A Student Assessment Tool for Standardized Patient Simulations (SAT-SPS): Psychometric analysis.

Science.gov (United States)

Castro-Yuste, Cristina; García-Cabanillas, María José; Rodríguez-Cornejo, María Jesús; Carnicer-Fuentes, Concepción; Paloma-Castro, Olga; Moreno-Corral, Luis Javier

2018-05-01

The evaluation of the level of clinical competence acquired by the student is a complex process that must meet various requirements to ensure its quality. The psychometric analysis of the data collected by the assessment tools used is a fundamental aspect to guarantee the student's competence level. To conduct a psychometric analysis of an instrument which assesses clinical competence in nursing students at simulation stations with standardized patients in OSCE-format tests. The construct of clinical competence was operationalized as a set of observable and measurable behaviors, measured by the newly-created Student Assessment Tool for Standardized Patient Simulations (SAT-SPS), which was comprised of 27 items. The categories assigned to the items were 'incorrect or not performed' (0), 'acceptable' (1), and 'correct' (2). 499 nursing students. Data were collected by two independent observers during the assessment of the students' performance at a four-station OSCE with standardized patients. Descriptive statistics were used to summarize the variables. The difficulty levels and floor and ceiling effects were determined for each item. Reliability was analyzed using internal consistency and inter-observer reliability. The validity analysis was performed considering face validity, content and construct validity (through exploratory factor analysis), and criterion validity. Internal reliability and inter-observer reliability were higher than 0.80. The construct validity analysis suggested a three-factor model accounting for 37.1% of the variance. These three factors were named 'Nursing process', 'Communication skills', and 'Safe practice'. A significant correlation was found between the scores obtained and the students' grades in general, as well as with the grades obtained in subjects with clinical content. The assessment tool has proven to be sufficiently reliable and valid for the assessment of the clinical competence of nursing students using standardized patients

Assessing the clinical probability of pulmonary embolism

International Nuclear Information System (INIS)

Miniati, M.; Pistolesi, M.

2001-01-01

Clinical assessment is a cornerstone of the recently validated diagnostic strategies for pulmonary embolism (PE). Although the diagnostic yield of individual symptoms, signs, and common laboratory tests is limited, the combination of these variables, either by empirical assessment or by a prediction rule, can be used to express a clinical probability of PE. The latter may serve as pretest probability to predict the probability of PE after further objective testing (posterior or post-test probability). Over the last few years, attempts have been made to develop structured prediction models for PE. In a Canadian multicenter prospective study, the clinical probability of PE was rated as low, intermediate, or high according to a model which included assessment of presenting symptoms and signs, risk factors, and presence or absence of an alternative diagnosis at least as likely as PE. Recently, a simple clinical score was developed to stratify outpatients with suspected PE into groups with low, intermediate, or high clinical probability. Logistic regression was used to predict parameters associated with PE. A score ≤ 4 identified patients with low probability of whom 10% had PE. The prevalence of PE in patients with intermediate (score 5-8) and high probability (score ≥ 9) was 38 and 81%, respectively. As opposed to the Canadian model, this clinical score is standardized. The predictor variables identified in the model, however, were derived from a database of emergency ward patients. This model may, therefore, not be valid in assessing the clinical probability of PE in inpatients. In the PISA-PED study, a clinical diagnostic algorithm was developed which rests on the identification of three relevant clinical symptoms and on their association with electrocardiographic and/or radiographic abnormalities specific for PE. Among patients who, according to the model, had been rated as having a high clinical probability, the prevalence of proven PE was 97%, while it was 3

Do pressure ulcer risk assessment scales improve clinical practice?

Directory of Open Access Journals (Sweden)

Jan Kottner

2010-07-01

Full Text Available Jan Kottner1, Katrin Balzer21Department of Nursing Science, Charité-Universitätsmedizin Berlin, Germany; 2Nursing Research Group, Institute for Social Medicine, Universitätsklinikum Schleswig-Holstein, Lübeck, GermanyAbstract: Standardized assessment instruments are deemed important for estimating pressure ulcer risk. Today, more than 40 so-called pressure ulcer risk assessment scales are available but still there is an ongoing debate about their usefulness. From a measurement point of view pressure ulcer (PU risk assessment scales have serious limitations. Empirical evidence supporting the validity of PU risk assessment scale scores is weak and obtained scores contain varying amounts of measurement error. The concept of pressure ulcer risk is strongly related to the general health status and severity of illness. A clinical impact due do the application of these scales could also not be demonstrated. It is questionable whether completion of standardized pressure ulcer risk scales in clinical practice is really needed.Keywords: Braden pressure ulcer, prevention, risk assessment, nursing assessment, predictive value, clinical effectiveness, review

Impact of standardized clinical assessment and management plans on resource utilization and costs in children after the arterial switch operation.

Science.gov (United States)

Rathod, Rahul H; Jurgen, Brittney; Hamershock, Rose A; Friedman, Kevin G; Marshall, Audrey C; Samnaliev, Mihail; Graham, Dionne A; Jenkins, Kathy; Lock, James E; Powell, Andrew J

2017-12-01

Standardized Clinical Assessment and Management Plans (SCAMPs) are a quality improvement initiative designed to reduce unnecessary utilization, decrease practice variation, and improve patient outcomes. We created a novel methodology, the SCAMP managed episode of care (SMEOC), which encompasses multiple encounters to assess the impact of the arterial switch operation (ASO) SCAMP on total costs. All ASO SCAMP patients (dates March 2009 to July 2015) were compared to a control group of ASO patients (January 2001 to February 2009). Patients were divided into "younger" (operation while maintaining quality of care. © 2017 Wiley Periodicals, Inc.

Minimum reporting standards for clinical research on groin pain in athletes

DEFF Research Database (Denmark)

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

2015-01-01

Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

Resource reduction in pediatric chest pain: Standardized clinical assessment and management plan.

Science.gov (United States)

Saleeb, Susan F; McLaughlin, Sarah R; Graham, Dionne A; Friedman, Kevin G; Fulton, David R

2018-01-01

Using a Standardized Clinical Assessment and Management Plan (SCAMP) for pediatric patients presenting to clinic with chest pain, we evaluated the cost impact associated with implementation of the care algorithm. Prior to introduction of the SCAMP, we analyzed charges for 406 patients with chest pain, seen in 2009, and predicted 21% reduction of overall charges had the SCAMP methodology been used. The SCAMP recommended an echocardiogram for history, examination, or ECG findings suggestive of a cardiac etiology for chest pain. Resource utilization was reviewed for 1517 patients (7-21 years) enrolled in the SCAMP from July 2010 to April 2014. Compared to the 2009 historic cohort, patients evaluated by the SCAMP had higher rates of exertional chest pain (45% vs 37%) and positive family history (5% vs 1%). The SCAMP cohort had fewer abnormal physical examination findings (1% vs 6%) and abnormal electrocardiograms (3% vs 5%). Echocardiogram use increased in the SCAMP cohort compared to the 2009 historic cohort (45% vs 41%), whereas all other ancillary testing was reduced: exercise stress testing (4% SCAMP vs 28% historic), Holter (4% vs 7%), event monitors (3% vs 10%), and MRI (1% vs 2%). Total charges were reduced by 22% ($822 625) by use of the Chest Pain SCAMP, despite a higher percentage of patients for whom echocardiogram was recommended compared to the historic cohort. The Chest Pain SCAMP effectively streamlines cardiac testing and reduces resource utilization. Further reductions can be made by algorithm refinement regarding echocardiograms for exertional symptoms. © 2017 Wiley Periodicals, Inc.

Clinical quality standards for radiotherapy

Science.gov (United States)

2012-01-01

Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

Science.gov (United States)

Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

2015-10-01

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy

Directory of Open Access Journals (Sweden)

Kjersti Marie Blytt

2017-10-01

Full Text Available Abstract Background Sleep disturbances are widespread among nursing home (NH patients and associated with numerous negative consequences. Identifying and treating them should therefore be of high clinical priority. No prior studies have investigated the degree to which sleep disturbances as detected by actigraphy and by the sleep-related items in the Cornell Scale for Depression in Dementia (CSDD and the Neuropsychiatric Inventory – Nursing Home version (NPI-NH provide comparable results. Such knowledge is highly needed, since both questionnaires are used in clinical settings and studies use the NPI-NH sleep item to measure sleep disturbances. For this reason, insight into their relative (disadvantages is valuable. Method Cross-sectional study of 83 NH patients. Sleep was objectively measured with actigraphy for 7 days, and rated by NH staff with the sleep items in the CSDD and the NPI-NH, and results were compared. McNemar's tests were conducted to investigate whether there were significant differences between the pairs of relevant measures. Cohen's Kappa tests were used to investigate the degree of agreement between the pairs of relevant actigraphy, NPI-NH and CSDD measures. Sensitivity and specificity analyses were conducted for each of the pairs, and receiver operating characteristics (ROC curves were designed as a plot of the true positive rate against the false positive rate for the diagnostic test. Results Proxy-raters reported sleep disturbances in 20.5% of patients assessed with NPI-NH and 18.1% (difficulty falling asleep, 43.4% (multiple awakenings and 3.6% (early morning awakenings of patients had sleep disturbances assessed with CSDD. Our results showed significant differences (p<0.001 between actigraphy measures and proxy-rated sleep by the NPI-NH and CSDD. Sensitivity and specificity analyses supported these results. Conclusions Compared to actigraphy, proxy-raters clearly underreported NH patients' sleep disturbances as assessed

Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian.

Science.gov (United States)

Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook

2017-04-01

This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

Science.gov (United States)

2010-10-01

... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

Science.gov (United States)

2010-10-01

... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

Positron emission tomography-computed tomography standardized uptake values in clinical practice and assessing response to therapy.

Science.gov (United States)

Kinahan, Paul E; Fletcher, James W

2010-12-01

The use of standardized uptake values (SUVs) is now common place in clinical 2-deoxy-2-[(18)F] fluoro-D-glucose (FDG) position emission tomography-computed tomography oncology imaging and has a specific role in assessing patient response to cancer therapy. Ideally, the use of SUVs removes variability introduced by differences in patient size and the amount of injected FDG. However, in practice there are several sources of bias and variance that are introduced in the measurement of FDG uptake in tumors and also in the conversion of the image count data to SUVs. In this article the overall imaging process is reviewed and estimates of the magnitude of errors, where known, are given. Recommendations are provided for best practices in improving SUV accuracy. Copyright © 2010 Elsevier Inc. All rights reserved.

State Standards and State Assessment Systems: A Guide to Alignment. Series on Standards and Assessments.

Science.gov (United States)

La Marca, Paul M.; Redfield, Doris; Winter, Phoebe C.

Alignment of content standards, performance standards, and assessments is crucial. This guide contains information to assist states and districts in aligning their assessment systems to their content and performance standards. It includes a review of current literature, both published and fugitive. The research is woven together with a few basic…

Assessing undergraduate nursing students in clinical practice: do preceptors use assessment strategies?

Science.gov (United States)

McCarthy, Bridie; Murphy, Siobhan

2008-04-01

Health care organisations such as the World Health Organisation (WHO) and An Bord Altranais (ABA, The Irish Nursing Registration Board) demand higher standards of new graduate nurses than heretofore. This is in conjunction with the implementation of degree programmes for undergraduate nurse education. These organisations stipulate that graduates must be well-educated, accountable, and can demonstrate the skills of a safe, caring and competent decision-making practitioner. The Bachelor of Science (BSc) four-year degree programme for undergraduate nurse education was introduced in Ireland in 2002, and is provided in universities and colleges of higher education throughout The Republic of Ireland. During the implementation process, each university and college of higher education developed a range of assessment strategies to clinically assess students. Preceptor nurses were subsequently assigned the responsibility of clinically assessing students, a remit previously undertaken by Clinical Ward/Unit Nurse Managers. Preceptors are qualified nurses, working in clinical units who are specially prepared to support BSc students during clinical placements. The purpose of this study was to explore to what extent preceptor nurses use the devised assessment strategies to clinically assess BSc students in one university in The Republic of Ireland. Data were collected by using a questionnaire distributed to all known preceptors in General, Psychiatric and Intellectual Disability nursing, during year four of the first cycle of the BSc programme. Findings from this descriptive study revealed that many preceptors were inexperienced, did not fully comprehend the assessment process and were not applying all of the recommended assessment strategies when assessing students in clinical practice. In light of these findings suggestions are made in the context of further research, management and education.

Inconsistent trial assessments by the National Institute for Health and Clinical Excellence and IQWiG: standards for the performance and interpretation of subgroup analyses are needed.

Science.gov (United States)

Hasford, J; Bramlage, P; Koch, G; Lehmacher, W; Einhäupl, K; Rothwell, P M

2010-12-01

The methodology for the critical assessment of medical interventions is well established. Regulatory agencies and institutions adhere, in principle, to the same standards. This consistency, however, is not always the case in practice. Using the evaluation of the CAPRIE (Clopidogrel versus Aspirin in Patients at risk of Ischemic Events) trial by the British National Institute for Health and Clinical Excellence (NICE) and the German Institute for Quality and Efficiency in Health Care (IQWiG), we illustrate that there was no consensus for the interpretation of possible heterogeneity in treatment comparisons across subgroups. The NICE concluded that CAPRIE demonstrated clinical benefit for the overall intention-to-treat (ITT) population with sufficient robustness to possible sources of heterogeneity. The IQWiG interpreted the alleged heterogeneity as implying that the clinical benefit only applied to the subgroup of patients with a statistically significant result irrespective of the results of the ITT analysis. International standards for the performance and interpretation of subgroup analyses as well as for the assessment of heterogeneity between strata are needed. Copyright © 2010 Elsevier Inc. All rights reserved.

Classification and clinical assessment

Directory of Open Access Journals (Sweden)

F. Cantini

2012-06-01

Full Text Available There are at least nine classification criteria for psoriatic arthritis (PsA that have been proposed and used in clinical studies. With the exception of the ESSG and Bennett rules, all of the other criteria sets have a good performance in identifying PsA patients. As the CASPAR criteria are based on a robust study methodology, they are considered the current reference standard. However, if there seems to be no doubt that they are very good to classify PsA patients (very high specificity, they might be not sensitive enough to diagnose patients with unknown early PsA. The vast clinical heterogeneity of PsA makes its assessment very challenging. Peripheral joint involvement is measured by 78/76 joint counts, spine involvement by the instruments used for ankylosing spondylitis (AS, dactylitis by involved digit count or by the Leeds dactylitis index, enthesitis by the number of affected entheses (several indices available and psoriasis by the Psoriasis Area and Severity Index (PASI. Peripheral joint damage can be assessed by a modified van der Heijde-Sharp scoring system and axial damage by the methods used for AS or by the Psoriatic Arthritis Spondylitis Radiology Index (PASRI. As in other arthritides, global evaluation of disease activity and severity by patient and physician and assessment of disability and quality of life are widely used. Finally, composite indices that capture several clinical manifestations of PsA have been proposed and a new instrument, the Psoriatic ARthritis Disease Activity Score (PASDAS, is currently being developed.

Standards for psychological assessment of nuclear facility personnel. Technical report

International Nuclear Information System (INIS)

Frank, F.D.; Lindley, B.S.; Cohen, R.A.

1981-07-01

The subject of this study was the development of standards for the assessment of emotional instability in applicants for nuclear facility positions. The investigation covered all positions associated with a nuclear facility. Conclusions reached in this investigation focused on the ingredients of an integrated selection system including the use of personality tests, situational simulations, and the clinical interview; the need for professional standards to ensure quality control; the need for a uniform selection system as organizations vary considerably in terms of instruments presently used; and the need for an on-the-job behavioral observation program

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study.

Science.gov (United States)

Tong, Tiffany; Chignell, Mark; Tierney, Mary C; Lee, Jacques

2016-05-27

We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=-.339, P games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making.

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study

Science.gov (United States)

Chignell, Mark; Tierney, Mary C.; Lee, Jacques

2016-01-01

Background We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. Objective The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. Methods We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). Results After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=–.339, P games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making. PMID:27234145

Updating contextualized clinical practice guidelines on stroke rehabilitation and low back pain management using a novel assessment framework that standardizes decisions.

Science.gov (United States)

Gambito, Ephraim D V; Gonzalez-Suarez, Consuelo B; Grimmer, Karen A; Valdecañas, Carolina M; Dizon, Janine Margarita R; Beredo, Ma Eulalia J; Zamora, Marcelle Theresa G

2015-11-04

Clinical practice guidelines need to be regularly updated with current literature in order to remain relevant. This paper reports on the approach taken by the Philippine Academy of Rehabilitation Medicine (PARM). This dovetails with its writing guide, which underpinned its foundational work in contextualizing guidelines for stroke and low back pain (LBP) in 2011. Working groups of Filipino rehabilitation physicians and allied health practitioners met to reconsider and modify, where indicated, the 'typical' Filipino patient care pathways established in the foundation guidelines. New clinical guidelines on stroke and low back pain which had been published internationally in the last 3 years were identified using a search of electronic databases. The methodological quality of each guideline was assessed using the iCAHE Guideline Quality Checklist, and only those guidelines which provided full text references, evidence hierarchy and quality appraisal of the included literature, were included in the PARM update. Each of the PARM-endorsed recommendations was then reviewed, in light of new literature presented in the included clinical guidelines. A novel standard updating approach was developed based on the criteria reported by Johnston et al. (Int J Technol Assess Health Care 19(4):646-655, 2003) and then modified to incorporate wording from the foundational PARM writing guide. The new updating tool was debated, pilot-tested and agreed upon by the PARM working groups, before being applied to the guideline updating process. Ten new guidelines on stroke and eleven for low back pain were identified. Guideline quality scores were moderate to good, however not all guidelines comprehensively linked the evidence body underpinning recommendations with the literature. Consequently only five stroke and four low back pain guidelines were included. The modified PARM updating guide was applied by all working groups to ensure standardization of the wording of updated recommendations

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

Science.gov (United States)

Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

2018-04-30

FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

The evolution of a clinical database: from local to standardized clinical languages.

OpenAIRE

Prophet, C. M.

2000-01-01

For more than twenty years, the University of Iowa Hospitals and Clinics Nursing Informatics (UIHC NI) has been developing a clinical database to support patient care planning and documentation in the INFORMM NIS (Information Network for Online Retrieval & Medical Management Nursing Information System). Beginning in 1992, the database content was revised to standardize orders and to incorporate the Standardized Nursing Languages (SNLs) of the North American Nursing Diagnosis Association (NAND...

42 CFR 493.1276 - Standard: Clinical cytogenetics.

Science.gov (United States)

2010-10-01

... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process...

A scheme for the audit of scientific and technological standards in clinical nuclear medicine

International Nuclear Information System (INIS)

Perkins, A.C.; Jarritt, P.H.

2002-01-01

Aim: Audit is the process whereby the quality of a service is monitored and optimised. It forms an essential component of the quality assurance process, whether by self-assessment or by external peer review. In the UK the British Nuclear Medicine Society (BNMS) has undertaken external organisational audit of departments providing clinical nuclear medicine services. This work aimed to develop a more thorough and service specific process for the audit of scientific and technological standards in nuclear medicine. Materials and Methods: The audit process has been implemented using written audit documents to facilitate the audit procedure. A questionnaire forms part of the formal documentation for audit of the scientific and technical standards of a clinical service. Scientific and technical standards were derived from a number of sources including legal requirements, regulatory obligations, notes for guidance, peer reviewed publications and accepted good clinical practice (GCP). Results: The audit process graded the standards of an individual department according to legal or safety requirements (Grade A), good practice (Grade B) and desirable aspects of service delivery (Grade C). The standards have been allocated into eight main categories. These are: Instrumentation; Software and data protection; Electrical Safety; Mechanical Safety; Workstation Safety; The Control of Substances Hazardous to Health (COSHH); Radiation Protection; Scientific and Technical staffing levels. During the audit visit a detailed inspection of clinical and laboratory areas and department written documentation is also necessary to validate the data obtained. Conclusion: The printed scheme now provides a means for external audit or self-assessment. There should be evidence of a well-organised and safe environment for both patients and staff. Health and Safety legislation requires written local rules and these records should be available to demonstrate the standard of service provision. Other

A Novel Clinical-Simulated Suture Education for Basic Surgical Skill: Suture on the Biological Tissue Fixed on Standardized Patient Evaluated with Objective Structured Assessment of Technical Skill (OSATS) Tools.

Science.gov (United States)

Shen, Zhanlong; Yang, Fan; Gao, Pengji; Zeng, Li; Jiang, Guanchao; Wang, Shan; Ye, Yingjiang; Zhu, Fengxue

2017-06-21

Clinical-simulated training has shown benefit in the education of medical students. However, the role of clinical simulation for surgical basic skill training such as suturing techniques remains unclear. Forty-two medical students were asked to perform specific suturing tasks at three stations with the different settings within four minutes (Station 1: Synthetic suture pad fixed on the bench, Station 2: Synthetic suture pad fixed on the standardized patient, Station 3: Pig skin fixed on the standardized patient); the OSATS (Objective Structured Assessment of Technical Skill) tool was used to evaluate the performance of students. A questionnaire was distributed to the students following the examination. Mean performance score of Station 3 was significant lower than that of Station 1 and 2 in the general performance including tissue handling, time, and motion. The suturing techniques of students at Station 2 and 3 were not as accurate as that at Station 1. Inappropriate tension was applied to the knot at Station 2 compared with Station 1 and 3. On the questionnaire, 93% of students considered clinical-simulated training of basic surgical skills was necessary and may increase their confidence in future clinical work as surgeons; 98% of students thought the assessment was more objective when OSATS tool was used for evaluation. Clinical simulation examination assessed with OSATS might throw a novel light on the education of basic surgical skills and may be worthy of wider adoption in the surgical education of medical students.

Standardized training in nurse model travel clinics.

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Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

2011-01-01

International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to

Postnatal Psychosocial Assessment and Clinical Decision-Making, a Descriptive Study.

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Sims, Deborah; Fowler, Cathrine

2018-05-18

The aim of this study is to describe experienced child and family health nurses' clinical decision-making during a postnatal psychosocial assessment. Maternal emotional wellbeing in the postnatal year optimises parenting and promotes infant development. Psychosocial assessment potentially enables early intervention and reduces the risk of a mental disorder occurring during this time of change. Assessment accuracy, and the interventions used are determined by the standard of nursing decision-making. A qualitative methodology was employed to explore decision-making behaviour when conducting a postnatal psychosocial assessment. This study was conducted in an Australian early parenting organisation. Twelve experienced child and family health nurses were interviewed. A detailed description of a postnatal psychosocial assessment process was obtained using a critical incident technique. Template analysis was used to determine the information domains the nurses accessed, and content analysis was used to determine the nurses' thinking strategies, to make clinical decisions from this assessment. The nurses described 24 domains of information and used 17 thinking strategies, in a variety of combinations. The four information domains most commonly used were parenting, assessment tools, women-determined issues and sleep. The seven thinking strategies most commonly used were searching for information, forming relationships between the information, recognising a pattern, drawing a conclusion, setting priorities, providing explanations for the information and judging the value of the information. The variety and complexity of the clinical decision-making involved in postnatal psychosocial assessment confirms that the nurses use information appropriately and within their scope of nursing practice. The standard of clinical decision-making determines the results of the assessment and the optimal access to care. Knowledge of the information domains and the decision-making strategies

Impact of the site specialty of a continuity practice on students' clinical skills: performance with standardized patients.

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Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L

2010-07-01

The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.

Implementing Home Health Standards in Clinical Practice.

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Gorski, Lisa A

2016-02-01

In 1986, the American Nurses Association (ANA) published the first Standards of Home Health Practice. Revised in 1992 and expanded in 1999 to become Home Health Nursing: Scope and Standards of Practice, it was revised in 2008 and again in 2014. In the 2014 edition, there are 6 standards of home healthcare nursing practice and 10 standards of professional performance for home healthcare nursing. The focus of this article is to describe the home healthcare standards and to provide guidance for implementation in clinical practice. It is strongly encouraged that home healthcare administrators, educators, and staff obtain a copy of the standards and fully read this essential home healthcare resource.

Clinical assessment of hip strength using a hand-held dynamometer is reliable

DEFF Research Database (Denmark)

Thorborg, K; Petersen, J; Magnusson, S P

2010-01-01

Hip strength assessment plays an important role in the clinical examination of the hip and groin region. The primary aim of this study was to examine the absolute test-retest measurement variation concerning standardized strength assessments of hip abduction (ABD), adduction (ADD), external...... tests. No systematic differences were present. Standardized strength assessment procedures of hip ABD, ER, IR, FLEX, with test-retest measurement variation below 5%, hip ADD below 6% and hip EXT below 8%, make it possible to determine even small changes in hip strength at the individual level....

Assessment of service quality of public antiretroviral treatment (ART clinics in South Africa: a cross-sectional study

Directory of Open Access Journals (Sweden)

Kinkel Hans F

2012-07-01

Full Text Available Abstract Background In South Africa the ever increasing demand for antiretroviral treatment (ART runs the risk of leading to sub-optimal care in public sector ART clinics that are overburdened and under resourced. This study assessed the quality of ART services to identify service areas that require improvement. Methods A cross-sectional study was carried out at 16 of 17 public ART clinics in the target area in greater Pretoria, South Africa. Trained participant observers presented as ART qualifying HIV positive patients that required a visit to assess treatment readiness. They evaluated each facility on five different occasions between June and November 2009, assessing the time it took to get an appointment, the services available and accessed, service quality and the duration of the visit. Services (reception area, clinician’s consultation, HIV counselling, pharmacy, nutrition counselling and social worker’s assessment were assessed against performance standards that apply to all clinics. Service quality was expressed as scores for clinic performance (CPS and service performance (SPS, defined as the percentage of performance standards met per clinic and service area. Results In most of the clinics (62.5% participant observers were able to obtain an appointment within one week, although on the day of their visit essential services could not always be accessed. The median CPS of the assessed facilities was 68.5 with four clinics not meeting minimum standards (CPS > 60. The service areas that performed least well were the clinician’s consultation (SPS 67.3 and HIV counselling (SPS 70.7. Most notably, clinicians performed a physical examination in only 41.1% of the visits and rarely did a complete TB symptom screening. Counsellors frequently failed to address prevention of HIV transmission. Conclusions Overall public sector ART clinics in greater Pretoria were easily accessible and their services were of an acceptable quality. However

Development of job standards for clinical nutrition therapy for dyslipidemia patients.

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Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

2015-04-01

Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

[New medical device hospital assessment: what kind of clinical data?].

Science.gov (United States)

Beaussier, H; Junot, H; Lancrenon, S; Faure, P

2012-01-01

Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Standards and measurements for assessing bone health-workshop report co-sponsored by the International Society for Clinical Densitometry (ISCD) and the National Institute of Standards and Technology (NIST).

Science.gov (United States)

Bennett, Herbert S; Dienstfrey, Andrew; Hudson, Lawrence T; Oreskovic, Tammy; Fuerst, Thomas; Shepherd, John

2006-01-01

This article reports and discusses the results of the recent ISCD-NIST Workshop on Standards and Measurements for Assessing Bone Health. The purpose of the workshop was to assess the status of efforts to standardize and compare results from dual-energy X-ray absorptiometry (DXA) scans, and then to identify and prioritize ongoing measurement and standards needs.

Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

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McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

2017-10-01

The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

Students' Assessment and Self-assessment of Nursing Clinical Faculty Competencies: Important Feedback in Clinical Education?

Science.gov (United States)

Lovrić, Robert; Prlić, Nada; Zec, Davor; Pušeljić, Silvija; Žvanut, Boštjan

2015-01-01

The students' assessment of clinical faculty competencies and the faculty members' self-assessment can provide important information about nursing clinical education. The aim of this study was to identify the differences between the students' assessment of the clinical faculty member's competencies and the faculty member's self-assessment. These differences can reveal interesting insights relevant for improving clinical practice.

MRI assessment of myelination: an age standardization

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Staudt, M. (Kinderklinik Dritter Orden, Passau (Germany)); Schropp, C. (Kinderklinik Dritter Orden, Passau (Germany)); Staudt, F. (Kinderklinik Dritter Orden, Passau (Germany)); Obletter, N. (Radiologische Praxis, Klinikum Ingolstadt (Germany)); Bise, K. (Neuropathologisches Inst., Muenchen Univ. (Germany)); Breit, A. (MR Tomographie, Klinikum Passau (Germany)); Weinmann, H.M. (Kinderklinik Schwabing, Muenchen (Germany))

1994-04-01

777 cerebral MRI examinations of children aged 3 days to 14 years were staged for myelination to establish an age standardization. Staging was performed using a system proposed in a previous paper, separately ranking 10 different regions of the brain. Interpretation of the results led to the identification of foue clinical diagnoses that are frequently associated with delays in myelination: West syndrome, cerebral palsy, developmental retardation, and congenital anomalies. In addition, it was found that assessment of myelination in children with head injuries was not practical as alterations in MRI signal can simulate earlier stages of myelination. Age limits were therefore calculated from the case material after excluding all children with these conditions. When simplifications of the definition of the stages are applied, these age limits for the various stages of myelination of each of the 10 regions of the brain make the staging system applicable for routine assessment of myelination. (orig.)

Assessing the predictive capability of optical imaging techniques, Spatial Frequency Domain Imaging (SFDI) and Laser Speckle Imaging (LSI), to the gold standard of clinical assessment in a controlled animal model

Science.gov (United States)

Ponticorvo, A.; Rowland, R.; Baldado, M.; Burmeister, D. M.; Christy, R. J.; Bernal, N.; Durkin, A. J.

2018-02-01

The current standard for assessment of burn severity and subsequent wound healing is through clinical examination, which is highly subjective. Accurate early assessment of burn severity is critical for dictating the course of wound management. Complicating matters is the fact that burn wounds are often large and can have multiple regions that vary in severity. In order to manage the treatment more effectively, a tool that can provide spatially resolved information related to mapping burn severity could aid clinicians when making decisions. Several new technologies focus on burn care in an attempt to help clinicians objectively determine burn severity. By quantifying perfusion, laser speckle imaging (LSI) has had success in categorizing burn wound severity at earlier time points than clinical assessment alone. Additionally, spatial frequency domain imaging (SFDI) is a new technique that can quantify the tissue structural damage associated with burns to achieve earlier categorization of burn severity. Here we compared the performance of a commercial LSI device (PeriCam PSI, Perimed Inc.), a SFDI device (Reflect RSTM, Modulated Imaging Inc.) and conventional clinical assessment in a controlled (porcine) model of graded burn wound severity over the course of 28 days. Specifically we focused on the ability of each system to predict the spatial heterogeneity of the healed wound at 28 days, based on the images at an early time point. Spatial heterogeneity was defined by clinical assessment of distinct regions of healing on day 28. Across six pigs, 96 burn wounds (3 cm diameter) were created. Clinical assessment at day 28 indicated that 39 had appeared to heal in a heterogeneous manner. Clinical observation at day 1 found 35 / 39 (90%) to be spatially heterogeneous in terms of burn severity. The LSI system was able to detect spatial heterogeneity of burn severity in 14 / 39 (36%) cases on day 1 and 23 / 39 cases (59%) on day 7. By contrast the SFDI system was able to

Shifting Gears: Standards, Assessments, Curriculum, & Instruction.

Science.gov (United States)

Dougherty, Eleanor

This book is designed to help educators move from a system that measures students against students to one that values mastery of central concepts and skills, striving for proficiency in publicly acknowledged standards of academic performance. It aims to connect the operative parts of standards-based education (standards, assessment, curriculum,…

Assessing children’s competence to consent in research by a standardized tool: a validity study

Science.gov (United States)

2012-01-01

Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish

Assessing children’s competence to consent in research by a standardized tool: a validity study

Directory of Open Access Journals (Sweden)

Hein Irma M

2012-09-01

Full Text Available Abstract Background Currently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents. Methods/design In this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s. It is anticipated that 160 participants will be recruited over 2 years to complete enrollment. Discussion A validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In

The development of clinical document standards for semantic interoperability in china.

Science.gov (United States)

Yang, Peng; Pan, Feng; Liu, Danhong; Xu, Yongyong; Wan, Yi; Tu, Haibo; Tang, Xuejun; Hu, Jianping

2011-12-01

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

Adapting Objective Structured Clinical Examinations to Assess Social Work Students' Performance and Reflections

Science.gov (United States)

Bogo, Marion; Regehr, Cheryl; Logie, Carmen; Katz, Ellen; Mylopoulos, Maria; Regehr, Glenn

2011-01-01

The development of standardized, valid, and reliable methods for assessment of students' practice competence continues to be a challenge for social work educators. In this study, the Objective Structured Clinical Examination (OSCE), originally used in medicine to assess performance through simulated interviews, was adapted for social work to…

Introduction of a new standardized assessment score of spine morphology in osteogenesis imperfecta

International Nuclear Information System (INIS)

Koerber, F.; Schulze Uphoff, U.; Koerber, S.; Maintz, D.; Schoenau, E.; Semler, O.

2012-01-01

Purpose: Osteogenesis imperfecta (OI) is a rare hereditary disease leading to multiple bone deformities and fractures. In the absence of causal therapy, a symptomatic approach is based on treatment with bisphosphonates and physiotherapy. The clinical and radiological manifestations vary. Therefore, standardization and quantification for an objective comparison, especially during therapy, are required. In this paper, radiological changes of the spine are quantified according to their clinical relevance to define a scoring system that transfers the morphological changes into a single value representing the severity of the disease. Materials and Methods: 268 lateral spine X-rays of 95 patients with OI (median age 5.6 years) were assessed. The findings were classified based on their clinical relevance. Results: The three criteria, vertebral compression, thoracolumbar kyphosis and deformity type, were quantified in a new grading system. Based on this, a 'severity classification' (1 to 5) was defined with implications for diagnostics and treatment. A mathematical formula that takes into account the three criteria and their correlations to clinical relevance, resulting in a 'severity score', was developed. Conclusion: 'Severity classification' and 'severity score' introduce a new concept for a standardized evaluation of spine X-rays in patients with OI. For both scientific and routine purposes, it provides the user with a simple and easy-to-handle tool for assessing and comparing different stages of severity prior to and during therapy with detailed accuracy. (orig.)

Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

Science.gov (United States)

Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

2015-09-01

An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

[Possible relation between clinical guidelines and legal standard of medicine].

Science.gov (United States)

Furukawa, Toshiharu; Kitagawa, Yuko

2010-10-01

Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

Clinical risk assessment in intensive care unit

Directory of Open Access Journals (Sweden)

Saeed Asefzadeh

2013-01-01

Full Text Available Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin′s Social Security Hospital (Razi Hospital through Failure Mode and Effect Analysis (FMEA. Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN was in respiratory care "Ventilator′s alarm malfunction (no alarm" with the score 288, and the lowest was in gastrointestinal "not washing the NG-Tube" with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care.

Standardized 15N tracer method for the determination of parameters of the whole-body protein metabolism in clinical practice

International Nuclear Information System (INIS)

Junghans, P.; Jung, K.; Matkowitz, R.

1984-01-01

A standardized 15 N tracer method is described for the assessment of nitrogen and protein metabolism in healthy and pathological changed organisms. The method represents an isotope technical procedure for the application in clinical research and practice. The clinical preparation of the patient/proband by means of a standardized nutritional regime, the tracer administration (single dose) and the sampling (urine, blood), the 15 N tracer technique (sample chemistry, emissionsspectrometric isotope analysis) and the mathematical evaluation of 15 N tracer data are described. (author)

Whole-body magnetic resonance angiography of patients using a standard clinical scanner

Energy Technology Data Exchange (ETDEWEB)

Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)

2006-01-01

The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)

Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

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Currie, Colin T; Hutchison, James D

To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

Science.gov (United States)

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

Introduction of a new standardized assessment score of spine morphology in osteogenesis imperfecta

Energy Technology Data Exchange (ETDEWEB)

Koerber, F.; Schulze Uphoff, U.; Koerber, S.; Maintz, D. [Koeln Univ. (Germany). Dept. of Radiology; Schoenau, E.; Semler, O. [Koeln Univ. (Germany). Children' s Hospital

2012-08-15

Purpose: Osteogenesis imperfecta (OI) is a rare hereditary disease leading to multiple bone deformities and fractures. In the absence of causal therapy, a symptomatic approach is based on treatment with bisphosphonates and physiotherapy. The clinical and radiological manifestations vary. Therefore, standardization and quantification for an objective comparison, especially during therapy, are required. In this paper, radiological changes of the spine are quantified according to their clinical relevance to define a scoring system that transfers the morphological changes into a single value representing the severity of the disease. Materials and Methods: 268 lateral spine X-rays of 95 patients with OI (median age 5.6 years) were assessed. The findings were classified based on their clinical relevance. Results: The three criteria, vertebral compression, thoracolumbar kyphosis and deformity type, were quantified in a new grading system. Based on this, a 'severity classification' (1 to 5) was defined with implications for diagnostics and treatment. A mathematical formula that takes into account the three criteria and their correlations to clinical relevance, resulting in a 'severity score', was developed. Conclusion: 'Severity classification' and 'severity score' introduce a new concept for a standardized evaluation of spine X-rays in patients with OI. For both scientific and routine purposes, it provides the user with a simple and easy-to-handle tool for assessing and comparing different stages of severity prior to and during therapy with detailed accuracy. (orig.)

Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment

DEFF Research Database (Denmark)

Nørskov, Anders Kehlet; Rosenstock, Charlotte Valentin; Wetterslev, Jørn

2013-01-01

-specific assessment. Data from patients' pre-operative airway assessment are registered in the Danish Anaesthesia Database. Objective scores for intubation and mask ventilation grade the severity of airway managements. The accuracy of predicting difficult intubation and mask ventilation is measured for each group...... the examination and registration of predictors for difficult mask ventilation with a non-specified clinical airway assessment on prediction of difficult mask ventilation.Method/Design: We cluster-randomized 28 Danish departments of anaesthesia to airway assessment either by the SARI or by usual non...... that registration of the SARI and predictors for difficult mask ventilation are mandatory for the intervention group but invisible to controls....

Achieving low anastomotic leak rates utilizing clinical perfusion assessment.

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Kream, Jacob; Ludwig, Kirk A; Ridolfi, Timothy J; Peterson, Carrie Y

2016-10-01

Anastomotic leak after colorectal resection increases morbidity, mortality, and in the setting of cancer, increases recurrences rates and reduces survival odds. Recent reports suggest that fluorescence evaluation of perfusion after colorectal anastomosis creation is associated with low anastomotic leak rates (1.4%). The purpose of this work was to evaluate whether a similar low anastomotic leak rate after left-sided colorectal resections could be achieved using standard assessment of blood flow to the bowel ends. We performed a retrospective chart review at an academic tertiary referral center, evaluating 317 consecutive patients who underwent a pelvic anastomosis after sigmoid colectomy, left colectomy, or low anterior resection. All operations were performed by a single surgeon from March 2008 to January 2015 with only standard clinical measures used to assess perfusion to the bowel ends. The primary outcome measure was the anastomotic leak rate as diagnosed by clinical symptoms, exam, or routine imaging. The average patient age was 59.7 years with an average body mass index of 28.8 kg/m(2). Rectal cancer (128, 40.4%) was the most common indication for operation while hypertension (134, 42.3%) was the most common comorbidity. In total, 177 operations were laparoscopic (55.8%), 13 were reoperative resections (4.1%), and 108 were protected with a loop ileostomy (34.1%). Preoperative chemotherapy was administered to 25 patients (7.9%) while preoperative chemo/radiation was administered to 64 patients (20.2%). The anastomotic leak rate was 1.6% (5/317). Our data suggests that standard, careful evaluation of adequate blood flow via inspection and confirmation of pulsatile blood flow to the bowel ends and meticulous construction of the colorectal or coloanal anastomoses can result in very low leak rates, similar to the rate reported when intraoperative imaging is used to assess perfusion. Copyright © 2016 Elsevier Inc. All rights reserved.

Regional Implementation of a Pediatric Cardiology Syncope Algorithm Using Standardized Clinical Assessment and Management Plans (SCAMPS) Methodology.

Science.gov (United States)

Paris, Yvonne; Toro-Salazar, Olga H; Gauthier, Naomi S; Rotondo, Kathleen M; Arnold, Lucy; Hamershock, Rose; Saudek, David E; Fulton, David R; Renaud, Ashley; Alexander, Mark E

2016-02-19

Pediatric syncope is common. Cardiac causes are rarely found. We describe and assess a pragmatic approach to these patients first seen by a pediatric cardiologist in the New England region, using Standardized Clinical Assessment and Management Plans (SCAMPs). Ambulatory patients aged 7 to 21 years initially seen for syncope at participating New England Congenital Cardiology Association practices over a 2.5-year period were evaluated using a SCAMP. Findings were iteratively analyzed and the care pathway was revised. The vast majority (85%) of the 1254 patients had typical syncope. A minority had exercise-related or more problematic symptoms. Guideline-defined testing identified one patient with cardiac syncope. Syncope Severity Scores correlated well between physician and patient perceived symptoms. Orthostatic vital signs were of limited use. Largely incidental findings were seen in 10% of ECGs and 11% of echocardiograms. The 10% returning for follow-up, by design, reported more significant symptoms, but did not have newly recognized cardiac disease. Iterative analysis helped refine the approach. SCAMP methodology confirmed that the vast majority of children referred to the outpatient pediatric cardiology setting had typical low-severity neurally mediated syncope that could be effectively evaluated in a single visit using minimal resources. A simple scoring system can help triage patients into treatment categories. Prespecified criteria permitted the effective diagnosis of the single patient with a clear cardiac etiology. Patients with higher syncope scores still have a very low risk of cardiac disease, but may warrant attention. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

ORAL CLINICAL LONG CASE PRESENTATION, THE NEED FOR STANDARDIZATION AND DOCUMENTATION.

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Agodirin, S O; Olatoke, S A; Rahman, G A; Agbakwuru, E A; Kolawole, O A

2015-01-01

The oral presentation of the clinical long case is commonly an implied knowledge. The challenge of the presentation is compounded by the examiners' preferences and sometimes inadequate understanding of what should be assessed. To highlight the different opinions and misconceptions of trainers as the basis for improving our understanding and assessment of oral presentation of the clinical long case. Questionnaire was administered during the West African College of Surgeons fellowship clinical examinations and at their workplaces. Eligibility criteria included being a surgeon, a trainer and responding to all questions. Of the 72 questionnaires that were returned, 36(50%) were eligible for the analysis. The 36 respondents were from 14 centers in Nigeria and Ghana. Fifty-two percent were examiners at the postgraduate medical colleges and 9(25%) were professors. Eight(22.2%) indicated they were unaware of the separate methods of oral presentation for different occasions while 21( 58.3%) respondents were aware that candidate used the "5Cs" method and the traditional compartmentalized method in long case oral presentation. Eleven(30.6%) wanted postgraduates to present differently on a much higher level than undergraduate despite not encountering same in literature and 21(58.3%) indicated it was an unwritten rule. Seventeen (47.2%) had not previously encountered the "5Cs" of history of presenting complaint in literature also 17(47.2%) teach it to medical students and their junior residents. This study has shown that examiners definitely have varying opinions on what form the oral presentation of the clinical long case at surgery fellowship/professional examination should be and it translates to their expectations of the residents or clinical students. This highlights the need for standardization and consensus of what is expected at a formal oral presentation during the clinical long case examination in order to avoid subjectivity and bias.

Standardized assessment of infrared thermographic fever screening system performance

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Ghassemi, Pejhman; Pfefer, Joshua; Casamento, Jon; Wang, Quanzeng

2017-03-01

Thermal modalities represent the only currently viable mass fever screening approach for outbreaks of infectious disease pandemics such as Ebola and SARS. Non-contact infrared thermometers (NCITs) and infrared thermographs (IRTs) have been previously used for mass fever screening in transportation hubs such as airports to reduce the spread of disease. While NCITs remain a more popular choice for fever screening in the field and at fixed locations, there has been increasing evidence in the literature that IRTs can provide greater accuracy in estimating core body temperature if appropriate measurement practices are applied - including the use of technically suitable thermographs. Therefore, the purpose of this study was to develop a battery of evaluation test methods for standardized, objective and quantitative assessment of thermograph performance characteristics critical to assessing suitability for clinical use. These factors include stability, drift, uniformity, minimum resolvable temperature difference, and accuracy. Two commercial IRT models were characterized. An external temperature reference source with high temperature accuracy was utilized as part of the screening thermograph. Results showed that both IRTs are relatively accurate and stable (<1% error of reading with stability of +/-0.05°C). Overall, results of this study may facilitate development of standardized consensus test methods to enable consistent and accurate use of IRTs for fever screening.

Organizational, technical, physical and clinical quality standards for radiotherapy

Science.gov (United States)

Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

2012-01-01

Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023

Standardized patients in audiology: a proposal for a new method of evaluating clinical competence.

Science.gov (United States)

Dinsmore, Brooke Freeman; Bohnert, Carrie; Preminger, Jill E

2013-05-01

While accrediting organizations require AuD programs to provide evidence that their students are able to demonstrate knowledge and competencies in specific content areas, there are no generally accepted mechanisms for the assessment and the measurement of these proficiencies. We propose that AuD programs consider developing standardized patient (SP) cases in order to develop consistent summative assessment programs within and across universities. The purpose of this article is to provide a framework for establishing SP programs to evaluate competencies in AuD students by detailing the history of SP cases and their use, developing a rationale for this method of assessment, and outlining the steps for writing and implementing SP cases. Literature review. SPs have been used to assess clinical competence in medical students for over 50 yr. The prevalence of SP assessment in allied health professions (e.g., dentistry, psychology, pharmacy) has increased over the last two decades but has only gained a limited following in audiology. SP assessment has been implemented in medical education using the Objective Structured Clinical Examination, a multistation, timed exam that uses fictional cases to assess students' clinical abilities. To date, only one published report has been completed that evaluates the use of SPs to assess clinical abilities in audiology students. This article expands upon the work of English et al (2007) and their efforts to use SPs to evaluate counseling abilities. To this end, we describe the steps necessary to write a case, procedures to determine performance requirements, and the need to develop remediation plans. As an example, we include a case that we have developed in order to evaluate vestibular assessment and patient communication skills. Utilizing SP assessment in audiology education would provide useful means to evaluate competence in a uniform way. Future research is necessary to develop reliable and valid cases that may be implemented

The clinical assessment of impulsivity

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Nagesh Brahmavar Pai

2018-01-01

Full Text Available The term impulsivity is often used to describe behavior that is both spontaneous and detrimental. Impulsivity is multidimensional and derives from personality, general psychopathology as well as specific mental disorders. Thus, the construct of impulsivity is important as it is associated with numerous mental disorders as well as socially deviant behaviors ranging from behaviors targeted towards others such as aggression, to behaviors targeted toward oneself, for example, self-harm and suicide. As a clinical construct impulsivity is highly predictive of poor prognosis thus further emphasizing its clinical relevance. Therefore, the need exists for impulsivity to be clinically assessed and this assessment should take place at the same time as the assessment of risk. As risk and impulsivity are interrelated and interact. Although there are existing self-report rating scales for trait-based impulsivity, a dearth exists in regards to assessment of impulsivity in clinical practice that is focused and pragmatic. Thus, a pragmatic rubric to guide the individualized assessment of impulsivity in a clinical population is proposed. The quadrants espoused will assist both with the formulation of questions and categorization of responses to determine the most appropriate interventions for the client.

Standards, Assessments & Opting Out, Spring 2015

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Advance Illinois, 2015

2015-01-01

In the spring, Illinois students will take new state assessments that reflect the rigor and relevance of the new Illinois Learning Standards. But some classmates will sit out and join the pushback against standardized testing. Opt-out advocates raise concerns about over-testing, and the resulting toll on students as well as the impact on classroom…

Assessment of Measurement Tools of Observation Rate of Nursing Handover Standards in Clinical Wards of Hospital

Directory of Open Access Journals (Sweden)

Saadi Amini

2015-08-01

Full Text Available Background and objectives : In health centers, clinical information of patient is transferred among care staffs regularly. One of the common cases in information transferring is during the time of nurses’ handover in hospital which performing it correctly will help schedule patient care, providing safety and facilitating exact transferring of information. The aim of this study is investigating validity and reliability of assessment of observance rate of shift handover in clinical wards checklist. Material and Methods : In order to determine the reliability of checklist, two experts panel meetings were held with the presence of 10 experts in clinical field that in those meetings the reliability was investigated with discussion and consensus of participants. Checklist validity was investigated through pilot study in 4 wards of 4 hospitals and calculated by Kronbach- alpha method with 28 cases of shifts handover in morning, noon, and night shift. Results : In studying reliability, the primary checklist was divided into two checklists: patient handover, equipments and ward handover that included 27 and 72 items, respectively. The reliability of patient handover checklist was verified with 0.9155 Kronbach-alpha and that of equipments and ward handover was verified with 0.8779 Kronbach-alpha. Conclusion : Verifying checklists by mentioned scientific and statistical methods showed that these are very powerful instruments that can be used as one of the assessment tools of shift handover in clinical wards to be used towards promoting received services by customers of healthcare system.

A quality assessment tool for markup-based clinical guidelines.

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Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

2008-11-06

We introduce a tool for quality assessment of procedural and declarative knowledge. We developed this tool for evaluating the specification of mark-up-based clinical GLs. Using this graphical tool, the expert physician and knowledge engineer collaborate to perform scoring, using pre-defined scoring scale, each of the knowledge roles of the mark-ups, comparing it to a gold standard. The tool enables scoring the mark-ups simultaneously at different sites by different users at different locations.

Performance Standards': Utility for Different Uses of Assessments

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Robert L. Linn

2003-09-01

Full Text Available Performance standards are arguably one of the most controversial topics in educational measurement. There are uses of assessments such as licensure and certification where performance standards are essential. There are many other uses, however, where performance standards have been mandated or become the preferred method of reporting assessment results where the standards are not essential to the use. Distinctions between essential and nonessential uses of performance standards are discussed. It is argued that the insistence on reporting in terms of performance standards in situations where they are not essential has been more harmful than helpful. Variability in the definitions of proficient academic achievement by states for purposes of the No Child Left Behind Act of 2001 is discussed and it is argued that the variability is so great that characterizing achievement is meaningless. Illustrations of the great uncertainty in standards are provided.

"Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

Science.gov (United States)

Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

2016-01-01

The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

Assessing Medical Students' Awareness of and Sensitivity to Diverse Health Beliefs Using a Standardized Patient Station.

Science.gov (United States)

Robins, Lynne S.; White, Casey B.; Alexander, Gwen L.; Gruppen, Larry D.; Grum, Cyril M.

2001-01-01

Assessed students' competence in addressing the health beliefs and cultural concerns of a standardized patient, an African American woman with diabetes, during a clinical interview. Found that minority students displayed greater competence in addressing the patient's concerns about altering culturally-based dietary behaviors; white students…

Assessment of clinical residents' needs for ten educational subjects

Directory of Open Access Journals (Sweden)

Mansour Razavi

2002-04-01

Full Text Available Background Fulfilling the learners' "real needs" will improve medical education. There are subjects that are necessary for any clinical residents not considering their field of specialty. Among the subjects ten seems to be the most important: research methodology and data analysis, computer-based programs, medical recording, cardiopulmonary and cerebral resuscitation, clinical teaching programs, communication skills, clinical ethics, laboratory examinations, reporting special diseases and death certification, and prescription. Purpose This cross-sectional study assessed educational needs of clinical residents for ten educational subjects. Methods A questionnaire prepared by board faculty members consisted of 10 close-ended questions, and one open­ ended question was distributed among 1307 residents from 22 clinical disciplines, who registered for preboard or promotion exam in June 2000. Results Among the subjects three were the most needed: computer-based programs 149 (60%, data collecting system 606 (49%, and clinical ethics 643 (46%. The prescription standard was the least required 177(13%. Conclusion Complementary training courses on these subjects can be an answer to the clinical residents needs. Keywords : research methodology, computer in medicine, cpr, clinical teaching methods, communication in medicine, medical ethics, laboratory ordering, disease coding system, death certificate, prescription writing

Impact assessment of commodity standards

NARCIS (Netherlands)

Ruben, Ruerd

2017-01-01

Voluntary commodity standards are widely used to enhance the performance of tropical agro-food chains and to support the welfare and sustainability of smallholder farmers. Different methods and approaches are used to assess the effectiveness and impact of these certification schemes at

Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

Science.gov (United States)

Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

2011-01-01

Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada. Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the

The accountability of clinical education: its definition and assessment.

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Murray, E; Gruppen, L; Catton, P; Hays, R; Woolliscroft, J O

2000-10-01

Medical education is not exempt from increasing societal expectations of accountability. Competition for financial resources requires medical educators to demonstrate cost-effective educational practice; health care practitioners, the products of medical education programmes, must meet increasing standards of professionalism; the culture of evidence-based medicine demands an evaluation of the effect educational programmes have on health care and service delivery. Educators cannot demonstrate that graduates possess the required attributes, or that their programmes have the desired impact on health care without appropriate assessment tools and measures of outcome. To determine to what extent currently available assessment approaches can measure potentially relevant medical education outcomes addressing practitioner performance, health care delivery and population health, in order to highlight areas in need of research and development. Illustrative publications about desirable professional behaviour were synthesized to obtain examples of required competencies and health outcomes. A MEDLINE search for available assessment tools and measures of health outcome was performed. There are extensive tools for assessing clinical skills and knowledge. Some work has been done on the use of professional judgement for assessing professional behaviours; scholarship; and multiprofessional team working; but much more is needed. Very little literature exists on assessing group attributes of professionals, such as clinical governance, evidence-based practice and workforce allocation, and even less on examining individual patient or population health indices. The challenge facing medical educators is to develop new tools, many of which will rely on professional judgement, for assessing these broader competencies and outcomes.

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

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Carmel Jacobs

Full Text Available Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

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Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2013-01-01

Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

Objective Structured Clinical Examinations (OSCEs, psychiatry and the Clinical assessment of Skills and Competencies (CASCSame Evidence, Different Judgement

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Marwaha Steven

2011-05-01

Full Text Available Abstract Background The Objective Structured Clinical Examination (OSCE, originally developed in the 1970's, has been hailed as the "gold standard" of clinical assessments for medical students and is used within medical schools throughout the world. The Clinical assessment of Skills and Competencies (CASC is an OSCE used as a clinical examination gateway, granting access to becoming a senior Psychiatrist in the UK. Discussion Van der Vleuten's utility model is used to examine the CASC from the viewpoint of a senior psychiatrist. Reliability may be equivalent to more traditional examinations. Whilst the CASC is likely to have content validity, other forms of validity are untested and authenticity is poor. Educational impact has the potential to change facets of psychiatric professionalism and influence future patient care. There are doubts about acceptability from candidates and more senior psychiatrists. Summary Whilst OSCEs may be the best choice for medical student examinations, their use in post graduate psychiatric examination in the UK is subject to challenge on the grounds of validity, authenticity and educational impact.

International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

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Soares, Christopher

2006-03-01

In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

Objective Structured Clinical Examination as an Assessment Tool for Clinical Skills in Dermatology.

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Saceda-Corralo, D; Fonda-Pascual, P; Moreno-Arrones, Ó M; Alegre-Sánchez, A; Hermosa-Gelbard, Á; Jiménez-Gómez, N; Vañó-Galván, S; Jaén-Olasolo, P

2017-04-01

Objective Structured Clinical Evaluation (OSCE) is an excellent method to evaluate student's abilities, but there are no previous reports implementing it in dermatology. To determine the feasibility of implementation of a dermatology OSCE in the medical school. Five stations with standardized patients and image-based assessment were designed. A specific checklist was elaborated in each station with different items which evaluated one competency and were classified into five groups (medical history, physical examination, technical skills, case management and prevention). A total of 28 students were tested. Twenty-five of them (83.3%) passed the exam globally. Concerning each group of items tested: medical interrogation had a mean score of 71.0; physical examination had a mean score of 63.0; management had a mean score of 58.0; and prevention had a mean score of 58.0 points. The highest results were obtained in interpersonal skills items with 91.8 points. Testing a small sample of voluntary students may hinder generalization of our study. OSCE is an useful tool for assessing clinical skills in dermatology and it is possible to carry it out. Our experience enhances that medical school curriculum needs to establish OSCE as an assessment tool in dermatology. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

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Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Can cognitive assessment really discriminate early stages of Alzheimer's and behavioural variant frontotemporal dementia at initial clinical presentation?

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Reul, Sophia; Lohmann, Hubertus; Wiendl, Heinz; Duning, Thomas; Johnen, Andreas

2017-08-09

Neuropsychological testing is considered crucial for differential diagnosis of Alzheimer's disease (AD) and behavioural variant frontotemporal dementia (bvFTD). In-depth neuropsychological assessment revealed specific dysfunctions in the two dementia syndromes. However, a significant overlap of cognitive impairments exists in early disease stages. We questioned whether a standard neuropsychological assessment at initial clinical presentation can delineate patients with AD versus bvFTD. In a retrospective approach, we evaluated and compared how cognitive profiles assessed at initial clinical presentation predicted the diagnosis of later verified AD (n = 43) and bvFTD (n = 26). Additionally, the neuropsychological standard domains memory, language, visuospatial skills, executive functions, praxis and social cognition were subjected to stepwise discriminant analysis to compare their differential contribution to diagnosis. Regardless of diagnosis, a percentage of patients presented with major deterioration in a wide range of cognitive domains when compared with age-matched normative data. Only few significant differences were detected on the group level: Patients with AD were relatively more impaired in the verbal recall, verbal recognition, figure copy, and surprisingly in the executive subdomains, set shifting and processing speed whereas bvFTD was characterised by more deficits in imitation of face postures. A combination of tests for verbal recall, imitation of limb and face postures, and figure copy showed the greatest discriminatory power. Our results imply that the contribution of a standard neuropsychological assessment is limited for differential diagnosis of AD and bvFTD at initial presentation. In contrast to current clinical guidelines, executive functions are neither particularly nor exclusively impaired in patients with bvFTD when assessed within a standard clinical neuropsychological test battery. The significant overlap of bvFTD and AD

Enhancing translation: guidelines for standard pre-clinical experiments in mdx mice.

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Willmann, Raffaella; De Luca, Annamaria; Benatar, Michael; Grounds, Miranda; Dubach, Judith; Raymackers, Jean-Marc; Nagaraju, Kanneboyina

2012-01-01

Duchenne Muscular Dystrophy is an X-linked disorder that affects boys and leads to muscle wasting and death due to cardiac involvement and respiratory complications. The cause is the absence of dystrophin, a large structural protein indispensable for muscle cell function and viability. The mdx mouse has become the standard animal model for pre-clinical evaluation of potential therapeutic treatments. Recent years have seen a rapid increase in the number of experimental compounds being evaluated in the mdx mouse. There is, however, much variability in the design of these pre-clinical experimental studies. This has made it difficult to interpret and compare published data from different laboratories and to evaluate the potential of a treatment for application to patients. The authors therefore propose the introduction of a standard study design for the mdx mouse model. Several aspects, including animal care, sampling times and choice of tissues, as well as recommended endpoints and methodologies are addressed and, for each aspect, a standard procedure is proposed. Testing of all new molecules/drugs using a widely accepted and agreed upon standard experimental protocol would greatly improve the power of pre-clinical experimentations and help identifying promising therapies for the translation into clinical trials for boys with Duchenne Muscular Dystrophy. Copyright © 2011 Elsevier B.V. All rights reserved.

Contribution of diagnostic tests for the etiological assessment of uveitis, data from the ULISSE study (Uveitis: Clinical and medicoeconomic evaluation of a standardized strategy of the etiological diagnosis).

Science.gov (United States)

Grumet, Pierre; Kodjikian, Laurent; de Parisot, Audrey; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Labetoulle, Marc; Broussolle, Christiane; Jamilloux, Yvan; Decullier, Evelyne; Sève, Pascal

2018-04-01

ULISSE is the only study that prospectively assessed the efficiency of a standardized strategy, compared to an open strategy for the etiologic diagnosis of uveitis. Our aim was to evaluate the diagnostic yield of the tests prescribed in the ULISSE study to clarify their relevance. ULISSE is a non-inferiority, prospective, multicenter and cluster randomized study. The standardized strategy is a two-steps strategy: in the first step, common standard tests were performed, and in the second step, tests were guided by the clinical and anatomic type of uveitis. We reported the relevance of the diagnostic tests used in the standardized strategy, as well as the profitability of the tests that were prescribed to more than twenty patients in each group. Based on diagnostic criteria, either an ophthalmologist, or an internist, established the profitability of a test by considering whether the test lead to a diagnosis or not. Among the 676 patients included (standardized 303; open 373), a diagnosis was made for 152 (50.4%) in the standardized group and 203 (54.4%) in the open group. The most common entities were HLA-B27 associated uveitis (22%), spondyloarthritis (11%), sarcoidosis (18%), tuberculosis (10.7%) and herpes virus infections (8.5%). Among the first step's systematic tests, tuberculin skin test was the most contributive investigation (17.1%), followed by chest X-ray (8.4%), C reactive protein and ESR (6.6% and 5.1%), complete blood count (2.2%) and VDRL (2.0%). The second step's most often contributive tests were: HLA B27 (56.3%), chest-CT (30.3%) and angiotensin converting enzyme (ACE) (16.5%). HLA B27 and ACE were significantly more contributive in the standardized group than in the open group. Immunological tests were never contributive. Among the free investigations, or among the investigations guided by clinical or paraclinical findings, the most often contributive tests were: Quantiferon® (24%), electrophoresis of serum protein (7.8%) and sacroiliac imagery

Integrating Interactive Web-Based Technology to Assess Adherence and Clinical Outcomes in Pediatric Sickle Cell Disease

Directory of Open Access Journals (Sweden)

Lori E. Crosby

2012-01-01

Full Text Available Research indicates that the quality of the adherence assessment is one of the best predictors for improving clinical outcomes. Newer technologies represent an opportunity for developing high quality standardized assessments to assess clinical outcomes such as patient experience of care but have not been tested systematically in pediatric sickle cell disease (SCD. The goal of the current study was to pilot an interactive web-based tool, the Take-Charge Program, to assess adherence to clinic visits and hydroxyurea (HU, barriers to adherence, solutions to overcome these barriers, and clinical outcomes in 43 patients with SCD age 6–21 years. Results indicate that the web-based tool was successfully integrated into the clinical setting while maintaining high patient satisfaction (>90%. The tool provided data consistent with the medical record, staff report, and/or clinical lab data. Participants reported that forgetting and transportation were major barriers for adherence to both clinic attendance and HU. A greater number of self-reported barriers (P<.01 and older age (P<.05 were associated with poorer clinic attendance and HU adherence. In summary, the tool represents an innovative approach to integrate newer technology to assess adherence and clinical outcomes for pediatric patients with SCD.

Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.

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Bamford, K B; Wood, S; Shaw, R J

2005-02-01

Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.

A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

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Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

2013-10-01

Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

Validation of assessment of intraoral digital photography for evaluation of dental restorations in clinical research.

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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.

Standard requirements for GCP-compliant data management in multinational clinical trials

LENUS (Irish Health Repository)

Ohmann, Christian

2011-03-22

Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit

STANDARDIZING QUALITY ASSESSMENT OF FUSED REMOTELY SENSED IMAGES

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C. Pohl

2017-09-01

Full Text Available The multitude of available operational remote sensing satellites led to the development of many image fusion techniques to provide high spatial, spectral and temporal resolution images. The comparison of different techniques is necessary to obtain an optimized image for the different applications of remote sensing. There are two approaches in assessing image quality: 1. Quantitatively by visual interpretation and 2. Quantitatively using image quality indices. However an objective comparison is difficult due to the fact that a visual assessment is always subject and a quantitative assessment is done by different criteria. Depending on the criteria and indices the result varies. Therefore it is necessary to standardize both processes (qualitative and quantitative assessment in order to allow an objective image fusion quality evaluation. Various studies have been conducted at the University of Osnabrueck (UOS to establish a standardized process to objectively compare fused image quality. First established image fusion quality assessment protocols, i.e. Quality with No Reference (QNR and Khan's protocol, were compared on varies fusion experiments. Second the process of visual quality assessment was structured and standardized with the aim to provide an evaluation protocol. This manuscript reports on the results of the comparison and provides recommendations for future research.

Standardizing Quality Assessment of Fused Remotely Sensed Images

Science.gov (United States)

Pohl, C.; Moellmann, J.; Fries, K.

2017-09-01

The multitude of available operational remote sensing satellites led to the development of many image fusion techniques to provide high spatial, spectral and temporal resolution images. The comparison of different techniques is necessary to obtain an optimized image for the different applications of remote sensing. There are two approaches in assessing image quality: 1. Quantitatively by visual interpretation and 2. Quantitatively using image quality indices. However an objective comparison is difficult due to the fact that a visual assessment is always subject and a quantitative assessment is done by different criteria. Depending on the criteria and indices the result varies. Therefore it is necessary to standardize both processes (qualitative and quantitative assessment) in order to allow an objective image fusion quality evaluation. Various studies have been conducted at the University of Osnabrueck (UOS) to establish a standardized process to objectively compare fused image quality. First established image fusion quality assessment protocols, i.e. Quality with No Reference (QNR) and Khan's protocol, were compared on varies fusion experiments. Second the process of visual quality assessment was structured and standardized with the aim to provide an evaluation protocol. This manuscript reports on the results of the comparison and provides recommendations for future research.

The need for international standardization in clinical beta dosimetry for brachytherapy

International Nuclear Information System (INIS)

Quast, U.; Boehm, J.; Kaulich, T.W.

2002-01-01

Beta radiation has found increasing interest in radiotherapy. Besides the curative treatment of small and medium-sized intraocular tumors by means of ophthalmic beta radiation plaques, intravascular brachytherapy has proven to successfully overcome the severe problem of restenosis after interventional treatment of arterial stenosis in coronaries and peripheral vessels in many clinical trials with a large number of patients. Prior to initiating procedures applying beta radiation in radiotherapy, however, there is a common need to specify methods for the determination and specification of the absorbed dose to water or tissue and their spatial distributions. The IAEA-TECDOC-1274 Calibration of photon and beta ray sources used in brachytherapy (2002) is a help for photon brachytherapy calibration. But, for beta seed and line sources, IAEA recommends well type ionization chambers as working standards which are far from measuring absorbed dose to water of the radiation clinically used. Although the application of such working standards seems to be more precise, large errors can occur when the medical physicist has to convert the calibration data to absorbed dose to water of the beta radiation emitted. The user must believe that the source is equally activated and that the manufacturer did not change the design and construction of the source encapsulation. With the DGMP Report 16 (2001) Guidelines for medical physical aspects of intravascular brachytherapy a very detailed code of practice is given, especially for the calibration and clinical dosimetry of intravascular beta radiation sources. As there is a global need for standardization in clinical dosimetry for intravascular brachytherapy utilizing beta radiation, the DIN-NAR, the German committee on standardization in radiology, task group dosimetry, has initiated an international adhoc working group for a new ISO work item proposal on the standardization of procedures in clinical dosimetry to guarantee reliable

Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

Science.gov (United States)

Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

2013-05-07

Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

Clinical and radiological instability following standard fenestration discectomy

Directory of Open Access Journals (Sweden)

Mascarenhas Amrithlal

2009-01-01

Full Text Available Background: Post-surgical lumbar instability is an established complication but there is limited evidence in the literature regarding the incidence of lumbar instability following fenestration and discectomy. We analyzed our results following fenestration discectomy with a special focus on instability. Materials and Methods: Eighty-three patients between the age of 17 and 52 years who had undergone fenestration discectomy for a single-level lumbar intervertebral disc prolapse were followed-up for a period of 1-5 years. The criteria for instability included "instability catch,", "painful catch," and "apprehension." The working capacity of the patient and the outcome score of the surgery were assessed by means of the Oswestry disability score and the Prolo economic and functional outcome score. Flexion-extension lateral radiographs were taken and analyzed for abnormal tilt and translation. Results: Of the 83 patients included, 70 were men and 13 were women, with an average age of 37.35 years (17-52 years at 5 years follow-up. Clinical instability was seen in 10 (12.04% patients. Radiological instability was noted in 29 (34.9% patients. Only six (60% of the 10 patients who demonstrated clinical instability had radiological evidence of instability. Twenty (68.96% patients with radiological instability were asymptomatic. Three (10.34% patients with only radiological instability had unsatisfactory outcome. The Oswestry scoring showed an average score of 19.8%. Mild disability was noted in 59 (71.08% patients and moderate disability was seen in 24 (28.91% patients. None of the patients had severe disability. These outcomes were compared with the outcomes in other studies in the literature for microdiscectomy and the results were found to be comparable. Conclusion: The favorable outcome of this study is in good agreement with other studies on microdiscectomy. Clinical instability in 12.04% of the patients is in agreement with other studies. Radiological

Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder

DEFF Research Database (Denmark)

Kessing, Lars Vedel; Hansen, Hanne Vibe; Hvenegaard, Anne

2013-01-01

BACKGROUND: Little is known about whether treatment in a specialised out-patient mood disorder clinic improves long-term prognosis for patients discharged from initial psychiatric hospital admissions for bipolar disorder. AIMS: To assess the effect of treatment in a specialised out-patient mood...... disorder clinic v. standard decentralised psychiatric treatment among patients discharged from one of their first three psychiatric hospital admissions for bipolar disorder. METHOD: Patients discharged from their first, second or third hospital admission with a single manic episode or bipolar disorder were...... randomised to treatment in a specialised out-patient mood disorder clinic or standard care (ClinicalTrials.gov: NCT00253071). The primary outcome measure was readmission to hospital, which was obtained from the Danish Psychiatric Central Register. RESULTS: A total of 158 patients with mania/bipolar disorder...

The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

Science.gov (United States)

Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

2017-06-20

Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

Standardized computer-based organized reporting of EEG

DEFF Research Database (Denmark)

Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C.

2017-01-01

Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted in the se......Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted...... in the second, revised version of SCORE (Standardized Computer-based Organized Reporting of EEG), which is presented in this paper. The revised terminology was implemented in a software package (SCORE EEG), which was tested in clinical practice on 12,160 EEG recordings. Standardized terms implemented in SCORE...... are used to report the features of clinical relevance, extracted while assessing the EEGs. Selection of the terms is context sensitive: initial choices determine the subsequently presented sets of additional choices. This process automatically generates a report and feeds these features into a database...

Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

DEFF Research Database (Denmark)

Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

2013-01-01

Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard

International Nuclear Information System (INIS)

Gwak, Yeon Joo; Kim, Hye Jung; Kwak, Jin Young; Son, Eun Ju; Ko, Kyung Hee; Lee, Jin Hwa; Lim, Hyo Soon; Lee, You Jin; Park, Ji Won; Shin, Kyung Min; Jang, Yun-Jin

2013-01-01

The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea

Developing an Evaluation Tool for Assessing Clinical Ethics Consultation Skills in Simulation Based Education: The ACES Project.

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Wasson, Katherine; Parsi, Kayhan; McCarthy, Michael; Siddall, Viva Jo; Kuczewski, Mark

2016-06-01

The American Society for Bioethics and Humanities has created a quality attestation (QA) process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing Clinical Ethics Skills (ACES) tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described.

Mock Pages Are a Valid Construct for Assessment of Clinical Decision Making and Interprofessional Communication.

Science.gov (United States)

Boehler, Margaret L; Schwind, Cathy J; Markwell, Stephen J; Minter, Rebecca M

2017-01-01

Answering pages from nurses about patients in need of immediate attention is one of the most difficult challenges a resident faces during their first days as a physician. A Mock Page program has been developed and adopted into a national surgical resident preparatory curriculum to prepare senior medical students for this important skill. The purpose of this study is to assess standardized mock page cases as a valid construct to assess clinical decision making and interprofessional communication skills. Mock page cases (n = 16) were administered to 213 senior medical students from 12 medical schools participating in a national surgical resident preparatory curriculum in 2013 and 2014. Clinical decision making and interprofessional communication were measured by case-specific assessments evaluating these skills which have undergone rigorous standard-setting to determine pass/fail cut points. Students' performance improved in general for both communication and clinical decision making over the 4-week course. Cases have been identified that seem to be best suited for differentiating high- from low-performing students. Chest pain, pulmonary embolus, and mental status change cases posed the greatest difficulty for student learners. Simulated mock pages demonstrate an innovative technique for training students in both effective interprofessional communication and management of common postoperative conditions they will encounter as new surgical interns.

A Standardized Narrative Profile Approach to Self-Reflection and Assessment of Cross-Cultural Communication

Directory of Open Access Journals (Sweden)

Kyle J Wilby

2017-03-01

Full Text Available Objectives: 1 to explore clinical assessor’s values regarding behaviours related to cultural aspects of care, 2 to generate standardized narrative profiles regarding cultural behavioural outcomes within clinical teaching settings, and 3 to rank order standardized narrative profiles according to performance expectations. Methods: Ten interviews were completed with clinicians to determine values and performance expectations for culturally competent behaviours. Transcripts were produced and coded. Six narrative profiles were developed based on data obtained. Twenty clinicians categorized profiles according to performance expectations and rank ordered. Intraclass correlation coefficients (ICCs determined inter-rater reliability. Clinicians rated usability of profiles in clinical training settings. Results: Eighteen categories were coded with communication, awareness and ability most frequently reported with each ranging from 9.6-11.5% of the utterances. Consensus for categorization of all profiles was achieved at a level of 70% (ICC = 0.837, 95% CI 0.654-0.969. High inter-rater reliability was achieved for rank ordering (ICC = 0.815, 95% CI 0.561 to 0.984. Seventeen (85% clinicians agreed that the profiles would be usable in clinical training settings. Conclusions: Standardized narrative profiles may aid assessment and self-reflection for student performance within culturally diverse interactions. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

Alignment between South African mathematics assessment standards and the TIMSS assessment frameworks

Directory of Open Access Journals (Sweden)

Mdutshekelwa Ndlovu

2012-12-01

Full Text Available South Africa’s performance in international benchmark tests is a major cause for concern amongst educators and policymakers, raising questions about the effectiveness of the curriculum reform efforts of the democratic era. The purpose of the study reported in this article was to investigate the degree of alignment between the TIMSS 2003 Grade 8 Mathematics assessment frameworks and the Revised National Curriculum Statements (RNCS assessment standards for Grade 8 Mathematics, later revised to become the Curriculum and Assessment Policy Statements (CAPS. Such an investigation could help to partly shed light on why South African learners do not perform well and point out discrepancies that need to be attended to. The methodology of document analysis was adopted for the study, with the RNCS and the TIMSS 2003 Grade 8 Mathematics frameworks forming the principal documents. Porter’s moderately complex index of alignment was adopted for its simplicity. The computed index of 0.751 for the alignment between the RNCS assessment standards and the TIMSS assessment objectives was found to be significantly statistically low, at the alpha level of 0.05, according to Fulmer’s critical values for 20 cells and 90 or 120 standard points. The study suggests that inadequate attention has been paid to the alignment of the South African mathematics curriculum to the successive TIMSS assessment frameworks in terms of the cognitive level descriptions. The study recommends that participation in TIMSS should rigorously and critically inform ongoing curriculum reform efforts.

Assessment of Sexual Desire for Clinical Trials of Women With Hypoactive Sexual Desire Disorder: Measures, Desire-Related Behavior, and Assessment of Clinical Significance.

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Pyke, Robert E; Clayton, Anita H

2018-01-19

The Female Sexual Function Index-desire subscale is the standard measure for clinical trials of hypoactive sexual desire disorder (HSDD), but lacks items assessing sexually related behaviors and attitudes toward partner. Counting satisfying sexual events is criticized, but sexual behavior remains important. Mean treatment differences cannot define clinical significance; responder and remitter analyses help. We reviewed measures on sexual desire and sexual behavior relevant to HSDD, and how to assess clinical significance. We conducted a literature review of measures of sexual desire comparing expert-proposed criteria for dysfunctional desire, expert-developed scales, and scales from patient input. Commonly recognized symptoms of HSDD were identified. Results of HSDD trials and scale validation studies were evaluated to extract responder and remitter values. The utility of distribution-based measures of responders and remitters was assessed. Symptom relevance was evaluated as the proportion of symptom sets that included the item; responder and remitter cut points were determined by distribution-based methods. 12 Validated rating scales, 5 scales primarily derived from expert recommendations and 7 scales initially from patient input, and 5 sets of diagnostic criteria for conditions like HSDD were compared. Content varied highly between scales despite compliance with U.S. Food and Drug Administration recommendations for patient-reported outcomes. This disunity favors an expert-recommended scale such as the Elements of Desire Questionnaire with each of the common items, plus a measure of frequency of sexual activity, eg, item in the Patient Reported Outcomes Measurement Information System. Registrational drug trials, but not psychological treatment trials, usually give responder/remitter analyses, using dichotomized global impressions or anchor-based definitions. Distribution-based methods are more uniformly applicable to define responder and remitter status. The

WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

Energy Technology Data Exchange (ETDEWEB)

Gabriel, P. [University of Pennsylvania (United States)

2015-06-15

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.

WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

International Nuclear Information System (INIS)

Gabriel, P.

2015-01-01

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented

“Heidelberg standard examination” and “Heidelberg standard procedures” – Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education

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Nikendei, C.; Ganschow, P.; Groener, J. B.; Huwendiek, S.; Köchel, A.; Köhl-Hackert, N.; Pjontek, R.; Rodrian, J.; Scheibe, F.; Stadler, A.-K.; Steiner, T.; Stiepak, J.; Tabatabai, J.; Utz, A.; Kadmon, M.

2016-01-01

The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects “Heidelberg standard examination” and “Heidelberg standard procedures”, which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties. PMID:27579354

Brain imaging with synthetic MR in children: clinical quality assessment

Energy Technology Data Exchange (ETDEWEB)

Betts, Aaron M.; Serai, Suraj [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Leach, James L.; Jones, Blaise V. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); University of Cincinnati College of Medicine, Cincinnati, OH (United States); Zhang, Bin [Cincinnati Children' s Hospital Medical Center, Biostatistics and Epidemiology, Cincinnati, OH (United States)

2016-10-15

Synthetic magnetic resonance imaging is a quantitative imaging technique that measures inherent T1-relaxation, T2-relaxation, and proton density. These inherent tissue properties allow synthesis of various imaging sequences from a single acquisition. Clinical use of synthetic MR imaging has been described in adult populations. However, use of synthetic MR imaging has not been previously reported in children. The purpose of this study is to report our assessment of diagnostic image quality using synthetic MR imaging in children. Synthetic MR acquisition was obtained in a sample of children undergoing brain MR imaging. Image quality assessments were performed on conventional and synthetic T1-weighted, T2-weighted, and FLAIR images. Standardized linear measurements were performed on conventional and synthetic T2 images. Estimates of patient age based upon myelination patterns were also performed. Conventional and synthetic MR images were evaluated on 30 children. Using a 4-point assessment scale, conventional imaging performed better than synthetic imaging for T1-weighted, T2-weighted, and FLAIR images. When the assessment was simplified to a dichotomized scale, the conventional and synthetic T1-weighted and T2-weighted images performed similarly. However, the superiority of conventional FLAIR images persisted in the dichotomized assessment. There were no statistically significant differences between linear measurements made on T2-weighted images. Estimates of patient age based upon pattern of myelination were also similar between conventional and synthetic techniques. Synthetic MR imaging may be acceptable for clinical use in children. However, users should be aware of current limitations that could impact clinical utility in the software version used in this study. (orig.)

Making Use of the New Student Assessment Standards To Enhance Technological Literacy.

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Russell, Jill

2003-01-01

Describes the student assessment standards outlined in "Advancing Excellence in Technological Literacy: Student Assessment, Professional Development, and Program Standards," a companion to the "Standards for Technological Literacy." Discusses how the standards apply to everyday teaching practices. (JOW)

Certifying a university ENT clinic using the ISO 9001:2000 international standard.

Science.gov (United States)

Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika

2010-01-01

Against statutory duties to introduce quality management systems, the increased importance of this subject has led to numerous activities in various public health institutions. Following the International Standardization Organization (ISO 9001:2000) prerequisites, Frankfurt Goethe University Hospital ENT clinic staff introduced a quality management system. This paper aims to investigate this process. Designing, planning and implementing the quality management system is described. Under the supervision of an executive quality management board, clinic quality goals were defined. Thereafter, several quality management teams performed an actual state analysis as well as developing and realising improvement proposals. Finally a quality management manual containing binding standards and working instructions concerning all patient care, research and teaching aspects was written. Successful certification by a neutral body ascertained that the clinic's quality management system conformed to current national and international standards while restructuring and reform improved procedural efficiency. The paper shows that mplementing the quality management system requires considerable effort but patients as well as staff profit considerably from the innovation. On the whole, the positive impact on structure and workflow in a specialist clinic predominates. Therefore, implementing a quality management system in all the clinic's wards and departments is recommended.

The use of standardized patients in the plastic surgery residency curriculum: teaching core competencies with objective structured clinical examinations.

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Davis, Drew; Lee, Gordon

2011-07-01

As of 2006, the Accreditation Council for Graduate Medical Education had defined six "core competencies" of residency education: interpersonal communication skills, medical knowledge, patient care, professionalism, practice-based learning and improvement, and systems-based practice. Objective structured clinical examinations using standardized patients are becoming effective educational tools, and the authors developed a novel use of the examinations in plastic surgery residency education that assesses all six competencies. Six plastic surgery residents, two each from postgraduate years 4, 5, and 6, participated in the plastic surgery-specific objective structured clinical examination that focused on melanoma. The examination included a 30-minute videotaped encounter with a standardized patient actor and a postencounter written exercise. The residents were scored on their performance in all six core competencies by the standardized patients and faculty experts on a three-point scale (1 = novice, 2 = moderately skilled, and 3 = proficient). Resident performance was averaged for each postgraduate year, stratified according to core competency, and scored from a total of 100 percent. Residents overall scored well in interpersonal communications skills (84 percent), patient care (83 percent), professionalism (86 percent), and practice-based learning (84 percent). Scores in medical knowledge showed a positive correlation with level of training (86 percent). All residents scored comparatively lower in systems-based practice (65 percent). The residents reported unanimously that the objective structured clinical examination was realistic and educational. The objective structured clinical examination provided comprehensive and meaningful feedback and identified areas of strengths and weakness for the residents and for the teaching program. The examination is an effective assessment tool for the core competencies and a valuable adjunct to residency training.

Predicting failing performance on a standardized patient clinical performance examination: the importance of communication and professionalism skills deficits.

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Chang, Anna; Boscardin, Christy; Chou, Calvin L; Loeser, Helen; Hauer, Karen E

2009-10-01

The purpose is to determine which assessment measures identify medical students at risk of failing a clinical performance examination (CPX). Retrospective case-control, multiyear design, contingency table analysis, n = 149. We identified two predictors of CPX failure in patient-physician interaction skills: low clerkship ratings (odds ratio 1.79, P = .008) and student progress review for communication or professionalism concerns (odds ratio 2.64, P = .002). No assessments predicted CPX failure in clinical skills. Performance concerns in communication and professionalism identify students at risk of failing the patient-physician interaction portion of a CPX. This correlation suggests that both faculty and standardized patients can detect noncognitive traits predictive of failing performance. Early identification of these students may allow for development of a structured supplemental curriculum with increased opportunities for practice and feedback. The lack of predictors in the clinical skills portion suggests limited faculty observation or feedback.

Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

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Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

2017-04-18

Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality

Leading the Transition from the Alternate Assessment Based on Modified Achievement Standards to the General Assessment

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Lazarus, Sheryl S.; Rieke, Rebekah

2013-01-01

Schools are facing many changes in the ways that teaching, learning, and assessment take place. Most states are moving from individual state standards to the new Common Core State Standards, which will be fewer, higher, and more rigorous than most current state standards. As the next generation of assessments used for accountability are rolled…

Standards of Ombudsman Assessment: A New Normative Concept?

Directory of Open Access Journals (Sweden)

Milan Remac

2013-07-01

Full Text Available Today, an ombudsman is a traditional component of democratic legal systems. Generally, reports of the ombudsman are not legally binding. Due to this fact, the ombudsman can rely only on his own persuasiveness, on his acceptance by individuals and state institutions, on the understanding of the administration and on the accessibility and transparency of rules that underpin his reports. During investigations, ombudsmen assess whether the administration has acted in accordance with certain legal or extra-legal standards. Depending on the legal system, ombudsmen can investigate whether there is an instance of maladministration in the activities of administrative bodies, whether the administration has acted ‘properly’, whether it has acted in accordance with the law, whether administrative actions have breached the human rights of complainants or whether the actions of the administration were in accordance with anti-corruption rules etc. Regardless of the legislative standard of an ombudsman’s control, the ombudsman should consider and assess the situation described in complaints against certain criteria or against certain normative standards. A distinct set of standards which ombudsmen use during their investigation, or at least a clear statement of their assessment criteria, can increase the transparency of their procedures and the persuasiveness of their reports. Are the normative standards used by different ombudsmen the same? Do they possibly create a new normative concept? And can it possibly lead to a higher acceptance of their reports by the administration?

The Gap Between Clinical Research and Standard of Care: A Review of Frailty Assessment Scales in Perioperative Surgical Settings.

Science.gov (United States)

Stoicea, Nicoleta; Baddigam, Ramya; Wajahn, Jennifer; Sipes, Angela C; Arias-Morales, Carlos E; Gastaldo, Nicholas; Bergese, Sergio D

2016-01-01

The elderly population in the United States is increasing exponentially in tandem with risk for frailty. Frailty is described by a clinically significant state where a patient is at risk for developing complications requiring increased assistance in daily activities. Frailty syndrome studied in geriatric patients is responsible for an increased risk for falls, and increased mortality. In efforts to prepare for and to intervene in perioperative complications and general frailty, a universal scale to measure frailty is necessary. Many methods for determining frailty have been developed, yet there remains a need to define clinical frailty and, therefore, the most effective way to measure it. This article reviews six popular scales for measuring frailty and evaluates their clinical effectiveness demonstrated in previous studies. By identifying the most time-efficient, criteria comprehensive, and clinically effective scale, a universal scale can be implemented into standard of care and reduce complications from frailty in both non-surgical and surgical settings, especially applied to the perioperative surgical home model. We suggest further evaluation of the Edmonton Frailty Scale for inclusion in patient care.

The Gap Between Clinical Research and Standard of Care: A Review of Frailty Assessment Scales in Perioperative Surgical Settings

Directory of Open Access Journals (Sweden)

Nicoleta Stoicea

2016-07-01

Full Text Available The elderly population in the United States is increasing exponentially in tandem with risk for frailty. Frailty is described by a clinically significant state where a patient is at risk for developing complications requiring increased assistance in daily activities. Frailty syndrome studied in geriatric patients is responsible for an increased risk for falls, and increased mortality. In efforts to prepare for and to intervene in perioperative complications and general frailty, a universal scale to measure frailty is necessary. Many methods for determining frailty have been developed, yet there remains a need to define clinical frailty and therefore the most effective way to measure it. This article reviews six popular scales for measuring frailty and evaluates their clinical effectiveness demonstrated in previous studies. By identifying the most time-efficient, criteria comprehensive, and clinically effective scale, a universal scale can be implemented into standard of care and reduce complications from frailty in both non-surgical and surgical settings, especially applied to the perioperative surgical home model. We suggest further evaluation of the Edmonton Frailty Scale for inclusion in patient care.

Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.

Science.gov (United States)

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

2014-12-01

An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver

Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

Science.gov (United States)

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-01-01

Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

Science.gov (United States)

Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

2014-07-01

Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

24 CFR 115.206 - Performance assessments; Performance standards.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Performance assessments; Performance standards. 115.206 Section 115.206 Housing and Urban Development Regulations Relating to Housing... AGENCIES Certification of Substantially Equivalent Agencies § 115.206 Performance assessments; Performance...

Balance Assessment Practices and Use of Standardized Balance Measures Among Ontario Physical Therapists

Science.gov (United States)

Sibley, Kathryn M.; Straus, Sharon E.; Inness, Elizabeth L.; Salbach, Nancy M.

2011-01-01

Background Balance impairment is a significant problem for older adults, as it can influence daily functioning. Treating balance impairment in this population is a major focus of physical therapist practice. Objective The purpose of this study was to document current practices in clinical balance assessment and compare components of balance assessed and measures used across practice areas among physical therapists. Design This was a cross-sectional study. Methods A survey questionnaire was mailed to 1,000 practicing physical therapists in Ontario, Canada. Results Three hundred sixty-nine individuals completed the survey questionnaire. More than 80% of respondents reported that they regularly (more than 60% of the time) assessed postural alignment, static and dynamic stability, functional balance, and underlying motor systems. Underlying sensory systems, cognitive contributions to balance, and reactive control were regularly assessed by 59.6%, 55.0%, and 41.2% of the respondents, respectively. The standardized measures regularly used by the most respondents were the single-leg stance test (79.1%), the Berg Balance Scale (45.0%), and the Timed “Up & Go” Test (27.6%). There was considerable variation in the components of balance assessed and measures used by respondents treating individuals in the orthopedic, neurologic, geriatric, and general rehabilitation populations. Limitations The survey provides quantitative data about what is done to assess balance, but does not explain the factors influencing current practice. Conclusions Many important components of balance and standardized measures are regularly used by physical therapists to assess balance. Further research, however, is needed to understand the factors contributing to the relatively lower rates of assessing reactive control, the component of balance most directly responsible for avoiding a fall. PMID:21868613

What influences assessors' internalised standards?

International Nuclear Information System (INIS)

Poole, C.; Boland, J.

2016-01-01

Purpose: The meaning assessors attach to assessment criteria during clinical placement is under-researched. While personal beliefs, values or expectations may influence judgements, there is scant evidence of how this manifests in a clinical attachment setting. This research explored the concept and source of internalised standards and how these may influence judgements. Methods: This study, within the constructivist paradigm, was informed by the principles of grounded theory. Seven radiation therapists, purposefully selected, were interviewed face-to-face using semi-structured interviews. The sample size allowed for the gathering of sufficient data for in-depth thematic analysis, using the functionality of CAQDAS (NVivo 9). Results: Radiation therapists' judgements when assessing students were influenced by their previous experience. They had different expectations of the appropriate standard for each criterion on students' assessment forms – relating to technical ability, clinical knowledge and attitude. They had their own set of values, or expectations which informed ‘internalised standards’ which influenced their judgements about student performance. Prior experience – as students and as qualified professionals – influenced these decisions. Conclusion: Assessment of students' performance may differ depending on the clinician conducting the assessment. Even where assessors are given the same criteria and training, this does not ensure reliability, as judgements are influenced by their internalised standards. This has implications for the design of more appropriate assessor training which recognises and addresses this phenomenon. These results will be of interest to radiation therapists, radiographers, medical educators, allied health professionals and any academic or professional body with responsibility for ensuring that we qualify competent practitioners. - Highlights: • Reliability of clinical assessment is of the upmost importance

Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

International Nuclear Information System (INIS)

Kun, Larry E.

1996-01-01

Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. Tumor type and clinical course are often correlated with age at presentation and anatomic site. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon age at presentation, tumor type, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of 'standard' radiation therapy and evolving chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of precision radiation techniques. Modifications in radiation delivery are fundamental to current investigations in medulloblastoma; the rationale for contemporary and projected

Do Simulation-Based Skill Exercises and Post-Encounter Notes Add Additional Value to a Standardized Patient-Based Clinical Skills Examination?

Directory of Open Access Journals (Sweden)

Michael D. Prislin

2011-01-01

Full Text Available Background. Standardized patient (SP clinical assessments have limited utility in assessing higher-level clinical competencies. This study explores the value of including simulation exercises and postencounter notes in an SP clinical skills examination. Methods. Two exercises involving cardiac auscultation and ophthalmic funduscopy simulations along with written post encounter notes were added to an SP-based performance examination. Descriptive analyses of students' performance and correlations with SP-based performance measures were obtained. Results. Students' abilities to detect abnormalities on physical exam were highly variable. There were no correlations between SP-based and simulation-derived measures of physical examination competency. Limited correlations were found between students' abilities to perform and document physical examinations and their formulation of appropriate differential diagnoses. Conclusions. Clinical simulation exercises add depth to SP-based assessments of performance. Evaluating the content of post encounter notes offers some insight into students' integrative abilities, and this appears to be improved by the addition of simulation-based post encounter skill exercises. However, further refinement of this methodology is needed.

A comparative analysis of quality management standards for contract research organisations in clinical trials.

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Murray, Elizabeth; McAdam, Rodney

2007-01-01

This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

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

Science.gov (United States)

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.

7 CFR 319.40-11 - Plant pest risk assessment standards.

Science.gov (United States)

2010-01-01

... analysis to determine the plant pest risks associated with each requested importation in order to determine... 7 Agriculture 5 2010-01-01 2010-01-01 false Plant pest risk assessment standards. 319.40-11... Unmanufactured Wood Articles § 319.40-11 Plant pest risk assessment standards. When evaluating a request to...

Clinical assessment of hip strength using a hand-held dynamometer is reliable

DEFF Research Database (Denmark)

Thorborg, K; Petersen, J; Magnusson, S P

2010-01-01

rotation (ER), internal rotation (IR), flexion (FLEX) and extension (EXT) using a hand-held dynamometer. Nine subjects (five males, four females), physically active for at least 2.5 h a week, were included. Twelve standardized isometric strength tests were performed twice with a 1-week interval in between......Hip strength assessment plays an important role in the clinical examination of the hip and groin region. The primary aim of this study was to examine the absolute test-retest measurement variation concerning standardized strength assessments of hip abduction (ABD), adduction (ADD), external...... by the same examiner. The test order was randomized to avoid systematic bias. Measurement variation between sessions was 3-12%. When the maximum value of four measurements was used, test-retest measurement variation was below 10% in 11 of the 12 individual hip strength tests and below 5% in five of the 12...

Assessment of Safety Standards for Automotive Electronic Control Systems

Science.gov (United States)

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Evaluation of dental restorations: a comparative study between clinical and digital photographic assessments.

Science.gov (United States)

Moncada, G; Silva, F; Angel, P; Oliveira, O B; Fresno, M C; Cisternas, P; Fernandez, E; Estay, J; Martin, J

2014-01-01

The aim of this study was to compare the efficacy of a direct clinical evaluation method with an indirect digital photographic method in assessing the quality of dental restorations. Seven parameters (color, occlusal marginal adaptation, anatomy form, roughness, occlusal marginal stain, luster, and secondary caries) were assessed in 89 Class I and Class II restorations from 36 adults using the modified US Public Health Service/Ryge criteria. Standardized photographs of the same restorations were digitally processed by Adobe Photoshop software, separated into the following four groups and assessed by two calibrated examiners: Group A: The original photograph displayed at 100%, without modifications (IMG100); Group B: Formed by images enlarged at 150% (IMG150); Group C: Formed by digital photographs displayed at 100% (mIMG100), with digital modifications (levels adjustment, shadow and highlight correction, color balance, unsharp Mask); and Group D: Formed by enlarged photographs displayed at 150% with modifications (mIMG150), with the same adjustments made to Group C. Photographs were assessed on a calibrated screen (Macbook) by two calibrated clinicians, and the results were statistically analyzed using Wilcoxon tests (SSPS 11.5) at 95% CI. The photographic method produced higher reliability levels than the direct clinical method in all parameters. The evaluation of digital images is more consistent with clinical assessment when restorations present some moderate defect (Bravo) and less consistent when restorations are clinically classified as either satisfactory (Alpha) or in cases of severe defects (Charlie). The digital photographic method is a useful tool for assessing the quality of dental restorations, providing information that goes unnoticed with the visual-tactile clinical examination method. Additionally, when analyzing restorations using the Ryge modified criteria, the digital photographic method reveals a significant increase of defects compared to those

Assessment and clinical factors associated with pain in patients undergoing transrectal prostate biopsy.

Science.gov (United States)

Gómez-Gómez, E; Ramírez, M; Gómez-Ferrer, A; Rubio-Briones, J; Iborra, I; J Carrasco-Valiente; Campos, J P; Ruiz-García, J; Requena-Tapia, M J; Solsona, E

2015-09-01

To quantify the degree of pain experienced by patients who undergo ultrasound-guided transrectal prostate biopsy in standard clinical practice and assess the clinical factors associated with increased pain. Analysis of a multicenter series of patients with prostate biopsy according to standard clinical practice. The biopsy was performed transrectally with a protocol of local anesthesia on the posterolateral nerve bundle. The pain was assessed at 20minutes into the procedure using the visual analog scale (0-10). The degree of pain was analyzed, and the association was studied using a univariate/multivariate analysis of selected clinical variables and the degree of pain. A total of 1188 patients with a median age of 64 years were analyzed. Thirty percent of the biopsies were diagnosed with a tumor. The median pain score was 2, with 65% of the patients reporting a pain score ≤2. The multivariate analysis showed that the prostate volume (RR, 1.34; 95% CI 1.01-1.77; P=.04), having a previous biopsy (RR, 2.25; 95% CI 1.44-3.52; P<.01), age (RR, .63; 95% CI .47-.85; P<.01) and feel palpation (RR, 1.95; 95% CI 1.28-2.96; P<.01) were factors independently associated with greater pain during the procedure. Transrectal biopsy with local anesthesia is a relatively painless technique. Factors such as age, a previous biopsy, pain on being touched and prostate volume were associated with the presence of greater pain during the procedure. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

The need for European professional standards and the challenges facing clinical microbiology.

Science.gov (United States)

Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

2010-06-01

Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

A review of standardized patients in clinical education: Implications for speech-language pathology programs.

Science.gov (United States)

Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

2010-06-01

The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

ASK Standards: Assessment, Skills, and Knowledge Content Standards for Student Affairs Practitioners and Scholars

Science.gov (United States)

ACPA College Student Educators International, 2011

2011-01-01

The Assessment Skills and Knowledge (ASK) standards seek to articulate the areas of content knowledge, skill and dispositions that student affairs professionals need in order to perform as practitioner-scholars to assess the degree to which students are mastering the learning and development outcomes the professionals intend. Consistent with…

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

Science.gov (United States)

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).

Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific.

Science.gov (United States)

Ashraf, Sania; Kao, Angie; Hugo, Cecilia; Christophel, Eva M; Fatunmbi, Bayo; Luchavez, Jennifer; Lilley, Ken; Bell, David

2012-10-24

Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a possibility both for supporting revival of national microcopy

Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific

Directory of Open Access Journals (Sweden)

Ashraf Sania

2012-10-01

Full Text Available Abstract Background Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Methods Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. Results External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. Conclusions While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a

Assessing Professionalism: A Theoretical Framework for Defining Clinical Rotation Assessment Criteria.

Science.gov (United States)

Armitage-Chan, Elizabeth

Although widely accepted as an important graduate competence, professionalism is a challenging outcome to define and assess. Clinical rotations provide an excellent opportunity to develop student professionalism through the use of experiential learning and effective feedback, but without appropriate theoretical frameworks, clinical teachers may find it difficult to identify appropriate learning outcomes. The adage "I know it when I see it" is unhelpful in providing feedback and guidance for student improvement, and criteria that are more specifically defined would help students direct their own development. This study sought first to identify how clinical faculty in one institution currently assess professionalism, using retrospective analysis of material obtained in undergraduate teaching and faculty development sessions. Subsequently, a faculty workshop was held in which a round-table type discussion sought to develop these ideas and identify how professionalism assessment could be improved. The output of this session was a theoretical framework for teaching and assessing professionalism, providing example assessment criteria and ideas for clinical teaching. This includes categories such as client and colleague interaction, respect and trust, recognition of limitations, and understanding of different professional identities. Each category includes detailed descriptions of the knowledge, skills, and behaviors expected of students in these areas. The criteria were determined by engaging faculty in the development of the framework, and therefore they should represent a focused development of criteria already used to assess professionalism, and not a novel and unfamiliar set of assessment guidelines. The faculty-led nature of this framework is expected to facilitate implementation in clinical teaching.

Psychological Assessment Training in Clinical Psychology Doctoral Programs.

Science.gov (United States)

Mihura, Joni L; Roy, Manali; Graceffo, Robert A

2017-01-01

We surveyed American Psychological Association-accredited clinical psychology doctoral programs' (n = 83) training in psychological assessment-specifically, their coverage of various assessment topics and tests in courses and practica, and whether the training was optional or required. We report results overall and separately per training model (clinical science, scientist-practitioner, and practitioner-focused). Overall, our results suggest that psychological assessment training is as active, or even more active, than in previous years. Areas of increased emphasis include clinical interviewing and psychometrics; multimethod, outcomes, health, and collaborative or therapeutic assessment; and different types of cognitive and self-report personality tests. All or almost all practice-focused programs offered training with the Thematic Apperception Test and Rorschach compared to about half of the scientist-practitioner programs and a third of the clinical science programs. Although almost all programs reported teaching multimethod assessment, what constitutes different methods of assessing psychopathology should be clarified in future studies because many programs appear to rely on one method-self-report (especially clinical science programs). Although doctoral programs covered many assessment topics and tests in didactic courses, there appears to be a shortage of program-run opportunities for students to obtain applied assessment training. Finally, we encourage doctoral programs to be familiar with (a) internships' assessment expectations and opportunities, (b) the professional guidelines for assessment training, and (c) the American Psychological Association's requirements for preinternship assessment competencies.

NUSS safety standards: A critical assessment

International Nuclear Information System (INIS)

Minogue, R.B.

1985-01-01

The NUSS safety standards are based on systematic review of safety criteria of many countries in a process carefully defined to assure completeness of coverage. They represent an international consensus of accepted safety principles and practices for regulation and for the design, construction, and operation of nuclear power plants. They are a codification of principles and practices already in use by some Member States. Thus, they are not standards which describe methodologies at their present state of evolution as a result of more recent experience and improvements in technological understanding. The NUSS standards assume an underlying body of national standards and a defined technological base. Detailed design and industrial practices vary between countries and the implementation of basic safety standards within countries has taken approaches that conform with national industrial practices. Thus, application of the NUSS standards requires reconciliation with the standards of the country where the reactor will be built as well as with the country from which procurement takes place. Experience in making that reconciliation will undoubtedly suggest areas of needed improvement. After the TMI accident a reassessment of the NUSS programme was made and it was concluded that, given the information at that time and the then level of technology, the basic approach was sound; the NUSS programme should be continued to completion, and the standards should be brought into use. It was also recognized, however, that in areas such as probabilistic risk assessment, human factors methodology, and consideration of detailed accident sequences, more advanced technology was emerging. As these technologies develop, and become more amenable to practical application, it is anticipated that the NUSS standards will need revision. Ideally those future revisions will also flow from experience in their use

Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Assessing barriers to adherence in routine clinical care for pediatric kidney transplant patients.

Science.gov (United States)

Varnell, Charles D; Rich, Kristin L; Nichols, Melissa; Dahale, Devesh; Goebel, Jens W; Pai, Ahna L H; Hooper, David K; Modi, Avani C

2017-11-01

Patient-identified barriers to immunosuppressive medications are associated with poor adherence and negative clinical outcomes in transplant patients. Assessment of adherence barriers is not part of routine post-transplant care, and studies regarding implementing such a process in a reliable way are lacking. Using the Model for Improvement and PDSA cycles, we implemented a system to identify adherence barriers, including patient-centered design of a barriers assessment tool, identification of eligible patients, clear roles for clinic staff, and creating a culture of non-judgmental discussion around adherence. We performed time-series analysis of our process measure. Secondary analyses examined the endorsement and concordance of adherence barriers between patient-caregiver dyads. After three methods of testing, the most reliable delivery system was an EHR-integrated tablet that alerted staff of patient eligibility for assessment. Barriers were endorsed by 35% of caregivers (n=85) and 43% of patients (n=60). The most frequently patient-endorsed barriers were forgetting, poor taste, and side effects. Caregivers endorsed forgetting and side effects. Concordance between patient-caregiver dyads was fair (k=0.299). Standardized adherence barriers assessment is feasible in the clinical care of pediatric kidney transplant patients. Features necessary for success included automation, redundant systems with designated staff to identify and mitigate failures, aligned reporting structures, and reliable measurement approaches. Future studies will examine whether barriers predict clinical outcomes (eg, organ rejection, graft loss). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

TDA Assessment of Recommendations for Space Data System Standards

Science.gov (United States)

Posner, E. C.; Stevens, R.

1984-01-01

NASA is participating in the development of international standards for space data systems. Recommendations for standards thus far developed are assessed. The proposed standards for telemetry coding and packet telemetry provide worthwhile benefit to the DSN; their cost impact to the DSN should be small. Because of their advantage to the NASA space exploration program, their adoption should be supported by TDA, JPL, and OSTDS.

Standardized computer-based organized reporting of EEG

DEFF Research Database (Denmark)

Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C.

2017-01-01

Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted in the se......Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted...... in the second, revised version of SCORE (Standardized Computer-based Organized Reporting of EEG), which is presented in this paper. The revised terminology was implemented in a software package (SCORE EEG), which was tested in clinical practice on 12,160 EEG recordings. Standardized terms implemented in SCORE....... In the end, the diagnostic significance is scored, using a standardized list of terms. SCORE has specific modules for scoring seizures (including seizure semiology and ictal EEG patterns), neonatal recordings (including features specific for this age group), and for Critical Care EEG Terminology. SCORE...

CT assessment of the correlation between clinical examination and bone involvement in oral malignant tumors

International Nuclear Information System (INIS)

Albuquerque, Marco Antonio Portela; Oliveira, Ilka Regina Souza; Cavalcanti, Marcelo Gusmao Paraiso; Kuruoshi, Marcia Etsuko

2009-01-01

Oral cancers have a tendency to invade the surrounding bone structures, and this has a direct influence on the treatment management and on outcomes. The objective of this study was to correlate the clinical parameters (location, clinical presentation and TNM staging) of oral malignant tumors that can be associated with a potential of bone invasion and determine the accuracy of clinical examination to predict bone involvement, using computed tomography (CT). Twenty five patients, with oral malignant tumors were submitted to clinical and CT examinations. CT was considered the standard parameter to evaluate the presence of bone involvement. Clinical assessment of location, presentation form and TNM staging of the tumors were then compared to the CT findings in predicting bone involvement. Bone involvement was observed in 68% of the cases. It was predicted that tumors located in the retromolar trigone and hard palate, with a clinical aspect of infiltrative ulcer or nodule and classified in stage IV had a high potential to cause bone involvement. The clinical examination assessment of these tumors showed to be a valuable tool to predict bone invasion, with high sensitivity (82%) and specificity (87.5%), based on the results found in the CT images. No statistical significance was found between the CT and clinical examinations regarding bone involvement. The identification of some clinical parameters such as location, clinical presentation, and TNM stage, associated with a detailed clinical examination, was considered a valuable tool for the assessment of bone destruction by oral malignant tumors. (author)

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a study protocol.

Science.gov (United States)

da Costa, Bruno R; Resta, Nina M; Beckett, Brooke; Israel-Stahre, Nicholas; Diaz, Alison; Johnston, Bradley C; Egger, Matthias; Jüni, Peter; Armijo-Olivo, Susan

2014-12-13

The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this investigation and present an intensive standardized training package for risk of bias assessment that could be used by contributors to the Cochrane Collaboration and other reviewers. This is a pilot study. We will first perform a systematic literature review to identify randomized clinical trials (RCTs) that will be used for risk of bias assessment. Using the identified RCTs, we will then do a randomized experiment, where raters will be allocated to two different training schemes: minimal training and intensive standardized training. We will calculate the chance-corrected weighted Kappa with 95% confidence intervals to quantify within- and between-group Kappa agreement for each of the domains of the risk of bias tool. To calculate between-group Kappa agreement, we will use risk of bias assessments from pairs of raters after resolution of disagreements. Between-group Kappa agreement will quantify the agreement between the risk of bias assessment of raters in the training groups and the risk of bias assessment of experienced raters. To compare agreement of raters under different training conditions, we will calculate differences between Kappa values with 95% confidence intervals. This study will investigate whether the reliability of the risk of bias tool can be improved by training raters using standardized instructions for risk of bias assessment. One group of inexperienced raters will receive intensive training on risk of bias assessment and the other will receive minimal training. By including a control group with minimal training, we will attempt to mimic what many review authors

Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods

DEFF Research Database (Denmark)

Larsen, Camilla Marie; Eshøj, Henrik; Ingwersen, Kim Gordon

2015-01-01

Assessment of scapular positioning and function as future effect measure of shoulder interventions – an inter-examiner reliability study of the clinical assessment methods Eshøj H1, Ingwersen KG1, Larsen CM1, 2, Søgaard K1, Juul-Kristensen B1, 3 1 University of Southern Denmark, Institute of Sports...... only been tested for intra-examiner reliability. The objective was to investigate the inter-examiner reliability of an extended battery of clinical tests for assessing scapular positioning and function. Methods A standardized three-phase protocol for clinical reliability studies was conducted...... coefficients (ICC) and kappa values were interpreted as: 0.0-0.40 (poor); 0.40-0.75 (fair to good); and 0.75-1.00 (good to excellent). Results A total of 41 subjects (23 males, yrs 25±9), were recruited among adult overhead athletes from the municipality of Odense, DK. Prevalence of the index condition was 54...

Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

Directory of Open Access Journals (Sweden)

Xiao J

2017-09-01

Full Text Available Juan Xiao,1,2 Lin Chen,3 Gengsheng Mao,1 Wenyong Gao,1,2 Ming Lu,4 Xijing He,5 Hongyun Huang1,2 On behalf of the Neurorestoratology Professional Committee of Chinese Medical Doctors Association (Chinese Association of Neurorestoratology 1Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China; 2Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China; 3Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China; 4Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University, Changsha, Hunan Province, People’s Republic of China; 5Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China Abstract: Olfactory ensheathing cells (OECs are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis. To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for

Clinical Skills Assessment in the Twenty-First Century.

Science.gov (United States)

Elder, Andrew

2018-05-01

Clinical skills remain fundamental to the practice of medicine and form a core component of the professional identity of the physician. However, evidence exists to suggest that the practice of some clinical skills is declining, particularly in the United States. A decline in practice of any skill can lead to a decline in its teaching and assessment, with further decline in practice as a result. Consequently, assessment not only drives learning of clinical skills, but their practice. This article summarizes contemporary approaches to clinical skills assessment that, if more widely adopted, could support the maintenance and reinvigoration of bedside clinical skills. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Physical Activity Stories: Assessing the "Meaning Standard" in Physical Education

Science.gov (United States)

Johnson, Tyler G.

2016-01-01

The presence of the "meaning standard" in both national and state content standards suggests that professionals consider it an important outcome of a quality physical education program. However, only 10 percent of states require an assessment to examine whether students achieve this standard. The purpose of this article is to introduce…

Teacher Assessment Literacy: A Review of International Standards and Measures

Science.gov (United States)

DeLuca, Christopher; LaPointe-McEwan, Danielle; Luhanga, Ulemu

2016-01-01

Assessment literacy is a core professional requirement across educational systems. Hence, measuring and supporting teachers' assessment literacy have been a primary focus over the past two decades. At present, there are a multitude of assessment standards across the world and numerous assessment literacy measures that represent different…

Psoriatic arthritis: An assessment of clinical, biochemical and ...

African Journals Online (AJOL)

, epidemiological, clinical and radiological studies of South African (SA) patients are scarce. Objectives. To assess clinical, biochemical and radiological features in a single-centre SA cohort. Methods. We conducted a prospective assessment ...

Transformative Shifts in Art History Teaching: The Impact of Standards-Based Assessment

Science.gov (United States)

Ormond, Barbara

2011-01-01

This article examines pedagogical shifts in art history teaching that have developed as a response to the implementation of a standards-based assessment regime. The specific characteristics of art history standards-based assessment in the context of New Zealand secondary schools are explained to demonstrate how an exacting form of assessment has…

Two-Dimensional Cutting (TDC Vitrectome: In Vitro Flow Assessment and Prospective Clinical Study Evaluating Core Vitrectomy Efficiency versus Standard Vitrectome

Directory of Open Access Journals (Sweden)

Mitrofanis Pavlidis

2016-01-01

Full Text Available Purpose. To evaluate comparative aspiration flow performance and also vitrectomy operating time efficiency using a double-cutting open port vitreous cutting system incorporated in a two-dimensional cutting (TDC, DORC International vitrectome design versus standard vitreous cutter. Methods. In vitro investigations compared aspiration flow rates in artificial vitreous humor at varying cutter speeds and vacuum levels using a TDC vitrectome and a standard vitrectome across different aspiration pump systems. A prospective single-centre clinical study evaluated duration of core vitrectomy in 80 patients with macular pucker undergoing 25-gauge or 27-gauge vitrectomy using either a TDC vitrectome at 16,000 cuts per minute (cpm or standard single-cut vitrectome, combined with a Valve Timing intelligence (VTi pump system (EVA, DORC International. Results. Aspiration flow rates remained constant independent of TDC vitrectome cut rate, while flow rates decreased linearly at higher cutter speeds using a classic single-blade vitrectome. Mean duration of core vitrectomy surgeries using a TDC vitreous cutter system was significantly (p<0.001 shorter than the mean duration of core vitrectomy procedures using a single-cut vitrectome of the same diameter (reduction range, 34%–50%. Conclusion. Vitrectomy surgery performed using a TDC vitrectome was faster than core vitrectomy utilizing a standard single-action vitrectome at similar cut speeds.

Clinical Reasoning: Survey of Teaching Methods, Integration, and Assessment in Entry-Level Physical Therapist Academic Education.

Science.gov (United States)

Christensen, Nicole; Black, Lisa; Furze, Jennifer; Huhn, Karen; Vendrely, Ann; Wainwright, Susan

2017-02-01

Although clinical reasoning abilities are important learning outcomes of physical therapist entry-level education, best practice standards have not been established to guide clinical reasoning curricular design and learning assessment. This research explored how clinical reasoning is currently defined, taught, and assessed in physical therapist entry-level education programs. A descriptive, cross-sectional survey was administered to physical therapist program representatives. An electronic 24-question survey was distributed to the directors of 207 programs accredited by the Commission on Accreditation in Physical Therapy Education. Descriptive statistical analysis and qualitative content analysis were performed. Post hoc demographic and wave analyses revealed no evidence of nonresponse bias. A response rate of 46.4% (n=96) was achieved. All respondents reported that their programs incorporated clinical reasoning into their curricula. Only 25% of respondents reported a common definition of clinical reasoning in their programs. Most respondents (90.6%) reported that clinical reasoning was explicit in their curricula, and 94.8% indicated that multiple methods of curricular integration were used. Instructor-designed materials were most commonly used to teach clinical reasoning (83.3%). Assessment of clinical reasoning included practical examinations (99%), clinical coursework (94.8%), written examinations (87.5%), and written assignments (83.3%). Curricular integration of clinical reasoning-related self-reflection skills was reported by 91%. A large number of incomplete surveys affected the response rate, and the program directors to whom the survey was sent may not have consulted the faculty members who were most knowledgeable about clinical reasoning in their curricula. The survey construction limited some responses and application of the results. Although clinical reasoning was explicitly integrated into program curricula, it was not consistently defined, taught, or

Assessing the Genetics Content in the Next Generation Science Standards.

Science.gov (United States)

Lontok, Katherine S; Zhang, Hubert; Dougherty, Michael J

2015-01-01

Science standards have a long history in the United States and currently form the backbone of efforts to improve primary and secondary education in science, technology, engineering, and math (STEM). Although there has been much political controversy over the influence of standards on teacher autonomy and student performance, little light has been shed on how well standards cover science content. We assessed the coverage of genetics content in the Next Generation Science Standards (NGSS) using a consensus list of American Society of Human Genetics (ASHG) core concepts. We also compared the NGSS against state science standards. Our goals were to assess the potential of the new standards to support genetic literacy and to determine if they improve the coverage of genetics concepts relative to state standards. We found that expert reviewers cannot identify ASHG core concepts within the new standards with high reliability, suggesting that the scope of content addressed by the standards may be inconsistently interpreted. Given results that indicate that the disciplinary core ideas (DCIs) included in the NGSS documents produced by Achieve, Inc. clarify the content covered by the standards statements themselves, we recommend that the NGSS standards statements always be viewed alongside their supporting disciplinary core ideas. In addition, gaps exist in the coverage of essential genetics concepts, most worryingly concepts dealing with patterns of inheritance, both Mendelian and complex. Finally, state standards vary widely in their coverage of genetics concepts when compared with the NGSS. On average, however, the NGSS support genetic literacy better than extant state standards.

Assessing the Genetics Content in the Next Generation Science Standards.

Directory of Open Access Journals (Sweden)

Katherine S Lontok

Full Text Available Science standards have a long history in the United States and currently form the backbone of efforts to improve primary and secondary education in science, technology, engineering, and math (STEM. Although there has been much political controversy over the influence of standards on teacher autonomy and student performance, little light has been shed on how well standards cover science content. We assessed the coverage of genetics content in the Next Generation Science Standards (NGSS using a consensus list of American Society of Human Genetics (ASHG core concepts. We also compared the NGSS against state science standards. Our goals were to assess the potential of the new standards to support genetic literacy and to determine if they improve the coverage of genetics concepts relative to state standards. We found that expert reviewers cannot identify ASHG core concepts within the new standards with high reliability, suggesting that the scope of content addressed by the standards may be inconsistently interpreted. Given results that indicate that the disciplinary core ideas (DCIs included in the NGSS documents produced by Achieve, Inc. clarify the content covered by the standards statements themselves, we recommend that the NGSS standards statements always be viewed alongside their supporting disciplinary core ideas. In addition, gaps exist in the coverage of essential genetics concepts, most worryingly concepts dealing with patterns of inheritance, both Mendelian and complex. Finally, state standards vary widely in their coverage of genetics concepts when compared with the NGSS. On average, however, the NGSS support genetic literacy better than extant state standards.

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

Science.gov (United States)

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

2014-06-01

The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P quality of the clinical images obtained by radiologists was the best. © 2014 by the American Institute of Ultrasound in Medicine.

Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland.

Science.gov (United States)

Glier, Hana; Heijnen, Ingmar; Hauwel, Mathieu; Dirks, Jan; Quarroz, Stéphane; Lehmann, Thomas; Rovo, Alicia; Arn, Kornelius; Matthes, Thomas; Hogan, Cassandra; Keller, Peter; Dudkiewicz, Ewa; Stüssi, Georg; Fernandez, Paula

2017-07-29

The EuroFlow Consortium developed a fully standardized flow cytometric approach from instrument settings, through antibody panel, reagents and sample preparation protocols, to data acquisition and analysis. The Swiss Cytometry Society (SCS) promoted a study to evaluate the feasibility of using such standardized measurements of 8-color data across two different flow cytometry platforms - Becton Dickinson (BD) FACSCanto II and Beckman Coulter (BC) Navios, aiming at increasing reproducibility and inter-laboratory comparability of immunophenotypic data in clinical laboratories in Switzerland. The study was performed in two phases, i.e. a learning phase (round 1) and an analytical phase (rounds 2 and 3) consisting of a total of three rounds. Overall, 10 laboratories using BD FACSCanto II (n=6) or BC Navios (n=4) flow cytometers participated. Each laboratory measured peripheral blood samples from healthy donors stained with a uniform antibody panel of reagents - EuroFlow Lymphoid Screening Tube (LST) - applying the EuroFlow standardized protocols for instrument setup and sample preparation (www.EuroFlow.org). All data files were analyzed centrally and median fluorescence intensity (MedFI) values for individual markers on defined lymphocyte subsets were recorded; variability from reference MedFI values was assessed using performance scores. Data troubleshooting and discussion of the results with the participants followed after each round at SCS meetings. The results of the learning phase demonstrated that standardized instrument setup and data acquisition are feasible in routine clinical laboratories without previous experience with EuroFlow. During the analytical phase, highly comparable data were obtained at the different laboratories using either BD FACSCanto II or BC Navios. The coefficient of variation of MedFI for 7 of 11 markers performed repeatedly below 30%. In the last study round, 89% of participants scored over 90% MedFI values within the acceptance criteria

Peer Review of Assessment Network: Supporting Comparability of Standards

Science.gov (United States)

Booth, Sara; Beckett, Jeff; Saunders, Cassandra

2016-01-01

Purpose: This paper aims to test the need in the Australian higher education (HE) sector for a national network for the peer review of assessment in response to the proposed HE standards framework and propose a sector-wide framework for calibrating and assuring achievement standards, both within and across disciplines, through the establishment of…

Assessing clinical reasoning abilities of medical students using clinical performance examination

Directory of Open Access Journals (Sweden)

Sunju Im

2016-03-01

Full Text Available Purpose: The purpose of this study is to investigate the reliability and validity of new clinical performance examination (CPX for assessing clinical reasoning skills and evaluating clinical reasoning ability of the students. Methods: Third-year medical school students (n=313 in Busan-Gyeongnam consortium in 2014 were included in the study. One of 12 stations was developed to assess clinical reasoning abilities. The scenario and checklists of the station were revised by six experts. Chief complaint of the case was rhinorrhea, accompanied by fever, headache, and vomiting. Checklists focused on identifying of the main problem and systematic approach to the problem. Students interviewed the patient and recorded subjective and objective findings, assessments, plans (SOAP note for 15 minutes. Two professors assessed students simultaneously. We performed statistical analysis on their scores and survey. Results: The Cronbach α of subject station was 0.878 and Cohen κ coefficient between graders was 0.785. Students agreed on CPX as an adequate tool to evaluate students’ performance, but some graders argued that the CPX failed to secure its validity due to their lack of understanding the case. One hundred eight students (34.5% identified essential problem early and only 58 (18.5% performed systematic history taking and physical examination. One hundred seventy-three of them (55.3% communicated correct diagnosis with the patient. Most of them had trouble in writing SOAP notes. Conclusion: To gain reliability and validity, interrater agreement should be secured. Students' clinical reasoning skills were not enough. Students need to be trained on problem identification, reasoning skills and accurate record-keeping.

Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

Science.gov (United States)

Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

2016-01-01

Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

Assessing the performance and satisfaction of medical residents utilizing standardized patient versus mannequin-simulated training

Directory of Open Access Journals (Sweden)

Alsaad AA

2017-07-01

Full Text Available Ali A Alsaad,1 Swetha Davuluri,2 Vandana Y Bhide,3 Amy M Lannen,4 Michael J Maniaci3 1Department of Internal Medicine, Mayo Clinic, 2University of Miami, Coral Gables, 3Division of Hospital Internal Medicine, 4J. Wayne and Delores Barr Weaver Simulation Center, Mayo Clinic, Jacksonville, FL, USA Background: Conducting simulations of rapidly decompensating patients are a key part of internal medicine (IM residency training. Traditionally, mannequins have been the simulation tool used in these scenarios. Objective: To compare IM residents’ performance and assess realism in specific-simulated decompensating patient scenarios using standardized patients (SPs as compared to mannequin. Methods: Nineteen IM residents were randomized to undergo simulations using either a mannequin or an SP. Each resident in the two groups underwent four different simulation scenarios (calcium channel blocker overdose, severe sepsis, severe asthma exacerbation, and acute bacterial meningitis. Residents completed pretest and post-test evaluations as well as a questionnaire to assess the reality perception (realism score. Results: Nine residents completed mannequin-based scenarios, whereas 10 completed SP-based scenarios. Improvement in the post-test scores was seen in both groups. However, there were significantly higher post-test scores achieved with SP simulations in three out of the four scenarios (P=0.01. When compared with the mannequin group, the SP simulation group showed a significantly higher average realism score (P=0.002. Conclusions: Applying SP-based specific-simulation scenarios in IM residency training may result in better performance and a higher sense of a realistic experience by medical residents. Keywords: simulation, standardized patient, satisfaction, mannequin, assessment, resident education

42 CFR 493.1299 - Standard: Postanalytic systems quality assessment.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Postanalytic systems quality assessment. 493.1299 Section 493.1299 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH....1291. (b) The postanalytic systems quality assessment must include a review of the effectiveness of...

42 CFR 493.1249 - Standard: Preanalytic systems quality assessment.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Preanalytic systems quality assessment. 493.1249 Section 493.1249 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH....1241 through 493.1242. (b) The preanalytic systems quality assessment must include a review of the...

Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

Directory of Open Access Journals (Sweden)

Kent David M

2010-08-01

Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

The Counseling Center Assessment of Psychological Symptoms (CCAPS): Merging clinical practice, training, and research.

Science.gov (United States)

Youn, Soo Jeong; Castonguay, Louis G; Xiao, Henry; Janis, Rebecca; McAleavey, Andrew A; Lockard, Allison J; Locke, Benjamin D; Hayes, Jeffrey A

2015-12-01

The goal of this article is to present information about a standardized multidimensional measure of psychological symptoms, the Counseling Center Assessment of Psychological Symptoms (CCAPS; Locke et al., 2011; Locke, McAleavey, et al., 2012; McAleavey, Nordberg, Hayes, et al., 2012), developed to assess difficulties specific to college students' mental health. We provide (a) a brief review and summary of the psychometric and research support for the CCAPS; (b) examples of the use of the CCAPS for various purposes, including clinical, training, policy, and counseling center advocacy; and (c) implications of the integration of routine outcome monitoring and feedback for the future of training, research, and clinical practice. In particular, the article emphasizes how the assimilation of and symbiotic relationship between research and practice can address the scientist-practitioner gap. (c) 2015 APA, all rights reserved).

Comparison of anthropometry with photogrammetry based on a standardized clinical photographic technique using a cephalostat and chair.

Science.gov (United States)

Han, Kihwan; Kwon, Hyuk Joon; Choi, Tae Hyun; Kim, Jun Hyung; Son, Daegu

2010-03-01

The aim of this study was to standardize clinical photogrammetric techniques, and to compare anthropometry with photogrammetry. To standardize clinical photography, we have developed a photographic cephalostat and chair. We investigated the repeatability of the standardized clinical photogrammetric technique. Then, with 40 landmarks, a total of 96 anthropometric measurement items was obtained from 100 Koreans. Ninety six photogrammetric measurements from the same subjects were also obtained from standardized clinical photographs using Adobe Photoshop version 7.0 (Adobe Systems Corporation, San Jose, CA, USA). The photogrammetric and anthropometric measurement data (mm, degree) were then compared. A coefficient was obtained by dividing the anthropometric measurements by the photogrammetric measurements. The repeatability of the standardized photography was statistically significantly high (p=0.463). Among the 96 measurement items, 44 items were reliable; for these items the photogrammetric measurements were not different to the anthropometric measurements. The remaining 52 items must be classified as unreliable. By developing a photographic cephalostat and chair, we have standardized clinical photogrammetric techniques. The reliable set of measurement items can be used as anthropometric measurements. For unreliable measurement items, applying a suitable coefficient to the photogrammetric measurement allows the anthropometric measurement to be obtained indirectly.

Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017

Directory of Open Access Journals (Sweden)

Ao Q

2017-12-01

Full Text Available Qiang Ao,1,* Juan Xiao,2,3,* Yanqiu Yu,4 Gengsheng Mao,2 Qingyan Zou,5 Wenyong Gao,2,3 Hongyun Huang2,3 On behalf of Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology 1Department of Tissue Engineering, China Medical University, Shen Yang, 2Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, 3Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, 4Department of Pathophysiology, China Medical University, Shen Yang, 5Guangdong 999 Brain Hospital, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Formulating common standards for the culture and quality control of umbilical cord mesenchymal stromal cells (MSCs is crucial for the standardization of clinical neurorestorative therapy. But to date, there have been no standardized guidelines for the culture and quality control of MSCs in neurorestorative clinical application. Based on a relatively comprehensive review of published clinical studies as well as the existing methods of MSC culture and quality control, the Chinese Association of Neurorestoratology has developed standards for the culture and quality control of umbilical cord MSCs which possess the potential in neurorestorative clinical application. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture and proliferation of umbilical cord MSCs; standardized management for cell preservation, transport and related safeguard measures; as well as standardization of a clean environment, routine maintenance and related tests and examinations and so on. These guidelines represent the minimum required standards for the culture and quality control of umbilical cord MSCs for potential use in current neurorestorative clinical therapy, and will be further

42 CFR 493.1289 - Standard: Analytic systems quality assessment.

Science.gov (United States)

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Analytic systems quality assessment. 493.1289 Section 493.1289 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... through 493.1283. (b) The analytic systems quality assessment must include a review of the effectiveness...

CLINICAL ASPECTS OF ACUTE POST-OPERATIVE PAIN MANAGEMENT & ITS ASSESSMENT

Directory of Open Access Journals (Sweden)

R.S.R Murthy

2010-06-01

Full Text Available Management of postoperative pain relieve suffering and leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. An effective postoperative management is not a standardized regime rather is tailored to the needs of the individual patient, taking into account medical, psychological, and physical condition; age; level of fear or anxiety; surgical procedure; personal preference; and response to therapeutic agents given. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen side effects & provide adequate analgesia. Postoperative pain is still under managed due to obstacles in implementation of Acute Pain Services due to insufficient education, fear of complications associated with available analgesic drugs, poor pain assessment and inadequate staff. This review reflects the clinical aspects of postoperative pain & its assessment & management with an emphasis on research for new analgesic molecules & delivery system.

Clinical aspects of acute post-operative pain management & its assessment

Directory of Open Access Journals (Sweden)

Anuj Gupta

2010-01-01

Full Text Available Management of postoperative pain relieve suffering and leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. An effective postoperative management is not a standardized regime rather is tailored to the needs of the individual patient, taking into account medical, psychological, and physical condition; age; level of fear or anxiety; surgical procedure; personal preference; and response to therapeutic agents given. The major goal in the management of postoperative pain is to minimize the dose of medications to lessen side effects & provide adequate analgesia. Postoperative pain is still under managed due to obstacles in implementation of Acute Pain Services due to insufficient education, fear of complications associated with available analgesic drugs, poor pain assessment and inadequate staff. This review reflects the clinical aspects of postoperative pain & its assessment & management with an emphasis on research for new analgesic molecules & delivery system.

Assessing the Effects of Corporate Social Responsibility Standards in Global Value Chains

DEFF Research Database (Denmark)

Lund-Thomsen, Peter

This paper considers the issue of corporate social responsibility (CSR) standard impact assessment in global value chains. CSR standards have proliferated in recent years, and several studies have attempted to assess their effects on local producers, workers, and the environment in developing...... countries. However, much less attention has been paid to the “dark side” of impact assessment – the ethical and political dilemmas that arise in the process of carrying out impact studies. This paper addresses this gap in literature, arguing that impact assessments of CSR standards may do more harm than...... good to the intended beneficiaries - developing country firms, farmers, workers, and communities - unless these ethical and political dilemmas are given serious consideration....

Environmental assessment. Energy efficiency standards for consumer products

Energy Technology Data Exchange (ETDEWEB)

McSwain, Berah

1980-06-01

The Energy Policy and Conservation Act of 1975 requires DOE to prescribe energy efficiency standards for 13 consumer products. The Consumer Products Efficiency Standards (CPES) program covers: refrigerators and refrigerator-freezers, freezers, clothes dryers, water heaters, room air conditioners, home heating equipment, kitchen ranges and ovens, central air conditioners (cooling and heat pumps), furnaces, dishwashers, television sets, clothes washers, and humidifiers and dehumidifiers. This Environmental Assessment evaluates the potential environmental and socioeconomic impacts expected as a result of setting efficiency standards for all of the consumer products covered by the CPES program. DOE has proposed standards for eight of the products covered by the Program in a Notice of Proposed Rulemaking (NOPR). DOE expects to propose standards for home heating equipment, central air conditioners (heat pumps only), dishwashers, television sets, clothes washers, and humidifiers and dehumidifiers in 1981. No significant adverse environmental or socioeconomic impacts have been found to result from instituting the CPES.

Basic Laparoscopic Skills Assessment Study: Validation and Standard Setting among Canadian Urology Trainees.

Science.gov (United States)

Lee, Jason Y; Andonian, Sero; Pace, Kenneth T; Grober, Ethan

2017-06-01

As urology training programs move to a competency based medical education model, iterative assessments with objective standards will be required. To develop a valid set of technical skills standards we initiated a national skills assessment study focusing initially on laparoscopic skills. Between February 2014 and March 2016 the basic laparoscopic skill of Canadian urology trainees and attending urologists was assessed using 4 standardized tasks from the AUA (American Urological Association) BLUS (Basic Laparoscopic Urological Surgery) curriculum, including peg transfer, pattern cutting, suturing and knot tying, and vascular clip applying. All performances were video recorded and assessed using 3 methods, including time and error based scoring, expert global rating scores and C-SATS (Crowd-Sourced Assessments of Technical Skill Global Rating Scale), a novel, crowd sourced assessment platform. Different methods of standard setting were used to develop pass-fail cut points. Six attending urologists and 99 trainees completed testing. Reported laparoscopic experience and training level correlated with performance (p standard setting methods to define pass-fail cut points for all 4 AUA BLUS tasks. The 4 AUA BLUS tasks demonstrated good construct validity evidence for use in assessing basic laparoscopic skill. Performance scores using the novel C-SATS platform correlated well with traditional time-consuming methods of assessment. Various standard setting methods were used to develop pass-fail cut points for educators to use when making formative and summative assessments of basic laparoscopic skill. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Providing support to nursing students in the clinical environment: a nursing standard requirement.

Science.gov (United States)

Anderson, Carina; Moxham, Lorna; Broadbent, Marc

2016-10-01

This discussion paper poses the question 'What enables or deters Registered Nurses to take up their professional responsibility to support undergraduate nursing students through the provision of clinical education?'. Embedded within many nursing standards are expectations that Registered Nurses provide support and professional development to undergraduate nursing students undertaking clinical placements. Expectations within nursing standards that Registered Nurses provide support and professional development to nursing students are important because nursing students depend on Registered Nurses to help them to become competent practitioners. Contributing factors that enable and deter Registered Nurses from fulfilling this expectation to support nursing students in their clinical learning include; workloads, preparedness for the teaching role, confidence in teaching and awareness of the competency requirement to support students. Factors exist which can enable or deter Registered Nurses from carrying out the licence requirement to provide clinical education and support to nursing students.

Standard setting and quality of assessment: A conceptual approach ...

African Journals Online (AJOL)

Quality performance standards and the effect of assessment outcomes are important in the educational milieu, as assessment remains the representative ... not be seen as a methodological process of setting pass/fail cut-off points only, but as a powerful catalyst for quality improvements in HPE by promoting excellence in ...

[The challenges of standardization in clinical diagnostic laboratories of medical organizations].

Science.gov (United States)

Men'shikov, V V

2013-04-01

The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

Comparison of Laser Doppler Imaging (LDI) and clinical assessment in differentiating between superficial and deep partial thickness burn wounds.

Science.gov (United States)

Jan, Saadia Nosheen; Khan, Farid Ahmed; Bashir, Muhammad Mustehsan; Nasir, Muneeb; Ansari, Hamid Hussain; Shami, Hussan Birkhez; Nazir, Umer; Hanif, Asif; Sohail, Muhammad

2018-03-01

To compare the accuracy of Laser Doppler Imaging (LDI) and clinical assessment in differentiating between superficial and deep partial thickness burns to decide whether early tangential excision and grafting or conservative management should be employed to optimize burn and patient management. March 2015 to November 2016. Ninety two wounds in 34 patients reporting within 5days of less than 40% burn surface area were included. Unstable patients, pregnant females and those who expired were excluded. The wounds were clinically assessed and LDI done concomitantly Plastic Surgeons blinded to each other's findings. Wound appearance, color, blanching, pain, hair follicle dislodgement were the clinical parameters that distinguished between superficial and deep partial thickness burns. On day 21, the wounds were again assessed for the presence of healing by the same plastic surgeons. The findings were correlated with the initial findings on LDI and clinical assessment and the results statistically analyzed. The data of 92 burn wounds was analyzed using SPSS (ver. 17). Clinical assessment correctly identified the depth of 75 and LDI 83 wounds, giving diagnostic accuracies of 81.52% and 90.21% respectively. The sensitivity of clinical assessment was 81% and of LDI 92.75%, whereas the specificity was 82% for both. The positive predictive value was 93% for clinical assessment and 94% for LDI while the negative predictive value was 59% and 79% respectively. Predictive accuracy of LDI was found to be better than clinical assessment in the prediction of wound healing, the gold standard for wound healing being 21 days. As such it can prove to be a reliable and viable cost effective alternative per se to clinical assessment. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

The Use of Non-Variant Sites to Improve the Clinical Assessment of Whole-Genome Sequence Data.

Directory of Open Access Journals (Sweden)

Alberto Ferrarini

Full Text Available Genetic testing, which is now a routine part of clinical practice and disease management protocols, is often based on the assessment of small panels of variants or genes. On the other hand, continuous improvements in the speed and per-base costs of sequencing have now made whole exome sequencing (WES and whole genome sequencing (WGS viable strategies for targeted or complete genetic analysis, respectively. Standard WGS/WES data analytical workflows generally rely on calling of sequence variants respect to the reference genome sequence. However, the reference genome sequence contains a large number of sites represented by rare alleles, by known pathogenic alleles and by alleles strongly associated to disease by GWAS. It's thus critical, for clinical applications of WGS and WES, to interpret whether non-variant sites are homozygous for the reference allele or if the corresponding genotype cannot be reliably called. Here we show that an alternative analytical approach based on the analysis of both variant and non-variant sites from WGS data allows to genotype more than 92% of sites corresponding to known SNPs compared to 6% genotyped by standard variant analysis. These include homozygous reference sites of clinical interest, thus leading to a broad and comprehensive characterization of variation necessary to an accurate evaluation of disease risk. Altogether, our findings indicate that characterization of both variant and non-variant clinically informative sites in the genome is necessary to allow an accurate clinical assessment of a personal genome. Finally, we propose a highly efficient extended VCF (eVCF file format which allows to store genotype calls for sites of clinical interest while remaining compatible with current variant interpretation software.

Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

Science.gov (United States)

Phinney, Karen W; Sempos, Christopher T; Tai, Susan S-C; Camara, Johanna E; Wise, Stephen A; Eckfeldt, John H; Hoofnagle, Andrew N; Carter, Graham D; Jones, Julia; Myers, Gary L; Durazo-Arvizu, Ramon; Miller, W Greg; Bachmann, Lorin M; Young, Ian S; Pettit, Juanita; Caldwell, Grahame; Liu, Andrew; Brooks, Stephen P J; Sarafin, Kurtis; Thamm, Michael; Mensink, Gert B M; Busch, Markus; Rabenberg, Martina; Cashman, Kevin D; Kiely, Mairead; Galvin, Karen; Zhang, Joy Y; Kinsella, Michael; Oh, Kyungwon; Lee, Sun-Wha; Jung, Chae L; Cox, Lorna; Goldberg, Gail; Guberg, Kate; Meadows, Sarah; Prentice, Ann; Tian, Lu; Brannon, Patsy M; Lucas, Robyn M; Crump, Peter M; Cavalier, Etienne; Merkel, Joyce; Betz, Joseph M

2017-09-01

The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

Summative clinical competency assessment: A survey of ultrasound practitioners' views.

Science.gov (United States)

Harrison, Gill

2015-02-01

Clinical competency and the assessment of core skills is a crucial element of any programme leading to an award with a clinical skills component. This has become a more prominent feature of current reports on quality health care provision. This project aimed to determine ultrasound practitioners' opinions about how best to assess clinical competency. An on-line questionnaire was sent to contacts from the Consortium for the Accreditation of Sonographic Education and details distributed at the British Medical Ultrasound Society conference in 2011. One hundred and sixteen responses were received from a range of clinical staff with an interest in ultrasound assessment. The majority of respondents suggested that competency assessments should take place in the clinical departments with or without an element of assessment at the education centre. Moderation was an important area highlighted by respondents, with 84% of respondents suggesting that two assessors were required and 66% of those stating some element of external moderation should be included. The findings suggest that respondents' preference is for some clinical competency assessments to take place on routine lists within the clinical department, assessed by two people one of which would be an external assessor. In view of recent reports relating to training and assessment of health care professionals, the ultrasound profession needs to begin the debate about how best to assess clinical competence and ensure appropriate first post-competency of anyone undertaking ultrasound examinations.

Risk assessment instruments in clinical practice.

Science.gov (United States)

Côté, Gilles; Crocker, Anne G; Nicholls, Tonia L; Seto, Michael C

2012-04-01

To determine whether the items in one of the most widely validated instruments of violence risk assessment, the Historical-Clinical-Risk Management-20 (HCR-20), are used in review board hearings to assess the risk of violence by people found Not Criminally Responsible on account of Mental Disorder (NCRMD). This study was conducted from October 2004 to August 2006 in Quebec's sole forensic psychiatric hospital and 2 large civil psychiatric hospitals designated for the care of people declared NCRMD in the Montreal metropolitan area. The risk assessments presented by clinicians at annual review board hearings and the boards' rationale for the release or detention of people found NCRMD were contrasted with the risk assessments conducted by the research team using the HCR-20. The final sample was comprised of 96 men. Very few of the risk factors identified by prior research (HCR-20 items) were mentioned in the hearing process, whether in clinical reports, discussions during the hearing, or in the disposition justification. The findings confirm that there remains a significant gap between research evidence and risk assessment practice.

Assessing Quality of Data Standards: Framework and Illustration Using XBRL GAAP Taxonomy

Science.gov (United States)

Zhu, Hongwei; Wu, Harris

The primary purpose of data standards or metadata schemas is to improve the interoperability of data created by multiple standard users. Given the high cost of developing data standards, it is desirable to assess the quality of data standards. We develop a set of metrics and a framework for assessing data standard quality. The metrics include completeness and relevancy. Standard quality can also be indirectly measured by assessing interoperability of data instances. We evaluate the framework using data from the financial sector: the XBRL (eXtensible Business Reporting Language) GAAP (Generally Accepted Accounting Principles) taxonomy and US Securities and Exchange Commission (SEC) filings produced using the taxonomy by approximately 500 companies. The results show that the framework is useful and effective. Our analysis also reveals quality issues of the GAAP taxonomy and provides useful feedback to taxonomy users. The SEC has mandated that all publicly listed companies must submit their filings using XBRL. Our findings are timely and have practical implications that will ultimately help improve the quality of financial data.

Review of clinically accessible methods to determine lean body mass for normalization of standardized uptake values

International Nuclear Information System (INIS)

DEVRIESE, Joke; POTTEL, Hans; BEELS, Laurence; MAES, Alex; VAN DE WIELE, Christophe; GHEYSENS, Olivier

2016-01-01

With the routine use of 2-deoxy-2-[ 18 F]-fluoro-D-glucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scans, metabolic activity of tumors can be quantitatively assessed through calculation of SUVs. One possible normalization parameter for the standardized uptake value (SUV) is lean body mass (LBM), which is generally calculated through predictive equations based on height and body weight. (Semi-)direct measurements of LBM could provide more accurate results in cancer populations than predictive equations based on healthy populations. In this context, four methods to determine LBM are reviewed: bioelectrical impedance analysis, dual-energy X-ray absorptiometry. CT, and magnetic resonance imaging. These methods were selected based on clinical accessibility and are compared in terms of methodology, precision and accuracy. By assessing each method’s specific advantages and limitations, a well-considered choice of method can hopefully lead to more accurate SUVLBM values, hence more accurate quantitative assessment of 18F-FDG PET images.

Clinical assessment, design and performance testing of mobile shower commodes for adults with spinal cord injury: an exploratory review.

Science.gov (United States)

Friesen, Emma; Theodoros, Deborah; Russell, Trevor

2013-07-01

The purpose of this article is to explore evidence concerning clinical assessment, design and performance testing of mobile shower commodes used by adults with spinal cord injury (SCI). Searches of electronic databases, conference proceedings and key journals were undertaken with no restriction on language or study design. Keywords included spinal cord injury, lesion, sanichair, sanitary chair, shower chair, bowel chair and commode. A total of 20 publications were included in this review. Common approaches to clinical assessments were questionnaires and observational analysis to assess bowel care routines, function and skin integrity. Design features addressed access for bowel care, postural support, transfers, stability, use in wet environments and skin integrity. Objective performance measures addressed requirements for static stability, backward-sloping seat angles, arm supports and seat materials. Evidence reviewed was of low methodological quality and lacking in validated instruments to guide clinical practice. Further high-quality research is needed to identify bathing, showering and personal hygiene tasks affecting mobile shower commodes use and to develop validated clinical assessment tools. Performance testing to published standards is also needed.

Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

Science.gov (United States)

Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

2013-01-01

Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

Science.gov (United States)

Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

2013-01-01

Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…

Appending Limited Clinical Data to an Administrative Database for Acute Myocardial Infarction Patients: The Impact on the Assessment of Hospital Quality.

Science.gov (United States)

Hannan, Edward L; Samadashvili, Zaza; Cozzens, Kimberly; Jacobs, Alice K; Venditti, Ferdinand J; Holmes, David R; Berger, Peter B; Stamato, Nicholas J; Hughes, Suzanne; Walford, Gary

2016-05-01

Hospitals' risk-standardized mortality rates and outlier status (significantly higher/lower rates) are reported by the Centers for Medicare and Medicaid Services (CMS) for acute myocardial infarction (AMI) patients using Medicare claims data. New York now has AMI claims data with blood pressure and heart rate added. The objective of this study was to see whether the appended database yields different hospital assessments than standard claims data. New York State clinically appended claims data for AMI were used to create 2 different risk models based on CMS methods: 1 with and 1 without the added clinical data. Model discrimination was compared, and differences between the models in hospital outlier status and tertile status were examined. Mean arterial pressure and heart rate were both significant predictors of mortality in the clinically appended model. The C statistic for the model with the clinical variables added was significantly higher (0.803 vs. 0.773, Pthe assessment of hospital mortality outliers for AMI. The strategy of adding limited but important clinical data elements to administrative datasets should be considered when evaluating hospital quality for procedures and other medical conditions.

Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

Science.gov (United States)

Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

2005-09-01

To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

White blood cell and platelet count as adjuncts to standard clinical evaluation for risk assessment in patients at low probability of acute aortic syndrome.

Science.gov (United States)

Morello, Fulvio; Cavalot, Giulia; Giachino, Francesca; Tizzani, Maria; Nazerian, Peiman; Carbone, Federica; Pivetta, Emanuele; Mengozzi, Giulio; Moiraghi, Corrado; Lupia, Enrico

2017-08-01

Pre-test probability assessment is key in the approach to suspected acute aortic syndromes (AASs). However, most patients with AAS-compatible symptoms are classified at low probability, warranting further evaluation for decision on aortic imaging. White blood cell count, platelet count and fibrinogen explore pathophysiological pathways mobilized in AASs and are routinely assayed in the workup of AASs. However, the diagnostic performance of these variables for AASs, alone and as a bundle, is unknown. We tested the hypothesis that white blood cell count, platelet count and/or fibrinogen at presentation may be applied as additional tools to standard clinical evaluation for pre-test risk assessment in patients at low probability of AAS. This was a retrospective observational study conducted on consecutive patients managed in our Emergency Department from 2009 to 2014 for suspected AAS. White blood cell count, platelet count and fibrinogen were assayed during evaluation in the Emergency Department. The final diagnosis was obtained by computed tomography angiography. The pre-test probability of AAS was defined according to guidelines. Of 1210 patients with suspected AAS, 1006 (83.1%) were classified at low probability, and 271 (22.4%) were diagnosed with AAS. Within patients at low probability, presence of at least one alteration among white blood cell count >9*10 3 /µl, platelet count probability, white blood cell count >9*10 3 /µl and platelet count probability, the estimated risk of AAS based on the number of alterations amongst white blood cell count >9*10 3 /µl and platelet count probability to fine-tune risk assessment of AAS.

What domains of clinical function should be assessed after sport-related concussion? A systematic review.

Science.gov (United States)

Feddermann-Demont, Nina; Echemendia, Ruben J; Schneider, Kathryn J; Solomon, Gary S; Hayden, K Alix; Turner, Michael; Dvořák, Jiří; Straumann, Dominik; Tarnutzer, Alexander A

2017-06-01

Sport-related concussion (SRC) is a clinical diagnosis made after a sport-related head trauma. Inconsistency exists regarding appropriate methods for assessing SRC, which focus largely on symptom-scores, neurocognitive functioning and postural stability. Systematic literature review. MEDLINE, EMBASE, PsycINFO, Cochrane-DSR, Cochrane CRCT, CINAHL, SPORTDiscus (accessed July 9, 2016). Original (prospective) studies reporting on postinjury assessment in a clinical setting and evaluation of diagnostic tools within 2 weeks after an SRC. Forty-six studies covering 3284 athletes were included out of 2170 articles. Only the prospective studies were considered for final analysis (n=33; 2416 athletes). Concussion diagnosis was typically made on the sideline by an (certified) athletic trainer (55.0%), mainly on the basis of results from a symptom-based questionnaire. Clinical domains affected included cognitive, vestibular and headache/migraine. Headache, fatigue, difficulty concentrating and dizziness were the symptoms most frequently reported. Neurocognitive testing was used in 30/33 studies (90.9%), whereas balance was assessed in 9/33 studies (27.3%). The overall quality of the studies was considered low. The absence of an objective, gold standard criterion makes the accurate diagnosis of SRC challenging. Current approaches tend to emphasise cognition, symptom assessment and postural stability with less of a focus on other domains of functioning. We propose that the clinical assessment of SRC should be symptom based and interdisciplinary. Whenever possible, the SRC assessment should incorporate neurological, vestibular, ocular motor, visual, neurocognitive, psychological and cervical aspects. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Web-based objective structured clinical examination with remote standardized patients and Skype: resident experience.

Science.gov (United States)

Langenau, Erik; Kachur, Elizabeth; Horber, Dot

2014-07-01

Using Skype and remote standardized patients (RSPs), investigators sought to evaluate user acceptance of a web-based objective structured clinical examination (OSCE) among resident physicians. After participating in four web-based clinical encounters addressing pain with RSPs, 59 residents from different training programs, disciplines and geographic locations completed a 52-item questionnaire regarding their experience with Skype and RSPs. Open-ended responses were solicited as well. The majority of participants (97%) agreed or strongly agreed the web-based format was convenient and a practical learning exercise, and 90% agreed or strongly agreed the format was effective in teaching communication skills. Although 93% agreed or strongly agreed they could communicate easily with RSPs using Skype, 80% preferred traditional face-to-face clinical encounters, and 58% reported technical difficulties during the encounters. Open-ended written responses supported survey results. Findings from this study expose challenges with technology and human factors, but positive experiences support the continued investigation of web-based OSCEs as a synchronous e-learning initiative for teaching and assessing doctor-patient communication. Such educational programs are valuable but unlikely to replace face-to-face encounters with patients. This web-based OSCE program provides physician learners with additional opportunity to improve doctor-patient communication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Teaching communication skills in clinical settings: comparing two applications of a comprehensive program with standardized and real patients.

Science.gov (United States)

Carvalho, Irene P; Pais, Vanessa G; Silva, Filipa R; Martins, Raquel; Figueiredo-Braga, Margarida; Pedrosa, Raquel; Almeida, Susana S; Correia, Luís; Ribeiro-Silva, Raquel; Castro-Vale, Ivone; Teles, Ana; Mota-Cardoso, Rui

2014-05-09

Communication is important for the quality of clinical practice, and programs have been implemented to improve healthcare providers' communication skills. However, the consistency of programs teaching communication skills has received little attention, and debate exists about the application of acquired skills to real patients. This study inspects whether (1) results from a communication program are replicated with different samples, and (2) results with standardized patients apply to interviews with real patients. A structured, nine-month communication program was applied in two consecutive years to two different samples of healthcare professionals (25 in the first year, 20 in the second year). Results were assessed at four different points in time, each year, regarding participants' confidence levels (self-rated), basic communication skills in interviews with standardized patients, and basic communication skills in interviews with real patients. Data were analyzed using GLM Repeated-Measures procedures. Improvements were statistically significant in both years in all measures except in simulated patients' assessment of the 2008 group. Differences between the two samples were non-significant. Differences between interviews with standardized and with real patients were also non-significant. The program's positive outcomes were replicated in different samples, and acquired skills were successfully applied to real-patient interviews. This reinforces this type of program structure as a valuable training tool, with results translating into real situations. It also adds to the reliability of the assessment instruments employed, though these may need adaptation in the case of real patients.

Clinical Significance: a Therapeutic Approach Topsychological Assessment in Treatment Planning

Directory of Open Access Journals (Sweden)

Afolabi Olusegun Emmanuel

2015-06-01

Full Text Available Psychological assessment has long been reported as a key component of clinical psychology. This paper examines the complexities surrounding the clinical significance of therapeutic approach to treatment planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed, 1 a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2 explained the conceptual meaning of clinical significant change in therapeutic assessment, 3 answered some of the questions regarding practicability and the clinical significance of therapeutic approach to treatment plans, particularly during or before treatment, 4 linked therapeutic assessment to change in clients’ clinical impression, functioning and therapeutic needs 5 analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the layman and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as ‘changed’ or ‘unchanged’ on the basis of clinical significance criteria.

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

Science.gov (United States)

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

Designing Standardized Patient Assessments to Measure SBIRT Skills

Science.gov (United States)

Wamsley, Maria A.; Julian, Katherine A.; O'Sullivan, Patricia; Satterfield, Jason M.; Satre, Derek D.; McCance-Katz, Elinore; Batki, Steven L.

2013-01-01

Objectives: Resident physicians report insufficient experience caring for patients with substance use disorders (SUDs). Resident training in Screening, Brief Intervention, and Referral to Treatment (SBIRT) has been recommended. We describe the development of a standardized patient (SP) assessment to measure SBIRT skills, resident perceptions of…

A Virtual Clinical Trial of FDG-PET Imaging of Breast Cancer: Effect of Variability on Response Assessment1

OpenAIRE

Harrison, Robert L; Elston, Brian F; Doot, Robert K; Lewellen, Thomas K; Mankoff, David A; Kinahan, Paul E

2014-01-01

INTRODUCTION: There is growing interest in using positron emission tomography (PET) standardized uptake values (SUVs) to assess tumor response to therapy. However, many error sources compromise the ability to detect SUV changes. We explore relationships between these errors and overall SUV variability. METHODS: We used simulations in a virtual clinical trial framework to study impacts of error sources from scanning and analysis effects on assessment of SUV changes. We varied tumor diameter, s...

Clinical assessment of the accuracy of blood glucose measurement devices.

Science.gov (United States)

Pfützner, Andreas; Mitri, Michael; Musholt, Petra B; Sachsenheimer, Daniela; Borchert, Marcus; Yap, Andrew; Forst, Thomas

2012-04-01

Blood glucose meters for patient self-measurement need to comply with the accuracy standards of the ISO 15197 guideline. We investigated the accuracy of the two new blood glucose meters BG*Star and iBG*Star (Sanofi-Aventis) in comparison to four other competitive devices (Accu-Chek Aviva, Roche Diagnostics; FreeStyle Freedom Lite, Abbott Medisense; Contour, Bayer; OneTouch Ultra 2, Lifescan) at different blood glucose ranges in a clinical setting with healthy subjects and patients with type 1 and type 2 diabetes. BGStar and iBGStar are employ dynamic electrochemistry, which is supposed to result in highly accurate results. The study was performed on 106 participants (53 female, 53 male, age (mean ± SD): 46 ± 16 years, type 1: 32 patients, type 2: 34 patients, and 40 healthy subjects). Two devices from each type and strips from two different production lots were used for glucose assessment (∼200 readings/meter). Spontaneous glucose assessments and glucose or insulin interventions under medical supervision were applied to perform measurements in the different glucose ranges in accordance with the ISO 15197 requirements. Sample values 400 mg/dL were prepared by laboratory manipulations. The YSI glucose analyzer (glucose oxidase method) served as the standard reference method which may be considered to be a limitation in light of glucose hexokinase-based meters. For all devices, there was a very close correlation between the glucose results compared to the YSI reference method results. The correlation coefficients were r = 0.995 for BGStar and r = 0.992 for iBGStar (Aviva: 0.995, Freedom Lite: 0.990, Contour: 0.993, Ultra 2: 0.990). Error-grid analysis according to Parkes and Clarke revealed both 100% of the readings to be within the clinically acceptable areas (Clarke: A + B with BG*Star (100 + 0), Aviva (97 + 3), and Contour (97 + 3); and 99.5% with iBG*Star (97.5 + 2), Freedom Lite (98 + 1.5), and Ultra 2 (97.5 + 2

Assessment of patient safety culture in clinical laboratories in the Spanish National Health System.

Science.gov (United States)

Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat

2015-01-01

There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.

The Definition of Pneumonia, the Assessment of Severity, and Clinical Standardization in the Pneumonia Etiology Research for Child Health Study

Science.gov (United States)

Wonodi, Chizoba; Moïsi, Jennifer C.; Deloria-Knoll, Maria; DeLuca, Andrea N.; Karron, Ruth A.; Bhat, Niranjan; Murdoch, David R.; Crawley, Jane; Levine, Orin S.; O’Brien, Katherine L.; Feikin, Daniel R.

2012-01-01

To develop a case definition for the Pneumonia Etiology Research for Child Health (PERCH) project, we sought a widely acceptable classification that was linked to existing pneumonia research and focused on very severe cases. We began with the World Health Organization’s classification of severe/very severe pneumonia and refined it through literature reviews and a 2-stage process of expert consultation. PERCH will study hospitalized children, aged 1–59 months, with pneumonia who present with cough or difficulty breathing and have either severe pneumonia (lower chest wall indrawing) or very severe pneumonia (central cyanosis, difficulty breastfeeding/drinking, vomiting everything, convulsions, lethargy, unconsciousness, or head nodding). It will exclude patients with recent hospitalization and children with wheeze whose indrawing resolves after bronchodilator therapy. The PERCH investigators agreed upon standard interpretations of the symptoms and signs. These will be maintained by a clinical standardization monitor who conducts repeated instruction at each site and by recurrent local training and testing. PMID:22403224

The Localized Scleroderma Cutaneous Assessment Tool: responsiveness to change in a pediatric clinical population.

Science.gov (United States)

Kelsey, Christina E; Torok, Kathryn S

2013-08-01

Lack of agreement on how to accurately capture disease outcomes in localized scleroderma (LS) has hindered the development of efficacious treatment protocols. The LS Cutaneous Assessment Tool (LoSCAT), consisting of the modified LS Skin Severity Index (mLoSSI) and the LS Damage Index, has potential for use in clinical trials. The goal of this article is to further evaluate the clinical responsiveness of the LoSCAT. Based on the modifiable nature of disease activity versus damage, we expected the mLoSSI to be responsive to change. At 2 study visits, a physician completed the LoSCAT and Physician Global Assessment (PGA) of Disease Activity and of Disease Damage for 29 patients with LS. Spearman correlations were used to examine the relationships between the change in the LoSCAT and the PGA scores. To evaluate contrasted group validity, patients were grouped according to disease activity classification and change scores of groups were compared. Minimal clinically important differences were calculated and compared with the standard error of measurement. Change in the mLoSSI score correlated strongly with change in the PGA of Disease Activity score, whereas change in the LS Damage Index score correlated weakly with change in the PGA of Disease Damage score. The mLoSSI and PGA of Disease Activity exhibited contrasted group validity. Minimal clinically important differences for the activity measures were greater than the respective standard errors of measurement. Only 2 study visits were included in analysis. This study gives further evidence that the LoSCAT, specifically the mLoSSI, is a responsive, valid measure of activity in LS and should be used in future treatment studies. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Training in Vocational Assessment: Preparing Rehabilitation Counselors and Meeting the Requirements of the CORE Standards

Science.gov (United States)

Tansey, Timothy N.

2008-01-01

Assessment represents a foundational component of rehabilitation counseling services. The revised Council on Rehabilitation Education (CORE) standards implemented in 2004 resulted in the redesign of the knowledge and outcomes under the Assessment standard. The author reviews the current CORE standard for training in assessment within the context…

Assessment of mental capacity to consent to treatment in anorexia nervosa: A comparison of clinical judgment and MacCAT-T and consequences for clinical practice.

Science.gov (United States)

Elzakkers, Isis F F M; Danner, Unna N; Grisso, Thomas; Hoek, Hans W; van Elburg, Annemarie A

Informed consent requires adequate mental capacity to consent to treatment. Mental capacity (MC) to consent to treatment refers to the ability to make medical decisions. MC is assessed in a general psychiatric interview, but this clinical assessment is known to overestimate mental capacity in patients and the inter rater reliability is low. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) has emerged as the gold standard to assess mental capacity to consent to treatment. The MacCAT-T is a semi-structured interview designed to aid clinicians in this assessment and has shown good inter rater reliability in patients with schizophrenia and other mental disorders, but has hardly been studied in patients with anorexia nervosa. Patients with anorexia nervosa (AN) regularly avoid treatment, even when severely ill and discussion includes assessing MC to consent to treatment. The aim of this study is to compare clinical judgment and the MacCAT-T in evaluating MC in patients with AN which in turn may influence use of the MacCAT-T in daily practice. In a sample of 70 consecutively referred severely ill patients with AN with a mean BMI of 15.5 kg/m 2 and a mean duration of illness of 8.6 years, clinical assessment of MC by experienced psychiatrists and the outcome of the MacCAT-T interview were compared. Agreement (κ-value) was calculated. Agreement between clinical assessment and outcome of the MacCAT-T was questionable (κ 0.23). Unlike in other psychiatric populations, clinicians judged a high proportion of patients with AN as having diminished MC. The MacCAT-T can be useful in assessing MC in AN when used in addition to clinical judgment to aid clinicians in complex cases. Why clinicians judge a relatively high proportion of patients with AN as having diminished MC, in contrast to lower proportions in other psychiatric disorders, is an area in need of further research. Copyright © 2018 Elsevier Ltd. All rights reserved.

Routine administration of standardized questionnaires that assess aspects of patients quality of life in medical oncology clinics: A systematic review

International Nuclear Information System (INIS)

Alsaleh, Kh.

2013-01-01

Purpose: Increasing interest in the Quality of Life outcomes in cancer patients led to increase implementation of their use in routine clinical practice. The aim of this systemic review is to review the scientific evidence behind recommending the use of quality of life (QoL) scales routinely in outpatient evaluation. Methods: Systematic review for all published randomized controlled trials in English language between January 1, 1990 till December 31, 2012. Out of 487 articles (476 identified by electronic search + 11 articles identified by manual search), six trials satisfied the eligibility criteria: (1) the study was a randomized controlled trial (RCT) with randomization of patients or health care providers; (2) the findings of the administered questionnaire or scale (the intervention) were given to health care provider, and compared to standard care with no questionnaire administered (the control); (3) study was conducted in outpatient oncology clinics; and (4) an outcome was measured that related to (i) QoL improvement, (ii) reduction in morbidity, (iii) reduction in stress for the patients, (iv) improvement in communication between patients and health care provider, or (v) improved patient satisfaction. Assessment for the quality of the study was done using the GRADE methodology. Results: Serious methodological issues were affecting most of the trials. Overall the evaluation of the quality of the evidence from these identified trials suggests that there is a weak recommendation to use QoL scales in routine oncology practice to improve communication between physicians and patients. Conclusion: The routine use of such tools in the outpatient settings at improving the patient outcome or satisfaction cannot be recommended based on the available evidence. The potential harm with the excess use of resources needed to implement, collect, store, analyse, and present such data to health care providers should be also considered. Further research and better designed

Puzzle test: A tool for non-analytical clinical reasoning assessment.

Science.gov (United States)

Monajemi, Alireza; Yaghmaei, Minoo

2016-01-01

Most contemporary clinical reasoning tests typically assess non-automatic thinking. Therefore, a test is needed to measure automatic reasoning or pattern recognition, which has been largely neglected in clinical reasoning tests. The Puzzle Test (PT) is dedicated to assess automatic clinical reasoning in routine situations. This test has been introduced first in 2009 by Monajemi et al in the Olympiad for Medical Sciences Students.PT is an item format that has gained acceptance in medical education, but no detailed guidelines exist for this test's format, construction and scoring. In this article, a format is described and the steps to prepare and administer valid and reliable PTs are presented. PT examines a specific clinical reasoning task: Pattern recognition. PT does not replace other clinical reasoning assessment tools. However, it complements them in strategies for assessing comprehensive clinical reasoning.

Meeting the challenge of assessing clinical competence of occupational therapists within a program management environment.

Science.gov (United States)

Salvatori, Penny; Simonavicius, Nijole; Moore, Joan; Rimmer, Georgina; Patterson, Michele

2008-02-01

Program management models have raised concerns among occupational therapists about professional standards related to clinical competence, performance review procedures, and quality improvement initiatives. This paper describes how a chart-stimulated recall (CSR) peer-review process and interview tool was revised, implemented, and evaluated as a pilot project to assess the clinical competence of occupational therapy staff at a large urban health centre in southern Ontario. Fourteen pairs (n=28) of occupational therapists representing various practice areas participated in this project. Half served as peer assessors and half as interviewees. Peer assessors conducted an independent chart review followed by a one-hour personal interview with a peer partner to discuss clinical management issues related to the client cases. Each interviewer rated his or her partner's clinical competence in eight areas of performance using a 7-point Likert scale. Results indicated that the CSR tool could discriminate among occupational therapists in terms of overall levels of clinical competence and also identify specific areas of concern that could be targeted for professional development. Feedback from participants was positive. The CSR tool was found to be useful for assessing clinical competence of occupational therapists in this large health centre as a quality improvement initiative within that discipline group. Further research is needed to establish the reliability and validity of the CSR tool.

Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments.

Science.gov (United States)

Maccall, Steven L

2006-04-01

The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log "hit" during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non-North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of Web server data warrant an exploratory assessment. This

Objective structured clinical examination for undergraduates: Is it a feasible approach to standardized assessment in India?

Directory of Open Access Journals (Sweden)

Kavita R Bhatnagar

2011-01-01

Full Text Available Background: There has been a growing concern among medical educators about the quality of medical graduates trained in various medical colleges in our country. Data based on the faculty and student perceptions of undergraduate curriculum indicate a need for laying more stress on practical skills during their training and assessment. The Objective Structured Clinical Examination (OSCE is a reliable and an established and effective multistation test for the assessment of practical skills in an objective and a transparent manner. The aim of this article is to sensitize universities, examiners, organizers, faculty, and students across India to OSCE. Materials and Methods: We designed an assessment based on 22-station OSCE and administered it to 67 students during their final year, integrating all the domains of learning, that is higher order cognitive domain, psychomotor domain, and affective domain. Data analysis was done using SPSS version 15. Results: The OSCE was feasible to conduct and had high perceived construct validity. There was a significant correlation between the station score and total examination score for 19 stations. The reliability of this OSCE was 0.778. Both students and faculty members expressed a high degree of satisfaction with the format. Conclusion: Integrating a range of modalities into an OSCE in ophthalmology appears to represent a valid and reliable method of examination. The biggest limitation with this format was the direct expenditure of time and energy of those organizing an OSCE; therefore, sustaining the motivation of faculty might pose a challenge.

Assessment set for evaluation of clinical outcomes in multiple sclerosis: psychometric properties

Directory of Open Access Journals (Sweden)

Rasova K

2012-10-01

Full Text Available Kamila Rasova,1 Patricia Martinkova,2 Jana Vyskotova,3 Michaela Sedova21Department of Rehabilitation, 3rd Faculty of Medicine, Charles University in Prague and Faculty Hospital Královské Vinohrady, Prague, Czech Republic; 2Center of Biomedical Informatics and Department of Medical Informatics and Biostatistics, Institute of Computer Science, AS CR, Prague, Czech Republic; 3Faculty of Medicine, Ostrava University, Ostrava, Czech RepublicPurpose: Multiple sclerosis (MS manifests itself in a wide range of symptoms. Physiotherapy plays an important role in the treatment of those symptoms connected with mobility. For this therapy to be at its most effective it should be based on a systematic examination that is able to describe and classify damaged clinical functions meaningfully. The purpose of this study was to develop and validate a battery of tests and composite tests that can be used to systematically evaluate clinical features of MS treatable by physiotherapy.Methods: The authors assembled a proposed battery of tests comprising known, standard, and validated assessments (low-contrast letter acuity testing; the Motricity Index; the Modified Ashworth Scale; the Berg Balance Scale; scales of postural reactions, tremor, dysdiadochokinesia, and dysmetria; the Nine-Hole Peg Test; the Timed 25-Foot Walk; and the 3-minute version of the Paced Auditory Serial Addition Test and one test (knee hyperextension of the authors’ own. Normalization was calculated and six composite assessments were measured. Seventeen ambulatory subjects with MS were tested twice with the assessment set before undergoing physiotherapy, and 12 were also tested with the assessment set after the physiotherapy. The test–retest reliability, stability, internal consistency of composite measurements, sensitivity to changes after therapy, and correlation between measurements and the Kurtzke Expanded Disability Status Scale score were evaluated for all tests in the assessment set

[Changes in clinical standards and the need for adjusting legal standards of care from the point of view of civil law].

Science.gov (United States)

Rosenberger, Rainer

2007-01-01

The legal standard of medical care is laid down in Sect. 276 of the German Civil Code (principle of due diligence). It applies to both contractual and tortious liability and likewise to the treatment of patients insured under the statutory health insurance scheme and self-payers. The legal standard of care conforms to the clinical standards because medical liability means medical professional liability. Liability law does not distinguish between different standards of care in the treatment of patients insured under the statutory health insurance scheme on the one hand and privately insured patients on the other. Changes in clinical standards immediately affect liability law without the need for formal adaptation of the legal standard of care. Liability law cannot claim more diligence than that owed from a medical point of view. Legislative changes that result in a lowering of medical standards (reduction in the quality of treatment) will have to be accepted by liability law, even if these are regulations pertaining to Social Law (SGB V, Book 5 of the German Social Code). In this respect, the principle of legal unity applies. In consideration of this kind of changes the due diligence requirements for the treatment of patients insured under the statutory health insurance scheme and privately insured patients remain basically equal. If these changes lead to an increase of risk for the patient, the resulting liabilities are not to be attributed to the therapist. What remains to be seen is whether there will be an increased attempt to minimise risk by "additionally purchasing health care services".

Clinical application of Assessment of Parenting Competencies (APC)

DEFF Research Database (Denmark)

Jacobsen, Stine Lindahl

This paper is part of a symposium on music therapy with families with Kirsi Tuomi as Chair. It revolves around the clinical application of a new music therapy assessment model on parent-child interaction and parenting competencies. APC was developed for emotional neglected children and their pare......This paper is part of a symposium on music therapy with families with Kirsi Tuomi as Chair. It revolves around the clinical application of a new music therapy assessment model on parent-child interaction and parenting competencies. APC was developed for emotional neglected children......, child somatic hospitals, centers for refuges and other populations where it would be clinical relevant to assess the parent-child interaction. APC is an observational and improvisational based assessment model evaluating dyads of parent and child (child age range is 5-12). It produces information...... (numbers, graphs, and descriptions) of parent-child interaction and parenting competencies including nonverbal communication, level of attunement in the dyad, and level of emotional support from the parent. It is based on video analysis and a fixed assessment protocol. It was developed through a completed...

Research progress of motor function assessments and their clinical applications in Duchenne muscular dystrophy

Directory of Open Access Journals (Sweden)

Wei SHI

2015-07-01

Full Text Available Duchenne muscular dystrophy (DMD, clinically featured as progressive skeletal muscle atrophy with gradual loss of muscle strength and activity abilities, is the most common genetic muscular disease in children throughout the world. The core and continuous characteristic of DMD is motor dysfunction. Motor function assessments of DMD are now focusing on muscle strength, walking ability, range of motion and ability of activities, still without unified standards. Confirming the comprehensive, scientific, reasonable and accurate evaluation tools for DMD assessment is the premise of research in motor developmental rules of DMD, which will help to better understand the motor progress of DMD and to supply evidences for choosing treatment methods, confirming timing of intervention, assessing effect of treatments and designing rehabilitation plans. DOI: 10.3969/j.issn.1672-6731.2015.06.002

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

Science.gov (United States)

Marson, Daniel

2016-09-01

The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Convergence or Divergence: Alignment of Standards, Assessment, and Issues of Diversity.

Science.gov (United States)

Carter, Norvella, Ed.

In this report, teacher educators scrutinize the relationships between the standards and assessment movement in education and the United States' increasingly multicultural population. The papers include: "Foreword" (Jacqueline Jordan Irvine); (1) "Diversity and Standards: Defining the Issues" (Norvella P. Carter); (2) "Accountability and…

Assess of the Status of the Karaj Operating Rooms in Comparison with International Standards in 2011

Directory of Open Access Journals (Sweden)

M.H. Naseri

2012-10-01

Full Text Available Background: Because of making money, the operating room (OR is known as the beating heart of any clinical & health center. The effective and regular activity of the operating room guarantees a sustainable income for the hospital. So, in order to provide high quality treatment and care services, and to save the health and safety of OR staff, exploiting standard equipments and spaces as well as employing professional and skilled personnel is necessary. This study was aimed to assess the status of the Karaj operating rooms from physical, safety, sterilization, staffing and equipment aspects in comparison to the International Standards. Methods: This sectional descriptive study was conducted in Alborz University of Medical Sciences in 2011. Samples were 10 operating room wards from 10 surgical hospitals. Data were collected by a 70 items check-list at 5 fields of physical, safety, sterilization, staffing and equipment conditions and then compared to the international standards. The data were recorded in SPSS software and analyzed by statistical methods. Results: The results showed that compared to the international standards, the physical aspect was 60.5%, safety aspect 66%, sterilization aspect 68%, staffing aspect 63%, and equipment aspect was 80% close to the standard criteria. On the whole, in 10 assessed hospitals, equipment aspect with 80% had the best and the physical aspect with 60.5% had the worst conditions respectively. Conclusion: Due to admission in different medical and paramedical programs in Alborz University of Medical Sciences, renovation of the ORs is essential for training skilled students. Considering the results of this study could help the University authorities to improve the current condition.

Standardized computer-based organized reporting of EEG SCORE - Second version

DEFF Research Database (Denmark)

Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C

2017-01-01

Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted in the se......Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted...... in the second, revised version of SCORE (Standardized Computer-based Organized Reporting of EEG), which is presented in this paper. The revised terminology was implemented in a software package (SCORE EEG), which was tested in clinical practice on 12,160 EEG recordings. Standardized terms implemented in SCORE....... In the end, the diagnostic significance is scored, using a standardized list of terms. SCORE has specific modules for scoring seizures (including seizure semiology and ictal EEG patterns), neonatal recordings (including features specific for this age group), and for Critical Care EEG Terminology. SCORE...

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

Science.gov (United States)

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.

Comparing Panelists' Understanding of Standard Setting across Multiple Levels of an Alternate Science Assessment

Science.gov (United States)

Hansen, Mary A.; Lyon, Steven R.; Heh, Peter; Zigmond, Naomi

2013-01-01

Large-scale assessment programs, including alternate assessments based on alternate achievement standards (AA-AAS), must provide evidence of technical quality and validity. This study provides information about the technical quality of one AA-AAS by evaluating the standard setting for the science component. The assessment was designed to have…

Simulation with standardized patients to prepare undergraduate nursing students for mental health clinical practice: An integrative literature review.

Science.gov (United States)

Øgård-Repål, Anita; De Presno, Åsne Knutson; Fossum, Mariann

2018-04-22

To evaluate the available evidence supporting the efficacy of using simulation with standardized patients to prepare nursing students for mental health clinical practice. Integrative literature review. A systematic search of the electronic databases CINAHL (EBSCOhost), Embase, MEDLINE, PsycINFO, and SveMed+ was conducted to identify empirical studies published until November 2016. Multiple search terms were used. Original empirical studies published in English and exploring undergraduate nursing students' experiences of simulation with standardized patients as preparation for mental health nursing practice were included. A search of reference lists and gray literature was also conducted. In total, 1677 studies were retrieved; the full texts of 78 were screened by 2 of the authors, and 6 studies reminded in the review. The authors independently reviewed the studies in three stages by screening the titles, abstracts, and full texts, and the quality of the included studies was assessed in the final stage. Design-specific checklists were used for quality appraisal. The thematic synthesizing method was used to summarize the findings of the included studies. The studies used four different research designs, both qualitative and quantitative. All studies scored fairly low in the quality appraisal. The five themes identified were enhanced confidence, clinical skills, anxiety regarding the unknown, demystification, and self-awareness. The findings of this study indicate that simulation with standardized patients could decrease students' anxiety level, shatter pre-assumptions, and increase self-confidence and self-awareness before entering clinical practice in mental health. More high-quality studies with larger sample sizes are required because of the limited evidence provided by the six studies in the present review. Copyright © 2018 Elsevier Ltd. All rights reserved.

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

Science.gov (United States)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

Science.gov (United States)

Winters, Ken

1990-01-01

Discusses relevant research findings of clinical assessment of adolescent chemical dependency so that service providers can better address these concerns. Three major issues are discussed: the definition of adolescent chemical dependency, clinical domains of assessment (chemical use problem severity, precipitating and perpetuating risk factors,…

Teaching communication skills in clinical settings: comparing two applications of a comprehensive program with standardized and real patients

Science.gov (United States)

2014-01-01

Background Communication is important for the quality of clinical practice, and programs have been implemented to improve healthcare providers’ communication skills. However, the consistency of programs teaching communication skills has received little attention, and debate exists about the application of acquired skills to real patients. This study inspects whether (1) results from a communication program are replicated with different samples, and (2) results with standardized patients apply to interviews with real patients. Methods A structured, nine-month communication program was applied in two consecutive years to two different samples of healthcare professionals (25 in the first year, 20 in the second year). Results were assessed at four different points in time, each year, regarding participants’ confidence levels (self-rated), basic communication skills in interviews with standardized patients, and basic communication skills in interviews with real patients. Data were analyzed using GLM Repeated-Measures procedures. Results Improvements were statistically significant in both years in all measures except in simulated patients’ assessment of the 2008 group. Differences between the two samples were non-significant. Differences between interviews with standardized and with real patients were also non-significant. Conclusions The program’s positive outcomes were replicated in different samples, and acquired skills were successfully applied to real-patient interviews. This reinforces this type of program structure as a valuable training tool, with results translating into real situations. It also adds to the reliability of the assessment instruments employed, though these may need adaptation in the case of real patients. PMID:24886341

A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics.

Science.gov (United States)

Bhavnani, Sanjeev P; Sola, Srikanth; Adams, David; Venkateshvaran, Ashwin; Dash, P K; Sengupta, Partho P

2018-04-01

This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD). Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated. A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year. An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Xpand chest drain: assessing equivalence to current standard ...

African Journals Online (AJOL)

leakage from 'open to air' system or breakage of glass bottle (with associated risk to ... and an air-leak detection system. It is connected to a ... need to add water. Xpand chest drain: assessing equivalence to current standard therapy – a randomised controlled trial. CHARL COOPER, M.B. CH.B. TIMOTHY HARDCASTLE ...

A clinical assessment tool used for physiotherapy students--is it reliable?

Science.gov (United States)

Lewis, Lucy K; Stiller, Kathy; Hardy, Frances

2008-01-01

Educational institutions providing professional programs such as physiotherapy must provide high-quality student assessment procedures. To ensure that assessment is consistent, assessment tools should have an acceptable level of reliability. There is a paucity of research evaluating the reliability of clinical assessment tools used for physiotherapy students. This study evaluated the inter- and intrarater reliability of an assessment tool used for physiotherapy students during a clinical placement. Five clinical educators and one academic participated in the study. Each rater independently marked 22 student written assessments that had been completed by students after viewing a videotaped patient physiotherapy assessment. The raters repeated the marking process 7 weeks later, with the assessments provided in a randomised order. The interrater reliability (Intraclass Correlation Coefficient) for the total scores was 0.32, representing a poor level of reliability. A high level of intrarater reliability (percentage agreement) was found for the clinical educators, with a difference in section scores of one mark or less on 93.4% of occasions. Further research should be undertaken to reevaluate the reliability of this clinical assessment tool following training. The reliability of clinical assessment tools used in other areas of physiotherapy education should be formally measured rather than assumed.

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

Science.gov (United States)

Schnyer, Rosa N; Allen, John J B

2002-10-01

An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

Medical school clinical placements - the optimal method for assessing the clinical educational environment from a graduate entry perspective.

Science.gov (United States)

Hyde, Sarah; Hannigan, Ailish; Dornan, Tim; McGrath, Deirdre

2018-01-05

Educational environment is a strong determinant of student satisfaction and achievement. The learning environments of medical students on clinical placements are busy workplaces, composed of many variables. There is no universally accepted method of evaluating the clinical learning environment, nor is there consensus on what concepts or aspects should be measured. The aims of this study were to compare the Dundee ready educational environment measure (DREEM - the current de facto standard) and the more recently developed Manchester clinical placement index (MCPI) for the assessment of the clinical learning environment in a graduate entry medical student cohort by correlating the scores of each and analysing free text comments. This study also explored student perceptionof how the clinical educational environment is assessed. An online, anonymous survey comprising of both the DREEM and MCPI instruments was delivered to students on clinical placement in a graduate entry medical school. Additional questions explored students' perceptions of instruments for giving feedback. Numeric variables (DREEM score, MCPI score, ratings) were tested for normality and summarised. Pearson's correlation coefficient was used to measure the strength of the association between total DREEM score and total MCPI scores. Thematic analysis was used to analyse the free text comments. The overall response rate to the questionnaire was 67% (n = 180), with a completed response rate for the MCPI of 60% (n = 161) and for the DREEM of 58% (n = 154). There was a strong, positive correlation between total DREEM and MCPI scores (r = 0.71, p < 0.001). On a scale of 0 to 7, the mean rating for how worthwhile students found completing the DREEM was 3.27 (SD 1.41) and for the MCPI was 3.49 (SD 1.57). 'Finding balance' and 'learning at work' were among the themes to emerge from analysis of free text comments. The present study confirms that DREEM and MCPI total scores are strongly correlated

Multislice computed tomography: angiographic emulation versus standard assessment for detection of coronary stenoses

Energy Technology Data Exchange (ETDEWEB)

Schnapauff, Dirk; Hamm, Bernd; Dewey, Marc [Humboldt-Universitaet zu Berlin, Department of Radiology, Charite - Universitaetsmedizin Berlin, Chariteplatz 1, P.O. Box 10098, Berlin (Germany); Duebel, Hans-Peter; Baumann, Gert [Charite - Universitaetsmedizin Berlin, Department of Cardiology, Berlin (Germany); Scholze, Juergen [Charite - Universitaetsmedizin Berlin, Charite Outpatient Centre, Berlin (Germany)

2007-07-15

The present study investigated angiographic emulation of multislice computed tomography (MSCT) (catheter-like visualization) as an alternative approach of analyzing and visualizing findings in comparison with standard assessment. Thirty patients (120 coronary arteries) were randomly selected from 90 prospectively investigated patients with suspected coronary artery disease who underwent MSCT (16-slice scanner, 0.5 mm collimation, 400 ms rotation time) prior to conventional coronary angiography for comparison of both approaches. Sensitivity and specificity of angiographic emulation [81% (26/32) and 93% (82/88)] were not significantly different from those of standard assessment [88% (28/32) and 99% (87/88)], while the per-case analysis time was significantly shorter for angiographic emulation than for standard assessment (3.4 {+-} 1.5 vs 7.0 {+-} 2.5 min, P < 0.001). Both interventional and referring cardiologists preferred angiographic emulation over standard curved multiplanar reformations of MSCT coronary angiography for illustration, mainly because of improved overall lucidity and depiction of sidebranches (P < 0.001). In conclusion, angiographic emulation of MSCT reduces analysis time, yields a diagnostic accuracy comparable to that of standard assessment, and is preferred by cardiologists for visualization of results. (orig.)

A comparative study on assessment procedures and metric properties of two scoring systems of the Coma Recovery Scale-Revised items: standard and modified scores.

Science.gov (United States)

Sattin, Davide; Lovaglio, Piergiorgio; Brenna, Greta; Covelli, Venusia; Rossi Sebastiano, Davide; Duran, Dunja; Minati, Ludovico; Giovannetti, Ambra Mara; Rosazza, Cristina; Bersano, Anna; Nigri, Anna; Ferraro, Stefania; Leonardi, Matilde

2017-09-01

The study compared the metric characteristics (discriminant capacity and factorial structure) of two different methods for scoring the items of the Coma Recovery Scale-Revised and it analysed scale scores collected using the standard assessment procedure and a new proposed method. Cross sectional design/methodological study. Inpatient, neurological unit. A total of 153 patients with disorders of consciousness were consecutively enrolled between 2011 and 2013. All patients were assessed with the Coma Recovery Scale-Revised using standard (rater 1) and inverted (rater 2) procedures. Coma Recovery Scale-Revised score, number of cognitive and reflex behaviours and diagnosis. Regarding patient assessment, rater 1 using standard and rater 2 using inverted procedures obtained the same best scores for each subscale of the Coma Recovery Scale-Revised for all patients, so no clinical (and statistical) difference was found between the two procedures. In 11 patients (7.7%), rater 2 noted that some Coma Recovery Scale-Revised codified behavioural responses were not found during assessment, although higher response categories were present. A total of 51 (36%) patients presented the same Coma Recovery Scale-Revised scores of 7 or 8 using a standard score, whereas no overlap was found using the modified score. Unidimensionality was confirmed for both score systems. The Coma Recovery Scale Modified Score showed a higher discriminant capacity than the standard score and a monofactorial structure was also supported. The inverted assessment procedure could be a useful evaluation method for the assessment of patients with disorder of consciousness diagnosis.

Validation and clinical significance of the Childhood Myositis Assessment Scale for assessment of muscle function in the juvenile idiopathic inflammatory myopathies.

Science.gov (United States)

Huber, Adam M; Feldman, Brian M; Rennebohm, Robert M; Hicks, Jeanne E; Lindsley, Carol B; Perez, Maria D; Zemel, Lawrence S; Wallace, Carol A; Ballinger, Susan H; Passo, Murray H; Reed, Ann M; Summers, Ronald M; White, Patience H; Katona, Ildy M; Miller, Frederick W; Lachenbruch, Peter A; Rider, Lisa G

2004-05-01

To examine the measurement characteristics of the Childhood Myositis Assessment Scale (CMAS) in children with juvenile idiopathic inflammatory myopathy (juvenile IIM), and to obtain preliminary data on the clinical significance of CMAS scores. One hundred eight children with juvenile IIM were evaluated on 2 occasions, 7-9 months apart, using various measures of physical function, strength, and disease activity. Interrater reliability, construct validity, and responsiveness of the CMAS were examined. The minimum clinically important difference (MID) and CMAS scores corresponding to various degrees of physical disability were estimated. The intraclass correlation coefficient for 26 patients assessed by 2 examiners was 0.89, indicating very good interrater reliability. The CMAS score correlated highly with the Childhood Health Assessment Questionnaire (C-HAQ) score and with findings on manual muscle testing (MMT) (r(s) = -0.73 and 0.73, respectively) and moderately with physician-assessed global disease activity and skin activity, parent-assessed global disease severity, and muscle magnetic resonance imaging (r(s) = -0.44 to -0.61), thereby demonstrating good construct validity. The standardized response mean was 0.81 (95% confidence interval 0.53, 1.09) in patients with at least 0.8 cm improvement on a 10-cm visual analog scale for physician-assessed global disease activity, indicating strong responsiveness. In bivariate regression models predicting physician-assessed global disease activity, MMT remained significant in models containing the CMAS (P = 0.03) while the C-HAQ did not (P = 0.4). Estimates of the MID ranged from 1.5 to 3.0 points on a 0-52-point scale. CMAS scores corresponding to no, mild, mild-to-moderate, and moderate physical disability, respectively, were 48, 45, 39, and 30. The CMAS exhibits good reliability, construct validity, and responsiveness, and is therefore a valid instrument for the assessment of physical function, muscle strength, and

Higher Education Quality Assessment Model: Towards Achieving Educational Quality Standard

Science.gov (United States)

Noaman, Amin Y.; Ragab, Abdul Hamid M.; Madbouly, Ayman I.; Khedra, Ahmed M.; Fayoumi, Ayman G.

2017-01-01

This paper presents a developed higher education quality assessment model (HEQAM) that can be applied for enhancement of university services. This is because there is no universal unified quality standard model that can be used to assess the quality criteria of higher education institutes. The analytical hierarchy process is used to identify the…

DIFFERENCES IN MANAGER ASSESSMENTS OF ISO 14000 STANDARD IMPLEMENTATION IN TURKEY

Directory of Open Access Journals (Sweden)

Sıtkı Gözlü

2005-12-01

Full Text Available This study reports the results of a survey about the improvements achieved as result of ISO 14000 Environmental Management System (EMS standard implementation and the differences of improvements with respect to firm characteristics. A survey has been conducted in order to explain the improvements related to environmental management process and overall firm performance. The survey involved sixty-six enterprises implementing ISO 14000 EMS standard in Turkey. In order to assess improvements obtained from ISO 14000 EMS implementation, statements related to environmental management process and overall firm performance indicators have been prepared. The statements in this study are relevant to previous research. A factor analysis was employed to determine the factors of the variables explaining improvements. Nine factors have been identified related to achieved improvements, such as establishment of pro-active environmental management system, effectiveness in resource utilization, effectiveness of process control, relationships with industry and government, meeting expectations of stakeholders, demonstration of social responsibility, profitability, productivity, and competitiveness. Then, a T- test was conducted to determine the differences of managers’ assessments with respect to certain firm characteristics. The findings have shown that there are differences in the assessments of improvements achieved as a result of ISO 14000 EMS standard implementation with respect to sales volume, foreign-capital possession, and ISO 14000 EMS standard implementation. On the other hand, industrial sector, age of establishment, and export orientation are not statistically significant for the differences in the assessments of improvements.

76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

Science.gov (United States)

2011-08-19

... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

Examination to assess the clinical examination and documentation of spine pathology among orthopedic residents.

Science.gov (United States)

Haglin, Jack M; Zeller, John L; Egol, Kenneth A; Phillips, Donna P

2017-12-01

The Accreditation Council for Graduate Medical Education (ACGME) guidelines requires residency programs to teach and evaluate residents in six overarching "core competencies" and document progress through educational milestones. To assess the progress of orthopedic interns' skills in performing a history, physical examination, and documentation of the encounter for a standardized patient with spinal stenosis, an objective structured clinical examination (OSCE) was conducted for 13 orthopedic intern residents, following a 1-month boot camp that included communications skills and curriculum in history and physical examination. Interns were objectively scored based on their performance of the physical examination, communication skills, completeness and accuracy of their electronic medical record (EMR), and their diagnostic conclusions gleaned from the patient encounter. The purpose of this study was to meaningfully assess the clinical skills of orthopedic post-graduate year (PGY)-1 interns. The findings can be used to develop a standardized curriculum for documenting patient encounters and highlight common areas of weakness among orthopedic interns with regard to the spine history and physical examination and conducting complete and accurate clinical documentation. A major orthopedic specialty hospital and academic medical center. Thirteen PGY-1 orthopedic residents participated in the OSCE with the same standardized patient presenting with symptoms and radiographs consistent with spinal stenosis. Videos of the encounters were independently viewed and objectively evaluated by one investigator in the study. This evaluation focused on the completeness of the history and the performance and completion of the physical examination. The standardized patient evaluated the communication skills of each intern with a separate objective evaluation. Interns completed these same scoring guides to evaluate their own performance in history, physical examination, and communications

Development and Psychometric Properties of the Standardized Assessment of Severity of Personality Disorder (SASPD).

Science.gov (United States)

Olajide, Kike; Munjiza, Jasna; Moran, Paul; O'Connell, Lesley; Newton-Howes, Giles; Bassett, Paul; Akintomide, Gbolagade; Ng, Nicola; Tyrer, Peter; Mulder, Roger; Crawford, Mike J

2018-02-01

Personality disorder (PD) is increasingly categorized according to its severity, but there is no simple way to screen for severity according to ICD-11 criteria. We set out to develop the Standardized Assessment of Severity of Personality Disorder (SASPD). A total of 110 patients completed the SASPD together with a clinical assessment of the severity of personality disorder. We examined the predictive ability of the SASPD using the area under the ROC curve (AUC). Two to four weeks later, 43 patients repeated the SASPD to examine reliability. The SASPD had good predictive ability for determining mild (AUC = 0.86) and moderate (AUC = 0.84) PD at cut points of 8 and 10, respectively. Test-retest reliability of the SASPD was high (intraclass correlation coefficient = 0.93, 95% CI [0.88, 0.96]). The SASPD thus provides a simple, brief, and reliable indicator of the presence of mild or moderate PD according to ICD-11 criteria.

Standardized handwriting to assess bradykinesia, micrographia and tremor in Parkinson's disease.

Directory of Open Access Journals (Sweden)

Esther J Smits

Full Text Available OBJECTIVE: To assess whether standardized handwriting can provide quantitative measures to distinguish patients diagnosed with Parkinson's disease from age- and gender-matched healthy control participants. DESIGN: Exploratory study. Pen tip trajectories were recorded during circle, spiral and line drawing and repeated character 'elelelel' and sentence writing, performed by Parkinson patients and healthy control participants. Parkinson patients were tested after overnight withdrawal of anti-Parkinsonian medication. SETTING: University Medical Center Groningen, tertiary care, the Netherlands. PARTICIPANTS: Patients with Parkinson's disease (n = 10; mean age 69.0 years; 6 male and healthy controls (n = 10; mean age 68.1 years; 6 male. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Movement time and velocity to detect bradykinesia and the size of writing to detect micrographia. A rest recording to investigate the presence of a rest-tremor, by frequency analysis. RESULTS: Mean disease duration in the Parkinson group was 4.4 years and the patients were in modified Hoehn-Yahr stages 1-2.5. In general, Parkinson patients were slower than healthy control participants. Median time per repetition, median velocity and median acceleration of the sentence task and median velocity of the elel task differed significantly between Parkinson patients and healthy control participants (all p<0.0014. Parkinson patients also wrote smaller than healthy control participants and the width of the 'e' in the elel task was significantly smaller in Parkinson patients compared to healthy control participants (p<0.0014. A rest-tremor was detected in the three patients who were clinically assessed as having rest-tremor. CONCLUSIONS: This study shows that standardized handwriting can provide objective measures for bradykinesia, tremor and micrographia to distinguish Parkinson patients from healthy control participants.

Safety standards for near surface disposal and the safety case and supporting safety assessment for demonstrating compliance with the standards

International Nuclear Information System (INIS)

Metcalf, P.

2003-01-01

The report presents the safety standards for near surface disposal (ICRP guidance and IAEA standards) and the safety case and supporting safety assessment for demonstrating compliance with the standards. Special attention is paid to the recommendations for disposal of long-lived solid radioactive waste. The requirements are based on the principle for the same level of protection of future individuals as for the current generation. Two types of exposure are considered: human intrusion and natural processes and protection measures are discussed. Safety requirements for near surface disposal are discussed including requirements for protection of human health and environment, requirements or safety assessments, waste acceptance and requirements etc

Quality standards for bone conduction implants.

Science.gov (United States)

Gavilan, Javier; Adunka, Oliver; Agrawal, Sumit; Atlas, Marcus; Baumgartner, Wolf-Dieter; Brill, Stefan; Bruce, Iain; Buchman, Craig; Caversaccio, Marco; De Bodt, Marc T; Dillon, Meg; Godey, Benoit; Green, Kevin; Gstoettner, Wolfgang; Hagen, Rudolf; Hagr, Abdulrahman; Han, Demin; Kameswaran, Mohan; Karltorp, Eva; Kompis, Martin; Kuzovkov, Vlad; Lassaletta, Luis; Li, Yongxin; Lorens, Artur; Martin, Jane; Manoj, Manikoth; Mertens, Griet; Mlynski, Robert; Mueller, Joachim; O'Driscoll, Martin; Parnes, Lorne; Pulibalathingal, Sasidharan; Radeloff, Andreas; Raine, Christopher H; Rajan, Gunesh; Rajeswaran, Ranjith; Schmutzhard, Joachim; Skarzynski, Henryk; Skarzynski, Piotr; Sprinzl, Georg; Staecker, Hinrich; Stephan, Kurt; Sugarova, Serafima; Tavora, Dayse; Usami, Shin-Ichi; Yanov, Yuri; Zernotti, Mario; Zorowka, Patrick; de Heyning, Paul Van

2015-01-01

Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

Health impact assessment in the United States: Has practice followed standards?

International Nuclear Information System (INIS)

Schuchter, Joseph; Bhatia, Rajiv; Corburn, Jason; Seto, Edmund

2014-01-01

As an emerging practice, Health Impact Assessment is heterogeneous in purpose, form, and scope and applied in a wide range of decision contexts. This heterogeneity challenges efforts to evaluate the quality and impact of practice. We examined whether information in completed HIA reports reflected objectively-evaluable criteria proposed by the North American HIA Practice Standards Working Group in 2009. From publically-available reports of HIAs conducted in the U.S. and published from 2009 to 2011, we excluded those that were components of, or comment letters on, Environmental Impact Assessments (5) or were demonstration projects or student exercises (8). For the remaining 23 reports, we used practice standards as a template to abstract data on the steps of HIA, including details on the rationale, authorship, funding, decision and decision-makers, participation, pathways and methods, quality of evidence, and recommendations. Most reports described screening, scoping, and assessment processes, but there was substantial variation in the extent of these processes and the degree of stakeholder participation. Community stakeholders participated in screening or scoping in just two-thirds of the HIAs (16). On average, these HIAs analyzed 5.5 determinants related to 10.6 health impacts. Most HIA reports did not include evaluation or monitoring plans. This study identifies issues for field development and improvement. The standards might be adapted to better account for variability in resources, produce fit-for-purpose HIAs, and facilitate innovation guided by the principles. - Highlights: • Our study examined reported HIAs in the U.S. against published practice standards. • Most HIAs used some screening, scoping and assessment elements from the standards. • The extent of these processes and stakeholder participation varied widely. • The average HIA considered multiple health determinants and impacts. • Evaluation or monitoring plans were generally not included in

Health impact assessment in the United States: Has practice followed standards?

Energy Technology Data Exchange (ETDEWEB)

Schuchter, Joseph, E-mail: jws@berkeley.edu [University of California, Berkeley, School of Public Health, Department of Environmental Health Sciences, 50 University Hall, Berkeley, CA 94720-7360 (United States); Bhatia, Rajiv [University of California, Berkeley, Institute of Urban and Regional Development (United States); Corburn, Jason [University of California, Berkeley, College of Environmental Design, Department of City and Regional Planning (United States); Seto, Edmund [University of Washington, School of Public Health, Department of Environmental and Occupational Health (United States)

2014-07-01

As an emerging practice, Health Impact Assessment is heterogeneous in purpose, form, and scope and applied in a wide range of decision contexts. This heterogeneity challenges efforts to evaluate the quality and impact of practice. We examined whether information in completed HIA reports reflected objectively-evaluable criteria proposed by the North American HIA Practice Standards Working Group in 2009. From publically-available reports of HIAs conducted in the U.S. and published from 2009 to 2011, we excluded those that were components of, or comment letters on, Environmental Impact Assessments (5) or were demonstration projects or student exercises (8). For the remaining 23 reports, we used practice standards as a template to abstract data on the steps of HIA, including details on the rationale, authorship, funding, decision and decision-makers, participation, pathways and methods, quality of evidence, and recommendations. Most reports described screening, scoping, and assessment processes, but there was substantial variation in the extent of these processes and the degree of stakeholder participation. Community stakeholders participated in screening or scoping in just two-thirds of the HIAs (16). On average, these HIAs analyzed 5.5 determinants related to 10.6 health impacts. Most HIA reports did not include evaluation or monitoring plans. This study identifies issues for field development and improvement. The standards might be adapted to better account for variability in resources, produce fit-for-purpose HIAs, and facilitate innovation guided by the principles. - Highlights: • Our study examined reported HIAs in the U.S. against published practice standards. • Most HIAs used some screening, scoping and assessment elements from the standards. • The extent of these processes and stakeholder participation varied widely. • The average HIA considered multiple health determinants and impacts. • Evaluation or monitoring plans were generally not included in

Student´s self-assessment of clinical competence and objective clinical performance in OSCE evaluation

OpenAIRE

Jünger, J; Schellberg, D; Nikendei, C

2006-01-01

[english] Overestimating one's clinical competence can be dangerous to patient's safety. Therefore the goal of this study was to identify students with high confidence in their own clinical competence but low performance in objective assessment. 171 students in the 14 week course in internal medicine completed the clinical skills-related self-assessment expectations (SE) and were tested in a 12 station OSCE. Both measures were obtained within three days. In total we identified 16% of students...

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

Science.gov (United States)

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations.

Science.gov (United States)

Stenner, Markus; Koopmann, Mario; Rudack, Claudia

2017-02-01

Although septorhinoplasty is the most commonly performed operation in plastic surgery, and the surgical plan as well as its outcome is directly related to the configuration of the anatomical structures in the nose, these are not routinely assessed preoperatively. The aim of our study was to evaluate the nasal soft tissue and cartilaginous structures by means of high-resolution ultrasonography to set up clinical correlations and standard values. We examined 44 patients before septorhinoplasty by high-resolution ultrasonography in noncontact mode. All pictures were quantitatively evaluated by measuring 13 lengths and 4 ratios. All patients underwent a rhinomanometry measuring the nasal air flow. Besides others, men as well as older patients have a significantly thicker alar cartilage. Patients with thinner alar cartilages have a significantly smaller interdomal distance as well as significantly thinner upper lateral cartilages. The soft tissue above the bony dorsum was significantly thicker in older patients. Younger patients have significantly thicker soft tissue in relation to their cartilage. Patients with thicker soft tissue and thinner cartilage have a smaller tip. The interdomal distance and the thickness of the cartilaginous septum significantly correlated with the nasal air flow. We set up standard values of nasal structures in septorhinoplasty patients which can be used as reference values. By judging cartilage and soft tissue characteristics preoperatively, relevant factors for distinct procedures could be analyzed and the surgical steps can be better planned. Visualization by ultrasonography enables the surgeon to achieve treatment goals in a more predictable fashion.

STAMINA - Model description. Standard Model Instrumentation for Noise Assessments

NARCIS (Netherlands)

Schreurs EM; Jabben J; Verheijen ENG; CMM; mev

2010-01-01

Deze rapportage beschrijft het STAMINA-model, dat staat voor Standard Model Instrumentation for Noise Assessments en door het RIVM is ontwikkeld. Het instituut gebruikt dit standaardmodel om omgevingsgeluid in Nederland in kaart te brengen. Het model is gebaseerd op de Standaard Karteringsmethode

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

Science.gov (United States)

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis.

Science.gov (United States)

Lopetegui, Marcelo A; Bai, Shasha; Yen, Po-Yin; Lai, Albert; Embi, Peter; Payne, Philip R O

2013-01-01

Understanding clinical workflow is critical for researchers and healthcare decision makers. Current workflow studies tend to oversimplify and underrepresent the complexity of clinical workflow. Continuous observation time motion studies (TMS) could enhance clinical workflow studies by providing rich quantitative data required for in-depth workflow analyses. However, methodological inconsistencies have been reported in continuous observation TMS, potentially reducing the validity of TMS' data and limiting their contribution to the general state of knowledge. We believe that a cornerstone in standardizing TMS is to ensure the reliability of the human observers. In this manuscript we review the approaches for inter-observer reliability assessment (IORA) in a representative sample of TMS focusing on clinical workflow. We found that IORA is an uncommon practice, inconsistently reported, and often uses methods that provide partial and overestimated measures of agreement. Since a comprehensive approach to IORA is yet to be proposed and validated, we provide initial recommendations for IORA reporting in continuous observation TMS.

Fall Risk Assessment Through Automatic Combination of Clinical Fall Risk Factors and Body-Worn Sensor Data.

Science.gov (United States)

Greene, Barry R; Redmond, Stephen J; Caulfield, Brian

2017-05-01

Falls are the leading global cause of accidental death and disability in older adults and are the most common cause of injury and hospitalization. Accurate, early identification of patients at risk of falling, could lead to timely intervention and a reduction in the incidence of fall-related injury and associated costs. We report a statistical method for fall risk assessment using standard clinical fall risk factors (N = 748). We also report a means of improving this method by automatically combining it, with a fall risk assessment algorithm based on inertial sensor data and the timed-up-and-go test. Furthermore, we provide validation data on the sensor-based fall risk assessment method using a statistically independent dataset. Results obtained using cross-validation on a sample of 292 community dwelling older adults suggest that a combined clinical and sensor-based approach yields a classification accuracy of 76.0%, compared to either 73.6% for sensor-based assessment alone, or 68.8% for clinical risk factors alone. Increasing the cohort size by adding an additional 130 subjects from a separate recruitment wave (N = 422), and applying the same model building and validation method, resulted in a decrease in classification performance (68.5% for combined classifier, 66.8% for sensor data alone, and 58.5% for clinical data alone). This suggests that heterogeneity between cohorts may be a major challenge when attempting to develop fall risk assessment algorithms which generalize well. Independent validation of the sensor-based fall risk assessment algorithm on an independent cohort of 22 community dwelling older adults yielded a classification accuracy of 72.7%. Results suggest that the present method compares well to previously reported sensor-based fall risk assessment methods in assessing falls risk. Implementation of objective fall risk assessment methods on a large scale has the potential to improve quality of care and lead to a reduction in associated hospital

Using generalizability theory to develop clinical assessment protocols.

Science.gov (United States)

Preuss, Richard A

2013-04-01

Clinical assessment protocols must produce data that are reliable, with a clinically attainable minimal detectable change (MDC). In a reliability study, generalizability theory has 2 advantages over classical test theory. These advantages provide information that allows assessment protocols to be adjusted to match individual patient profiles. First, generalizability theory allows the user to simultaneously consider multiple sources of measurement error variance (facets). Second, it allows the user to generalize the findings of the main study across the different study facets and to recalculate the reliability and MDC based on different combinations of facet conditions. In doing so, clinical assessment protocols can be chosen based on minimizing the number of measures that must be taken to achieve a realistic MDC, using repeated measures to minimize the MDC, or simply based on the combination that best allows the clinician to monitor an individual patient's progress over a specified period of time.

EMBEDding the CEFR in Academic Writing Assessment : A case study in training and standardization

NARCIS (Netherlands)

Haines, Kevin; Lowie, Wander; Jansma, Petra; Schmidt, Nicole

2013-01-01

The CEFR is increasingly being used as the framework of choice for the assessment of language proficiency at universities across Europe. However, to attain consistent assessment, familiarization and standardization are essential. In this paper we report a case study of embedding a standardization

Assessing MBA Student Teamwork under the AACSB Assurance of Learning Standards

Science.gov (United States)

Procino, Matthew C.

2012-01-01

Since the 2003 release of the AACSB's Assurance of Learning standards, outcomes assessment has been a required practice for business schools wishing to receive their endorsement. While most accredited institutions had been dabbling with the measurement of student learning, the new standards raised the bar considerably. It is now necessary to…

Using Microsoft Excel to Assess Standards: A "Techtorial". Article #2 in a 6-Part Series

Science.gov (United States)

Mears, Derrick

2009-01-01

Standards-based assessment is a term currently being used quite often in educational reform discussions. The philosophy behind this initiative is to utilize "standards" or "benchmarks" to focus instruction and assessments of student learning. The National Standards for Physical Education (NASPE, 2004) provide a framework to guide this process for…

Using plant clinic registers to assess the quality of diagnoses and advice given to farmers

DEFF Research Database (Denmark)

Danielsen, Solveig; Boa, Eric; Mafabi, Moses

2012-01-01

doctors. Assessment of quality of diagnoses was based on five validation criteria applied on the ten most common crops. Quality of advice was assessed for the four major problems considering efficacy and feasibility. Findings: The quality of diagnoses varied between crops, from 68% completely validated...... validated diagnoses. The majority of recommendations (82%) were assessed ‘partially effective’. ‘Best practice’ was recommended for 10% and ineffective advice was given in 8% of the cases with considerable variation between diseases. Practical implications: Plant doctors need more training in symptom...... recognition, pest management and record keeping as well as better technical backstopping to solve unknown problems. Common standards and procedures for clinic data collection and analysis should be established, and roles and responsibilities clearly defined. Originality/value: This is the first time plant...

Walking adaptability after a stroke and its assessment in clinical settings.

Science.gov (United States)

Balasubramanian, Chitralakshmi K; Clark, David J; Fox, Emily J

2014-01-01

Control of walking has been described by a tripartite model consisting of stepping, equilibrium, and adaptability. This review focuses on walking adaptability, which is defined as the ability to modify walking to meet task goals and environmental demands. Walking adaptability is crucial to safe ambulation in the home and community environments and is often severely compromised after a stroke. Yet quantification of walking adaptability after stroke has received relatively little attention in the clinical setting. The objectives of this review were to examine the conceptual challenges for clinical measurement of walking adaptability and summarize the current state of clinical assessment for walking adaptability. We created nine domains of walking adaptability from dimensions of community mobility to address the conceptual challenges in measurement and reviewed performance-based clinical assessments of walking to determine if the assessments measure walking adaptability in these domains. Our literature review suggests the lack of a comprehensive well-tested clinical assessment tool for measuring walking adaptability. Accordingly, recommendations for the development of a comprehensive clinical assessment of walking adaptability after stroke have been presented. Such a clinical assessment will be essential for gauging recovery of walking adaptability with rehabilitation and for motivating novel strategies to enhance recovery of walking adaptability after stroke.

Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments*

Science.gov (United States)

MacCall, Steven L.

2006-01-01

Objective: The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. Design: A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Measurement: Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log “hit” during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Results: Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. Conclusions: The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non–North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of

Re-thinking clinical assessment: What can we learn from the medical literature?

International Nuclear Information System (INIS)

Yielder, Jill; Thompson, Andrea; De Bueger, Tracy

2012-01-01

This article explores the literature available in the field of medical education on the topic of clinical assessment, in order to suggest different ways of assessing clinical experience that may not have been considered within undergraduate radiography programmes. The medical literature is contrasted with the clinical assessment currently being used in a medical imaging programme in New Zealand, with the aim of offering suggestions that may benefit the assessment of the clinical and professional elements of radiography programmes more generally. The authors conclude that ideally students need to be assessed in the clinical domain by multiple assessors, with varied assessment methods used repeatedly over a period of time and with the provision of frequent and constructive feedback. Various methods of clinical assessment are suggested and it is emphasised that the methods selected need to be valid, reliable and psychometrically supported. This encourages an evidence-based practice approach that is supportive of on-going programme development and change.

Large observer variation of clinical assessment of dyspnoeic wheezing children.

Science.gov (United States)

Bekhof, Jolita; Reimink, Roelien; Bartels, Ine-Marije; Eggink, Hendriekje; Brand, Paul L P

2015-07-01

In children with acute dyspnoea, the assessment of severity of dyspnoea and response to treatment is often performed by different professionals, implying that knowledge of the interobserver variation of this clinical assessment is important. To determine intraobserver and interobserver variation in clinical assessment of children with dyspnoea. From September 2009 to September 2010, we recorded a convenience sample of 27 acutely wheezing children (aged 3 months-7 years) in the emergency department of a general teaching hospital in the Netherlands, on video before and after treatment with inhaled bronchodilators. These video recordings were independently assessed by nine observers scoring wheeze, prolonged expiratory phase, retractions, nasal flaring and a general assessment of dyspnoea on a Likert scale (0-10). Assessment was repeated after 2 weeks to evaluate intraobserver variation. We analysed 972 observations. Intraobserver reliability was the highest for supraclavicular retractions (κ 0.84) and moderate-to-substantial for other items (κ 0.49-0.65). Interobserver reliability was considerably worse, with κ3 points) was larger than the minimal important change (meaning that in 69% of observations a clinically important change after treatment cannot be distinguished from measurement error. Intraobserver variation is modest, and interobserver variation is large for most clinical findings in children with dyspnoea. The measurement error induced by this variation is too large to distinguish potentially clinically relevant changes in dyspnoea after treatment in two-thirds of observations. The poor interobserver reliability of clinical dyspnoea assessment in children limits its usefulness in clinical practice and research, and highlights the need to use more objective measurements in these patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Quantitative Risk Assessment of Contact Sensitization

DEFF Research Database (Denmark)

Api, Anne Marie; Belsito, Donald; Bickers, David

2010-01-01

Background: Contact hypersensitivity quantitative risk assessment (QRA) for fragrance ingredients is being used to establish new international standards for all fragrance ingredients that are potential skin sensitizers. Objective: The objective was to evaluate the retrospective clinical data...... as potential sensitizers. Methods: This article reviews clinical data for three fragrance ingredients cinnamic aldehyde, citral, and isoeugenol to assess the utility of the QRA approach for fragrance ingredients. Results: This assessment suggests that had the QRA approach been available at the time standards...

Assessment of acquired capability for suicide in clinical practice.

Science.gov (United States)

Rimkeviciene, Jurgita; Hawgood, Jacinta; O'Gorman, John; De Leo, Diego

2016-12-01

The Interpersonal Psychological Theory of suicide proposes that the interaction between Thwarted Belongingness, Perceived Burdensomeness, and Acquired Capability for Suicide (ACS) predicts proximal risk of death by suicide. Instruments to assess all three constructs are available. However, research on the validity of one of them, the acquired capability for suicide scale (ACSS), has been limited, especially in terms of its clinical relevance. This study aimed to explore the utility of the different versions of the ACSS in clinical assessment. Three versions of the scale were investigated, the full 20-item version, a 7-item version and a single item version representing self-perceived capability for suicide. In a sample of patients recruited from a clinic specialising in the treatment of suicidality and in a community sample, all versions of the ACSS were found to show reasonable levels of reliability and to correlate as expected with reports of suicidal ideation, self-harm, and attempted suicide. The item assessing self-perceived acquired capacity for suicide showed highest correlations with all levels of suicidal behaviour. However, no version of the ACSS on its own showed a capacity to indicate suicide attempts in the combined sample. It is concluded that the versions of the scale have construct validity, but their clinical utility is limited. An assessment using a single item on self-perceived ACS outperforms the full and shortened versions of ACSS in clinical settings and can be recommended with caution for clinicians interested in assessing this characteristic.

Triangular model integrating clinical teaching and assessment.

Science.gov (United States)

Abdelaziz, Adel; Koshak, Emad

2014-01-01

Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment.

Newly graduated doctors' competence in managing cardiopulmonary arrests assessed using a standardized Advanced Life Support (ALS) assessment

DEFF Research Database (Denmark)

Jensen, Morten Lind; Hesselfeldt, Rasmus; Rasmussen, Maria Birkvad

2008-01-01

Aim of the study: Several studies using a variety of assessment approaches have demonstrated that young doctors possess insufficient resuscitation competence. The aims of this study were to assess newly graduated doctors’ resuscitation competence against an internationally recognised standard and...

Health Literacy Assessment in an Otolaryngology Clinic Population.

Science.gov (United States)

Megwalu, Uchechukwu C; Lee, Jennifer Y

2016-12-01

To assess health literacy in an adult tertiary care otolaryngology clinic population and to explore potential determinants of inadequate health literacy. Cross-sectional study. Tertiary care otolaryngology clinic. The study population included all adult patients treated at 3 of Stanford University's adult otolaryngology clinic sites between March 1 and 11, 2016. Data were collected via an anonymous questionnaire. Health literacy was assessed with the Brief Health Literacy Screen. Ten percent of patients had inadequate health literacy. White race (odds ratio [OR], 0.23) and having English as the primary language (OR, 0.12) were associated with adequate health literacy, while high school or lower level of education (OR, 3.2) was associated with inadequate health literacy. Age, sex, and Hispanic ethnicity were not associated with health literacy. Our study highlights the need for health literacy screening in the otolaryngology clinic setting and identifies sociodemographic risk factors for inadequate health literacy. Further studies are needed to assess the impact of health literacy on patient outcomes and to test specific interventions to address health literacy and health outcomes. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

Planning the Unplanned Experiment: Towards Assessing the Efficacy of Standards for Safety-Critical Software

Science.gov (United States)

Graydon, Patrick J.; Holloway, C. M.

2015-01-01

Safe use of software in safety-critical applications requires well-founded means of determining whether software is fit for such use. While software in industries such as aviation has a good safety record, little is known about whether standards for software in safety-critical applications 'work' (or even what that means). It is often (implicitly) argued that software is fit for safety-critical use because it conforms to an appropriate standard. Without knowing whether a standard works, such reliance is an experiment; without carefully collecting assessment data, that experiment is unplanned. To help plan the experiment, we organized a workshop to develop practical ideas for assessing software safety standards. In this paper, we relate and elaborate on the workshop discussion, which revealed subtle but important study design considerations and practical barriers to collecting appropriate historical data and recruiting appropriate experimental subjects. We discuss assessing standards as written and as applied, several candidate definitions for what it means for a standard to 'work,' and key assessment strategies and study techniques and the pros and cons of each. Finally, we conclude with thoughts about the kinds of research that will be required and how academia, industry, and regulators might collaborate to overcome the noted barriers.

Clinical assessment of scapular positioning in musicians: an intertester reliability study.

Science.gov (United States)

Struyf, Filip; Nijs, Jo; De Coninck, Kris; Giunta, Marco; Mottram, Sarah; Meeusen, Romain

2009-01-01

The reliability of the measurement of the distance between the posterior border of the acromion and the wall and the reliability of the modified lateral scapular slide test have not been studied. Overall, the reliability of the clinical tools used to assess scapular positioning has not been studied in musicians. To examine the intertester reliability of scapular observation and 2 clinical tests for the assessment of scapular positioning in musicians. Intertester reliability study. University research laboratory. Thirty healthy student musicians at a single university. Two assessors performed a standardized observation protocol, the measurement of the distance between the posterior border of the acromion and the wall, and the modified lateral scapular slide test. Each assessor was blinded to the other's findings. The intertester reliability coefficients (kappa) for the observation in relaxed position, during unloaded movement, and during loaded movement were 0.41, 0.63, and 0.36, respectively. The kappa values for the observation of tilting and winging at rest were 0.48 and 0.42, respectively; during unloaded movement, the kappa values were 0.52 and 0.78, respectively; and with a 1-kg load, the kappa values were 0.24 and 0.50, respectively. The intraclass correlation coefficient (ICC) of the measurement of the acromial distance was 0.72 in relaxed position and 0.75 with the participant actively retracting both shoulders. The ICCs for the modified lateral scapular slide test varied between 0.63 and 0.58. Our results demonstrated that the modified lateral scapular slide test was not a reliable tool to assess scapular positioning in these participants. Our data indicated that scapular observation in the relaxed position and during unloaded abduction in the frontal plane was a reliable assessment tool. The reliability of the measurement of the distance between the posterior border of the acromion and the wall in healthy musicians was moderate.

25 CFR 36.12 - Standard III-Program needs assessment.

Science.gov (United States)

2010-04-01

...., (1) Perceptions of the parents, tribes, educators, and the students with regard to the relevance and....12 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION MINIMUM ACADEMIC STANDARDS... Program Evaluation. This assessment shall include at least the following: (a) A clear statement of student...

Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care.

Science.gov (United States)

Vekemans, Johan; Marsh, Kevin; Greenwood, Brian; Leach, Amanda; Kabore, William; Soulanoudjingar, Solange; Asante, Kwaku Poku; Ansong, Daniel; Evans, Jennifer; Sacarlal, Jahit; Bejon, Philip; Kamthunzi, Portia; Salim, Nahya; Njuguna, Patricia; Hamel, Mary J; Otieno, Walter; Gesase, Samwel; Schellenberg, David

2011-08-04

An effective malaria vaccine, deployed in conjunction with other malaria interventions, is likely to substantially reduce the malaria burden. Efficacy against severe malaria will be a key driver for decisions on implementation. An initial study of an RTS, S vaccine candidate showed promising efficacy against severe malaria in children in Mozambique. Further evidence of its protective efficacy will be gained in a pivotal, multi-centre, phase III study. This paper describes the case definitions of severe malaria used in this study and the programme for standardized assessment of severe malaria according to the case definition. Case definitions of severe malaria were developed from a literature review and a consensus meeting of expert consultants and the RTS, S Clinical Trial Partnership Committee, in collaboration with the World Health Organization and the Malaria Clinical Trials Alliance. The same groups, with input from an Independent Data Monitoring Committee, developed and implemented a programme for standardized data collection.The case definitions developed reflect the typical presentations of severe malaria in African hospitals. Markers of disease severity were chosen on the basis of their association with poor outcome, occurrence in a significant proportion of cases and on an ability to standardize their measurement across research centres. For the primary case definition, one or more clinical and/or laboratory markers of disease severity have to be present, four major co-morbidities (pneumonia, meningitis, bacteraemia or gastroenteritis with severe dehydration) are excluded, and a Plasmodium falciparum parasite density threshold is introduced, in order to maximize the specificity of the case definition. Secondary case definitions allow inclusion of co-morbidities and/or allow for the presence of parasitaemia at any density. The programmatic implementation of standardized case assessment included a clinical algorithm for evaluating seriously sick children

Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

Directory of Open Access Journals (Sweden)

Sandra Álvarez Guerra

2005-12-01

assessed. By means of these aspects, both standards contribute to the quality of clinical assays for a better protection of patients, reliable results, both external and domestic users´ satisfaction, ongoing improvement and setting of contingency plans and preventive measures. It was concluded that both standards are not opposite and may be used as a way of assuring excellence in rendered service.

New clinical validation method for automated sphygmomanometer: a proposal by Japan ISO-WG for sphygmomanometer standard.

Science.gov (United States)

Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

2007-12-01

Owing to fast or stepwise cuff deflation, or measuring at places other than the upper arm, the clinical accuracy of most recent automated sphygmomanometers (auto-BPMs) cannot be validated by one-arm simultaneous comparison, which would be the only accurate validation method based on auscultation. Two main alternative methods are provided by current standards, that is, two-arm simultaneous comparison (method 1) and one-arm sequential comparison (method 2); however, the accuracy of these validation methods might not be sufficient to compensate for the suspicious accuracy in lateral blood pressure (BP) differences (LD) and/or BP variations (BPV) between the device and reference readings. Thus, the Japan ISO-WG for sphygmomanometer standards has been studying a new method that might improve validation accuracy (method 3). The purpose of this study is to determine the appropriateness of method 3 by comparing immunity to LD and BPV with those of the current validation methods (methods 1 and 2). The validation accuracy of the above three methods was assessed in human participants [N=120, 45+/-15.3 years (mean+/-SD)]. An oscillometric automated monitor, Omron HEM-762, was used as the tested device. When compared with the others, methods 1 and 3 showed a smaller intra-individual standard deviation of device error (SD1), suggesting their higher reproducibility of validation. The SD1 by method 2 (P=0.004) significantly correlated with the participant's BP, supporting our hypothesis that the increased SD of device error by method 2 is at least partially caused by essential BPV. Method 3 showed a significantly (P=0.0044) smaller interparticipant SD of device error (SD2), suggesting its higher interparticipant consistency of validation. Among the methods of validation of the clinical accuracy of auto-BPMs, method 3, which showed the highest reproducibility and highest interparticipant consistency, can be proposed as being the most appropriate.

A simple framework for assessing technical skills in a resident observed structured clinical examination (OSCE): vaginal laceration repair.

Science.gov (United States)

Winkel, Abigail Ford; Lerner, Veronica; Zabar, Sondra R; Szyld, Demian

2013-01-01

Educators of trainees in procedure-based specialties need focused assessment tools that are valid, objective, and assess technical skills in a realistic context. A framework for hybrid assessment using standardized patient scenarios and bench skills testing might facilitate evaluation of competency. Seven PGY-1 obstetrics and gynecology residents participated in a hybrid assessment that used observed structured clinical examination (OSCE) by a standardized patient who had sustained a vaginal laceration during vaginal delivery. The residents elicited a history and counseled the patient, and then completed a laceration repair on a pelvic model. The residents were rated on their performance in the scenario, which included issues of cultural competency, rapport-building, patient counseling. The technical skills were videotaped and rated using a modified global assessment form by 2 faculty members on a 3-point scale from "not done" to "partly done" to "well-done." Residents also completed a subjective assessment of the station. Mean technical performance of the residents on the technical skills was 55% "well-done," with a range of 20%-90%. The assessment identified 3 residents as below the mean, and 1 resident with areas of deficiency. Subjective assessment by the residents was that juggling the technical, cognitive, and affective components of the examination was challenging. Technical skills can be included in a case-based assessment using scenarios that address a range of cognitive and affective skills required of physicians. Results may help training programs assess individuals' abilities as well as identify program needs for curricular improvement. This framework might be useful in setting standards for competency and identifying poor performers. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Mid-level healthcare personnel training: an evaluation of the revised, nationally-standardized, pre-service curriculum for clinical officers in Mozambique.

Science.gov (United States)

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2014-01-01

Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009-2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the pTMG scores on both the clinical cases and physical exam. TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time.

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

Science.gov (United States)

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

[How to assess clinical practice guidelines with AGREE II: The example of neonatal jaundice].

Science.gov (United States)

Renesme, L; Bedu, A; Tourneux, P; Truffert, P

2016-03-01

Neonatal jaundice is a very frequent condition that occurs in approximately 50-70% of term or near-term (>35 GA) babies in the 1st week of life. In some cases, a high bilirubin blood level can lead to kernicterus. There is no consensus for the management of neonatal jaundice and few countries have published national clinical practice guidelines for the management of neonatal jaundice. The aim of this study was to assess the quality of these guidelines. We conducted a systematic review of the literature for national clinical practice guidelines for the management of neonatal jaundice in term or near-term babies. Four independent reviewers assessed the quality of each guideline using the AGREE II evaluation. For each of the clinical practice guidelines, the management modalities were analyzed (screening, treatment, follow-up, etc.). Seven national clinical practice guidelines were found (South Africa, USA AAP, UK NICE, Canada, Norway, Switzerland, and Israel). The AGREE II score showed widespread variation regarding the quality of these national guidelines. There was no major difference between the guidelines concerning the clinical management of these babies. The NICE guideline is the most valuable guideline regarding the AGREE II score. NICE showed that, despite a strong and rigorous methodology, there is no evidenced-based recommended code of practice (RCP). Comparing RCPs, we found no major differences. The NICE guideline showed the best quality. The AGREE II instrument should be used as a framework when developing clinical practice guidelines to improve the quality of the future guideline. In France, a national guideline is needed for a more standardized management of neonatal jaundice. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Clinically assessed mediolateral knee motion: impact on gait

DEFF Research Database (Denmark)

Thorlund, Jonas Bloch; Creaby, Mark W; Simic, Milena

2011-01-01

Mediolateral knee movement can be assessed visually with clinical tests. A knee-medial-to-foot position is associated with an increased risk of knee injuries and pathologies. However, the implications of such findings on daily tasks are not well understood. The aim of this study was to investigat...... if a knee-medial-to-foot position assessed during a clinical test was associated with altered hip and knee joint kinematics and knee joint kinetics during gait compared with those with a knee-over-foot position....

Cognitive Assessment of Elderly Inpatients: A Clinical Audit

Directory of Open Access Journals (Sweden)

Elizabeth Shermon

2015-01-01

Full Text Available Background: Comprehensive geriatric assessment including cognitive assessment results in better outcomes and quality of life through facilitating access to support and further care. The National Audit of Dementia Care revealed too few patients were being assessed for cognition and therefore failing to receive adequate care. Methods: This was a retrospective clinical audit in a district general hospital with systematic sampling of the clinical records of 50 inpatients on an elderly care ward. A descriptive analysis of the results was performed. Results: Despite guidance that cognitive assessment should be performed on admission, this was only documented in 22% of the medical notes. However, this rate improved to 56% by discharge. The most commonly used tool was the Abbreviated Mental Test (AMT 10. Assessment completion was independent of gender or social support, but only patients aged over 75 years were assessed. Of those, 75% had some level of cognitive impairment and 36.8% received a new or suspected diagnosis of dementia. Discussion: Cognitive assessment rates continue to be low. Our findings support the need for increased education regarding the importance and benefits of assessment as well as how to complete and document the assessment correctly. Conclusion: Cognitive assessment rates need to be further improved to promote better outcomes for patients with dementia.

Structured assessment of microsurgery skills in the clinical setting.

Science.gov (United States)

Chan, WoanYi; Niranjan, Niri; Ramakrishnan, Venkat

2010-08-01

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

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

Science.gov (United States)

Rechmann, Peter; Featherstone, John D B

2014-09-01

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

Technical Standards on the Safety Assessment of a HLW Repository in Other Countries

International Nuclear Information System (INIS)

Lee, Sung Ho; Hwang, Yong Soo

2009-01-01

The basic function of HLW disposal system is to prevent excessive radio-nuclides being leaked from the repository in a short time. To do this, many technical standards should be developed and established on the components of disposal system. Safety assessment of a repository is considered as one of technical standards, because it produces quantitative results of the future evolution of a repository based on a reasonably simplified model. In this paper, we investigated other countries' regulations related to safely assessment focused on the assessment period, radiation dose limits and uncertainties of the assessment. Especially, in the investigation process of the USA regulations, the USA regulatory bodies' approach to assessment period and peak dose is worth taking into account in case of a conflict between peak dose from safety assessment and limited value in regulation.

Outcomes assessment of dental hygiene clinical teaching workshops.

Science.gov (United States)

Wallace, Juanita S; Infante, Taline D

2008-10-01

Faculty development courses related to acquiring clinical teaching skills in the health professions are limited. Consequently, the Department of Dental Hygiene at the University of Texas Health Science Center at San Antonio conducted a series of clinical teaching workshops to address clinical teaching methodology. The goal of these workshops was to promote a problem-solving learning atmosphere for dental hygiene faculty to acquire and share sound clinical teaching strategies. To determine the value of the annual workshops on clinical teaching and evaluation, a web-based qualitative program assessment was developed using software by Survey Tracker. Four open-ended questions were designed to elicit perceptions regarding what significant changes in teaching strategies were achieved, what barriers or challenges were encountered in making these changes, and what strategies were used to overcome the barriers. The assessment was sent to dental hygiene educators representing thirty-eight dental hygiene programs who had participated in two or more of these workshops. Twenty-eight programs provided collective responses to the questions, and the narrative data were analyzed, using a qualitative methodology. Responses revealed that programs had made productive changes to their clinical education curricula and the information gained from the workshops had a positive effect on clinical teaching.

Facilitating peer based learning through summative assessment - An adaptation of the Objective Structured Clinical Assessment tool for the blended learning environment.

Science.gov (United States)

Wikander, Lolita; Bouchoucha, Stéphane L

2018-01-01

Adapting a course from face to face to blended delivery necessitates that assessments are modified accordingly. In Australia the Objective Structured Clinical Assessment tool, as a derivative from the Objective Structured Clinical Examination, has been used in the face-to-face delivery mode as a formative or summative assessment tool in medicine and nursing since 1990. The Objective Structured Clinical Assessment has been used at Charles Darwin University to assess nursing students' simulated clinical skills prior to the commencement of their clinical placements since 2008. Although the majority of the course is delivered online, students attend a one-week intensive clinical simulation block yearly, prior to attending clinical placements. Initially, the Objective Structured Clinical Assessment was introduced as a lecturer assessed summative assessment, over time it was adapted to better suit the blended learning environment. The modification of the tool from an academic to peer assessed assessment tool, was based on the empirical literature, student feedback and a cross-sectional, qualitative study exploring academics' perceptions of the Objective Structured Clinical Assessment (Bouchoucha et al., 2013a, b). This paper presents an overview of the process leading to the successful adaptation of the Objective Structured Clinical Assessment to suit the requirements of a preregistration nursing course delivered through blended learning. This is significant as many universities are moving their curriculum to fully online or blended delivery, yet little attention has been paid to adapting the assessment of simulated clinical skills. The aim is to identify the benefits and drawbacks of using the peer assessed Objective Structured Clinical Assessment and share recommendations for successful implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

Directory of Open Access Journals (Sweden)

Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

Directory of Open Access Journals (Sweden)

Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

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Tropp Hans

2005-06-01

Full Text Available Abstract Background The tissue origin of low back pain (LBP or referred lower extremity symptoms (LES may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216 with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement

Assessing quality of reports on randomized clinical trials in nursing journals.

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Parent, Nicole; Hanley, James A

2009-01-01

Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

Instructor and Dental Student Perceptions of Clinical Communication Skills via Structured Assessments.

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McKenzie, Carly T

2016-05-01

The aim of this study was to use structured assessments to assess dental students' clinical communication skills exhibited during patient appointments. Fourth-year dental students (n=55) at the University of Alabama at Birmingham evaluated their own interpersonal skills in a clinical setting utilizing the Four Habits Coding Scheme. An instructor also assessed student-patient clinical communication. These assessments were used to identify perceived strengths and weaknesses in students' clinical communication. Both instructor assessments and student self-assessments pinpointed the following clinical communication skills as effective the most often: patient greeting, avoidance of jargon, and non-verbal behavior. There was also relative agreement between instructor assessments and student self-assessments regarding clinical communication skills that were rated as not effective most frequently: ensuring patient comprehension, identification of patient feelings, and exploration of barriers to treatment. These resulted pointed to strengths and weaknesses in the portion of the curriculum designed to prepare students for effective provider-patient communication. These results may suggest a need for the school's current behavioral science curriculum to better address discussion of potential treatment barriers and patient feelings as well as techniques to ensure patient comprehension.

Formative assessment of GP trainees' clinical skills.

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Wiener-Ogilvie, Sharon; Begg, Drummond

2012-03-01

Clinical skill assessment (CSA) has been an integral part of the Royal College of General Practitioners' membership examination (MRCGP) since 2008. It is an expensive, high-stakes examination with first time pass rates ranging from 76.4 to 81.3. In this paper we describe the South East Scotland Deanery, NHS Education Scotland, pilot of a formative clinical skills assessment (fCSA) using the principles of formative assessment and OSCE. The purpose of the study was to assess the acceptability of the fCSA and to examine whether trainees, identified during the fCSA as 'at risk of failing the MRCGP CSA exam', are more likely to fail the MRCGP CSA exam later on in the year. Trainees were assessed in four clinical skills stations under exam conditions. After each station they were given verbal feedback and subsequently both trainee and their trainer received written feedback. We assessed the value of the exercise through written feedback from trainees and trainers. Each trainee's performance in fCSA was triangulated with trainer assessment to identify 'flagged trainees'. We compared flagged and non-flagged trainees' performance in MRCGP CSA. Both trainees and trainers highly rated the fCSA. Overall 97% of non-flagged trainees have passed the RCGP CSA exam by May of that year in comparison to 80% of flagged trainees who have passed the RCGP CSA (P = 0.005). Trainers and trainees rated the fCSA as excellent and useful. We were able to demonstrate that the fCSA can be used to identify those trainees likely to fail the RCGP CSA. Contrary to reservations about the potential to demoralise trainees, the fCSA was viewed as a useful and a positive experience by both trainees and trainers. In addition, we suggest that feedback from fCSA was useful in triggering appropriate educational interventions. Early intervention with trainees who are predicted to fail the CSA has the potential to reduce deaneries overall fail rate. Preventing one trainee failure could save over £30 000.

Personality Assessment Use by Clinical Neuropsychologists

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Smith, Steven R.; Gorske, Tad T.; Wiggins, Chauntel; Little, Jessica A.

2010-01-01

The present study is an exploration of the personality assessment practices of clinical neuropsychologists. Professional members of the National Academy of Neuropsychology and the International Neuropsychological Society (N = 404) were surveyed to examine use of several forms of personality, behavior, and emotional function measures. Results…

Current standards of neuropsychological assessment in epilepsy surgery centers across Europe.

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Vogt, Viola Lara; Äikiä, Marja; Del Barrio, Antonio; Boon, Paul; Borbély, Csaba; Bran, Ema; Braun, Kees; Carette, Evelien; Clark, Maria; Cross, Judith Helen; Dimova, Petia; Fabo, Daniel; Foroglou, Nikolaos; Francione, Stefano; Gersamia, Anna; Gil-Nagel, Antonio; Guekht, Alla; Harrison, Sue; Hecimovic, Hrvoje; Heminghyt, Einar; Hirsch, Edouard; Javurkova, Alena; Kälviäinen, Reetta; Kavan, Nicole; Kelemen, Anna; Kimiskidis, Vasilios K; Kirschner, Margarita; Kleitz, Catherine; Kobulashvili, Teia; Kosmidis, Mary H; Kurtish, Selin Yagci; Lesourd, Mathieu; Ljunggren, Sofia; Lossius, Morten Ingvar; Malmgren, Kristina; Mameniskiené, Ruta; Martin-Sanfilippo, Patricia; Marusic, Petr; Miatton, Marijke; Özkara, Çiğdem; Pelle, Federica; Rubboli, Guido; Rudebeck, Sarah; Ryvlin, Philippe; van Schooneveld, Monique; Schmid, Elisabeth; Schmidt, Pia-Magdalena; Seeck, Margitta; Steinhoff, Bernhard J; Shavel-Jessop, Sara; Tarta-Arsene, Oana; Trinka, Eugen; Viggedal, Gerd; Wendling, Anne-Sophie; Witt, Juri-Alexander; Helmstaedter, Christoph

2017-03-01

We explored the current practice with respect to the neuropsychological assessment of surgical epilepsy patients in European epilepsy centers, with the aim of harmonizing and establishing common standards. Twenty-six epilepsy centers and members of "E-PILEPSY" (a European pilot network of reference centers in refractory epilepsy and epilepsy surgery), were asked to report the status of neuropsychological assessment in adults and children via two different surveys. There was a consensus among these centers regarding the role of neuropsychology in the presurgical workup. Strong agreement was found on indications (localization, epileptic dysfunctions, adverse drugs effects, and postoperative monitoring) and the domains to be evaluated (memory, attention, executive functions, language, visuospatial skills, intelligence, depression, anxiety, and quality of life). Although 186 different tests are in use throughout these European centers, a core group of tests reflecting a moderate level of agreement could be discerned. Variability exists with regard to indications, protocols, and paradigms for the assessment of hemispheric language dominance. For the tests in use, little published evidence of clinical validity in epilepsy was provided. Participants in the survey reported a need for improvement concerning the validity of the tests, tools for the assessment of everyday functioning and accelerated forgetting, national norms, and test co-normalization. Based on the present survey, we documented a consensus regarding the indications and principles of neuropsychological testing. Despite the variety of tests in use, the survey indicated that there may be a core set of tests chosen based on experience, as well as on published evidence. By combining these findings with the results of an ongoing systematic literature review, we aim for a battery that can be recommended for the use across epilepsy surgical centers in Europe. Wiley Periodicals, Inc. © 2017 International League

[Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

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Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

2011-12-01

The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

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

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

2009-10-01

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

Determining nurses\\' clinical competence in hospitals of Bushehr University of Medical Sciences by self assessment method

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Masood mahreini

2008-09-01

Full Text Available Background: Nurses’ self awareness of their own level of clinical competence is essential in maintaining high standards of care and identifying areas of educational need and professional development. Self-assessment is a method for measuring clinical competence, and encourages nurses to use reflective thinking and take an active part in the learning process. Although nurse competence may vary between hospitals, very few studies have been done on this subject. Methods: In this cross sectional study, we analyzed clinical competency of 190 registered nurses working in different hospitals in Bushehr by self assessment method. The instrument for data collection was a valid and reliable questionnaire consisting of 73 items from seven categories which were devised from Benner's “from Novice to Expert” framework. The level of competence was assessed on a scale of 0-100 and the frequency of using the competencies was assessed on a Likert scale. Results: the nurses reported their overall level of competence as “good” (51-75. They felt more competent in the categories of “managing situations” and “helping role” (with maximum score of 79.54 and least competent in “teaching – coaching” and “ensuring quality” categories (with minimum score of 61.15. The frequency of practicing competencies had a positive correlation with the level of nursing clinical competence. Conclusion: The level of nursing competence and frequency of using competencies varied in different hospitals. Although the nurses reported their overall level of competence as good, we should be concerned about 24% of competencies which are not used by the nurses, especially in "teaching – coaching" and "ensuring quality" categories.

Safety assessment standards for modern plants in the UK

International Nuclear Information System (INIS)

Harbison, S.A.; Hannaford, J.

1993-01-01

The NII has revised its safety assessment principles (SAPs). This paper discusses the revised SAPs and their links with international standards. It considers the licensing of foreign designs of plant - a matter under active consideration in the UK -and discusses how the SAPs and the licensing process cater for that possibility. (author)

Professional practice assessment. Pertinence of positron emission tomography clinical indications in oncology

International Nuclear Information System (INIS)

Le Stanc, E.; Tainturier, C.; Swaenepoel, J.

2009-01-01

Introduction As part of the health care quality and safety policy in France, Professional Practice Assessment (P.P.A.) are mandatory in the health services 'certification' process. We present our study regarding the pertinence of Positron Emission Tomography (PET) indications in oncology. Materials and methods A multidisciplinary task group used the Quick Audit method with two rounds of 100 request forms each. The assessment list of criteria comprised four items of decreasing relevance grading the PET scans clinical indications, which were derived from the three French published guidelines (S.O.R. [F.N.C.L.C.C]., 'Guide du bon usage des examens d'imagerie medicale' [S.F.R.-S.F.M.N.], 'Guide pour la redaction de protocoles pour la TEP au F.D.G. en cancerologie' [S.F.M.N.]) and five additional items: clinical information, patient's body weight, previous treatments dates, diabetes, claustrophobia. Results The first round showed that 68% of the requested scans corresponded to the two most relevant groups of indications (S.O.R. Standards and Options). The request forms were correctly filled in regarding the clinical information, but this was not the case for the other items we tested. Several actions were conducted: dedicated PET request form, availability of the S.O.R. on the hospital intranet, boost of the referring physicians awareness during the multidisciplinary oncology meetings (Reunions de Concertation Pluridisciplinaires RCP). The second round showed a better pertinence of the PET scans indications (75% versus 68%); the patient's body weight was more frequently mentioned on the request form. Discussion This study is an example of P.P.A. in our discipline. It led to an improvement of the oncologic PET scans clinical indications in our hospital. This work is pursued in everyday discussion with the referring clinicians, especially during the RCP. (authors)

A randomized trial of standardized nursing patient assessment using wireless devices.

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Dykes, Patricia C; Carroll, Diane L; Benoit, Angela; Coakley, Amanda; Chang, Frank; Empoliti, Joanne; Gallagher, Joan; Lasala, Cynthia; O'Malley, Rosemary; Rath, Greg; Silva, Judy; Li, Qi

2007-10-11

A complete and accurate patient assessment database is essential for effective communication, problem identification, planning and evaluation of patient status. When employed consistently for point-of-care documentation, information systems are associated with completeness and quality of documentation. The purpose of this paper is to report on the findings of a randomized, cross-over study conducted to evaluate the adequacy of a standard patient assessment module to support problem identification, care planning and tracking of nursing sensitive patient outcomes. The feasibility of wireless devices to support patient assessment data collection at the point-of-care was evaluated using wireless PDAs and tablet PCs. Seventy-nine (79) nurses from two patient care units at Massachusetts General Hospital (Boston, MA) were recruited into the study and randomized to complete patient assessment using wireless or paper devices. At the end of six weeks, nurses who where randomized to the paper assessment module were assigned to a device and those who used a device were assigned to paper for an additional six weeks. Impact was evaluated with regard to data capture, workflow implications and nurse satisfaction. Findings suggest that a standard patient assessment set promotes patient sensitive and quality data capture, which is augmented by the use of wireless devices.

Comparison of clinical outcomes with orodispersible versus standard oral olanzapine tablets in nonadherent patients with schizophrenia or bipolar disorder.

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Novick, Diego; Montgomery, William; Treuer, Tamas; Koyanagi, Ai; Aguado, Jaume; Kraemer, Susanne; Haro, Josep Maria

2017-01-01

Medication nonadherence is common in the treatment of patients with severe mental illness and is a frequent cause of relapse. Different formulations have been developed in an effort to improve medication adherence. The aim of this study was to explore whether there are differential clinical outcomes between two different formulations of olanzapine (orodispersible tablets [ODTs] vs standard oral tablets [SOT]) for the treatment of nonadherent patients with schizophrenia or bipolar disorder. Data for this analysis were from an observational study conducted in Europe (N=903). Adult schizophrenia and bipolar disorder patients in outpatient settings who initiated or changed to either olanzapine ODT or SOT according to physician decision within the last 45 days were eligible for enrollment. The follow-up period was 1 year. Of the 903 participants, 266 nonadherent patients (Medication Adherence Rating Scale score 0-4 at baseline) were included in the analysis. Clinical outcomes of interest were: 1) hospitalization and 2) relapse identified by the participating psychiatrist or hospitalization. An adjusted logistic regression model was fitted. Patients taking ODT had more severe illness at baseline ( P <0.001) as assessed with the Clinical Global Impression with mean (standard deviation [SD]) scores of ODT 4.63 (1.03) and SOT 4 (1.16). In the regression models adjusted for potential confounders, patients taking ODT had significantly lower odds for hospitalization (odds ratio =0.355; 95% confidence interval =0.13-0.974) and relapse or hospitalization (odds ratio =0.368; 95% confidence interval =0.183-0.739), respectively. Nonadherent patients with schizophrenia or bipolar disorder treated with the orodispersible formulation were less likely to be hospitalized or suffer relapse compared to those patients taking the standard oral coated tablets.

Quantitative Rapid Assessment of Leukoaraiosis in CT : Comparison to Gold Standard MRI.

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Hanning, Uta; Sporns, Peter Bernhard; Schmidt, Rene; Niederstadt, Thomas; Minnerup, Jens; Bier, Georg; Knecht, Stefan; Kemmling, André

2017-10-20

The severity of white matter lesions (WML) is a risk factor of hemorrhage and predictor of clinical outcome after ischemic stroke; however, in contrast to magnetic resonance imaging (MRI) reliable quantification for this surrogate marker is limited for computed tomography (CT), the leading stroke imaging technique. We aimed to present and evaluate a CT-based automated rater-independent method for quantification of microangiopathic white matter changes. Patients with suspected minor stroke (National Institutes of Health Stroke scale, NIHSS < 4) were screened for the analysis of non-contrast computerized tomography (NCCT) at admission and compared to follow-up MRI. The MRI-based WML volume and visual Fazekas scores were assessed as the gold standard reference. We employed a recently published probabilistic brain segmentation algorithm for CT images to determine the tissue-specific density of WM space. All voxel-wise densities were quantified in WM space and weighted according to partial probabilistic WM content. The resulting mean weighted density of WM space in NCCT, the surrogate of WML, was correlated with reference to MRI-based WML parameters. The process of CT-based tissue-specific segmentation was reliable in 79 cases with varying severity of microangiopathy. Voxel-wise weighted density within WM spaces showed a noticeable correlation (r = -0.65) with MRI-based WML volume. Particularly in patients with moderate or severe lesion load according to the visual Fazekas score the algorithm provided reliable prediction of MRI-based WML volume. Automated observer-independent quantification of voxel-wise WM density in CT significantly correlates with microangiopathic WM disease in gold standard MRI. This rapid surrogate of white matter lesion load in CT may support objective WML assessment and therapeutic decision-making during acute stroke triage.

Prospective evaluation of [11C]Choline PET/CT in therapy response assessment of standardized docetaxel first-line chemotherapy in patients with advanced castration refractory prostate cancer

International Nuclear Information System (INIS)

Schwarzenboeck, Sarah M.; Krause, Bernd J.; Eiber, Matthias; Schwaiger, Markus; Kundt, Guenther; Retz, Margitta; Treiber, Uwe; Nawroth, Roman; Gschwend, Juergen E.; Thalgott, Mark; Sakretz, Monique; Kurth, Jens; Rummeny, Ernst J.

2016-01-01

The aim of this study was to prospectively evaluate the value of [ 11 C] Choline PET/CT in monitoring early and late response to a standardized first-line docetaxel chemotherapy in castration refractory prostate cancer (mCRPC) patients. Thirty-two patients were referred for [ 11 C] Choline PET/CT before the start of docetaxel chemotherapy, after one and ten chemotherapy cycles (or - in case of discontinuation - after the last administered cycle) for therapy response assessment. [ 11 C] Choline uptake (SUV max , SUV mean ), CT derived Houndsfield units (HU max , HU mean ), and volume of bone, lung, and nodal metastases and local recurrence were measured semi-automatically at these timepoints. Change in SUV max , SUV mean , HU max , HU mean, and volume was assessed between PET 2 and 1 (early response assessment, ERA) and PET 3 and 1 (late response assessment, LRA) on a patient and lesion basis. Results of PET/CT were compared to clinically used RECIST 1.1 and clinical criteria based therapy response assessment including PSA for defining progressive disease (PD) and non-progressive disease (nPD), respectively. Relationships between changes of SUV max and SUV mean (early and late) and changes of PSA early and PSA late were evaluated. Prognostic value of initial SUV max and SUV mean was assessed. Statistical analyses were performed using SPSS. In the patient-based ERA and LRA there were no statistically significant differences in change of choline uptake, HU, and volume between PD and nPD applying RECIST or clinical response criteria. In the lesion-based ERA, decrease in choline uptake of bone metastases was even higher in PD (applying RECIST criteria), whereas in LRA the decrease was higher in nPD (applying clinical criteria). There were only significant correlations between change in choline uptake and PSA in ERA in PD, in LRA no significant correlations were discovered. Initial SUV max and SUV mean were statistically significantly higher in nPD (applying clinical

Towards a Standardized e-Assessment System: Motivations, Challenges and First Findings

Directory of Open Access Journals (Sweden)

Denis Helic

2009-10-01

Full Text Available “Global Learning” with shared learning contents, resources, activities and goals is one of the contributions of Globalization. With the capability to use new Information and Communication Technologies (ICT it is a bit easier to have a technology based learning systems that enable learners to share the learning resources and possibilities. As a result many Learning Management Systems (LMS were developed with divers of platforms and approaches. Consequently, sharing learning resources and components has become a major challenge. E-assessment as a primary activity of any LMS is facing the same challenges and problems. In order to stand on this challenge people in the field of technology enhanced learning have recommended that LMS should conform to specific standards. This paper discuses this challenge, the consequences and limitations of standards in the modern learning settings. Moreover, it shows a service oriented framework for assessment which aims to make the e-assessment systems flexible and also to initiate the term of “Global Learning Assessment” with the possibility of sharing the e-assessment system components.

Variation in assessment and standard setting practices across UK undergraduate medicine and the need for a benchmark.

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MacDougall, Margaret

2015-10-31

The principal aim of this study is to provide an account of variation in UK undergraduate medical assessment styles and corresponding standard setting approaches with a view to highlighting the importance of a UK national licensing exam in recognizing a common standard. Using a secure online survey system, response data were collected during the period 13 - 30 January 2014 from selected specialists in medical education assessment, who served as representatives for their respective medical schools. Assessment styles and corresponding choices of standard setting methods vary markedly across UK medical schools. While there is considerable consensus on the application of compensatory approaches, individual schools display their own nuances through use of hybrid assessment and standard setting styles, uptake of less popular standard setting techniques and divided views on norm referencing. The extent of variation in assessment and standard setting practices across UK medical schools validates the concern that there is a lack of evidence that UK medical students achieve a common standard on graduation. A national licensing exam is therefore a viable option for benchmarking the performance of all UK undergraduate medical students.

Clinical reasoning in nursing: teaching strategies and assessment tools

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Emília Campos de Carvalho

Full Text Available ABSTRACT Objective: To present the concept and development of teaching strategies and the assessment tools regarding clinical reasoning for accurate practice. Method: This is a theoretical reflection based on scientific studies. Results: Comprehension of the essential concepts of the thought process and its articulation with the different teaching strategies and the assessment tools which has allowed presenting ways to improve the process of diagnostic or therapeutic clinical reasoning. Conclusion: The use of new strategies and assessment tools should be encouraged in order to contribute to the development of skills that lead to safe and effective decision making.

77 FR 23250 - HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations

Science.gov (United States)

2012-04-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations AGENCY: Office of the National Coordinator for Health Information... 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy...

76 FR 25355 - HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations

Science.gov (United States)

2011-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations AGENCY: Office of the National Coordinator for Health Information... 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy...

78 FR 29134 - HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations

Science.gov (United States)

2013-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations AGENCY: Office of the National Coordinator for Health Information... 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy...

Standardization of Data for Clinical Use and Research in Spinal Cord Injury

DEFF Research Database (Denmark)

Biering-Sørensen, Fin; Noonan, Vanessa K

2016-01-01

for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements......Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able...

A counterfactual p-value approach for benefit-risk assessment in clinical trials.

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Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

2015-01-01

Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

Triangular model integrating clinical teaching and assessment

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Abdelaziz A

2014-03-01

Full Text Available Adel Abdelaziz,1,2 Emad Koshak3 1Medical Education Development Unit, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia; 2Medical Education Department, Faculty of Medicine, Suez Canal University, Egypt; 3Dean and Internal Medicine Department, Faculty of Medicine, Al Baha University, Al Baha, Saudi Arabia Abstract: Structuring clinical teaching is a challenge facing medical education curriculum designers. A variety of instructional methods on different domains of learning are indicated to accommodate different learning styles. Conventional methods of clinical teaching, like training in ambulatory care settings, are prone to the factor of coincidence in having varieties of patient presentations. Accordingly, alternative methods of instruction are indicated to compensate for the deficiencies of these conventional methods. This paper presents an initiative that can be used to design a checklist as a blueprint to guide appropriate selection and implementation of teaching/learning and assessment methods in each of the educational courses and modules based on educational objectives. Three categories of instructional methods were identified, and within each a variety of methods were included. These categories are classroom-type settings, health services-based settings, and community service-based settings. Such categories have framed our triangular model of clinical teaching and assessment. Keywords: curriculum development, teaching, learning, assessment, apprenticeship, community-based settings, health service-based settings

Linear associations between clinically assessed upper motor neuron disease and diffusion tensor imaging metrics in amyotrophic lateral sclerosis.

Science.gov (United States)

Woo, John H; Wang, Sumei; Melhem, Elias R; Gee, James C; Cucchiara, Andrew; McCluskey, Leo; Elman, Lauren

2014-01-01

To assess the relationship between clinically assessed Upper Motor Neuron (UMN) disease in Amyotrophic Lateral Sclerosis (ALS) and local diffusion alterations measured in the brain corticospinal tract (CST) by a tractography-driven template-space region-of-interest (ROI) analysis of Diffusion Tensor Imaging (DTI). This cross-sectional study included 34 patients with ALS, on whom DTI was performed. Clinical measures were separately obtained including the Penn UMN Score, a summary metric based upon standard clinical methods. After normalizing all DTI data to a population-specific template, tractography was performed to determine a region-of-interest (ROI) outlining the CST, in which average Mean Diffusivity (MD) and Fractional Anisotropy (FA) were estimated. Linear regression analyses were used to investigate associations of DTI metrics (MD, FA) with clinical measures (Penn UMN Score, ALSFRS-R, duration-of-disease), along with age, sex, handedness, and El Escorial category as covariates. For MD, the regression model was significant (p = 0.02), and the only significant predictors were the Penn UMN Score (p = 0.005) and age (p = 0.03). The FA regression model was also significant (p = 0.02); the only significant predictor was the Penn UMN Score (p = 0.003). Measured by the template-space ROI method, both MD and FA were linearly associated with the Penn UMN Score, supporting the hypothesis that DTI alterations reflect UMN pathology as assessed by the clinical examination.

Clinical assessment of transthoracic echocardiography skills: a generalizability study

DEFF Research Database (Denmark)

Nielsen, Dorte Guldbrand; O'Neill, Lotte; Jensen, Signe

2015-01-01

Context: Transthoracic echocardiography (TTE) is a widely used cardiac imaging technique that all cardiologists should be able to perform competently. Traditionally, TTE competence has been assessed by unstructured observation or in test situations separated from daily clinical practice. An objec......Context: Transthoracic echocardiography (TTE) is a widely used cardiac imaging technique that all cardiologists should be able to perform competently. Traditionally, TTE competence has been assessed by unstructured observation or in test situations separated from daily clinical practice....... An objective assessment instrument for TTE technical proficiency including a global rating score and a checklist score has previously been shown reliability and validity in a standardised setting. Objectives: As clinical test situations typically have several sources of error giving rise to variance in scores......, a more thorough examination of the generalizability of the test scores is needed. Methods Nine physicians performed a TTE scan on the same three patients. Then, two raters rated all 27 TTE scans using the TTE technical assessment in a fully crossed generalizability study. Estimated variance components...

Technical quality assessment of breast ultrasound according to American College of Radiology (ACR) Standards

International Nuclear Information System (INIS)

Ko, Kyung Hee; Kim, Eun Kyung; Kim, Young Ah; Son, Eun Ju; Oh, Ki Keun; Chung, Sun Yang

2003-01-01

To evaluate the technical quality of breast ultrasound based on American College of Radiology(ACR) standards. Between March 2002 and July 2002, ninety three breast sonograms obtained from 73 institutions were evaluated based on ACR standards for the hardware, technical settings, labeling of the images and identification. Of 93 breast sonograms, a satisfactory compliance with all ACR standards in the performance of breast US examinations was documented in 31% while the remaining 69% did not fully meet all ACR standards. 4.3% of breast US examinations were performed with a convex transducers, and the focal zone was inappropriately positioned in 14.2%. Gray-scale gain was subjectively characterized as inappropriate in 26.9%, and the size of lesion was not measured in 7.5%. Anatomic location of lesions was inappropriately described in 9.3%. The orientation of an US transducer was not properly labeled on any images in 33.3%. Inadequate recording of patient's information was noted in 43.3%. 50% of sonograms at University medical centers and larger general hospitals fully met all ACR standards while 36.8% at radiologic clinics and 12.1% at other private clinics met all ACR standards. Overall, 69% of breast sonograms failed to meet the quality criteria of the ACR standards. Therefore, it is essential to educate the basic technical details in performing breast US for the quality control.

Future Directions in Assessment: Influences of Standards and Implications for Language Learning

Science.gov (United States)

Cox, Troy L.; Malone, Margaret E.; Winke, Paula

2018-01-01

As "Foreign Language Annals" concludes its 50th anniversary, it is fitting to review the past and peer into the future of standards-based education and assessment. Standards are a common yardstick used by educators and researchers as a powerful framework for conceptualizing teaching and measuring learner success. The impact of standards…

Clinical trial or standard treatment? Shared decision making at the department of oncology

DEFF Research Database (Denmark)

Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

2016-01-01

Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

Psychosocial Assessment as a Standard of Care in Pediatric Cancer

NARCIS (Netherlands)

Kazak, Anne E.; Abrams, Annah N.; Banks, Jaime; Christofferson, Jennifer; DiDonato, Stephen; Grootenhuis, Martha A.; Kabour, Marianne; Madan-Swain, Avi; Patel, Sunita K.; Zadeh, Sima; Kupst, Mary Jo

2015-01-01

This paper presents the evidence for a standard of care for psychosocial assessment in pediatric cancer. An interdisciplinary group of investigators utilized EBSCO, PubMed, PsycINFO, Ovid, and Google Scholar search databases, focusing on five areas: youth/family psychosocial adjustment, family

Skills in clinical communication: Are we correctly assessing them at undergraduate level?

Directory of Open Access Journals (Sweden)

Alberto Zamora Cervantes

2014-07-01

Full Text Available Communicating with the patient in clinical practice refers to the way in which the doctor and the patient interact both verbally and nonverbally, in order to achieve a shared understanding of problems and solutions. Traditional learning and assessment systems are overwhelmed when it comes to addressing the complex and multi-dimensional problems of professional practice. Problem Based Learning (PBL has been put forward as an alternative to the mere reproduction of knowledge and pre-established patterns, enabling students to develop their own learning strategies to overcome problems in their future professional practice. The challenge is to determine how to assess the acquisition of clinical communication skills. The authors have recommended a summative assessment of clinical communication skills based on the combination of different methods. It highlights the importance of feedback-based formative assessment. This raises the need to develop and validate assessment scales in clinical communication at an undergraduate level. Based on this work, the authors put forward a "fanned out" assessment in terms of clinical communication skills in Medicine degrees, with the use of different instruments in a "spiraled" manner, where the greater the contact with clinical practice in the various degree and integral courses, the greater difficulty experienced, with the participation of all the stakeholders involved (self, hetero and peer assessment without precluding the involvement of patients (real or simulated in the design of assessment instruments.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

Science.gov (United States)

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Quality assurance of radiotherapy and its clinical assessment

International Nuclear Information System (INIS)

Inoue, Toshihiko

2002-01-01

We investigated the clinical quality assurance (QA) of radiotherapy in Japan since 1981. The aim of this study was to establish the QA of a radiotherapy system and its clinical assessment in Japan. We introduced the Patterns of Care Study (PCS) into Japan to perform this study in 1996. The PCS is a retrospective study designed to establish the national practice for cancer patients during a specific period and should be a complementary study to a prospective randomized controlled study. We collected precise data for 4399 patients with carcinomas of the breast, cervix, esophagus, lung and prostate by means of external audits for 96 institutes from 1998 through 2001. Patients were randomly sampled with two-stage cluster sampling. We stratified 556 institutes into four categories according to the academic condition and annual number of radiotherapy patients. National and regional averages of various factors of radiotherapy could be calculated and were used to measure QA of radiotherapy. Using a standard score, we could compare the process of individual institutions with national averages and feed back the evaluation score to each institution. With a PCS process survey, we could observe the dissemination of the treatment method under evidence-based medicine from the prospective randomized controlled study. We proposed future prediction of the number of radiotherapy patients and a counter plan for equipment and personnel. The first US-Japan PCS Workshop was held at San Francisco in 2001. We could establish QA of a radiotherapy system using PCS 1995-97 in Japan. (author)

Using standardized patients to assess the communication skills of graduating physicians for the comprehensive osteopathic medical licensing examination (COMLEX) level 2-performance evaluation (level 2-PE).

Science.gov (United States)

Weidner, Angela C; Gimpel, John R; Boulet, John R; Solomon, Mia

2010-01-01

Standardized patients can be trained to assess the communication and interpersonal skills of medical students and graduates. The purpose of this study is to present data to support the psychometric adequacy of the communication ratings provided by standardized patients. Using the data from testing of 3, 450 examinees over a 1-year period, a number of psychometric analyses were undertaken. These included a variance component analysis, the calculation of various validity coefficients, the comparison of communication ratings for select examinee cohorts and case characteristics, and the investigation of some potential sources of score invalidity. Communication skills scores are moderately correlated to other competencies (knowledge, skills) and may be influenced by candidate characteristics such as gender and English language proficiency. They are not dependant on the age of the examinees, the clinical case content, or the gender of the standardized patients. For a multistation assessment, a reasonably precise and valid estimate of a candidate's communication ability can be obtained from trained standardized patients.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

Science.gov (United States)

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

The Objective Structured Clinical Examination (OSCE) as a strategy for assessing clinical competence in midwifery education in Ireland: a critical review.

Science.gov (United States)

Smith, Valerie; Muldoon, Kathryn; Biesty, Linda

2012-09-01

In Ireland, to register as a midwife, all student midwives must be deemed competent to practice with the assessment of competence an essential component of midwifery education. A variety of assessment strategies, including observed practice, clinical interviews, portfolios of reflection, the Objective Structured Clinical Examination (OSCE) and written examination papers, are utilised to assess midwifery students' clinical competence. In this paper, a critical review of the OSCE as a strategy for assessing clinical competence in one third level institution in Ireland is offered. Although utilised for assessing competence across a range of areas (e.g. obstetric emergencies and pharmacology/drug administration), the use of the OSCE for assessing midwifery students' competence in lactation and infant feeding practices, as an example for this paper, is described. The advantages, disadvantages, validity and reliability of the OSCE, as an assessment strategy, are critically explored. Recognising that no single assessment strategy can provide all the information required to assess something as complex as clinical performance, the OSCE, when viewed alongside other forms of assessment, and with relevance to the topic under examination, may be considered a valuable strategy for enhancing the assessment of students' clinical competence, and for embracing diversity within midwifery education and training. Copyright © 2012 Elsevier Ltd. All rights reserved.

Curricular Innovation in the Surgery Clerkship: Can Assessment Methods Influence Development of Critical Thinking and Clinical Skills?

Science.gov (United States)

McClintic, James A; Snyder, Clifford L; Brown, Kimberly M

2018-03-12

Although key clinical skills have been defined in the Core Entrustable Professional Activities, there is a need to improve medical school curricula with standardized training opportunities and assessments of these skills. Thus, we aimed to develop an innovative curriculum that emphasized critical thinking and clinical skills. We hypothesized that we would be able to observe measurable improvement on assessments of students' critical thinking and clinical skills after the implementation of the new curriculum. Prospective, Quasi-Experimental study with the use of historical controls. This study took place through the third-year surgical clerkship at the University of Texas Medical Branch at the Galveston, Houston, and Austin, Texas, locations. A total of 214 students taking the third-year surgical clerkship for the first time during the periods of interest were included. Although the students with traditional curriculum improved 9.5% on a short answer exam from preclerkship to postclerkship completion, the students with new curriculum improved by 40%. Students under the new curriculum performed significantly better on the Objective Structured Clinical Exam; however, their shelf scores were lower. Under this new curriculum and grading system, we demonstrated that students can be incentivized to improve critical thinking and clinical skills, but this needs to be balanced with knowledge-based incentives. Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Endotyping early childhood asthma by quantitative symptom assessment

DEFF Research Database (Denmark)

Bisgaard, Hans; Pipper, Christian Bressen; Bønnelykke, Klaus

2011-01-01

Asthmatic symptoms in young children reflect a heterogeneous group of diseases. Symptoms remain the primary end-point in both research and clinical management, but there is a need for standardized symptom assessment.......Asthmatic symptoms in young children reflect a heterogeneous group of diseases. Symptoms remain the primary end-point in both research and clinical management, but there is a need for standardized symptom assessment....

Motivational Effects of Standardized Language Assessment on Chinese Young Learners

Science.gov (United States)

Zhao, Chuqiao

2016-01-01

This review paper examines how standardized language assessment affects Chinese young learners' motivation for second-language learning. By presenting the historical and contemporary contexts of the testing system in China, this paper seeks to demonstrate the interrelationship among cultural, social, familial, and individual factors, which…

Clinical evaluation of further-developed MRCP sequences in comparison with standard MRCP sequences

International Nuclear Information System (INIS)

Hundt, W.; Scheidler, J.; Reiser, M.; Petsch, R.

2002-01-01

The purpose of this study was the comparison of technically improved single-shot magnetic resonance cholangiopancreatography (MRCP) sequences with standard single-shot rapid acquisition with relaxation enhancement (RARE) and half-Fourier acquired single-shot turbo spin-echo (HASTE) sequences in evaluating the normal and abnormal biliary duct system. The bile duct system of 45 patients was prospectively investigated on a 1.5-T MRI system. The investigation was performed with RARE and HASTE MR cholangiography sequences with standard and high spatial resolutions, and with a delayed-echo half-Fourier RARE (HASTE) sequence. Findings of the improved MRCP sequences were compared with the standard MRCP sequences. The level of confidence in assessing the diagnosis was divided into five groups. The Wilcoxon signed-rank test at a level of p<0.05 was applied. In 15 patients no pathology was found. The MRCP showed stenoses of the bile duct system in 10 patients and choledocholithiasis and cholecystolithiasis in 16 patients. In 12 patients a dilatation of the bile duct system was found. Comparison of the low- and high spatial resolution sequences and the short and long TE times of the half-Fourier RARE (HASTE) sequence revealed no statistically significant differences regarding accuracy of the examination. The diagnostic confidence level in assessing normal or pathological findings for the high-resolution RARE and half-Fourier RARE (HASTE) was significantly better than for the standard sequences. For the delayed-echo half-Fourier RARE (HASTE) sequence no statistically significant difference was seen. The high-resolution RARE and half-Fourier RARE (HASTE) sequences had a higher confidence level, but there was no significant difference in diagnosis in terms of detection and assessment of pathological changes in the biliary duct system compared with standard sequences. (orig.)

Prospective evaluation of [{sup 11}C]Choline PET/CT in therapy response assessment of standardized docetaxel first-line chemotherapy in patients with advanced castration refractory prostate cancer

Energy Technology Data Exchange (ETDEWEB)

Schwarzenboeck, Sarah M.; Krause, Bernd J. [Technical University of Munich, Department of Nuclear Medicine, Klinikum rechts der Isar, Munich (Germany); Rostock University Medical Centre, Department of Nuclear Medicine, Rostock (Germany); Eiber, Matthias; Schwaiger, Markus [Technical University of Munich, Department of Nuclear Medicine, Klinikum rechts der Isar, Munich (Germany); Kundt, Guenther [Rostock University Medical Centre, Department of Biostatistics and Informatics, Rostock (Germany); Retz, Margitta; Treiber, Uwe; Nawroth, Roman; Gschwend, Juergen E.; Thalgott, Mark [Technical University of Munich, Department of Urology, Klinikum rechts der Isar, Munich (Germany); Sakretz, Monique; Kurth, Jens [Rostock University Medical Centre, Department of Nuclear Medicine, Rostock (Germany); Rummeny, Ernst J. [Technical University of Munich, Institute of Radiology, Klinikum rechts der Isar, Munich (Germany)

2016-11-15

The aim of this study was to prospectively evaluate the value of [{sup 11}C] Choline PET/CT in monitoring early and late response to a standardized first-line docetaxel chemotherapy in castration refractory prostate cancer (mCRPC) patients. Thirty-two patients were referred for [{sup 11}C] Choline PET/CT before the start of docetaxel chemotherapy, after one and ten chemotherapy cycles (or - in case of discontinuation - after the last administered cycle) for therapy response assessment. [{sup 11}C] Choline uptake (SUV{sub max}, SUV{sub mean}), CT derived Houndsfield units (HU{sub max}, HU{sub mean}), and volume of bone, lung, and nodal metastases and local recurrence were measured semi-automatically at these timepoints. Change in SUV{sub max}, SUV{sub mean}, HU{sub max}, HU{sub mean,} and volume was assessed between PET 2 and 1 (early response assessment, ERA) and PET 3 and 1 (late response assessment, LRA) on a patient and lesion basis. Results of PET/CT were compared to clinically used RECIST 1.1 and clinical criteria based therapy response assessment including PSA for defining progressive disease (PD) and non-progressive disease (nPD), respectively. Relationships between changes of SUV{sub max} and SUV{sub mean} (early and late) and changes of PSA{sub early} and PSA{sub late} were evaluated. Prognostic value of initial SUV{sub max} and SUV{sub mean} was assessed. Statistical analyses were performed using SPSS. In the patient-based ERA and LRA there were no statistically significant differences in change of choline uptake, HU, and volume between PD and nPD applying RECIST or clinical response criteria. In the lesion-based ERA, decrease in choline uptake of bone metastases was even higher in PD (applying RECIST criteria), whereas in LRA the decrease was higher in nPD (applying clinical criteria). There were only significant correlations between change in choline uptake and PSA in ERA in PD, in LRA no significant correlations were discovered. Initial SUV{sub max

Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies.

Science.gov (United States)

VanDevanter, Donald R; Mayer-Hamblett, Nicole

2017-11-01

Evolving cystic fibrosis 'standards of care' have influenced recent cystic fibrosis clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Three cystic fibrosis therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced cystic fibrosis transmembrane conductance regulator [CFTR] protein function) differ with respect to the duration for which recognized 'standards of care' have been available. However, developers of new therapies in all the three areas are affected by similar challenges: standards of care have become so strongly entrenched that traditional placebo-controlled studies in cystic fibrosis populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active-comparator trial designs, that have substantial challenges of their own. Foremost among these are the selection of 'valid' active comparator(s), estimation of a comparator's current clinical efficacy (required for testing noninferiority hypotheses), and effective blinding of commercially available comparators. Recent and future cystic fibrosis clinical trial designs will have to creatively address this collateral result of successful past development of effective cystic fibrosis therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.

A standardized model for predicting flap failure using indocyanine green dye

Science.gov (United States)

Zimmermann, Terence M.; Moore, Lindsay S.; Warram, Jason M.; Greene, Benjamin J.; Nakhmani, Arie; Korb, Melissa L.; Rosenthal, Eben L.

2016-03-01

Techniques that provide a non-invasive method for evaluation of intraoperative skin flap perfusion are currently available but underutilized. We hypothesize that intraoperative vascular imaging can be used to reliably assess skin flap perfusion and elucidate areas of future necrosis by means of a standardized critical perfusion threshold. Five animal groups (negative controls, n=4; positive controls, n=5; chemotherapy group, n=5; radiation group, n=5; chemoradiation group, n=5) underwent pre-flap treatments two weeks prior to undergoing random pattern dorsal fasciocutaneous flaps with a length to width ratio of 2:1 (3 x 1.5 cm). Flap perfusion was assessed via laser-assisted indocyanine green dye angiography and compared to standard clinical assessment for predictive accuracy of flap necrosis. For estimating flap-failure, clinical prediction achieved a sensitivity of 79.3% and a specificity of 90.5%. When average flap perfusion was more than three standard deviations below the average flap perfusion for the negative control group at the time of the flap procedure (144.3+/-17.05 absolute perfusion units), laser-assisted indocyanine green dye angiography achieved a sensitivity of 81.1% and a specificity of 97.3%. When absolute perfusion units were seven standard deviations below the average flap perfusion for the negative control group, specificity of necrosis prediction was 100%. Quantitative absolute perfusion units can improve specificity for intraoperative prediction of viable tissue. Using this strategy, a positive predictive threshold of flap failure can be standardized for clinical use.

Standards in neurosonology. Part I

Directory of Open Access Journals (Sweden)

Joanna Wojcza

2015-09-01

Full Text Available The paper presents standards related to ultrasound imaging of the cerebral vasculature and structures. The aim of this paper is to standardize both the performance and description of ultrasound imaging of the extracranial and intracranial cerebral arteries as well as a study of a specifi c brain structure, i.e. substantia nigra hyperechogenicity. The following aspects are included in the description of standards for each ultrasonographic method: equipment requirements, patient preparation, study technique and documentation as well as the required elements of ultrasound description. Practical criteria for the diagnosis of certain pathologies in accordance with the latest literature were also presented. Furthermore, additional comments were included in some of the sections. Part I discusses standards for the performance, documentation and description of different ultrasound methods (Duplex, Doppler. Part II and III are devoted to standards for specifi c clinical situations (vasospasm, monitoring after the acute stage of stroke, detection of a right-toleft shunts, confi rmation of the arrest of the cerebral circulation, an assessment of the functional effi ciency of circle of Willis, an assessment of the cerebrovascular vasomotor reserve as well as the measurement of substantia nigra hyperechogenicity.

Standards in neurosonology. Part III

Directory of Open Access Journals (Sweden)

Joanna Wojczal

2016-06-01

Full Text Available The paper presents standards related to ultrasound imaging of the cerebral vasculature and structures. The aim of this paper is to standardize both the performance and description of ultrasound imaging of the extracranial and intracranial cerebral arteries as well as a study of a specific brain structure, i.e. substantia nigra hyperechogenicity. The following aspects are included in the description of standards for each ultrasonographic method: equipment requirements, patient preparation, study technique and documentation as well as the required elements of ultrasound description. Practical criteria for the diagnosis of certain pathologies in accordance with the latest literature were also presented. Furthermore, additional comments were included in some of the sections. Part I discusses standards for the performance, documentation and description of different ultrasound methods (Duplex, Doppler. Part II and III are devoted to standards for specific clinical situations (vasospasm, monitoring after the acute stage of stroke, detection of a right-to-left shunts, confirmation of the arrest of the cerebral circulation, an assessment of the functional efficiency of circle of Willis, an assessment of the cerebrovascular vasomotor reserve as well as the measurement of substantia nigra hyperechogenicity.

Cross-cultural validity of standardized motor development screening and assessment tools: a systematic review.

Science.gov (United States)

Mendonça, Bianca; Sargent, Barbara; Fetters, Linda

2016-12-01

To investigate whether standardized motor development screening and assessment tools that are used to evaluate motor abilities of children aged 0 to 2 years are valid in cultures other than those in which the normative sample was established. This was a systematic review in which six databases were searched. Studies were selected based on inclusion/exclusion criteria and appraised for evidence level and quality. Study variables were extracted. Twenty-three studies representing six motor development screening and assessment tools in 16 cultural contexts met the inclusion criteria: Alberta Infant Motor Scale (n=7), Ages and Stages Questionnaire, 3rd edition (n=2), Bayley Scales of Infant and Toddler Development, 3rd edition (n=8), Denver Developmental Screening Test, 2nd edition (n=4), Harris Infant Neuromotor Test (n=1), and Peabody Developmental Motor Scales, 2nd edition (n=1). Thirteen studies found significant differences between the cultural context and normative sample. Two studies established reliability and/or validity of standardized motor development assessments in high-risk infants from different cultural contexts. Five studies established new population norms. Eight studies described the cross-cultural adaptation of a standardized motor development assessment. Standardized motor development assessments have limited validity in cultures other than that in which the normative sample was established. Their use can result in under- or over-referral for services. © 2016 Mac Keith Press.

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

DEFF Research Database (Denmark)

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

2014-01-01

%) 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...... 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...

Evaluation of Diagnostic Values of Clinical Assessment in Determining the Maturation of Arteriovenous Fistulas for Satisfactory Hemodialysis.

Science.gov (United States)

Salimi, Fereshteh; Shahabi, Shahab; Talebzadeh, Hamid; Keshavarzian, Amir; Pourfakharan, Mohammad; Safaei, Mansour

2017-01-01

Fistulas are the preferred permanent hemodialysis vascular access, but a significant obstacle to increasing their prevalence is the fistula's high "failure to mature" (FTM) rate. This study aimed to identify postoperative clinical characteristics that are predictive of fistula FTM. This descriptive cross-sectional study was performed on 80 end-stage renal disease patients who referred to Al Zahra Hospital, Isfahan, for brachiocephalic fistula placement. After 4 weeks, the clinical criteria (trill, firmness, vein length, and venous engorgement) examined and the fistulas situation divided to favorable or unfavorable by each criterion, and the results comprised with dialysis possibility. Data were analyzed with SPSS version 21. Diagnostic index for CLINICAL examination was calculated. Among the 80 cases, 25 (31.2%) female and 55 (68.8%) male were studied with the mean age of 51.9 (standard deviation = 17) year ranged between 18 and 86 years old. Sixty-two (77.5%) cases had successful hemodialysis. All four clinical assessments were significantly more acceptable in patients with successful dialysis ( P < 0.001). According to the results of our study, the accuracy of all physical assessments was above 70% and except vein length other criteria had a sensitivity and negative predictive value of 100%. In this study, firmness of vein has highest specificity and positive predictive value (83.9% and 64.3%, respectively). Results of our study showed that high sensitivity and relatively low specificity of the clinical criterion. It means that unfavorable results of each clinical criterion predict unfavorable dialysis. Clinical evaluation of a newly created fistula 4-6 weeks after surgery should be considered mandatory.

Computed-tomography-guided anatomic standardization for quantitative assessment of dopamine transporter SPECT

Energy Technology Data Exchange (ETDEWEB)

Yokoyama, Kota [National Center of Neurology and Psychiatry, Department of Radiology, Tokyo (Japan); National Center of Neurology and Psychiatry, Integrative Brain Imaging Center, Tokyo (Japan); Imabayashi, Etsuko; Matsuda, Hiroshi [National Center of Neurology and Psychiatry, Integrative Brain Imaging Center, Tokyo (Japan); Sumida, Kaoru; Sone, Daichi; Kimura, Yukio; Sato, Noriko [National Center of Neurology and Psychiatry, Department of Radiology, Tokyo (Japan); Mukai, Youhei; Murata, Miho [National Center of Neurology and Psychiatry, Department of Neurology, Tokyo (Japan)

2017-03-15

For the quantitative assessment of dopamine transporter (DAT) using [{sup 123}I]FP-CIT single-photon emission computed tomography (SPECT) (DaTscan), anatomic standardization is preferable for achieving objective and user-independent quantification of striatal binding using a volume-of-interest (VOI) template. However, low accumulation of DAT in Parkinson's disease (PD) would lead to a deformation error when using a DaTscan-specific template without any structural information. To avoid this deformation error, we applied computed tomography (CT) data obtained using SPECT/CT equipment to anatomic standardization. We retrospectively analyzed DaTscan images of 130 patients with parkinsonian syndromes (PS), including 80 PD and 50 non-PD patients. First we segmented gray matter from CT images using statistical parametric mapping 12 (SPM12). These gray-matter images were then anatomically standardized using the diffeomorphic anatomical registration using exponentiated Lie algebra (DARTEL) algorithm. Next, DaTscan images were warped with the same parameters used in the CT anatomic standardization. The target striatal VOIs for decreased DAT in PD were generated from the SPM12 group comparison of 20 DaTscan images from each group. We applied these VOIs to DaTscan images of the remaining patients in both groups and calculated the specific binding ratios (SBRs) using nonspecific counts in a reference area. In terms of the differential diagnosis of PD and non-PD groups using SBR, we compared the present method with two other methods, DaTQUANT and DaTView, which have already been released as software programs for the quantitative assessment of DaTscan images. The SPM12 group comparison showed a significant DAT decrease in PD patients in the bilateral whole striatum. Of the three methods assessed, the present CT-guided method showed the greatest power for discriminating PD and non-PD groups, as it completely separated the two groups. CT-guided anatomic standardization using

A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

Directory of Open Access Journals (Sweden)

Renata Mahfuz Daud-Gallotti

2011-01-01

Full Text Available INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59 ± 1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54 offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical

Implementing Trauma-Informed Partner Violence Assessment in Family Planning Clinics.

Science.gov (United States)

Decker, Michele R; Flessa, Sarah; Pillai, Ruchita V; Dick, Rebecca N; Quam, Jamie; Cheng, Diana; McDonald-Mosley, Raegan; Alexander, Kamila A; Holliday, Charvonne N; Miller, Elizabeth

2017-09-01

Intimate partner violence (IPV) and reproductive coercion (RC) are associated with poor reproductive health. Little is known about how family planning clinics implement brief IPV/RC assessment interventions in practice. We describe the uptake and impact of a brief, trauma-informed, universal IPV/RC assessment and education intervention. Intervention implementation was evaluated via a mixed methods study among women ages 18 and up receiving care at one of two family planning clinics in greater Baltimore, MD. This mixed methods study entailed a quasi-experimental, single group pretest-posttest study with family planning clinic patients (baseline and exit survey n = 132; 3-month retention n = 68; retention rate = 52%), coupled with qualitative interviews with providers and patients (total n = 35). Two thirds (65%) of women reported receiving at least one element of the intervention on their exit survey immediately following the clinic-visit. Patients reported that clinic-based IPV assessment is helpful, irrespective of IPV history. Relative to those who reported neither, participants who received either intervention element reported greater perceived caring from providers, confidence in provider response to abusive relationships, and knowledge of IPV-related resources at follow-up. Providers and patients alike described the educational card as a valuable tool. Participants described trade-offs of paper versus in-person, electronic medical record-facilitated screening, and patient reluctance to disclose current situations of abuse. In real-world family planning clinic settings, a brief assessment and support intervention was successful in communicating provider caring and increasing knowledge of violence-related resources, endpoints previously deemed valuable by IPV survivors. Results emphasize the merit of universal education in IPV/RC clinical interventions over seeking IPV disclosure.

Validation of the Rowland Universal Dementia Assessment Scale for multicultural screening in Danish memory clinics.

Science.gov (United States)

Nielsen, T Rune; Andersen, Birgitte Bo; Gottrup, Hanne; Lützhøft, Jan H; Høgh, Peter; Waldemar, Gunhild

2013-01-01

The Rowland Universal Dementia Assessment Scale (RUDAS) is a brief cognitive screening test that was developed to detect dementia in multicultural populations. The RUDAS has not previously been validated in multicultural populations outside of Australia. The aim of this study was to evaluate the diagnostic accuracy of the RUDAS in a multicultural sample of patients referred to Danish memory clinics. Data were collected from 137 consecutive patients (34 with an immigrant background) in three Danish memory clinics. All patients were given the RUDAS as a supplement to the standard diagnostic workup. Diagnostic accuracy for the RUDAS [area under the curve (AUC) = 0.838] was similar to that of the Mini-Mental State Examination (MMSE; AUC = 0.840). The cutoff score with the best balance of sensitivity, specificity and accuracy was multicultural patient populations. © 2013 S. Karger AG, Basel.

A conceptual analysis of standard setting in large-scale assessments

NARCIS (Netherlands)

van der Linden, Willem J.

1994-01-01

Elements of arbitrariness in the standard setting process are explored, and an alternative to the use of cut scores is presented. The first part of the paper analyzes the use of cut scores in large-scale assessments, discussing three different functions: (1) cut scores define the qualifications used

A primer on standards setting as it applies to surgical education and credentialing.

Science.gov (United States)

Cendan, Juan; Wier, Daryl; Behrns, Kevin

2013-07-01

Surgical technological advances in the past three decades have led to dramatic reductions in the morbidity associated with abdominal procedures and permanently altered the surgical practice landscape. Significant changes continue apace including surgical robotics, natural orifice-based surgery, and single-incision approaches. These disruptive technologies have on occasion been injurious to patients, and high-stakes assessment before adoption of new technologies would be reasonable. We reviewed the drivers for well-established psychometric techniques available for the standards-setting process. We present a series of examples that are relevant in the surgical domain including standards setting for knowledge and skills assessments. Defensible standards for knowledge and procedural skills will likely become part of surgical clinical practice. Understanding the methodology for determining standards should position the surgical community to assist in the process and lead within their clinical settings as standards are considered that may affect patient safety and physician credentialing.

The left ventricle in aortic stenosis--imaging assessment and clinical implications.

Science.gov (United States)

Călin, Andreea; Roşca, Monica; Beladan, Carmen Cristiana; Enache, Roxana; Mateescu, Anca Doina; Ginghină, Carmen; Popescu, Bogdan Alexandru

2015-04-29

Aortic stenosis has an increasing prevalence in the context of aging population. In these patients non-invasive imaging allows not only the grading of valve stenosis severity, but also the assessment of left ventricular function. These two goals play a key role in clinical decision-making. Although left ventricular ejection fraction is currently the only left ventricular function parameter that guides intervention, current imaging techniques are able to detect early changes in LV structure and function even in asymptomatic patients with significant aortic stenosis and preserved ejection fraction. Moreover, new imaging parameters emerged as predictors of disease progression in patients with aortic stenosis. Although proper standardization and confirmatory data from large prospective studies are needed, these novel parameters have the potential of becoming useful tools in guiding intervention in asymptomatic patients with aortic stenosis and stratify risk in symptomatic patients undergoing aortic valve replacement.This review focuses on the mechanisms of transition from compensatory left ventricular hypertrophy to left ventricular dysfunction and heart failure in aortic stenosis and the role of non-invasive imaging assessment of the left ventricular geometry and function in these patients.

A generic standard for assessing and managing activities with significant risk to health and safety

International Nuclear Information System (INIS)

Wilde, T.S.; Sandquist, G.M.

2005-01-01

Some operations and activities in industry, business, and government can present an unacceptable risk to health and safety if not performed according to established safety practices and documented procedures. The nuclear industry has extensive experience and commitment to assessing and controlling such risks. This paper provides a generic standard based upon DOE Standard DOE-STD-3007- 93, Nov 1993, Change Notice No. 1, Sep 1998. This generic standard can be used to assess practices and procedures employed by any industrial and government entity to ensure that an acceptable level of safety and control prevail for such operations. When any activity and operation is determined to involve significant risk to health and safety to workers or the public, the organization should adopt and establish an appropriate standard and methodology to ensure that adequate health and safety prevail. This paper uses DOE experience and standards to address activities with recognized potential for impact upon health and safety. Existing and future assessments of health and safety issues can be compared and evaluated against this generic standard for insuring that proper planning, analysis, review, and approval have been made. (authors)

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research.

Science.gov (United States)

Cofiel, Luciana; Zammar, Guilherme R; Zaveri, Amrapali J; Shah, Jatin Y; Carvalho, Elias; Nahm, Meredith; Kesselring, Gustavo; Pietrobon, Ricardo

2010-12-31

Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Future studies should explore ways of creating mechanisms which decrease the time and cost

A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research

Science.gov (United States)

2010-01-01

Background Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Methods Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. Results A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Conclusions Future studies should explore ways of creating

Cross-Cultural Aspect of Behavior Assessment System for Children-2, Parent Rating Scale-Child: Standardization in Korean Children

Science.gov (United States)

Song, Jungeun; Leventhal, Bennett L.; Koh, Yun-Joo; Cheon, Keun-Ah; Hong, Hyun Ju; Kim, Young-Key; Cho, Kyungjin; Lim, Eun-Chung; Park, Jee In

2017-01-01

Purpose Our study aimed to examine psychometric properties and cross-cultural utility of the Behavior Assessment System for Children-2, Parent Rating Scale-Child (BASC-2 PRS-C) in Korean children. Materials and Methods Two study populations were recruited: a general population sample (n=2115) of 1st to 6th graders from 16 elementary schools and a clinical population (n=219) of 6–12 years old from 5 child psychiatric clinics and an epidemiological sample of autism spectrum disorder. We assessed the validity and reliability of the Korean version of BASC-2 PRS-C (K-BASC-2 PRS-C) and compared subscales with those used for US populations. Results Our results indicate that the K-BASC-2 PRS-C is a valuable instrument with reliability and validity for measuring developmental psychopathology that is comparable to those in Western population. However, there were some differences noted in the mean scores of BASC-2 PRS-C between Korean and US populations. Conclusion K-BASC-2 PRS-C is an effective and useful instrument with psychometric properties that permits measurement of general developmental psychopathology. Observed Korean-US differences in patterns of parental reports of children's behaviors indicate the importance of the validation, standardization and cultural adaptation for tools assessing psychopathology especially when used in populations different from those for which the instrument was originally created. PMID:28120577

Cross-Cultural Aspect of Behavior Assessment System for Children-2, Parent Rating Scale-Child: Standardization in Korean Children.

Science.gov (United States)

Song, Jungeun; Leventhal, Bennett L; Koh, Yun Joo; Cheon, Keun Ah; Hong, Hyun Ju; Kim, Young Key; Cho, Kyungjin; Lim, Eun Chung; Park, Jee In; Kim, Young Shin

2017-03-01

Our study aimed to examine psychometric properties and cross-cultural utility of the Behavior Assessment System for Children-2, Parent Rating Scale-Child (BASC-2 PRS-C) in Korean children. Two study populations were recruited: a general population sample (n=2115) of 1st to 6th graders from 16 elementary schools and a clinical population (n=219) of 6-12 years old from 5 child psychiatric clinics and an epidemiological sample of autism spectrum disorder. We assessed the validity and reliability of the Korean version of BASC-2 PRS-C (K-BASC-2 PRS-C) and compared subscales with those used for US populations. Our results indicate that the K-BASC-2 PRS-C is a valuable instrument with reliability and validity for measuring developmental psychopathology that is comparable to those in Western population. However, there were some differences noted in the mean scores of BASC-2 PRS-C between Korean and US populations. K-BASC-2 PRS-C is an effective and useful instrument with psychometric properties that permits measurement of general developmental psychopathology. Observed Korean-US differences in patterns of parental reports of children's behaviors indicate the importance of the validation, standardization and cultural adaptation for tools assessing psychopathology especially when used in populations different from those for which the instrument was originally created.

Standardization of Data for Clinical Use and Research in Spinal Cord Injury

Science.gov (United States)

Biering-Sørensen, Fin; Noonan, Vanessa K.

2016-01-01

Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society’s International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities. PMID:27529284

Compiling standardized information from clinical practice: using content analysis and ICF Linking Rules in a goal-oriented youth rehabilitation program.

Science.gov (United States)

Lustenberger, Nadia A; Prodinger, Birgit; Dorjbal, Delgerjargal; Rubinelli, Sara; Schmitt, Klaus; Scheel-Sailer, Anke

2017-09-23

To illustrate how routinely written narrative admission and discharge reports of a rehabilitation program for eight youths with chronic neurological health conditions can be transformed to the International Classification of Functioning, Disability and Health. First, a qualitative content analysis was conducted by building meaningful units with text segments assigned of the reports to the five elements of the Rehab-Cycle ® : goal; assessment; assignment; intervention; evaluation. Second, the meaningful units were then linked to the ICF using the refined ICF Linking Rules. With the first step of transformation, the emphasis of the narrative reports changed to a process oriented interdisciplinary layout, revealing three thematic blocks of goals: mobility, self-care, mental, and social functions. The linked 95 unique ICF codes could be grouped in clinically meaningful goal-centered ICF codes. Between the two independent linkers, the agreement rate was improved after complementing the rules with additional agreements. The ICF Linking Rules can be used to compile standardized health information from narrative reports if prior structured. The process requires time and expertise. To implement the ICF into common practice, the findings provide the starting point for reporting rehabilitation that builds upon existing practice and adheres to international standards. Implications for Rehabilitation This study provides evidence that routinely collected health information from rehabilitation practice can be transformed to the International Classification of Functioning, Disability and Health by using the "ICF Linking Rules", however, this requires time and expertise. The Rehab-Cycle ® , including assessments, assignments, goal setting, interventions and goal evaluation, serves as feasible framework for structuring this rehabilitation program and ensures that the complexity of local practice is appropriately reflected. The refined "ICF Linking Rules" lead to a standardized

Formative assessment promotes learning in undergraduate clinical ...

African Journals Online (AJOL)

Introduction. Clinical clerkships, typically situated in environments lacking educational structure, form the backbone of undergraduate medical training. The imperative to develop strategies that enhance learning in this context is apparent. This study explored the impact of longitudinal bedside formative assessment on ...

Validation of a clinical assessment tool for spinal anaesthesia.

LENUS (Irish Health Repository)

Breen, D

2011-07-01

There is a need for a procedure-specific means of assessment of clinical performance in anaesthesia. The aim of this study was to devise a tool for assessing the performance of spinal anaesthesia, which has both content and construct validity.

Assessment of the Japanese Energy Efficiency Standards Program

Directory of Open Access Journals (Sweden)

Jun Arakawa

2015-03-01

Full Text Available Japanese energy efficiency standards program for appliances is a unique program which sets and revises mandatory standards based on the products of the highest energy efficiency on the markets. This study assessed the cost-effectiveness of the standard settings for air conditioner as a major residential appliance or typical example in the program. Based on analyses of empirical data, the net costs and effects from 1999 to 2040 were estimated. When applying a discount rate of 3%, the cost of abating CO2 emissions realized through the considered standards was estimated to be -13700 JPY/t-CO2. The sensitivity analysis, however, showed the cost turns into positive at a discount rate of 26% or higher. The authors also revealed that the standards’ “excellent” cost-effectiveness largely depends on that of the 1st standard setting, and the CO2 abatement cost through the 2nd standard was estimated to be as high as 26800 JPY/t-CO2. The results imply that the government is required to be careful about the possible economic burden imposed when considering introducing new, additional standards.

Non-Standard Assessment Practices in the Evaluation of Communication in Australian Aboriginal Children

Science.gov (United States)

Gould, Judith

2008-01-01

Australian Aboriginal children typically receive communication assessment services from Standard Australian English (SAE) speaking non-Aboriginal speech-language pathologists (SLPs). Educational assessments, including intelligence testing, are also primarily conducted by non-Aboriginal educational professionals. While the current paper will show…

Assessment of blinding success among dental implant clinical trials: A systematic review

Directory of Open Access Journals (Sweden)

Jafar Kolahi

2015-01-01

Full Text Available Introduction: It is widely believed that blinding is a cornerstone of randomized clinical trials and that significant bias may result from unsuccessful blinding. However, it is not enough to claim that a clinical trial is single- or double-blinded and that assessment of the success of blinding is ideal. The aim of this study was to evaluate the prevalence of assessment of blinding success among dental implant clinical trials and to introduce methods of blinding assessment to the implant research community. Methods: In November 2014, PubMed was searched by blinded and experienced researchers with the query "implant AND (blindFNx01 OR maskFNx01" using the following filters: (1 Article type: clinical trial; (2 Journal categories: dental journals; (3 Field: title/abstract. Consequently, title/abstract was reviewed in all relevant articles to find any attempt to assess the success of blinding in dental implant clinical trials. Results: The PubMed search results yielded 86 clinical trials. The point of interest is that when "blindFNx01 OR maskFNx01" was deleted from the query, the number of results increased to 1688 clinical trials. This shows that only 5% of dental implant clinical trials tried to use blinding. Disappointingly, we could not find any dental implant clinical trial reporting any attempt to assess the success of blinding. Conclusion: The current status of turning a blind eye to unblinding in dental implant clinical trials is not tolerable and needs to be improved. Researchers, protocol reviewers, local ethical committees, journal reviewers, and editors should make a concerted effort to incorporate, report, and publish such information to understand its potential impact on study results.

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

Science.gov (United States)

Rosenberg, Arlene S

2017-12-01

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

Implementation of the Kids-CAT in clinical settings: a newly developed computer-adaptive test to facilitate the assessment of patient-reported outcomes of children and adolescents in clinical practice in Germany.

Science.gov (United States)

Barthel, D; Fischer, K I; Nolte, S; Otto, C; Meyrose, A-K; Reisinger, S; Dabs, M; Thyen, U; Klein, M; Muehlan, H; Ankermann, T; Walter, O; Rose, M; Ravens-Sieberer, U

2016-03-01

To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report. The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians. The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients. The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL.

Standardized Handwriting to Assess Bradykinesia, Micrographia and Tremor in Parkinson's Disease

NARCIS (Netherlands)

Smits, Esther J.; Tolonen, Antti J.; Cluitmans, Luc; van Gils, Mark; Conway, Bernard A.; Zietsma, Rutger C.; Leenders, Klaus L.; Maurits, Natasha M.

2014-01-01

Objective: To assess whether standardized handwriting can provide quantitative measures to distinguish patients diagnosed with Parkinson's disease from age- and gender-matched healthy control participants. Design: Exploratory study. Pen tip trajectories were recorded during circle, spiral and line

A clinical assessment tool for ultrasound-guided axillary brachial plexus block.

LENUS (Irish Health Repository)

Sultan, S F

2012-05-01

Competency in anesthesia traditionally has been determined subjectively in practice. Optimal training in procedural skills requires valid and reliable forms of assessment. The objective was to examine a procedure-specific clinical assessment tool for ultrasound-guided axillary brachial plexus block for inter-rater reliability and construct validity in a clinical setting.

Computer assisted Objective structured clinical examination versus Objective structured clinical examination in assessment of Dermatology undergraduate students.

Science.gov (United States)

Chaudhary, Richa; Grover, Chander; Bhattacharya, S N; Sharma, Arun

2017-01-01

The assessment of dermatology undergraduates is being done through computer assisted objective structured clinical examination at our institution for the last 4 years. We attempted to compare objective structured clinical examination (OSCE) and computer assisted objective structured clinical examination (CA-OSCE) as assessment tools. To assess the relative effectiveness of CA-OSCE and OSCE as assessment tools for undergraduate dermatology trainees. Students underwent CA-OSCE as well as OSCE-based evaluation of equal weightage as an end of posting assessment. The attendance as well as the marks in both the examination formats were meticulously recorded and statistically analyzed using SPSS version 20.0. Intercooled Stata V9.0 was used to assess the reliability and internal consistency of the examinations conducted. Feedback from both students and examiners was also recorded. The mean attendance for the study group was 77% ± 12.0%. The average score on CA- OSCE and OSCE was 47.4% ± 19.8% and 53.5% ± 18%, respectively. These scores showed a mutually positive correlation, with Spearman's coefficient being 0.593. Spearman's rank correlation coefficient between attendance scores and assessment score was 0.485 for OSCE and 0.451 for CA-OSCE. The Cronbach's alpha coefficient for all the tests ranged from 0.76 to 0.87 indicating high reliability. The comparison was based on a single batch of 139 students. Such an evaluation on more students in larger number of batches over successive years could help throw more light on the subject. Computer assisted objective structured clinical examination was found to be a valid, reliable and effective format for dermatology assessment, being rated as the preferred format by examiners.

A Valid and Reliable Tool to Assess Nursing Students` Clinical Performance

OpenAIRE

Mehrnoosh Pazargadi; Tahereh Ashktorab; Sharareh Khosravi; Hamid Alavi majd

2013-01-01

Background: The necessity of a valid and reliable assessment tool is one of the most repeated issues in nursing students` clinical evaluation. But it is believed that present tools are not mostly valid and can not assess students` performance properly.Objectives: This study was conducted to design a valid and reliable assessment tool for evaluating nursing students` performance in clinical education.Methods: In this methodological study considering nursing students` performance definition; th...

Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation

NARCIS (Netherlands)