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

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.

[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.

Evaluation of a respiratory symptom diary for clinical studies of idiopathic pulmonary fibrosis.

PubMed

Bacci, Elizabeth Dansie; O'Quinn, Sean; Leidy, Nancy Kline; Murray, Lindsey; Vernon, Margaret

2018-01-01

There are no validated patient diaries for evaluating respiratory symptoms in idiopathic pulmonary fibrosis (IPF). To evaluate the performance properties of the chronic obstructive pulmonary disease (COPD) Evaluating Respiratory Symptoms™ (E-RS™: COPD) measure in patients with IPF. Concept elicitation and cognitive interviews were conducted with IPF patients to evaluate content validity, including comprehensiveness, relevance, and interpretability of E-RS™ items in this patient population. Secondary analyses of IPF clinical study data were performed to evaluate the scoring structure of the tool. With modifications, reliability, validity, and responsiveness of the instrument (E-RS™: IPF) were evaluated. Qualitative interviews (n = 30) were conducted. During the elicitation interviews (n = 20), concept saturation for IPF respiratory symptoms was achieved; all respiratory symptoms covered by the E-RS™ were endorsed by ≥ 30% of the sample. During cognitive interviews (n = 10), all participants found the items interpretable and relevant. Factor analyses conducted via secondary analysis of IPF clinical study data identified no total score and four symptom scales: Chest, Breathlessness, Cough, and Sputum. Reliability of each scale was high (internal consistency [α] >0.85); 2-day reproducibility (ICC >0.88). Validity was supported through significant (P < 0.0001) relationships with the St. George's Respiratory Questionnaire (SGRQ), the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ), and other variables. The scales were responsive to change when evaluated using SGRQ Symptoms, UCSD-SOBQ, and Patient Global Impression of Change as anchors (P < 0.01 to P < 0.0001). The E-RS™: IPF is a valid, reliable, and responsive tool for evaluating respiratory symptoms in patients with IPF. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Clinical Evaluation of Tinnitus.

PubMed

Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J

2016-05-01

The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Three-year clinical evaluation of two ceramic crown systems: a preliminary study.

PubMed

Etman, Maged K; Woolford, M J

2010-02-01

The clinical performance and failure mechanisms of recently introduced ceramic crown systems used to restore posterior teeth have not been adequately examined. The purpose of this prospective clinical study was to evaluate and compare the clinical performance of 2 new ceramic crown systems with that of metal ceramic crowns using modified United States Public Health Services (USPHS) criteria. Ninety posterior teeth requiring crown restorations in 48 patients were randomized into 3 equal groups (n=30) for which different crown systems were used: an experimental hot-pressed glass ceramic based on a modified lithium disilicate ceramic (IPS e.max Press), an alumina-coping-based ceramic (Procera AllCeram), and a metal ceramic (Simidur S 2 veneered with IPS Classic Porcelain). The crowns were assessed over 3 years using the modified USPHS criteria. Crowns that developed visible cracks were sectioned and removed, and the surfaces were analyzed using a scanning electron microscope (SEM). The data were analyzed using the Kruskal-Wallis nonparametric statistical test, followed by the Mann-Whitney test with Bonferroni correction (alpha=.05). USPHS evaluation showed that the IPS e.max Press and metal ceramic crowns experienced fewer clinical changes than Procera AllCeram. Visible roughness, wear, and deformity were noticed in occlusal contact areas of Procera AllCeram crowns. SEM images showed well defined wear facets in both ceramic crown systems. Kruskal-Wallis tests showed a significant difference (P<.05) in Alpha scores among the 3 crown systems. Mann-Whitney tests showed significant differences among groups. IPS e.max Press crowns demonstrated clinical behavior comparable to Procera AllCeram and metal ceramic crowns, but the wear resistance of this crown type was superior to the Procera AllCeram crowns, according to modified USPHS criteria.

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.

Usefulness of myocardial parametric imaging to evaluate myocardial viability in experimental and in clinical studies

PubMed Central

Korosoglou, G; Hansen, A; Bekeredjian, R; Filusch, A; Hardt, S; Wolf, D; Schellberg, D; Katus, H A; Kuecherer, H

2006-01-01

Objective To evaluate whether myocardial parametric imaging (MPI) is superior to visual assessment for the evaluation of myocardial viability. Methods and results 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 (κ  =  0.87 v κ  =  0.75, p < 0.05). Conclusion 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. PMID:15939722

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.

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.

Evaluation of Athletic Training Students' Clinical Proficiencies

PubMed Central

Walker, Stacy E; Weidner, Thomas G; Armstrong, Kirk J

2008-01-01

Context: Appropriate methods for evaluating clinical proficiencies are essential in ensuring entry-level competence. Objective: To investigate the common methods athletic training education programs use to evaluate student performance of clinical proficiencies. Design: Cross-sectional design. Setting: Public and private institutions nationwide. Patients or Other Participants: All program directors of athletic training education programs accredited by the Commission on Accreditation of Allied Health Education Programs as of January 2006 (n  =  337); 201 (59.6%) program directors responded. Data Collection and Analysis: The institutional survey consisted of 11 items regarding institutional and program demographics. The 14-item Methods of Clinical Proficiency Evaluation in Athletic Training survey consisted of respondents' demographic characteristics and Likert-scale items regarding clinical proficiency evaluation methods and barriers, educational content areas, and clinical experience settings. We used analyses of variance and independent t tests to assess differences among athletic training education program characteristics and the barriers, methods, content areas, and settings regarding clinical proficiency evaluation. Results: Of the 3 methods investigated, simulations (n  =  191, 95.0%) were the most prevalent method of clinical proficiency evaluation. An independent-samples t test revealed that more opportunities existed for real-time evaluations in the college or high school athletic training room (t189  =  2.866, P  =  .037) than in other settings. Orthopaedic clinical examination and diagnosis (4.37 ± 0.826) and therapeutic modalities (4.36 ± 0.738) content areas were scored the highest in sufficient opportunities for real-time clinical proficiency evaluations. An inadequate volume of injuries or conditions (3.99 ± 1.033) and injury/condition occurrence not coinciding with the clinical proficiency assessment timetable (4.06 ± 0.995) were

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.

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

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

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

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

A call for change: clinical evaluation of student registered nurse anesthetists.

PubMed

Collins, Shawn; Callahan, Margaret Faut

2014-02-01

The ability to integrate theory with practice is integral to a student's success. A common reason for attrition from a nurse anesthesia program is clinical issues. To document clinical competence, students are evaluated using various tools. For use of a clinical evaluation tool as possible evidence for a student's dismissal, an important psychometric property to ensure is instrument validity. Clinical evaluation instruments of nurse anesthesia programs are not standardized among programs, which suggests a lack of instrument validity. The lack of established validity of the instruments used to evaluate students' clinical progress brings into question their ability to detect a student who is truly in jeopardy of attrition. Given this possibility, clinical instrument validity warrants research to be fair to students and improve attrition rates based on valid data. This ex post facto study evaluated a 17-item clinical instrument tool to demonstrate the need for validity of clinical evaluation tools. It also compared clinical scores with scores on the National Certification Examination.

Evaluating impact of clinical guidelines using a realist evaluation framework.

PubMed

Reddy, Sandeep; Wakerman, John; Westhorp, Gill; Herring, Sally

2015-12-01

The Remote Primary Health Care Manuals (RPHCM) project team manages the development and publication of clinical protocols and procedures for primary care clinicians practicing in remote Australia. The Central Australian Rural Practitioners Association Standard Treatment Manual, the flagship manual of the RPHCM suite, has been evaluated for accessibility and acceptability in remote clinics three times in its 20-year history. These evaluations did not consider a theory-based framework or a programme theory, resulting in some limitations with the evaluation findings. With the RPHCM having an aim of enabling evidence-based practice in remote clinics and anecdotally reported to do so, testing this empirically for the full suite is vital for both stakeholders and future editions of the RPHCM. The project team utilized a realist evaluation framework to assess how, why and for what the RPHCM were being used by remote practitioners. A theory regarding the circumstances in which the manuals have and have not enabled evidence-based practice in the remote clinical context was tested. The project assessed this theory for all the manuals in the RPHCM suite, across government and aboriginal community-controlled clinics, in three regions of Australia. Implementing a realist evaluation framework to generate robust findings in this context has required innovation in the evaluation design and adaptation by researchers. This article captures the RPHCM team's experience in designing this evaluation. © 2015 John Wiley & Sons, Ltd.

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

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

Evaluating critical thinking in clinical practice.

PubMed

Oermann, M H

1997-01-01

Although much has been written about measurement instruments for evaluating critical thinking in nursing, this article describes clinical evaluation strategies for critical thinking. Five methods are discussed: 1) observation of students in practice; 2) questions for critical thinking, including Socratic questioning; 3) conferences; 4) problem-solving strategies; and 5) written assignments. These methods provide a means of evaluating students' critical thinking within the context of clinical practice.

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

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.

Usability Evaluation of Electronic Health Record System around Clinical Notes Usage-An Ethnographic Study.

PubMed

Rizvi, Rubina F; Marquard, Jenna L; Hultman, Gretchen M; Adam, Terrence J; Harder, Kathleen A; Melton, Genevieve B

2017-10-01

Background A substantial gap exists between current Electronic Health Record (EHR) usability and potential optimal usability. One of the fundamental reasons for this discrepancy is poor incorporation of a User-Centered Design (UCD) approach during the Graphical User Interface (GUI) development process. Objective To evaluate usability strengths and weaknesses of two widely implemented EHR GUIs for critical clinical notes usage tasks. Methods Twelve Internal Medicine resident physicians interacting with one of the two EHR systems (System-1 at Location-A and System-2 at Location-B) were observed by two usability evaluators employing an ethnographic approach. User comments and observer findings were analyzed for two critical tasks: (1) clinical notes entry and (2) related information-seeking tasks. Data were analyzed from two standpoints: (1) usability references categorized by usability evaluators as positive, negative, or equivocal and (2) usability impact of each feature measured through a 7-point severity rating scale. Findings were also validated by user responses to a post observation questionnaire. Results For clinical notes entry, System-1 surpassed System-2 with more positive (26% vs. 12%) than negative (12% vs. 34%) usability references. Greatest impact features on EHR usability (severity score pertaining to each feature) for clinical notes entry were: autopopulation (6), screen options (5.5), communication (5), copy pasting (4.5), error prevention (4.5), edit ability (4), and dictation and transcription (3.5). Both systems performed equally well on information-seeking tasks and features with greatest impacts on EHR usability were navigation for notes (7) and others (e.g., looking for ancillary data; 5.5). Ethnographic observations were supported by follow-up questionnaire responses. Conclusion This study provides usability-specific insights to inform future, improved, EHR interface that is better aligned with UCD approach.

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

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.

Evaluation of complementary-alternative medicine (CAM) questionnaire development for Indonesian clinical psychologists: A pilot study.

PubMed

Liem, Andrian; Newcombe, Peter A; Pohlman, Annie

2017-08-01

This study aimed to evaluate questionnaire development to measure the knowledge of Complementary-Alternative Medicine (CAM), attitudes towards CAM, CAM experiences, and CAM educational needs of clinical psychologists in Indonesia. A 26-item questionnaire was developed through an extensive literature search. Data was obtained from provisional psychologists from the Master of Professional Clinical Psychology programs at two established public universities in urban areas of Indonesia. To validate the questionnaire, panel reviews by executive members of the Indonesian Clinical Psychology Association (ICPA), experts in health psychology, and experts in public health and CAM provided their professional judgements. The self-reporting questionnaire consisted of four scales including: knowledge of CAM (6 items), attitudes towards CAM (10 items), CAM experiences (4 items), and CAM educational needs (6 items). All scales, except CAM Experiences, were assessed on a 7-point Likert scale. Sixty provisional psychologists were eligible to complete the questionnaire with a response rate of 73% (N=44). The results showed that the CAM questionnaire was reliable (Cronbach's coefficient alpha range=0.62-0.96; item-total correlation range=0.14-0.92) and demonstrated content validity. Following further psychometric evaluation, the CAM questionnaire may provide the evidence-based information to inform the education and practice of Indonesian clinical psychologists. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

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.

["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.

Clinical and computerized evaluation in study of temporo-mandibular joint intracapsular disease.

PubMed

Ciavarella, D; Mastrovincenzo, M; Sabatucci, A; Parziale, V; Granatelli, F; Violante, F; Bossù, M; Lo Muzio, L; Chimenti, C

2010-03-01

In this work authors show a diagnostic criteria in study of TMID: neuro occlusal clinical evaluation (NOE), T-Scan 2 system and surface electromyography (sEMG). Nine patients 25-30 years old with TMID problem and 9 healthy group control have been selected and examined. On each patients it has been performed NOE, T-Scan and sEMG test. NOE has been calculated on each patient photos lateral mandibular excursion angle called: masticatory functional angle (AFM). T-Scan System is a computerized occlusal analyzer that provide in-depth understanding of the overall balance of the occlusion. At the same time of T-Scan record sEMG tests, in resting position and in maximum clench, have been performed. In healthy control there were no AFM difference. In no healthy group there were difference between the two AFM greater than 6 degrees. T-Scan COF showed how in healthy group control there was never a difference of COF greater than 5%. In no healthy group the difference were greater than 5% P<0.05. T-scan showed difference of time force in maximum intercuspidation (MIFT) in healthy respect TMID patients. In healthy patients MIFT was higher than TMID patients P<0.05. sEMG test showed in non healthy group a great asymmetrical activation of masseter (MM). MM activation were greater on side affected by joint sound than the balance side P<0.001. sEMG show how in TMID patients maximum masseter activation is always lower than maximum masseter activation of healthy subjects P<0.001. Neuro occlusal clinical evaluation (NOE) in TMID patients is supported by instrumental evaluation.

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.

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

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.

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

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…

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.

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.

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.

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

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

PubMed

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

2014-07-01

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

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.

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.

Clinical education and clinical evaluation of respiratory therapy students.

PubMed

Cullen, Deborah L

2005-09-01

Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of

Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

PubMed

Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

2015-06-01

National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

Clinical evaluation of patients with patellofemoral disorders.

PubMed

Post, W R

1999-01-01

Accurate clinical evaluation of patients with patellofemoral disorders is the cornerstone of effective treatment. This article defines how a careful history and physical examination can direct strategies for nonoperative and operative management. A critical analysis of traditional methods of evaluation and a streamlined rational approach to clinical evaluation is presented. Key questions and important physical findings that affect treatment decisions are emphasized.

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

PubMed Central

2012-01-01

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

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.

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

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

[Organization of an anaesthesia preoperative evaluation clinic - The Anaesthesia/Patient Blood Management Clinic: one Model].

PubMed

Schöpper, Christa; Venherm, Stefan; Van Aken, Hugo; Ellermann, Ines; Steinbicker, Andrea

2016-04-01

The anesthesia preoperative evaluation has been developed in recent years in a centralized clinic, that can be visited by the majority of patients, in order to evaluate and obtain patient's consent for anesthesia. In the current article, the organization and structure of such a central anesthesia preoperative evaluation clinic in the Department of Anesthesia, Intensive Care and Pain Medicine at the University Hospital of Muenster, is described. Besides the central preoperative evaluation clinic, 3 clinics are localized in separate buildings and preoperative visits have to be completed in special scenarios on the wards, too. A pharmaceutical evaluation for patient's medication and the patient blood management have been integrated into the anesthesia preoperative evaluation clinic. Processes are explained and current numbers of patients are mentioned. © Georg Thieme Verlag Stuttgart · New York.

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.

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

[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.

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.

Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE).

PubMed

Paquette-Warren, Jann; Harris, Stewart B; Naqshbandi Hayward, Mariam; Tompkins, Jordan W

2016-10-01

Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real-world evaluation. Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real-world comprehensive evaluations in health care settings. The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub-steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built-in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale-up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Clinical Evaluation of Baccalaureate Nursing Students Using SBAR Format: Faculty versus Self Evaluation

ERIC Educational Resources Information Center

Saied, Hala; James, Joemol; Singh, Evangelin Jeya; Al Humaied, Lulawah

2016-01-01

Clinical training is of paramount importance in nursing education and clinical evaluation is one of the most challenging responsibilities of nursing faculty. The use of objective tools and criteria and involvement of the students in the evaluation process are some techniques to facilitate quality learning in the clinical setting. Aim: The aim of…

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

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

PubMed

Turner, Leigh

2017-09-01

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

A New Wrist Clinical Evaluation Score.

PubMed

Herzberg, Guillaume; Burnier, Marion; Nakamura, Toshiyasu

2018-04-01

Background  The number of available wrist scoring systems is limited; some of them do not include forearm rotation criteria. Purpose  To describe a new electronic wrist clinical score and to present a new patient's generated wrist evaluation criterion, the subjective wrist value (SWV). Materials and Methods  A new electronic wrist clinical score, the Lyon wrist score (LWS) including wrist VAS pain and function, active range of motion and strength was built into an excel file. VAS flexion-extension pain and function were evaluated independently from pronation-supination pain and function. A new patient's generated wrist evaluation criterion, SWV was described. Results  The LWS is available in two versions, standard and full (the latter including forearm rotation strength). Both standard and full LWS are displayed into an automatically generated diamond-shaped graph providing a comprehensive visual display of the clinical status of most osteoarticular wrist disorders. The graph also includes SWV. The LWS, combined with SWV into a graph that may be directly exported to a PowerPoint presentation, provide a new practical and comprehensive tool for following/comparing wrist osteoarticular clinical status/outcomes. Both standard and full LWS charts are available in colored versions on a related website for free download. Conclusion  A comprehensive updated electronic display of osteoarticular wrist clinical status including forearm rotation criteria is provided and displayed into a graph which may be exported as such into a PowerPoint presentation for clinical analysis/comparisons. Level of Evidence  Level II.

A multi-institution evaluation of clinical profile anonymization.

PubMed

Heatherly, Raymond; Rasmussen, Luke V; Peissig, Peggy L; Pacheco, Jennifer A; Harris, Paul; Denny, Joshua C; Malin, Bradley A

2016-04-01

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. We apply a state-of-the-artk-anonymization algorithm, withkset 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. 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. Sharing large volumes of clinical data in support of phenome-wide association studies is possible while safeguarding privacy to the underlying individuals. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance in clinical research. Therefore also clinical trialists have to involve health economic aspects more frequently. However, whereas they are quite familiar with classical effect measures in clinical trials, the corresponding parameters in health economic evaluation of therapeutic and diagnostic procedures are still not this common. The concepts of incremental cost effectiveness ratios (ICERs) and incremental net health benefit (INHB) will be illustrated and contrasted along the cost effectiveness evaluation of cataract surgery with monofocal and multifocal intraocular lenses. ICERs relate the costs of a treatment to its clinical benefit in terms of a ratio expression (indexed as Euro per clinical benefit unit). Therefore ICERs can be directly compared to a pre-specified willingness to pay (WTP) benchmark, which represents the maximum costs, health insurers would invest to achieve one clinical benefit unit. INHBs estimate a treatment's net clinical benefit after accounting for its cost increase versus an established therapeutic standard. Resource allocation rules can be formulated by means of both effect measures. Both the ICER and the INHB approach enable the definition of directional resource allocation rules. The allocation decisions arising from these rules are identical, as long as the willingness to pay benchmark is fixed in advance. Therefore both strategies crucially call for a priori determination of both the underlying clinical benefit endpoint (such as gain in vision lines after cataract surgery or gain in quality-adjusted life years) and the corresponding willingness to pay benchmark. The use of incremental cost effectiveness and net health benefit estimates provides a rationale for health economic allocation discussions and founding decisions. It implies the same requirements on trial protocols as yet established for clinical trials, that is the a priori

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

Lea's Shield, a new barrier contraceptive preliminary clinical evaluations three-day tolerance study.

PubMed

Hunt, W L; Gabbay, L; Potts, M

1994-12-01

In this study the Lea's Shield was evaluated for its tolerance by women who wore the device for three consecutive days. Ten women who wore the Lea's Shield for 72 hours completed the tolerance study without adverse effects. Examination of the cervix and vagina revealed that the device did not provoke any significant cellular or microbial changes among the wearers. No major changes in the appearance or prevalence of vaginal flora occurred in the women after three days of wearing the device. A gradient in the pH could be detected between the contents of the vagina, which was more acidic than the contents of the bowl of the device. The range of cervical shapes and vaginal morphology among the study participants has had no influence upon the ability of the device to remain in its proper position. The device "settles in place" as it is pushed in, thereby obviating any special maneuvers for proper positioning. No vaginal nor cervical trauma occurred. We have concluded from these basic clinical evaluations that Lea's Shield is well tolerated during three days of use. Efficacy trials in women at risk recently completed have confirmed the high degree of acceptability and that the device can function adequately as one size fits all.

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

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.

Challenges of teacher-based clinical evaluation from nursing students' point of view: Qualitative content analysis.

PubMed

Sadeghi, Tabandeh; Seyed Bagheri, Seyed Hamid

2017-01-01

Clinical evaluation is very important in the educational system of nursing. One of the most common methods of clinical evaluation is evaluation by the teacher, but the challenges that students would face in this evaluation method, have not been mentioned. Thus, this study aimed to explore the experiences and views of nursing students about the challenges of teacher-based clinical evaluation. This study was a descriptive qualitative study with a qualitative content analysis approach. Data were gathered through semi-structured focused group sessions with undergraduate nursing students who were passing their 8 th semester at Rafsanjan University of Medical Sciences. Date were analyzed using Graneheim and Lundman's proposed method. Data collection and analysis were concurrent. According to the findings, "factitious evaluation" was the main theme of study that consisted of three categories: "Personal preferences," "unfairness" and "shirking responsibility." These categories are explained using quotes derived from the data. According to the results of this study, teacher-based clinical evaluation would lead to factitious evaluation. Thus, changing this approach of evaluation toward modern methods of evaluation is suggested. The finding can help nursing instructors to get a better understanding of the nursing students' point of view toward this evaluation approach and as a result could be planning for changing of this approach.

[Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

PubMed

Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

2011-10-01

As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

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.

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

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

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.

A concept mapping study evaluating the UK's first NHS generic fatigue clinic.

PubMed

Hackett, Katie L; Lambson, Rebecca L; Strassheim, Victoria; Gotts, Zoe; Deary, Vincent; Newton, Julia L

2016-10-01

development concepts were grouped into thematic clusters and prioritized for both importance and current success. The resulting concept maps depict where the CRESTA Fatigue Clinic successfully addresses issues which matter to patients and highlights areas for service enhancement. Unmet needs of patients have been identified in a rigorous service evaluation, and these are currently being addressed in collaboration with a service-user group. © 2015 The Authors. Health Expectations. Published by John Wiley & Sons Ltd.

Evaluating online diagnostic decision support tools for the clinical setting.

PubMed

Pryor, Marie; White, David; Potter, Bronwyn; Traill, Roger

2012-01-01

Clinical decision support tools available at the point of care are an effective adjunct to support clinicians to make clinical decisions and improve patient outcomes. We developed a methodology and applied it to evaluate commercially available online clinical diagnostic decision support (DDS) tools for use at the point of care. We identified 11 commercially available DDS tools and assessed these against an evaluation instrument that included 6 categories; general information, content, quality control, search, clinical results and other features. We developed diagnostically challenging clinical case scenarios based on real patient experience that were commonly missed by junior medical staff. The evaluation was divided into 2 phases; an initial evaluation of all identified and accessible DDS tools conducted by the Clinical Information Access Portal (CIAP) team and a second phase that further assessed the top 3 tools identified in the initial evaluation phase. An evaluation panel consisting of senior and junior medical clinicians from NSW Health conducted the second phase. Of the eleven tools that were assessed against the evaluation instrument only 4 tools completely met the DDS definition that was adopted for this evaluation and were able to produce a differential diagnosis. From the initial phase of the evaluation 4 DDS tools scored 70% or more (maximum score 96%) for the content category, 8 tools scored 65% or more (maximum 100%) for the quality control category, 5 tools scored 65% or more (maximum 94%) for the search category, and 4 tools score 70% or more (maximum 81%) for the clinical results category. The second phase of the evaluation was focused on assessing diagnostic accuracy for the top 3 tools identified in the initial phase. Best Practice ranked highest overall against the 6 clinical case scenarios used. Overall the differentiating factor between the top 3 DDS tools was determined by diagnostic accuracy ranking, ease of use and the confidence and

Angular stable plates in proximal meta-epiphyseal tibial fractures: study of joint restoration and clinical and functional evaluation.

PubMed

Giannotti, S; Giovannelli, D; Dell'Osso, G; Bottai, V; Bugelli, G; Celli, F; Citarelli, C; Guido, G

2016-04-01

The tibial plateau fractures involve one of the main weight bearing joints of the human body. The goals of surgical treatment are anatomical reduction, articular surface reconstruction and high primary stability. The aim of this study was to evaluate the clinical and functional outcomes after internal plate fixation of this kind of fractures. From January 2009 to December 2012, we treated 75 cases of tibial plateau fracture with angular stable plates. We used Rasmussen Score and the Knee Society Score for the clinical and functional evaluation. Twenty-five cases that underwent hardware removal had arthroscopic and CT evaluation of the joint. No complications occurred. The clinical and functional evaluation, performed by the KSS and Rasmussen Score, highlighted the high percentage of good-to-excellent results (over 90 %). In every case, the range of motion was good with flexion >90°. Arthroscopy showed the presence of chondral damage in 100 % of patients. In all the cases, we found that X-ray images seem better than the CT images. Angular stable plates allow to obtain a good primary stability, permitting an early joint recovery with an excellent range of motion. Avoiding to perform a knee arthrotomy at the time of fracture reduction could prove to be an advantage in terms of functional recovery. The meniscus on the injured bone should be preserved in order to maintain good function of the joint. X-ray images remain the gold standard in checking the progression of post-traumatic osteoarthritis.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors

[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.

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.

[Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

PubMed

He, Wei; Xie, Yanming; Wang, Yongyan

2011-12-01

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

Accuracy in clinically evaluating pigmented lesions.

PubMed Central

Curley, R. K.; Cook, M. G.; Fallowfield, M. E.; Marsden, R. A.

1989-01-01

OBJECTIVE--To determine the ability of three doctors experienced in managing melanocytic lesions to diagnose correctly melanoma, dysplastic naevi, and various benign pigmented lesions. DESIGN--Independent clinical evaluation and histopathological assessment. SETTING--Pigmented lesion clinic, which patients attend without an appointment for early diagnosis of melanoma. PATIENTS--86 Patients with lesions that were judged to be benign by at least one of the three doctors. INTERVENTIONS--The lesions were excised under local anaesthesia and sent for histopathological examination in coded bottles without clinical details. MAIN OUTCOME MEASURE--Comparison of clinical with histopathological diagnosis for each lesion. RESULTS--A total of 120 lesions were evaluated by at least two of the three doctors. The histopathological diagnoses were made by the same pathologist. The overall sensitivity (diagnostic accuracy) for the three doctors for all types of lesion was 50%. Of the 39 dysplastic naevi, only 19 were identified correctly by all observers, and a further 24 banal lesions were wrongly diagnosed as dysplastic by at least one doctor. Particular difficulty was experienced with small (less than 5 mm), flat lesions, which can be banal or potentially malignant. CONCLUSIONS--Critical diagnosis and management decisions concerning pigmented lesions should always be based on a combination of clinical and histopathological assessments and the history of the patient. PMID:2503192

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.

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

PubMed

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

2018-05-01

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

Non-stroke neurological syndromes associated with antiphospholipid antibodies: evaluation of clinical and experimental studies.

PubMed

Chapman, J; Rand, J H; Brey, R L; Levine, S R; Blatt, I; Khamashta, M A; Shoenfeld, Y

2003-01-01

Although many types of neurological disorders and events have been described in association with antiphospholipid antibodies (aPL) and the antiphospholipid syndrome (APS), only ischaemic stroke is reasonably well established and accepted as a diagnostic criterion for the syndrome. We propose to evaluate, classify and rank the association of other neurological manifestations as possible, probable, or definite according to the data available from clinical studies and animal models. By these criteria, none of the neurological disorders or events such as epilepsy, psychiatric disease, dementia, transverse myelitis, multiple sclerosis-like disease, chorea, migraine, Guillian-Barrè syndrome, and sensory-neural hearing loss, can be definitely associated with aPL or APS.

[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.

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.

Robotic and clinical evaluation of upper limb motor performance in patients with Friedreich's Ataxia: an observational study.

PubMed

Germanotta, Marco; Vasco, Gessica; Petrarca, Maurizio; Rossi, Stefano; Carniel, Sacha; Bertini, Enrico; Cappa, Paolo; Castelli, Enrico

2015-04-23

Friedreich's ataxia (FRDA) is the most common hereditary autosomal recessive form of ataxia. In this disease there is early manifestation of gait ataxia, and dysmetria of the arms and legs which causes impairment in daily activities that require fine manual dexterity. To date there is no cure for this disease. Some novel therapeutic approaches are ongoing in different steps of clinical trial. Development of sensitive outcome measures is crucial to prove therapeutic effectiveness. The aim of the study was to assess the reliability and sensitivity of quantitative and objective assessment of upper limb performance computed by means of the robotic device and to evaluate the correlation with clinical and functional markers of the disease severity. Here we assess upper limb performances by means of the InMotion Arm Robot, a robot designed for clinical neurological applications, in a cohort of 14 children and young adults affected by FRDA, matched for age and gender with 18 healthy subjects. We focused on the analysis of kinematics, accuracy, smoothness, and submovements of the upper limb while reaching movements were performed. The robotic evaluation of upper limb performance consisted of planar reaching movements performed with the robotic system. The motors of the robot were turned off, so that the device worked as a measurement tool. The status of the disease was scored using the Scale for the Assessment and Rating of Ataxia (SARA). Relationships between robotic indices and a range of clinical and disease characteristics were examined. All our robotic indices were significantly different between the two cohorts except for two, and were highly and reliably discriminative between healthy and subjects with FRDA. In particular, subjects with FRDA exhibited slower movements as well as loss of accuracy and smoothness, which are typical of the disease. Duration of Movement, Normalized Jerk, and Number of Submovements were the best discriminative indices, as they were

Certainty rating in pre-and post-tests of study modules in an online clinical pharmacy course - A pilot study to evaluate teaching and learning.

PubMed

Luetsch, Karen; Burrows, Judith

2016-10-14

Graduate and post-graduate education for health professionals is increasingly delivered in an e-learning environment, where automated, continuous formative testing with integrated feedback can guide students' self-assessment and learning. Asking students to rate the certainty they assign to the correctness of their answers to test questions can potentially provide deeper insights into the success of teaching, with test results informing course designers whether learning outcomes have been achieved. It may also have implications for decision making in clinical practice. A study of pre-and post-tests for five study modules was designed to evaluate the teaching and learning within a pharmacotherapeutic course in an online postgraduate clinical pharmacy program. Certainty based marking of multiple choice questions (MCQ) was adapted for formative pre- and post-study module testing by asking students to rate their certainty of correctness of MCQ answers. Paired t-tests and a coding scheme were used to analyse changes in answers and certainty between pre-and post-tests. A survey evaluated students' experience with the novel formative testing design. Twenty-nine pharmacists enrolled in the postgraduate program participated in the study. Overall 1315 matched pairs of MCQ answers and certainty ratings between pre- and post-module tests were available for evaluation. Most students identified correct answers in post-tests and increased their certainty compared to pre-tests. Evaluation of certainty ratings in addition to correctness of answers identified MCQs and topic areas for revision to course designers. A survey of students showed that assigning certainty ratings to their answers assisted in structuring and focusing their learning throughout online study modules, facilitating identification of areas of uncertainty and gaps in their clinical knowledge. Adding certainty ratings to MCQ answers seems to engage students with formative testing and feedback and focus their

Clinical peer review program self-evaluation for US hospitals.

PubMed

Edwards, Marc T

2010-01-01

Prior research has shown wide variation in clinical peer review program structure, process, governance, and perceived effectiveness. This study sought to validate the utility of a Peer Review Program Self-Evaluation Tool as a potential guide to physician and hospital leaders seeking greater program value. Data from 330 hospitals show that the total score from the self-evaluation tool is strongly associated with perceived quality impact. Organizational culture also plays a significant role. When controlling for these factors, there was no evidence of benefit from a multispecialty review process. Physicians do not generally use reliable methods to measure clinical performance. A high rate of change since 2007 has not produced much improvement. The Peer Review Program Self-Evaluation Tool reliably differentiates hospitals along a continuum of perceived program performance. The full potential of peer review as a process to improve the quality and safety of care has yet to be realized.

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.

Administrative clinical supervision as evaluated by the first-line managers in one health care organization district.

PubMed

Sirola-Karvinen, Pirjo; Hyrkäs, Kristiina

2008-07-01

The aim of this article is to increase knowledge and understanding of administrative clinical supervision. Administrative clinical supervision is a learning process for leaders that is based on experiences. Only a few studies have focused on administrative clinical supervision. The materials for this study were evaluations collected in 2002-2005 using a clinical supervision evaluation scale (MCSS). The respondents (n = 126) in the study were nursing leaders representing different specialties. The data were analysed statistically. The findings showed that the supervision succeeded very well. The contents of the sessions differed depending on the nurse leader's position. Significant differences were found in the evaluations between specialties and within years of work experience. Clinical supervision was utilized best in the psychiatric and mental health sector. The supervisees' who had long work experience scored the importance and value of clinical supervision as high. Clinical supervision is beneficial for nursing leaders. The experiences were positive and the nursing leaders appreciated the importance and value of clinical supervision. It is important to plan and coordinate a longitudinal evaluation so that clinical supervision for nursing leaders is systematically implemented and continuously developed.

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.

A study on mastectomy samples to evaluate breast imaging quality and potential clinical relevance of differential phase contrast mammography.

PubMed

Hauser, Nik; Wang, Zhentian; Kubik-Huch, Rahel A; Trippel, Mafalda; Singer, Gad; Hohl, Michael K; Roessl, Ewald; Köhler, Thomas; van Stevendaal, Udo; Wieberneit, Nataly; Stampanoni, Marco

2014-03-01

Differential phase contrast and scattering-based x-ray mammography has the potential to provide additional and complementary clinically relevant information compared with absorption-based mammography. The purpose of our study was to provide a first statistical evaluation of the imaging capabilities of the new technique compared with digital absorption mammography. We investigated non-fixed mastectomy samples of 33 patients with invasive breast cancer, using grating-based differential phase contrast mammography (mammoDPC) with a conventional, low-brilliance x-ray tube. We simultaneously recorded absorption, differential phase contrast, and small-angle scattering signals that were combined into novel high-frequency-enhanced images with a dedicated image fusion algorithm. Six international, expert breast radiologists evaluated clinical digital and experimental mammograms in a 2-part blinded, prospective independent reader study. The results were statistically analyzed in terms of image quality and clinical relevance. The results of the comparison of mammoDPC with clinical digital mammography revealed the general quality of the images to be significantly superior (P < 0.001); sharpness, lesion delineation, as well as the general visibility of calcifications to be significantly more assessable (P < 0.001); and delineation of anatomic components of the specimens (surface structures) to be significantly sharper (P < 0.001). Spiculations were significantly better identified, and the overall clinically relevant information provided by mammoDPC was judged to be superior (P < 0.001). Our results demonstrate that complementary information provided by phase and scattering enhanced mammograms obtained with the mammoDPC approach deliver images of generally superior quality. This technique has the potential to improve radiological breast diagnostics.

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

PubMed

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

2018-03-01

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. 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. 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. 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. 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.

Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

PubMed Central

Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

2014-01-01

Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the development and psychometric testing process of an instrument to evaluate the characteristics of Iranian effective clinical nurse instructor. Materials and Methods: Following a precise review of Iranian literatures and expert consultation, 83 statements about the characteristics that make clinical nurse instructors effective were extracted. In the next phase, the psychometric properties of the instrument were established by looking at the content validity, face validity, and internal consistency. Content validity of the instrument was assessed based on the comments of an expert panel including 10 nursing faculty members. During this phase, 30 items of the instrument were omitted or merged. Face validity of the instrument was assured based on the advices of 10 nursing students and 10 nursing faculty members. Finally, in the pilot test, the data of 168 filled questionnaires were gathered and analyzed by an exploratory factor analysis to reduce the items and identify the factor structure of the instrument. Results: Through subsequent analyses, of the 83 items, 31 items were merged or omitted. At last, 52 retained items were divided into four subscales including student-centric behaviors, clinical performances, planning ability, and personality traits. The Cronbach's alpha level of the inventory was 0.96, with the value for each domain ranging from 0.87 to 0.94. Conclusions: Iranian Effective Clinical Nurse Instructor evaluation tool has acceptable psychometric properties and can be

Evaluation of esophageal motor function in clinical practice.

PubMed

Gyawali, C P; Bredenoord, A J; Conklin, J L; Fox, M; Pandolfino, J E; Peters, J H; Roman, S; Staiano, A; Vaezi, M F

2013-02-01

Esophageal motor function is highly coordinated between central and enteric nervous systems and the esophageal musculature, which consists of proximal skeletal and distal smooth muscle in three functional regions, the upper and lower esophageal sphincters, and the esophageal body. While upper endoscopy is useful in evaluating for structural disorders of the esophagus, barium esophagography, radionuclide transit studies, and esophageal intraluminal impedance evaluate esophageal transit and partially assess motor function. However, esophageal manometry is the test of choice for the evaluation of esophageal motor function. In recent years, high-resolution manometry (HRM) has streamlined the process of acquisition and display of esophageal pressure data, while uncovering hitherto unrecognized esophageal physiologic mechanisms and pathophysiologic patterns. New algorithms have been devised for analysis and reporting of esophageal pressure topography from HRM. The clinical value of HRM extends to the pediatric population, and complements preoperative evaluation prior to foregut surgery. Provocative maneuvers during HRM may add to the assessment of esophageal motor function. The addition of impedance to HRM provides bolus transit data, but impact on clinical management remains unclear. Emerging techniques such as 3-D HRM and impedance planimetry show promise in the assessment of esophageal sphincter function and esophageal biomechanics. © 2013 Blackwell Publishing Ltd.

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.

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 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

[Critical revision of the available methods for evaluate the body composition in population-based and clinical studies].

PubMed

Rezende, Fabiane; Rosado, Lina; Franceschinni, Sylvia; Rosado, Gilberto; Ribeiro, Rita; Marins, João Carlos Bouzas

2007-12-01

The corporal composition evaluation is extremely important for the individual and population nutritional state diagnosis and for the establishment of appropriate clinical-nutritional conducts. An excess of body fat is frequently associated with important metabolic alterations and chronic diseases, such as diabetes, hypertension and dyslipidemia The availability of methods to assess body composition is essential to evaluate health status of individuals. There are several methods for the corporal composition analysis, and it is important to know the limitation of each one and his/her validity so that the obtained estimates are reliable and correctly interpreted. The purpose of this study was to revise the applicability of some nutritional state indicators and corporal composition evaluation methods, such as corporal mass index, waist circumference and waist-hip relation, skinfold measurements, bioelectrical impedance analysis and near-infrared interactance.

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

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.

Evaluation of a Computerized Clinical Information System (Micromedex).

PubMed Central

Lundsgaarde, H. P.; Moreshead, G. E.

1991-01-01

This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database. PMID:1807583

Evaluation of a Computerized Clinical Information System (Micromedex).

PubMed

Lundsgaarde, H P; Moreshead, G E

1991-01-01

This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database.

[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.

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.

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.

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.

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.

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.

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.

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

Evaluation of clinical methods for peroneal muscle testing.

PubMed

Sarig-Bahat, Hilla; Krasovsky, Andrei; Sprecher, Elliot

2013-03-01

Manual muscle testing of the peroneal muscles is well accepted as a testing method in musculoskeletal physiotherapy for the assessment of the foot and ankle. The peroneus longus and brevis are primary evertors and secondary plantar flexors of the ankle joint. However, some international textbooks describe them as dorsi flexors, when instructing peroneal muscle testing. The identified variability raised a question whether these educational texts are reflected in the clinical field. The purposes of this study were to investigate what are the methods commonly used in the clinical field for peroneal muscle testing and to evaluate their compatibility with functional anatomy. A cross-sectional study was conducted, using an electronic questionnaire sent to 143 Israeli physiotherapists in the musculoskeletal field. The survey questioned on the anatomical location of manual resistance and the combination of motions resisted. Ninety-seven responses were received. The majority (69%) of respondents related correctly to the peronei as evertors, but asserted that resistance should be located over the dorsal aspect of the fifth metatarsus, thereby disregarding the peroneus longus. Moreover, 38% of the respondents described the peronei as dorsi flexors, rather than plantar flexors. Only 2% selected the correct method of resisting plantarflexion and eversion at the base of the first metatarsus. We consider this technique to be the most compatible with the anatomy of the peroneus longus and brevis. The Fisher-Freeman-Halton test indicated that there was a significant relationship between responses on the questions (P = 0.0253, 95% CI 0.0249-0.0257), thus justifying further correspondence analysis. The correspondence analysis found no clustering of the answers that were compatible with anatomical evidence and were applied in the correct technique, but did demonstrate a common error, resisting dorsiflexion rather than plantarflexion, which was in agreement with the described

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.

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

PubMed

Hsu, Li-Ling

2007-08-01

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

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.

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

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.

Feasibility of automatic evaluation of clinical rules in general practice.

PubMed

Opondo, Dedan; Visscher, Stefan; Eslami, Saied; Medlock, Stephanie; Verheij, Robert; Korevaar, Joke C; Abu-Hanna, Ameen

2017-04-01

To assess the extent to which clinical rules (CRs) can be implemented for automatic evaluation of quality of care in general practice. We assessed 81 clinical rules (CRs) adapted from a subset of Assessing Care of Vulnerable Elders (ACOVE) clinical rules, against Dutch College of General Practitioners (NHG) data model. Each CR was analyzed using the Logical Elements Rule METHOD: (LERM). LERM is a stepwise method of assessing and formalizing clinical rules for decision support. Clinical rules that satisfied the criteria outlined in the LERM method were judged to be implementable in automatic evaluation in general practice. Thirty-three out of 81 (40.7%) Dutch-translated ACOVE clinical rules can be automatically evaluated in electronic medical record systems. Seven out of 7 CRs (100%) in the domain of diabetes can be automatically evaluated, 9/17 (52.9%) in medication use, 5/10 (50%) in depression care, 3/6 (50%) in nutrition care, 6/13 (46.1%) in dementia care, 1/6 (16.6%) in end of life care, 2/13 (15.3%) in continuity of care, and 0/9 (0%) in the fall-related care. Lack of documentation of care activities between primary and secondary health facilities and ambiguous formulation of clinical rules were the main reasons for the inability to automate the clinical rules. Approximately two-fifths of the primary care Dutch ACOVE-based clinical rules can be automatically evaluated. Clear definition of clinical rules, improved GP database design and electronic linkage of primary and secondary healthcare facilities can improve prospects of automatic assessment of quality of care. These findings are relevant especially because the Netherlands has very high automation of primary care. Copyright © 2017 Elsevier B.V. All rights reserved.

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

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Evaluation of a new clinical librarian service.

PubMed

Vaughn, Cynthia J

2009-01-01

In order to evaluate a new Clinical Medical Librarian (CML) service at Preston Medical Library in Knoxville, Tennessee, the three departments participating in the service were surveyed and interviewed. Participants in the study shed light on how much impact the attendance of a librarian at rounds and other meetings has had on their patient care decisions as well as their use of the library. Overall, the CML service has been well received by residents and faculty and will continue to serve at least these three departments.

Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

PubMed

Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

2014-11-01

The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014

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.

Clinical evaluation incorporating a personal genome

PubMed Central

Ashley, Euan A.; Butte, Atul J.; Wheeler, Matthew T.; Chen, Rong; Klein, Teri E.; Dewey, Frederick E.; Dudley, Joel T.; Ormond, Kelly E.; Pavlovic, Aleksandra; Hudgins, Louanne; Gong, Li; Hodges, Laura M.; Berlin, Dorit S.; Thorn, Caroline F.; Sangkuhl, Katrin; Hebert, Joan M.; Woon, Mark; Sagreiya, Hersh; Whaley, Ryan; Morgan, Alexander A.; Pushkarev, Dmitry; Neff, Norma F; Knowles, Joshua W.; Chou, Mike; Thakuria, Joseph; Rosenbaum, Abraham; Zaranek, Alexander Wait; Church, George; Greely, Henry T.; Quake, Stephen R.; Altman, Russ B.

2010-01-01

Background The cost of genomic information has fallen steeply but the path to clinical translation of risk estimates for common variants found in genome wide association studies remains unclear. Since the speed and cost of sequencing complete genomes is rapidly declining, more comprehensive means of analyzing these data in concert with rare variants for genetic risk assessment and individualisation of therapy are required. Here, we present the first integrated analysis of a complete human genome in a clinical context. Methods An individual with a family history of vascular disease and early sudden death was evaluated. Clinical assessment included risk prediction for coronary artery disease, screening for causes of sudden cardiac death, and genetic counselling. Genetic analysis included the development of novel methods for the integration of whole genome sequence data including 2.6 million single nucleotide polymorphisms and 752 copy number variations. The algorithm focused on predicting genetic risk of genes associated with known Mendelian disease, recognised drug responses, and pathogenicity for novel variants. In addition, since integration of risk ratios derived from case control studies is challenging, we estimated posterior probabilities from age and sex appropriate prior probability and likelihood ratios derived for each genotype. In addition, we developed a visualisation approach to account for gene-environment interactions and conditionally dependent risks. Findings We found increased genetic risk for myocardial infarction, type II diabetes and certain cancers. Rare variants in LPA are consistent with the family history of coronary artery disease. Pharmacogenomic analysis suggested a positive response to lipid lowering therapy, likely clopidogrel resistance, and a low initial dosing requirement for warfarin. Many variants of uncertain significance were reported. Interpretation Although challenges remain, our results suggest that whole genome sequencing can

Resident evaluation of clinical teachers based on teachers' certification.

PubMed

Steiner, Ivan P; Yoon, Philip W; Kelly, Karen D; Diner, Barry M; Donoff, Michel G; Mackey, Duncan S; Rowe, Brian H

2003-07-01

To examine the influence of emergency medicine (EM) certification of clinical teaching faculty on evaluations provided by residents. A prospective cohort analysis was conducted of assessments between July 1994 and July 2000 on residents' evaluations of EM faculty at the University of Alberta, Edmonton, Canada. Resident- and faculty-related variables were entered anonymously using the validated evaluation tool (ER Scale). Credentialing and demographic information on EM faculty was supplemented by data obtained through a nine-question survey. Groups were compared using ANOVA. The 562 residents returned 705 (91%) valid evaluation sheets on 115 EM faculty members. The four domains of didactic teaching, clinical teaching, approachability, and helpfulness were assessed. The majority of ratings were in the very good or superb categories for each domain. Instructors with certification in EM had higher scores in didactic, clinical teaching compared with others, and teachers without national certification scored lower in the helpful and approachable categories (p < 0.05). The route of obtaining EM certifications either through training or practice eligibility did not affect scores. Instructors under the age of 40 years had higher scores than the older age groups in three of four categories (p < 0.05). Instructors working at the teaching sites on a half-time basis received higher scores than those working full-time, and scores varied based on site. Overall, teaching ratings improved over the study period (p < 0.05). Significant differences exist among instructors in the EM setting that affect their teaching rating scores. National certification in EM, academic track, rotation year, and site are all correlated with better teaching performance.

[The effect of acupuncture in the treatment of insomnia. Clinical study of subjective and objective evaluation].

PubMed

Montakab, H; Langel, G

1994-01-01

The sleep-wake cycle is the most important circadian rhythm in man and thus constitutes an excellent indicator of internal equilibrium and of health. Sleep disorders, and particularly insomnia, affect a great percentage of the population. In daily practice, an inappropriate treatment may transform a bad sleeper into an insomniac dependent on pharmaceuticals for life. It is therefore necessary to give priority to non-chemical treatments in the management of insomnia. Acupuncture, which offers a personalized treatment, is particularly indicated for reharmonizing a disturbed sleep-wake cycle. Furthermore, there is an interesting similarity between the 5000-year-old theoretical basis of Chinese medicine and the recent scientific discoveries about man's internal rhythms. Clinical and statistical studies of the effects of acupuncture on insomnia are rare and evaluate only the subjective appreciation of sleep. Objective analysis of sleep by polysomnography permits evaluation of sleep architecture and visualizes the site and depth of action of the therapeutic method. Such studies have only been conducted in relation to pharmaceutical treatments. No such study has been carried out for acupuncture. A scientific and objective evaluation of the effects of acupuncture on insomnia by polysomnography could be not only of academic but mainly of great practical interest. If the efficiency of acupuncture is thus verified, this method could be integrated and proposed along with other classical therapeutic technics.

Nursing students' conception of clinical skills training before and after their first clinical placement: A quantitative, evaluative study.

PubMed

Struksnes, Solveig; Engelien, Ragna Ingeborg

2016-01-01

Education institution and practice field have a joint responsibility with regard to facilitating a learning environment for the nursing students that provides learning outcomes in accordance with the National Curriculum. Using simulated patient situations is about ensuring a safe learning environment where mistakes are not putting real patients' lives in danger. To compare nursing students' experiences with a skills training situation immediately after the training and after their ten weeks clinical placement in nursing homes. Quantitative, cross-sectional and evaluative. Full- and part-time students in their first year of a Bachelor of Nursing degree. The students answered a questionnaire on two different occasions, immediately after skills training and after internship in a nursing home. Being a "patient" and a "nurse" in simulation was experienced as useful to clinical practice. Students with previous experience had a significantly higher perception of mastering the procedure after the internship, while unexperienced fellow students did not report any significant increase with regard to a sense of coping during their clinical practice. The findings raise questions if there are aspects with the education institution or the practice field that should be improved to help facilitate a better learning process for students without any previous experience. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluating clinical periodontal measures as surrogates for bacterial exposure: The Oral Infections and Vascular Disease Epidemiology Study (INVEST)

PubMed Central

2010-01-01

Background Epidemiologic studies of periodontal infection as a risk factor for cardiovascular disease often use clinical periodontal measures as a surrogate for the underlying bacterial exposure of interest. There are currently no methodological studies evaluating which clinical periodontal measures best reflect the levels of subgingival bacterial colonization in population-based settings. We investigated the characteristics of clinical periodontal definitions that were most representative of exposure to bacterial species that are believed to be either markers, or themselves etiologic, of periodontal disease. Methods 706 men and women aged ≥ 55 years, residing in northern Manhattan were enrolled. Using DNA-DNA checkerboard hybridization in subgingival biofilms, standardized values for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia were averaged within mouth and summed to define "bacterial burden". Correlations of bacterial burden with clinical periodontal constructs defined by the severity and extent of attachment loss (AL), pocket depth (PD) and bleeding on probing (BOP) were assessed. Results Clinical periodontal constructs demonstrating the highest correlations with bacterial burden were: i) percent of sites with BOP (r = 0.62); ii) percent of sites with PD ≥ 3 mm (r = 0.61); and iii) number of sites with BOP (r = 0.59). Increasing PD or AL severity thresholds consistently attenuated correlations, i.e., the correlation of bacterial burden with the percent of sites with PD ≥ 8 mm was only r = 0.16. Conclusions Clinical exposure definitions of periodontal disease should incorporate relatively shallow pockets to best reflect whole mouth exposure to bacterial burden. PMID:20056008

Interim Outcomes Assessment of the Comprehensive Clinical Performance Grid for Student Evaluation.

ERIC Educational Resources Information Center

Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack

2001-01-01

Assessed the viability of the Comprehensive Clinical Performance Grid for Student Evaluation, introduced at The New England College of Optometry in 1996 in clinical student assessment. Analyzed faculty and student feedback and consistency with previous evaluations, between evaluators, and between clinical sites and tracts. Found satisfaction with…

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.

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

PubMed

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

2016-06-01

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

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.

Controlled clinical evaluations of chlorine dioxide, chlorite and chlorate in man.

PubMed Central

Lubbers, J R; Chauan, S; Bianchine, J R

1982-01-01

To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. Phase II considered the impact on normal subjects of daily ingestion of the disinfectants at a concentration of 5 mg/l. for twelve consecutive weeks. Persons with a low level of glucose-6-phosphate dehydrogenase may be expected to be especially susceptible to oxidative stress; therefore, in Phase III, chlorite at a concentration of 5 mg/l. was administered daily for twelve consecutive weeks to a small group of potentially at-risk glucose-6-phosphate dehydrogenase-deficient subjects. Physiological impact was assessed by evaluation of a battery of qualitative and quantitative tests. The three phases of this controlled double-blind clinical evaluation of chlorine dioxide and its potential metabolites in human male volunteer subjects were completed uneventfully. There were no obvious undesirable clinical sequellae noted by any of the participating subjects or by the observing medical team. In several cases, statistically significant trends in certain biochemical or physiological parameters were associated with treatment; however, none of these trends was judged to have physiological consequence. One cannot rule out the possibility that, over a longer treatment period, these trends might indeed achieve proportions of clinical importance. However, by the absence of detrimental physiological responses within the limits of the study, the relative safety of oral ingestion of chlorine dioxide and its metabolites, chlorite and chlorate, was demonstrated. PMID:6961033

Evaluation of Hi-Tec Implant Restoration in Mandibular First Molar Region- A Prospective Clinical Study.

PubMed

Sreeram, Roopa Rani S; Prasad, L Krishna; Chakravarthi, P Srinivas; Devi, Naga Neelima; Kattimani, Vivekanand S; Sreeram, Sanjay Krishna

2015-08-01

Missing teeth lead to loss of structural balance, inefficient function, poor aesthetics and psychological effects on human beings, which needs restoration for normal contour, function and aesthetics. Several natural or synthetic substitutes are being used for replacement of missing tooth since centuries. Implants are the latest modality of replacement. So, the study was aimed to assess clinical success rate of Hi-Tec implant; which is economical and new in market. Results of the study will help clinician for appropriate implant selection. The study included 10 patients from 19 to 31 years and needed restoration of missing mandibular first molar. Restoration had done using Hi Tec Single-tooth implants with metal-ceramic single crown prosthesis after three months of osseointegration. The implants were evaluated clinically (bleeding on probing, probing depth, implant mobility- periotest) and radiographically (marginal bone loss and peri-implant radiolucency) for six years. The observers were blinded for the duration of the study to prevent bias. All the patients had uneventful post-surgical healing. No bleeding on probing, Implant mobility, peri-implant radiolucency with minimal marginal bone loss and constant probing depths were observed well within the normal range during follow-up periods. Two stage single-tooth Hi Tec implant restoration can be used as a successful treatment modality for replacing mandibular first molar in an economic way. However, these results were obtained after 6 years of follow up with a smaller sample size, so long term multi center studies with a larger sample size is recommended for the predictability of success rate conclusively.

Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

PubMed

Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

2012-12-17

Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

Evaluating faculty clinical excellence in the academic health sciences center.

PubMed

Carey, R M; Wheby, M S; Reynolds, R E

1993-11-01

Although excellence in the clinical care of patients is the cornerstone of medicine, academic health sciences centers have increasingly given more weight to research and correspondingly less emphasis to patient care. To better recognize and reward clinical excellence, it is first necessary to effectively evaluate physicians' performances in patient care. In addition to addressing the value of faculty clinical excellence in the academic setting, the authors discuss different approaches to clinical assessment, theoretical and practical problems in assessing the performances of clinical faculty, and a system of evaluation being initiated at the University of Virginia School of Medicine. This system of evaluation combines--in annual individual reviews--a limited amount of objective assessment data with subjective evaluations from several sources. The objective data include board certification and recertification, analysis of outcomes data, and documentation of scholarly activity. The subjective evaluations include letters of recognition and appreciation from faculty colleagues and written observations from department chairs, housestaff, students, and nurses. The system has been accepted by department chairs, members of the Promotion and Tenure Committee, and the general faculty. In implementing this new system, periodic review of the pace and direction of change will be crucial to track progress and provide feedback for further modification.

Nursing students' experiences of the clinical learning environment in nursing homes: a questionnaire study using the CLES+T evaluation scale.

PubMed

Carlson, Elisabeth; Idvall, Ewa

2014-07-01

One major challenge facing the health care systems worldwide is the growing demand for registered nurses able to provide qualified nursing care for a vulnerable population. Positive learning experiences during clinical practice influence not only learning outcomes, but also how students reason in relation to future career choices. To investigate student nurses' experiences of the clinical learning environment during clinical practice in nursing homes, and to compare perceptions among student nurses with or without prior work experience as health care assistants in elderly care. A cross-sectional study was designed, utilising the Swedish version of the CLES+T evaluation scale. 260 student nurses (response rate 76%) who had completed a five week long clinical placement in nursing homes returned the questionnaire during the data collection period in 2011-2012. Data were analysed using descriptive statistics. Mann-Whitney U-test was used to examine differences in relation to students with or without prior experience of elderly care. Overall, the clinical learning environment was evaluated in a predominantly positive way. The sub-dimension Supervisory relationship displayed the highest mean value, and the lowest score was calculated for the sub-dimension Leadership style of the ward manager. Statistical significant differences between sub-groups were displayed for four out of 34 items. The supervisory relationship had the greatest impact on how student nurses experienced the clinical learning environment in nursing homes. It is therefore, of utmost importance that collaborative activities, between educational and nursing home settings, supporting the work of preceptors are established and maintained. Copyright © 2014 Elsevier Ltd. All rights reserved.

EVALUATION OF CLINICAL PERIODONTAL CONDITIONS IN SMOKERS AND NON-SMOKERS

PubMed Central

Luzzi, Lucinara Ignez Tavares; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir; Sant'ana, Adriana Campos Passanezi; Lauris, José Roberto Pereira; Cestari, Tânia Mary

2007-01-01

Given that tobacco smoking habit is a risk factor for periodontal diseases, the aim of this study was to compare clinical periodontal aspects between smokers and non-smokers. The clinical status were assessed in 55 patients, 29 smokers and 26 non-smokers, aged 30 to 50 years, with mean age of 40. The clinical parameters used were: probing depth (PD), plaque index (PI), gingival index (GI), clinical attachment level (CAL), gingival recession (GR) and gingival bleeding index (GBI) for arches (upper and lower) and teeth (anterior and posterior). Tooth loss was also evaluated in both groups. Multiple regression analysis showed: tendency of greater probing depth and clinical attachment level means for smokers; greater amount of plaque in smokers in all regions; greater gingival index means for non-smokers with clinical significance (p<0.05) in all regions. Although, without statistical significance, the analysis showed greater gingival bleeding index means almost always for non-smokers; similar gingival recession means in both groups and tendency of upper tooth loss in smokers and lower tooth loss in non-smokers. The findings of this study showed that clinical periodontal parameters may be different in smokers when compared to non-smokers and that masking of some periodontal signs can be a result of nicotine's vasoconstrictor effect. PMID:19089190

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.

Electronic clinical safety reporting system: a benefits evaluation.

PubMed

Elliott, Pamela; Martin, Desmond; Neville, Doreen

2014-06-11

Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

A new universal simplified adhesive: 6-month clinical evaluation.

PubMed

Mena-Serrano, Alexandra; Kose, Carlos; De Paula, Eloisa Andrade; Tay, Lidia Yileng; Reis, Alessandra; Loguercio, Alessandro D; Perdigão, Jorge

2013-02-01

Multimode adhesives, which can be used as etch-and-rinse or as self-etch adhesives, have been recently introduced without clinical data to back their use. To evaluate the 6-month clinical performance of Scotchbond Universal Adhesive (SU; 3M ESPE, St. Paul, MN, USA) in noncarious cervical lesions (NCCLs) using two evaluation criteria. Thirty-nine patients participated in this study. Two hundred restorations were assigned to four groups: SU-TEm: etch-and-rinse + moist dentin; SU-TEd: etch-and-rinse + dry dentin; SU-SEet: selective enamel etching; and SU-SE: self-etch. The composite resin Filtek Supreme Ultra (3M ESPE) was placed incrementally. The restorations were evaluated at baseline and after 6 months using both the World Dental Federation (FDI) and the United States Public Health Service (USPHS) criteria. Statistical analyses were performed with Friedman repeated measures analysis of variance by rank and McNemar test for significance in each pair (α = 0.05). Only four restorations (SU-SE: 3 and SU-TEm: 1) were lost after 6 months (p > 0.05 for either criteria). Marginal discoloration occurred in one restoration in the SU-SE group (p > 0.05 for either criteria). Only 2/200 restorations were scored as bravo for marginal adaptation using the USPHS criteria (one for SU-SE and one for SU-SEet, p > 0.05). However, when using the FDI criteria, the percentage of bravo scores for marginal adaptation at 6 months were 32%, 36%, 42%, and 46% for groups SU-TEm, SU-TEd, SU-SEet, and SU-SE, respectively (p > 0.05). The clinical behavior of the multimode adhesive does not depend on the bonding strategy at 6 months. The FDI evaluation criteria are more sensitive than the USPHS criteria. At 6 months, the clinical behavior of the new multimode adhesive Scotchbond Universal was found to be reliable when used in noncarious cervical lesions and may not depend on the bonding strategy employed. © 2012 Wiley Periodicals, Inc.

Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study.

PubMed

Björling, Gunilla; Johansson, Dorota; Bergström, Linda; Jalal, Shah; Kohn, Ivar; Frostell, Claes; Kalman, Sigridur

2015-12-01

Hospital acquired infections worsen the outcome of patients treated in intensive care units and are costly. Coatings with silver or metal alloys may reduce or alter the formation of biofilm on invasive medical devices. An endotracheal tube (ETT) is used to connect the patient to a ventilator and coated tubes have been tested in relation to bacterial colonization and respiratory infection. In the present study, we aimed to evaluate and compare a coated and uncoated ETT for patient symptoms and local tracheal tolerability during short term clinical use. Degree of bacterial colonization was also described. A silver-palladium-gold alloy coating ('Bactiguard®'Infection Protection, BIP) has been extensively used on urinary tract catheters and lately also on central venous catheters. We performed a randomised, single-blinded, controlled, first in man, post Conformité Européenne (EC) certification and CE marking study, focused on Bactiguard® coated ETTs (BIP ETT). Thirty patients at a tertiary university hospital scheduled for upper abdominal elective surgery with an expected duration of anaesthesia of at least 3 h were randomised; BIP ETT (n = 20) or standard ETT (n = 10). The tolerability was assessed with a modified version of Quality of Life Head and Neck Module, QLQ-H&N35 and by inspection of the tracheal mucosa with a fibre-optic bronchoscope before intubation and at extubation. Adverse Events (AE) and bacterial adherence were also studied. Statistical evaluations were carried out with the Fisher's Exact Test, the Clopper-Pearson method, as well as a Proportional Odds Model. Differences between groups were identified in 2 of 8 patient related symptoms with regard to tolerability by QLQ-H&N35 (cough, p = 0.022 and dry mouth, p = 0.014 in the treatment group.). No mucosal damage was identified with bronchoscopy. A low level of bacterial colonization with normal flora, equal between groups, was seen after short-term of intubation (median 5 h). No

Multicentered Study Evaluating Pharmacy Students' Perception of Palliative Care and Clinical Reasoning Using Script Concordance Testing.

PubMed

Atayee, Rabia S; Lockman, Kashelle; Brock, Cara; Abazia, Daniel T; Brooks, Tracy L; Pawasauskas, Jayne; Edmonds, Kyle P; Herndon, Christopher M

2018-01-01

As the role of the pharmacist on the transdisciplinary palliative care team grows, the need for adequate instruction on palliative care and clinical reasoning skills in schools of pharmacy grows accordingly. This study evaluates second- and third-year pharmacy students from 6 accredited schools of pharmacy that participated in surveys before and after the delivery of a didactic palliative care elective. The survey collected student demographics, perceptions of the importance of and student skill level in palliative care topics. The script concordance test (SCT) was used to assess clinical decision-making skills on patient cases. Student scores on the SCT were compared to those of a reference panel of experts. A total of 89 students completed the pre-/postsurveys and were included in data analysis. There was no statistically significant difference in student perceived importance of palliative care skills before and after the elective. Students from all 6 institutions showed significant increase in confidence in their palliative care skills at the end of the course. There was also a significant improvement across all institutions in clinical reasoning skills in most of the SCT questions used to assess these skills. Students choosing an elective in palliative care likely do so because they already have an understanding of the importance of these topics in their future practice settings. Delivery of a palliative care elective in the pharmacy curriculum significantly increases both student confidence in their palliative care skills and their clinical reasoning skills in these areas.

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.

Evaluating biomarkers for prognostic enrichment of clinical trials.

PubMed

Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

2017-12-01

A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

[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.

Advances in clinical pharmacy education in Germany: a quasi-experimental single-blinded study to evaluate a patient-centred clinical pharmacy course in psychiatry.

PubMed

Dircks, Monika; Mayr, Andreas; Freidank, Annette; Kornhuber, Johannes; Dörje, Frank; Friedland, Kristina

2017-12-12

The pharmacy profession has shifted towards patient-centred care. To meet the new challenges it is necessary to provide students with clinical competencies. A quasi-experimental single-blinded teaching and learning study was carried out using a parallel-group design to evaluate systematically the benefits of clinical teaching in pharmacy education in Germany. A clinical pharmacy course on a psychiatric ward was developed and implemented for small student groups. The learning aims included: the improvement of patient and interdisciplinary communication skills and the identification and management of pharmaceutical care issues. The control group participated only in the preparation lecture, while the intervention group took part in the complete course. The effects were assessed by an objective structured clinical examination (OSCE) and a student satisfaction survey. The intervention group achieved significantly better overall results on the OSCE assessment (46.20 ± 10.01 vs. 26.58 ± 12.91 of a maximum of 90 points; p < 0.0001).The practical tasks had the greatest effect, as reflected in the outcomes of tasks 1-5 (34.94 ± 9.60 vs. 18.63 ± 10.24 of a maximum of 60 points; p < 0.0001). Students' performance on the theoretical tasks (tasks 6-10) was improved but unsatisfying in both groups considering the maximum score (11.50 ± 4.75 vs. 7.50 ± 4.00 of a maximum of 30 points; p < 0.0001). Of the students, 93% rated the course as practice-orientated, and 90% felt better prepared for patient contact. Many students suggested a permanent implementation and an extension of the course. The results suggest that the developed ward-based course provided learning benefits for clinical skills. Students' perception of the course was positive. Implementation into the regular clinical pharmacy curriculum is therefore advisable.

Evaluation of the Clinical Learning Experience of Nursing Students: a Cross-Sectional Descriptive Study.

PubMed

Gurková, Elena; Žiaková, Katarína

2018-05-18

The purpose of the cross-sectional descriptive study was to explore and compare the students' experiences of the clinical environment and supervision in Slovakia. Students' clinical learning experience were measured by the valid and reliable clinical learning instrument. A higher frequency of successful supervisory experience was found in the universities which provided accredited mentor preparation programmes or courses and individualised supervisory approaches. Frequency of supervision meetings, the occupational title of a supervisor and mainly the supervision model have an association with students 'perceptions of different domains of clinical learning environment. The duration of the placement was not related to students' experience and perceptions of the learning environment. Slovak students reported higher score regarding the quality of nursing care or ward culture than in the supervisory relationships between students, clinical and school staff. Further studies in this field, extended to different Eastern European countries and clinical settings, may help us to understand factors affecting workplace training.

Influences on self-evaluation during a clinical skills programme for nurses.

PubMed

Yeo, J; Steven, A; Pearson, P; Price, C

2010-05-01

Education has moved from teacher to student-centred practices. Increasing emphasis is placed on 'life-long' learning in the context of a rapidly changing knowledge base. Self-evaluation is seen as one strategy to facilitate student-centred continuous professional development. The literature, however, suggests that learners' ability to self-assess is mixed, and little is known regarding how students perform self-assessment. This study focussed on senior nurses undertaking a scenario-based clinical skills course. Learners were asked to self-evaluate several times during the course. This research explored the influences on using the self-evaluation exercise. The study drew upon grounded theory methodology and was influenced by constructionist and postmodernist theories. Three methods of data collection were used: semi-structured interviews, observation of supervision sessions and recording of the numerical self-evaluation ratings. Multiple interviews with students (n = 14) and the educational supervisor (n = 1) were conducted. Thematic analysis and data collection were conducted iteratively. The study found that feeling confident and stating that confidence were not necessarily the same. Feeling confident was complex, influenced by changing perceptions of clinical skills and credibility. Changing frames of reference were used to judge feelings of confidence. Stating confidence appeared to be socially negotiated, influenced by social acceptability considerations such as modesty and the need to show progress over time. The discourses of empowerment and surveillance were influential and self-evaluation is discussed using Foucault's theory of governmentality, illustrating how learners can be both empowered and controlled through self-evaluation. Further consideration of the socially constructed nature of self-evaluations would benefit both educational practice and future research.

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

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning

Evaluating hospital discharge planning: a randomized clinical trial.

PubMed

Evans, R L; Hendricks, R D

1993-04-01

To select patients for early discharge planning, a randomized clinical trial evaluated a protocol that used risk factors identified upon hospital admission. The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care. Of 13,255 patients screened, 835 study participants were identified as "at risk" for frequent health care resource use. Half of the high-risk patients were randomly assigned to the experimental group (n = 417) and received discharge planning from day 3 of their hospital stay, while the control group (n = 418) received discharge planning only if there was a written physician request. Those patients receiving early, systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period. Length of the index hospital stay was not affected by early planning, however. The major clinical implication is the potential for discharge planners to decrease the need for, and use of, health care resources after hospital admission.

Preparation and clinical evaluation of succinylated collagen punctal plugs in dry eye syndrome: a pilot study.

PubMed

Hadassah, J; Bhuvaneshwari, Namita; Singh, Deepti; Sehgal, P K

2010-01-01

This is a pilot study of 10 eyes of 6 patients. This paper describes the preparation and clinical evaluation of succinylated collagen punctal plugs (SCPP) in the treatment of dry eye syndrome (DES). SCPP were prepared from succinylated collagen with the exact dimensions of the punctum (length 1.5-2.5 mm, diameter 0.2-0.5 mm, water content between 50 and 55%). All the patients were clinically evaluated for best corrected visual acuity (BCVA), tear fluid levels (TFL), protein content, tear fluid osmolarity (TFO), fluorescence staining of the cornea and tear break-up time (TBUT) before and after punctal occlusion with SCPP. TFL improved among all the patients after punctal occlusion with SCPP. BCVA showed improvement in case 4 (right eye/left eye), case 5 (left eye) and case 6 (right eye), who had developed dry eyes due to environmental conditions. Protein content increased on day 7 in all the patients and gradually decreased. TFO decreased on days 3 and 5 in all patients after punctal occlusion with SCPP, and showed the same levels on day 14. TFL, PC, TFO and TBUT showed significant improvement in all the patients after punctal occlusion with SCPP. All patients experienced symptomatic relief after punctal occlusion with SCPP. There was no discomfort, foreign body sensation, plug extrusion, corneal aberration, infection, or formation of pyogenic granuloma with SCPP. SCPP stands as a promising alternative to other punctal plugs in the treatment of DES. Copyright 2010 S. Karger AG, Basel.

Best practices for clinical pathology testing in carcinogenicity studies.

PubMed

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

2011-02-01

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

Clinical evaluation of P-glycoprotein inhibition by venetoclax: a drug interaction study with digoxin.

PubMed

Chiney, Manoj S; Menon, Rajeev M; Bueno, Orlando F; Tong, Bo; Salem, Ahmed Hamed

2018-09-01

1. Venetoclax is a novel, small molecule B-cell lymphoma-2 (BCL-2) inhibitor that has demonstrated clinical efficacy in a variety of haematological malignancies. Since venetoclax is an inhibitor of P glycoprotein (P-gp) transporter, a study was conducted in healthy, female volunteers to evaluate the effect of venetoclax on the pharmacokinetics of digoxin, a P-gp probe substrate. 2. Volunteers received a single oral dose of digoxin (0.5 mg) with or without a single oral dose of venetoclax (100  mg). Serial blood samples were obtained for pharmacokinetic assessments of digoxin and venetoclax and serial urine samples were obtained for measurement of digoxin concentrations. Safety was assessed throughout the study. 3. Coadministration of digoxin and venetoclax increased digoxin maximum observed plasma concentration (C max ) by 35% and area under the plasma-concentration time curve (AUC 0-∞) by 9%. Digoxin half-life, renal clearance and the fraction excreted unchanged in urine remained relatively similar. The results of this study indicate that venetoclax can increase the concentrations of P-gp substrates. Narrow therapeutic index P-gp substrates should be administered six hours prior to venetoclax to minimise the potential interaction.

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.

Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

PubMed

Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

2016-10-01

Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

[The Italian instrument evaluating the nursing students clinical learning quality].

PubMed

Palese, Alvisa; Grassetti, Luca; Mansutti, Irene; Destrebecq, Anne; Terzoni, Stefano; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Benaglio, Carla; Dal Ponte, Adriana; De Biasio, Laura; Dimonte, Valerio; Gambacorti, Benedetta; Fasci, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Montalti, Sandra; Nicotera, Raffaela; Randon, Giulia; Stampfl, Brigitte; Tollini, Morena; Canzan, Federica; Saiani, Luisa; Zannini, Lucia

2017-01-01

. The Clinical Learning Quality Evaluation Index for nursing students. The Italian nursing programs, the need to introduce tools evaluating the quality of the clinical learning as perceived by nursing students. Several tools already exist, however, several limitations suggesting the need to develop a new tool. A national project aimed at developing and validating a new instrument capable of measuring the clinical learning quality as experience by nursing students. A validation study design was undertaken from 2015 to 2016. All nursing national programs (n=43) were invited to participate by including all nursing students attending regularly their clinical learning. The tool developed based upon a) literature, b) validated tools already established among other healthcare professionals, and c) consensus expressed by experts and nursing students, was administered to the eligible students. 9606 nursing in 27 universities (62.8%) participated. The psychometric properties of the new instrument ranged from good to excellent. According to the findings, the tool consists in 22 items and five factors: a) quality of the tutorial strategies, b) learning opportunities; c) safety and nursing care quality; d) self-direct learning; e) quality of the learning environment. The tool is already used. Its systematic adoption may support comparison among settings and across different programs; moreover, the tool may also support in accrediting new settings as well as in measuring the effects of strategies aimed at improving the quality of the clinical learning.

[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

An overview of clinical studies on fiber post systems.

PubMed

Dikbas, Idil; Tanalp, Jale

2013-01-01

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

An Overview of Clinical Studies on Fiber Post Systems

PubMed Central

Dikbas, Idil; Tanalp, Jale

2013-01-01

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

Evaluation of concordance between CAD/CAM and clinical positions of abutment shoulder against mucosal margin: an observational study.

PubMed

Pietruski, Jan K; Skurska, Anna; Bernaczyk, Anna; Milewski, Robert; Pietruska, Maria Julia; Gehrke, Peter; Pietruska, Małgorzata D

2018-05-02

While working on CAD/CAM-customized abutments, the use of standard impression copings with a circular diameter produces inconsistency within the emergence profile. It may begin with a collapse of the supra-implant mucosa during impression taking, then lead to a computer-generated mismatch of the position and outline of the abutment shoulder, and consequently result in a compromised outcome of anticipated treatment. The aim of the study was to compare the virtual and clinical positions of the abutment shoulder in relation to the mucosal margin after the abutment delivery. Conventional open-tray impression takings followed uncovering surgery. Master casts were scanned with a desktop scanner. Clinical examinations took place after abutment's insertion and temporization (T1) and prior to cementation of the definitive crown (T2). The distances between the abutment shoulder and marginal soft tissue were measured intraorally in four aspects and juxtaposed with those on the virtual model. The study evaluated 257 dental implants and CAD/CAM-customized abutments. As T1 and T2 showed, there was a positive correlation between the virtually designed abutment shoulder position and matching clinical location relative to the mucosal margin. In 42.1% of cases, the distance between the mucosal margin and the abutment shoulder did not change. It increased in 36.3% of cases while a decrease occurred in 21.6% of them. Computer-set position of the abutment shoulder in relation to the mucosal margin can be predictably implemented in clinical practice.

Clinical classification and neuro-vestibular evaluation in chronic dizziness.

PubMed

Oh, Sun-Young; Kim, Do-Hyung; Yang, Tae-Ho; Shin, Byoung-Soo; Jeong, Seul-Ki

2015-01-01

This study attempts to clarify the clinical characteristics of chronic dizziness and its relationships with specific vestibular, oculomotor, autonomic and psychiatric dysfunctions. 73 Patients with idiopathic chronic dizziness were recruited and classified based on history taking and clinical examination into the following four clinical subgroups; vestibular migraine (VM), dysautonomia, psychogenic, and unspecified groups. They were also evaluated using oculomotor, otolithic and autonomic function tests, and psychologic investigation. Patients in the VM group showed a high proportion of abnormality on smooth pursuit and otolithic function testing compared to the other groups. The dysautonomia group revealed significant abnormalities in sympathetic and cardiovagal autonomic function, while the psychogenic group had a high frequency of abnormality in sympathetic autonomic testing and in Beck's anxiety inventory scale. The unspecified group showed abnormalities on saccade, smooth pursuit and autonomic function testing. Clinical classification of patients with chronic dizziness was relevant and they showed a correlation with disease-specific abnormal results in oculomotor, otolithic, autonomic function and psychology testing. Appropriate diagnostic investigation based on precise clinical diagnosis of chronic dizziness reduces the need for extensive laboratory testing, neuroimaging, and other low-yield tests. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study

PubMed Central

Purra, Aamir Rashid; Mushtaq, Mubashir; Acharya, Shashi Rashmi; Saraswati, Vidya

2014-01-01

Aim: The purpose of this clinical study was to evaluate the efficacy of saturated ethanolic solution of Propolis for the treatment of dentin hypersensitivity. Materials and Methods: Ten patients aged 20-40 years with 156 hypersensitive teeth were selected for a 3-month study. Each patient was subjected to treatment with saturated ethanolic solution of Propolis, 5% potassium nitrate and distilled water. The patients were recalled at seventh day, 2 weeks and 4 weeks for the application of the agent and re-evaluation. The final re-evaluation of the patients was done after 3 months from the first application. The responses of the patients to the test temperatures were converted to a ranking and data was statistically analyzed. A statistical analysis was done using ANOVA and Bonferroni test and Tukey HSD test for multicomparison. Results: The results between the Propolis group and the potassium nitrate group showed no significant difference in the immediate post-treatment period; however, the results were significant at the end of first week and second week. At 4 weeks and 3 months period, a comparison between the groups again showed no significant difference. Conclusion: It was concluded that Propolis was more effective than 5% potassium nitrate in relieving dentinal hypersensitivity and had an immediate and sustained effect. PMID:25210261

FRAIL-HF, a study to evaluate the clinical complexity of heart failure in nondependent older patients: rationale, methods and baseline characteristics.

PubMed

Vidán, María T; Sánchez, Elísabet; Fernández-Avilés, Francisco; Serra-Rexach, José A; Ortiz, Javier; Bueno, Héctor

2014-12-01

The clinical scenario of heart failure (HF) in older hospitalized patients is complex and influenced by acute and chronic comorbidities, coexistent geriatric syndromes, the patient's ability for self-care after discharge, and degree of social support. The impact of all these factors on clinical outcomes or disability evolution is not sufficiently known. FRAIL-HF is a prospective observational cohort study designed to evaluate clinical outcomes (mortality and readmission), functional evolution, quality of life, and use of social resources at 1, 3, 6, and 12 months after admission in nondependent elderly patients hospitalized for HF. Clinical features, medical treatment, self-care ability, and health literacy were prospectively evaluated and a comprehensive geriatric assessment with special focus on frailty was systematically performed in hospital to assess interactions and relationships with postdischarge outcomes. Between May 2009 and May 2011, 450 consecutive patients with a mean age of 80 ± 6 years were enrolled. Comorbidity was high (mean Charlson index, 3.4 ± 2.9). Despite being nondependent, 118 (26%) had minor disability for basic activities of daily living, only 76 (16.2%) had no difficulty in walking 400 meters, and 340 (75.5%) were living alone or with another elderly person. In addition, 316 patients (70.2%) fulfilled frailty criteria. Even nondependent older patients hospitalized for HF show a high prevalence of clinical and nonclinical factors that may influence prognosis and are usually not considered in routine clinical practice. The results of FRAIL-HF will provide important information about the relationship between these factors and different postdischarge clinical, functional, and quality-of-life outcomes. © 2014 Wiley Periodicals, Inc.

[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 and Evaluation of a Clinical Note Section Header Terminology

PubMed Central

Denny, Joshua C.; Miller, Randolph A.; Johnson, Kevin B.; Spickard, Anderson

2008-01-01

Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as “history of present illness” or “physical examination.” We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 “major sections.” There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

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

Brief review of published alprazolam clinical studies

PubMed Central

Straw, R. N.

1985-01-01

1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879

Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study.

PubMed

Delnoy, Peter Paul; Ritter, Philippe; Naegele, Herbert; Orazi, Serafino; Szwed, Hanna; Zupan, Igor; Goscinska-Bis, Kinga; Anselme, Frederic; Martino, Maria; Padeletti, Luigi

2013-08-01

The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction <35%), two groups were retrospectively composed a posteriori on the basis of the frequency of their AVD and VVD optimization: Group 1 (n = 66) was composed of patients 'systematically' optimized at implant, at 3 and 6 months; Group 2 (n = 133) was composed of all other patients optimized 'non-systematically' (less than three times) during the 1 year study. The primary endpoint was a composite of all-cause mortality, heart failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients.

Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

PubMed

Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

2017-01-01

For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

Prospective evaluation of the clinical utility of laryngeal electromyography.

PubMed

Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

2014-12-01

To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

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

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

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.

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'…

Gynecomastia: Clinical evaluation and management

PubMed Central

Cuhaci, Neslihan; Polat, Sefika Burcak; Evranos, Berna; Ersoy, Reyhan; Cakir, Bekir

2014-01-01

Gynecomastia is the benign enlargement of male breast glandular tissue and is the most common breast condition in males. At least 30% of males will be affected during their life. Since it causes anxiety, psychosocial discomfort and fear of breast cancer, early diagnostic evaluation is important and patients usually seek medical attention. Gynecomastia was reported to cause an imbalance between estrogen and androgen action or an increased estrogen to androgen ratio, due to increased estrogen production, decreased androgen production or both. Evaluation of gynecomastia must include a detailed medical history, clinical examination, specific blood tests, imaging and tissue sampling. Individual treatment requirements can range from simple reassurance to medical treatment or even surgery. The main aim of any intervention is to relieve the symptoms and exclude other etiological factors. PMID:24741509

Evaluating current automatic de-identification methods with Veteran's health administration clinical documents.

PubMed

Ferrández, Oscar; South, Brett R; Shen, Shuying; Friedlin, F Jeffrey; Samore, Matthew H; Meystre, Stéphane M

2012-07-27

The increased use and adoption of Electronic Health Records (EHR) causes a tremendous growth in digital information useful for clinicians, researchers and many other operational purposes. However, this information is rich in Protected Health Information (PHI), which severely restricts its access and possible uses. A number of investigators have developed methods for automatically de-identifying EHR documents by removing PHI, as specified in the Health Insurance Portability and Accountability Act "Safe Harbor" method.This study focuses on the evaluation of existing automated text de-identification methods and tools, as applied to Veterans Health Administration (VHA) clinical documents, to assess which methods perform better with each category of PHI found in our clinical notes; and when new methods are needed to improve performance. We installed and evaluated five text de-identification systems "out-of-the-box" using a corpus of VHA clinical documents. The systems based on machine learning methods were trained with the 2006 i2b2 de-identification corpora and evaluated with our VHA corpus, and also evaluated with a ten-fold cross-validation experiment using our VHA corpus. We counted exact, partial, and fully contained matches with reference annotations, considering each PHI type separately, or only one unique 'PHI' category. Performance of the systems was assessed using recall (equivalent to sensitivity) and precision (equivalent to positive predictive value) metrics, as well as the F(2)-measure. Overall, systems based on rules and pattern matching achieved better recall, and precision was always better with systems based on machine learning approaches. The highest "out-of-the-box" F(2)-measure was 67% for partial matches; the best precision and recall were 95% and 78%, respectively. Finally, the ten-fold cross validation experiment allowed for an increase of the F(2)-measure to 79% with partial matches. The "out-of-the-box" evaluation of text de

Portfolio assessment and evaluation: implications and guidelines for clinical nursing education.

PubMed

Chabeli, M M

2002-08-01

With the advent of Outcomes-Based Education in South Africa, the quality of nursing education is debatable, especially with regard to the assessment and evaluation of clinical nursing education, which is complex and renders the validity and reliability of the methods used questionable. This paper seeks to explore and describe the use of portfolio assessment and evaluation, its implications and guidelines for its effective use in nursing education. Firstly, the concepts of assessment, evaluation, portfolio and alternative methods of evaluation are defined. Secondly, a comparison of the characteristics of the old (traditional) methods and the new alternative methods of evaluation is made. Thirdly, through deductive analysis, synthesis and inference, implications and guidelines for the effective use of portfolio assessment and evaluation are described. In view of the qualitative, descriptive and exploratory nature of the study, a focus group interview with twenty students following a post-basic degree at a university in Gauteng regarding their perceptions on the use of portfolio assessment and evaluation method in clinical nursing education was used. A descriptive method of qualitative data analysis of open coding in accordance with Tesch's protocol (in Creswell 1994:155) was used. Resultant implications and guidelines were conceptualised and described within the existing theoretical framework. Principles of trustworthiness were maintained as described by (Lincoln & Guba 1985:290-327). Ethical considerations were in accordance with DENOSA's standards of research (1998:7).

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.

Clinical and histological evaluation of thermal injury thresholds in human teeth: a preliminary study.

PubMed

Baldissara, P; Catapano, S; Scotti, R

1997-11-01

The effect on healthy dental pulp of thermal increases ranging from 8.9 to 14.7 degrees C was evaluated. These temperature increases correspond approximately to those caused by certain restorative procedures, such as tooth preparation with high-speed instruments and the fabrication of direct provisional crowns. Two criteria of evaluation have been used in conjunction, a clinical (symptomatic) and a histological one, to assert with greater precision potential damage to the pulp. The results suggest a low susceptibility of cells to heat, which does not appear to be a major factor of injury, at least in the short term. The main cause of postoperative inflammation or necrosis of the pulp is probably the injury of the dentine, a tissue in direct functional and physiological connection with the pulp.

Evaluation of the clinical usefulness of modulated arc treatment

NASA Astrophysics Data System (ADS)

Lee, Young Kyu; Jang, Hong Seok; Kim, Yeon Sil; Choi, Byung Ock; Kang, Young-Nam; Nam, Sang Hee; Park, Hyeong Wook; Kim, Shin Wook; Shin, Hun Joo; Lee, Jae Choon; Kim, Ji Na; Park, Sung Kwang; Kim, Jin Young

2015-07-01

The purpose of this study is to evaluate the clinical usefulness of modulated arc (mARC) treatment techniques. The mARC treatment plans for non-small-cell lung cancer (NSCLC) patients were made in order to verify the clinical usefulness of mARC. A pre-study was conducted to find the best plan condition for mARC treatment, and the usefulness of the mARC treatment plan was evaluated by comparing it with other Arc treatment plans such as tomotherapy and RapidArc plans. In the case of mARC, the optimal condition for the mARC plan was determined by comparing the dosimetric performance of the mARC plans developed by using various parameters, which included the photon energy (6 MV, 10 MV), the optimization point angle (6°- 10°intervals), and the total number of segments (36 - 59 segments). The best dosimetric performance of mARC was observed at a 10 MV photon energy, a point angle 6 degrees, and 59 segments. The treatment plans for the three different techniques were compared by using the following parameters: the conformity index (CI), homogeneity index (HI), the target coverage, the dose to the OARs, the number of monitor units (MU), the beam on time, and the normal tissue complication probability (NTCP). As a result, the three different treatment techniques showed similar target coverages. The mARC plan had the lowest V20 (volume of lung receiving > 20 Gy) and MU per fraction compared with both the RapidArc and the tomotherapy plans. The mARC plan reduced the beam on time as well. Therefore, the results of this study provide satisfactory evidence that the mARC technique can be considered as a useful clinical technique for radiation treatment.

Evaluating sub-clinical cognitive dysfunction and event-related potentials (P300) in clinically isolated syndrome.

PubMed

Kocer, Belgin; Unal, Tugba; Nazliel, Bijen; Biyikli, Zeynep; Yesilbudak, Zulal; Karakas, Sirel; Irkec, Ceyla

2008-12-01

This study investigated the presence of sub-clinical cognitive dysfunction in patients with clinically isolated syndrome (CIS) and the abnormalities of cognitive event-related potentials (ERPs). Subclinical cognitive dysfunction was assessed in 20 patients with CIS and in 20 healthy controls. Patients had impairments in verbal learning and long-term memory, evaluating attention, executive function and visuospatial skills, in decreasing order of frequency. SDLT and SIT were the most, and COWAT and BNT were the least affected tests. The N200 and P200 latencies were prolonged, and N100, N200 and P200 amplitudes were reduced in the patients relative to the controls, from the Fz, Cz and Pz electrode positions (p<0.05). Detailed cognitive testing is valuable in determining subclinical cognitive dysfunction in CIS patients. ERP abnormalities as well as abnormalities in detailed cognitivetesting in patients with CIS are helpful in the diagnosis of sub-clinical cognitive dysfunction.

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

[Elaboration and critical evaluation of clinical guidelines].

PubMed

García Villar, C

2015-11-01

Clinical guidelines are documents to help professionals and patients select the best diagnostic or therapeutic option. Elaborating guidelines requires an efficient literature search and a critical evaluation of the articles found to select the most appropriate ones. After that, the recommendations are formulated and then must be externally evaluated before they can be disseminated. Even when the guidelines are very thorough and rigorous, it is important to know whether they fulfill all the methodological requisites before applying them. With this aim, various scales have been developed to critically appraise guidelines. Of these, the AGREE II instrument is currently the most widely used. This article explains the main steps in elaborating clinical guidelines and the main aspects that should be analyzed to know whether the guidelines are well written. Copyright © 2015 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

[Clinical evaluation of cefdinir 5% fine granules in pediatrics].

PubMed

Iwai, N; Nakamura, H; Taneda, Y; Miyazu, M; Kasai, K; Watanabe, Y

1991-10-01

Clinical evaluation in pediatrics on cefdinir (CFDN, FK482) (5% fine granules), a new oral cephem, was performed. 1. CFDN was administered to 112 pediatric patients with ages between 1 month to 13 years with various infections. Dose levels used were 3.0-8.9 mg/kg (mean 5.1 mg/kg) t.i.d. for 3-14 days (mean 6.7 days). The studied patients included 2 patients with scarlet fever, 6 with acute pharyngitis, 6 with acute rhinopharyngitis, 52 with acute purulent tonsillitis, 8 with acute bronchitis, 24 with acute pneumonia, 7 with acute urinary tract infections, 1 with acute vaginitis, and 6 with impetigo. Total doses ranged from 0.6 to 4.05 g. One hundred eleven of the 112 patients were evaluated for clinical efficacy and all the patients were evaluated for safety. 2. Clinical effects were excellent in 51 cases, good in 57, and fair in 3 with an extremely high efficacy rate of 97.3%. Efficacy rates were 100% in scarlet fever, acute pharyngitis, acute purulent tonsillitis, acute bronchitis, acute vaginitis and impetigo, and 83.3%, 95.7%, 85.7% in acute rhinopharyngitis, acute pneumonia, and acute urinary tract infections, respectively. Good clinical effects were observed regardless of diseases. 3. Causative organisms were identified in 79 cases, of which 71 were found to be monobacterial infections and 8 were found to be multi-bacterial infections. In mono-bacterial infections, clinical efficacies were 100% for those caused by Staphylococcus aureus/Streptococcus pyogenes/Streptococcus pneumoniae/beta-Streptococcus except those in A and B groups with an overall efficacy of 100% against Gram-positive cocci (GPC) and they were 89.5%, 100%, 100% for those caused by Haemophilus influenzae, Haemophilus parainfluenzae, and Escherichia coli, respectively, with an overall efficacy of 90.3% in Gram-negative rods (GNR). In multi-bacterial infections also, a clinical efficacy of 100% was obtained. 4. Bacteriological effects were studied for 89 strains in the 79 cases. The eradication

How to Implement Therapeutic Evaluative Conditioning in a Clinical Setting.

PubMed

Franklin, Joseph C; Fox, Kathryn R; Ribeiro, Jessica D

2017-05-01

Self-injurious behaviors (SIBs), including both suicidal and nonsuicidal self-injury, are major public health problems that have been on the rise in recent decades. There are few effective SIB interventions, and those that are effective cannot reach most people who are in need of help-that is, these interventions are not scalable. To address this need, we recently developed a scalable, app-based treatment called Therapeutic Evaluative Conditioning (TEC) that preliminary studies have shown causes reductions in SIBs (Franklin et al., 2016). Although TEC was developed and evaluated as a standalone, self-administered intervention, it may also be a valuable therapeutic tool within traditional clinical settings. Here we provide a case illustration of a young adult female who presented at an outpatient clinic with a long history of self-injurious behaviors and multiple failed treatment attempts. In discussing this case, we describe how to implement TEC within such a setting and what might be expected as a result. © 2017 Wiley Periodicals, Inc.

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

PubMed

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

2017-01-01

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

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.

Comparison of Alvarado score evaluation and clinical judgment in acute appendicitis.

PubMed

Abou Merhi, Bassem; Khalil, Mahmoud; Daoud, Nabil

2014-01-01

Acute appendicitis is the most common surgical emergency in children, but its diagnosis is sometimes difficult. The aim of this study is to evaluate retrospectively the Alvarado score in relation to the surgical management based on clinical judgment. Medical files of 232 children who underwent appendectomy at Makassed General Hospital from January 1997 till December 2006 were reviewed. Demographic characteristics, symptoms and signs, laboratory results and imaging findings for all children were recorded. The positive predictive value of our clinical judgment was 86.4% and the negative appendectomy rate was 13.6% based on the pathology results. The reliability of Alvarado score in our population found a PPV of 80.7% and a negative appendectomy rate of 11.3%. A multivariate analysis revealed that anorexia, neutrophils left shift and rebound tenderness are significantly correlated with a correct diagnosis of appendicitis (p = 0.012, 0.023 and 0.046 respectively). Although, Alvarado score provides measurably useful diagnostic information in evaluating children with suspected appendicitis, we found that good clinical judgment remain the main stay of correct diagnosis of appendicitis.

Swallowing in children with neurologic disorders: clinical and videofluoroscopic evaluations.

PubMed

Marrara, Jamille Lays; Duca, Ana Paula; Dantas, Roberto Oliveira; Trawitzki, Luciana Vitaliano Voi; Lima, Raquel Aparecida Cardozo de; Pereira, José Carlos

2008-01-01

swallowing in children with neurologic disorders. to relate the data obtained in the clinical and in the videofluoroscopic evaluations of swallowing in children with neurologic disorders. a retrospective analysis of 24 protocols of speech-language evaluation and of medical records of children, of both genders, referred to clinical and videofluoroscopic evaluations of swallowing at the School of Medicine of Ribeirão Preto - University of São Paulo, from January 2001 to June 2005. The following aspects were analyzed in the clinical evaluation: diet consistency, functional aspects of the swallowing mechanism and results of the cervical auscultation. Videofluoroscopic evaluation was performed to determine the dynamic aspects of the oral and pharyngeal phases. during the clinical evaluation of the oral phase, for both liquid and pasty consistencies, a greater occurrence of inadequate bolus control was observed (n = 15 e n = 14, respectively). In the pharyngeal phase, also for both consistencies, an adequate cervical auscultate was more frequently observed before swallowing (n = 16 e n = 13) followed by the inadequate cervical auscultation during swallowing (n = 15 e n = 12). In the videofluoroscopic evaluation, during the oral phase, for both consistencies, the presence of inadequate food propulsion was the most frequent finding (n = 13 e n = 13) and, in the pharyngeal phase, the most frequent finding was the absence of laryngotracheal aspiration (n = 12 e n = 17). There was a statistically significant correlation between the cervical auscultate and the excursion of the hyoid and the larynx, and between the cervical auscultate and laryngotracheal aspiration of liquid and pasty consistencies. both procedures are important and complementary in the diagnosis of dysphagia.

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

Evidenced-based review of clinical studies on periodontics.

PubMed

2009-08-01

Periodontal diseases have several implications for the practice of endodontics. First, advanced periodontitis often has direct implications for the long-term prognosis of the case and requires careful evaluation and coordinated treatment of both the periodontic and endodontic diseases. Second, the potential for functional interactions between odontogenic pathoses and marginal periodontitis requires careful collection of clinical observations and monitoring the outcome of various treatments. In this section, we provide an analysis of recent clinical studies in this area.

Hair and Scalp Disorders in a Tuscan Pediatric Dermatological Outpatient Clinic: A Clinical and Epidemiological Evaluation.

PubMed

Conti, Rossana; Colucci, Roberta; Arunachalam, Meena; Berti, Samantha; Fabroni, Caterina; De Martino, Maurizio; Dragoni, Federica; Lazzeri, Linda; Pisaneschi, Lisa; Moretti, Silvia

2016-01-01

The aim of this study was to evaluate the clinical and epidemiological profile of hair and scalp disorders in children referred to the Pediatric Dermatology Outpatient Clinic. We performed a retrospective study of children with hair loss problems or scalp diseases who turned to the Pediatric Dermatology Service, Anna Meyer Pediatric Hospital, Florence, Italy, from January 1, 2009, to December 31, 2009. Demographics, personal and familial medical history, laboratory tests, clinical examination, final diagnosis and therapeutic interventions were obtained from the manual chart review. Of the 2,640 children who had access to the Pediatric Dermatology Service, 190 (7.19%) had a hair or scalp disorder. Among the 190 children, 60 (31.57%) presented with nonscarring alopecia, 56 (29.47%) had benign neoplasias, hamartomas or vascular malformations of the scalp, 51 (26.84%) had scalp inflammatory diseases, 14 (7.36%) had scarring alopecia, 5 (2.63%) had infections and 2 (1.05%) had infestation of the scalp. A case of constitutional hypertrichosis (0.52%) and also a case (0.52%) of lamellar ichthyosis were diagnosed. Our results underline that hair and scalp diseases represent an important percentage of admittances to a dermatological pediatric outpatient clinic. The variety and complexity of the diseases observed in this study included diseases commonly found also in adulthood. © 2015 S. Karger AG, Basel.

Transient ischaemic attack clinic: an evaluation of diagnoses and clinical decision making.

PubMed

Lee, Will; Frayne, Judith

2015-04-01

The diagnosis of transient ischaemic attack (TIA) is based largely on the patient's symptom recall and clinical judgement. This decision-making process is highly subjective and the inter-observer reliability of TIA diagnosis is at best moderate, even among neurologists. The aim of this study is to examine the presenting features and final diagnoses of referrals to a TIA clinic and to evaluate characteristics that favoured the diagnosis of TIA over other TIA "mimics". Consecutive new referrals to a tertiary metropolitan hospital TIA clinic over a 9month period were examined. Characteristics between TIA and non-TIA diagnoses were compared and analysed. Eighty-two patients were recruited. Eighteen (22%) were given a final diagnosis of TIA or stroke. Major alternative diagnoses included migraine (n=17, 21%), presyncope/syncope (n=13, 16%) and anxiety (n=7, 9%). Four (5%) patients had unclassifiable symptoms with no clear final diagnosis. Mean age was 67±a standard deviation of 17years and patients diagnosed with TIA/stroke were on average older than those with non-TIA diagnoses (77±10 versus 64±17years, p=0.003). A diagnosis of TIA/stroke was favoured in the presence of moderate to severe weakness (p=0.032), dysphasia (p=0.037) or dysarthria (p=0.005). Unclassifiable symptoms (for example, palpitations, confusion, headache) were reported in 27 patients (33%) and their presence favoured non-TIA diagnoses (p=0.0003). TIA constituted a minority of the referrals to our clinic. Accurate clinical diagnosis of TIA facilitates early stroke prevention and avoids unnecessary investigations and prescriptions. Attempts to improve diagnostic accuracy of TIA should target improving the education and awareness of frontline medical practitioners. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical and translational scientist career success: metrics for evaluation.

PubMed

Lee, Linda S; Pusek, Susan N; McCormack, Wayne T; Helitzer, Deborah L; Martina, Camille A; Dozier, Ann M; Ahluwalia, Jasjit S; Schwartz, Lisa S; McManus, Linda M; Reynolds, Brian D; Haynes, Erin N; Rubio, Doris M

2012-10-01

Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. © 2012 Wiley Periodicals, Inc.

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.

Development and implementation of a competency-based clinical evaluation tool for midwifery education.

PubMed

Woeber, Kate

2018-07-01

The learning goals and evaluation strategies of competency-based midwifery programs must be explicit and well-defined. In the US, didactic learning is evaluated through a standardized certification examination, but standardized clinical competence evaluation is lacking. The Midwifery Competency Assessment Tool (MCAT) has been adapted from the International Confederation of Midwives' (ICM) "Essential Competencies" and from the American College of Nurse-Midwives' (ACNM) "Core Competencies", with student self-evaluation based on Benner's Novice-to-Expert theory. The MCAT allows for the measurement and monitoring of competence development in all domains of full-scope practice over the course of the midwifery program. Strengths of the MCAT are that it provides clear learning goals and performance evaluations for students, ensures and communicates content mapping across a curriculum, and highlights strengths and gaps in clinical opportunities at individual clinical sites and for entire programs. Challenges of the MCAT lie in balancing the number of competency items to be measured with the tedium of form completion, in ensuring the accuracy of student self-evaluation, and in determining "adequate" competence achievement when particular clinical opportunities are limited. Use of the MCAT with competency-based clinical education may facilitate a more standardized approach to clinical evaluation, as well as a more strategic approach to clinical site development and use. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical evaluation of a composite resin system with a dentin bonding agent for restoration of permanent posterior teeth: a 3-year study.

PubMed

Roberts, M W; Folio, J; Moffa, J P; Guckes, A D

1992-03-01

This study evaluated the clinical performance of a visible light-cured small particle bimodally filled hybrid condensable composite resin system that included a dentin bonding agent compared with an amalgam alloy in class II restorations of permanent teeth. A total of 108 restorations were placed in 34 patients. Fifty-three composite resin and 55 amalgam restorations were inserted. Each restoration was evaluated immediately after placement and then on an annual basis for a 3-year period using the Public Health Service (PHS) criteria. In addition, the Moffa-Lugassy scale was used to measure the loss of material on the occlusal surface of these materials. One hundred percent of the resin and amalgam restorations were evaluated, measured, and reasons for replacement were recorded over the 3-year period. There was no significant difference (p greater than 0.05) in the clinical performance of the composite resin and the amalgam when evaluated by the PHS criteria. Analyses of wear at each of the three annual recall periods did not reveal any significant difference (p greater than 0.05) between the two restorative materials when measured by the Moffa-Lugassy scale.

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.

Evaluation of stratification factors and score-scales in clinical trials of treatment of clinical mastitis in dairy cows.

PubMed

Hektoen, L; Ødegaard, S A; Løken, T; Larsen, S

2004-05-01

There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.

Clinical and Radiographic Evaluation of Procedural Errors during Preparation of Curved Root Canals with Hand and Rotary Instruments: A Randomized Clinical Study.

PubMed

Khanna, Rajesh; Handa, Aashish; Virk, Rupam Kaur; Ghai, Deepika; Handa, Rajni Sharma; Goel, Asim

2017-01-01

The process of cleaning and shaping the canal is not an easy goal to obtain, as canal curvature played a significant role during the instrumentation of the curved canals. The present in vivo study was conducted to evaluate procedural errors during the preparation of curved root canals using hand Nitiflex and rotary K3XF instruments. Procedural errors such as ledge formation, instrument separation, and perforation (apical, furcal, strip) were determined in sixty patients, divided into two groups. In Group I, thirty teeth in thirty patients were prepared using hand Nitiflex system, and in Group II, thirty teeth in thirty patients were prepared using K3XF rotary system. The evaluation was done clinically as well as radiographically. The results recorded from both groups were compiled and put to statistical analysis. Chi-square test was used to compare the procedural errors (instrument separation, ledge formation, and perforation). In the present study, both hand Nitiflex and rotary K3XF showed ledge formation and instrument separation. Although ledge formation and instrument separation by rotary K3XF file system was less as compared to hand Nitiflex. No perforation was seen in both the instrument groups. Canal curvature played a significant role during the instrumentation of the curved canals. Procedural errors such as ledge formation and instrument separation by rotary K3XF file system were less as compared to hand Nitiflex.

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

PubMed Central

Rubio, Doris M.; Thomas, Veronica G.

2013-01-01

Abstract The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality. PMID:23919366

[Clinical value evaluation of Chinese herbal formula in context of multi-omics network].

PubMed

Li, Bing; Han, Fei; Wang, Zhong; Wang, Yong-Yan

2017-03-01

Clinical value evaluation is the key issue to solve the problems such as high repetition rate, fuzzy clinical positioning, broad indications and unclear clinical values in Chinese herbal formula(Chinese patent medicine). By analyzing the challenges and opportunities of Chinese herbal formula in clinical value evaluation, this paper introduced a strategy of multi-omic network analysis. Through comparative analysis of three stroke treatment formulas, we suggested their different characteristic advantages for variant symptoms or phenotypes of stroke, which may provide reference for rational clinical choice. Such multi-omic network analysis strategy may open a unique angle of view for clinical evaluation and comparison of Chinese herbal formula. Copyright© by the Chinese Pharmaceutical Association.

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 Method to Evaluate Critical Factors for Successful Implementation of Clinical Pathways.

PubMed

Dong, W; Huang, Z

2015-01-01

Clinical pathways (CPs) have been viewed as a multidisciplinary tool to improve the quality and efficiency of evidence-based care. Despite widespread enthusiasm for CPs, research has shown that many CP initiatives are unsuccessful. To this end, this study provides a methodology to evaluate critical success factors (CSFs) that can aid healthcare organizations to achieve successful CP implementation. This study presents a new approach to evaluate CP implementation CSFs, with the aims being: (1) to identify CSFs for implementation of CPs through a comprehensive literature review and interviews with collaborative experts; (2) to use a filed study data with a robust fuzzy DEMATEL (the decision making trial and evaluation laboratory) approach to visualize the structure of complicated causal relationships between CSFs and obtain the influence level of these factors. The filed study data is provided by ten clinical experts of a Chinese hospital. 23 identified CSF factors which are initially identified through a review of the literature and interviews with collaborative experts. Then, a number of direct and indirect relationships are derived from the data such that different perceptions can be integrated into a compromised cause and effect model of CP implementation. The results indicate that the proposed approach can systematically evaluate CSFs and realize the importance of each factor such that the most common causes of failure of CP implementation could be eliminated or avoided. Therefore, the tool proposed would help healthcare organizations to manage CP implementation in a more effective and proactive way.

Assessment of periodontal bone level revisited: a controlled study on the diagnostic accuracy of clinical evaluation methods and intra-oral radiography.

PubMed

Christiaens, Véronique; De Bruyn, Hugo; Thevissen, Eric; Koole, Sebastiaan; Dierens, Melissa; Cosyn, Jan

2018-01-01

The accuracy of analogue and especially digital intra-oral radiography in assessing interdental bone level needs further documentation. The aim of this study was to compare clinical and radiographic bone level assessment to intra-surgical bone level registration (1) and to identify the clinical variables rendering interdental bone level assessment inaccurate (2). The study sample included 49 interdental sites in 17 periodontitis patients. Evaluation methods included vertical relative probing attachment level (RAL-V), analogue and digital intra-oral radiography and bone sounding without and with flap elevation. The latter was considered the true bone level. Five examiners evaluated all radiographs. Significant underestimation of the true bone level was observed for all evaluation methods pointing to 2.7 mm on average for analogue radiography, 2.5 mm for digital radiography, 1.8 mm for RAL-V and 0.6 mm for bone sounding without flap elevation (p < 0.001). Radiographic underestimation of the true bone level was higher in the (pre)molar region (p ≤ 0.047) and increased with defect depth (p < 0.001). Variation between clinicians was huge (range analogue radiography 2.2-3.2 mm; range digital radiography 2.1-3.0 mm). All evaluation methods significantly underestimated the true bone level. Bone sounding was most accurate, whereas intra-oral radiographs were least accurate. Deep periodontal defects in the (pre)molar region were most underrated by intra-oral radiography. Bone sounding had the highest accuracy in assessing interdental bone level.

Two-year clinical evaluation of IPS Empress II ceramic onlays/inlays.

PubMed

Tagtekin, D A; Ozyöney, G; Yanikoglu, F

2009-01-01

The stronger the ceramic material, the longer the restoration stays in the mouth. The current study evaluated the two-year clinical performance of a strong ceramic system, IPS Empress II, with increased strength on onlay/inlay restorations of molars. Teeth from 35 patients, including three premolars and 32 molars, were prepared for 28 onlay and seven inlay restorations with IPS Empress II ceramics. The restorations were cemented with a highly viscous, dual-curing luting composite cement (Bifix) and evaluated by two examiners using USPHS criteria at baseline (one week following insertion), six months, one year and two years. The baseline scores and recalls were assessed by Wilcoxon signed rank test. Statistically significant marginal discoloration at the Bravo level was found at the 12- and 24-month recalls (p=0.046). One debonding was statistically insignificant. No changes were observed with respect to anamnesis, such as any symptom from the TMJ or masticatory muscles. No restorations were replaced due to hypersensitivity or were missing at the two-year evaluation. Any wear on the restoration, antagonist tooth or any changes of proximal contacts were not observed. IPS Empress II Ceramics were found to be appropriate as onlay/inlay restorations for clinical use under the conditions of the current study.

[Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

PubMed

Lázaro de Mercado, P

1997-06-01

Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

[Comparative evaluation of clinical practice guidelines for the treatment of schizophrenia].

PubMed

Delessert, D; Pomini, V; Grasset, F; Baumann, P

2008-01-01

Many clinical practice guidelines (CPG) have been published in reply to the development of the concept of "evidence-based medicine" (EBM) and as a solution to the difficulty of synthesizing and selecting relevant medical literature. Taking into account the expansion of new CPG, the question of choice arises: which CPG to consider in a given clinical situation? It is of primary importance to evaluate the quality of the CPG, but until recently, there has been no standardized tool of evaluation or comparison of the quality of the CPG. An instrument of evaluation of the quality of the CPG, called "AGREE" for appraisal of guidelines for research and evaluation was validated in 2002. The six principal CPG concerning the treatment of schizophrenia are compared with the help of the "AGREE" instrument: (1) "the Agence nationale pour le développement de l'évaluation médicale (ANDEM) recommendations"; (2) "The American Psychiatric Association (APA) practice guideline for the treatment of patients with schizophrenia"; (3) "The quick reference guide of APA practice guideline for the treatment of patients with schizophrenia"; (4) "The schizophrenia patient outcomes research team (PORT) treatment recommendations"; (5) "The Texas medication algorithm project (T-MAP)" and (6) "The expert consensus guideline for the treatment of schizophrenia". The results of our study were then compared with those of a similar investigation published in 2005, structured on 24 CPG tackling the treatment of schizophrenia. The "AGREE" tool was also used by two investigators in their study. In general, the scores of the two studies differed little and the two global evaluations of the CPG converged; however, each of the six CPG is perfectible. The rigour of elaboration of the six CPG was in general average. The consideration of the opinion of potential users was incomplete, and an effort made in the presentation of the recommendations would facilitate their clinical use. Moreover, there was little

PACS in the Utrecht University Hospital: final conclusions of the clinical evaluation

NASA Astrophysics Data System (ADS)

Wilmink, J. B.; ter Haar Romeny, Bart M.; Barneveld Binkhuysen, Frits H.; Achterberg, A. J.; Zuiderveld, Karel J.; Calkoen, P.; Kouwenberg, Jef M.

1990-08-01

In the past three years, a clinical evaluation of a PACS has been performed in the Utrecht University Hospital as part of the Dutch PACS project. The clinical evaluation focussed on the following aspects: technical evaluation of the prototype PACS equipment coupled to the HIS; diagnostic accuracy studies; studies concerning the impact on the organization of the radiology-department and the referring wards; and cost-savings analysis. Some of the results of these subprojects have already been presented at previous SPIE conferences. In this paper the general condusions are presented about the usefulness of the evaluated PAC-System in the daily routine of radiology department and clinic. By making available the images of radiological examinations fast, complete, reliable and continously on the ward, concrete improvements with regard to the current process could be realized. The possibilities of PACS caused an increasing enthousiasm among the clinicians. By the easier access to all images of their patients during 24 hours/day, they saw more images on the day of the examination and images could be more easily used at consultations of other specialists. The overall conclusion is positive, but a lot of work has to be done to transform PACS from an experimental setup into a routine production system on which a flimless hospital can be based. A complete PACS needs an inteffigent Image Management System, which indudes prefetching algorithms based on data from the Hospital Information System and automated procedures for removing obsolete images from the local buffers in the workstations. As yet PACS is very expensive, and the direct savings in the hospital cannot compensate for the high costs of investment. Possibly PACS can contribute to a shorter stay of patients in the hospital. This will lead to savings for government and health insurance companies and they can be expected to contribute to PAS implementation studies.

Nursing students' evaluation of quality indicators during learning in clinical practice.

PubMed

Jansson, Inger; Ene, Kerstin W

2016-09-01

A supportive clinical learning environment is important for nursing students' learning. In this study, a contract between a county and a university involving a preceptor model of clinical education for nursing students is described. The aim of this study was to describe nursing students' clinical education based on quality indicators and to describe the students' experiences of what facilitated or hindered the learning process during their clinical practice. During autumn 2012 and spring 2013, 269 student evaluations with quantitative and qualitative answers were filled out anonymously. Quantitative data from the questionnaires concerning the quality indicators: Administration/information, Assessments/examinations and Reflection were processed to generate descriptive statistics that revealed gaps in what the preceptor model demands and what the students reported. The answers from the qualitative questions concerning the quality indicator Learning were analysed using content analysis. Four categories emerged: Independence and responsibility, continuity of learning, time, and the competence and attitudes of the staff. The study underlines that reflection, continuity, communication and feedback were important for the students' learning process, whereas heavy workload among staff and being supervised by many different preceptors were experienced as stressful and hindering by students. Copyright © 2016 Elsevier Ltd. All rights reserved.

Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

PubMed

Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

2010-10-01

New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

Clinical and Translational Scientist Career Success: Metrics for Evaluation

PubMed Central

Lee, Linda S.; Pusek, Susan N.; McCormack, Wayne T.; Helitzer, Deborah L.; Martina, Camille A.; Dozier, Ann M.; Ahluwalia, Jasjit S.; Schwartz, Lisa S.; McManus, Linda M.; Reynolds, Brian D.; Haynes, Erin N.; Rubio, Doris M.

2012-01-01

Abstract Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. Clin Trans Sci 2012; Volume 5: 400–407 PMID:23067352

Evaluating Study Withdrawal Among Biologics and Immunomodulators in Treating Ulcerative Colitis: A Meta-analysis of Controlled Clinical Trials.

PubMed

Shah, Eric D; Siegel, Corey A; Chong, Kelly; Melmed, Gil Y

2016-04-01

We conducted a systematic review and meta-analysis to evaluate the efficacy and adverse event (AE)-associated tolerability of treatment with immunomodulators and biologics in ulcerative colitis clinical trials. We performed a literature search of PubMed and the Cochrane databases to identify randomized placebo-controlled trials of immunomodulators and biologics. Tolerability was defined through study withdrawal due to AEs and efficacy through clinical response in induction trials and clinical remission in maintenance trials. We performed meta-analyses using a random-effects model to determine relative risks (RRs) of efficacy and study withdrawal. Number needed to treat (NNT) and number needed to stop (NNS) were determined. The ratio of NNS/NNT was calculated, with a higher ratio indicating a greater number of patients in remission for every AE study discontinuation. We examined 13 single-agent trials representing biologics (infliximab, adalimumab, golimumab, and vedolizumab) and immunomodulators (tacrolimus and azathioprine). Induction therapy did not result in excess study withdrawal with immunomodulators (RR = 0.9, 95% CI 0.1-12.0) or biologics (RR = 0.7, 95% CI 0.3-1.8), therefore the NNS/NNT ratio could not be assessed because of high tolerability. Maintenance immunomodulator therapy resulted in a NNS of 14 (RR = 2.8, 95% CI 0.7-10.5) and NNS/NNT ratio of 2.4 in 2 trials. Biologics did not result in excess study withdrawal in maintenance (RR = 0.7, 95% CI 0.3-1.7) or combined induction-and-maintenance (RR = 0.6, 95% CI 0.4-1.0) trials. Biologics were not associated with a higher RR of study withdrawal due to AE than placebo. There were insufficient data to compare these results with immunomodulators.

Sonographic Evaluation of Clinically Significant Perigraft Hematomas in Kidney Transplant Recipients.

PubMed

Fananapazir, Ghaneh; Rao, Rajiv; Corwin, Michael T; Naderi, Sima; Santhanakrishnan, Chandrasekar; Troppmann, Christoph

2015-10-01

The purpose of this study was to assess the sensitivity of ultrasound in evaluating peritransplant hematomas that require surgical evacuation in recipients of kidney transplants. Thirty-four patients who underwent 37 hematoma evacuations underwent ultrasound examinations in the 24 hours before surgical evacuation. The operative reports were evaluated for presence and size of collection, presence of active bleeding at operation, and composition of the hematoma. The clinical findings leading to the ultrasound examination were recorded. Ultrasound examinations were evaluated in consensus by two board-certified and fellowship-trained abdominal radiologists for the presence, size, and echogenicity of the collection; subjective perfusion visualized with color and power Doppler ultrasound; velocities of the renal arteries; and arcuate artery resistive indexes. Ten of the 37 imaged hematomas (27%) had either no or small (< 50 mL) fluid collections on ultrasound examination. With sonographic volumetry, the reported intraoperative volumes were underestimated by 46%. The mean arcuate artery resistive index was 0.82 in the superior pole, 0.81 in the mid pole, and 0.78 in the inferior pole of the kidney. A decrease in hemoglobin level was the most sensitive clinical finding for determining the presence of perigraft hematomas. Our results suggest that gray-scale sonography alone appears to have limited sensitivity in detecting clinically significant peritransplant hematomas and that its use may result in overall underestimates of hematomas.

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.

Generation and evaluation of 3D digital casts of maxillary defects based on multisource data registration: A pilot clinical study.

PubMed

Ye, Hongqiang; Ma, Qijun; Hou, Yuezhong; Li, Man; Zhou, Yongsheng

2017-12-01

Digital techniques are not clinically applied for 1-piece maxillary prostheses containing an obturator and removable partial denture retained by the remaining teeth because of the difficulty in obtaining sufficiently accurate 3-dimensional (3D) images. The purpose of this pilot clinical study was to generate 3D digital casts of maxillary defects, including the defective region and the maxillary dentition, based on multisource data registration and to evaluate their effectiveness. Twelve participants with maxillary defects were selected. The maxillofacial region was scanned with spiral computer tomography (CT), and the maxillary arch and palate were scanned using an intraoral optical scanner. The 3D images from the CT and intraoral scanner were registered and merged to form a 3D digital cast of the maxillary defect containing the anatomic structures needed for the maxillary prosthesis. This included the defect cavity, maxillary dentition, and palate. Traditional silicone impressions were also made, and stone casts were poured. The accuracy of the digital cast in comparison with that of the stone cast was evaluated by measuring the distance between 4 anatomic landmarks. Differences and consistencies were assessed using paired Student t tests and the intraclass correlation coefficient (ICC). In 3 participants, physical resin casts were produced by rapid prototyping from digital casts. Based on the resin casts, maxillary prostheses were fabricated by using conventional methods and then evaluated in the participants to assess the clinical applicability of the digital casts. Digital casts of the maxillary defects were generated and contained all the anatomic details needed for the maxillary prosthesis. Comparing the digital and stone casts, a paired Student t test indicated that differences in the linear distances between landmarks were not statistically significant (P>.05). High ICC values (0.977 to 0.998) for the interlandmark distances further indicated the high

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.

Clinical evaluation of disc battery ingestion in children.

PubMed

Mirshemirani, AliReza; Khaleghnejad-Tabari, Ahmad; Kouranloo, Jaefar; Sadeghian, Naser; Rouzrokh, Mohsen; Roshanzamir, Fatolah; Razavi, Sajad; Sayary, Ali Akbar; Imanzadeh, Farid

2012-04-01

BACKGROUND The purpose of this study was to evaluate the characteristics, management, and outcomes of disc battery ingestion in children. METHODS We reviewed the medical records of children admitted to Mofid Children's Hospital due to disc battery ingestion from January 2006 to January 2010. Clear history, clinical symptoms and results of imaging studies revealed diagnosis of disc battery ingestion in suspected patients. The clinical data reviewed included age, gender, clinical manifestation, radiologic findings, location of disc battery, duration of ingestion, endoscopic results and surgical treatment. RESULTS We found 22 cases (11 males and 11 females) of disc battery ingestion with a mean age of 4.3 years (range: 9 months to 12 years). Common symptoms were vomiting, cough, dysphagia, and dyspnea. The mean duration of ingestion was 2.7 days (4 hours to 1.5 months). A total of 19 patients had histories of disc battery ingestion, but three cases referred with the above symptoms, and the batteries were accidentally found by x-ray. Only three cases had batteries impacted in the esophagus. Twelve batteries were removed endoscopically, 6 batteries spontaneously passed through the gastrointestinal (GI) tract within 5 to 7 days, and 4 patients underwent surgery due to complications: 3 due to tracheo-esophageal fistula (TEF) and 1 due to intestinal perforation. There was no mortality in our study. CONCLUSION Most cases of disc battery ingestion run uneventful courses, but some may be complicated. If the battery lodges in the esophagus, emergency endoscopic management is necessary. However, once in the stomach, it will usually pass through the GI tract.

Job-sharing a clinical teacher's position: an evaluation.

PubMed

Williams, S; Murphy, L

1994-01-01

The aim of this study was to evaluate the effects on staff of having two teachers share one clinical teaching position in their intensive care unit (ICU). Three, six and 12 months after the job-sharing arrangement was initiated, an 11 item questionnaire was distributed to 26 students in post-registration critical care courses, 41 clinical staff in ICU and 9 RN-managers with responsibilities for the unit. The overall response rate to the three questionnaires was 58%. All groups agreed that job-sharing was a viable alternative to full-time work. Three months after the shared position was initiated, there was uncertainty about the consistency of the teachers' performance and the adequacy of communication between them. Nine months later, there was a high level of positive responses to all areas of the teachers' performance. Most respondents felt they could approach either teacher and that more diverse ideas were generated by having two people in the teaching position.

Evaluating the impact of clinical librarians on clinical questions during inpatient rounds

PubMed Central

Brian, Riley; Orlov, Nicola; Werner, Debra; Martin, Shannon K.; Arora, Vineet M.; Alkureishi, Maria

2018-01-01

Objective The investigation sought to determine the effects of a clinical librarian (CL) on inpatient team clinical questioning quality and quantity, learner self-reported literature searching skills, and use of evidence-based medicine (EBM). Methods Clinical questioning was observed over 50 days of inpatient pediatric and internal medicine attending rounds. A CL was present for 25 days and absent for 25 days. Questioning was compared between groups. Question quality was assessed by a blinded evaluator, who used a rubric adapted from the Fresno Test of Competence in Evidence-Based Medicine. Team members were surveyed to assess perceived impacts of the CL on rounds. Results Rounds with a CL (CLR) were associated with significantly increased median number of questions asked (5 questions CLR vs. 3 NCLR; p<0.01) and answered (3 CLR vs. 2 NCLR; p<0.01) compared to rounds without a CL (NCLR). CLR were also associated with increased mean time spent asking (1.39 minutes CLR vs. 0.52 NCLR; p<0.01) and answering (2.15 minutes CLR vs. 1.05 NCLR; p=0.02) questions. Rounding time per patient was not significantly different between CLR and NCLR. Questions during CLR were 2 times higher in adapted Fresno Test quality than during NCLR (p<0.01). Select participants described how the CL’s presence improved their EBM skills and care decisions. Conclusions Inpatient CLR were associated with more and improved clinical questioning and subjectively perceived to improve clinicians’ EBM skills. CLs may directly affect patient care; further study is required to assess this. CLs on inpatient rounds may be an effective means for clinicians to learn and use EBM skills. PMID:29632440

Implementation and evaluation of Parkinson disease management in an outpatient clinical pharmacist-run neurology telephone clinic.

PubMed

Stefan, Teodora Cristina; Elharar, Nicole; Garcia, Guadalupe

2018-05-01

Parkinson disease (PD) is a progressive, debilitating neurodegenerative disease that often requires complex pharmacologic treatment regimens. Prior to this clinic, there was no involvement of a clinical pharmacy specialist (CPS) in the outpatient neurology clinic at the West Palm Beach Veterans Affairs Medical Center. This was a prospective, quality-improvement project to develop a clinical pharmacist-run neurology telephone clinic and evaluate pharmacologic and nonpharmacologic interventions in an effort to improve the quality of care for patients with PD. Additionally, the CPS conducted medication education groups to 24 patients with PD and their caregivers, if applicable, at this medical center with the purpose of promoting patient knowledge and medication awareness. Medication management was performed via telephone rather than face to face. Only patients with a concomitant mental health diagnosis for which they were receiving at least one psychotropic medication were included for individual visits due to the established scope of practice of the CPS being limited to mental health and primary care medications. Data collection included patient and clinic demographics as well as pharmacologic and nonpharmacologic interventions made for patients enrolled from January 6, 2017, through March 31, 2017. A total of 49 pharmacologic and nonpharmacologic interventions were made for 10 patients. We successfully implemented and evaluated a clinical pharmacist-run neurology telephone clinic for patients with PD. Expansion of this clinic to patients with various neurological disorders may improve access to care using an innovative method of medication management expertise by a CPS.

Evaluation of gastric emptying function in clinical practice.

PubMed

Poitras, P; Picard, M; Déry, R; Giguère, A; Picard, D; Morais, J; Plourde, V; Boivin, M

1997-11-01

In this retrospective analysis, we compared different methods to evaluate gastric emptying function, aiming to improve the sensitivity and the clinical availability of our diagnostic testing. In the first study, we compared, in 72 patients clinically suspected of gastroparesis, the emptying of a meal containing two solid nutrients with different disintegration rates: 111In-labeled scrambled eggs and 99Tc-labeled liver cubes. Gastric emptying of 111In-labeled egg was delayed in 12 of our patients and the evacuation of the 99Tc-labeled liver was prolonged in 19 patients. The choice of the nutrient was not important for the identification of diabetic gastroparesis (43% vs 57%; NS), but it was determinant in the case of patients suspected of idiopathic gastroparesis (12% were positive with the egg and 25% with the liver; P < 0.05). In the second study, we compared two different diagnostic methods in 46 patients: a simple radiological detection of the gastric emptying of radiopaque pellets, and the scintigraphic emptying of a solid meal containing 99Tc-labeled liver cubes. Both tests correlated perfectly in 78% of our patients. In 15% of the population (six of these seven patients were diabetics suspected of gastroparesis) the scintigraphic method was normal, while the evacuation of radiopaque pellets was delayed. For clinical purposes, we therefore propose: (1) the scintigraphic method should use liver rather than egg as a radiolabeled tracer in order to improve the sensitivity of the test for detection of gastroparesis; and (2) the radiological detection of radiopaque markers is a reliable and convenient method for the detection of gastroparesis in clinical practice. It is possibly more sensitive than scintigraphy.

Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T).

PubMed

Coleman, Susanne; Smith, Isabelle L; McGinnis, Elizabeth; Keen, Justin; Muir, Delia; Wilson, Lyn; Stubbs, Nikki; Dealey, Carol; Brown, Sarah; Nelson, E Andrea; Nixon, Jane

2018-02-01

To test the psychometric properties and clinical usability of a new Pressure Ulcer Risk Assessment Instrument including inter-rater and test-retest reliability, convergent validity and data completeness. Methodological and practical limitations associated with traditional Pressure Ulcer Risk Assessment Instruments, prompted a programme to work to develop a new instrument, as part of the National Institute for Health Research funded, Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056). Observational field test. For this clinical evaluation 230 patients were purposefully sampled across four broad levels of pressure ulcer risk with representation from four secondary care and four community NHS Trusts in England. Blinded and simultaneous paired (ward/community nurse and expert nurse) PURPOSE-T assessments were undertaken. Follow-up retest was undertaken by the expert nurse. Field notes of PURPOSE-T use were collected. Data were collected October 2012-January 2013. The clinical evaluation demonstrated "very good" (kappa) inter-rater and test-retest agreement for PURPOSE-T assessment decision overall. The percentage agreement for "problem/no problem" was over 75% for the main risk factors. Convergent validity demonstrated moderate to high associations with other measures of similar constructs. The PURPOSE-T evaluation facilitated the initial validation and clinical usability of the instrument and demonstrated that PURPOSE-T is suitable of use in clinical practice. Further study is needed to evaluate the impact of using the instrument on care processes and outcomes. © 2017 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face.

PubMed

Careta, Mariana Figueiroa; Leite, Claudia da Costa; Cresta, Fernando; Albino, Jose; Tsunami, Mirian; Romiti, Ricardo

2013-09-01

Scleroderma featuring rare connective tissue disease that manifests as skin sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement and localized scleroderma or morphea which classically presents benign evolution and self-limited, confined to the skin and/or underlying tissue. Recent studies show that the localized form may possibly course with involvement of internal organs and variable morbidity. This study aimed to determine the demographic characteristics, the prevalence of systemic manifestations and laboratory findings, as well as the association with autoimmune diseases, and the evolution of neurological findings, both clinical as brain MRI in patients with scleroderma of the face and its relation with the activity skin. Patients with localized scleroderma with facial involvement were evaluated and underwent neurological examination, magnetic resonance imaging and ophthalmology evaluation. After 3years, the patients were subjected again to MRI. We studied 12 patients with localized scleroderma of the face. Of this total, headache being the most frequent complaint found in 66.7% of patients, 33.3% had neurological changes possibly associated with scleroderma. As for ophthalmologic evaluation, 25% of patients showed abnormalities. The most frequent parenchymal finding was the presence of lesions with hyperintense or hypointense signal in 75% of patients, followed by ventricular asymmetry at 16.7%. Of the patients who had neurological deficits, 75% also had a change to MRI. In all patients, imaging findings after 3years were unchanged. During this interval of 3years, 25% of patients showed signs of activity of scleroderma. Patients with localized scleroderma of the face have a high prevalence of neurological and ophthalmological changes. Based on these findings, we suggest that all cases of localized scleroderma of the face should be thoroughly

Echocardiographic evaluation of clinically healthy Florida manatees (Trichechus manatus latirostris).

PubMed

Gerlach, Trevor J; Estrada, Amara H; Sosa, Ivan S; Powell, Melanie; Maisenbacher, Herbert W; de Wit, Martine; Ball, Ray L; Walsh, Michael T

2013-06-01

Antemortem studies pertaining to the manatee cardiovascular and cardiopulmonary systems are limited despite reports of cardiac disease in postmortem specimens. The objective of this project was to develop a technique for echocardiography in the Florida manatee (Trichechus manatus latirostris). Because of their unique anatomy, a ventral approach was employed by use of an echocardiography table designed specifically for this study. Fourteen clinically healthy, free-ranging and captive Florida manatees underwent echocardiography between the fall of 2011 and winter of 2012. Eight females and six males of various age categories were included in the study. Clear visualization of all valves and chambers was accomplished, and length and width measurements of the left atrium, peak aortic flow velocity, and ejection fraction percentage were calculated in most animals. Abnormalities observed during the study included atrioventricular regurgitation and severe right-atrial enlargement. Based on the results of this study, echocardiography in the Florida manatee is possible, which has both clinical and research implications in larger epidemiologic studies evaluating diseases of the cardiopulmonary and cardiovascular systems.

21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

Code of Federal Regulations, 2010 CFR

2010-04-01

... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

Clinical-pathological findings of otitis media and media-interna in calves and (clinical) evaluation of a standardized therapeutic protocol.

PubMed

Bertone, I; Bellino, C; Alborali, G L; Cagnasso, A; Cagnotti, G; Dappiano, E; Lizzi, M; Miciletta, M; Ramacciotti, A; Gianella, P; D'Angelo, A

2015-12-03

The aims of this field trial were to describe the clinical-pathologic findings in calves with otitis media (OM) and media-interna (OMI), to evaluate, through the development of a scoring system, the effectiveness of a standardized therapeutic protocol, and to identify the causative pathogens and their possible correlation with concurrent respiratory disease. All animals underwent physical and neurological examinations at three experimental time points: at diagnosis/beginning of treatment (T0), 1 week (T1) and 2 weeks (T2) after therapy was started, respectively. Follow-up telephone interviews with animal owners were conducted 1 month later. The therapeutic protocol consisted of tulathromycin (Draxxin®; Zoetis), oxytetracycline hydrochloride (Terramicina 100®; Zoetis), and carprofen (Rimadyl®; Zoetis). Twenty-two calves were enrolled. Physical and otoscopic examination at T0 revealed monolateral and bilateral otorrhea in 16 and 6 calves, respectively, with peripheral vestibular system involvement in calves presenting with neurological signs (n = 17; 77 %). A significant improvement of clinical and neurological scores was observed in 20 (90 %) calves, a full recovery in only 1 (5 %). One calf worsened between T0 and T1 and it was removed from the study. None of the other animals showed a worsening of clinical conditions and/or required further treatments at one month follow up. Mycoplasma bovis was isolated in 89 % of the affected ears either alone or together with P. multocida (n = 5), Streptococcus spp. (n = 1), Staphylococcus spp. (n = 1), and Pseudomonas spp. (n = 1). M. bovis either alone or together with these bacteria was also isolated from the upper and/or lower respiratory tract in 19 (86 %) calves. This is the first prospective study to evaluate the effectiveness of a standardized therapeutic protocol for the treatment of OM/OMI in calves. The therapy led to clinical improvement in the majority of the calves. Persistence of mild clinical

Developing an evaluation framework for clinical redesign programs: lessons learnt.

PubMed

Samaranayake, Premaratne; Dadich, Ann; Fitzgerald, Anneke; Zeitz, Kathryn

2016-09-19

Purpose The purpose of this paper is to present lessons learnt through the development of an evaluation framework for a clinical redesign programme - the aim of which was to improve the patient journey through improved discharge practices within an Australian public hospital. Design/methodology/approach The development of the evaluation framework involved three stages - namely, the analysis of secondary data relating to the discharge planning pathway; the analysis of primary data including field-notes and interview transcripts on hospital processes; and the triangulation of these data sets to devise the framework. The evaluation framework ensured that resource use, process management, patient satisfaction, and staff well-being and productivity were each connected with measures, targets, and the aim of clinical redesign programme. Findings The application of business process management and a balanced scorecard enabled a different way of framing the evaluation, ensuring measurable outcomes were connected to inputs and outputs. Lessons learnt include: first, the importance of mixed-methods research to devise the framework and evaluate the redesigned processes; second, the need for appropriate tools and resources to adequately capture change across the different domains of the redesign programme; and third, the value of developing and applying an evaluative framework progressively. Research limitations/implications The evaluation framework is limited by its retrospective application to a clinical process redesign programme. Originality/value This research supports benchmarking with national and international practices in relation to best practice healthcare redesign processes. Additionally, it provides a theoretical contribution on evaluating health services improvement and redesign initiatives.

Evaluation of Clinical and Communication Skills of Pharmacy Students and Pharmacists with an Objective Structured Clinical Examination.

PubMed

Urteaga, Elizabeth M; Attridge, Rebecca L; Tovar, John M; Witte, Amy P

2015-10-25

Objective. To evaluate how effectively pharmacy students and practicing pharmacists communicate and apply knowledge to simulations of commonly encountered patient scenarios using an objective structured clinical examination (OSCE). Design. Second-, third-, and fourth-year pharmacy students completed an OSCE as part of their required courses in 2012 and 2013. All students in both years completed identical OSCE cases. Licensed pharmacists were recruited to complete the OSCE and serve as controls in 2012. A survey assessed student perception and acceptance of the OSCE as well as student confidence in performance. Assessment. Licensed pharmacists had significantly higher clinical and communication skills scores than did pharmacy students. Student progression in communication and clinical skills improved significantly over time. Survey results indicated that students felt the OSCE was well-structured and assessed clinical skills taught in pharmacy school; 86% of students felt confident they could provide these skills. Conclusion. Objective structured clinical examinations can evaluate clinical competence and communication skills among professional students. Implementation of OSCEs may be an effective tool for assessment of the Center for the Advancement of Pharmacy Education domains.

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.

Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

PubMed

Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

2001-08-01

Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

IT-benchmarking of clinical workflows: concept, implementation, and evaluation.

PubMed

Thye, Johannes; Straede, Matthias-Christopher; Liebe, Jan-David; Hübner, Ursula

2014-01-01

Due to the emerging evidence of health IT as opportunity and risk for clinical workflows, health IT must undergo a continuous measurement of its efficacy and efficiency. IT-benchmarks are a proven means for providing this information. The aim of this study was to enhance the methodology of an existing benchmarking procedure by including, in particular, new indicators of clinical workflows and by proposing new types of visualisation. Drawing on the concept of information logistics, we propose four workflow descriptors that were applied to four clinical processes. General and specific indicators were derived from these descriptors and processes. 199 chief information officers (CIOs) took part in the benchmarking. These hospitals were assigned to reference groups of a similar size and ownership from a total of 259 hospitals. Stepwise and comprehensive feedback was given to the CIOs. Most participants who evaluated the benchmark rated the procedure as very good, good, or rather good (98.4%). Benchmark information was used by CIOs for getting a general overview, advancing IT, preparing negotiations with board members, and arguing for a new IT project.

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

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.

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

PubMed

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

Comparison of Alvarado Score Evaluation and Clinical Judgment in Acute Appendicitis

PubMed Central

Merhi, Bassem Abou; Khalil, Mahmoud; Daoud, Nabil

2014-01-01

ABSTRACT Background: Acute appendicitis is the most common surgical emergency in children, but its diagnosis is sometimes difficult. The aim: of this study is to evaluate retrospectively the Alvarado score in relation to the surgical management based on clinical judgment. Methods: Medical files of 232 children who underwent appendectomy at Makassed General Hospital from January 1997 till December 2006 were reviewed. Demographic characteristics, symptoms and signs, laboratory results and imaging findings for all children were recorded. Results: The positive predictive value of our clinical judgment was 86.4% and the negative appendectomy rate was 13.6% based on the pathology results. The reliability of Alvarado score in our population found a PPV of 80.7% and a negative appendectomy rate of 11.3%. A multivariate analysis revealed that anorexia, neutrophils left shift and rebound tenderness are significantly correlated with a correct diagnosis of appendicitis (p = 0.012, 0.023 and 0.046 respectively). Conclusion: Although, Alvarado score provides measurably useful diagnostic information in evaluating children with suspected appendicitis, we found that good clinical judgment remain the main stay of correct diagnosis of appendicitis. PMID:24783903

The integrity of bonded amalgam restorations: a clinical evaluation after five years.

PubMed

Mach, Zbynek; Regent, Jan; Staninec, Michal; Mrklas, Lubor; Setcos, James C

2002-04-01

Bonded amalgam restorations have been studied extensively in vitro, but few long term clinical studies exist. The authors examined the clinical performance of bonded amalgam restorations after five years of clinical service an compared it with that of nonbonded amalgam restorations. The authors placed 75 bonded and 62 nonbonded amalgam restorations in patients needing restorations. Most of the restorations were placed in conventional preparations; six bonded restorations were placed in nonretentive cavities. They were evaluated after a five-year period of clinical service by two trained dentists using a mirror and explorer and following modified U.S. Public Health Service criteria. Statistical analysis (via Fisher exact test) showed no significant differences between the two techniques when conventional preparations were used. Restorations in nonretentive preparations were successful during this period. Bonded and nonbonded amalgam restorations yielded similar results in conventional preparations after five years of clinical service. Bonded amalgam restorations were clinically successful in a limited number of nonretentive preparations over a five-year period. Bonded amalgam restorations can be used successfully in conventional preparations and possibly in nonretentive preparations as well, and can be expected to last at least five years.

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.

Goldmann tonometer error correcting prism: clinical evaluation.

PubMed

McCafferty, Sean; Lim, Garrett; Duncan, William; Enikov, Eniko T; Schwiegerling, Jim; Levine, Jason; Kew, Corin

2017-01-01

Clinically evaluate a modified applanating surface Goldmann tonometer prism designed to substantially negate errors due to patient variability in biomechanics. A modified Goldmann prism with a correcting applanation tonometry surface (CATS) was mathematically optimized to minimize the intraocular pressure (IOP) measurement error due to patient variability in corneal thickness, stiffness, curvature, and tear film adhesion force. A comparative clinical study of 109 eyes measured IOP with CATS and Goldmann prisms. The IOP measurement differences between the CATS and Goldmann prisms were correlated to corneal thickness, hysteresis, and curvature. The CATS tonometer prism in correcting for Goldmann central corneal thickness (CCT) error demonstrated a reduction to <±2 mmHg in 97% of a standard CCT population. This compares to only 54% with CCT error <±2 mmHg using the Goldmann prism. Equal reductions of ~50% in errors due to corneal rigidity and curvature were also demonstrated. The results validate the CATS prism's improved accuracy and expected reduced sensitivity to Goldmann errors without IOP bias as predicted by mathematical modeling. The CATS replacement for the Goldmann prism does not change Goldmann measurement technique or interpretation.

Evaluating information prescriptions in two clinical environments*

PubMed Central

Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

2011-01-01

Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

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

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.

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors

PubMed Central

Lentine, Krista L.; Kasiske, Bertram L.; Levey, Andrew S.; Adams, Patricia L.; Alberú, Josefina; Bakr, Mohamed A.; Gallon, Lorenzo; Garvey, Catherine A.; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L.; Taler, Sandra J.; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G.; Cheung, Michael; Garg, Amit X.

2017-01-01

Abstract The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a “proof-in-concept” risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided. In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

PubMed

Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

2017-08-01

The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the

Ultrareliable PACS: design and clinical evaluation

NASA Astrophysics Data System (ADS)

Goble, John C.; Kronander, Torbjorn; Wilske, Nils-Olof; Yngvesson, Jonas T.; Ejderholm, Henrik; Ekstrom, Marie

1999-07-01

We describe our experience in the design, installation and clinical evaluation o fan ultra-reliable PACS - a system in which the fundamental design constraint was system availability. This syste has ben constructed using commercial, off-the-shelf hardware and software, using an open system, standards-based approach. The system is deployed in the film-free Department of Pediatric Radiology at the Astrid Lindgren Barnsjukhus a nit of the Karolinska Institute in Stockholm, Sweden.

Clinical evaluation of post-operative cerebral infarction in traumatic epidural haematoma.

PubMed

Zhang, Suojun; Wang, Sheng; Wan, Xueyan; Liu, Shengwen; Shu, Kai; Lei, Ting

2017-01-01

Patients with traumatic epidural haematoma, undergoing the prompt and correct treatment, usually have favourable outcomes. However, secondary cerebral infarction may be life-threatening condition, as it is difficult to be identified before neurological impairment occurs. To evaluate the clinical data of patients with traumatic EDH and assess potential risk factors for post-operative cerebral infarction. The clinical data of patients with traumatic EDH were collected and analysed retrospectively. The univariate analysis revealed 10 potential risk factors (the haematoma location, volume, the largest thickness and mid-line shift, basal cisterns compression, traumatic subarachnoid haemorrhage, pupil dilatation, pre-operative Glasgow Coma Scale score, ∆GCS and intraoperative brain pressure) for cerebral infarction with statistically significant difference. Of these factors, haematoma volume and basal cistern compression turned out to be the most significant risk factors through final multivariate logistic regression analysis. The findings of this study can provide predictive factors for development of cerebral infarction and information for clinical decision-making and future studies.

The Clinical Evaluation of Hypertension

PubMed Central

de Champlain, Jacques

1985-01-01

The incidence of secondary hypertension in clinical practice is probably below 5%. The majority of those cases are of renal origin. Extensive and costly investigations for rarer forms of hypertension therefore do not appear justified. A comprehensive medical history, plus a good physical exam and some critical laboratory analyses can uncover the great majority of primary and secondary forms of hypertension, allowing for the detection of additional risks factors. Current research trends will eventually provide newer approaches which may permit a better evaluation of the prognosis of hypertension, as well as the development of more efficient therapies. Imagesp307-a PMID:21274102

Evaluation of a filmed clinical scenario as a teaching resource for an introductory pharmacology unit for undergraduate health students: A pilot study.

PubMed

East, Leah; Hutchinson, Marie

2015-12-01

Simulation is frequently being used as a learning and teaching resource for both undergraduate and postgraduate students, however reporting of the effectiveness of simulation particularly within the pharmacology context is scant. The aim of this pilot study was to evaluate a filmed simulated pharmacological clinical scenario as a teaching resource in an undergraduate pharmacological unit. Pilot cross-sectional quantitative survey. An Australian university. 32 undergraduate students completing a healthcare degree including nursing, midwifery, clinical science, health science, naturopathy, and osteopathy. As a part of an undergraduate online pharmacology unit, students were required to watch a filmed simulated pharmacological clinical scenario. To evaluate student learning, a measurement instrument developed from Bloom's cognitive domains (knowledge, comprehension, application, analysis, synthesis and evaluation) was employed to assess pharmacological knowledge conceptualisation and knowledge application within the following fields: medication errors; medication adverse effects; medication interactions; and, general pharmacology. The majority of participants were enrolled in an undergraduate nursing or midwifery programme (72%). Results demonstrated that the majority of nursing and midwifery students (56.52%) found the teaching resource complementary or more useful compared to a lecture although less so compared to a tutorial. Students' self-assessment of learning according to Bloom's cognitive domains indicated that the filmed scenario was a valuable learning tool. Analysis of variance indicated that health science students reported higher levels of learning compared to midwifery and nursing. Students' self-report of the learning benefits of a filmed simulated clinical scenario as a teaching resource suggest enhanced critical thinking skills and knowledge conceptualisation regarding pharmacology, in addition to being useful and complementary to other teaching and

Clinical and Radiographic Evaluation of Procedural Errors during Preparation of Curved Root Canals with Hand and Rotary Instruments: A Randomized Clinical Study

PubMed Central

Khanna, Rajesh; Handa, Aashish; Virk, Rupam Kaur; Ghai, Deepika; Handa, Rajni Sharma; Goel, Asim

2017-01-01

Background: The process of cleaning and shaping the canal is not an easy goal to obtain, as canal curvature played a significant role during the instrumentation of the curved canals. Aim: The present in vivo study was conducted to evaluate procedural errors during the preparation of curved root canals using hand Nitiflex and rotary K3XF instruments. Materials and Methods: Procedural errors such as ledge formation, instrument separation, and perforation (apical, furcal, strip) were determined in sixty patients, divided into two groups. In Group I, thirty teeth in thirty patients were prepared using hand Nitiflex system, and in Group II, thirty teeth in thirty patients were prepared using K3XF rotary system. The evaluation was done clinically as well as radiographically. The results recorded from both groups were compiled and put to statistical analysis. Statistical Analysis: Chi-square test was used to compare the procedural errors (instrument separation, ledge formation, and perforation). Results: In the present study, both hand Nitiflex and rotary K3XF showed ledge formation and instrument separation. Although ledge formation and instrument separation by rotary K3XF file system was less as compared to hand Nitiflex. No perforation was seen in both the instrument groups. Conclusion: Canal curvature played a significant role during the instrumentation of the curved canals. Procedural errors such as ledge formation and instrument separation by rotary K3XF file system were less as compared to hand Nitiflex. PMID:29042727

[Clinical study of PC-904 in pediatrics (author's transl)].

PubMed

Minamitani, M; Hachimori, K

1978-07-01

Clinical study of PC-904 was performed in 8 children with infectious diseases and the following results were obtained. 1) The patients treated with PC-904 were each one case of acute pharyngitis, lacunar tonsillitis, scarlet fever, phlegmone, acute bronchitis and lung abscess, and 2 cases of bronchopneumonia. 2) The administration methods were drip infusion, one-shot intravenous injection and the combined use of these administrations. The daily dosage varied from 30 to 49 mg/kg in 3 cases and from 50 to 70 mg/kg in 3 cases, and was 227 mg/kg in 1 case. 3) Clinical evaluation was examined in 7 cases and 57.1% of effectiveness was obtained. Out of 2 cases of pneumonia, one case with the causative organism of My. pneumoniae was excluded from the clinical evaluation. 4) No side effects were observed in all 8 cases treated with PC-904.

Evaluation of RxNorm for Medication Clinical Decision Support.

PubMed

Freimuth, Robert R; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS.

Pulmonary contusions after blunt chest trauma: clinical significance and evaluation of patient management.

PubMed

Požgain, Z; Kristek, D; Lovrić, I; Kondža, G; Jelavić, M; Kocur, J; Danilović, M

2017-11-22

A pulmonary contusion is an entity defined as alveolar haemorrhage and pulmonary parenchymal destruction after blunt chest trauma. According to the literature, most pulmonary contusions can only be seen on a chest CT. The aim of this study was to evaluate the patients with pulmonary contusions, as well as their management, considering diagnostic and therapeutic options related to their outcomes, since we assumed, based on everyday clinical practice, that an 'overdiagnosing' and 'overtreatment' attitude towards this injury could be present. The research was a retrospective study including 5042 patients admitted to the Department of Traumatology in the Clinical Hospital Centre Osijek, during a 3-year period. The medical data of the patients who suffered pulmonary contusion were evaluated considering significant characteristics, known risk factors, procedures undergone, and outcomes. During the 3-year period, 2% of all the admitted patients were diagnosed with a pulmonary contusion. In 54% of the cases, the patient suffered polytraumatic injuries. The pulmonary contusion was an isolated injury in 7% of the patients. In 31% of the cases, there was no liquidothorax or pneumothorax (isolated pulmonary contusion). In 89% of the patients the pulmonary contusion was diagnosed using a CT scan. In 68% of the patients there were no interventions regarding the thorax; thoracocentesis was performed in 25% of the cases, and pleural punction in 14% of the cases. 25% of the patients developed respiratory insufficiency and 16% required mechanical ventilation. Regarding isolated pulmonary contusions, respiratory insufficiency was present in 8% of the cases. We suggest that a pulmonary contusion seen on CT only has limited clinical significance and that the use of CT scans in diagnosing and follow-up of these patients should be re-evaluated. Further prospective and randomised studies should be conducted and the patients should be clinically evaluated, with the administration of

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.

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.

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

PubMed

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

2016-12-12

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

Sociodemographic and clinical features of gender identity disorder: an Italian multicentric evaluation.

PubMed

Fisher, Alessandra D; Bandini, Elisa; Casale, Helen; Ferruccio, Naika; Meriggiola, Maria C; Gualerzi, Anna; Manieri, Chiara; Jannini, Emmanuele; Mannucci, Edoardo; Monami, Matteo; Stomaci, Niceta; Delle Rose, Augusto; Susini, Tommaso; Ricca, Valdo; Maggi, Mario

2013-02-01

Male to female (MtFs) and female to male (FtMs) subjects with gender identity disorder (GID) seem to differ with regard to some sociodemographic and clinical features. Currently, no descriptive studies focusing on MtFs and FtMs attending an Italian clinic are available. To describe the sociodemographic characteristics of a GID population seeking assistance for gender transition and to assess possible differences in those features between MtFs and FtMs. A consecutive series of 198 patients was evaluated for gender dysphoria from July 2008 to May 2011 in four dedicated centers. A total of 140 subjects (mean age 32.6 ± 9.0 years old) meeting the criteria for GID, with their informed consent and without genital reassignment surgery having already been performed, were considered (92 MtFs and 48 FtMs). Diagnosis was based on formal psychiatric classification criteria. Medical history and sociodemographic characteristics were investigated. Subjects were asked to complete the Body Uneasiness Test (a self-rating scale exploring different areas of body-related psychopathology), Symptom Checklist-90 Revised (a self-rating scale to measure psychological state), and the Bem Sex Role Inventory (a self-rating scale to evaluate gender role). The presence of psychiatric comorbidities was evaluated using the Structured Clinical Interviews for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID I and SCID II). Several significant differences were found between MtFs and FtMs regarding lifestyle and sociodemographic factors and in psychometric test scores. No differences were found in terms of psychiatric comorbidity. This is the first large study reporting the sociodemographic characteristics of a GID sample referring to Italian clinics, and it provides different profiles for MtFs and FtMs. In particular, FtMs display significantly better social functioning. © 2012 International Society for Sexual Medicine.

Cost-evaluation model for clinical trials in a hospital pharmacy service.

PubMed

Idoate, A; Ortega, A; Carrera, F J; Aldaz, A; Giráldez, J

1995-09-22

A cost-evaluation model was applied to clinical trial protocols to estimate their cost for the hospital pharmacy service. The steps taken in the drug management of clinical research were identified. Fixed costs (common to all clinical trials) and variable costs (peculiar to each clinical trial) were determined for each step. The number of patients, the number of operations, the planned services (receptions, storage, drug dispensing), the timing and difficulty of the study (randomization) were included in the variable costs. The economic assessment of these items was based on the costs of the materials and means used, the cost of staff time and finally the cost of drug storage during the clinical trial. This model was applied to 24 clinical trials carried out in the University Clinic of Navarra. 83% of all pharmacy costs of a clinical trial were variable. Drug dispensing, stock management and return drugs account for 94% of the time expended. The approximate cost of the pharmacy providing investigational services was $1,766 per trial or $174 per patient. Drug storage costs were not an important source of expenditure among the variable costs (7.4%). The best way to determine the cost of a trial is to calculate the number of operations.

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task

PubMed Central

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-01-01

Abstract. Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors’ success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task.

PubMed

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-04-01

Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors' success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria

Regression of Moral Reasoning during Medical Education: Combined Design Study to Evaluate the Effect of Clinical Study Years

PubMed Central

Hren, Darko; Marušić, Matko; Marušić, Ana

2011-01-01

Background Moral reasoning is important for developing medical professionalism but current evidence for the relationship between education and moral reasoning does not clearly apply to medical students. We used a combined study design to test the effect of clinical teaching on moral reasoning. Methods We used the Defining Issues Test-2 as a measure of moral judgment, with 3 general moral schemas: Personal Interest, Maintaining Norms, and Postconventional Schema. The test was applied to 3 consecutive cohorts of second year students in 2002 (n = 207), 2003 (n = 192), and 2004 (n = 139), and to 707 students of all 6 study years in 2004 cross-sectional study. We also tested 298 age-matched controls without university education. Results In the cross-sectional study, there was significant main effect of the study year for Postconventional (F(5,679) = 3.67, P = 0.003) and Personal Interest scores (F(5,679) = 3.38, P = 0.005). There was no effect of the study year for Maintaining Norms scores. 3rd year medical students scored higher on Postconventional schema score than all other study years (p<0.001). There were no statistically significant differences among 3 cohorts of 2nd year medical students, demonstrating the absence of cohort or point-of-measurement effects. Longitudinal study of 3 cohorts demonstrated that students regressed from Postconventional to Maintaining Norms schema-based reasoning after entering the clinical part of the curriculum. Interpretation Our study demonstrated direct causative relationship between the regression in moral reasoning development and clinical teaching during medical curriculum. The reasons may include hierarchical organization of clinical practice, specific nature of moral dilemmas faced by medical students, and hidden medical curriculum. PMID:21479204

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.

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.

Determination of spondylolisthesis in low back pain by clinical evaluation.

PubMed

Kalpakcioglu, Banu; Altinbilek, Turgay; Senel, Kazim

2009-01-01

Current guides recommend to evaluate the patients with low back pain complaints with initial clinical assessment and history, and to utilize radiological or other imaging technics, in case of possible diagnosis. The aim of this study was to compare the findings of radiological and clinical assessment, and validate the reliability of spondylolisthesis diagnosed with clinical assessment. This study is conducted on 100 patients with, and 30 patients without (control group) radiological diagnosis of spondylolisthesis, who had applied to Department of Physical Therapy and Rehabilitation, Haydarpasa Numune Hospital with low back pain complaints in one and a half year. Clinic assessment was consisted of 20 parameters including examinations of motor system such as, sign of slipping observed on palpation and inspection, extension of trunk and increase in lumbar lordosis. Antero-posterior, lateral, oblique and lateral flexion/extension radiographies were used for radiological assessment. Slipping degree and lumbar lordosis angle were measured. Women/men patients ratio was 91/9 in spondylolisthesis group and 22/8 in control group. Age of 69% of patients were 50 and over. In both groups, sciatalgia was observed in more than half of the patients, and no significant difference was detected in localization (p > 0.05). In clinical assessment, weak and drooping abdominal wall, paravertebral muscle hypertrophy, increase in lumbar lordosis, sign of slipping observed on palpation and inspection, hamstring muscle spasm, pain during lateral trunk flexion-extension tasks and during double leg raising task were found to be positively correlated with radiological assesment (p < 0.05). In our study, a systematic clinical assessment was proved to be useful in determination of possible spondylolisthesis cases. Radiological assessments are required in order to make the diagnosis clear and to determine the grade and prognosis of spondylolisthesis. Advanced imaging techniques like MRI and CT

[What and how to evaluate clinical-surgical competence. The resident and staff surgeon perspective].

PubMed

Cervantes-Sánchez, Carlos Roberto; Chávez-Vizcarra, Paola; Barragán-Ávila, María Cristina; Parra-Acosta, Haydee; Herrera-Mendoza, Renzo Eduardo

2016-01-01

Evaluation is a means for significant and rigorous improvement of the educational process. Therefore, competence evaluation should allow assessing the complex activity of medical care, as well as improving the training process. This is the case in the evaluation process of clinical-surgical competences. A cross-sectional study was designed to measure knowledge about the evaluation of clinical-surgical competences for the General Surgery residency program at the Faculty of Medicine, Universidad Autónoma de Chihuahua (UACH). A 55-item questionnaire divided into six sections was used (perception, planning, practice, function, instruments and strategies, and overall evaluation), with a six level Likert scale, performing a descriptive, correlation and comparative analysis, with a significance level of 0.001. In both groups perception of evaluation was considered as a further qualification. As regards tools, the best known was the written examination. As regards function, evaluation was considered as a further administrative requirement. In the correlation analysis, evaluation was perceived as qualification and was significantly associated with measurement, assessment and accreditation. In the comparative analysis between residents and staff surgeons, a significant difference was found as regards the perception of the evaluation as a measurement of knowledge (Student t test: p=0.04). The results provide information about the concept we have about the evaluation of clinical-surgical competences, considering it as a measure of learning achievement for a socially required certification. There is confusion as regards the perception of evaluation, its function, goals and scopes as benefit for those evaluated. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Hand function evaluation: a factor analysis study.

PubMed

Jarus, T; Poremba, R

1993-05-01

The purpose of this study was to investigate hand function evaluations. Factor analysis with varimax rotation was used to assess the fundamental characteristics of the items included in the Jebsen Hand Function Test and the Smith Hand Function Evaluation. The study sample consisted of 144 subjects without disabilities and 22 subjects with Colles fracture. Results suggest a four factor solution: Factor I--pinch movement; Factor II--grasp; Factor III--target accuracy; and Factor IV--activities of daily living. These categories differentiated the subjects without Colles fracture from the subjects with Colles fracture. A hand function evaluation consisting of these four factors would be useful. Such an evaluation that can be used for current clinical purposes is provided.

Current status of functional gastrointestinal evaluation in clinical practice

PubMed Central

Ang, Daphne; Fock, Kwong Ming; Law, Ngai Moh; Ang, Tiing Leong

2015-01-01

Neurogastroenterology and motility disorders of the gastrointestinal (GI) tract encompass a broad spectrum of diseases involving the GI tract and central nervous system. They have varied pathophysiology, clinical presentation and management, and make up a substantial proportion of outpatient clinic visits. Typically, patients experience persistent symptoms referable to the GI tract despite normal endoscopic and radiologic findings. An appropriate evaluation is thus important in the patient’s care. Advances in technology and understanding of the disease pathophysiology have provided better insight into the physiological basis of disease and a more rational approach to patient management. While technological advances serve to explain patients’ persistent symptoms, they should be balanced against the costs of diagnostic tests. This review highlights the GI investigative modalities employed to evaluate patients with persistent GI symptoms in the absence of a structural lesion, with particular emphasis on investigative modalities available locally and the clinical impact of such tools. PMID:25715853

Microbiological evaluation of female patients in STD clinics.

PubMed

Iyer, S V; Deodhar, L; Gogate, A

1991-03-01

A total of 215 women patients attending the STD clinic were evaluated in an attempt to isolate the different microorganisms in sexually transmitted diseases (STD). Mycoplasmas (30.22%), Candida species (20.00%), Trichomonas vaginalis (wet mount study; 15.81%), beta haemolytic streptococci (13.48%), Neisseria gonorrhoeae (9.30%), Staphylococcus aureus (13.95%), inclusion bodies of Chlamydia trachomatis (11.60%) and Gram negative organisms (9.30%) were isolated from these patients. Sera of all patients screened for HBsAg by ELISA showed a carrier rate of 12.5 per cent; 29.8 per cent sera were reactive in the VDRL test at the dilutions varying from 1:4 to 1:64.

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

Evaluating online continuing medical education seminars: evidence for improving clinical practices.

PubMed

Weston, Christine M; Sciamanna, Christopher N; Nash, David B

2008-01-01

The purpose of this study was to evaluate the potential for online continuing medical education (CME) seminars to improve quality of care. Primary care physicians (113) participated in a randomized controlled trial to evaluate an online CME series. Physicians were randomized to view either a seminar about type 2 diabetes or a seminar about systolic heart failure. Following the seminar, physicians were presented with 4 clinical vignettes and asked to describe what tests, treatments, counseling, or referrals they would recommend. Physicians who viewed the seminars were significantly more likely to recommend guideline-consistent care to patients in the vignettes. For example, physicians who viewed the diabetes seminar were significantly more likely to order an eye exam for diabetes patients (63%) compared with physicians in the control group (27%). For some guidelines there were no group differences. These results provide early evidence of the effectiveness of online CME programs to improve physician clinical practice.

[Clinical evaluation of open and close treatment in pediatric condylar fractures].

PubMed

Han, Jing; Li, Zhi; Zhou, Haihua; Yang, Rongtao; Xiong, Guizhong; Li, Zubing

2014-08-01

To evaluate the long-term clinical and radiographic outcomes of open and close treatment of condylar fractures of mandible in children. A total of 78 cases (105 mandibular condylar fractures) were included in this study. All patients (younger than 12 years at the time of injury were followed up for at least 3 years. According to the classification of the condylar fractures, open or close treatment was chosen. Clinical outcomes were classified as favorable or unfavorable depending on the mouth opening, pattern of mouth opening, occlusion, facial symmetry. Condylar remodeling was defined as complete, moderate, or poor based on the radiographic findings. Depending on the classification, 14 sides of type I, 48 sides of type II and 43 sides of type III were included in this study. Open treatment was chosen in 51 sides and close treatment was chosen in 54 sides. Most of the patients acquired satisfactory clinical outcomes. Better radiologic remodeling of the condylar process was found in the patients treated by open treatment. Favorable long-term clinical outcomes were obtained in both open and close treatment of mandibular condylar fractures. A better morphological remodeling of condylar process was found in patients with open treatment.

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.

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.

Interdisciplinary evaluation of dysphagia: clinical swallowing evaluation and videoendoscopy of swallowing.

PubMed

Sordi, Marina de; Mourão, Lucia Figueiredo; Silva, Ariovaldo Armando da; Flosi, Luciana Claudia Leite

2009-01-01

Patients with dysphagia have impairments in many aspects, and an interdisciplinary approach is fundamental to define diagnosis and treatment. A joint approach in the clinical and videoendoscopy evaluation is paramount. To study the correlation between the clinical assessment (ACD) and the videoendoscopic (VED) assessment of swallowing by classifying the degree of severity and the qualitative/descriptive analyses of the procedures. cross-sectional, descriptive and comparative. held from March to December of 2006, at the Otolaryngology/Dysphagia ward of a hospital in the country side of São Paulo. 30 dysphagic patients with different disorders were assessed by ACD and VED. The data was classified by means of severity scales and qualitative/ descriptive analysis. the correlation between severity ACD and VED scales pointed to a statistically significant low agreement (KAPA = 0.4) (p=0,006). The correlation between the qualitative/descriptive analysis pointed to an excellent and statistically significant agreement (KAPA=0.962) (p<0.001) concerning the entire sample. the low agreement between the severity scales point to a need to perform both procedures, reinforcing VED as a doable procedure. The descriptive qualitative analysis pointed to an excellent agreement, and such data reinforces our need to understand swallowing as a process.

An integrated evaluation for the performance of clinical engineering department.

PubMed

Yousry, Ahmed M; Ouda, Bassem K; Eldeib, Ayman M

2014-01-01

Performance benchmarking have become a very important component in all successful organizations nowadays that must be used by Clinical Engineering Department (CED) in hospitals. Many researchers identified essential mainstream performance indicators needed to improve the CED's performance. These studies revealed mainstream performance indicators that use the database of a CED to evaluate its performance. In this work, we believe that those indicators are insufficient for hospitals. Additional important indicators should be included to improve the evaluation accuracy. Therefore, we added new indicators: technical/maintenance indicators, economic indicators, intrinsic criticality indicators, basic hospital indicators, equipment acquisition, and safety indicators. Data is collected from 10 hospitals that cover different types of healthcare organizations. We developed a software tool that analyses collected data to provide a score for each CED under evaluation. Our results indicate that there is an average gap of 67% between the CEDs' performance and the ideal target. The reasons for the noncompliance are discussed in order to improve performance of CEDs under evaluation.

Portfolio as a tool to evaluate clinical competences of traumatology in medical students.

PubMed

Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

2016-01-01

This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students' portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching.

Health worker perspectives on barriers to delivery of routine tuberculosis diagnostic evaluation services in Uganda: a qualitative study to guide clinic-based interventions.

PubMed

Cattamanchi, Adithya; Miller, Cecily R; Tapley, Asa; Haguma, Priscilla; Ochom, Emmanuel; Ackerman, Sara; Davis, J Lucian; Katamba, Achilles; Handley, Margaret A

2015-01-22

Studies of the quality of tuberculosis (TB) diagnostic evaluation of patients in high burden countries have generally shown poor adherence to international or national guidelines. Health worker perspectives on barriers to improving TB diagnostic evaluation are critical for developing clinic-level interventions to improve guideline implementation. We conducted structured, in-depth interviews with staff at six district-level health centers in Uganda to elicit their perceptions regarding barriers to TB evaluation. Interviews were transcribed, coded with a standardized framework, and analyzed to identify emergent themes. We used thematic analysis to develop a logic model depicting health system and contextual barriers to recommended TB evaluation practices. To identify possible clinic-level interventions to improve TB evaluation, we categorized findings into predisposing, enabling, and reinforcing factors as described by the PRECEDE model, focusing on potentially modifiable behaviors at the clinic-level. We interviewed 22 health center staff between February 2010 and November 2011. Participants identified key health system barriers hindering TB evaluation, including: stock-outs of drugs/supplies, inadequate space and infrastructure, lack of training, high workload, low staff motivation, and poor coordination of health center services. Contextual barrier challenges to TB evaluation were also reported, including the time and costs borne by patients to seek and complete TB evaluation, poor health literacy, and stigma against patients with TB. These contextual barriers interacted with health system barriers to contribute to sub-standard TB evaluation. Examples of intervention strategies that could address these barriers and are related to PRECEDE model components include: assigned mentors/peer coaching for new staff (targets predisposing factor of low motivation and need for support to conduct job duties); facilitated workshops to implement same day microscopy (targets

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder.

PubMed

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1-10. Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

PubMed Central

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid

Evaluating the effects of cognitive support on psychiatric clinical comprehension.

PubMed

Dalai, Venkata V; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L; Cohen, Trevor

2014-10-01

Clinicians' attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians' decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more "expert-like" in their emphasis, and that cognitive support was more effective in the more complex case. Cognitive support impacts

Evaluating the effects of cognitive support on psychiatric clinical comprehension

PubMed Central

Dalai, Venkata V.; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L.; Cohen, Trevor

2014-01-01

Objective Clinicians’ attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians’ decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. Methods and Materials To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Results Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more “expert-like” in their emphasis, and that cognitive support was more effective in the

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.

Evaluation of RxNorm for Medication Clinical Decision Support

PubMed Central

Freimuth, Robert R.; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G.

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS. PMID:25954360

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

PubMed

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

2017-06-01

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

Cauda equina syndrome: evaluation of the clinical outcome.

PubMed

Tamburrelli, F C; Genitiempo, M; Bochicchio, M; Donisi, L; Ratto, C

2014-01-01

Cauda equina syndrome is a rare but highly impairing syndrome involving lower limbs as well as urinary, defecatory and sexual function. In the literature the most investigated sphincter dysfunction is the urinary. Bowel and sexual function are often overlooked since they become more relevant after the acute phase. Eight consecutive male patients affected by cauda equina syndrome with sphincter dysfunction due to herniated disc disease of lumbar spine were treated between 2007 and 2009. Five patients were followed-up for at least two years. Sexual function was evaluated by IIEF-5 questionnaire; bowel function was investigated by means of clinical and instrumental investigation and manometry. Although little clinical improved, patients still complained severe symptoms at first year follow-up while all but one improved significantly in the following year. At two years follow-up only the patient whose cauda equina syndrome was misdiagnosed and surgically treated late respect to the onset of the syndrome, complained a persistent severe sexual and bowel dysfunction. Our results show that a long-term follow-up is mandatory to evaluate the real outcome of surgical managed cauda equine syndrome because short-term evaluation could be misleading about the residual capacity of late neurologic improving. Despite the relatively low number of cases evaluated, our results confirm that early diagnosing and treating the syndrome are relevant for the final outcome.

A new universal simplified adhesive: 18-month clinical evaluation.

PubMed

Perdigão, J; Kose, C; Mena-Serrano, A P; De Paula, E A; Tay, L Y; Reis, A; Loguercio, A D

2014-01-01

To evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, SU, 3M ESPE, St Paul, MN, USA) in noncarious cervical lesions (NCCLs) using two evaluation criteria. Thirty-nine patients participated in this study. Two-hundred restorations were assigned to four groups: ERm, etch-and-rinse + moist dentin; ERd, etch-and-rinse + dry dentin; Set, selective enamel etching; and SE, self-etch. The composite resin, Filtek Supreme Ultra (3M ESPE), was placed incrementally. The restorations were evaluated at baseline, and at 18 months, using both the World Dental Federation (FDI) and the United States Public Health Service (USPHS) criteria. Statistical analyses were performed using Friedman repeated-measures analysis of variance by rank and McNemar test for significance in each pair (α=0.05). Five restorations (SE: 3; Set: 1; and ERm: 1) were lost after 18 months (p>0.05 for either criteria). Marginal staining occurred in four and 10% of the restorations evaluated (p>0.05), respectively, for USPHS and FDI criteria. Nine restorations were scored as bravo for marginal adaptation using the USPHS criteria and 38%, 40%, 36%, and 44% for groups ERm, ERd, Set, and SE, respectively, when the FDI criteria were applied (p>0.05). However, when semiquantitative scores (or SQUACE) for marginal adaptation were used, SE resulted in a significantly greater number of restorations, with more than 30% of the total length of the interface showing marginal discrepancy (28%) in comparison with the other groups (8%, 6%, and 8%, respectively, for ERm, ERd, and Set). The clinical retention of the multimode adhesive at 18 months does not depend on the bonding strategy. The only differences between strategies were found for the parameter marginal adaptation, for which the FDI criteria were more sensitive than the USPHS criteria.

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

PubMed

Furukawa, Hiroshi

2016-04-01

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

Mirror movements in parkinsonism: evaluation of a new clinical sign

PubMed Central

Espay, A; Li, J; Johnston, L; Chen, R; Lang, A

2005-01-01

Background: Mirror movements (MM) are not widely appreciated in parkinsonism and no report has evaluated this clinical sign in detail. Objectives: To define the parkinsonian clinical features associated with MM in patients with early, asymmetric parkinsonism. Methods: Twenty seven patients with early Parkinson's disease were evaluated using a standardised videotaping protocol. MM were scored from blinded video assessment using a clinical scale that rates the amplitude, distribution, and proportion of mirroring in the less affected limb. Parkinsonian features were combined into axial and lateralised scores using related items of the Unified Parkinson's Disease Rating Scale. Results: MM were present in 24 of 27 patients. There was a significant linear correlation between the degree of asymmetry of motor deficits and MM on the less affected side. The effect of asymmetry was greater when the proportional rather than the absolute motor difference between sides was largest. Asymmetry in leg rigidity was the most important examination feature in the prediction of contralateral foot mirroring. Conclusions: MM are a clinical feature of the unaffected or less affected side in mild asymmetric parkinsonism. Their presence may be a useful clinical finding in early parkinsonism. PMID:16170075

Development and evaluation of learning module on clinical decision-making in Prosthodontics.

PubMed

Deshpande, Saee; Lambade, Dipti; Chahande, Jayashree

2015-01-01

Best practice strategies for helping students learn the reasoning skills of problem solving and critical thinking (CT) remain a source of conjecture, particularly with regard to CT. The dental education literature is fundamentally devoid of research on the cognitive components of clinical decision-making. This study was aimed to develop and evaluate the impact of blended learning module on clinical decision-making skills of dental graduates for planning prosthodontics rehabilitation. An interactive teaching module consisting of didactic lectures on clinical decision-making and a computer-assisted case-based treatment planning software was developed Its impact on cognitive knowledge gain in clinical decision-making was evaluated using an assessment involving problem-based multiple choice questions and paper-based case scenarios. Mean test scores were: Pretest (17 ± 1), posttest 1 (21 ± 2) and posttest 2 (43 ± 3). Comparison of mean scores was done with one-way ANOVA test. There was overall significant difference in between mean scores at all the three points (P < 0.001). A pair-wise comparison of mean scores was done with Bonferroni test. The mean difference is significant at the 0.05 level. The pair-wise comparison shows that posttest 2 score is significantly higher than posttest 1 and posttest 1 is significantly higher than pretest that is, pretest 2 > posttest 1 > pretest. Blended teaching methods employing didactic lectures on the clinical decision-making as well as computer assisted case-based learning can be used to improve quality of clinical decision-making in prosthodontic rehabilitation for dental graduates.

Web-based unfolding cases: a strategy to enhance and evaluate clinical reasoning skills.

PubMed

Johnson, Gail; Flagler, Susan

2013-10-01

Clinical reasoning involves the use of both analytical and nonanalytical intuitive cognitive processes. Fostering student development of clinical reasoning skills and evaluating student performance in this cognitive arena can challenge educators. The use of Web-based unfolding cases is proposed as a strategy to address these challenges. Unfolding cases mimic real-life clinical situations by presenting only partial clinical information in sequential segments. Students receive immediate feedback after submitting a response to a given segment. The student's comparison of the desired and submitted responses provides information to enhance the development of clinical reasoning skills. Each student's set of case responses are saved for the instructor in an individual-student electronic file, providing a record of the student's knowledge and thinking processes for faculty evaluation. For the example case given, the approaches used to evaluate individual components of clinical reasoning are provided. Possible future uses of Web-based unfolding cases are described. Copyright 2013, SLACK Incorporated.

Development and Psychometric Evaluation of a Clinical Global Impression for Schizoaffective Disorder Scale

PubMed Central

Daniel, David G; Revicki, Dennis A; Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong-Jing; Alphs, Larry; Ishak, K. Jack; Bartko, John J; Lindenmayer, Jean-Pierre

2012-01-01

Objective: The Clinical Global Impression for Schizoaffective Disorder scale is a new rating scale adapted from the Clinical Global Impression scale for use in patients with schizoaffective disorder. The psychometric characteristics of the Clinical Global Impression for Schizoaffective Disorder are described. Design: Content validity was assessed using an investigator questionnaire. Inter-rater reliability was determined with 12 sets of videotaped interviews rated independently by two trained individuals. Test-retest reliability was assessed using 30 randomly selected raters from clinical trials who evaluated the same videos on separate occasions two weeks apart. Convergent and divergent validity and effect size were evaluated by comparing scores between the Clinical Global Impression for Schizoaffective Disorder and the Positive and Negative Syndrome Scale, 21-item Hamilton Rating Scale for Depression, and Young Mania Rating Scale scales using pooled patient data from two clinical trials. Clinical Global Impression for Schizoaffective Disorder scores were then linked to corresponding Positive and Negative Syndrome Scale scores. Results: Content validity was strong. Inter-rater agreement was good to excellent for most scales and subscales (intra-class correlation coefficient ≥0.50). Test-retest showed good reproducibility, with intraclass correlation coefficients ranging from 0.444 to 0.898. Spearman correlations between Clinical Global Impression for Schizoaffective Disorder domains and corresponding symptom scales were 0.60 or greater, and effect sizes for Clinical Global Impression for Schizoaffective Disorder overall and domain scores were similar to Positive and Negative Syndrome Scale Young Mania Rating Scale, and 21-item Hamilton Rating Scale for Depression scores. Raters anticipated that the scale might be less effective in distinguishing negative from depressive symptoms, and, in fact, the results here may reflect that clinical reality. Conclusion

Development and psychometric evaluation of a clinical global impression for schizoaffective disorder scale.

PubMed

Allen, Michael H; Daniel, David G; Revicki, Dennis A; Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong-Jing; Alphs, Larry; Ishak, K Jack; Bartko, John J; Lindenmayer, Jean-Pierre

2012-01-01

The Clinical Global Impression for Schizoaffective Disorder scale is a new rating scale adapted from the Clinical Global Impression scale for use in patients with schizoaffective disorder. The psychometric characteristics of the Clinical Global Impression for Schizoaffective Disorder are described. Content validity was assessed using an investigator questionnaire. Inter-rater reliability was determined with 12 sets of videotaped interviews rated independently by two trained individuals. Test-retest reliability was assessed using 30 randomly selected raters from clinical trials who evaluated the same videos on separate occasions two weeks apart. Convergent and divergent validity and effect size were evaluated by comparing scores between the Clinical Global Impression for Schizoaffective Disorder and the Positive and Negative Syndrome Scale, 21-item Hamilton Rating Scale for Depression, and Young Mania Rating Scale scales using pooled patient data from two clinical trials. Clinical Global Impression for Schizoaffective Disorder scores were then linked to corresponding Positive and Negative Syndrome Scale scores. Content validity was strong. Inter-rater agreement was good to excellent for most scales and subscales (intra-class correlation coefficient ≥ 0.50). Test-retest showed good reproducibility, with intraclass correlation coefficients ranging from 0.444 to 0.898. Spearman correlations between Clinical Global Impression for Schizoaffective Disorder domains and corresponding symptom scales were 0.60 or greater, and effect sizes for Clinical Global Impression for Schizoaffective Disorder overall and domain scores were similar to Positive and Negative Syndrome Scale Young Mania Rating Scale, and 21-item Hamilton Rating Scale for Depression scores. Raters anticipated that the scale might be less effective in distinguishing negative from depressive symptoms, and, in fact, the results here may reflect that clinical reality. Multiple lines of evidence support the

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.

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.

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.

Self-verification in clinical depression: the desire for negative evaluation.

PubMed

Giesler, R B; Josephs, R A; Swann, W B

1996-08-01

Do clinically depressed individuals seek favorable or unfavorable information about the self? Self-verification theory makes the counterintuitive prediction that depressed individuals solicit feedback that confirms their negative self-views. To test this prediction, participants were classified on the basis of a structured clinical interview and self-report measures into high-esteem, low self-esteem, and depressed groups. All participants were offered a choice between receiving favorable or unfavorable feedback; 82% of the depressed participants chose the unfavorable feedback, compared to 64% of the low self-esteem participants and 25% of the high self-esteem participants. Additional evidence indicated that depressed individuals also failed to exploit fully an opportunity to acquire favorable evaluations that were self-verifying. The authors discuss how seeking negative evaluations and failing to seek favorable evaluations may help maintain depression.

Accuracy evaluation of intraoral optical impressions: A clinical study using a reference appliance.

PubMed

Atieh, Mohammad A; Ritter, André V; Ko, Ching-Chang; Duqum, Ibrahim

2017-09-01

Trueness and precision are used to evaluate the accuracy of intraoral optical impressions. Although the in vivo precision of intraoral optical impressions has been reported, in vivo trueness has not been evaluated because of limitations in the available protocols. The purpose of this clinical study was to compare the accuracy (trueness and precision) of optical and conventional impressions by using a novel study design. Five study participants consented and were enrolled. For each participant, optical and conventional (vinylsiloxanether) impressions of a custom-made intraoral Co-Cr alloy reference appliance fitted to the mandibular arch were obtained by 1 operator. Three-dimensional (3D) digital models were created for stone casts obtained from the conventional impression group and for the reference appliances by using a validated high-accuracy reference scanner. For the optical impression group, 3D digital models were obtained directly from the intraoral scans. The total mean trueness of each impression system was calculated by averaging the mean absolute deviations of the impression replicates from their 3D reference model for each participant, followed by averaging the obtained values across all participants. The total mean precision for each impression system was calculated by averaging the mean absolute deviations between all the impression replicas for each participant (10 pairs), followed by averaging the obtained values across all participants. Data were analyzed using repeated measures ANOVA (α=.05), first to assess whether a systematic difference in trueness or precision of replicate impressions could be found among participants and second to assess whether the mean trueness and precision values differed between the 2 impression systems. Statistically significant differences were found between the 2 impression systems for both mean trueness (P=.010) and mean precision (P=.007). Conventional impressions had higher accuracy with a mean trueness of 17.0 �

Portfolio as a tool to evaluate clinical competences of traumatology in medical students

PubMed Central

Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

2016-01-01

This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students’ portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching. PMID:26929675

A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth gaps.

PubMed

Gahlert, Michael; Kniha, Heinz; Weingart, Dieter; Schild, Sabine; Gellrich, Nils-Claudius; Bormann, Kai-Hendrik

2016-12-01

Dental implants have traditionally been made from titanium or its alloys, but recently full-ceramic implants have been developed with comparable osseointegration properties and functional strength properties to titanium. These ceramic implants may have advantages in certain patients and situations, for example, where esthetic outcomes are particularly important. The objective of this investigation was to evaluate the performance of a newly developed full-ceramic ZrO 2 monotype implant design (PURE Ceramic Implant; Institut Straumann AG, Basel, Switzerland) in single-tooth gaps in the maxilla and mandible. This was a prospective, open-label, single-arm study in patients requiring implant rehabilitation in single-tooth gaps. Full-ceramic implants were placed, with provisional and final prostheses inserted after 3 and 6 months, respectively. Crestal bone level was measured at implant placement and after 6 and 12 months. Implant survival and success were evaluated after 6 and 12 months. Further evaluations are planned after 24 and 36 months. Forty-six patients were screened for potential study participation, of whom 44 (17 men and 27 women, mean age 48 ± 14 years) were recruited into the study. The majority of implants (90.9%) were placed in the maxilla. The implant survival and implant success rate after 12 months were 97.6%. A minor change of the mean bone level occurred between implant loading (final prosthesis insertion after 6 months) and 12 months (-0.14 mm) after initial bone remodeling was observed between implant placement and loading (-0.88 mm). The results indicated that monotype ceramic implants can achieve clinical outcomes comparable to published outcomes of equivalent titanium implants. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[A clinical study of PC-904 in pediatrics (author's transl)].

PubMed

Hori, M; Kono, S; Hashimoto, F

1978-07-01

A clinical study of PC-904 was performed in children. The results were as follows; 1) Serum levels of PC-904 after single administration of 20 mg/kg were studied in patients by one-shot intravenous injection or drip infusion for 1 hour or 2 hours. The results obtained in this fundamental study led to the suggestion that the proper dosage in bacterial infections would be 50 approximately 100 mg/kg intravenously in 3 approximately 4 divided doses daily. 2) A clinical study of PC-904 was performed in 16 patients including acute pharyngitis and bronchitis (3 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), abscess with chronic granuloma (2 cases) and urinary tract infection (5 cases). About 50 approximately 100 mg/kg of PC-904 were administered in 3 approximately 4 divided doses daily by one-shot intravenous injection. The clinical effects of 2 cases out of 16 were impossible to be evaluated, and thses cases were excluded from the clinical evaluation. Ten cases out of 14 showed excellent or good responses (efficacy rate: 71.4%). 3) The bacteriological examinations were performed and the causative or isolated organisms were determined in 11 cases. The responses were "disappeared" in 6 cases, "decreased" in 2 cases and "not disappeared" in 3 cases. 4) No side effects were observed. Abnormalities of laboratory findings were not also noticed.

Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

PubMed

Dario, Claudio; Delise, Pietro; Gubian, Lorenzo; Saccavini, Claudio; Brandolino, Glauco; Mancin, Silvia

2016-01-13

Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per

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

PubMed

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

2010-09-01

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

Uncorrected amteropia among children hospitalized for headache evaluation: a clinical descriptive study.

PubMed

Dotan, Gad; Stolovitch, Chaim; Moisseiev, Elad; Cohen, Shlomi; Kesler, Anat

2014-09-29

Headache is a common complaint in children occasionally requiring hospital admission. The purposes of the present study were to analyze the prevalence of uncorrected ametropia in children with headache admitted to the hospital, and evaluate the importance of refraction assessment as part of their evaluation. A retrospective review of children admitted to the Tel Aviv Medical Center for headache evaluation from December 2008 to March 2013, in whom the only abnormality found was an uncorrected refractive error. During the study period 917 children with headache were hospitalized for evaluation and 16 (1.7%) of them (9 boys, mean age 12 years, range 8-18 years) were found to have an uncorrected ametropia. Average headache duration was 4 months (range, 1 week to 1 year) and mean follow-up was 15 months (range, 1 month to 3 years). Twelve (75%) children had brain imaging and 4 children (25%) had a lumbar puncture before their refractive abnormality was identified. Anisometropia and myopia were the most common refractive errors encountered (n = 10 each), followed by hyperopia (n = 6) and astigmatism (n = 3). Despite having uncorrected refractive errors most children (n = 10) did not complain of any visual difficulty. All children were given proper refractive correction and 14 of them reported complete headache resolution on re-examination one month later. Uncorrected ametropia is a possible cause of headache among hospitalized children. Therefore, complete ophthalmic evaluation, which includes proper refraction assessment, is important as it can identify a treatable headache etiology. Children without visual difficulty should be equally evaluated, as many children with headache and uncorrected amteropia do not have vision complaints.

Burning mouth syndrome: Evaluation of clinical and laboratory findings.

PubMed

Halac, Gulistan; Tekturk, Pinar; Eroglu, Saliha; Cikrikcioglu, Mehmet Ali; Cimendur, Ozlem; Kilic, Elif; Asil, Talip

2016-07-30

Burning mouth syndrome is a chronic and persistent painful condition characterized by burning sensation in the oral mucosa. We investigated the etiological factors of patients presented with the history of burning in the mouth who admitted our outpatient clinics over the 8-years period and who had no underlying identifiable local factors. We also tried to determine their demographic and clinical characteristics. Our aim was to investigate the association between burning mouth and psychiatric disorders such as depression and anxiety, chronic diseases like diabetes mellitus (DM) and other laboratory studies in patients complaining of solely burning in the mouth. The study included patients with the history of burning in mouth who presented in our outpatient clinic between 2005 and 2012. They were evaluated by a neurologist, a psychiatrist, an internist, and a dentist. Complete blood counts, biochemical analysis and cranial magnetic resonance imaging (MRI) were performed for all patients. A total of 26 (22 (84%) females, 4 (15%) males; mean age 55.9 years) patients were enrolled in this study. Five (19.2%) of the patients had depression, 2 (7.7%) had anxiety disorder, 2 (7.7%) had diabetes mellitus, 8 (30%) had B12 vitamin deficiency, 3 (11.5%) had decreased ferritin levels in blood, and 1 (3.8%) had folic acid deficiency. Cranial MRI of all patients were normal. Nine patients (34.6%) had no etiological causes. A multidisciplinary approach in the management of burning mouth and establishment of common criteria for the diagnosis would provide insight into the underlying pathophysiological mechanism.

An evaluation of nursing students' communication ability during practical clinical training.

PubMed

Xie, Jianfei; Ding, Siqing; Wang, Chunmei; Liu, Aizhong

2013-08-01

To investigate communication abilities and other influential factors on nursing students at the beginning of clinical practical session. A cluster sample of 312 nursing students from 22 nursing colleges or universities was recruited. Communication ability of these participants was evaluated by 4 questionnaires for demographic data, clinical communication behavior, treatment communication skills and interpersonal communication skills at the beginning of clinical practical session. The stability and accuracy of the questionnaires were established with an overall content validity index of 0.78, the Cronbach's Alpha index ranged from 0.872 to 0.951, and the letter index fluctuates from 0.85 to 0.89. Results demonstrated that 88.1% of the nursing students require extra training in clinical communication behavior, treatment communication skills, and interpersonal communication skills. The Pearson analysis revealed significantly positive correlations between communication abilities and the students' educational level, clinical training experience, living circumstances and number of siblings. Most nursing students need communication skill training. Multiple factors, including educational level, living circumstances, number of siblings, and training experience significantly affect nursing students' communication abilities. Our study suggested a need to widely establish a communication course or clinical communication training program to improve nursing students' communication skills. Copyright © 2012 Elsevier Ltd. All rights reserved.

The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

PubMed Central

2013-01-01

Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

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.

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

PubMed

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

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.

Pressure Ulcer Risk Evaluation in Critical Patients: Clinical and Social Characteristics.

PubMed

de Azevedo Macena, Mônica Suêla; da Costa Silva, Rayanne Suely; Dias Fernandes, Maria Isabel Da Conceição; de Almeida Medeiros, Ana Beatriz; Batista Lúcio, Kadyjina Daiane; de Carvalho Lira, Ana Luisa Brandão

2017-01-01

Pressure ulcers increase hospital stays and treatment costs due to their complications. Therefore, recognizing factors that contribute to pressure ulcer risk are important to patient safety. To evaluate the association between the scores of the Waterlow, Braden, and Norton scales and clinical and social characteristics in critically ill patients. A cross-sectional study of 78 patients in an adult intensive care unit of a university hospital in Northeastern Brazil was conducted from July to December 2015. Data included social and clinical information and the risk factors of the Braden, Norton and Waterlow scales. Data were analysed by the descriptive and inferential statistics. Most of the participants were female, adults and elderly people with brown skin colour, low education levels and insufficient income. Most of them showed a high risk for developing pressure ulcers using the three evaluated scales. Age, smoking status, diabetes and hypertension were associated with scores on the Waterlow, Braden and Norton scales. Age, use of the tobacco, diabetes and hypertension were associated with the risk of pressure ulcers in ICU patients.

Is it the time to rethink clinical decision-making strategies? From a single clinical outcome evaluation to a Clinical Multi-criteria Decision Assessment (CMDA).

PubMed

Migliore, Alberto; Integlia, Davide; Bizzi, Emanuele; Piaggio, Tomaso

2015-10-01

There are plenty of different clinical, organizational and economic parameters to consider in order having a complete assessment of the total impact of a pharmaceutical treatment. In the attempt to follow, a holistic approach aimed to provide an evaluation embracing all clinical parameters in order to choose the best treatments, it is necessary to compare and weight multiple criteria. Therefore, a change is required: we need to move from a decision-making context based on the assessment of one single criteria towards a transparent and systematic framework enabling decision makers to assess all relevant parameters simultaneously in order to choose the best treatment to use. In order to apply the MCDA methodology to clinical decision making the best pharmaceutical treatment (or medical devices) to use to treat a specific pathology, we suggest a specific application of the Multiple Criteria Decision Analysis for the purpose, like a Clinical Multi-criteria Decision Assessment CMDA. In CMDA, results from both meta-analysis and observational studies are used by a clinical consensus after attributing weights to specific domains and related parameters. The decision will result from a related comparison of all consequences (i.e., efficacy, safety, adherence, administration route) existing behind the choice to use a specific pharmacological treatment. The match will yield a score (in absolute value) that link each parameter with a specific intervention, and then a final score for each treatment. The higher is the final score; the most appropriate is the intervention to treat disease considering all criteria (domain an parameters). The results will allow the physician to evaluate the best clinical treatment for his patients considering at the same time all relevant criteria such as clinical effectiveness for all parameters and administration route. The use of CMDA model will yield a clear and complete indication of the best pharmaceutical treatment to use for patients

An approach for utilizing clinical statements in HL7 RIM to evaluate eligibility criteria.

PubMed

Bache, Richard; Daniel, Christel; James, Julie; Hussain, Sajjad; McGilchrist, Mark; Delaney, Brendan; Taweel, Adel

2014-01-01

The HL7 RIM (Reference Information Model) is a commonly used standard for the exchange of clinical data and can be employed for integrating the patient care and clinical research domains. Yet it is not sufficiently well specified to ensure a canonical representation of structured clinical data when used for the automated evaluation of eligibility criteria from a clinical trial protocol. We present an approach to further constrain the RIM to create a common information model to hold clinical data. In order to demonstrate our approach, we identified 132 distinct data elements from 10 rich clinical trails. We then defined a taxonomy to (i) identify the types of data elements that would need to be stored and (ii) define the types of predicate that would be used to evaluate them. This informed the definition of a pattern used to represent the data, which was shown to be sufficient for storing and evaluating the clinical statements required by the trials.

Evaluation of psychology practitioner competence in clinical supervision.

PubMed

Gonsalvez, Craig J; Crowe, Trevor P

2014-01-01

There is a growing consensus favouring the development, advancement, and implementation of a competency-based approach for psychology training and supervision. There is wide recognition that skills, attitude-values, and relationship competencies are as critical to a psychologist's competence as are knowledge capabilities, and that these key competencies are best measured during placements, leaving the clinical supervisor in an unparalleled position of advantage to provide formative and summative evaluations on the supervisee's progression towards competence. Paradoxically, a compelling body of literature from across disciplines indicates that supervisor ratings of broad domains of competence are systematically compromised by biases, including leniency error and halo effect. The current paper highlights key issues affecting summative competency evaluations by supervisors: what competencies should be evaluated, who should conduct the evaluation, how (tools) and when evaluations should be conducted, and process variables that affect evaluation. The article concludes by providing research recommendations to underpin and promote future progress and by offering practice recommendations to facilitate a more credible and meaningful evaluation of competence and competencies.

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

PubMed Central

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

2017-01-01

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

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.