["I dreamed that I dreamed": some notes on the clinical evaluation of therapist interventions, exemplified by Deserno's case study (session 290)].

PubMed

Berns, U; Hemprich, L

2001-01-01

In No. 8, 48th year, August 1998, of the journal "Psychotherapie--Psychosomatik--Medizinische Psychologie" the tape recorder transcription of the 290th session of a long-term analysis was studied by three methods (BIP, Frames, ZBKT). The paper presented here was stimulated by this publication. From the author's viewpoint substantial clinical aspects of evaluation could be added by applying a clinical evaluation method developed by R. Langs and his corresponding concept of interpretation. Clinical vignettes exemplify the possibility to resolve pathological countertransference by using this evaluation method. With the help of this method the presented transcription of the 290th session is evaluated partially.

76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in... entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific...

Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis.

PubMed

Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic; d'Agostino, Maria-Antonietta; Backhaus, Marina; Bentin, Jacques; Chalès, Gérard; Chary-Valckenaere, Isabelle; Conaghan, Philip; Etchepare, Fabien; Gaudin, Philippe; Grassi, Walter; van der Heijde, Désirée; Sellam, Jérémie; Naredo, Esperanza; Szkudlarek, Marcin; Wakefield, Richard; Saraux, Alain

2010-05-01

To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter. To study selected global scoring systems, for the clinical, B mode and power Doppler techniques, the following joints were evaluated: 28 joints (28-joint Disease Activity Score (DAS28)), 20 joints (metacarpophalangeals (MCPs) + metatarsophalangeals (MTPs)) and 38 joints (28 joints + MTPs) using either a binary (yes/no) or a 0-3 grade. The study was a prospective, 4-month duration follow-up of 76 patients with RA requiring anti-tumour necrosis factor (TNF) therapy (complete follow-up data: 66 patients). Intraobserver reliability was evaluated using the intraclass correlation coefficient (ICC), construct validity was evaluated using the Cronbach alpha test and external validity was evaluated using level of correlation between scoring system and C reactive protein (CRP). Sensitivity to change was evaluated using the standardised response mean. Discriminating capacity was evaluated using the standardised mean differences in patients considered by the doctor as significantly improved or not at the end of the study. Different clinimetric properties of various US scoring systems were at least as good as the clinical scores with, for example, intraobserver reliability ranging from 0.61 to 0.97 versus from 0.53 to 0.82, construct validity ranging from 0.76 to 0.89 versus from 0.76 to 0.88, correlation with CRP ranging from 0.28 to 0.34 versus from 0.28 to 0.35 and sensitivity to change ranging from 0.60 to 1.21 versus from 0.96 to 1.36 for US versus clinical scoring systems, respectively. This study suggests that US evaluation of synovitis is an outcome measure at least as relevant as physical examination. Further studies are required in order to achieve optimal US scoring systems for monitoring patients with RA in clinical trials and in clinical practice.

Melanoma detection. A prospective study comparing diagnosis with the naked eye, dermatoscopy and telespectrophotometry.

PubMed

Bono, Aldo; Bartoli, Cesare; Cascinelli, Natale; Lualdi, Manuela; Maurichi, Andrea; Moglia, Daniele; Tragni, Gabrina; Tomatis, Stefano; Marchesini, Renato

2002-01-01

Successful treatment of melanoma depends directly on early diagnosis. Such a diagnosis is based on clinical examination and dermatoscopy. Recently, automated instruments for melanoma detection are under development. To prospectively evaluate the diagnostic possibilities provided by clinical and dermatoscopic examinations and by a computerized telespectrophotometric system (TS). The study involves a consecutive series of 298 patients with 313 cutaneous pigmented lesions (66 melanomas and 247 non-melanoma lesions). Each lesion was subjected to the triple diagnostic evaluation, before surgery. Results were expressed in terms of sensitivity and specificity of each kind of evaluation. Clinical evaluation had sensitivity and specificity values of 86 and 77%, respectively, whereas dermatoscopy gave corresponding values of 91 and 74%. TS assessment resulted in a sensitivity of 80% and a specificity of 49%. Differences between clinical and dermatoscopic diagnoses lacked statistical significance (p = 0.22), whereas there was a significant difference comparing both clinical and TS evaluations (p < 0.01) and dermatoscopic and TS evaluations (p < 0.01). Combining clinical and dermatoscopic evaluations, a sensitivity of 97% was achieved. Addition of TS has not changed this figure. Results of this study confirm and stress the importance of dermatoscopy in the diagnosis of melanoma. Clinical evaluation coupled with dermatoscopy can be considered the cornerstone of such a diagnosis. Although TS is able to achieve interesting results, at present it cannot significantly compete with any of the other tested methods. Copyright 2002 S. Karger AG, Basel

Evaluation Apprehension and Impression Management in Clinical Medical Education.

PubMed

McGaghie, William C

2018-05-01

Historically, clinical medical education has relied on subjective evaluations of students and residents to judge their clinical competence. The uncertainty associated with these subjective clinical evaluations has produced evaluation apprehension among learners and attempts to manage one's professional persona (impression management) among peers and supervisors. Such behavior has been documented from antiquity through the Middle Ages to the present, including in two new qualitative studies in this issue of Academic Medicine on the social psychology of clinical medical education. New approaches to medical education, including competency-based education, mastery learning, and assessment methods that unite evaluation and education, are slowly changing the culture of clinical medical education. The author of this Invited Commentary argues that this shift will bring greater transparency and accountability to clinical medical education and gradually reduce evaluation apprehension and the impression management motives it produces.

Longitudinal construct validity: establishment of clinical meaning in patient evaluative instruments.

PubMed

Liang, M H

2000-09-01

Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda. Analytical review. The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions. Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.

Reporter-Interpreter-Manager-Educator (RIME) descriptive ratings as an evaluation tool in an emergency medicine clerkship.

PubMed

Ander, Douglas S; Wallenstein, Joshua; Abramson, Jerome L; Click, Lorie; Shayne, Philip

2012-10-01

Emergency Medicine (EM) clerkships traditionally assess students using numerical ratings of clinical performance. The descriptive ratings of the Reporter, Interpreter, Manager, and Educator (RIME) method have been shown to be valuable in other specialties. We hypothesized that the RIME descriptive ratings would correlate with clinical performance and examination scores in an EM clerkship, indicating that the RIME ratings are a valid measure of performance. This was a prospective cohort study of an evaluation instrument for 4(th)-year medical students completing an EM rotation. This study received exempt Institutional Review Board status. EM faculty and residents completed shift evaluation forms including both numerical and RIME ratings. Students completed a final examination. Mean scores for RIME and clinical evaluations were calculated. Linear regression models were used to determine whether RIME ratings predicted clinical evaluation scores or final examination scores. Four hundred thirty-nine students who completed the EM clerkship were enrolled in the study. After excluding items with missing data, there were 2086 evaluation forms (based on 289 students) available for analysis. There was a clear positive relationship between RIME category and clinical evaluation score (r(2)=0.40, p<0.01). RIME ratings correlated most strongly with patient management skills and least strongly with humanistic qualities. A very weak correlation was seen with RIME and final examination. We found a positive association between RIME and clinical evaluation scores, suggesting that RIME is a valid clinical evaluation instrument. RIME descriptive ratings can be incorporated into EM evaluation instruments and provides useful data related to patient management skills. Copyright © 2012 Elsevier Inc. All rights reserved.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Evaluating the impact of a pre-rotation workshop on student preparation for clinical advanced pharmacy practice experiences.

PubMed

Medina, Melissa S; Stark, Jennifer E; Vesta, Kimi S; Lockhart, Staci M

2008-10-01

This pilot study was designed to evaluate the impact of a pre-rotation workshop (PRW) on pharmacy students' clinical skills and preparation for clinical Advanced Pharmacy Practice Experiences (APPE) involving direct patient care. Randomized controlled trial of an educational intervention with Institutional Review Board approval. PRW activities designed to simulate rotation activities around five competencies, patient charts, medication histories, SOAP notes, patient presentations, and professionalism. Endpoints were evaluated using clinical rotation preceptors' evaluation of performance and students' performance on objective structured clinical exams (OSCE). Eight fourth-year students and eight GPA matched controls (20% of the total class) were selected to voluntarily participate. The PRW demonstrated a positive impact on students' clinical skills and preparation for rotations by improving OSCE performance. However, no significant differences were found between groups when comparing preceptor evaluations of skills on rotations. These results are limited by the small sample size, potential OSCE "test-wiseness" effects, lack of OSCE evaluator blinding to study groups, potential case specificity effects due to the limited number of cases used on the OSCE and possible lack of sensitivity of the rotation evaluation tool to capture true differences among the experimental and control group participants. The PRW was successful at advancing students' clinical skills and preparation for rotations and may be considered as a tool to help bridge didactic to clinical experiences in the Pharm.D. curriculum.

Evaluation Criteria for Nursing Student Application of Evidence-Based Practice: A Delphi Study.

PubMed

Bostwick, Lina; Linden, Lois

2016-06-01

Core clinical evaluation criteria do not exist for measuring prelicensure baccalaureate nursing students' application of evidence-based practice (EBP) during direct care assignments. The study objective was to achieve consensus among EBP nursing experts to create clinical criteria for faculty to use in evaluating students' application of EBP principles. A three-round Delphi method was used. Experts were invited to participate in Web-based surveys. Data were analyzed using qualitative coding and categorizing. Quantitative analyses were descriptive calculations for rating and ranking. Expert consensus occurred in the Delphi rounds. The study provides a set of 10 core clinical evaluation criteria for faculty evaluating students' progression toward competency in their application of EBP. A baccalaureate program curriculum requiring the use of Bostwick's EBP Core Clinical Evaluation Criteria will provide a clear definition for understanding basic core EBP competence as expected for the assessment of student learning. [J Nurs Educ. 2016;55(5):336-341.]. Copyright 2016, SLACK Incorporated.

Maintenance of a smoking cessation program in public health clinics beyond the experimental evaluation period.

PubMed Central

Manfredi, C.; Crittenden, K.; Cho, Y. I.; Engler, J.; Warnecke, R.

2001-01-01

OBJECTIVES: As phase 3 of a study to evaluate a smoking cessation program in public health practice, the authors assess the maintenance and impact of the It's Time smoking cessation program in seven public maternal and child health clinics in Chicago. METHODS: The authors interviewed 404 clinic patients in the study's baseline phase (prior to introduction of the It's Time intervention program), and 610 in the program maintenance phase (in the year after experimental evaluation had ended) to assess exposure to smoking cessation interventions offered at the clinic, and smoking cessation outcomes (quit, actions toward quitting, scores on action, motivation, readiness, and confidence scales). The authors controlled for clustering of smokers within clinics, smokers' characteristics prior to clinic visit, and type of clinic service. They compared outcomes by study group (control or intervention) to which each clinic had been assigned in the earlier experimental phase. RESULTS: Compared to baseline, smokers in the maintenance phase had greater exposure to posters, provider advice and booklet, and better outcomes on seven of eight smoking cessation measures, including quitting. These improvements were larger for clinics with prior experience implementing It's Time. CONCLUSION: Participation in the experimental evaluation of the It's Time program prepared and possibly motivated the clinics to continue the program. Continuing the program resulted in greater delivery of interventions and improved smoking cessation outcomes for smokers in the clinics. PMID:11889280

Analyzing the effectiveness of teaching and factors in clinical decision-making.

PubMed

Hsieh, Ming-Chen; Lee, Ming-Shinn; Chen, Tsung-Ying; Tsai, Tsuen-Chiuan; Pai, Yi-Fong; Sheu, Min-Muh

2017-01-01

The aim of this study is to prepare junior physicians, clinical education should focus on the teaching of clinical decision-making. This research is designed to explore teaching of clinical decision-making and to analyze the benefits of an "Analogy guide clinical decision-making" as a learning intervention for junior doctors. This study had a "quasi-experimental design" and was conducted in a medical center in eastern Taiwan. Participants and Program Description: Thirty junior doctors and three clinical teachers were involved in the study. The experimental group (15) received 1 h of instruction from the "Analogy guide for teaching clinical decision-making" every day for 3 months. Program Evaluation: A "Clinical decision-making self-evaluation form" was used as the assessment tool to evaluate participant learning efficiency before and after the teaching program. Semi-structured qualitative research interviews were also conducted. We found using the analogy guide for teaching clinical decision-making could help enhance junior doctors' self-confidence. Important factors influencing clinical decision-making included workload, decision-making, and past experience. Clinical teaching using the analogy guide for clinical decision-making may be a helpful tool for training and can contribute to a more comprehensive understanding of decision-making.

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

Genomic markers for decision making: what is preventing us from using markers?

PubMed

Coyle, Vicky M; Johnston, Patrick G

2010-02-01

The advent of novel genomic technologies that enable the evaluation of genomic alterations on a genome-wide scale has significantly altered the field of genomic marker research in solid tumors. Researchers have moved away from the traditional model of identifying a particular genomic alteration and evaluating the association between this finding and a clinical outcome measure to a new approach involving the identification and measurement of multiple genomic markers simultaneously within clinical studies. This in turn has presented additional challenges in considering the use of genomic markers in oncology, such as clinical study design, reproducibility and interpretation and reporting of results. This Review will explore these challenges, focusing on microarray-based gene-expression profiling, and highlights some common failings in study design that have impacted on the use of putative genomic markers in the clinic. Despite these rapid technological advances there is still a paucity of genomic markers in routine clinical use at present. A rational and focused approach to the evaluation and validation of genomic markers is needed, whereby analytically validated markers are investigated in clinical studies that are adequately powered and have pre-defined patient populations and study endpoints. Furthermore, novel adaptive clinical trial designs, incorporating putative genomic markers into prospective clinical trials, will enable the evaluation of these markers in a rigorous and timely fashion. Such approaches have the potential to facilitate the implementation of such markers into routine clinical practice and consequently enable the rational and tailored use of cancer therapies for individual patients.

Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.

PubMed

Madsen, Lydia T; Kuban, Deborah A; Choi, Seungtaek; Davis, John W; Kim, Jeri; Lee, Andrew K; Domain, Delora; Levy, Larry; Pisters, Louis L; Pettaway, Curtis A; Ward, John F; Logothetis, Christopher; Hoffman, Karen E

2014-07-01

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative. Copyright © 2014 by the National Comprehensive Cancer Network.

A pilot study of clinical agreement in cardiovascular preparticipation examinations: how good is the standard of care?

PubMed

O'Connor, Francis G; Johnson, Jeremy D; Chapin, Mark; Oriscello, Ralph G; Taylor, Dean C

2005-05-01

To evaluate the interobserver agreement between physicians regarding a abnormal cardiovascular assessment on athletic preparticipation examinations. Cross-sectional clinical survey. Outpatient Clinic, United States Military Academy, West Point, NY. We randomly selected 101 out of 539 cadet-athletes presenting for a preparticipation examination. Two primary care sports medicine fellows and a cardiologist examined the cadets. After obtaining informed consent from all participants, all 3 physicians separately evaluated all 101 cadets. The physicians recorded their clinical findings and whether they thought further cardiovascular evaluation (echocardiography) was indicated. Rate of referral for further cardiovascular evaluation, clinical agreement between sports medicine fellows, and clinical agreement between sports medicine fellows and the cardiologist. Each fellow referred 6 of the 101 evaluated cadets (5.9%). The cardiologist referred none. Although each fellow referred 6 cadets, only 1 cadet was referred by both. The kappa statistic for clinical agreement between fellows is 0.114 (95% CI, -0.182 to 0.411). There was no clinical agreement between the fellows and the cardiologist. This pilot study reveals a low level of agreement between physicians regarding which athletes with an abnormal examination deserved further testing. It challenges the standard of care and questions whether there is a need for improved technologies or improved training in cardiovascular clinical assessment.

[Clinical practice guidelines (II): searching and critical evaluation].

PubMed

Alonso, P; Bonfill, X

2007-01-01

Clinical practice guidelines have unique characteristics of the Internet era in which they are starting to be increasingly popular. The fact that they are often elaborated by governmental agencies and are not published in conventional journals means that they may not be accessible using the usual search methods employed for other types of scientific studies and documents (clinical trials, reviews, etc.). The Internet has become an essential tool for locating clinical practice guidelines, and meta-search engines, specific databases, directories, and elaborating institutions are of special importance. The relative lack of indexing of clinical practice guides means that Medline and Embase are not as useful in this context as in searching for original studies. With the aim of evaluating the validity, reproducibility, and reliability of clinical practice guidelines, a series of European institutions designed a tool to evaluate clinical practice guidelines at the end of the 1990s. This instrument, named AGREE, aims to offer a framework for the evaluation of the quality of clinical practice guidelines. It can also be useful in the design of new clinical practice guidelines as well as in the evaluation of the validity of guidelines to be updated or adapted. The AGREE instrument has become the reference for those that use guidelines, those that elaborate them, and for healthcare providers.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93% of the total target number of participants.

Results from an audit feedback strategy for chronic obstructive pulmonary disease in-hospital care: a joint analysis from the AUDIPOC and European COPD audit studies.

PubMed

Lopez-Campos, Jose Luis; Asensio-Cruz, M Isabel; Castro-Acosta, Ady; Calero, Carmen; Pozo-Rodriguez, Francisco

2014-01-01

Clinical audits have emerged as a potential tool to summarize the clinical performance of healthcare over a specified period of time. However, the effectiveness of audit and feedback has shown inconsistent results and the impact of audit and feedback on clinical performance has not been evaluated for COPD exacerbations. In the present study, we analyzed the results of two consecutive nationwide clinical audits performed in Spain to evaluate both the in-hospital clinical care provided and the feedback strategy. The present study is an analysis of two clinical audits performed in Spain that evaluated the clinical care provided to COPD patients who were admitted to the hospital for a COPD exacerbation. The first audit was performed from November-December 2008. The feedback strategy consisted of personalized reports for each participant center, the presentation and discussion of the results at regional, national and international meetings and the creation of health-care quality standards for COPD. The second audit was part of a European study during January and February 2011. The impact of the feedback strategy was evaluated in term of clinical care provided and in-hospital survival. A total of 94 centers participated in the two audits, recruiting 8,143 admissions (audit 1∶3,493 and audit 2∶4,650). The initially provided clinical care was reasonably acceptable even though there was considerable variability. Several diagnostic and therapeutic procedures improved in the second audit. Although the differences were significant, the degree of improvement was small to moderate. We found no impact on in-hospital mortality. The present study describes COPD hospital care in Spanish hospitals and evaluates the impact of peer-benchmarked, individually written and group-oral feedback strategy on the clinical outcomes for treating COPD exacerbations. It describes small to moderate improvements in the clinical care provided to COPD patients with no impact on in-hospital mortality.

Implementing clinical guidelines to prevent catheter-associated urinary tract infections and improve catheter care in nursing homes: Systematic review.

PubMed

Gould, Dinah; Gaze, Sarah; Drey, Nicholas; Cooper, Tracey

2017-05-01

Catheter-associated urinary tract infection is the most common health care-associated infection, is considered avoidable, and has cost implications for health services. Prevalence is high in nursing homes, but little research has been undertaken to establish whether implementing clinical guidelines can reduce infection rates in long-term care or improve quality of urinary catheter care. Systematic search and critical appraisal of the literature. Three studies evaluated the impact of implementing a complete clinical guideline. Five additional studies evaluated the impact of implementing individual elements of a clinical guideline. Prevention of catheter-associated urinary tract infection in nursing homes has received little clinical or research attention. Studies concerned with whole guideline implementation emerged as methodologically poor using recognized criteria for critically appraising epidemiologic studies concerned with infection prevention. Research evaluating the impact of single elements of clinical guidelines is more robust, and their findings could be implemented to prevent urinary infections in nursing homes. Copyright © 2017. Published by Elsevier Inc.

Accuracy of clinical swallowing evaluation for diagnosis of dysphagia in children with laryngomalacia or glossoptosis.

PubMed

Gasparin, Marisa; Schweiger, Cláudia; Manica, Denise; Maciel, Antônio Carlos; Kuhl, Gabriel; Levy, Deborah Salle; Marostica, Paulo José Cauduro

2017-01-01

To investigate the accuracy of clinical evaluation of swallowing in a sample of children with laryngomalacia or glossoptosis and describe the prevalence of dysphagia in each of these diseases, as well as characterize the swallow response to speech and language therapy interventions. Children aged 1 month to 11 years receiving care at the Department of Otolaryngology, Hospital de Clínicas de Porto Alegre, Brazil, were evaluated in a cross-sectional design. Evaluation of swallowing was performed at two time points by two blinded speech-language pathologists, one responsible for clinical evaluation and the other for videofluoroscopic study. The protocols employed were based on the instruments proposed by DeMatteo et al. (DeMatteo C, Matovich D, Hjartarson A. Comparison of clinical and videofluoroscopic evaluation of children with feeding and swallowing difficulties. Dev Med Child Neurol 2005;47:149-157.). The study sample consisted of 29 patients: 10 patients with laryngomalacia and 19 patients with glossoptosis. The sensitivity of clinical evaluation did not exceed 50% in any of the evaluations, but specificity reached 100% in some cases, using thickened liquids. The prevalence of dysphagia was 100%, and the use of thickened liquids significantly reduced tracheal aspiration. Dysphagia was highly prevalent in this sample. The sensitivity of clinical evaluation to detect laryngeal penetration and tracheal aspiration was low, as the majority of aspiration events were silent. The videofluoroscopic study is important in order to determine a safest method to feed the patient. Pediatr Pulmonol. 2017;52:41-47. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Competence evaluation processes for nursing students abroad: Findings from an international case study.

PubMed

Tommasini, Cristina; Dobrowolska, Beata; Zarzycka, Danuta; Bacatum, Claudia; Bruun, Anne Marie Gran; Korsath, Dag; Roel, Siv; Jansen, Mette Bro; Milling, Tine; Deschamps, Anne; Mantzoukas, Stefanos; Mantzouka, Christine; Palese, Alvisa

2017-04-01

Assessing clinical competence in nursing students abroad is a challenge, and requires both methods and instruments capable of capturing the multidimensional nature of the clinical competences acquired. The aim of the study was to compare the clinical competence assessment processes and instruments adopted for nursing students during their clinical placement abroad. A case study design was adopted in 2015. A purposeful sample of eight nursing programmes located in seven countries (Belgium, Denmark, Greece, Norway, Poland, Portugal and Italy) were approached. Tools as instruments for evaluating competences developed in clinical training by international nursing students, and written procedures aimed at guiding the evaluation process, were scrutinised through a content analysis method. All clinical competence evaluation procedures and instruments used in the nursing programmes involved were provided in English. A final evaluation of the competences was expected by all nursing programmes at the end of the clinical placement, while only four provided an intermediate evaluation. Great variability emerged in the tools, with between five and 88 items included. Through content analysis, 196 items emerged, classified into 12 different core competence categories, the majority were categorised as 'Technical skills' (=60), 'Self-learning and critical thinking' (=27) and 'Nursing care process' (=25) competences. Little emphasis was given in the tools to competences involving 'Self-adaptation', 'Inter-professional skills', 'Clinical documentation', 'Managing nursing care', 'Patient communication', and 'Theory and practice integration'. Institutions signing Bilateral Agreements should agree upon the competences expected from students during their clinical education abroad. The tools used in the process, as well as the role expected by the student, should also be agreed upon. Intercultural competences should be further addressed in the process of evaluation, in addition to adaptation to different settings. There is also a need to establish those competences achievable or not in the host country, aiming at increasing transparency in learning expectations and evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Link between immunoexpression of hMLH1 and hMSH2 proteins and clinical-epidemiological aspects of actinic cheilitis*

PubMed Central

Sarmento, Dmitry José de Santana; Godoy, Gustavo Pina; Miguel, Márcia Cristina da Costa; da Silveira, Éricka Janine Dantas

2016-01-01

Background The studies found in the literature associate the immunoexpression of hMLH1 and hMSH2 proteins with histologic aspects, but do not correlate it with clinical and epidemiological data. Objective To evaluate the immunoexpression of hMLH1 and hMSH2 in actinic cheilitis, correlating it with clinical characteristics. Methods We analyzed 40 cases. Histological and immunohistochemical analyses were performed. The following clinical variables were evaluated: gender, age range, ethnicity, clinical aspect and occupational sunlight exposure. Statistical evaluation included the Student t-test, while the significance level was set at 5%. Results Greater immunoexpression of hMLH1 and hMSH2 was observed in females, individuals aged over 40, and mixed-race/black patients. Furthermore, the immunoexpression of these proteins was greater in actinic cheilitis with a white-colored appearance and in patients without occupational sunlight exposure. No statistical differences were observed for the variables studied. Conclusion This study uncovered variations of hMLH1 and hMSH2 protein expression upon evaluation of clinical aspects in actinic cheilitis. PMID:27579741

Link between immunoexpression of hMLH1 and hMSH2 proteins and clinical-epidemiological aspects of actinic cheilitis.

PubMed

Sarmento, Dmitry José de Santana; Godoy, Gustavo Pina; Miguel, Márcia Cristina da Costa; Silveira, Éricka Janine Dantas da

2016-01-01

The studies found in the literature associate the immunoexpression of hMLH1 and hMSH2 proteins with histologic aspects, but do not correlate it with clinical and epidemiological data. To evaluate the immunoexpression of hMLH1 and hMSH2 in actinic cheilitis, correlating it with clinical characteristics. We analyzed 40 cases. Histological and immunohistochemical analyses were performed. The following clinical variables were evaluated: gender, age range, ethnicity, clinical aspect and occupational sunlight exposure. Statistical evaluation included the Student t-test, while the significance level was set at 5%. Greater immunoexpression of hMLH1 and hMSH2 was observed in females, individuals aged over 40, and mixed-race/black patients. Furthermore, the immunoexpression of these proteins was greater in actinic cheilitis with a white-colored appearance and in patients without occupational sunlight exposure. No statistical differences were observed for the variables studied. This study uncovered variations of hMLH1 and hMSH2 protein expression upon evaluation of clinical aspects in actinic cheilitis.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

PubMed

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

Evidence of the economic benefit of clinical pharmacy services: 1996-2000.

PubMed

Schumock, Glen T; Butler, Melissa G; Meek, Patrick D; Vermeulen, Lee C; Arondekar, Bhakti V; Bauman, Jerry L

2003-01-01

We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly assigned to reviewers who confirmed inclusion and abstracted key information. Results were compared with those of a similar review of literature published from 1988-1995. In the 59 included articles, the studies were conducted across a variety of practice sites that consisted of hospitals (52%), community pharmacies and clinics (41%), health maintenance organizations (3%), and long-term or intermediate care facilities (3%). They focused on a broad range of clinical pharmacy services such as general pharmacotherapeutic monitoring (47%), target drug programs (20%), disease management programs (10%), and patient education or cognitive services (10%). Compared with the studies of the previous review, a greater proportion of evaluations were conducted in community pharmacies or clinics, and the types of services evaluated tended to be more comprehensive rather than specialized. Articles were categorized by type of evaluation: 36% were considered outcome analyses, 24% full economic analyses, 17% outcome descriptions, 15% cost and outcome descriptions, and 8% cost analyses. Compared with the studies of the previous review, a greater proportion of studies in the current review used more rigorous study designs. Most studies reported positive financial benefits of the clinical pharmacy service evaluated. In 16 studies, a benefit:cost ratio was reported by the authors or was able to be calculated by the reviewers (these ranged from 1.7:1-17.0:1, median 4.68:1). The body of literature from this 5-year period provides continued evidence of the economic benefit of clinical pharmacy services. Although the quality of study design has improved, whenever possible, future evaluations of this type should incorporate methodologies that will further enhance the strength of evidence of this literature and the conclusions that may be drawn from it.

Exploring the validity and reliability of a questionnaire for evaluating veterinary clinical teachers' supervisory skills during clinical rotations.

PubMed

Boerboom, T B B; Dolmans, D H J M; Jaarsma, A D C; Muijtjens, A M M; Van Beukelen, P; Scherpbier, A J J A

2011-01-01

Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. We examined the validity and reliability of the Maastricht Clinical Teaching Questionnaire (MCTQ) as an instrument to evaluate individual clinical teachers during short clinical rotations in veterinary education. We examined four sources of validity evidence: (1) Content was examined based on theory of effective learning. (2) Response process was explored in a pilot study. (3) Internal structure was assessed by confirmatory factor analysis using 1086 student evaluations and reliability was examined utilizing generalizability analysis. (4) Relations with other relevant variables were examined by comparing factor scores with other outcomes. Content validity was supported by theory underlying the cognitive apprenticeship model on which the instrument is based. The pilot study resulted in an additional question about supervision time. A five-factor model showed a good fit with the data. Acceptable reliability was achievable with 10-12 questionnaires per teacher. Correlations between the factors and overall teacher judgement were strong. The MCTQ appears to be a valid and reliable instrument to evaluate clinical teachers' performance during short rotations.

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.

Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

PubMed

Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

2017-03-01

The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error, criterion validity), whereas others were frequently estimated, but using different coefficients and statistical analyses (e.g., internal consistency, structural validity), thus rendering comparison across instruments difficult. Moreover, the methodological quality adopted in the property assessments was poor or fair in most studies, compromising the goodness of the psychometric values estimated. Clinical learning placements represent the key strategies in educating the future nursing workforce: instruments evaluating the quality of the settings, as well as their capacity to promote significant learning, are strongly recommended. Studies estimating psychometric properties, using an increased quality of research methodologies are needed in order to support nursing educators in the process of clinical placements accreditation and quality improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Factors associated with agreement between self-perception and clinical evaluation of dental treatment needs in adults in Brazil and Minas Gerais.

PubMed

Nascimento, Alex Rodrigues do; Andrade, Fabíola Bof de; César, Cibele Comini

2016-11-03

This study sought to describe the agreement between self-perception and clinical evaluation of dental treatment needs in adults and analyze associated factors. The sample comprised adult individuals who took part in SBBrazil 2010 and SBMinas Gerais 2012. The study's outcome was agreement between self-perception and clinical evaluation of dental treatment needs. We used multiple Poisson regression in order to determine the factors associated with the outcome. Agreement between self-perception and clinical evaluation was 78.8% in Brazil and 73.8% in Minas Gerais. Clinical and self-reported oral health conditions that affect function and quality of life were associated with a higher agreement, while a recent visit to the dentist was associated with a lower agreement. Identifying associated factors may enable the development of questionnaires that favor correct self-perception regarding treatment needs.

A short-term clinical evaluation of IPS Empress 2 crowns.

PubMed

Toksavul, Suna; Toman, Muhittin

2007-01-01

The aim of this study was to evaluate the clinical performance of all-ceramic crowns made with the IPS Empress 2 system after an observation period of 12 to 60 months. Seventy-nine IPS Empress 2 crowns were placed in 21 patients. The all-ceramic crowns were evaluated clinically, radiographically, and using clinical photographs. The evaluations took place at baseline (2 days after cementation) and at 6-month intervals for 12 to 60 months. Survival rate of the crowns was determined using Kaplan-Meier statistical analysis. Based on the US Public Health Service criteria, 95.24% of the crowns were rated satisfactory after a mean follow-up period of 58 months. Fracture was registered in only 1 crown. One endodontically treated tooth failed as a result of fracture at the cervical margin area. In this in vivo study, IPS Empress 2 crowns exhibited a satisfactory clinical performance during an observation period ranging from 12 to 60 months.

Service impact of a national clinical leadership development programme: findings from a qualitative study.

PubMed

Fealy, Gerard M; McNamara, Martin S; Casey, Mary; O'Connor, Tom; Patton, Declan; Doyle, Louise; Quinlan, Christina

2015-04-01

The study reported here was part of a larger study, which evaluated a national clinical leadership development programme with reference to resources, participant experiences, participant outcomes and service impact. The aim of the present study was to evaluate the programme's service impact. Clinical leadership development develops competencies that are expressed in context. The outcomes of clinical leadership development occur at individual, departmental and organisational levels. The methods used to evaluate the service impact were focus groups, group interviews and individual interviews. Seventy participants provided data in 18 separate qualitative data collection events. The data contained numerous accounts of service development activities, initiated by programme participants, which improved service and/or improved the culture of the work setting. Clinical leadership development programmes that incorporate a deliberate service impact element can result in identifiable positive service outcomes. The nuanced relationship between leader development and service development warrants further investigation. This study demonstrates that clinical leadership development can impact on service in distinct and identifiable ways. Clinical leadership development programmes should focus on the setting in which the leadership competencies will be demonstrated. © 2013 John Wiley & Sons Ltd.

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

PubMed Central

2012-01-01

Background Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. Methods The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Results Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. Conclusions This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high “rule in” ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs. PMID:22646313

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools.

PubMed

Pressler, Taylor R; Yen, Po-Yin; Ding, Jing; Liu, Jianhua; Embi, Peter J; Payne, Philip R O

2012-05-30

Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high "rule in" ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs.

[Clinical and videofluoroscopic evaluation of deglutition in children with tetraparetic spastic cerebral palsy].

PubMed

Furkim, Ana Maria; Behlau, Mara Suzana; Weckx, Luc Louis Maurice

2003-09-01

Cerebral palsy is a condition that may be associated with swallowing disorders, that is, oropharingeal dysphagia. The aim of this study was to characterize and compare the swallowing processes of 32 children with this condition, by clinical and videofluoroscopic evaluation, with special focus on tracheal aspiration detectability. Results show an important compromise of oral phase. The most important findings during the pharyngeal phase were velopharingeal incompetence and residuals on the pharyngeal recesses. Aspiration was more common with liquids, before and after deglutition. On clinical and videofluoroscopic evaluation, cervical hyperextension was the commonest postural abnormality. Videofluoroscopy confirmed the occurrence of aspiration on most of the cases that presented suggestive signs of aspiration during clinical evaluation. We conclude that clinical and videofluoroscopic evaluations are complementary on deglutition evaluation and together may point to the most specific rehabilitation procedure.

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

PubMed Central

2012-01-01

Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

PubMed

Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

2012-12-21

There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

Exploring the screening capacity of the Fear of Cancer Recurrence Inventory-Short Form for clinical levels of fear of cancer recurrence.

PubMed

Fardell, Joanna E; Jones, Georden; Smith, Allan Ben; Lebel, Sophie; Thewes, Belinda; Costa, Daniel; Tiller, Kerry; Simard, Sébastien; Feldstain, Andrea; Beattie, Sara; McCallum, Megan; Butow, Phyllis

2018-02-01

Fear of cancer recurrence (FCR) is a common concern among cancer survivors. Identifying survivors with clinically significant FCR requires validated screening measures and clinical cut-offs. We evaluated the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) clinical cut-off in 2 samples. Level of FCR in study 1 participants (from an Australian randomized controlled trial: ConquerFear) was compared with FCRI-SF scores. Based on a biopsychosocial interview, clinicians rated participants as having nonclinical, subclinical, or clinical FCR. Study 2 participants (from a Canadian FCRI-English validation study) were classified as having clinical or nonclinical FCR by using the semistructured clinical interview for FCR (SIFCR). Receiver operating characteristic analyses evaluated the screening ability of the FCRI-SF against clinician ratings (study 1) and the SIFCR (study 2). In study 1, 167 cancer survivors (mean age: 53 years, SD = 10.1) participated. Clinicians rated 43% as having clinical FCR. In study 2, 40 cancer survivors (mean age: 68 years, SD = 7.0) participated; 25% met criteria for clinical FCR according to the SIFCR. For both studies 1 and 2, receiver operating characteristic analyses suggested a cut-off ≥22 on the FCRI-SF identified cancer survivors with clinical levels of FCR with adequate sensitivity and specificity. Establishing clinical cut-offs on FCR screening measures is crucial to tailoring individual care and conducting rigorous research. Our results suggest using a higher cut-off on the FCRI-SF than previously reported to identify clinically significant FCR. Continued evaluation and validation of the FCRI-SF cut-off is required across diverse cancer populations. Copyright © 2017 John Wiley & Sons, Ltd.

The effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model.

PubMed

Maddineshat, Maryam; Hashemi, Mitra; Besharati, Reza; Gholami, Sepideh; Ghavidel, Fatemeh

2018-01-01

Clinical experience associated with the fear and anxiety of nursing students in the psychiatric unit. Mental health nursing instructors find it challenging to teach nursing students to deal with patients with mental disorders in an environment where they need to provide patient teaching and clinical decision-making based on evidence and new technology. To measure the effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model evaluation in the psychiatry unit of Imam Reza Hospital, Bojnurd, Iran. This cross-sectional study was carried out from 2011 to 2016 on 76 nursing students from a university as part of a clinical mental health course in two semesters. The students were selected by a non-probable convenient sampling method. After completing their clinical education, each student responded to checklist questions based on the four-level Kirkpatrick's model evaluation and open questions relating to clinical supervision. Finally, all data was analyzed using the SPSS version 16. The students have evaluated clinical supervision as a useful approach, and appreciated the instructor's supportive behavior during teaching and imparting clinical skills. This has made them feel relaxed at the end of the clinical teaching course. In addition, in the evaluation through Kirkpatrick's model, more than 70% of the students have been satisfied with the method of conducting the teaching and average score of nursing students' attitude toward mental health students: Their mean self-confidence score was 18.33±1.69, and the mean score of their performance in the study was evaluated to be 93.74±5.3 from 100 points. The results of clinical mental health teaching through clinical supervision and Kirkpatrick's model evaluation show that the satisfaction, self-esteem, attitude, and skill of nursing students are excellent, thereby portraying the effectiveness of clinical teaching. But this program still needs to be reformed. To establish long-term goals and obtain knowledge and clinical skills of nursing, it is recommended to develop a curriculum and evaluate it appropriately.

Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

PubMed

Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

2015-07-01

To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Effects of structured written feedback by cards on medical students' performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic.

PubMed

Haghani, Fariba; Hatef Khorami, Mohammad; Fakhari, Mohammad

2016-07-01

Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students' performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students' externship. The students' performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations.

Healthcare students' evaluation of the clinical learning environment and supervision - a cross-sectional study.

PubMed

Pitkänen, Salla; Kääriäinen, Maria; Oikarainen, Ashlee; Tuomikoski, Anna-Maria; Elo, Satu; Ruotsalainen, Heidi; Saarikoski, Mikko; Kärsämänoja, Taina; Mikkonen, Kristina

2018-03-01

The purpose of clinical placements and supervision is to promote the development of healthcare students´ professional skills. High-quality clinical learning environments and supervision were shown to have significant influence on healthcare students´ professional development. This study aimed to describe healthcare students` evaluation of the clinical learning environment and supervision, and to identify the factors that affect these. The study was performed as a cross-sectional study. The data (n = 1973) were gathered through an online survey using the Clinical Learning Environment, Supervision and Nurse Teacher scale during the academic year 2015-2016 from all healthcare students (N = 2500) who completed their clinical placement at a certain university hospital in Finland. The data were analysed using descriptive statistics and binary logistic regression analysis. More than half of the healthcare students had a named supervisor and supervision was completed as planned. The students evaluated the clinical learning environment and supervision as 'good'. The students´ readiness to recommend the unit to other students and the frequency of separate private unscheduled sessions with the supervisor were the main factors that affect healthcare students` evaluation of the clinical learning environment and supervision. Individualized and goal-oriented supervision in which the student had a named supervisor and where supervision was completed as planned in a positive environment that supported learning had a significant impact on student's learning. The clinical learning environment and supervision support the development of future healthcare professionals' clinical competence. The supervisory relationship was shown to have a significant effect on the outcomes of students' experiences. We recommend the planning of educational programmes for supervisors of healthcare students for the enhancement of supervisors' pedagogical competencies in supervising students in the clinical practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical Amyloid Imaging.

PubMed

Mallik, Atul; Drzezga, Alex; Minoshima, Satoshi

2017-01-01

Amyloid plaques, along with neurofibrillary tangles, are a neuropathologic hallmark of Alzheimer disease (AD). Recently, amyloid PET radiotracers have been developed and approved for clinical use in the evaluation of suspected neurodegenerative disorders. In both research and clinical settings, amyloid PET imaging has provided important diagnostic and prognostic information for the management of patients with possible AD, mild cognitive impairment (MCI), and other challenging diagnostic presentations. Although the overall impact of amyloid imaging is still being evaluated, the Society of Nuclear Medicine and Molecular Imaging and Alzheimer's Association Amyloid Imaging Task Force have created appropriate use criteria for the standard clinical use of amyloid PET imaging. By the appropriate use criteria, amyloid imaging is appropriate for patients with (1) persistent or unexplained MCI, (2) AD as a possible but still uncertain diagnosis after expert evaluation and (3) atypically early-age-onset progressive dementia. To better understand the clinical and economic effect of amyloid imaging, the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study is an ongoing large multicenter study in the United States, which is evaluating how amyloid imaging affects diagnosis, management, and outcomes for cognitively impaired patients who cannot be completely evaluated by clinical assessment alone. Multiple other large-scale studies are evaluating the prognostic role of amyloid PET imaging for predicting MCI progression to AD in general and high-risk populations. At the same time, amyloid imaging is an important tool for evaluating potential disease-modifying therapies for AD. Overall, the increased use of amyloid PET imaging has led to a better understanding of the strengths and limitations of this imaging modality and how it may best be used with other clinical, molecular, and imaging assessment techniques for the diagnosis and management of neurodegenerative disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Understanding resident ratings of teaching in the workplace: a multi-centre study.

PubMed

Fluit, Cornelia R M G; Feskens, Remco; Bolhuis, Sanneke; Grol, Richard; Wensing, Michel; Laan, Roland

2015-08-01

Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced these evaluations, and the relation between residents' scores and their teachers' self-scores. The evaluation and feedback for effective clinical teaching questionnaire (EFFECT) was used to (self)assess clinical teachers from 12 disciplines (15 departments, four hospitals). Items were scored on a five-point Likert scale. Main outcome measures were residents' mean overall scores (MOSs), specific scale scores (MSSs), and clinical teachers' self-evaluation scores. Multilevel regression analysis was used to identify predictors. Residents' scores and self-evaluations were compared. Residents filled in 1,013 questionnaires, evaluating 230 clinical teachers. We received 160 self-evaluations. 'Planning Teaching' and 'Personal Support' (4.52, SD .61 and 4.53, SD .59) were rated highest, 'Feedback Content' (CanMEDS related) (4.12, SD .71) was rated lowest. Teachers in affiliated hospitals showed highest MOS and MSS. Medical specialty did not influence MOS. Female clinical teachers were rated higher for most MSS, achieving statistical significance. Residents in year 1-2 were most positive about their teachers. Residents' gender did not affect the mean scores, except for role modeling. At group level, self-evaluations and residents' ratings correlated highly (Kendall's τ 0.859). Resident evaluations of clinical teachers are influenced by teacher's gender, year of residency training, type of hospital, and to a lesser extent teachers' gender. Clinical teachers and residents agree on strong and weak points of clinical teaching.

Relation between spiritual intelligence and clinical competency of nurses in Iran

PubMed Central

Karimi-Moonaghi, Hossein; Gazerani, Akram; Vaghee, Saeed; Gholami, Hassan; Salehmoghaddam, Amir Reza; Gharibnavaz, Raheleh

2015-01-01

Background: Clinical competency is one of the most important requirements in nursing profession, based on which nurses are assessed. To obtain an effective and improved form of clinical competency, several factors are observed and monitored by the health educational systems. Among these observed factors, spiritual intelligence is considered as one of the most significant factors in nurses’ success and efficacy. In this study, it is aimed to determine the spiritual intelligence status and its relationship with clinical competency. Materials and Methods: The descriptive–correlational research was carried out on 250 nurses in Mashhad educational hospitals, selected by multi-stage sampling. Demographic, clinical competency, and spiritual intelligence questionnaires were used for data collection and 212 questionnaires were analyzed. Results: About 53.3% of nurses obtained above average scores in spiritual intelligence. Clinical competency was evaluated by both self-evaluation and head nurse evaluation methods. Most nurses (53.8%) were having good level of clinical competency based on self-evaluation, 48.2% were at average level based on head nurse evaluation, and 53.3% were at average level based on overall score. A significant correlation was found between spiritual intelligence and clinical competency. Conclusions: In this study, the positive significant correlation between nurses’ spiritual intelligence and their clinical competency is investigated. Because of the positive effects of spiritual intelligence on nurses’ clinical competency and quality of care, it is recommended to develop nurses’ spiritual intelligence during their education and by way of continuous medical education. PMID:26793250

Understanding Resident Ratings of Teaching in the Workplace: A Multi-Centre Study

ERIC Educational Resources Information Center

Fluit, Cornelia R. M. G.; Feskens, Remco; Bolhuis, Sanneke; Grol, Richard; Wensing, Michel; Laan, Roland

2015-01-01

Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced these evaluations, and the relation between…

[Family doctor clinical aptitude confronting gestational diabetes patients].

PubMed

Pivaral, Carlos Enrique Cabrera; Clara, Elizabeth Rivera; Peña, Luz María Adriana Balderas; Centeno, Mayari Cabrera; Reynoso, Carlos Alonso

2008-02-01

Gestational diabetes mellitus complicates 7% of all pregnancies. Recognizing and treating this entity result in a diminished number of materno-fetal complications; this study explores the family physician clinical aptitude to identify risk factors, to diagnose and treat gestational diabetes. Identify clinical aptitude level of family physician to the treatment of diabetes gestational patients. Transversal study to describe the level of clinical aptitude in 85 family physicians working in Guadalajara. Were studied: speciality, genre, work condition, working years, working hours, and place of work. The evaluation instrument was designed to this specific purpose and validated by an expert group; were evaluated four indicators: 1) identification of risk factors, 2) diagnosis, 3) use of therapeutic resources and 4) use of paraclinic resources. Confidence coefficient to the assessment instrument was (21 formula from Kuder-Richardson) 0.92 in global evaluation. The global clinical aptitude in the four family medicine units studied was less than 21 points in 41% of physician population and very low (22 a 40 points) in 38% of the evaluated physicians. The clinical aptitude from family physician in gestational diabetes is low, this situation represents an urgent need to design a system to provide to these groups of health providers specialized continuous education to enhance the attention quality to this group of patients in family medicine units.

Surgery Clerkship Evaluations Are Insufficient for Clinical Skills Appraisal: The Value of a Medical Student Surgical Objective Structured Clinical Examination.

PubMed

Butler, Kathryn L; Hirsh, David A; Petrusa, Emil R; Yeh, D Dante; Stearns, Dana; Sloane, David E; Linder, Jeffrey A; Basu, Gaurab; Thompson, Lisa A; de Moya, Marc A

Optimal methods for medical student assessment in surgery remain elusive. Faculty- and housestaff-written evaluations constitute the chief means of student assessment in medical education. However, numerous studies show that this approach has poor specificity and a high degree of subjectivity. We hypothesized that an objective structured clinical examination (OSCE) in the surgery clerkship would provide additional data on student performance that would confirm or augment other measures of assessment. We retrospectively reviewed data from OSCEs, National Board of Medical Examiners shelf examinations, oral presentations, and written evaluations for 51 third-year Harvard Medical School students rotating in surgery at Massachusetts General Hospital from 2014 to 2015. We expressed correlations between numeric variables in Pearson coefficients, stratified differences between rater groups by one-way analysis of variance, and compared percentages with 2-sample t-tests. We examined commentary from both OSCE and clinical written evaluations through textual analysis and summarized these results in percentages. OSCE scores and clinical evaluation scores correlated poorly with each other, as well as with shelf examination scores and oral presentation grades. Textual analysis of clinical evaluation comments revealed a heavy emphasis on motivational factors and praise, whereas OSCE written comments focused on cognitive processes, patient management, and methods to improve performance. In this single-center study, an OSCE provided clinical skills data that were not captured elsewhere in the surgery clerkship. Textual analysis of faculty evaluations reflected an emphasis on interpersonal skills, rather than appraisal of clinical acumen. These findings suggest complementary roles of faculty evaluations and OSCEs in medical student assessment. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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

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.

Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

PubMed

Mureddu, Gian F; Nistri, Stefano; Faggiano, Pompilio; Fimiani, Biagio; Misuraca, Gianfranco; Maggi, Antonio; Gori, Anna M; Uguccioni, Massimo; Tavazzi, Luigi; Zito, Giovanni B

2016-07-01

Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy.

A Systems Approach to Designing Effective Clinical Trials Using Simulations

PubMed Central

Fusaro, Vincent A.; Patil, Prasad; Chi, Chih-Lin; Contant, Charles F.; Tonellato, Peter J.

2013-01-01

Background Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit compared to standard clinical therapy. This study demonstrates a computational framework to systematically evaluate pre-clinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes. Methods and Results We programmatically created an end-to-end framework that systematically evaluates warfarin clinical trial designs. The framework includes options to create a patient population, multiple dosing strategies including genetic-based and non-genetic clinical-based, multiple dose adjustment protocols, pharmacokinetic/pharmacodynamics (PK/PD) modeling and international normalization ratio (INR) prediction, as well as various types of outcome measures. We validated the framework by conducting 1,000 simulations of the CoumaGen clinical trial primary endpoints. The simulation predicted a mean time in therapeutic range (TTR) of 70.6% and 72.2% (P = 0.47) in the standard and pharmacogenetic arms, respectively. Then, we evaluated another dosing protocol under the same original conditions and found a significant difference in TTR between the pharmacogenetic and standard arm (78.8% vs. 73.8%; P = 0.0065), respectively. Conclusions We demonstrate that this simulation framework is useful in the pre-clinical assessment phase to study and evaluate design options and provide evidence to optimize the clinical trial for patient efficacy and reduced risk. PMID:23261867

Development and validation of a nursing professionalism evaluation model in a career ladder system.

PubMed

Kim, Yeon Hee; Jung, Young Sun; Min, Ja; Song, Eun Young; Ok, Jung Hui; Lim, Changwon; Kim, Kyunghee; Kim, Ji-Su

2017-01-01

The clinical ladder system categorizes the degree of nursing professionalism and rewards and is an important human resource tool for managing nursing. We developed a model to evaluate nursing professionalism, which determines the clinical ladder system levels, and verified its validity. Data were collected using a clinical competence tool developed in this study, and existing methods such as the nursing professionalism evaluation tool, peer reviews, and face-to-face interviews to evaluate promotions and verify the presented content in a medical institution. Reliability and convergent and discriminant validity of the clinical competence evaluation tool were verified using SmartPLS software. The validity of the model for evaluating overall nursing professionalism was also analyzed. Clinical competence was determined by five dimensions of nursing practice: scientific, technical, ethical, aesthetic, and existential. The structural model explained 66% of the variance. Clinical competence scales, peer reviews, and face-to-face interviews directly determined nursing professionalism levels. The evaluation system can be used for evaluating nurses' professionalism in actual medical institutions from a nursing practice perspective. A conceptual framework for establishing a human resources management system for nurses and a tool for evaluating nursing professionalism at medical institutions is provided.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. Discussion This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. Trial registration ClinicalTrials.gov: NCT01815710 PMID:23692634

Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

PubMed

Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

2011-01-01

New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

PubMed Central

Walden, Anita; Nahm, Meredith; Barnett, M. Edwina; Conde, Jose G.; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E.; Eisenstein, Eric L.

2012-01-01

Background New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. Methods We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. Main Outcome Measures The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Results Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Conclusion Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs. PMID:21335692

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

PubMed

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

2009-08-01

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

Growth/differentiation factor-5: pre-clinical and clinical evaluations of periodontal regeneration and alveolar augmentation--review.

PubMed

Lee, Jaebum; Wikesjö, Ulf M E

2014-08-01

Growth/differentiation factor-5 (GDF-5) plays critical roles in mesenchymal cell differentiation and stimulates human periodontal ligament cell proliferation. Potentially, GDF-5 may also play roles in wound healing including periodontal regeneration and alveolar augmentation. The objective of this review was to provide up-to-date information from pre-clinical/clinical studies evaluating GDF-5 for these indications. A comprehensive search using PubMed and Google search engines was conducted to identify reports on GDF-5 applied to periodontal and alveolar indications. Two reviewers independently screened the titles and abstracts from a total of 479 reports. Full-length articles of 17 pre-clinical and four clinical studies were selected and reviewed. Canine-, porcine- and non-human primate-based models as well as human clinical trials were used in the evaluation of GDF-5 in support of periodontal regeneration and alveolar augmentation. An absorbable collagen sponge (ACS), β-tricalcium phosphate (β-TCP) and a poly(lactic-co-glycolic) acid (PLGA) were evaluated as candidate carriers for GDF-5 using various dose and healing intervals demonstrating significantly enhanced periodontal regeneration/alveolar augmentation including cementum, periodontal ligament and alveolar bone with limited, if any, adverse effects. Growth/differentiation factor-5 supports periodontal regeneration/alveolar augmentation without aberrant healing events documented in qualified pre-clinical models and clinical pilot studies. In perspective, GDF-5 appears a promising technology for periodontal regeneration/alveolar augmentation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Development and clinical evaluation of an anesthesia information management system].

PubMed

Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

2010-09-21

To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

The effectiveness of clinical supervision for a group of ward managers based in a district general hospital: an evaluative study.

PubMed

Davis, Cynthia; Burke, Linda

2012-09-01

To present an evaluative audit assessing the effectiveness of clinical supervision for ward managers. A year-long project to introduce clinical supervision to ward managers was implemented and evaluated. The objectives were to evaluate staff perceptions of implementing clinical supervision and determine its outcomes. An audit evaluation process was used. Findings are presented against perceptions, implementation and reported outcomes of clinical supervision. Insights were gained into its relevance and importance to nurses and the organisation. Findings show that clinical supervision was perceived to be effective and helped improve patient care, but some feared it becoming a form of managerial control. Ward managers perceived advantages for personal and professional development from adopting this process. There is a need for greater understanding of clinical supervision before Trusts implement it. The introduction of a resource pack for clinical areas would also be of value. Finally, there needs to be a named person who has a special knowledge of clinical supervision to act as a champion and change agent in effecting implementation at both the executive level and within each clinical area. © 2011 Blackwell Publishing Ltd.

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. PMID:26069574

Feedback-giving behaviour in performance evaluations during clinical clerkships.

PubMed

Bok, Harold G J; Jaarsma, Debbie A D C; Spruijt, Annemarie; Van Beukelen, Peter; Van Der Vleuten, Cees P M; Teunissen, Pim W

2016-01-01

Narrative feedback documented in performance evaluations by the teacher, i.e. the clinical supervisor, is generally accepted to be essential for workplace learning. Many studies have examined factors of influence on the usage of mini-clinical evaluation exercise (mini-CEX) instruments and provision of feedback, but little is known about how these factors influence teachers' feedback-giving behaviour. In this study, we investigated teachers' use of mini-CEX in performance evaluations to provide narrative feedback in undergraduate clinical training. We designed an exploratory qualitative study using an interpretive approach. Focusing on the usage of mini-CEX instruments in clinical training, we conducted semi-structured interviews to explore teachers' perceptions. Between February and June 2013, we conducted interviews with 14 clinicians participated as teachers during undergraduate clinical clerkships. Informed by concepts from the literature, we coded interview transcripts and iteratively reduced and displayed data using template analysis. We identified three main themes of interrelated factors that influenced teachers' practice with regard to mini-CEX instruments: teacher-related factors; teacher-student interaction-related factors, and teacher-context interaction-related factors. Four issues (direct observation, relationship between teacher and student, verbal versus written feedback, formative versus summative purposes) that are pertinent to workplace-based performance evaluations were presented to clarify how different factors interact with each other and influence teachers' feedback-giving behaviour. Embedding performance observation in clinical practice and establishing trustworthy teacher-student relationships in more longitudinal clinical clerkships were considered important in creating a learning environment that supports and facilitates the feedback exchange. Teachers' feedback-giving behaviour within the clinical context results from the interaction between personal, interpersonal and contextual factors. Increasing insight into how teachers use mini-CEX instruments in daily practice may offer strategies for creating a professional learning culture in which feedback giving and seeking would be enhanced.

Group intervention for burnout in parents of chronically ill children - a small-scale study.

PubMed

Lindström, Caisa; Åman, Jan; Anderzén-Carlsson, Agneta; Lindahl Norberg, Annika

2016-12-01

Long-term stress leading to burnout symptoms is prevalent in parents of chronically ill children. The aim of the study was to evaluate the effect of a group intervention by measuring changes in self-rated clinical burnout and performance-based self-esteem. In addition, the parental perceptions of the acceptability of the intervention were explored. Previously, we have explored the prevalence of clinical burnout in parents of patients 1-18 years with type 1 diabetes mellitus (T1DM) and inflammatory bowel disease (IBD) in the county of Örebro. All parents who exhibited clinical burnout symptoms in accordance with the Shirom-Melamed Burnout Questionnaire (SMBQ) were then invited to participate in a group intervention, which was evaluated in the present small-scale study. The group intervention consisted of eight sessions over a 12-week period, including education about behaviour, cognition and symptoms associated with burnout, intending to help the parents to develop adequate strategies for coping with and reducing stress. We evaluated the effect of the intervention in terms of self-rated clinical burnout and performance-based self-esteem (PBSE). In addition, the acceptability of the intervention was evaluated by analyses of recruitment and retention and self-reports from parents. Sixteen parents (13 of children with TIDM and three of children with IBD) out of 104 reporting clinical burnout participated in the intervention. All participants completed the intervention, and the mean attendance rate at all sessions was 90%. Parents' subjective evaluations were mainly positive, and SMBQ (p = 0.01) and PBSE scale (p = 0.04) measurements were significantly reduced, which effects remained 6 months after completion of the intervention. Despite the small-scale study, we consider that this intervention for parents with clinical burnout was appreciated and well accepted. The significant reduction in clinical burnout symptoms requires further evaluation in randomised controlled studies based on larger groups of parents. © 2015 Nordic College of Caring Science.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating imbalances of adverse events during biosimilar development

PubMed Central

Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

2016-01-01

ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction.

PubMed

Park, Seong Ho; Han, Kyunghwa

2018-03-01

The use of artificial intelligence in medicine is currently an issue of great interest, especially with regard to the diagnostic or predictive analysis of medical images. Adoption of an artificial intelligence tool in clinical practice requires careful confirmation of its clinical utility. Herein, the authors explain key methodology points involved in a clinical evaluation of artificial intelligence technology for use in medicine, especially high-dimensional or overparameterized diagnostic or predictive models in which artificial deep neural networks are used, mainly from the standpoints of clinical epidemiology and biostatistics. First, statistical methods for assessing the discrimination and calibration performances of a diagnostic or predictive model are summarized. Next, the effects of disease manifestation spectrum and disease prevalence on the performance results are explained, followed by a discussion of the difference between evaluating the performance with use of internal and external datasets, the importance of using an adequate external dataset obtained from a well-defined clinical cohort to avoid overestimating the clinical performance as a result of overfitting in high-dimensional or overparameterized classification model and spectrum bias, and the essentials for achieving a more robust clinical evaluation. Finally, the authors review the role of clinical trials and observational outcome studies for ultimate clinical verification of diagnostic or predictive artificial intelligence tools through patient outcomes, beyond performance metrics, and how to design such studies. © RSNA, 2018.

Health effects of intermittent fasting: hormesis or harm? A systematic review.

PubMed

Horne, Benjamin D; Muhlestein, Joseph B; Anderson, Jeffrey L

2015-08-01

Intermittent fasting, alternate-day fasting, and other forms of periodic caloric desistance are gaining popularity in the lay press and among animal research scientists. Whether clinical evidence exists for or is strong enough to support the use of such dietary regimens as health interventions is unclear. This review sought to identify rigorous, clinically relevant research studies that provide high-quality evidence that therapeutic fasting regimens are clinically beneficial to humans. A systematic review of the published literature through January 2015 was performed by using sensitive search strategies to identify randomized controlled clinical trials that evaluated the effects of fasting on either clinically relevant surrogate outcomes (e.g., weight, cholesterol) or actual clinical event endpoints [e.g., diabetes, coronary artery disease (CAD)] and any other studies that evaluated the effects of fasting on clinical event outcomes. Three randomized controlled clinical trials of fasting in humans were identified, and the results were published in 5 articles, all of which evaluated the effects of fasting on surrogate outcomes. Improvements in weight and other risk-related outcomes were found in the 3 trials. Two observational clinical outcomes studies in humans were found in which fasting was associated with a lower prevalence of CAD or diabetes diagnosis. No randomized controlled trials of fasting for clinical outcomes were identified. Clinical research studies of fasting with robust designs and high levels of clinical evidence are sparse in the literature. Whereas the few randomized controlled trials and observational clinical outcomes studies support the existence of a health benefit from fasting, substantial further research in humans is needed before the use of fasting as a health intervention can be recommended. © 2015 American Society for Nutrition.

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

Considerations for Clinical Review of Cellular Therapy Products: Perspectives of the China Food and Drug Administration Center for Drug Evaluation.

PubMed

Liu, Yantong; Zhao, Chenyang; Gao, Liucun; Yang, Huan; He, Ruyi; Gao, Chenyan

2018-02-01

With increasing numbers of technical developments and clinical studies, pioneering cellular/gene therapies are now available that could cure life-threatening disease. Cellular/gene therapy products are broad-ranging and complicated, and thereby bring challenges for clinical review by regulatory agencies. This review discusses principles for the clinical review of cellular therapy products, including protection of clinical trial populations, pharmacodynamics, pharmacokinetics, dose evaluation, clinical efficacy, clinical safety, and risk-management plans. Based on these principles, key points in the clinical review of chimeric antigen receptor T-cell therapy are also discussed.

Pre-admission criteria and pre-clinical achievement: Can they predict medical students performance in the clinical phase?

PubMed

Salem, Raneem O; Al-Mously, Najwa; AlFadil, Sara; Baalash, Amal

2016-01-01

Various factors affect medical students' performance during clinical phase. Identifying these factors would help in mentoring weak students and help in selection process for residency programmes. Our study objective is to evaluate the impact of pre-admission criteria, and pre-clinical grade point average (GPA) on undergraduate medical students' performance during clinical phase. This study has a cross-sectional design that includes fifth- and sixth-year female medical students (71). Data of clinical and pre-clinical GPA in medical school and pre-admission to medical school tests scores were collected. A significant correlation between clinical GPA with the pre-clinical GPA was observed (p < 0.05). Such significant correlation was not seen with other variables under study. A regression analysis was performed, and the only significant predictor of students clinical performance was the pre-clinical GPA (p < 0.001). However, no significant difference between students' clinical and pre-clinical GPA for both cohorts was observed (p > 0.05). Pre-clinical GPA is strongly correlated with and can predict medical students' performance during clinical years. Our study highlighted the importance of evaluating the academic performances of students in pre-clinical years before they move into clinical years in order to identify weak students to mentor them and monitor their progress.

[Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

PubMed

Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

2014-09-01

Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

Evaluation of the end user (dentist) experience of undertaking clinical audit in the post April 2001 general dental services (GDS) scheme.

PubMed

Cannell, P J

2012-09-01

A mandatory scheme for clinical audit in the general dental services (GDS) was launched in April 2001. No evaluation of this mandatory scheme exists in the literature. This study provides an evaluation of this scheme. More recently a new dental contract was introduced in the general dental services (GDS) in April 2006. Responsibility for clinical audit activities was devolved to primary care trusts (PCTs) as part of their clinical governance remit. All GDPs within Essex were contacted by letter and invited to participate in the research. A qualitative research method was selected for this evaluation, utilising audio-taped semi-structured research interviews with eight general dental practitioners (GDPs) who had taken part in the GDS clinical audit scheme and who fitted the sampling criteria and strategy. The evaluation focused on dentists' experiences of the scheme. The main findings from the analysis of the GDS scheme data suggest that there is clear evidence of change following audit activities occurring within practices and for the benefit of patients. However, often it is the dentist only that undertakes a clinical audit project rather than the dental team, there is a lack of dissemination of project findings beyond the individual participating practices, very little useful feedback provided to participants who have completed a project and very limited use of formal re-auditing of a particular topic. This study provides evaluation of the GDS clinical audit scheme. Organisations who propose to undertake clinical audit activities in conjunction with dentistry in the future may benefit from incorporating and/or developing some findings from this evaluation into their project design and avoiding others.

The effectiveness of toolkits as knowledge translation strategies for integrating evidence into clinical care: a systematic review

PubMed Central

Yamada, Janet; Shorkey, Allyson; Barwick, Melanie; Widger, Kimberley; Stevens, Bonnie J

2015-01-01

Objectives The aim of this systematic review was to evaluate the effectiveness of toolkits as a knowledge translation (KT) strategy for facilitating the implementation of evidence into clinical care. Toolkits include multiple resources for educating and/or facilitating behaviour change. Design Systematic review of the literature on toolkits. Methods A search was conducted on MEDLINE, EMBASE, PsycINFO and CINAHL. Studies were included if they evaluated the effectiveness of a toolkit to support the integration of evidence into clinical care, and if the KT goal(s) of the study were to inform, share knowledge, build awareness, change practice, change behaviour, and/or clinical outcomes in healthcare settings, inform policy, or to commercialise an innovation. Screening of studies, assessment of methodological quality and data extraction for the included studies were conducted by at least two reviewers. Results 39 relevant studies were included for full review; 8 were rated as moderate to strong methodologically with clinical outcomes that could be somewhat attributed to the toolkit. Three of the eight studies evaluated the toolkit as a single KT intervention, while five embedded the toolkit into a multistrategy intervention. Six of the eight toolkits were partially or mostly effective in changing clinical outcomes and six studies reported on implementation outcomes. The types of resources embedded within toolkits varied but included predominantly educational materials. Conclusions Future toolkits should be informed by high-quality evidence and theory, and should be evaluated using rigorous study designs to explain the factors underlying their effectiveness and successful implementation. PMID:25869686

Use of antipsychotic blood levels in clinician decision making: A cross-over study using clinical vignettes of patients with schizophrenia.

PubMed

Savitz, Adam; Melkote, Rama; Riley, Ralph; Pobre, Maria A; McQuarrie, Kelly; Williamson, David; Banderas, Benjamin

2018-05-19

The cause of treatment failure of antipsychotic medications is often difficult to determine in patients with schizophrenia. Evaluation of antipsychotic blood levels (ABLs) may aid clinicians in determining the cause of antipsychotic failure. The Clinical Assessment of the Schizophrenia Patient (CASP) was developed to evaluate clinical decision making during outpatient visits. The CASP assesses changes in medications, psychosocial treatments, and acute interventions along with factors influencing clinical decision making. Nine vignettes representative of clinical situations in patients with schizophrenia were created in two versions (one with ABLs, one without ABLs). The CASP was used to evaluate clinical decisions using the vignettes. Thirty-four clinicians participated in the study. In 8 out of 9 vignettes, most clinicians (at least 89.7%) made a different clinical decision with ABLs compared to without ABLs. In assessing the usefulness of ABLs, a majority (60.7%-85.7%, depending on the vignette) of clinicians responded that ABLs changed their clinical decision for 8 vignettes. Most clinicians (79%-93%) responded that they were more confident in their decisions with ABL information. This study demonstrated that ABLs have the potential to influence clinical decision making in the treatment of patients with schizophrenia. Copyright © 2018. Published by Elsevier B.V.

Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

PubMed

Doolittle, B R; Justice, A C; Fiellin, D A

2018-06-01

This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

Evaluation of clinical practice guidelines.

PubMed Central

Basinski, A S

1995-01-01

Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed. PMID:7489550

Using Multiple Assessments to Evaluate Medical Students' Clinical Ability in Psychiatric Clerkships

ERIC Educational Resources Information Center

Wang, Peng-Wei; Cheng, Cheng-Chung; Chou, Frank Huang-Chih; Tsang, Hin-Yeung; Chang, Yu-San; Huang, Mei-Feng; Yen, Cheng-Fang

2011-01-01

Background: No single assessment method can successfully evaluate the clinical ability of medical students in psychiatric clerkships; however, few studies have examined the efficacy of multiple assessments, especially in psychiatry. The aim of this study was to examine the relationship among different types of assessments of medical students'…

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. 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/.

Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of Mouse Models and Clinical Implementation

DTIC Science & Technology

2008-03-01

CONTRACT NUMBER Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of Mouse Models and Clinical Implementation...research proposed here can directly lead to clinical improvements in both early breast cancer detection, as well as effective breast cancer therapy. To date... cancer is a major prognostic factor in the management of the disease. In particular, detecting breast cancer in its pre-invasive form as ductal carcinoma

Evaluating clinical ethics support in mental healthcare: a systematic literature review.

PubMed

Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

2015-06-01

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

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

The use of mechanistic evidence in drug approval.

PubMed

Aronson, Jeffrey K; La Caze, Adam; Kelly, Michael P; Parkkinen, Veli-Pekka; Williamson, Jon

2018-06-11

The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015–2019

PubMed Central

Jeong, Hyunsuk; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-01-01

Introduction In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. Methods and analysis The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. Ethics and dissemination This study is approved by the Institutional Review Board of the Catholic University of Korea. Results will be published in peer-reviewed journals. Trial registration number ClinicalTrials.gov (identifier: NCT02415322). PMID:28982839

The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study.

PubMed

Lee, Jaewon; Kim, Hong-Sik; Shim, Kyu-Dong; Park, Ye-Soo

2017-06-01

The aim of this study is to evaluate the effect of depression, anxiety, and optimism on postoperative satisfaction and clinical outcomes in patients who underwent less than two-level posterior instrumented fusions for lumbar spinal stenosis and degenerative spondylolisthesis. Preoperative psychological status of subjects, such as depression, anxiety, and optimism, was evaluated using the Hospital Anxiety and Depression Scale (HADS) and the Revised Life Orientation Test (LOT-R). Clinical evaluation was determined by measuring changes in a visual analogue scale (VAS) and the Oswestry Disability Index (ODI) before and after surgery. Postoperative satisfaction of subjects assessed using the North American Spine Society lumbar spine questionnaire was comparatively analyzed against the preoperative psychological status. The correlation between patient's preoperative psychological status (depression, anxiety, and optimism) and clinical outcomes (VAS and ODI) was evaluated. VAS and ODI scores significantly decreased after surgery ( p < 0.001), suggesting clinically favorable outcomes. Preoperative psychological status of patients (anxiety, depression, and optimism) was not related to the degree of improvement in clinical outcomes (VAS and ODI) after surgery. However, postoperative satisfaction was moderately correlated with optimism. Anxiety and optimism were more correlated with patient satisfaction than clinical outcomes. Accordingly, the surgeon can predict postoperative satisfaction of patients based on careful evaluation of psychological status before surgery.

A meta-analysis of mammographic screening with and without clinical breast examination

PubMed Central

Hamashima, Chisato; Ohta, Koji; Kasahara, Yoshio; Katayama, Takafumi; Nakayama, Tomio; Honjo, Satoshi; Ohnuki, Koji

2015-01-01

Mammographic screening with clinical breast examination has been recommended in Japan since 2000. Although mammographic screening without clinical breast examination has not been recommended, its introduction is anticipated. The efficacies of mammographic screening with and without clinical breast examination were evaluated based on the results of randomized controlled trials. PubMed and other databases for studies published between 1985 and 2014 were searched. The study design was limited to randomized controlled trials to evaluate mortality reduction from breast cancer. Five studies were eligible for meta-analysis of mammographic screening without clinical breast examination. The relative risk for women aged 40–74 years was 0.75 (95% confidence interval, 0.67–0.83). Three studies evaluated the efficacy of mammographic screening with clinical breast examination. The relative risk for women aged 40–64 years was 0.87 (95% confidence interval, 0.77–0.98). The number needed to invite was always lower in mammographic screening without clinical breast examination than in mammographic screening with clinical breast examination. In both screening methods, the number needed to invite was higher in women aged 40–49 years than in women aged 50–70 years. These results suggest that mammographic screening without clinical breast examination can afford higher benefits to women aged 50 years and over. Although evidence of the efficacy of mammographic screening without clinical breast examination was confirmed based on the results of the randomized controlled trials, a Japanese study is needed to resolve local problems. PMID:25959787

Salicylic acid for the treatment of melasma: new acquisitions for monitoring the clinical improvement.

PubMed

Fabbrocini, Gabriella; De Vita, Valerio; Marasca, Claudio; Palmisano, Franco; Monfrecola, Giuseppe

2013-11-01

The Melasma Area and Severity Index (MASI) and the Melasma Severity Score (MSS) are calculated on the basis of only a subjective clinical assessment. This raises the need to have an objective score, uniform in the evaluation by different clinicians. The purpose of this study was to establish if the images by Canfield Reveal Imager can be correlated to MASI score to better evaluate the clinical efficacy of salicylic acid 33% peeling in the treatment of melasma respect to the clinical observation. The study was a voluntary observational study. Twenty female patients affected with melasma, aged between 30 and 60 years, were included in the study. Treatment with salicylic acid 33% was performed once a month, for a total of four times. The dermatologist (Doc A) examined each patient's melasma areas using MASI score, at the face-to-face observation and at Reveal images evaluation during the first (T0) and the end point time (T4). Digital photographs were also evaluated by another experienced dermatologist (Doc B), who has never seen clinically the patients before and who evaluated MASI score by Reveal images at time T0 and T4. Student's t-test and linear regression test were performed, showing statistically significant values comparing MASI score obtained by digital photo and MASI score obtained clinically. The monitoring of the improvement by Reveal images can optimize the treatment approach and the efficacy of same dermocosmetics procedures can be revised following standard criteria. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

A pilot study evaluating changes in pancreatic lipase immunoreactivity concentrations in canines treated with L-asparaginase (ASNase), vincristine, or both for lymphoma.

PubMed

Wright, Zachary; Steiner, Joerg; Suchodolski, Jan; Rogers, Kenita; Barton, Claudia; Brown, Marjorie

2009-04-01

L-asparaginase (ASNase) is a common chemotherapy agent for the treatment of lymphoid malignancies. L-asparaginase has been reported to cause clinical pancreatitis in both humans and canines. Canine pancreatic lipase immunoreactivity (cPLI) is now a common diagnostic tool for evaluating pancreatitis in dogs. A total of 52 dogs were enrolled into this study. Canine pancreatic lipase immunoreactivity (cPLI) concentrations were evaluated before and after administration of ASNase, vincristine, or both. All dogs enrolled in the study were evaluated for signs compatible with clinical pancreatitis. No dogs receiving ASNase alone showed evidence of clinical pancreatitis after administration. Also, there was no statistically significant change in cPLI concentrations before or after treatment. Fourteen percent of dogs that received both vincristine and ASNase concurrently had elevated concentrations of cPLI after treatment. Of the 11 dogs with clinical signs compatible with pancreatitis after any chemotherapy treatment, no dog had a cPLI concentration > 400 microg/dL. In conclusion, ASNase did not cause clinical pancreatitis in this cohort of dogs but larger sample sizes are required to further validate this data.

A pilot study evaluating changes in pancreatic lipase immunoreactivity concentrations in canines treated with L-asparaginase (ASNase), vincristine, or both for lymphoma

PubMed Central

Wright, Zachary; Steiner, Joerg; Suchodolski, Jan; Rogers, Kenita; Barton, Claudia; Brown, Marjorie

2009-01-01

L-asparaginase (ASNase) is a common chemotherapy agent for the treatment of lymphoid malignancies. L-asparaginase has been reported to cause clinical pancreatitis in both humans and canines. Canine pancreatic lipase immunoreactivity (cPLI) is now a common diagnostic tool for evaluating pancreatitis in dogs. A total of 52 dogs were enrolled into this study. Canine pancreatic lipase immunoreactivity (cPLI) concentrations were evaluated before and after administration of ASNase, vincristine, or both. All dogs enrolled in the study were evaluated for signs compatible with clinical pancreatitis. No dogs receiving ASNase alone showed evidence of clinical pancreatitis after administration. Also, there was no statistically significant change in cPLI concentrations before or after treatment. Fourteen percent of dogs that received both vincristine and ASNase concurrently had elevated concentrations of cPLI after treatment. Of the 11 dogs with clinical signs compatible with pancreatitis after any chemotherapy treatment, no dog had a cPLI concentration > 400 μg/dL. In conclusion, ASNase did not cause clinical pancreatitis in this cohort of dogs but larger sample sizes are required to further validate this data. PMID:19436578

Clinical Performance Evaluations of Third-Year Medical Students and Association With Student and Evaluator Gender.

PubMed

Riese, Alison; Rappaport, Leah; Alverson, Brian; Park, Sangshin; Rockney, Randal M

2017-06-01

Clinical performance evaluations are major components of medical school clerkship grades. But are they sufficiently objective? This study aimed to determine whether student and evaluator gender is associated with assessment of overall clinical performance. This was a retrospective analysis of 4,272 core clerkship clinical performance evaluations by 829 evaluators of 155 third-year students, within the Alpert Medical School grading database for the 2013-2014 academic year. Overall clinical performance, assessed on a three-point scale (meets expectations, above expectations, exceptional), was extracted from each evaluation, as well as evaluator gender, age, training level, department, student gender and age, and length of observation time. Hierarchical ordinal regression modeling was conducted to account for clustering of evaluations. Female students were more likely to receive a better grade than males (adjusted odds ratio [AOR] 1.30, 95% confidence interval [CI] 1.13-1.50), and female evaluators awarded lower grades than males (AOR 0.72, 95% CI 0.55-0.93), adjusting for department, observation time, and student and evaluator age. The interaction between student and evaluator gender was significant (P = .03), with female evaluators assigning higher grades to female students, while male evaluators' grading did not differ by student gender. Students who spent a short time with evaluators were also more likely to get a lower grade. A one-year examination of all third-year clerkship clinical performance evaluations at a single institution revealed that male and female evaluators rated male and female students differently, even when accounting for other measured variables.

Building clinical networks: a developmental evaluation framework.

PubMed

Carswell, Peter; Manning, Benjamin; Long, Janet; Braithwaite, Jeffrey

2014-05-01

Clinical networks have been designed as a cross-organisational mechanism to plan and deliver health services. With recent concerns about the effectiveness of these structures, it is timely to consider an evidence-informed approach for how they can be developed and evaluated. To document an evaluation framework for clinical networks by drawing on the network evaluation literature and a 5-year study of clinical networks. We searched literature in three domains: network evaluation, factors that aid or inhibit network development, and on robust methods to measure network characteristics. This material was used to build a framework required for effective developmental evaluation. The framework's architecture identifies three stages of clinical network development; partner selection, network design and network management. Within each stage is evidence about factors that act as facilitators and barriers to network growth. These factors can be used to measure progress via appropriate methods and tools. The framework can provide for network growth and support informed decisions about progress. For the first time in one place a framework incorporating rigorous methods and tools can identify factors known to affect the development of clinical networks. The target user group is internal stakeholders who need to conduct developmental evaluation to inform key decisions along their network's developmental pathway.

Early diagnosis of amyotrophic lateral sclerosis mimic syndromes: pros and cons of current clinical diagnostic criteria.

PubMed

Cortés-Vicente, Elena; Pradas, Jesús; Marín-Lahoz, Juan; De Luna, Noemi; Clarimón, Jordi; Turon-Sans, Janina; Gelpí, Ellen; Díaz-Manera, Jordi; Illa, Isabel; Rojas-Garcia, Ricard

2017-08-01

To describe the frequency and clinical characteristics of patients referred to a tertiary neuromuscular clinic as having amyotrophic lateral sclerosis (ALS) but who were re-diagnosed as having an ALS mimic syndrome, and to identify the reasons that led to the revision of the diagnosis. We reviewed the final diagnosis of all patients prospectively registered in the Sant Pau-MND register from 1 January 2004 to 31 December 2015. A detailed clinical evaluation and a clinically-guided electrophysiological study were performed at first evaluation. Twenty of 314 (6.4%) patients included were re-diagnosed as having a condition other than ALS, in 18 cases already at first evaluation. An alternative specific diagnosis was identified in 17 of those 20, consisting of a wide range of conditions. The main finding leading to an alternative diagnosis was the result of the electrophysiological study. Fifty per cent did not fulfil the El Escorial revised criteria (EECr) for ALS. The most common clinical phenotype at onset in patients with ALS mimic syndromes was progressive muscular atrophy (PMA). Misdiagnosing ALS is still a common problem. Early identification of ALS mimic syndromes is possible based on atypical clinical features and a clinically-guided electrophysiological study. Patients should be attended in specialised centres. The application of EECr helps to identify ALS misdiagnoses.

Periocular mexametric melanin and erythema indexes in adult glaucoma patients treated with topical prostaglandin analogs.

PubMed

Duman, Nilay; Duman, Reşat; Yavaş, Güliz Fatma; Doğruk Kaçar, Seval; Özuğuz, Pınar; Çetinkaya, Ersan

2017-03-01

Although topical prostaglandin analogs (PGAs) have been previously associated with periocular skin hyperpigmentation, studies using objective clinical methods are lacking. Furthermore changes in periocular skin erythema indexes associated with topical PGAs have not been reported previously. The purpose of the present study was to evaluate periocular melanin and erythema indexes in patients treated with topical PGA using an objective clinical method - Mexameter. About 45 glaucoma patients treated with topical PGA therapy, and 30 age-, and sex-matched controls were enrolled in the study. Demographic data, medical history including duration of therapy, PGA type, involved eye (unilateral, bilateral) were noted, and skin phototypes were evaluated. Melanin and erythema indexes on medial and lateral upper and lower eyelids, and normal skin from the upper cheeks were measured using Mexameter MX-18. The index of difference for lower/upper eyelid was calculated. Reading results of patients and controls were compared. Melanin and erythema indexes of upper/lower eyelids, and the index of differences for upper/lower eyelids were significantly higher in patients despite similar clinical findings (p < 0.05). Duration of therapy and type of PGA were not associated with skin changes (p > 0.05). Both periocular melanin and erythema indexes increased in both upper and lower eyelids due to PGA therapy compared to controls, despite similar clinical findings. Mexametric evaluation is more sensitive than clinical evaluation, and may be used as an objective, sensitive clinical method to evaluate periocular skin changes, even smallest changes, in such patients.

Clinical Epidemiology Unit - overview of research areas

Cancer.gov

Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

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

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

The impact of rheologically controlled materials on the identification of airway compromise on the clinical and videofluoroscopic swallowing examinations.

PubMed

Groher, Michael E; Crary, Michael A; Carnaby Mann, Giselle; Vickers, Zata; Aguilar, Carlos

2006-10-01

Numerous studies have suggested that the clinical evaluation of swallowing fails to adequately identify those patients who aspirate or do not aspirate on a videofluoroscopic swallowing examination. These conclusions, however, are based on comparisons between swallowed materials that were not rheologically matched. The present study used a battery of rheologically matched test materials, involving thin and thick liquids and cohesive and adhesive semisolids. Using these test items, results from a clinical swallow evaluation were compared to the results of a videofluorographic evaluation using identical test materials. Results suggest that the use of three test materials, including thin and thick liquids given in volumes of 5 and 10 ml, demonstrated the strongest associations between cough on the clinical examination and aspiration on the videofluoroscopic examination.

Development and initial evaluation of an instrument to assess physiotherapists' clinical reasoning focused on clients' behavior change.

PubMed

Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

2018-05-01

A systematically developed and evaluated instrument is needed to support investigations of physiotherapists' clinical reasoning integrated with the process of clients' behavior change. This study's aim was to develop an instrument to assess physiotherapy students' and physiotherapists' clinical reasoning focused on clients' activity-related behavior and behavior change, and initiate its evaluation, including feasibility and content validity. The study was conducted in three phases: 1) determination of instrument structure and item generation, based on a model, guidelines for assessing clinical reasoning, and existing measures; 2) cognitive interviews with five physiotherapy students to evaluate item understanding and feasibility; and 3) a Delphi process with 18 experts to evaluate content relevance. Phase 1 resulted in an instrument with four domains: Physiotherapist; Input from client; Functional behavioral analysis; and Strategies for behavior change. The instrument consists of case scenarios followed by items in which key features are identified, prioritized, or interpreted. Phase 2 resulted in revisions of problems and approval of feasibility. Phase 3 demonstrated high level of consensus regarding the instrument's content relevance. This feasible and content-validated instrument shows potential for use in investigations of physiotherapy students' and physiotherapists' clinical reasoning, however continued development and testing are needed.

A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

ERIC Educational Resources Information Center

Lee, Seon Ah

2010-01-01

The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

A Study on Fitts' Law Based Gait Symmetric Evaluation and It's Clinic Application.

PubMed

Rencheng, Wang; Meiqin, Zhang; Xiaonan, Deng; Dewen, Jin; Maobin, Wang; Guangqing, Li

2005-01-01

Symmetry, one of the prominent characters of normal human gait, could be destroyed by some special or abnormal factors such as barrier spanning, walking impediment, etc. Therefore, it becomes an important factor used to evaluate qualities and functions of walking. In this paper, the fitts' law based symmetry index calculation is introduced and its application in clinic test is also reported. The results show that the fitts' law based index is effective in clinic evaluation.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Critical Review of Data Evaluation in Teaching Clinics of Traditional Chinese Medicine Outside China: Implications for Education.

PubMed

Jiang, Jian; Peng, Wenbo; Gu, Tieguang; King, Catherine; Yin, J Kevin

2016-01-01

The increasing acceptance of traditional Chinese medicine (TCM) worldwide has highlighted the importance of ensuring the provision of high-quality TCM clinical education. This clinical training should be partly guided by a robust assessment of patient data outcomes in TCM teaching clinics. We undertook a comprehensive literature review to examine the data evaluation in TCM teaching clinics outside China and its implications for TCM education. Literature was retrieved via MEDLINE (from 1946 to January 2015), EMBASE (from 1980 to February 2015), and Google Scholar for studies conducted outside China. The search was restricted to English articles reporting empirical findings related to the assessments of patient data in TCM teaching clinics, with implications for TCM education in countries other than China. Only seven articles from six studies met the inclusion criteria. The characteristics and main symptoms of patients who received any TCM treatment in the context of teaching clinics among all included studies were similar. Symptom relief as well as a high level of patient satisfaction with TCM treatment were found in TCM teaching clinics. Conventional healthcare providers and other complementary practitioners were not the main source of referral to TCM practitioners but rather patients׳ friends/relatives. Patients received acupuncture treatment more frequently than treatments utilizing Chinese herbal medicine in teaching clinics. A standardized and consistent framework for patient records within TCM teaching clinics is currently lacking. There was no robust study which "translated" TCM clinic data evaluation findings into implications for TCM education and clinical training. Recognizing that TCM evolves over time and its practice varies in different settings, there is an urgent need to conduct large-scale, rigorous evaluations of TCM clinic data to address the findings of our review, with the purpose of better informing TCM education and clinical training in countries beyond China. Expansions for scientific efforts supporting TCM education are essential to ensure that qualified TCM practitioners are able to provide safe, efficacious, and cost-effective TCM treatment modalities. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Methodological Reflections on the Contribution of Qualitative Research to the Evaluation of Clinical Ethics Support Services.

PubMed

Wäscher, Sebastian; Salloch, Sabine; Ritter, Peter; Vollmann, Jochen; Schildmann, Jan

2017-05-01

This article describes a process of developing, implementing and evaluating a clinical ethics support service intervention with the goal of building up a context-sensitive structure of minimal clinical-ethics in an oncology department without prior clinical ethics structure. Scholars from different disciplines have called for an improvement in the evaluation of clinical ethics support services (CESS) for different reasons over several decades. However, while a lot has been said about the concepts and methodological challenges of evaluating CESS up to the present time, relatively few empirical studies have been carried out. The aim of this article is twofold. On the one hand, it describes a process of development, modifying and evaluating a CESS intervention as part of the ETHICO research project, using the approach of qualitative-formative evaluation. On the other hand, it provides a methodological analysis which specifies the contribution of qualitative empirical methods to the (formative) evaluation of CESS. We conclude with a consideration of the strengths and limitations of qualitative evaluation research with regards to the evaluation and development of context sensitive CESS. We further discuss our own approach in contrast to rather traditional consult or committee models. © 2017 John Wiley & Sons Ltd.

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

Practitioner involvement in clinical evaluation.

PubMed

Penka, C E; Kirk, S A

1991-11-01

Contrary to popular belief, social workers are evaluating their practice, but what they do falls short of the use of quantitative procedures that researchers have promoted. Data obtained from a survey of social workers drawn from the National Association of Social Workers national membership list suggest that the gap between practitioners and clinical researchers may stem in part from different mindsets as well as from actual differences in the commitment to the importance of clinical evaluation. Moreover, in the minds of practitioners there appears to be a sharp distinction between formal single-subject design studies and the general evaluative tasks in which they routinely engage.

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 its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice. PMID:28182155

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. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice.

Interexaminer reliability in physical examination of patients with low back pain.

PubMed

Strender, L E; Sjöblom, A; Sundell, K; Ludwig, R; Taube, A

1997-04-01

Seventy-one patients with low back pain were examined by two physiotherapists (50 patients) and two physicians (21 patients). The two physiotherapists had worked together for many years, but the two physicians had not. The interexaminer reliability of the clinical tests included in the physical examination was evaluated. To evaluate the interexaminer reliability of clinical tests used in the physical examination of patients with low back pain under ideal circumstances, which was the case for the physiotherapists. Numerous clinical tests are used in the evaluation of patients with low back pain. To reach the correct diagnosis, only tests with an acceptable validity and reliability should be used. Previous studies have mainly shown low reliability. It is important that clinical tests not be rejected because of low reliability caused by differences between examiners in performance of the examination and in their definition of normal results. Two examiners, either two physiotherapists or two physicians, independently examined patients with low back pain. In approximately half of the clinical tests studied, an acceptable reliability was demonstrated. On the basis of the physiotherapists series, the reliability was acceptable for a number of clinical tests that are used in the evaluation of patients with low back pain. The results suggest that clinical tests should be standardized to a much higher degree than they are today.

Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using ex vivo analyses.

PubMed

Koenig, Vinciane; Wulfman, Claudine P; Derbanne, Mathieu A; Dupont, Nathalie M; Le Goff, Stéphane O; Tang, Mie-Leng; Seidel, Laurence; Dewael, Thibaut Y; Vanheusden, Alain J; Mainjot, Amélie K

2016-12-15

Recent introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) monolithic zirconia dental prostheses raises the issue of material low thermal degradation (LTD), a well-known problem with zirconia hip prostheses. This phenomenon could be accentuated by masticatory mechanical stress. Until now zirconia LTD process has only been studied in vitro . This work introduces an original protocol to evaluate LTD process of monolithic zirconia prostheses in the oral environment and to study their general clinical behavior, notably in terms of wear. 101 posterior monolithic zirconia tooth elements (molars and premolars) are included in a 5-year prospective clinical trial. On each element, several areas between 1 and 2 mm 2 (6 on molars, 4 on premolars) are determined on restoration surface: areas submitted or non-submitted to mastication mechanical stress, glazed or non-glazed. Before prosthesis placement, ex vivo analyses regarding LTD and wear are performed using Raman spectroscopy, SEM imagery and 3D laser profilometry. After placement, restorations are clinically evaluated following criteria of the World Dental Federation (FDI), complemented by the analysis of fracture clinical risk factors. Two independent examiners perform the evaluations. Clinical evaluation and ex vivo analyses are carried out after 6 months and then each year for up to 5 years. For clinicians and patients, the results of this trial will justify the use of monolithic zirconia restorations in dental practice. For researchers, the originality of a clinical study including ex vivo analyses of material aging will provide important data regarding zirconia properties.Trial registration: ClinicalTrials.gov Identifier: NCT02150226.

The prognostic value of sleep patterns in disorders of consciousness in the sub-acute phase.

PubMed

Arnaldi, Dario; Terzaghi, Michele; Cremascoli, Riccardo; De Carli, Fabrizio; Maggioni, Giorgio; Pistarini, Caterina; Nobili, Flavio; Moglia, Arrigo; Manni, Raffaele

2016-02-01

This study aimed to evaluate, through polysomnographic analysis, the prognostic value of sleep patterns, compared to other prognostic factors, in patients with disorders of consciousness (DOCs) in the sub-acute phase. Twenty-seven patients underwent 24-h polysomnography and clinical evaluation 3.5 ± 2 months after brain injury. Their clinical outcome was assessed 18.5 ± 9.9 months later. Polysomnographic recordings were evaluated using visual and quantitative indexes. A general linear model was applied to identify features able to predict clinical outcome. Clinical status at follow-up was analysed as a function of the baseline clinical status, the interval between brain injury and follow-up evaluation, patient age and gender, the aetiology of the injury, the lesion site, and visual and quantitative sleep indexes. A better clinical outcome was predicted by a visual index indicating the presence of sleep integrity (p=0.0006), a better baseline clinical status (p=0.014), and younger age (p=0.031). Addition of the quantitative sleep index strengthened the prediction. More structured sleep emerged as a valuable predictor of a positive clinical outcome in sub-acute DOC patients, even stronger than established predictors (e.g. age and baseline clinical condition). Both visual and quantitative sleep evaluation could be helpful in predicting clinical outcome in sub-acute DOCs. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Assessing the feasibility of mobile phones for follow-up of acutely unwell children presenting to village clinics in rural northern Malawi.

PubMed

Hardy, Victoria; Hsieh, Jenny; Chirambo, Baxter; Wu, Tsung-Shu Joseph; O'Donoghue, John; Muula, Adamson S; Thompson, Matthew

2017-03-01

Patient follow-up is a routine component of clinical practice and valuable for evaluating the effectiveness of interventions, but because of the broad dispersion of health facilities and lack of standardised medical reporting in Malawi, collecting patient outcome data can be challenging. Increasing accessibility and affordability of mobile technology in resource-poor settings may facilitate patient follow-up in the community. The objective of this study was to evaluate the potential utility of mobile phones for collecting follow-up clinical data from parents or caregivers of acutely unwell under-5 children, for intervention evaluation purposes. Parents' or caregivers' mobile phone numbers were obtained by health surveillance assistants (HSAs) during study enrollment. Guardians who provided a telephone number were contacted by the study team to establish re-consultations or hospitalisations of their child(ren) within 14 days of recruitment. Health records at village clinics and higher-level health facilities were hand-searched to identify or confirm presentations and abstract clinical data. 87 out of 149 (58.4%) guardians provided a mobile telephone number, of whom the study team could contact 44 (29.5%). Seven guardians stated they took their child for further treatment: three of these returned to village clinics and four presented to secondary care facilities; attendance could only be confirmed from health records for one child. With continued expansion of cellular network coverage and mobile ownership in Malawi, mobile phones may facilitate collection of patient outcomes for intervention evaluation purposes. Future consideration should also be given to integrating mobile technologies into HSA clinical practice.

Evaluation of moral case deliberation at the Dutch Health Care Inspectorate: a pilot study.

PubMed

Seekles, Wike; Widdershoven, Guy; Robben, Paul; van Dalfsen, Gonny; Molewijk, Bert

2016-05-21

Moral case deliberation (MCD) as a form of clinical ethics support is usually implemented in health care institutions and educational programs. While there is no previous research on the use of clinical ethics support on the level of health care regulation, employees of regulatory bodies are regularly confronted with moral challenges. This pilot study describes and evaluates the use of MCD at the Dutch Health Care Inspectorate (IGZ). The objective of this pilot study is to investigate: 1) the current way of dealing with moral issues at the IGZ; 2) experience with and evaluation of MCD as clinical ethics support, and 3) future preferences and (perceived) needs regarding clinical ethics support for dealing with moral questions at the IGZ. We performed an explorative pilot study. The research questions were assessed by means of: 1) interviews with MCD participants during four focus groups; and 2) interviews with six key stakeholders at the IGZ. De qualitative data is illustrated by data from questionnaires on MCD outcomes, perspective taking and MCD evaluation. Professionals do not always recognize moral issues. Employees report a need for regular and structured moral support in health care regulation. The MCD meetings are evaluated positively. The most important outcomes of MCD are feeling secure and learning from others. Additional support is needed to successfully implement MCD at the Inspectorate. We conclude that the respondents perceive moral case deliberation as a useful form of clinical ethics support for dealing with moral questions and issues in health care regulation.

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

An Evaluative Study of Clinical Preceptorship.

ERIC Educational Resources Information Center

Kaviani, Nayer; Stillwell, Yvonne

2000-01-01

A training institute to prepare nurses to serve as preceptors of undergraduate clinical experience was evaluated by focus groups of 6 preceptors, 13 students, and 2 nurse managers. Formal preceptorship training enhanced student learning and promoted positive relationships between nurse educators and practitioners. (SK)

Hospital-Based Clinical Pharmacy Services to Improve Ambulatory Management of Chronic Obstructive Pulmonary Disease

PubMed Central

Smith, Amber Lanae; Palmer, Valerie; Farhat, Nada; Kalus, James S.; Thavarajah, Krishna; DiGiovine, Bruno; MacDonald, Nancy C.

2016-01-01

Background: No systematic evaluations of a comprehensive clinical pharmacy process measures currently exist to determine an optimal ambulatory care collaboration model for chronic obstructive pulmonary disease (COPD) patients. Objective: Describe the impact of a pharmacist-provided clinical COPD bundle on the management of COPD in a hospital-based ambulatory care clinic. Methods: This retrospective cohort analysis evaluated patients with COPD managed in an outpatient pulmonary clinic. The primary objective of this study was to assess the completion of 4 metrics known to improve the management of COPD: (1) medication therapy management, (2) quality measures including smoking cessation and vaccines, (3) patient adherence, and (4) patient education. The secondary objective was to evaluate the impact of the clinical COPD bundle on clinical and economic outcomes at 30 and 90 days post–initial visit. Results: A total of 138 patients were included in the study; 70 patients served as controls and 68 patients received the COPD bundle from the clinical pharmacist. No patients from the control group had all 4 metrics completed as documented, compared to 66 of the COPD bundle group (P < .0001). Additionally, a statistically significant difference was found in all 4 metrics when evaluated individually. Clinical pharmacy services reduced the number of phone call consults at 90 days (P = .04) but did not have a statistically significant impact on any additional pre-identified clinical outcomes. Conclusion: A pharmacist-driven clinical COPD bundle was associated with significant increases in the completion and documentation of 4 metrics known to improve the outpatient management of COPD.

Student-generated e-learning for clinical education.

PubMed

Isaacs, Alex N; Nisly, Sarah; Walton, Alison

2017-04-01

Within clinical education, e-learning facilitates a standardised learning experience to augment the clinical experience while enabling learner and teacher flexibility. With the shift of students from consumers to creators, student-generated content is expanding within higher education; however, there is sparse literature evaluating the impact of student-developed e-learning within clinical education. The aim of this study was to implement and evaluate a student-developed e-learning clinical module series within ambulatory care clinical pharmacy experiences. Three clinical e-learning modules were developed by students for use prior to clinical experiences. E-learning modules were created by fourth-year professional pharmacy students and reviewed by pharmacy faculty members. A pre-/post-assessment was performed to evaluate knowledge comprehension before and after participating in the e-learning modules. Additionally, a survey on student perceptions of this educational tool was performed at the end of the clinical experience. There is sparse literature evaluating the impact of student-developed e-learning within clinical education RESULTS: Of the 31 students eligible for study inclusion, 94 per cent participated in both the pre- and post-assessments. The combined post-assessment score was significantly improved after participating in the student-developed e-learning modules (p = 0.008). The student perception survey demonstrated positive perceptions of e-learning within clinical education. Student-generated e-learning was able to enhance knowledge and was positively perceived by learners. As e-learning continues to expand within health sciences education, students can be incorporated into the development and execution of this educational tool. © 2016 John Wiley & Sons Ltd.

Evaluation and impact of cardiotocography training programmes: a systematic review.

PubMed

Pehrson, C; Sorensen, J L; Amer-Wåhlin, I

2011-07-01

The interpretation and management of cardiotocography (CTG) tracings are often criticised in obstetric malpractice cases. As a consequence, regular CTG training has been recommended, even though little is known about the effect of CTG training. To perform a systematic review of the existing literature on studies on CTG training in order to assess educational strategies, evaluation of training programmes, and impact of training programmes. The Medline database was searched to identify studies describing and/or evaluating CTG training programmes. The literature search resulted in 409 citations. Twenty studies describing and evaluating CTG training programmes were included. There was no restriction on study design. Data regarding study design, study quality, educational strategies used for training in CTG interpretation and decision making, target groups, number of participants, methods used for evaluation, quality of evaluation, level of evaluation and results of training was extracted from 20 articles, and analysed using Kirkpatrick's four-level model for the evaluation of education. Training was associated with improvements on all Kirkpatrick levels, resulting in increased CTG knowledge and interpretive skills, higher interobserver agreement, better management of intrapartum CTG, and improved quality of care. Computer-based training (CBT) might be less time-consuming than classroom teaching. Clinical skills seem to decrease faster than theoretical knowledge. Training can improve CTG competence and clinical practise. Further research on CBT, test-enhanced learning and long-term retention, evaluation of training and impact on clinical outcomes is recommended. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

Nursing students’ satisfaction about their field of study

PubMed Central

HAKIM, ASHRAFALSADAT

2014-01-01

Introduction: Nowadays students' opinion is considered as a necessary factor to evaluate quality in universities. This study was performed to evaluate the nursing students' satisfaction about their field of study. Methods: The research population in this study consists of all the students of nursing studying at the second to fourth year of university (72 students). The data were collected from all the studied population. Data collection instrument was a research questionnaire. In this cross-sectional research, nursing students' satisfaction (72 students) in 6 major topics (situation of educational environment, situation of clinical environment, trainers, social image, relation to colleagues and management) was studied. The data were analyzed in SPSS, version 14, using quantitative variables and descriptive statistics including frequency distribution tables and diagrams. Results: The findings indicated that 83.3% of the students had little satisfaction as to the situation of educational environment, 47.2% about situation of clinical environment, 41.7% concerning the theoretical educational method by professors, and 41.7% as to the method of clinical education by clinical trainers. Also 47.2% were not that satisfied with the method of evaluation by the school professors, 80.6% with the method of relationship with colleagues and also 62.5% with the nursing social image. Moreover, findings indicated that 33.3% of the participants in this research were dissatisfied with the method of evaluation by clinical trainers and 50% with the method of nursing management. Conclusion: In the present study, most students had little satisfaction concerning their field of study. So it is necessary to make an attempt for continuous development of quality services. PMID:25512925

Nursing students' satisfaction about their field of study.

PubMed

Hakim, Ashrafalsadat

2014-04-01

Nowadays students' opinion is considered as a necessary factor to evaluate quality in universities. This study was performed to evaluate the nursing students' satisfaction about their field of study. The research population in this study consists of all the students of nursing studying at the second to fourth year of university (72 students). The data were collected from all the studied population. Data collection instrument was a research questionnaire. In this cross-sectional research, nursing students' satisfaction (72 students) in 6 major topics (situation of educational environment, situation of clinical environment, trainers, social image, relation to colleagues and management) was studied. The data were analyzed in SPSS, version 14, using quantitative variables and descriptive statistics including frequency distribution tables and diagrams. The findings indicated that 83.3% of the students had little satisfaction as to the situation of educational environment, 47.2% about situation of clinical environment, 41.7% concerning the theoretical educational method by professors, and 41.7% as to the method of clinical education by clinical trainers. Also 47.2% were not that satisfied with the method of evaluation by the school professors, 80.6% with the method of relationship with colleagues and also 62.5% with the nursing social image. Moreover, findings indicated that 33.3% of the participants in this research were dissatisfied with the method of evaluation by clinical trainers and 50% with the method of nursing management. In the present study, most students had little satisfaction concerning their field of study. So it is necessary to make an attempt for continuous development of quality services.

Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

PubMed

de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

2015-06-01

To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

Recommendations for imaging tumor response in neurofibromatosis clinical trials

PubMed Central

Ardern-Holmes, Simone L.; Babovic-Vuksanovic, Dusica; Barker, Fred G.; Connor, Steve; Evans, D. Gareth; Fisher, Michael J.; Goutagny, Stephane; Harris, Gordon J.; Jaramillo, Diego; Karajannis, Matthias A.; Korf, Bruce R.; Mautner, Victor; Plotkin, Scott R.; Poussaint, Tina Y.; Robertson, Kent; Shih, Chie-Schin; Widemann, Brigitte C.

2013-01-01

Objective: Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Methods: Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. Results: MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. Conclusions: The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors. PMID:24249804

Recommendations for imaging tumor response in neurofibromatosis clinical trials.

PubMed

Dombi, Eva; Ardern-Holmes, Simone L; Babovic-Vuksanovic, Dusica; Barker, Fred G; Connor, Steve; Evans, D Gareth; Fisher, Michael J; Goutagny, Stephane; Harris, Gordon J; Jaramillo, Diego; Karajannis, Matthias A; Korf, Bruce R; Mautner, Victor; Plotkin, Scott R; Poussaint, Tina Y; Robertson, Kent; Shih, Chie-Schin; Widemann, Brigitte C

2013-11-19

Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors.

Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial.

PubMed

Frakking, Thuy T; Chang, Anne B; O'Grady, Kerry-Ann F; Walker-Smith, Katie; Weir, Kelly A

2013-11-07

Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of 'CFE + CA' versus 'CFE' only compared to MBS-identified OPA. Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility of CA in assessing and diagnosing OPA risk in young children. Australia and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12613000589785.

Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. Methods We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of ‘CFE + CA’ versus ‘CFE’ only compared to MBS-identified OPA. Discussion Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility of CA in assessing and diagnosing OPA risk in young children. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12613000589785. PMID:24199872

Practice-based clinical evaluation of ceramic single crowns after at least five years.

PubMed

Dhima, Matilda; Paulusova, Vladimira; Carr, Alan B; Rieck, Kevin L; Lohse, Christine; Salinas, Thomas J

2014-02-01

Long-term practice-based clinical evaluations of various contemporary ceramic crown restorations from multiple practitioners are limited. The aims of this study were to evaluate the clinical performance of ceramic single crowns and to identify factors that influence their clinical performance. Ceramic single crowns that had been placed at the Mayo Clinic and in function since 2005 were identified and included in the study. The restorations were examined clinically, radiographically, and with photographs. Modified United States Public Health Services criteria were used for the clinical evaluation. The ceramic systems evaluated were bilayer and monolayer. Fifty-nine patients (41 women, 18 men) with 226 single teeth and implants restored with single ceramic crowns were identified. The mean duration from insertion date to study examination date was 6.1 years. Thirteen restorations (6%) were replaced at a mean 3.3 years after insertion date (range, 0.1-6.1 years). Estimated replacement-free survival rates (95% confidence interval [CI]; number of teeth/implants still at risk) at 5 years after insertion date were 95.1% (95% CI, 92.2-98.1; 153) and at 10 years were 92.8% (95% CI, 89.1-96.8; 8). The most common reason for replacement was fracture to the core of posterior layered ceramic crowns. The most commonly used luting agent was resin-modified ionomer cement. Most restorations exhibited clinically acceptable marginal integrity, shade, no caries recurrence, and no periapical pathology. The clinical performance of ceramic single crowns at 5 and 10 years supports their application in all areas of the mouth. With the majority of fractures to the core occurring early in the lifetime of layered ceramic posterior crowns, consideration of other monolithic ceramic systems for posterior crowns is advised. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

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

PubMed

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

2016-01-01

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

Associations of medical student personality and health/wellness characteristics with their medical school performance across the curriculum.

PubMed

Haight, Scott J; Chibnall, John T; Schindler, Debra L; Slavin, Stuart J

2012-04-01

To assess the relationships of cognitive and noncognitive performance predictors to medical student preclinical and clinical performance indicators across medical school years 1 to 3 and to evaluate the association of psychological health/wellness factors with performance. In 2010, the authors conducted a cross-sectional, correlational, retrospective study of all 175 students at the Saint Louis University School of Medicine who had just completed their third (first clinical) year. Students were asked to complete assessments of personality, stress, anxiety, depression, social support, and community cohesion. Performance measures included total Medical College Admission Test (MCAT) score, preclinical academic grades, National Board of Medical Examiners subject exam scores, United States Medical Licensing Examination Step 1 score, clinical evaluations, and Humanism in Medicine Honor Society nominations. A total of 152 students (87%) participated. MCAT scores predicted cognitive performance indicators (academic tests), whereas personality variables (conscientiousness, extraversion, empathy) predicted noncognitive indicators (clinical evaluations, humanism nominations). Conscientiousness predicted all clinical skills, extraversion predicted clinical skills reflecting interpersonal behavior, and empathy predicted motivation. Health/wellness variables had limited associations with performance. In multivariate analyses that included control for shelf exam scores, conscientiousness predicted clinical evaluations, and extraversion and empathy predicted humanism nominations. This study identified two sets of skills (cognitive, noncognitive) used during medical school, with minimal overlap across the types of performance (e.g., exam performance versus clinical interpersonal skills) they predict. Medical school admission and evaluation efforts may need to be modified to reflect the importance of personality and other noncognitive factors.

A systematic literature review of automated clinical coding and classification systems

PubMed Central

Williams, Margaret; Fenton, Susan H; Jenders, Robert A; Hersh, William R

2010-01-01

Clinical coding and classification processes transform natural language descriptions in clinical text into data that can subsequently be used for clinical care, research, and other purposes. This systematic literature review examined studies that evaluated all types of automated coding and classification systems to determine the performance of such systems. Studies indexed in Medline or other relevant databases prior to March 2009 were considered. The 113 studies included in this review show that automated tools exist for a variety of coding and classification purposes, focus on various healthcare specialties, and handle a wide variety of clinical document types. Automated coding and classification systems themselves are not generalizable, nor are the results of the studies evaluating them. Published research shows these systems hold promise, but these data must be considered in context, with performance relative to the complexity of the task and the desired outcome. PMID:20962126

A systematic literature review of automated clinical coding and classification systems.

PubMed

Stanfill, Mary H; Williams, Margaret; Fenton, Susan H; Jenders, Robert A; Hersh, William R

2010-01-01

Clinical coding and classification processes transform natural language descriptions in clinical text into data that can subsequently be used for clinical care, research, and other purposes. This systematic literature review examined studies that evaluated all types of automated coding and classification systems to determine the performance of such systems. Studies indexed in Medline or other relevant databases prior to March 2009 were considered. The 113 studies included in this review show that automated tools exist for a variety of coding and classification purposes, focus on various healthcare specialties, and handle a wide variety of clinical document types. Automated coding and classification systems themselves are not generalizable, nor are the results of the studies evaluating them. Published research shows these systems hold promise, but these data must be considered in context, with performance relative to the complexity of the task and the desired outcome.

Efficacy of scheduled return visits for emergency department patients with non-specific abdominal pain.

PubMed

Boendermaker, Annemieke E; Coolsma, Constant W; Emous, Marloes; Ter Avest, Ewoud

2018-06-02

Many patients presenting with abdominal pain to emergency departments (EDs) are discharged without a definitive diagnosis. For these patients, often designated as having non-specific abdominal pain, re-evaluation is often advocated. We aimed to investigate how often re-evaluation changes the diagnosis and clinical management and discern factors that could help identify patients likely to benefit from re-evaluation. This was a retrospective study conducted in the Netherlands between 1 January 2014 and 31 December 2015 of patients asked to return to the ED after an initial presentation with acute non-traumatic abdominal pain. The primary outcome was a clinically relevant change in treatment (surgery, endoscopy during admission and/or hospitalisation) and diagnosis at ED re-evaluation within 30 hours. During the 2-year study period, 358 ED patients with non-specific abdominal pain were scheduled for re-evaluation. Of these, 14% (11%-18%)) did not present for re-evaluation. Re-evaluation resulted in a clinically relevant change in diagnosis and treatment in, respectively, 21.3% (17%-29%)) and 22.3% (18%-27%)) of the subjects. Of the clinical, biochemical and radiological factors available at the index visit, C reactive protein (CRP) at the index visit predicted a change in treatment (CRP >27 mg/L likelihood ratio (LR)+ 1.69 (1.21-2.36)), while an increase in CRP of >25 mg/L between index and re-evaluation visit (LR+ 2.85 (1.88-4.32)) and the conduct of radiological studies at the re-evaluation visit were associated with changes in treatment (LR+ 3.05 (2.41-3.86)). Re-evaluation within 30 hours for ED patients discharged with non-specific abdominal pain resulted in a clinically relevant change in diagnosis and therapy in almost one-quarter of patients. Elevated CRP at the index visit might assist in correctly identifying patients with a greater likelihood of needing treatment in follow-up, and a low threshold for radiological studies should be considered during re-evaluation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical evaluation of fiber-reinforced epoxy resin posts and cast post and cores.

PubMed

Ferrari, M; Vichi, A; García-Godoy, F

2000-05-01

This retrospective study evaluated treatment outcome of cast post and core and Composipost systems after 4 yrs of clinical service. 200 patients were included in the study. They were divided in two groups of 100 endodontically treated teeth restored with a post. Group 1: Composipost systems were luted into root canal following the manufacturer's instructions. Group 2: Cast post and cores were cemented into root canal preparations with a traditional technique. The patients were recalled after 6 months, 1, 2 and 4 yrs and clinical and radiographic examinations were completed. Endodontic and prosthodontic results were recorded. Group 1: 95% of the teeth restored with Composiposts showed clinical success; 3% of these samples were excluded for noncompliance and 2% showed endodontic failure. Group 2: Clinical success was found with 84% of teeth restored with cast post and core. 2% of these samples were excluded for noncompliance, 9% showed root fracture, 2% dislodgment of crown and 3% endodontic failure. Statistical evaluation showed significant differences between Groups 1 and 2 (P < 0.001). The results of this retrospective study indicated that the Composipost system was superior to the conventional cast post and core system after 4 yrs of clinical service.

Attitudes of affiliate faculty members toward medical student summative evaluation for clinical clerkships: a qualitative analysis.

PubMed

Wang, Karen E; Fitzpatrick, Caroline; George, David; Lane, Lindsey

2012-01-01

Summative evaluation of medical students is a critical component of the educational process. Despite extensive literature on evaluation, few studies have centered on affiliate faculty members' attitudes toward summative evaluation of students, though it has been suggested that these attitudes influence their effectiveness as evaluators. The objective is to examine affiliate faculty members' attitudes toward clinical clerkship evaluation using primarily qualitative research methods. The study used a nonexperimental research design and employed mixed methods. Data were collected through interviews, focus groups, and a questionnaire from 11 affiliate faculty members. Themes emerging from the data fell into three broad categories: (a) factors that influence grading, (b) consequences of negative evaluations, and (c) disconnections in the grading process. The quantitative portion of the study revealed important discrepancies supporting the use of qualitative methods. The study highlights faculty members' struggles with the evaluative process and emphasizes the need for improvements in evaluation tools and faculty development.

Considerations in the Design of Clinical Trials for Cognitive Aging

PubMed Central

Brinton, Roberta Diaz; Katz, Russell; Petersen, Ronald C.; Negash, Selam; Mungas, Dan; Aisen, Paul S.

2012-01-01

What will it take to develop interventions for the treatment of age-related cognitive decline? Session V of the Summit provided perspectives on the design of clinical trials to evaluate promising but unproven interventions, and some of the steps needed to accelerate the discovery and evaluation of promising treatments. It considered strategies to further characterize the biological and cognitive changes associated with normal aging and their translation into the development of new treatments. It provided regulatory, scientific, and clinical perspectives about neurocognitive aging treatments, their potential benefits and risks, and the strategies and endpoints needed to evaluate them in the most rapid, rigorous, and clinically meaningful way. It considered lessons learned from the study of Alzheimer's disease, the promising roles of biomarkers in neurocognitive aging research, and ways to help galvanize the scientific study and treatment of neurocognitive aging. PMID:22573913

Considerations in the design of clinical trials for cognitive aging.

PubMed

Reiman, Eric M; Brinton, Roberta Diaz; Katz, Russell; Petersen, Ronald C; Negash, Selam; Mungas, Dan; Aisen, Paul S

2012-06-01

What will it take to develop interventions for the treatment of age-related cognitive decline? Session V of the Summit provided perspectives on the design of clinical trials to evaluate promising but unproven interventions, and some of the steps needed to accelerate the discovery and evaluation of promising treatments. It considered strategies to further characterize the biological and cognitive changes associated with normal aging and their translation into the development of new treatments. It provided regulatory, scientific, and clinical perspectives about neurocognitive aging treatments, their potential benefits and risks, and the strategies and endpoints needed to evaluate them in the most rapid, rigorous, and clinically meaningful way. It considered lessons learned from the study of Alzheimer's disease, the promising roles of biomarkers in neurocognitive aging research, and ways to help galvanize the scientific study and treatment of neurocognitive aging.

Development and psychometric evaluation of the nursing instructors' clinical teaching performance inventory.

PubMed

A Farahani, Mansoureh; Emamzadeh Ghasemi, Hormat Sadat; Nikpaima, Nasrin; Fereidooni, Zhila; Rasoli, Maryam

2014-10-29

Evaluation of nursing instructors' clinical teaching performance is a prerequisite to the quality assurance of nursing education. One of the most common procedures for this purpose is using student evaluations. This study was to develop and evaluate the psychometric properties of Nursing Instructors' Clinical Teaching Performance Inventory (NICTPI). The primary items of the inventory were generated by reviewing the published literature and the existing questionnaires as well as consulting with the members of the Faculties Evaluation Committee of the study setting. Psychometric properties were assessed by calculating its content validity ratio and index, and test-retest correlation coefficient as well as conducting an exploratory factor analysis and an internal consistency assessment. The content validity ratios and indices of the items were respectively higher than 0.85 and 0.79. The final version of the inventory consisted of 25 items, and in the exploratory factor analysis, items were loaded on three factors which jointly accounting for 72.85% of the total variance. The test-retest correlation coefficient and the Cronbach's alpha of the inventory were 0.93 and 0.973, respectively. The results revealed that the developed inventory is an appropriate, valid, and reliable instrument for evaluating nursing instructors' clinical teaching performance.

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

PubMed

Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

2005-12-01

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

The Ling 6(HL) test: typical pediatric performance data and clinical use evaluation.

PubMed

Glista, Danielle; Scollie, Susan; Moodie, Sheila; Easwar, Vijayalakshmi

2014-01-01

The Ling 6(HL) test offers a calibrated version of naturally produced speech sounds in dB HL for evaluation of detection thresholds. Aided performance has been previously characterized in adults. The purpose of this work was to evaluate and refine the Ling 6(HL) test for use in pediatric hearing aid outcome measurement. This work is presented across two studies incorporating an integrated knowledge translation approach in the characterization of normative and typical performance, and in the evaluation of clinical feasibility, utility, acceptability, and implementation. A total of 57 children, 28 normally hearing and 29 with binaural sensorineural hearing loss, were included in Study 1. Children wore their own hearing aids fitted using Desired Sensation Level v5.0. Nine clinicians from The Network of Pediatric Audiologists participated in Study 2. A CD-based test format was used in the collection of unaided and aided detection thresholds in laboratory and clinical settings; thresholds were measured clinically as part of routine clinical care. Confidence intervals were derived to characterize normal performance and typical aided performance according to hearing loss severity. Unaided-aided performance was analyzed using a repeated-measures analysis of variance. The audiologists completed an online questionnaire evaluating the quality, feasibility/executability, utility/comparative value/relative advantage, acceptability/applicability, and interpretability, in addition to recommendation and general comments sections. Ling 6(HL) thresholds were reliably measured with children 3-18 yr old. Normative and typical performance ranges were translated into a scoring tool for use in pediatric outcome measurement. In general, questionnaire respondents generally agreed that the Ling 6(HL) test was a high-quality outcome evaluation tool that can be implemented successfully in clinical settings. By actively collaborating with pediatric audiologists and using an integrated knowledge translation framework, this work supported the creation of an evidence-based clinical tool that has the potential to be implemented in, and useful to, clinical practice. More research is needed to characterize performance in alternative listening conditions to facilitate use with infants, for example. Future efforts focused on monitoring the use of the Ling 6(HL) test in daily clinical practice may help describe whether clinical use has been maintained across time and if any additional adaptations are necessary to facilitate clinical uptake. American Academy of Audiology.

Expert Systems In Medical Studies - A New Twist

NASA Astrophysics Data System (ADS)

Slagle, James R.; Long, John M.; Wick, Michael R.; Matts, John P.; Leon, Arthur S.

1986-03-01

The use of experts to evaluate large amounts of trial data results in increasingly expensive and time consuming research. We are investigating the role expert systems can play in reducing the time and expense of research projects. Current methods in large clinical studies for evaluating data are often crude and superficial. We have developed, for a large clinical trial, an expert system for analysis of treadmill exercise ECG test results. In the cases we are studying, a patient is given a treadmill exercise ECG test once a year for five years. Pairs of these exercise tests are then evaluated by cardiologists to determine the condition of the patient's heart. The results of our system show great promise for the use of expert systems in reducing the time and expense of large clinical trials.

Clinical image quality evaluation for panoramic radiography in Korean dental clinics

PubMed Central

Choi, Bo-Ram; Choi, Da-Hye; Huh, Kyung-Hoe; Yi, Won-Jin; Heo, Min-Suk; Choi, Soon-Chul; Bae, Kwang-Hak

2012-01-01

Purpose The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Materials and Methods Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. Results A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Conclusion Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively. PMID:23071969

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…

An audit of inpatient case records and suggestions for improvements.

PubMed

Arshad, A R; Ganesananthan, S; Ajik, S

2000-09-01

A study was carried out in Kuala Lumpur Hospital to review the adequacy of documentation of bio-data and clinical data including clinical examination, progress review, discharge process and doctor's identification in ten of our clinical departments. Twenty criteria were assessed in a retrospective manner to scrutinize the contents of medical notes and subsequently two prospective evaluations were conducted to see improvement in case notes documentation. Deficiencies were revealed in all the criteria selected. However there was a statistically significant improvement in the eleven clinical data criteria in the subsequent two evaluations. Illegibility of case note entries and an excessive usage of abbreviations were noted during this audit. All clinical departments and hospitals should carry out detailed studies into the contents of their medical notes.

Effects of the Non-Nutritive Sweeteners on Glucose Metabolism and Appetite Regulating Hormones: Systematic Review of Observational Prospective Studies and Clinical Trials

PubMed Central

Romo-Romo, Alonso; Aguilar-Salinas, Carlos A.; Brito-Córdova, Griselda X.; Gómez Díaz, Rita A.; Vilchis Valentín, David

2016-01-01

Background The effects of non-nutritive sweeteners (NNS) on glucose metabolism and appetite regulating hormones are not clear. There is an ongoing debate concerning NNS use and deleterious changes in metabolism. Objectives The aim of this review is to analyze the scientific available evidence regarding the effects of NNS on glucose metabolism and appetite regulating hormones. Data Sources and Study Eligibility Criteria We identified human observational studies evaluating the relation between NNS consumption and obesity, diabetes, and metabolic syndrome, in addition to clinical trials evaluating the effects of NNS in glucose metabolism and appetite regulating hormones. Results Fourteen observational studies evaluating the association between NNS consumption and the development of metabolic diseases and twenty-eight clinical trials studying the effects of NNS on metabolism were included. Finally, two meta-analyses evaluating the association between the consumption of NNS-containing beverages and the development of type 2 diabetes were identified. Conclusions Some observational studies suggest an association between NNS consumption and development of metabolic diseases; however, adiposity is a confounder frequently found in observational studies. The effects of the NNS on glucose metabolism are not clear. The results of the identified clinical trials are contradictory and are not comparable because of the major existing differences between them. Studies evaluating specific NNS, with an adequate sample size, including a homogeneous study group, identifying significant comorbidities, with an appropriate control group, with an appropriate exposure time, and considering adjustment for confounder variables such as adiposity are needed. PMID:27537496

Determination of minimum suction level necessary for field dental units.

PubMed

Charlton, David G

2010-04-01

A significant problem with most field dental units is that their suction is too weak to effectively remove debris from the mouth. The purpose of this study was to determine the minimum clinically acceptable suction level for routine dentistry. A vacuum pump was connected to a high-volume dental evacuation line in a simulated clinical setting and different suction airflow rates were evaluated by nine evaluator dentists for their capability to effectively remove amalgam debris and water. Airflow levels were rated as "clinically acceptable" or "clinically unacceptable" by each evaluator. Data were analyzed using a chi2 test for trend. Analysis indicated a significant linear trend between airflow and ratings (p < 0.0001). The first airflow level considered by all evaluators as producing clinically acceptable suction was 4.5 standard cubic feet per minute (0.127 standard cubic meters per minute). This value should be the minimum level required for all military field dental units.

Stroke prevention in atrial fibrillation: re-defining 'real-world data' within the broader data universe.

PubMed

Fanaroff, Alexander C; Steffel, Jan; Alexander, John H; Lip, Gregory Y H; Califf, Robert M; Lopes, Renato D

2018-04-23

Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design). Under this framework, RWD refers only to data source, and a study incorporates RWD when it primarily uses data collected for non-research purposes, such as insurance claims data or the electronic health record, regardless of study design. Separation of study design, data source, and context enables parallel evaluation of two critical elements: (i) whether a study can support claims of causal inference, which can be assured with a high degree of confidence only in studies where patients are assigned treatments by protocol; and (ii) whether the study population and clinical context mirror clinical practice, a strength of observational studies using data from clinical practice or administrative claims. In this review, we describe the strengths and weaknesses of observational and non-observational studies, and studies involving RWD and non-RWD, through the lens of anticoagulation for atrial fibrillation (AF). Observational studies employing RWD are useful for describing how oral anticoagulants are used in clinical practice, but generally cannot be used to make claims regarding comparative treatment effects. Questions regarding treatment effect generally are best answered through an RCT, and additional pragmatic RCTs are needed to compare different antithrombotic agents for the prevention of thrombotic events in AF.

Cementless anatomical prosthesis for the treatment of 3-part and 4-part proximal humerus fractures: cadaver study and prospective clinical study with minimum 2 years followup

PubMed Central

Obert, Laurent; Saadnia, Rachid; Loisel, François; Uhring, Julien; Adam, Antoine; Rochet, Séverin; Clappaz, Pascal; Lascar, Tristan

2016-01-01

Introduction: The purpose of this study was to evaluate the functional and radiological outcomes of a cementless, trauma-specific locked stem for 3- and 4-part proximal humeral fractures. Materials and methods: This study consisted of two parts: a cadaver study with 22 shoulders and a multicenter prospective clinical study of 23 fracture patients evaluated at least 2 years after treatment. In the cadaver study, the locked stem (HumelockTM, FX Solutions) and its instrumentation were evaluated. In the clinical study, five senior surgeons at four different hospitals performed the surgical procedures. An independent surgeon evaluated the patients using clinical (Constant score, QuickDASH) and radiological (X-rays, CT scans) outcome measures. Results: The cadaver study allowed us to validate the height landmarks relative to the pectoralis major tendon. In the clinical study, at the review, abduction was 95° (60–160), forward flexion was 108° (70–160), external rotation (elbow at body) was 34° (0–55), the QuickDASH was 31 (4.5–59), the overall Constant score was 54 (27–75), and the weighted Constant score was 76 (31.5–109). Discussion: This preliminary study of hemiarthroplasty (HA) with a locked stem found results that were at least equivalent to published series. As all patients had at least a 2-year follow-up, integration of the locked stem did not cause any specific complications. These results suggest that it is possible to avoid using cement when hemiarthroplasty is performed for the humeral stem. This implant makes height adjustment and transosseous suturing of the tuberosities more reproducible. PMID:27194107

Unattended Sleep Studies in a VA Population: Initial Evaluation by Chart Review Versus Clinic Visit by a Midlevel Provider.

PubMed

Alsharif, Abdelhamid M; Potts, Michelle; Laws, Regina; Freire, Amado X; Sultan-Ali, Ibrahim

2016-10-01

Obstructive sleep apnea (OSA) is a prevalent disorder that is associated with multiple medical consequences. Although in-laboratory polysomnography is the gold standard for the diagnosis of OSA, portable monitors have been developed and studied to help increase efficiency and ease of diagnosis. We aimed to assess the adequacy of a midlevel provider specializing in sleep medicine to risk-stratify patients for OSA based on a chart review versus a comprehensive clinic evaluation before scheduling an unattended sleep study. This study was an observational, nonrandomized, retrospective data collection by chart review of patients accrued prospectively who underwent an unattended sleep study at the Sleep Health Center at the Memphis Veterans Affairs Medical Center during the first 13 months of the program (May 1, 2011-May 31, 2012). A total of 205 patients were included in the data analysis. Analysis showed no statistically significant differences between chart review and clinic visit groups ( P = 0.54) in terms of OSA diagnosis. Although not statistically significant, the analysis shows a trend toward higher mean age (50.3 vs 47.4 years; P = 0.10) and lower mean body mass index (34.4 vs 36.0; P = 0.08) in individuals who were evaluated during a comprehensive clinic visit. A statistically significant difference is seen in terms of the pretest clinical probability of OSA being moderate or high in 62.2% of patients in the clinic visit group and 95.7% in the chart review group, with a χ 2 P ≤ 0.0001. In the Veterans Health Administration's system, the assessment of pretest probability may be determined by a midlevel provider using chart review with equal efficacy to a comprehensive face-to-face evaluation in terms of OSA diagnosis via unattended sleep studies.

A Brief Course on Clinical Communication Skills: A Multi- Centered Study.

PubMed

Franco, Camila; Franco, Renato; Severo, Milton; Ferreira, Maria Amélia

2016-12-30

This paper describes and analyses the results of a multicenter course on clinical communication skills with the use of the learning in small groups, patient actors and feedback. The aim of the course was to encourage participants to develop a more effective clinical communication to recognize the different manifestations of the same disease in different patients (disease versus illness). The course was applied to third and fourth year medical students in three Brazilian universities and one university in Portugal. The evaluation was performed using scales regarding the participants' point of view, multiple choice questionnaire, a self-efficacy and attitudinal questionnaire. The study was conducted in 69 participants at the four universities. The overall evaluation of the course (from 1 - 5) was 4.70 (SD 0.494), the self-evaluation on participation was 4.07 (SD 0.671); and the evaluation about the use of simulated patients 4.51 (SD 0.501). The multiple choice questionnaire and self-efficacy scale showed significant improvement. The course methods had an excellent evaluation by students regardless of the context in which the course has been applied. Furthermore, it allowed an improvement on the knowledge and attitude of students regarding clinical communication. It was possible to develop a multi-centric learning strategy for clinical communication with a high evaluation by students who came from a Portuguese university in a cooperation project with teachers from Brazilian universities.

Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education –Effects of Introduction of an Education System Using OSCE–

PubMed Central

Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo

2013-01-01

[Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE. PMID:24259918

Evaluation Criteria of Noninvasive Telemonitoring for Patients With Heart Failure: Systematic Review.

PubMed

Farnia, Troskah; Jaulent, Marie-Christine; Steichen, Olivier

2018-01-16

Telemonitoring can improve heart failure (HF) management, but there is no standardized evaluation framework to comprehensively evaluate its impact. Our objectives were to list the criteria used in published evaluations of noninvasive HF telemonitoring projects, describe how they are used in the evaluation studies, and organize them into a consistent scheme. Articles published from January 1990 to August 2015 were obtained through MEDLINE, Web of Science, and EMBASE. Articles were eligible if they were original reports of a noninvasive HF telemonitoring evaluation study in the English language. Studies of implantable telemonitoring devices were excluded. Each selected article was screened to extract the description of the telemonitoring project and the evaluation process and criteria. A qualitative synthesis was performed. We identified and reviewed 128 articles leading to 52 evaluation criteria classified into 6 dimensions: clinical, economic, user perspective, educational, organizational, and technical. The clinical and economic impacts were evaluated in more than 70% of studies, whereas the educational, organizational, and technical impacts were studied in fewer than 15%. User perspective was the most frequently covered dimension in the development phase of telemonitoring projects, whereas clinical and economic impacts were the focus of later phases. Telemonitoring evaluation frameworks should cover all 6 dimensions appropriately distributed along the telemonitoring project lifecycle. Our next goal is to build such a comprehensive evaluation framework for telemonitoring and test it on an ongoing noninvasive HF telemonitoring project. ©Troskah Farnia, Marie-Christine Jaulent, Olivier Steichen. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 16.01.2018.

[Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

PubMed

Ruiz, Martial; Thibult, François

2014-06-01

The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

Clinic Workflow Simulations using Secondary EHR Data

PubMed Central

Hribar, Michelle R.; Biermann, David; Read-Brown, Sarah; Reznick, Leah; Lombardi, Lorinna; Parikh, Mansi; Chamberlain, Winston; Yackel, Thomas R.; Chiang, Michael F.

2016-01-01

Clinicians today face increased patient loads, decreased reimbursements and potential negative productivity impacts of using electronic health records (EHR), but have little guidance on how to improve clinic efficiency. Discrete event simulation models are powerful tools for evaluating clinical workflow and improving efficiency, particularly when they are built from secondary EHR timing data. The purpose of this study is to demonstrate that these simulation models can be used for resource allocation decision making as well as for evaluating novel scheduling strategies in outpatient ophthalmology clinics. Key findings from this study are that: 1) secondary use of EHR timestamp data in simulation models represents clinic workflow, 2) simulations provide insight into the best allocation of resources in a clinic, 3) simulations provide critical information for schedule creation and decision making by clinic managers, and 4) simulation models built from EHR data are potentially generalizable. PMID:28269861

Clinical and cost-effectiveness of non-medical prescribing: A systematic review of randomised controlled trials

PubMed Central

Marriott, John; Graham-Clarke, Emma; Shirley, Debra; Rushton, Alison

2018-01-01

Objective To evaluate the clinical and cost-effectiveness of non-medical prescribing (NMP). Design Systematic review. Two reviewers independently completed searches, eligibility assessment and assessment of risk of bias. Data sources Pre-defined search terms/combinations were utilised to search electronic databases. In addition, hand searches of reference lists, key journals and grey literature were employed alongside consultation with authors/experts. Eligibility criteria for included studies Randomised controlled trials (RCTs) evaluating clinical or cost-effectiveness of NMP. Measurements reported on one or more outcome(s) of: pain, function, disability, health, social impact, patient-safety, costs-analysis, quality adjusted life years (QALYs), patient satisfaction, clinician perception of clinical and functional outcomes. Results Three RCTs from two countries were included (n = 932 participants) across primary and tertiary care settings. One RCT was assessed as low risk of bias, one as high risk of bias and one as unclear risk of bias. All RCTs evaluated clinical effectiveness with one also evaluating cost-effectiveness. Clinical effectiveness was evaluated using a range of safety and patient-reported outcome measures. Participants demonstrated significant improvement in outcomes when receiving NMP compared to treatment as usual (TAU) in all RCTs. An associated cost analysis showed NMP to be more expensive than TAU (regression coefficient p = 0.0000), however experimental groups generated increased QALYs compared to TAU. Conclusion Limited evidence with overall unclear risk of bias exists evaluating clinical and cost-effectiveness of NMP across all professions and clinical settings. GRADE assessment revealed moderate quality evidence. Evidence suggests that NMP is safe and can provide beneficial clinical outcomes. Benefits to the health economy remain unclear, with the cost-effectiveness of NMP assessed by a single pilot RCT of low risk of bias. Adequately powered low risk of bias RCTs evaluating clinical and cost effectiveness are required to evaluate NMP across clinical specialities, professions and settings. Registration PROSPERO (CRD42015017212). PMID:29509763

Study protocol of the internet user Cohort for Unbiased Recognition of gaming disorder in Early adolescence (iCURE), Korea, 2015-2019.

PubMed

Jeong, Hyunsuk; Yim, Hyeon Woo; Jo, Sun-Jin; Lee, Seung-Yup; Kim, Eunjin; Son, Hye Jung; Han, Hyun-Ho; Lee, Hae Kook; Kweon, Yong-Sil; Bhang, Soo-Young; Choi, Jung-Seok; Kim, Bung-Nyun; Gentile, Douglas A; Potenza, Marc N

2017-10-05

In 2013, the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine internet gaming disorder (IGD) diagnostic criteria as a condition warranting further empirical and clinical research. The aim of this study is to clarify the natural and clinical courses of IGD proposed DSM-5 in adolescents and to evaluate its risk and protective factors. The Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence (iCURE) study is an ongoing multidisciplinary, prospective, longitudinal cohort study conducted in 21 schools in Korea. Participant recruitment commenced in March 2015 with the goal of registering 3000 adolescents. The baseline assessment included surveys on emotional, social and environmental characteristics. A parent or guardian completed questionnaires and a structured psychiatric comorbidity diagnostic interview regarding their children. Adolescents with the Internet Game Use-Elicited Symptom Screen total scores of 6 or higher were asked to participate in the clinical diagnostic interview. Two subcohorts of adolescents were constructed: a representative subcohort and a clinical evaluation subcohort. The representative subcohort comprises a randomly selected 10% of the iCURE to investigate the clinical course of IGD based on clinical diagnosis and to estimate the false negative rate. The clinical evaluation subcohort comprised participants meeting three or more of the nine IGD criteria, determined by clinical diagnostic interview, to show the clinical course of IGD. Follow-up data will be collected annually for the 3 years following the baseline assessments. The primary endpoint is 2-year incidence, remission and recurrence rates of IGD. Cross-sectional and longitudinal associations between exposures and outcomes as well as mediation factors will be evaluated. This study is approved by the Institutional Review Board of the Catholic University of Korea. Results will be published in peer-reviewed journals. ClinicalTrials.gov (identifier: NCT02415322). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical and electrophysiologic attributes as predictors of results of autonomic function tests

NASA Technical Reports Server (NTRS)

Wu, C. L.; Denq, J. C.; Harper, C. M.; O'Brien, P. C.; Low, P. A.

1998-01-01

Autonomic dysfunction is a feature of some neuropathies and not others. It has been suggested that some clinical and electrophysiologic attributes are predictable of autonomic impairment detected using laboratory testing; however, dear guidelines are unavailable. We evaluated 138 relatively unselected patients with peripheral neuropathy who underwent neurologic evaluation, electromyography (EMG), nerve conduction studies, and autonomic function tests to determine which variables were predictive of laboratory findings of autonomic failure. The variables evaluated were 1) clinical somatic neuropathic findings, 2) clinical autonomic symptoms, and 3) electrophysiologic findings. Autonomic symptoms were strongly predictive (Rs = 0.40, p < 0.001) of autonomic failure. Among the non-autonomic indices, absent ankle reflexes were mildly predictive (Rs = 0.19, p = 0.022) of autonomic impairment, but all others were not (duration, clinical pattern, severity, weakness, sensory loss). Electrophysiologic changes of an axonal neuropathy predicted autonomic impairment while demyelinating neuropathy did not. We conclude that autonomic studies will most likely be abnormal in patients who have symptoms of autonomic involvement and those who have an axonal neuropathy.

Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism.

PubMed

van Rumund, Anouke; Aerts, Marjolein B; Esselink, Rianne A J; Meijer, Frederick J A; Verbeek, Marcel M; Bloem, Bastiaan R

2018-05-16

Differentiation of Parkinson's disease (PD) from the various types of atypical parkinsonism (AP) such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), dementia with Lewy bodies (DLB), corticobasal syndrome (CBS) and vascular parkinsonism (VP), can be challenging, especially early in the disease course when symptoms overlap. A major unmet need in the diagnostic workup of these disorders is a diagnostic tool that differentiates the various disorders, preferably in the earliest disease stages when the clinical presentation is similar. Many diagnostic tests have been evaluated, but their added value was studied mostly in retrospective case-control studies that included patients with a straightforward clinical diagnosis. Here, we describe the design of a prospective cohort study in patients with parkinsonism in an early disease stage who have an uncertain clinical diagnosis. Our aim is to evaluate the diagnostic accuracy of (1) detailed clinical examination by a movement disorder specialist, (2) magnetic resonance imaging (MRI) techniques and (3) cerebrospinal fluid (CSF) biomarkers. Patients with parkinsonism with an uncertain clinical diagnosis and a disease course less than three years will be recruited. Patients will undergo extensive neurological examination, brain MRI including conventional and advanced sequences, and a lumbar puncture. The diagnosis (including level of certainty) will be defined by a movement disorders expert, neuroradiologist and neurochemist based on clinical data, MRI results and CSF results, respectively. The clinical diagnosis after three years' follow-up will serve as the "gold standard" reference diagnosis, based on consensus criteria and as established by two movement disorder specialists (blinded to the test results). Diagnostic accuracy of individual instruments and added value of brain MRI and CSF analysis after evaluation by a movement disorder expert will be calculated, expressed as the change in percentage of individuals that are correctly diagnosed with PD or AP. This study will yield new insights into the diagnostic value of clinical evaluation by a movement disorder specialist, brain MRI and CSF analysis in discriminating PD from AP in early disease stages. The outcome has the potential to help clinicians in choosing the optimal diagnostic strategy for patients with an uncertain clinical diagnosis. NCT01249768, registered November 26 2010.

Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial.

PubMed

Leavy, Breiffni; Kwak, Lydia; Hagströmer, Maria; Franzén, Erika

2017-02-07

If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings. This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants. An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice. ClinicalTrials.gov march 2016, NCT02727478 .

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

A Descriptive Study of Nursing Peer-Review Programs in US Magnet® Hospitals.

PubMed

Roberts, Holli; Cronin, Sherill Nones

2017-04-01

The goal of this study was to assess the types of nursing peer review (NPR) programs in US Magnet® organizations. The 2 most predominant models of NPR programs in the literature are performance evaluation and clinical peer review. The literature on clinical peer review is primarily descriptive, outlining structures and anecdotal outcomes. Participants from hospitals holding Magnet recognition were selected using a stratified random-sampling method. A survey developed by the researchers assessed the presence of NPR. If clinical NPR was in place, program design, evaluation measurements, and barriers were explored. Findings suggest wide variability in NPR models. More than one-third of the respondents conduct peer evaluation as the only mechanism of NPR. Most hospitals with a clinical peer-review program reported a case review structure and process measurements not supported by data. The variations noted in this study suggest more research is needed to measure the effectiveness of NPR models and associated outcomes.

Evaluating Random Error in Clinician-Administered Surveys: Theoretical Considerations and Clinical Applications of Interobserver Reliability and Agreement.

PubMed

Bennett, Rebecca J; Taljaard, Dunay S; Olaithe, Michelle; Brennan-Jones, Chris; Eikelboom, Robert H

2017-09-18

The purpose of this study is to raise awareness of interobserver concordance and the differences between interobserver reliability and agreement when evaluating the responsiveness of a clinician-administered survey and, specifically, to demonstrate the clinical implications of data types (nominal/categorical, ordinal, interval, or ratio) and statistical index selection (for example, Cohen's kappa, Krippendorff's alpha, or interclass correlation). In this prospective cohort study, 3 clinical audiologists, who were masked to each other's scores, administered the Practical Hearing Aid Skills Test-Revised to 18 adult owners of hearing aids. Interobserver concordance was examined using a range of reliability and agreement statistical indices. The importance of selecting statistical measures of concordance was demonstrated with a worked example, wherein the level of interobserver concordance achieved varied from "no agreement" to "almost perfect agreement" depending on data types and statistical index selected. This study demonstrates that the methodology used to evaluate survey score concordance can influence the statistical results obtained and thus affect clinical interpretations.

Molecular Indicators of Castration-Resistant Prostate Cancer

DTIC Science & Technology

2015-12-01

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

Epidemiological, clinical and sleep laboratory evaluations of insomnia

NASA Technical Reports Server (NTRS)

Bixler, E. O.; Kales, A.; Kales, J. D.

1975-01-01

Epidemiological studies have contributed to the understanding of the total scope of the insomnia problem, both in terms of the incidence of sleep difficulties, and the extent and frequency of hypnotic drug use. Clinical studies - at the Sleep Research and Treatment Center - have been used to evaluate the medical, psychological, pharmacological and situational factors contributing to insomnia, and to evaluate the psychotherapy and chemotherapy best suited to treatment of insomnia. The sleep laboratory studies were of two types: (1) the study of sleep induction, sleep maintenance, and sleep stages, and (2) the use of hypnotic drugs, emphasizing their effectiveness in inducing and maintaining sleep, and the duration of this effectiveness.

Impact of Image Noise on Gamma Index Calculation

NASA Astrophysics Data System (ADS)

Chen, M.; Mo, X.; Parnell, D.; Olivera, G.; Galmarini, D.; Lu, W.

2014-03-01

Purpose: The Gamma Index defines an asymmetric metric between the evaluated image and the reference image. It provides a quantitative comparison that can be used to indicate sample-wised pass/fail on the agreement of the two images. The Gamma passing/failing rate has become an important clinical evaluation tool. However, the presence of noise in the evaluated and/or reference images may change the Gamma Index, hence the passing/failing rate, and further, clinical decisions. In this work, we systematically studied the impact of the image noise on the Gamma Index calculation. Methods: We used both analytic formulation and numerical calculations in our study. The numerical calculations included simulations and clinical images. Three different noise scenarios were studied in simulations: noise in reference images only, in evaluated images only, and in both. Both white and spatially correlated noises of various magnitudes were simulated. For clinical images of various noise levels, the Gamma Index of measurement against calculation, calculation against measurement, and measurement against measurement, were evaluated. Results: Numerical calculations for both the simulation and clinical data agreed with the analytic formulations, and the clinical data agreed with the simulations. For the Gamma Index of measurement against calculation, its distribution has an increased mean and an increased standard deviation as the noise increases. On the contrary, for the Gamma index of calculation against measurement, its distribution has a decreased mean and stabilized standard deviation as the noise increases. White noise has greater impact on the Gamma Index than spatially correlated noise. Conclusions: The noise has significant impact on the Gamma Index calculation and the impact is asymmetric. The Gamma Index should be reported along with the noise levels in both reference and evaluated images. Reporting of the Gamma Index with switched roles of the images as reference and evaluated images or some composite metrics would be a good practice.

Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

PubMed

Penberthy, Lynne; Brown, Richard; Puma, Federico; Dahman, Bassam

2010-05-01

Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials. This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer. Copyright (c) 2010 Elsevier Inc. All rights reserved.

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

PubMed

Visco, Anthony G; Fraser, Matthew O; Newgreen, Donald; Oelke, Matthias; Cardozo, Linda

2016-02-01

The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. © 2016 Wiley Periodicals, Inc.

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.

Scleroderma Research Foundation

MedlinePlus

... with suspected lung hypertension. Scleroderma Patients Needed for Research Study to Evaluate Internet Self-Management Program January-2017 ... year before a standard clinical test could. Clinical Research Study for Scleroderma with Interstitial Lung Disease (lung scarring) ...

Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III.

PubMed

Newman, Craig G J; Bevins, Adam D; Zajicek, John P; Hodges, John R; Vuillermoz, Emil; Dickenson, Jennifer M; Kelly, Denise S; Brown, Simona; Noad, Rupert F

2018-01-01

Ensuring reliable administration and reporting of cognitive screening tests are fundamental in establishing good clinical practice and research. This study captured the rate and type of errors in clinical practice, using the Addenbrooke's Cognitive Examination-III (ACE-III), and then the reduction in error rate using a computerized alternative, the ACEmobile app. In study 1, we evaluated ACE-III assessments completed in National Health Service (NHS) clinics ( n  = 87) for administrator error. In study 2, ACEmobile and ACE-III were then evaluated for their ability to capture accurate measurement. In study 1, 78% of clinically administered ACE-IIIs were either scored incorrectly or had arithmetical errors. In study 2, error rates seen in the ACE-III were reduced by 85%-93% using ACEmobile. Error rates are ubiquitous in routine clinical use of cognitive screening tests and the ACE-III. ACEmobile provides a framework for supporting reduced administration, scoring, and arithmetical error during cognitive screening.

Outcome Measures in Spinal Cord Injury

PubMed Central

Alexander, Marcalee S.; Anderson, Kim; Biering-Sorensen, Fin; Blight, Andrew R.; Brannon, Ruth; Bryce, Thomas; Creasey, Graham; Catz, Amiram; Curt, Armin; Donovan, William; Ditunno, John; Ellaway, Peter; Finnerup, Nanna B.; Graves, Daniel E.; Haynes, Beth Ann; Heinemann, Allen W.; Jackson, Amie B.; Johnston, Mark; Kalpakjian, Claire Z.; Kleitman, Naomi; Krassioukov, Andrei; Krogh, Klaus; Lammertse, Daniel; Magasi, Susan; Mulcahey, MJ; Schurch, Brigitte; Sherwood, Arthur; Steeves, John D.; Stiens, Steven; Tulsky, David S.; van Hedel, Hubertus J.A.; Whiteneck, Gale

2009-01-01

Study Design review by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain, and psycho-social tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial. PMID:19381157

Outcome definitions and clinical predictors influence pharmacogenetic associations between HTR3A gene polymorphisms and response to clozapine in patients with schizophrenia.

PubMed

Rajkumar, A P; Poonkuzhali, B; Kuruvilla, A; Srivastava, A; Jacob, M; Jacob, K S

2012-12-01

Pharmacogenetics of schizophrenia has not yet delivered anticipated clinical dividends. Clinical heterogeneity of schizophrenia contributes to the poor replication of the findings of pharmacogenetic association studies. Functionally important HTR3A gene single-nucleotide polymorphisms (SNPs) were reported to be associated with response to clozapine. The aim of this study was to investigate how the association between HTR3A gene SNP and response to clozapine is influenced by various clinical predictors and by differing outcome definitions in patients with treatment-resistant schizophrenia (TRS). We recruited 101 consecutive patients with TRS, on stable doses of clozapine, and evaluated their HTR3A gene SNP (rs1062613 and rs2276302), psychopathology, and serum clozapine levels. We assessed their socio-demographic and clinical profiles, premorbid adjustment, traumatic events, cognition, and disability using standard assessment schedules. We evaluated their response to clozapine, by employing six differing outcome definitions. We employed appropriate multivariate statistics to calculate allelic and genotypic association, accounting for the effects of various clinical variables. T allele of rs1062613 and G allele of rs2276302 were significantly associated with good clinical response to clozapine (p = 0.02). However, varying outcome definitions make these associations inconsistent. rs1062613 and rs2276302 could explain only 13.8 % variability in the responses to clozapine, while combined clinical predictors and HTR3A pharmacogenetic association model could explain 38 % variability. We demonstrated that the results of pharmacogenetic studies in schizophrenia depend heavily on their outcome definitions and that combined clinical and pharmacogenetic models have better predictive values. Future pharmacogenetic studies should employ multiple outcome definitions and should evaluate associated clinical variables.

Development and pilot testing of an interprofessional patient-centered team training programme in medical rehabilitation clinics in Germany: a process evaluation.

PubMed

Becker, Sonja; Körner, Mirjam; Müller, Christian; Lippenberger, Corinna; Rundel, Manfred; Zimmermann, Linda

2017-07-14

Interprofessional teamwork is considered to be a key component of patient-centred treatment in healthcare, and especially in the rehabilitation sector. To date, however, no interventions exist for improving teamwork in rehabilitation clinics in Germany. A team training programme was therefore designed that is individualised in content but standardised regarding methods and process. It is clinic specific, task related, solution focused and context oriented. The aim of the study was to implement and evaluate this training for interprofessional teams in rehabilitation clinics in Germany. The measure consists of a training of a varying number of sessions with rehabilitation teams that consists of four distinct phases. Those are undergone chronologically, each with clinic-specific contents. It was implemented between 2013 and 2014 in five rehabilitation clinics in Germany and evaluated by the participants via questionnaire (n = 52). Staff in three clinics evaluated the programme as helpful, in particular rating moderation, discussions and communication during the training positively. Staff in the remaining two clinics rated it as not very or not helpful and mentioned long-term structural problems or a lack of need for team training as a reason for this. The team training is applicable and accepted by staff. It should, however, be tested in a greater sample and compared with a control group. Processes should be studied in more detail in order to determine what differentiates successful from non-successful interventions and the different requirements each of these might have.

Melaleuca alternifolia and its application against dental plaque and periodontal diseases: A systematic review.

PubMed

Casarin, Maísa; Pazinatto, Josiele; Santos, Roberto Christ Vianna; Zanatta, Fabricio Batistin

2018-02-01

This is a systematic review of clinical and laboratory studies evaluating the effect of Melaleuca alternifolia on periodontopathogens, dental plaque, gingivitis, periodontitis, and inflammatory responses. The PubMed, Cochrane, Web of science, Bireme, Lilacs, Prospero, Open Grey, and Clinical Trials databases were searched to identify potentially eligible studies through October 2016. Of 1,654 potentially eligible studies, 25 were included in the systematic review. Their methodology was evaluated through the Cochrane Handbook for clinical studies and the GRADE system for in vivo/in vitro studies. Although clinical studies must be interpreted with caution due to methodological limitations, laboratory studies have found promising results. In vitro evidences showed that M. alternifolia has bactericidal and bacteriostatic effects against the most prevalent periodontopathogens. Clinical studies found comparable effects to chlorhexidine 0.12% in reducing gingival inflammation, although the antiplaque effect was lower. M. alternifolia also showed antioxidant properties, which are beneficial to the host, allied to the reduction on immune-inflammatory responses to pathogens. This systematic review suggests that the M. alternifolia has potential anti-inflammatory and antimicrobial properties, which can be easily applied to the periodontal tissues. However, further clinical trials are needed to elucidate the clinical relevance of its application. Copyright © 2017 John Wiley & Sons, Ltd.

Simulation-Based Dysphagia Training: Teaching Interprofessional Clinical Reasoning in a Hospital Environment.

PubMed

Miles, Anna; Friary, Philippa; Jackson, Bianca; Sekula, Julia; Braakhuis, Andrea

2016-06-01

This study evaluated hospital readiness and interprofessional clinical reasoning in speech-language pathology and dietetics students following a simulation-based teaching package. Thirty-one students participated in two half-day simulation workshops. The training included orientation to the hospital setting, part-task skill learning and immersive simulated cases. Students completed workshop evaluation forms. They filled in a 10-question survey regarding confidence, knowledge and preparedness for working in a hospital environment before and immediately after the workshops. Students completed written 15-min clinical vignettes at 1 month prior to training, immediately prior to training and immediately after training. A marking rubric was devised to evaluate the responses to the clinical vignettes within a framework of interprofessional education. The simulation workshops were well received by all students. There was a significant increase in students' self-ratings of confidence, preparedness and knowledge following the study day (p < .001). There was a significant increase in student overall scores in clinical vignettes after training with the greatest increase in clinical reasoning (p < .001). Interprofessional simulation-based training has benefits in developing hospital readiness and clinical reasoning in allied health students.

[Function of the present systematic evaluation in establishment of guidance for clinical practice].

PubMed

Yang, Jin-Hong; Hu, Jing; Yang, Feng-Chun; Zhang, Ning; Wang, Bing; Li, Xin

2012-07-01

Treatment of insomnia with acupuncture is taken as an example to explore the significance and problems existed in the present systematic evaluation in establishment of guidance for clinical practice. Fifteen articles on systematic evaluation of both English and Chinese were retrieved and studied carefully, their basic information was analyzed. Through study on the establishing process of the guidance of clinical practice, researches were focused on the possible significance of the articles to the guidance as well as the notes in the reuse of those articles since problem still existed. It is held that the systematic evaluation has great significance on the establishment of the guidance from the aspects of applicable people, recommended standards of diagnosis and therapeutic evaluation, extended recommendation and methodology. Great importance should also be attached to the direct application of the research result and understanding of the evaluation result. The data should be rechecked when necessary. Great guiding function can be found on the systematic evaluation of articles to the guidance. Moreover, if information needed to be taken into a full play, specific analysis should also be done on the concrete research targets.

Development of the Clinical Teaching Effectiveness Questionnaire in the United States.

PubMed

Wormley, Michelle E; Romney, Wendy; Greer, Anna E

2017-01-01

The purpose of this study was to develop a valid measure for assessing clinical teaching effectiveness within the field of physical therapy. The Clinical Teaching Effectiveness Questionnaire (CTEQ) was developed via a 4-stage process, including (1) initial content development, (2) content analysis with 8 clinical instructors with over 5 years of clinical teaching experience, (3) pilot testing with 205 clinical instructors from 2 universities in the Northeast of the United States, and (4) psychometric evaluation, including principal component analysis. The scale development process resulted in a 30-item questionnaire with 4 sections that relate to clinical teaching: learning experiences, learning environment, communication, and evaluation. The CTEQ provides a preliminary valid measure for assessing clinical teaching effectiveness in physical therapy practice.

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

ERIC Educational Resources Information Center

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

2012-01-01

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

[Assessment of the correlation between histological degeneration and radiological and clinical parameters in a series of patients who underwent lumbar disc herniation surgery].

PubMed

Munarriz, Pablo M; Paredes, Igor; Alén, José F; Castaño-Leon, Ana M; Cepeda, Santiago; Hernandez-Lain, Aurelio; Lagares, Alfonso

The use of histological degeneration scores in surgically-treated herniated lumbar discs is not common in clinical practice and its use has been primarily restricted to research. The objective of this study is to evaluate if there is an association between a higher grade of histological degeneration when compared with clinical or radiological parameters. Retrospective consecutive analysis of 122 patients who underwent single-segment lumbar disc herniation surgery. Clinical information was available on all patients, while the histological study and preoperative magnetic resonance imaging were also retrieved for 75 patients. Clinical variables included age, duration of symptoms, neurological deficits, or affected deep tendon reflex. The preoperative magnetic resonance imaging was evaluated using Modic and Pfirrmann scores for the affected segment by 2 independent observers. Histological degeneration was evaluated using Weiler's score; the presence of inflammatory infiltrates and neovascularization, not included in the score, were also studied. Correlation and chi-square tests were used to assess the association between histological variables and clinical or radiological variables. Interobserver agreement was also evaluated for the MRI variables using weighted kappa. No statistically significant correlation was found between histological variables (histological degeneration score, inflammatory infiltrates or neovascularization) and clinical or radiological variables. Interobserver agreement for radiological scores resulted in a kappa of 0.79 for the Pfirrmann scale and 0.65 for the Modic scale, both statistically significant. In our series of patients, we could not demonstrate any correlation between the degree of histological degeneration or the presence of inflammatory infiltrates when compared with radiological degeneration scales or clinical variables such as the patient's age or duration of symptoms. Copyright © 2017 Sociedad Española de Neurocirugía. Publicado por Elsevier España, S.L.U. All rights reserved.

Redesigning a clinical mentoring program for improved outcomes in the clinical training of clerks

PubMed Central

Lin, Chia-Der; Lin, Blossom Yen-Ju; Lin, Cheng-Chieh; Lee, Cheng-Chun

2015-01-01

Introduction Mentorship has been noted as critical to medical students adapting to clinical training in the medical workplace. A lack of infrastructure in a mentoring program might deter relationship building between mentors and mentees. This study assessed the effect of a redesigned clinical mentoring program from the perspective of clerks. The objective was to assess the benefits of the redesigned program and identify potential improvements. Methods A redesigned clinical mentoring program was launched in a medical center according to previous theoretical and practical studies on clinical training workplaces, including the elements of mentor qualifications, positive and active enhancers for mentor–mentee relationship building, the timing of mentoring performance evaluation, and financial and professional incentives. A four-wave web survey was conducted, comprising one evaluation of the former mentoring program and three evaluations of the redesigned clinical mentoring program. Sixty-four fifth-year medical students in clerkships who responded to the first wave and to at least two of the three following waves were included in the study. A structured and validated questionnaire encompassing 15 items on mentor performance and the personal characteristics of the clerks was used. Mixed linear models were developed for repeated measurements and to adjust for personal characteristics. Results The results revealed that the redesigned mentoring program improved the mentors’ performance over time for most evaluated items regarding professional development and personal support provided to the mentees. Conclusions Our findings serve as an improved framework for the role of the institution and demonstrate how institutional policies, programs, and structures can shape a clinical mentoring program. We recommend the adoption of mentorship schemes for other cohorts of medical students and for different learning and training stages involved in becoming a physician. PMID:26384479

[Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

PubMed

He, Wei; Xie, Yanming; Wang, Yongyan

2011-10-01

The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

Overuse of EEG in the evaluation of common neurologic conditions.

PubMed

Matoth, Israel; Taustein, Ilana; Kay, Barrie S; Shapira, Yehuda A

2002-11-01

The objective of the present study was to analyze the diagnostic indications that most often prompt the referral of children and adolescents in the outpatient clinical pediatric practice for electroencephalographic evaluation and to check its utility in these clinical conditions. The electroencephalographic records of 547 consecutive children and adolescents (5-16 years of age) referred to a single community laboratory for the evaluation of various neurologic disorders were prospectively read by a single blinded investigator. Common diagnostic indications included the following: clinical seizures (42%), attention-deficit-hyperactivity disorder (23%), headaches (10.4%), syncope (9.9%), and tic disorder (4.9%). Overall, 76% of records were normal. Slowing of electroencephalographic activity was noted in 1% (attention-deficit-hyperactivity disorder) to 26% (probable epilepsy), and epileptiform activity in 53% of the probable and 29% of the clinically possible epileptics. Epileptiform activity was rarely found in the nonepileptic patients. The results of the present study demonstrate that standard interictal electroencephalogram is being overused during evaluation of various neurologic disorders in children and adolescents, suggesting that its use should be reserved for supporting the diagnosis in those cases in which epilepsy is a reasonable clinical possibility.

Evaluation of drug reviews.

PubMed

Hendrickson, N M; Amerson, A B

1986-10-01

Drug reviews appearing in Clinical Pharmacy, Drug Intelligence and Clinical Pharmacy (DICP), Drugs, and Pharmacotherapy from January 1982 through December 1984 were evaluated for number, duplication among journals, timeliness, scope, and format. The design of this study was primarily quantitative rather than qualitative. Pharmacotherapy published the most reviews (49), followed by Drugs (43), Clinical Pharmacy (37), and DICP (29). Drugs and Pharmacotherapy published the largest number of unique reviews (agents not reviewed by the other journals during the study period), while Pharmacotherapy and Clinical Pharmacy published the most reviews on newly marketed drugs. Reviews of four drugs (acyclovir, moxalactam, ranitidine, and trazodone) were compared in terms of major sections, terminology and format, bibliography, use of tables and figures, scope of evaluative comments, and review process. Reviews in Drugs consistently contained the most references and tables and provided the most detail. Information was most accessible in Drugs, followed by Pharmacotherapy. Drugs used the largest panel of reviewers. All of the journals provided evaluative comments, although the scope varied. Continuing-education credit is available for review articles in Clinical Pharmacy and DICP. In selecting one or more of these journals, individuals or institutions should compare their needs with regard to the timeliness, scope, and format of the review articles in each journal.

Effectiveness of a five-step method for teaching clinical skills to students in a dental college in India.

PubMed

Virdi, Mandeep S; Sood, Meenakshi

2011-11-01

This study conducted at the PDM Dental College and Research Institute, Haryana, India, had the purpose of developing a teaching method based upon a five-step method for teaching clinical skills to students proposed by the American College of Surgeons. This five-step teaching method was used to place fissure sealants as an initial procedure by dental students in clinics. The sealant retention was used as an objective evaluation of the skill learnt by the students. The sealant retention was 92 percent at six- and twelve-month evaluations and 90 percent at the eighteen-month evaluation. These results indicate that simple methods can be devised for teaching clinical skills and achieve high success rates in clinical procedures requiring multiple steps.

Child and Adolescent Behavior Inventory (CABI): Standardization for Age 6-17 Years and First Clinical Application

PubMed Central

Cianchetti, Carlo; Pasculli, Marcello; Pittau, Andrea; Campus, Maria Grazia; Carta, Valeria; Littarru, Roberta; Fancello, Giuseppina Sannio; Zuddas, Alessandro; Ledda, Maria Giuseppina

2017-01-01

Background: The Child and Adolescent Behavior Inventory (CABI) is a questionnaire designed to collect information from the parents of children and adolescents, both for the preparation of screening and epidemiological studies and for clinical evaluation. It has been published in CPEMH in 2013, with the first data on 8-10 years old school children. Here we report an extended standardization on a school population 6-17 years old and the first results of the application in a clinical sample. Methods: Parents, after giving their informed consent, answered to the questionnaire. Complete and reliable data were obtained from the parents of 659 school children and adolescents 6-17 y.o., with a balanced distribution of gender. Moreover, in a population of 84 patients, the results with the CABI were compared with the clinical evaluation and the CBCL. Results: In the school population, scores were different in relation to gender and age. The values of externalizing disorders were higher in males, with the highest values for ADHD in the 6-10 y.o. children. On the contrary, the scores of internalizing disorders and of eating disorders tended to be slightly higher in females. In the clinical population, scores at the CABI were in agreement with the clinical evaluation in 84% cases for depressive symptoms (compared to CBCL 66%), 53% for anxiety symptoms (CBCL 42%) and 87% for ODD (CBCL 69%), differences, however; without statistical significance (chi square). Conclusion: The study obtained normative data for the CABI and gave information of the behavioral differences in relation to age and gender of the school population as evaluated by parents/caregivers. Clinically, the CABI provided useful information for the clinical evaluation of the patient, sometimes with better agreement with the final diagnosis compared to the CBCL. PMID:28458717

[The tinnitus questionnaire. A standard instrument for grading the degree of tinnitus. Results of a multicenter study with the tinnitus questionnaire].

PubMed

Goebel, G; Hiller, W

1994-03-01

The clinical examination of patients with severe and chronic tinnitus must include associated psychological disturbances. The present paper describes traditional diagnostic methods of ENT practice as well as the Tinnitus Questionnaire (TQ) which has been evaluated in a number of studies. This instrument differentiates between emotional and cognitive distress, auditory perceptual difficulties and self-experienced intrusiveness produced by the tinnitus. The results of a German multicenter study are presented which show that the TQ can be used to demonstrate differences of tinnitus distress under different clinical conditions (e.g., ENT clinic vs psychosomatic clinic and in- vs out-patient care). The TQ can be employed for comparative studies in different tinnitus-related institutions and for the evaluation of the relative effects of different treatment approaches.

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

PubMed

Hasford, J; Lamprecht, T

1998-01-01

Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

PubMed

Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

2014-07-01

The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design such as parallel crossover design, alternative endpoints, or adaptive trials should be pursued to improve the outlook for future interventional trials in sepsis.

Challenges of assessing critical thinking and clinical judgment in nurse practitioner students.

PubMed

Gorton, Karen L; Hayes, Janice

2014-03-01

The purpose of this study was to determine whether there was a relationship between critical thinking skills and clinical judgment in nurse practitioner students. The study used a convenience, nonprobability sampling technique, engaging participants from across the United States. Correlational analysis demonstrated no statistically significant relationship between critical thinking skills and examination-style questions, critical thinking skills and scores on the evaluation and reevaluation of consequences subscale of the Clinical Decision Making in Nursing Scale, and critical thinking skills and the preceptor evaluation tool. The study found no statistically significant relationships between critical thinking skills and clinical judgment. Educators and practitioners could consider further research in these areas to gain insight into how critical thinking is and could be measured, to gain insight into the clinical decision making skills of nurse practitioner students, and to gain insight into the development and measurement of critical thinking skills in advanced practice educational programs. Copyright 2014, SLACK Incorporated.

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.

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

PubMed

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

2017-09-01

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

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

PubMed

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

2014-10-01

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

Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

PubMed

Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

2013-04-08

The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact of complex roles and interventions in health care outcomes and service delivery. Case study design is an appropriate methodology to use when study outcomes relate to clinical practice.

A comparison of dentifrices for clinical relief from dentin hypersensitivity using the Jay Sensitivity Sensor Probe.

PubMed

Hegde, Shashikanth; Rao, B H Sripathi; Kakar, Ravish Chander; Kakar, Ashish

2013-05-01

To evaluate the clinical relief from dentin hypersensitivity among subjects provided with a dentifrice formulated with 8% arginine, calcium carbonate and 1,000 ppm fluoride [sodium monofluorophosphate (MFP)] in comparison to those issued a commercially available dentifrice containing 1,000 ppm fluoride [as sodium monofluorophosphate (MFP)]. Clinical evaluations for hypersensitivity were performed with a novel tactile hypersensitivity measuring instrument--the Jay Sensitivity Sensor (Jay) Probe--in conjunction with evaporative triggers by air blast (Schiff scale) and Visual Analog Scores (VAS). Qualified adults from the Mangalore, India area who presented two teeth with dentin hypersensitivity were enrolled for this double-blind, randomized, parallel, controlled clinical trial conducted in an outpatient clinical setting. At baseline, dentin hypersensitivity was evaluated by the Jay Probe (tactile), air blast and VAS methods. Subjects were randomly issued a study dentifrice and instructed to brush their teeth for 1 minute twice daily with the provided dentifrice. Clinical evaluations for hypersensitivity were repeated after 2, 4 and 8 weeks of product use. 86 subjects (35 males and 51 females) complied with the study protocol and completed the entire study. At each recall visit, both treatment groups demonstrated significant reductions in dentin hypersensitivity from their corresponding baselines (P < 0.05). Subjects assigned the 8% arginine, calcium carbonate and 1,000 ppm fluoride dentifrice demonstrated statistically significant reductions in responses to tactile stimuli, air blast, and VAS responses in comparison to those using the dentifrice containing 1,000 ppm fluoride after 2, 4, and 8 weeks, respectively.

1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

PubMed

Muramatsu, Takashi; Onuma, Yoshinobu; van Geuns, Robert-Jan; Chevalier, Bernard; Patel, Tejas M; Seth, Ashok; Diletti, Roberto; García-García, Hector M; Dorange, Cécile C; Veldhof, Susan; Cheong, Wai-Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W; Abizaid, Alexandre; Serruys, Patrick W

2014-05-01

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Differential effects on socioeconomic groups of modelling the location of mammography screening clinics using Geographic Information Systems.

PubMed

Hyndman, J C; Holman, C D

2000-06-01

To evaluate spatial access to mammography clinics and to investigate whether relocating clinics can improve global access. To determine whether any change in access is distributed equitably between different social groups. The study was undertaken in Perth, Western Australia in 1996. It was an analysis of travel distances to mammography clinics, comparing distances to the pattern of existing clinics and modelled relocated clinics. The study population was the 151,162 women aged 40-64 years resident in Perth in 1991. Overall travel distances to the existing clinics was reduced by 14% when a GIS system was used to relocate them so as to minimise the travel distance for all women. The travel distance of the most disadvantaged groups fell by 2% and by 24% for the least disadvantaged group. GIS modelling can be used to advantage to evaluate potential locations for screening clinics that improve the access for the target population, however global analysis should be supplemented by analysis of special groups to ensure that no group is disadvantaged by the proposal. If new technology is not used to evaluate the placement of health services, population travel distances may be greater than necessary, with possible impacts on attendance rates.

The Correction of Myopia Evaluation Trial: lessons from the study design.

PubMed

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

[The comparative evaluation of level of security culture in medical organizations].

PubMed

Roitberg, G E; Kondratova, N V; Galanina, E V

2016-01-01

The study was carried out on the basis of clinic “Medicine” in 2014-2015 concerning security culture. The sampling included 465 filled HSPSC questionnaires. The comparative analysis of received was implemented. The “Zubovskaia district hospital” Having no accreditation according security standards and group of clinics from USA functioning for many years in the system of patient security support were selected as objects for comparison. The evaluation was implemented concerning dynamics of security culture in organization at implementation of strategies of security of patients during 5 years and comparison of obtained results with USA clinics was made. The study results demonstrated that in conditions of absence of implemented standards of security in medical organization total evaluation of security remains extremely low. The study of security culture using HSPSC questionnaire is an effective tool for evaluating implementation of various strategies of security ofpatient. The functioning in the system of international standards of quality, primarily JCI standards, permits during several years to achieve high indices of security culture.

The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations.

PubMed

Staccini, Laura; Tomba, Elena; Grandi, Silvana; Keitner, Gabor I

2015-03-01

A large body of research, documenting the impact of a family's functioning on health outcomes, highlights the importance of introducing the evaluation of patients' family dynamics into clinical judgment. The Family Assessment Device (FAD) is a self-report questionnaire designed to assess specific dimensions of family functioning. This qualitative systematic review, which follows PRISMA guidelines, aimed to identify the FAD's clinimetric properties and to report the incremental utility of its inclusion in clinical settings. A thorough literature search was performed, using both computerized and manual searches, yielding a total of 148 studies that were included in this review. The FAD has been extensively used in a variety of research contexts. In the majority of studies it was able to discriminate between clinical populations and controls and among groups of patients with different illnesses. The FAD also showed good test-retest and concurrent reliability, and modest sensitivity to change after treatment. FAD-dysfunctional family functioning was related to several patient clinical outcomes, including lower recovery rates and adherence to treatment, longer recovery time, poorer quality of life, and increased risk of relapse and drop-out. The present review demonstrates that the FAD is a suitable instrument for the evaluation of family functioning both in clinical and research settings. © 2014 Family Process Institute.

Bilateral robots for upper-limb stroke rehabilitation: State of the art and future prospects.

PubMed

Sheng, Bo; Zhang, Yanxin; Meng, Wei; Deng, Chao; Xie, Shengquan

2016-07-01

Robot-assisted bilateral upper-limb training grows abundantly for stroke rehabilitation in recent years and an increasing number of devices and robots have been developed. This paper aims to provide a systematic overview and evaluation of existing bilateral upper-limb rehabilitation devices and robots based on their mechanisms and clinical-outcomes. Most of the articles studied here were searched from nine online databases and the China National Knowledge Infrastructure (CNKI) from year 1993 to 2015. Devices and robots were categorized as end-effectors, exoskeletons and industrial robots. Totally ten end-effectors, one exoskeleton and one industrial robot were evaluated in terms of their mechanical characteristics, degrees of freedom (DOF), supported control modes, clinical applicability and outcomes. Preliminary clinical results of these studies showed that all participants could gain certain improvements in terms of range of motion, strength or physical function after training. Only four studies supported that bilateral training was better than unilateral training. However, most of clinical results cannot definitely verify the effectiveness of mechanisms and clinical protocols used in robotic therapies. To explore the actual value of these robots and devices, further research on ingenious mechanisms, dose-matched clinical protocols and universal evaluation criteria should be conducted in the future. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

A novel non-contrast-enhanced MRA using silent scan for evaluation of brain arteriovenous malformation: A case report and review of literature.

PubMed

Moon, Jin Il; Baek, Hye Jin; Ryu, Kyeong Hwa; Park, Hyun

2017-11-01

Brain arteriovenous malformations (AVMs) are congenital vascular abnormalities involving abnormal connections between arteries and veins. In clinical practice, imaging studies help evaluate feeding arteries, niduses, draining venous systems, and coexisting complications in patients with brain AVM. They also have an impact on decision-making regarding clinical management. We applied a novel non-contrast-enhanced MR angiography (MRA) technique, termed "silent MRA," for evaluating an incidental brain AVM. Here, we describe the clinical case with radiological review and highlight the technical background and clinical usefulness of silent MRA. A 60-year-old woman underwent neuroimaging study including MRA to evaluate intracranial cause of headache. The brain AVM, including its nidus and draining veins, was conspicuously delineated on silent MRA images; these findings correlated well with conventional angiographic findings. The patient did not receive interventional or surgical treatment. The patient is being followed up regularly at the outpatient department. The silent MRA can be a suitable imaging modality for repeated follow-up evaluation for not only brain AVMs but also various intracranial vascular diseases without the use of contrast materials.

Peer group reflection helps clinical teachers to critically reflect on their teaching.

PubMed

Boerboom, Tobias B B; Jaarsma, Debbie; Dolmans, Diana H J M; Scherpbier, Albert J J A; Mastenbroek, Nicole J J M; Van Beukelen, Peter

2011-01-01

Student evaluations can help clinical teachers to reflect on their teaching skills and find ways to improve their teaching. Studies have shown that the mere presentation of student evaluations is not a sufficient incentive for teachers to critically reflect on their teaching. We evaluated and compared the effectiveness of two feedback facilitation strategies that were identical except for a peer reflection meeting. In this study, 54 clinical teachers were randomly assigned to two feedback strategies. In one strategy, a peer reflection was added as an additional step. All teachers completed a questionnaire evaluating the strategy that they had experienced. We analysed the reflection reports and the evaluation questionnaire. Both strategies stimulated teachers to reflect on feedback and formulate alternative actions for their teaching practice. The teachers who had participated in the peer reflection meeting showed deeper critical reflection and more concrete plans to change their teaching. All feedback strategies were considered effective by the majority of the teachers. Strategies with student feedback and self-assessment stimulated reflection on teaching and helped clinical teachers to formulate plans for improvement. A peer reflection meeting seemed to enhance reflection quality. Further research should establish whether it can have lasting effects on teaching quality.

A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

DTIC Science & Technology

2011-03-31

evidence based medicine into clinical practice. It will decrease costs and enable multiple stakeholders to work in an open content/source environment to exchange clinical content, develop and test technology and explore processes in applied CDS. Design: Comparative study between the KMR infrastructure and capabilities developed as an open source, vendor agnostic solution for aCPG execution within AHLTA and the current DoD/MHS standard evaluating: H1: An open source, open standard KMR and Clinical Decision Support Engine can enable organizations to share domain

Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.

PubMed

Zhang, Helen L; Omondi, Michael W; Musyoka, Augustine M; Afwamba, Isaac A; Swai, Remigi P; Karia, Francis P; Muiruri, Charles; Reddy, Elizabeth A; Crump, John A; Rubach, Matthew P

2016-08-01

Using a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting. Using a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis. During the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years. These findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Unruly grandmothers, ghosts and ancestors: Chinese elders and the importance of culture in dementia evaluations.

PubMed

Elliott, Kathryn S; Di Minno, Mariann

2006-01-01

This article explores the cultural clashes that occurred when Chinese patients at an Alzheimer's center in California were evaluated for dementia. Lack of familiarity with Chinese culture made the culturally mainstream American clinicians at this center more likely to misinterpret the behavior of elderly Chinese-speaking patients and their families and, thereby, more likely to misdiagnose such patients and suggest culturally inappropriate recommendations. This tendency was reduced when relevant cultural knowledge was incorporated into the clinical evaluation. The evaluation process at this clinic and two patient examples are discussed to illustrate that familiarity with a patient's cultural background is essential for accurate diagnosis and referral. This ethnographic case study places the evaluation process in one particular clinic in cultural context and is suggestive in the way that exploratory qualitative research is meant to be, rather than broadly representative of dementia clinics or clinicians as a whole. However, problems created by cultural clashes at this clinic do suggest that what may be happening at other dementia clinics as they encounter increasingly more patients from diverse cultural backgrounds is an important empirical question worthy of further research, using both qualitative and quantitative methods.

Clinical evaluation of GEM 21S® and a collagen membrane with a coronally advanced flap as a root coverage procedure in the treatment of gingival recession defects: A comparative study

PubMed Central

Singh, Preetinder; Suresh, D. K.

2012-01-01

Aim: Clinical evaluation of efficacy of rhPDGF-BB plus beta tricalcium phosphate (GEM 21S®) along with a collagen membrane in root coverage using a coronally advanced flap. Materials and Methods: This human case series evaluated the clinical outcome of rhPDGF-BB with beta-tricalcium phosphate (GEM 21S®) and a collagen membrane in the treatment of recession defects using a coronally advanced flap. Patients were followed postoperatively, and healing was evaluated at 1, 3, and 6 months, with recession depth as the primary outcome measure. Results: This pioneer case series revealed a favorable tissue response to GEM 21S® and collagen membrane from both clinical and esthetic point of view in regenerative periodontal surgery. PMID:23493720

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.

Exercise intolerance in pulmonary hypertension: mechanism, evaluation and clinical implications.

PubMed

Babu, Abraham Samuel; Arena, Ross; Myers, Jonathan; Padmakumar, Ramachandran; Maiya, Arun G; Cahalin, Lawrence P; Waxman, Aaron B; Lavie, Carl J

2016-09-01

Exercise intolerance in pulmonary hypertension (PH) is a major factor affecting activities of daily living and quality of life. Evaluation strategies (i.e., non-invasive and invasive tests) are integral to providing a comprehensive assessment of clinical and functional status. Despite a growing body of literature on the clinical consequences of PH, there are limited studies discussing the contribution of various physiological systems to exercise intolerance in this patient population. This review, through a search of various databases, describes the physiological basis for exercise intolerance across the various PH etiologies, highlights the various exercise evaluation methods and discusses the rationale for exercise training amongst those diagnosed with PH. Expert commentary: With the growing importance of evaluating exercise capacity in PH (class 1, Level C recommendation), understanding why exercise performance is altered in PH is crucial. Thus, the further study is required for better quality evidence in this area.

Evaluation of extemporaneous oral itraconazole suspensions by dissolution profiles mapping.

PubMed

Tong, Henry H Y; Chan, Hokman; Du, Zhen; Zheng, Ying

2010-01-01

The objective of this study was to evaluate by dissolution profiles mapping five extemporaneous oral itraconazole suspensions reported in the literature. Dissolution profiles of the extemporaneous oral itraconazole preparations were mapped and correlated with their reported clinical data therein. Four out of five extemporaneous preparations had either too early or insufficient release of itraconazole during the dissolution study, potentially limiting the in vivo oral bioavailability in patients. Dissolution profiles in the remaining extemporaneous preparation was closely similar to that in commercial itraconazole capsules. Based on the reported clinical data and dissolution results in this study, the extemporaneous preparation proposed in a study by Ong and Fobes seems to be the most reasonable choice for our patients. Dissolution profile evaluation is an important quality-control parameter during the evaluation of extemporaneous preparations by pharmacists.

Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

PubMed

Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

A comparison of propensity score-based approaches to health service evaluation: a case study of a preoperative physician-led clinic for high-risk surgical patients.

PubMed

Pham, Clarabelle T; Gibb, Catherine L; Mittinty, Murthy N; Fitridge, Robert A; Marshall, Villis R; Karnon, Jonathan D

2016-10-01

A physician-led clinic for the preoperative optimization and management of high-risk surgical patients was implemented in a South Australian public hospital in 2008. This study aimed to estimate the costs and effects of the clinic using a mixed retrospective and prospective observational study design. Alternative propensity score estimation methods were applied to retrospective routinely collected administrative and clinical data, using weighted and matched cohorts. Supplementary survey-based prospective data were collected to inform the analysis of the retrospective data and reduce potential unmeasured confounding. Using weighted cohorts, clinic patients had a significantly longer mean length of stay and higher mean cost. With the matched cohorts, reducing the calliper width resulted in a shorter mean length of stay in the clinic group, but the costs remained significantly higher. The prospective data indicated potential unmeasured confounding in all analyses other than in the most tightly matched cohorts. The application of alternative propensity-based approaches to a large sample of retrospective data, supplemented with a smaller sample of prospective data, informed a pragmatic approach to reducing potential observed and unmeasured confounding in an evaluation of a physician-led preoperative clinic. The need to generate tightly matched cohorts to reduce the potential for unmeasured confounding indicates that significant uncertainty remains around the effects of the clinic. This study illustrates the value of mixed retrospective and prospective observational study designs but also underlines the need to prospectively plan for the evaluation of costs and effects alongside the implementation of significant service innovations. © 2016 John Wiley & Sons, Ltd.

Invited review: A systematic review and qualitative analysis of treatments other than conventional antimicrobials for clinical mastitis in dairy cows.

PubMed

Francoz, D; Wellemans, V; Dupré, J P; Roy, J P; Labelle, F; Lacasse, P; Dufour, S

2017-10-01

Clinical mastitis is an important disease in dairies. Its treatment is mainly based on the use of antimicrobial drugs. Numerous non-antimicrobial drugs and treatment strategies have already been reported for clinical mastitis treatment, but data on their efficacy have never been collated in a systematic way. The objective of this systematic review was to identify treatments other than conventional antimicrobials for the treatment of clinical mastitis in lactating dairy cows. A systematic review was performed with studies written in English or French selected from CAB Abstracts, PubMed, and Web of Science from January 1970 to June 2014. Controlled clinical trials, observational studies, and experimental challenges were retained. Lactating dairy cows with clinical mastitis were the participant of interest. All treatments other than conventional antimicrobials for clinical mastitis during lactation were retained. Only studies comparing the treatment under investigation to a negative or positive control, or both, were included. Outcomes evaluated were clinical and bacteriological cure rates and milk production. Selection of the study, data extraction, and assessment of risk of bias was performed by 3 reviewers. Assessment of risk of bias was evaluated using the Cochrane Collaboration tool for systematic review of interventions. A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and 1 was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on noninferiority or nonsuperiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis. However, probiotics and oxytocin with or without frequent milk out should not be recommended. We concluded that homeopathic treatments are not efficient for management of clinical mastitis. The Authors. Published by the Federation of Animal Science Societies and Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges

PubMed Central

Blank, Melissa D.; Breland, Alison B.; Cobb, Caroline O.; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

2017-01-01

Objective Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. Methods The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Results Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Conclusions Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation. PMID:28819633

Clinical Laboratory Evaluation of Electronic Cigarettes/Electronic Nicotine Delivery Systems: Methodological Challenges.

PubMed

Blank, Melissa D; Breland, Alison B; Cobb, Caroline O; Spindle, Tory; Ramôa, Carolina; Eissenberg, Thomas

2016-10-01

Evaluating electronic cigarettes (ECIGs) in the clinical laboratory is critical to understanding their effects. However, laboratory evaluation of ECIGs can be challenging, as they are a novel, varied, and evolving class of products. The objective of this paper is to describe some methodological challenges to the clinical laboratory evaluation of ECIGs. The authors gathered information about challenges involved in the laboratory evaluation of ECIGs. Challenges were categorized and solutions provided when possible. Methods used to study combustible cigarettes may need to be adapted to account for ECIG novelty and differences within the class. Challenges to ECIG evaluation can include issues related to 1) identification of ECIG devices and liquids, 2) determination of short -term ECIG abstinence, 3) measurement of use behavior, and 4) assessment of dependence. These challenges are discussed, and some suggestions to inform ECIG evaluation using clinical laboratory methods are provided. Awareness of challenges and developing, validating, and reporting methods used to address them aids interpretation of results and replication efforts, thus enhancing the rigor of science used to protect public health through appropriate, empirically-based, ECIG regulation.

Evaluate the ability of clinical decision support systems (CDSSs) to improve clinical practice.

PubMed

Ajami, Sima; Amini, Fatemeh

2013-01-01

Prevalence of new diseases, medical science promotion and increase of referring to health care centers, provide a good situation for medical errors growth. Errors can involve medicines, surgery, diagnosis, equipment, or lab reports. Medical errors can occur anywhere in the health care system: In hospitals, clinics, surgery centers, doctors' offices, nursing homes, pharmacies, and patients' homes. According to the Institute of Medicine (IOM), 98,000 people die every year from preventable medical errors. In 2010 from all referred medical error records to Iran Legal Medicine Organization, 46/5% physician and medical team members were known as delinquent. One of new technologies that can reduce medical errors is clinical decision support systems (CDSSs). This study was unsystematic-review study. The literature was searched on evaluate the "ability of clinical decision support systems to improve clinical practice" with the help of library, books, conference proceedings, data bank, and also searches engines available at Google, Google scholar. For our searches, we employed the following keywords and their combinations: medical error, clinical decision support systems, Computer-Based Clinical Decision Support Systems, information technology, information system, health care quality, computer systems in the searching areas of title, keywords, abstract, and full text. In this study, more than 100 articles and reports were collected and 38 of them were selected based on their relevancy. The CDSSs are computer programs, designed for help to health care careers. These systems as a knowledge-based tool could help health care manager in analyze evaluation, improvement and selection of effective solutions in clinical decisions. Therefore, it has a main role in medical errors reduction. The aim of this study was to express ability of the CDSSs to improve

[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

PubMed

Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

2013-11-01

By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

Updates on ultrasound research in implant dentistry: a systematic review of potential clinical indications.

PubMed

Bhaskar, Vaishnavi; Chan, Hsun-Liang; MacEachern, Mark; Kripfgans, Oliver D

2018-05-23

Ultrasonography has shown promising diagnostic value in dental implant imaging research; however, exactly how ultrasound was used and at what stage of implant therapy it can be applied has not been systematically evaluated. Therefore, the aim of this review is to investigate potential indications of ultrasound use in the three implant treatment phases, namely planning, intraoperative and postoperative phase. Eligible manuscripts were searched in major databases with a combination of key words related to the use of ultrasound imaging in implant therapy. An initial search yielded 414 articles, after further review, 28 articles were finally included for this systematic review. Ultrasound was found valuable, though at various development stages, for evaluating (1) soft tissues, (2) hard tissues (3) vital structures and (4) implant stability. B-mode, the main function to image anatomical structures of interest, has been evaluated in pre-clinical and clinical studies. Quantitative ultrasound parameters, e.g. sound speed and amplitude, are being developed to evaluate implant-bone stability, mainly in simulation and pre-clinical studies. Ultrasound could be potentially useful in all 3 treatment phases. In the planning phase, ultrasound could evaluate vital structures, tissue biotype, ridge width/density, and cortical bone thickness. During surgery, it can provide feedback by identifying vital structures and bone boundary. At follow-up visits, it could evaluate marginal bone level and implant stability. Understanding the current status of ultrasound imaging research for implant therapy would be extremely beneficial for accelerating translational research and its use in dental clinics.

Using "Swivl" Robotic Technology in Teacher Education Preparation: A Pilot Study

ERIC Educational Resources Information Center

Franklin, Robin Kesterson; O'Neill Mitchell, Justin; Walters, Kari Siko; Livingston, Beth; Lineberger, Matthew Blake; Putman, Cynthia; Yarborough, Reba; Karges-Bone, Linda

2018-01-01

Based on requirements to promote for reflective practice, both CAEP and edTPA suggest adding a video component to clinical practice. This qualitative pilot study evaluated "Swivl" as that potential recording technological device for clinical practice. During a clinical practice cycle at a private university in the southeastern region of…

Do Clinical Clerks Provide Candidates with Adequate Formative Assessment during Objective Structured Clinical Examinations?

ERIC Educational Resources Information Center

Reiter, Harold I.; Rosenfeld, Jack; Nandagopal, Kiruthiga; Eva, Kevin W.

2004-01-01

Context: Various research studies have examined the question of whether expert or non-expert raters, faculty or students, evaluators or standardized patients, give more reliable and valid summative assessments of performance on Objective Structured Clinical Examinations (OSCEs). Less studied has been the question of whether or not non-faculty…

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

PubMed Central

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

An Evaluation of the Development of MFT Competencies and the Influence of the Supervisory Relationship

ERIC Educational Resources Information Center

Burke, Jay Evan

2017-01-01

Practicum training is an essential part of The Chicago School of Professional Psychology (TCSPP) Marriage and Family Therapy (MFT) Master's degree program, and the cornerstone for preparing students for clinical practice. To characterize the development across clinical competency areas, the current study examined midpoint and final evaluation data…

Portable handheld diffuse reflectance spectroscopy system for clinical evaluation of skin: a pilot study in psoriasis patients

PubMed Central

Tzeng, Shih-Yu; Guo, Jean-Yan; Yang, Chao-Chun; Hsu, Chao-Kai; Huang, Hung Ji; Chou, Shih-Jie; Hwang, Chi-Hung; Tseng, Sheng-Hao

2016-01-01

Diffuse reflectance spectroscopy (DRS) has been utilized to study biological tissues for a variety of applications. However, many DRS systems are not designed for handheld use and/or relatively expensive which limit the extensive clinical use of this technique. In this paper, we report a handheld, low-cost DRS system consisting of a light source, optical switch, and a spectrometer, that can precisely quantify the optical properties of tissue samples in the clinical setting. The handheld DRS system was employed to determine the skin chromophore concentrations, absorption and scattering properties of 11 patients with psoriasis. The measurement results were compared to the clinical severity of psoriasis as evaluated by dermatologist using PASI (Psoriasis Area and Severity Index) scores. Our statistical analyses indicated that the handheld DRS system could be a useful non-invasive tool for objective evaluation of the severity of psoriasis. It is expected that the handheld system can be used for the objective evaluation and monitoring of various skin diseases such as keloid and psoriasis. PMID:26977366

A case study evaluation of a Critical Care Information System adoption using the socio-technical and fit approach.

PubMed

Yusof, Maryati Mohd

2015-07-01

Clinical information systems have long been used in intensive care units but reports on their adoption and benefits are limited. This study evaluated a Critical Care Information System implementation. A case study summative evaluation was conducted, employing observation, interview, and document analysis in operating theatres and 16-bed adult intensive care units in a 400-bed Malaysian tertiary referral centre from the perspectives of users (nurses and physicians), management, and information technology staff. System implementation, factors influencing adoption, fit between these factors, and the impact of the Critical Care Information System were evaluated after eight months of operation. Positive influences on system adoption were associated with technical factors, including system ease of use, usefulness, and information relevancy; human factors, particularly user attitude; and organisational factors, namely clinical process-technology alignment and champions. Organisational factors such as planning, project management, training, technology support, turnover rate, clinical workload, and communication were barriers to system implementation and use. Recommendations to improve the current system problems were discussed. Most nursing staff positively perceived the system's reduction of documentation and data access time, giving them more time with patients. System acceptance varied among doctors. System use also had positive impacts on timesaving, data quality, and clinical workflow. Critical Care Information Systems is crucial and has great potentials in enhancing and delivering critical care. However, the case study findings showed that the system faced complex challenges and was underutilised despite its potential. The role of socio-technical factors and their fit in realizing the potential of Critical Care Information Systems requires continuous, in-depth evaluation and stakeholder understanding and acknowledgement. The comprehensive and specific evaluation measures of the Human-Organisation-Technology Fit framework can flexibly evaluate Critical Care Information Systems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Dose reduction of up to 89% while maintaining image quality in cardiovascular CT achieved with prospective ECG gating

NASA Astrophysics Data System (ADS)

Londt, John H.; Shreter, Uri; Vass, Melissa; Hsieh, Jiang; Ge, Zhanyu; Adda, Olivier; Dowe, David A.; Sabllayrolles, Jean-Louis

2007-03-01

We present the results of dose and image quality performance evaluation of a novel, prospective ECG-gated Coronary CT Angiography acquisition mode (SnapShot Pulse, LightSpeed VCT-XT scanner, GE Healthcare, Waukesha, WI), and compare it to conventional retrospective ECG gated helical acquisition in clinical and phantom studies. Image quality phantoms were used to measure noise, slice sensitivity profile, in-plane resolution, low contrast detectability and dose, using the two acquisition modes. Clinical image quality and diagnostic confidence were evaluated in a study of 31 patients scanned with the two acquisition modes. Radiation dose reduction in clinical practice was evaluated by tracking 120 consecutive patients scanned with the prospectively gated scan mode. In the phantom measurements, the prospectively gated mode resulted in equivalent or better image quality measures at dose reductions of up to 89% compared to non-ECG modulated conventional helical scans. In the clinical study, image quality was rated excellent by expert radiologist reviewing the cases, with pathology being identical using the two acquisition modes. The average dose to patients in the clinical practice study was 5.6 mSv, representing 50% reduction compared to a similar patient population scanned with the conventional helical mode.

Effectiveness of teaching quality improvement to clinicians: a systematic review.

PubMed

Boonyasai, Romsai T; Windish, Donna M; Chakraborti, Chayan; Feldman, Leonard S; Rubin, Haya R; Bass, Eric B

2007-09-05

Accreditation requirements mandate teaching quality improvement (QI) concepts to medical trainees, yet little is known about the effectiveness of teaching QI. To perform a systematic review of the effectiveness of published QI curricula for clinicians and to determine whether teaching methods influence the effectiveness of such curricula. The electronic literature databases of MEDLINE, EMBASE, CINAHL, and ERIC were searched for English-language articles published between January 1, 1980, and April 30, 2007. Experts in the field of QI were queried about relevant studies. Two independent reviewers selected studies for inclusion if the curriculum taught QI principles to clinicians and the evaluation used a comparative study design. Information about the features of each curriculum, its use of 9 principles of adult learning, and the type of educational and clinical outcomes were extracted. The relationship between the outcomes and the number of educational principles used was assessed. Of 39 studies that met eligibility criteria, 31 described team-based projects; 37 combined didactic instruction with experiential learning. The median number of adult learning principles used was 7 (range, 2-8). Evaluations included 22 controlled trials (8 randomized and 14 nonrandomized) and 17 pre/post or time series studies. Fourteen studies described educational outcomes (attitudes, knowledge, or skills or behaviors) and 28 studies described clinical process or patient outcomes. Nine of the 10 studies that evaluated knowledge reported only positive effects but only 2 of these described a validated assessment tool. The 6 assessments of attitudes found mixed results. Four of the 6 studies on skill or behavior outcomes reported only positive effects. Eight of the 28 studies of clinical outcomes reported only beneficial effects. Controlled studies were more likely than other studies to report mixed or null effects. Only 4 studies evaluated both educational and clinical outcomes, providing limited evidence that educational outcomes influence the clinical effectiveness of the interventions. Most published QI curricula apply sound adult learning principles and demonstrate improvement in learners' knowledge or confidence to perform QI. Additional studies are needed to determine whether educational methods have meaningful clinical benefits.

Use of Portable Digital Devices to Analyze Autonomic Stress Response in Psychology Objective Structured Clinical Examination.

PubMed

Beltrán-Velasco, Ana Isabel; Bellido-Esteban, Alberto; Ruisoto-Palomera, Pablo; Clemente-Suárez, Vicente Javier

2018-01-12

The aim of the present study was to explore changes in the autonomic stress response of Psychology students in a Psychology Objective Structured Clinical Examination (OSCE) and their relationship with OSCE performance. Variables of autonomic modulation by the analysis of heart rate variability in temporal, frequency and non-linear domains, subjective perception of distress strait and academic performance were measured before and after the two different evaluations that composed the OSCE. A psychology objective structured clinical examination composed by two different evaluation scenarios produced a large anxiety anticipatory response, a habituation response in the first of the evaluation scenarios and a in the entire evaluation, and a no habituation response in the second evaluation scenario. Autonomic modulation parameters do not correlate with academic performance of students.

Comparative oncology evaluation of intravenous recombinant oncolytic Vesicular Stomatitis Virus therapy in spontaneous canine cancer

PubMed Central

Naik, Shruthi; Galyon, Gina D.; Jenks, Nathan J.; Steele, Michael B.; Miller, Amber C.; Allstadt, Sara D.; Suksanpaisan, Lukkana; Peng, Kah Whye; Federspiel, Mark J.; Russell, Stephen J.; LeBlanc, Amy K.

2017-01-01

Clinical translation of intravenous therapies to treat disseminated or metastatic cancer is imperative. Comparative oncology, the evaluation of novel cancer therapies in animals with spontaneous cancer, can be utilized to inform and accelerate clinical translation. Preclinical murine studies demonstrate that single shot systemic therapy with a VSV-IFNβ-NIS, a novel recombinant oncolytic Vesicular stomatitis virus (VSV), can induce curative remission in tumor bearing mice. Clinical translation of VSV-IFNβ-NIS therapy is dependent on comprehensive assessment of clinical toxicities, virus shedding, pharmacokinetics, and efficacy in clinically relevant models. Dogs spontaneously develop cancer with comparable etiology, clinical progression and response to therapy as human malignancies. A comparative oncology study was carried out to investigate feasibility and tolerability of intravenous oncolytic VSV-IFNβ-NIS therapy in pet dogs with spontaneous cancer. Nine dogs with various malignancies were treated with a single intravenous dose of VSV-IFNβ-NIS. Two dogs with high-grade peripheral T-cell lymphoma had rapid but transient remission of disseminated disease and transient hepatotoxicity that resolved spontaneously. There was no shedding of infectious virus. Correlative pharmacokinetic studies revealed elevated levels of VSV RNA in blood in dogs with measurable disease remission. This is the first evaluation of intravenous oncolytic virus therapy for spontaneous canine cancer, demonstrating that VSV-IFNβ-NIS is well-tolerated and safe in dogs with advanced or metastatic disease. This approach has informed clinical translation, including dose and target indication selection, leading to a clinical investigation of intravenous VSV-IFNβ-NIS therapy, and provided preliminary evidence of clinical efficacy, and potential biomarkers that correlate with therapeutic response. PMID:29158470

[Comparison of participative educative strategy versus traditional educative strategy in health personnel].

PubMed

Barrera de León, Juan Carlos; Barajas-Serrano, Tanya Lizbeth; Jiménez-Hernández, Jacive Elizabeth; Barrera-López, Efrén; González-Bernal, Cesáreo; Higareda-Almaraz, Martha Alicia

2015-01-01

To compare the clinical aptitude in neonatal resuscitation with participative educative strategy versus traditional educative strategy in health personnel. Quasi-experimental study design including physicians and nurses distributed in two groups: (i) participative educative strategies n=156, and (ii) traditional n=158, were imparted in 12 sessions. Evaluation of clinical aptitude evaluated with validated questionnaire. Descriptive and interferential statistical inter- and intragroup. Clinical aptitude median score before/after: participative educative strategy 25.0/36.5 (p=0.000) and traditional 24.5/31.0 (p=0.000); differences between intergroup p=0.040. Changes to higher category according to the score before/after in participative 114 (73%) vs. traditional 65 (41%); p=0.010. There were no significant differences in the intergroup results in the category of evaluation of clinical aptitude, but there were differences in the intragroup when we evaluated median before and after with both strategies. Increase of clinical aptitude in neonatal resuscitation in health personnel,with both educative strategies being higher with participative strategy.

Integrating HL7 RIM and ontology for unified knowledge and data representation in clinical decision support systems.

PubMed

Zhang, Yi-Fan; Tian, Yu; Zhou, Tian-Shu; Araki, Kenji; Li, Jing-Song

2016-01-01

The broad adoption of clinical decision support systems within clinical practice has been hampered mainly by the difficulty in expressing domain knowledge and patient data in a unified formalism. This paper presents a semantic-based approach to the unified representation of healthcare domain knowledge and patient data for practical clinical decision making applications. A four-phase knowledge engineering cycle is implemented to develop a semantic healthcare knowledge base based on an HL7 reference information model, including an ontology to model domain knowledge and patient data and an expression repository to encode clinical decision making rules and queries. A semantic clinical decision support system is designed to provide patient-specific healthcare recommendations based on the knowledge base and patient data. The proposed solution is evaluated in the case study of type 2 diabetes mellitus inpatient management. The knowledge base is successfully instantiated with relevant domain knowledge and testing patient data. Ontology-level evaluation confirms model validity. Application-level evaluation of diagnostic accuracy reaches a sensitivity of 97.5%, a specificity of 100%, and a precision of 98%; an acceptance rate of 97.3% is given by domain experts for the recommended care plan orders. The proposed solution has been successfully validated in the case study as providing clinical decision support at a high accuracy and acceptance rate. The evaluation results demonstrate the technical feasibility and application prospect of our approach. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Evaluation of the William S. Hall Psychiatric Institute Clinical Psychology Internship: a replication and extension.

PubMed

Stader, Sandra R; Myers, DeRosset; Forand, Angela Q; Holmes, George R; McNulty, George F; Frey, Linda; Bolton, Staci S

2010-12-01

This study extends three earlier investigations involving participants who completed their predoctoral clinical psychology internship at the William S. Hall Psychiatric Institute. Intern graduates (N = 37) evaluated how effectively their internship training prepared them for seven aspects of their current work as practicing psychologists. Participants also rated the relevancy of 24 different internship training experiences to their current work and how much these experiences contributed to their development as clinical psychologists. The present study, in conjunction with the three previous studies, covers most of the 40-year period since the inception of the internship program. Analysis of the current data indicates the internship has improved over time and was deemed an exceptional training experience by its graduates. Findings may be of particular interest to internship directors and faculty interested in improving their training program and those who plan to conduct a self-study to maintain their accreditation for clinical psychology internship.

Actigraphy in Human African Trypanosomiasis as a Tool for Objective Clinical Evaluation and Monitoring: A Pilot Study

PubMed Central

Njamnshi, Alfred K.; Seke Etet, Paul F.; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y.; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

2012-01-01

Background Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Methods/Principal Findings Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. Conclusions/Significance The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to the clinical assessment of HAT patients. This method could be incorporated into a clinical scoring system adapted to HAT to be used in the evaluation of novel treatments and laboratory biomarkers. PMID:22348168

Evaluation and justification of clinical pharmacy services.

PubMed

Anderson, Scott V; Schumock, Glen T

2009-12-01

Pharmacy managers often must justify clinical pharmacy services (CPSs). This can be done by generalizing evidence from the literature or by conducting local evaluations. In either case, it is important that the clinical, humanistic or economic benefits of CPSs are considered, and limitations of the studies recognized. The basic model for the evaluation of CPSs includes the consideration of costs and outcomes, as well as the inclusion of a comparator group. Recent systematic reviews and individual studies provide good evidence regarding the value of CPSs, and are discussed here. Benefit-to-cost ratios of selected CPSs are also provided. While much of the evidence for CPSs has been conducted in the hospital setting, in the future, CPS expansion will occur in ambulatory care settings and will be benefited by healthcare reform efforts.

The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications.

PubMed

de Graaf, Gimon; Postmus, Douwe; Westerink, Jan; Buskens, Erik

2018-01-01

Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. This requires an early estimate of the potential clinical impact and commercial value. In this paper, we aim to demonstratively evaluate a set of novel biomarkers in terms of clinical impact and commercial value, using occurrence of cardiovascular disease (CVD) in type-2 diabetes (DM2) patients as a case study. We defined a clinical application for the novel biomarkers, and subsequently used data from a large cohort study in The Netherlands in a modeling exercise to assess the potential clinical impact and headroom for the biomarkers. The most likely application of the biomarkers would be to identify DM2 patients with a low CVD risk and subsequently withhold statin treatment. As a result, one additional CVD event in every 75 patients may be expected. The expected downstream savings resulted in a headroom for a point-of-care device ranging from €119.09 at a willingness to accept of €0 for one additional CVD event, to €0 at a willingness to accept of €15,614 or more. It is feasible to evaluate novel biomarkers on outcomes directly relevant to technological development and clinical adoption. Importantly, this may be attained at the same point in time and using the same data as used for the evaluation of association with disease and predictive power.

The use of the functional independence measure in elderly.

PubMed

Ribeiro, Dâmarys Kohlbeck de Melo Neu; Lenardt, Maria Helena; Lourenço, Tânia Maria; Betiolli, Susanne Elero; Seima, Marcia Daniele; Guimarães, Carlos Alberto

2018-06-07

To analyze in scientific publications how the Functional Independence Measure (FIM) has been employed to evaluate the elderly. Integrative review of periodical publications between 2011 and 2015, available online in full-text in Portuguese, English and Spanish. 129 articles were found; after the application of the criteria, they resulted in 21. The studies were categorized into two groups: A) follow or compare scores in FIM (cohort studies, case-control, clinical trials), focusing on rehabilitation, evaluation of programs and changes in the functional level after procedures/interventions; and B) measure/associate the functionality of the elderly (cross-sectional studies), focused on evaluation protocols in elderly health and associations to the caregiver burden, hospital stay, balance, satisfaction with life, cognition and clinical/socio-demographic aspects. The FIM was used in several scenarios of healthcare for the elderly, particularly in rehabilitation and outpatient clinics or health centers.

Probiotic and synbiotic safety in infants under two years of age.

PubMed

van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J

2014-03-01

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

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Panic Disorder in Clinically Referred Children and Adolescents

ERIC Educational Resources Information Center

Doerfler, Leonard A.; Connor, Daniel F.; Volungis, Adam M.; Toscano, Peter F., Jr.

2007-01-01

The present study examined the frequency and characteristics of panic disorder in children and adolescents who had been referred to a pediatric psychopharmacology clinic. Of the 280 children and adolescents evaluated in this clinic, 35 were diagnosed with panic disorder using a semi-structured clinical interview (K-SADS) and other objective…

Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

PubMed

Saito, Masami; Iwasaki, Kiyotaka

2017-03-01

Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

CFD for evaluation and treatment planning of aneurysms: review of proposed clinical uses and their challenges.

PubMed

Chung, Bongjae; Cebral, Juan Raul

2015-01-01

Computational fluid dynamics (CFD) has been used for several years to identify mechanical risk factors associated with aneurysmal evolution and rupture as well as to understand flow characteristics before and after surgical treatments in order to help the clinical decision making process. We used the keywords, "CFD" and "aneurysms" to search recent publications since about 2000, and categorized them into (i) studies of rupture risk factors and (ii) investigations of pre- and post-evaluations of surgical treatment with devices like coils and flow diverters (FD). This search enables us to examine the current status of CFD as a clinical tool and to determine if CFD can potentially become an important part of the routine clinical practice for the evaluation and treatment of aneurysms in near future. According to previous reports, it has been argued that CFD has become a quite robust non-invasive tool for the evaluation of surgical devices, especially in the early stages of device design and it has also been applied successfully to the study of rupture risk assessment. However, we find that due to the large number of pre-processing inputs further efforts of validation and reproducibility of CFD with larger clinical datasets are still essential to identify standardized mechanical risk factors. As a result, we identify the following needs to have a robust CFD tool for clinical use: (i) more reliability tests through validation studies, (ii) analyses of larger generalized clinical datasets to find converging universal risk parameters, (iii) fluid structure interaction (FSI) analyses to better understand the detailed vascular remodeling processes associated with aneurysm growth, evolution and rupture, and (iv) better coordinated and organized communications and collaborations between engineers and clinicians.

A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

PubMed

Akhloufi, H; Hulscher, M; van der Hoeven, C P; Prins, J M; van der Sijs, H; Melles, D C; Verbon, A

2018-04-26

To evaluate a clinical decision support system (CDSS) based on consensus-based intravenous to oral switch criteria, which identifies intravenous to oral switch candidates. A three-step evaluation study of a stand-alone CDSS with electronic health record interoperability was performed at the Erasmus University Medical Centre in the Netherlands. During the first step, we performed a technical validation. During the second step, we determined the sensitivity, specificity, negative predictive value and positive predictive value in a retrospective cohort of all hospitalized adult patients starting at least one therapeutic antibacterial drug between 1 and 16 May 2013. ICU, paediatric and psychiatric wards were excluded. During the last step the clinical relevance and usefulness was prospectively assessed by reports to infectious disease specialists. An alert was considered clinically relevant if antibiotics could be discontinued or switched to oral therapy at the time of the alert. During the first step, one technical error was found. The second step yielded a positive predictive value of 76.6% and a negative predictive value of 99.1%. The third step showed that alerts were clinically relevant in 53.5% of patients. For 43.4% it had already been decided to discontinue or switch the intravenous antibiotics by the treating physician. In 10.1%, the alert resulted in advice to change antibiotic policy and was considered useful. This prospective cohort study shows that the alerts were clinically relevant in >50% (n = 449) and useful in 10% (n = 85). The CDSS needs to be evaluated in hospitals with varying activity of infectious disease consultancy services as this probably influences usefulness.

[Implementation of the new clinical practice training model in Andalusia: a qualitative evaluation of the Nursing and Physiotherapy degrees].

PubMed

Fernández-Sola, Cayetano; Granero-Molina, José; Márquez-Membrive, Josefa; Aguilera-Manrique, Gabriel; Castro-Sánchez, Adelaida M

2014-01-01

The design of new Bachelor degree courses, together with the agreement reached between the Regional Government of Andalusia and Andalusian universities shape the new clinical training model for Health Science students. The aim of this project is to present a qualitative evaluation of the implementation of the new model in Nursing and Physiotherapy degrees at the University of Almeria and the Andalusian Public Health System. An exploratory qualitative study using document content analysis techniques, by analyzing 12 reports from teachers and those responsible for Practicum in Nursing and Physiotherapy degrees at the University of Almeria. The reports included opinions and proposals from university and clinical placement teachers, healthcare professionals or clinical placement tutors, students, and those in positions of responsibility as regards clinical placements. Three categories emerged in the data analysis: Health system organization, with sub-categories of disparity between shifts, difficulties with supervisor coordination, feelings of a lack of control, disparities in evaluation criteria and geographic distribution; academic organization, with sub-categories of short rotations, a lack of information received by the clinical placement tutor, and carrying out placements without studying the theory; and management of the work agreement, with sub-categories of being discouraged by what is received in return, extra work for those in charge, and delays in evaluations. The study suggests a need to support and guide clinical tutors, to increase coordination between the university and health services, to organize the students' theoretical and practical training and to provide the management of the model with flexibility and transparency. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Acrylamine-induced autoimmune phenomena.

PubMed

Rothschild, Bruce

2010-09-01

The objective of this study is to document a series of cases of occupationally derived autoimmune disease. Individuals with occupational exposure to acrylamides were evaluated clinically and biochemically/immunologically for evidence of autoimmune disease. Symptoms and signs and immuno-reactivity were monitored during exposure-free and re-exposure as part of the individuals' clinical evaluation. Six individuals with occupational acrylamide exposure had clinical and laboratory alterations characteristic of drug-induced autoimmune disease, specifically lupus, anti-phospholipid syndrome, Sjogren's syndrome, scleroderma, and polymyositis. The similarity of the full spectrum of disease in the reported patients to that found with procainamide strongly suggests the effects of occupational exposure. This uncontrolled study suggests the need for a full epidemiologic analysis of all individuals working with such occupational exposure, including full clinical and immunological examination.

The anti-candidal activity of Satureja khuzistanica ethanol extract against clinical isolates of C. albicans.

PubMed

Mahboubi, M; Kazempour, N

2016-03-01

Candida albicans is the common cause of some infectious diseases such as vaginal candidiasis or candidemia. Due to the emergence of drug resistant isolates of C. albicans, finding a new anti-Candida agent is a new strategy for current treatments. This study evaluated the anti-candidal activity of Satureja khuzistanica ethanol extract against clinical isolates of C. albicans. S. khuzistanica ethanol extract from aerial parts of plant at full flowering stage was evaluated against 30 clinical isolates and two ATCC reference strains of C. albicans by disc diffusion and micro-broth dilution assay. Also, in this study we evaluated the synergistic effects of amphotericin B, clotrimazole and ketoconazole with S. khuzistanica ethanol extract. The means of MIC and MFC of S. khuzistanica ethanol extract against clinical isolates were 299.4 and 722.6 (μg/mL), respectively. S. khuzistanica ethanol extract increased the anti-candidal effect of amphotericin B and ketoconazole, while it had no synergistic effect on clotrimazole against clinical isolates of C. albicans. Therefore, S. khuzistanica ethanol extract can be introduced as a new source of anti-candidal agent against clinical isolates of C. albicans. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

What is the benefit of treatment with multiple lines of chemotherapy for patients with metastatic breast cancer? A retrospective cohort study.

PubMed

Bakker, J L; Wever, K; van Waesberghe, J H; Beeker, A; Meijers-Heijboer, H; Konings, I R; Verheul, H M W

2015-12-01

Despite the extensive clinical experience, it is still under debate to what extent patients with metastatic breast cancer (MBC) benefit from multiple lines of chemotherapy beyond standard first or second line treatment. Selection of patients with MBC who will benefit from treatment is crucial to improve outcome and reduce unnecessary toxicity. In this retrospective study, systemic treatment outcome for patients with metastatic MBC is being evaluated. We evaluated to what extent the clinical benefit of prior chemotherapy can predict the success of a subsequent treatment line. Ninety-one patients treated with chemotherapy for MBC between January 2005 and January 2009 were included in this study. Clinical characteristics of patients, choices of chemotherapy and response at first evaluation of every treatment line was evaluated based on radiologic and clinical data. Patients received multiple systemic cytotoxic and biological (combination) therapies. 30% of these patients received more than five consecutive systemic (combination) treatments. First line chemotherapy was mostly anthracycline-based, followed by taxanes, capecitabine and vinorelbine. The response rate (RR, complete response plus partial response according to RECIST 1.1) decreased from 20% (95% CI 11-28%) upon first line of treatment to 0% upon the fourth line. The clinical benefit rate (combining RR and stable disease) decreased from 85% (95% CI 78-93%) in the first to 54% (95% CI 26-67) upon the fourth line. 24% of the patients with clinical benefit at first evaluation did not receive a subsequent line of treatment when progressive disease occurred, while sixty-one percent of the patients with progressive disease at first evaluation of a treatment did not receive a subsequent line of chemotherapy. When applied, the efficacy of a subsequent line of treatment was similar for patients independent of previous treatment benefit. The clinical benefit at first evaluation from systemic treatment in MBC does not predict for subsequent treatment benefit in this retrospective analysis. The fact that 61% of patients did not receive subsequent treatment after previous treatment failure suggests that either clinical judgement is of critical value in selection of patients to prevent them from unnecessary toxicity or, alternatively indicates that based on the assumption that prior treatment failure predicts for lack of benefit undertreatment of patients occurs. Therefore, a more adequate clinical judgement tool or predictive biomarkers for response are urgently needed to improve treatment outcome. Copyright © 2015. Published by Elsevier Ltd.

Concept mapping in a critical care orientation program: a pilot study to develop critical thinking and decision-making skills in novice nurses.

PubMed

Wahl, Stacy E; Thompson, Anita M

2013-10-01

Newly graduated registered nurses who were hired into a critical care intensive care unit showed a lack of critical thinking skills to inform their clinical decision-making abilities. This study evaluated the effectiveness of concept mapping as a teaching tool to improve critical thinking and clinical decision-making skills in novice nurses. A self-evaluation tool was administered before and after the learning intervention. The 25-item tool measured five key indicators of the development of critical thinking skills: problem recognition, clinical decision-making, prioritization, clinical implementation, and reflection. Statistically significant improvements were seen in 10 items encompassing all five indicators. Concept maps are an effective tool for educators to use in assisting novice nurses to develop their critical thinking and clinical decision-making skills. Copyright 2013, SLACK Incorporated.

Using reusable learning objects (rlos) in injection skills teaching: Evaluations from multiple user types.

PubMed

Williams, Julia; O'Connor, Mórna; Windle, Richard; Wharrad, Heather J

2015-12-01

Clinical skills are a critical component of pre-registration nurse education in the United Kingdom, yet there is widespread concern about the clinical skills displayed by newly-qualified nurses. Novel means of supporting clinical skills education are required to address this. A package of Reusable Learning Objects (RLOs) was developed to supplement pre-registration teaching on the clinical skill of administering injection medication. RLOs are electronic resources addressing a single learning objective whose interactivity facilitates learning. This article evaluates a package of five injection RLOs across three studies: (1) questionnaires administered to pre-registration nursing students at University of Nottingham (UoN) (n=46) evaluating the RLO package as a whole; (2) individual RLOs evaluated in online questionnaires by educators and students from UoN; from other national and international institutions; and healthcare professionals (n=265); (3) qualitative evaluation of the RLO package by UoN injection skills tutors (n=6). Data from all studies were assessed for (1) access to, (2) usefulness, (3) impact and (4) integration of the RLOs. Study one found that pre-registration nursing students rate the RLO package highly across all categories, particularly underscoring the value of their self-test elements. Study two found high ratings in online assessments of individual RLOs by multiple users. The global reach is particularly encouraging here. Tutors reported insufficient levels of student-RLO access, which might be explained by the timing of their student exposure. Tutors integrate RLOs into teaching and agree on their use as teaching supplements, not substitutes for face-to-face education. This evaluation encompasses the first years postpackage release. Encouraging data on evaluative categories in this early review suggest that future evaluations are warranted to track progress as the package is adopted and evaluated more widely. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of clinical and financial outcomes of a new no-sting barrier film and barrier cream in a large UK primary care organisation.

PubMed

Stephen-Haynes, Jackie; Stephens, Claire

2013-12-01

The study involves 95 subjects within a UK Primary Care Organisation and was undertaken in two arms. The objective was to determine the clinical outcomes and clinical acceptability of a newly available range of no-sting barrier film and no-sting barrier cream products offering significant financial benefits. The importance of undertaking this study is underpinned by evidence in the literature relating to the use of no-sting barrier preparations within clinical practice. The first part of the study (arm 1) involved extensive evaluation of either the film or cream barrier in 36 patients and was compared to existing standardised barrier protection care within the organisation. The results indicated that the new product range met all the criteria for formulary inclusion and following this the barrier range was further evaluated in arm 2, 33 patients with barrier cream and 26 patients with barrier film. The entire study was conducted over a 3-month period with patient treatment lasting a minimum of 2 days to a maximum 4-week period adhering to the agreed evaluation protocol as approved by clinical governance. In arm 1 (n = 36), the clinical expectation of the product was met in 32 cases relating to ease of use, conformability, no-sting, quick drying, ease of absorption, compatibility with devices, frequency of application, prevention and management including visual skin improvement resulting in a recommendation for formulary listing in 31 of 36 cases. In arm 2 (n = 59), barrier film and barrier cream performance was consistently rated same as, better than or much better than the existing barrier used. A formulary listing recommendation was made in 51 of 59 cases. © 2012 The Authors. International Wound Journal © 2012 John Wiley & Sons Ltd and Medicalhelplines.com Inc.

Evaluation of thermal antinociceptive effects after intramuscular administration of hydromorphone hydrochloride to American kestrels (Falco sparverius)

USGS Publications Warehouse

Guzman, David Sanchez-Migallon; Drazenovich, Tracy L.; Olsen, Glenn H.; Willits, Neil H.; Paul-Murphy, Joanne R.

2013-01-01

Conclusions and Clinical Relevance—Hydromorphone at the doses evaluated significantly increased the thermal nociception threshold for American kestrels for 3 to 6 hours. Additional studies with other types of stimulation, formulations, dosages, routes of administration, and testing times are needed to fully evaluate the analgesic and adverse effects of hydromorphone in kestrels and other avian species and the use of hydromorphone in clinical settings.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

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

PubMed

Parker, Carol; Weiner, Michael; Reeves, Mathew

2016-03-01

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

Hospitalist workload influences faculty evaluations by internal medicine clerkship students.

PubMed

Robinson, Robert L

2015-01-01

The last decade has brought significant changes to internal medicine clerkships through resident work-hour restrictions and the widespread adoption of hospitalists as medical educators. These key medical educators face competing demands for quality teaching and clinical service intensity. The study reported here was conducted to explore the relationship between clinical service intensity and teaching evaluations of hospitalists by internal medicine clerkship students. A retrospective correlation analysis of clinical service intensity and teaching evaluations of hospitalists by internal medicine clerkship students during the 2009 to 2013 academic years at Southern Illinois University School of Medicine was conducted. Internal medicine hospitalists who supervise the third-year inpatient experience for medical students during the 2009 to 2013 academic years participated in the study. Clinical service intensity data in terms of work relative value units (RVUs), patient encounters, and days of inpatient duty were collected for all members of the hospitalist service. Medical students rated hospitalists in the areas of patient rapport, enthusiasm about the profession, clinical skills, sharing knowledge and skills, encouraging the students, probing student knowledge, stimulating independent learning, providing timely feedback, providing constructive criticism, and observing patient encounters with students. Significant negative correlations between higher work RVU production, total patient encounters, duty days, and learner evaluation scores for enthusiasm about the profession, clinical skills, probing the student for knowledge and judgment, and observing a patient encounter with the student were identified. Higher duty days had a significant negative correlation with sharing knowledge/skills and encouraging student initiative. Higher work RVUs and total patient encounters were negatively correlated with timely feedback and constructive criticism. The results suggest that internal medicine clerkship student evaluations of hospitalist faculty are negatively influenced by high clinical service intensity measured in terms of annual work RVUs, patient encounters, and duty days.

Task-oriented evaluation of electronic medical records systems: development and validation of a questionnaire for physicians

PubMed Central

2004-01-01

Background Evaluation is a challenging but necessary part of the development cycle of clinical information systems like the electronic medical records (EMR) system. It is believed that such evaluations should include multiple perspectives, be comparative and employ both qualitative and quantitative methods. Self-administered questionnaires are frequently used as a quantitative evaluation method in medical informatics, but very few validated questionnaires address clinical use of EMR systems. Methods We have developed a task-oriented questionnaire for evaluating EMR systems from the clinician's perspective. The key feature of the questionnaire is a list of 24 general clinical tasks. It is applicable to physicians of most specialties and covers essential parts of their information-oriented work. The task list appears in two separate sections, about EMR use and task performance using the EMR, respectively. By combining these sections, the evaluator may estimate the potential impact of the EMR system on health care delivery. The results may also be compared across time, site or vendor. This paper describes the development, performance and validation of the questionnaire. Its performance is shown in two demonstration studies (n = 219 and 80). Its content is validated in an interview study (n = 10), and its reliability is investigated in a test-retest study (n = 37) and a scaling study (n = 31). Results In the interviews, the physicians found the general clinical tasks in the questionnaire relevant and comprehensible. The tasks were interpreted concordant to their definitions. However, the physicians found questions about tasks not explicitly or only partially supported by the EMR systems difficult to answer. The two demonstration studies provided unambiguous results and low percentages of missing responses. In addition, criterion validity was demonstrated for a majority of task-oriented questions. Their test-retest reliability was generally high, and the non-standard scale was found symmetric and ordinal. Conclusion This questionnaire is relevant for clinical work and EMR systems, provides reliable and interpretable results, and may be used as part of any evaluation effort involving the clinician's perspective of an EMR system. PMID:15018620

Task-oriented evaluation of electronic medical records systems: development and validation of a questionnaire for physicians.

PubMed

Laerum, Hallvard; Faxvaag, Arild

2004-02-09

Evaluation is a challenging but necessary part of the development cycle of clinical information systems like the electronic medical records (EMR) system. It is believed that such evaluations should include multiple perspectives, be comparative and employ both qualitative and quantitative methods. Self-administered questionnaires are frequently used as a quantitative evaluation method in medical informatics, but very few validated questionnaires address clinical use of EMR systems. We have developed a task-oriented questionnaire for evaluating EMR systems from the clinician's perspective. The key feature of the questionnaire is a list of 24 general clinical tasks. It is applicable to physicians of most specialties and covers essential parts of their information-oriented work. The task list appears in two separate sections, about EMR use and task performance using the EMR, respectively. By combining these sections, the evaluator may estimate the potential impact of the EMR system on health care delivery. The results may also be compared across time, site or vendor. This paper describes the development, performance and validation of the questionnaire. Its performance is shown in two demonstration studies (n = 219 and 80). Its content is validated in an interview study (n = 10), and its reliability is investigated in a test-retest study (n = 37) and a scaling study (n = 31). In the interviews, the physicians found the general clinical tasks in the questionnaire relevant and comprehensible. The tasks were interpreted concordant to their definitions. However, the physicians found questions about tasks not explicitly or only partially supported by the EMR systems difficult to answer. The two demonstration studies provided unambiguous results and low percentages of missing responses. In addition, criterion validity was demonstrated for a majority of task-oriented questions. Their test-retest reliability was generally high, and the non-standard scale was found symmetric and ordinal. This questionnaire is relevant for clinical work and EMR systems, provides reliable and interpretable results, and may be used as part of any evaluation effort involving the clinician's perspective of an EMR system.

Using program evaluation to support knowledge translation in an interprofessional primary care team: a case study.

PubMed

Donnelly, Catherine; Shulha, Lyn; Klinger, Don; Letts, Lori

2016-10-06

Evaluation is a fundamental component in building quality primary care and is ideally situated to support individual, team and organizational learning by offering an accessible form of participatory inquiry. The evaluation literature has begun to recognize the unique features of KT evaluations and has described attributes to consider when evaluating KT activities. While both disciplines have focused on the evaluation of KT activities neither has explored the role of evaluation in KT. The purpose of the paper is to examine how participation in program evaluation can support KT in a primary care setting. A mixed methods case study design was used, where evaluation was conceptualized as a change process and intervention. A Memory Clinic at an interprofessional primary care clinic was the setting in which the study was conducted. An evaluation framework, Pathways of Influence provided the theoretical foundation to understand how program evaluation can facilitate the translation of knowledge at the level of the individual, inter-personal (Memory Clinic team) and the organization. Data collection included questionnaires, interviews, evaluation log and document analysis. Questionnaires and interviews were administered both before and after the evaluation: Pattern matching was used to analyze the data based on predetermined propositions. Individuals gained program knowledge that resulted in changes to both individual and program practices. One of the key themes was the importance clinicians placed on local, program based knowledge. The evaluation had less influence on the broader health organization. Program evaluation facilitated individual, team and organizational learning. The use of evaluation to support KT is ideally suited to a primary care setting by offering relevant and applicable knowledge to primary care team members while being sensitive to local context.

Evaluation of the activity of rheumatoid arthritis in clinical practice. Agreement between self-rated clinimetric evaluation and clinical evaluation with activity indexes: DAS28, CDAI and SDAI.

PubMed

Horta-Baas, Gabriel; Pérez Bolde-Hernández, Arturo; Hernández-Cabrera, María Fernanda; Vergara-Sánchez, Imelda; Romero-Figueroa, María Del Socorro

2017-10-11

To achieve control of rheumatoid arthritis (RA) it is necessary to be able to evaluate its activity. The American College of Rheumatology (ACR) recommends for this purpose indexes of activity that can be performed by the patient (PAS-II and RAPID-3) and IA including medical evaluation with laboratory studies (DAS28 and SDAI) or without them (CDAI). The objective was to analyze the concordance between self-rated clinimetric evaluation and clinimetric evaluation performed by the physician. Analytical cross-sectional study in 126 patients with RA. The agreement was evaluated through the weighted κ coefficient and the Krippendorff's α coefficient. The PAS-II and RAPID-3 significantly correlated with all variables included in the core set of measures recommended by the ACR/EULAR. The agreement between PAS-II and CDAI-SDAI was good (κ: 0.6, α: 0.61-0.62), and moderate with DAS28-ESR (κ: 0.53, α: 0.56). The concordance between RAPID-3 and CDAI-SDAI was moderate (κ: 0.55-0.57, α: 0.50-0.51), and moderate with DAS28-ESR (κ: 0.55, α: 0.53). When categorizing the activity in remission/low activity vs. moderate/severe activity, the agreement was greater with the PAS-II (0.59 vs. 0.34; P=.012). The good concordance between PAS-II and SDAI supports their use in clinical practice, especially if biomarkers of inflammation or the possibility of joint count are not available. However, in order to recommend its routine application in clinical practice, it is necessary to perform longitudinal studies that assess its responsiveness. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Assessing progression of clinical reasoning through virtual patients: An exploratory study.

PubMed

Forsberg, Elenita; Ziegert, Kristina; Hult, Håkan; Fors, Uno

2016-01-01

To avoid test-driven learning, there have been discussions regarding the use of more formative assessments in health care education to promote students' deep learning. Feedback is important in formative assessment, but many students ignore it; therefore, interventions should be introduced which stimulate them to reflect on the new knowledge. The aim for this study was to explore if Virtual Patient (VP)-based formative assessments, in connection with self-evaluations, had an impact on postgraduate pediatric nursing students' development of clinical reasoning abilities. Students' self-evaluations served as the basis for measuring progress. Data was analysed using deductive content analysis. The findings showed a clear progression of the clinical reasoning ability of the students. After the first assessment, the students described feelings of uncertainty and that their knowledge gaps were exposed. At the mid-course assessment the awareness of improved clinical reasoning was obvious and the students were more certain of knowing how to solve the VP cases. In the final assessment, self-efficacy was expressed. VP-based assessments, in connection with self-evaluations, early in the education resulted in a gain of students' own identification of the concept of clinical reasoning, awareness of what to focus on during clinical practice and visualised expected clinical competence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials. © The Author(s) 2014.

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

Reproducibility of clinical research in critical care: a scoping review.

PubMed

Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T

2018-02-21

The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.

An integrated review of the correlation between critical thinking ability and clinical decision-making in nursing.

PubMed

Lee, Daphne Sk; Abdullah, Khatijah Lim; Subramanian, Pathmawathi; Bachmann, Robert Thomas; Ong, Swee Leong

2017-12-01

To explore whether there is a correlation between critical thinking ability and clinical decision-making among nurses. Critical thinking is currently considered as an essential component of nurses' professional judgement and clinical decision-making. If confirmed, nursing curricula may be revised emphasising on critical thinking with the expectation to improve clinical decision-making and thus better health care. Integrated literature review. The integrative review was carried out after a comprehensive literature search using electronic databases Ovid, EBESCO MEDLINE, EBESCO CINAHL, PROQuest and Internet search engine Google Scholar. Two hundred and 22 articles from January 1980 to end of 2015 were retrieved. All studies evaluating the relationship between critical thinking and clinical decision-making, published in English language with nurses or nursing students as the study population, were included. No qualitative studies were found investigating the relationship between critical thinking and clinical decision-making, while 10 quantitative studies met the inclusion criteria and were further evaluated using the Quality Assessment and Validity Tool. As a result, one study was excluded due to a low-quality score, with the remaining nine accepted for this review. Four of nine studies established a positive relationship between critical thinking and clinical decision-making. Another five studies did not demonstrate a significant correlation. The lack of refinement in studies' design and instrumentation were arguably the main reasons for the inconsistent results. Research studies yielded contradictory results as regard to the relationship between critical thinking and clinical decision-making; therefore, the evidence is not convincing. Future quantitative studies should have representative sample size, use critical thinking measurement tools related to the healthcare sector and evaluate the predisposition of test takers towards their willingness and ability to think. There is also a need for qualitative studies to provide a fresh approach in exploring the relationship between these variables uncovering currently unknown contributing factors. This review confirmed that evidence to support the existence of relationships between critical thinking and clinical decision-making is still unsubstantiated. Therefore, it serves as a call for nurse leaders and nursing academics to produce quality studies in order to firmly support or reject the hypothesis that there is a statistically significant correlation between critical thinking and clinical decision-making. © 2017 John Wiley & Sons Ltd.

A Clinical Evaluation of Cone Beam Computed Tomography

DTIC Science & Technology

2013-07-31

body of literature lacks in vivo studies comparing CBCT images with clinical findings. The purpose of this descriptive case series was to...All (18/18) bone measurements were underrepresented on CBCT images in this study . This case series also identified limitations in accuracy when... study was to compare pre-surgical CBCT images against the actual clinical presentation of the hard tissues. METHOD: Eleven patients requiring

Development and validation of a Clinical Assessment Tool for Nursing Education (CAT-NE).

PubMed

Skúladóttir, Hafdís; Svavarsdóttir, Margrét Hrönn

2016-09-01

The aim of this study was to develop a valid assessment tool to guide clinical education and evaluate students' performance in clinical nursing education. The development of the Clinical Assessment Tool for Nursing Education (CAT-NE) was based on the theory of nursing as professional caring and the Bologna learning outcomes. Benson and Clark's four steps of instrument development and validation guided the development and assessment of the tool. A mixed-methods approach with individual structured cognitive interviewing and quantitative assessments was used to validate the tool. Supervisory teachers, a pedagogical consultant, clinical expert teachers, clinical teachers, and nursing students at the University of Akureyri in Iceland participated in the process. This assessment tool is valid to assess the clinical performance of nursing students; it consists of rubrics that list the criteria for the students' expected performance. According to the students and their clinical teachers, the assessment tool clarified learning objectives, enhanced the focus of the assessment process, and made evaluation more objective. Training clinical teachers on how to assess students' performances in clinical studies and use the tool enhanced the quality of clinical assessment in nursing education. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Quantitative Evaluation of the Clinical and Translational Science Awards (CTSA) Program Based on Science Mapping and Scientometric Analysis

PubMed Central

Zhang, Yin; Wang, Lei

2013-01-01

Abstract The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. PMID:24330689

Progression of leprosy neuropathy: a case series study

PubMed Central

Vital, Robson T; Illarramendi, Ximena; Nascimento, Osvaldo; Hacker, Mariana A; Sarno, Euzenir N; Jardim, Marcia R

2012-01-01

A need still exists to determine the clinical and neurophysiological characteristics of leprosy neuropathy at distinct times of the disease by different methods that measure the various nerve fiber functions. A prospective clinical study was performed with 10 paucibacillary (PB) and 12 multibacillary (MB) patients evaluated at diagnosis and one year after cessation of multidrug therapy (MDT). Peripheral nerve function was assessed clinically and by means of the sympathetic skin response, skin vasomotor reflex, and nerve conduction study (NCS). At diagnosis, 73% of the total 22 patients had nerve function impairment (NFI). Autonomic function (χ2= 5.5, P= 0.019) and NCS (χ2= 7.765, P= 0.01) were significantly more altered in MB than PB patients. At final evaluation, NFI of the MB patients had worsened, especially among the six who had leprosy reaction. As the NFI of PB patients showed improvement, a significant difference between the two groups (χ2= 12.320, P= 0.001) was observed. A high prevalence of neuropathy was observed in newly diagnosed patients. Associating different tests with a thorough clinical neurological evaluation increases detection rates. PMID:22741099

The quantitative evaluation of the Clinical and Translational Science Awards (CTSA) program based on science mapping and scientometric analysis.

PubMed

Zhang, Yin; Wang, Lei; Diao, Tianxi

2013-12-01

The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. © 2013 Wiley Periodicals, Inc.

ComOn Coaching: Study protocol of a randomized controlled trial to assess the effect of a varied number of coaching sessions on transfer into clinical practice following communication skills training.

PubMed

Niglio de Figueiredo, Marcelo; Rudolph, Bärbel; Rodolph, Bärbel; Bylund, Carma L; Goelz, Tanja; Heußner, Pia; Sattel, Heribert; Fritzsche, Kurt; Wuensch, Alexander

2015-07-07

Communication skills training has proven to be an effective means to enhance communication of health care professionals in oncology. These effects are well studied in standardized settings. The question of transferring these skills into clinical consultations remains open. We build up on a previous developed training concept consisting of a workshop and coaching. This training achieved a medium effect size in two studies with standardized patients. In the current study, we expanded and manualized the coaching concept, and we will evaluate effects of a varied number of coaching sessions on real clinical consultations. Our aim is to determine how much coaching oncologists need to transfer communication skills into clinical practice. Physicians of two German medical centers will participate in a workshop for communication skills and will be randomized to either a group with one coaching session or a group with four coaching sessions following the workshop. The participation is voluntary and the physicians will receive medical education points. Consultations held by the participating physicians with actual patients who gave their informed consent will be filmed at three time points. These consultations will be evaluated by blinded raters using a checklist based on the training content (primary outcome). Secondary outcomes will be the self-evaluated communication competence by physicians and an evaluation of the consultations by both physicians and patients. We will evaluate our communication training concept on three levels - rater, physician and patient - and concentrate on the transfer of communication skills into real life situations. As we emphasize the external validity in this study design, limitations will be expected due to heterogeneity of data. With this study we aim to gain data on how to improve communication skills training that will result in better patient outcomes. German Clinical Trials Register DRKS00004385 .

Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns.

PubMed

Hickel, Reinhard; Roulet, Jean-François; Bayne, Stephen; Heintze, Siegward D; Mjör, Ivar A; Peters, Mathilde; Rousson, Valentin; Randall, Ros; Schmalz, Gottfried; Tyas, Martin; Vanherle, Guido

2007-01-01

About 35 years ago, Ryge provided a practical approach to the evaluation of the clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance, and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short-term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and nonstandard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to interpret meaningfully. In many cases, the insensitivity of the original Ryge methods leads to misinterpretation as good clinical performance. While there are many good features of the original system, it is now time to move on to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial 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 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.

Using wireless handheld computers to seek information at the point of care: an evaluation by clinicians.

PubMed

Hauser, Susan E; Demner-Fushman, Dina; Jacobs, Joshua L; Humphrey, Susanne M; Ford, Glenn; Thoma, George R

2007-01-01

To evaluate: (1) the effectiveness of wireless handheld computers for online information retrieval in clinical settings; (2) the role of MEDLINE in answering clinical questions raised at the point of care. A prospective single-cohort study: accompanying medical teams on teaching rounds, five internal medicine residents used and evaluated MD on Tap, an application for handheld computers, to seek answers in real time to clinical questions arising at the point of care. All transactions were stored by an intermediate server. Evaluators recorded clinical scenarios and questions, identified MEDLINE citations that answered the questions, and submitted daily and summative reports of their experience. A senior medical librarian corroborated the relevance of the selected citation to each scenario and question. Evaluators answered 68% of 363 background and foreground clinical questions during rounding sessions using a variety of MD on Tap features in an average session length of less than four minutes. The evaluator, the number and quality of query terms, the total number of citations found for a query, and the use of auto-spellcheck significantly contributed to the probability of query success. Handheld computers with Internet access are useful tools for healthcare providers to access MEDLINE in real time. MEDLINE citations can answer specific clinical questions when several medical terms are used to form a query. The MD on Tap application is an effective interface to MEDLINE in clinical settings, allowing clinicians to quickly find relevant citations.

Using Wireless Handheld Computers to Seek Information at the Point of Care: An Evaluation by Clinicians

PubMed Central

Hauser, Susan E.; Demner-Fushman, Dina; Jacobs, Joshua L.; Humphrey, Susanne M.; Ford, Glenn; Thoma, George R.

2007-01-01

Objective To evaluate: (1) the effectiveness of wireless handheld computers for online information retrieval in clinical settings; (2) the role of MEDLINE® in answering clinical questions raised at the point of care. Design A prospective single-cohort study: accompanying medical teams on teaching rounds, five internal medicine residents used and evaluated MD on Tap, an application for handheld computers, to seek answers in real time to clinical questions arising at the point of care. Measurements All transactions were stored by an intermediate server. Evaluators recorded clinical scenarios and questions, identified MEDLINE citations that answered the questions, and submitted daily and summative reports of their experience. A senior medical librarian corroborated the relevance of the selected citation to each scenario and question. Results Evaluators answered 68% of 363 background and foreground clinical questions during rounding sessions using a variety of MD on Tap features in an average session length of less than four minutes. The evaluator, the number and quality of query terms, the total number of citations found for a query, and the use of auto-spellcheck significantly contributed to the probability of query success. Conclusion Handheld computers with Internet access are useful tools for healthcare providers to access MEDLINE in real time. MEDLINE citations can answer specific clinical questions when several medical terms are used to form a query. The MD on Tap application is an effective interface to MEDLINE in clinical settings, allowing clinicians to quickly find relevant citations. PMID:17712085

Pros and cons of CLA consumption: an insight from clinical evidences.

PubMed

Benjamin, Sailas; Prakasan, Priji; Sreedharan, Sajith; Wright, Andre-Denis G; Spener, Friedrich

2015-01-01

This comprehensive review critically evaluates whether supposed health benefits propounded upon human consumption of conjugated linoleic acids (CLAs) are clinically proven or not. With a general introduction on the chemistry of CLA, major clinical evidences pertaining to intervention strategies, body composition, cardio-vascular health, immunity, asthma, cancer and diabetes are evaluated. Supposed adverse effects such as oxidative stress, insulin resistance, irritation of intestinal tract and milk fat depression are also examined. It seems that no consistent result was observed even in similar studies conducted at different laboratories, this may be due to variations in age, gender, racial and geographical disparities, coupled with type and dose of CLA supplemented. Thus, supposed promising results reported in mechanistic and pre-clinical studies cannot be extrapolated with humans, mainly due to the lack of inconsistency in analyses, prolonged intervention studies, follow-up studies and international co-ordination of concerted studies. Briefly, clinical evidences accumulated thus far show that CLA is not eliciting significantly promising and consistent health effects so as to uphold it as neither a functional nor a medical food.

A Nurse-Led Smoking Cessation Clinic--Quit Rate Results and Views of Participants

ERIC Educational Resources Information Center

Thompson, K. A.; Parahoo, A. K.; Blair, N.

2007-01-01

This study evaluated the success of a community nurse-led smoking cessation clinic, based in one trust in Northern Ireland. The clinic operated a group therapy approach. The study employed quantitative and qualitative methods of data collection to measure smoking behaviour and to gain the views of participants. Smoking behaviour was measured by…

National Assessment of Clinical Education of Allied Health Manpower: Volume IV: Bibliography.

ERIC Educational Resources Information Center

Booz Allen and Hamilton, Inc., Washington, DC.

The document is the last volume of a four-part report of a study conducted to evaluate and assess the national state of clinical education and training of allied health manpower. It presents a bibliography of all significant clinical education materials, documentary materials and ongoing studies, through August 30, 1973 but after 1965. The…

Quantifying the quality of medical x-ray images: An evaluation based on normal anatomy for lumbar spine and chest radiography

NASA Astrophysics Data System (ADS)

Tingberg, Anders Martin

Optimisation in diagnostic radiology requires accurate methods for determination of patient absorbed dose and clinical image quality. Simple methods for evaluation of clinical image quality are at present scarce and this project aims at developing such methods. Two methods are used and further developed; fulfillment of image criteria (IC) and visual grading analysis (VGA). Clinical image quality descriptors are defined based on these two methods: image criteria score (ICS) and visual grading analysis score (VGAS), respectively. For both methods the basis is the Image Criteria of the ``European Guidelines on Quality Criteria for Diagnostic Radiographic Images''. Both methods have proved to be useful for evaluation of clinical image quality. The two methods complement each other: IC is an absolute method, which means that the quality of images of different patients and produced with different radiographic techniques can be compared with each other. The separating power of IC is, however, weaker than that of VGA. VGA is the best method for comparing images produced with different radiographic techniques and has strong separating power, but the results are relative, since the quality of an image is compared to the quality of a reference image. The usefulness of the two methods has been verified by comparing the results from both of them with results from a generally accepted method for evaluation of clinical image quality, receiver operating characteristics (ROC). The results of the comparison between the two methods based on visibility of anatomical structures and the method based on detection of pathological structures (free-response forced error) indicate that the former two methods can be used for evaluation of clinical image quality as efficiently as the method based on ROC. More studies are, however, needed for us to be able to draw a general conclusion, including studies of other organs, using other radiographic techniques, etc. The results of the experimental evaluation of clinical image quality are compared with physical quantities calculated with a theoretical model based on a voxel phantom, and correlations are found. The results demonstrate that the computer model can be a useful toot in planning further experimental studies.

Effectiveness of a Web-Based Simulation in Improving Nurses' Workplace Practice With Deteriorating Ward Patients: A Pre- and Postintervention Study.

PubMed

Liaw, Sok Ying; Wong, Lai Fun; Lim, Eunice Ya Ping; Ang, Sophia Bee Leng; Mujumdar, Sandhya; Ho, Jasmine Tze Yin; Mordiffi, Siti Zubaidah; Ang, Emily Neo Kim

2016-02-19

Nurses play an important role in detecting patients with clinical deterioration. However, the problem of nurses failing to trigger deteriorating ward patients still persists despite the implementation of a patient safety initiative, the Rapid Response System. A Web-based simulation was developed to enhance nurses' role in recognizing and responding to deteriorating patients. While studies have evaluated the effectiveness of the Web-based simulation on nurses' clinical performance in a simulated environment, no study has examined its impact on nurses' actual practice in the clinical setting. The objective of this study was to evaluate the impact of Web-based simulation on nurses' recognition of and response to deteriorating patients in clinical settings. The outcomes were measured across all levels of Kirkpatrick's 4-level evaluation model with clinical outcome on triggering rates of deteriorating patients as the primary outcome measure. A before-and-after study was conducted on two general wards at an acute care tertiary hospital over a 14-month period. All nurses from the two study wards who undertook the Web-based simulation as part of their continuing nursing education were invited to complete questionnaires at various time points to measure their motivational reaction, knowledge, and perceived transfer of learning. Clinical records on cases triggered by ward nurses from the two study wards were evaluated for frequency and types of triggers over a period of 6 months pre- and 6 months postintervention. The number of deteriorating patients triggered by ward nurses in a medical general ward increased significantly (P<.001) from pre- (84/937, 8.96%) to postintervention (91/624, 14.58%). The nurses reported positively on the transfer of learning (mean 3.89, SD 0.49) from the Web-based simulation to clinical practice. A significant increase (P<.001) on knowledge posttest score from pretest score was also reported. The nurses also perceived positively their motivation (mean 3.78, SD 0.56) to engage in the Web-based simulation. This study provides evidence on the effectiveness of Web-based simulation in improving nursing practice when recognizing and responding to deteriorating patients. This educational tool could be implemented by nurse educators worldwide to address the educational needs of a large group of hospital nurses responsible for patients in clinical deterioration.

Prospective evaluation of oro-pharyngeal dysphagia after severe traumatic brain injury.

PubMed

Terré, Rosa; Mearin, Fermín

2007-12-01

To evaluate clinical, videofluoroscopic findings and clinical evolution of neurogenic dysphagia and to establish the prognostic factors. Prospective cohort study. Forty-eight patients with severe traumatic brain injury (TBI) and clinically-suspected oro-pharyngeal dysphagia were studied. Clinical evaluation of oro-pharyngeal dysphagia and videofluoroscopic examination were performed. Clinical evolution was based on feeding mode at discharge, the presence of respiratory complications and body mass index (BMI) at admission and at discharge. Sixty-five per cent of patients had impaired gag reflex and 44% cough during oral feeding. Videofluoroscopy revealed some type of disorder in 90% of cases: 65% in the oral phase and 73% in the pharyngeal phase (aspiration in 62.5%, being silent in 41%). At discharge, 45% were on normal diet, 27% on a modified oral diet, 14% combined oral intake and gastrostomy feeding and 14% were fed exclusively by gastrostomy. Feeding mode at discharge substantially correlated with RLCF score at admission (p=0.04) and with RLCF (p=0.009) and DRS (p=0.02) scores at discharge. Aspiration is very frequent in patients with severe TBI, being silent in almost half. Cognitive function evaluated with the RLCF is the best prognostic factor. At discharge, 72% of the patients were on oral food intake despite having severe TBI.

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

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

Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

ERIC Educational Resources Information Center

Wilson, Lynda Law; Rice, Marti; Jones, Carolynn T.; Joiner, Cynthia; LaBorde, Jennifer; McCall, Kimberly; Jester, Penelope M.; Carter, Sheree C.; Boone, Chrissy; Onwuzuligbo, Uzoma; Koneru, Alaya

2013-01-01

Introduction: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the…

Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

ERIC Educational Resources Information Center

Marshall, Keith; Willoughby-Booth, Simon

2007-01-01

There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic

PubMed Central

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B.

2016-01-01

Background: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. Objectives: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. Study Design/Methods: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. Results: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. Conclusions: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies. PMID:29444602

Development of a simulation evaluation tool for assessing nursing students' clinical judgment in caring for children with dehydration.

PubMed

Kim, Shin-Jeong; Kim, Sunghee; Kang, Kyung-Ah; Oh, Jina; Lee, Myung-Nam

2016-02-01

The lack of reliable and valid tools to evaluate learning outcomes during simulations has limited the adoption and progress of simulation-based nursing education. This study had two aims: (a) to develop a simulation evaluation tool (SET(c-dehydration)) to assess students' clinical judgment in caring for children with dehydration based on the Lasater Clinical Judgment Rubric (LCJR) and (b) to examine its reliability and validity. Undergraduate nursing students from two nursing schools in South Korea participated in this study from March 3 through June 10, 2014. The SET(c-dehydration) was developed, and 120 nursing students' clinical judgment was evaluated. Descriptive statistics, Cronbach's alpha, Cohen's kappa coefficient, and confirmatory factor analysis (CFA) were used to analyze the data. A 41-item version of the SET(c-dehydration) with three subscales was developed. Cohen's kappa (measuring inter-observer reliability) of the sessions ranged from .73 to .95, and Cronbach's alpha was .87. The mean total rating of the SET(c-dehydration) by the instructors was 1.92 (±.25), and the mean scores for the four LCJR dimensions of clinical judgment were as follows: noticing (1.74±.27), interpreting (1.85±.43), responding (2.17±.32), and reflecting (1.79±.35). CFA, which was performed to test construct validity, showed that the four dimensions of the SET(c-dehydration) was an appropriate framework. The SET(c-dehydration) provides a means to evaluate clinical judgment in simulation education. Its reliability and validity should be examined further. Copyright © 2015 Elsevier Ltd. All rights reserved.

Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

PubMed

Evans, Scott R; Pennello, Gene; Pantoja-Galicia, Norberto; Jiang, Hongyu; Hujer, Andrea M; Hujer, Kristine M; Manca, Claudia; Hill, Carol; Jacobs, Michael R; Chen, Liang; Patel, Robin; Kreiswirth, Barry N; Bonomo, Robert A

2016-09-15

The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk trade-offs of diagnostics that assist in medical decision making. Benefit-Risk Evaluation of Diagnostics: A Framework (BED-FRAME) is a strategy for pragmatic evaluation of diagnostics designed to supplement traditional approaches. BED-FRAME evaluates diagnostic yield and addresses 2 key issues: (1) that diagnostic yield depends on prevalence, and (2) that different diagnostic errors carry different clinical consequences. As such, evaluating and comparing diagnostics depends on prevalence and the relative importance of potential errors. BED-FRAME provides a tool for communicating the expected clinical impact of diagnostic application and the expected trade-offs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision making. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

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 document entry time and users did not feel a significant delay when using rCARD for clinical document entry. The study indicates that it is feasible to integrate a real-time, NLP-enabled abbreviation recognition and disambiguation module with clinical documentation systems.

[Clinical evaluation of heavy-particle radiotherapy using dose volume histogram (DVH)].

PubMed

Terahara, A; Nakano, T; Tsujii, H

1998-01-01

Radiotherapy with heavy particles such as proton and heavy-charged particles is a promising modality for treatment of localized malignant tumors because of the good dose distribution. A dose calculation and radiotherapy planning system which is essential for this kind of treatment has been developed in recent years. It has the capability to compute the dose volume histogram (DVH) which contains dose-volume information for the target volume and other interesting volumes. Recently, DVH is commonly used to evaluate and compare dose distributions in radiotherapy with both photon and heavy particles, and it shows that a superior dose distribution is obtained in heavy particle radiotherapy. DVH is also utilized for the evaluation of dose distribution related to clinical outcomes. Besides models such as normal tissue complication probability (NTCP) and tumor control probability (TCP), which can be calculated from DVH are proposed by several authors, they are applied to evaluate dose distributions themselves and to evaluate them in relation to clinical results. DVH is now a useful and important tool, but further studies are needed to use DVH and these models practically for clinical evaluation of heavy-particle radiotherapy.

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients

PubMed Central

2012-01-01

Background Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. Method/design For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework. Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. Discussion The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making. PMID:23216708

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients.

PubMed

Fung, Colman S C; Chin, Weng Yee; Dai, Daisy S K; Kwok, Ruby L P; Tsui, Eva L H; Wan, Yuk Fai; Wong, Wendy; Wong, Carlos K H; Fong, Daniel Y T; Lam, Cindy L K

2012-12-05

Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework.Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making.

The impact of an interprofessional problem-based learning curriculum of clinical ethics on medical and nursing students' attitudes and ability of interprofessional collaboration: a pilot study.

PubMed

Lin, Yu-Chih; Chan, Te-Fu; Lai, Chung-Sheng; Chin, Chi-Chun; Chou, Fan-Hao; Lin, Hui-Ju

2013-09-01

Clinical ethic situations in modern multiprofessional healthcare systems may involve different healthcare professions who work together for patient care. The undergraduate interprofessional education of clinical ethics would help to incubate healthcare students' ability of interprofessional collaboration in solving ethical problems. However, the impact from an interprofessional educational model on student's attitudes and confidence of interprofessional collaboration should be carefully evaluated during the process of curricular development. This study aimed to conduct a pilot interprofessional PBL curriculum of clinical ethics and evaluate the curricular impact on interprofessional students' attitude and confidence of collaborative teamwork. Thirty-six medical and nursing students volunteered to participate in this study and were divided into three groups (medical group, nursing group, and mixed group). Tutors were recruited from the Medical School and the College of Nursing. The pilot curriculum included one lecture of clinical ethics, one PBL case study with two tutorial sessions, and one session of group discussion and feedback. A narrative story with multiple story lines and a multiperspective problem analysis tool were used in the PBL tutorials. The students' self-evaluation of learning questionnaire was used to evaluate students' learning of clinical ethics and interprofessional collaborative skills and attitude. The internal consistency of the questionnaire was measured by Cronbach α, and the criterion-related validity of the questionnaire was evaluated through associations between the dimension scores with the student group by one-way analysis of variance test (ANOVA) test and Tukey-Kramer honestly significant difference (HSD) comparison. There was significant difference among different groups in students' ability and attitudes about "interprofessional communication and collaboration" (p = 0.0184). The scores in the mixed group (37.58 ± 3.26) were higher than the medical group (32.10 ± 4.98). In conclusion, our model for the interprofessional PBL curriculum of clinical ethics is practicable and will produce positive impacts on students' attitudes and confidence of interprofessional collaboration. Copyright © 2013. Published by Elsevier B.V.

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.

Safety and Biocompatibility of a New High-Density Polyethylene-Based Spherical Integrated Porous Orbital Implant: An Experimental Study in Rabbits

PubMed Central

Fernandez-Bueno, Ivan; Di Lauro, Salvatore; Alvarez, Ivan; Lopez, Jose Carlos; Garcia-Gutierrez, Maria Teresa; Fernandez, Itziar; Larra, Eva; Pastor, Jose Carlos

2015-01-01

Purpose. To evaluate clinically and histologically the safety and biocompatibility of a new HDPE-based spherical porous orbital implants in rabbits. Methods. MEDPOR (Porex Surgical, Inc., Fairburn, GA, USA), OCULFIT I, and OCULFIT II (AJL Ophthalmic S.A., Vitoria, Spain) implants were implanted in eviscerated rabbis. Animals were randomly divided into 6 groups (n = 4 each) according to the 3 implant materials tested and 2 follow-up times of 90 or 180 days. Signs of regional pain and presence of eyelid swelling, conjunctival hyperemia, and amount of exudate were semiquantitatively evaluated. After animals sacrifice, the implants and surrounding ocular tissues were processed for histological staining and polarized light evaluation. Statistical study was performed by ANOVA and Kaplan-Meier analysis. Results. No statistically significant differences in regional pain, eyelid swelling, or conjunctival hyperemia were shown between implants and/or time points evaluated. However, amount of exudate differed, with OCULFIT I causing the smallest amount. No remarkable clinical complications were observed. Histological findings were similar in all three types of implants and agree with minor inflammatory response. Conclusions. OCULFIT ophthalmic tolerance and biocompatibility in rabbits were comparable to the clinically used MEDPOR. Clinical studies are needed to determine if OCULFIT is superior to the orbital implants commercially available. PMID:26689343

Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision.

PubMed

Vestergaard, Rikke Falsig; Søballe, Kjeld; Hasenkam, John Michael; Stilling, Maiken

2018-05-18

A small, but unstable, saw-gap may hinder bone-bridging and induce development of painful sternal dehiscence. We propose the use of Radiostereometric Analysis (RSA) for evaluation of sternal instability and present a method validation. Four bone analogs (phantoms) were sternotomized and tantalum beads were inserted in each half. The models were reunited with wire cerclage and placed in a radiolucent separation device. Stereoradiographs (n = 48) of the phantoms in 3 positions were recorded at 4 imposed separation points. The accuracy and precision was compared statistically and presented as translations along the 3 orthogonal axes. 7 sternotomized patients were evaluated for clinical RSA precision by double-examination stereoradiographs (n = 28). In the phantom study, we found no systematic error (p > 0.3) between the three phantom positions, and precision for evaluation of sternal separation was 0.02 mm. Phantom accuracy was mean 0.13 mm (SD 0.25). In the clinical study, we found a detection limit of 0.42 mm for sternal separation and of 2 mm for anterior-posterior dislocation of the sternal halves for the individual patient. RSA is a precise and low-dose image modality feasible for clinical evaluation of sternal stability in research. ClinicalTrials.gov Identifier: NCT02738437 , retrospectively registered.

Evaluating clinical librarian services: a systematic review.

PubMed

Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

2011-03-01

  Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

Assessing the effectiveness of strategies to implement clinical guidelines for the management of chronic diseases at primary care level in EU Member States: a systematic review.

PubMed

Brusamento, Serena; Legido-Quigley, Helena; Panteli, Dimitra; Turk, Eva; Knai, Cecile; Saliba, Vanessa; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

This review aimed to evaluate the effectiveness of strategies to implement clinical guidelines for chronic disease management in primary care in EU Member States. We conducted a systematic review of interventional studies assessing the implementation of clinical guidelines. We searched five databases (EMBASE, MEDLINE, CENTRAL, Eppi-Centre and Clinicaltrials.gov) following a strict Cochrane methodology. We included studies focusing on the management of chronic diseases in adults in primary care. A total of 21 studies were found. The implementation strategy was fully effective in only four (19%), partially effective in eight (38%), and not effective in nine (43%). The probability that an intervention would be effective was only slightly higher with multifaceted strategies, compared to single interventions. However, effect size varied across studies; therefore it was not possible to determine the most successful strategy. Only eight studies evaluated the impact on patients' health and only two of those showed significant improvement, while in five there was an improvement in the process of care which did not translate into an improvement in health outcomes. Only four studies reported any data on the cost of the implementation but none undertook a cost-effectiveness analysis. Only one study presented data on the barriers to the implementation of guidelines, noting a lack of awareness and agreement about clinical guidelines. Our results reveal that there are only a few rigorous studies which assess the effectiveness of a strategy to implement clinical guidelines in Europe. Moreover, the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation. Therefore, further research is needed to develop more rigorous studies to evaluate health outcomes associated with the implementation of clinical guidelines; to assess the cost-effectiveness of implementing clinical guidelines; and to investigate the perspective of service users and health service staff. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Cross-System Evaluation of Clinical Trial Search Engines

PubMed Central

Jiang, Silis Y.; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities. PMID:25954590

Cross-system evaluation of clinical trial search engines.

PubMed

Jiang, Silis Y; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

Model for teaching population health and community-based care across diverse clinical experiences.

PubMed

Van Dyk, Elizabeth J; Valentine-Maher, Sarah K; Tracy, Janet P

2015-02-01

The pillars constructivist model is designed to offer a unifying clinical paradigm to support consistent learning opportunities across diverse configurations of community and public health clinical sites. Thirty-six students and six faculty members participated in a mixed methods evaluation to assess the model after its inaugural semester of implementation. The evaluation methods included a rating scale that measures the model's ability to provide consistent learning opportunities at both population health and direct care sites, a case study to measure student growth within the five conceptual pillars, and a faculty focus group. Results revealed that the model served as an effective means of clinical education to support the use of multiple, small-scale public health sites. Although measurements of student growth within the pillars are inconclusive, the findings suggest efficacy. The authors recommend the continued use of the pillars constructivist model in baccalaureate programs, with further study of the author-designed evaluation tools. Copyright 2015, SLACK Incorporated.

Monoscopic versus stereoscopic photography in screening for clinically significant macular edema.

PubMed

Welty, Christopher J; Agarwal, Anita; Merin, Lawrence M; Chomsky, Amy

2006-01-01

The purpose of the study was to determine whether monoscopic photography could serve as an accurate tool when used to screen for clinically significant macular edema. In a masked randomized fashion, two readers evaluated monoscopic and stereoscopic retinal photographs of 100 eyes. The photographs were evaluated first individually for probable clinically significant macular edema based on the Early Treatment Diabetic Retinopathy Study criteria and then as stereoscopic pairs. Graders were evaluated for sensitivity and specificity individually and in combination. Individually, reader one had a sensitivity of 0.93 and a specificity of 0.77, and reader two had a sensitivity of 0.88 and a specificity of 0.94. In combination, the readers had a sensitivity of 0.91 and a specificity of 0.86. They correlated on 0.76 of the stereoscopic readings and 0.92 of the monoscopic readings. These results indicate that the use of monoscopic retinal photography may be an accurate screening tool for clinically significant macular edema.

Comparison of midwifery students' satisfaction with direct observation of procedural skills and current methods in evaluation of procedural skills in Mashhad Nursing and Midwifery School.

PubMed

Hoseini, Bibi Leila; Mazloum, Seyed Reza; Jafarnejad, Farzaneh; Foroughipour, Mohsen

2013-03-01

The clinical evaluation, as one of the most important elements in medical education, must measure students' competencies and abilities. The implementation of any assessment tool is basically dependent on the acceptance of students. This study tried to assess midwifery students' satisfaction with Direct Observation of Procedural Skills (DOPS) and current clinical evaluation methods. This quasi-experimental study was conducted in the university hospitals affiliated to Mashhad University of Medical Sciences. The subjects comprised 67 undergraduate midwifery students selected by convenience sampling and allocated to control and intervention groups according to the training transposition. Current method was performed in the control group, and DOPS was conducted in the intervention group. The applied tools included DOPS rating scales, logbook, and satisfaction questionnaires with clinical evaluation methods. Validity and reliability of these tools were approved. At the end of training, students' satisfaction with the evaluation methods was assessed by the mentioned tools. The data were analyzed by descriptive and analytical statistics. Satisfaction mean scores of midwifery students with DOPS and current methods were 76.7 ± 12.9 and 62.6 ± 14.7 (out of 100), respectively. DOPS students' satisfaction mean score was significantly higher than the score obtained in current method (P < 0.000). The most satisfactory domains in the current method were "consistence with learning objectives" (71.2 ± 14.9) and "objectiveness" in DOPS (87.9 ± 15.0). In contrast, the least satisfactory domains in the current method were "interested in applying the method" (57.8 ± 26.5) and "number of assessments for each skill" (58.8 ± 25.9) in DOPS method. This study showed that DOPS method is associated with greater students' satisfaction. Since the students' satisfaction with the current method was also acceptable, we recommend combining this new clinical evaluation method with the current method, which covers its weaknesses, to promote the students' satisfaction with clinical evaluation methods in a perfect manner.

Towards developing standard operating procedures for pre-clinical testing in the mdx mouse model of Duchenne muscular dystrophy

PubMed Central

Grounds, Miranda D.; Radley, Hannah G.; Lynch, Gordon S.; Nagaraju, Kanneboyina; De Luca, Annamaria

2008-01-01

This review discusses various issues to consider when developing standard operating procedures for pre-clinical studies in the mdx mouse model of Duchenne muscular dystrophy (DMD). The review describes and evaluates a wide range of techniques used to measure parameters of muscle pathology in mdx mice and identifies some basic techniques that might comprise standardised approaches for evaluation. While the central aim is to provide a basis for the development of standardised procedures to evaluate efficacy of a drug or a therapeutic strategy, a further aim is to gain insight into pathophysiological mechanisms in order to identify other therapeutic targets. The desired outcome is to enable easier and more rigorous comparison of pre-clinical data from different laboratories around the world, in order to accelerate identification of the best pre-clinical therapies in the mdx mouse that will fast-track translation into effective clinical treatments for DMD. PMID:18499465

A Functional Neuroimaging Study of the Clinical Reasoning of Medical Students

ERIC Educational Resources Information Center

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

2016-01-01

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.…

Staff Perspectives of Service User Involvement on Two Clinical Psychology Training Courses

ERIC Educational Resources Information Center

Clarke, Simon P.; Holttum, Sue

2013-01-01

This study investigated both negative and positive staff perspectives of service user involvement on two clinical psychology training courses as part of an ongoing process of service evaluation. Ten clinical psychology staff from two training courses were interviewed over the telephone by a current trainee clinical psychologist using a…

Quality assurance in ultrasound screening for hepatocellular carcinoma using a standardized phantom and standard clinical images: a 3-year national investigation in Korea.

PubMed

Choi, Joon-Il; Jung, Seung Eun; Kim, Pyo Nyun; Cha, Sang Hoon; Jun, Jae Kwan; Lee, Hoo-Yeon; Park, Eun-Cheol

2014-06-01

The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P < .001). Approximately 20% of US scanners failed the phantom image evaluation. The year of scanner manufacture was not significantly associated with the results of the phantom image evaluation. The quality of the clinical images obtained by radiologists was the best. © 2014 by the American Institute of Ultrasound in Medicine.

Assessment of metal artifact reduction methods in pelvic CT

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

Abdoli, Mehrsima; Mehranian, Abolfazl; Ailianou, Angeliki

2016-04-15

Purpose: Metal artifact reduction (MAR) produces images with improved quality potentially leading to confident and reliable clinical diagnosis and therapy planning. In this work, the authors evaluate the performance of five MAR techniques for the assessment of computed tomography images of patients with hip prostheses. Methods: Five MAR algorithms were evaluated using simulation and clinical studies. The algorithms included one-dimensional linear interpolation (LI) of the corrupted projection bins in the sinogram, two-dimensional interpolation (2D), a normalized metal artifact reduction (NMAR) technique, a metal deletion technique, and a maximum a posteriori completion (MAPC) approach. The algorithms were applied to ten simulatedmore » datasets as well as 30 clinical studies of patients with metallic hip implants. Qualitative evaluations were performed by two blinded experienced radiologists who ranked overall artifact severity and pelvic organ recognition for each algorithm by assigning scores from zero to five (zero indicating totally obscured organs with no structures identifiable and five indicating recognition with high confidence). Results: Simulation studies revealed that 2D, NMAR, and MAPC techniques performed almost equally well in all regions. LI falls behind the other approaches in terms of reducing dark streaking artifacts as well as preserving unaffected regions (p < 0.05). Visual assessment of clinical datasets revealed the superiority of NMAR and MAPC in the evaluated pelvic organs and in terms of overall image quality. Conclusions: Overall, all methods, except LI, performed equally well in artifact-free regions. Considering both clinical and simulation studies, 2D, NMAR, and MAPC seem to outperform the other techniques.« less

Process Evaluation of a Community Garden at an Urban Outpatient Clinic.

PubMed

Milliron, Brandy-Joe; Vitolins, Mara Z; Gamble, Elizabeth; Jones, Robert; Chenault, Margaret C; Tooze, Janet A

2017-08-01

In addition to expediting patient recovery, community gardens that are associated with medical facilities can provide fresh produce to patients and their families, serve as a platform for clinic-based nutrition education, and help patients develop new skills and insights that can lead to positive health behavior change. While community gardening is undergoing resurgence, there is a strong need for evaluation studies that employ valid and reliable measures. The objective of this study was to conduct a process evaluation of a community garden program at an urban medical clinic to estimate the prevalence of patient awareness and participation, food security, barriers to participation, and personal characteristics; garden volunteer satisfaction; and clinic staff perspectives in using the garden for patient education/treatment. Clinic patients (n = 411) completed a community garden participation screener and a random sample completed a longer evaluation survey (n = 152); garden volunteers and medical staff completed additional surveys. Among patients, 39% had heard of and 18% had received vegetables from the garden; the greatest barrier for participation was lack of awareness. Volunteers reported learning about gardening, feeling more involved in the neighborhood, and environmental concern; and medical staff endorsed the garden for patient education/treatment. Comprehensive process evaluations can be utilized to quantify benefits of community gardens in medical centers as well as to point out areas for further development, such as increasing patient awareness. As garden programming at medical centers is formalized, future research should include systematic evaluations to determine whether this unique component of the healthcare environment helps improve patient outcomes.

Experimental evaluation of clinical colon anastomotic leakage.

PubMed

Pommergaard, Hans-Christian

2014-03-01

Colorectal anastomotic leakage remains a frequent and serious complication in gastrointestinal surgery. Patient and procedure related risk factors for anastomotic leakage have been identified. However, the responsible pathophysiological mechanisms are still unknown. Among these, ischemia and insufficient surgical technique have been suggested to play a central role. Animal models are valuable means to evaluate pathophysiological mechanisms and may be used to test preventive measures aiming at reducing the risk of anastomotic leakage, such as external anastomotic coating. The aim of this thesis was to: Clarify the best suited animal to model clinical anastomotic leakage in humans; Create animal models mimicking anastomotic leakage in humans induced by insufficient surgical technique and tissue ischemia; Determine the best suited coating materials to prevent anastomotic leakage. This study is a systematic review using the databases MEDLINE and Rex. MEDLINE was searched up to October 2010 to identify studies on experimental animal models of clinical colon anastomotic leakage. From the Rex database, textbooks on surgical aspects as well as gastrointestinal physiology and anatomy of experimental animals were identified. The results indicated that the mouse and the pig are the best suited animals to evaluate clinical anastomotic leakage. However, the pig model is less validated and more costly to use compared with the mouse. Most frequently, rats are used as models. However, extreme interventions are needed to create clinical leakage in these animals. The knowledge from this study formed the basis for selecting the animal species most suited for the models in the next studies. STUDY 2: In this experimental study, technically insufficient colonic anastomoses were performed in 110 C57BL/6 mice. The number of sutures in the intervention group was reduced to produce a suitable leakage rate. Moreover, the analgesia and suture material were changed in order to optimize the model. In the final experiment, the four-suture anastomoses resulted in a 40% leakage rate in the intervention groups, whereas the eight-suture control anastomoses had a 0% leakage rate. Furthermore, the use of absorbable suture together with voluntarily ingested Temgesic in chocolate spread as analgesic regimen were feasible. This model may be used to test the leakage reducing potential of coating materials. STUDY 3: This experimental study used 53 C57BL/6 mice, in which sufficient eight-suture anastomoses were created. By using bipolar electro-cautery, blood supply was reduced in a stepwise manner to create anastomotic leakage as a result of ischemia. The study showed that reduced blood supply led to large bowel obstruction instead of clinical leakage. However, anastomotic breaking strength was reduced in the ischemic anastomoses. STUDY 4: In this systematic review MEDLINE, Embase and Cinahl were searched up to September 2011 to identify studies evaluating external coating of colonic anastomoses. Most studies were experimental, in which designs were not comparable and many results were contradictory. In a clinical study, a non-significant benefit of fibrin sealant was found. Based on the available clinical and experimental data it was concluded that the fibrin-based sealants, such as Tisseel and Tachosil, and polyethylene glycols may be beneficial. However, further experimental and clinical studies are needed before routine clinical use can be recommended. The studies in this thesis may be valuable for the experimental research field of clinical anastomotic leakage. The model of technical insufficiency has been improved and is now thoroughly validated. If used by researchers worldwide, comparison of results is possible. Pure ischemia/anoxia may be too simple an approach to create a clinical leakage model. Thus, future models could focus on multiple risk factors. Conclusively, large-scale clinical multicenter studies are needed to definitively evaluate whether coating of colorectal anastomoses may reduce the leakage rate.

Evaluating and improving recruitment and retention in an mHealth clinical trial: an example of iterating methods during a trial.

PubMed

Pfammatter, Angela Fidler; Mitsos, Alexa; Wang, Shirlene; Hood, Susan Hammett; Spring, Bonnie

2017-01-01

Recruitment and retention strategy investigations in mHealth clinical trials are rare. Technology presents an opportunity to intensely and remotely evaluate recruitment, use of mobile apps, and retention, leading to new insights for continuous improvement of mHealth trials. The objective of this paper is to present a case study in which a trial evaluated and changed strategies during a clinical trial to improve recruitment, adherence to study protocols, and retention in the mHealth trial. In Fall 2015, the NUYou trial enrolled 150 college freshmen in an mHealth protocol. Three months after study initiation, NUYou struggled to meet recruitment goals and maintain anticipated usage levels of the study smartphone application. Two sets of data were collected to improve recruitment and retention: a survey about recruitment was sent to the target population and surveys regarding usability of the app was sent to the study sample. Survey results informed improvements in recruitment strategies, the study retention protocol, and the smartphone application. Survey results revealed several insights including misunderstanding components of the trial by potential participants, low perceived usefulness of the app, and little recall or impact of the incentive structure. After implementation of user-centered improvements, the second cohort of NUYou recruitment in the fall of 2016 produced an equal sample size in 4 weeks less time. Winter quarter of 2016 compared to 2017 demonstrated an improvement in retention via app use and completion of weekly in-app surveys. Recruitment and retention in clinical trials continues to be a critical challenge and mHealth trials may present both unique challenges and opportunities. To our knowledge, this is the first study to describe a systematic evaluation followed by changes and further evaluation to recruitment, use of the mHealth application, adherence to study protocol, and retention during an mHealth clinical trial. Future work should adopt and explicitly study these processes to optimize both enrollment and retention in these types of trials to preserve validity and reliability of research results.

Curriculum gaps in teaching clinical skills to Iranian undergraduate medical students.

PubMed

Mirzazadeh, Azim; Bavarian, Behrouz; Labaf, Ali; Afshari, Ali; Nikoo, Mohammad; Meshkani, Zahra Sadat; Khashayar, Patricia

2013-04-20

The inefficacy of clinical skill education during the clerkship has been reported in several studies. The present study was conducted to evaluate the competency of medical students in performing several clinical skills through an Objective Structured Clinical Examination (OSCE), aiming to evaluate the quality of the existing curriculum in the clerkship phase. The cross sectional study was conducted at the end of the clerkship period, before the students had entered the internship. The OSCE exam was conducted in the morning (2 different tracts) and in the evening (2 similar tracts) and 86 students participated in the exam. Each tract consisted of seven stations. The students' points in the stations assessing history taking and clinical skills were compared. The students gained the highest points in the history taking stations, whereas the procedure stations accounted for the lowest points; there was a significant difference between these stations (p < 0.001). The female students achieved higher scores in the OSCE exam compared to males (p = 0.004). The OSCE exam revealed the inefficacy of the current medical curriculum in teaching the required clinical skill to undergraduate medical students during the clerkship.

Capacity of clinical pathways--a strategic multi-level evaluation tool.

PubMed

Cardoen, Brecht; Demeulemeester, Erik

2008-12-01

In this paper we strategically evaluate the efficiency of clinical pathways and their complex interdependencies with respect to joint resource usage and patient throughput. We propose a discrete-event simulation approach that allows for the simultaneous evaluation of multiple clinical pathways and the inherent uncertainty (resource, duration and arrival) that accompanies medical processes. Both the consultation suite and the surgery suite may be modeled and examined in detail by means of sensitivity or scenario analyses. Since each medical facility can somehow be represented as a combination of clinical pathways, i.e. they are conceptually similar, the simulation model is generic in nature. Next to the formulation of the model, we illustrate its applicability by means of a case study that was conducted in a Belgian hospital.

Electrophysiology of Cranial Nerve Testing: Spinal Accessory and Hypoglossal Nerves.

PubMed

Stino, Amro M; Smith, Benn E

2018-01-01

Multiple techniques have been developed for the electrodiagnostic evaluation of cranial nerves XI and XII. Each of these carries both benefits and limitations, with more techniques and data being available in the literature for spinal accessory than hypoglossal nerve evaluation. Spinal accessory and hypoglossal neuropathy are relatively uncommon cranial mononeuropathies that may be evaluated in the outpatient electrodiagnostic laboratory setting. A review of available literature using PubMed was conducted regarding electrodiagnostic technique in the evaluation of spinal accessory and hypoglossal nerves searching for both routine nerve conduction studies and repetitive nerve conduction studies. The review provided herein provides a resource by which clinical neurophysiologists may develop and implement clinical and research protocols for the evaluation of both of these lower cranial nerves in the outpatient setting.

Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies.

PubMed

Hulme, Paul A; Krebs, Jörg; Ferguson, Stephen J; Berlemann, Ulrich

2006-08-01

Systematic literature review. To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures. This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed. A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.

Clinical evaluation of two "packable" posterior composite resins.

PubMed

Lopes, L G; Cefaly, D F G; Franco, E B; Mondelli, R F L; Lauris, J R P; Navarro, M F L

2002-06-01

The purpose of this study was to evaluate the clinical performance of two "packable" posterior composites: Prodigy Condensable (P) (Kerr) and Definite (D) (Degussa). Thirty-six patients participated in the study. A total of 78 restorations were made, 40 with D and 38 with P. Each patient received at least two restorations, one of each studied material. The materials were handled according to the manufacturer's instructions. The restorations were finished and polished after 1 week. They were evaluated at baseline and after 1 year by two independent evaluators using the United States Public Health Service (USPHS) criteria. Colored slides were made of all the restorations. After 1 year, 35 patients and 76 restorations (39 with D and 37 with P) were available for evaluation. All restorations received A criteria except the following ones, which received B criteria: color P (one restoration) and D (one restoration), marginal staining P (three restorations) and D (two restorations), surface staining P (nine restorations) and D (three restorations), anatomic form P (one restoration) and D (three restorations), and marginal adaptation P (one restoration) and D (eight restorations). The obtained data were tabulated and statistically analyzed using the Fisher and McNemar tests. After 1 year, P showed a significant increase in superficial staining. For D, the marginal adaptation became significantly worse than baseline and P. The studied materials can be considered acceptable during this evaluation period. Further evaluations are necessary for a better clinical performance analysis.

A Study of the Competency of Third Year Medical Students to Interpret Biochemically Based Clinical Scenarios Using Knowledge and Skills Gained in Year 1 and 2

ERIC Educational Resources Information Center

Gowda, Veena Bhaskar S.; Nagaiah, Bhaskar Hebbani; Sengodan, Bharathi

2016-01-01

Medical students build clinical knowledge on the grounds of previously obtained basic knowledge. The study aimed to evaluate the competency of third year medical students to interpret biochemically based clinical scenarios using knowledge and skills gained during year 1 and 2 of undergraduate medical training. Study was conducted on year 3 MBBS…

Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice.

PubMed

Maignen, François; Osipenko, Leeza; Pinilla-Dominguez, Pilar; Crowe, Emily

2017-03-01

The primary objective of the study was to analyse the proposed clinical development and economic evaluation plans for investigational medicinal products for which pharmaceutical companies have sought health technology assessment (HTA) scientific advice (SA). We have selected and analysed all the scientific advice procedures undertaken by National Institute for Health and Care Excellence (NICE) SA between 1 January 2009 and 3 December 2015 for investigational medicinal products. We have mapped the questions asked by the companies and the areas of advice highlighted in the advice reports to the sections of the NICE methods guide to the technology appraisals (2013). An overwhelming proportion of SA procedures have addressed questions related to the clinical development and specifically the main pivotal efficacy studies. Approximately a quarter of the questions relate to the approaches to economic evaluation. Questions raised in European Medicines Agency-HTA procedures generally focus on clinical efficacy issues whereas cost-effectiveness ones tend to dominate in NICE-only procedures. Our analysis shows that the issues mostly discussed in the HTA SA are the choice of comparator, the generalisability of the clinical trial evidence to the NHS practice and the impact of the clinical trial outcomes on quality of life and survival. Less disagreement with the developers' plans was seen in the choice of clinical endpoints, population definition, position of the technology in the treatment pathway and study design. Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

Diagnosis of cystocele--the correlation between clinical and radiological evaluation.

PubMed

Altman, Daniel; Mellgren, Anders; Kierkegaard, Jonas; Zetterström, Jan; Falconer, Christian; López, Annika

2004-01-01

In patients with genital prolapse involving several compartments simultaneously, radiologic investigation can be used to complement the clinical assessment. Contrast medium in the urinary bladder enables visualization of the bladder base at cystodefecoperitoneography (CDP). The aim of the present study was to evaluate the correlation between clinical examination using the Pelvic Organ Prolapse Quantification system (POP-Q) and CDP. Thirty-three women underwent clinical assessment and CDP. Statistical analysis using Pearson's correlation coefficient ( r) demonstrated a wide variability between the current definition of cystocele at CDP and POP-Q ( r=0.67). An attempt to provide an alternative definition of cystocele at CDP had a similar outcome ( r=0.63). The present study demonstrates a moderate correlation between clinical and radiologic findings in patients with anterior vaginal wall prolapse. It does not support the use of bladder contrast at radiologic investigation in the routine preoperative assessment of patients with genital prolapse.

Healthcare students' experiences of an interprofessional, student-led neuro-rehabilitation community-based clinic.

PubMed

Gustafsson, Louise; Hutchinson, Laura; Theodoros, Deborah; Williams, Katrina; Copley, Anna; Fagan, Amy; Desha, Laura

2016-01-01

Student-led clinics are becoming more prominent as educators seek alternate models of clinical education for health professionals. The purpose of this study was to evaluate healthcare students' experiences of an interprofessional student-led clinic for clients with neurological conditions. Thirteen students representing occupational therapy, physiotherapy, and speech pathology were recruited for the study. A sequential mixed-methods evaluation was employed and the results from the Interprofessional Education Scale and focus group revealed that the students experienced positive perceptions of working collaboratively with other professions, forming good relationships with others, as well as an increased respect for the roles of other professions. The findings suggest that providing a capstone opportunity, where students can work as part of an interprofessional team with a real client, in a format they may come across in future clinical practice, may be beneficial in providing them with essential interprofessional skills as new graduate health professionals.

Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

PubMed

Dall'Oglio, Federica; Tedeschi, Aurora; Guardabasso, Vincenzo; Micali, Giuseppe

2015-09-01

To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

Reflective practice groups for nurses: a consultation liaison psychiatry nursing initiative: part 2--the evaluation.

PubMed

Dawber, Chris

2013-06-01

This paper outlines an evaluation of reflective practice groups (RPG) involving nurses and midwives from three clinical nursing specialties at Redcliffe and Caboolture Hospitals, Queensland, Australia. The groups were facilitated by the consultation liaison psychiatry nurse and author using a process-focused, whole-of-group approach to explore clinical narrative in a supportive group setting. This was a preliminary evaluation utilizing a recently-developed tool, the Clinical Supervision Evaluation Questionnaire, along with externally-facilitated focus groups. Nurses and midwives responded favourably to RPG, reporting a positive impact on clinical practice, self-awareness, and resilience. The majority of participants considered RPG had positive implications for team functioning. The focus groups identified the importance of facilitation style and the need to address aspects of workplace culture to enable group development and enhance the capacity for reflection. Evaluation of the data indicates this style of RPG can improve reflective thinking, promote team cohesion, and provide support for nurses and midwives working in clinical settings. Following on from this study, a second phase of research has commenced, providing more detailed, longitudinal evaluation across a larger, more diverse group of nurses. © 2012 The Author; International Journal of Mental Health Nursing © 2012 Australian College of Mental Health Nurses Inc.

Extracting important information from Chinese Operation Notes with natural language processing methods.

PubMed

Wang, Hui; Zhang, Weide; Zeng, Qiang; Li, Zuofeng; Feng, Kaiyan; Liu, Lei

2014-04-01

Extracting information from unstructured clinical narratives is valuable for many clinical applications. Although natural Language Processing (NLP) methods have been profoundly studied in electronic medical records (EMR), few studies have explored NLP in extracting information from Chinese clinical narratives. In this study, we report the development and evaluation of extracting tumor-related information from operation notes of hepatic carcinomas which were written in Chinese. Using 86 operation notes manually annotated by physicians as the training set, we explored both rule-based and supervised machine-learning approaches. Evaluating on unseen 29 operation notes, our best approach yielded 69.6% in precision, 58.3% in recall and 63.5% F-score. Copyright © 2014 Elsevier Inc. All rights reserved.

[Clinical data that are essential for the primary care clinical records: an experience of evaluation and improvement].

PubMed

López-Picazo Ferrer, J J; Agulló Roca, F; Villaescusa Pedemonte, M; Cerezo Corbalán, J M

2002-06-30

To evaluate and improve the presence of essential clinical data in the clinical records of a primary care management area (PCMA) by means of an intervention programme. Intervention study without a control, using evaluation and improvement-of-quality methods. We chose 4 criteria from the minimum technical standards: personal history (PH), family background (FB), allergies to medicines (AM) and list of problems (LP). We evaluated overall compliance and compliance per primary care team (PCT) through batch quality acceptance of samples (LQAS), designed an intervention to improve the situation, and then re-evaluated. PCMA of Murcia (45 PCTs). Participants. 42 PCTs (3 were excluded because they had poor coverage in their records). These lasted 12 months (October 1999-October 2000) and involved the following: graphic report per PCT; session with the PCT; discussion on results and strategies in the Area Management Council; and inclusion of an explicit objective, with incentives, in the management contracts. Significant improvement of the four criteria of the PCMA (improvements: FB, 48.1%; PH, 51.1%; AM, 55.4%; LP, 50.9%). LQAS analysis: we rejected 24 batches (14.3%) at the 1st evaluation and 15 (9.0%) at the second, with FB being the criterion most rejected in both instances. Defects appeared in 14 PCT (33.3%; 3 PCT accounted for 41.7%) at the 1st evaluation, and 7 PCT at the re-evaluation (16.7%; 2 reaching 46.7%). The presence of essential clinical data in clinical records has improved. LQAS proved to be a rapid and simple method for evaluating, improving and monitoring quality in primary care.

[Evaluation of preventive care in the dentistry department clinics of the University Cheikh Anta Diop in Dakar].

PubMed

Diouf, M; Faye, A; Cisse, D; Faye, D; Lo, C M M

2011-01-01

This was a cross-sectional study of 295 patients treated by dentistry students that aimed to evaluate the preventive care received by patients attending clinics of the dentistry department of the University Cheikh Anta Diop in Dakar. The sociodemographic characteristics of the patients, clinic specialty, patients' brushing technique and the other preventive care was recorded. The study sample comprised 48.5% men and 76.6% adults. Over 32% of the patients were from the conservative dentistry clinic. For 52.2% of the patients, no preventive action was provided. The use of visual aids when teaching oral hygen ne was observed for 17.4% of cases. Attitudes and practices of the dentistry students in relation to care require more vigilance and emphasis on prevention.

Correlation between clinical and histopathological diagnoses in periapical inflammatory lesions.

PubMed

Diegues, Liliane Lopes; Colombo Robazza, Carlos Roberto; Costa Hanemann, João Adolfo; Costa Pereira, Alessandro Antônio; Silva, Cléverson O

2011-08-01

  The purpose of the present study was to evaluate the correlation between clinical and histopathological diagnoses of periapical inflammatory lesions, focusing mainly on cystic conditions.   Files dating from 1998 to 2006 at the Oral Pathology Laboratory, School of Dentistry, Alfenas Federal University, Brazil, were reviewed to identify cases with histopathological diagnoses of periapical inflammatory lesions. A total of 1788 files were analyzed, and 255 cases were identified with clinical diagnoses of periapical inflammatory lesions.   The most prevalent clinical diagnosis was apical periodontal cyst (59%), followed by periapical granuloma (20%), and dentoalveolar abscess (2%). After histopathological analysis, 53% of the cases represented apical periodontal cyst, 42% periapical granuloma, and 5% dentoalveolar abscess.   The outcomes of the present study show a high prevalence of periapical cysts among periapical inflammatory lesions. Moreover, this study highlights the importance of histopathological evaluation for the correct diagnosis of periapical inflammatory lesions. © 2011 Blackwell Publishing Asia Pty Ltd.

The clinical development process for a novel preventive vaccine: An overview.

PubMed

Singh, K; Mehta, S

2016-01-01

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

Penile Fracture: Our Experience in a Tertiary Care Hospital.

PubMed

Mahapatra, Rajkumar Singha; Kundu, Anup Kumar; Pal, Dilip Kumar

2015-08-01

Penile fracture is rare, but it is a urological emergency that always requires immediate attention. Moreover, penile fracture has been reported more frequently in recent years. It may have devastating physical, functional, and psychological consequences if not properly managed in time. The objective of this study was to highlight the causes, clinical presentation, and outcomes of cases of penile fracture. This was a prospective observational study extending from November 2012 to November 2014. Each patient underwent a thorough clinical evaluation and received proper treatment. Twenty patients with penile fracture, aged 19 to 56 years (mean, 28 years) were evaluated in this study. Vaginal intercourse was the most common mechanism of injury. Most of the patients (95%) were diagnosed clinically with a proper history and clinical examination. Nineteen patients were treated surgically. The patients underwent six months of follow-up, and were evaluated with local examinations, questionnaires, and colour Doppler ultrasonography as necessary. Although penile fracture is an under-reported urological emergency, its incidence is increasing. It is usually diagnosed based on a clinical examination, but ultrasonography can be very helpful in diagnosis. Especially in cases where treatment is delayed, surgery is preferable to conservative management, because it is associated with better outcomes and fewer long-term complications.

Penile Fracture: Our Experience in a Tertiary Care Hospital

PubMed Central

Mahapatra, Rajkumar Singha; Kundu, Anup Kumar

2015-01-01

Purpose Penile fracture is rare, but it is a urological emergency that always requires immediate attention. Moreover, penile fracture has been reported more frequently in recent years. It may have devastating physical, functional, and psychological consequences if not properly managed in time. Materials and Methods The objective of this study was to highlight the causes, clinical presentation, and outcomes of cases of penile fracture. This was a prospective observational study extending from November 2012 to November 2014. Each patient underwent a thorough clinical evaluation and received proper treatment. Results Twenty patients with penile fracture, aged 19 to 56 years (mean, 28 years) were evaluated in this study. Vaginal intercourse was the most common mechanism of injury. Most of the patients (95%) were diagnosed clinically with a proper history and clinical examination. Nineteen patients were treated surgically. The patients underwent six months of follow-up, and were evaluated with local examinations, questionnaires, and colour Doppler ultrasonography as necessary. Conclusions Although penile fracture is an under-reported urological emergency, its incidence is increasing. It is usually diagnosed based on a clinical examination, but ultrasonography can be very helpful in diagnosis. Especially in cases where treatment is delayed, surgery is preferable to conservative management, because it is associated with better outcomes and fewer long-term complications. PMID:26331126

How does feedback from patients impact upon healthcare student clinical skill development and learning? A systematic review.

PubMed

Finch, Emma; Lethlean, Jennifer; Rose, Tanya; Fleming, Jennifer; Theodoros, Deborah; Cameron, Ashley; Coleman, Adele; Copland, David; McPhail, Steven M

2018-03-01

A key feature of health professionals' training, irrespective of discipline, is the acquisition and application of clinical and communication skills. Despite this, little is known about the potential role of patient feedback on this process. This systematic review aimed to answer the question: How does feedback from patients impact upon healthcare student clinical skill development and learning? Systematic review of published literature. Electronic databases were searched for studies that explored the effects of patient feedback on student learning and were published before March 2016. Eligible articles underwent methodological evaluation using the McMaster University Critical Evaluation Forms and data extraction. A total of 237 articles were retrieved following searches of electronic databases and hand searches of reference lists. Twelve (7 quantitative, 2 qualitative, 3 mixed methods) studies met the inclusion criteria. Eleven studies reported that patient feedback improved students' clinical skills. Minimal research has explored the impact of patient feedback on student learning. The research to date suggests that direct feedback from patients may be beneficial for the development of students' communication and clinical skills; however, the wide variety of evaluation methods and the lack of validated tools for patients to provide feedback suggest that further exploration is warranted.

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.

PubMed

Naci, Huseyin; Wouters, Olivier J; Gupta, Radhika; Ioannidis, John P A

2017-06-01

Policy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. Agents receiving accelerated approval are often tested concurrently in several therapeutic areas. For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies. There appears to be a tendency for therapeutic agents receiving accelerated approval to quickly become an integral component of standard treatment, despite potential shortcomings in their evidence base. Therapeutic agents treating serious conditions are eligible for Food and Drug Administration (FDA) accelerated approval. The clinical evidence accrued on agents receiving accelerated approval has not been systematically evaluated. Our objective was to assess the timing and characteristics of available studies. We first identified clinical studies of novel therapeutic agents receiving accelerated approval. We then (1) categorized those studies as randomized or nonrandomized, (2) explored whether they evaluated the FDA-approved indications, and (3) documented the available treatment comparisons. We also meta-analyzed the difference in start times between randomized studies that (1) did or did not evaluate approved indications and (2) were or were not designed to evaluate the agent's effectiveness. In total, 37 novel therapeutic agents received accelerated approval between 2000 and 2013. Our search of ClinicalTrials.gov identified 7,757 studies, which included 1,258,315 participants. Only one-third of identified studies were randomized controlled trials. Of 1,631 randomized trials with advanced recruitment status, 906 were conducted in therapeutic areas for which agents received initial accelerated approval, 202 were in supplemental indications, and 523 were outside approved indications. Only 411 out of 906 (45.4%) trials were designed to test the effectiveness of agents that received accelerated approval ("evaluation" trials); others used these agents as common background treatment in both arms ("background" trials). There was no detectable lag between average start times of trials conducted within and outside initially approved indications. Evaluation trials started on average 1.52 years (95% CI: 0.87 to 2.17) earlier than background trials. Cumulative evidence on agents with accelerated approvals has major limitations. Most clinical studies including these agents are small and nonrandomized, and about a third are conducted in unapproved areas, typically concurrently with those conducted in approved areas. Most randomized trials including these therapeutic agents are not designed to directly evaluate their clinical benefits but to incorporate them as standard treatment. © 2017 Milbank Memorial Fund.

Malformations of cortical development: clinical spectrum in a series of 101 patients and review of the literature (Part I).

PubMed

Güngör, Serdal; Yalnizoğlu, Dilek; Turanli, Güzide; Saatçi, Işil; Erdoğan-Bakar, Emel; Topçu, Meral

2007-01-01

Patients with malformations of cortical development (MCD) present with a wide spectrum of clinical manifestations ranging from asymptomatic cases to those with epilepsy and neurodevelopmental problems. Thorough clinical delineation of patients with MCD may provide clues for future phenotype-genotype correlation studies. We studied clinical features of patients with MCD, including developmental risk factors and family history. We evaluated 10 patients with MCD at Hacettepe University Children's Hospital, Department of Pediatric Neurology. All patients underwent neurological evaluation with detailed medical and family history, and neuropsychological evaluation. Routine EEG and MRI were obtained. The patients were between 1 month and 19 years of age (mean: 6.1 +/- 4.4 years). Fifty-four patients were diagnosed with polymicrogyria (PMG), 23 patients with lissencephaly, 12 patients with schizencephaly, and 12 patients with heterotopia. Parents were relatives in 31.7% of the cases; consanguinity was most common in patients with lissencephaly and other MCDs with diffuse/bilateral involvement. Initial clinical presentation was seizures in 61.4% of the cases, developmental delays in 12.9%, and microcephaly in 9.9%. Neurological evaluation revealed most severe abnormalities in patients with lissencephaly, and relatively better outcome in patients with heterotopias. Cognitive functions were better in patients with heterotopias compared to other groups. Overall, 71.3% of patients ha epilepsy. In conclusion, initial presentation and clinical course of patients with MCD are variable and seem to be correlated with the extent of cortical involvement. Epilepsy and mental retardation are the most common problems. The most severe clinical outcome was seen in patients with lissencephaly.

Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

PubMed Central

Pellicoro, C.; Marsella, R.; Ahrens, K.

2013-01-01

This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

[Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

PubMed

Fu, Yingkun; Xie, Yanming

2011-10-01

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

A clinical evaluation of mineral trioxide aggregate for root-end closure of non-vital immature permanent incisors in children-a pilot study.

PubMed

Sarris, Spyridoula; Tahmassebi, Jinous F; Duggal, Monty S; Cross, Ian A

2008-02-01

The aim of this pilot study was to evaluate the clinical efficacy of mineral trioxide aggregate (MTA) as an apexification material when used in non-vital immature permanent incisors in children. Fifteen children with a mean age of 11.7 years and 17 non-vital permanent incisors were ajudged suitable for inclusion. Standard endodontic procedures were followed and an apical plug of 3-4 mm was created by using MTA after a calcium hydroxide intracanal dressing had been applied for at least 1 week. Final obturation was completed by using thermoplastisized Gutta-Percha (Obtura II) at least 1 week following MTA placement. Subjects were reviewed clinically and radiographically at 3-month intervals. Mean follow-up time for MTA was 12.53 months (+/-2.94 SD). Of the total of 17 teeth treated, MTA placement was considered to be adequate in 13 teeth. The procedure showed clinical success in 94.1% of the cases, radiographic success was found to be 76.5% and in further three cases (17.6%) the outcome was considered to be uncertain. This is one of the very few studies that have reported the out coming of MTA as an apexification material in children with non-vital teeth and incomplete root development. However, larger clinical studies are required to evaluate the long-term success of this procedure.

The ART of Social Networking: How SART member clinics are connecting with patients online

PubMed Central

OMURTAG, Kenan; JIMENEZ, Patricia T.; RATTS, Valerie; ODEM, Randall; COOPER, Amber R.

2013-01-01

Objective To study and describe the use of social networking websites among SART member clinics Design Cross-sectional study Setting University Based Practice Patients Not Applicable Interventions Not Applicable Main Outcome Measure Prevalence of social networking websites among SART member clinics and evaluation of content, volume and location (i.e mandated state, region) using multivariate regression analysis Results 384 SART registered clinics and 1,382 social networking posts were evaluated. Of the clinics, 96% have a website and 30% link to a social networking website. The majority of clinics (89%) with social networking websites were affiliated with non-academic centers. Social networking posts mostly provide information (31%) and/or advertise (28%), while the remaining offer support (19%) or are irrelevant (17%) to the target audience. Only 5% of posts involved patients requesting information. Clinic volume correlates with the presence of a clinic website and a social networking website (p<0.001). Conclusion Almost all SART member clinics have a website. Nearly one-third of these clinics host a social networking website like Facebook, Twitter and/or a Web-log (“blog”). Larger volume clinics commonly host social networking websites. These sites provide new ways to communicate with patients, but clinics should maintain policies on the incorporation of social networks into practice. PMID:22088209

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Evaluation of a New Grading System for Clinical Skills in Dental Student Clinics.

PubMed

Bodenmann, Aurel D; Bühler, Julia M; Amato, Mauro; Weiger, Ronald; Zitzmann, Nicola U

2017-05-01

Several evaluation systems for clinical exams have been suggested over the years, but no systematic analysis of checklists or criteria-based exam forms has yet been undertaken. The aims of this study were to analyze criteria-based evaluation forms and to identify areas in the teaching process potentially requiring improvements. All evaluation forms introduced in 2012 at the Clinic for Periodontology, Endodontology, and Cariology at the University Center of Dental Medicine in Basel, Switzerland, and applied over a three-year period (n=1,093 in 2015) were analyzed using predefined criteria. The authors investigated how well clinical tasks were examined with the given criteria and which criteria were preferably evaluated with a grading system (0-2) or a yes/no choice. The average final grades ranged from 0.89 (n=92) for gold inlay preparation to 1.76 (n=46) for periodontal treatment. Comments were made in 38.5% (n=356) of all exams, mainly highlighting specific aspects of existing criteria. Overall, 13 criteria out of 66 should be checked instead of graded. This methodological analysis of exam forms assessing tasks in operative dentistry yielded valuable information on areas with potential for improvement in the dental curriculum and the evaluation process. Aspects that require more theoretical background and/or hands-on recommendations from experienced clinicians were identified, and ways of further refining and redesigning the evaluation forms were proposed.

Clinical Fit of Partial Removable Dental Prostheses Based on Alginate or Polyvinyl Siloxane Impressions.

PubMed

Fokkinga, Wietske A; Witter, Dick J; Bronkhorst, Ewald M; Creugers, Nico H

The aim of this study was to analyze the clinical fit of metal-frame partial removable dental prostheses (PRDPs) based on custom trays used with alginate or polyvinyl siloxane impression material. Fifth-year students of the Nijmegen Dental School made 25 correct impressions for 23 PRDPs for 21 patients using alginate, and 31 correct impressions for 30 PRDPs for 28 patients using polyvinyl siloxane. Clinical fit of the framework as a whole and of each retainer separately were evaluated by calibrated supervisors during framework try-in before (first evaluation) and after (second evaluation) possible adjustments (score 0 = poor fit, up to score 3 = good fit). Framework fit and fit of the denture base were evaluated at delivery (third evaluation). Finally, postinsertion sessions were evaluated and total number of sessions needed, sore spots, adjustments to the denture base, and reported food-impaction were recorded. No significant differences in clinical fit (of the framework as a whole, for the retainers, or for the denture base) were found between the groups in the three evaluation sessions. Differences were not found for postinsertion sessions with one exception: in the alginate group, four subjects reported food impaction, versus none in the polyvinyl siloxane group. Clinical fit of metal-frame PRDPs based on impressions with custom trays combined with alginate or polyvinyl siloxane was similar.

Psychometric Evaluation of Children with Auditory Processing Disorder (APD): Comparison with Normal-Hearing and Clinical Non-APD Groups

ERIC Educational Resources Information Center

Iliadou, Vasiliki; Bamiou, Doris Eva

2012-01-01

Purpose: To investigate the clinical utility of the Children's Auditory Processing Performance Scale (CHAPPS; Smoski, Brunt, & Tannahill, 1992) to evaluate listening ability in 12-year-old children referred for auditory processing assessment. Method: This was a prospective case control study of 97 children (age range = 11;4 [years;months] to…

The Use of Videotape Recordings to Teach Clinical Skills (Evaluation and Remediation) In the Fields of Communicative Disorders.

ERIC Educational Resources Information Center

Billeaud, Frances P.

A study was undertaken to evaluate the benefits derived by speech and language pathology students who used video tape recordings to learn diagnosis of communication disorders, to observe professional therapists and therapy programs, and to improve their own clinical techniques through self-observation. The use of video tapes to teach clinical…

Decoding Skills Acquired by Low Readers Taught in Regular Classrooms Using Clinical Techniques. Research Report No. 35.

ERIC Educational Resources Information Center

Gallistel, Elizabeth; Fischer, Phyllis

This study evaluated the decoding skills acquired by low readers in an experimental project that taught low readers in regular class through the use of clinical procedures based on a synthetic phonic, multisensory approach. An evaluation instrument which permitted the tabulation of specific decoding skills was administered as a pretest and…

Pulsed Nd:YAG laser selective ablation of surface enamel caries: II. Histology and clinical trials

NASA Astrophysics Data System (ADS)

Harris, David M.; Goodis, Harold E.; White, Joel M.; Arcoria, Charles J.; Simon, James; Burkart, John; Yessik, Michael J.; Myers, Terry D.

2000-03-01

High intensity infrared light from the pulsed Nd:YAG dental laser is absorbed by pigmented carious enamel and not absorbed by normal enamel. Therefore, this system is capable of selective removal of surface enamel caries. Safety and efficacy of the clinical procedure was evaluated in two sets of clinical trials at three dental schools. Carious lesions were randomized to drill or laser treatment. Pulp vitality, surface condition, preparations and restorations were evaluated by blinded evaluators. In Study 1 surface caries were removed from 104 third molars scheduled for extraction. One week post-treatment teeth were extracted and the pulp was examined histologically. In Study 2 90 patients with 422 lesions on 376 teeth were randomized to laser or drill and followed for six months. There were no adverse events and both clinical and histological evaluations of pulp vitality showed no abnormalities. Caries were removed in all conditions. A significantly greater number of preparations in the drill groups vs. laser groups entered dentin (drill equals 11, laser equals 1, p less than 0.001). This indicates that the more conservative laser treatment removed the caries but not the sound enamel below the lesion.

Evaluation of diabetes care management in primary clinics based on the guidelines of American Diabetes Association.

PubMed

Albarrak, Ahmed Ismail; Mohammed, Rafiuddin; Assery, Bushra; Allam, Dalya; Morit, Sarah Al; Saleh, Reem Al; Zare'a, Reem

2018-01-01

There is a rapid increase in the incidence of diabetes mellitus in Saudi Arabia. Diabetes management is an essential constituent to prevent prognosis of diabetes complications. The main objective of this study was to assess diabetes care in primary clinics based on the guidelines of American Diabetes Association (ADA). A retrospective study at King Khaled University Hospitals, Riyadh, Saudi Arabia. A total of 200 patients were randomly selected from the databases of primary care clinics. An evaluation checklist was created based on the ADA treatment guidelines such as medical history, physical examination, laboratory evaluation, and referrals. The result showed that elements achieving the ADA targets for overall care were medical history (44.9%), physical examination (59.6%), laboratory evaluation (36.3%), and referrals (19.3%). The other subelement indicators such as referral to diabetes self-management education clinics (10%), dental examination (2%), HbA1c regular monitoring (33.5%), and blood pressure determination (100%) were documented with adherence to ADA standards. Diabetes management standards are an essential element in the success of the management plan. Most of the elements examined are not in full compliance with the ADA standard. Continues monitoring and self-review are recommended.

Specialized inpatient treatment of adult anorexia nervosa: effectiveness and clinical significance of changes.

PubMed

Schlegl, Sandra; Quadflieg, Norbert; Löwe, Bernd; Cuntz, Ulrich; Voderholzer, Ulrich

2014-09-06

Previous studies have predominantly evaluated the effectiveness of inpatient treatment for anorexia nervosa at the group level. The aim of this study was to evaluate treatment outcomes at an individual level based on the clinical significance of improvement. Patients' treatment outcomes were classified into four groups: deteriorated, unchanged, reliably improved and clinically significantly improved. Furthermore, the study set out to explore predictors of clinically significant changes in eating disorder psychopathology. A total of 435 inpatients were assessed at admission and at discharge on the following measures: body-mass-index, eating disorder symptoms, general psychopathology, depression and motivation for change. 20.0-32.0% of patients showed reliable changes and 34.1-55.3% showed clinically significant changes in the various outcome measures. Between 23.0% and 34.5% remained unchanged and between 1.7% and 3.0% deteriorated. Motivation for change and depressive symptoms were identified as positive predictors of clinically significant changes in eating disorder psychopathology, whereas body dissatisfaction, impulse regulation, social insecurity and education were negative predictors. Despite high rates of reliable and clinically significant changes following intensive inpatient treatment, about one third of anorexia nervosa patients showed no significant response to treatment. Future studies should focus on the identification of non-responders as well as on the development of treatment strategies for these patients.

Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel.

PubMed

Graham, Stephen M; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E; Gale, Marianne; Gie, Robert P; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J; McNeeley, David F; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R; Swaminathan, Soumya; Wingfield, Claire

2012-05-15

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology

PubMed Central

Ryan, Michael C.; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C.; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R.V. Paul; Chiang, Michael F.

2014-01-01

Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis. PMID:25954463

Cost-effectiveness analysis of a postoperative clinical care pathway in head and neck surgery with microvascular reconstruction.

PubMed

Dautremont, Jonathan F; Rudmik, Luke R; Yeung, Justin; Asante, Tiffany; Nakoneshny, Steve C; Hoy, Monica; Lui, Amanda; Chandarana, Shamir P; Matthews, Thomas W; Schrag, Christiaan; Dort, Joseph C

2013-12-19

The objective of this study is to evaluate the cost-effectiveness of a postoperative clinical care pathway for patients undergoing major head and neck oncologic surgery with microvascular reconstruction. This is a comparative trial of a prospective treatment group managed on a postoperative clinical care pathway and a historical group managed prior to pathway implementation. Effectiveness outcomes evaluated were total hospital days, return to OR, readmission to ICU and rate of pulmonary complications. Costing perspective was from the government payer. 118 patients were included in the study. All outcomes demonstrated that the postoperative pathway group was both more effective and less costly, and is therefore a dominant clinical intervention. The overall mean pre- and post-pathway costs are $22,733 and $16,564 per patient, respectively. The incremental cost reduction associated with the postoperative pathway was $6,169 per patient. Implementing the postoperative clinical care pathway in patients undergoing head and neck oncologic surgery with reconstruction resulted in improved clinical outcomes and reduced costs.

The development, implementation and evaluation of clinical practice guidelines in Gulf Cooperation Council (GCC) countries: a systematic review of literature.

PubMed

Koornneef, Erik; Robben, Paul; Hajat, Cother; Ali, Azhar

2015-12-01

Our aim was to examine and describe the current situation in Gulf Cooperation Council (GCC) member countries regarding the development, implementation and evaluation of clinical practice guidelines (CPG). The objectives were to describe from where the studies originated, what the clinical focus was of each study and examine the methodology and the status of each study (i.e. development, dissemination, implementation and evaluation). Review of literature - two stages: stage 1: screening through an abstract review, followed by independent adjudicator; stage 2: detailed assessment and classification. Considering the widespread acceptance that CPG's are useful and effective tools for quality improvement in health care, it is worth noting that relatively few studies have been conducted in the GCC region that examine CPG. Furthermore, the reviewers found that the quality of the research methods used could be improved. The majority of the studies that were conducted evaluated the effects of guidelines and focused on the 'lifestyle diseases', in particular diabetes and cardiovascular diseases. It is also worth noting that there has been a steady increase in the number of publications over the 10 years period. More attention needs to be given to developing, disseminating, implementing and evaluating CPG's in the GCC region in order to improve the quality and safety of health care. © 2015 John Wiley & Sons, Ltd.

Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

PubMed

Sowinski, Joseph A; Kakar, Ashish; Kakar, Kanupriya

2013-05-01

To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

PubMed

McNally, Dayre; Amrein, Karin; O'Hearn, Katharine; Fergusson, Dean; Geier, Pavel; Henderson, Matt; Khamessan, Ali; Lawson, Margaret L; McIntyre, Lauralyn; Redpath, Stephanie; Weiler, Hope A; Menon, Kusum

2017-01-01

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD. The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding). Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to rapidly and safely normalize vitamin D levels in critically ill children. Study findings will be used to inform the design of a multicenter phase III trial evaluating the clinical and economic benefits to rapid normalization. Recruitment for this trial was initiated in January 2016 and is expected to continue until November 30, 2017. Clinicaltrials.gov NCT02452762.

Determinants and effects of medical students’ core self-evaluation tendencies on clinical competence and workplace well-being in clerkship

PubMed Central

Lin, Yung Kai

2017-01-01

Core self-evaluation (CSE) is a personality trait that involves a person’s evaluation of his or her own worth, competence, and capability. The objective of this study was to determine whether medical students’ CSEs exert beneficial effects on their adaptation to their clerkship in terms of their clinical competence and workplace well-being and whether their preclinical academic performance can be a trait-relevant situation that enhances their CSE expression. In total, 127 medical students from 2 cohorts were included as participants in this study. We analyzed complete measures of personal background, objective and subjective preclinical academic performance (course evaluation grades and self-reported efficacy), CSE tendencies, and clinical competence (as objective structured clinical examination scores) and workplace well-being (as compassion satisfaction and burnout) during their 2-year clerkship. Mixed linear models for repeated measures and multiple regressions were employed. Participants’ CSE tendencies had positive effects on their workplace compassion satisfaction and burnout but not on their clinical competence during their clerkship. Additionally, using the objective and subjective preclinical academic performance of the medical students as indicators, we observed that neither could be trait-relevant situations to enhance their CSE expression. CSE personality tendencies might be key to medical students’ ability to noncognitively adapt to clinical training during their clerkships. These tendencies should be identified earlier so that mentors can provide prompt care and support to mentees (medical students) during clerkships. PMID:29186158

Determinants and effects of medical students' core self-evaluation tendencies on clinical competence and workplace well-being in clerkship.

PubMed

Lin, Yung Kai; Chen, Der-Yuan; Lin, Blossom Yen-Ju

2017-01-01

Core self-evaluation (CSE) is a personality trait that involves a person's evaluation of his or her own worth, competence, and capability. The objective of this study was to determine whether medical students' CSEs exert beneficial effects on their adaptation to their clerkship in terms of their clinical competence and workplace well-being and whether their preclinical academic performance can be a trait-relevant situation that enhances their CSE expression. In total, 127 medical students from 2 cohorts were included as participants in this study. We analyzed complete measures of personal background, objective and subjective preclinical academic performance (course evaluation grades and self-reported efficacy), CSE tendencies, and clinical competence (as objective structured clinical examination scores) and workplace well-being (as compassion satisfaction and burnout) during their 2-year clerkship. Mixed linear models for repeated measures and multiple regressions were employed. Participants' CSE tendencies had positive effects on their workplace compassion satisfaction and burnout but not on their clinical competence during their clerkship. Additionally, using the objective and subjective preclinical academic performance of the medical students as indicators, we observed that neither could be trait-relevant situations to enhance their CSE expression. CSE personality tendencies might be key to medical students' ability to noncognitively adapt to clinical training during their clerkships. These tendencies should be identified earlier so that mentors can provide prompt care and support to mentees (medical students) during clerkships.

An evaluation of the role of the clinical education facilitator.

PubMed

McCormack, Brendan; Slater, Paul

2006-02-01

The objective of the study was to identify whether clinical education facilitators made a difference to the learning experiences of nurses in a large teaching hospital. Strategies for enabling continuous professional development are well established in health care organizations as key components of approaches to lifelong learning. The benefits of continuous professional development include the maintenance of high standards of care, the improvement and development of services, ensuring the competency of all nursing staff and guaranteeing the accountability of nurses for their actions. The role of clinical education facilitator is relatively new and little evaluation of this role has been undertaken. This study highlights important issues to be considered in developing a 'learning culture' in a hospital organization, through the adoption of such roles as clinical education facilitators. Whilst the roles have had an important function in the active coordination of learning activities in the hospital, there is little evidence of the role directly impacting on the learning culture of clinical settings. Learning mechanisms have been identified. The results of this evaluation can be subjected to further testing through ongoing evaluation of the outcomes arising from the learning mechanisms in place. Given the emphasis on work-based learning and continuing professional development in health care, then this ongoing evaluation can yield important information about future directions for nurse education. The study highlights the importance of supported learning in the workplace. However, more importantly, it identifies the need for a culture of professional practice to be developed in order to sustain learning in practice. Classroom-based learning alone, cannot create a culture of development in nursing and there is thus a need for models of work-based learning to be integrated into practice environments.

Formulation, in-vitro characterization and clinical evaluation of curcumin in-situ gel for treatment of periodontitis.

PubMed

Nasra, Maha M A; Khiri, Heba M; Hazzah, Heba A; Abdallah, Ossama Y

2017-11-01

This study aimed to develop syringeable in-situ curcumin (cur) gel for the treatment of periodontal pockets as well as to evaluate the clinical efficacy of Cur in-situ gel formulation. Different in-situ gel formulations of Cur were prepared using 30% of pluronic F127, and 1% of carbopol P934. The formulations were evaluated regarding gelation temperature, pH, viscosity, syringeability study, in-vitro release and chemical stability of cur. The effect of aging of gel formulations for 3months in refrigerator was investigated. The selected formulation was clinically evaluated through the determination of probing depth, plaque index, and bleeding index at baseline and 1 month after application. The formulations showed accepted gelation temperature ranging from 28 to 34 °C and all had pH value of 4. The viscosity of the formulations at 4 °C ranged from 19 000 to 37 000 cP. All formulations were easily syringeable through 21 gauge needle at cold temperature. Curcumin stability during the release study was maintained. Aging showed no significant effect on release profile, drug content, or the pH after 3 months, while it showed a slight increase in viscosity with concomitant decrease in gelation temperature. Selected formulations delivered into periodontal pocket evaluated clinically showed to be effective. The treated group revealed that the adjunctive use of intracrevicular 2% curcumin in-situ gel adjunct to mechanical treatment in patients with adult periodontitis could aid in significant clinical reduction of probing depth, bleeding index, and to less extent of plaque. This indicates that curcumin in this novel drug delivery system is an excellent candidate for periodontal disease treatment.

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

PubMed

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

2016-01-14

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

The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

PubMed

Fleeman, N; McLeod, C; Bagust, A; Beale, S; Boland, A; Dundar, Y; Jorgensen, A; Payne, K; Pirmohamed, M; Pushpakom, S; Walley, T; de Warren-Penny, P; Dickson, R

2010-01-01

To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources. The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members. A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out. For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing. Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

Translational phases of evidence in a prognostic biomarker: a systematic review and meta-analysis of natriuretic peptides and the prognosis of stable coronary disease.

PubMed

Sutaria, Shailen; Philipson, Peter; Fitzpatrick, Natalie K; Abrams, Keith; Moreno, Santiago G; Timmis, Adam; Hingorani, Aroon D; Hemingway, Harry

2012-04-01

Translational phases of study are important in evaluating whether a prognostic biomarker is likely to have impact on clinical practice but systematic evaluations of such evidence are lacking. To systematically evaluate the clinical usefulness of the published literature on the association of natriuretic peptides (NP) and prognosis in stable coronary disease. MEDLINE and EMBASE until the end of July 2009, without restrictions. Prospective studies measuring NP in people with stable coronary disease who were followed-up for all cause mortality, coronary or cardiovascular events. Two independent reviewers categorised studies according to the American Heart Association phase of study, and extracted data according to the study reporting guidelines from the American Heart Association and REMARK. Systematic review of 19 studies found 17 which were phase 2, reporting an association between NP and events, two phase 3 studies, statistically examining the incremental prognostic value of NP, but no studies assessing whether NP predicted risk sufficiently to change management (phase 4), improve clinical outcomes (phase 5) or cost effectiveness (phase 6). No study referred to a statistical analytic protocol. Meta-analysis of 14 studies, reporting 18,841 patients and 1655 outcome events, found an RR for events of 3.28 (95% CI 2.45 to 4.38) comparing top versus bottom third of NP. This effect was 26% lower among the five studies which adjusted for a priori confounders (age, sex, renal function and left ventricular function) and 38% lower when adjusting for publication bias (Egger's p=0.001). The unbiased strength of association of NP with prognosis in stable coronary disease is unclear, and there is a lack of reports of clinically useful measures of prediction and discrimination or studies relating NP levels to clinical decision making. The available literature is confined to early phases and is of limited clinical usefulness.

How to measure kyphosis in everyday clinical practice: a reliability study on different methods.

PubMed

Zaina, Fabio; Donzelli, Sabrina; Lusini, Monia; Negrini, Stefano

2012-01-01

The sagittal plane measures have a relevant role both in Idiopathic Scoliosis (AIS) and in Hyperkyphosis (HK) management. Nevertheless, clinical tools for everyday use are scarce and not adequately studied. To assess the repeatability of different methods for the collection of the sagittal profile of patients with spinal deformities during everyday clinics. We performed 4 different studies in 4 different populations of AIS and HK patients. In the first study we reported the normative data and measurement error of the plumbline measures in a general population of 180 adolescents. In the second study we compared the sagittal distances from the plumbline of C7, T12, L3, and Sagittal Index (SI = C7+L3) with the measures of the Video Rasterstereography at the same levels and the angles of kyphosis and lordosis in 100 AIS patients. In the third study we evaluated the intra and inter-rater repeatability and the measurement error of kyphosis and lordosis angles measured with the Inclimed in 100 AIS patients. In the last study we evaluated the repeatability of the sagittal distances from the plumbline, by using a 1 mm change instead of 5 mm in a population of 40 patients. repeatability has been evaluated according to Bland and Altman, to identify the limits of variation that are clinically significant. Results. Study 1: the normative data were: females: 34 ± 11 mm for C7; 34 ± 15 mm for L3, males: 34 ± 10 mm for C7; 48 ± 10 mm for L3;. Study 2: a coefficient of correlation was calculated in order to compare measures. Study 3: the k value for Inclimed varied from fair to good. Study 4: the repeatability was fair for this measure. Some clinical instruments are now available for sagittal plane assessment in AIS and hyperkyphosis. The results of the present study report the limits during measurements in a clinical setting of parameters that are routinely collected by some clinicians.

Metabolism and catabolism in hip fracture patients: nutritional and anabolic intervention--a review.

PubMed

Hedström, Margareta; Ljungqvist, Olle; Cederholm, Tommy

2006-10-01

Patients suffering from hip fracture are known to be at risk of catabolism and protein-energy malnutrition. In this review we discuss the pathogenesis of hip fracture-related catabolism per- and postoperatively. We also describe the consequences of malnutrition after a hip fracture and summarize studies that have evaluated the effect of nutritional or anabolic treatment of these patients. There has been relatively little published on the effects of nutritional and anabolic pharmacological interventions for improvement of nutritional status and on the role of nutritional status in clinical outcomes. Even so, there have been 19 randomized studies in this field. 12 studies evaluated nutritional supplementation or protein supplementation. 6 found improved clinical outcome with fewer complications, faster recovery and shorter length of hospital stay, whereas the others reported no difference in clinical outcome. For pharmacological interventions, the outcomes have been even less clear. Supplementation studies in general appear to be underpowered or suffer logistic problems. Studies of higher scientific quality are needed, and enteral feeding, anabolic treatment and multimodal approaches need to be evaluated in greater depth.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Usefulness of myocardial parametric imaging to evaluate myocardial viability in experimental and in clinical studies.

PubMed

Korosoglou, G; Hansen, A; Bekeredjian, R; Filusch, A; Hardt, S; Wolf, D; Schellberg, D; Katus, H A; Kuecherer, H

2006-03-01

To evaluate whether myocardial parametric imaging (MPI) is superior to visual assessment for the evaluation of myocardial viability. Myocardial contrast echocardiography (MCE) was assessed in 11 pigs before, during, and after left anterior descending coronary artery occlusion and in 32 patients with ischaemic heart disease by using intravenous SonoVue administration. In experimental studies perfusion defect area assessment by MPI was compared with visually guided perfusion defect planimetry. Histological assessment of necrotic tissue was the standard reference. In clinical studies viability was assessed on a segmental level by (1) visual analysis of myocardial opacification; (2) quantitative estimation of myocardial blood flow in regions of interest; and (3) MPI. Functional recovery between three and six months after revascularisation was the standard reference. In experimental studies, compared with visually guided perfusion defect planimetry, planimetric assessment of infarct size by MPI correlated more significantly with histology (r2 = 0.92 versus r2 = 0.56) and had a lower intraobserver variability (4% v 15%, p < 0.05). In clinical studies, MPI had higher specificity (66% v 43%, p < 0.05) than visual MCE and good accuracy (81%) for viability detection. It was less time consuming (3.4 (1.6) v 9.2 (2.4) minutes per image, p < 0.05) than quantitative blood flow estimation by regions of interest and increased the agreement between observers interpreting myocardial perfusion (kappa = 0.87 v kappa = 0.75, p < 0.05). MPI is useful for the evaluation of myocardial viability both in animals and in patients. It is less time consuming than quantification analysis by regions of interest and less observer dependent than visual analysis. Thus, strategies incorporating this technique may be valuable for the evaluation of myocardial viability in clinical routine.

Rehabilitation technologies and interventions for individuals with spinal cord injury: translational potential of current trends.

PubMed

Musselman, Kristin E; Shah, Meeral; Zariffa, José

2018-05-16

In the past, neurorehabilitation for individuals with neurological damage, such as spinal cord injury (SCI), was focused on learning compensatory movements to regain function. Presently, the focus of neurorehabilitation has shifted to functional neurorecovery, or the restoration of function through repetitive movement training of the affected limbs. Technologies, such as robotic devices and electrical stimulation, are being developed to facilitate repetitive motor training; however, their implementation into mainstream clinical practice has not been realized. In this commentary, we examined how current SCI rehabilitation research aligns with the potential for clinical implementation. We completed an environmental scan of studies in progress that investigate a physical intervention promoting functional neurorecovery. We identified emerging interventions among the SCI population, and evaluated the strengths and gaps of the current direction of SCI rehabilitation research. Seventy-three study postings were retrieved through website and database searching. Study objectives, outcome measures, participant characteristics and the mode(s) of intervention being studied were extracted from the postings. The FAME (Feasibility, Appropriateness, Meaningfulness, Effectiveness, Economic Evidence) Framework was used to evaluate the strengths and gaps of the research with respect to likelihood of clinical implementation. Strengths included aspects of Feasibility, as the research was practical, aspects of Appropriateness as the research aligned with current scientific literature on motor learning, and Effectiveness, as all trials aimed to evaluate the effect of an intervention on a clinical outcome. Aspects of Feasibility were also identified as a gap; with two thirds of the studies examining emerging technologies, the likelihood of successful clinical implementation was questionable. As the interventions being studied may not align with the preferences of clinicians and priorities of patients, the Appropriateness of these interventions for the current health care environment was questioned. Meaningfulness and Economic Evidence were also identified as gaps since few studies included measures reflecting the perceptions of the participants or economic factors, respectively. The identified gaps will likely impede the clinical uptake of many of the interventions currently being studied. Future research may lessen these gaps through a staged approach to the consideration of the FAME elements as novel interventions and technologies are developed, evaluated and implemented.

Brachial Plexus Injuries in Adults: Evaluation and Diagnostic Approach

PubMed Central

Sakellariou, Vasileios I.; Badilas, Nikolaos K.; Mazis, George A.; Stavropoulos, Nikolaos A.; Kotoulas, Helias K.; Kyriakopoulos, Stamatios; Tagkalegkas, Ioannis; Sofianos, Ioannis P.

2014-01-01

The increased incidence of motor vehicle accidents during the past century has been associated with a significant increase in brachial plexus injuries. New imaging studies are currently available for the evaluation of brachial plexus injuries. Myelography, CT myelography, and magnetic resonance imaging (MRI) are indicated in the evaluation of brachial plexus. Moreover, a series of specialized electrodiagnostic and nerve conduction studies in association with the clinical findings during the neurologic examination can provide information regarding the location of the lesion, the severity of trauma, and expected clinical outcome. Improvements in diagnostic approaches and microsurgical techniques have dramatically changed the prognosis and functional outcome of these types of injuries. PMID:24967130

Are We Using Slow-Acting Symptomatic Chondroprotective Drugs Conscious Enough?

PubMed

Gumustas, Seyit Ali; Oznam, Kadir; Mutlu, Cagri Ata; Kaya, Yasin Emre; Yilmaz, Ibrahim; Isyar, Mehmet; Guzelant, Aliye Yıldırım; Guler, Olcay; Akkaya, Semih; Mahirogullari, Mahir

2017-01-01

Osteochondral injuries constitute an entity that is widespread and can be seen in patients of all ages. Actual treatment modalities aim to relieve pain, obtain full range of movement of the joint, and improve the quality of life. There are many slow-acting chondroprotective agents prevalently used in the United States that are classified as nutritional support but not as medicines . This study presents the importance of clinical adverse effect profiles as well as the pharmacological mechanism of action and application of combinations of drugs that are widely prescribed and not subjected to control. Electronic databases were searched with keywords about the chondroprotective drugs without any language restriction. Evaluations of the descriptive statistics were represented via Microsoft Office Excel 2010 lists in the form of a mean±standard deviation or frequency (%). The first evaluation showed that 1502 studies were potentially relevant. Following exclusion of the 1277 studies which were not clinical, full versions of the remaining 225 studies were subjected to further evaluation. No controlled, blinded, randomized and/or comparative studies met the inclusion criteria of the study, and no studies evaluated the comparative clinical results of the hyaluronan of different molecular weights. The findings of this study concluded that especially when prescribing drugs with ingredients like GS and CS, many patients' pre-existing conditions must be considered, such as whether the patient has a glucose intolerance or not. Additionally, mineral toxication should be considered since the drugs contain minerals, and after the application of injected hyaluronan, complications should be considered. Clinical, controlled and comparative studies about the use of chondroprotective drugs must be performed to define the benefits of these drugs, if any, in order to determine the most suitable time for operative intervention.

Development of the e-Baby serious game with regard to the evaluation of oxygenation in preterm babies: contributions of the emotional design.

PubMed

Fonseca, Luciana Mara Monti; Dias, Danielle Monteiro Vilela; Góes, Fernanda Dos Santos Nogueira; Seixas, Carlos Alberto; Scochi, Carmen Gracinda Silvan; Martins, José Carlos Amado; Rodrigues, Manuel Alves

2014-09-01

The present study aimed to describe the development process of a serious game that enables users to evaluate the respiratory process in a preterm infant based on an emotional design model. The e-Baby serious game was built to feature the simulated environment of an incubator, in which the user performs a clinical evaluation of the respiratory process in a virtual preterm infant. The user learns about the preterm baby's history, chooses the tools for the clinical evaluation, evaluates the baby, and determines whether his/her evaluation is appropriate. The e-Baby game presents phases that contain respiratory process impairments of higher or lower complexity in the virtual preterm baby. Included links give the user the option of recording the entire evaluation procedure and sharing his/her performance on a social network. e-Baby integrates a Clinical Evaluation of the Preterm Baby course in the Moodle virtual environment. This game, which evaluates the respiratory process in preterm infants, could support a more flexible, attractive, and interactive teaching and learning process that includes simulations with features very similar to neonatal unit realities, thus allowing more appropriate training for clinical oxygenation evaluations in at-risk preterm infants. e-Baby allows advanced user-technology-educational interactions because it requires active participation in the process and is emotionally integrated.

Effectiveness of a Simulated Clinical Examination in the Assessment of the Clinical Competencies of Entry-Level Trainees in a Family Medicine Residency Programme

ERIC Educational Resources Information Center

Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge

2012-01-01

Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…

Clinical evaluation of an innovative operative procedure in the treatment of the tethered cord syndrome.

PubMed

Hou, Yang; Sun, Jingchuan; Shi, Jiangang; Guo, Yongfei; Wang, Yuan; Shi, Guodong; Xu, Guohua

2018-06-01

The tethered cord syndrome (TCS) characterized by urination dysfunction has long been a worldwide clinical problem, of which clinical effects remains controversial. The objective of this study was to evaluate the clinical effects of an innovative surgical method for the treatment of TCS. This is a retrospective clinical study. There were 15 patients included in this study. The visual analog scale (VAS) and the Japanese Orthopaedic Association (JOA) scores were evaluated. The incidence of complications after surgery was also analyzed. A total of 15 patients including 9 men and 6 women with TCS underwent homogeneous spinal-shortening axial decompression (HSAD) from September 2011 to February 2015. The average age at the time of surgery was 38.1±17.7 years. The average postoperative follow-up period was 21.5±7.5 months. The VAS and JOA scores were used to evaluate the clinical effects of the new operational procedure. In addition, the incidence of complications was also recorded and analyzed. The VAS scores decreased from 3.93±2.52 to 1.80±1.21 at the final follow-up after surgery with a significant statistical difference (p=.006). The JOA scores also significantly increased from 9.93±3.43 to 21.20±4.18 at the final follow-up (p<.001). Fourteen cases (93.3%) with bladder dysfunction and 7 cases with sensory dysfunction of the lower limbs (87.5%) had a significant improvement postoperatively. Complications such as infection, pulmonary embolism, nerve injury, and broken rod were not observed during the follow-up period. The operation of HSAD was an effective and safe surgical method for TCS, which can achieve direct decompression of the tethered spinal cord. Copyright © 2017. Published by Elsevier Inc.

Prospective evaluation of surgical management of sliding hiatal hernia and gastroesophageal reflux in dogs.

PubMed

Mayhew, Philipp D; Marks, Stanley L; Pollard, Rachel; Culp, William T N; Kass, Philip H

2017-11-01

To evaluate response to surgical management of sliding hiatal hernia (SHH) and gastroesophageal reflux (GER) in dogs using standardized clinical scoring, videofluoroscopic swallow studies, and impedance planimetry. Prospective clinical trial. A total of 17 client-owned dogs. Dogs were included if they had clinical signs and videofluoroscopic evidence of SHH and/or GER. Owners were asked to complete a standardized canine dysphagia assessment tool (CDAT) preoperatively and postoperatively. Conscious videofluoroscopic swallowing studies and impedance planimetry (IP) were used to evaluate esophageal function and lower esophageal sphincter location and geometry preoperatively and in a subsection of dogs postoperatively. Preoperatively, 13/17 dogs included in the study had a history of regurgitation, and 4/17 had radiographic evidence of aspiration pneumonia. Postprandial regurgitation improved in 8/10 dogs with preoperative regurgitation, and for which completed preoperative and postoperative CDAT questionnaires were available (P < .01). The hiatal hernia severity score improved postoperatively (P = .046) in dogs with preoperative and postoperative videofluoroscopic swallowing studies (n = 12). However, hernia frequency score (P = .2) and IP parameters did not differ significantly between time points. Clinical signs of SHH generally improved with surgery but did not consistently resolve. Videofluoroscopic studies provide evidence that GER and SHH can persist postoperatively in some patients. Based on IP findings, clinical improvement may be attributed to a mechanism independent of lower esophageal sphincter attenuation. © 2017 The American College of Veterinary Surgeons.

In Vitro and Clinical Evaluations of the Drug-Drug Interaction Potential of a Metabotropic Glutamate 2/3 Receptor Agonist Prodrug with Intestinal Peptide Transporter 1

PubMed Central

Long, Amanda J.; Annes, William F.; Witcher, Jennifer W.; Knadler, Mary Pat; Ayan-Oshodi, Mosun A.; Mitchell, Malcolm I.; Leese, Phillip; Hillgren, Kathleen M.

2017-01-01

Despite peptide transporter 1 (PEPT1) being responsible for the bioavailability for a variety of drugs, there has been little study of its potential involvement in drug-drug interactions. Pomaglumetad methionil, a metabotropic glutamate 2/3 receptor agonist prodrug, utilizes PEPT1 to enhance absorption and bioavailability. In vitro studies were conducted to guide the decision to conduct a clinical drug interaction study and to inform the clinical study design. In vitro investigations determined the prodrug (LY2140023 monohydrate) is a substrate of PEPT1 with Km value of approximately 30 µM, whereas the active moiety (LY404039) is not a PEPT1 substrate. In addition, among the eight known PEPT1 substrates evaluated in vitro, valacyclovir was the most potent inhibitor (IC50 = 0.46 mM) of PEPT1-mediated uptake of the prodrug. Therefore, a clinical drug interaction study was conducted to evaluate the potential interaction between the prodrug and valacyclovir in healthy subjects. No effect of coadministration was observed on the pharmacokinetics of the prodrug, valacyclovir, or either of their active moieties. Although in vitro studies showed potential for the prodrug and valacyclovir interaction via PEPT1, an in vivo study showed no interaction between these two drugs. PEPT1 does not appear to easily saturate because of its high capacity and expression in the intestine. Thus, a clinical interaction at PEPT1 is unlikely even with a compound with high affinity for the transporter. PMID:27895114

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

PubMed Central

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

2012-01-01

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

Clinical Evaluation of Indirect Particle-Filled Composite Resin CAD/CAM Partial Crowns after 24 Months.

PubMed

Zimmermann, Moritz; Koller, Christina; Reymus, Marcel; Mehl, Albert; Hickel, Reinhard

2017-04-19

Resin-based CAD/CAM compound materials might be promising for single-tooth restorations. Insufficient clinical data are available for this new material class. The purpose of this study was to describe initial clinical in vivo results for indirect particle-filled composite resin CAD/CAM restorations after 24 months. Indirect particle-filled composite resin restorations were fabricated with a CAD/CAM method (CEREC Bluecam intraoral scanner, CEREC MCXL milling unit) by calibrated dental students. Forty-two partial crown restorations were seated adhesively in 30 patients with caries lesions or insufficient restorations (baseline). Strict inclusion criteria were defined for the patient collective. Follow-up evaluation comprised 40 restorations after 12 months and 33 restorations after 24 months. Evaluation criteria were modified FDI criteria with grades (1) to (5). Rating with FDI criteria (5) was defined as clinical failure. Statistical analysis was performed with Wilcoxon-Test (p < 0.05). The success rate of indirect particle-filled composite resin CAD/CAM restorations after 12 months was 95.0% with two debondings observed. The cumulative success rate for indirect particle-filled composite resin CAD/CAM restorations after 24 months was 85.7% with two tooth fractures and one debonding. Statistically significant differences were found for baseline and 24-month follow-up evaluation for anatomic form and marginal adaptation criterion examined in respect to FDI criteria guidelines (Wilcoxon-Test, p < 0.05). This study demonstrates particle-filled composite resin CAD/CAM restorations having a clinical success rate of 85.7% after 24 months. Adhesive bonding procedures need to be ensured carefully. A longer clinical evaluation period is necessary to draw further conclusions. © 2017 by the American College of Prosthodontists.

Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

PubMed

Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

2016-05-01

Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An average of 5 emails (0-11) per patient were sent to the laboratory technicians to communicate the improvisation the CAD design of the dentures. An average of 3.3 denture adjustments were needed after insertion (0-10) during the 1-year period. For patient-centered outcomes, median ratings of all 14 participants indicated each of the 12 studied outcomes was favorable at the 1-year recall. Statistically significant improvements in patient ratings from baseline to 1 year were observed for the absence of denture sore spots and treatment time to make the dentures (P<.05). Minor complications related to loss of retention, excessive wear of teeth and the need for additional visits were observed in 5 participants. No other adverse clinical outcomes related to the CAD/CAM dentures were noted in the 14 evaluated participants, and all dentures were intact and in good condition at the 1-year follow-up. Clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated using a 2-visit protocol were evaluated favorably at a 1-year follow-up. However, the proportion of excellent and good ratings for overall satisfaction and assessment was higher for patients than clinicians. A considerable amount of the clinician's time and effort was devoted to aiding in the digital process for the fabrication of CAD/CAM dentures. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Validation of assessment of intraoral digital photography for evaluation of dental restorations in clinical research.

PubMed

Signori, Cácia; Collares, Kauê; Cumerlato, Catarina B F; Correa, Marcos B; Opdam, Niek J M; Cenci, Maximiliano S

2018-04-01

The aim of this study was to investigate the validity of assessment of intraoral digital photography in the evaluation of dental restorations. Intraoral photographs of anterior and posterior restorations were classified based on FDI criteria according to the need for intervention: no intervention, repair and replacement. Evaluations were performed by an experienced expert in restorative dentistry (gold standard evaluator) and 3 trained dentists (consensus). The clinical inspection was the reference standard method. The prevalence of failures was explored. Cohen's kappa statistic was used. Validity was accessed by sensitivity, specificity, likelihood ratio and predictives values. Higher prevalence of failed restorations intervention was identified by the intraoral photography (17.7%) in comparison to the clinical evaluation (14.1%). Moderate agreement in the diagnosis of total failures was shown between the methods for the gold standard evaluator (kappa = 0.51) and consensus of evaluators (kappa = 0.53). Gold standard evaluator and consensus showed substantial and moderate agreement for posterior restorations (kappa = 0.61; 0.59), and fair and moderate agreement for anterior restorations (kappa = 0.36; 0.43), respectively. The accuracy was 84.8% in the assessment by intraoral photographs. Sensitivity and specificity values of 87.5% and 89.3% were found. Under the limits of this study, the assessment of digital photography performed by intraoral camera is an indirect diagnostic method valid for the evaluation of dental restorations, mainly in posterior teeth. This method should be employed taking into account the higher detection of defects provided by the images, which are not always clinically relevant. Copyright © 2018 Elsevier Ltd. All rights reserved.

Concise Review: Endothelial Progenitor Cells in Regenerative Medicine: Applications and Challenges

PubMed Central

Chong, Mark Seow Khoon; Ng, Wei Kai

2016-01-01

Endothelial progenitor cells (EPCs) are currently being studied as candidate cell sources for revascularization strategies. Significant advances have been made in understanding the biology of EPCs, and preclinical studies have demonstrated the vasculogenic, angiogenic, and beneficial paracrine effects of transplanted EPCs in the treatment of ischemic diseases. Despite these promising results, widespread clinical acceptance of EPCs for clinical therapies remains hampered by several challenges. The present study provides a concise summary of the different EPC populations being studied for ischemic therapies and their known roles in the healing of ischemic tissues. The challenges and issues surrounding the use of EPCs and the current strategies being developed to improve the harvest efficiency and functionality of EPCs for application in regenerative medicine are discussed. Significance Endothelial progenitor cells (EPCs) have immense clinical value for cardiovascular therapies. The present study provides a concise description of the EPC subpopulations being evaluated for clinical applications. The current major lines of investigation involving preclinical and clinical evaluations of EPCs are discussed, and significant gaps limiting the translation of EPCs are highlighted. The present report could be useful for clinicians and clinical researchers with interests in ischemic therapy and for basic scientists working in the related fields of tissue engineering and regenerative medicine. PMID:26956207

Students' approaches to learning in a clinical practicum: A psychometric evaluation based on item response theory.

PubMed

Zhao, Yue; Kuan, Hoi Kei; Chung, Joyce O K; Chan, Cecilia K Y; Li, William H C

2018-07-01

The investigation of learning approaches in the clinical workplace context has remained an under-researched area. Despite the validation of learning approach instruments and their applications in various clinical contexts, little is known about the extent to which an individual item, that reflects a specific learning strategy and motive, effectively contributes to characterizing students' learning approaches. This study aimed to measure nursing students' approaches to learning in a clinical practicum using the Approaches to Learning at Work Questionnaire (ALWQ). Survey research design was used in the study. A sample of year 3 nursing students (n = 208) who undertook a 6-week clinical practicum course participated in the study. Factor analyses were conducted, followed by an item response theory analysis, including model assumption evaluation (unidimensionality and local independence), item calibration and goodness-of-fit assessment. Two subscales, deep and surface, were derived. Findings suggested that: (a) items measuring the deep motive from intrinsic interest and deep strategies of relating new ideas to similar situations, and that of concept mapping served as the strongest discriminating indicators; (b) the surface strategy of memorizing facts and details without an overall picture exhibited the highest discriminating power among all surface items; and, (c) both subscales appeared to be informative in assessing a broad range of the corresponding latent trait. The 21-item ALWQ derived from this study presented an efficient, internally consistent and precise measure. Findings provided a useful psychometric evaluation of the ALWQ in the clinical practicum context, added evidence to the utility of the ALWQ for nursing education practice and research, and echoed the discussions from previous studies on the role of the contextual factors in influencing student choices of different learning strategies. They provided insights for clinical educators to measure nursing students' approaches to learning and facilitate their learning in the clinical practicum setting. Copyright © 2018. Published by Elsevier Ltd.

Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

PubMed

Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

2015-03-01

Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Health benefits and health claims of probiotics: bridging science and marketing.

PubMed

Rijkers, Ger T; de Vos, Willem M; Brummer, Robert-Jan; Morelli, Lorenzo; Corthier, Gerard; Marteau, Philippe

2011-11-01

Health claims for probiotics are evaluated by the Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority. Despite a substantial amount of basic and clinical research on the beneficial effects of probiotics, all of the evaluated claim applications thus far have received a negative opinion. With the restrictions on the use of clinical endpoints, validated biomarkers for gut health and immune health in relation to reduction in disease risk are needed. Clear-cut criteria for design as well as evaluation of future studies are needed. An open dialogue between basic and clinical scientists, regulatory authorities, food and nutrition industry, and consumers could bridge the gap between science and marketing of probiotics.

Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

PubMed

Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

2016-08-01

This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients. Copyright © 2016. Published by Elsevier B.V.

Systematic Review of Economic Evaluations of Units Dedicated to Acute Coronary Syndromes.

PubMed

Azeredo-Da-Silva, André Luis Ferreira; Perini, Silvana; Rigotti Soares, Pedro Henrique; Polaczyk, Carisi Anne

2016-01-01

Dedicated units for the care of acute coronary syndrome (ACS) have been submitted to economic evaluations; however, the results have not been systematically presented. To identify and summarize economic outcomes of studies on hospital units dedicated to the initial care of patients with suspected or confirmed ACS. A systematic review of literature to identify economic evaluations of chest pain unit (CPU), coronary care unit (CCU), or equivalent units was done. Two search strategies were used: the first one to identify economic evaluations irrespective of study design, and the second one to identify randomized clinical trials that reported economic outcomes. The following databases were searched: MEDLINE, EMBASE, CENTRAL, and National Health Service (NHS)Economic Evaluation Database. Data extraction was performed by two independent reviewers. Costs were inflated to 2012 values. Search strategies retrieved five partial economic evaluations based on observational studies, six randomized clinical trials that reported economic outcomes, and five model-based economic evaluations. Overall, cost estimates based on observational studies and randomized clinical trials reported statistically significant cost savings of more than 50% with the adoption of CPU care instead of routine hospitalization or CCU care for suspected low-to-intermediate risk patients with ACS (median per-patient cost US $1,969.89; range US $1,002.12-13,799.15). Model-based economic evaluations reported incremental cost-effectiveness ratios below US $ 50,000/quality-adjusted life-year for all comparisons between intermediate care unit, CPU, or CCU with routine hospital admissions. This finding was sensible to myocardial infarction probability. Published economic evaluations indicate that more intensive care is likely to be cost-effective in comparison to routine hospital admission for patients with suspected ACS. Copyright © 2016. Published by Elsevier Inc.

Can the Liebowitz Social Anxiety Scale - self-report version be used to differentiate clinical and non-clinical SAD groups among Brazilians?

PubMed

Santos, Larissa F; Loureiro, Sonia R; Crippa, José A S; Osório, Flávia L

2015-01-01

The Liebowitz Social Anxiety Scale (LSAS) was the first evaluation instrument developed for screening for the signs and symptoms of Social Anxiety Disorder (SAD) and is currently still the most used worldwide. The aim of this study is to evaluate the ability of the LSAS - self-report version (LSAS-SR) to discriminate different Social Anxiety Disorder (SAD) clinical groups. The sample was composed of Brazilians university students, allocated into three different groups, i.e., cases (C=118), non-cases (NC=95) and subclinical cases (SC=39). To achieve the aim, calculations of the ROC Curve and ANOVA were performed. The results found were excellent regardless of the technique used, highlighting the discriminatory capacity of the LSAS-SR. The score equal to or greater than 32 is suggested as a cutoff score for the Brazilian population, since this presented balance between the standards evaluated and the ability to differentiate both clinical and subclinical SAD cases from non-cases. Despite the specific sample used in this study being composed only of university students, the use of the LSAS-SR can be indicated, in the Brazilian setting, for SAD screening in both clinical and research contexts.

A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.

PubMed

Khanna, Reena; Bouguen, Guillaume; Feagan, Brian G; DʼHaens, Geert; Sandborn, William J; Dubcenco, Elena; Baker, K Adam; Levesque, Barrett G

2014-10-01

Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.

A framework for evaluating the appropriateness of clinical decision support alerts and responses

PubMed Central

Waitman, Lemuel R; Lewis, Julia B; Wright, Julie A; Choma, David P; Miller, Randolph A; Peterson, Josh F

2011-01-01

Objective Alerting systems, a type of clinical decision support, are increasingly prevalent in healthcare, yet few studies have concurrently measured the appropriateness of alerts with provider responses to alerts. Recent reports of suboptimal alert system design and implementation highlight the need for better evaluation to inform future designs. The authors present a comprehensive framework for evaluating the clinical appropriateness of synchronous, interruptive medication safety alerts. Methods Through literature review and iterative testing, metrics were developed that describe successes, justifiable overrides, provider non-adherence, and unintended adverse consequences of clinical decision support alerts. The framework was validated by applying it to a medication alerting system for patients with acute kidney injury (AKI). Results Through expert review, the framework assesses each alert episode for appropriateness of the alert display and the necessity and urgency of a clinical response. Primary outcomes of the framework include the false positive alert rate, alert override rate, provider non-adherence rate, and rate of provider response appropriateness. Application of the framework to evaluate an existing AKI medication alerting system provided a more complete understanding of the process outcomes measured in the AKI medication alerting system. The authors confirmed that previous alerts and provider responses were most often appropriate. Conclusion The new evaluation model offers a potentially effective method for assessing the clinical appropriateness of synchronous interruptive medication alerts prior to evaluating patient outcomes in a comparative trial. More work can determine the generalizability of the framework for use in other settings and other alert types. PMID:21849334

Family Medicine Residents' Performance with Detected Versus Undetected Simulated Patients Posing as Problem Drinkers.

PubMed

Kahan, Meldon; Liu, Eleanor; Borsoi, Diane; Wilson, Lynn; Brewster, Joan M; Sobell, Mark B; Sobell, Linda C

2004-12-01

Simulated patients are commonly used to evaluate medical trainees. Unannounced simulated patients provide an accurate measure of physician performance. To determine the effects of detection of SPs on physician performance, and identify factors leading to detection. Fixty-six family medicine residents were each visited by two unannounced simulated patients presenting with alcohol-induced hypertension or insomnia. Residents were then surveyed on their detection of SPs. SPs were detected on 45 out of 104 visits. Inner city clinics had higher detection rates than middle class clinics. Residents' checklist and global rating scores were substantially higher on detected than undetected visits, for both between-subject and within-subject comparisons. The most common reasons for detection concerned SP demographics and behaviour; the SP "did not act like a drinker" and was of a different social class than the typical clinic patient. Multi-clinic studies involving residents experienced with SPs should ensure that the SP role and behavior conform to physician expectations and the demographics of the clinic. SP station testing does not accurately reflect physicians' actual clinical behavior and should not be relied on as the primary method of evaluation. The study also suggests that physicians' poor performance in identifying and managing alcohol problems is not entirely due to lack of skill, as they demonstrated greater clinical skills when they became aware that they were being evaluated. Physicians' clinical priorities, sense of responsibility and other attitudinal determinants of their behavior should be addressed when training physicians on the management of alcohol problems.

[Quantitative Prediction of Drug-Drug Interaction Caused by CYP Inhibition and Induction from In Vivo Data and Its Application in Daily Clinical Practices-Proposal for the Pharmacokinetic Interaction Significance Classification System (PISCS)].

PubMed

Ohno, Yoshiyuki

2018-01-01

　Drug-drug interactions (DDIs) can affect the clearance of various drugs from the body; however, these effects are difficult to sufficiently evaluate in clinical studies. This article outlines our approach to improving methods for evaluating and providing drug information relative to the effects of DDIs. In a previous study, total exposure changes to many substrate drugs of CYP caused by the co-administration of inhibitor or inducer drugs were successfully predicted using in vivo data. There are two parameters for the prediction: the contribution ratio of the enzyme to oral clearance for substrates (CR), and either the inhibition ratio for inhibitors (IR) or the increase in clearance of substrates produced by induction (IC). To apply these predictions in daily pharmacotherapy, the clinical significance of any pharmacokinetic changes must be carefully evaluated. We constructed a pharmacokinetic interaction significance classification system (PISCS) in which the clinical significance of DDIs was considered in a systematic manner, according to pharmacokinetic changes. The PISCS suggests that many current 'alert' classifications are potentially inappropriate, especially for drug combinations in which pharmacokinetics have not yet been evaluated. It is expected that PISCS would contribute to constructing a reliable system to alert pharmacists, physicians and consumers of a broad range of pharmacokinetic DDIs in order to more safely manage daily clinical practices.

Factors influencing emergency medicine physicians' management of sports-related concussions: a community-wide study.

PubMed

Giebel, Stephen; Kothari, Rashmi; Koestner, Amy; Mohney, Gretchen; Baker, Robert

2011-12-01

Numerous guidelines to grade and manage sports-related concussions have been published. However, little is known about how frequently they are implemented in the emergency department. This study evaluates the current practices of emergency physicians (EPs) in managing sports-related concussions. To evaluate the current practice of EP evaluation and management of sports-related concussions. All EPs and emergency medicine residents in Kalamazoo County were surveyed regarding their management of sports-related concussions. The surveys obtained demographic data, participants' use of guidelines, and the importance of clinical and non-clinical factors in deciding when to allow a player to return to play. Of the 73 EP respondents, only 23% used a nationally recognized guideline, with no significant difference between attending and resident EPs. The symptomatic complaints of loss of consciousness, amnesia of the event, and difficulty concentrating were ranked most important by EPs in assessing patients with sports-related concussions. Among non-clinical factors, residents were significantly more likely than attendings to report that medical-legal, parental, and players' concerns were more likely to influence their decision in allowing a patient to return to play. EPs take into consideration important clinical factors in assessing patients with sports-related concussion. However, almost 75% do not use any nationally recognized guideline in their evaluation. Residents are more likely than attendings to be influenced by non-clinical factors. Copyright © 2011 Elsevier Inc. All rights reserved.

Implementing novel imaging methods for improved diagnosis of disorder of consciousness patients.

PubMed

Bick, Atira S; Leker, Ronen R; Ben-Hur, Tamir; Levin, Netta

2013-11-15

The clinical evaluation of consciousness in disorder of consciousness (DOC) patients based on their exhibited behavior is difficult and remains erroneous in many cases. Recent studies demonstrated different levels of stimulus processing as well as evidence of some level of awareness in sub-groups of these patients. The aim of the current study was to examine the plausibility and challenges of implementing a clinical service for evaluation of consciousness level in DOC patients. Eleven Patients (ages 11-67) diagnosed as being in vegetative or minimal conscious states were included. Functional MRI evaluations included auditory, language, voice familiarity, imagery, and visual tests. In 9 patients auditory-related activation was found, however only in 5 of the subjects was differential activation found for language. Six patients exhibited differential response to their own name. In three patients a response to visual stimuli was identified. In one patient the auditory and linguistic systems were clearly activated in a hierarchical pattern, and moreover willful modulation of brain activity was identified in the imagery test. We discuss the importance of using a wide battery of tests, the difference between our clinical cohort and previous publications, as well as the challenges of clinically implementing this method. Translating novel imaging methods into the clinical evaluation of DOC patients is essential for better diagnosis and may encourage treatment development. © 2013 Elsevier B.V. All rights reserved.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

A phase I clinical study of immunotherapy for advanced colorectal cancers using carcinoembryonic antigen-pulsed dendritic cells mixed with tetanus toxoid and subsequent IL-2 treatment.

PubMed

Liu, Ko-Jiunn; Chao, Tsu-Yi; Chang, Jang-Yang; Cheng, Ann-Lii; Ch'ang, Hui-Ju; Kao, Woei-Yau; Wu, Yu-Chen; Yu, Wei-Lan; Chung, Tsai-Rong; Whang-Peng, Jacqueline

2016-08-24

To better evaluate and improve the efficacy of dendritic cell (DC)-based cancer immunotherapy, we conducted a clinical study of patients with advanced colorectal cancer using carcinoembryonic antigen (CEA)-pulsed DCs mixed with tetanus toxoid and subsequent interleukin-2 treatment. The tetanus toxoid in the vaccine preparation serves as an adjuvant and provides a non-tumor specific immune response to enhance vaccine efficacy. The aims of this study were to (1) evaluate the toxicity of this treatment, (2) observe the clinical responses of vaccinated patients, and (3) investigate the immune responses of patients against CEA before and after treatment. Twelve patients were recruited and treated in this phase I clinical study. These patients all had metastatic colorectal cancer and failed standard chemotherapy. We first subcutaneously immunized patients with metastatic colorectal cancer with 1 × 10(6) CEA-pulsed DCs mixed with tetanus toxoid as an adjuvant. Patients received 3 successive injections with 1 × 10(6) CEA-pulsed DCs alone. Low-dose interleukin-2 was administered subcutaneously following the final DC vaccination to boost the growth of T cells. Patients were evaluated for adverse event and clinical status. Blood samples collected before, during, and after treatment were analyzed for T cell proliferation responses against CEA. No severe treatment-related side effects or toxicity was observed in patients who received the regular 4 DC vaccine injections. Two patients had stable disease and 10 patients showed disease progression. A statistically significant increase in proliferation against CEA by T cells collected after vaccination was observed in 2 of 9 patients. The results of this study indicate that it is feasible and safe to treat colorectal cancer patients using this protocol. An increase in the anti-CEA immune response and a clinical benefit was observed in a small fraction of patients. This treatment protocol should be further evaluated in additional colorectal cancer patients with modifications to enhance T cell responses. ClinicalTrials.gov (identifier NCT00154713 ), September 8, 2005.

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

PubMed

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

2014-12-01

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

[Clinical research XXIII. From clinical judgment to meta-analyses].

PubMed

Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Noyola-Castillo, Maura E; Talavera, Juan O

2014-01-01

Systematic reviews (SR) are studies made in order to ask clinical questions based on original articles. Meta-analysis (MTA) is the mathematical analysis of SR. These analyses are divided in two groups, those which evaluate the measured results of quantitative variables (for example, the body mass index -BMI-) and those which evaluate qualitative variables (for example, if a patient is alive or dead, or if he is healing or not). Quantitative variables generally use the mean difference analysis and qualitative variables can be performed using several calculations: odds ratio (OR), relative risk (RR), absolute risk reduction (ARR) and hazard ratio (HR). These analyses are represented through forest plots which allow the evaluation of each individual study, as well as the heterogeneity between studies and the overall effect of the intervention. These analyses are mainly based on Student's t test and chi-squared. To take appropriate decisions based on the MTA, it is important to understand the characteristics of statistical methods in order to avoid misinterpretations.

Ideal discrimination of discrete clinical endpoints using multilocus genotypes.

PubMed

Hahn, Lance W; Moore, Jason H

2004-01-01

Multifactor Dimensionality Reduction (MDR) is a method for the classification and prediction of discrete clinical endpoints using attributes constructed from multilocus genotype data. Empirical studies with both real and simulated data suggest that MDR has good power for detecting gene-gene interactions in the absence of independent main effects. The purpose of this study is to develop an objective, theory-driven approach to evaluate the strengths and limitations of MDR. To accomplish this goal, we borrow concepts from ideal observer analysis used in visual perception to evaluate the theoretical limits of classifying and predicting discrete clinical endpoints using multilocus genotype data. We conclude that MDR ideally discriminates between low risk and high risk subjects using attributes constructed from multilocus genotype data. We also how that the classification approach used once a multilocus attribute is constructed is similar to that of a naive Bayes classifier. This study provides a theoretical foundation for the continued development, evaluation, and application of the MDR as a data mining tool in the domain of statistical genetics and genetic epidemiology.

Sensory physiology assessed by evoked potentials in survivors of poliomyelitis.

PubMed

Prokhorenko, Olga A; Vasconcelos, Olavo M; Lupu, Vitalie D; Campbell, William W; Jabbari, Bahman

2008-10-01

Evidence suggests that sensory loss may occur in a proportion of patients affected by poliomyelitis. We hypothesize that sensory problems may be a lasting sequela in some polio survivors. Sensory pathways in polio survivors were evaluated clinically and electrophysiologically using sensory evoked potentials (SEPs). Patients with sensory deficits or abnormal SEPs were further evaluated by magnetic resonance imaging (MRI). Twenty-two patients were studied. The mean age was 64.7 years (age range: 56-81 years). Clinically, sensory impairments were found in 4 patients. Upper limb SEPs were normal. Lower limb SEPs were abnormal in 10 patients. In 1 patient, clinical and electrographic findings correlated with a patch of atrophy in the spinal cord, as shown by MRI. Sensory derangements may be found in a proportion of aging polio survivors. SEP studies may add sensitivity when evaluating sensory function in this cohort. It remains unclear whether these sensory abnormalities are related to remote poliomyelitis. Further studies are necessary.

A systematic review of the association between radiographic and clinical osteoarthritis of hip and knee.

PubMed

Kinds, M B; Welsing, P M J; Vignon, E P; Bijlsma, J W J; Viergever, M A; Marijnissen, A C A; Lafeber, F P J G

2011-07-01

There is ongoing debate on whether an association between radiographic and clinical osteoarthritis (OA) exists. We hypothesized that the inconsistency in the detection of an association might be caused by different definitions of OA, by different radiographic protocols, and by scoring methods for radiographic damage and symptoms. The goal of this study was to evaluate which methodological criteria are important to detect an association between radiographic and clinical OA of hip and knee. A literature search was performed with the keywords 'OA', 'hip', 'knee', 'radiographic', and 'clinical' and results were screened for relevant studies. Quality criteria for study characteristics and methodology were developed. Studies were classified according to these criteria and the presence of an association between radiographic and clinical OA was scored. The importance of methodological quality and patient characteristics on the presence of an association was evaluated. The literature search resulted in 39 studies describing an association between radiographic and clinical OA. The frequency of an association between radiographic and clinical OA outcome measures diminished when less quality criteria were fulfilled. Specifically the criterion for standardized outcome measures appeared important in the detection of an association. The association was not influenced by patient characteristics. Only four studies were identified that fulfilled all quality criteria and in these studies an association was found for the knee joint and an inconsistent association was found for the hip joint. Methodological quality criteria are of importance to reveal an association between radiographic and clinical OA. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Social vs. Clinical Perspectives on the Use of Information: Implications for School-based Information Systems. Systemic Evaluation Project.

ERIC Educational Resources Information Center

Sirotnik, Kenneth A.; And Others

This paper presents a study of the contrast of social and clinical perspectives on the selection and use of information by school staff, including: (1) an outline of the context and activities of the study; (2) a definition and discussion of the basic distinction between social and clinical perspectives; (3) an examination of case material…

Pre-clinical characterization of tissue engineering constructs for bone and cartilage regeneration

PubMed Central

Trachtenberg, Jordan E.; Vo, Tiffany N.; Mikos, Antonios G.

2014-01-01

Pre-clinical animal models play a crucial role in the translation of biomedical technologies from the bench top to the bedside. However, there is a need for improved techniques to evaluate implanted biomaterials within the host, including consideration of the care and ethics associated with animal studies, as well as the evaluation of host tissue repair in a clinically relevant manner. This review discusses non-invasive, quantitative, and real-time techniques for evaluating host-materials interactions, quality and rate of neotissue formation, and functional outcomes of implanted biomaterials for bone and cartilage tissue engineering. Specifically, a comparison will be presented for pre-clinical animal models, histological scoring systems, and non-invasive imaging modalities. Additionally, novel technologies to track delivered cells and growth factors will be discussed, including methods to directly correlate their release with tissue growth. PMID:25319726

Pre-clinical characterization of tissue engineering constructs for bone and cartilage regeneration.

PubMed

Trachtenberg, Jordan E; Vo, Tiffany N; Mikos, Antonios G

2015-03-01

Pre-clinical animal models play a crucial role in the translation of biomedical technologies from the bench top to the bedside. However, there is a need for improved techniques to evaluate implanted biomaterials within the host, including consideration of the care and ethics associated with animal studies, as well as the evaluation of host tissue repair in a clinically relevant manner. This review discusses non-invasive, quantitative, and real-time techniques for evaluating host-materials interactions, quality and rate of neotissue formation, and functional outcomes of implanted biomaterials for bone and cartilage tissue engineering. Specifically, a comparison will be presented for pre-clinical animal models, histological scoring systems, and non-invasive imaging modalities. Additionally, novel technologies to track delivered cells and growth factors will be discussed, including methods to directly correlate their release with tissue growth.

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility.

PubMed

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context.

Clinical performance of a glass ionomer restorative system: a 6-year evaluation.

PubMed

Gurgan, Sevil; Kutuk, Zeynep Bilge; Ergin, Esra; Oztas, Sema Seval; Cakir, Filiz Yalcin

2017-09-01

The aim of this study is to evaluate the long-term clinical performance of a glass ionomer (GI) restorative system in the restoration of posterior teeth compared with a micro-filled hybrid posterior composite. A total of 140 (80 Cl1 and 60 Cl2) lesions in 59 patients were restored with a GI system (Equia) or a micro hybrid composite (Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Negative replicas at each recall were observed under SEM to evaluate surface characteristics. Data were analyzed with Cohcran's Q and McNemar's tests (p < 0.05). One hundred fifteen (70 Cl1 and 45 Cl2) restorations were evaluated in 47 patients with a recall rate of 79.6% at 6 years. Significant differences were found in marginal adaptation and marginal discoloration for both restorative materials for Cl1 and Cl2 restorations (p < 0.05). However, none of the materials were superior to the other (p > 0.05). A significant decrease in color match was observed in Equia restorations (p < 0.05). Only one Cl2 Equia restoration was missing at 3 years and another one at 4 years. No failures were observed at 5 and 6 years. Both materials exhibited clinically successful performance after 6 years. SEM evaluations were in accordance with the clinical findings. Both materials showed a good clinical performance for the restoration of posterior teeth during the 6-year evaluation. The clinical effectiveness of Equia and Gradia Direct Posterior was acceptable in Cl1 and Cl2 cavities subsequent to 6-year evaluation.

Reliability of Performance-Based Clinical Measurements to Assess Shoulder Girdle Kinematics and Positioning: Systematic Review.

PubMed

D'hondt, Norman E; Kiers, Henri; Pool, Jan J M; Hacquebord, Sijmen T; Terwee, Caroline B; Veeger, Dirkjan H E J

2017-01-01

Deviant shoulder girdle movement is suggested as an eminent factor in the etiology of shoulder pain. Reliable measurements of shoulder girdle kinematics are a prerequisite for optimizing clinical management strategies. The purpose of this study was to evaluate the reliability, measurement error, and internal consistency of measurements with performance-based clinical tests for shoulder girdle kinematics and positioning in patients with shoulder pain. The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception to August 2015. Articles published in Dutch, English, or German were included if they involved the evaluation of at least one of the measurement properties of interest. Two reviewers independently evaluated the methodological quality per studied measurement property with the 4-point-rating scale of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist, extracted data, and assessed the adequacy of the measurement properties. Forty studies comprising more than 30 clinical tests were included. Actual reported measurements of the tests were categorized into: (1) positional measurement methods, (2) measurement methods to determine dynamic characteristics, and (3) tests to diagnose impairments of shoulder girdle function. Best evidence synthesis of the tests was performed per measurement for each measurement property. All studies had significant limitations, including incongruence between test description and actual reported measurements and a lack of reporting on minimal important change. In general, the methodological quality of the selected studies was fair to poor. High-quality evidence indicates that measurements obtained with the Modified Scapular Assistance Test are not reliable for clinical use. Sound recommendations for the use of other tests could not be made due to inadequate evidence. Across studies, diversity in description, performance, and interpretation of similar tests was present, and different criteria were used to establish similar diagnoses, mostly without taking into account a clinically meaningful context. Consequently, these tests lack face validity, which hampers their clinical use. Further research on validity and how to integrate a clinically meaningful context of movement into clinical tests is warranted. © 2017 American Physical Therapy Association

Evaluation of the impact of a clinical pathway on the organization of a multidisciplinary dental sleep clinic.

PubMed

Ten Berge, D M; Braem, M J; Altenburg, A; Dieltjens, M; Van de Heyning, P H; Vanhaecht, K; Vanderveken, O M

2014-05-01

Clinical pathways are used to organize complex care processes by providing structure and standardization. The multidisciplinary approach of oral appliance (OA) therapy for sleep-disordered breathing (SDB) is a complex and dynamic process suitable for such a structured pathway approach. A clinical pathway for patients referred for OA therapy was developed and implemented. The aim of this study was to evaluate the impact of this clinical pathway on the time to delivery of the OA and the organization of the multidisciplinary dental sleep clinic (MDSC). The latter was achieved using the care process self-evaluation tool (CPSET). First, development and implementation of the clinical pathway gave structure and shortened the mean time to delivery by 102 days (240 ± 70 vs. 138 ± 33 days) (Mann-Whitney U: P < 0.001). Second, the CPSET scores were obtained in a cohort of 49 healthcare professionals involved in the pathway. Overall, patient-focused organization received the highest scores (80.5 ± 9.0%), whereas cooperation with primary care received the lowest score (66.7 ± 12.4%). This is the first project on clinical pathways in OA therapy for SDB. The implementation of the pathway in our MDSC has created a significant shortening of the time to delivery. A first evaluation of the clinical pathway using the CPSET scores indicates that all disciplines involved should be thoroughly informed in an ongoing approach.

Clinical and radiographic evaluation of zinc oxide with aloe vera as an obturating material in pulpectomy: an in vivo study.

PubMed

Khairwa, Abhishek; Bhat, Manohar; Sharma, Rajesh; Satish, V; Maganur, Prabhadevi; Goyal, Anil Kumar

2014-01-01

Pulp therapy for pulpally involved primary teeth continues to be a challenge to clinicians. One of the major areas of continued research is in the area of finding obturating materials to suit the specific properties of these teeth. Zinc oxide eugenol is used frequently in pulpectomy for the obturation of the primary teeth. To evaluate clinically and radiographically a mixture of zinc oxide eugenol and aloe vera as an obturating material. A total of 50 children, aged between 4 and 9 years, who were screened for unilateral or bilateral carious deciduous molars were studied. Out of these, 15 children were randomly selected for endodontic treatment. Obturation was done with a mixture of zinc oxide powder and aloe vera gel. Clinical and radiographic evaluation was done after 7 days, 1 month, 3 months, 6 months, and 9 months. The data were statistically analyzed. Endodontic treatment using a mixture of zinc oxide powder and aloe vera gel in primary teeth has shown good clinical and radiographic success. A detailed observational study with longer follow-up will highlight the benefits of aloe vera in primary teeth as an obturating medium.

The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.

PubMed

Lassere, Marissa N

2008-06-01

There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Section 2 is a systematic, historical review of the biomarker-surrogate endpoint literature with special reference to the nomenclature, the systems of classification and statistical methods developed for their evaluation. In Section 3 an explicit, criterion-based, quantitative, multidimensional hierarchical levels of evidence schema - Biomarker-Surrogacy Evaluation Schema - is proposed to evaluate and co-ordinate the multiple dimensions (biological, epidemiological, statistical, clinical trial and risk-benefit evidence) of the biomarker clinical endpoint relationships. The schema systematically evaluates and ranks the surrogacy status of biomarkers and surrogate endpoints using defined levels of evidence. The schema incorporates the three independent domains: Study Design, Target Outcome and Statistical Evaluation. Each domain has items ranked from zero to five. An additional category called Penalties incorporates additional considerations of biological plausibility, risk-benefit and generalizability. The total score (0-15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. The term ;surrogate' is restricted to markers attaining Levels 1 or 2 only. Surrogacy status of markers can then be directly compared within and across different areas of medicine to guide individual, trial-based or drug-development decisions. This schema would facilitate communication between clinical, researcher, regulatory, industry and consumer participants necessary for evaluation of the biomarker-surrogate-clinical endpoint relationship in their different settings.

Combination Immunotherapy in Non-small Cell Lung Cancer.

PubMed

Marmarelis, Melina E; Aggarwal, Charu

2018-05-08

Checkpoint blockade has changed the treatment landscape in non-small cell lung cancer (NSCLC), but single-agent approaches are effective for only a select subset of patients. Here, we will review the evidence for combination immunotherapies in NSCLC and the clinical data evaluating the efficacy of this approach. Clinical trials evaluating combination PD-1 and CTLA-4 blockade as well as PD-1 in combination with agents targeting IDO1, B7-H3, VEGF, and EGFR show promising results. Additional studies targeting other immune pathways like TIGIT, LAG-3, and cellular therapies are ongoing. Combination immunotherapy has the potential to improve outcomes in NSCLC. Data from early clinical trials is promising and reveals that these agents can be administered together safely without a significant increase in toxicity. Further studies are needed to evaluate their long-term safety and efficacy and to determine appropriate patient selection.

Clinical utilization of musculoskeletal sonography involving non-physician rehabilitation providers: A scoping review

PubMed Central

Roll, Shawn C.; Asai, Christina; Tsai, Julieann

2015-01-01

Background Musculoskeletal sonography use in point-of-care physical medicine and rehabilitation is rapidly expanding, not only by physiatrists, but also by non-physician rehabilitation providers. Aim To evaluate the current range, extent and nature of literature and to identify emerging areas of evidence for the use of musculoskeletal sonography involving non-physician rehabilitation providers to guide research and clinical practice. Design Scoping Review Setting Inpatient, Outpatient, Other Population Musculoskeletal conditions Methods Five databases were searched and 578 unique abstracts were identified and screened for eligibility. Three raters independently read 68 full texts and 36 articles that reported on applied uses of sonography by non-physician rehabilitation providers were included. Results Eighteen studies described direct clinical use, primarily for outcomes measurement (n=12) or as a biofeedback intervention (n=10). Twelve laboratory studies were included that related morphology to patient reports or validated clinical interventions. Six additional studies, although not involving non-physician providers, were included as they presented potential valuable uses that were not noted in the other included studies, such as monitoring bone healing, tendon repair, and evaluation of idiopathic symptom reports or non-specific primary diagnoses. Conclusion This review indicates that non-physician rehabilitation providers use sonography for outcomes measurement and biofeedback interventions. Research is needed to evaluate effects of these uses on patient outcomes and to explore additional potential uses for clinical reasoning, treatment planning, and monitoring of tissue healing related to intervention. Clinical Rehabilitation Impact Implementation of musculoskeletal sonography by non-physician rehabilitation providers has the potential to be a critically advantageous addition to improve care. PMID:26201705

78 FR 46994 - Proposed Collection; 60-Day Comment Request: National Institute of Mental Health Recruitment and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center... NIMH-sponsored clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best...

The Treatment for Adolescents with Depression Study (TADS): Demographic and Clinical Characteristics

ERIC Educational Resources Information Center

n/a; n/a

2005-01-01

Objective: The Treatment for Adolescents With Depression Study is a multicenter, randomized clinical trial sponsored by the NIMH. This study is designed to evaluate the short- and long-term effectiveness of four treatments for adolescents with major depressive disorder: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely,…

The development and validation of the Clinical Teaching Behavior Inventory (CTBI-23): Nurse preceptors' and new graduate nurses' perceptions of precepting.

PubMed

Lee-Hsieh, Jane; O'Brien, Anthony; Liu, Chieh-Yu; Cheng, Su-Fen; Lee, Yea-Wen; Kao, Yu-Hsiu

2016-03-01

Few studies have examined the perceptions of clinical teaching behaviors among both nurse preceptors and preceptees. To develop a Clinical Teaching Behavior Inventory (CTBI) for nurse preceptors' self-evaluation, and for new graduate nurse preceptee evaluation of preceptor clinical teaching behaviors and to test the validity and reliability of the CTBI. This study used mixed research techniques in five phases. Phase I: based on a literature review, the researchers developed an instrument to measure clinical teaching behaviors. Phase II: 17 focus group interviews were conducted with 63 preceptors and 24 new graduate nurses from five hospitals across Taiwan. Clinical teaching behavior themes were extracted from the focus group data and integrated into the domains and items of the CTBI. Phase III: two rounds of an expert Delphi study were conducted to determine the content validity of the instrument. Phase IV: a total of 290 nurse preceptors and 260 new graduate nurses were recruited voluntarily in the same five hospitals in Taiwan. Of these, 521 completed questionnaires to test the construct validity of CTBI by using confirmatory factory analysis. Phase V: the internal consistency and reliability of the instrument were tested. CTBI consists of 23 items in six domains: (1) 'Committing to Teaching'; (2) 'Building a Learning Atmosphere'; (3) 'Using Appropriate Teaching Strategies'; (4) 'Guiding Inter-professional Communication'; (5) 'Providing Feedback and Evaluation'; and (6) 'Showing Concern and Support'. The confirmatory factor analysis yielded a good fit and reliable scores for the CTBI-23 model. The CTBI-23 is a valid and reliable instrument for identifying the clinical teaching behaviors of a preceptor as perceived by preceptors and new graduate preceptees. The CTBI-23 depicts clinical teaching behaviors of nurse preceptors in Taiwan. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of the implementation of a clinical pharmacy service on an acute internal medicine ward in Italy.

PubMed

Lombardi, Nicola; Wei, Li; Ghaleb, Maisoon; Pasut, Enrico; Leschiutta, Silvia; Rossi, Paolo; Troncon, Maria Grazia

2018-04-10

Successful implementation of clinical pharmacy services is associated with improvement of appropriateness of prescribing. Both high clinical significance of pharmacist interventions and their high acceptance rate mean that potential harm to patients could be avoided. Evidence shows that low acceptance rate of pharmacist interventions can be associated with lack of communication between pharmacists and the rest of the healthcare team. The objective of this study was to evaluate the effect of a structured communication strategy on acceptance rate of interventions made by a clinical pharmacist implementing a ward-based clinical pharmacy service targeting elderly patients at high risk of drug-related problems. Characteristics of interventions made to improve appropriateness of prescribing, their clinical significance and intervention acceptance rate by doctors were recorded. A clinical pharmacy intervention study was conducted between September 2013 and December 2013 in an internal medicine ward of a teaching hospital. A trained clinical pharmacist provided pharmaceutical care to 94 patients aged over 70 years. The clinical pharmacist used the following communication and marketing tools to implement the service described: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis; Specific, Measurable, Achievable, Realistic and Timely (SMART) goals; Awareness, Interest, Desire, Action (AIDA) model. A total of 740 interventions were made by the clinical pharmacist. The most common drug classes involved in interventions were: antibacterials for systemic use (11.1%) and anti-parkinson drugs (10.8%). The main drug-related problem categories triggering interventions were: no specific problem (15.9%) and prescription writing error (12.0%). A total of 93.2% of interventions were fully accepted by physicians. After assessment by an external panel 63.2% of interventions (96 interventions/ per month) were considered of moderate clinical significance and 23.4% (36 interventions/ per month) of major clinical significance. The most frequent interventions were to educate a healthcare professional (20.4%) and change dose (16.1%). To our knowledge this is the first study evaluating the effect of a structured communication strategy on acceptance rate of pharmacist interventions. Pharmaceutical care delivered by the clinical pharmacist is likely to have had beneficial outcomes. Clinical pharmacy services like the one described should be implemented widely to increase patient safety.

Clinical and Immunoinflammatory Evaluation of One-Stage Full-Mouth Ultrasonic Debridement as a Therapeutic Approach for Smokers With Generalized Aggressive Periodontitis: A Short-Term Follow-Up Study.

PubMed

De Genaro Modanese, Danielle; Tiosso-Tamburi, Renato; Furletti de Goes, Vivian Fernandes; de Cássia Bergamaschi, Cristiane; Martinez, Elizabeth Ferreira; Napimoga, Marcelo Henrique; Peruzzo, Daiane Cristina

2016-09-01

This study aims to evaluate the effect of one-stage full-mouth ultrasonic debridement (OSFMUD) on clinical and immunoinflammatory parameters in smokers with generalized aggressive periodontitis (GAgP). Fourteen smoking and 14 non-smoking patients with GAgP were selected. After initial supragingival therapy, patients were treated by OSFMUD. Full-mouth parameters evaluated were: 1) plaque index (PI); 2) bleeding scores (BS); 3) probing depth (PD); and 4) clinical attachment level (CAL). Clinical evaluation was performed, and gingival crevicular fluid (GCF) was collected for selected sites (ss) at baseline and 1, 3, and 6 months. GCF was analyzed via enzyme-linked immunosorbent assay for: 1) receptor activator of nuclear factor-κ B ligand (RANKL); 2) osteoprotegerin (OPG); 3) interleukin (IL)-6; and 4) tumor necrosis factor (TNF)-α, whereas secreted osteoclastogenic factor of activated T-cells (SOFAT) was evaluated by Western blotting. Significant reduction (P <0.05) was observed between baseline and 6 months for: 1) PI; 2) BS; and 3) PD, with no difference between smoking and non-smoking patients (P >0.05). Regarding CAL, only non-smoking patients showed a significant decrease (P <0.05). Significant reduction (P <0.05) was observed in both groups for: 1) PIss; 2) PDss; 3) bleeding on probing; and 4) relative CAL. Smoking and non-smoking patients presented significantly decreased levels of IL-6 and TNF-α over time (P <0.05); however, no difference was observed between groups (P >0.05). RANKL was significantly different (P <0.05) only for non-smokers at 6 months, whereas OPG was not significant (P >0.05). SOFAT expression was significantly lower (P <0.05) after OSFMUD for non-smokers only. Considering the clinical and immunoinflammatory parameters evaluated in this short-term follow-up study, it can be concluded that OSFMUD can be used as an alternative treatment for smokers with GAgP.

Evaluation of Mother-Child Agreement and Factorial Structures of the SCARED Questionnaire in an Italian Clinical Sample

PubMed Central

Scaini, Simona; Ogliari, Anna; De Carolis, Ludovica; Bellodi, Laura; Di Serio, Clelia; Brombin, Chiara

2017-01-01

Background: A great part of the literature has confirmed the importance of both child and parents reports as source of factual information, especially for childhood emotional syndromes. In our study we aimed at: (i) calculating mother-child agreement and (ii) evaluating factorial structure of the Screen for Child Anxiety Related Emotional Disorders (SCARED) questionnaire in an Italian clinical sample. The novelty of this contribution is two-fold: first, from a clinical point of view, we investigated the parent-child agreement level and examined separately the factorial structures of both parent and child versions of the SCARED for the first time in an Italian clinical sample. Second, unlike previous studies, we used statistical approaches specifically suited to account for the ordinal nature of the collected variables. Method: In a clinical sample of 171 children and adolescents aged 8–18 and their mothers we evaluated inter-rater agreement using weighted kappa indices to assess agreement for each item belonging to a certain SCARED subscale. Exploratory factor analysis for ordinal data was then performed on the polychoric correlation matrix calculated on SCARED items. Differences in the numbers of symptoms reported by children and parents were evaluated as well. Results and Conclusions: Our results reveal moderate to strong mother-child agreement. A significant age effect is present. Two different factorial solutions emerged for parent and child SCARED versions (a 5 factor structure for parents and a 6 factor solution in the child version, including a new factor “Worry about Parents”). This study confirmed the importance of evaluating both child and parent reports in assessment protocols for anxiety disorders. Our findings could help clinicians to determine which information, and from which rater, must be accounted for in evaluating treatment decisions. Moreover, we find that patients characteristics, such as gender and age, should be taken into account when assessing agreement. PMID:28286488

Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

2015-04-08

The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.

Evaluating the Efficacy of a Short Aging Simulation Workshop for an Interdisciplinary Group of Health-Care Employees at a Veterans Affairs Medical Center

ERIC Educational Resources Information Center

Halpin, Sean N.

2015-01-01

Several interventions aimed at increasing positive attitudes towards older adults among health-care professionals have been introduced. These interventions tend to focus on a small subset of clinical employees, ignoring other clinical and nonclinical hospital staff. The objective of this study was to evaluate the efficacy of a short aging…

Comparative study between ultrasonography and optical coherence tomography in interventional cardiology

NASA Astrophysics Data System (ADS)

Fanjul-Vélez, Félix; de la Torre-Hernández, José María; Ortega-Quijano, Noé; Zueco-Gil, José Javier; Arce-Diego, José Luis

2009-07-01

In this work, we present clinical images of IVUS and OCT in the evaluation of pharmacological stent endothelization. These preliminary imaging results are analyzed and compared in order to determine the ability of these technologies to visualize relevant intravascular features of interest in interventional cardiology. The results enable to compare the performance of both techniques and to evaluate their potential for clinical purposes.

Decision-Based Design of a Low Vision Aid

DTIC Science & Technology

1999-12-05

No loss ML 32 Aniridia Cloudy No Loss TT 35 Glaucoma Cloudy No Loss MM 23 Stargardt Disease Clear Loss AP 40 Congenital Retinal Malformations...brief clinical background evaluation, and a post-experiment questionnaire. The study was further expanded in scope to gather data for the VRD...Introduction and clinical evaluation 3) Experiments with red, blue and green images 4) Experiments with white images 5) Post experiment

Diagnosing ASD in Adults without ID: Accuracy of the ADOS-2 and the ADI-R

ERIC Educational Resources Information Center

Fusar-Poli, Laura; Brondino, Natascia; Rocchetti, Matteo; Panisi, Cristina; Provenzani, Umberto; Damiani, Stefano; Politi, Pierluigi

2017-01-01

Diagnosing autism spectrum disorder (ASD) in adulthood often represents a challenge in clinical practice. The aim of the present study was to evaluate the sensitivity and specificity of the ADOS and ADI-R in diagnosing ASD in adults. 113 subjects with an IQ of 70 or above were assessed through an extensive clinical evaluation. The ADOS-2 Module 4…

Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently.

PubMed

Swords, Ronan T; Kelly, Kevin R; Cohen, Stephen C; Miller, Larry J; Philbeck, Thomas E; Hacker, Sander O; Spadaccini, Cathy J; Giles, Francis J; Brenner, Andrew J

2010-06-01

Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. A pre-clinical evaluation of the device (OnControl, Vidacare Corporation, San Antonio, TX, USA) on anesthetized pigs was conducted, in addition to a clinical evaluation in hematology clinic patients requiring a bone marrow biopsy. Twenty-six samples were collected from the swine model. No cellular artifact or thermal damage was reported in any of the samples obtained. For the clinical evaluation of the device, 16 patients were recruited. Mean time from needle contact with skin to needle removal was 38.5 +/- 13.94 seconds. No complications were reported. In this study, the manual and powered samples were equivalent in specimen quality. In the patients evaluated, the device was safe, easy to use and the mean procedural time was significantly faster than previously reported with a manual technique.

A Data Model for Teleconsultation in Managing High-Risk Pregnancies: Design and Preliminary Evaluation

PubMed Central

Deldar, Kolsoum

2017-01-01

Background Teleconsultation is a guarantor for virtual supervision of clinical professors on clinical decisions made by medical residents in teaching hospitals. Type, format, volume, and quality of exchanged information have a great influence on the quality of remote clinical decisions or tele-decisions. Thus, it is necessary to develop a reliable and standard model for these clinical relationships. Objective The goal of this study was to design and evaluate a data model for teleconsultation in the management of high-risk pregnancies. Methods This study was implemented in three phases. In the first phase, a systematic review, a qualitative study, and a Delphi approach were done in selected teaching hospitals. Systematic extraction and localization of diagnostic items to develop the tele-decision clinical archetypes were performed as the second phase. Finally, the developed model was evaluated using predefined consultation scenarios. Results Our review study has shown that present medical consultations have no specific structure or template for patient information exchange. Furthermore, there are many challenges in the remote medical decision-making process, and some of them are related to the lack of the mentioned structure. The evaluation phase of our research has shown that data quality (P<.001), adequacy (P<.001), organization (P<.001), confidence (P<.001), and convenience (P<.001) had more scores in archetype-based consultation scenarios compared with routine-based ones. Conclusions Our archetype-based model could acquire better and higher scores in the data quality, adequacy, organization, confidence, and convenience dimensions than ones with routine scenarios. It is probable that the suggested archetype-based teleconsultation model may improve the quality of physician-physician remote medical consultations. PMID:29242181

Identifying Drivers of Overall Satisfaction in Patients Receiving HIV Primary Care: A Cross-Sectional Study

PubMed Central

Dang, Bich N.; Westbrook, Robert A.; Rodriguez-Barradas, Maria C.; Giordano, Thomas P.

2012-01-01

Objective This study seeks to understand the drivers of overall patient satisfaction in a predominantly low-income, ethnic-minority population of HIV primary care patients. The study’s primary aims were to determine 1) the component experiences which contribute to patients’ evaluations of their overall satisfaction with care received, and 2) the relative contribution of each component experience in explaining patients’ evaluation of overall satisfaction. Methods We conducted a cross-sectional study of 489 adult patients receiving HIV primary care at two clinics in Houston, Texas, from January 13–April 21, 2011. The participation rate among eligible patients was 94%. The survey included 15 questions about various components of the care experience, 4 questions about the provider experience and 3 questions about overall care. To ensure that the survey was appropriately tailored to our clinic population and the list of component experiences reflected all aspects of the care experience salient to patients, we conducted in-depth interviews with key providers and clinic staff and pre-tested the survey instrument with patients. Results Patients’ evaluation of their provider correlated the strongest with their overall satisfaction (standardized β = 0.445, p<0.001) and accounted for almost half of the explained variance. Access and availability, like clinic hours and ease of calling the clinic, also correlated with overall satisfaction, but less strongly. Wait time and parking, despite receiving low patient ratings, did not correlate with overall satisfaction. Conclusions The patient-provider relationship far exceeds other component experiences of care in its association with overall satisfaction. Our study suggests that interventions to improve overall patient satisfaction should focus on improving patients’ evaluation of their provider. PMID:22912770

Comparison between student rating, faculty self-rating and evaluation of faculty members by heads of respective academic departments in the school of medicine in Birjand University of Medical Sciences in Iran.

PubMed

Taheri, Mohammad Mehdi Hassanzadeh; Ryasi, Hamid Reza; Afshar, Mohammad; Mofatteh, Mohammad Reza

2014-01-01

University teachers are one of the main pillars of university and the quality of their performance must continuously and systematically be evaluated. This evaluation can be carried out in various ways. The aim of the present study was to survey and to compare the evaluation of faculty members in the medical school in Birjand University of Medical Sciences by three different sources: Student rating, self-assessment, and evaluation by head of related department. This descriptive analytical cross-sectional study was conducted in the academic year 2009-2010. Sampling was drawn from all students studying basic science and clinical training in the first and the second semesters. All heads of departments in basic science and clinical training and their faculty members took part in this study. Means of data collection were four different questionnaires designed in the education development center (EDC) and their validity and reliability had been verified by the center. These questionnaires were based on student rating, self-assessment, and evaluation of faculty members by heads of clinical and basic sciences academic departments. After the questionnaires were filled out, the obtained data was analyzed by Statistical Package for the Social Sciences (SPSS) software (version 13), independent t-test, and Pearson's correlation coefficient at the significant level of α = 0.05. In the present study, 2417 students completed the questionnaires regarding 63 faculty members, 87 faculty members completed the self-assessment form, and for 60 faculty members, 48 members in clinical and 12 members in basic science, the questionnaires were completed by heads of respective departments. Mean and standard deviation of student evaluation, self-assessment, and teachers evaluation by heads of departments were 3.23 ± 0.38, 3.51 ± 0.33, and 3.60 ± 0.32, respectively, and the difference between student rating and self-assessment was significant (P = 0.02). In comparing between managers scores with students evaluation, no significant difference was observed (P = 0.68). Comparison between self-assessment and teachers scores by managers showed a significant difference (P = 0.04). Mean scores of faculty members in clinical training and in basic science were 3.23 ± 0.73 and 3.31 ± 0.69 on the part of students, respectively; thus, the difference was significant (P = 0.004). Since, the present study was inconsistent with similar previously carried out investigations, the observed difference among the three procedures was statically significant; hence, it can be suggested that student's scores of teachers evaluation, previously used as the only one of evaluation source is not enough and other sources such as assessment by the respective department heads, dean of faculty, and self-assessment must also be taken into consideration. This collection can definitely yield a more favorable evaluation of faculty members and feedback can be more acceptable to them and it will be more effective in improving their education.

Evaluating Trauma Sonography for Operational Use in the Microgravity Environment

NASA Technical Reports Server (NTRS)

Kirkpatrick, Andrew W.; Jones, Jeffrey A.; Sargsyan, Ashot; Hamilton, Douglas; Melton, Shannon; Beck, George; Nicolaou, Savvas; Campbell, Mark; Dulchavsky, Scott

2007-01-01

Sonography is the only medical imaging modality aboard the ISS, and is likely to remain the leading imaging modality in future human space flight programs. While trauma sonography (TS) has been well recognized for terrestrial trauma settings, the technique had to be evaluated for suitability in space flight prior to adopting it as an operational capability. The authors found the following four-phased evaluative approach applicable to this task: 1) identifying standard or novel terrestrial techniques for potential use in space medicine; 2) developing and testing these techniques with suggested modifications on the ground (1g) either in clinical settings or in animal models, as appropriate; 3) evaluating and refining the techniques in parabolic flight (0g); and 4) validating and implementing for clinical use in space. In Phase I of the TS project, expert opinion and literature review suggested TS to be a potential screening tool for trauma in space. In Phase II, animal models were developed and tested in ground studies, and clinical studies were carried out in collaborating trauma centers. In Phase III, animal models were flight-tested in the NASA KC-135 Reduced Gravity Laboratory. Preliminary results of the first three phases demonstrated potential clinical utility of TS in microgravity. Phase IV studies have begun to address crew training issues, on-board imaging protocols, and data transfer procedures necessary to offer the modified TS technique for space use.

An evaluation of clinical, radiological and three-dimensional dental tomography findings in ectodermal dysplasia cases.

PubMed

Doğan, Mehmet-Sinan; Callea, Michele; Yavuz, Ìzzet; Aksoy, Orhan; Clarich, Gabriella; Günay, Ayse; Günay, Ahmet; Güven, Sedat; Maglione, Michele; Akkuş, Zeki

2015-05-01

This study aimed to review the results related to head and jaw disorders in cases of ectodermal dysplasia. The evaluation of ectodermal dysplasia cases was made by clinical examination and examination of the jaw and facial areas radiologically and on cone-beam 3-dimensional dental tomography (CBCT) images. In the 36 cases evaluated in the study, typical clinical findings of pure hypohidrotic ectodermal displasia (HED) were seen, such as missing teeth, dry skin, hair and nail disorders. CBCT images were obtained from 12 of the 36 cases, aged 1.5- 45 years, and orthodontic analyses were made on these images. The clinical and radiological evaluations determined, hypodontia or oligodontia, breathing problems, sweating problems, a history of fever, sparse hair, saddle nose, skin peeling, hypopigmentation, hyperpigmentation, finger and nail deformities, conical teeth anomalies, abnormal tooth root formation, tooth resorption in the root, gingivitis, history of epilepsy, absent lachrymal canals and vision problems in the cases which included to the study. Ectodermal dysplasia cases have a particular place in dentistry and require a professional, multi-disciplinary approach in respect of the chewing function, orthognathic problems, growth, oral and dental health. It has been understood that with data obtained from modern technologies such as three-dimensional dental tomography and the treatments applied, the quality of life of these cases can be improved.

A study to determine the difference in clinical judgment abilities between BSN and non-BSN graduates.

PubMed

Sanford, M; Genrich, S; Nowotny, M

1992-02-01

The purpose of this retrospective study is to determine the difference in clinical judgment abilities of recent baccalaureate nurses (BSN) seeking employment in a large metropolitan hospital and of nurses without a baccalaureate degree. Using an ex post facto design, the orientation records of 116 newly hired nurses were analyzed to determine the clinical judgment abilities using video vignettes produced by Medcom, Inc. Findings indicated that there was no difference in clinical judgment in newly hired BSN and non-BSN graduates. These findings indicate a need for more research studies to determine how clinical judgment is developed and to evaluate teaching strategies that facilitate clinical judgment.

Physiotherapy Student Clinical Examinations: The Influence of Subjective Judgments on Observational Assessment.

ERIC Educational Resources Information Center

Alexander, Helen A.

1996-01-01

A study investigated the role of subjective assessment in the evaluation of physiotherapy students in clinical programs. Clinical teachers, visiting lecturers, and students recorded perceptions of daily events and interactions in journals. Analysis suggests that assessors make subjective judgments about students that influence grades, and…

Clinical Perspective: What Do Addison and Cushing Tell Us About Glucocorticoid Action?

PubMed

Harris, Charles

2015-01-01

This chapter is distinct from the others in its clinical subject matter. I will attempt to outline the major points of interest in glucocorticoids clinically. To aid the illustration in the evaluation of a patient with Cushing disease I have created a case study.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Group Supervision Attitudes: Supervisory Practices Fostering Resistance to Adoption of Evidence-Based Practices

ERIC Educational Resources Information Center

Brooks, Charles T.; Patterson, David A.; McKiernan, Patrick M.

2012-01-01

The focus of this study was to qualitatively evaluate worker's attitudes about clinical supervision. It is believed that poor attitudes toward clinical supervision can create barriers during supervision sessions. Fifty-one participants within a social services organization completed an open-ended questionnaire regarding their clinical supervision…

78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Science Research and Development Service on the relevance and feasibility of proposed projects and the...

Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

PubMed

Tian, Shaoqi; Liu, Jiangjun; Yuan, Wanqing; Wang, Yuanhe; Ha, Chengzhi; Liu, Lun; Li, Qicai; Yang, Xu; Sun, Kang

2017-01-01

The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR) for medial knee arthropathy through a minimally invasive approach (MIA). From January 2006 to June 2010, 442 consecutive patients (485 knees) were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA) from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score), the Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index and visual analog scale (VAS) for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter. Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees) were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS) were significantly different (p < 0.05) from pre and post-operative evaluations. The survival rate was 99.1% at 73 months, and the revision rate was 0.9%. The midterm clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer-term follow-up studies should be performed in these patients.

Systematic Evaluation of Promising Clinical Trials-Gene Silencing for the Treatment of Glioblastoma.

PubMed

Karaarslan, Numan; Yilmaz, Ibrahim; Ozbek, Hanefi; Caliskan, Tezcan; Topuk, Savas; Sirin, Duygu Yasar; Ates, Ozkan

2018-04-06

The aim of this study was to systematically investigate the role of artificial small interfering RNA (siRNA) molecules in glioblastoma treatment and to give a detailed overview of the literature concerning studies performed in this field worldwide in the last 31 years. Articles about clinical trials conducted between December 1, 1949 and November 8, 2017, were identified from the Cochrane Collaboration, the Cochrane Library, Ovid MEDLINE, ProQuest, the National Library of Medicine, and PubMed electronic databases, using the terms "post transcriptional gene silencing," "small interfering RNA," "siRNA," and "glioblastoma," either individually or combined (\\"OR\\" and \\"AND"), without language and country restrictions. Articles that met the examination criteria were included in the study. After descriptive statistical evaluation, the results were reported in frequency (%). After scanning 2.752 articles, five articles were found that met the research criteria. Examination of full texts of the five identified articles provided no sufficient evidence for research conducted with regard to the use of gene silencing via siRNAs in glioblastoma treatment. To be able to evaluate the clinical use of siRNAs, there is an urgent need for in-vivo studies and for trials with randomized, controlled, and clinical designs that provide long-term functional outcomes.

SPF-RR sequential photothermal fractional resurfacing and remodeling with the variable pulse Er:YAG laser and scanner-assisted Nd:YAG laser.

PubMed

Marini, Leonardo

2009-12-01

Many different lasers, polychromatic high-intensity light sources (PCLs), and RF devices have claimed clinical efficacy in rejuvenating the skin. In this study, the sequential combination of two different laser wavelengths was evaluated to produce reliably significant clinical improvements optimizing treatment parameters. The left volar aspects of the forearms of four volunteers were treated with nine different parameter settings using a variable pulsewidth fractional Er:YAG 2940-nm laser with and without air cooling. The pain perception level was recorded on a 0-10 point scale (0=No pain; 10=Most severe pain). Three evaluations were made: during treatment, immediately after treatment, and 5 minutes after treatment. The same investigation was made on the right volar aspects of the same four volunteers using a short-pulse, random pattern, 3-mm spot, scanner-assisted Nd-YAG 1064-nm laser at 0.3 ms pulsewidth at seven different parameter settings. Clinical evaluations were made concerning erythema and edema 3 days after treatment, as well as pre-operative and 60 days postoperative skin texture plus color uniformity. Considering that the majority of cosmetic patients are willing to accept a relatively short and uneventful downtime (2-4 days according to a study we are presently conducting) and do prefer to limit their intra- and postoperative pain to a minimum, the best combination of clinical improvement matching these two important parameters were selected for our study. A treatment strategy combining two sequential passes of long-pulse Nd:YAG laser (Nd:YAG-LP) at 0.3 and 35 ms followed by two passes of long-pulse fractional Er:YAG laser (Er:YAG-FT) at 600 micros was designed to treat the facial regions of 10 volunteers affected by a combination of intrinsic (chrono-) and extrinsic (mostly photo-) aging. The pain perception level was recorded on a 0-10 scale (0=No pain; 10=Most severe pain). Three evaluations were made: during, immediately after, and 5 minutes after treatment. Erythema and edema were evaluated on a 0-3 point scale (0=No clinical signs; 3=Severe Clinical signs) at 7, 15 and 30 days. Improvements were determined by blind evaluation of photographs before, at 4 weeks, and at 8 weeks following treatments. Patient satisfaction was also evaluated on a 0-4 point scale (0=No satisfaction; 4=Excellent perceived improvement, 76-100%). At the 30-day follow-up, participants had clinically detectable improvements of facial telangiectasias (1-25%), lentigines (25-50%), diffuse dyspigmentation (25-75%), fine lines (25-75%), and skin texture (25-75%). Clinical improvements were maintained at the 60-day follow-up, demonstrating the prolonged photothermally induced biological effect on skin function and texture. All volunteers confirmed their willingness to undergo the same procedure again to maintain and possibly improve their clinical results. Further clinical evaluations at 4 and 6 months will therefore be needed to identify a suitably convenient interval between two consecutive procedures. The present study demonstrates objective and subjective improvements in fine lines, skin texture and dyspigmentation of facial skin after one sequential non-ablative and ablative laser treatment combining two different laser sources (Nd:YAG laser + Er:YAG laser).

Effectiveness of computerized clinical decision support systems for asthma and chronic obstructive pulmonary disease in primary care: a systematic review.

PubMed

Fathima, Mariam; Peiris, David; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol Lyn

2014-12-02

The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases, which requires recurrent visits to multiple health professionals, disease and medication monitoring and modification of patient behavior. The aim of this review was to systematically review randomized controlled trials evaluating the effectiveness of computerized clinical decision systems (CCDSS) in the care of people with asthma and COPD. Randomized controlled trials published between 2003 and 2013 were searched using multiple electronic databases Medline, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases. To be included, RCTs had to evaluate the role of the CCDSSs for asthma and/or COPD in primary care. Nineteen studies representing 16 RCTs met our inclusion criteria. The majority of the trials were conducted in patients with asthma. Study quality was generally high. Meta-analysis was not conducted because of methodological and clinical heterogeneity. The use of CCDSS improved asthma and COPD care in 14 of the 19 studies reviewed (74%). Nine of the nineteen studies showed statistically significant (p < 0.05) improvement in the primary outcomes measured. The majority of the studies evaluated health care process measures as their primary outcomes (10/19). Evidence supports the effectiveness of CCDSS in the care of people with asthma. However there is very little information of its use in COPD care. Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs, its effects on user workload and efficiency, safety, costs of care, provider and patient satisfaction remain understudied.

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.

Five-year evaluation of a low-shrinkage Silorane resin composite material: a randomized clinical trial.

PubMed

Schmidt, Malene; Dige, Irene; Kirkevang, Lise-Lotte; Vaeth, Michael; Hørsted-Bindslev, Preben

2015-03-01

The aim of the present study was to investigate the clinical performance of a low-shrinkage silorane-based composite material (Filtek™ Silorane, 3 M-Espe) by comparing it with a methacrylate-based composite material (Ceram•X™, Dentsply DeTrey). A number of 72 patients (158 restorations) participated in the study. After 5 years, a total of 107 restorations (52 Filtek™ Silorane, 55 Ceram•X™) in 48 patients were evaluated. Only class II restorations were included. All the restorations were placed by the same dentist, and the restorations were scored by one experienced dentist/evaluator. Materials were applied following the manufacturer's instructions. The primary outcome was marginal adaptation. Secondary outcomes were: marginal discoloration, approximal contact, anatomic form, fracture, secondary caries, and hypersensitivity. After 5 years, no statistically significant differences between the two materials were found in marginal adaptation either occlusally (p = 0.96) or approximally (p = 0.62). No statistically significant differences were found between the two materials in terms of approximal contact, anatomic form, fractures, or discoloration. Secondary caries was found in two teeth (Filtek™ Silorane). One tooth showed hypersensitivity (Ceram•X™). Restorations of both materials were clinically acceptable after 5 years. This study did not find any advantage of the silorane-based composite over the methacrylate-based composite, which indicates that the low-shrinkage of Filtek™ Silorane may not be a determinant factor for clinical success in class II cavities. This paper is the first to evaluate the 5-year clinical performance of a low-shrinkage composite material.

Assessment of Clinical Teachers' Professionalism in Iran: From Residents and Fellowships' Perspective.

PubMed

Garshasbi, Sima; Bahador, Hamidollah; Fakhraei, Nahid; Farbod, Abolfazl; Mohammadi, Maryam; Ahmady, Soleiman; Emami Razavi, Seyed Hassan

2017-01-01

In the present study, professional conduct of clinical teachers in Tehran University of Medical Sciences in Iran was assessed by their residents (n=292) and fellowships (n=48) using a standard questioner called self-reported measurement equipment. This evaluation was a descriptive cross-sectional study. Professionalism was questioned in four domains including clinical teacher-patient, clinical teacher-student, inter-professional and clinical teacher-self relationships. Accordingly, mean scores of the teachers in cases of clinical teacher-patient; clinical teacher-student, inter-professional (teamwork) and clinical teacher-self relations were 61%, 62.2%, 60.6% and 57.6%, respectively. Generally, the teachers achieved 60.35% of the positive scores, and as a result, they were assessed intermediate in the professional behaviors. The residents and fellowships stated that they were not completely satisfied with their teacher's professional conduct and had hidden concerns. It shows that the clinical teachers in our project may not be ideal role models. As a result, developing a comprehensive professionalism and implementing regulations to ensure a successful professionalism are necessary. The precise evaluation of professional conduct in clinical faculty could encourage the maintenance of professional behaviors and potentially decrease negative role modeling and positively influence the hidden curriculums. Operational approaches to formulating regulations and appropriate measures for establishing professional ethics are of great importance.

Evaluation of a Standardized Extract from Morus alba against α-Glucosidase Inhibitory Effect and Postprandial Antihyperglycemic in Patients with Impaired Glucose Tolerance: A Randomized Double-Blind Clinical Trial

PubMed Central

Hwang, Seung Hwan; Li, Hong Mei; Wang, Zhiqiang

2016-01-01

To evaluate the antihyperglycemic effect of a standardized extract of the leaves of Morus alba (SEMA), the present study was designed to investigate the α-glucosidase inhibitory effect and acute single oral toxicity as well as evaluate blood glucose reduction in animals and in patients with impaired glucose tolerance in a randomized double-blind clinical trial. SEMA was found to inhibit α-glucosidase at a fourfold higher level than the positive control (acarbose), in a concentration-dependent manner. Moreover, blood glucose concentration was suppressed by SEMA in vivo. Clinical signs and weight changes were observed when conducting an evaluation of the acute toxicity of SEMA through a single-time administration, with clinical observation conducted more than once each day. After administration of the SEMA, observation was for 14 days; all of the animals did not die and did not show any abnormal symptoms. In addition, the inhibitory effects of rice coated with SEMA were evaluated in a group of impaired glucose tolerance patients on postprandial glucose and a group of normal persons, and results showed that SEMA had a clear inhibitory effect on postprandial hyperglycemia in both groups. Overall, SEMA showed excellent potential in the present study as a material for improving postprandial hyperglycemia. PMID:27974904

Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

ERIC Educational Resources Information Center

Kelly, Peter James

2010-01-01

The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…

Accuracy of physical examination for chronic lumbar radiculopathy

PubMed Central

2013-01-01

Background Clinical examination of patients with chronic lumbar radiculopathy aims to clarify whether there is nerve root impingement. The aims of this study were to investigate the association between findings at clinical examination and nerve root impingement, to evaluate the accuracy of clinical index tests in a specialised care setting, and to see whether imaging clarifies the cause of chronic radicular pain. Methods A total of 116 patients referred with symptoms of lumbar radiculopathy lasting more than 12 weeks and at least one positive index test were included. The tests were the straight leg raising test, and tests for motor muscle strength, dermatome sensory loss, and reflex impairment. Magnetic resonance imaging (n = 109) or computer tomography (n = 7) were imaging reference standards. Images were analysed at the level of single nerve root(s), and nerve root impingement was classified as present or absent. Sensitivities, specificities, and positive and negative likelihood ratios (LR) for detection of nerve root impingement were calculated for each individual index test. An overall clinical evaluation, concluding on the level and side of the radiculopathy, was performed. Results The prevalence of disc herniation was 77.8%. The diagnostic accuracy of individual index tests was low with no tests reaching positive LR >4.0 or negative LR <0.4. The overall clinical evaluation was slightly more accurate, with a positive LR of 6.28 (95% CI 1.06–37.21) for L4, 1.74 (95% CI 1.04–2.93) for L5, and 1.29 (95% CI 0.97–1.72) for S1 nerve root impingement. An overall clinical evaluation, concluding on the level and side of the radiculopathy was also performed, and receiver operating characteristic (ROC) analysis with area under the curve (AUC) calculation for diagnostic accuracy of this evaluation was performed. Conclusions The accuracy of individual clinical index tests used to predict imaging findings of nerve root impingement in patients with chronic lumbar radiculopathy is low when applied in specialised care, but clinicians’ overall evaluation improves diagnostic accuracy slightly. The tests are not very helpful in clarifying the cause of radicular pain, and are therefore inaccurate for guidance in the diagnostic workup of the patients. The study population was highly selected and therefore the results from this study should not be generalised to unselected patient populations in primary care nor to even more selected surgical populations. PMID:23837886

An evaluation of multimedia and online support groups (OSG) contents and application of information by infertile patients: Mixed method study

NASA Astrophysics Data System (ADS)

Wiweko, Budi; Narasati, Shabrina; Agung, Prince Gusti; Zesario, Aulia; Wibawa, Yohanes Satrya; Maidarti, Mila; Harzif, Achmad Kemal; Pratama, Gita; Sumapradja, Kanadi; Muharam, Raden; Hestiantoro, Andon

2018-02-01

Background: The presence of Online Support Groups (OSG) is expected to empower patients with infertility, thus allowing patients to be the focus of healthcare services. This study will evaluate multimedia content, OSG, and utilization of information for decision-making by patients using infertility services. This study is a mixed method study conducted from January - June 2016 at Yasmin IVF Clinic, Dr. Cipto Mangunkusumo General Hospital; and SMART IVF Clinic, Jakarta. The subjects are patients with infertility who sought treatment at the clinics. Data was collected through a structured interview in the form of a questionnaire. Informed consent was obtained from all individual participants included in the study. All procedures that performed in studies were by the ethical standards of the institutional. The result from 72 respondents showed quantitative analysis did not reveal any association between multimedia and OSG information sources with patient knowledge regarding infertility management. However, qualitative analysis highlighted three issues: the information regarding infertility services in the available multimedia and the OSG; use of the available information by patients when deciding to use infertility services. The level of awareness of respondents on searching information regarding infertility on the clinic website is still limited. It happened because most of the patients in the clinic are unaware of clinic website existence which provided the infertility information. Therefore, the clinic website needs to be promoted so the usage of this website will increase in the future.

eTACTS: a method for dynamically filtering clinical trial search results.

PubMed

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-12-01

Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

eTACTS: A Method for Dynamically Filtering Clinical Trial Search Results

PubMed Central

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-01-01

Objective Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. Materials and Methods eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. Results eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. Discussion eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. Conclusion A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. PMID:23916863

Evaluation of a Clinical Pharmacist Intervention on Clinical and Drug-Related Problems Among Coronary Heart Disease Inpatients: A pre-experimental prospective study at a general hospital in Indonesia.

PubMed

Sagita, Vina A; Bahtiar, Anton; Andrajati, Retnosari

2018-02-01

This study aimed to evaluate the role of a clinical pharmacist intervention in decreasing subsequent clinical and drug-related problems (DRPs) among coronary heart disease (CHD) inpatients with at least one previous DRP. This pre-experimental study with a pre-post design was carried out from January to April 2017 among inpatients with at least one previous DRP at a general hospital in Tangerang District, Banten, Indonesia. Clinical and DRPs were documented prospectively by a clinical pharmacist, with DRPs classified using Version 6.2 of the DRP classification scheme of the Pharmaceutical Care Network Europe Foundation. The intervention consisted of a discussion of identified DRPs with physicians, patients, pharmaceutical logistics clerks, nurses and nutritionists. Following this, any subsequent clinical and DRPs were re-identified and further interventions were conducted as necessary. A total of 75 inpatients were included in the study. Pre-intervention, there were 443 DRPs and 202 clinical problems. The most frequent DRPs were adverse drug reactions (52.6%), followed by drug effects (41.8%). Most DRPs were of moderate severity and would have resulted in moderate consequences had the pharmacist not intervened. The interventions resulted in a significant reduction in the number of DRPs, type of DRPs and number of clinical problems ( P <0.05 each). Patients with complications were 26.047 times more likely to have no reduction or an increased number of clinical problems compared to patients without complications ( P <0.05). Clinical pharmacist interventions were found to reduce subsequent DRPs and clinical problems among CHD patients with at least one previous DRP.

Rating the raters: assessing the quality of Hamilton rating scale for depression clinical interviews in two industry-sponsored clinical drug trials.

PubMed

Engelhardt, Nina; Feiger, Alan D; Cogger, Kenneth O; Sikich, Dawn; DeBrota, David J; Lipsitz, Joshua D; Kobak, Kenneth A; Evans, Kenneth R; Potter, William Z

2006-02-01

The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar multicenter, randomized, placebo-controlled depression trials sponsored by 2 pharmaceutical companies. A total of 104 audiotaped HAM-D clinical interviews were evaluated by a blinded expert reviewer for interview quality using the Rater Applied Performance Scale (RAPS). The RAPS assesses adherence to a structured interview guide, clarification of and follow-up to patient responses, neutrality, rapport, and adequacy of information obtained. HAM-D interviews were brief and cursory and the quality of interviews was below what would be expected in a clinical drug trial. Thirty-nine percent of the interviews were conducted in 10 minutes or less, and most interviews were rated fair or unsatisfactory on most RAPS dimensions. Results from our small sample illustrate that the clinical interview skills of raters who administered the HAM-D were below what many would consider acceptable. Evaluation and training of clinical interview skills should be considered as part of a rater training program.

Evaluation of a clinical needs assessment and exploration of the associated supports for students with a disability in clinical practice: part 2.

PubMed

Howlin, Frances; Halligan, Phil; O'Toole, Sinead

2014-09-01

Engagement and successful completion of nursing and midwifery programmes may be predicated on the identification and implementation of reasonable accommodations to facilitate clinical learning for students with a disability. This qualitative study aims to evaluate a clinical needs assessment for students with a disability and explore their experiences of support in clinical practice. A purposive sample of year one undergraduate students was used. Four students consented to participate and undertook an individual interview. Their disabilities were categorised as specific learning disability (dyslexia) (n = 3) and mental health (n = 1). Data analysis revealed two main themes 'students' experiences of disclosure' and 'receiving support'. Findings revealed that all students disclosed on placement, however, the extent of disclosure was influenced by personal and environmental factors. Students used the clinical needs assessment to highlight accommodations to clinical staff on placement. Issues of concern that arose, included communication between all key stakeholders, negative staff attitudes and the need to improve the provision of accommodations. This preliminary evaluation indicates that the Clinical Needs Assessment bridges the gap in provision of student support between higher education and healthcare institutions. Findings suggest that competence based needs assessments can identify individualised reasonable accommodations for students undertaking clinical placements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Evaluations of refraction competencies of ophthalmic technicians in Mozambique.

PubMed

Shah, Kajal; Naidoo, Kovin; Chagunda, Margarida; Loughman, James

2016-01-01

Ophthalmic technicians (OT) work at health facilities in Mozambique and are trained to provide primary and secondary eye care services including basic refraction. This study was designed to assess OT competence and confidence in refraction, and investigate whether an upskilling programme is effective in developing their competence and confidence at refraction. Thirty-one trainee OTs and 16 qualified OTs were recruited to the study. A background questionnaire was administered to determine the demographic profile of the OTs. A confidence levels questionnaire explored their self-reported skills. Clinical competencies were assessed in relation to knowledge (theory exam) and clinical skills (patient exams). 11 OTs were upskilled and the clinical evaluations carried out post training. Initial evaluations demonstrated that confidence and competence levels varied depending on the OTs training (location and duration), and their location of work (clinical load, availability of equipment and other eye care personnel). The qualified OTs were more competent than trainee OTs in most of the evaluations. Post upskilling results demonstrated significant positive impact on confidence and competence levels. These evaluations identified factors affecting the refraction competencies of the OTs and demonstrated that upskilling is effective in improving confidence and competence levels for refraction. They demonstrate the need for a refraction competency framework. The overarching aim of this research was to inform the development of a nationwide programme of OT mentoring, upskilling and leading to the establishment of clinical competency standards for the new OT curricula, relevant to the professional demands. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Measuring team-based interprofessional education outcomes in clinical dentistry: psychometric evaluation of a new scale at an Australian dental school.

PubMed

Storrs, Mark J; Alexander, Heather; Sun, Jing; Kroon, Jeroen; Evans, Jane L

2015-03-01

Previous research on interprofessional education (IPE) assessment has shown the need to evaluate the influence of team-based processes on the quality of clinical education. This study aimed to develop a valid and reliable instrument to evaluate the effectiveness of interprofessional team-based treatment planning (TBTP) on the quality of clinical education at the Griffith University School of Dentistry and Oral Health, Queensland, Australia. A scale was developed and evaluated to measure interprofessional student team processes and their effect on the quality of clinical education for dental, oral health therapy, and dental technology students (known more frequently as intraprofessional education). A face validity analysis by IPE experts confirmed that items on the scale reflected the meaning of relevant concepts. After piloting, 158 students (61% response rate) involved with TBTP participated in a survey. An exploratory factor analysis using the principal component method retained 23 items with a total variance of 64.6%, suggesting high content validity. Three subscales accounted for 45.7%, 11.4%, and 7.5% of the variance. Internal consistency of the scale (α=0.943) and subscales 1 (α=0.953), 2 (α=0.897), and 3 (α=0.813) was high. A reliability analysis yielded moderate (rs=0.43) to high correlations (0.81) with the remaining scale items. Confirmatory factor analyses verified convergent validity and confirmed that this structure had a good model fit. This study suggests that the instrument might be useful in evaluating interprofessional or intraprofessional team-based processes and their influence on the quality of clinical education in academic dental institutions.

Micrometastases in neuroblastoma: are they clinically important?

PubMed Central

Burchill, S A

2004-01-01

Despite advances in the treatment of neuroblastoma (NBL), recurrence and metastases continue to pose major problems in clinical management. The relation between micrometastases and the development of secondary disease is not fully understood. However, accurate methods to detect low numbers of tumour cells may allow the evaluation of their role in the disease process, and by implication the possible benefits of eliminating them. Although there is substantial evidence for the increased sensitivity of current molecular methods for the detection of NBL cells compared with more conventional cytology, the clinical relevance and usefulness of detecting this disease remain controversial. The primary goal of current translational research must be to evaluate the clinical relevance of micrometastatic disease detected by these methods in multicentre prospective clinical outcome studies. Only then can the clinical usefulness of these methods be defined so that they may be introduced into relevant clinical practice. PMID:14693828

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.

Reliability and Validity of the KIPPPI: An Early Detection Tool for Psychosocial Problems in Toddlers

PubMed Central

Kruizinga, Ingrid; Jansen, Wilma; de Haan, Carolien L.; Raat, Hein

2012-01-01

Background The KIPPPI (Brief Instrument Psychological and Pedagogical Problem Inventory) is a Dutch questionnaire that measures psychosocial and pedagogical problems in 2-year olds and consists of a KIPPPI Total score, Wellbeing scale, Competence scale, and Autonomy scale. This study examined the reliability, validity, screening accuracy and clinical application of the KIPPPI. Methods Parents of 5959 2-year-old children in the Rotterdam area, the Netherlands, were invited to participate in the study. Parents of 3164 children (53.1% of all invited parents) completed the questionnaire. The internal consistency was evaluated and in subsamples the test-retest reliability and concurrent validity with regard to the Child Behavioral Checklist (CBCL). Discriminative validity was evaluated by comparing scores of parents who worried about their child’s upbringing and parent’s that did not. Screening accuracy of the KIPPPI was evaluated against the CBCL by calculating the Receiver Operating Characteristic (ROC) curves. The clinical application was evaluated by the relation between KIPPPI scores and the clinical decision made by the child health professionals. Results Psychometric properties of the KIPPPI Total score, Wellbeing scale, Competence scale and Autonomy scale were respectively: Cronbach’s alphas: 0.88, 0.86, 0.83, 0.58. Test-retest correlations: 0.80, 0.76, 0.73, 0.60. Concurrent validity was as hypothesised. The KIPPPI was able to discriminate between parents that worried about their child and parents that did not. Screening accuracy was high (>0.90) for the KIPPPI Total score and for the Wellbeing scale. The KIPPPI scale scores and clinical decision of the child health professional were related (p<0.05), indicating a good clinical application. Conclusion The results in this large-scale study of a diverse general population sample support the reliability, validity and clinical application of the KIPPPI Total score, Wellbeing scale and Competence scale. Also, the screening accuracy of the KIPPPI Total score and Wellbeing scale were supported. The Autonomy scale needs further study. PMID:23185388

A practical model for economic evaluation of tissue-engineered therapies.

PubMed

Tan, Tien-En; Peh, Gary S L; Finkelstein, Eric A; Mehta, Jodhbir S

2015-01-01

Tissue-engineered therapies are being developed across virtually all fields of medicine. Some of these therapies are already in clinical use, while others are still in clinical trials or the experimental phase. Most initial studies in the evaluation of new therapies focus on demonstration of clinical efficacy. However, cost considerations or economic viability are just as important. Many tissue-engineered therapies have failed to be impactful because of shortcomings in economic competitiveness, rather than clinical efficacy. Furthermore, such economic viability studies should be performed early in the process of development, before significant investment has been made. Cost-minimization analysis combined with sensitivity analysis is a useful model for the economic evaluation of new tissue-engineered therapies. The analysis can be performed early in the development process, and can provide valuable information to guide further investment and research. The utility of the model is illustrated with the practical real-world example of tissue-engineered constructs for corneal endothelial transplantation. The authors have declared no conflicts of interest for this article. © 2015 Wiley Periodicals, Inc.

Integrating service development with evaluation in telehealthcare: an ethnographic study.

PubMed

Finch, Tracy; May, Carl; Mair, Frances; Mort, Maggie; Gask, Linda

2003-11-22

To identify issues that facilitate the successful integration of evaluation and development of telehealthcare services. Ethnographic study using various qualitative research techniques to obtain data from several sources, including in-depth semistructured interviews, project steering group meetings, and public telehealthcare meetings. Seven telehealthcare evaluation projects (four randomised controlled trials and three pragmatic service evaluations) in the United Kingdom, studied over two years. Projects spanned a range of specialties-dermatology, psychiatry, respiratory medicine, cardiology, and oncology. Clinicians, managers, technical experts, and researchers involved in the projects. Key problems in successfully integrating evaluation and service development in telehealthcare are, firstly, defining existing clinical practices (and anticipating changes) in ways that permit measurement; secondly, managing additional workload and conflicting responsibilities brought about by combining clinical and research responsibilities (including managing risk); and, thirdly, understanding various perspectives on effectiveness and the limitations of evaluation results beyond the context of the research study. Combined implementation and evaluation of telehealthcare systems is complex, and is often underestimated. The distinction between quantitative outcomes and the workability of the system is important for producing evaluative knowledge that is of practical value. More pragmatic approaches to evaluation, that permit both quantitative and qualitative methods, are required to improve the quality of such research and its relevance for service provision in the NHS.

Comparison of Efficacy Between Endoscopic Cyclophotocoagulation and Alternative Surgeries in Refractory Glaucoma

PubMed Central

Yang, Yangfan; Zhong, Jing; Dun, Zhongjun; Liu, Xiao-an; Yu, Minbin

2015-01-01

Abstract Refractory glaucoma refers to uncontrolled intraocular pressure (IOP) despite anti-glaucoma medication and surgical treatment, which remains a challenge to be treated. The objective of this study is to evaluate and statistically compare the clinical efficacy between endoscopic cyclophotocoagulation (ECP) and alternative surgical techniques in the treatment of refractory glaucoma in this article, as a meta-analysis. Data sources are China Biomedical Database (Sinomed, online version), China National Knowledge Infrastructure (CNKI), Cqvip, Wanfang database, and PubMed. The randomized controlled trial (RCT) and case–control study literatures evaluating the clinical efficacy between ECP and other surgical techniques were searched electronically from public databases. The methodology quality of the retrieved articles was evaluated according to the RCT or case–control study criteria. The success rate of treatment, intraocular pressure (IOP) and visual acuity were statistically compared. RevMan 5.3 software was used for the meta-analysis. In total, 6 relevant control studies were selected in this study with a total sampling of 429 cases (429 eyes), including 204 eyes in the ECP group and 225 in the non-ECP group. Meta-analysis demonstrated that the clinical efficacy did not significantly differ between 2 groups (P > 0.05). Postoperative IOP was dramatically reduced in both groups. However, it was difficult to evaluate the combined influence of ECP and non-ECP therapies upon IOP reduction. In conclusion, ECP and non-ECP treatment yielded almost equivalent clinical efficacy in treating refractory glaucoma. The IOP-lowering degree, safety, and incidence of complications remain to be further elucidated by RCTs with a larger sample size. PMID:26426659

The assessment, serial evaluation, and subsequent sequelae of acute kidney injury (ASSESS-AKI) study: design and methods.

PubMed

Go, Alan S; Parikh, Chirag R; Ikizler, T Alp; Coca, Steven; Siew, Edward D; Chinchilli, Vernon M; Hsu, Chi-Yuan; Garg, Amit X; Zappitelli, Michael; Liu, Kathleen D; Reeves, W Brian; Ghahramani, Nasrollah; Devarajan, Prasad; Faulkner, Georgia Brown; Tan, Thida C; Kimmel, Paul L; Eggers, Paul; Stokes, John B

2010-08-27

The incidence of acute kidney injury (AKI) has been increasing over time and is associated with a high risk of short-term death. Previous studies on hospital-acquired AKI have important methodological limitations, especially their retrospective study designs and limited ability to control for potential confounding factors. The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study was established to examine how a hospitalized episode of AKI independently affects the risk of chronic kidney disease development and progression, cardiovascular events, death, and other important patient-centered outcomes. This prospective study will enroll a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at three Clinical Research Centers, as well as 100 children undergoing cardiac surgery at three Clinical Research Centers. Participants will be followed for up to four years, and will undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens will be collected at each visit, along with information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography and urinalysis. ASSESS-AKI will characterize the short-term and long-term natural history of AKI, evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI, and identify a subset of high-risk patients who could be targeted for future clinical trials to improve outcomes after AKI.

Characteristics of antimicrobial studies registered in the USA through ClinicalTrials.Gov

PubMed Central

Stockmann, Chris; Sherwin, Catherine M.T.; Ampofo, Krow; Hersh, Adam L.; Pavia, Andrew T.; Byington, Carrie L.; Ward, Robert M.; Spigarelli, Michael G.

2013-01-01

Increasing rates of antimicrobial-resistant infections and the dwindling pipeline of new agents necessitate judicious, evidence-based antimicrobial prescribing. Clinical trials represent a vital resource for establishing evidence of safety and efficacy, which are crucial to guiding antimicrobial treatment decisions. The objective of this study was to comprehensively evaluate the characteristics of antimicrobial research studies registered in ClinicalTrials.gov. Primary outcome measures, funding sources, inclusion criteria and the reporting of study results were evaluated for 16 055 antimicrobial studies registered in ClinicalTrials.gov as of mid 2012. Interventional studies accounted for 93% of registered antimicrobial studies. Clinical trials of drugs (82%) and biologics (9%) were most common. Antibacterial, antiviral and antifungal studies accounted for 43%, 41% and 16% of drug trials, respectively. Among interventional drug trials, 73% featured randomised allocation to study arms and 71% included measures of safety and/or efficacy as primary endpoints. Children were eligible for enrolment in 26% of studies. Among the studies, 60% were sponsored primarily by non-profit organisations, 30% by industry and 10% by the federal government. Only 7% of studies reported results; however, 71% of these were sponsored primarily by industry. Antimicrobial studies commonly incorporated elements of high-quality trial design, including randomisation and safety/efficacy endpoints. Publication of study results and updating of ClinicalTrials.gov should be encouraged for all studies, with particular attention paid to research sponsored by non-profit organisations and governmental agencies. Leveraging the application of these data to guide the careful selection of antimicrobial agents will be essential to preserve their utility for years to come. PMID:23726436

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up.

PubMed

Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M

2016-01-01

In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan-Meier method. None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study.

Evaluation of Diagnostic Values of Clinical Assessment in Determining the Maturation of Arteriovenous Fistulas for Satisfactory Hemodialysis.

PubMed

Salimi, Fereshteh; Shahabi, Shahab; Talebzadeh, Hamid; Keshavarzian, Amir; Pourfakharan, Mohammad; Safaei, Mansour

2017-01-01

Fistulas are the preferred permanent hemodialysis vascular access, but a significant obstacle to increasing their prevalence is the fistula's high "failure to mature" (FTM) rate. This study aimed to identify postoperative clinical characteristics that are predictive of fistula FTM. This descriptive cross-sectional study was performed on 80 end-stage renal disease patients who referred to Al Zahra Hospital, Isfahan, for brachiocephalic fistula placement. After 4 weeks, the clinical criteria (trill, firmness, vein length, and venous engorgement) examined and the fistulas situation divided to favorable or unfavorable by each criterion, and the results comprised with dialysis possibility. Data were analyzed with SPSS version 21. Diagnostic index for CLINICAL examination was calculated. Among the 80 cases, 25 (31.2%) female and 55 (68.8%) male were studied with the mean age of 51.9 (standard deviation = 17) year ranged between 18 and 86 years old. Sixty-two (77.5%) cases had successful hemodialysis. All four clinical assessments were significantly more acceptable in patients with successful dialysis ( P < 0.001). According to the results of our study, the accuracy of all physical assessments was above 70% and except vein length other criteria had a sensitivity and negative predictive value of 100%. In this study, firmness of vein has highest specificity and positive predictive value (83.9% and 64.3%, respectively). Results of our study showed that high sensitivity and relatively low specificity of the clinical criterion. It means that unfavorable results of each clinical criterion predict unfavorable dialysis. Clinical evaluation of a newly created fistula 4-6 weeks after surgery should be considered mandatory.

A critical evaluation of the clinical evidence for pomegranate preparations in the prevention and treatment of cardiovascular diseases.

PubMed

Vlachojannis, Christian; Erne, Paul; Schoenenberger, Andreas W; Chrubasik-Hausmann, Sigrun

2015-04-01

This study attempts a critical evaluation of the clinical evidence behind the use of dietary pomegranate preparations in the prevention and treatment of cardiovascular diseases. A search of PubMed on August 10, 2014 identified 228 references, which yielded extractable data from 24 clinical studies of pomegranate preparations. Hand searching identified two further studies. The quality of the studies and evidence of effectiveness of pomegranate were assessed by an established set of conventional criteria. Overall, the study quality was poor. Even in the best studies, indications of benefit did not reach the conventional levels of statistical significance. The only study with a definitive design had a biochemical rather than a clinical endpoint: it showed the expected difference in blood concentrations of myeloperoxidase after a single dose of either pomegranate or placebo. Only 10 of the 26 studies provided HPLC data on the amounts of co-active ingredients in the preparations that were consumed by the subjects. If pomegranate has a role in the prevention and treatment of cardiovascular diseases, there is a pressing need for dose-finding and long-term confirmatory studies. The ultimate endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques would be useful surrogates. Sample sizes for various assumptions are provided. Future studies need to prove the clinical benefit. Copyright © 2015 John Wiley & Sons, Ltd.

Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

PubMed

Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

2015-04-01

This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Effectiveness of vaginal breech birth training strategies: An integrative review of the literature.

PubMed

Walker, Shawn; Breslin, Eamonn; Scamell, Mandie; Parker, Pam

2017-06-01

The safety of vaginal breech birth depends on the skill of the attendant. The objective of this review was to identify, synthesize, and report the findings of evaluated breech birth training strategies. A systematic search of the following on-line databases: Medline, CINAHL Plus, PsychINFO, EBM Reviews/Cochrane Library, EMBASE, Maternity and Infant Care, and Pubmed, using a structured search strategy. Studies were included in the review if they evaluated the efficacy of a breech birth training program or particular strategies, including obstetric emergency training evaluations that reported differentiated outcomes for breech. Out of 1040 original citings, 303 full-text articles were assessed for eligibility, and 17 methodologically diverse studies met the inclusion criteria. A data collection form was used to extract relevant information. Data were synthesized, using an evaluation levels framework, including reaction, learning (subjective and objective assessment), and behavioral change. No evaluations included clinical outcome data. Improvements in self-assessed skill and confidence were not associated with improvements in objective assessments or behavioral change. Inclusion of breech birth as part of an obstetric emergencies training package without support in practice was negatively associated with subsequent attendance at vaginal breech births. As a result of the heterogeneity of the studies available, and the lack of evidence concerning neonatal or maternal outcomes, no conclusive practice recommendations can be made. However, the studies reviewed suggest that vaginal breech birth training may be enhanced by reflection, repetition, and experienced clinical support in practice. Further evaluation studies should prioritize clinical outcome data. © 2017 Wiley Periodicals, Inc.

The ART of social networking: how SART member clinics are connecting with patients online.

PubMed

Omurtag, Kenan; Jimenez, Patricia T; Ratts, Valerie; Odem, Randall; Cooper, Amber R

2012-01-01

To study and describe the use of social networking websites among Society for Assisted Reproductive Technology (SART) member clinics. Cross-sectional study. University-based practice. Not applicable. Not applicable. Prevalence of social networking websites among SART member clinics and evaluation of content, volume, and location (i.e., mandated state, region) using multivariate regression analysis. A total of 384 SART-registered clinics and 1,382 social networking posts were evaluated. Of the clinics, 96% had a website and 30% linked to a social networking website. The majority of clinics (89%) with social networking websites were affiliated with nonacademic centers. Social networking posts mostly provided information (31%) and/or advertising (28%), and the remaining offered support (19%) or were irrelevant (17%) to the target audience. Only 5% of posts involved patients requesting information. Clinic volume correlated with the presence of a clinic website and a social networking website. Almost all SART member clinics have a website. Nearly one-third of these clinics host a social networking website such as Facebook, Twitter, and/or a blog. Large-volume clinics commonly host social networking websites. These sites provide new ways to communicate with patients, but clinics should maintain policies on the incorporation of social networks into practice. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Clinical leadership and pre-registration nursing programmes: A model for clinical leadership and a prospective curriculum implementation and evaluation research strategy.

PubMed

Brown, Angela; Dewing, Jan; Crookes, Patrick

2016-07-01

To present for wider debate a conceptual model for clinical leadership development in pre-registration nursing programmes and a proposed implementation plan. Globally, leadership in nursing has become a significant issue. Whilst there is continued support for leadership preparation in pre-registration nursing programmes, there have been very few published accounts of curriculum content and/or pedagogical approaches that foster clinical leadership development in pre-registration nursing. A doctoral research study has resulted in the creation of an overarching model for clinical leadership. A multi-method research study using theoretical and empirical literature 1974-2015, a focus group, expert opinion and a national on-line survey. A conceptual model of clinical leadership development in pre-registration nursing programme is presented, including the infinity loop of clinical leadership, an integral curriculum thread and a conceptual model: a curriculum-pedagogy nexus for clinical leadership. In order to test out usability and evaluate effectiveness, a multi method programme of research in one school of nursing in Australia is outlined. Implementation of the proposed conceptual model for clinical leadership development in pre-registration nursing programmes and a programme of (post-doctoral) research will contribute to what is known about curriculum content and pedagogy for nurse academics. Importantly, for nursing students and the profession as a whole, there is a clearer expectation of what clinical leadership might look like in the novice registered nurse. For nurse academics a model is offered for consideration in curriculum design and implementation with an evaluation strategy that could be replicated. Copyright © 2016 Elsevier Ltd. All rights reserved.

Harmonization of blood-based indicators of iron status: making the hard work matter.

PubMed

Hoofnagle, Andrew N

2017-12-01

Blood-based indicators that are used in the assessment of iron status are assumed to be accurate. In practice, inaccuracies in these measurements exist and stem from bias and variability. For example, the analytic variability of serum ferritin measurements across laboratories is very high (>15%), which increases the rate of misclassification in clinical and epidemiologic studies. The procedures that are used in laboratory medicine to minimize bias and variability could be used effectively in clinical research studies, particularly in the evaluation of iron deficiency and its associated anemia in pregnancy and early childhood and in characterizing states of iron repletion and excess. The harmonization and standardization of traditional and novel bioindicators of iron status will allow results from clinical studies to be more meaningfully translated into clinical practice by providing a firm foundation for clinical laboratories to set appropriate cutoffs. In addition, proficiency testing monitors the performance of the methods over time. It is important that measures of iron status be evaluated, validated, and performed in a manner that is consistent with standard procedures in laboratory medicine. © 2017 American Society for Nutrition.

Evaluating markers for the early detection of cancer: overview of study designs and methods.

PubMed

Baker, Stuart G; Kramer, Barnett S; McIntosh, Martin; Patterson, Blossom H; Shyr, Yu; Skates, Steven

2006-01-01

The field of cancer biomarker development has been evolving rapidly. New developments both in the biologic and statistical realms are providing increasing opportunities for evaluation of markers for both early detection and diagnosis of cancer. To review the major conceptual and methodological issues in cancer biomarker evaluation, with an emphasis on recent developments in statistical methods together with practical recommendations. We organized this review by type of study: preliminary performance, retrospective performance, prospective performance and cancer screening evaluation. For each type of study, we discuss methodologic issues, provide examples and discuss strengths and limitations. Preliminary performance studies are useful for quickly winnowing down the number of candidate markers; however their results may not apply to the ultimate target population, asymptomatic subjects. If stored specimens from cohort studies with clinical cancer endpoints are available, retrospective studies provide a quick and valid way to evaluate performance of the markers or changes in the markers prior to the onset of clinical symptoms. Prospective studies have a restricted role because they require large sample sizes, and, if the endpoint is cancer on biopsy, there may be bias due to overdiagnosis. Cancer screening studies require very large sample sizes and long follow-up, but are necessary for evaluating the marker as a trigger of early intervention.

Evaluation of a pediatric liquid formulation to improve 6-mercaptopurine therapy in children.

PubMed

Tiphaine, Adam de Beaumais; Hjalgrim, Lisa Lynqsie; Nersting, Jacob; Breitkreutz, Joerg; Nelken, Brigitte; Schrappe, Martin; Stanulla, Martin; Thomas, Caroline; Bertrand, Yves; Leverger, Guy; Baruchel, André; Schmiegelow, Kjeld; Jacqz-Aigrain, Evelyne

2016-02-15

6-mercaptopurine (6-MP), a key drug for treatment of acute lymphoblastic leukemia (ALL), has until recently had no adequate formulation for pediatric patients. Several approaches have been taken but the only oral paraben-free 6-MP liquid formulation named Loulla was developed and evaluated in the target population. Preclinical and clinical evaluations were performed according to a Pediatric Investigation Plan, in order to apply for a Pediatric Use Marketing Authorization. The pre-clinical study assessed the maximum tolerated dosage-volume and evaluated local mucosal toxicity of 28 daily administrations in treated compared to controls gold hamsters. The multi-centre clinical study was single-dose, open-label, crossover trial, conducted in 15 ALL children during maintenance therapy. The bioavailability and palatability of a single 50mg fixed dose of Loulla compared to 50mg registered tablets were evaluated in a random order on two consecutive days. Seven blood samples over 9h were obtained each day to determine 6-MP pharmacokinetic parameters, including Tmax, Cmax, AUC0-9 and AUC0-∞. A questionnaire adapted to children testing Loulla palatability and preference for either Loulla or the usual 6-MP tablet was completed. Occurrence of adverse events was determined at study visits by vital sign measurements, patient's spontaneous reporting, investigator's questioning and clinical examination. The preclinical study in gold hamsters showed that dosage-volume of 75 mg/kg/day was well tolerated. The relative bioavailability of liquid Loulla formulation compared to the reference presentation is 76% for AUC0-9 and AUC0-∞ and 80% for Cmax. The taste of Loulla and the mouth feeling after ingestion compare favorably to the tablet. No adverse event occurred. Pharmacokinetic, palatability and safety data support the use of Loulla in children. Copyright © 2015 Elsevier B.V. All rights reserved.

Reporting standards for Bland-Altman agreement analysis in laboratory research: a cross-sectional survey of current practice.

PubMed

Chhapola, Viswas; Kanwal, Sandeep Kumar; Brar, Rekha

2015-05-01

To carry out a cross-sectional survey of the medical literature on laboratory research papers published later than 2012 and available in the common search engines (PubMed, Google Scholar) on the quality of statistical reporting of method comparison studies using Bland-Altman (B-A) analysis. Fifty clinical studies were identified which had undertaken method comparison of laboratory analytes using B-A. The reporting of B-A was evaluated using a predesigned checklist with following six items: (1) correct representation of x-axis on B-A plot, (2) representation and correct definition of limits of agreement (LOA), (3) reporting of confidence interval (CI) of LOA, (4) comparison of LOA with a priori defined clinical criteria, (5) evaluation of the pattern of the relationship between difference (y-axis) and average (x-axis) and (6) measures of repeatability. The x-axis and LOA were presented correctly in 94%, comparison with a priori clinical criteria in 74%, CI reporting in 6%, evaluation of pattern in 28% and repeatability assessment in 38% of studies. There is incomplete reporting of B-A in published clinical studies. Despite its simplicity, B-A appears not to be completely understood by researchers, reviewers and editors of journals. There appear to be differences in the reporting of B-A between laboratory medicine journals and other clinical journals. A uniform reporting of B-A method will enhance the generalizability of results. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

PubMed

Chandra, Praveen; Kumar, Tarun

2014-01-01

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

A multi-institution evaluation of clinical profile anonymization

PubMed Central

Heatherly, Raymond; Rasmussen, Luke V; Peissig, Peggy L; Pacheco, Jennifer A; Harris, Paul; Denny, Joshua C

2016-01-01

Background and objective: There is an increasing desire to share de-identified electronic health records (EHRs) for secondary uses, but there are concerns that clinical terms can be exploited to compromise patient identities. Anonymization algorithms mitigate such threats while enabling novel discoveries, but their evaluation has been limited to single institutions. Here, we study how an existing clinical profile anonymization fares at multiple medical centers. Methods: We apply a state-of-the-art k-anonymization algorithm, with k set to the standard value 5, to the International Classification of Disease, ninth edition codes for patients in a hypothyroidism association study at three medical centers: Marshfield Clinic, Northwestern University, and Vanderbilt University. We assess utility when anonymizing at three population levels: all patients in 1) the EHR system; 2) the biorepository; and 3) a hypothyroidism study. We evaluate utility using 1) changes to the number included in the dataset, 2) number of codes included, and 3) regions generalization and suppression were required. Results: Our findings yield several notable results. First, we show that anonymizing in the context of the entire EHR yields a significantly greater quantity of data by reducing the amount of generalized regions from ∼15% to ∼0.5%. Second, ∼70% of codes that needed generalization only generalized two or three codes in the largest anonymization. Conclusions: Sharing large volumes of clinical data in support of phenome-wide association studies is possible while safeguarding privacy to the underlying individuals. PMID:26567325

Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

PubMed

Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

2015-01-01

Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, randomized, open-label study.

PubMed

West, Mike; Boulanger, Bernard R; Fogarty, Charles; Tennenberg, Alan; Wiesinger, Barbara; Oross, Margaret; Wu, Shu-Chen; Fowler, Cynthia; Morgan, Nancy; Kahn, James B

2003-02-01

Therapy of nosocomial pneumonia is usually empiric and includes > or = 1 broad-spectrum antimicrobial agent. When considering the use of fluoroquinolones in these difficult-to-treat infections--in which drug delivery to the site of infection may be impaired or organisms with higher minimum inhibitory concentrations may be present--an agent should be chosen whose pharmacodynamics ensure maximal drug exposure. Use of the 750-mg dose of levofloxacin should enhance therapeutic benefit in patients with nosocomial pneumonia. The goal of this study was to compare the efficacy and safety of levofloxacin 750 mg and imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia. This was a multicenter, prospective, randomized, open-label trial conducted in North America. Patients were randomly assigned to 1 of 2 treatment arms: levofloxacin 750 mg QD given i.v. and then orally for 7 to 15 days or imipenem/cilastatin 500 mg to 1 g i.v. every 6 to 8 hours, followed by oral ciprofloxacin 750 mg every 12 hours for 7 to 15 days. Adjunctive antibacterial therapy was mandatory in patients with documented or suspected Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus infection. The primary predefined outcome measure was the clinical response (cure, improvement, failure, or unable to evaluate) in microbiologically evaluable patients 3 to 15 days after the end of therapy. The study enrolled 438 adult patients (315 men, 123 women; mean [SD] age, 55.7 [20.04] years). Two hundred twenty patients received levofloxacin, and 218 received the comparator regimen. Demographic and baseline clinical characteristics were similar in the intent-to-treat and clinically evaluable populations. In patients evaluable for microbiologic efficacy, clinical success (cure or improvement) was achieved in 58.1% (54/93) of patients who received levofloxacin, compared with 60.6% (57/94) of patients who received the comparator regimen (95% CI, -12.0 to 17.2). Similar clinical results were seen in patients evaluable for clinical efficacy and in the intent-to-treat population. In the 187 patients evaluable for microbiologic efficacy, eradication was achieved in 66.7% (62/93) of patients receiving levofloxacin and 60.6% (57/94) of patients receiving the comparator regimen (95% CI, -20.3 to 8.3). In this study, levofloxacin was at least as effective and was as well tolerated as imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia, as demonstrated by comparable clinical and microbiologic success rates.

Exploring the acquisition of entry-to-practice competencies by second-degree nursing students during a preceptorship experience.

PubMed

Sedgwick, Monique; Kellett, Peter; Kalischuck, Ruth Grant

2014-03-01

Nursing programs across Canada have begun to implement at an unprecedented rate second-degree nursing programs in response to consumer demands and a nursing shortage. While these types of programs are enjoying considerable popularity among prospective students and employers, it is imperative that nursing programs assess their graduates' ability to meet Registered Nursing entry-to-practice competencies (ETCs). This study sought to determine if second-degree undergraduate nursing students achieved the entry-to-practice competencies established by the provincial regulatory body for registered nurses of Alberta, Canada. The study took place in southern Alberta, Canada as the first cohort of second-degree undergraduate nursing students were completing the final practice course for the program. In this exploratory study, quantitative and qualitative data generation approaches were used. Quantitative data were collected using the nursing program's standardized Clinical Evaluation Tool which is mapped to the 119 ETCs established by the regulatory body. Qualitative data were generated by conducting focus group interviews with students, faculty advisors, and preceptors. A convenience sample consisting of both male and female students (n=14) submitted their mid-term and final clinical evaluations for inclusion in the dataset. Thirteen preceptors submitted mid-term and final clinical evaluations. Three students, three faculty advisors, and two preceptors participated in focus group interviews. At mid-term, statistically significant differences were noted on 31% of the indicators within the clinical evaluation tool between students and preceptors with preceptors consistently ranking students higher than the students' ratings of their performance. Student and preceptor ratings of students' clinical performance were more consistent on the final evaluation. However, where there were differences, preceptors rated students higher than student ratings. Qualitative data analysis suggests that the concept of competence is complex and multifaceted and understood differently by students, preceptors, and advisors. The findings of this study suggest that there is ambiguity among second-degree students, preceptors and faculty advisors surrounding the concept of competence. In order to develop an understanding of competence, nursing program administrators must encourage faculty advisors, preceptors and students to engage in a discussion at the outset of the preceptored practice experience in regard to what is meant by competence within various practice setting. Further, we suggest nursing programs in collaboration with their clinical partners and re-examine their practice evaluation tools to determine the degree to which they are sensitive to the clinical practice context. Copyright © 2013 Elsevier Ltd. All rights reserved.

Efficacy of curcumin for age-associated cognitive decline: a narrative review of preclinical and clinical studies.

PubMed

Sarker, Marjana Rahman; Franks, Susan F

2018-04-21

Processes such as aberrant redox signaling and chronic low-grade systemic inflammation have been reported to modulate age-associated pathologies such as cognitive impairment. Curcumin, the primary therapeutic component of the Indian spice, Turmeric (Curcuma longa), has long been known for its strong anti-inflammatory and antioxidant activity attributable to its unique molecular structure. Recently, an interest in this polyphenol as a cognitive therapeutic for the elderly has emerged. The purpose of this paper is to critically review preclinical and clinical studies that have evaluated the efficacy of curcumin in ameliorating and preventing age-associated cognitive decline and address the translational progress of preclinical to clinical efficacy. PubMed, semantic scholar, and Google scholar searches were used for preclinical studies; and clinicaltrials.gov , the Australian and New Zealand clinical trials registry, and PubMed search were used to select relevant completed clinical studies. Results from preclinical studies consistently demonstrate curcumin and its analogues to be efficacious for various aspects of cognitive impairment and processes that contribute to age-associated cognitive impairment. Results of published clinical studies, while mixed, continue to show promise for curcumin's use as a therapeutic for cognitive decline but overall remain inconclusive at this time. Both in vitro and in vivo studies have found that curcumin can significantly decrease oxidative stress, systemic inflammation, and obstruct pathways that activate transcription factors that augment these processes. Future clinical studies would benefit from including evaluation of peripheral and cerebrospinal fluid biomarkers of dementia and behavioral markers of cognitive decline, as well as targeting the appropriate population.

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

PubMed Central

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

2017-01-01

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

Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial.

PubMed

de Resende, Daniel Romeu Benchimol; Greghi, Sebastião Luiz Aguiar; Siqueira, Aline Franco; Benfatti, César Augusto Magalhães; Damante, Carla Andreotti; Ragghianti Zangrando, Mariana Schutzer

2018-04-30

This split-mouth controlled randomized clinical trial evaluated clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG) for keratinized tissue augmentation. Twenty-five patients with the absence or deficiency of keratinized tissue (50 sites) were treated with FGG (control group) and ADM (test group). Clinical parameters included keratinized tissue width (KTW) (primary outcome), soft tissue thickness (TT), recession depth (RD), probing depth (PD), and clinical attachment level (CAL). Esthetic perception was evaluated by patients and by a calibrated periodontist using visual analog scale (VAS). Histological analysis included biopsies of five different patients from both test and control sites for each evaluation period (n = 25). The analysis included percentage of connective tissue components, epithelial luminal to basal surface ratio, tissue maturation, and presence of elastic fibers. Data were evaluated by ANOVA complemented by Tukey's tests (p < 0.05). After 6 months, PD and CAL demonstrated no differences between groups. ADM presented higher RD compared to FGG in all periods. Mean tissue shrinkage for control and test groups was 12.41 versus 55.7%. TT was inferior for ADM group compared to FGG. Esthetics perception by professional evaluation showed superior results for ADM. Histomorphometric analysis demonstrated higher percentage of cellularity, blood vessels, and epithelial luminal to basal surface ratio for FGG group. ADM group presented higher percentage of collagen fibers and inflammatory infiltrate. Both treatments resulted in improvement of clinical parameters, except for RD. ADM group presented more tissue shrinkage and delayed healing, confirmed histologically, but superior professional esthetic perception. This study added important clinical and histological data to contribute in the decision-making process between indication of FGG or ADM.

[Axillary hyperhidrosis--efficacy and tolerability of an aluminium chloride antiperspirant. Prospective evaluation on 20 patients with idiopathic axillary hyperhidrosis].

PubMed

Streker, M; Reuther, T; Verst, S; Kerscher, M

2010-02-01

The purpose of this study was to evaluate the efficacy and tolerability of aluminium chloride gel for treatment of axillary hyperhidrosis. A total of 20 patients aged 22-38 (mean age: 26.9+/-4.3) with idiopathic axillary hyperhidrosis were included and treated with an antiperspirant (Sweat-off, Sweat-off GmbH, Hügelsheim). Study duration was 42 days. Treatment efficacy was evaluated clinically, as well as by starch-iodine test, gravimetric analysis and evaluation of the skin surface pH. After treatment there was a significant clinical improvement accompanied by significant qualitative and quantitative reduction of sweat as well as a significant reduction of skin surface pH. Except for slight skin irritation in 6 patients, there were no other side effects. Patient satisfaction improved markedly during the study. Treatment of axillary hyperhidrosis with aluminium chloride is an effective, safe and inexpensive treatment modality.

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

PubMed Central

Pinheiro, Simone P.; Rivera, Donna R.; Graham, David J.; Freedman, Andrew N.; Major, Jacqueline M.; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C.; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2017-01-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. PMID:27663208

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.

PubMed

Pinheiro, Simone P; Rivera, Donna R; Graham, David J; Freedman, Andrew N; Major, Jacqueline M; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2016-11-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. Published by Elsevier Inc.