressive disorder (MDD). This would enable us to predict the clinical significance of the number of depressive symptoms in MDD patients. Using data from the Clinical Research Center for Depression (CRESCEND) study in Korea, 853 patients with DSM-IV MDD were recruited. The baseline and clinical characteristics of groups with different numbers of depressive symptoms were compared using the χ(2) test for discrete variables and covariance (ANCOVA) for continuous variables. In addition, the scores of these groups on the measurement tools were compared by ANCOVA after adjusting the potential effects of confounding variables. After adjusting the effects of monthly income and history of depression, a larger number of depressive symptoms indicated higher overall severity of depression (F [4, 756] = 21.458, P < 0.001) and higher levels of depressive symptoms (F [4, 767] = 19.145, P < 0.001), anxiety symptoms (F [4, 765] = 12.890, P < 0.001) and suicidal ideation (F [4, 653] = 6.970, P < 0.001). It also indicated lower levels of social function (F [4, 760] = 13.343, P < 0.001), and quality of life (F [4, 656] = 11.975, P < 0.001). However, there were no significant differences in alcohol consumption (F [4, 656] = 11.975, P < 0.001). The number of depressive symptoms can be used as an index of greater illness burden in clinical psychiatry.

  9. A Clinical Study of Subtype-based Prevalence of Dry Eye.

    PubMed

    Rege, Aditya; Kulkarni, Varsha; Puthran, Neelam; Khandgave, Tejaswini

    2013-10-01

    Dry Eye is a multifactorial disease of the tearfilm and the ocular surface which may be due to reduced tear production or excessive tear evaporation resulting in discomfort, visual disturbance, and tear film instability with a potential damage to the ocular surface. Various population-based studies have been done to find out the prevalence and the magnitude of the problem. Women Health Study reported prevalence of 7.8% after screening 36995 subjects above 49 years by interview. The prevalence reported by Blue Mountain Study was 15.3% .The Beaver Dam Study and Shiphai Eye studies are other studies reporting prevalence of 14.5% and 33.7% respectively. McMonnies questionnaire is a widely used screening instrument for Dry-Eye syndromes with sensitivity reportedly varying between 87% and 98% and specificity between 87% and 97%. Prevalence studies use McMonnie's questionnaire for screening individuals for Dry Eye, whereafter tests like Schirmer's test, Tear Film Break Up Time test, Rose Bengal test, Lissamine Green test and Meibomian Gland Dysfunction test are useful for further evaluation. While these tests help to differentiate the subtypes of Dry Eye such as Lipid Anomaly Dry Eye, Aqueous Tear Deficiency and Mucin Layer Deficiency, however, their sensitivity and specificity has not been widely studied. Additionally, very few studies have reported the prevalence of the various subtypes of Dry Eye. To determine the subtype-based prevalence of Dry Eye, to study the specificity and sensitivity of clinical tests for Dry Eye and to correlate McMonnies questionnaire with Dry Eye tests results. A prospective, cross-sectional, observational study, duly approved by the Institutional Ethics Committee, was conducted from October 2010 to April 2012. A total of 4750 subjects above 18 yrs of age were screened by the McMonnies questionnaire. Respondents having a score greater than 14.5 were subjected to clinical Dry Eye tests. The data obtained was analyzed using chi-square test. p

  10. Candidate Proteins, Metabolites and Transcripts in the Biomarkers for Spinal Muscular Atrophy (BforSMA) Clinical Study

    PubMed Central

    Finkel, Richard S.; Crawford, Thomas O.; Swoboda, Kathryn J.; Kaufmann, Petra; Juhasz, Peter; Li, Xiaohong; Guo, Yu; Li, Rebecca H.; Trachtenberg, Felicia; Forrest, Suzanne J.; Kobayashi, Dione T.; Chen, Karen S.; Joyce, Cynthia L.; Plasterer, Thomas

    2012-01-01

    Background Spinal Muscular Atrophy (SMA) is a neurodegenerative motor neuron disorder resulting from a homozygous mutation of the survival of motor neuron 1 (SMN1) gene. The gene product, SMN protein, functions in RNA biosynthesis in all tissues. In humans, a nearly identical gene, SMN2, rescues an otherwise lethal phenotype by producing a small amount of full-length SMN protein. SMN2 copy number inversely correlates with disease severity. Identifying other novel biomarkers could inform clinical trial design and identify novel therapeutic targets. Objective: To identify novel candidate biomarkers associated with disease severity in SMA using unbiased proteomic, metabolomic and transcriptomic approaches. Materials and Methods: A cross-sectional single evaluation was performed in 108 children with genetically confirmed SMA, aged 2–12 years, manifesting a broad range of disease severity and selected to distinguish factors associated with SMA type and present functional ability independent of age. Blood and urine specimens from these and 22 age-matched healthy controls were interrogated using proteomic, metabolomic and transcriptomic discovery platforms. Analyte associations were evaluated against a primary measure of disease severity, the Modified Hammersmith Functional Motor Scale (MHFMS) and to a number of secondary clinical measures. Results A total of 200 candidate biomarkers correlate with MHFMS scores: 97 plasma proteins, 59 plasma metabolites (9 amino acids, 10 free fatty acids, 12 lipids and 28 GC/MS metabolites) and 44 urine metabolites. No transcripts correlated with MHFMS. Discussion In this cross-sectional study, “BforSMA” (Biomarkers for SMA), candidate protein and metabolite markers were identified. No transcript biomarker candidates were identified. Additional mining of this rich dataset may yield important insights into relevant SMA-related pathophysiology and biological network associations. Additional prospective studies are needed to confirm

  11. Periodontal conditions in vegetarians: a clinical study.

    PubMed

    Staufenbiel, I; Weinspach, K; Förster, G; Geurtsen, W; Günay, H

    2013-08-01

    Investigations about possible correlations between vegetarian diet and periodontal conditions are rare and characterized by small case numbers. The aim of this clinical study was to investigate the influence of a vegetarian diet on periodontal parameters with an appropriate sample size. A total of 200 patients, 100 vegetarians and 100 non-vegetarians, were included in the study. All patients were examined including a full mouth assessment of the periodontal and dental conditions. In addition, a questionnaire was handed out to ask for patients' oral hygiene habits and level of education. For statistical analysis the Mann-Whitney Test (χ(2) for analysis of the questionnaire) was applied (level of significance: P<0.05). Well known periodontal risk factors like age, gender and smoking habits were equally distributed within each group (71 females, 29 males, respectively and 10 smokers in each group; mean age: 41.45 years vegetarians versus 41.72 years non-vegetarians). Vegetarians had significantly lower probing pocket depths (P=0.039), bleeding on probing (P=0.001), periodontal screening index (P=0.012), a better hygiene index (P<0.001) and less mobile teeth (P=0.013). Dental examinations revealed significantly less missing teeth (P=0.018) but also more decayed (P=0.001) and eroded (P=0.026) teeth in vegetarians. Furthermore, vegetarians had a higher level of education (P<0.001), but visited dentists significantly less frequent. Vegetarians revealed better periodontal conditions (less inflammation signs, less periodontal damage and a better dental home care). However, it should be considered that vegetarians are not only avoiding meat in their nutrition but are also characterized by an overall healthier life style.

  12. Clinical studies of the effectiveness and safety of antivenoms.

    PubMed

    Williams, David J; Habib, Abdulrazaq G; Warrell, David A

    2018-05-07

    In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomized comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomized controlled trial data. Antivenoms in some poorly regulated markets may have high rates of potentially fatal adverse effects and their use must be balanced by demonstrable effectiveness. Even those manufactured to strict regulatory requirements may pose a rare risk of severe adverse reactions. Most antivenoms currently marketed around the world were registered without first being studied clinically. There is increasing pressure to subject antivenoms, even those that are long-established, to the same protocols of rigorous pre-clinical and clinical assessment that are standard regulatory requirements for other drugs. Conventional clinical testing progresses through Phases I, II, III to IV. Most authorities consider antivenoms too dangerous to be used in Phase I studies in healthy volunteers. An alternative method for preliminary estimation of safety, dose-finding and effectiveness, is proposed - the "3 + 3" dose escalation or de-escalation design, in volunteer patients, as used in oncology to test cytotoxic drugs. Antivenoms are so widely used and well trusted, that there are few ethical justifications for placebo controls. However, placebo might be ethically justified if there were no proven effective treatment and or if withholding or delaying treatment posed acceptably negligible risks to the participants. Antivenom trials are most urgently needed in low-to middle-income countries where there are many

  13. An Alternative Study of Transfer of Learning in Clinical Evaluation.

    ERIC Educational Resources Information Center

    Patel, Vimla; Cranton, Patricia A.

    The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

  14. IPS Empress inlays and onlays after four years--a clinical study.

    PubMed

    Krämer, N; Frankenberger, R; Pelka, M; Petschelt, A

    1999-07-01

    Ceramic inlays are used as esthetic alternatives to amalgam and other metallic materials for the restoration of badly damaged teeth. However, only limited clinical data are available regarding adhesive inlays and onlays with proximal margins located in dentine. In a prospective, controlled clinical study, the performance of IPS Empress inlays and onlays with cuspal replacements and margins below the amelocemental junction was examined. Ninety-six IPS Empress fillings were placed in 34 patients by six clinicians. The restorations were luted with four different composite systems. The dentin bonding system Syntac Classic was used in addition to the acid-etch-technique. At baseline and after 6 months, one, two and four years after placement the restorations were assessed by two calibrated investigators using modified USPHS codes and criteria. A representative sample of the restorations was investigated by scanning electron microscopy to evaluate wear. Seven of the 96 restorations investigated had to be replaced (failure rate 7%; Kaplan-Meier). Four inlays had suffered cohesive bulk fractures and three teeth required endodontic treatment. After four years in clinical service, significant deterioration (Friedman 2-way Anova; p < 0.05) was found to have occurred in the marginal adaptation of the remaining restorations. Seventy-nine percent of the surviving restorations exhibited marginal deficiencies, independent of the luting composite. Neither the absence of enamel margins, nor cuspal replacement significantly affected the adhesion or marginal quality of the restorations. After four years, extensive IPS Empress inlays and onlays bonded with the dentin bonding system Syntac Classic were found to have a 7% failure rate with 79% of the remaining restorations having marginal deficiencies.

  15. 76 FR 29210 - Procurement List; Proposed Additions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ... Type/Location: Laundry Services, U.S. Naval Hospital & Naval Dental Clinic Base, Farenholt Road, Agana... additions to the Procurement List. SUMMARY: The Committee is proposing to add products and services to the... identified in this notice will be required to procure the products and services listed below from nonprofit...

  16. Addition of Granulocyte/Monocyte Apheresis to Oral Prednisone for Steroid-dependent Ulcerative Colitis: A Randomized Multicentre Clinical Trial.

    PubMed

    Domènech, Eugeni; Panés, Julián; Hinojosa, Joaquín; Annese, Vito; Magro, Fernando; Sturniolo, Giacomo Carlo; Bossa, Fabrizio; Fernández, Francisco; González-Conde, Benito; García-Sánchez, Valle; Dignass, Axel; Herrera, José Manuel; Cabriada, José Luis; Guardiola, Jordi; Vecchi, Maurizio; Portela, Francisco; Ginard, Daniel

    2018-05-25

    Steroid-dependency occurs in up to 30% of patients with ulcerative colitis [UC]. In this setting, few drugs have demonstrated efficacy in inducing steroid-free remission. The aim of this study was to evaluate the efficacy and safety of adding granulocyte/monocyte apheresis [GMA] to oral prednisone in patients with steroid-dependent UC. This was a randomized, multicentre, open trial comparing 7 weekly sessions of GMA plus oral prednisone [40 mg/day and tapering] with prednisone alone, in patients with active, steroid-dependent UC [Mayo score 4-10 and inability to withdraw corticosteroids in 3 months or relapse within the first 3 months after discontinuation]. Patients were stratified by concomitant use of thiopurines at inclusion. A 9-week tapering schedule of prednisone was pre-established in both study groups. The primary endpoint was steroid-free remission [defined as a total Mayo score ≤2, with no subscore >1] at Week 24, with no re-introduction of corticosteroids. In all 123 patients were included [63 GMA group, 62 prednisone alone]. In the intention-to-treat analysis, steroid-free remission at Week 24 was achieved in 13% (95% confidence interval [CI] 6-24) in the GMA group and 7% [95% CI 2-16] in the control group [p = 0.11]. In the GMA group, time to relapse was significantly longer (hazard ratio [HR] 1.7 [1.16-2.48], P = 0.005) and steroid-related adverse events were significantly lower [6% vs 20%, P < 0.05]. In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse.

  17. In-hospital death and adverse clinical events in elderly patients according to disease clustering: the REPOSI study.

    PubMed

    Marengoni, A; Bonometti, F; Nobili, A; Tettamanti, M; Salerno, F; Corrao, S; Iorio, A; Marcucci, M; Mannucci, P M

    2010-08-01

    The aim of the study was to recognize clusters of diseases among hospitalized elderly and to identify groups of patients at risk of in-hospital death and adverse clinical events according to disease clustering. This was a cross-sectional study conducted in 38 internal medicine and geriatric wards in Italy participating in the Registro Politerapie SIMI (REPOSI) study during 2008. The subjects were 1,332 inpatients aged 65 years or older. Clusters of diseases (i.e., two or more co-occurrent diseases) were identified using the odds ratios (OR) for the associations between pairs of conditions, followed by cluster analysis. Logistic regression models were used to evaluate the effect of disease clusters on in-hospital death and adverse clinical events. A total of 86.7% of the patients were discharged, 8.3% were transferred to another hospital unit, and 5.0% died during hospitalization; 36.4% of the patients had at least one adverse clinical event. Patients affected by the clusters, including heart failure (HF) and either chronic renal failure (CRF) or chronic obstructive pulmonary disease, had a significant association with in-hospital death (OR, 4.3;95% confidence interval [CI], 1.6-11.5; OR, 2.9; 95% CI, 1.1-8.3, respectively), as well as patients affected by CRF and anemia (OR, 6.1; 95% CI, 2.3-16.2). The cluster including HF and CRF was also associated with adverse clinical events (OR, 3.5; 95% CI, 1.5-7.8). The effect of both HF and CRF and anemia and CRF on in-hospital death was additive. Several groups of older patients at risk of in-hospital death and adverse clinical events were identified according to disease clustering. Knowledge of the relationship among co-occurring diseases may help developing strategies to improve clinical practice and preventative interventions.

  18. Primer: establishing a clinical trial unit--obtaining studies and patients.

    PubMed

    Fleischmann, Roy

    2007-08-01

    Rheumatologists with clinical expertise should perform clinical investigations of new molecules in an effort to discover therapies that could be of greater benefit or safety than those currently available for patients with chronic rheumatic diseases. Over the past few years, many studies have been conducted outside the United States and Europe because of the dearth of investigative sites in these countries. A clinician, whether in private practice or academia, who has the resources and desire to conduct clinical investigations, should be able to become involved in the process. The task of starting a new investigative unit is daunting, as it involves acquiring studies, hiring staff and obtaining space prior to any cash flow. If done properly, however, clinical investigation can be rewarding--both intellectually and financially.

  19. Pilot clinical study for quantitative spectral diagnosis of non-melanoma skin cancer.

    PubMed

    Rajaram, Narasimhan; Reichenberg, Jason S; Migden, Michael R; Nguyen, Tri H; Tunnell, James W

    2010-12-01

    Several research groups have demonstrated the non-invasive diagnostic potential of diffuse optical spectroscopy (DOS) and laser-induced fluorescence (LIF) techniques for early cancer detection. By combining both modalities, one can simultaneously measure quantitative parameters related to the morphology, function and biochemical composition of tissue and use them to diagnose malignancy. The objective of this study was to use a quantitative reflectance/fluorescence spectroscopic technique to determine the optical properties of normal skin and non-melanoma skin cancers and the ability to accurately classify them. An additional goal was to determine the ability of the technique to differentiate non-melanoma skin cancers from normal skin. The study comprised 48 lesions measured from 40 patients scheduled for a biopsy of suspected non-melanoma skin cancers. White light reflectance and laser-induced fluorescence spectra (wavelength range = 350-700 nm) were collected from each suspected lesion and adjacent clinically normal skin using a custom-built, optical fiber-based clinical instrument. After measurement, the skin sites were biopsied and categorized according to histopathology. Using a quantitative model, we extracted various optical parameters from the measured spectra that could be correlated to the physiological state of tissue. Scattering from cancerous lesions was significantly lower than normal skin for every lesion group, whereas absorption parameters were significantly higher. Using numerical cut-offs for our optical parameters, our clinical instrument could classify basal cell carcinomas with a sensitivity and specificity of 94% and 89%, respectively. Similarly, the instrument classified actinic keratoses and squamous cell carcinomas with a sensitivity of 100% and specificity of 50%. The measured optical properties and fluorophore contributions of normal skin and non-melanoma skin cancers are significantly different from each other and correlate well

  20. [Clinical and genetic study patients with tuberous sclerosis complex].

    PubMed

    Rubilar, Carla; López, Francisca; Troncoso, Mónica; Barrios, Andrés; Herrera, Luisa

    2017-02-01

    Tuberous sclerosis complex (TSC) is a multisystem autosomal dominant disease caused by mutations in the tumor suppressor genes TSC1 or TSC2. To characterize clinically and genetically patients diagnosed with TSC. Descriptive study of clinical records of 42 patients from a pediatric neuropsychiatry department diagnosed with TSC and genetic study in 21 of them. The exon 15 of TSC1 gene and exons 33, 36 and 37 of TSC2 gene were amplified by polymerase chain reaction and sequenced. The relationship between the mutations found with the severity and clinical course were analyzed. In 61.9% of the patients the symptoms began before 6 months of age. The initial most frequent manifestations of TSC were new onset of seizures (73.8%) and the detection of cardiac rhabdomyomas (16.6%). During the evolution of the disease all patients had neurological involvement; 92.9% had epilepsy. All patients presented hypomelanotic spots, 47.6% facial angiofibromas, 23.8% Shagreen patch, 47.6 heart rhabdomyomas and 35.7% retinal hamartomas. In the genetic study of 21 patients two heterozygous pathogenic mutations in TSC1 and one in TSC2 genes were identified. The latter had a more severe clinical phenotype. Neurological and dermatological manifestations were the most frequent ones in patients with TSC. Two pathogenic mutations in TSC1 and one in TSC2 genes were identified. The patient with TSC2 mutation manifested a more severe clinical phenotype.

  1. Microwave Sanitization of Color Additives Used in Cosmetics: Feasibility Study

    PubMed Central

    Jasnow, S. B.; Smith, J. L.

    1975-01-01

    Microwave exposure has been explored as a method of microbiologically sanitizing color additives used in cosmetic products. Selected microbiologically unacceptable cosmetic color additives, D&C red no. 7 Ca lake (certified synthetic organic color), carmine (natural organic color not subject to certification), and chromium hydroxide green (inorganic color not subject to certification), were submitted to microwave exposure. Gram-negative bacteria were eliminated, as verified by enrichment procedures, and levels of gram-positive bacteria were reduced. Generally, analytical and dermal safety studies indicated no significant alterations in physical, chemical, and toxicological properties of the colors. Sanitization was also successfully performed on other colors (D&C red no. 9 Ba lake, D&C red no. 12 Ba lake, D&C green no. 5, and FD&C red no. 4); initial physical and chemical tests were satisfactory. Results indicated that this method of sanitization is feasible and warrants further investigation. PMID:1164010

  2. Determinants of successful clinical networks: the conceptual framework and study protocol.

    PubMed

    Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

    2012-03-13

    Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

  3. Rethinking clinical governance: healthcare professionals' views: a Delphi study.

    PubMed

    Veenstra, Gepke L; Ahaus, Kees; Welker, Gera A; Heineman, Erik; van der Laan, Maarten J; Muntinghe, Friso L H

    2017-01-12

    Although the guiding principle of clinical governance states that healthcare professionals are the leading contributors to quality and safety in healthcare, little is known about what healthcare professionals perceive as important for clinical governance. The aim of this study is to clarify this by exploring healthcare professionals' views on clinical governance. Based on a literature search, a list of 99 elements related to clinical governance was constructed. This list was refined, extended and restricted during a three-round Delphi study. The panel of experts was formed of 24 healthcare professionals from an academic hospital that is seen as a leader in terms of its clinical governance expertise in the Netherlands. Rated importance of each element on a four-point scale. The 50 elements that the panel perceived as most important related to adopting a bottom-up approach to clinical governance, ownership, teamwork, learning from mistakes and feedback. The panel did not reach a consensus concerning elements that referred to patient involvement. Elements that referred to a managerial approach to clinical governance and standardisation of work were rejected by the panel. In the views of the panel of experts, clinical governance is a practice-based, value-driven approach that has the goal of delivering the highest possible quality care and ensuring the safety of patients. Bottom-up approaches and effective teamwork are seen as crucial for high quality and safe healthcare. Striving for high quality and safe healthcare is underpinned by continuous learning, shared responsibility and good relationships and collaboration between healthcare professionals, managers and patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. Additive Manufacturing of Biomaterials, Tissues, and Organs.

    PubMed

    Zadpoor, Amir A; Malda, Jos

    2017-01-01

    The introduction of additive manufacturing (AM), often referred to as three-dimensional (3D) printing, has initiated what some believe to be a manufacturing revolution, and has expedited the development of the field of biofabrication. Moreover, recent advances in AM have facilitated further development of patient-specific healthcare solutions. Customization of many healthcare products and services, such as implants, drug delivery devices, medical instruments, prosthetics, and in vitro models, would have been extremely challenging-if not impossible-without AM technologies. The current special issue of the Annals of Biomedical Engineering presents the latest trends in application of AM techniques to healthcare-related areas of research. As a prelude to this special issue, we review here the most important areas of biomedical research and clinical practice that have benefited from recent developments in additive manufacturing techniques. This editorial, therefore, aims to sketch the research landscape within which the other contributions of the special issue can be better understood and positioned. In what follows, we briefly review the application of additive manufacturing techniques in studies addressing biomaterials, (re)generation of tissues and organs, disease models, drug delivery systems, implants, medical instruments, prosthetics, orthotics, and AM objects used for medical visualization and communication.

  5. Adaptive clinical trial design.

    PubMed

    Chow, Shein-Chung

    2014-01-01

    In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its flexibility and efficiency in pharmaceutical/clinical development. In practice, adaptive design may provide the investigators a second chance to modify or redesign the trial while the study is still ongoing. However, it is a concern that a shift in target patient population may occur after significant adaptations are made. In addition, the overall type I error rate may not be preserved. Moreover, the results may not be reliable and hence are difficult to interpret. As indicated by the US Food and Drug Administration draft guidance on adaptive design clinical trials, the adaptive design has to be a prospectively planned opportunity and should be based on information collected within the study, with or without formal statistical hypothesis testing. This article reviews the relative advantages, limitations, and feasibility of commonly considered adaptive designs in clinical trials. Statistical concerns when implementing adaptive designs are also discussed.

  6. Clinical application of antidepressant pharmacogenetics: considerations for the design of future studies.

    PubMed

    Fabbri, Chiara; Serretti, Alessandro

    2018-06-12

    A frustrating inertia has affected the development of clinical applications of antidepressant pharmacogenetics and personalized treatments of depression are still lacking 20 years after the first findings. Candidate gene studies provided replicated findings for some polymorphisms, but each of them shows at best a small effect on antidepressant efficacy and the cumulative effect of different polymorphisms is unclear. Further, no candidate was immune by at least some negative studies. These considerations give rise to some concerns about the clinical benefits of currently available pharmacogenetic tests since they are based on the results of candidate gene studies. Clinical guidelines in fact suggest that only polymorphisms that alter cytochrome 2D6 or 2C19 enzymatic activity probably provide useful clinical indications, while variants in genes involved in antidepressant pharmacodynamics have no recommended clinical applications. The present review discusses possible strategies to facilitate the identification of genetic biomarkers with clinical usefulness in guiding antidepressant treatments. These include analysis methods for the study of the polygenic/omnigenic nature of antidepressant response, the prioritization of polymorphisms on the basis of functional considerations, the incorporation of clinical-demographic predictors in pharmacogenetic studies (e.g. mixed polygenic and clinical risk scores), the application of methodological improvements to the design of future studies in order to maximize the comparability of results and improve power. Copyright © 2018. Published by Elsevier B.V.

  7. The narcotic clinic in New Orleans, 1919-21.

    PubMed

    Tallaksen, Amund

    2017-09-01

    This paper traces the history of the narcotic clinic in New Orleans, Louisiana, comparing its merits to a similar clinic in Shreveport. How do the clinics compare, and why did the Shreveport clinic operate for longer than its New Orleans counterpart? Qualitative analysis of contemporary medical journals and newspapers, as well as archival materials from the Narcotic Division. In addition, the records of Louisiana Governor John M. Parker, the papers of Dr Willis P. Butler in Shreveport, as well as the records of the Orleans Parish Medical Society have been utilized. The narcotic clinic in Shreveport benefited from strong local support, while the New Orleans clinic faced a more vocal opposition. In addition, the Shreveport clinic offered a broad array of services and was a pillar of the community; the New Orleans clinic was newly established and offered fewer services. It was especially the influx of out-of-state addicts that angered many New Orleanians, many of whom witnessed the addicts lined up in the French Quarter. The effectiveness of the narcotic clinics in Louisiana (1919-23) was influenced by local opinion. The New Orleans clinic faced a tougher political climate than its counterpart in Shreveport, and therefore proved less resilient in the face of federal opposition. © 2017 Society for the Study of Addiction.

  8. Specialist nurses' perceptions of inviting patients to participate in clinical research studies: a qualitative descriptive study of barriers and facilitators.

    PubMed

    French, Caroline; Stavropoulou, Charitini

    2016-08-11

    Increasing the number of patients participating in research studies is a current priority in the National Health Service (NHS) in the United Kingdom. The role of specialist nurses in inviting patients to participate is important, yet little is known about their experiences of doing so. The aim of this study was to explore the perceptions of barriers and facilitators held by specialist nurses with experience of inviting adult NHS patients to a wide variety of research studies. A cross-sectional qualitative descriptive study was conducted between March and July 2015. Participants were 12 specialist nurses representing 7 different clinical specialties and 7 different NHS Trusts. We collected data using individual semi-structured interviews, and analysed transcripts using the Framework method to inductively gain a descriptive overview of barriers and facilitators. Barriers and facilitators were complex and interdependent. Perceptions varied among individuals, however barriers and facilitators centred on five main themes: i) assessing patient suitability, ii) teamwork, iii) valuing research, iv) the invitation process and v) understanding the study. Facilitators to inviting patients to participate in research often stemmed from specialist nurses' attitudes, skills and experience. Positive research cultures, effective teamwork and strong relationships between research and clinical teams at the local clinical team level were similarly important. Barriers were reported when specialist nurses felt they were providing patients with insufficient information during the invitation process, and when specialist nurses felt they did not understand studies to their satisfaction. Our study offers several new insights regarding the role of specialist nurses in recruiting patients for research. It shows that strong local research culture and teamwork overcome some wider organisational and workload barriers reported in previous studies. In addition, and in contrast to common practice

  9. Autologous temporomandibular joint reconstruction independent of exogenous additives: a proof-of-concept study for guided self-generation.

    PubMed

    Wei, Jiao; Herrler, Tanja; Han, Dong; Liu, Kai; Huang, Rulin; Guba, Markus; Dai, Chuanchang; Li, Qingfeng

    2016-11-28

    Joint defects are complex and difficult to reconstruct. By exploiting the body's own regenerative capacity, we aimed to individually generate anatomically precise neo-tissue constructs for autologous joint reconstruction without using any exogenous additives. In a goat model, CT scans of the mandibular condyle including articular surface and a large portion of the ascending ramus were processed using computer-aided design and manufacturing. A corresponding hydroxylapatite negative mold was printed in 3D and temporarily embedded into the transition zone of costal periosteum and perichondrium. A demineralized bone matrix scaffold implanted on the contralateral side served as control. Neo-tissue constructs obtained by guided self-generation exhibited accurate configuration, robust vascularization, biomechanical stability, and function. After autologous replacement surgery, the constructs showed stable results with similar anatomical, histological, and functional findings compared to native controls. Further studies are required to assess long-term outcome and possible extensions to other further applications. The absence of exogenous cells, growth factors, and scaffolds may facilitate clinical translation of this approach.

  10. Recommended practices for computerized clinical decision support and knowledge management in community settings: a qualitative study

    PubMed Central

    2012-01-01

    Background The purpose of this study was to identify recommended practices for computerized clinical decision support (CDS) development and implementation and for knowledge management (KM) processes in ambulatory clinics and community hospitals using commercial or locally developed systems in the U.S. Methods Guided by the Multiple Perspectives Framework, the authors conducted ethnographic field studies at two community hospitals and five ambulatory clinic organizations across the U.S. Using a Rapid Assessment Process, a multidisciplinary research team: gathered preliminary assessment data; conducted on-site interviews, observations, and field surveys; analyzed data using both template and grounded methods; and developed universal themes. A panel of experts produced recommended practices. Results The team identified ten themes related to CDS and KM. These include: 1) workflow; 2) knowledge management; 3) data as a foundation for CDS; 4) user computer interaction; 5) measurement and metrics; 6) governance; 7) translation for collaboration; 8) the meaning of CDS; 9) roles of special, essential people; and 10) communication, training, and support. Experts developed recommendations about each theme. The original Multiple Perspectives framework was modified to make explicit a new theoretical construct, that of Translational Interaction. Conclusions These ten themes represent areas that need attention if a clinic or community hospital plans to implement and successfully utilize CDS. In addition, they have implications for workforce education, research, and national-level policy development. The Translational Interaction construct could guide future applied informatics research endeavors. PMID:22333210

  11. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

    PubMed Central

    2011-01-01

    Background Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. Methods/design A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale), anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS); anxiety visual analog scale (VAS rating); depression (Center for Epidemiologic Studies Depression Scale), sexual functioning (Sexual Activity Questionnaire), sleep quality (Pittsburgh Sleep Quality Index) and cortisol. Discussion

  12. Evidenced-based review of clinical studies on periodontics.

    PubMed

    2009-08-01

    Periodontal diseases have several implications for the practice of endodontics. First, advanced periodontitis often has direct implications for the long-term prognosis of the case and requires careful evaluation and coordinated treatment of both the periodontic and endodontic diseases. Second, the potential for functional interactions between odontogenic pathoses and marginal periodontitis requires careful collection of clinical observations and monitoring the outcome of various treatments. In this section, we provide an analysis of recent clinical studies in this area.

  13. Evaluating Drugs and Food Additives for Public Use: A Case Studies Approach.

    ERIC Educational Resources Information Center

    Merritt, Sheridan V.

    1980-01-01

    Described is a case study used in an introductory college biology course that provides a basis for generating debate on an issue concerning the regulation of controversial food additives and prescription drugs. The case study contained within this article deals with drug screening, specifically with information related to thalidomide. (CS)

  14. Importance of population-based studies in clinical practice

    PubMed Central

    Ronnie, George; Ve, Ramesh Sathyamangalam; Velumuri, Lokapavani; Asokan, Rashima; Vijaya, Lingam

    2011-01-01

    In the last decade, there have been reports on the prevalence of glaucoma from the Vellore Eye Survey, Andhra Pradesh Eye Diseases Survey, Aravind Comprehensive Eye Survey, Chennai Glaucoma Study and West Bengal Glaucoma Study. Population-based studies provide important information regarding the prevalence and risk factors for glaucoma. They also highlight regional differences in the prevalence of various types of glaucoma. It is possible to gather important insights regarding the number of persons affected with glaucoma and the proportion with undiagnosed disease. We reviewed the different population-based studies from India and compare their findings. The lacunae in ophthalmic care that can be inferred from these studies are identified and possible reasons and solutions are discussed. We also discuss the clinical relevance of the various findings, and how it reflects on clinical practice in the country. Since India has a significantly high disease burden, we examine the possibility of population-based screening for disease in the Indian context. PMID:21150021

  15. Challenges in evaluating clinical governance systems in iran: a qualitative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-04-01

    In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

  16. Clinicians' experiences of becoming a clinical manager: a qualitative study.

    PubMed

    Spehar, Ivan; Frich, Jan C; Kjekshus, Lars Erik

    2012-11-22

    There has been an increased interest in recruiting health professionals with a clinical background to management positions in health care. We know little about the factors that influence individuals' decisions to engage in management. The aim of this study is to explore clinicians' journeys towards management positions in hospitals, in order to identify potential drivers and barriers to management recruitment and development. We did a qualitative study which included in-depth interviews with 30 clinicians in middle and first-line management positions in Norwegian hospitals. In addition, participant observation was conducted with 20 of the participants. The informants were recruited from medical and surgical departments, and most had professional backgrounds as medical doctors or nurses. Interviews were analyzed by systemic text condensation. We found that there were three phases in clinicians' journey into management; the development of leadership awareness, taking on the manager role and the experience of entering management. Participants' experiences suggest that there are different journeys into management, in which both external and internal pressure emerged as a recurrent theme. They had not anticipated a career in clinical management, and experienced that they had been persuaded to take the position. Being thrown into the position, without being sufficiently prepared for the task, was a common experience among participants. Being left to themselves, they had to learn management "on the fly". Some were frustrated in their role due to increasing administrative workloads, without being able to delegate work effectively. Path dependency and social pressure seems to influence clinicians' decisions to enter into management positions. Hospital organizations should formalize pathways into management, in order to identify, attract, and retain the most qualified talents. Top managers should make sure that necessary support functions are available locally, especially

  17. Clinicians’ experiences of becoming a clinical manager: a qualitative study

    PubMed Central

    2012-01-01

    Background There has been an increased interest in recruiting health professionals with a clinical background to management positions in health care. We know little about the factors that influence individuals’ decisions to engage in management. The aim of this study is to explore clinicians’ journeys towards management positions in hospitals, in order to identify potential drivers and barriers to management recruitment and development. Methods We did a qualitative study which included in-depth interviews with 30 clinicians in middle and first-line management positions in Norwegian hospitals. In addition, participant observation was conducted with 20 of the participants. The informants were recruited from medical and surgical departments, and most had professional backgrounds as medical doctors or nurses. Interviews were analyzed by systemic text condensation. Results We found that there were three phases in clinicians’ journey into management; the development of leadership awareness, taking on the manager role and the experience of entering management. Participants’ experiences suggest that there are different journeys into management, in which both external and internal pressure emerged as a recurrent theme. They had not anticipated a career in clinical management, and experienced that they had been persuaded to take the position. Being thrown into the position, without being sufficiently prepared for the task, was a common experience among participants. Being left to themselves, they had to learn management “on the fly”. Some were frustrated in their role due to increasing administrative workloads, without being able to delegate work effectively. Conclusions Path dependency and social pressure seems to influence clinicians’ decisions to enter into management positions. Hospital organizations should formalize pathways into management, in order to identify, attract, and retain the most qualified talents. Top managers should make sure that necessary

  18. Comparison of progressive addition lenses for general purpose and for computer vision: an office field study.

    PubMed

    Jaschinski, Wolfgang; König, Mirjam; Mekontso, Tiofil M; Ohlendorf, Arne; Welscher, Monique

    2015-05-01

    Two types of progressive addition lenses (PALs) were compared in an office field study: 1. General purpose PALs with continuous clear vision between infinity and near reading distances and 2. Computer vision PALs with a wider zone of clear vision at the monitor and in near vision but no clear distance vision. Twenty-three presbyopic participants wore each type of lens for two weeks in a double-masked four-week quasi-experimental procedure that included an adaptation phase (Weeks 1 and 2) and a test phase (Weeks 3 and 4). Questionnaires on visual and musculoskeletal conditions as well as preferences regarding the type of lenses were administered. After eight more weeks of free use of the spectacles, the preferences were assessed again. The ergonomic conditions were analysed from photographs. Head inclination when looking at the monitor was significantly lower by 2.3 degrees with the computer vision PALs than with the general purpose PALs. Vision at the monitor was judged significantly better with computer PALs, while distance vision was judged better with general purpose PALs; however, the reported advantage of computer vision PALs differed in extent between participants. Accordingly, 61 per cent of the participants preferred the computer vision PALs, when asked without information about lens design. After full information about lens characteristics and additional eight weeks of free spectacle use, 44 per cent preferred the computer vision PALs. On average, computer vision PALs were rated significantly better with respect to vision at the monitor during the experimental part of the study. In the final forced-choice ratings, approximately half of the participants preferred either the computer vision PAL or the general purpose PAL. Individual factors seem to play a role in this preference and in the rated advantage of computer vision PALs. © 2015 The Authors. Clinical and Experimental Optometry © 2015 Optometry Australia.

  19. Influence of study design on digital pathology image quality evaluation: the need to define a clinical task

    PubMed Central

    Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

    2017-01-01

    Abstract. Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors’ success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to

  20. Influence of study design on digital pathology image quality evaluation: the need to define a clinical task.

    PubMed

    Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

    2017-04-01

    Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors' success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria

  1. Expert views on clinical supervision: a study based on interviews.

    PubMed

    Severinsson, E I; Borgenhammar, E V

    1997-05-01

    Clinical supervision is a didactic process of the purpose of human development and maturity. The aim of this study is to analyse views on clinical supervision held by a number of experts, and to reflect on the effects and value of clinical supervision in relation to public health. Data were collected by interviews and analysed in accordance with the grounded theory construction model. The results showed that clinical supervision is an integration process guiding a person from 'novice to expert' by establishing a relationship of trust between supervisor and supervisee. This study indicates that implementation of systematic clinical supervision may positively affect quality of care, and patients' recovery, create improved feeling of confidence in one's work, and prevent burnout among staff. The negative aspects, as reported, were the possibility of high 'opportunity costs', e.g. the time loss for patient care by those participating in organized systematic supervision. On the other hand, clinical supervision contributes towards more efficient use of resources and hence avoids unnecessary costs. However, neither of these aspects were further elaborated on by the experts but clearly indicate an important field for further research.

  2. Clinical evaluation of watermarked medical images.

    PubMed

    Zain, Jasni M; Fauzi, Abdul M; Aziz, Azian A

    2006-01-01

    Digital watermarking medical images provides security to the images. The purpose of this study was to see whether digitally watermarked images changed clinical diagnoses when assessed by radiologists. We embedded 256 bits watermark to various medical images in the region of non-interest (RONI) and 480K bits in both region of interest (ROI) and RONI. Our results showed that watermarking medical images did not alter clinical diagnoses. In addition, there was no difference in image quality when visually assessed by the medical radiologists. We therefore concluded that digital watermarking medical images were safe in terms of preserving image quality for clinical purposes.

  3. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  4. Application of addition-cured silicone denture relining materials to adjust mouthguards.

    PubMed

    Fukasawa, Shintaro; Churei, Hiroshi; Chowdhury, Ruman Uddin; Shirako, Takahiro; Shahrin, Sharika; Shrestha, Abhishekhi; Wada, Takahiro; Uo, Motohiro; Takahashi, Hidekazu; Ueno, Toshiaki

    2016-01-01

    The purposes of this study were to examine the shock absorption capability of addition-cured silicone denture relining materials and the bonding strength of addition-cured silicone denture relining materials and a commercial mouthguard material to determine its applicability to mouthguard adjustment. Two addition-cured silicone denture relining materials and eleven commercial mouthguard materials were selected as test materials. The impact test was applied by a free-falling steel ball. On the other hand, bonding strength was determined by a delamination test. After prepared surface treatments using acrylic resin on MG sheet surface, 2 types of addition-cured silicone denture relining materials were glued to MG surface. The peak intensity, the time to peak intensity from the onset of the transmitted force and bonding strength were statistically analyzed using ANOVA and Tukey's honest significant difference post hoc test (p<0.05). These results suggest that the silicone denture relining materials could be clinically applicable as a mouthguard adjustment material.

  5. Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database

    PubMed Central

    Koeks, Zaïda; Bladen, Catherine L.; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E.; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I.; Roy, Anna J.; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C.; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C.; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A. Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V.; Martin, Ann S.; Peay, Holly L.; Kirschner, Jan; Flanigan, Kevin M.; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J.; Lochmüller, Hanns

    2017-01-01

    Background: Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. Objective: To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. Methods: In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Results: Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. Conclusions: This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field. PMID:29125504

  6. Clinical Outcomes in Duchenne Muscular Dystrophy: A Study of 5345 Patients from the TREAT-NMD DMD Global Database.

    PubMed

    Koeks, Zaïda; Bladen, Catherine L; Salgado, David; van Zwet, Erik; Pogoryelova, Oksana; McMacken, Grace; Monges, Soledad; Foncuberta, Maria E; Kekou, Kyriaki; Kosma, Konstantina; Dawkins, Hugh; Lamont, Leanne; Bellgard, Matthew I; Roy, Anna J; Chamova, Teodora; Guergueltcheva, Velina; Chan, Sophelia; Korngut, Lawrence; Campbell, Craig; Dai, Yi; Wang, Jen; Barišić, Nina; Brabec, Petr; Lähdetie, Jaana; Walter, Maggie C; Schreiber-Katz, Olivia; Karcagi, Veronika; Garami, Marta; Herczegfalvi, Agnes; Viswanathan, Venkatarman; Bayat, Farhad; Buccella, Filippo; Ferlini, Alessandra; Kimura, En; van den Bergen, Janneke C; Rodrigues, Miriam; Roxburgh, Richard; Lusakowska, Anna; Kostera-Pruszczyk, Anna; Santos, Rosário; Neagu, Elena; Artemieva, Svetlana; Rasic, Vedrana Milic; Vojinovic, Dina; Posada, Manuel; Bloetzer, Clemens; Klein, Andrea; Díaz-Manera, Jordi; Gallardo, Eduard; Karaduman, A Ayşe; Oznur, Tunca; Topaloğlu, Haluk; El Sherif, Rasha; Stringer, Angela; Shatillo, Andriy V; Martin, Ann S; Peay, Holly L; Kirschner, Jan; Flanigan, Kevin M; Straub, Volker; Bushby, Kate; Béroud, Christophe; Verschuuren, Jan J; Lochmüller, Hanns

    2017-01-01

    Recent short-term clinical trials in patients with Duchenne Muscular Dystrophy (DMD) have indicated greater disease variability in terms of progression than expected. In addition, as average life-expectancy increases, reliable data is required on clinical progression in the older DMD population. To determine the effects of corticosteroids on major clinical outcomes of DMD in a large multinational cohort of genetically confirmed DMD patients. In this cross-sectional study we analysed clinical data from 5345 genetically confirmed DMD patients from 31 countries held within the TREAT-NMD global DMD database. For analysis patients were categorised by corticosteroid background and further stratified by age. Loss of ambulation in non-steroid treated patients was 10 years and in corticosteroid treated patients 13 years old (p = 0.0001). Corticosteroid treated patients were less likely to need scoliosis surgery (p < 0.001) or ventilatory support (p < 0.001) and there was a mild cardioprotective effect of corticosteroids in the patient population aged 20 years and older (p = 0.0035). Patients with a single deletion of exon 45 showed an increased survival in contrast to other single exon deletions. This study provides data on clinical outcomes of DMD across many healthcare settings and including a sizeable cohort of older patients. Our data confirm the benefits of corticosteroid treatment on ambulation, need for scoliosis surgery, ventilation and, to a lesser extent, cardiomyopathy. This study underlines the importance of data collection via patient registries and the critical role of multi-centre collaboration in the rare disease field.

  7. Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

    PubMed

    Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

    2015-06-01

    National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

  8. Tribological study on rapeseed oil with nano-additives in close contact sliding situation

    NASA Astrophysics Data System (ADS)

    Gupta, Rajeev Nayan; Harsha, A. P.; Singh, Sagar

    2018-02-01

    The present work deals with the tribological evaluation of three types of nano-additives, i.e., copper oxide (CuO; ≈ 151.2 nm), cerium oxide (CeO2; ≈ 80 nm) and polytetrafluoroethylene (PTFE; ≈ 90.4 nm) with rapeseed oil under steel-steel sliding contacts. The nano-additives concentrations in the base oil were 0.1, 0.25 and 0.5% w/v for the lubricant formulation. Further, the rapeseed oil was also epoxidized by a chemical method and the tribological behavior was compared with the base oil (unmodified oil) at similar nano-additives concentrations. The ASTM standards were followed for the study of wear preventive and extreme-pressure analysis of nanolubricants, and it was carried out using four-ball tester. In the antiwear test, CeO2 and PTFE nano-additives have shown the significant reduction in the wear scar diameter at the concentration of 0.1% w/v. In the extreme-pressure test, 0.5% w/v concentration was optimum for oxide nanoparticles; however, PTFE nanoparticles did not show positive effect with both the base oils. Different characterization techniques were employed to confirm the oil modification and for the study of the worn surfaces.

  9. Clinical and Para Clinical Information Needs of Infertility Electronic Health Records in Iran: A Delphi Study.

    PubMed

    Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana

    2017-09-01

    infertility is referred to the person's inability to conceive pregnancy after one year of intercourse without using protection. This study paves the ground for creating a complete, united, and coherent source of patients' medical information. this is an applied research of descriptive-cross sectional type which has been carried out through qualitative - quantitative methods. The sample of the present study was 50 specialists in the field of infertility which has been chosen based on purposive sampling method. Designing the questionnaire was done based on library studies and Gathering experts' views was done based on Delphi technique. 261 items from clinical and Para clinical information of infertile patients' electronic health records were subjected to an opinion poll by experts. During this process 223 items were accepted and 38 items have been rejected after two sessions of surveys by infertility experts. Para clinical information section consisted of 57 items that all of them have been accepted by the experts. Also, clinical information section consisted of 242 items from which 204 items were accepted and 38 items were rejected by the experts. existence of a structured electronic record system of infertile patients' information leads to the integration of patients' information, improvement of health care services and a decrease in treatment costs: all working to increase information safety. Furthermore, only essential and relevant information would be provided for the specialists and it will facilitate and direct the future infertility related studies due to the coherence, unity and relevance of the information.

  10. Depression, social support, and clinical outcomes following lung transplantation: a single-center cohort study.

    PubMed

    Smith, Patrick J; Snyder, Laurie D; Palmer, Scott M; Hoffman, Benson M; Stonerock, Gregory L; Ingle, Krista K; Saulino, Caroline K; Blumenthal, James A

    2018-05-01

    Depressive symptoms are common among lung transplant candidates and have been associated with poorer clinical outcomes in some studies. Previous studies have been plagued by methodologic problems, including small sample sizes, few clinical events, and uncontrolled confounders, particularly perioperative complications. In addition, few studies have examined social support as a potential protective factor. We therefore examined the association between pretransplant depressive symptoms, social support, and mortality in a large sample of lung transplant recipients. As a secondary aim, we also examined the associations between psychosocial factors, perioperative outcomes [indexed by hospital length of stay (LOS)], and mortality. We hypothesized that depression would be associated with longer LOS and that the association between depression, social support, and mortality would be moderated by LOS. Participants included lung transplant recipients, transplanted at Duke University Medical Center from January 2009 to December 2014. Depressive symptoms were evaluated using the Beck Depression Inventory (BDI-II) and social support using the Perceived Social Support Scale (PSSS). Medical risk factors included forced vital capacity (FVC), partial pressure of carbon dioxide (PCO 2 ), donor age, acute rejection, and transplant type. Functional status was assessed using six-minute walk distance (6MWD). We also controlled for demographic factors, including age, gender, and native disease. Transplant hospitalization LOS was examined as a marker of perioperative clinical outcomes. Participants included 273 lung recipients (174 restrictive, 67 obstructive, 26 cystic fibrosis, and six "other"). Pretransplant depressive symptoms were common, with 56 participants (21%) exhibiting clinically elevated levels (BDI-II ≥ 14). Greater depressive symptoms were associated with longer LOS [adjusted b = 0.20 (2 days per 7-point higher BDI-II score), P < 0.01]. LOS moderated the associations

  11. Toward a Two-Dimensional Model of Social Cognition in Clinical Neuropsychology: A Systematic Review of Factor Structure Studies.

    PubMed

    Etchepare, Aurore; Prouteau, Antoinette

    2018-04-01

    Social cognition has received growing interest in many conditions in recent years. However, this construct still suffers from a considerable lack of consensus, especially regarding the dimensions to be studied and the resulting methodology of clinical assessment. Our review aims to clarify the distinctiveness of the dimensions of social cognition. Based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements, a systematic review was conducted to explore the factor structure of social cognition in the adult general and clinical populations. The initial search provided 441 articles published between January 1982 and March 2017. Eleven studies were included, all conducted in psychiatric populations and/or healthy participants. Most studies were in favor of a two-factor solution. Four studies drew a distinction between low-level (e.g., facial emotion/prosody recognition) and high-level (e.g., theory of mind) information processing. Four others reported a distinction between affective (e.g., facial emotion/prosody recognition) and cognitive (e.g., false beliefs) information processing. Interestingly, attributional style was frequently reported as an additional separate factor of social cognition. Results of factor analyses add further support for the relevance of models differentiating level of information processing (low- vs. high-level) from nature of processed information (affective vs. cognitive). These results add to a significant body of empirical evidence from developmental, clinical research and neuroimaging studies. We argue the relevance of integrating low- versus high-level processing with affective and cognitive processing in a two-dimensional model of social cognition that would be useful for future research and clinical practice. (JINS, 2018, 24, 391-404).

  12. Characteristics of student preparedness for clinical learning: clinical educator perspectives using the Delphi approach

    PubMed Central

    2012-01-01

    Background During clinical placements, clinical educators facilitate student learning. Previous research has defined the skills, attitudes and practices that pertain to an ideal clinical educator. However, less attention has been paid to the role of student readiness in terms of foundational knowledge and attitudes at the commencement of practice education. Therefore, the aim of this study was to ascertain clinical educators’ views on the characteristics that they perceive demonstrate that a student is well prepared for clinical learning. Methods A two round on-line Delphi study was conducted. The first questionnaire was emailed to a total of 636 expert clinical educators from the disciplines of occupational therapy, physiotherapy and speech pathology. Expert clinical educators were asked to describe the key characteristics that indicate a student is prepared for a clinical placement and ready to learn. Open-ended responses received from the first round were subject to a thematic analysis and resulted in six themes with 62 characteristics. In the second round, participants were asked to rate each characteristic on a 7 point Likert Scale. Results A total of 258 (40.56%) responded to the first round of the Delphi survey while 161 clinical educators completed the second (62.40% retention rate). Consensus was reached on 57 characteristics (six themes) using a cut off of greater than 70% positive respondents and an interquartile deviation IQD of equal or less than 1. Conclusions This study identified 57 characteristics (six themes) perceived by clinical educators as indicators of a student who is prepared and ready for clinical learning. A list of characteristics relating to behaviours has been compiled and could be provided to students to aid their preparation for clinical learning and to universities to incorporate within curricula. In addition, the list provides a platform for discussions by professional bodies about the role of placement education. PMID:23145840

  13. Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

    PubMed Central

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

  14. [Laboratory and clinical study of intravenous miconazole].

    PubMed

    Sawae, Y; Okada, K; Kumagai, Y

    1987-02-01

    Laboratory and clinical study was carried out on miconazole (MCZ), a new synthetic imidazole. The antifungal activity of MCZ was studied and expressed as MICs for clinical isolates. The drug proved to have the highest activity against Cryptococcus neoformans, with MICs of no more than 0.16 micrograms/ml for all isolates of this species. MICs of Torulopsis glabrata were 0.08-5 micrograms/ml for all isolates and those of Candida albicans and Candida tropicalis were 5-20 micrograms/ml for more than 90% of the isolates. Most of other strains were less than 10 micrograms/ml. When 3 healthy adult men were administered each with 200 mg of MCZ by intravenous drip infusion for 1.25 hours, the mean serum MCZ concentration was 1.39 micrograms/ml at the end of the infusion, then decreased rapidly to 0.49 microgram/ml in following 30 minutes, and then decreased gradually to 0.17 microgram/ml 6 hours later. The mean cumulative urinary excretion rate of the drug was as low as 3.0% at this stage. A total of 25 patients with ages of 30-78 years, comprising 17 men and 8 women, were treated with 200-1,800 mg of MCZ daily for 3-93 days. The clinical effectiveness was ascertained in 19 cases among the patients; 9 cases with candidiasis, 3 with cryptococcosis and 7 with aspergillosis. Clinical responses were excellent in 2, good in 9 and poor in 8 cases, and its efficacy rates was 58%. The efficacy rate of the combination therapy with other antifungal agents was 60% in comparison with 57% of MCZ alone. Adverse reactions to the drug such as nausea, vomiting and anorexia were observed in 3 cases (12%). Abnormal changes in laboratory parameters were also observed: 3 patients with elevations of GOT and GPT, and another with eosinophilia.

  15. Enrichment of clinical study populations.

    PubMed

    Temple, R

    2010-12-01

    Those who conduct clinical trials "enrich" study populations in a variety of ways in order to identify a population of patients in whom a drug effect, if present, is more likely to be demonstrable. The principal ways to do this are as follows: (i) practical enrichment, i.e., generally seeking to reduce noise (variability of measurement) and heterogeneity (by avoiding the enrollment of patients with other diseases and individuals in whom the disease disappears spontaneously), (ii) prognostic enrichment, i.e., finding patients who are likely to have the event of interest when enrolling for risk-reduction studies, and (iii) predictive enrichment, i.e., finding the individuals who are more likely to respond. Enrichment fits well into the growing interest in "individualization" of therapy but creates some tension with another trend, namely, the desire for "real-world studies" with less restrictive entry criteria and other requirements.

  16. Recommendations for Planning Pilot Studies in Clinical and Translational Research

    PubMed Central

    Moore, Charity G.; Carter, Rickey E.; Nietert, Paul J.; Stewart, Paul W.

    2011-01-01

    Abstract  Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase “pilot study” is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well‐designed pilot studies play in the advancement of science and scientific careers. Clin Trans Sci 2011; Volume 4: 332–337 PMID:22029804

  17. Adjunctive Effects of A Piscean Collagen-Based Controlled-Release Chlorhexidine Chip in the Treatment of Chronic Periodontitis: A Clinical and Microbiological Study

    PubMed Central

    John, Priya; Lazarus, Flemingson; Selvam, Arul; Prabhuji, Munivenkatappa Lakshmaiah Venkatesh

    2015-01-01

    Introduction PerioChip a bovine origin gelatine based CHX chip has shown beneficial effects in the management of Chronic Periodontitis. A new fish collagen based CHX chip similar to PerioChip is currently available; however this product has not been thoroughly researched. Aim The aim of the present study was to evaluate the effectiveness of a new Piscean collagen-based controlled-release chlorhexidine chip (CHX chip) as an adjunctive therapy to scaling and root planing (SRP). Settings and Design The study was conducted as a randomised, split-mouth, controlled clinical trial at Krishnadevaraya College of Dental Sciences, Bangalore, India. Materials and Methods In a split–mouth study involving 20 sites in 10 patients with chronic periodontitis, control sites received scaling and root planing and test sites received scaling and root planing (SRP) and the intrapocket CHX chip placement as an adjunct. Subgingival plaque samples were collected from both control and test sites at baseline, 11 days and 11 weeks and the anaerobic colony count were assessed. Clinical parameters that were recorded at baseline and 11 weeks were gingival index, Plaque index, Probing pocket depth (PPD), and Clinical attachment level (CAL). Plaque index was recorded additionally at 11 days. Results In the test group there was a statistically significant reduction in the total anaerobic colony count, gingival index and plaque scores from baseline as compared to control sites at all time intervals. An additional 0.8mm reduction in mean probing pocket depth was noted in the test group. Gain in Clinical attachment level was comparable in both groups. Conclusion The adjunctive use of the new collagen-based CHX chip yielded significant antimicrobial benefit accompanied by a reduction in probing depth and a clinical attachment level gain as compared to SRP alone. This suggests that it may be a useful treatment option of nonsurgical periodontal treatment of chronic periodontitis. PMID:26155567

  18. Prospective study of POLG mutations presenting in children with intractable epilepsy: prevalence and clinical features.

    PubMed

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-06-01

    To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. If any of the three tested mutations were found, all the exons and the exon-intron boundaries of the POLG gene were sequenced. In addition, we retrospectively reviewed the notes of patients presenting with intractable epilepsy in which we had found POLG mutations. All available clinical data were collected by questionnaire and by reviewing the medical records. We analyzed 213 blood DNA samples from patients fulfilling the inclusion criteria of the prospective study. Among these, five patients (2.3%) were found with one of the three common POLG mutations as homozygous or compound heterozygous states. In addition, three patients were retrospectively identified. Seven of the eight patients had either raised cerebrospinal fluid (CSF) lactate (n = 3) or brain magnetic resonance imaging (MRI) changes (n = 4) at presentation with intractable epilepsy. Three patients later developed liver dysfunction, progressing to fatal liver failure in two without previous treatment with sodium valproate (VPA). Furthermore, it is worth mentioning that one patient presented first with an autism spectrum disorder before seizures emerged. Mutations in POLG are an important cause of early and juvenile onset nonsyndromic intractable epilepsy with highly variable associated manifestations including autistic features. This study emphasizes that genetic testing for POLG mutations in patients with nonsyndromic intractable epilepsies is very important for clinical diagnostics, genetic counseling, and treatment decisions

  19. Prospective study of POLG mutations presenting in children with intractable epilepsy: Prevalence and clinical features

    PubMed Central

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-01-01

    Purpose To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Methods Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. If any of the three tested mutations were found, all the exons and the exon–intron boundaries of the POLG gene were sequenced. In addition, we retrospectively reviewed the notes of patients presenting with intractable epilepsy in which we had found POLG mutations. All available clinical data were collected by questionnaire and by reviewing the medical records. Key Findings We analyzed 213 blood DNA samples from patients fulfilling the inclusion criteria of the prospective study. Among these, five patients (2.3%) were found with one of the three common POLG mutations as homozygous or compound heterozygous states. In addition, three patients were retrospectively identified. Seven of the eight patients had either raised cerebrospinal fluid (CSF) lactate (n = 3) or brain magnetic resonance imaging (MRI) changes (n = 4) at presentation with intractable epilepsy. Three patients later developed liver dysfunction, progressing to fatal liver failure in two without previous treatment with sodium valproate (VPA). Furthermore, it is worth mentioning that one patient presented first with an autism spectrum disorder before seizures emerged. Significance Mutations in POLG are an important cause of early and juvenile onset nonsyndromic intractable epilepsy with highly variable associated manifestations including autistic features. This study emphasizes that genetic testing for POLG mutations in patients with nonsyndromic intractable epilepsies is very important for clinical diagnostics

  20. Mitochondrial dysfunction in myocardium obtained from clinically normal dogs, clinically normal anesthetized dogs, and dogs with dilated cardiomyopathy.

    PubMed

    Sleeper, Meg M; Rosato, Bradley P; Bansal, Seema; Avadhani, Narayan G

    2012-11-01

    To compare mitochondrial complex I and complex IV activity in myocardial mitochondria of clinically normal dogs, clinically normal dogs exposed to inhalation anesthesia, and dogs affected with dilated cardiomyopathy. Myocardial samples obtained from 21 euthanized dogs (6 clinically normal [control] dogs, 5 clinically normal dogs subjected to inhalation anesthesia with isoflurane prior to euthanasia, 5 dogs with juvenile-onset dilated cardiomyopathy, and 5 dogs with adult-onset dilated cardiomyopathy). Activity of mitochondrial complex I and complex IV was assayed spectrophotometrically in isolated mitochondria from left ventricular tissue obtained from the 4 groups of dogs. Activity of complex I and complex IV was significantly decreased in anesthetized dogs, compared with activities in the control dogs and dogs with juvenile-onset or adult-onset dilated cardiomyopathy. Inhalation anesthesia disrupted the electron transport chain in the dogs, which potentially led to an outburst of reactive oxygen species that caused mitochondrial dysfunction. Inhalation anesthesia depressed mitochondrial function in dogs, similar to results reported in other species. This effect is important to consider when anesthetizing animals with myocardial disease and suggested that antioxidant treatments may be beneficial in some animals. Additionally, this effect should be considered when designing studies in which mitochondrial enzyme activity will be measured. Additional studies that include a larger number of animals are warranted.

  1. Poikiloderma of Civatte: a clinical and epidemiological study.

    PubMed

    Katoulis, A C; Stavrianeas, N G; Georgala, S; Bozi, E; Kalogeromitros, D; Koumantaki, E; Katsambas, A D

    2005-07-01

    Although a common dermatosis, idiopathic poikiloderma of the face and neck has not been studied in depth for decades. To reassess the clinical and epidemiological characteristics of poikiloderma of Civatte (PC). Fifty consecutive patients with PC. Evaluation included history taking and physical examination. Epidemiological and clinical parameters were recorded and analysed. The literature from 1923 until today, was reviewed thoroughly. The frequency of PC among dermatologic patients was estimated to be 1.4%. There were 34 females (68%) and 16 males in the present study. The mean age at diagnosis was 47.8 years for females and 61.7 years for males. The majority (88%) had skin phototype II or III. Among females, 26 were at their peri-menopausal stage, including three cases of iatrogenic menopause. Four patients reported that other blood-related family members also had PC. The v and the sides of the neck and the upper chest were most often affected in a symmetric distribution. The face (preauricular and parotid region) was involved in 19 patients (38%). The erythemato-telangiectatic clinical type predominated (58%), followed by the mixed (22%) and the pigmented type (20%). Almost half of the patients (46%) were symptomatic (itching, burning and 'flushing'). The mean duration from onset to diagnosis was 6.2 years according to the patients' report. The course was usually slowly progressive (82%) and irreversible. PC shows characteristic features, supporting the theory that it represents a distinct entity. It is rather common in Greece. Although menopausal women predominated in our cohort, men were not uncommonly affected and were diagnosed at an older age. Based on the predominating clinical feature, PC can be classified into three clinical forms. Symmetry and sparing of the anatomically shaded areas of the neck are highly characteristic for PC. Face involvement was not as common and as severe as it had been considered in the past. Recognition of clinical type is

  2. A longitudinal study of clinical peer review's impact on quality and safety in U.S. hospitals.

    PubMed

    Edwards, Marc T

    2013-01-01

    Clinical peer review is the dominant method of event analysis in U.S. hospitals. It is pivotal to medical staff efforts to improve quality and safety, yet the quality assurance process model that has prevailed for the past 30 years evokes fear and is fundamentally antithetical to a culture of safety. Two prior national studies characterized a quality improvement model that corrects this dysfunction but failed to demonstrate progress toward its adoption despite a high rate of program change between 2007 and 2009. This study's online survey of 470 organizations participating in either of the prior studies further assessed relationships between clinical peer review program factors, including the degree of conformance to the quality improvement model (the QI model score), and subjectively measured program impact variables. Among the 300 hospitals (64%) that responded, the median QI model score was only 60 on a 100-point scale. Scores increased somewhat for the 2007 cohort (mean pair-wise difference of 5.9 [2-10]), but not for the 2009 cohort. The QI model is expanded as the result of the finding that self-reporting of adverse events, near misses, and hazardous conditions--an essential practice in high-reliability organizations--is no longer rare in hospitals. Self-reporting and the quality of case review are additional multivariate predictors of the perceived ongoing impact of clinical peer review on quality and safety, medical staff perceptions of the program, and medical staff engagement in quality and safety initiatives. Hospital leaders and trustees who seek to improve patient outcomes should facilitate the adoption of this best practice model for clinical peer review.

  3. [Clinical studies on flomoxef in neonates].

    PubMed

    Tabuki, K; Nishimura, T

    1993-07-01

    Clinical studies on flomoxef (FMOX) were performed in neonates and the results obtained are summarized as follows. Treatment with FMOX was made in 4 cases of neonatal bacterial infections; 2 cases of sepsis (suspected) and 1 case each of infection of umbilicus and staphylococcal scalded skin syndrome. Results obtained were excellent in 1 case, good in 3 cases. No significant side effects due to the drug were observed in any cases.

  4. Pre-clinical and Clinical Safety Studies of CMX-2043: A Cytoprotective Lipoic Acid Analogue for Ischaemia–Reperfusion Injury

    PubMed Central

    Kates, Steven A; Lader, Alan S; Casale, Ralph; Beeuwkes, Reinier

    2014-01-01

    CMX-2043 is an α-lipoic acid analogue targeted to reduction of cellular injury and organ damage due to ischaemia–reperfusion injury (IRI). It has been shown to be effective in a rat model of cardiac IRI. The studies here reported evaluate its safety and pharmacokinetic profile in preparation for human clinical studies in procedures associated with IRI. Safety and tolerability were tested in standard pre-clinical in vitro and animal models and in a Phase 1 human clinical trial. CMX-2043 did not bind to a wide range of receptors and specific targets at approximately 4 μg/mL (10 μM). It was not mutagenic by Ames assay, did not produce chromosome aberrations in Chinese hamster ovary (CHO) cells, and was negative for clastogenic potential. Toxicological studies in rats including both single and 14-day repeat intravenous doses and in dogs (single intravenous dose) with a 2-week recovery period were conducted. The NOAEL in rats and dogs was 30 and >10 mg/kg, respectively. No serious adverse events were reported in a placebo-controlled, sequential dose escalation Phase 1 clinical trial. The low toxicity in the pre-clinical studies and the absence of adverse events in the Phase 1 trial have supported investigation of CMX-2043 in a human efficacy trial. PMID:24751172

  5. Temporal and geographical external validation study and extension of the Mayo Clinic prediction model to predict eGFR in the younger population of Swiss ADPKD patients.

    PubMed

    Girardat-Rotar, Laura; Braun, Julia; Puhan, Milo A; Abraham, Alison G; Serra, Andreas L

    2017-07-17

    Prediction models in autosomal dominant polycystic kidney disease (ADPKD) are useful in clinical settings to identify patients with greater risk of a rapid disease progression in whom a treatment may have more benefits than harms. Mayo Clinic investigators developed a risk prediction tool for ADPKD patients using a single kidney value. Our aim was to perform an independent geographical and temporal external validation as well as evaluate the potential for improving the predictive performance by including additional information on total kidney volume. We used data from the on-going Swiss ADPKD study from 2006 to 2016. The main analysis included a sample size of 214 patients with Typical ADPKD (Class 1). We evaluated the Mayo Clinic model performance calibration and discrimination in our external sample and assessed whether predictive performance could be improved through the addition of subsequent kidney volume measurements beyond the baseline assessment. The calibration of both versions of the Mayo Clinic prediction model using continuous Height adjusted total kidney volume (HtTKV) and using risk subclasses was good, with R 2 of 78% and 70%, respectively. Accuracy was also good with 91.5% and 88.7% of the predicted within 30% of the observed, respectively. Additional information regarding kidney volume did not substantially improve the model performance. The Mayo Clinic prediction models are generalizable to other clinical settings and provide an accurate tool based on available predictors to identify patients at high risk for rapid disease progression.

  6. Using Theater to Teach Clinical Empathy: A Pilot Study

    PubMed Central

    Leong, David; Anderson, Aaron; Wenzel, Richard P.

    2007-01-01

    Background Clinical empathy, a critical skill for the doctor–patient relationship, is infrequently taught in graduate medical education. No study has tested if clinical empathy can be taught effectively. Objective To assess whether medicine residents can learn clinical empathy techniques from theater professors. Design A controlled trial of a clinical empathy curriculum taught and assessed by 4 theater professors. Setting Virginia Commonwealth University, Richmond, Virginia, a large urban university and health system. Participants Twenty Internal Medicine residents: 14 in the intervention group, 6 in the control group. Intervention Six hours of classroom instruction and workshop time with professors of theater. Measurements Scores derived from an instrument with 6 subscores designed to measure empathy in real-time patient encounters. Baseline comparisons were made using two-sample T tests. A mixed-effects analysis of variance model was applied to test for significance between the control and intervention groups. Results The intervention group demonstrated significant improvement (p ≤ .011) across all 6 subscores between pre-intervention and post-intervention observations. Compared to the control group, the intervention group had better posttest scores in 5 of 6 subscores (p ≤ .01). Limitations The study was neither randomized nor blinded. Conclusions Collaborative efforts between the departments of theater and medicine are effective in teaching clinical empathy techniques. PMID:17486385

  7. Learning a Language and Studying Content in an Additional Language: Student Opinions

    ERIC Educational Resources Information Center

    Ger, Ugur; Bahar, Mustafa

    2018-01-01

    This study aims to understand the opinions of middle school and high school students about language learning and studying other content in an additional language in the school settings where English is used as the medium of instruction to teach more than 50% of the curriculum. For this end, 261 students from three different schools were…

  8. Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites

    PubMed Central

    Prosperi, Christine; Baggett, Henry C.; Brooks, W. Abdullah; Deloria Knoll, Maria; Hammitt, Laura L.; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; O’Brien, Katherine L.; Thea, Donald M.; Awori, Juliet O.; Bunthi, Charatdao; DeLuca, Andrea N.; Driscoll, Amanda J.; Ebruke, Bernard E.; Goswami, Doli; Hidgon, Melissa M.; Karron, Ruth A.; Kazungu, Sidi; Kourouma, Nana; Mackenzie, Grant; Moore, David P.; Mudau, Azwifari; Mwale, Magdalene; Nahar, Kamrun; Park, Daniel E.; Piralam, Barameht; Seidenberg, Phil; Sylla, Mamadou; Feikin, Daniel R.; Scott, J. Anthony G.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey

    2017-01-01

    Abstract Background. Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study. Methods. Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. Results. MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62–0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills. Conclusions. Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection. PMID:28575355

  9. Retrospective cohort study of the clinical performance of 1-stage dental implants.

    PubMed

    Carr, Alan B; Choi, Yong-Geun; Eckert, Steven E; Desjardins, Ronald P

    2003-01-01

    To evaluate long-term clinical performance of 1-stage dental implant prostheses at a single clinic, emphasizing clinical and demographic characteristics that affect implant survival. Dental records of all 308 patients (674 implants) treated with 1-stage implants at Mayo Clinic from October 1993 through May 2000 were reviewed from implant placement to last visit. Exposure and outcome variables affecting performance were collected separately to control bias in the data collection process. Additional confounding factors (age and sex) were adjusted with the stratified Cox proportional hazards model. Implant survival was determined by means of a Kaplan-Meier survival estimate. The log-rank test was used to determine the role of clinical and demographic variables in implant survival. The relative risk associated with the possible effect of clinical and demographic variables on implant survival was estimated with the Cox proportional hazards model. The implant survival rate (n = 654 implants) was 97% (mean +/- SD follow-up, 21.0 +/- 18.8 months; range, 1 to 78 months). Performance bias was limited because nearly all patients were treated by 1 prosthodontist. Two implants failed after loading (6 and 9 months). The incidence of complications was less than 4%. Among the implant failures, use of heterogeneous bone graft was associated with 4.8 times more failures than was use of autogenous bone graft (P = .04). After augmentation, delaying implant placement for 5 to 6 months resulted in 8.6 times more failures than the rate after earlier placement (P < .001). Retrospective review of the clinical performance of a 1-stage dental implant system yielded a 97% survival rate, with no failures noted after 13 months. Prosthetic complications were low, especially for fixed implant prostheses. Clinical performance of 1-stage dental implant prostheses between 1993 and 2000 demonstrated a high level of predictability.

  10. Clinical simulation training improves the clinical performance of Chinese medical students

    PubMed Central

    Zhang, Ming-ya; Cheng, Xin; Xu, An-ding; Luo, Liang-ping; Yang, Xuesong

    2015-01-01

    Background Modern medical education promotes medical students’ clinical operating capacity rather than the mastery of theoretical knowledge. To accomplish this objective, clinical skill training using various simulations was introduced into medical education to cultivate creativity and develop the practical ability of students. However, quantitative analysis of the efficiency of clinical skill training with simulations is lacking. Methods In the present study, we compared the mean scores of medical students (Jinan University) who graduated in 2013 and 2014 on 16 stations between traditional training (control) and simulative training groups. In addition, in a clinical skill competition, the objective structured clinical examination (OSCE) scores of participating medical students trained using traditional and simulative training were compared. The data were statistically analyzed and qualitatively described. Results The results revealed that simulative training could significantly enhance the graduate score of medical students compared with the control. The OSCE scores of participating medical students in the clinical skill competition, trained using simulations, were dramatically higher than those of students trained through traditional methods, and we also observed that the OSCE marks were significantly increased for the same participant after simulative training for the clinical skill competition. Conclusions Taken together, these data indicate that clinical skill training with a variety of simulations could substantially promote the clinical performance of medical students and optimize the resources used for medical education, although a precise analysis of each specialization is needed in the future. PMID:26478142

  11. Integration of preclinical and clinical knowledge to predict intravenous PK in human: bilastine case study.

    PubMed

    Vozmediano, Valvanera; Ortega, Ignacio; Lukas, John C; Gonzalo, Ana; Rodriguez, Monica; Lucero, Maria Luisa

    2014-03-01

    Modern pharmacometrics can integrate and leverage all prior proprietary and public knowledge. Such methods can be used to scale across species or comparators, perform clinical trial simulation across alternative designs, confirm hypothesis and potentially reduce development burden, time and costs. Crucial yet typically lacking in integration is the pre-clinical stage. Prediction of PK in man, using in vitro and in vivo studies in different animal species, is increasingly well theorized but could still find wider application in drug development. The aim of the present work was to explore methods for bridging pharmacokinetic knowledge from animal species (i.v. and p.o.) and man (p.o.) into i.v. in man using the antihistamine drug bilastine as example. A model, predictive of i.v. PK in man, was developed on data from two pre-clinical species (rat and dog) and p.o. in man bilastine trials performed earlier. In the knowledge application stage, two different approaches were used to predict human plasma concentration after i.v. of bilastine: allometry (several scaling methods) and a semi-physiological method. Both approaches led to successful predictions of key i.v. PK parameters of bilastine in man. The predictive i.v. PK model was validated using later data from a clinical study of i.v. bilastine. Introduction of such knowledge in development permits proper leveraging of all emergent knowledge as well as quantification-based exploration of PK scenario, e.g. in special populations (pediatrics, renal insufficiency, comedication). In addition, the methods permit reduction or elimination and certainly optimization of learning trials, particularly those concerning alternative off-label administration routes.

  12. Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

    PubMed

    Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

    2016-07-01

    A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

  13. Poor relation between biomechanical and clinical studies for the proximal femoral locking compression plate

    PubMed Central

    Viberg, Bjarke; Rasmussen, Katrine M V; Overgaard, Søren; Rogmark, Cecilia

    2017-01-01

    Background and purpose The proximal femur locking compression plate (PF-LCP) is a new concept in the treatment of hip fractures. When releasing new implants onto the market, biomechanical studies are conducted to evaluate performance of the implant. We investigated the relation between biomechanical and clinical studies on PF-LCP. Methods A systematic literature search of relevant biomechanical and clinical studies was conducted in PubMed on December 1, 2015. 7 biomechanical studies and 15 clinical studies were included. Results Even though the biomechanical studies showed equivalent or higher failure loads for femoral neck fracture, the clinical results were far worse, with a 37% complication rate. There were no biomechanical studies on pertrochanteric fractures. Biomechanical studies on subtrochanteric fractures showed that PF-LCP had a lower failure load than with proximal femoral nail, but higher than with angled blade plate. 4 clinical studies had complication rates less than 8% and 9 studies had complication rates between 15% and 53%. Interpretation There was no clear relation between biomechanical and clinical studies. Biomechanical studies are generally inherently different from clinical studies, as they examine the best possible theoretical use of the implant without considering the long-term outcome in a clinical setting. Properly designed clinical studies are mandatory when introducing new implants, and they cannot be replaced by biomechanical studies. PMID:28287002

  14. Risk factors of flare in rheumatoid arthritis patients with both clinical and ultrasonographic remission: a retrospective study from China.

    PubMed

    Han, Jingjing; Geng, Yan; Deng, Xuerong; Zhang, Zhuoli

    2017-08-01

    Ultrasonographic remission in addition to clinical remission is probably becoming a new target in the treatment of rheumatoid arthritis. The current study aimed to investigate the risk factors of flare in RA patients who achieved both clinical and ultrasonographic remission. RA patients fulfilled both clinical remission and ultrasonographic remissions were retrospectively enrolled in this study. Baseline clinical, laboratory, and ultrasonographic data were collected. Durations of clinical remission before enrollment and medication strategy during follow-up were recorded. Differences between the flare and the non-flare group were analyzed. Risk factors of flare were assessed with univariate and multivariate Cox proportional hazards models. One hundred and twenty-one RA patients were included. Forty-eight patients relapsed during a median follow-up period of 12.3 months. The flare group had higher percentage of females, shorter duration of clinical remission before enrollment, higher baseline ESR and DAS28 (ESR), and lower baseline gray scale score. Univariate Cox regression revealed female, short duration of remission, high DAS28 (ESR), and failure to achieve 2010 ACR/EULAR remission criteria were risk factors of flare. Furthermore, multivariate analysis showed short duration of remission was the only independent risk factor of flare (HR 0.93, 95% CI 0.88-0.98, P = 0.007). One more month in duration of remission led to a reduction in flare of 7.3%. Short duration of remission at baseline could be an independent risk factor of flare in RA patients who achieved both clinical and ultrasonographic remission, which implicates the significance of sustained remission in the prognosis of RA patients.

  15. Quantification of Treatment Effect Modification on Both an Additive and Multiplicative Scale

    PubMed Central

    Girerd, Nicolas; Rabilloud, Muriel; Pibarot, Philippe; Mathieu, Patrick; Roy, Pascal

    2016-01-01

    Background In both observational and randomized studies, associations with overall survival are by and large assessed on a multiplicative scale using the Cox model. However, clinicians and clinical researchers have an ardent interest in assessing absolute benefit associated with treatments. In older patients, some studies have reported lower relative treatment effect, which might translate into similar or even greater absolute treatment effect given their high baseline hazard for clinical events. Methods The effect of treatment and the effect modification of treatment were respectively assessed using a multiplicative and an additive hazard model in an analysis adjusted for propensity score in the context of coronary surgery. Results The multiplicative model yielded a lower relative hazard reduction with bilateral internal thoracic artery grafting in older patients (Hazard ratio for interaction/year = 1.03, 95%CI: 1.00 to 1.06, p = 0.05) whereas the additive model reported a similar absolute hazard reduction with increasing age (Delta for interaction/year = 0.10, 95%CI: -0.27 to 0.46, p = 0.61). The number needed to treat derived from the propensity score-adjusted multiplicative model was remarkably similar at the end of the follow-up in patients aged < = 60 and in patients >70. Conclusions The present example demonstrates that a lower treatment effect in older patients on a relative scale can conversely translate into a similar treatment effect on an additive scale due to large baseline hazard differences. Importantly, absolute risk reduction, either crude or adjusted, can be calculated from multiplicative survival models. We advocate for a wider use of the absolute scale, especially using additive hazard models, to assess treatment effect and treatment effect modification. PMID:27045168

  16. Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective, randomized, multicenter study.

    PubMed

    Kamiya, K; Nakanishi, M; Ishii, R; Kobashi, H; Igarashi, A; Sato, N; Shimizu, K

    2012-10-01

    To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome. This study evaluated 64 eyes of 32 patients (age: 62.6±12.8 years (mean±SD)) in whom treatment with 0.1% sodium hyaluronate was insufficiently responsive. The eyes were randomly assigned to one of the two regimens in each patient: topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye, and that of sodium hyaluronate in the other. Before treatment, and 2 and 4 weeks after treatment, we determined tear volume, tear film break-up time (BUT), fluorescein and rose bengal vital staining scores, subjective symptoms, and adverse events. We found a significant improvement in BUT (P=0.049, Dunnett test), fluorescein and rose bengal staining scores (P=0.02), and in subjective symptoms (P=0.004 for dry eye sensation, P=0.02 for pain, and P=0.02 for foreign body sensation) 4 weeks after treatment in the diquafosol eyes. On the other hand, we found no significant change in these parameters after treatment in the control eyes. In dry eyes, where sodium hyaluronate monotherapy was insufficient, diquafosol tetrasodium was effective in improving objective and subjective symptoms, suggesting its viability as an option for the additive treatment of such eyes.

  17. Utility of an Equine Clinical Skills Course: A Pilot Study.

    PubMed

    Christensen, Bruce W; Danielson, Jared A

    Recent publications have revealed inadequacies in the veterinary training of future equine practitioners. To help address this problem, a 2-week Equine Clinical Skills course was designed and implemented to provide fourth-year veterinary students with opportunities to have hands-on experience with common equine clinical skills using live animals and cadavers. Alumni and employers of alumni were surveyed to determine whether or not students participating in the course were more competent performing clinical skills during their first year post-graduation than those who had not participated in the course. Students who participated in the course were also surveyed before and after completing the course to determine whether or not their self-assessed skills improved during the course. Alumni who had taken the course rated their ability to perform the clinical skills more highly than alumni who had not taken the course. Similarly, students participating in the course indicated that they were significantly more able to perform the clinical skills after the course than when it began. Employers did not indicate a difference between the clinical skills of those who had taken the course and those who had not. Because this study involved a limited number of respondents from one institution, further studies should be conducted to replicate these findings and determine their generalizability.

  18. [Clinical study of bladder injury].

    PubMed

    Abe, Kazuhiro; Oishi, Yukihiko; Onodera, Syoichi; Ikemoto, Isao; Kiyota, Hiroshi; Asano, Koji; Ueda, Masataka; Wada, Tetsuro; Tashiro, Kazuya

    2002-03-01

    Since bladder injury has no specific clinical symptoms, accurate diagnosis at first consultation is relatively difficult. To elucidate the clinical characters type of injury, clinical symptoms, laboratory findings, methods of therapy and diagnosis, we reviewed 15 patients with bladder injury over a 9-year-period 1990-1998 (10 were traumatic injuries and 5 spontaneous injuries). We found no specific clinical symptom of bladder injury. Bladder injury may occur anywhere in the bladder wall, but most commonly occurred at the dome of the bladder (60.0%). Gross hematuria was not seen in 40.0% of the cases. The accuracy of diagnosis at first consultation was relatively low (46.7%) and the tendency to make a misdiagnosis as acute abdomen on digestive organs was found. Of the traumatic injuries 60% were afflicted in the drunken state, so alcohol intoxication was considered as an important enviromental factor of bladder injury. Surgical repair of injury sites was employed in 11 cases (73.3%: 7 were intraperitoneal injuries, 4 were extraperitoneal injuries), 4 cases were managed with indwelling urethral catheter. With appropriate treatment, the prognosis is excellent.

  19. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

    PubMed Central

    2013-01-01

    Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

  20. The politics of nursing: a case study--clinical grading.

    PubMed

    Gavin, J N

    1995-08-01

    This paper is a study of the clinical grading policy for nurses in the United Kingdom and the extent to which the participating groups in the policy development process realized their objectives. The study is based on the literature available at the time of the research and the results of structured interviews with a range of individuals involved in the policy process. The results expose the cleavages between the different representative groups on the staff side. They also shed light on the differing power bases of the groups involved. In particular, they expose the weakness of nursing as a professional pressure group and the strength of the state and its agents in determining the outcomes of policy in the public arena. It is suggested that this weakness vis-à-vis the state is responsible for the failure of nurses to achieve a reward system which recognizes the value of clinical nursing expertise, and that the 'clinical grading' system, in practice, is having the opposite effect. The policy is explored from its origins, its acceptance on to the political agenda, its negotiation and agreement, its contentious implementation, the final outcomes, and its failure to establish a valid 'clinical' pay structure.

  1. Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial

    PubMed Central

    2011-01-01

    Background Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. Methods/Design This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months. Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. Discussion To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. Trial registration ClinicalTrials NCT01039337 PMID:21542914

  2. Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: protocol for a three-armed randomized clinical trial.

    PubMed

    Poulsen, Erik; Christensen, Henrik W; Roos, Ewa M; Vach, Werner; Overgaard, Søren; Hartvigsen, Jan

    2011-05-04

    Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. ClinicalTrials NCT01039337.

  3. Nutritional clinical studies in dermatology.

    PubMed

    Liakou, Aikaterini I; Theodorakis, Michael J; Melnik, Bodo C; Pappas, Apostolos; Zouboulis, Christos C

    2013-10-01

    Nutrition has long been associated with skin health, beauty, integrity and aging through multiple pathways and cofactors implicated in skin biology. The onset and clinical course of various common skin diseases, especially acne, psoriasis, atopic dermatitis, and hair loss, have been suggested to be critically affected by nutrition patterns and habits. The relationship between acne and diet, predominantly the role of high glycemic load diets and dairy consumption have recently gained increased interest. Abnormal nutritional conditions such as obesity or malnutrition often manifest themselves by specific cutaneous features and altered skin function. Skin photoprotection, rendered by various nutrients, is well documented and appropriate nutritional supplementation has been shown to exert beneficial effects upon impaired skin integrity, restore its appearance and promote skin health. It is our intention to provide a comprehensive review of the most recent information on the role of nutrition for common skin diseases and regulation of skin biology. Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin". The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.

  4. Midwifery students' experiences of learning clinical skills in Iran: a qualitative study.

    PubMed

    Ahmadi, Golnoosh; Shahriari, Mohsen; Keyvanara, Mahmood; Kohan, Shahnaz

    2018-03-09

    A qualitative study was used. Midwifery students from three universities in Iran participated. The study used a convenience sample of eighteen students. Data for this study was collected using semi-structured interviews (N=12) and focus groups (N=6). Data were recorded on a digital audio recorder and then transcribed. The qualitative data were analyzed using a content analysis approach. Six broad themes emerged from the analysis: Limited opportunities to experience skills, difficulties with course plan gaps, need for creating a supportive clinical environment, learning drives, confusion between different methods, and stress in the clinical setting. Short verbatim quotations from the participants were presented to provide evidence for the interpretation of data. The findings of this study have provided a clear picture of the factors and mechanisms involved in learning clinical skills by midwifery students. This study showed that students had some difficulties and concerns during learning of clinical midwifery skills. The findings of this study suggest that midwifery educators conduct further studies to tackle these issues in clinical skills learning. The findings of this study are subject to some limitations which are discussed.

  5. How 3 rural safety net clinics integrate care for patients: a qualitative case study.

    PubMed

    Derrett, Sarah; Gunter, Kathryn E; Nocon, Robert S; Quinn, Michael T; Coleman, Katie; Daniel, Donna M; Wagner, Edward H; Chin, Marshall H

    2014-11-01

    Integrated care focuses on care coordination and patient centeredness. Integrated care supports continuity of care over time, with care that is coordinated within and between settings and is responsive to patients' needs. Currently, little is known about care integration for rural patients. To examine challenges to care integration in rural safety net clinics and strategies to address these challenges. Qualitative case study. Thirty-six providers and staff from 3 rural clinics in the Safety Net Medical Home Initiative. Interviews were analyzed using the framework method with themes organized within 3 constructs: Team Coordination and Empanelment, External Coordination and Partnerships, and Patient-centered and Community-centered Care. Participants described challenges common to safety net clinics, including limited access to specialists for Medicaid and uninsured patients, difficulty communicating with external providers, and payment models with limited support for care integration activities. Rurality compounded these challenges. Respondents reported benefits of empanelment and team-based care, and leveraged local resources to support care for patients. Rural clinics diversified roles within teams, shared responsibility for patient care, and colocated providers, as strategies to support care integration. Care integration was supported by 2 fundamental changes to organize and deliver care to patients-(1) empanelment with a designated group of patients being cared for by a provider; and (2) a multidisciplinary team able to address rural issues. New funding and organizational initiatives of the Affordable Care Act may help to further improve care integration, although additional solutions may be necessary to address particular needs of rural communities.

  6. Feline leprosy due to Candidatus 'Mycobacterium lepraefelis': Further clinical and molecular characterisation of eight previously reported cases and an additional 30 cases.

    PubMed

    O'Brien, Carolyn R; Malik, Richard; Globan, Maria; Reppas, George; McCowan, Christina; Fyfe, Janet A

    2017-09-01

    This paper, the last in a series of three on 'feline leprosy', provides a detailed description of disease referable to the previously unnamed species, Candidatus 'Mycobacterium lepraefelis', a close relative of the human pathogens Mycobacterium leprae and Mycobacterium lepromatosis. Cases were sourced retrospectively and prospectively for this observational study, describing clinical, geographical and molecular microbiological data for cats definitively diagnosed with Candidatus 'M lepraefelis' infection. A total of 145 cases of feline leprosy were scrutinised; 114 'new' cases were sourced from the Victorian Infectious Diseases Reference Laboratory (VIDRL) records, veterinary pathology laboratories or veterinarians, and 31 cases were derived from six published studies. Thirty-eight cats were definitively diagnosed with Candidatus 'M lepraefelis' infection. Typically, cats tended to be middle-aged or older when first infected, with a male predilection. Affected cats typically had widespread cutaneous lesions, in some cases after initially localised disease. Advanced cases were often systemically unwell. All cats had outdoor access. The histological picture was lepromatous in the majority of patients, although two cases had tuberculoid disease. In one case that underwent necropsy, lesions were evident in the liver, spleen and lungs. Treatment was varied, although most cats received a combination of oral clarithromycin and rifampicin. Prognosis for recovery was variable, but typically poor. Candidatus 'M lepraefelis' typically causes high bacterial index (lepromatous) feline leprosy that in some cases progresses to systemic mycobacteriosis. The disease has a variable clinical course and prognosis. Many cases either died or were euthanased due to the infection. Multilocus sequence analysis reveals a heterogeneous picture and further analysis of draft genome sequencing may give clues to the taxonomy and epidemiology of this organism. Prospective treatment trials and

  7. Thinking through postoperative cognitive dysfunction: How to bridge the gap between clinical and pre-clinical perspectives.

    PubMed

    Hovens, Iris B; Schoemaker, Regien G; van der Zee, Eddy A; Heineman, Erik; Izaks, Gerbrand J; van Leeuwen, Barbara L

    2012-10-01

    Following surgery, patients may experience cognitive decline, which can seriously reduce quality of life. This postoperative cognitive dysfunction (POCD) is mainly seen in the elderly and is thought to be mediated by surgery-induced inflammatory reactions. Clinical studies tend to define POCD as a persisting, generalised decline in cognition, without specifying which cognitive functions are impaired. Pre-clinical research mainly describes early hippocampal dysfunction as a consequence of surgery-induced neuroinflammation. These different approaches to study POCD impede translation between clinical and pre-clinical research outcomes and may hamper the development of appropriate interventions. This article analyses which cognitive domains deteriorate after surgery and which brain areas might be involved. The most important outcomes are: (1) POCD encompasses a wide range of cognitive impairments; (2) POCD affects larger areas of the brain; and (3) individual variation in the vulnerability of neuronal networks to neuroinflammatory mechanisms may determine if and how POCD manifests itself. We argue that, for pre-clinical and clinical research of POCD to advance, the effects of surgery on various cognitive functions and brain areas should be studied. Moreover, in addition to general characteristics, research should take inter-relationships between cognitive complaints and physical and mental characteristics into account. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Three-dimensional ultrasound for prenatal assessment of conjoined twins: additional advantages?

    PubMed

    Wataganara, Tuangsit; Ruangvutilert, Pornpimol; Sunsaneevithayakul, Prasert; Russameecharoen, Kusol; Nawapun, Katika; Phithakwatchara, Nisarat

    2017-08-28

    Conjoined twins are a rare, but serious, complication of monozygotic twins. Early prenatal diagnosis of conjoined twins is increasingly made with transvaginal ultrasound and color Doppler studies. Most prenatally diagnosed conjoined twins are terminated due to the high perinatal mortality, but advancement in pediatric surgery has allowed for successful postnatal separation in a small number of cases, and some parents may consider this option over termination of pregnancy. It is important to get a detailed prenatal ultrasound for the site and extent of fusion for an accurate categorization. Three-dimensional ultrasound (3DUS) provides images that can facilitate counselling for the parents. Additional information that impacts on diagnosis, prognostication, and perinatal management of conjoined twins could be obtained from selective use of 3DUS, particularly those with atypical fetal union. Most of the proposed additional benefits of 3DUS are based on case reports. Magnetic resonance imaging (MRI) has been increasingly used for the purpose of identifying intricate organ sharing. Because of the rarity of this condition, and the heterogeneity of fetal fusion, added benefits of either 3DUS or MRI for prenatal diagnosis and perinatal management of conjoined twins have not been demonstrated by well-conducted clinical trials. This article aims to review clinical application of various 3DUS display modes in prenatal assessment of conjoined twins, focusing on their potential additional benefits, risks and misuses. 3DUS may help detecting additional findings that are not possible with 2DUS, but, it has not been scientifically shown to improve the survival rate of the twins or reduce maternal morbidity.

  9. Targeted hepatic sonography during clinic visits for detection of fatty liver in overweight children: a pilot study.

    PubMed

    Perito, Emily R; Tsai, Patrika M; Hawley, Sarah; Lustig, Robert H; Feldstein, Vickie A

    2013-04-01

    The purpose of this study was to assess the feasibility and utility of targeted hepatic sonography to evaluate for hepatic steatosis during a subspecialty clinic visit. In this pilot study, we performed targeted hepatic sonography on 25 overweight children aged 7 to 17 years consecutively seen in a pediatric obesity clinic. Long-axis images of the right lobe of the liver and a split-screen image of liver and spleen were taken. Images were interpreted in real time by the radiologist and shown to the family. Demographics, clinical measurements, and laboratory parameters were also collected from the specialty clinic visit on the same day. Sonography required a median of 4 minutes during the visit (interquartile range, 3-5 minutes). All consented patients completed the study. The median alanine aminotransferase (ALT) level was 23 U/L in those with no steatosis (n = 14), 26 U/L with mild steatosis (n = 6), and 41 U/L with moderate/marked steatosis (n = 5). Children with ALT levels of 25 to 50 U/L had very variable sonographic measures of hepatic steatosis. When the participants were categorized by the overall degree of fatty liver, hepatic steatosis was significantly associated with the aspartate aminotransferase level (P = .028), ALT level (P = .003), and diastolic blood pressure (P = .05) but did not correlate with age, sex, Latino race, or insulin resistance. Targeted hepatic sonography added information not apparent from routine ALT screening and provided immediate feedback to clinicians and families about the effect of obesity on end organs. This examination could be a feasible, informative addition to screening for children at high risk for nonalcoholic fatty liver disease who are seen in clinics that specialize in obesity.

  10. The psychopharmacology of aggressive behavior: a translational approach: part 2: clinical studies using atypical antipsychotics, anticonvulsants, and lithium.

    PubMed

    Comai, Stefano; Tau, Michael; Pavlovic, Zoran; Gobbi, Gabriella

    2012-04-01

    Patients experiencing mental disorders are at an elevated risk for developing aggressive behavior. In the past 10 years, the psychopharmacological treatment of aggression has changed dramatically owing to the introduction of atypical antipsychotics on the market and the increased use of anticonvulsants and lithium in the treatment of aggressive patients.This review (second of 2 parts) uses a translational medicine approach to examine the neurobiology of aggression, discussing the major neurotransmitter systems implicated in its pathogenesis (serotonin, glutamate, norepinephrine, dopamine, and γ-aminobutyric acid) and the neuropharmacological rationale for using atypical antipsychotics, anticonvulsants, and lithium in the therapeutics of aggressive behavior. A critical review of all clinical trials using atypical antipsychotics (aripiprazole, clozapine, loxapine, olanzapine, quetiapine, risperidone, ziprasidone, and amisulpride), anticonvulsants (topiramate, valproate, lamotrigine, and gabapentin), and lithium are presented. Given the complex, multifaceted nature of aggression, a multifunctional combined therapy, targeting different receptors, seems to be the best strategy for treating aggressive behavior. This therapeutic strategy is supported by translational studies and a few human studies, even if additional randomized, double-blind, clinical trials are needed to confirm the clinical efficacy of this framework.

  11. Iranian Clinical Nurses’ Activities for Self-Directed Learning: A Qualitative Study

    PubMed Central

    Ghiyasvandian, Shahrzad; Malekian, Morteza; Cheraghi, Mohammad Ali

    2016-01-01

    Background: Clinical nurses need lifelong learning skills for responding to the rapid changes of clinical settings. One of the best strategies for lifelong learning is self-directed learning. The aim of this study was to explore Iranian clinical nurses’ activities for self-directed learning. Methods: In this qualitative study, 23 semi-structured personal interviews were conducted with nineteen clinical nurses working in all four hospitals affiliated to Isfahan Social Security Organization, Isfahan, Iran. Study data were analyzed by using the content analysis approach. The study was conducted from June 2013 to October 2014. Findings: Study participants’ activities for self-directed learning fell into two main categories of striving for knowledge acquisition and striving for skill development. The main theme of the study was ‘Revising personal performance based on intellectual-experiential activities’. Conclusions: Study findings suggest that Iranian clinical nurses continually revise their personal performance by performing self-directed intellectual and experiential activities to acquire expertise. The process of acquiring expertise is a linear process which includes two key steps of knowledge acquisition and knowledge development. In order to acquire and advance their knowledge, nurses perform mental learning activities such as sensory perception, self-evaluation, and suspended judgment step-by-step. Moreover, they develop their skills through doing activities like apprenticeship, masterly performance, and self-regulation. The absolute prerequisite to expertise acquisition is that a nurse needs to follow these two steps in a sequential manner. PMID:26652072

  12. A Preliminary Study of Clinical Abbreviation Disambiguation in Real Time.

    PubMed

    Wu, Y; Denny, J C; Rosenbloom, S T; Miller, R A; Giuse, D A; Song, M; Xu, H

    2015-01-01

    To save time, healthcare providers frequently use abbreviations while authoring clinical documents. Nevertheless, abbreviations that authors deem unambiguous often confuse other readers, including clinicians, patients, and natural language processing (NLP) systems. Most current clinical NLP systems "post-process" notes long after clinicians enter them into electronic health record systems (EHRs). Such post-processing cannot guarantee 100% accuracy in abbreviation identification and disambiguation, since multiple alternative interpretations exist. Authors describe a prototype system for real-time Clinical Abbreviation Recognition and Disambiguation (rCARD) - i.e., a system that interacts with authors during note generation to verify correct abbreviation senses. The rCARD system design anticipates future integration with web-based clinical documentation systems to improve quality of healthcare records. When clinicians enter documents, rCARD will automatically recognize each abbreviation. For abbreviations with multiple possible senses, rCARD will show a ranked list of possible meanings with the best predicted sense at the top. The prototype application embodies three word sense disambiguation (WSD) methods to predict the correct senses of abbreviations. We then conducted three experments to evaluate rCARD, including 1) a performance evaluation of different WSD methods; 2) a time evaluation of real-time WSD methods; and 3) a user study of typing clinical sentences with abbreviations using rCARD. Using 4,721 sentences containing 25 commonly observed, highly ambiguous clinical abbreviations, our evaluation showed that the best profile-based method implemented in rCARD achieved a reasonable WSD accuracy of 88.8% (comparable to SVM - 89.5%) and the cost of time for the different WSD methods are also acceptable (ranging from 0.630 to 1.649 milliseconds within the same network). The preliminary user study also showed that the extra time costs by rCARD were about 5% of total

  13. Conducting feasibilities in clinical trials: an investment to ensure a good study.

    PubMed

    Rajadhyaksha, Viraj

    2010-07-01

    Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  14. American Association for Clinical Chemistry

    MedlinePlus

    ... did not need additional cardiac testing. Read the study LAB TESTS ONLINE USPSTF Updates Draft Recommendations on Cervical Cancer ... to follow colleagues and receive updates when they post in a forum, as well as enhanced email and messaging tools. Search ... AACC Programs and Partners Lab Tests Online Harmonization.net Commission on Accreditation in Clinical ...

  15. A Multi-center Milestone Study of Clinical Vertebral CT Segmentation

    PubMed Central

    Yao, Jianhua; Burns, Joseph E.; Forsberg, Daniel; Seitel, Alexander; Rasoulian, Abtin; Abolmaesumi, Purang; Hammernik, Kerstin; Urschler, Martin; Ibragimov, Bulat; Korez, Robert; Vrtovec, Tomaž; Castro-Mateos, Isaac; Pozo, Jose M.; Frangi, Alejandro F.; Summers, Ronald M.; Li, Shuo

    2017-01-01

    A multiple center milestone study of clinical vertebra segmentation is presented in this paper. Vertebra segmentation is a fundamental step for spinal image analysis and intervention. The first half of the study was conducted in the spine segmentation challenge in 2014 International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI) Workshop on Computational Spine Imaging (CSI 2014). The objective was to evaluate the performance of several state-of-the-art vertebra segmentation algorithms on computed tomography (CT) scans using ten training and five testing dataset, all healthy cases; the second half of the study was conducted after the challenge, where additional 5 abnormal cases are used for testing to evaluate the performance under abnormal cases. Dice coefficients and absolute surface distances were used as evaluation metrics. Segmentation of each vertebra as a single geometric unit, as well as separate segmentation of vertebra substructures, was evaluated. Five teams participated in the comparative study. The top performers in the study achieved Dice coefficient of 0.93 in the upper thoracic, 0.95 in the lower thoracic and 0.96 in the lumbar spine for healthy cases, and 0.88 in the upper thoracic, 0.89 in the lower thoracic and 0.92 in the lumbar spine for osteoporotic and fractured cases. The strengths and weaknesses of each method as well as future suggestion for improvement are discussed. This is the first multi-center comparative study for vertebra segmentation methods, which will provide an up-to-date performance milestone for the fast growing spinal image analysis and intervention. PMID:26878138

  16. Voluntary attendance of small-group brainstorming tutoring courses intensify new clerk's "excellence in clinical care": a pilot study.

    PubMed

    Yang, Ling-Yu; Huang, Chia-Chang; Hsu, Hui-Chi; Yang, Ying-Ying; Chang, Ching-Chi; Chuang, Chiao-Lin; Lee, Wei-Shin; Liang, Jen-Feng; Cheng, Hao Min; Huang, Chin-Chou; Lee, Fa-Yauh; Ho, Shung-Tai; Kirby, Ralph

    2017-01-06

    Clerkship provides a unique way of transferring the knowledge and skills gathered during medical school's curriculum into real-ward clinical care environment. The annual program evaluation has indicated that the training of clerks in diagnostic and clinical reasoning skills needed to be enhanced. Recently, "clinical excellence" program have been promoted in our institution to augment the excellence in clinical care of new clerks. Current study aims to evaluate whether this pilot program improve the "clinical excellence" of new clerks. In a pilot study, groups of new clerks in years 2013 and 2014 voluntarily attended either a small-group brainstorming course or a didactic classroom tutoring courses as part of their 3-month internal medicine clinical rotation block. A third group of new clerks did not join either of the above courses and this group served as the control group. Pre-block/post-block self-assessment and post-block 5-station mini-Objective Subjective Clinical Examinations (OSCEs) were used to evaluate the effectiveness of these two additional courses that trained diagnostic and clinical reasoning skills. Overtime, the percentages of new clerks that attended voluntarily either the small-group brainstorming or classroom tutoring courses were increased. Higher post-block self-assessed diagnostic and clinical reasoning skill scores were found among individuals who attended the small-group brainstorming courses compared to either the didactic group or the control group. In a corresponding manner, the small-group brainstorming group obtained higher summary OSCE diag and OSCE reason scores than either the didactic group or control group. For all basic images/laboratory OSCE stations, the individual diagnostic skill (OSCE diag ) scores of the small-group brainstorming group were higher than those of the didactic group. By way of contrast, only the clinical reasoning skill (OSCE reason ) scores of the basic electrocardiogram and complete blood count

  17. Cortical Thickness and Anxiety Symptoms Among Cognitively Normal Elderly Persons: The Mayo Clinic Study of Aging.

    PubMed

    Pink, Anna; Przybelski, Scott A; Krell-Roesch, Janina; Stokin, Gorazd B; Roberts, Rosebud O; Mielke, Michelle M; Spangehl, Kathleen A; Knopman, David S; Jack, Clifford R; Petersen, Ronald C; Geda, Yonas E

    2017-01-01

    The authors conducted a cross-sectional study to investigate the association between anxiety symptoms and cortical thickness, as well as amygdalar volume. A total of 1,505 cognitively normal participants, aged ≥70 years, were recruited from the Mayo Clinic Study of Aging in Olmsted County, Minnesota, on whom Beck Anxiety Inventory and 3T brain MRI data were available. Even though the effect sizes were small in this community-dwelling group of participants, anxiety symptoms were associated with reduced global cortical thickness and reduced thickness within the frontal and temporal cortex. However, after additionally adjusting for comorbid depressive symptoms, only the association between anxiety symptoms and reduced insular thickness remained significant.

  18. A systematic review of clinical supervision evaluation studies in nursing.

    PubMed

    Cutcliffe, John R; Sloan, Graham; Bashaw, Marie

    2018-02-15

    According to the international, extant literature published during the last 20 years or so, clinical supervision (CS) in nursing is now a reasonably common phenomenon. Nevertheless, what appears to be noticeably 'thin on the ground' in this body of literature are empirical evaluations of CS, especially those pertaining to client outcomes. Accordingly, the authors undertook a systematic review of empirical evaluations of CS in nursing to determine the state of the science. Adopting the approach documented by Stroup et al. (JAMA, 283, 2000, 2008), the authors searched for reports of evaluation studies of CS in nursing - published during the years 1995 to 2015. Keywords for the search were 'clinical supervision', 'evaluation', 'efficacy', 'nursing', and combinations of these keywords. Electronic databases used were CINAHL, MEDLINE, PsychLIT, and the British Nursing Index. The research evidence from twenty-eight (28) studies reviewed is presented, outlining the main findings with an overview of each study presented. The following broad themes were identified and are each discussed in the study: narrative/anecdotal accounts of positive outcomes for clinical supervision, narrative/anecdotal accounts of negative outcomes for clinical supervision, empirical positive outcomes reported by supervisee, and empirical findings showing no effect by supervisee. © 2018 Australian College of Mental Health Nurses Inc.

  19. Clinical and experimental study of TMJ distraction: preliminary results.

    PubMed

    Festa, F; Galluccio, G

    1998-01-01

    A physiotherapeutic approach, with manual maneuvers and/or distraction appliances, is indicated in the treatment of temporomandibular joint disorders (TMDs) to prevent the progressive fibrosis of the muscle fibers. In this article, the authors report preliminary results of experimental and clinical studies conducted to assess the real effect of distraction in temporomandibular joint disorders. The experimental invivo studies confirmed the structural alteration due to compression and distraction on the capsular and condylar tissues. Clinical cases are reported to show the increase of the intraarticular vertical dimension, with a forward and downward movement of the condyles in a more physiologic condition.

  20. Examining the proportion of dietary phosphorus from plants, animals and food additives excreted in urine

    PubMed Central

    St-Jules, David E; Jagannathan, Ram; Gutekunst, Lisa; Kalantar-Zadeh, Kamyar; Sevick, Mary Ann

    2016-01-01

    Phosphorus bioavailability is an emerging topic of interest in the field of renal nutrition that has important research and clinical implications. Estimates of phosphorus bioavailability, based on digestibility, indicate that bioavailability of phosphorus increases from plants to animals to food additives. In this commentary, we examined the proportion of dietary phosphorus from plants, animals and food additives excreted in urine from four controlled feeding studies conducted in healthy adults and patients with chronic kidney disease. As expected, a smaller proportion of phosphorus from plant foods was excreted in urine compared to animal foods. However, contrary to expectations, phosphorus from food additives appeared to be incompletely absorbed. The apparent discrepancy between digestibility of phosphorus additives and the proportion excreted in urine suggests a need for human balance studies to determine the bioavailability of different sources of phosphorus. PMID:27810171

  1. Primary healthcare provider knowledge, beliefs and clinic-based practices regarding alternative tobacco products and marijuana: a qualitative study

    PubMed Central

    Bascombe, Ta Misha S.; Scott, Kimberly N.; Ballard, Denise; Smith, Samantha A.; Thompson, Winifred; Berg, Carla J.

    2016-01-01

    Use prevalence of alternative tobacco products and marijuana has increased dramatically. Unfortunately, clinical guidelines have focused on traditional cigarettes with limited attention regarding these emerging public health issues. Thus, it is critical to understand how healthcare professionals view this issue and are responding to it. This qualitative study explored knowledge, beliefs and clinic-based practices regarding traditional and alternative tobacco products (cigar-like products, smokeless tobacco, hookah, e-cigarettes) and marijuana among rural and urban Georgia primary healthcare providers. The sample comprised 20 healthcare providers in primary care settings located in the Atlanta Metropolitan area and rural southern Georgia who participated in semi-structured interviews. Results indicated a lack of knowledge about these products, with some believing that some products were less harmful than traditional cigarettes or that they may be effective in promoting cessation or harm reduction. Few reported explicitly assessing use of these various products in clinic. In addition, healthcare providers reported a need for empirical evidence to inform their clinical practice. Healthcare providers must systematically assess use of the range of tobacco products and marijuana. Evidence-based recommendations or information sources are needed to inform clinical practice and help providers navigate conversations with patients using or inquiring about these products. PMID:26802106

  2. Physician’ entrepreneurship explained: a case study of intra-organizational dynamics in Dutch hospitals and specialty clinics

    PubMed Central

    2014-01-01

    Background Challenges brought about by developments such as continuing market reforms and budget reductions have strained the relation between managers and physicians in hospitals. By applying neo-institutional theory, we research how intra-organizational dynamics between physicians and managers induce physicians to become entrepreneurs by starting a specialty clinic. In addition, we determine the nature of this change by analyzing the intra-organizational dynamics in both hospitals and clinics. Methods For our research, we interviewed a total of fifteen physicians and eight managers in four hospitals and twelve physicians and seven managers in twelve specialty clinics. Results We found evidence that in becoming entrepreneurs, physicians are influenced by intra-organizational dynamics, including power dependence, interest dissatisfaction, and value commitments, between physicians and managers as well as among physicians’ groups. The precise motivation for starting a new clinic can vary depending on the medical or business logic in which the entrepreneurs are embedded, but also the presence of an entrepreneurial nature or nurture. Finally we found that the entrepreneurial process of starting a specialty clinic is a process of sedimented change or hybridized professionalism in which elements of the business logic are added to the existing logic of medical professionalism, leading to a hybrid logic. Conclusions These findings have implications for policy at both the national and hospital level. Shared ownership and aligned incentives may provide the additional cement in which the developing entrepreneurial values are ‘glued’ to the central medical logic. PMID:24885912

  3. Physician' entrepreneurship explained: a case study of intra-organizational dynamics in Dutch hospitals and specialty clinics.

    PubMed

    Koelewijn, Wout T; de Rover, Matthijs; Ehrenhard, Michel L; van Harten, Wim H

    2014-05-19

    Challenges brought about by developments such as continuing market reforms and budget reductions have strained the relation between managers and physicians in hospitals. By applying neo-institutional theory, we research how intra-organizational dynamics between physicians and managers induce physicians to become entrepreneurs by starting a specialty clinic. In addition, we determine the nature of this change by analyzing the intra-organizational dynamics in both hospitals and clinics. For our research, we interviewed a total of fifteen physicians and eight managers in four hospitals and twelve physicians and seven managers in twelve specialty clinics. We found evidence that in becoming entrepreneurs, physicians are influenced by intra-organizational dynamics, including power dependence, interest dissatisfaction, and value commitments, between physicians and managers as well as among physicians' groups. The precise motivation for starting a new clinic can vary depending on the medical or business logic in which the entrepreneurs are embedded, but also the presence of an entrepreneurial nature or nurture. Finally we found that the entrepreneurial process of starting a specialty clinic is a process of sedimented change or hybridized professionalism in which elements of the business logic are added to the existing logic of medical professionalism, leading to a hybrid logic. These findings have implications for policy at both the national and hospital level. Shared ownership and aligned incentives may provide the additional cement in which the developing entrepreneurial values are 'glued' to the central medical logic.

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

    PubMed

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

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

  5. Annual impact of scribes on physician productivity and revenue in a cardiology clinic

    PubMed Central

    Bank, Alan J; Gage, Ryan M

    2015-01-01

    Objective Scribes are increasingly being used in clinics to assist physicians with documentation during patient care. The annual effect of scribes in a real-world clinic on physician productivity and revenue has not been evaluated. Methods We performed a retrospective study comparing the productivity during routine clinic visits of ten cardiologists using scribes vs 15 cardiologists without scribes. We tracked patients per hour and patients per year seen per physician. Average direct revenue (clinic visit) and downstream revenue (cardiovascular revenue in the 2 months following a clinic visit) were measured in 486 patients and used to calculate annual revenue generated as a result of increased productivity. Results Physicians with scribes saw 955 new and 4,830 follow-up patients vs 1,318 new and 7,150 follow-up patients seen by physicians without scribes. Physicians with scribes saw 9.6% more patients per hour (2.50±0.27 vs 2.28±0.15, P<0.001). This improved productivity resulted in 84 additional new and 423 additional follow-up patients seen, 3,029 additional work relative value units (wRVUs) generated, and an increased cardiovascular revenue of $1,348,437. Physicians with scribes also generated an additional revenue of $24,257 by producing clinic notes that were coded at a higher level. Total additional revenue generated was $1,372,694 at a cost of $98,588 for the scribes. Conclusion Physician productivity in a cardiology clinic was ∼10% higher for physicians using scribes. This improved productivity resulted in 84 additional new and 423 additional follow-up patients seen in 1 year. The use of scribes resulted in the generation of 3,029 additional wRVUs and an additional annual revenue of $1,372,694 at a cost of $98,588. PMID:26457055

  6. Annual impact of scribes on physician productivity and revenue in a cardiology clinic.

    PubMed

    Bank, Alan J; Gage, Ryan M

    2015-01-01

    Scribes are increasingly being used in clinics to assist physicians with documentation during patient care. The annual effect of scribes in a real-world clinic on physician productivity and revenue has not been evaluated. We performed a retrospective study comparing the productivity during routine clinic visits of ten cardiologists using scribes vs 15 cardiologists without scribes. We tracked patients per hour and patients per year seen per physician. Average direct revenue (clinic visit) and downstream revenue (cardiovascular revenue in the 2 months following a clinic visit) were measured in 486 patients and used to calculate annual revenue generated as a result of increased productivity. Physicians with scribes saw 955 new and 4,830 follow-up patients vs 1,318 new and 7,150 follow-up patients seen by physicians without scribes. Physicians with scribes saw 9.6% more patients per hour (2.50±0.27 vs 2.28±0.15, P<0.001). This improved productivity resulted in 84 additional new and 423 additional follow-up patients seen, 3,029 additional work relative value units (wRVUs) generated, and an increased cardiovascular revenue of $1,348,437. Physicians with scribes also generated an additional revenue of $24,257 by producing clinic notes that were coded at a higher level. Total additional revenue generated was $1,372,694 at a cost of $98,588 for the scribes. Physician productivity in a cardiology clinic was ∼10% higher for physicians using scribes. This improved productivity resulted in 84 additional new and 423 additional follow-up patients seen in 1 year. The use of scribes resulted in the generation of 3,029 additional wRVUs and an additional annual revenue of $1,372,694 at a cost of $98,588.

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

    ERIC Educational Resources Information Center

    Birch, Herbert G.; And Others

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

  8. The wish to hasten death: a review of clinical studies.

    PubMed

    Monforte-Royo, Cristina; Villavicencio-Chávez, Christian; Tomás-Sábado, Joaquín; Balaguer, Albert

    2011-08-01

    It is common for patients who are faced with physical or psychological suffering, particularly those in the advanced stages of a disease, to have some kind of wish to hasten death (WTHD). This paper reviews and summarises the current state of knowledge about the WTHD among people with end-stage disease, doing so from a clinical perspective and on the basis of published clinical research. Studies were identified through a search strategy applied to the main scientific databases. Clinical studies show that the WTHD has a multi-factor aetiology. The literature review suggests-perhaps in line with better management of physical pain-that psychological and spiritual aspects, including social factors, are the most important cause of such a wish. One of the difficulties facing clinical research is the lack of terminological and conceptual precision in defining the construct. Indeed, studies frequently blur the distinction between a generic wish to die, a WTDH (whether sporadic or persistent over time), the explicit expression of a wish to die, and a request for euthanasia or physician-assisted suicide. A notable contribution to knowledge in this field has been made by scales designed to evaluate the WTHD, although the problems of conceptual definition may once again limit the conclusions, which can be drawn from the results. Studies using qualitative methodology have also provided new information that can help in understanding such wishes. Further clinical research is needed to provide a complete understanding of this phenomenon and to foster the development of suitable care plans. Copyright © 2010 John Wiley & Sons, Ltd.

  9. International Pediatric MS Study Group Clinical Trials Summit: meeting report.

    PubMed

    Chitnis, Tanuja; Tardieu, Marc; Amato, Maria Pia; Banwell, Brenda; Bar-Or, Amit; Ghezzi, Angelo; Kornberg, Andrew; Krupp, Lauren B; Pohl, Daniela; Rostasy, Kevin; Tenembaum, Silvia; Waubant, Emmanuelle; Wassmer, Evangeline

    2013-03-19

    Pediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research. The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions. The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge. Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders.

  10. The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School.

    PubMed

    Yates, Janet; James, David

    2010-07-28

    The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown.The study objective was to determine whether UKCAT scores predict performance during the first two years of the 5-year undergraduate medical course at Nottingham. We studied a single cohort of students, who entered Nottingham Medical School in October 2007 and had taken the UKCAT. We used linear regression analysis to identify independent predictors of marks for different parts of the 2-year preclinical course. Data were available for 204/260 (78%) of the entry cohort. The UKCAT total score had little predictive value. Quantitative Reasoning was a significant independent predictor of course marks in Theme A ('The Cell'), (p = 0.005), and Verbal Reasoning predicted Theme C ('The Community') (p < 0.001), but otherwise the effects were slight or non-existent. This limited study from a single entry cohort at one medical school suggests that the predictive value of the UKCAT, particularly the total score, is low. Section scores may predict success in specific types of course assessment.The ultimate test of validity will not be available for some years, when current cohorts of students graduate. However, if this test of mental ability does not predict preclinical performance, it is arguably less likely to predict the outcome in the clinical years. Further research from medical schools with different types of curriculum and assessment is needed, with longitudinal studies throughout the course.

  11. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    PubMed

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  12. PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. Methods/Design PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. Discussion This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin

  13. PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

    PubMed

    Mathieson, Stephanie; Maher, Christopher G; McLachlan, Andrew J; Latimer, Jane; Koes, Bart W; Hancock, Mark J; Harris, Ian; Day, Richard O; Pik, Justin; Jan, Stephen; Billot, Laurent; Lin, Chung-Wei Christine

    2013-07-11

    Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life

  14. Psychological functioning in adolescents referred to specialist gender identity clinics across Europe: a clinical comparison study between four clinics.

    PubMed

    de Graaf, Nastasja M; Cohen-Kettenis, Peggy T; Carmichael, Polly; de Vries, Annelou L C; Dhondt, Karlien; Laridaen, Jolien; Pauli, Dagmar; Ball, Juliane; Steensma, Thomas D

    2018-07-01

    Adolescents seeking professional help with their gender identity development often present with psychological difficulties. Existing literature on psychological functioning of gender diverse young people is limited and mostly bound to national chart reviews. This study examined the prevalence of psychological functioning and peer relationship problems in adolescents across four European specialist gender services (The Netherlands, Belgium, the UK, and Switzerland), using the Child Behavioural Checklist (CBCL) and the Youth Self-Report (YSR). Differences in psychological functioning and peer relationships were found in gender diverse adolescents across Europe. Overall, emotional and behavioural problems and peer relationship problems were most prevalent in adolescents from the UK, followed by Switzerland and Belgium. The least behavioural and emotional problems and peer relationship problems were reported by adolescents from The Netherlands. Across the four clinics, a similar pattern of gender differences was found. Birth-assigned girls showed more behavioural problems and externalising problems in the clinical range, as reported by their parents. According to self-report, internalising problems in the clinical range were more prevalent in adolescent birth-assigned boys. More research is needed to gain a better understanding of the difference in clinical presentations in gender diverse adolescents and to investigate what contextual factors that may contribute to this.

  15. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

    PubMed

    Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

    2017-05-03

    The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

  16. Food additive carrageenan: Part II: A critical review of carrageenan in vivo safety studies.

    PubMed

    Weiner, Myra L

    2014-03-01

    Carrageenan (CGN) is a seaweed-derived high molecular weight (Mw) hydrocolloid, primarily used as a stabilizer and thickener in food. The safety of CGN regarding its use in food is reviewed. Based on experimental studies in animals, ingested CGN is excreted quantitatively in the feces. Studies have shown that CGN is not significantly degraded by low gastric pH or microflora in the gastrointestinal (GI) tract. Due to its Mw, structure and its stability when bound to protein, CGN is not significantly absorbed or metabolized. CGN also does not significantly affect the absorption of nutrients. Subchronic and chronic feeding studies in rodents indicate that CGN at doses up to 5% in the diet does not induce any toxicological effects other than soft stools or diarrhea, which are a common effect for non-digestible high molecular weight compounds. Review of several studies from numerous species indicates that food grade CGN does not produce intestinal ulceration at doses up to 5% in the diet. Effects of CGN on the immune system following parenteral administration are well known, but not relevant to food additive uses. The majority of the studies evaluating the immunotoxicity potential were conducted with CGN administered in drinking water or by oral gavage where CGN exists in a random, open structured molecular conformation, particularly the lambda form; hence, it has more exposure to the intestinal mucosa than when bound to protein in food. Based on the many animal subchronic and chronic toxicity studies, CGN has not been found to affect the immune system, as judged by lack of effects on organ histopathology, clinical chemistry, hematology, normal health, and the lack of target organ toxicities. In these studies, animals consumed CGN at orders of magnitude above levels of CGN in the human diet: ≥1000 mg/kg/d in animals compared to 18-40 mg/kg/d estimated in the human diet. Dietary CGN has been shown to lack carcinogenic, tumor promoter, genotoxic, developmental, and

  17. Clinical handover practices in maternity services in Ireland: A qualitative descriptive study.

    PubMed

    Fealy, Gerard; Munroe, Deirdre; Riordan, Fiona; Croke, Eilish; Conroy, Celine; McNamara, Martin; Shannon, Michael

    2016-08-01

    the objective was to examine and describe clinical handover practices in Irish maternity services. the study design incorporated interviews and focus group discussions with a purposive sample of healthcare practitioners working in Irish maternity services. five maternity hospitals and fourteen co-located maternity units. midwives, obstetricians and other healthcare professionals, specifically physiotherapists and radiologists, midwifery students and health care assistants working in maternity services. the study participants provided nuanced and differentiated accounts of clinical handover practices, which indicated a general absence of formal policy and training on clinical handover and the practice of midwifery and medical teams holding separate clinical handovers based on their separate, respective needs for transferring information and clinical responsibility. Participants spoke of barriers to effective clinical handover, including unsuitable environments, lack of dedicated time and fatigue during duty shift clinical handover, lack of supportive information technology (IT) infrastructure, and resistance of some staff to the adoption of new technologies to support clinical handover. whether internal and external to clinical handover events, the barriers to effective clinical handover represent threats to patient safety and quality of care, since effective clinical handover is essential to the provision of safe quality care. clear and effective communication between collaborating professionals within maternity teams is essential. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Studies for understanding effects of additions on the strength of cement concrete

    NASA Astrophysics Data System (ADS)

    Bucur, R. D.; Barbuta, M.; Konvalina, P.; Serbanoiu, A. A.; Bernas, J.

    2017-09-01

    The paper analyzes the effects of different types of additions introduced in concrete mix on the compressive strength. The current studies show that additions contribute to improve some characteristics of concrete and to reduce the cement dosage, so it can obtain concretes which are cheaper and friendlier with environment. In the experimental mixes were introduced: crushed natural aggregates, slag aggregates, silica fume, fly ash, chopped tire, polystyrene granule, glass fibers and metallic fibers. The experimental values of compressive strengths were compared for two concrete grades (C20/25 and C25/30). The study shown that near the well-known possibilities of improving mechanical strengths of cement concrete by increasing cement dosage and strength, by using crushed aggregates and by reducing the water/cement ratio, there are other methods in which less cement is used by replacing it with different wastes or by adding fiber.

  19. A simulations approach for meta-analysis of genetic association studies based on additive genetic model.

    PubMed

    John, Majnu; Lencz, Todd; Malhotra, Anil K; Correll, Christoph U; Zhang, Jian-Ping

    2018-06-01

    Meta-analysis of genetic association studies is being increasingly used to assess phenotypic differences between genotype groups. When the underlying genetic model is assumed to be dominant or recessive, assessing the phenotype differences based on summary statistics, reported for individual studies in a meta-analysis, is a valid strategy. However, when the genetic model is additive, a similar strategy based on summary statistics will lead to biased results. This fact about the additive model is one of the things that we establish in this paper, using simulations. The main goal of this paper is to present an alternate strategy for the additive model based on simulating data for the individual studies. We show that the alternate strategy is far superior to the strategy based on summary statistics.

  20. [A clinical study of endodontic flare-ups].

    PubMed

    Yeh, S J; Lin, Y T; Lu, S Y

    1994-06-01

    The purpose of this study was to investigate the clinical variables influencing endodontic flare-ups. Three hundred and thirteen teeth receiving endodontic treatment at the Endodontic Department, Chang Gung Memorial Hospital were studied from December 1992 to February 1993. Among them, 21 teeth with significant pain and 9 with apical swelling were noted after the first appointment of treatment. Three teeth with persistent pain and one with apical swelling were also found one week after completion of endodontic therapy. The results showed significant improvement of clinical symptoms and signs one week after completion of endodontic treatment in comparison with pretreatment and after the first appointment (p < 0.025). The factors such as presence of pretreatment complaints, periapical lesions and vital pulp had significant effects on the incidence of endodontic flare-ups after the first appointment of treatment (P < 0.025). In contrast, patients' sex, the number of visits, and whether this was a retreatment case or not had no significant effect on the frequency of these endodontic flare-ups.

  1. Problems and challenges of nursing students’ clinical evaluation: A qualitative study

    PubMed Central

    Rafiee, Ghazanfar; Moattari, Marzieh; Nikbakht, Alireza N; Kojuri, Javad; Mousavinasab, Masoud

    2014-01-01

    Background: The purpose of this qualitative exploratory study was to explore the views of nursing trainers and students about nursing students’ clinical evaluation problems and drawbacks in Shiraz Nursing and Midwifery School. Materials and Methods: A qualitative exploratory approach was used in this study at Shiraz Nursing and Midwifery School in 2012. A purposeful sample of 8 nursing instructors and 40 nursing students was interviewed and the data on their opinions about the problems of the clinical evaluation were collected through semi-structured deep interviews. Initially, four open-ended questions, which were related to the clinical evaluation status, problems, were used to stimulate discussions in the interview sessions. Content analysis was employed in order to analyze the transcribed data. The recorded interviews were initially transcribed, read, and reread on a number of occasions to get an overall feeling of what the participants were saying. Each line or incident was described, and then a code, which reflected the essence of the participants’ comments, was given. Results: The codes were compared for similarity and differences, merged together, and categorized. Finally, five themes emerged: In appropriate clinical evaluation method, problems of clinical evaluation Process, problems related to clinical instructors, unsuitable programming of clinical education, and organizational shortcomings. Conclusion: Besides focusing on upgrading the current clinical evaluation forms, nursing trainers should improve their knowledge about a complete and comprehensive clinical evaluation. They should also apply other appropriate and objective clinical evaluation methods and tools, and perform a formative and summative clinical evaluation. Also, workload adjustment of the nursing trainers needs revision. Therefore, despite using traditional and sometimes limited evaluation methods for assessing nursing students, a co mprehensive and appropriate evaluation of nursing

  2. Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

    PubMed

    Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

    2011-11-01

    Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

  3. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ...] Guidance for Industry: Studies To Evaluate the Utility of Anti- Salmonella Chemical Food Additives in Feeds... Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is... of Anti-Salmonella Chemical Food Additives in Feeds (GFI 80) is to help sponsors design efficacy...

  4. Diabetes Is Associated with Worse Clinical Presentation in Tuberculosis Patients from Brazil: A Retrospective Cohort Study

    PubMed Central

    Hickson, Lucas S.; Daltro, Carla; Castro, Simone; Kornfeld, Hardy; Netto, Eduardo M.; Andrade, Bruno B.

    2016-01-01

    Background The rising prevalence of diabetes mellitus (DM) worldwide, especially in developing countries, and the persistence of tuberculosis (TB) as a major public health issue in these same regions, emphasize the importance of investigating this association. Here, we compared the clinical profile and disease outcomes of TB patients with or without coincident DM in a TB reference center in Brazil. Methods We performed a retrospective analysis of a TB patient cohort (treatment naïve) of 408 individuals recruited at a TB primary care center in Brazil between 2004 and 2010. Data on diagnosis of TB and DM were used to define the groups. The study groups were compared with regard to TB disease presentation at diagnosis as well as to clinical outcomes such as cure and mortality rates upon anti-tuberculosis therapy (ATT) initiation. A composite score utilizing clinical, radiological and microbiological parameters was used to compare TB severity between the groups. Results DM patients were older than non-diabetic TB patients. In addition, diabetic individuals more frequently presented with cough, night sweats, hemoptysis and malaise than those without DM. The overall pattern of lung lesions assessed by chest radiographic examination was similar between the groups. Compared to non-diabetic patients, those with TB-diabetes exhibited positive acid-fast bacilli in sputum samples more frequently at diagnosis and at 30 days after ATT initiation. Notably, higher values of the TB severity score were significantly associated with TB-diabetes comorbidity after adjustment for confounding factors. Moreover, during ATT, diabetic patients required more frequent transfers to TB reference hospitals for complex clinical management. Nevertheless, overall mortality and cure rates were indistinguishable between the study groups. Conclusions These findings reinforce the idea that diabetes negatively impacts pulmonary TB severity. Our study argues for the systematic screening for DM in TB

  5. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    PubMed

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  6. First impressions count: does FAIRness affect adaptation of clinical clerks in their first clinical placement?

    PubMed

    Edafe, Ovie; Mistry, Natasha; Chan, Philip

    2013-09-01

    FAIRness (Feedback, Activity, Individualisation, Relevance) teaching is a structured program, comprising series of classes in which student work is anonymised and reviewed by the whole class, as well as students receiving private feedback on their written work. The class work emphasises logic, structure and order in history and examination, with a diagnostic and management focus. The effect of FAIRness teaching methods on the adaptation of medical students entering their first clinical rotations was studied. 18 students in FAIRness placements and 72 students in conventional placements, all in medical/surgical units in the same University teaching hospital were studied. They completed questionnaires relating to effectiveness and quality of clinical teaching. Some students additionally attended focus groups, at the start of placement to discuss their expectations, and after 3 weeks, to discuss their adaptation to the clinical learning environment. All students entering clinical placements had low expectations of their future teaching. Students in standard placements still expressed negative attitudes after 3 weeks, while students on FAIRness placements felt positive. Students in FAIRness placements scored significantly higher on questions related to feedback and review of student work. FAIRness teaching practices help students to adapt to their first clinical placements.

  7. Self-study program on HTML browser--application to Clinical Nursing General Remarks Course.

    PubMed

    Ochiai, N; Sota, Y; Ezumi, H

    1997-01-01

    We created a self-study program using HTML browser on the Clinical Nursing General Remarks Course, Eighty-three students each selected a published book on a personal history (written personal reflections from individuals who had undergone medical treatment and hospitalization), read it and submitted reports of their impressions of the histories. Their reports were arranged from a nursing perspective and entered on the home page of our college using HTML browser. We intended that the students would become more interested in reading of the personal histories, and that they would acquire new self-study skills and increase their interest in Internet through use of our program. In addition, we hoped that this program would encourage positive communication and mutual sharing of information. The students were able to easily refer to a personal history according to their interest from a nursing perspective. Therefore this program realized the mutual learning among students and other users.

  8. Autologous temporomandibular joint reconstruction independent of exogenous additives: a proof-of-concept study for guided self-generation

    PubMed Central

    Wei, Jiao; Herrler, Tanja; Han, Dong; Liu, Kai; Huang, Rulin; Guba, Markus; Dai, Chuanchang; Li, Qingfeng

    2016-01-01

    Joint defects are complex and difficult to reconstruct. By exploiting the body’s own regenerative capacity, we aimed to individually generate anatomically precise neo-tissue constructs for autologous joint reconstruction without using any exogenous additives. In a goat model, CT scans of the mandibular condyle including articular surface and a large portion of the ascending ramus were processed using computer-aided design and manufacturing. A corresponding hydroxylapatite negative mold was printed in 3D and temporarily embedded into the transition zone of costal periosteum and perichondrium. A demineralized bone matrix scaffold implanted on the contralateral side served as control. Neo-tissue constructs obtained by guided self-generation exhibited accurate configuration, robust vascularization, biomechanical stability, and function. After autologous replacement surgery, the constructs showed stable results with similar anatomical, histological, and functional findings compared to native controls. Further studies are required to assess long-term outcome and possible extensions to other further applications. The absence of exogenous cells, growth factors, and scaffolds may facilitate clinical translation of this approach. PMID:27892493

  9. Addition of meloxicam to the treatment of bovine clinical mastitis results in a net economic benefit to the dairy farmer.

    PubMed

    van Soest, Felix J S; Abbeloos, Elke; McDougall, Scott; Hogeveen, Henk

    2018-04-01

    Recently, it has been shown that the addition of meloxicam to standard antimicrobial therapy for clinical mastitis (CM) improves the conception rate of dairy cows contracting CM in the first 120 d in milk. The objective of our study was to assess whether this improved reproduction through additional treatment with meloxicam would result in a positive net economic benefit for the farmer. We developed a stochastic bio-economic simulation model, in which a dairy cow with CM in the first 120 d in milk was simulated. Two scenarios were simulated in which CM cases were treated with meloxicam in conjunction with antimicrobial therapy or with antimicrobial therapy alone. The scenarios differed for conception rates (31% with meloxicam or 21% without meloxicam) and for the cost of CM treatment. Sensitivity analyses were undertaken for the biological and economic components of the model to assess the effects of a wide range of inputs on inferences about the cost effectiveness of meloxicam treatment. Model results showed an average net economic benefit of €42 per CM case per year in favor of the meloxicam scenario. Cows in the no-meloxicam treatment scenario had higher returns on milk production, lower costs upon calving, and reduced costs of treatment. However, these did not outweigh the savings associated with lower feed intake, reduced number of inseminations, and the reduced culling rate. The net economic benefit favoring meloxicam therapy was a consequence of the better reproductive performance in the meloxicam scenario in which cows had a shorter calving to conception interval (132 vs. 143 d), a shorter intercalving interval (405 vs. 416 d), and fewer inseminations per conception (2.9 vs. 3.7) compared with cows in the no-meloxicam treatment scenario. This resulted in a shorter lactation, hence a lower lactational milk production (8,441 vs. 8,517 kg per lactation) with lower feeding costs in the meloxicam group. A lower culling rate (12 vs. 25%) resulted in lower

  10. Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.

    PubMed

    Stockmann, Chris; Sherwin, Catherine M T; Koren, Gideon; Campbell, Sarah C; Constance, Jonathan E; Linakis, Matthew; Balch, Alfred; Varner, Michael W; Spigarelli, Michael G

    2014-04-01

    Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007 to 2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than 2 years ago, only 11% had reported results and <7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated. © 2013, The American College of Clinical Pharmacology.

  11. Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

    PubMed

    Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

    2013-01-01

    Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

  12. Clinical study using novel endoscopic system for measuring size of gastrointestinal lesion

    PubMed Central

    Oka, Kiyoshi; Seki, Takeshi; Akatsu, Tomohiro; Wakabayashi, Takao; Inui, Kazuo; Yoshino, Junji

    2014-01-01

    AIM: To verify the performance of a lesion size measurement system through a clinical study. METHODS: Our proposed system, which consists of a conventional endoscope, an optical device, an optical probe, and a personal computer, generates a grid scale to measure the lesion size from an endoscopic image. The width of the grid scale is constantly adjusted according to the distance between the tip of the endoscope and lesion because the lesion size on an endoscopic image changes according to the distance. The shape of the grid scale was corrected to match the distortion of the endoscopic image. The distance was calculated using the amount of laser light reflected from the lesion through an optical probe inserted into the instrument channel of the endoscope. The endoscopist can thus measure the lesion size without contact by comparing the lesion with the size of the grid scale on the endoscopic image. (1) A basic test was performed to verify the relationship between the measurement error eM and the tilt angle of the endoscope; and (2) The sizes of three colon polyps were measured using our system during endoscopy. These sizes were immediately measured by scale after their removal. RESULTS: There was no error at α = 0°. In addition, the values of eM (mean ± SD) were 0.24 ± 0.11 mm (α = 10°), 0.90 ± 0.58 mm (α = 20°) and 2.31 ± 1.41 mm (α = 30°). According to these results, our system has been confirmed to measure accurately when the tilt angle is less than 20°. The measurement error was approximately 1 mm in the clinical study. Therefore, it was concluded that our proposed measurement system was also effective in clinical examinations. CONCLUSION: By combining simple optical equipment with a conventional endoscope, a quick and accurate system for measuring lesion size was established. PMID:24744595

  13. A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments.

    PubMed

    Wallace, David K; Dean, Trevano W; Hartnett, Mary Elizabeth; Kong, Lingkun; Smith, Lois E; Hubbard, G Baker; McGregor, Mary Lou; Jordan, Catherine O; Mantagos, Iason S; Bell, Edward F; Kraker, Raymond T

    2018-06-07

    Intravitreal bevacizumab is increasingly used to treat severe retinopathy of prematurity (ROP), but it enters the bloodstream, and there is concern that it may alter development of other organs. Previously we reported short-term outcomes of 61 infants enrolled in a dose de-escalation study, and we report the late recurrences and additional treatments. Masked, multicenter, dose de-escalation study. A total of 61 premature infants with type 1 ROP. If type 1 ROP was bilateral at enrollment, then the study eye was randomly selected. In the study eye, bevacizumab intravitreal injections were given at de-escalating doses of 0.25 mg, 0.125 mg, 0.063 mg, or 0.031 mg; if needed, fellow eyes received 1 dose level higher: 0.625 mg, 0.25 mg, 0.125 mg, or 0.063 mg, respectively. After 4 weeks, additional treatment was at the discretion of the investigator. Early and late ROP recurrences, additional treatments, and structural outcomes after 6 months. Of 61 study eyes, 25 (41%; 95% confidence interval [CI], 29%-54%) received additional treatment: 3 (5%; 95% CI, 1%-14%) for early failure (within 4 weeks), 11 (18%; 95% CI, 9%-30%) for late recurrence of ROP (after 4 weeks), and 11 (18%; 95% CI, 9%-30%) for persistent avascular retina. Re-treatment for early failure or late recurrence occurred in 2 of 11 eyes (18%; 95% CI, 2%-52%) treated with 0.25 mg, 4 of 16 eyes (25%; 95% CI, 7%-52%) treated with 0.125 mg, 8 of 24 eyes (33%; 95% CI, 16%-55%) treated with 0.063 mg, and 0 (0%; 95% CI, 0%-31%) of 10 eyes treated with 0.031 mg. By 6 months corrected age, 56 of 61 study eyes had regression of ROP with normal posterior poles, 1 study eye had developed a Stage 5 retinal detachment, and 4 infants had died of preexisting medical conditions. Retinal structural outcomes are very good after low-dose bevacizumab treatment for ROP, although many eyes received additional treatment. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  14. Ubiquitous Multicriteria Clinic Recommendation System.

    PubMed

    Chen, Toly

    2016-05-01

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

  15. Resveratrol and Clinical Trials: The Crossroad from In Vitro Studies to Human Evidence

    PubMed Central

    Tomé-Carneiro, Joao; Larrosa, Mar; González-Sarrías, Antonio; Tomás-Barberán, Francisco A.; García-Conesa, María Teresa; Espín, Juan Carlos

    2013-01-01

    Resveratrol (3,5,4’-trihydroxy-trans-stilbene) is a non-flavonoid polyphenol that may be present in a limited number of food-stuffs such as grapes and red wine. Resveratrol has been reported to exert a plethora of health benefits through many different mechanisms of action. This versatility and presence in the human diet have drawn the worldwide attention of many research groups over the past twenty years, which has resulted in a huge output of in vitro and animal (preclinical) studies. In line with this expectation, many resveratrol-based nutraceuticals are consumed all over the world with questionable clinical/scientific support. In fact, the confirmation of these benefits in humans through randomized clinical trials is still very limited. The vast majority of preclinical studies have been performed using assay conditions with a questionable extrapolation to humans, i.e. too high concentrations with potential safety concerns (adverse effects and drug interactions), short-term exposures, in vitro tests carried out with non-physiological metabolites and/or concentrations, etc. Unfortunately, all these hypothesis-generating studies have contributed to increased the number of ‘potential’ benefits and mechanisms of resveratrol but confirmation in humans is very limited. Therefore, there are many issues that should be addressed to avoid an apparent endless loop in resveratrol research. The so-called ‘Resveratrol Paradox’, i.e., low bioavailability but high bioactivity, is a conundrum not yet solved in which the final responsible actor (if any) for the exerted effects has not yet been unequivocally identified. It is becoming evident that resveratrol exerts cardioprotective benefits through the improvement of inflammatory markers, atherogenic profile, glucose metabolism and endothelial function. However, safety concerns remain unsolved regarding chronic consumption of high RES doses, specially in medicated people. This review will focus on the currently

  16. Training Load, Immune Status, and Clinical Outcomes in Young Athletes: A Controlled, Prospective, Longitudinal Study

    PubMed Central

    Blume, Katharina; Körber, Nina; Hoffmann, Dieter; Wolfarth, Bernd

    2018-01-01

    Introduction: Beside positive effects on athlete's health, competitive sport can be linked with an increased risk of illness and injury. Because of high relative increases in training, additional physical and psychological strains, and an earlier specialization and professionalization, adolescent athletes needs an increased attention. Training can alter the immune system by inducing a temporary immunosuppression, finally developing infection symptoms. Previous studies identified Epstein Barr Virus (EBV) as potential indicator for the immune status. In addition to the identification of triggering risk factors for recurrent infections, the aim was to determine the interaction between training load, stress sense, immunological parameters, and clinical symptoms. Methods: A controlled, prospective, longitudinal study on young athletes (n = 274, mean age: 13.8 ± 1.5 yrs) was conducted between 2010 and 2014. Also 285 controls (students, who did not perform competitive sports, mean age: 14.5 ± 1.9 yrs) were recruited. Athletes were examined 3 times each year to determine the effects of stress factors (training load: training hours per week [Th/w]) on selected outcome parameters (clinical [susceptibility to infection, WURSS-21: 21-item Wisconsin Upper Respiratory Symptom Survey], immunological, psychological end points). As part of each visit, EBV serostatus and EBV-specific IgG tiers were studied longitudinally as potential immune markers. Results: Athletes (A) trained 14.9 ± 5.6 h weekly. Controls (C) showed no lower stress levels compared to athletes (p = 0.387). Twelve percent of athletes reported recurrent infections (C: 8.5%, p = 0.153), the presence of an upper respiratory tract infection (URTI) was achieved in 30.7%. EBV seroprevalence of athletes was 60.3% (C: 56.6%, p = 0.339). Mean EBV-specific IgG titer of athletes was 166 ± 115 U/ml (C: 137 ± 112 U/ml, p = 0.030). With increasing Th/w, higher stress levels were observed (p < 0.001). Analyzes of WURSS-21

  17. Students' Perspectives of Same-Day Clinical Assignments: A Qualitative Descriptive Study.

    PubMed

    Harris, Allyssa L; Stamp, Kelly D

    2016-01-01

    The clinical experience is essential to the nursing education process, but the process by which students are assigned patients has remained unchanged for decades. The purpose of this qualitative descriptive study was to determine the acceptability of a same-day clinical assignment process from the perspective of pre-licensure nursing students. Students' (n = 104) perceptions of the same-day clinical assignment process were collected via focus groups. Two themes emerged that may assist educators in implementing new methods for clinical assignments.

  18. Impact of clinical leadership in teams’ course on quality, efficiency, responsiveness and trust in the emergency department: study protocol of a trailing research study

    PubMed Central

    Husebø, Sissel Eikeland; Olsen, Øystein Evjen

    2016-01-01

    Introduction Clinical leadership has long been recognised as critical for optimising patient safety, quality of care and interprofessional teamwork in busy and stressful healthcare settings. There is a need to compensate for the absence of the conventional mentor-to-apprentice transfer of clinical leadership knowledge and skills. While young doctors and nurses are increasingly proficient in medical, surgical and technical skills, their training in, and knowledge of clinical leadership skills, is not adequate to meet the demands for these non-technical skills in the emergency department. Thus, the purpose of the paper is to present and discuss the study protocol of clinical leadership in a course for teams that aims to improve quality, efficiency, responsiveness of healthcare services and collegial trust in the emergency department. Methods and analysis The study employs a trailing research design using multiple quantitative and qualitative methods in the summative (pretest and post-test) and formative evaluation. Quantitative data have been collected from a patient questionnaire, the emergency departments’ database and by the observation of team performance. Qualitative data have been collected by shadowing healthcare professionals and through focus group interviews. To ensure trustworthiness in the data analysis, we will apply member checks and analyst triangulation, in addition to providing contextual and sample description to allow for evaluation of transferability of our results to other contexts and groups. Ethics and dissemination The study is approved by the ethics committee of the western part of Norway and the hospital. The study is based on voluntary participation and informed written consent. Informants can withdraw at any point in time. The results will be disseminated at research conferences, peer review journals and through public presentations to people outside the scientific community. PMID:27515758

  19. Impact of clinical leadership in teams' course on quality, efficiency, responsiveness and trust in the emergency department: study protocol of a trailing research study.

    PubMed

    Husebø, Sissel Eikeland; Olsen, Øystein Evjen

    2016-08-10

    Clinical leadership has long been recognised as critical for optimising patient safety, quality of care and interprofessional teamwork in busy and stressful healthcare settings. There is a need to compensate for the absence of the conventional mentor-to-apprentice transfer of clinical leadership knowledge and skills. While young doctors and nurses are increasingly proficient in medical, surgical and technical skills, their training in, and knowledge of clinical leadership skills, is not adequate to meet the demands for these non-technical skills in the emergency department. Thus, the purpose of the paper is to present and discuss the study protocol of clinical leadership in a course for teams that aims to improve quality, efficiency, responsiveness of healthcare services and collegial trust in the emergency department. The study employs a trailing research design using multiple quantitative and qualitative methods in the summative (pretest and post-test) and formative evaluation. Quantitative data have been collected from a patient questionnaire, the emergency departments' database and by the observation of team performance. Qualitative data have been collected by shadowing healthcare professionals and through focus group interviews. To ensure trustworthiness in the data analysis, we will apply member checks and analyst triangulation, in addition to providing contextual and sample description to allow for evaluation of transferability of our results to other contexts and groups. The study is approved by the ethics committee of the western part of Norway and the hospital. The study is based on voluntary participation and informed written consent. Informants can withdraw at any point in time. The results will be disseminated at research conferences, peer review journals and through public presentations to people outside the scientific community. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

  20. Factors affecting clinical reasoning of occupational therapists: a qualitative study

    PubMed Central

    Shafaroodi, Narges; Kamali, Mohammad; Parvizy, Soroor; Mehraban, Afsoon Hassani; O’Toole, Giyn

    2014-01-01

    Background: Clinical reasoning is generally defined as the numerous modes of thinking that guide clinical practice but little is known about the factors affecting how occupational therapists manage the decision-making process. The aim of this qualitative study was to explore the factors influencing the clinical reasoning of occupational therapists. Methods: Twelve occupational therapy practitioners working in mental and physical dysfunction fields participated in this study. The sampling method was purposeful and interviews were continued until data saturation. All the interviews were recorded and transcribed. The data were analyzed through a qualitative content analysis method. Results: There were three main themes. The first theme: socio-cultural conditions included three subthemes: 1- client beliefs; 2- therapist values and beliefs; 3- social attitude to disability. The second theme: individual attributions included two subthemes 1- client attributions; 2- therapist attributions. The final theme was the workplace environment with the three subthemes: 1- knowledge of the managers of rehabilitation services, 2- working in an inter-professional team; 3- limited clinical facilities and resources. Conclusion: In this study, the influence of the attitudes and beliefs of client, therapist and society about illness, abilities and disabilities upon reasoning was different to previous studies. Understanding these factors, especially the socio-cultural beliefs basis can play a significant role in the quality of occupational therapy services. Accurate understanding of these influential factors requires more extensive qualitative and quantitative studies. PMID:25250253

  1. Clinical use of an epinephrine-reduced (1/400,000) articaine solution in short-time dental routine treatments--a multicenter study.

    PubMed

    Daubländer, Monika; Kämmerer, Peer W; Willershausen, Brita; Leckel, Michael; Lauer, Hans-Christoph; Buff, Siegmar; Rösl, Benita

    2012-08-01

    The addition of epinephrine in dental local anaesthesia results in a longer and deeper anaesthesia under almost ischemic conditions. For short-time dental treatments, epinephrine-reduced anaesthetics may offer shorter and more individual anaesthesia with reduced potential side effects. The aim of this study was a clinical evaluation of anaesthetic potency and adverse effects of an epinephrine-reduced articaine formulation in dental patients undergoing short-time routine treatment. In a prospective clinical, not interventional, study between January 2008 and February 2009, 908 patients undergoing short-time dental treatment in five medical centers were anaesthetized with 4% articaine 1:400,000 epinephrine (Ubistesin, 3M/ESPE, Seefeld, Germany). Efficacy and safety in clinical use were evaluated. A follow-up after 1 day was conducted by telephone survey. A mean amount of 1.3-ml anaesthetic solution was needed to achieve a complete or sufficient anaesthesia in 97% (n = 876) of cases. A second injection had to be done in 3.7% (n = 34) before and in 11.9% (n = 108) during treatment. Here, the second injection had to be applied after a mean of 48.6 min. The mean duration of soft tissue anaesthesia after infiltration was 146.6 min, after nerve block 187.7 min. The painful treatment took a mean of 50.2 min and the total treatment time summed up to 68.8 min. In 1.7% cases (n = 15), unwanted side effects were observed. The results indicate that a lower concentration of epinephrine in combination with the 4% articaine solution leads to a high success rate of efficacy. The clinical use of a 4% articaine 1:400,000 epinephrine solution can be stated as safe and effective in short dental routine treatments. Reconsiderations concerning limitations of indication or additional contraindications are not necessary.

  2. The effects of scaffold architecture and fibrin gel addition on tendon cell phenotype.

    PubMed

    Pawelec, K M; Wardale, R J; Best, S M; Cameron, R E

    2015-01-01

    Development of tissue engineering scaffolds relies on careful selection of pore architecture and chemistry of the cellular environment. Repair of skeletal soft tissue, such as tendon, is particularly challenging, since these tissues have a relatively poor healing response. When removed from their native environment, tendon cells (tenocytes) lose their characteristic morphology and the expression of phenotypic markers. To stimulate tendon cells to recreate a healthy extracellular matrix, both architectural cues and fibrin gels have been used in the past, however, their relative effects have not been studied systematically. Within this study, a combination of collagen scaffold architecture, axial and isotropic, and fibrin gel addition was assessed, using ovine tendon-derived cells to determine the optimal strategy for controlling the proliferation and protein expression. Scaffold architecture and fibrin gel addition influenced tendon cell behavior independently in vitro. Addition of fibrin gel within a scaffold doubled cell number and increased matrix production for all architectures studied. However, scaffold architecture dictated the type of matrix produced by cells, regardless of fibrin addition. Axial scaffolds, mimicking native tendon, promoted a mature matrix, with increased tenomodulin, a marker for mature tendon cells, and decreased scleraxis, an early transcription factor for connective tissue. This study demonstrated that both architectural cues and fibrin gel addition alter cell behavior and that the combination of these signals could improve clinical performance of current tissue engineering constructs.

  3. The recurrent PPP1CB mutation p.Pro49Arg in an additional Noonan-like syndrome individual: Broadening the clinical phenotype.

    PubMed

    Bertola, Débora; Yamamoto, Guilherme; Buscarilli, Michelle; Jorge, Alexander; Passos-Bueno, Maria Rita; Kim, Chong

    2017-03-01

    We report on a 12-year-old Brazilian boy with the p.Pro49Arg mutation in PPP1CB, a novel gene associated with RASopathies. This is the fifth individual described, and the fourth presenting the same variant, suggesting a mutational hotspot. Phenotypically, he also showed the same hair pattern-sparse, thin, and with slow growing-, similar to the typical ectodermal finding observed in Noonan syndrome-like disorder with loose anagen hair. Additionally, he presented craniosynostosis, a rare clinical finding in RASopathies. This report gives further support that this novel RASopathy-PPP1CB-related Noonan syndrome with loose anagen hair-shares great similarity to Noonan syndrome-like disorder with loose anagen hair, and expands the phenotypic spectrum by adding the cranial vault abnormality. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  4. Intraoral ultrasonography: development of a specific high-frequency probe and clinical pilot study.

    PubMed

    Salmon, Benjamin; Le Denmat, Dominique

    2012-04-01

    Although ultrasonography is a non-invasive, inexpensive and painless diagnostic tool for soft tissue imaging, this technique is not currently used for oral exploration. Therefore, we developed a 25-MHz high-frequency ultrasound probe, specially designed for intraoral applications. This paper aims to present clinical intraoral ultrasound images actually interpretable, in order to identify the relevant applications of this novel tool and to design future oral studies. Two independent radiologists performed ultrasound examinations on three healthy volunteers. All the teeth were explored on the lingual and buccal sides (162 samples) to evaluate the ergonomics of the system and the visualisation of anatomic structures. Osseointegrated dental implants and a mucocele were also scanned. At the gingivodental junction of the maxillary and mandibular teeth, the device clearly identifies the tooth surfaces, the alveolar bone reflection with its surrounding subepithelial connective tissue of the gingiva and the gingival epithelia. The bone level and the thickness of soft tissue around the implant are measurable on the buccal and lingual sides. Therefore, intraoral ultrasonography provides additional morphological information that is not accessible by conventional dental x-rays. We propose a novel diagnostic tool that explores the biological width and is able to define the thin or thick nature of the gums. Moreover, intraoral ultrasonography may help to monitor precancerous lesions. This promising device requires large-scale clinical studies to determine whether it should remain a research tool or be used as a diagnostic tool for daily dental practice.

  5. Acute Respiratory Distress Syndrome Measurement Error. Potential Effect on Clinical Study Results

    PubMed Central

    Cooke, Colin R.; Iwashyna, Theodore J.; Hofer, Timothy P.

    2016-01-01

    Rationale: Identifying patients with acute respiratory distress syndrome (ARDS) is a recognized challenge. Experts often have only moderate agreement when applying the clinical definition of ARDS to patients. However, no study has fully examined the implications of low reliability measurement of ARDS on clinical studies. Objectives: To investigate how the degree of variability in ARDS measurement commonly reported in clinical studies affects study power, the accuracy of treatment effect estimates, and the measured strength of risk factor associations. Methods: We examined the effect of ARDS measurement error in randomized clinical trials (RCTs) of ARDS-specific treatments and cohort studies using simulations. We varied the reliability of ARDS diagnosis, quantified as the interobserver reliability (κ-statistic) between two reviewers. In RCT simulations, patients identified as having ARDS were enrolled, and when measurement error was present, patients without ARDS could be enrolled. In cohort studies, risk factors as potential predictors were analyzed using reviewer-identified ARDS as the outcome variable. Measurements and Main Results: Lower reliability measurement of ARDS during patient enrollment in RCTs seriously degraded study power. Holding effect size constant, the sample size necessary to attain adequate statistical power increased by more than 50% as reliability declined, although the result was sensitive to ARDS prevalence. In a 1,400-patient clinical trial, the sample size necessary to maintain similar statistical power increased to over 1,900 when reliability declined from perfect to substantial (κ = 0.72). Lower reliability measurement diminished the apparent effectiveness of an ARDS-specific treatment from a 15.2% (95% confidence interval, 9.4–20.9%) absolute risk reduction in mortality to 10.9% (95% confidence interval, 4.7–16.2%) when reliability declined to moderate (κ = 0.51). In cohort studies, the effect on risk factor associations

  6. Physiotherapy students and clinical educators perceive several ways in which incorporating peer-assisted learning could improve clinical placements: a qualitative study.

    PubMed

    Sevenhuysen, Samantha; Farlie, Melanie K; Keating, Jennifer L; Haines, Terry P; Molloy, Elizabeth

    2015-04-01

    What are the experiences of students and clinical educators in a paired student placement model incorporating facilitated peer-assisted learning (PAL) activities, compared to a traditional paired teaching approach? Qualitative study utilising focus groups. Twenty-four physiotherapy students and 12 clinical educators. Participants in this study had experienced two models of physiotherapy clinical undergraduate education: a traditional paired model (usual clinical supervision and learning activities led by clinical educators supervising pairs of students) and a PAL model (a standardised series of learning activities undertaken by student pairs and clinical educators to facilitate peer interaction using guided strategies). Peer-assisted learning appears to reduce the students' anxiety, enhance their sense of safety in the learning environment, reduce educator burden, maximise the use of downtime, and build professional skills including collaboration and feedback. While PAL adds to the clinical learning experience, it is not considered to be a substitute for observation of the clinical educator, expert feedback and guidance, or hands-on immersive learning activities. Cohesion of the student-student relationship was seen as an enabler of successful PAL. Students and educators perceive that PAL can help to position students as active learners through reduced dependence on the clinical educator, heightened roles in observing practice, and making and communicating evaluative judgments about quality of practice. The role of the clinical educator is not diminished with PAL, but rather is central in designing flexible and meaningful peer-based experiences and in balancing PAL with independent learning opportunities. ACTRN12610000859088. [Sevenhuysen S, Farlie MK, Keating JL, Haines TP, Molloy E (2015) Physiotherapy students and clinical educators perceive several ways in which incorporating peer-assisted learning could improve clinical placements: a qualitative study

  7. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    PubMed

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P < .001) or ranibizumab (+13.6 [8.5]; 95% CI, +0.7 to +6.0; P = .009). When VA was 20/50 or worse at baseline, bevacizumab reduced CST less than the other agents at 1 year, but at 2 years the differences had diminished. In subgroups stratified by baseline VA, anti-VEGF agent, and whether focal/grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those

  8. Radiomics in Oncological PET/CT: Clinical Applications.

    PubMed

    Lee, Jeong Won; Lee, Sang Mi

    2018-06-01

    18 F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) is widely used for staging, evaluating treatment response, and predicting prognosis in malignant diseases. FDG uptake and volumetric PET parameters such as metabolic tumor volume have been used and are still used as conventional PET parameters to assess biological characteristics of tumors. However, in recent years, additional features derived from PET images by computational processing have been found to reflect intratumoral heterogeneity, which is related to biological tumor features, and to provide additional predictive and prognostic information, which leads to the concept of radiomics. In this review, we focus on recent clinical studies of malignant diseases that investigated intratumoral heterogeneity on PET/CT, and we discuss its clinical role in various cancers.

  9. Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

    PubMed

    Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

    2017-05-01

    According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  10. The nature of placebo response in clinical studies of major depressive disorder.

    PubMed

    Papakostas, George I; Østergaard, Søren D; Iovieno, Nadia

    2015-04-01

    To review factors influencing placebo response and clinical trial outcome in depression, and suggest ways to optimize trial success in mood disorders. PubMed searches were conducted by cross-referencing the terms depression, depressive with placebo, clinical trial, and clinical trials for studies published in English between 1970 and September 2013. Relevant abstracts were identified in PubMed, including clinical trials, quantitative studies, and qualitative research. We obtained and reviewed relevant articles and utilized their information to synthesize the present review. Included articles were grouped in the following areas of relevance: (1) biological validity of illness, (2) baseline severity of illness, (3) chronicity of the index episode of depression, (4) age of participants, (5) medical and psychiatric comorbidity, (6) probability of receiving placebo, (7) use of prospective treatment phases (lead-in) (8) dosing schedule, (9) trial duration, (10) frequency of follow-up assessments, and (11) study outcome measure. Several key elements emerge as critical to the ultimate success of a clinical trial, including the probability of receiving placebo, study duration, dosing schedule, visit frequency, the use of blinded lead-in phases, the use of centralized raters, illness severity and duration, and comorbid anxiety. Our increasing understanding of the placebo response in clinical trials of major depressive disorder lends to a, gradually, more predictable phenomenon and, hopefully, to one that becomes lesser in magnitude and variability. Several elements have emerged that seem to play a critical role in trial success, gradually reshaping the design of clinical, translational, as well as mechanistic studies in depression. © Copyright 2015 Physicians Postgraduate Press, Inc.

  11. Impact of clinical and health services research projects on decision-making: a qualitative study.

    PubMed

    Solans-Domènech, Maite; Adam, Paula; Guillamón, Imma; Permanyer-Miralda, Gaietà; Pons, Joan M V; Escarrabill, Joan

    2013-05-10

    This article reports on the impact assessment experience of a funding program of non-commercial clinical and health services research. The aim was to assess the level of implementation of results from a subgroup of research projects (on respiratory diseases), and to detect barriers (or facilitators) in the translation of new knowledge to informed decision-making. A qualitative study was performed. The sample consisted of six projects on respiratory diseases funded by the Agency for Health Quality and Assessment of Catalonia between 1996 and 2004. Semi-structured interviews to key informants including researchers and healthcare decision-makers were carried out. Interviews were recorded, transcribed verbatim and analysed on an individual (key informant) and group (project) basis. In addition, the differences between achieved and expected impacts were described. Twenty-three semi-structured interviews were conducted. Most participants indicated changes in health services or clinical practice had resulted from research. The channels used to transfer new knowledge were mainly conventional ones, but also in less explicit ways, such as with the involvement of local scientific societies, or via debates and discussions with colleagues and local leaders. The barriers and facilitators identified were mostly organizational (in research management, and clinical and healthcare practice), although there were also some related to the nature of the research as well as personal factors. Both the expected and achieved impacts enabled the identification of the gaps between what is expected and what is truly achieved. In this study and according to key informants, the impact of these research projects on decision-making can be direct (the application of a finding or innovation) or indirect, contributing to a more complex change in clinical practice and healthcare organization, both having other contextual factors. The channels used to transfer this new knowledge to clinical practice

  12. Impact of clinical and health services research projects on decision-making: a qualitative study

    PubMed Central

    2013-01-01

    Background This article reports on the impact assessment experience of a funding program of non-commercial clinical and health services research. The aim was to assess the level of implementation of results from a subgroup of research projects (on respiratory diseases), and to detect barriers (or facilitators) in the translation of new knowledge to informed decision-making. Methods A qualitative study was performed. The sample consisted of six projects on respiratory diseases funded by the Agency for Health Quality and Assessment of Catalonia between 1996 and 2004. Semi-structured interviews to key informants including researchers and healthcare decision-makers were carried out. Interviews were recorded, transcribed verbatim and analysed on an individual (key informant) and group (project) basis. In addition, the differences between achieved and expected impacts were described. Results Twenty-three semi-structured interviews were conducted. Most participants indicated changes in health services or clinical practice had resulted from research. The channels used to transfer new knowledge were mainly conventional ones, but also in less explicit ways, such as with the involvement of local scientific societies, or via debates and discussions with colleagues and local leaders. The barriers and facilitators identified were mostly organizational (in research management, and clinical and healthcare practice), although there were also some related to the nature of the research as well as personal factors. Both the expected and achieved impacts enabled the identification of the gaps between what is expected and what is truly achieved. Conclusions In this study and according to key informants, the impact of these research projects on decision-making can be direct (the application of a finding or innovation) or indirect, contributing to a more complex change in clinical practice and healthcare organization, both having other contextual factors. The channels used to transfer

  13. Long-Term Clinical Response to Treatment and Maintenance of Localized Aggressive Periodontitis: A Cohort Study

    PubMed Central

    Miller, Karina A. F. S.; Branco-de-Almeida, Luciana S.; Wolf, Sandra; Hovencamp, Nicole; Treloar, Tina; Harrison, Peter; Aukhil, Ikramuddin; Gong, Yan; Shaddox, Luciana M.

    2016-01-01

    Aim To evaluate long-term clinical response to periodontal therapy and maintenance in localized aggressive periodontitis (LAP). Materials and Methods One hundred forty-one African-Americans diagnosed with LAP, aged 5–25 years, were enrolled. Patients underwent periodontal mechanical debridement plus one week of amoxicillin/metronidazole. Mechanical therapy was repeated as needed and clinical parameters were recorded at baseline, 3, 6, 12, 18, and 24 months, and 2 additional annual follow-up visits after treatment. Radiographs from primary dentition of patients with LAP in permanent dentition, and additional healthy siblings (HS) were analyzed retrospectively. Results Periodontal therapy significantly improved probing depth and clinical attachment level up to 4 years (mean reductions: 2.18 ± 1.03 and 2.80 ± 1.43 mm, respectively). Percentage of affected sites was reduced at all timepoints and maintained up to 4 years. Noncompliance with antibiotics/appointments negatively affected the treatment response. Ninety percent of LAP patients in permanent dentition and 32% of HS presented radiographic bone loss in primary dentition. Conclusions Mechanical debridement with one-week of systemic antibiotics along with proper periodontal maintenance was effective in the treatment and successful maintenance of LAP for up to 4 years. LAP in permanent dentition may be preceded in the primary dentition. Clinicaltrials.gov #NCT01330719. PMID:27767222

  14. Performance of procalcitonin in diagnosing parapneumonic pleural effusions: A clinical study and meta-analysis.

    PubMed

    He, Chao; Wang, Bo; Li, Danni; Xu, Huan; Shen, Yongchun

    2017-08-01

    Parapneumonic pleural effusion (PPE) is a common complication of pneumonia. The accurate diagnosis of PPE remains a challenge. Recent studies suggest that procalcitonin (PCT) emerges as a potential biomarker for PPE. Our study aimed to determine the diagnostic value of PCT for PPE by a clinical study and summarize the overall diagnostic performance of PCT through a meta-analysis. Demographic and clinical data of the patients with PPE and controls were collected in our clinical study. The diagnostic performances of serum PCT (s-PCT) were analyzed via receiver operating characteristic (ROC) curve analysis, using area under the curve (AUC) as a measure of accuracy. Literature databases were systematically searched for the studies examining the accuracy of PCT for diagnosing PPE. Data on sensitivity, specificity, positive/negative likelihood ratio (PLR/NLR), and diagnostic odds ratio (DOR) were pooled. Summary ROC curves and AUC were used to evaluate overall test performance. In our clinical study, 47 patients with PPE and 101 controls were included. The s-PCT levels were significantly increased in the setting of PPE (5.44 ± 9.82 ng/mL) compared with malignant PE (0.15 ± 0.19 ng/mL), tuberculous PE (0.18 ± 0.16 ng/mL), and transudates (0.09 ± 0.03 ng/mL) (P < .001). Using a cutoff value of 0.195 ng/mL, the sensitivity and specificity of s-PCT in diagnosing PPE were 0.83 and 0.80, respectively, and AUC was 0.89. In addition, 11 studies were included in our meta-analysis. Summary performance estimates for s-PCT in diagnosing PPE were as follows: sensitivity, 0.78 (95% CI: 0.71-0.84); specificity, 0.74 (95% CI: 0.69-0.78); PLR, 3.46 (95% CI: 2.09-5.74); NLR, 0.27 (95% CI: 0.14-0.54); DOR, 12.37 (95% CI: 4.34-41.17); and AUC, 0.84. The corresponding estimates for p-PCT were as follows: sensitivity, 0.62 (95% CI: 0.57-0.67); specificity, 0.71 (95% CI: 0.68-0.75); PLR 2.31 (95% CI: 1.81-2.95); NLR, 0.47 (95% CI: 0.35-0.63); DOR, 5.48 (95% CI

  15. Examining the Proportion of Dietary Phosphorus From Plants, Animals, and Food Additives Excreted in Urine.

    PubMed

    St-Jules, David E; Jagannathan, Ram; Gutekunst, Lisa; Kalantar-Zadeh, Kamyar; Sevick, Mary Ann

    2017-03-01

    Phosphorus bioavailability is an emerging topic of interest in the field of renal nutrition that has important research and clinical implications. Estimates of phosphorus bioavailability, based on digestibility, indicate that bioavailability of phosphorus increases from plants to animals to food additives. In this commentary, we examined the proportion of dietary phosphorus from plants, animals, and food additives excreted in urine from four controlled-feeding studies conducted in healthy adults and patients with chronic kidney disease. As expected, a smaller proportion of phosphorus from plant foods was excreted in urine compared to animal foods. However, contrary to expectations, phosphorus from food additives appeared to be incompletely absorbed. The apparent discrepancy between digestibility of phosphorus additives and the proportion excreted in urine suggests a need for human balance studies to determine the bioavailability of different sources of phosphorus. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  16. Prevalence, clinical features and risk assessment of pre-diabetes in Spain: the prospective Mollerussa cohort study

    PubMed Central

    Vilanova, María Belén; Falguera, Mireia; Marsal, Josep Ramon; Rubinat, Esther; Alcubierre, Núria; Catelblanco, Esmeralda; Granado-Casas, Minerva; Miró, Neus; Molló, Àngels; Mata-Cases, Manel; Franch-Nadal, Josep; Mauricio, Didac

    2017-01-01

    Purpose The Mollerussa prospective cohort was created to study pre-diabetes in a population-based sample from the primary care setting in the semirural area of Pla d’Urgell in Catalonia (Spain). The aims of the study were to assess the prevalence of pre-diabetes in our population, the likelihood to develop overt diabetes over time and to identify risk factors associated with the progression of the condition. Participants The cohort includes 594 subjects randomly selected between March 2011 and July 2014 from our primary care population, who were older than 25 years, consented to participate and did not have a recorded diagnosis of diabetes. Findings to date At baseline, we performed a clinical interview to collect demographic, clinical and lifestyle (including a nutritional survey) characteristics; carotid ultrasound imaging to assess subclinical cardiovascular disease was also performed, and a blood sample was collected, with an overall <5% rate of missing data. An additional blood draw was performed 12 months after initial recruitment to reassess laboratory results in patients initially identified as having pre-diabetes, with an 89.6% retention rate. Several studies investigating various hypotheses are currently ongoing. Future plans All subjects recruited during the cohort creation will be followed long-term through annual extraction of data from health records stored in the electronic Clinical station in Primary Care database. The Mollerussa cohort will thus be a sound population-based sample for multiple future research projects to generate insights into the epidemiology and natural history of pre-diabetes in Spain. PMID:28606902

  17. Study to determine the clinical significance of HEmolysis During Orbital AtheRectomy (CLEAR study).

    PubMed

    Staniloae, Cezar S; Korabathina, Ravikiran; Lane, Thomas A; Dattilo, Raymond; Church, Kevin J; Mody, Kanika P; Mayeda, Guy S

    2011-02-01

    To evaluate the incidence of clinically evident hemolysis associated with orbital atherectomy used to treat severe peripheral artery disease. The observational CLEAR study enrolled 31 subjects (16 men; mean age 71 ± 10 years, range 44-92) with claudication (58.1%) or critical limb ischemia (38.7%) who underwent orbital atherectomy with the Diamondback 360 system at 4 US centers. The 42 lesions in 31 limbs were located in the superficial femoral (n = 19, 45.2%), popliteal (n = 8, 19.0%), and tibial arteries (n = 15, 35.8%). The majority of lesions (34, 81.0%) were de novo; moderate or severe calcification was identified in 90.5% of cases. Lesion and procedural parameters were analyzed at a core laboratory. Blood samples were collected during and post procedure and analyzed for markers of hemolysis. The primary endpoint was the occurrence of clinically significant hemolysis. The secondary endpoints included the occurrence of any clinical symptoms/signs potentially related to hemolysis. Statistical analysis was performed to identify predictors for hemolysis. Laboratory evidence of hemolysis was seen in 11 (35.5%) subjects. No one met the clinical event criteria, and so the primary endpoint of the study was not reached. The secondary endpoints were hypertensive crisis (1, 3.2%) and transient hemoglobinuria (3, 9.7%). Lower glomerular filtration rates, calcified plaque, long atherectomy runs, and solid crown selection were independent predictors of hemolysis. There was no clinically significant hemolysis after orbital atherectomy. The results of this study will enable users to predict conditions that predispose to high levels of red cell hemolysis following orbital atherectomy and to take appropriate measures to limit its occurrence.

  18. Impact of regulatory assessment on clinical studies in Brazil.

    PubMed

    Russo, Luis Augusto Tavares; Eliaschewitz, Freddy Goldberg; Harada, Vitor; Trefiglio, Roberta Pereira; Picciotti, Raffaella; Machado, Paula Goulart Pinheiro; Kesselring, Gustavo Luiz Ferreira

    2016-01-01

    Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process. The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process. 46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses. Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.

  19. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    PubMed

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  20. Recommendations for the Definition of Clinical Responder in Insulin Preservation Studies

    PubMed Central

    Gitelman, Stephen E.; Palmer, Jerry P.

    2014-01-01

    Clinical responder studies should contribute to the translation of effective treatments and interventions to the clinic. Since ultimately this translation will involve regulatory approval, we recommend that clinical trials prespecify a responder definition that can be assessed against the requirements and suggestions of regulatory agencies. In this article, we propose a clinical responder definition to specifically assist researchers and regulatory agencies in interpreting the clinical importance of statistically significant findings for studies of interventions intended to preserve β-cell function in newly diagnosed type 1 diabetes. We focus on studies of 6-month β-cell preservation in type 1 diabetes as measured by 2-h–stimulated C-peptide. We introduce criteria (bias, reliability, and external validity) for the assessment of responder definitions to ensure they meet U.S. Food and Drug Administration and European Medicines Agency guidelines. Using data from several published TrialNet studies, we evaluate our definition (no decrease in C-peptide) against published alternatives and determine that our definition has minimum bias with external validity. We observe that reliability could be improved by using changes in C-peptide later than 6 months beyond baseline. In sum, to support efficacy claims of β-cell preservation therapies in type 1 diabetes submitted to U.S. and European regulatory agencies, we recommend use of our definition. PMID:24722251

  1. Cartilage Repair With Autologous Bone Marrow Mesenchymal Stem Cell Transplantation: Review of Preclinical and Clinical Studies.

    PubMed

    Yamasaki, Shinya; Mera, Hisashi; Itokazu, Maki; Hashimoto, Yusuke; Wakitani, Shigeyuki

    2014-10-01

    Clinical trials of various procedures, including bone marrow stimulation, mosaicplasty, and autologous chondrocyte implantation, have been explored to treat articular cartilage defects. However, all of them have some demerits. We focused on autologous culture-expanded bone marrow mesenchymal stem cells (BMSC), which can proliferate without losing their capacity for differentiation. First, we transplanted BMSC into the defective articular cartilage of rabbit and succeeded in regenerating osteochondral tissue. We then applied this transplantation in humans. Our previous reports showed that treatment with BMSC relieves the clinical symptoms of chondral defects in the knee and elbow joint. We investigated the efficacy of BMSC for osteoarthritic knee treated with high tibial osteotomy, by comparing 12 BMSC-transplanted patients with 12 cell-free patients. At 16-month follow-up, although the difference in clinical improvement between both groups was not significant, the arthroscopic and histological grading score was better in the cell-transplanted group. At the over 10-year follow-up, Hospital for Special Surgery knee scores improved to 76 and 73 in the BMSC-transplanted and cell-free groups, respectively, which were better than preoperative scores. Additionally, neither tumors nor infections were observed in all patients, and in the clinical study, we have never observed hypertrophy of repaired tissue, thereby guaranteeing the clinical safety of this therapy. Although we have never observed calcification above the tidemark in rabbit model and human histologically, the repair cartilage was not completely hyaline cartilage. To elucidate the optimum conditions for cell therapy, other stem cells, culture conditions, growth factors, and gene transfection methods should be explored.

  2. Perspective: Recommendations for benchmarking pre-clinical studies of nanomedicines

    PubMed Central

    Dawidczyk, Charlene M.; Russell, Luisa M.; Searson, Peter C.

    2015-01-01

    Nanoparticle-based delivery systems provide new opportunities to overcome the limitations associated with traditional small molecule drug therapy for cancer, and to achieve both therapeutic and diagnostic functions in the same platform. Pre-clinical trials are generally designed to assess therapeutic potential and not to optimize the design of the delivery platform. Consequently, progress in developing design rules for cancer nanomedicines has been slow, hindering progress in the field. Despite the large number of pre-clinical trials, several factors restrict comparison and benchmarking of different platforms, including variability in experimental design, reporting of results, and the lack of quantitative data. To solve this problem, we review the variables involved in the design of pre-clinical trials and propose a protocol for benchmarking that we recommend be included in in vivo pre-clinical studies of drug delivery platforms for cancer therapy. This strategy will contribute to building the scientific knowledge base that enables development of design rules and accelerates the translation of new technologies. PMID:26249177

  3. Registered nurses' clinical reasoning skills and reasoning process: A think-aloud study.

    PubMed

    Lee, JuHee; Lee, Young Joo; Bae, JuYeon; Seo, Minjeong

    2016-11-01

    As complex chronic diseases are increasing, nurses' prompt and accurate clinical reasoning skills are essential. However, little is known about the reasoning skills of registered nurses. This study aimed to determine how registered nurses use their clinical reasoning skills and to identify how the reasoning process proceeds in the complex clinical situation of hospital setting. A qualitative exploratory design was used with a think-aloud method. A total of 13 registered nurses (mean years of experience=11.4) participated in the study, solving an ill-structured clinical problem based on complex chronic patients cases in a hospital setting. Data were analyzed using deductive content analysis. Findings showed that the registered nurses used a variety of clinical reasoning skills. The most commonly used skill was 'checking accuracy and reliability.' The reasoning process of registered nurses covered assessment, analysis, diagnosis, planning/implementation, and evaluation phase. It is critical that registered nurses apply appropriate clinical reasoning skills in complex clinical practice. The main focus of registered nurses' reasoning in this study was assessing a patient's health problem, and their reasoning process was cyclic, rather than linear. There is a need for educational strategy development to enhance registered nurses' competency in determining appropriate interventions in a timely and accurate fashion. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Interpretation of biomonitoring data in clinical medicine and the exposure sciences

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

    Williams, Bryan L.; Barr, Dana B.; Wright, J. Michael

    2008-11-15

    Biomonitoring has become a fundamental tool in both exposure science and clinical medicine. Despite significant analytical advances, the clinical use of environmental biomarkers remains in its infancy. Clinical use of environmental biomarkers poses some complex scientific and ethical challenges. The purpose of this paper is compare how the clinical and exposure sciences differ with respect to their interpretation and use of biological data. Additionally, the clinical use of environmental biomonitoring data is discussed. A case study is used to illustrate the complexities of conducting biomonitoring research on highly vulnerable populations in a clinical setting.

  5. Osteoarthritis subpopulations and implications for clinical trial design

    PubMed Central

    2011-01-01

    Treatment guidelines for osteoarthritis have stressed the need for research on clinical predictors of response to different treatments. However, identifying such clinical predictors of response is less easy than it seems, and there is not a given classification of osteoarthritis subpopulations. This review article highlights the key methodical issues when analyzing and designing clinical studies to detect important subgroups with respect to treatment effect. In addition, we discuss the main osteoarthritis subpopulations and give examples of how specific treatment effects in these subpopulations have been assessed. PMID:21470393

  6. An open-label, 12-week clinical and sleep EEG study of nefazodone in chronic combat-related posttraumatic stress disorder.

    PubMed

    Gillin, J C; Smith-Vaniz, A; Schnierow, B; Rapaport, M H; Kelsoe, J; Raimo, E; Marler, M R; Goyette, L M; Stein, M B; Zisook, S

    2001-10-01

    We examined the effects of nefazodone on polysomnographic sleep measures and subjective reports of sleep quality and nightmares. as well as other symptoms, in patients with chronic combat-related posttraumatic stress disorder (PTSD) during a 12-week, open-label clinical trial. To our knowledge, this is the first polysomnographic study of treatment in patients with PTSD. The subjects were 12 male veterans (mean age = 54 years) who met DSM-IV diagnostic criteria for PTSD (mean duration = 30 years). All but I patient also met DSM-IV criteria for major depressive disorder. Patients were evaluated weekly with clinical ratings in an open-label clinical trial. Polysomnographic recordings for 2 consecutive nights were obtained before treatment and at 2, 4, 8, and 12 weeks. The dose of nefazodone was adjusted according to individual clinical needs. Final mean daily dose was 441 mg. The patients reported significantly fewer nightmares and sleep problems during treatment. Nevertheless, contrary to studies in depressed patients, nefazodone did not significantly affect polysomnographic sleep measures compared with baseline. In addition, the patients showed significant improvement in the Clinical Global Impressions of PTSD symptoms (global score, hyperarousals and intrusions subscales), the Clinician-Administered PTSD Scale (global, hyperarousal, and intrusions subscales), the Hamilton Rating Scale for Depression (HAM-D). and the Beck Depression Inventory (BDI). These patients with chronic, treatment-resistant, combat-related PTSD showed significant improvement of subjective symptoms of nightmares and sleep disturbance, as well as depression and PTSD symptoms. in this 12-week open-label clinical trial. Nevertheless, objective polysomnographic sleep measures did not change. Further studies, including double-blind. placebo-controlled trials, are needed to extend these findings and to understand the relationships between the physiology of sleep and symptoms of poor sleep and

  7. Parameters and pitfalls to consider in the conduct of food additive research, Carrageenan as a case study.

    PubMed

    Weiner, Myra L

    2016-01-01

    This paper provides guidance on the conduct of new in vivo and in vitro studies on high molecular weight food additives, with carrageenan, the widely used food additive, as a case study. It is important to understand the physical/chemical properties and to verify the identity/purity, molecular weight and homogeneity/stability of the additive in the vehicle for oral delivery. The strong binding of CGN to protein in rodent chow or infant formula results in no gastrointestinal tract exposure to free CGN. It is recommended that doses of high Mw non-caloric, non-nutritive additives not exceed 5% by weight of total solid diet to avoid potential nutritional effects. Addition of some high Mw additives at high concentrations to liquid nutritional supplements increases viscosity and may affect palatability, caloric intake and body weight gain. In in vitro studies, the use of well-characterized, relevant cell types and the appropriate composition of the culture media are necessary for proper conduct and interpretation. CGN is bound to media protein and not freely accessible to cells in vitro. Interpretation of new studies on food additives should consider the interaction of food additives with the vehicle components and the appropriateness of the animal or cell model and dose-response. Copyright © 2015 FMC Corporation. Published by Elsevier Ltd.. All rights reserved.

  8. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    PubMed

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  9. Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.

    PubMed

    Paul, Jisna R; Ranganathan, Prabha

    2012-06-01

    The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.

  10. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study.

    PubMed

    Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

    2015-01-01

    Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p < 0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs' abilities to apply EBP knowledge and skills when supervising students.

  11. Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

    PubMed Central

    Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

    2015-01-01

    Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

  12. Clinical Manifestation and Risk Factors of Tuberculosis Infection in Malaysia: Case Study of a Community Clinic

    PubMed Central

    Shanmuganathan, Rohan; Shanmuganathan, Indra Devi

    2015-01-01

    Introduction: The main aim of this study was to describe the clinical manifestation of tuberculosis infection cases in Malaysia and to determine the individual risk factors for their occurrence. Methodology: The study adopted a quantitative research approach with use of descriptive statistical approach. The study setting was a community clinic which treats walk in patients who are mainly living and working in the surrounding areas. The study was conducted for a period of one year. All tuberculosis patients who sought treatment in the clinic during the time were included in this study. The total number of cases was 40. Data was collected from the medical records of the tuberculosis patients. The risk factors selected for investigation were demographic characteristics of age and sex, personal habits such as smoking, drug use and alcohol and presence of diseases such as human immunodeficiency virus positive (HIV+), diabetes mellitus, cancer, cyanotic heart disease, renal failure and steroid use. Results: Patients in the age group ranging from 41 to 50 years had the highest incidence of the infection. Smoking appears to be the most important risk factor for contracting followed by drug abuse, HIV+ infection and diabetes mellitus. Conclusions: People with diseases such as diabetes mellitus and HIV that are high risk factors for TB should be screened for TB so that early detection and intervention is possible. Educational programs should be carried out to create awareness among the at risk groups. PMID:25946947

  13. Clinical manifestation and risk factors of tuberculosis infection in Malaysia: case study of a community clinic.

    PubMed

    Shanmuganathan, Rohan; Subramaniam, Indra Devi

    2015-01-01

    The main aim of this study was to describe the clinical manifestation of tuberculosis infection cases in Malaysia and to determine the individual risk factors for their occurrence. The study adopted a quantitative research approach with use of descriptive statistical approach. The study setting was a community clinic which treats walk in patients who are mainly living and working in the surrounding areas. The study was conducted for a period of one year. All tuberculosis patients who sought treatment in the clinic during the time were included in this study. The total number of cases was 40. Data was collected from the medical records of the tuberculosis patients. The risk factors selected for investigation were demographic characteristics of age and sex, personal habits such as smoking, drug use and alcohol and presence of diseases such as human immunodeficiency virus positive (HIV+), diabetes mellitus, cancer, cyanotic heart disease, renal failure and steroid use. Patients in the age group ranging from 41 to 50 years had the highest incidence of the infection. Smoking appears to be the most important risk factor for contracting followed by drug abuse, HIV+ infection and diabetes mellitus. People with diseases such as diabetes mellitus and HIV that are high risk factors for TB should be screened for TB so that early detection and intervention is possible. Educational programs should be carried out to create awareness among the at risk groups.

  14. Pilot study of digital tools to support multimodal hand hygiene in a clinical setting.

    PubMed

    Thirkell, Gary; Chambers, Joanne; Gilbart, Wayne; Thornhill, Kerrill; Arbogast, James; Lacey, Gerard

    2018-03-01

    Digital tools for hand hygiene do not share data, limiting their potential to support multimodal programs. The Christie NHS Foundation Trust, United Kingdom, worked with GOJO (in the United States), MEG (in Ireland), and SureWash (in Ireland) to integrate their systems and pilot their combined use in a clinical setting. A 28-bed medical oncology unit piloted the system for 5 weeks. Live data from the tools were combined to create a novel combined risk status metric that was displayed publicly and via a management Web site. The combined risk status reduced over the pilot period. However, larger and longer duration studies are required to reach statistical significance. Staff and especially patient reaction was positive in that 70% of the hand hygiene training events were by patients. The digital tools did not negatively impact clinical workflow and received positive engagement from staff and patients. The combined risk status did not change significantly over the short pilot period because there was also no specific hand hygiene improvement campaign underway at the time of the pilot study. The results indicate that integrated digital tools can provide both rich data and novel tools that both measure impact and provide feedback to support the implementation of multimodal hand hygiene campaigns, reducing the need for significant additional personnel resources. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

  15. [Modeling the academic performance of medical students in basic sciences and pre-clinical courses: a longitudinal study].

    PubMed

    Zúñiga, Denisse; Mena, Beltrán; Oliva, Rose; Pedrals, Nuria; Padilla, Oslando; Bitran, Marcela

    2009-10-01

    The study of predictors of academic performance is relevant for medical education. Most studies of academic performance use global ratings as outcome measure, and do not evaluate the influence of the assessment methods. To model by multivariate analysis, the academic performance of medical considering, besides academic and demographic variables, the methods used to assess students' learning and their preferred modes of information processing. Two hundred seventy two students admitted to the medical school of the Pontificia Universidad Católica de Chile from 2000 to 2003. Six groups of variables were studied to model the students' performance in five basic science courses (Anatomy, Biology, Calculus, Chemistry and Physics) and two pre-clinical courses (Integrated Medical Clinic I and IT). The assessment methods examined were multiple choice question tests, Objective Structured Clinical Examination and tutor appraisal. The results of the university admission tests (high school grades, mathematics and biology tests), the assessment methods used, the curricular year and previous application to medical school, were predictors of academic performance. The information processing modes influenced academic performance, but only in interaction with other variables. Perception (abstract or concrete) interacted with the assessment methods, and information use (active or reflexive), with sex. The correlation between the real and predicted grades was 0.7. In addition to the academic results obtained prior to university entrance, the methods of assessment used in the university and the information processing modes influence the academic performance of medical students in basic and preclinical courses.

  16. Mining the preferences of patients for ubiquitous clinic recommendation.

    PubMed

    Chen, Tin-Chih Toly; Chiu, Min-Chi

    2018-03-06

    A challenge facing all ubiquitous clinic recommendation systems is that patients often have difficulty articulating their requirements. To overcome this problem, a ubiquitous clinic recommendation mechanism was designed in this study by mining the clinic preferences of patients. Their preferences were defined using the weights in the ubiquitous clinic recommendation mechanism. An integer nonlinear programming problem was solved to tune the values of the weights on a rolling basis. In addition, since it may take a long time to adjust the values of weights to their asymptotic values, the back propagation network (BPN)-response surface method (RSM) method is applied to estimate the asymptotic values of weights. The proposed methodology was tested in a regional study. Experimental results indicated that the ubiquitous clinic recommendation system outperformed several existing methods in improving the successful recommendation rate.

  17. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies

    PubMed Central

    Iffland, Kerstin; Grotenhermen, Franjo

    2017-01-01

    Abstract Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile. This could improve patients' compliance and adherence to treatment. CBD is often used as adjunct therapy. Therefore, more clinical research is warranted on CBD action on hepatic enzymes, drug transporters, and interactions with other drugs and to see if this mainly leads to positive or negative effects, for example, reducing the needed clobazam doses in epilepsy and therefore clobazam's side effects. Conclusion: This review also illustrates that some important toxicological parameters are yet to be studied, for example, if CBD has an effect on hormones. Additionally, more clinical trials with a greater number of participants and longer chronic CBD administration are still lacking. PMID:28861514

  18. Therapeutic horticulture in clinical depression: a prospective study.

    PubMed

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p < .001) and were clinically relevant (deltaBDI > or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  19. Interpreting and Integrating Clinical and Anatomic Pathology Results.

    PubMed

    Ramaiah, Lila; Hinrichs, Mary Jane; Skuba, Elizabeth V; Iverson, William O; Ennulat, Daniela

    2017-01-01

    The continuing education course on integrating clinical and anatomical pathology data was designed to communicate the importance of using a weight of evidence approach to interpret safety findings in toxicology studies. This approach is necessary, as neither clinical nor anatomic pathology data can be relied upon in isolation to fully understand the relationship between study findings and the test article. Basic principles for correlating anatomic pathology and clinical pathology findings and for integrating these with other study end points were reviewed. To highlight these relationships, a series of case examples, presented jointly by a clinical pathologist and an anatomic pathologist, were used to illustrate the collaborative effort required between clinical and anatomical pathologists. In addition, the diagnostic utility of traditional liver biomarkers was discussed using results from a meta-analysis of rat hepatobiliary marker and histopathology data. This discussion also included examples of traditional and novel liver and renal biomarker data implementation in nonclinical toxicology studies to illustrate the relationship between discrete changes in biochemistry and tissue morphology.

  20. Influence of Polarization on Carbohydrate Hydration: A Comparative Study Using Additive and Polarizable Force Fields.

    PubMed

    Pandey, Poonam; Mallajosyula, Sairam S

    2016-07-14

    Carbohydrates are known to closely modulate their surrounding solvent structures and influence solvation dynamics. Spectroscopic investigations studying far-IR regions (below 1000 cm(-1)) have observed spectral shifts in the libration band (around 600 cm(-1)) of water in the presence of monosaccharides and polysaccharides. In this paper, we use molecular dynamics simulations to gain atomistic insight into carbohydrate-water interactions and to specifically highlight the differences between additive (nonpolarizable) and polarizable simulations. A total of six monosaccharide systems, α and β anomers of glucose, galactose, and mannose, were studied using additive and polarizable Chemistry at HARvard Macromolecular Mechanics (CHARMM) carbohydrate force fields. Solvents were modeled using three additive water models TIP3P, TIP4P, and TIP5P in additive simulations and polarizable water model SWM4 in polarizable simulations. The presence of carbohydrate has a significant effect on the microscopic water structure, with the effects being pronounced for proximal water molecules. Notably, disruption of the tetrahedral arrangement of proximal water molecules was observed due to the formation of strong carbohydrate-water hydrogen bonds in both additive and polarizable simulations. However, the inclusion of polarization resulted in significant water-bridge occupancies, improved ordered water structures (tetrahedral order parameter), and longer carbohydrate-water H-bond correlations as compared to those for additive simulations. Additionally, polarizable simulations also allowed the calculation of power spectra from the dipole-dipole autocorrelation function, which corresponds to the IR spectra. From the power spectra, we could identify spectral signatures differentiating the proximal and bulk water structures, which could not be captured from additive simulations.